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RA: Obefazimod (ABX464) shows promise in phase 2
Key clinical point: Obefazimod (ABX464) at a dose of 50 mg showed promising efficacy and was safe and well-tolerated in patients with moderate-to-severely active rheumatoid arthritis (RA).
Major finding: A dose of 50 mg ABX464 vs. placebo was associated with numerically more severe adverse events (14.3% vs. 5%) but with no malignancies, opportunistic infections, or deaths, and a significant reduction in the Disease Activity Score 28-C reactive protein (−1.41 vs. −0.60; P = .043) and Clinical Disease Activity Index Score (−15.8 vs. −6.9; P = .020) at week 12.
Study details: This was a phase 2 trial including 60 patients with moderate-to-severely active RA and inadequate response to methotrexate or anti-tumor necrosis factor alpha therapy who were randomly assigned to ABX464 or placebo in combination with methotrexate for 12 weeks.
Disclosures: The study was supported by Abivax. C Daien reported receiving consulting fees, punctual links, or research grants from Abivax and other sources. Ten authors reported being current/former employees or investigators contracted by Abivax.
Source: Daien C et al. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFα therapy: A placebo-controlled phase II study. Ann Rheum Dis. 2022 (May 31). Doi: 10.1136/annrheumdis-2022-222228
Key clinical point: Obefazimod (ABX464) at a dose of 50 mg showed promising efficacy and was safe and well-tolerated in patients with moderate-to-severely active rheumatoid arthritis (RA).
Major finding: A dose of 50 mg ABX464 vs. placebo was associated with numerically more severe adverse events (14.3% vs. 5%) but with no malignancies, opportunistic infections, or deaths, and a significant reduction in the Disease Activity Score 28-C reactive protein (−1.41 vs. −0.60; P = .043) and Clinical Disease Activity Index Score (−15.8 vs. −6.9; P = .020) at week 12.
Study details: This was a phase 2 trial including 60 patients with moderate-to-severely active RA and inadequate response to methotrexate or anti-tumor necrosis factor alpha therapy who were randomly assigned to ABX464 or placebo in combination with methotrexate for 12 weeks.
Disclosures: The study was supported by Abivax. C Daien reported receiving consulting fees, punctual links, or research grants from Abivax and other sources. Ten authors reported being current/former employees or investigators contracted by Abivax.
Source: Daien C et al. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFα therapy: A placebo-controlled phase II study. Ann Rheum Dis. 2022 (May 31). Doi: 10.1136/annrheumdis-2022-222228
Key clinical point: Obefazimod (ABX464) at a dose of 50 mg showed promising efficacy and was safe and well-tolerated in patients with moderate-to-severely active rheumatoid arthritis (RA).
Major finding: A dose of 50 mg ABX464 vs. placebo was associated with numerically more severe adverse events (14.3% vs. 5%) but with no malignancies, opportunistic infections, or deaths, and a significant reduction in the Disease Activity Score 28-C reactive protein (−1.41 vs. −0.60; P = .043) and Clinical Disease Activity Index Score (−15.8 vs. −6.9; P = .020) at week 12.
Study details: This was a phase 2 trial including 60 patients with moderate-to-severely active RA and inadequate response to methotrexate or anti-tumor necrosis factor alpha therapy who were randomly assigned to ABX464 or placebo in combination with methotrexate for 12 weeks.
Disclosures: The study was supported by Abivax. C Daien reported receiving consulting fees, punctual links, or research grants from Abivax and other sources. Ten authors reported being current/former employees or investigators contracted by Abivax.
Source: Daien C et al. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFα therapy: A placebo-controlled phase II study. Ann Rheum Dis. 2022 (May 31). Doi: 10.1136/annrheumdis-2022-222228
Efficacy of tofacitinib independent of baseline BMI in moderate-to-severe RA
Key clinical point: A dose of 5 or 10 mg tofacitinib twice daily improved clinical efficacy outcomes compared with placebo in patients with moderate-to-severe rheumatoid arthritis (RA) regardless of baseline body mass index (BMI).
Major finding: The American College of Rheumatology 20/50/70 response rates at 6 months were significantly higher in patients who received 5 or 10 mg tofacitinib vs. placebo (P < .05) and were comparable across baseline BMI (<25, 25 to <30, and ≥30 kg/m2) categories.
Study details: This was a post hoc analysis of six phase 3 trials including 3880 patients with moderate-to-severe RA who were randomly assigned to receive tofacitinib (5 or 10 mg), placebo, or active controls (methotrexate or adalimumab).
Disclosures: The study was sponsored by Pfizer Inc. Several authors reported being on speaker’s bureaus or receiving grants, consulting fees, or other remuneration from various sources, including Pfizer. Five authors reported being employees or shareholders of Pfizer or companies contracting with Pfizer.
Source: Dikranian AH et al. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: An analysis of pooled data from phase 3 studies. RMD Open. 2022;8:e002103 (May 16). Doi: 10.1136/rmdopen-2021-002103
Key clinical point: A dose of 5 or 10 mg tofacitinib twice daily improved clinical efficacy outcomes compared with placebo in patients with moderate-to-severe rheumatoid arthritis (RA) regardless of baseline body mass index (BMI).
Major finding: The American College of Rheumatology 20/50/70 response rates at 6 months were significantly higher in patients who received 5 or 10 mg tofacitinib vs. placebo (P < .05) and were comparable across baseline BMI (<25, 25 to <30, and ≥30 kg/m2) categories.
Study details: This was a post hoc analysis of six phase 3 trials including 3880 patients with moderate-to-severe RA who were randomly assigned to receive tofacitinib (5 or 10 mg), placebo, or active controls (methotrexate or adalimumab).
Disclosures: The study was sponsored by Pfizer Inc. Several authors reported being on speaker’s bureaus or receiving grants, consulting fees, or other remuneration from various sources, including Pfizer. Five authors reported being employees or shareholders of Pfizer or companies contracting with Pfizer.
Source: Dikranian AH et al. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: An analysis of pooled data from phase 3 studies. RMD Open. 2022;8:e002103 (May 16). Doi: 10.1136/rmdopen-2021-002103
Key clinical point: A dose of 5 or 10 mg tofacitinib twice daily improved clinical efficacy outcomes compared with placebo in patients with moderate-to-severe rheumatoid arthritis (RA) regardless of baseline body mass index (BMI).
Major finding: The American College of Rheumatology 20/50/70 response rates at 6 months were significantly higher in patients who received 5 or 10 mg tofacitinib vs. placebo (P < .05) and were comparable across baseline BMI (<25, 25 to <30, and ≥30 kg/m2) categories.
Study details: This was a post hoc analysis of six phase 3 trials including 3880 patients with moderate-to-severe RA who were randomly assigned to receive tofacitinib (5 or 10 mg), placebo, or active controls (methotrexate or adalimumab).
Disclosures: The study was sponsored by Pfizer Inc. Several authors reported being on speaker’s bureaus or receiving grants, consulting fees, or other remuneration from various sources, including Pfizer. Five authors reported being employees or shareholders of Pfizer or companies contracting with Pfizer.
Source: Dikranian AH et al. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: An analysis of pooled data from phase 3 studies. RMD Open. 2022;8:e002103 (May 16). Doi: 10.1136/rmdopen-2021-002103
No more ‘escape hatch’: Post Roe, new worries about meds linked to birth defects
As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?
“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”
Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”
Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.
Only 20 states and the District of Columbia have firm abortion protections in place.
Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.
Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.
“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”
Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.
Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.
What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”
Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.
“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”
Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”
The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.
“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”
Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”
The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.
While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.
“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”
The physicians quoted in this article report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?
“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”
Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”
Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.
Only 20 states and the District of Columbia have firm abortion protections in place.
Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.
Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.
“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”
Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.
Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.
What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”
Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.
“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”
Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”
The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.
“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”
Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”
The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.
While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.
“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”
The physicians quoted in this article report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?
“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”
Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”
Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.
Only 20 states and the District of Columbia have firm abortion protections in place.
Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.
Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.
“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”
Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.
Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.
What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”
Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.
“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”
Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”
The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.
“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”
Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”
The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.
While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.
“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”
The physicians quoted in this article report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Race drives disparities in life expectancy across states
“Life expectancy is an important measure of the health of the entire population,” corresponding author Gregory Roth, MD, a cardiologist at the University of Washington, Seattle, said in an interview. “We know race, ethnicity and where you live all affect health, but we wanted to look at the long arc over many decades to understand where subpopulations have been, and where they are headed. Also, it is important to understand how race and place interact, so we looked at race/ethnicity groups within each state to see where disparities exist that need to be addressed.”
In the study, published in Annals of Internal Medicine, researchers led by Catherine O. Johnson, PhD, of the University of Washington, Seattle, reviewed data from 23 states, using regression models based on Census data and deidentified death records. They examined life expectancy for subgroups of individuals reporting Hispanic, non-Hispanic Black, or non-Hispanic White race or ethnicity.
Overall, most states showed an improvement in life expectancy between 1990 and 2019. For women, the mean life expectancy across states increased from 79.3 years in 1990 to 81.3 years in 2019. For men, the mean life expectancy across states increased from 72.6 years in 1990 to 76.3 years in 2019.
However, the researchers found significant disparities across the three racial subgroups between and within states when life expectancy was examined by race/ethnicity, independent of the average life expectancy for an entire state overall. They defined disparity as the difference in life expectancy between states for those in different racial/ethnic groups.
Without considering race/ethnicity, disparities in life expectancy across states decreased from 8.0 years and 12.2 years in 1990 to 7.9 and 7.8 years in 2019, for females and males, respectively.
When race/ethnicity was taken into account, disparities in life expectancy decreased, but the differences across states were greater than when race was not considered; 20.7 years for females and 24.5 years for males in 1990, decreasing to 18.5 years for females and 23.7 years for males in 2019.
Despite the overall improvements, disparities in life expectancy persisted across all states within each race/ethnicity group.
Among females, for example, non-Hispanic Black females had the lowest mean life expectancy across states in 1990 (74.2 years) but had the greatest improvement on average (6.9% increase) by 2019. However, the mean LE for non-Hispanic Black females remained lower than it did for non-Hispanic White and Hispanic females.
Among males, the researchers found differences in life expectancies across states between the people of the three different ethnicities they studied. The greatest difference in life expectancies in 1990 was 24.5 years. This occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Georgia. The life expectancy for these non-Hispanic Black males was 59.4 years, versus 83.8 years for these Hispanic males that year.
This reduced life expectancy for non-Hispanic Black males persisted, although it improved slightly by 2019. That year, the largest race-based disparity – which was approximately 24 years – occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Virginia. For the Hispanic males in Virgina, the LE was 90.7 years versus 66.9 years for non-Hispanic Black males in the District of Columbia.
The findings were limited by several factors including the review of data from only 23 states, the focus on life expectancy from birth versus other ages, and the challenges of defining Hispanic ethnicity, the researchers noted. However, the results support that the potential use of state-level analysis that includes race/ethnicity could be a valuable tool for measuring health inequity as part of national average trends, they said.
Health has truly stagnated for some in certain states
“Subpopulations in some states have much longer life expectancy now than 30 years ago. But in some states, we were struck by how health has truly stagnated for some,” Dr. Roth said in an interview. “We were surprised by the scale of the overall gap; a difference of about 8 years between states is more than twice that if you drill down to race/ethnicity groups in each state.”
A key message from the study is the need for all clinicians to advocate for improved access to primary care, “which is increasingly hard to obtain for many people,” said Dr. Roth. “So much of health is determined by key risk factors such as high blood pressure, high cholesterol, obesity, diabetes, alcohol use, tobacco use. But many of the determinants of health are not in the healthcare system, and include efforts to improve education, interrupt cycles of poverty, and teach healthy behaviors at a very young age. “Racism remains a underdiscussed part of these disparities, and we need better ways to measure the impact of social policies that end up impacting health down the road,” he said.
Looking ahead: “There is a lot to be learned from the states that have improved life expectancy the most. We need researchers to work together to identify and communicate what are those best practices, and what state governments can do to play their part.”
State-level differences reveal variations in health care
“The findings add to our growing knowledge of large and persistent racial/ethnic health disparities and changes in disparities during recent stagnation in U.S. life expectancy,” wrote Hedwig Lee, PhD, of Washington University in St. Louis, and Kathleen M. Harris, PhD, of the University of North Carolina at Chapel Hill, in an accompanying editorial.
The focus on state-level differences provides a unique window into the huge variation in life expectancy by race/ethnicity across the United States. The data suggest that “a person’s life expectancy in the United States may depend more on where you live than it has in the past,” they noted. For example, the editorialists highlighted that life expectancy for non-Hispanic Black men in 2019 averaged 81.1 years in Rhode Island, but 66.9 years in the District of Columbia.
They also noted the study’s lack of data for many states with high mortality rates and high proportions of non-Hispanic Black persons, Hispanic persons, and those with low socioeconomic states. Including data from these areas may have yielded even greater disparities in life expectancy.
“Despite substantial declines in mortality among Black persons during the study period, a non-Hispanic Black person’s life expectancy remained persistently lower than that of non-Hispanic White and Hispanic persons, both within and across states,” the editorialists wrote. “Future research needs to unpack the complex web of factors driving health and well-being by enabling better understanding of the places where we see persistent health disadvantage and advantage and the state-based explanations for these increasingly important differences determining population risk and resilience. We should be outraged by disparities in longevity and called to act to eliminate them.”
Identifying the problem is the first step
“In order to address or fix a problem we should first identify and quantify the problem,” Noel Deep, MD, an internal medicine physician in private practice in Antigo, Wisc., said in an interview.
“This study provides us with the information regarding the trends in life expectancy within states and the disparities in life expectancy when race/ ethnicity and gender are factored into the equation,” said Dr. Deep, who was not involved in the study. “Based on previously available data, we are aware of the increase in life expectancy in the United States over the last few decades, as well as differences in life expectancy for the different ethnicities/races and genders, but these data provide averages, not state or geographical differences. By having this knowledge at a state level, we can use that data to make health policies that address those health inequities and allocate appropriate resources at a state or local level.”
Several studies have identified disparities in health care and life expectancy based on the zip codes, such as the U.S. Small-Area Life Expectancy Estimates Project in 2018. The current study “provides further information for health care professionals and policy makers about the disparities in health outcomes and life expectancy based on race as well as gender, and it is quite detailed,” he said.
“As clinicians, we should strive to ensure that we are addressing these health inequities through our provision of clinical care and through our advocacy on behalf of our patients so that our nation’s health will improve overall,” he said.
“I would like to see future studies look at the socioeconomic status (income), urban versus rural residence, and place of birth (especially for immigrants),” said Dr. Deep. He also emphasized a need for studies to include the demographics for Hispanic populations; given the possible selection error “because of only healthy individuals immigrating to the United States or the older sicker Hispanics who might be migrating back to their homelands and not being included in the data and falsely increasing the life expectancy for this race/ ethnic groups.
“I would also like to see some research into the cultural and social factors that might explain why Hispanic populations might have a higher life expectancy even if their socioeconomic status is poor,” he said.
The study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News and as chair of the AMA’s Council on Science and Public Health.
“Life expectancy is an important measure of the health of the entire population,” corresponding author Gregory Roth, MD, a cardiologist at the University of Washington, Seattle, said in an interview. “We know race, ethnicity and where you live all affect health, but we wanted to look at the long arc over many decades to understand where subpopulations have been, and where they are headed. Also, it is important to understand how race and place interact, so we looked at race/ethnicity groups within each state to see where disparities exist that need to be addressed.”
In the study, published in Annals of Internal Medicine, researchers led by Catherine O. Johnson, PhD, of the University of Washington, Seattle, reviewed data from 23 states, using regression models based on Census data and deidentified death records. They examined life expectancy for subgroups of individuals reporting Hispanic, non-Hispanic Black, or non-Hispanic White race or ethnicity.
Overall, most states showed an improvement in life expectancy between 1990 and 2019. For women, the mean life expectancy across states increased from 79.3 years in 1990 to 81.3 years in 2019. For men, the mean life expectancy across states increased from 72.6 years in 1990 to 76.3 years in 2019.
However, the researchers found significant disparities across the three racial subgroups between and within states when life expectancy was examined by race/ethnicity, independent of the average life expectancy for an entire state overall. They defined disparity as the difference in life expectancy between states for those in different racial/ethnic groups.
Without considering race/ethnicity, disparities in life expectancy across states decreased from 8.0 years and 12.2 years in 1990 to 7.9 and 7.8 years in 2019, for females and males, respectively.
When race/ethnicity was taken into account, disparities in life expectancy decreased, but the differences across states were greater than when race was not considered; 20.7 years for females and 24.5 years for males in 1990, decreasing to 18.5 years for females and 23.7 years for males in 2019.
Despite the overall improvements, disparities in life expectancy persisted across all states within each race/ethnicity group.
Among females, for example, non-Hispanic Black females had the lowest mean life expectancy across states in 1990 (74.2 years) but had the greatest improvement on average (6.9% increase) by 2019. However, the mean LE for non-Hispanic Black females remained lower than it did for non-Hispanic White and Hispanic females.
Among males, the researchers found differences in life expectancies across states between the people of the three different ethnicities they studied. The greatest difference in life expectancies in 1990 was 24.5 years. This occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Georgia. The life expectancy for these non-Hispanic Black males was 59.4 years, versus 83.8 years for these Hispanic males that year.
This reduced life expectancy for non-Hispanic Black males persisted, although it improved slightly by 2019. That year, the largest race-based disparity – which was approximately 24 years – occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Virginia. For the Hispanic males in Virgina, the LE was 90.7 years versus 66.9 years for non-Hispanic Black males in the District of Columbia.
The findings were limited by several factors including the review of data from only 23 states, the focus on life expectancy from birth versus other ages, and the challenges of defining Hispanic ethnicity, the researchers noted. However, the results support that the potential use of state-level analysis that includes race/ethnicity could be a valuable tool for measuring health inequity as part of national average trends, they said.
Health has truly stagnated for some in certain states
“Subpopulations in some states have much longer life expectancy now than 30 years ago. But in some states, we were struck by how health has truly stagnated for some,” Dr. Roth said in an interview. “We were surprised by the scale of the overall gap; a difference of about 8 years between states is more than twice that if you drill down to race/ethnicity groups in each state.”
A key message from the study is the need for all clinicians to advocate for improved access to primary care, “which is increasingly hard to obtain for many people,” said Dr. Roth. “So much of health is determined by key risk factors such as high blood pressure, high cholesterol, obesity, diabetes, alcohol use, tobacco use. But many of the determinants of health are not in the healthcare system, and include efforts to improve education, interrupt cycles of poverty, and teach healthy behaviors at a very young age. “Racism remains a underdiscussed part of these disparities, and we need better ways to measure the impact of social policies that end up impacting health down the road,” he said.
Looking ahead: “There is a lot to be learned from the states that have improved life expectancy the most. We need researchers to work together to identify and communicate what are those best practices, and what state governments can do to play their part.”
State-level differences reveal variations in health care
“The findings add to our growing knowledge of large and persistent racial/ethnic health disparities and changes in disparities during recent stagnation in U.S. life expectancy,” wrote Hedwig Lee, PhD, of Washington University in St. Louis, and Kathleen M. Harris, PhD, of the University of North Carolina at Chapel Hill, in an accompanying editorial.
The focus on state-level differences provides a unique window into the huge variation in life expectancy by race/ethnicity across the United States. The data suggest that “a person’s life expectancy in the United States may depend more on where you live than it has in the past,” they noted. For example, the editorialists highlighted that life expectancy for non-Hispanic Black men in 2019 averaged 81.1 years in Rhode Island, but 66.9 years in the District of Columbia.
They also noted the study’s lack of data for many states with high mortality rates and high proportions of non-Hispanic Black persons, Hispanic persons, and those with low socioeconomic states. Including data from these areas may have yielded even greater disparities in life expectancy.
“Despite substantial declines in mortality among Black persons during the study period, a non-Hispanic Black person’s life expectancy remained persistently lower than that of non-Hispanic White and Hispanic persons, both within and across states,” the editorialists wrote. “Future research needs to unpack the complex web of factors driving health and well-being by enabling better understanding of the places where we see persistent health disadvantage and advantage and the state-based explanations for these increasingly important differences determining population risk and resilience. We should be outraged by disparities in longevity and called to act to eliminate them.”
Identifying the problem is the first step
“In order to address or fix a problem we should first identify and quantify the problem,” Noel Deep, MD, an internal medicine physician in private practice in Antigo, Wisc., said in an interview.
“This study provides us with the information regarding the trends in life expectancy within states and the disparities in life expectancy when race/ ethnicity and gender are factored into the equation,” said Dr. Deep, who was not involved in the study. “Based on previously available data, we are aware of the increase in life expectancy in the United States over the last few decades, as well as differences in life expectancy for the different ethnicities/races and genders, but these data provide averages, not state or geographical differences. By having this knowledge at a state level, we can use that data to make health policies that address those health inequities and allocate appropriate resources at a state or local level.”
Several studies have identified disparities in health care and life expectancy based on the zip codes, such as the U.S. Small-Area Life Expectancy Estimates Project in 2018. The current study “provides further information for health care professionals and policy makers about the disparities in health outcomes and life expectancy based on race as well as gender, and it is quite detailed,” he said.
“As clinicians, we should strive to ensure that we are addressing these health inequities through our provision of clinical care and through our advocacy on behalf of our patients so that our nation’s health will improve overall,” he said.
“I would like to see future studies look at the socioeconomic status (income), urban versus rural residence, and place of birth (especially for immigrants),” said Dr. Deep. He also emphasized a need for studies to include the demographics for Hispanic populations; given the possible selection error “because of only healthy individuals immigrating to the United States or the older sicker Hispanics who might be migrating back to their homelands and not being included in the data and falsely increasing the life expectancy for this race/ ethnic groups.
“I would also like to see some research into the cultural and social factors that might explain why Hispanic populations might have a higher life expectancy even if their socioeconomic status is poor,” he said.
The study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News and as chair of the AMA’s Council on Science and Public Health.
“Life expectancy is an important measure of the health of the entire population,” corresponding author Gregory Roth, MD, a cardiologist at the University of Washington, Seattle, said in an interview. “We know race, ethnicity and where you live all affect health, but we wanted to look at the long arc over many decades to understand where subpopulations have been, and where they are headed. Also, it is important to understand how race and place interact, so we looked at race/ethnicity groups within each state to see where disparities exist that need to be addressed.”
In the study, published in Annals of Internal Medicine, researchers led by Catherine O. Johnson, PhD, of the University of Washington, Seattle, reviewed data from 23 states, using regression models based on Census data and deidentified death records. They examined life expectancy for subgroups of individuals reporting Hispanic, non-Hispanic Black, or non-Hispanic White race or ethnicity.
Overall, most states showed an improvement in life expectancy between 1990 and 2019. For women, the mean life expectancy across states increased from 79.3 years in 1990 to 81.3 years in 2019. For men, the mean life expectancy across states increased from 72.6 years in 1990 to 76.3 years in 2019.
However, the researchers found significant disparities across the three racial subgroups between and within states when life expectancy was examined by race/ethnicity, independent of the average life expectancy for an entire state overall. They defined disparity as the difference in life expectancy between states for those in different racial/ethnic groups.
Without considering race/ethnicity, disparities in life expectancy across states decreased from 8.0 years and 12.2 years in 1990 to 7.9 and 7.8 years in 2019, for females and males, respectively.
When race/ethnicity was taken into account, disparities in life expectancy decreased, but the differences across states were greater than when race was not considered; 20.7 years for females and 24.5 years for males in 1990, decreasing to 18.5 years for females and 23.7 years for males in 2019.
Despite the overall improvements, disparities in life expectancy persisted across all states within each race/ethnicity group.
Among females, for example, non-Hispanic Black females had the lowest mean life expectancy across states in 1990 (74.2 years) but had the greatest improvement on average (6.9% increase) by 2019. However, the mean LE for non-Hispanic Black females remained lower than it did for non-Hispanic White and Hispanic females.
Among males, the researchers found differences in life expectancies across states between the people of the three different ethnicities they studied. The greatest difference in life expectancies in 1990 was 24.5 years. This occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Georgia. The life expectancy for these non-Hispanic Black males was 59.4 years, versus 83.8 years for these Hispanic males that year.
This reduced life expectancy for non-Hispanic Black males persisted, although it improved slightly by 2019. That year, the largest race-based disparity – which was approximately 24 years – occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Virginia. For the Hispanic males in Virgina, the LE was 90.7 years versus 66.9 years for non-Hispanic Black males in the District of Columbia.
The findings were limited by several factors including the review of data from only 23 states, the focus on life expectancy from birth versus other ages, and the challenges of defining Hispanic ethnicity, the researchers noted. However, the results support that the potential use of state-level analysis that includes race/ethnicity could be a valuable tool for measuring health inequity as part of national average trends, they said.
Health has truly stagnated for some in certain states
“Subpopulations in some states have much longer life expectancy now than 30 years ago. But in some states, we were struck by how health has truly stagnated for some,” Dr. Roth said in an interview. “We were surprised by the scale of the overall gap; a difference of about 8 years between states is more than twice that if you drill down to race/ethnicity groups in each state.”
A key message from the study is the need for all clinicians to advocate for improved access to primary care, “which is increasingly hard to obtain for many people,” said Dr. Roth. “So much of health is determined by key risk factors such as high blood pressure, high cholesterol, obesity, diabetes, alcohol use, tobacco use. But many of the determinants of health are not in the healthcare system, and include efforts to improve education, interrupt cycles of poverty, and teach healthy behaviors at a very young age. “Racism remains a underdiscussed part of these disparities, and we need better ways to measure the impact of social policies that end up impacting health down the road,” he said.
Looking ahead: “There is a lot to be learned from the states that have improved life expectancy the most. We need researchers to work together to identify and communicate what are those best practices, and what state governments can do to play their part.”
State-level differences reveal variations in health care
“The findings add to our growing knowledge of large and persistent racial/ethnic health disparities and changes in disparities during recent stagnation in U.S. life expectancy,” wrote Hedwig Lee, PhD, of Washington University in St. Louis, and Kathleen M. Harris, PhD, of the University of North Carolina at Chapel Hill, in an accompanying editorial.
The focus on state-level differences provides a unique window into the huge variation in life expectancy by race/ethnicity across the United States. The data suggest that “a person’s life expectancy in the United States may depend more on where you live than it has in the past,” they noted. For example, the editorialists highlighted that life expectancy for non-Hispanic Black men in 2019 averaged 81.1 years in Rhode Island, but 66.9 years in the District of Columbia.
They also noted the study’s lack of data for many states with high mortality rates and high proportions of non-Hispanic Black persons, Hispanic persons, and those with low socioeconomic states. Including data from these areas may have yielded even greater disparities in life expectancy.
“Despite substantial declines in mortality among Black persons during the study period, a non-Hispanic Black person’s life expectancy remained persistently lower than that of non-Hispanic White and Hispanic persons, both within and across states,” the editorialists wrote. “Future research needs to unpack the complex web of factors driving health and well-being by enabling better understanding of the places where we see persistent health disadvantage and advantage and the state-based explanations for these increasingly important differences determining population risk and resilience. We should be outraged by disparities in longevity and called to act to eliminate them.”
Identifying the problem is the first step
“In order to address or fix a problem we should first identify and quantify the problem,” Noel Deep, MD, an internal medicine physician in private practice in Antigo, Wisc., said in an interview.
“This study provides us with the information regarding the trends in life expectancy within states and the disparities in life expectancy when race/ ethnicity and gender are factored into the equation,” said Dr. Deep, who was not involved in the study. “Based on previously available data, we are aware of the increase in life expectancy in the United States over the last few decades, as well as differences in life expectancy for the different ethnicities/races and genders, but these data provide averages, not state or geographical differences. By having this knowledge at a state level, we can use that data to make health policies that address those health inequities and allocate appropriate resources at a state or local level.”
Several studies have identified disparities in health care and life expectancy based on the zip codes, such as the U.S. Small-Area Life Expectancy Estimates Project in 2018. The current study “provides further information for health care professionals and policy makers about the disparities in health outcomes and life expectancy based on race as well as gender, and it is quite detailed,” he said.
“As clinicians, we should strive to ensure that we are addressing these health inequities through our provision of clinical care and through our advocacy on behalf of our patients so that our nation’s health will improve overall,” he said.
“I would like to see future studies look at the socioeconomic status (income), urban versus rural residence, and place of birth (especially for immigrants),” said Dr. Deep. He also emphasized a need for studies to include the demographics for Hispanic populations; given the possible selection error “because of only healthy individuals immigrating to the United States or the older sicker Hispanics who might be migrating back to their homelands and not being included in the data and falsely increasing the life expectancy for this race/ ethnic groups.
“I would also like to see some research into the cultural and social factors that might explain why Hispanic populations might have a higher life expectancy even if their socioeconomic status is poor,” he said.
The study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News and as chair of the AMA’s Council on Science and Public Health.
FROM ANNALS OF INTERNAL MEDICINE
Upadacitinib recommended for nonradiographic axSpA in Europe
Upadacitinib may soon be used for the treatment of nonradiographic axial spondyloarthritis (nr-axSpA) after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave it its stamp of approval.
AbbVie, the drug’s manufacturer, announced on June 27 that the committee approved the use on June 23. The recommendation to approve market authorization for upadacitinib for nr-axSpA now goes to the European Commission, which is expected to make a decision by the third quarter of 2022.
“The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need,” said Neil Gallagher, MD, vice president of development and chief medical officer of AbbVie. He noted that currently, there are few options to treat symptoms such as inflammation, back pain, and stiffness for these patients.
Officially, the new indication for upadacitinib (Rinvoq) 15 mg once daily is for the treatment of active nr-axSpA in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or MRI, whose condition has responded inadequately to NSAIDs.
Upadacitinib is a selective Janus kinase (JAK) inhibitor that in human cellular assays preferentially inhibits signaling by JAK1 or JAK1/3.
In the European Union, upadacitinib is currently approved for use in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis. In addition to these indications, it is approved in the United States for ulcerative colitis but not for nr-axSpA.
The committee based its decision on the results of the nr-axSpA study within the SELECT-AXIS-2 trial, recently reported at the European Alliance of Associations for Rheumatology (EULAR) 2022 annual meeting.
The nr-axSpA study met the primary endpoint of a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) and the first 12 of 14 ranked secondary endpoints, according to AbbVie.
The most commonly reported adverse reactions with upadacitinib 15 mg were upper respiratory tract infections, elevated blood creatine phosphokinase levels, elevated alanine transaminase levels, bronchitis, nausea, cough, elevated aspartate transaminase levels, and hypercholesterolemia. These occurred in 2% or more of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in clinical trials.
The safety profile of upadacitinib with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications, AbbVie said.
A version of this article first appeared on Medscape.com.
Upadacitinib may soon be used for the treatment of nonradiographic axial spondyloarthritis (nr-axSpA) after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave it its stamp of approval.
AbbVie, the drug’s manufacturer, announced on June 27 that the committee approved the use on June 23. The recommendation to approve market authorization for upadacitinib for nr-axSpA now goes to the European Commission, which is expected to make a decision by the third quarter of 2022.
“The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need,” said Neil Gallagher, MD, vice president of development and chief medical officer of AbbVie. He noted that currently, there are few options to treat symptoms such as inflammation, back pain, and stiffness for these patients.
Officially, the new indication for upadacitinib (Rinvoq) 15 mg once daily is for the treatment of active nr-axSpA in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or MRI, whose condition has responded inadequately to NSAIDs.
Upadacitinib is a selective Janus kinase (JAK) inhibitor that in human cellular assays preferentially inhibits signaling by JAK1 or JAK1/3.
In the European Union, upadacitinib is currently approved for use in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis. In addition to these indications, it is approved in the United States for ulcerative colitis but not for nr-axSpA.
The committee based its decision on the results of the nr-axSpA study within the SELECT-AXIS-2 trial, recently reported at the European Alliance of Associations for Rheumatology (EULAR) 2022 annual meeting.
The nr-axSpA study met the primary endpoint of a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) and the first 12 of 14 ranked secondary endpoints, according to AbbVie.
The most commonly reported adverse reactions with upadacitinib 15 mg were upper respiratory tract infections, elevated blood creatine phosphokinase levels, elevated alanine transaminase levels, bronchitis, nausea, cough, elevated aspartate transaminase levels, and hypercholesterolemia. These occurred in 2% or more of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in clinical trials.
The safety profile of upadacitinib with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications, AbbVie said.
A version of this article first appeared on Medscape.com.
Upadacitinib may soon be used for the treatment of nonradiographic axial spondyloarthritis (nr-axSpA) after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave it its stamp of approval.
AbbVie, the drug’s manufacturer, announced on June 27 that the committee approved the use on June 23. The recommendation to approve market authorization for upadacitinib for nr-axSpA now goes to the European Commission, which is expected to make a decision by the third quarter of 2022.
“The CHMP’s recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need,” said Neil Gallagher, MD, vice president of development and chief medical officer of AbbVie. He noted that currently, there are few options to treat symptoms such as inflammation, back pain, and stiffness for these patients.
Officially, the new indication for upadacitinib (Rinvoq) 15 mg once daily is for the treatment of active nr-axSpA in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or MRI, whose condition has responded inadequately to NSAIDs.
Upadacitinib is a selective Janus kinase (JAK) inhibitor that in human cellular assays preferentially inhibits signaling by JAK1 or JAK1/3.
In the European Union, upadacitinib is currently approved for use in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis. In addition to these indications, it is approved in the United States for ulcerative colitis but not for nr-axSpA.
The committee based its decision on the results of the nr-axSpA study within the SELECT-AXIS-2 trial, recently reported at the European Alliance of Associations for Rheumatology (EULAR) 2022 annual meeting.
The nr-axSpA study met the primary endpoint of a 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) and the first 12 of 14 ranked secondary endpoints, according to AbbVie.
The most commonly reported adverse reactions with upadacitinib 15 mg were upper respiratory tract infections, elevated blood creatine phosphokinase levels, elevated alanine transaminase levels, bronchitis, nausea, cough, elevated aspartate transaminase levels, and hypercholesterolemia. These occurred in 2% or more of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in clinical trials.
The safety profile of upadacitinib with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications, AbbVie said.
A version of this article first appeared on Medscape.com.
Hydroxychloroquine risk found in some older patients with RA
Hydroxychloroquine should be initiated with caution in older patients with rheumatoid arthritis who also have heart failure or are at risk for it, say the authors of a study suggesting that the drug could increase their risk for major adverse cardiovascular events (MACE), compared with methotrexate.
A cohort study published online in the Journal of the American College of Cardiology looked at outcomes in 54,462 patients with RA aged 65 years or older and not previously treated with disease-modifying antirheumatic drugs. Half were initiated on methotrexate and half on hydroxychloroquine, making 27,231 propensity-matched pairs.
Across the entire cohort, hydroxychloroquine was not associated with a higher risk for sudden cardiac arrest, ventricular arrhythmia, or MACE, compared with methotrexate. When broken down into individual cardiovascular events, the data suggested a statistically significant 17% increase in the risk for cardiovascular mortality and 10% increase in all-cause mortality with hydroxychloroquine, although there were no differences in the risks for myocardial infarction or stroke.
However, a subgroup analysis revealed a significant 30% increase in the risk for MACE among patients starting hydroxychloroquine who also had a history of heart failure, compared with patients taking methotrexate. The researchers found no difference between the two drugs in patients without a history of heart failure. The study also suggested an overall 41% increase in the risk for hospitalization with heart failure with hydroxychloroquine, regardless of heart failure history.
Hydroxychloroquine was also associated with a 34% increase in the risk for cardiovascular mortality, a 22% increase in the risk for all-cause mortality, and a 74% increase in the risk for MI.
The lead author of the study, Elvira D’Andrea, MD, PhD, of Brigham and Women’s Hospital and Harvard Medical School in Boston, said that hydroxychloroquine is used as a first-line treatment for RA, but there was limited evidence on its cardiovascular risks. The pandemic in particular shined a spotlight on these concerns and prompted the researchers to extend their original prepandemic study to encompass additional cardiovascular outcomes.
“The emerging concerns on its cardiovascular safety in early 2020 has led the rheumatological community, and patients regularly taking hydroxychloroquine for rheumatoid arthritis, to confusion,” Dr. D’Andrea said in an interview.
She advised that clinicians be cautious when initiating hydroxychloroquine in older patients with existing heart failure or who have risk factors for it. “Although heart failure is a known concern for hydroxychloroquine use, these findings helped to clarify the relationship between the use of hydroxychloroquine or methotrexate and heart failure. Clinicians should pay careful attention to clinical manifestations of cardiomyopathy or heart failure in older patients with rheumatoid arthritis treated with hydroxychloroquine.”
Hydroxychloroquine is associated with cardiotoxicity, particularly cardiomyopathy, which may help precipitate MACE or heart failure exacerbations in patients who already have deterioration of their cardiac tissue, the authors suggested.
Short follow-up period leaves risk attribution under question
In an accompanying editorial, Elizabeth Blair Solow, MD, and Bonnie L. Bermas, MD, of the University of Texas Southwestern Medical Center, Dallas, commented that the lack of an increased risk for arrhythmic events or MACE in the overall cohort taking hydroxychloroquine was reassuring. They also suggested the subgroup analysis findings among patients with preexisting heart failure were still “exploratory and hypothesis-generating” and should be interpreted with caution.
They noted that the follow-up time of the study was relatively short – a median of 209 days – given that hydroxychloroquine does not reach a steady-state level for 6 months.
“Evidence to date suggests cardiomyopathy from HCQ [hydroxychloroquine] takes years to develop, many months beyond the exposures described here, bringing into question as to whether HCQ itself increased HF hospitalizations,” the editorialists wrote.
The editorial also raised the question of whether the association observed in the study was related to a possible cardioprotective effect of methotrexate, given that previous studies have suggested this effect in older patients with RA.
The study authors did an exploratory analysis comparing hydroxychloroquine with sulfasalazine, which appeared to support their main findings of a possible cardiovascular effect of hydroxychloroquine. However, they qualified this by pointing out that the analysis involved small numbers of patients.
Senior investigator Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, also noted that the study only looked at outcomes in patients aged 65 years and older.
“It would be clinically important to further examine the cardiovascular safety of hydroxychloroquine versus methotrexate in a younger population with rheumatic conditions,” she said.
The study was supported by the National Institutes of Health, Brigham and Women’s Hospital, and Harvard Medical School. Four authors declared unrelated research grants from the pharmaceutical sector, with one also declaring stock options and consulting work with the pharmaceutical sector. No other conflicts of interest were declared.
A version of this article first appeared on Medscape.com.
Hydroxychloroquine should be initiated with caution in older patients with rheumatoid arthritis who also have heart failure or are at risk for it, say the authors of a study suggesting that the drug could increase their risk for major adverse cardiovascular events (MACE), compared with methotrexate.
A cohort study published online in the Journal of the American College of Cardiology looked at outcomes in 54,462 patients with RA aged 65 years or older and not previously treated with disease-modifying antirheumatic drugs. Half were initiated on methotrexate and half on hydroxychloroquine, making 27,231 propensity-matched pairs.
Across the entire cohort, hydroxychloroquine was not associated with a higher risk for sudden cardiac arrest, ventricular arrhythmia, or MACE, compared with methotrexate. When broken down into individual cardiovascular events, the data suggested a statistically significant 17% increase in the risk for cardiovascular mortality and 10% increase in all-cause mortality with hydroxychloroquine, although there were no differences in the risks for myocardial infarction or stroke.
However, a subgroup analysis revealed a significant 30% increase in the risk for MACE among patients starting hydroxychloroquine who also had a history of heart failure, compared with patients taking methotrexate. The researchers found no difference between the two drugs in patients without a history of heart failure. The study also suggested an overall 41% increase in the risk for hospitalization with heart failure with hydroxychloroquine, regardless of heart failure history.
Hydroxychloroquine was also associated with a 34% increase in the risk for cardiovascular mortality, a 22% increase in the risk for all-cause mortality, and a 74% increase in the risk for MI.
The lead author of the study, Elvira D’Andrea, MD, PhD, of Brigham and Women’s Hospital and Harvard Medical School in Boston, said that hydroxychloroquine is used as a first-line treatment for RA, but there was limited evidence on its cardiovascular risks. The pandemic in particular shined a spotlight on these concerns and prompted the researchers to extend their original prepandemic study to encompass additional cardiovascular outcomes.
“The emerging concerns on its cardiovascular safety in early 2020 has led the rheumatological community, and patients regularly taking hydroxychloroquine for rheumatoid arthritis, to confusion,” Dr. D’Andrea said in an interview.
She advised that clinicians be cautious when initiating hydroxychloroquine in older patients with existing heart failure or who have risk factors for it. “Although heart failure is a known concern for hydroxychloroquine use, these findings helped to clarify the relationship between the use of hydroxychloroquine or methotrexate and heart failure. Clinicians should pay careful attention to clinical manifestations of cardiomyopathy or heart failure in older patients with rheumatoid arthritis treated with hydroxychloroquine.”
Hydroxychloroquine is associated with cardiotoxicity, particularly cardiomyopathy, which may help precipitate MACE or heart failure exacerbations in patients who already have deterioration of their cardiac tissue, the authors suggested.
Short follow-up period leaves risk attribution under question
In an accompanying editorial, Elizabeth Blair Solow, MD, and Bonnie L. Bermas, MD, of the University of Texas Southwestern Medical Center, Dallas, commented that the lack of an increased risk for arrhythmic events or MACE in the overall cohort taking hydroxychloroquine was reassuring. They also suggested the subgroup analysis findings among patients with preexisting heart failure were still “exploratory and hypothesis-generating” and should be interpreted with caution.
They noted that the follow-up time of the study was relatively short – a median of 209 days – given that hydroxychloroquine does not reach a steady-state level for 6 months.
“Evidence to date suggests cardiomyopathy from HCQ [hydroxychloroquine] takes years to develop, many months beyond the exposures described here, bringing into question as to whether HCQ itself increased HF hospitalizations,” the editorialists wrote.
The editorial also raised the question of whether the association observed in the study was related to a possible cardioprotective effect of methotrexate, given that previous studies have suggested this effect in older patients with RA.
The study authors did an exploratory analysis comparing hydroxychloroquine with sulfasalazine, which appeared to support their main findings of a possible cardiovascular effect of hydroxychloroquine. However, they qualified this by pointing out that the analysis involved small numbers of patients.
Senior investigator Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, also noted that the study only looked at outcomes in patients aged 65 years and older.
“It would be clinically important to further examine the cardiovascular safety of hydroxychloroquine versus methotrexate in a younger population with rheumatic conditions,” she said.
The study was supported by the National Institutes of Health, Brigham and Women’s Hospital, and Harvard Medical School. Four authors declared unrelated research grants from the pharmaceutical sector, with one also declaring stock options and consulting work with the pharmaceutical sector. No other conflicts of interest were declared.
A version of this article first appeared on Medscape.com.
Hydroxychloroquine should be initiated with caution in older patients with rheumatoid arthritis who also have heart failure or are at risk for it, say the authors of a study suggesting that the drug could increase their risk for major adverse cardiovascular events (MACE), compared with methotrexate.
A cohort study published online in the Journal of the American College of Cardiology looked at outcomes in 54,462 patients with RA aged 65 years or older and not previously treated with disease-modifying antirheumatic drugs. Half were initiated on methotrexate and half on hydroxychloroquine, making 27,231 propensity-matched pairs.
Across the entire cohort, hydroxychloroquine was not associated with a higher risk for sudden cardiac arrest, ventricular arrhythmia, or MACE, compared with methotrexate. When broken down into individual cardiovascular events, the data suggested a statistically significant 17% increase in the risk for cardiovascular mortality and 10% increase in all-cause mortality with hydroxychloroquine, although there were no differences in the risks for myocardial infarction or stroke.
However, a subgroup analysis revealed a significant 30% increase in the risk for MACE among patients starting hydroxychloroquine who also had a history of heart failure, compared with patients taking methotrexate. The researchers found no difference between the two drugs in patients without a history of heart failure. The study also suggested an overall 41% increase in the risk for hospitalization with heart failure with hydroxychloroquine, regardless of heart failure history.
Hydroxychloroquine was also associated with a 34% increase in the risk for cardiovascular mortality, a 22% increase in the risk for all-cause mortality, and a 74% increase in the risk for MI.
The lead author of the study, Elvira D’Andrea, MD, PhD, of Brigham and Women’s Hospital and Harvard Medical School in Boston, said that hydroxychloroquine is used as a first-line treatment for RA, but there was limited evidence on its cardiovascular risks. The pandemic in particular shined a spotlight on these concerns and prompted the researchers to extend their original prepandemic study to encompass additional cardiovascular outcomes.
“The emerging concerns on its cardiovascular safety in early 2020 has led the rheumatological community, and patients regularly taking hydroxychloroquine for rheumatoid arthritis, to confusion,” Dr. D’Andrea said in an interview.
She advised that clinicians be cautious when initiating hydroxychloroquine in older patients with existing heart failure or who have risk factors for it. “Although heart failure is a known concern for hydroxychloroquine use, these findings helped to clarify the relationship between the use of hydroxychloroquine or methotrexate and heart failure. Clinicians should pay careful attention to clinical manifestations of cardiomyopathy or heart failure in older patients with rheumatoid arthritis treated with hydroxychloroquine.”
Hydroxychloroquine is associated with cardiotoxicity, particularly cardiomyopathy, which may help precipitate MACE or heart failure exacerbations in patients who already have deterioration of their cardiac tissue, the authors suggested.
Short follow-up period leaves risk attribution under question
In an accompanying editorial, Elizabeth Blair Solow, MD, and Bonnie L. Bermas, MD, of the University of Texas Southwestern Medical Center, Dallas, commented that the lack of an increased risk for arrhythmic events or MACE in the overall cohort taking hydroxychloroquine was reassuring. They also suggested the subgroup analysis findings among patients with preexisting heart failure were still “exploratory and hypothesis-generating” and should be interpreted with caution.
They noted that the follow-up time of the study was relatively short – a median of 209 days – given that hydroxychloroquine does not reach a steady-state level for 6 months.
“Evidence to date suggests cardiomyopathy from HCQ [hydroxychloroquine] takes years to develop, many months beyond the exposures described here, bringing into question as to whether HCQ itself increased HF hospitalizations,” the editorialists wrote.
The editorial also raised the question of whether the association observed in the study was related to a possible cardioprotective effect of methotrexate, given that previous studies have suggested this effect in older patients with RA.
The study authors did an exploratory analysis comparing hydroxychloroquine with sulfasalazine, which appeared to support their main findings of a possible cardiovascular effect of hydroxychloroquine. However, they qualified this by pointing out that the analysis involved small numbers of patients.
Senior investigator Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, also noted that the study only looked at outcomes in patients aged 65 years and older.
“It would be clinically important to further examine the cardiovascular safety of hydroxychloroquine versus methotrexate in a younger population with rheumatic conditions,” she said.
The study was supported by the National Institutes of Health, Brigham and Women’s Hospital, and Harvard Medical School. Four authors declared unrelated research grants from the pharmaceutical sector, with one also declaring stock options and consulting work with the pharmaceutical sector. No other conflicts of interest were declared.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Treat-to-target strategy with tapering proves effective in PsA and axSpA
Aiming for a disease activity target while reducing biologic therapy could be a winning approach for patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), according to the results of a new study presented at the annual European Congress of Rheumatology.
The findings show that a treat-to-target (T2T) strategy with tapering using a tumor necrosis factor (TNF) inhibitor produces results that are noninferior to a T2T strategy that doesn’t include tapering in these patients.
“Our study has for the first time shown that a treat-to-target tapering strategy is just as good as full-dose continuation, while reducing medication use substantially,” first author Celia Michielsens, MD, a PhD student and researcher at Sint Maartenskliniek in Nijmegen, the Netherlands, said in an interview before her presentation of the study during an oral abstract session at the congress. “Stepwise tapering is also better than fixed-dose reduction or discontinuation, since it is much more individualized.”
The study is now published in Annals of the Rheumatic Diseases.
In the randomized, controlled, open-label, noninferiority study, researchers enrolled patients with PsA or axSpA who were using a TNF inhibitor such as etanercept, adalimumab, or infliximab, and had stable low disease activity for at least 6 months. Patients needed to have a Psoriatic Arthritis Disease Activity Score (PASDAS) of 3.2 or less, or an Ankylosing Spondylitis Disease Activity Score (ASDAS) of at 2.1 or less. In cases of flare, patients were treated with NSAIDs and/or glucorticoids, and if they still had not reached low disease activity after a month, their previous TNF inhibitor dose was reinstated to the last effective interval or dosage, which was maintained throughout the study period. When the patient was already using a full TNF-inhibitor dose or if dose adjustment did not suffice, patients were switched to another biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD).
Participants were randomized, from January 2019 to June 2021, to a tapering or a nontapering T2T strategy in a 2:1 fashion. Then researchers then followed them for 12 months and aimed to determine if the tapering strategy proved noninferior to not tapering within a predefined 20% margin for noninferiority, which Dr. Michielsens said was derived from other studies and what her group determined to be “an acceptable risk.”
Results show strategy is ‘feasible in daily clinical care’
A total of 81 patients – 42 with PsA and 39 with axSpA – were in the group with tapering, and 41 were in the group without tapering: 22 with PsA and 19 with axSpA.
At 12 months, researchers found that 69% of the patients in the group with tapering had low disease activity, measured via the PASDAS and ASDAS, compared with 73% in patients who did not taper. And those in the tapering group saw their medication use dramatically reduced. At the 12-month mark, they were taking just 53% of the defined daily dose for maintenance, compared with 91% of the defined daily dose for the group that didn’t taper.
The researchers were able to successfully taper 72% of the patients in the tapering group, with 28% of them discontinuing their TNF-inhibitor medication entirely. The incidence of flares was 85% in the tapering group and 78% in the nontapering group, a nonsignificant difference (P = .32).
The start of a new medication or an increase in use of an existing medication was more frequent in the tapering group, and significantly so for NSAIDs. An increase in NSAID use was seen in 54% of the tapering group and in just 24% of the nontapering group (P = .002).
Conventional synthetic DMARD use went up in the tapering group, compared with the nontapering group, but this was only among the PsA patients and the change in use was not statistically significant. There were also more frequent increases in glucocorticoid use in the tapering group, compared with the nontapering group, but this was not significant.
Dr. Michielsens said the findings show the value of an individualized approach in treating patients with PsA or axSpA.
“Our study – and those [studies] in rheumatoid arthritis earlier – deliver the highest quality of evidence that disease activity–guided dose personalization can, and in fact should, be used in clinical practice,” she said. “Our pragmatic treat-to-target tapering strategy is feasible in daily clinical care, although treat-to-target using PASDAS and ASDAS needs some implementation. In shared decision-making with patients, a 50% reduction in TNFi use is obtainable, while maintaining low disease activity.”
The increase in the use of NSAIDs is something to be aware of, but it is “not concerning,” Dr. Michielsens added. She pointed out that the NSAID use was typically temporary, used when flares arose, and that the drugs are effective, safe, and inexpensive. She also noted that the use of TNF blockers decreased more than the use of NSAIDs increased.
“This seems a perfectly acceptable trade-off that can be discussed with your patient,” she said.
The 12-month duration of the study is likely long enough to show that the tapering strategy works, Dr. Michielsens said. In rheumatoid arthritis studies, for example, differences in strategies didn’t change after 1 year.
“That said, we are doing an observational extension study to provide more insights in the long-term effects of this treat-to-target strategy,” she said. “At the end of this summer, all patients will have completed their extended follow-up period – a 12-month observational period – so hopefully we can present the results next year at EULAR.”
This study received funding from ReumaNederland. Dr. Michielsens did not have any financial interests to disclose. Two coauthors reported financial relationships with numerous pharmaceutical companies.
Aiming for a disease activity target while reducing biologic therapy could be a winning approach for patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), according to the results of a new study presented at the annual European Congress of Rheumatology.
The findings show that a treat-to-target (T2T) strategy with tapering using a tumor necrosis factor (TNF) inhibitor produces results that are noninferior to a T2T strategy that doesn’t include tapering in these patients.
“Our study has for the first time shown that a treat-to-target tapering strategy is just as good as full-dose continuation, while reducing medication use substantially,” first author Celia Michielsens, MD, a PhD student and researcher at Sint Maartenskliniek in Nijmegen, the Netherlands, said in an interview before her presentation of the study during an oral abstract session at the congress. “Stepwise tapering is also better than fixed-dose reduction or discontinuation, since it is much more individualized.”
The study is now published in Annals of the Rheumatic Diseases.
In the randomized, controlled, open-label, noninferiority study, researchers enrolled patients with PsA or axSpA who were using a TNF inhibitor such as etanercept, adalimumab, or infliximab, and had stable low disease activity for at least 6 months. Patients needed to have a Psoriatic Arthritis Disease Activity Score (PASDAS) of 3.2 or less, or an Ankylosing Spondylitis Disease Activity Score (ASDAS) of at 2.1 or less. In cases of flare, patients were treated with NSAIDs and/or glucorticoids, and if they still had not reached low disease activity after a month, their previous TNF inhibitor dose was reinstated to the last effective interval or dosage, which was maintained throughout the study period. When the patient was already using a full TNF-inhibitor dose or if dose adjustment did not suffice, patients were switched to another biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD).
Participants were randomized, from January 2019 to June 2021, to a tapering or a nontapering T2T strategy in a 2:1 fashion. Then researchers then followed them for 12 months and aimed to determine if the tapering strategy proved noninferior to not tapering within a predefined 20% margin for noninferiority, which Dr. Michielsens said was derived from other studies and what her group determined to be “an acceptable risk.”
Results show strategy is ‘feasible in daily clinical care’
A total of 81 patients – 42 with PsA and 39 with axSpA – were in the group with tapering, and 41 were in the group without tapering: 22 with PsA and 19 with axSpA.
At 12 months, researchers found that 69% of the patients in the group with tapering had low disease activity, measured via the PASDAS and ASDAS, compared with 73% in patients who did not taper. And those in the tapering group saw their medication use dramatically reduced. At the 12-month mark, they were taking just 53% of the defined daily dose for maintenance, compared with 91% of the defined daily dose for the group that didn’t taper.
The researchers were able to successfully taper 72% of the patients in the tapering group, with 28% of them discontinuing their TNF-inhibitor medication entirely. The incidence of flares was 85% in the tapering group and 78% in the nontapering group, a nonsignificant difference (P = .32).
The start of a new medication or an increase in use of an existing medication was more frequent in the tapering group, and significantly so for NSAIDs. An increase in NSAID use was seen in 54% of the tapering group and in just 24% of the nontapering group (P = .002).
Conventional synthetic DMARD use went up in the tapering group, compared with the nontapering group, but this was only among the PsA patients and the change in use was not statistically significant. There were also more frequent increases in glucocorticoid use in the tapering group, compared with the nontapering group, but this was not significant.
Dr. Michielsens said the findings show the value of an individualized approach in treating patients with PsA or axSpA.
“Our study – and those [studies] in rheumatoid arthritis earlier – deliver the highest quality of evidence that disease activity–guided dose personalization can, and in fact should, be used in clinical practice,” she said. “Our pragmatic treat-to-target tapering strategy is feasible in daily clinical care, although treat-to-target using PASDAS and ASDAS needs some implementation. In shared decision-making with patients, a 50% reduction in TNFi use is obtainable, while maintaining low disease activity.”
The increase in the use of NSAIDs is something to be aware of, but it is “not concerning,” Dr. Michielsens added. She pointed out that the NSAID use was typically temporary, used when flares arose, and that the drugs are effective, safe, and inexpensive. She also noted that the use of TNF blockers decreased more than the use of NSAIDs increased.
“This seems a perfectly acceptable trade-off that can be discussed with your patient,” she said.
The 12-month duration of the study is likely long enough to show that the tapering strategy works, Dr. Michielsens said. In rheumatoid arthritis studies, for example, differences in strategies didn’t change after 1 year.
“That said, we are doing an observational extension study to provide more insights in the long-term effects of this treat-to-target strategy,” she said. “At the end of this summer, all patients will have completed their extended follow-up period – a 12-month observational period – so hopefully we can present the results next year at EULAR.”
This study received funding from ReumaNederland. Dr. Michielsens did not have any financial interests to disclose. Two coauthors reported financial relationships with numerous pharmaceutical companies.
Aiming for a disease activity target while reducing biologic therapy could be a winning approach for patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), according to the results of a new study presented at the annual European Congress of Rheumatology.
The findings show that a treat-to-target (T2T) strategy with tapering using a tumor necrosis factor (TNF) inhibitor produces results that are noninferior to a T2T strategy that doesn’t include tapering in these patients.
“Our study has for the first time shown that a treat-to-target tapering strategy is just as good as full-dose continuation, while reducing medication use substantially,” first author Celia Michielsens, MD, a PhD student and researcher at Sint Maartenskliniek in Nijmegen, the Netherlands, said in an interview before her presentation of the study during an oral abstract session at the congress. “Stepwise tapering is also better than fixed-dose reduction or discontinuation, since it is much more individualized.”
The study is now published in Annals of the Rheumatic Diseases.
In the randomized, controlled, open-label, noninferiority study, researchers enrolled patients with PsA or axSpA who were using a TNF inhibitor such as etanercept, adalimumab, or infliximab, and had stable low disease activity for at least 6 months. Patients needed to have a Psoriatic Arthritis Disease Activity Score (PASDAS) of 3.2 or less, or an Ankylosing Spondylitis Disease Activity Score (ASDAS) of at 2.1 or less. In cases of flare, patients were treated with NSAIDs and/or glucorticoids, and if they still had not reached low disease activity after a month, their previous TNF inhibitor dose was reinstated to the last effective interval or dosage, which was maintained throughout the study period. When the patient was already using a full TNF-inhibitor dose or if dose adjustment did not suffice, patients were switched to another biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD).
Participants were randomized, from January 2019 to June 2021, to a tapering or a nontapering T2T strategy in a 2:1 fashion. Then researchers then followed them for 12 months and aimed to determine if the tapering strategy proved noninferior to not tapering within a predefined 20% margin for noninferiority, which Dr. Michielsens said was derived from other studies and what her group determined to be “an acceptable risk.”
Results show strategy is ‘feasible in daily clinical care’
A total of 81 patients – 42 with PsA and 39 with axSpA – were in the group with tapering, and 41 were in the group without tapering: 22 with PsA and 19 with axSpA.
At 12 months, researchers found that 69% of the patients in the group with tapering had low disease activity, measured via the PASDAS and ASDAS, compared with 73% in patients who did not taper. And those in the tapering group saw their medication use dramatically reduced. At the 12-month mark, they were taking just 53% of the defined daily dose for maintenance, compared with 91% of the defined daily dose for the group that didn’t taper.
The researchers were able to successfully taper 72% of the patients in the tapering group, with 28% of them discontinuing their TNF-inhibitor medication entirely. The incidence of flares was 85% in the tapering group and 78% in the nontapering group, a nonsignificant difference (P = .32).
The start of a new medication or an increase in use of an existing medication was more frequent in the tapering group, and significantly so for NSAIDs. An increase in NSAID use was seen in 54% of the tapering group and in just 24% of the nontapering group (P = .002).
Conventional synthetic DMARD use went up in the tapering group, compared with the nontapering group, but this was only among the PsA patients and the change in use was not statistically significant. There were also more frequent increases in glucocorticoid use in the tapering group, compared with the nontapering group, but this was not significant.
Dr. Michielsens said the findings show the value of an individualized approach in treating patients with PsA or axSpA.
“Our study – and those [studies] in rheumatoid arthritis earlier – deliver the highest quality of evidence that disease activity–guided dose personalization can, and in fact should, be used in clinical practice,” she said. “Our pragmatic treat-to-target tapering strategy is feasible in daily clinical care, although treat-to-target using PASDAS and ASDAS needs some implementation. In shared decision-making with patients, a 50% reduction in TNFi use is obtainable, while maintaining low disease activity.”
The increase in the use of NSAIDs is something to be aware of, but it is “not concerning,” Dr. Michielsens added. She pointed out that the NSAID use was typically temporary, used when flares arose, and that the drugs are effective, safe, and inexpensive. She also noted that the use of TNF blockers decreased more than the use of NSAIDs increased.
“This seems a perfectly acceptable trade-off that can be discussed with your patient,” she said.
The 12-month duration of the study is likely long enough to show that the tapering strategy works, Dr. Michielsens said. In rheumatoid arthritis studies, for example, differences in strategies didn’t change after 1 year.
“That said, we are doing an observational extension study to provide more insights in the long-term effects of this treat-to-target strategy,” she said. “At the end of this summer, all patients will have completed their extended follow-up period – a 12-month observational period – so hopefully we can present the results next year at EULAR.”
This study received funding from ReumaNederland. Dr. Michielsens did not have any financial interests to disclose. Two coauthors reported financial relationships with numerous pharmaceutical companies.
FROM THE EULAR 2022 CONGRESS
‘Can I survive without payments from insurers?’
It took Michael Golden, MD, 5 years to decide to switch to a concierge practice, in which patients pay a monthly or annual fee for more personalized care. Dr. Golden, an internist in Beverly, Mass., changed course in 2021, during the COVID-19 pandemic.
“I’m not sure why I hesitated for so long,” said Dr. Golden.
But taking the plunge is a big step that they sometimes put off for years.
“The main factors for waiting are fear, uncertainty, and doubt,” said Leigh “Jack” Forbush, DO, a family physician who runs a DPC practice in Hampden, Maine, and mentors doctors contemplating the switch.
According to Dr. Forbush, the critical questions doctors ask themselves are, “Will I be able to find enough paying patients?” and – in the case of DPC practices, which cancel insurance – “Can I live without the money I get from insurers?”
Terry Bauer, CEO of Specialdocs Consultants in Highland Park, Ill., which helps doctors move to a concierge practice, said many of his clients put off the decision for as long as 15 years.
“Clients became progressively worn out – or even burnt out – by the demands of fee-for-service medicine,” said Dr. Bauer. “For women, the tipping point can be when their kids ask, ‘Mom, do you like your job better than me?’ For men, it may be more about feeling tired and unsatisfied with their work.”
But once these doctors make the switch, it’s with all their heart. “A client recently told me that if he couldn’t open a concierge practice, he might have to quit medicine,” Dr. Bauer said. “And he’s only 51.”
Few doctors regret switching
A 2020 survey of DPC physicians for the Society of Actuaries found that 99% reported having better or much better overall personal and professional satisfaction.
Retainer-based physicians report feeling much more relaxed after they start a concierge practice. On many workdays, Dr. Golden takes a walk on a trail in the woods behind his office. “That’s something I couldn’t do before,” he said. “And I go to my kids’ soccer games. I’m able to be present in their lives now.”
Since retainer-based doctors have markedly fewer patients, they can form personal relationships with each one. When Dr. Golden switched, he “went from having a couple of thousand patients to a few hundred,” he said.
“I know each patient now,” said Dorothy Cohen Serna, MD, an internist in Cypress, Tex., who moved to concierge in 2017. “I don’t need to look at their chart to know who they are.”
Dr. Serna said patients’ close relationship with her helped them get through the worst months of the pandemic. “They were scared, depressed, and concerned, and they needed a lot of individual attention,” she said.
Because they see fewer patients, concierge doctors can lengthen appointment times to about 30 minutes – or longer, if necessary. They no longer have a problem answering patients’ “doorknob questions” – wholly new concerns brought up at the end of the visit.
“The appointment might be for a sprained ankle, and then the patient might mention they haven’t been sleeping well,” Dr. Golden said. “I have time to talk about that without worrying that my schedule is getting backed up.”
Why patients sign up
Retainer-based practices are still an exotic concept in many areas, but patients are beginning to understand the value, said Shalini Kaneriya, MD, an internist in Herndon, Va,, who switched her practice to concierge in 2018.
Several hundred patients followed her into her new practice because “people realized their care would be better if they had a concierge doctor,” she said. Two years ago, partly because of growing demand, she recruited another physician as an associate.
“People want a relationship with their doctor,” Dr. Serna added. “It’s hard to provide that in a regular practice.”
Todd Granger, MD, an internist who opened a DPC practice in Chapel Hill, N.C., in 2016, said new patients often mention feeling rushed through appointments with their previous doctors. Also, “it’s hard to get to see a doctor around here.”
Scott Bernstein, MD, an internist who runs a DPC practice in Scottsdale, Ariz., said he can arrange to have patients see specialists much faster than if they try to make appointments on their own. “I personally call specialists and then prep my patients on how to deal with the appointment,” he said.
Retainer-based practices tend to have a greater number of older and chronically ill patients, but they also attract patients who need less care. “The healthier patients find value in our proactive approach to prevention and wellness,” Dr. Serna said.
Some concierge physicians charge higher fees to patients who need more care, but many decide this is too complicated and charge everyone the same fee. Dr. Granger said he initially had a variable fee schedule, but when some lower-paying patients began to need more visits, he had to consider charging them extra. “Now I basically have just one fee,” he said.
Not a good fit for many physicians
Dr. Bauer said a lot of physicians are interested in retainer-based practice, but many of them might not make the income they had hoped for. Specialdocs interviews physicians who inquire about the model and ultimately doesn’t contract with 80% of them, Dr. Bauer said.
To be able to sign up and retain enough patients, the doctor’s attitude is important. “You have to be driven by the desire to go deep with patients -- to work hard with them and deal with their issues,” said Erika Bliss, MD, who runs a DPC practice in Seattle.
Dr. Bernstein said retainer-based physicians have to be interested in lifestyle issues, such as diet, exercise, and sleep. “I spend a lot of time dealing with issues like how to incorporate physical activity into daily routines,” he said. “Some doctors wouldn’t enjoy doing that.”
Also, concierge physicians have to be available all the time. “Patients have my cell phone number,” Dr. Granger said. “They could call in the middle of the night, but they usually don’t.”
To ensure that they get some time off, many concierge physicians have partners. Dr. Bernstein and another DPC doctor maintain separate practices but cover for each other. Each takes every other weekend off plus 6 weeks every year.
Can you attract enough patients?
A key challenge is finding enough patients to sustain a concierge practice. Planning the switch involves setting a target number of patients needed for the doctor to make a decent income after paying practice expenses. For example, a doctor charging $300 a month to 250 patients would gross $900,000 per year, and then pay practice expenses from that.
Attracting the target number of patients can take months or even years. After almost 6 years, Dr. Granger said, he has around 240 patients ― well below his target number of 440.
Partly because the practice model is not well known in North Carolina, Dr. Granger set his fee very low, at $60 a month, then raised it to $75. That means his practice has been grossing just $216,000 a year. But he is not about to give up. He plans to raise his fee in July and hopes that word of mouth will add more patients.
If physicians cannot earn enough in their concierge practice, Dr. Bauer said, they may moonlight at a local hospital or work for a telemedicine company. He hasn’t heard of physicians closing their concierge practice and returning to their previous practice model. “They didn’t like what they were doing before,” he said.
Opening up to lower-income patients
Dr. Granger’s $75 monthly fee is an example of how retainer-based medicine has transformed itself from a gold-plated service for rich people to a service that middle-class and even lower-income people can afford. DPC practices like Dr. Granger’s have dramatically lowered expenses by cutting out the need to bill insurance companies. Some DPC practices further reduce expenses by not having any staff and by renting out office space.
Dr. Forbush’s Pine Tree State patients are mostly blue-collar workers – electricians, plumbers, people who work in small businesses. He charges them $150 a month, which most patients who don’t have health insurance can afford. He said three-quarters of his patients lack health insurance, although some have back-up finances, such as health savings accounts.
Since his patients have to pay out of pocket for tests and specialists, Dr. Forbush keeps referrals in check by handling many problems himself. “Since I have more time to spend with the patient, I can often work out issues that other doctors might ask specialists to deal with,” he said.
He has learned some dermatologic procedures. “There are plenty of things I can handle on my own,” he said.
Dr. Granger adds that by examining patients during longer appointments, expensive diagnostic exams are not always necessary.
The challenges for this model
Many experts warn that retainer-based practices won’t work for doctors who want to leave employment or for doctors fresh out of residency. Not having your own patients to bring into the new practice is a big minus, because this is the best way to start the new practice.
Still, there are other ways to find patients. Dr. Bauer said physicians can advertise online, make themselves known by giving speeches in the community, or contract with small employers to treat their workers.
Dr. Bauer said some of his clients were employed physicians, and he thinks they will become a bigger factor now that fewer doctors remain in private practice. The chief barrier for employed physicians is the restrictive covenant that prevents them from setting up a practice nearby. But Dr. Bauer said some employers are willing to waive restrictive covenants for retainer-based doctors.
New physicians are also adopting the concierge model. Dr. Forbush said physicians straight out of residency have set up DPC practices in Maine. They signed up patients for their new practices even before they graduated, he said.
Retainer-based medicine is still mainly limited to primary care physicians, but according to Dr. Bauer, it can also work for specialists who have long-term relationships with patients, such as cardiologists, ob.gyns., rheumatologists, neurologists, and endocrinologists.
No going back
Most doctors who make the switch to retainer-based practice understand that there’s likely no going back. When Dr. Bernstein switched, he announced the change to patients and canceled insurance contracts. “It was make or break,” he said. “I had no parachute.”
A version of this article first appeared on Medscape.com.
It took Michael Golden, MD, 5 years to decide to switch to a concierge practice, in which patients pay a monthly or annual fee for more personalized care. Dr. Golden, an internist in Beverly, Mass., changed course in 2021, during the COVID-19 pandemic.
“I’m not sure why I hesitated for so long,” said Dr. Golden.
But taking the plunge is a big step that they sometimes put off for years.
“The main factors for waiting are fear, uncertainty, and doubt,” said Leigh “Jack” Forbush, DO, a family physician who runs a DPC practice in Hampden, Maine, and mentors doctors contemplating the switch.
According to Dr. Forbush, the critical questions doctors ask themselves are, “Will I be able to find enough paying patients?” and – in the case of DPC practices, which cancel insurance – “Can I live without the money I get from insurers?”
Terry Bauer, CEO of Specialdocs Consultants in Highland Park, Ill., which helps doctors move to a concierge practice, said many of his clients put off the decision for as long as 15 years.
“Clients became progressively worn out – or even burnt out – by the demands of fee-for-service medicine,” said Dr. Bauer. “For women, the tipping point can be when their kids ask, ‘Mom, do you like your job better than me?’ For men, it may be more about feeling tired and unsatisfied with their work.”
But once these doctors make the switch, it’s with all their heart. “A client recently told me that if he couldn’t open a concierge practice, he might have to quit medicine,” Dr. Bauer said. “And he’s only 51.”
Few doctors regret switching
A 2020 survey of DPC physicians for the Society of Actuaries found that 99% reported having better or much better overall personal and professional satisfaction.
Retainer-based physicians report feeling much more relaxed after they start a concierge practice. On many workdays, Dr. Golden takes a walk on a trail in the woods behind his office. “That’s something I couldn’t do before,” he said. “And I go to my kids’ soccer games. I’m able to be present in their lives now.”
Since retainer-based doctors have markedly fewer patients, they can form personal relationships with each one. When Dr. Golden switched, he “went from having a couple of thousand patients to a few hundred,” he said.
“I know each patient now,” said Dorothy Cohen Serna, MD, an internist in Cypress, Tex., who moved to concierge in 2017. “I don’t need to look at their chart to know who they are.”
Dr. Serna said patients’ close relationship with her helped them get through the worst months of the pandemic. “They were scared, depressed, and concerned, and they needed a lot of individual attention,” she said.
Because they see fewer patients, concierge doctors can lengthen appointment times to about 30 minutes – or longer, if necessary. They no longer have a problem answering patients’ “doorknob questions” – wholly new concerns brought up at the end of the visit.
“The appointment might be for a sprained ankle, and then the patient might mention they haven’t been sleeping well,” Dr. Golden said. “I have time to talk about that without worrying that my schedule is getting backed up.”
Why patients sign up
Retainer-based practices are still an exotic concept in many areas, but patients are beginning to understand the value, said Shalini Kaneriya, MD, an internist in Herndon, Va,, who switched her practice to concierge in 2018.
Several hundred patients followed her into her new practice because “people realized their care would be better if they had a concierge doctor,” she said. Two years ago, partly because of growing demand, she recruited another physician as an associate.
“People want a relationship with their doctor,” Dr. Serna added. “It’s hard to provide that in a regular practice.”
Todd Granger, MD, an internist who opened a DPC practice in Chapel Hill, N.C., in 2016, said new patients often mention feeling rushed through appointments with their previous doctors. Also, “it’s hard to get to see a doctor around here.”
Scott Bernstein, MD, an internist who runs a DPC practice in Scottsdale, Ariz., said he can arrange to have patients see specialists much faster than if they try to make appointments on their own. “I personally call specialists and then prep my patients on how to deal with the appointment,” he said.
Retainer-based practices tend to have a greater number of older and chronically ill patients, but they also attract patients who need less care. “The healthier patients find value in our proactive approach to prevention and wellness,” Dr. Serna said.
Some concierge physicians charge higher fees to patients who need more care, but many decide this is too complicated and charge everyone the same fee. Dr. Granger said he initially had a variable fee schedule, but when some lower-paying patients began to need more visits, he had to consider charging them extra. “Now I basically have just one fee,” he said.
Not a good fit for many physicians
Dr. Bauer said a lot of physicians are interested in retainer-based practice, but many of them might not make the income they had hoped for. Specialdocs interviews physicians who inquire about the model and ultimately doesn’t contract with 80% of them, Dr. Bauer said.
To be able to sign up and retain enough patients, the doctor’s attitude is important. “You have to be driven by the desire to go deep with patients -- to work hard with them and deal with their issues,” said Erika Bliss, MD, who runs a DPC practice in Seattle.
Dr. Bernstein said retainer-based physicians have to be interested in lifestyle issues, such as diet, exercise, and sleep. “I spend a lot of time dealing with issues like how to incorporate physical activity into daily routines,” he said. “Some doctors wouldn’t enjoy doing that.”
Also, concierge physicians have to be available all the time. “Patients have my cell phone number,” Dr. Granger said. “They could call in the middle of the night, but they usually don’t.”
To ensure that they get some time off, many concierge physicians have partners. Dr. Bernstein and another DPC doctor maintain separate practices but cover for each other. Each takes every other weekend off plus 6 weeks every year.
Can you attract enough patients?
A key challenge is finding enough patients to sustain a concierge practice. Planning the switch involves setting a target number of patients needed for the doctor to make a decent income after paying practice expenses. For example, a doctor charging $300 a month to 250 patients would gross $900,000 per year, and then pay practice expenses from that.
Attracting the target number of patients can take months or even years. After almost 6 years, Dr. Granger said, he has around 240 patients ― well below his target number of 440.
Partly because the practice model is not well known in North Carolina, Dr. Granger set his fee very low, at $60 a month, then raised it to $75. That means his practice has been grossing just $216,000 a year. But he is not about to give up. He plans to raise his fee in July and hopes that word of mouth will add more patients.
If physicians cannot earn enough in their concierge practice, Dr. Bauer said, they may moonlight at a local hospital or work for a telemedicine company. He hasn’t heard of physicians closing their concierge practice and returning to their previous practice model. “They didn’t like what they were doing before,” he said.
Opening up to lower-income patients
Dr. Granger’s $75 monthly fee is an example of how retainer-based medicine has transformed itself from a gold-plated service for rich people to a service that middle-class and even lower-income people can afford. DPC practices like Dr. Granger’s have dramatically lowered expenses by cutting out the need to bill insurance companies. Some DPC practices further reduce expenses by not having any staff and by renting out office space.
Dr. Forbush’s Pine Tree State patients are mostly blue-collar workers – electricians, plumbers, people who work in small businesses. He charges them $150 a month, which most patients who don’t have health insurance can afford. He said three-quarters of his patients lack health insurance, although some have back-up finances, such as health savings accounts.
Since his patients have to pay out of pocket for tests and specialists, Dr. Forbush keeps referrals in check by handling many problems himself. “Since I have more time to spend with the patient, I can often work out issues that other doctors might ask specialists to deal with,” he said.
He has learned some dermatologic procedures. “There are plenty of things I can handle on my own,” he said.
Dr. Granger adds that by examining patients during longer appointments, expensive diagnostic exams are not always necessary.
The challenges for this model
Many experts warn that retainer-based practices won’t work for doctors who want to leave employment or for doctors fresh out of residency. Not having your own patients to bring into the new practice is a big minus, because this is the best way to start the new practice.
Still, there are other ways to find patients. Dr. Bauer said physicians can advertise online, make themselves known by giving speeches in the community, or contract with small employers to treat their workers.
Dr. Bauer said some of his clients were employed physicians, and he thinks they will become a bigger factor now that fewer doctors remain in private practice. The chief barrier for employed physicians is the restrictive covenant that prevents them from setting up a practice nearby. But Dr. Bauer said some employers are willing to waive restrictive covenants for retainer-based doctors.
New physicians are also adopting the concierge model. Dr. Forbush said physicians straight out of residency have set up DPC practices in Maine. They signed up patients for their new practices even before they graduated, he said.
Retainer-based medicine is still mainly limited to primary care physicians, but according to Dr. Bauer, it can also work for specialists who have long-term relationships with patients, such as cardiologists, ob.gyns., rheumatologists, neurologists, and endocrinologists.
No going back
Most doctors who make the switch to retainer-based practice understand that there’s likely no going back. When Dr. Bernstein switched, he announced the change to patients and canceled insurance contracts. “It was make or break,” he said. “I had no parachute.”
A version of this article first appeared on Medscape.com.
It took Michael Golden, MD, 5 years to decide to switch to a concierge practice, in which patients pay a monthly or annual fee for more personalized care. Dr. Golden, an internist in Beverly, Mass., changed course in 2021, during the COVID-19 pandemic.
“I’m not sure why I hesitated for so long,” said Dr. Golden.
But taking the plunge is a big step that they sometimes put off for years.
“The main factors for waiting are fear, uncertainty, and doubt,” said Leigh “Jack” Forbush, DO, a family physician who runs a DPC practice in Hampden, Maine, and mentors doctors contemplating the switch.
According to Dr. Forbush, the critical questions doctors ask themselves are, “Will I be able to find enough paying patients?” and – in the case of DPC practices, which cancel insurance – “Can I live without the money I get from insurers?”
Terry Bauer, CEO of Specialdocs Consultants in Highland Park, Ill., which helps doctors move to a concierge practice, said many of his clients put off the decision for as long as 15 years.
“Clients became progressively worn out – or even burnt out – by the demands of fee-for-service medicine,” said Dr. Bauer. “For women, the tipping point can be when their kids ask, ‘Mom, do you like your job better than me?’ For men, it may be more about feeling tired and unsatisfied with their work.”
But once these doctors make the switch, it’s with all their heart. “A client recently told me that if he couldn’t open a concierge practice, he might have to quit medicine,” Dr. Bauer said. “And he’s only 51.”
Few doctors regret switching
A 2020 survey of DPC physicians for the Society of Actuaries found that 99% reported having better or much better overall personal and professional satisfaction.
Retainer-based physicians report feeling much more relaxed after they start a concierge practice. On many workdays, Dr. Golden takes a walk on a trail in the woods behind his office. “That’s something I couldn’t do before,” he said. “And I go to my kids’ soccer games. I’m able to be present in their lives now.”
Since retainer-based doctors have markedly fewer patients, they can form personal relationships with each one. When Dr. Golden switched, he “went from having a couple of thousand patients to a few hundred,” he said.
“I know each patient now,” said Dorothy Cohen Serna, MD, an internist in Cypress, Tex., who moved to concierge in 2017. “I don’t need to look at their chart to know who they are.”
Dr. Serna said patients’ close relationship with her helped them get through the worst months of the pandemic. “They were scared, depressed, and concerned, and they needed a lot of individual attention,” she said.
Because they see fewer patients, concierge doctors can lengthen appointment times to about 30 minutes – or longer, if necessary. They no longer have a problem answering patients’ “doorknob questions” – wholly new concerns brought up at the end of the visit.
“The appointment might be for a sprained ankle, and then the patient might mention they haven’t been sleeping well,” Dr. Golden said. “I have time to talk about that without worrying that my schedule is getting backed up.”
Why patients sign up
Retainer-based practices are still an exotic concept in many areas, but patients are beginning to understand the value, said Shalini Kaneriya, MD, an internist in Herndon, Va,, who switched her practice to concierge in 2018.
Several hundred patients followed her into her new practice because “people realized their care would be better if they had a concierge doctor,” she said. Two years ago, partly because of growing demand, she recruited another physician as an associate.
“People want a relationship with their doctor,” Dr. Serna added. “It’s hard to provide that in a regular practice.”
Todd Granger, MD, an internist who opened a DPC practice in Chapel Hill, N.C., in 2016, said new patients often mention feeling rushed through appointments with their previous doctors. Also, “it’s hard to get to see a doctor around here.”
Scott Bernstein, MD, an internist who runs a DPC practice in Scottsdale, Ariz., said he can arrange to have patients see specialists much faster than if they try to make appointments on their own. “I personally call specialists and then prep my patients on how to deal with the appointment,” he said.
Retainer-based practices tend to have a greater number of older and chronically ill patients, but they also attract patients who need less care. “The healthier patients find value in our proactive approach to prevention and wellness,” Dr. Serna said.
Some concierge physicians charge higher fees to patients who need more care, but many decide this is too complicated and charge everyone the same fee. Dr. Granger said he initially had a variable fee schedule, but when some lower-paying patients began to need more visits, he had to consider charging them extra. “Now I basically have just one fee,” he said.
Not a good fit for many physicians
Dr. Bauer said a lot of physicians are interested in retainer-based practice, but many of them might not make the income they had hoped for. Specialdocs interviews physicians who inquire about the model and ultimately doesn’t contract with 80% of them, Dr. Bauer said.
To be able to sign up and retain enough patients, the doctor’s attitude is important. “You have to be driven by the desire to go deep with patients -- to work hard with them and deal with their issues,” said Erika Bliss, MD, who runs a DPC practice in Seattle.
Dr. Bernstein said retainer-based physicians have to be interested in lifestyle issues, such as diet, exercise, and sleep. “I spend a lot of time dealing with issues like how to incorporate physical activity into daily routines,” he said. “Some doctors wouldn’t enjoy doing that.”
Also, concierge physicians have to be available all the time. “Patients have my cell phone number,” Dr. Granger said. “They could call in the middle of the night, but they usually don’t.”
To ensure that they get some time off, many concierge physicians have partners. Dr. Bernstein and another DPC doctor maintain separate practices but cover for each other. Each takes every other weekend off plus 6 weeks every year.
Can you attract enough patients?
A key challenge is finding enough patients to sustain a concierge practice. Planning the switch involves setting a target number of patients needed for the doctor to make a decent income after paying practice expenses. For example, a doctor charging $300 a month to 250 patients would gross $900,000 per year, and then pay practice expenses from that.
Attracting the target number of patients can take months or even years. After almost 6 years, Dr. Granger said, he has around 240 patients ― well below his target number of 440.
Partly because the practice model is not well known in North Carolina, Dr. Granger set his fee very low, at $60 a month, then raised it to $75. That means his practice has been grossing just $216,000 a year. But he is not about to give up. He plans to raise his fee in July and hopes that word of mouth will add more patients.
If physicians cannot earn enough in their concierge practice, Dr. Bauer said, they may moonlight at a local hospital or work for a telemedicine company. He hasn’t heard of physicians closing their concierge practice and returning to their previous practice model. “They didn’t like what they were doing before,” he said.
Opening up to lower-income patients
Dr. Granger’s $75 monthly fee is an example of how retainer-based medicine has transformed itself from a gold-plated service for rich people to a service that middle-class and even lower-income people can afford. DPC practices like Dr. Granger’s have dramatically lowered expenses by cutting out the need to bill insurance companies. Some DPC practices further reduce expenses by not having any staff and by renting out office space.
Dr. Forbush’s Pine Tree State patients are mostly blue-collar workers – electricians, plumbers, people who work in small businesses. He charges them $150 a month, which most patients who don’t have health insurance can afford. He said three-quarters of his patients lack health insurance, although some have back-up finances, such as health savings accounts.
Since his patients have to pay out of pocket for tests and specialists, Dr. Forbush keeps referrals in check by handling many problems himself. “Since I have more time to spend with the patient, I can often work out issues that other doctors might ask specialists to deal with,” he said.
He has learned some dermatologic procedures. “There are plenty of things I can handle on my own,” he said.
Dr. Granger adds that by examining patients during longer appointments, expensive diagnostic exams are not always necessary.
The challenges for this model
Many experts warn that retainer-based practices won’t work for doctors who want to leave employment or for doctors fresh out of residency. Not having your own patients to bring into the new practice is a big minus, because this is the best way to start the new practice.
Still, there are other ways to find patients. Dr. Bauer said physicians can advertise online, make themselves known by giving speeches in the community, or contract with small employers to treat their workers.
Dr. Bauer said some of his clients were employed physicians, and he thinks they will become a bigger factor now that fewer doctors remain in private practice. The chief barrier for employed physicians is the restrictive covenant that prevents them from setting up a practice nearby. But Dr. Bauer said some employers are willing to waive restrictive covenants for retainer-based doctors.
New physicians are also adopting the concierge model. Dr. Forbush said physicians straight out of residency have set up DPC practices in Maine. They signed up patients for their new practices even before they graduated, he said.
Retainer-based medicine is still mainly limited to primary care physicians, but according to Dr. Bauer, it can also work for specialists who have long-term relationships with patients, such as cardiologists, ob.gyns., rheumatologists, neurologists, and endocrinologists.
No going back
Most doctors who make the switch to retainer-based practice understand that there’s likely no going back. When Dr. Bernstein switched, he announced the change to patients and canceled insurance contracts. “It was make or break,” he said. “I had no parachute.”
A version of this article first appeared on Medscape.com.
Why it’s so hard to prevent physician suicide
Kip Wenger, DO, an emergency physician and systems medical director of Team Health, Knoxville, Tenn., was asked to see a patient in the emergency department. He was shocked when he realized who the patient was – a 33-year-old female physician friend and colleague.
She was bleeding from multiple self-inflicted injuries and ultimately died. “I was devastated and couldn’t wrap my head around what had just happened,” Dr. Wenger told this news organization.
It’s important for physicians to be aware of warning signs in their colleagues, such as showing up late, being irritable and short-tempered with staff, missing shifts, making mistakes, or receiving an increasing number of patient complaints, Dr. Wenger says.
Dr. Wenger had had dinner with her several weeks earlier and saw some subtle changes. He had known her as a “positive, upbeat person,” but her demeanor was different during dinner.
“There were no typical telltale signs – she was talking about her plans for the future, including buying a new bicycle – but she wasn’t herself and seemed to become tearful when I hugged her at the end of the evening,” he said. He later heard from another colleague that she had shared feeling “hopeless.”
The scope of the problem
According to the American Society for Suicide Prevention, roughly 300-400 physicians die by suicide annually. Although one study suggests a lower number, official reports likely underestimate suicides, study author Katherine Gold, MD, MSW, associate professor of family medicine, obstetrics, and gynecology, Michigan Medicine, University of Michigan, Ann Arbor, said in an interview.
Peter Yellowlees, MD, MBBS, professor of psychiatry, University of California, Davis, concurs, suggesting that some single-car accidents involving physicians might be suicides. Perry Lin, MD, assistant clinical professor, Heritage College of Osteopathic Medicine, Ohio University, Athens, and national co-chair of the Physician Suicide Awareness Committee of the American Association of Suicidology, says that some death certificates state that the deceased died of “accidental causes” because the physician who completes the certificate, possibly a colleague, is reluctant to list the actual cause of death to protect his colleague’s memory or the family’s feelings.
In general, and among physicians, White men older than 65 “represent the largest percentage of people who die from suicide nationwide,” says Dr. Lin.
But younger people are also susceptible, Dr. Lin adds. One of the most vulnerable periods for potential suicide is during the first few months of residency. This dovetails with the findings of Medscape’s 2022 report Suicide: A Tragedy of the Profession. In that report, a difference was found between frequency of suicidal thoughts in younger physicians, compared with older physicians (14% in those < 35 years vs. 8% for those ≥ 45 years).
Hurdles to preventing physician suicide
“The best thing that can happen in our profession is upstream intervention – if people seek help before they get to the point of suicidality, recognizing they’re under stress and duress and that they might be going down a bad pathway,” says Dr. Lin. But research suggests that many physicians don’t do so.
Gary Price, MD, attending surgeon and clinical assistant professor of surgery, Yale–New Haven Hospital, Connecticut, and president of the Physicians Foundation, says his organization has identified barriers that prevent physicians from seeking help.
Physicians feel they may put their licensure at risk if they admit to receiving help for mental issues. These concerns were expressed by respondents in Medscape’s above mentioned 2022 report, many of whom didn’t seek treatment for depression, burnout, or suicidal thoughts lest it affect their professional standing when renewing their license or seeking credentialing.
Although organizations and societies are advocating against these questions, a recent study found that almost 70% of U.S. states and territories continue to ask physicians about their mental health, and 28% ask for diagnoses (beyond current impairments) – a violation of the Americans With Disabilities Act.
“Mental health illness is different from mental health impairment,” Ryan Mire, MD, a Nashville, Tenn.–based internist, said in an interview. “As physicians, we’re comfortable with licensing boards asking whether the physician has any condition that might impair their care for patients, but not about a history of mental illness.”
The second barrier, says Dr. Price, is that hospital credentialing committees sometimes ask similar questions, as do commercial and malpractice insurers.
Another roadblock is that in some states, undergoing treatment for a mental health problem could be subject to discovery by a plaintiff’s attorney in a malpractice case, even if the physician’s mental health history had no effect on patient care. But that’s uncommon, says Daniel Shapiro, PhD, author of “Delivering Doctor Amelia,” a book about his treatment of a suicidal physician who underwent a malpractice lawsuit. “I’ve never seen that happen.”
A final barrier is that many employers require employees to receive treatment within their own institution or health system. “Physicians may be reluctant to get help where they work, with colleagues and friends knowing about their illness or being involved with their care,” says Dr. Price.
In 2022, the American College of Physicians (ACP) issued a toolkit to help members encourage licensing and credentialing boards to remove questions about mental health on applications and include language that supports receiving treatment, Dr. Mire says.
Layers of vulnerability
There are few data regarding relative risk among particular races or ethnicities, “but we know racism is a social stressor,” says Dr. Mire. “Obviously, people from historically disadvantaged populations tend to have societal stressors like discrimination and racism that add an extra layer of burden.”
Intersectionality – having multiple intersecting risk factors – may confer even higher risk. “For example, if you’re a female physician from a historically marginalized race and a resident dealing with the ‘hidden curriculum’ of trying to be resilient, you have multiple layers of vulnerability.”
There are also limited data regarding which specialties or work environments are associated with highest risk. “Obviously, challenges exist in every segment of medicine and at different ages, stages, and work environments, and they intersect with each individual physician’s personal risk factors,” says Dr. Mire, president of the ACP and assistant clinical professor of clinical medical education, University of Tennessee Health Science Center, Memphis.
Pamela Wible, MD, is an Oregon-based retired physician who herself went through a suicidal period about 11 years into her career that motivated her to embrace a new vision of clinical practice and change her practice model. After a series of physician suicides in her area, she began to speak and write openly about physician suicide, and since her retirement from clinical practice, she makes herself available on a full-time basis to distressed physicians. “When I address a conference of a particular medical specialty or a group in a particular geographical region, I focus on the specific vulnerabilities in that specialty or region,” she says.
What increases the chances of suicide?
“Many factors, both within and outside the professional setting, affect someone’s decision to die by suicide – after all, physicians have the same stressors as other people, like family, finances, and their own health,” Dr. Mire says. When it comes to non–work-related factors, marital stressors and comorbid psychiatric illness particularly raise the risk, says Dr. Lin.
But certain drivers are specific to the practice of medicine, with burnout and depression first in line.
Dr. Shapiro, who is vice dean for faculty and administrative affairs, Penn State University, Hershey, and the Garner James Cline Professor of Medical Humanism, conducts burnout evaluations throughout the country. “Simple depression screeners prior to the pandemic showed about a 10% major depression rate in physicians,” he told this news organization. “Now, we’re seeing a 30%-33% depression rate, even in those who weren’t frontline providers during the pandemic.”
Dr. Price agrees, noting that burnout in physicians has gone from 40% to 60% since the pandemic. But burnout doesn’t always lead to suicide. It’s when burnout progresses to depression, becomes more severe, and is untreated that the suicidal risk arises, he emphasizes.
Additionally, being a doctor isn’t “just a profession” but a “calling and identity,” says Dr. Gold. Job-related problems (for example, a malpractice suit, complaints to the medical board, loss of autonomy, changing work demands) can raise suicidal risk.
And job-related problems can inform the location of suicide, says Dr. Wible, who is the author of “Physicians Suicide Letters – Answered.”
“A work-related catalyst makes it more likely that the person will attempt or complete suicide in the work setting. Physicians have stepped off hospital rooftops, shot or stabbed themselves in hospital parking lots, or [hanged] themselves in hospital chapels. Perhaps it’s because they’re choosing to die in the place where they’ve been most wounded.”
You are not at fault
“If you’re feeling suicidal, you might feel utterly alone, but if there’s one message I can give you, it’s that you’re not alone, and there are many things you can do to mitigate your pain and despair,” Dr. Wible says. “And you’re not defective. It’s the health care system that’s defective. You have nothing to be ashamed of.”
Some institutions have a “buddy system” that pairs clinicians to provide mutual peer support. A partner who notices concerning signs can refer the other partner for help. Physicians can also be paired with a “buddy,” even without a formal institutional structure.
A “buddy” is a step in the right direction, but Dr. Shapiro cautions it might be necessary to consult a trained professional for serious depression or suicidality. Several states provide connection to local resources. Employee assistance programs (EAPs) might be helpful, although many physicians don’t trust their institution’s EAP. Or physicians can ask colleagues to recommend a “doctor’s doctor” who specializes in treating physicians, suggests Dr. Yellowlees, author of “Physician Suicide: Cases and Commentaries.”
In Medscape’s 2022 report, almost all respondents who reported having suicidal colleagues said they offered help, including emotional support, practical assistance, referrals, speaking to family members, or even personally taking the colleague to the ED or to a therapist.
To enhance physicians’ ability to help each other, Dr. Lin recommends “gatekeeper training,” which has been shown to reduce suicide. “This strategy utilizes a peer-to-peer model, but, rather than a single ‘peer buddy,’ everyone is a ‘gatekeeper’ trained in approaches, such as QPR – Question, Persuade, Refer. ‘Gatekeepers’ are taught how to recognize warning signs of suicide, question the potentially suicidal individual, persuade him/her to get help, and provide referrals.”
Other ways to prevent suicide
Dr. Lin advises physicians to “create a personalized safety plan and write down signs and clues that they may be going down the wrong path and what they can do – like breathing exercises, relaxation – and identifying people to talk to, places to go, or phone numbers to call, if those initial measures aren’t enough.” The plan is private and allows the physician to determine at what point help is needed and who should be consulted. “Sometimes, when a person is in acute stress, even looking up a phone number can seem insurmountable. But having it on paper lowers the barrier, making it more achievable.”
Resources should be posted in places where physicians gather so that those who don’t already have a safety plan have easy access to that information, he suggests.
In addition, consideration may be given to reaching out for support if a colleague has died by suicide, experts suggest. Whether offered by one’s institution, a peer arrangement, spiritual counseling, or psychotherapy, one may need help dealing with the trauma, guilt, and grief that often accompany this type of loss.
A version of this article first appeared on Medscape.com.
Kip Wenger, DO, an emergency physician and systems medical director of Team Health, Knoxville, Tenn., was asked to see a patient in the emergency department. He was shocked when he realized who the patient was – a 33-year-old female physician friend and colleague.
She was bleeding from multiple self-inflicted injuries and ultimately died. “I was devastated and couldn’t wrap my head around what had just happened,” Dr. Wenger told this news organization.
It’s important for physicians to be aware of warning signs in their colleagues, such as showing up late, being irritable and short-tempered with staff, missing shifts, making mistakes, or receiving an increasing number of patient complaints, Dr. Wenger says.
Dr. Wenger had had dinner with her several weeks earlier and saw some subtle changes. He had known her as a “positive, upbeat person,” but her demeanor was different during dinner.
“There were no typical telltale signs – she was talking about her plans for the future, including buying a new bicycle – but she wasn’t herself and seemed to become tearful when I hugged her at the end of the evening,” he said. He later heard from another colleague that she had shared feeling “hopeless.”
The scope of the problem
According to the American Society for Suicide Prevention, roughly 300-400 physicians die by suicide annually. Although one study suggests a lower number, official reports likely underestimate suicides, study author Katherine Gold, MD, MSW, associate professor of family medicine, obstetrics, and gynecology, Michigan Medicine, University of Michigan, Ann Arbor, said in an interview.
Peter Yellowlees, MD, MBBS, professor of psychiatry, University of California, Davis, concurs, suggesting that some single-car accidents involving physicians might be suicides. Perry Lin, MD, assistant clinical professor, Heritage College of Osteopathic Medicine, Ohio University, Athens, and national co-chair of the Physician Suicide Awareness Committee of the American Association of Suicidology, says that some death certificates state that the deceased died of “accidental causes” because the physician who completes the certificate, possibly a colleague, is reluctant to list the actual cause of death to protect his colleague’s memory or the family’s feelings.
In general, and among physicians, White men older than 65 “represent the largest percentage of people who die from suicide nationwide,” says Dr. Lin.
But younger people are also susceptible, Dr. Lin adds. One of the most vulnerable periods for potential suicide is during the first few months of residency. This dovetails with the findings of Medscape’s 2022 report Suicide: A Tragedy of the Profession. In that report, a difference was found between frequency of suicidal thoughts in younger physicians, compared with older physicians (14% in those < 35 years vs. 8% for those ≥ 45 years).
Hurdles to preventing physician suicide
“The best thing that can happen in our profession is upstream intervention – if people seek help before they get to the point of suicidality, recognizing they’re under stress and duress and that they might be going down a bad pathway,” says Dr. Lin. But research suggests that many physicians don’t do so.
Gary Price, MD, attending surgeon and clinical assistant professor of surgery, Yale–New Haven Hospital, Connecticut, and president of the Physicians Foundation, says his organization has identified barriers that prevent physicians from seeking help.
Physicians feel they may put their licensure at risk if they admit to receiving help for mental issues. These concerns were expressed by respondents in Medscape’s above mentioned 2022 report, many of whom didn’t seek treatment for depression, burnout, or suicidal thoughts lest it affect their professional standing when renewing their license or seeking credentialing.
Although organizations and societies are advocating against these questions, a recent study found that almost 70% of U.S. states and territories continue to ask physicians about their mental health, and 28% ask for diagnoses (beyond current impairments) – a violation of the Americans With Disabilities Act.
“Mental health illness is different from mental health impairment,” Ryan Mire, MD, a Nashville, Tenn.–based internist, said in an interview. “As physicians, we’re comfortable with licensing boards asking whether the physician has any condition that might impair their care for patients, but not about a history of mental illness.”
The second barrier, says Dr. Price, is that hospital credentialing committees sometimes ask similar questions, as do commercial and malpractice insurers.
Another roadblock is that in some states, undergoing treatment for a mental health problem could be subject to discovery by a plaintiff’s attorney in a malpractice case, even if the physician’s mental health history had no effect on patient care. But that’s uncommon, says Daniel Shapiro, PhD, author of “Delivering Doctor Amelia,” a book about his treatment of a suicidal physician who underwent a malpractice lawsuit. “I’ve never seen that happen.”
A final barrier is that many employers require employees to receive treatment within their own institution or health system. “Physicians may be reluctant to get help where they work, with colleagues and friends knowing about their illness or being involved with their care,” says Dr. Price.
In 2022, the American College of Physicians (ACP) issued a toolkit to help members encourage licensing and credentialing boards to remove questions about mental health on applications and include language that supports receiving treatment, Dr. Mire says.
Layers of vulnerability
There are few data regarding relative risk among particular races or ethnicities, “but we know racism is a social stressor,” says Dr. Mire. “Obviously, people from historically disadvantaged populations tend to have societal stressors like discrimination and racism that add an extra layer of burden.”
Intersectionality – having multiple intersecting risk factors – may confer even higher risk. “For example, if you’re a female physician from a historically marginalized race and a resident dealing with the ‘hidden curriculum’ of trying to be resilient, you have multiple layers of vulnerability.”
There are also limited data regarding which specialties or work environments are associated with highest risk. “Obviously, challenges exist in every segment of medicine and at different ages, stages, and work environments, and they intersect with each individual physician’s personal risk factors,” says Dr. Mire, president of the ACP and assistant clinical professor of clinical medical education, University of Tennessee Health Science Center, Memphis.
Pamela Wible, MD, is an Oregon-based retired physician who herself went through a suicidal period about 11 years into her career that motivated her to embrace a new vision of clinical practice and change her practice model. After a series of physician suicides in her area, she began to speak and write openly about physician suicide, and since her retirement from clinical practice, she makes herself available on a full-time basis to distressed physicians. “When I address a conference of a particular medical specialty or a group in a particular geographical region, I focus on the specific vulnerabilities in that specialty or region,” she says.
What increases the chances of suicide?
“Many factors, both within and outside the professional setting, affect someone’s decision to die by suicide – after all, physicians have the same stressors as other people, like family, finances, and their own health,” Dr. Mire says. When it comes to non–work-related factors, marital stressors and comorbid psychiatric illness particularly raise the risk, says Dr. Lin.
But certain drivers are specific to the practice of medicine, with burnout and depression first in line.
Dr. Shapiro, who is vice dean for faculty and administrative affairs, Penn State University, Hershey, and the Garner James Cline Professor of Medical Humanism, conducts burnout evaluations throughout the country. “Simple depression screeners prior to the pandemic showed about a 10% major depression rate in physicians,” he told this news organization. “Now, we’re seeing a 30%-33% depression rate, even in those who weren’t frontline providers during the pandemic.”
Dr. Price agrees, noting that burnout in physicians has gone from 40% to 60% since the pandemic. But burnout doesn’t always lead to suicide. It’s when burnout progresses to depression, becomes more severe, and is untreated that the suicidal risk arises, he emphasizes.
Additionally, being a doctor isn’t “just a profession” but a “calling and identity,” says Dr. Gold. Job-related problems (for example, a malpractice suit, complaints to the medical board, loss of autonomy, changing work demands) can raise suicidal risk.
And job-related problems can inform the location of suicide, says Dr. Wible, who is the author of “Physicians Suicide Letters – Answered.”
“A work-related catalyst makes it more likely that the person will attempt or complete suicide in the work setting. Physicians have stepped off hospital rooftops, shot or stabbed themselves in hospital parking lots, or [hanged] themselves in hospital chapels. Perhaps it’s because they’re choosing to die in the place where they’ve been most wounded.”
You are not at fault
“If you’re feeling suicidal, you might feel utterly alone, but if there’s one message I can give you, it’s that you’re not alone, and there are many things you can do to mitigate your pain and despair,” Dr. Wible says. “And you’re not defective. It’s the health care system that’s defective. You have nothing to be ashamed of.”
Some institutions have a “buddy system” that pairs clinicians to provide mutual peer support. A partner who notices concerning signs can refer the other partner for help. Physicians can also be paired with a “buddy,” even without a formal institutional structure.
A “buddy” is a step in the right direction, but Dr. Shapiro cautions it might be necessary to consult a trained professional for serious depression or suicidality. Several states provide connection to local resources. Employee assistance programs (EAPs) might be helpful, although many physicians don’t trust their institution’s EAP. Or physicians can ask colleagues to recommend a “doctor’s doctor” who specializes in treating physicians, suggests Dr. Yellowlees, author of “Physician Suicide: Cases and Commentaries.”
In Medscape’s 2022 report, almost all respondents who reported having suicidal colleagues said they offered help, including emotional support, practical assistance, referrals, speaking to family members, or even personally taking the colleague to the ED or to a therapist.
To enhance physicians’ ability to help each other, Dr. Lin recommends “gatekeeper training,” which has been shown to reduce suicide. “This strategy utilizes a peer-to-peer model, but, rather than a single ‘peer buddy,’ everyone is a ‘gatekeeper’ trained in approaches, such as QPR – Question, Persuade, Refer. ‘Gatekeepers’ are taught how to recognize warning signs of suicide, question the potentially suicidal individual, persuade him/her to get help, and provide referrals.”
Other ways to prevent suicide
Dr. Lin advises physicians to “create a personalized safety plan and write down signs and clues that they may be going down the wrong path and what they can do – like breathing exercises, relaxation – and identifying people to talk to, places to go, or phone numbers to call, if those initial measures aren’t enough.” The plan is private and allows the physician to determine at what point help is needed and who should be consulted. “Sometimes, when a person is in acute stress, even looking up a phone number can seem insurmountable. But having it on paper lowers the barrier, making it more achievable.”
Resources should be posted in places where physicians gather so that those who don’t already have a safety plan have easy access to that information, he suggests.
In addition, consideration may be given to reaching out for support if a colleague has died by suicide, experts suggest. Whether offered by one’s institution, a peer arrangement, spiritual counseling, or psychotherapy, one may need help dealing with the trauma, guilt, and grief that often accompany this type of loss.
A version of this article first appeared on Medscape.com.
Kip Wenger, DO, an emergency physician and systems medical director of Team Health, Knoxville, Tenn., was asked to see a patient in the emergency department. He was shocked when he realized who the patient was – a 33-year-old female physician friend and colleague.
She was bleeding from multiple self-inflicted injuries and ultimately died. “I was devastated and couldn’t wrap my head around what had just happened,” Dr. Wenger told this news organization.
It’s important for physicians to be aware of warning signs in their colleagues, such as showing up late, being irritable and short-tempered with staff, missing shifts, making mistakes, or receiving an increasing number of patient complaints, Dr. Wenger says.
Dr. Wenger had had dinner with her several weeks earlier and saw some subtle changes. He had known her as a “positive, upbeat person,” but her demeanor was different during dinner.
“There were no typical telltale signs – she was talking about her plans for the future, including buying a new bicycle – but she wasn’t herself and seemed to become tearful when I hugged her at the end of the evening,” he said. He later heard from another colleague that she had shared feeling “hopeless.”
The scope of the problem
According to the American Society for Suicide Prevention, roughly 300-400 physicians die by suicide annually. Although one study suggests a lower number, official reports likely underestimate suicides, study author Katherine Gold, MD, MSW, associate professor of family medicine, obstetrics, and gynecology, Michigan Medicine, University of Michigan, Ann Arbor, said in an interview.
Peter Yellowlees, MD, MBBS, professor of psychiatry, University of California, Davis, concurs, suggesting that some single-car accidents involving physicians might be suicides. Perry Lin, MD, assistant clinical professor, Heritage College of Osteopathic Medicine, Ohio University, Athens, and national co-chair of the Physician Suicide Awareness Committee of the American Association of Suicidology, says that some death certificates state that the deceased died of “accidental causes” because the physician who completes the certificate, possibly a colleague, is reluctant to list the actual cause of death to protect his colleague’s memory or the family’s feelings.
In general, and among physicians, White men older than 65 “represent the largest percentage of people who die from suicide nationwide,” says Dr. Lin.
But younger people are also susceptible, Dr. Lin adds. One of the most vulnerable periods for potential suicide is during the first few months of residency. This dovetails with the findings of Medscape’s 2022 report Suicide: A Tragedy of the Profession. In that report, a difference was found between frequency of suicidal thoughts in younger physicians, compared with older physicians (14% in those < 35 years vs. 8% for those ≥ 45 years).
Hurdles to preventing physician suicide
“The best thing that can happen in our profession is upstream intervention – if people seek help before they get to the point of suicidality, recognizing they’re under stress and duress and that they might be going down a bad pathway,” says Dr. Lin. But research suggests that many physicians don’t do so.
Gary Price, MD, attending surgeon and clinical assistant professor of surgery, Yale–New Haven Hospital, Connecticut, and president of the Physicians Foundation, says his organization has identified barriers that prevent physicians from seeking help.
Physicians feel they may put their licensure at risk if they admit to receiving help for mental issues. These concerns were expressed by respondents in Medscape’s above mentioned 2022 report, many of whom didn’t seek treatment for depression, burnout, or suicidal thoughts lest it affect their professional standing when renewing their license or seeking credentialing.
Although organizations and societies are advocating against these questions, a recent study found that almost 70% of U.S. states and territories continue to ask physicians about their mental health, and 28% ask for diagnoses (beyond current impairments) – a violation of the Americans With Disabilities Act.
“Mental health illness is different from mental health impairment,” Ryan Mire, MD, a Nashville, Tenn.–based internist, said in an interview. “As physicians, we’re comfortable with licensing boards asking whether the physician has any condition that might impair their care for patients, but not about a history of mental illness.”
The second barrier, says Dr. Price, is that hospital credentialing committees sometimes ask similar questions, as do commercial and malpractice insurers.
Another roadblock is that in some states, undergoing treatment for a mental health problem could be subject to discovery by a plaintiff’s attorney in a malpractice case, even if the physician’s mental health history had no effect on patient care. But that’s uncommon, says Daniel Shapiro, PhD, author of “Delivering Doctor Amelia,” a book about his treatment of a suicidal physician who underwent a malpractice lawsuit. “I’ve never seen that happen.”
A final barrier is that many employers require employees to receive treatment within their own institution or health system. “Physicians may be reluctant to get help where they work, with colleagues and friends knowing about their illness or being involved with their care,” says Dr. Price.
In 2022, the American College of Physicians (ACP) issued a toolkit to help members encourage licensing and credentialing boards to remove questions about mental health on applications and include language that supports receiving treatment, Dr. Mire says.
Layers of vulnerability
There are few data regarding relative risk among particular races or ethnicities, “but we know racism is a social stressor,” says Dr. Mire. “Obviously, people from historically disadvantaged populations tend to have societal stressors like discrimination and racism that add an extra layer of burden.”
Intersectionality – having multiple intersecting risk factors – may confer even higher risk. “For example, if you’re a female physician from a historically marginalized race and a resident dealing with the ‘hidden curriculum’ of trying to be resilient, you have multiple layers of vulnerability.”
There are also limited data regarding which specialties or work environments are associated with highest risk. “Obviously, challenges exist in every segment of medicine and at different ages, stages, and work environments, and they intersect with each individual physician’s personal risk factors,” says Dr. Mire, president of the ACP and assistant clinical professor of clinical medical education, University of Tennessee Health Science Center, Memphis.
Pamela Wible, MD, is an Oregon-based retired physician who herself went through a suicidal period about 11 years into her career that motivated her to embrace a new vision of clinical practice and change her practice model. After a series of physician suicides in her area, she began to speak and write openly about physician suicide, and since her retirement from clinical practice, she makes herself available on a full-time basis to distressed physicians. “When I address a conference of a particular medical specialty or a group in a particular geographical region, I focus on the specific vulnerabilities in that specialty or region,” she says.
What increases the chances of suicide?
“Many factors, both within and outside the professional setting, affect someone’s decision to die by suicide – after all, physicians have the same stressors as other people, like family, finances, and their own health,” Dr. Mire says. When it comes to non–work-related factors, marital stressors and comorbid psychiatric illness particularly raise the risk, says Dr. Lin.
But certain drivers are specific to the practice of medicine, with burnout and depression first in line.
Dr. Shapiro, who is vice dean for faculty and administrative affairs, Penn State University, Hershey, and the Garner James Cline Professor of Medical Humanism, conducts burnout evaluations throughout the country. “Simple depression screeners prior to the pandemic showed about a 10% major depression rate in physicians,” he told this news organization. “Now, we’re seeing a 30%-33% depression rate, even in those who weren’t frontline providers during the pandemic.”
Dr. Price agrees, noting that burnout in physicians has gone from 40% to 60% since the pandemic. But burnout doesn’t always lead to suicide. It’s when burnout progresses to depression, becomes more severe, and is untreated that the suicidal risk arises, he emphasizes.
Additionally, being a doctor isn’t “just a profession” but a “calling and identity,” says Dr. Gold. Job-related problems (for example, a malpractice suit, complaints to the medical board, loss of autonomy, changing work demands) can raise suicidal risk.
And job-related problems can inform the location of suicide, says Dr. Wible, who is the author of “Physicians Suicide Letters – Answered.”
“A work-related catalyst makes it more likely that the person will attempt or complete suicide in the work setting. Physicians have stepped off hospital rooftops, shot or stabbed themselves in hospital parking lots, or [hanged] themselves in hospital chapels. Perhaps it’s because they’re choosing to die in the place where they’ve been most wounded.”
You are not at fault
“If you’re feeling suicidal, you might feel utterly alone, but if there’s one message I can give you, it’s that you’re not alone, and there are many things you can do to mitigate your pain and despair,” Dr. Wible says. “And you’re not defective. It’s the health care system that’s defective. You have nothing to be ashamed of.”
Some institutions have a “buddy system” that pairs clinicians to provide mutual peer support. A partner who notices concerning signs can refer the other partner for help. Physicians can also be paired with a “buddy,” even without a formal institutional structure.
A “buddy” is a step in the right direction, but Dr. Shapiro cautions it might be necessary to consult a trained professional for serious depression or suicidality. Several states provide connection to local resources. Employee assistance programs (EAPs) might be helpful, although many physicians don’t trust their institution’s EAP. Or physicians can ask colleagues to recommend a “doctor’s doctor” who specializes in treating physicians, suggests Dr. Yellowlees, author of “Physician Suicide: Cases and Commentaries.”
In Medscape’s 2022 report, almost all respondents who reported having suicidal colleagues said they offered help, including emotional support, practical assistance, referrals, speaking to family members, or even personally taking the colleague to the ED or to a therapist.
To enhance physicians’ ability to help each other, Dr. Lin recommends “gatekeeper training,” which has been shown to reduce suicide. “This strategy utilizes a peer-to-peer model, but, rather than a single ‘peer buddy,’ everyone is a ‘gatekeeper’ trained in approaches, such as QPR – Question, Persuade, Refer. ‘Gatekeepers’ are taught how to recognize warning signs of suicide, question the potentially suicidal individual, persuade him/her to get help, and provide referrals.”
Other ways to prevent suicide
Dr. Lin advises physicians to “create a personalized safety plan and write down signs and clues that they may be going down the wrong path and what they can do – like breathing exercises, relaxation – and identifying people to talk to, places to go, or phone numbers to call, if those initial measures aren’t enough.” The plan is private and allows the physician to determine at what point help is needed and who should be consulted. “Sometimes, when a person is in acute stress, even looking up a phone number can seem insurmountable. But having it on paper lowers the barrier, making it more achievable.”
Resources should be posted in places where physicians gather so that those who don’t already have a safety plan have easy access to that information, he suggests.
In addition, consideration may be given to reaching out for support if a colleague has died by suicide, experts suggest. Whether offered by one’s institution, a peer arrangement, spiritual counseling, or psychotherapy, one may need help dealing with the trauma, guilt, and grief that often accompany this type of loss.
A version of this article first appeared on Medscape.com.
Alcohol consumption habits can predict gout tophi
The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.
The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.
Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.
Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.
“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.
This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.
Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.
Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
Results from US and clinically detected tophi
Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).
After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.
Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).
Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.
“I wouldn’t expect them to be specific to the Chinese population,” he said.
Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.
Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.
“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.
Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.
“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”
Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.
He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.
“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”
This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.
The authors of the study and Dr. Gaffo report no relevant financial relationships.
The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.
The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.
Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.
Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.
“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.
This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.
Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.
Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
Results from US and clinically detected tophi
Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).
After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.
Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).
Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.
“I wouldn’t expect them to be specific to the Chinese population,” he said.
Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.
Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.
“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.
Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.
“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”
Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.
He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.
“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”
This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.
The authors of the study and Dr. Gaffo report no relevant financial relationships.
The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.
The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.
Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.
Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.
“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.
This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.
Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.
Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
Results from US and clinically detected tophi
Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).
After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.
Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).
Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.
“I wouldn’t expect them to be specific to the Chinese population,” he said.
Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.
Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.
“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.
Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.
“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”
Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.
He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.
“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”
This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.
The authors of the study and Dr. Gaffo report no relevant financial relationships.
FROM ARTHRITIS CARE AND RESEARCH