Rheumatology News

Women with Sjögren’s syndrome have pregnancy outcomes similar to those of the general population, according to the first study to prospectively track pregnancy outcomes among people with the autoimmune condition.

“Most early studies of pregnancy in rheumatic disease patients were retrospective and included only small numbers, making it difficult to know how generalizable the reported results were,” said Lisa Sammaritano, MD, a rheumatologist at Hospital for Special Surgery in New York, in an email interview with this news organization. She was not involved with the research.

Most of these previous studies suggested an increased risk of adverse outcomes, such as miscarriages, preterm deliveries, and small-for-gestational-age birth weight. But in addition to small patient numbers, retrospective studies “are subject to greater reporting bias, which may predispose patients with negative outcomes being more likely to be included because they were followed more closely,” Dr. Sammaritano said.

“This prospective study has several advantages over the earlier retrospective reports: The same data were collected in the same way for all the patients, the patients were recruited at similar time points, and – due to the multicenter nature of the cohort – numbers are larger than in prior studies. All these factors make the results stronger and more generalizable to the Sjögren’s patients we see in our practices,” she added.

In the study, published May 8 in The Lancet Rheumatology, first author Grégoire Martin de Frémont, MD, of the rheumatology service at Bicêtre Hospital, Paris-Saclay University and colleagues used the GR2 registry, an observational database of pregnancies of women with systemic autoimmune diseases managed at 76 participating centers in France, to identify pregnant women with primary Sjögren’s syndrome. To avoid bias, only women who entered the database before 18 weeks’ gestation were included. The final cohort included 106 pregnancies in 96 women with primary Sjögren’s syndrome and 420 control pregnancies that were matched from the general population.

Adverse pregnancy outcomes, including preterm delivery (< 37 weeks of gestation), intrauterine growth retardation, and low birth weight occurred in nine pregnancies (9%) in the Sjögren’s syndrome group and in 28 pregnancies in the control group (7%). Adverse pregnancy outcomes were not significantly associated with Sjögren’s syndrome (P = .52). Researchers found that there were more adverse pregnancy outcomes among women with Sjögren’s syndrome with antiphospholipid (aPL) antibodies. Negative outcomes also increased among those with anti-RNP antibodies, but this association was not statistically significant.

“The main message – based on strong data from a well-designed study – is that patients with Sjögren’s overall do as well as the general population in terms of standard adverse pregnancy outcomes. The rate of flare of Sjögren’s disease was relatively low during the second and third trimesters, also reassuring,” Dr. Sammaritano said. She noted that the association between adverse pregnancy outcomes and aPL antibodies was not unexpected, given that they are a known risk factor.

The study authors recommend that patients with Sjögren’s syndrome be screened for aPL and anti-RNP antibodies prior to conception because of the potential increased risk for complications and that patients with positive screens be closely monitored during their pregnancy.

Dr. Sammaritano noted that there are other health problems to keep in mind. “It is important to remember that Sjögren’s patients – more than any other rheumatic disease patients – have the additional risk for neonatal lupus and complete heart block in their infant, since about two-thirds of Sjögren’s patients are positive for anti-Ro/SSA antibody,” she said. “This is a distinct issue related to the presence of this antibody alone and not specifically related to the underlying diagnosis. In clinical practice, positive anti-Ro/SSA antibody is often the main reason for counseling, monitoring, and even recommending therapy (hydroxychloroquine) in these patients.”

The study received funding from Lupus France, the France Association of Scleroderma, and the Association Gougerot Sjögren, among others. Dr. Sammaritano reports no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Women with Sjögren’s syndrome have pregnancy outcomes similar to those of the general population, according to the first study to prospectively track pregnancy outcomes among people with the autoimmune condition.

“Most early studies of pregnancy in rheumatic disease patients were retrospective and included only small numbers, making it difficult to know how generalizable the reported results were,” said Lisa Sammaritano, MD, a rheumatologist at Hospital for Special Surgery in New York, in an email interview with this news organization. She was not involved with the research.

Most of these previous studies suggested an increased risk of adverse outcomes, such as miscarriages, preterm deliveries, and small-for-gestational-age birth weight. But in addition to small patient numbers, retrospective studies “are subject to greater reporting bias, which may predispose patients with negative outcomes being more likely to be included because they were followed more closely,” Dr. Sammaritano said.

“This prospective study has several advantages over the earlier retrospective reports: The same data were collected in the same way for all the patients, the patients were recruited at similar time points, and – due to the multicenter nature of the cohort – numbers are larger than in prior studies. All these factors make the results stronger and more generalizable to the Sjögren’s patients we see in our practices,” she added.

In the study, published May 8 in The Lancet Rheumatology, first author Grégoire Martin de Frémont, MD, of the rheumatology service at Bicêtre Hospital, Paris-Saclay University and colleagues used the GR2 registry, an observational database of pregnancies of women with systemic autoimmune diseases managed at 76 participating centers in France, to identify pregnant women with primary Sjögren’s syndrome. To avoid bias, only women who entered the database before 18 weeks’ gestation were included. The final cohort included 106 pregnancies in 96 women with primary Sjögren’s syndrome and 420 control pregnancies that were matched from the general population.

Adverse pregnancy outcomes, including preterm delivery (< 37 weeks of gestation), intrauterine growth retardation, and low birth weight occurred in nine pregnancies (9%) in the Sjögren’s syndrome group and in 28 pregnancies in the control group (7%). Adverse pregnancy outcomes were not significantly associated with Sjögren’s syndrome (P = .52). Researchers found that there were more adverse pregnancy outcomes among women with Sjögren’s syndrome with antiphospholipid (aPL) antibodies. Negative outcomes also increased among those with anti-RNP antibodies, but this association was not statistically significant.

“The main message – based on strong data from a well-designed study – is that patients with Sjögren’s overall do as well as the general population in terms of standard adverse pregnancy outcomes. The rate of flare of Sjögren’s disease was relatively low during the second and third trimesters, also reassuring,” Dr. Sammaritano said. She noted that the association between adverse pregnancy outcomes and aPL antibodies was not unexpected, given that they are a known risk factor.

The study authors recommend that patients with Sjögren’s syndrome be screened for aPL and anti-RNP antibodies prior to conception because of the potential increased risk for complications and that patients with positive screens be closely monitored during their pregnancy.

Dr. Sammaritano noted that there are other health problems to keep in mind. “It is important to remember that Sjögren’s patients – more than any other rheumatic disease patients – have the additional risk for neonatal lupus and complete heart block in their infant, since about two-thirds of Sjögren’s patients are positive for anti-Ro/SSA antibody,” she said. “This is a distinct issue related to the presence of this antibody alone and not specifically related to the underlying diagnosis. In clinical practice, positive anti-Ro/SSA antibody is often the main reason for counseling, monitoring, and even recommending therapy (hydroxychloroquine) in these patients.”

The study received funding from Lupus France, the France Association of Scleroderma, and the Association Gougerot Sjögren, among others. Dr. Sammaritano reports no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Women with Sjögren’s syndrome have pregnancy outcomes similar to those of the general population, according to the first study to prospectively track pregnancy outcomes among people with the autoimmune condition.

“Most early studies of pregnancy in rheumatic disease patients were retrospective and included only small numbers, making it difficult to know how generalizable the reported results were,” said Lisa Sammaritano, MD, a rheumatologist at Hospital for Special Surgery in New York, in an email interview with this news organization. She was not involved with the research.

Most of these previous studies suggested an increased risk of adverse outcomes, such as miscarriages, preterm deliveries, and small-for-gestational-age birth weight. But in addition to small patient numbers, retrospective studies “are subject to greater reporting bias, which may predispose patients with negative outcomes being more likely to be included because they were followed more closely,” Dr. Sammaritano said.

“This prospective study has several advantages over the earlier retrospective reports: The same data were collected in the same way for all the patients, the patients were recruited at similar time points, and – due to the multicenter nature of the cohort – numbers are larger than in prior studies. All these factors make the results stronger and more generalizable to the Sjögren’s patients we see in our practices,” she added.

In the study, published May 8 in The Lancet Rheumatology, first author Grégoire Martin de Frémont, MD, of the rheumatology service at Bicêtre Hospital, Paris-Saclay University and colleagues used the GR2 registry, an observational database of pregnancies of women with systemic autoimmune diseases managed at 76 participating centers in France, to identify pregnant women with primary Sjögren’s syndrome. To avoid bias, only women who entered the database before 18 weeks’ gestation were included. The final cohort included 106 pregnancies in 96 women with primary Sjögren’s syndrome and 420 control pregnancies that were matched from the general population.

Adverse pregnancy outcomes, including preterm delivery (< 37 weeks of gestation), intrauterine growth retardation, and low birth weight occurred in nine pregnancies (9%) in the Sjögren’s syndrome group and in 28 pregnancies in the control group (7%). Adverse pregnancy outcomes were not significantly associated with Sjögren’s syndrome (P = .52). Researchers found that there were more adverse pregnancy outcomes among women with Sjögren’s syndrome with antiphospholipid (aPL) antibodies. Negative outcomes also increased among those with anti-RNP antibodies, but this association was not statistically significant.

“The main message – based on strong data from a well-designed study – is that patients with Sjögren’s overall do as well as the general population in terms of standard adverse pregnancy outcomes. The rate of flare of Sjögren’s disease was relatively low during the second and third trimesters, also reassuring,” Dr. Sammaritano said. She noted that the association between adverse pregnancy outcomes and aPL antibodies was not unexpected, given that they are a known risk factor.

The study authors recommend that patients with Sjögren’s syndrome be screened for aPL and anti-RNP antibodies prior to conception because of the potential increased risk for complications and that patients with positive screens be closely monitored during their pregnancy.

Dr. Sammaritano noted that there are other health problems to keep in mind. “It is important to remember that Sjögren’s patients – more than any other rheumatic disease patients – have the additional risk for neonatal lupus and complete heart block in their infant, since about two-thirds of Sjögren’s patients are positive for anti-Ro/SSA antibody,” she said. “This is a distinct issue related to the presence of this antibody alone and not specifically related to the underlying diagnosis. In clinical practice, positive anti-Ro/SSA antibody is often the main reason for counseling, monitoring, and even recommending therapy (hydroxychloroquine) in these patients.”

The study received funding from Lupus France, the France Association of Scleroderma, and the Association Gougerot Sjögren, among others. Dr. Sammaritano reports no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Amid growing criticism of health insurers’ onerous prior authorization practices, lawmakers in 30 states have introduced bills this year that aim to rein in insurer gatekeeping and improve patient care.

“This is something that goes on in every doctor’s office every day; the frustrations, the delays, and the use of office staff time are just unbelievable,” said Steven Orland, MD, a board-certified urologist and president of the Medical Society of New Jersey.

The bills, which cover private health plans and insurers that states regulate, may provide some relief for physicians as federal efforts to streamline prior authorization for some Medicare patients have lagged.

Last year, Congress failed to pass the Improving Seniors’ Timely Access to Care Act of 2021, despite 326 co-sponsors. The bill would have compelled insurers covering Medicare Advantage enrollees to speed up prior authorizations, make the process more transparent, and remove obstacles such as requiring fax machine submissions.

Last month, however, the Centers for Medicare & Medicaid Services issued a final rule that will improve some aspects of prior authorizations in Medicare Advantage insurance plans and ensure that enrollees have the same access to necessary care as traditional Medicare enrollees.

The insurance industry has long defended prior authorization requirements and opposed legislation that would limit them.

America’s Health Insurance Plans (AHIP) and the Blue Cross Blue Shield Association said in a 2019 letter to a congressional committee when the federal legislation was first introduced, “Prior authorizations enforce best practices and guidelines for care management and help physicians identify and avoid care techniques that would harm patient outcomes, such as designating prescriptions that could feed into an opioid addiction.” AHIP didn’t respond to repeated requests for comment.

But some major insurers now appear willing to compromise and voluntarily reduce the volume of prior authorizations they require. Days before the federal final rule was released, three major insurers – United HealthCare, Cigna, and Aetna CVS Health – announced they plan to drop some prior authorization requirements and automate processes.

United HealthCare said it will eliminate almost 20% of its prior authorizations for some nonurgent surgeries and procedures starting this summer. It also will create a national Gold Card program in 2024 for physicians who meet its eligibility requirements, which would eliminate prior authorization requirements for most procedures. Both initiatives will apply to commercial, Medicare Advantage, and Medicaid businesses, said the insurer in a statement.

However, United HealthCare also announced that in June it will start requiring prior authorization for diagnostic (not screening) gastrointestinal endoscopies for its nearly 27 million privately insured patients, citing data it says shows potentially harmful overuse of scopes. Physician groups have publicly criticized the move, saying it could delay lifesaving treatment, and have asked the insurer to reconsider.

Cigna and Aetna also have moved to pare back prior authorization processes. Scott Josephs, national medical officer for Cigna, told Healthcare Dive that Cigna has removed prior authorization reviews from nearly 500 services since 2020.

An Aetna spokesperson told Healthcare Dive that the CVS-owned payer has implemented a gold card program and rolled back prior authorization requirements on cataract surgeries, video EEGs, and home infusion for some drugs, according to Healthcare Dive.

Cigna has faced increased scrutiny from some state regulators since a ProPublica/The Capitol Forum article revealed in March that its doctors were denying claims without opening patients’ files, contrary to what insurance laws and regulations require in many states.

Over a period of 2 months last year, Cigna doctors denied over 300,000 requests for payments using this method, spending an average of 1.2 seconds on each case, the investigation found. In a written response, Cigna said the reporting by ProPublica and The Capitol Forum was “biased and incomplete.”
 

States aim to reduce prior authorization volume

The American Medical Association said it has been tracking nearly 90 prior authorization reform bills in 30 states. More than a dozen bills are still being considered in this legislative session, including in Arkansas, California, New Jersey, North Carolina, Maryland, and Washington, D.C.

“The groundswell of activity in the states reflects how big a problem this is,” said an AMA legislative expert. “The issue used to be ‘how can we automate and streamline processes’; now the issue is focused on reducing the volume of prior authorizations and the harm that can cause patients.”

The state bills use different strategies to reduce excessive prior authorization requirements. Maryland’s proposed bill, for example, would require just one prior authorization to stay on a prescription drug, if the insurer has previously approved the drug and the patient continues to successfully be treated by the drug.

Washington, D.C. and New Jersey have introduced comprehensive reform bills that include a “grace period” of 60 days, to ensure continuity of care when a patient switches health plans. They also would eliminate repeat authorizations for chronic and long-term conditions, set explicit timelines for insurers to respond to prior authorization requests and appeals, and require that practicing physicians review denials that are appealed.

Many state bills also would require insurers to be more transparent by posting information on their websites about which services and drugs require prior authorization and what their approval rates are for them, said AMA’s legislative expert.

“There’s a black hole of information that insurers have access to. We would really like to know how many prior authorization requests are denied, the time it takes to deny them, and the reasons for denial,” said Josh Bengal, JD, the director of government relations for the Medical Society of New Jersey.

The legislation in New Jersey and other states faces stiff opposition from the insurance lobby, especially state associations of health plans affiliated with AHIP. The California Association of Health Plans, for example, opposes a “gold card” bill (SB 598), introduced in February, that would allow a select group of high-performing doctors to skip prior authorizations for 1 year.

The CAHP states, “Californians deserve safe, high quality, high-value health care. Yet SB 598 will derail the progress we have made in our health care system by lowering the value and safety that Californians should expect from their health care providers,” according to a fact sheet.

The fact-sheet defines “low-value care” as medical services for which there is little to no benefit and poses potential physical or financial harm to patients, such as unnecessary CT scans or MRIs for uncomplicated conditions.

California is one of about a dozen states that have introduced gold card legislation this year. If enacted, they would join five states with gold card laws: West Virginia, Texas, Vermont, Michigan, and Louisiana.
 

How do gold cards work?

Physicians who achieve a high approval rate of prior authorizations from insurers for 1 year are eligible to be exempted from obtaining prior authorizations the following year.

The approval rate is at least 90% for a certain number of eligible health services, but the number of prior authorizations required to qualify can range from 5 to 30, depending on the state law.

Gold card legislation typically also gives the treating physician the right to have an appeal of a prior authorization denial by a physician peer of the same or similar specialty.

California’s bill would also apply to all covered health services, which is broader than what United HealthCare has proposed for its gold card exemption. The bill would also require a plan or insurer to annually monitor rates of prior authorization approval, modification, appeal, and denial, and to discontinue services, items, and supplies that are approved 95% of the time.

“These are important reforms that will help ensure that patients can receive the care they need, when they need it,” said CMA president Donaldo Hernandez, MD.

However, it’s not clear how many physicians will meet “gold card” status based on Texas’ recent experience with its own “gold card” law.

The Texas Department of Insurance estimated that only 3.3% of licensed physicians in the state have met “gold card” status since the bill became law in 2021, said Zeke Silva, MD, an interventional radiologist who serves on the Council of Legislation for the Texas Medical Association.

He noted that the legislation has had a limited effect for several reasons. Commercial health plans only make up only about 20% of all health plans in Texas. Also, the final regulations didn’t go into effect until last May and physicians are evaluated by health plans for “gold card” status every 6 months, said Dr. Silva.

In addition, physicians must have at least five prior authorizations approved for the same health service, which the law left up to the health plans to define, said Dr. Silva.

Now, the Texas Medical Association is lobbying for legislative improvements. “We want to reduce the number of eligible services that health plans require for prior authorizations and have more oversight of prior authorization denials by the Texas Department of Insurance and the Texas Medical Board,” said Dr. Silva.

He’s optimistic that if the bill becomes law, the number of physicians eligible for gold cards may increase.

Meanwhile, the AMA’s legislative expert, who declined to be identified because of organization policy, acknowledged the possibility that some prior authorization bills will die in state legislatures this year.

“We remain hopeful, but it’s an uphill battle. The state medical associations face a lot of opposition from health plans who don’t want to see these reforms become law.”

A version of this article originally appeared on Medscape.com.

Amid growing criticism of health insurers’ onerous prior authorization practices, lawmakers in 30 states have introduced bills this year that aim to rein in insurer gatekeeping and improve patient care.

“This is something that goes on in every doctor’s office every day; the frustrations, the delays, and the use of office staff time are just unbelievable,” said Steven Orland, MD, a board-certified urologist and president of the Medical Society of New Jersey.

The bills, which cover private health plans and insurers that states regulate, may provide some relief for physicians as federal efforts to streamline prior authorization for some Medicare patients have lagged.

Last year, Congress failed to pass the Improving Seniors’ Timely Access to Care Act of 2021, despite 326 co-sponsors. The bill would have compelled insurers covering Medicare Advantage enrollees to speed up prior authorizations, make the process more transparent, and remove obstacles such as requiring fax machine submissions.

Last month, however, the Centers for Medicare & Medicaid Services issued a final rule that will improve some aspects of prior authorizations in Medicare Advantage insurance plans and ensure that enrollees have the same access to necessary care as traditional Medicare enrollees.

The insurance industry has long defended prior authorization requirements and opposed legislation that would limit them.

America’s Health Insurance Plans (AHIP) and the Blue Cross Blue Shield Association said in a 2019 letter to a congressional committee when the federal legislation was first introduced, “Prior authorizations enforce best practices and guidelines for care management and help physicians identify and avoid care techniques that would harm patient outcomes, such as designating prescriptions that could feed into an opioid addiction.” AHIP didn’t respond to repeated requests for comment.

But some major insurers now appear willing to compromise and voluntarily reduce the volume of prior authorizations they require. Days before the federal final rule was released, three major insurers – United HealthCare, Cigna, and Aetna CVS Health – announced they plan to drop some prior authorization requirements and automate processes.

United HealthCare said it will eliminate almost 20% of its prior authorizations for some nonurgent surgeries and procedures starting this summer. It also will create a national Gold Card program in 2024 for physicians who meet its eligibility requirements, which would eliminate prior authorization requirements for most procedures. Both initiatives will apply to commercial, Medicare Advantage, and Medicaid businesses, said the insurer in a statement.

However, United HealthCare also announced that in June it will start requiring prior authorization for diagnostic (not screening) gastrointestinal endoscopies for its nearly 27 million privately insured patients, citing data it says shows potentially harmful overuse of scopes. Physician groups have publicly criticized the move, saying it could delay lifesaving treatment, and have asked the insurer to reconsider.

Cigna and Aetna also have moved to pare back prior authorization processes. Scott Josephs, national medical officer for Cigna, told Healthcare Dive that Cigna has removed prior authorization reviews from nearly 500 services since 2020.

An Aetna spokesperson told Healthcare Dive that the CVS-owned payer has implemented a gold card program and rolled back prior authorization requirements on cataract surgeries, video EEGs, and home infusion for some drugs, according to Healthcare Dive.

Cigna has faced increased scrutiny from some state regulators since a ProPublica/The Capitol Forum article revealed in March that its doctors were denying claims without opening patients’ files, contrary to what insurance laws and regulations require in many states.

Over a period of 2 months last year, Cigna doctors denied over 300,000 requests for payments using this method, spending an average of 1.2 seconds on each case, the investigation found. In a written response, Cigna said the reporting by ProPublica and The Capitol Forum was “biased and incomplete.”
 

States aim to reduce prior authorization volume

The American Medical Association said it has been tracking nearly 90 prior authorization reform bills in 30 states. More than a dozen bills are still being considered in this legislative session, including in Arkansas, California, New Jersey, North Carolina, Maryland, and Washington, D.C.

“The groundswell of activity in the states reflects how big a problem this is,” said an AMA legislative expert. “The issue used to be ‘how can we automate and streamline processes’; now the issue is focused on reducing the volume of prior authorizations and the harm that can cause patients.”

The state bills use different strategies to reduce excessive prior authorization requirements. Maryland’s proposed bill, for example, would require just one prior authorization to stay on a prescription drug, if the insurer has previously approved the drug and the patient continues to successfully be treated by the drug.

Washington, D.C. and New Jersey have introduced comprehensive reform bills that include a “grace period” of 60 days, to ensure continuity of care when a patient switches health plans. They also would eliminate repeat authorizations for chronic and long-term conditions, set explicit timelines for insurers to respond to prior authorization requests and appeals, and require that practicing physicians review denials that are appealed.

Many state bills also would require insurers to be more transparent by posting information on their websites about which services and drugs require prior authorization and what their approval rates are for them, said AMA’s legislative expert.

“There’s a black hole of information that insurers have access to. We would really like to know how many prior authorization requests are denied, the time it takes to deny them, and the reasons for denial,” said Josh Bengal, JD, the director of government relations for the Medical Society of New Jersey.

The legislation in New Jersey and other states faces stiff opposition from the insurance lobby, especially state associations of health plans affiliated with AHIP. The California Association of Health Plans, for example, opposes a “gold card” bill (SB 598), introduced in February, that would allow a select group of high-performing doctors to skip prior authorizations for 1 year.

The CAHP states, “Californians deserve safe, high quality, high-value health care. Yet SB 598 will derail the progress we have made in our health care system by lowering the value and safety that Californians should expect from their health care providers,” according to a fact sheet.

The fact-sheet defines “low-value care” as medical services for which there is little to no benefit and poses potential physical or financial harm to patients, such as unnecessary CT scans or MRIs for uncomplicated conditions.

California is one of about a dozen states that have introduced gold card legislation this year. If enacted, they would join five states with gold card laws: West Virginia, Texas, Vermont, Michigan, and Louisiana.
 

How do gold cards work?

Physicians who achieve a high approval rate of prior authorizations from insurers for 1 year are eligible to be exempted from obtaining prior authorizations the following year.

The approval rate is at least 90% for a certain number of eligible health services, but the number of prior authorizations required to qualify can range from 5 to 30, depending on the state law.

Gold card legislation typically also gives the treating physician the right to have an appeal of a prior authorization denial by a physician peer of the same or similar specialty.

California’s bill would also apply to all covered health services, which is broader than what United HealthCare has proposed for its gold card exemption. The bill would also require a plan or insurer to annually monitor rates of prior authorization approval, modification, appeal, and denial, and to discontinue services, items, and supplies that are approved 95% of the time.

“These are important reforms that will help ensure that patients can receive the care they need, when they need it,” said CMA president Donaldo Hernandez, MD.

However, it’s not clear how many physicians will meet “gold card” status based on Texas’ recent experience with its own “gold card” law.

The Texas Department of Insurance estimated that only 3.3% of licensed physicians in the state have met “gold card” status since the bill became law in 2021, said Zeke Silva, MD, an interventional radiologist who serves on the Council of Legislation for the Texas Medical Association.

He noted that the legislation has had a limited effect for several reasons. Commercial health plans only make up only about 20% of all health plans in Texas. Also, the final regulations didn’t go into effect until last May and physicians are evaluated by health plans for “gold card” status every 6 months, said Dr. Silva.

In addition, physicians must have at least five prior authorizations approved for the same health service, which the law left up to the health plans to define, said Dr. Silva.

Now, the Texas Medical Association is lobbying for legislative improvements. “We want to reduce the number of eligible services that health plans require for prior authorizations and have more oversight of prior authorization denials by the Texas Department of Insurance and the Texas Medical Board,” said Dr. Silva.

He’s optimistic that if the bill becomes law, the number of physicians eligible for gold cards may increase.

Meanwhile, the AMA’s legislative expert, who declined to be identified because of organization policy, acknowledged the possibility that some prior authorization bills will die in state legislatures this year.

“We remain hopeful, but it’s an uphill battle. The state medical associations face a lot of opposition from health plans who don’t want to see these reforms become law.”

A version of this article originally appeared on Medscape.com.

Amid growing criticism of health insurers’ onerous prior authorization practices, lawmakers in 30 states have introduced bills this year that aim to rein in insurer gatekeeping and improve patient care.

“This is something that goes on in every doctor’s office every day; the frustrations, the delays, and the use of office staff time are just unbelievable,” said Steven Orland, MD, a board-certified urologist and president of the Medical Society of New Jersey.

The bills, which cover private health plans and insurers that states regulate, may provide some relief for physicians as federal efforts to streamline prior authorization for some Medicare patients have lagged.

Last year, Congress failed to pass the Improving Seniors’ Timely Access to Care Act of 2021, despite 326 co-sponsors. The bill would have compelled insurers covering Medicare Advantage enrollees to speed up prior authorizations, make the process more transparent, and remove obstacles such as requiring fax machine submissions.

Last month, however, the Centers for Medicare & Medicaid Services issued a final rule that will improve some aspects of prior authorizations in Medicare Advantage insurance plans and ensure that enrollees have the same access to necessary care as traditional Medicare enrollees.

The insurance industry has long defended prior authorization requirements and opposed legislation that would limit them.

America’s Health Insurance Plans (AHIP) and the Blue Cross Blue Shield Association said in a 2019 letter to a congressional committee when the federal legislation was first introduced, “Prior authorizations enforce best practices and guidelines for care management and help physicians identify and avoid care techniques that would harm patient outcomes, such as designating prescriptions that could feed into an opioid addiction.” AHIP didn’t respond to repeated requests for comment.

But some major insurers now appear willing to compromise and voluntarily reduce the volume of prior authorizations they require. Days before the federal final rule was released, three major insurers – United HealthCare, Cigna, and Aetna CVS Health – announced they plan to drop some prior authorization requirements and automate processes.

United HealthCare said it will eliminate almost 20% of its prior authorizations for some nonurgent surgeries and procedures starting this summer. It also will create a national Gold Card program in 2024 for physicians who meet its eligibility requirements, which would eliminate prior authorization requirements for most procedures. Both initiatives will apply to commercial, Medicare Advantage, and Medicaid businesses, said the insurer in a statement.

However, United HealthCare also announced that in June it will start requiring prior authorization for diagnostic (not screening) gastrointestinal endoscopies for its nearly 27 million privately insured patients, citing data it says shows potentially harmful overuse of scopes. Physician groups have publicly criticized the move, saying it could delay lifesaving treatment, and have asked the insurer to reconsider.

Cigna and Aetna also have moved to pare back prior authorization processes. Scott Josephs, national medical officer for Cigna, told Healthcare Dive that Cigna has removed prior authorization reviews from nearly 500 services since 2020.

An Aetna spokesperson told Healthcare Dive that the CVS-owned payer has implemented a gold card program and rolled back prior authorization requirements on cataract surgeries, video EEGs, and home infusion for some drugs, according to Healthcare Dive.

Cigna has faced increased scrutiny from some state regulators since a ProPublica/The Capitol Forum article revealed in March that its doctors were denying claims without opening patients’ files, contrary to what insurance laws and regulations require in many states.

Over a period of 2 months last year, Cigna doctors denied over 300,000 requests for payments using this method, spending an average of 1.2 seconds on each case, the investigation found. In a written response, Cigna said the reporting by ProPublica and The Capitol Forum was “biased and incomplete.”
 

States aim to reduce prior authorization volume

The American Medical Association said it has been tracking nearly 90 prior authorization reform bills in 30 states. More than a dozen bills are still being considered in this legislative session, including in Arkansas, California, New Jersey, North Carolina, Maryland, and Washington, D.C.

“The groundswell of activity in the states reflects how big a problem this is,” said an AMA legislative expert. “The issue used to be ‘how can we automate and streamline processes’; now the issue is focused on reducing the volume of prior authorizations and the harm that can cause patients.”

The state bills use different strategies to reduce excessive prior authorization requirements. Maryland’s proposed bill, for example, would require just one prior authorization to stay on a prescription drug, if the insurer has previously approved the drug and the patient continues to successfully be treated by the drug.

Washington, D.C. and New Jersey have introduced comprehensive reform bills that include a “grace period” of 60 days, to ensure continuity of care when a patient switches health plans. They also would eliminate repeat authorizations for chronic and long-term conditions, set explicit timelines for insurers to respond to prior authorization requests and appeals, and require that practicing physicians review denials that are appealed.

Many state bills also would require insurers to be more transparent by posting information on their websites about which services and drugs require prior authorization and what their approval rates are for them, said AMA’s legislative expert.

“There’s a black hole of information that insurers have access to. We would really like to know how many prior authorization requests are denied, the time it takes to deny them, and the reasons for denial,” said Josh Bengal, JD, the director of government relations for the Medical Society of New Jersey.

The legislation in New Jersey and other states faces stiff opposition from the insurance lobby, especially state associations of health plans affiliated with AHIP. The California Association of Health Plans, for example, opposes a “gold card” bill (SB 598), introduced in February, that would allow a select group of high-performing doctors to skip prior authorizations for 1 year.

The CAHP states, “Californians deserve safe, high quality, high-value health care. Yet SB 598 will derail the progress we have made in our health care system by lowering the value and safety that Californians should expect from their health care providers,” according to a fact sheet.

The fact-sheet defines “low-value care” as medical services for which there is little to no benefit and poses potential physical or financial harm to patients, such as unnecessary CT scans or MRIs for uncomplicated conditions.

California is one of about a dozen states that have introduced gold card legislation this year. If enacted, they would join five states with gold card laws: West Virginia, Texas, Vermont, Michigan, and Louisiana.
 

How do gold cards work?

Physicians who achieve a high approval rate of prior authorizations from insurers for 1 year are eligible to be exempted from obtaining prior authorizations the following year.

The approval rate is at least 90% for a certain number of eligible health services, but the number of prior authorizations required to qualify can range from 5 to 30, depending on the state law.

Gold card legislation typically also gives the treating physician the right to have an appeal of a prior authorization denial by a physician peer of the same or similar specialty.

California’s bill would also apply to all covered health services, which is broader than what United HealthCare has proposed for its gold card exemption. The bill would also require a plan or insurer to annually monitor rates of prior authorization approval, modification, appeal, and denial, and to discontinue services, items, and supplies that are approved 95% of the time.

“These are important reforms that will help ensure that patients can receive the care they need, when they need it,” said CMA president Donaldo Hernandez, MD.

However, it’s not clear how many physicians will meet “gold card” status based on Texas’ recent experience with its own “gold card” law.

The Texas Department of Insurance estimated that only 3.3% of licensed physicians in the state have met “gold card” status since the bill became law in 2021, said Zeke Silva, MD, an interventional radiologist who serves on the Council of Legislation for the Texas Medical Association.

He noted that the legislation has had a limited effect for several reasons. Commercial health plans only make up only about 20% of all health plans in Texas. Also, the final regulations didn’t go into effect until last May and physicians are evaluated by health plans for “gold card” status every 6 months, said Dr. Silva.

In addition, physicians must have at least five prior authorizations approved for the same health service, which the law left up to the health plans to define, said Dr. Silva.

Now, the Texas Medical Association is lobbying for legislative improvements. “We want to reduce the number of eligible services that health plans require for prior authorizations and have more oversight of prior authorization denials by the Texas Department of Insurance and the Texas Medical Board,” said Dr. Silva.

He’s optimistic that if the bill becomes law, the number of physicians eligible for gold cards may increase.

Meanwhile, the AMA’s legislative expert, who declined to be identified because of organization policy, acknowledged the possibility that some prior authorization bills will die in state legislatures this year.

“We remain hopeful, but it’s an uphill battle. The state medical associations face a lot of opposition from health plans who don’t want to see these reforms become law.”

A version of this article originally appeared on Medscape.com.

Two commonly used screening tools to detect risk of fracture often fail at that purpose for younger postmenopausal women of every race and ethnicity, according to a study published in JAMA Internal Medicine.

One of the screenings, the U.S. Fracture Risk Assessment Tool (FRAX), proved relatively ineffective at identifying women who developed osteoporosis. The other screening, the Osteoporosis Self-Assessment Tool (OST), excelled at identifying osteoporosis for women in every racial and ethnic group, but also failed at identifying who was most likely to experience a fracture. Osteoporosis experts say that primary care physicians should test for the condition in anyone with any risk factor for it, even if a screening tool suggests doing so is unnecessary.

The United States Preventive Services Task Force (USPSTF) recommends routine testing of bone mineral density in women age 65 years and older to detect risk of developing osteoporosis, which in turn leads to an increased risk for fractures of the hip, spine, shoulder, or forearm. For women aged 50-64, whether bone mineral density accurately reflects who will develop osteoporosis is less clear. In this age range, the USPSTF recommends using either FRAX or OST rather than routine bone mineral density tests.

“I have the utmost respect for the United States Preventive Services Task Force, which lists both of these as valid screening tools for younger postmenopausal women. What I hope this study does is to inform the next iteration of the screening guidelines,” by maintaining the recommendation to use the OST while not keeping FRAX, said Carolyn J. Crandall, MD, MS, an internal medicine physician and health services researcher at University of California, Los Angeles, who helped conduct the research.

The U.S. version of FRAX requires identifying someone’s race, height, and weight, then answering whether they have different risk factors for a fracture such as a previous fracture, rheumatoid arthritis, or smoking. The result was thought to indicate a cumulative risk for major fracture over the next 10 years. Patients at significant risk should then undergo a bone density test.

The tool can also incorporate information about bone mineral density, if available, but the FRAX analyses in Dr. Crandall’s study did not include those data because the study aimed to test the measure’s predictive ability in the absence of a bone scan.

The OST includes only two variables – weight and age – to calculate risk for osteoporosis, and generally takes seconds to complete. It does not include race. As with FRAX, anyone deemed at significant risk for developing osteoporosis should undergo a bone density test.

“OST is really simple; that makes it very appealing,” Dr. Crandall said. “OST could probably be automatically calculated in the electronic medical record.” 

Using data from the Women’s Health Initiative, Dr. Crandall and colleagues tracked more than 67,000 women aged 50-64 years for 10 years following enrollment in the study to see who experienced a fracture or developed osteoporosis over that decade. The investigators found that neither FRAX nor OST was particularly good at predicting who went on to experience a fracture. 

The accuracy of FRAX at fracture prediction peaked at 65% for Asian women (area under the receiver operating curve, 0.65; 95% confidence interval, 0.58-0.71), and was lowest for Black women (AUC 0.55; 95% CI, 0.52-0.59). OST also was most accurate for Asian women, but only up to 62% (AUC 0.62; 95% CI, 0.56-0.69), and was again lowest for Black women (AUC 0.53; 95% CI, 0.50 - 0.57)

“It is just very hard to predict fractures in this age group,” Dr. Crandall said, noting that more evidence exists about risk for fracture in people older than 65.

The story diverges with predicting risk of osteoporosis in the neck. The OST did this roughly 80% of the time, for all racial groups. That figure proved better than FRAX, without including race.
 

Treatment gap

“This evidence supports using OST instead of FRAX” for selecting younger postmenopausal women who should undergo a bone mineral density exam, said E. Michael Lewiecki, MD, director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque. 

UNM Health Sciences Center

Dr. Lewiecki, who was not involved in the new study, noted that the U.S. version of FRAX specifies race because of some clinical evidence that different races have different rates of fracture. But he and Dr. Crandall said the validity of race-based algorithms to guide clinical care is a controversial and evolving topic in medicine. Dr. Lewiecki said the Canadian version of FRAX, which is similarly applied to a diverse population as in the United States, omits race and works as well as the U.S. version. Future iterations of the instrument in the United States may not include race, Dr. Lewiecki said.

“The study is perfectly valid as far as it goes. But the big gorilla in the room is that most patients who need a bone density test are not getting it,” Dr. Lewiecki added. Sometimes a patient might break a bone in their wrist, for example, and tell their primary care provider that anyone would have broken that bone because the fall was so hard. Even if that’s true, Dr. Lewiecki said, any woman older than 45 who has broken a bone should undergo a bone density test to determine if they have osteoporosis, even if it seems like there are other possible reasons for why the break occurred.

“Most of the clinical practice guidelines that are used by physicians recommend getting a bone density test in postmenopausal women under the age of 65 who have a risk factor for fracture,” Dr. Lewiecki said, with a primary risk factor being a prior fracture. Dr. Lewiecki said he would rather that anyone who could benefit from a bone density test receive it, rather than someone foregoing a scan based on a screening tool that may be flawed.

“Most patients – men and women – who have osteoporosis are currently not being identified. Even when they are being identified, they are commonly not being treated. And when they are started on treatment, many patients discontinue treatment before they’ve taken it long enough to benefit,” Dr. Lewiecki said.

Dr. Crandall and Dr. Lewiecki report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Two commonly used screening tools to detect risk of fracture often fail at that purpose for younger postmenopausal women of every race and ethnicity, according to a study published in JAMA Internal Medicine.

One of the screenings, the U.S. Fracture Risk Assessment Tool (FRAX), proved relatively ineffective at identifying women who developed osteoporosis. The other screening, the Osteoporosis Self-Assessment Tool (OST), excelled at identifying osteoporosis for women in every racial and ethnic group, but also failed at identifying who was most likely to experience a fracture. Osteoporosis experts say that primary care physicians should test for the condition in anyone with any risk factor for it, even if a screening tool suggests doing so is unnecessary.

The United States Preventive Services Task Force (USPSTF) recommends routine testing of bone mineral density in women age 65 years and older to detect risk of developing osteoporosis, which in turn leads to an increased risk for fractures of the hip, spine, shoulder, or forearm. For women aged 50-64, whether bone mineral density accurately reflects who will develop osteoporosis is less clear. In this age range, the USPSTF recommends using either FRAX or OST rather than routine bone mineral density tests.

“I have the utmost respect for the United States Preventive Services Task Force, which lists both of these as valid screening tools for younger postmenopausal women. What I hope this study does is to inform the next iteration of the screening guidelines,” by maintaining the recommendation to use the OST while not keeping FRAX, said Carolyn J. Crandall, MD, MS, an internal medicine physician and health services researcher at University of California, Los Angeles, who helped conduct the research.

The U.S. version of FRAX requires identifying someone’s race, height, and weight, then answering whether they have different risk factors for a fracture such as a previous fracture, rheumatoid arthritis, or smoking. The result was thought to indicate a cumulative risk for major fracture over the next 10 years. Patients at significant risk should then undergo a bone density test.

The tool can also incorporate information about bone mineral density, if available, but the FRAX analyses in Dr. Crandall’s study did not include those data because the study aimed to test the measure’s predictive ability in the absence of a bone scan.

The OST includes only two variables – weight and age – to calculate risk for osteoporosis, and generally takes seconds to complete. It does not include race. As with FRAX, anyone deemed at significant risk for developing osteoporosis should undergo a bone density test.

“OST is really simple; that makes it very appealing,” Dr. Crandall said. “OST could probably be automatically calculated in the electronic medical record.” 

Using data from the Women’s Health Initiative, Dr. Crandall and colleagues tracked more than 67,000 women aged 50-64 years for 10 years following enrollment in the study to see who experienced a fracture or developed osteoporosis over that decade. The investigators found that neither FRAX nor OST was particularly good at predicting who went on to experience a fracture. 

The accuracy of FRAX at fracture prediction peaked at 65% for Asian women (area under the receiver operating curve, 0.65; 95% confidence interval, 0.58-0.71), and was lowest for Black women (AUC 0.55; 95% CI, 0.52-0.59). OST also was most accurate for Asian women, but only up to 62% (AUC 0.62; 95% CI, 0.56-0.69), and was again lowest for Black women (AUC 0.53; 95% CI, 0.50 - 0.57)

“It is just very hard to predict fractures in this age group,” Dr. Crandall said, noting that more evidence exists about risk for fracture in people older than 65.

The story diverges with predicting risk of osteoporosis in the neck. The OST did this roughly 80% of the time, for all racial groups. That figure proved better than FRAX, without including race.
 

Treatment gap

“This evidence supports using OST instead of FRAX” for selecting younger postmenopausal women who should undergo a bone mineral density exam, said E. Michael Lewiecki, MD, director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque. 

UNM Health Sciences Center

Dr. Lewiecki, who was not involved in the new study, noted that the U.S. version of FRAX specifies race because of some clinical evidence that different races have different rates of fracture. But he and Dr. Crandall said the validity of race-based algorithms to guide clinical care is a controversial and evolving topic in medicine. Dr. Lewiecki said the Canadian version of FRAX, which is similarly applied to a diverse population as in the United States, omits race and works as well as the U.S. version. Future iterations of the instrument in the United States may not include race, Dr. Lewiecki said.

“The study is perfectly valid as far as it goes. But the big gorilla in the room is that most patients who need a bone density test are not getting it,” Dr. Lewiecki added. Sometimes a patient might break a bone in their wrist, for example, and tell their primary care provider that anyone would have broken that bone because the fall was so hard. Even if that’s true, Dr. Lewiecki said, any woman older than 45 who has broken a bone should undergo a bone density test to determine if they have osteoporosis, even if it seems like there are other possible reasons for why the break occurred.

“Most of the clinical practice guidelines that are used by physicians recommend getting a bone density test in postmenopausal women under the age of 65 who have a risk factor for fracture,” Dr. Lewiecki said, with a primary risk factor being a prior fracture. Dr. Lewiecki said he would rather that anyone who could benefit from a bone density test receive it, rather than someone foregoing a scan based on a screening tool that may be flawed.

“Most patients – men and women – who have osteoporosis are currently not being identified. Even when they are being identified, they are commonly not being treated. And when they are started on treatment, many patients discontinue treatment before they’ve taken it long enough to benefit,” Dr. Lewiecki said.

Dr. Crandall and Dr. Lewiecki report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Two commonly used screening tools to detect risk of fracture often fail at that purpose for younger postmenopausal women of every race and ethnicity, according to a study published in JAMA Internal Medicine.

One of the screenings, the U.S. Fracture Risk Assessment Tool (FRAX), proved relatively ineffective at identifying women who developed osteoporosis. The other screening, the Osteoporosis Self-Assessment Tool (OST), excelled at identifying osteoporosis for women in every racial and ethnic group, but also failed at identifying who was most likely to experience a fracture. Osteoporosis experts say that primary care physicians should test for the condition in anyone with any risk factor for it, even if a screening tool suggests doing so is unnecessary.

The United States Preventive Services Task Force (USPSTF) recommends routine testing of bone mineral density in women age 65 years and older to detect risk of developing osteoporosis, which in turn leads to an increased risk for fractures of the hip, spine, shoulder, or forearm. For women aged 50-64, whether bone mineral density accurately reflects who will develop osteoporosis is less clear. In this age range, the USPSTF recommends using either FRAX or OST rather than routine bone mineral density tests.

“I have the utmost respect for the United States Preventive Services Task Force, which lists both of these as valid screening tools for younger postmenopausal women. What I hope this study does is to inform the next iteration of the screening guidelines,” by maintaining the recommendation to use the OST while not keeping FRAX, said Carolyn J. Crandall, MD, MS, an internal medicine physician and health services researcher at University of California, Los Angeles, who helped conduct the research.

The U.S. version of FRAX requires identifying someone’s race, height, and weight, then answering whether they have different risk factors for a fracture such as a previous fracture, rheumatoid arthritis, or smoking. The result was thought to indicate a cumulative risk for major fracture over the next 10 years. Patients at significant risk should then undergo a bone density test.

The tool can also incorporate information about bone mineral density, if available, but the FRAX analyses in Dr. Crandall’s study did not include those data because the study aimed to test the measure’s predictive ability in the absence of a bone scan.

The OST includes only two variables – weight and age – to calculate risk for osteoporosis, and generally takes seconds to complete. It does not include race. As with FRAX, anyone deemed at significant risk for developing osteoporosis should undergo a bone density test.

“OST is really simple; that makes it very appealing,” Dr. Crandall said. “OST could probably be automatically calculated in the electronic medical record.” 

Using data from the Women’s Health Initiative, Dr. Crandall and colleagues tracked more than 67,000 women aged 50-64 years for 10 years following enrollment in the study to see who experienced a fracture or developed osteoporosis over that decade. The investigators found that neither FRAX nor OST was particularly good at predicting who went on to experience a fracture. 

The accuracy of FRAX at fracture prediction peaked at 65% for Asian women (area under the receiver operating curve, 0.65; 95% confidence interval, 0.58-0.71), and was lowest for Black women (AUC 0.55; 95% CI, 0.52-0.59). OST also was most accurate for Asian women, but only up to 62% (AUC 0.62; 95% CI, 0.56-0.69), and was again lowest for Black women (AUC 0.53; 95% CI, 0.50 - 0.57)

“It is just very hard to predict fractures in this age group,” Dr. Crandall said, noting that more evidence exists about risk for fracture in people older than 65.

The story diverges with predicting risk of osteoporosis in the neck. The OST did this roughly 80% of the time, for all racial groups. That figure proved better than FRAX, without including race.
 

Treatment gap

“This evidence supports using OST instead of FRAX” for selecting younger postmenopausal women who should undergo a bone mineral density exam, said E. Michael Lewiecki, MD, director of the New Mexico Clinical Research & Osteoporosis Center in Albuquerque. 

UNM Health Sciences Center

Dr. Lewiecki, who was not involved in the new study, noted that the U.S. version of FRAX specifies race because of some clinical evidence that different races have different rates of fracture. But he and Dr. Crandall said the validity of race-based algorithms to guide clinical care is a controversial and evolving topic in medicine. Dr. Lewiecki said the Canadian version of FRAX, which is similarly applied to a diverse population as in the United States, omits race and works as well as the U.S. version. Future iterations of the instrument in the United States may not include race, Dr. Lewiecki said.

“The study is perfectly valid as far as it goes. But the big gorilla in the room is that most patients who need a bone density test are not getting it,” Dr. Lewiecki added. Sometimes a patient might break a bone in their wrist, for example, and tell their primary care provider that anyone would have broken that bone because the fall was so hard. Even if that’s true, Dr. Lewiecki said, any woman older than 45 who has broken a bone should undergo a bone density test to determine if they have osteoporosis, even if it seems like there are other possible reasons for why the break occurred.

“Most of the clinical practice guidelines that are used by physicians recommend getting a bone density test in postmenopausal women under the age of 65 who have a risk factor for fracture,” Dr. Lewiecki said, with a primary risk factor being a prior fracture. Dr. Lewiecki said he would rather that anyone who could benefit from a bone density test receive it, rather than someone foregoing a scan based on a screening tool that may be flawed.

“Most patients – men and women – who have osteoporosis are currently not being identified. Even when they are being identified, they are commonly not being treated. And when they are started on treatment, many patients discontinue treatment before they’ve taken it long enough to benefit,” Dr. Lewiecki said.

Dr. Crandall and Dr. Lewiecki report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Imagine a day when a simple injection prompts a broken bone to heal. When tiny, ingestible devices linger in the body, unnoticed, tracking our health or delivering life-saving medications. When brain and heart implants mesh with flesh so seamlessly that the body thinks they’ve been there all along.

These are the dreams of materials scientists who have toiled for decades to mimic the complex architecture of the human body in hopes of replacing broken parts or treating disease.

The problem, say bioengineers, is that most replacement and corrective parts – from prosthetics to pacemakers – are made of hard, dry, lifeless materials, like metal or plastic, while biological tissue is soft, wet, and living. 

The body knows the difference and tends to reject imitations.

Enter hydrogels, three-dimensional networks of molecules swollen with – by definition – water. 

First described in 1960 by creators of soft contact lenses, these weird, shape-shifting substances are able to morph from liquid to solid to a squishy in-between. (Early, simple uses include hair gel or Jell-O.). Slow to gain attention, growing to just 1,000 studies published by 1982, they’ve become the subject of intense study recently, with 100,000 papers published by 2020, and 3,800 already this year alone.

As chemists, biologists, and engineers begin to work more with one another and with medical doctors, the burgeoning hydrogel field is poised to transform the way we take medication and treat worn-out joints and pave the way for a seemingly sci-fi future in which organs, including brains, can interact directly with machines.

“We are, essentially, hydrogels,” said Benjamin Wiley, PhD, a chemistry professor at Duke University in Durham, N.C. “As people develop new hydrogels that more closely match the tissues in our body, we’ll be able to treat a whole host of ailments we couldn’t treat before.”
 

From contact lenses to brain implants

Put simply, a hydrogel is like a mesh bag of water. 

The mesh is made of polymers, or spaghetti-like strands of molecules, stitched together in a repeating pattern and swollen with H₂O, much like the way 3D matrixes in our body surround, support, and give structure to our cells and tissues.

“Imagine a soccer net, with all of these long fibers woven together to create the net,” said Eric Appel, PhD, associate professor of materials science and engineering at Stanford (Calif.) University.

While the broader category of “gels” could be filled with anything, including chemical solvents, water is the key ingredient that sets hydrogels apart, making them ideal for, as some scientists put it, “merging humans and machines.”

Human bones are about 25% water, while muscles hover around 70% and the brain is 85%. The precious liquid plays a host of critical roles, from shuttling nutrients in and waste out to helping cells talk to each other. 

Lab-made hydrogels can be loaded with cargo (like a ball in the net), including cells or drugs that help mimic some of those functions.

Hydrogels are soft and pliable like flesh. So, if used in implants, they may be less likely to damage surrounding tissue.

“Think about a metal spoon in your bowl of pudding. As you’re shaking the bowl, the spoon doesn’t stay in place, and you get scarring around the spoon,” said Christina Tringides, PhD, a materials scientist who studies neural engineering. That, she says, is exactly what happens to brain implants when patients breathe or move. “It’s a mechanical mismatch. But with hydrogels, you could get perfect mechanical matching.”

Hydrogels also tend to be nontoxic, so the immune system may be less likely to attack them as foreign bodies.

All this has made hydrogels the new darling of the bioengineering world. 

“There has been an absolute explosion of interest in these materials,” Dr. Appel said.
 

Smarter drug delivery and ingestible electronics

Early versions of hydrogels were thick and gooey, making it hard to get them inside the body.

“Think of a block of Jell-O. You couldn’t inject something like that,” Dr. Appel said.

But Dr. Appel, whose lab develops new drug delivery systems, has been tinkering with gel formulas for years in hopes that these high-tech globs could someday ferry timed-release drugs to just the right spot in the body.

His new hydrogels start as fully formed gels (which help preserve the drug contents) inside a syringe. But once the plunger is pushed, they magically shape-shift to a liquid thin enough to flow easily through a standard needle. Upon exit, they immediately reform into gels, protecting the inherent cargo from degrading.

This could be a game changer at a time when many cutting-edge drugs – think Humira for arthritis or Ozempic for type 2 diabetes – are made of quickly degrading proteins too large and complex to simply jam into a pill. Instead, they must be injected, often frequently.

“Because the gel takes months to dissolve, it slowly delivers the drug over time,” Dr. Appel said. “You could conceivably go from a shot once a week to once every 4 months.”

Such slow-release hydrogels could make vaccines last longer, in turn teaching the body to better resist emerging virus variants, and deliver tumor-busting therapies more precisely, said Dr. Appel, who has formed a startup and hopes to fast-track the first hydrogel drug delivery system to clinical trials within a few years.

Meanwhile, another team at the Massachusetts Institute of Technology has taken a different approach, developing a standard-sized ingestible hydrogel pill that swells up like a puffer fish in the stomach, lasting a month and slowly releasing drugs all the while. To remove the pill, a patient simply drinks a salt-based solution that shrivels the ping-pong ball–sized device so it can be passed out of the body.

In a paper in Nature Communications, the scientists showed the puffer fish pill could also be loaded with tiny cameras or monitors to track conditions like ulcers or cancer.

“The dream is to have a Jell-O-like smart pill that, once swallowed, stays in the stomach and monitors the patient’s health,” said Xuanhe Zhao, PhD, a researcher on the project and associate professor of mechanical engineering at MIT.
 

Building joints and regrowing bones

Since the 1970s, researchers have mulled using hydrogels to replace human cartilage, a remarkably strong and flexible tissue made of about 90% water but able to withstand the weight of a car on an area about the size of a coin.

Until recently, those efforts have largely failed. Meaning when knee cartilage wears down, things like cartilage transplants, drilling holes to stimulate new growth, or total joint replacements – all of which require lengthy rehab – are the only options. 

But that may be about to change.

Dr. Wiley and his colleagues at Duke recently reported that they’d developed the first gel-based cartilage substitute even stronger and more durable than the real thing.

By attaching their hydrogel to a titanium backing to help stick it in place, they hope to repair damaged cartilage “much like a dentist fills a cavity” long before surgery is necessary.

They too have partnered with industry to bring their hydrogel to market – starting with knees.

“Ultimately, the goal is to do any joint – hips, ankles, fingers, and toes,” Dr. Wiley said. 

At the University of Toronto, chemist Karina Carneiro, PhD, and dentist Christopher McCulloch, DDS, are also thinking big.

In a recent paper in Proceedings of the National Academy of Sciences, they describe a hydrogel, designed by Dr. Carneiro and made of DNA, that can be injected, migrate to a defect in bone – an irreparable break, hole from surgery, or jawbone withered by age – and fill in the gap like putty. But not only does it patch the hole, it prompts the bone to regenerate. 

In rats with holes in their skulls due to surgery, they found that the treatment did not work as well as the existing gold standard for repairing holes in bone – grafting bone from elsewhere in the body. But it did work.

“These are very early days for DNA hydrogels,” cautioned Dr. McCulloch, a study coauthor and professor in the Faculty of Dentistry, noting that it will likely be a decade or more before such technology could be available to patients. “But there is the potential that DNA hydrogel could someday grow bone without having to have highly invasive surgical procedures. That’s a significant advancement.”
 

A sci-fi future

Perhaps the wildest, and weirdest, potential applications of hydrogels come in the realm of human-machine interaction.

Numerous companies are already dabbling in neural prosthetic or brain computer interfaces that might someday, for instance, let someone who is paralyzed and can’t speak write on a laptop using their thoughts.

The spoon-in-the-Jell-O problem has been a major stumbling block.

But Dr. Tringides, who recently earned her PhD in biophysics from Harvard, is working on it.

She and her team have developed a seaweed-based hydrogel loaded with tiny flecks of nanomaterials that can not only meld nicely into squishy brain tissue but also conduct electricity.

Within a decade, she says, this could replace the clunky platinum metal discs used for electrocorticography – recording electrical activity in the brain to identify where seizures start or doing precise brain surgery.

In 30 to 50 years? Let your imagination run wild.

“I’m a skeptic. I like to take research step by step,” she said. “But things are definitely progressing in an interesting direction.”
 

A version of this article first appeared on WebMD.com.

Imagine a day when a simple injection prompts a broken bone to heal. When tiny, ingestible devices linger in the body, unnoticed, tracking our health or delivering life-saving medications. When brain and heart implants mesh with flesh so seamlessly that the body thinks they’ve been there all along.

These are the dreams of materials scientists who have toiled for decades to mimic the complex architecture of the human body in hopes of replacing broken parts or treating disease.

The problem, say bioengineers, is that most replacement and corrective parts – from prosthetics to pacemakers – are made of hard, dry, lifeless materials, like metal or plastic, while biological tissue is soft, wet, and living. 

The body knows the difference and tends to reject imitations.

Enter hydrogels, three-dimensional networks of molecules swollen with – by definition – water. 

First described in 1960 by creators of soft contact lenses, these weird, shape-shifting substances are able to morph from liquid to solid to a squishy in-between. (Early, simple uses include hair gel or Jell-O.). Slow to gain attention, growing to just 1,000 studies published by 1982, they’ve become the subject of intense study recently, with 100,000 papers published by 2020, and 3,800 already this year alone.

As chemists, biologists, and engineers begin to work more with one another and with medical doctors, the burgeoning hydrogel field is poised to transform the way we take medication and treat worn-out joints and pave the way for a seemingly sci-fi future in which organs, including brains, can interact directly with machines.

“We are, essentially, hydrogels,” said Benjamin Wiley, PhD, a chemistry professor at Duke University in Durham, N.C. “As people develop new hydrogels that more closely match the tissues in our body, we’ll be able to treat a whole host of ailments we couldn’t treat before.”
 

From contact lenses to brain implants

Put simply, a hydrogel is like a mesh bag of water. 

The mesh is made of polymers, or spaghetti-like strands of molecules, stitched together in a repeating pattern and swollen with H₂O, much like the way 3D matrixes in our body surround, support, and give structure to our cells and tissues.

“Imagine a soccer net, with all of these long fibers woven together to create the net,” said Eric Appel, PhD, associate professor of materials science and engineering at Stanford (Calif.) University.

While the broader category of “gels” could be filled with anything, including chemical solvents, water is the key ingredient that sets hydrogels apart, making them ideal for, as some scientists put it, “merging humans and machines.”

Human bones are about 25% water, while muscles hover around 70% and the brain is 85%. The precious liquid plays a host of critical roles, from shuttling nutrients in and waste out to helping cells talk to each other. 

Lab-made hydrogels can be loaded with cargo (like a ball in the net), including cells or drugs that help mimic some of those functions.

Hydrogels are soft and pliable like flesh. So, if used in implants, they may be less likely to damage surrounding tissue.

“Think about a metal spoon in your bowl of pudding. As you’re shaking the bowl, the spoon doesn’t stay in place, and you get scarring around the spoon,” said Christina Tringides, PhD, a materials scientist who studies neural engineering. That, she says, is exactly what happens to brain implants when patients breathe or move. “It’s a mechanical mismatch. But with hydrogels, you could get perfect mechanical matching.”

Hydrogels also tend to be nontoxic, so the immune system may be less likely to attack them as foreign bodies.

All this has made hydrogels the new darling of the bioengineering world. 

“There has been an absolute explosion of interest in these materials,” Dr. Appel said.
 

Smarter drug delivery and ingestible electronics

Early versions of hydrogels were thick and gooey, making it hard to get them inside the body.

“Think of a block of Jell-O. You couldn’t inject something like that,” Dr. Appel said.

But Dr. Appel, whose lab develops new drug delivery systems, has been tinkering with gel formulas for years in hopes that these high-tech globs could someday ferry timed-release drugs to just the right spot in the body.

His new hydrogels start as fully formed gels (which help preserve the drug contents) inside a syringe. But once the plunger is pushed, they magically shape-shift to a liquid thin enough to flow easily through a standard needle. Upon exit, they immediately reform into gels, protecting the inherent cargo from degrading.

This could be a game changer at a time when many cutting-edge drugs – think Humira for arthritis or Ozempic for type 2 diabetes – are made of quickly degrading proteins too large and complex to simply jam into a pill. Instead, they must be injected, often frequently.

“Because the gel takes months to dissolve, it slowly delivers the drug over time,” Dr. Appel said. “You could conceivably go from a shot once a week to once every 4 months.”

Such slow-release hydrogels could make vaccines last longer, in turn teaching the body to better resist emerging virus variants, and deliver tumor-busting therapies more precisely, said Dr. Appel, who has formed a startup and hopes to fast-track the first hydrogel drug delivery system to clinical trials within a few years.

Meanwhile, another team at the Massachusetts Institute of Technology has taken a different approach, developing a standard-sized ingestible hydrogel pill that swells up like a puffer fish in the stomach, lasting a month and slowly releasing drugs all the while. To remove the pill, a patient simply drinks a salt-based solution that shrivels the ping-pong ball–sized device so it can be passed out of the body.

In a paper in Nature Communications, the scientists showed the puffer fish pill could also be loaded with tiny cameras or monitors to track conditions like ulcers or cancer.

“The dream is to have a Jell-O-like smart pill that, once swallowed, stays in the stomach and monitors the patient’s health,” said Xuanhe Zhao, PhD, a researcher on the project and associate professor of mechanical engineering at MIT.
 

Building joints and regrowing bones

Since the 1970s, researchers have mulled using hydrogels to replace human cartilage, a remarkably strong and flexible tissue made of about 90% water but able to withstand the weight of a car on an area about the size of a coin.

Until recently, those efforts have largely failed. Meaning when knee cartilage wears down, things like cartilage transplants, drilling holes to stimulate new growth, or total joint replacements – all of which require lengthy rehab – are the only options. 

But that may be about to change.

Dr. Wiley and his colleagues at Duke recently reported that they’d developed the first gel-based cartilage substitute even stronger and more durable than the real thing.

By attaching their hydrogel to a titanium backing to help stick it in place, they hope to repair damaged cartilage “much like a dentist fills a cavity” long before surgery is necessary.

They too have partnered with industry to bring their hydrogel to market – starting with knees.

“Ultimately, the goal is to do any joint – hips, ankles, fingers, and toes,” Dr. Wiley said. 

At the University of Toronto, chemist Karina Carneiro, PhD, and dentist Christopher McCulloch, DDS, are also thinking big.

In a recent paper in Proceedings of the National Academy of Sciences, they describe a hydrogel, designed by Dr. Carneiro and made of DNA, that can be injected, migrate to a defect in bone – an irreparable break, hole from surgery, or jawbone withered by age – and fill in the gap like putty. But not only does it patch the hole, it prompts the bone to regenerate. 

In rats with holes in their skulls due to surgery, they found that the treatment did not work as well as the existing gold standard for repairing holes in bone – grafting bone from elsewhere in the body. But it did work.

“These are very early days for DNA hydrogels,” cautioned Dr. McCulloch, a study coauthor and professor in the Faculty of Dentistry, noting that it will likely be a decade or more before such technology could be available to patients. “But there is the potential that DNA hydrogel could someday grow bone without having to have highly invasive surgical procedures. That’s a significant advancement.”
 

A sci-fi future

Perhaps the wildest, and weirdest, potential applications of hydrogels come in the realm of human-machine interaction.

Numerous companies are already dabbling in neural prosthetic or brain computer interfaces that might someday, for instance, let someone who is paralyzed and can’t speak write on a laptop using their thoughts.

The spoon-in-the-Jell-O problem has been a major stumbling block.

But Dr. Tringides, who recently earned her PhD in biophysics from Harvard, is working on it.

She and her team have developed a seaweed-based hydrogel loaded with tiny flecks of nanomaterials that can not only meld nicely into squishy brain tissue but also conduct electricity.

Within a decade, she says, this could replace the clunky platinum metal discs used for electrocorticography – recording electrical activity in the brain to identify where seizures start or doing precise brain surgery.

In 30 to 50 years? Let your imagination run wild.

“I’m a skeptic. I like to take research step by step,” she said. “But things are definitely progressing in an interesting direction.”
 

A version of this article first appeared on WebMD.com.

Imagine a day when a simple injection prompts a broken bone to heal. When tiny, ingestible devices linger in the body, unnoticed, tracking our health or delivering life-saving medications. When brain and heart implants mesh with flesh so seamlessly that the body thinks they’ve been there all along.

These are the dreams of materials scientists who have toiled for decades to mimic the complex architecture of the human body in hopes of replacing broken parts or treating disease.

The problem, say bioengineers, is that most replacement and corrective parts – from prosthetics to pacemakers – are made of hard, dry, lifeless materials, like metal or plastic, while biological tissue is soft, wet, and living. 

The body knows the difference and tends to reject imitations.

Enter hydrogels, three-dimensional networks of molecules swollen with – by definition – water. 

First described in 1960 by creators of soft contact lenses, these weird, shape-shifting substances are able to morph from liquid to solid to a squishy in-between. (Early, simple uses include hair gel or Jell-O.). Slow to gain attention, growing to just 1,000 studies published by 1982, they’ve become the subject of intense study recently, with 100,000 papers published by 2020, and 3,800 already this year alone.

As chemists, biologists, and engineers begin to work more with one another and with medical doctors, the burgeoning hydrogel field is poised to transform the way we take medication and treat worn-out joints and pave the way for a seemingly sci-fi future in which organs, including brains, can interact directly with machines.

“We are, essentially, hydrogels,” said Benjamin Wiley, PhD, a chemistry professor at Duke University in Durham, N.C. “As people develop new hydrogels that more closely match the tissues in our body, we’ll be able to treat a whole host of ailments we couldn’t treat before.”
 

From contact lenses to brain implants

Put simply, a hydrogel is like a mesh bag of water. 

The mesh is made of polymers, or spaghetti-like strands of molecules, stitched together in a repeating pattern and swollen with H₂O, much like the way 3D matrixes in our body surround, support, and give structure to our cells and tissues.

“Imagine a soccer net, with all of these long fibers woven together to create the net,” said Eric Appel, PhD, associate professor of materials science and engineering at Stanford (Calif.) University.

While the broader category of “gels” could be filled with anything, including chemical solvents, water is the key ingredient that sets hydrogels apart, making them ideal for, as some scientists put it, “merging humans and machines.”

Human bones are about 25% water, while muscles hover around 70% and the brain is 85%. The precious liquid plays a host of critical roles, from shuttling nutrients in and waste out to helping cells talk to each other. 

Lab-made hydrogels can be loaded with cargo (like a ball in the net), including cells or drugs that help mimic some of those functions.

Hydrogels are soft and pliable like flesh. So, if used in implants, they may be less likely to damage surrounding tissue.

“Think about a metal spoon in your bowl of pudding. As you’re shaking the bowl, the spoon doesn’t stay in place, and you get scarring around the spoon,” said Christina Tringides, PhD, a materials scientist who studies neural engineering. That, she says, is exactly what happens to brain implants when patients breathe or move. “It’s a mechanical mismatch. But with hydrogels, you could get perfect mechanical matching.”

Hydrogels also tend to be nontoxic, so the immune system may be less likely to attack them as foreign bodies.

All this has made hydrogels the new darling of the bioengineering world. 

“There has been an absolute explosion of interest in these materials,” Dr. Appel said.
 

Smarter drug delivery and ingestible electronics

Early versions of hydrogels were thick and gooey, making it hard to get them inside the body.

“Think of a block of Jell-O. You couldn’t inject something like that,” Dr. Appel said.

But Dr. Appel, whose lab develops new drug delivery systems, has been tinkering with gel formulas for years in hopes that these high-tech globs could someday ferry timed-release drugs to just the right spot in the body.

His new hydrogels start as fully formed gels (which help preserve the drug contents) inside a syringe. But once the plunger is pushed, they magically shape-shift to a liquid thin enough to flow easily through a standard needle. Upon exit, they immediately reform into gels, protecting the inherent cargo from degrading.

This could be a game changer at a time when many cutting-edge drugs – think Humira for arthritis or Ozempic for type 2 diabetes – are made of quickly degrading proteins too large and complex to simply jam into a pill. Instead, they must be injected, often frequently.

“Because the gel takes months to dissolve, it slowly delivers the drug over time,” Dr. Appel said. “You could conceivably go from a shot once a week to once every 4 months.”

Such slow-release hydrogels could make vaccines last longer, in turn teaching the body to better resist emerging virus variants, and deliver tumor-busting therapies more precisely, said Dr. Appel, who has formed a startup and hopes to fast-track the first hydrogel drug delivery system to clinical trials within a few years.

Meanwhile, another team at the Massachusetts Institute of Technology has taken a different approach, developing a standard-sized ingestible hydrogel pill that swells up like a puffer fish in the stomach, lasting a month and slowly releasing drugs all the while. To remove the pill, a patient simply drinks a salt-based solution that shrivels the ping-pong ball–sized device so it can be passed out of the body.

In a paper in Nature Communications, the scientists showed the puffer fish pill could also be loaded with tiny cameras or monitors to track conditions like ulcers or cancer.

“The dream is to have a Jell-O-like smart pill that, once swallowed, stays in the stomach and monitors the patient’s health,” said Xuanhe Zhao, PhD, a researcher on the project and associate professor of mechanical engineering at MIT.
 

Building joints and regrowing bones

Since the 1970s, researchers have mulled using hydrogels to replace human cartilage, a remarkably strong and flexible tissue made of about 90% water but able to withstand the weight of a car on an area about the size of a coin.

Until recently, those efforts have largely failed. Meaning when knee cartilage wears down, things like cartilage transplants, drilling holes to stimulate new growth, or total joint replacements – all of which require lengthy rehab – are the only options. 

But that may be about to change.

Dr. Wiley and his colleagues at Duke recently reported that they’d developed the first gel-based cartilage substitute even stronger and more durable than the real thing.

By attaching their hydrogel to a titanium backing to help stick it in place, they hope to repair damaged cartilage “much like a dentist fills a cavity” long before surgery is necessary.

They too have partnered with industry to bring their hydrogel to market – starting with knees.

“Ultimately, the goal is to do any joint – hips, ankles, fingers, and toes,” Dr. Wiley said. 

At the University of Toronto, chemist Karina Carneiro, PhD, and dentist Christopher McCulloch, DDS, are also thinking big.

In a recent paper in Proceedings of the National Academy of Sciences, they describe a hydrogel, designed by Dr. Carneiro and made of DNA, that can be injected, migrate to a defect in bone – an irreparable break, hole from surgery, or jawbone withered by age – and fill in the gap like putty. But not only does it patch the hole, it prompts the bone to regenerate. 

In rats with holes in their skulls due to surgery, they found that the treatment did not work as well as the existing gold standard for repairing holes in bone – grafting bone from elsewhere in the body. But it did work.

“These are very early days for DNA hydrogels,” cautioned Dr. McCulloch, a study coauthor and professor in the Faculty of Dentistry, noting that it will likely be a decade or more before such technology could be available to patients. “But there is the potential that DNA hydrogel could someday grow bone without having to have highly invasive surgical procedures. That’s a significant advancement.”
 

A sci-fi future

Perhaps the wildest, and weirdest, potential applications of hydrogels come in the realm of human-machine interaction.

Numerous companies are already dabbling in neural prosthetic or brain computer interfaces that might someday, for instance, let someone who is paralyzed and can’t speak write on a laptop using their thoughts.

The spoon-in-the-Jell-O problem has been a major stumbling block.

But Dr. Tringides, who recently earned her PhD in biophysics from Harvard, is working on it.

She and her team have developed a seaweed-based hydrogel loaded with tiny flecks of nanomaterials that can not only meld nicely into squishy brain tissue but also conduct electricity.

Within a decade, she says, this could replace the clunky platinum metal discs used for electrocorticography – recording electrical activity in the brain to identify where seizures start or doing precise brain surgery.

In 30 to 50 years? Let your imagination run wild.

“I’m a skeptic. I like to take research step by step,” she said. “But things are definitely progressing in an interesting direction.”
 

A version of this article first appeared on WebMD.com.

SEOUL, SOUTH KOREA – A once-daily, oral dose of the investigational drug cenerimod, developed for the treatment of systemic lupus erythematosus, has shown a greater response rate among individuals with more severe disease, according to data presented at an international congress on SLE.

Cenerimod is a potent, highly-selective sphingosine 1–phosphate receptor 1 (S1P1) modulator with attenuated calcium signaling, which targets an important signaling molecule in immunity and cell migration, said rheumatologist Sandra Navarra, MD, of the University of Santo Tomas Hospital and St. Luke’s Medical Center in Manila, Philippines.

SEOUL, SOUTH KOREA – A once-daily, oral dose of the investigational drug cenerimod, developed for the treatment of systemic lupus erythematosus, has shown a greater response rate among individuals with more severe disease, according to data presented at an international congress on SLE.

Cenerimod is a potent, highly-selective sphingosine 1–phosphate receptor 1 (S1P1) modulator with attenuated calcium signaling, which targets an important signaling molecule in immunity and cell migration, said rheumatologist Sandra Navarra, MD, of the University of Santo Tomas Hospital and St. Luke’s Medical Center in Manila, Philippines.

SEOUL, SOUTH KOREA – A once-daily, oral dose of the investigational drug cenerimod, developed for the treatment of systemic lupus erythematosus, has shown a greater response rate among individuals with more severe disease, according to data presented at an international congress on SLE.

Cenerimod is a potent, highly-selective sphingosine 1–phosphate receptor 1 (S1P1) modulator with attenuated calcium signaling, which targets an important signaling molecule in immunity and cell migration, said rheumatologist Sandra Navarra, MD, of the University of Santo Tomas Hospital and St. Luke’s Medical Center in Manila, Philippines.

SEOUL, SOUTH KOREA – Regular testing of hydroxychloroquine levels in patients with systemic lupus erythematosus – especially those who are experiencing a disease flare – could help to identify patients who are not taking their treatment and are at risk of worse outcomes.

Data presented at an international congress on systemic lupus erythematosus showed that 7.3% of patients with SLE are severely nonadherent to their medication and have a higher risk of flare, early damage, and mortality.

Rheumatologist Nathalie Costedoat-Chalumeau, MD, PhD, professor of internal medicine at Cochin Hospital, Paris, presented data from 660 patients enrolled in the international longitudinal SLICC Inception Cohort, who had all been on hydroxychloroquine therapy for at least 3 months at baseline.

Bianca Nogrady/MDedge News

Patients’ serum hydroxychloroquine levels were measured at baseline and follow-up, and severe nonadherence was defined as below 106 ng/mL for those on 400 mg/day or 53 ng/mL for those on 200 mg/day.

Dr. Costedoat-Chalumeau said that those thresholds were chosen based on earlier work that analyzed the blood concentration of hydroxychloroquine in a group of patients and identified a group with very low concentrations corresponding to severe nonadherence.

“Since then, it has been reproduced by others with the same threshold,” she said. “When you have very low levels of hydroxychloroquine in their blood, you know that your patients don’t take their treatment.”

In the present study, the 7.3% of patients who met the criteria for severe nonadherence had a significant 3.3-fold higher risk of disease flare within a year of enrollment than did those who were adherent. They also had significantly higher mortality at 5 years after enrollment.

While the study didn’t show a significant difference in the level of damage at 5 years – defined as a worsening of their SLICC damage index – Dr. Costedoat-Chalumeau said they saw significantly greater damage occurring at 1, 2, and 3 years after enrollment among those who were severely nonadherent.

The challenge with recognizing these nonadherent patients is that they have no obvious differences at baseline from those who are adherent, Dr. Costedoat-Chalumeau said. The rates of nonadherence were similar regardless of what dose the patient was on, their ethnicity, gender, education level, or other demographic variables.

“I believe strongly that there is a benefit of testing hydroxychloroquine levels in the blood or serum to detect severe nonadherence,” she said.

At Dr. Costedoat-Chalumeau’s clinic, patients’ hydroxychloroquine levels are tested at every clinic visit, she said in an interview, and especially if they are experiencing a disease flare. “We want to know if the flare is because the patient is not taking the treatment or if it’s because the treatment is not effective, which is very different in terms of management,” she said. She recommended waiting at least 1 month after patients start treatment before measuring their hydroxychloroquine levels.

As to why some patients choose to stop taking their medication, Dr. Costedoat-Chalumeau said sometimes it was because patients were worried about side effects, but others were also unclear about why they needed to keep taking hydroxychloroquine.

“They think steroids are effective because when they take it they are better, but they don’t see the effect of hydroxychloroquine,” she said. “You have to explain that it doesn’t work the same.”

Commenting on the findings, session chair Joan Merrill, MD, professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, said the data show that severe nonadherence does have prognostic significance. “Many patients with SLE have low-grade disease or inflammation in the blood vessels that may not be clinically apparent and which hydroxychloroquine can help, so it might be wise to routinely get blood levels,” she said.

Dr. Costedoat-Chalumeau reported no relevant financial relationships apart from unrestricted institutional research grants from UCB and Roche.

SEOUL, SOUTH KOREA – Regular testing of hydroxychloroquine levels in patients with systemic lupus erythematosus – especially those who are experiencing a disease flare – could help to identify patients who are not taking their treatment and are at risk of worse outcomes.

Data presented at an international congress on systemic lupus erythematosus showed that 7.3% of patients with SLE are severely nonadherent to their medication and have a higher risk of flare, early damage, and mortality.

Rheumatologist Nathalie Costedoat-Chalumeau, MD, PhD, professor of internal medicine at Cochin Hospital, Paris, presented data from 660 patients enrolled in the international longitudinal SLICC Inception Cohort, who had all been on hydroxychloroquine therapy for at least 3 months at baseline.

Bianca Nogrady/MDedge News

Patients’ serum hydroxychloroquine levels were measured at baseline and follow-up, and severe nonadherence was defined as below 106 ng/mL for those on 400 mg/day or 53 ng/mL for those on 200 mg/day.

Dr. Costedoat-Chalumeau said that those thresholds were chosen based on earlier work that analyzed the blood concentration of hydroxychloroquine in a group of patients and identified a group with very low concentrations corresponding to severe nonadherence.

“Since then, it has been reproduced by others with the same threshold,” she said. “When you have very low levels of hydroxychloroquine in their blood, you know that your patients don’t take their treatment.”

In the present study, the 7.3% of patients who met the criteria for severe nonadherence had a significant 3.3-fold higher risk of disease flare within a year of enrollment than did those who were adherent. They also had significantly higher mortality at 5 years after enrollment.

While the study didn’t show a significant difference in the level of damage at 5 years – defined as a worsening of their SLICC damage index – Dr. Costedoat-Chalumeau said they saw significantly greater damage occurring at 1, 2, and 3 years after enrollment among those who were severely nonadherent.

The challenge with recognizing these nonadherent patients is that they have no obvious differences at baseline from those who are adherent, Dr. Costedoat-Chalumeau said. The rates of nonadherence were similar regardless of what dose the patient was on, their ethnicity, gender, education level, or other demographic variables.

“I believe strongly that there is a benefit of testing hydroxychloroquine levels in the blood or serum to detect severe nonadherence,” she said.

At Dr. Costedoat-Chalumeau’s clinic, patients’ hydroxychloroquine levels are tested at every clinic visit, she said in an interview, and especially if they are experiencing a disease flare. “We want to know if the flare is because the patient is not taking the treatment or if it’s because the treatment is not effective, which is very different in terms of management,” she said. She recommended waiting at least 1 month after patients start treatment before measuring their hydroxychloroquine levels.

As to why some patients choose to stop taking their medication, Dr. Costedoat-Chalumeau said sometimes it was because patients were worried about side effects, but others were also unclear about why they needed to keep taking hydroxychloroquine.

“They think steroids are effective because when they take it they are better, but they don’t see the effect of hydroxychloroquine,” she said. “You have to explain that it doesn’t work the same.”

Commenting on the findings, session chair Joan Merrill, MD, professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, said the data show that severe nonadherence does have prognostic significance. “Many patients with SLE have low-grade disease or inflammation in the blood vessels that may not be clinically apparent and which hydroxychloroquine can help, so it might be wise to routinely get blood levels,” she said.

Dr. Costedoat-Chalumeau reported no relevant financial relationships apart from unrestricted institutional research grants from UCB and Roche.

SEOUL, SOUTH KOREA – Regular testing of hydroxychloroquine levels in patients with systemic lupus erythematosus – especially those who are experiencing a disease flare – could help to identify patients who are not taking their treatment and are at risk of worse outcomes.

Data presented at an international congress on systemic lupus erythematosus showed that 7.3% of patients with SLE are severely nonadherent to their medication and have a higher risk of flare, early damage, and mortality.

Rheumatologist Nathalie Costedoat-Chalumeau, MD, PhD, professor of internal medicine at Cochin Hospital, Paris, presented data from 660 patients enrolled in the international longitudinal SLICC Inception Cohort, who had all been on hydroxychloroquine therapy for at least 3 months at baseline.

Bianca Nogrady/MDedge News

Patients’ serum hydroxychloroquine levels were measured at baseline and follow-up, and severe nonadherence was defined as below 106 ng/mL for those on 400 mg/day or 53 ng/mL for those on 200 mg/day.

Dr. Costedoat-Chalumeau said that those thresholds were chosen based on earlier work that analyzed the blood concentration of hydroxychloroquine in a group of patients and identified a group with very low concentrations corresponding to severe nonadherence.

“Since then, it has been reproduced by others with the same threshold,” she said. “When you have very low levels of hydroxychloroquine in their blood, you know that your patients don’t take their treatment.”

In the present study, the 7.3% of patients who met the criteria for severe nonadherence had a significant 3.3-fold higher risk of disease flare within a year of enrollment than did those who were adherent. They also had significantly higher mortality at 5 years after enrollment.

While the study didn’t show a significant difference in the level of damage at 5 years – defined as a worsening of their SLICC damage index – Dr. Costedoat-Chalumeau said they saw significantly greater damage occurring at 1, 2, and 3 years after enrollment among those who were severely nonadherent.

The challenge with recognizing these nonadherent patients is that they have no obvious differences at baseline from those who are adherent, Dr. Costedoat-Chalumeau said. The rates of nonadherence were similar regardless of what dose the patient was on, their ethnicity, gender, education level, or other demographic variables.

“I believe strongly that there is a benefit of testing hydroxychloroquine levels in the blood or serum to detect severe nonadherence,” she said.

At Dr. Costedoat-Chalumeau’s clinic, patients’ hydroxychloroquine levels are tested at every clinic visit, she said in an interview, and especially if they are experiencing a disease flare. “We want to know if the flare is because the patient is not taking the treatment or if it’s because the treatment is not effective, which is very different in terms of management,” she said. She recommended waiting at least 1 month after patients start treatment before measuring their hydroxychloroquine levels.

As to why some patients choose to stop taking their medication, Dr. Costedoat-Chalumeau said sometimes it was because patients were worried about side effects, but others were also unclear about why they needed to keep taking hydroxychloroquine.

“They think steroids are effective because when they take it they are better, but they don’t see the effect of hydroxychloroquine,” she said. “You have to explain that it doesn’t work the same.”

Commenting on the findings, session chair Joan Merrill, MD, professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, said the data show that severe nonadherence does have prognostic significance. “Many patients with SLE have low-grade disease or inflammation in the blood vessels that may not be clinically apparent and which hydroxychloroquine can help, so it might be wise to routinely get blood levels,” she said.

Dr. Costedoat-Chalumeau reported no relevant financial relationships apart from unrestricted institutional research grants from UCB and Roche.

Doctors or AI? Lukewarm vote of confidence goes to …

Well, we’ve got some good news for the physicians out there, and we’ve got some bad news. Which do you want first? Okay, we’re mostly hearing good news, so here goes: Most people would choose a human doctor over artificial intelligence for the diagnosis and treatment of their medical conditions.

Alexandra_Koch/Pixabay

And the bad news? In the survey we’re talking about, “most” was 53%, so not exactly a huge victory for the carbon-based life forms. Yup, about 47% of the 2,472 respondents said they would prefer an AI-based clinic over a human specialist, and that number went up if individuals were told that their primary care physicians were on board with AI, “or otherwise nudged to consider AI as good,” the research team said in a written statement released by the University of Arizona, Tucson.

They went on to add that “this signaled the significance of the human physician in guiding a patient’s decision.” So patients will still need their doctors in the future to … um … this is a bit awkward … tell them how good the AI is?

And yes, we know that ChatGPT is already doing the same thing to journalists, but could it write a medical-humor column? Not a chance. Probably can’t even tell a joke.

How do ghosts get rid of wrinkles? Boo-tox. There, let’s see ChatGPT do that.
 

Explaining the joke makes it funnier, right?

Here at LOTME headquarters, we live by one simple rule, passed down directly from the Buddha himself: “Never let a good presurgical assessment of refractory epilepsy go to waste. Also, don’t believe everything you read on the Internet.”

Amy/Pixabay

This human-created joke has been brought to you by the leading theory of humor, which states that comedy stems from our brain reacting to an incongruous part of reality in a positive way. These positive emotions light up our neurons in a specific fashion, and boom, comedy is achieved.

Previous studies into the science of comedy have typically used functional MRI to analyze the brain while it was gripped in the throes of a comedic reaction. Unfortunately, fMRI cannot detect the entirety of the electromagnetic spectrum generated by the brain during these moments, so observing scientists have been, quite literally, missing out on some of the joke. And that’s where a new study from France comes in.

In the study, the researchers showed a group of patients with epilepsy who were hooked up to deep brain electrodes and a high-tech neuroimaging machine – part of the aforementioned presurgical assessment – a 3-minute excerpt from a Charlie Chaplin movie and analyzed their brain activity. Why Charlie Chaplin? Simple. Slapstick is perhaps the most accessible form of comedy across cultures. We can all appreciate a man getting hit in the head with a coconut. The world’s oldest bar joke or whatever this is? Not so much.

During the funniest scenes, all study participants showed increased high-frequency gamma waves (indicating high cognitive engagement) and a decrease in low-frequency waves (indicating reduced inattention and introspection). During unfunny scenes, such as transition moments, the opposite occurred. Importantly, this inverse relationship occurred in the temporal lobe but not in other regions, supporting previous research that indicated humor was mainly processed in the temporal lobe.

The investigators suggested future research should focus on longer videos with more complex forms of comedy, such as jokes, irony, sarcasm, or reference humor. So, uh, a guy getting hit in the head with two coconuts? That’s high-brow stuff right there.
 

Hot take: Humans aren’t that special

We humans have always prided ourselves on being different from “the animals” in an exceptional way. News flash! We aren’t. We may be the apex predator, but new research shows that humans, as part of the animal kingdom, just aren’t special.

jacoblund/iStock/Getty Images

Not special? How can they say that? Are gorillas doing open-heart surgery? Do wolverines tell jokes? At a more basic level, though, the way we operate as mammals in societies is not unique or even new. Elephants are known to mourn their deceased and to have funeral-like practices, ants invented agriculture, and we’re certainly not the only species that has figured out how to use tools.

This new research just demonstrates another way we aren’t exceptional, and that’s in our mating practices and outcomes.

“Humans appear to resemble mammals that live in monogamous partnerships and to some extent, those classified as cooperative breeders, where breeding individuals have to rely on the help of others to raise their offspring,” Monique Borgerhoff Mulder, PhD, professor emerita of anthropology at the University of California, Davis, said in a written statement.

The research team, which consisted of over 100 investigators, looked at 90 human populations based on data from over 80,000 people globally and compared the human data with 49 different nonhuman mammal species. In polygynous societies in which men take several wives, they found, women have more access to resources like food, shelter, and parenting help. Monogamy, on the other hand, “can drive significant inequalities among women,” Dr. Borgerhoff Mulder said, by promoting large differences in the number of children couples produce.

Human day-to-day behavior and child-rearing habits – one parent taking a daughter to ballet class and fixing dinner so the other parent can get to exercise class before picking up the son from soccer practice – may have us thinking that we are part of an evolved society, but really we are not much different than other mammals that hunt, forage for food, and rear and teach their children, the researchers suggested.

So, yes, humans can travel to the moon, create a vaccine for smallpox, and hit other humans with coconuts, but when it comes to simply having offspring or raising them, we’re not all that special. Get over it.

Doctors or AI? Lukewarm vote of confidence goes to …

Well, we’ve got some good news for the physicians out there, and we’ve got some bad news. Which do you want first? Okay, we’re mostly hearing good news, so here goes: Most people would choose a human doctor over artificial intelligence for the diagnosis and treatment of their medical conditions.

Alexandra_Koch/Pixabay

And the bad news? In the survey we’re talking about, “most” was 53%, so not exactly a huge victory for the carbon-based life forms. Yup, about 47% of the 2,472 respondents said they would prefer an AI-based clinic over a human specialist, and that number went up if individuals were told that their primary care physicians were on board with AI, “or otherwise nudged to consider AI as good,” the research team said in a written statement released by the University of Arizona, Tucson.

They went on to add that “this signaled the significance of the human physician in guiding a patient’s decision.” So patients will still need their doctors in the future to … um … this is a bit awkward … tell them how good the AI is?

And yes, we know that ChatGPT is already doing the same thing to journalists, but could it write a medical-humor column? Not a chance. Probably can’t even tell a joke.

How do ghosts get rid of wrinkles? Boo-tox. There, let’s see ChatGPT do that.
 

Explaining the joke makes it funnier, right?

Here at LOTME headquarters, we live by one simple rule, passed down directly from the Buddha himself: “Never let a good presurgical assessment of refractory epilepsy go to waste. Also, don’t believe everything you read on the Internet.”

Amy/Pixabay

This human-created joke has been brought to you by the leading theory of humor, which states that comedy stems from our brain reacting to an incongruous part of reality in a positive way. These positive emotions light up our neurons in a specific fashion, and boom, comedy is achieved.

Previous studies into the science of comedy have typically used functional MRI to analyze the brain while it was gripped in the throes of a comedic reaction. Unfortunately, fMRI cannot detect the entirety of the electromagnetic spectrum generated by the brain during these moments, so observing scientists have been, quite literally, missing out on some of the joke. And that’s where a new study from France comes in.

In the study, the researchers showed a group of patients with epilepsy who were hooked up to deep brain electrodes and a high-tech neuroimaging machine – part of the aforementioned presurgical assessment – a 3-minute excerpt from a Charlie Chaplin movie and analyzed their brain activity. Why Charlie Chaplin? Simple. Slapstick is perhaps the most accessible form of comedy across cultures. We can all appreciate a man getting hit in the head with a coconut. The world’s oldest bar joke or whatever this is? Not so much.

During the funniest scenes, all study participants showed increased high-frequency gamma waves (indicating high cognitive engagement) and a decrease in low-frequency waves (indicating reduced inattention and introspection). During unfunny scenes, such as transition moments, the opposite occurred. Importantly, this inverse relationship occurred in the temporal lobe but not in other regions, supporting previous research that indicated humor was mainly processed in the temporal lobe.

The investigators suggested future research should focus on longer videos with more complex forms of comedy, such as jokes, irony, sarcasm, or reference humor. So, uh, a guy getting hit in the head with two coconuts? That’s high-brow stuff right there.
 

Hot take: Humans aren’t that special

We humans have always prided ourselves on being different from “the animals” in an exceptional way. News flash! We aren’t. We may be the apex predator, but new research shows that humans, as part of the animal kingdom, just aren’t special.

jacoblund/iStock/Getty Images

Not special? How can they say that? Are gorillas doing open-heart surgery? Do wolverines tell jokes? At a more basic level, though, the way we operate as mammals in societies is not unique or even new. Elephants are known to mourn their deceased and to have funeral-like practices, ants invented agriculture, and we’re certainly not the only species that has figured out how to use tools.

This new research just demonstrates another way we aren’t exceptional, and that’s in our mating practices and outcomes.

“Humans appear to resemble mammals that live in monogamous partnerships and to some extent, those classified as cooperative breeders, where breeding individuals have to rely on the help of others to raise their offspring,” Monique Borgerhoff Mulder, PhD, professor emerita of anthropology at the University of California, Davis, said in a written statement.

The research team, which consisted of over 100 investigators, looked at 90 human populations based on data from over 80,000 people globally and compared the human data with 49 different nonhuman mammal species. In polygynous societies in which men take several wives, they found, women have more access to resources like food, shelter, and parenting help. Monogamy, on the other hand, “can drive significant inequalities among women,” Dr. Borgerhoff Mulder said, by promoting large differences in the number of children couples produce.

Human day-to-day behavior and child-rearing habits – one parent taking a daughter to ballet class and fixing dinner so the other parent can get to exercise class before picking up the son from soccer practice – may have us thinking that we are part of an evolved society, but really we are not much different than other mammals that hunt, forage for food, and rear and teach their children, the researchers suggested.

So, yes, humans can travel to the moon, create a vaccine for smallpox, and hit other humans with coconuts, but when it comes to simply having offspring or raising them, we’re not all that special. Get over it.

Doctors or AI? Lukewarm vote of confidence goes to …

Well, we’ve got some good news for the physicians out there, and we’ve got some bad news. Which do you want first? Okay, we’re mostly hearing good news, so here goes: Most people would choose a human doctor over artificial intelligence for the diagnosis and treatment of their medical conditions.

Alexandra_Koch/Pixabay

And the bad news? In the survey we’re talking about, “most” was 53%, so not exactly a huge victory for the carbon-based life forms. Yup, about 47% of the 2,472 respondents said they would prefer an AI-based clinic over a human specialist, and that number went up if individuals were told that their primary care physicians were on board with AI, “or otherwise nudged to consider AI as good,” the research team said in a written statement released by the University of Arizona, Tucson.

They went on to add that “this signaled the significance of the human physician in guiding a patient’s decision.” So patients will still need their doctors in the future to … um … this is a bit awkward … tell them how good the AI is?

And yes, we know that ChatGPT is already doing the same thing to journalists, but could it write a medical-humor column? Not a chance. Probably can’t even tell a joke.

How do ghosts get rid of wrinkles? Boo-tox. There, let’s see ChatGPT do that.
 

Explaining the joke makes it funnier, right?

Here at LOTME headquarters, we live by one simple rule, passed down directly from the Buddha himself: “Never let a good presurgical assessment of refractory epilepsy go to waste. Also, don’t believe everything you read on the Internet.”

Amy/Pixabay

This human-created joke has been brought to you by the leading theory of humor, which states that comedy stems from our brain reacting to an incongruous part of reality in a positive way. These positive emotions light up our neurons in a specific fashion, and boom, comedy is achieved.

Previous studies into the science of comedy have typically used functional MRI to analyze the brain while it was gripped in the throes of a comedic reaction. Unfortunately, fMRI cannot detect the entirety of the electromagnetic spectrum generated by the brain during these moments, so observing scientists have been, quite literally, missing out on some of the joke. And that’s where a new study from France comes in.

In the study, the researchers showed a group of patients with epilepsy who were hooked up to deep brain electrodes and a high-tech neuroimaging machine – part of the aforementioned presurgical assessment – a 3-minute excerpt from a Charlie Chaplin movie and analyzed their brain activity. Why Charlie Chaplin? Simple. Slapstick is perhaps the most accessible form of comedy across cultures. We can all appreciate a man getting hit in the head with a coconut. The world’s oldest bar joke or whatever this is? Not so much.

During the funniest scenes, all study participants showed increased high-frequency gamma waves (indicating high cognitive engagement) and a decrease in low-frequency waves (indicating reduced inattention and introspection). During unfunny scenes, such as transition moments, the opposite occurred. Importantly, this inverse relationship occurred in the temporal lobe but not in other regions, supporting previous research that indicated humor was mainly processed in the temporal lobe.

The investigators suggested future research should focus on longer videos with more complex forms of comedy, such as jokes, irony, sarcasm, or reference humor. So, uh, a guy getting hit in the head with two coconuts? That’s high-brow stuff right there.
 

Hot take: Humans aren’t that special

We humans have always prided ourselves on being different from “the animals” in an exceptional way. News flash! We aren’t. We may be the apex predator, but new research shows that humans, as part of the animal kingdom, just aren’t special.

jacoblund/iStock/Getty Images

Not special? How can they say that? Are gorillas doing open-heart surgery? Do wolverines tell jokes? At a more basic level, though, the way we operate as mammals in societies is not unique or even new. Elephants are known to mourn their deceased and to have funeral-like practices, ants invented agriculture, and we’re certainly not the only species that has figured out how to use tools.

This new research just demonstrates another way we aren’t exceptional, and that’s in our mating practices and outcomes.

“Humans appear to resemble mammals that live in monogamous partnerships and to some extent, those classified as cooperative breeders, where breeding individuals have to rely on the help of others to raise their offspring,” Monique Borgerhoff Mulder, PhD, professor emerita of anthropology at the University of California, Davis, said in a written statement.

The research team, which consisted of over 100 investigators, looked at 90 human populations based on data from over 80,000 people globally and compared the human data with 49 different nonhuman mammal species. In polygynous societies in which men take several wives, they found, women have more access to resources like food, shelter, and parenting help. Monogamy, on the other hand, “can drive significant inequalities among women,” Dr. Borgerhoff Mulder said, by promoting large differences in the number of children couples produce.

Human day-to-day behavior and child-rearing habits – one parent taking a daughter to ballet class and fixing dinner so the other parent can get to exercise class before picking up the son from soccer practice – may have us thinking that we are part of an evolved society, but really we are not much different than other mammals that hunt, forage for food, and rear and teach their children, the researchers suggested.

So, yes, humans can travel to the moon, create a vaccine for smallpox, and hit other humans with coconuts, but when it comes to simply having offspring or raising them, we’re not all that special. Get over it.

CLEVELAND – About half (52%) of patients living with both axial spondyloarthritis and inflammatory bowel disease (IBD) reached clinical remission of axSpA at 12 months after starting a tumor necrosis factor inhibitor (TNFi), researchers have found.

The disease course for axSpA among patients with IBD who start anti-TNF agents is not well understood.

Rahul S. Dalal, MD, an advanced fellow in IBD with the division of gastroenterology, hepatology, and endoscopy at Brigham and Women’s Hospital, Boston, and colleagues studied whether certain clinical factors were associated with remission of axSpA after patients with axSpA, who also had Crohn’s disease (CD) or ulcerative colitis (UC), started anti-TNF therapy.
 

Short IBD duration, adalimumab linked with higher remission odds

They found that those who had IBD for less than 5 years and those taking the TNFi adalimumab (Humira and biosimilars), as opposed to another TNFi, had a higher likelihood of reaching axSpA remission at 1 year. The odds ratios calculated for those factors were statistically significant.

Dr. Dalal said that most of the patients in the study (70%) were prescribed adalimumab, and because the study didn’t compare TNFis head to head, it’s hard to say whether adalimumab should be the preferred treatment for these patients.

“But it’s an interesting question that should be addressed in a bigger study,” he said.

Other TNFis included infliximab (Remicade and biosimilars) in 27%, golimumab (Simponi) in 2%, and certolizumab pegol (Cimzia) in 1%.

He presented the results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Study details

Included in the retrospective cohort study were 82 adults with IBD and either ankylosing spondylitis or sacroiliitis who started anti-TNF agents approved for IBD between January 2012 and October 2021 at a large academic center.

Clinical remission of axSpA was the primary outcome, defined as the absence or adequate control of pain and/or stiffness related to axSpA as documented in the rheumatology note 1 year (+/– 2 months) after starting anti-TNF agents.

The secondary outcome was clinical remission of IBD, defined as 2 or less on the simple clinical colitis activity index, a score of less than 5 on the Harvey-Bradshaw Index, or provider assessment with no use of oral or intravenous glucocorticoids for 30 days. Dr. Dalal said 74% in the study reached that endpoint in the study period.

“Some patients had good response to anti-TNF treatments for their IBD but not necessarily for their spondyloarthritis,” he explained.

There were insufficient observations to calculate odds ratios for the variables, including Hispanic ethnicity, endoscopic inflammation, and prior history of using vedolizumab (Entyvio), secukinumab (Cosentyx), and ustekinumab (Stelara), the authors noted.

Dr. Dalal said it’s important to study this population because patients with IBD and axSpA take some of the same medications, but it’s not known how each medication acts in patients.

“We don’t have much data to tell us who’s going to respond to treatments from both diseases simultaneously,” he said.
 

Conclusions called ‘reassuring’

Jean Liew, MD, a spondyloarthritis specialist at Boston University, who was not part of the study, noted that the team reported univariate associations of clinical factors with achievement of clinical axSpA remission, but no multivariable analyses with adjustment for potential confounders.

She said the finding of half the patients achieving clinical remission is “reassuring, as anecdotally we may find that patients with IBD-associated spondyloarthritis tend to have more difficult-to-treat symptoms as well as more limited treatment options. For example, they cannot use [interleukin]-17 inhibitors.”

She noted the study is small and descriptive and further analyses are limited by the small number of patients.

“I think if a study of the same type could be performed at a larger scale with larger numbers, it could generate more data on which type of patient with IBD-associated spondyloarthritis is more likely to have a good response after starting a TNF inhibitor,” she said. “Of course, the other question is how long those patients would have good disease control while on the TNF inhibitor. What is the persistence of the medication? This study doesn’t ask or answer that question.”

Dr. Dalal added that in future research it will be important to look at response to medications beyond TNFis, especially Janus kinase inhibitors.

That will help show “whether there is a treatment algorithm that can be tailored to this population in terms of what agents to choose first,” he said. “I think we need multicenter studies to do this.”

Dr. Dalal has received grant funding from Pfizer and Janssen and has served as a consultant for Centaur Labs and Janssen. Dr. Liew has no relevant financial relationships.

CLEVELAND – About half (52%) of patients living with both axial spondyloarthritis and inflammatory bowel disease (IBD) reached clinical remission of axSpA at 12 months after starting a tumor necrosis factor inhibitor (TNFi), researchers have found.

The disease course for axSpA among patients with IBD who start anti-TNF agents is not well understood.

Rahul S. Dalal, MD, an advanced fellow in IBD with the division of gastroenterology, hepatology, and endoscopy at Brigham and Women’s Hospital, Boston, and colleagues studied whether certain clinical factors were associated with remission of axSpA after patients with axSpA, who also had Crohn’s disease (CD) or ulcerative colitis (UC), started anti-TNF therapy.
 

Short IBD duration, adalimumab linked with higher remission odds

They found that those who had IBD for less than 5 years and those taking the TNFi adalimumab (Humira and biosimilars), as opposed to another TNFi, had a higher likelihood of reaching axSpA remission at 1 year. The odds ratios calculated for those factors were statistically significant.

Dr. Dalal said that most of the patients in the study (70%) were prescribed adalimumab, and because the study didn’t compare TNFis head to head, it’s hard to say whether adalimumab should be the preferred treatment for these patients.

“But it’s an interesting question that should be addressed in a bigger study,” he said.

Other TNFis included infliximab (Remicade and biosimilars) in 27%, golimumab (Simponi) in 2%, and certolizumab pegol (Cimzia) in 1%.

He presented the results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Study details

Included in the retrospective cohort study were 82 adults with IBD and either ankylosing spondylitis or sacroiliitis who started anti-TNF agents approved for IBD between January 2012 and October 2021 at a large academic center.

Clinical remission of axSpA was the primary outcome, defined as the absence or adequate control of pain and/or stiffness related to axSpA as documented in the rheumatology note 1 year (+/– 2 months) after starting anti-TNF agents.

The secondary outcome was clinical remission of IBD, defined as 2 or less on the simple clinical colitis activity index, a score of less than 5 on the Harvey-Bradshaw Index, or provider assessment with no use of oral or intravenous glucocorticoids for 30 days. Dr. Dalal said 74% in the study reached that endpoint in the study period.

“Some patients had good response to anti-TNF treatments for their IBD but not necessarily for their spondyloarthritis,” he explained.

There were insufficient observations to calculate odds ratios for the variables, including Hispanic ethnicity, endoscopic inflammation, and prior history of using vedolizumab (Entyvio), secukinumab (Cosentyx), and ustekinumab (Stelara), the authors noted.

Dr. Dalal said it’s important to study this population because patients with IBD and axSpA take some of the same medications, but it’s not known how each medication acts in patients.

“We don’t have much data to tell us who’s going to respond to treatments from both diseases simultaneously,” he said.