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FDA passes on olorofim despite critical need for antifungals
The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.
Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.
The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.
The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.
David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.
“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
Early results ‘exciting’
Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”
Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.
Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.
It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.
Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
Complete response letter issued
F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”
Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.
Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”
In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.
“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
Plant drug undermining olorofim efficacy in humans
“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.
Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”
F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.
Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.
The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.
The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.
David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.
“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
Early results ‘exciting’
Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”
Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.
Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.
It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.
Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
Complete response letter issued
F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”
Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.
Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”
In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.
“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
Plant drug undermining olorofim efficacy in humans
“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.
Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”
F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.
Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.
The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.
The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.
David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.
“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
Early results ‘exciting’
Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”
Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.
Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.
It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.
Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
Complete response letter issued
F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”
Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.
Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”
In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.
“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
Plant drug undermining olorofim efficacy in humans
“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.
Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”
F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.
A version of this article first appeared on Medscape.com.
Few of those eligible get lung cancer screening, despite USPSTF recommendations
Only 12.8% of eligible adults get CT screening for lung cancer, despite recommendations from the U.S. Preventive Services Task Force.
Kristin G. Maki, PhD, with Karmanos Cancer Institute, Wayne State University, Detroit, led a team that estimated lung cancer screening (LCS) from the 2021 Behavioral Risk Factor Surveillance System in four states (Maine, Michigan, New Jersey, and Rhode Island).
“Increasing LCS among eligible adults is a national priority,” the authors wrote in the study, published online in JAMA Network Open. Lung cancer remains the top cause of cancer in the United States and smoking accounts for approximately 90% of cases.
Screening much higher for other cancers
The authors pointed out that screening rates for eligible people are much higher for other cancers. Melzer and colleagues wrote in a 2021 editorial that breast and colon cancer screening rates are near 70% “despite combined annual death rates less than two-thirds that of lung cancer.”
The USPSTF updated its recommendations for lung cancer screening in March 2021.
Eligibility now includes anyone aged between 50 and 80 years who has smoked at least 20 pack-years and either still smokes or quit within the last 15 years.
The researchers found that, when comparing screening by health status, the highest odds for screening were seen in those who reported they were in poor health, which is concerning, the authors note, because those patients may not be healthy enough to benefit from treatment for their lung cancer.
The odds ratio for getting screening was 2.88 (95% confidence interval, 0.85-9.77) times higher than that of the reference group, which reported excellent health.
Rates differ by state
Consistent with previous studies, this analysis found that screening rates differed by state. Their analysis, for example, showed a higher likelihood of screening for respondents in Rhode Island, compared with Maine (OR, 1.96; 95% CI, 1.05-3.67; P = .03).
Patients who reported having a primary health professional were more than five times more likely to undergo screening, compared with those without one (OR, 5.62; 95% CI, 1.19-26.49).
The authors said their results also highlight the need for Medicare coverage for screening as those with public insurance had lower odds of screening than those with private insurance (OR, 0.81; 95% CI, 0.42-1.56).
Neelima Navuluri, MD, assistant professor in the division of pulmonary, allergy, and critical care at Duke University and the Duke Global Health Institute, both in Durham, N.C., pointed out that the study highlights age, smoking status, and health care access as key factors associated with lack of uptake.
Work needed on all levels
Dr. Navuluri said in an interview that multifaceted patient-, provider- and system-level interventions are needed to improve screening rates.
“For example, we need more community engagement to increase knowledge and awareness of eligibility for lung cancer screening,” she said.
She highlighted the need for interventions around improving and streamlining shared decision-making conversations about screening (a CMS requirement that does not exist for other cancer screening).
Emphasis is needed on younger age groups, people who currently smoke, and communities of color as well as policy to improve insurance coverage of screening, she said.
Dr. Navuluri, who also works with the Durham Veterans Affairs Medical Center, was lead author on a study published in JAMA Network Open on racial disparities in screening among veterans.
“We demonstrate similar findings related to age, smoking status, and poor health status,” she said. “We discuss the need for more qualitative studies to better understand the role of these factors as well as implementation studies to assess effectiveness of various interventions to improve disparities in lung cancer screening rates.”
“Research to identify facilitators for LCS among persons who currently smoke is needed, including a focus on the role of stigma as a barrier to screening,” they wrote.
One coauthor is supported by the cancer prevention and research training program at the University of Texas MD Anderson Cancer Center and the Cancer Prevention and Research Institute of Texas. No other disclosures were reported. Dr. Navuluri receives funding from the National Comprehensive Cancer Network for work on lung cancer screening.
Only 12.8% of eligible adults get CT screening for lung cancer, despite recommendations from the U.S. Preventive Services Task Force.
Kristin G. Maki, PhD, with Karmanos Cancer Institute, Wayne State University, Detroit, led a team that estimated lung cancer screening (LCS) from the 2021 Behavioral Risk Factor Surveillance System in four states (Maine, Michigan, New Jersey, and Rhode Island).
“Increasing LCS among eligible adults is a national priority,” the authors wrote in the study, published online in JAMA Network Open. Lung cancer remains the top cause of cancer in the United States and smoking accounts for approximately 90% of cases.
Screening much higher for other cancers
The authors pointed out that screening rates for eligible people are much higher for other cancers. Melzer and colleagues wrote in a 2021 editorial that breast and colon cancer screening rates are near 70% “despite combined annual death rates less than two-thirds that of lung cancer.”
The USPSTF updated its recommendations for lung cancer screening in March 2021.
Eligibility now includes anyone aged between 50 and 80 years who has smoked at least 20 pack-years and either still smokes or quit within the last 15 years.
The researchers found that, when comparing screening by health status, the highest odds for screening were seen in those who reported they were in poor health, which is concerning, the authors note, because those patients may not be healthy enough to benefit from treatment for their lung cancer.
The odds ratio for getting screening was 2.88 (95% confidence interval, 0.85-9.77) times higher than that of the reference group, which reported excellent health.
Rates differ by state
Consistent with previous studies, this analysis found that screening rates differed by state. Their analysis, for example, showed a higher likelihood of screening for respondents in Rhode Island, compared with Maine (OR, 1.96; 95% CI, 1.05-3.67; P = .03).
Patients who reported having a primary health professional were more than five times more likely to undergo screening, compared with those without one (OR, 5.62; 95% CI, 1.19-26.49).
The authors said their results also highlight the need for Medicare coverage for screening as those with public insurance had lower odds of screening than those with private insurance (OR, 0.81; 95% CI, 0.42-1.56).
Neelima Navuluri, MD, assistant professor in the division of pulmonary, allergy, and critical care at Duke University and the Duke Global Health Institute, both in Durham, N.C., pointed out that the study highlights age, smoking status, and health care access as key factors associated with lack of uptake.
Work needed on all levels
Dr. Navuluri said in an interview that multifaceted patient-, provider- and system-level interventions are needed to improve screening rates.
“For example, we need more community engagement to increase knowledge and awareness of eligibility for lung cancer screening,” she said.
She highlighted the need for interventions around improving and streamlining shared decision-making conversations about screening (a CMS requirement that does not exist for other cancer screening).
Emphasis is needed on younger age groups, people who currently smoke, and communities of color as well as policy to improve insurance coverage of screening, she said.
Dr. Navuluri, who also works with the Durham Veterans Affairs Medical Center, was lead author on a study published in JAMA Network Open on racial disparities in screening among veterans.
“We demonstrate similar findings related to age, smoking status, and poor health status,” she said. “We discuss the need for more qualitative studies to better understand the role of these factors as well as implementation studies to assess effectiveness of various interventions to improve disparities in lung cancer screening rates.”
“Research to identify facilitators for LCS among persons who currently smoke is needed, including a focus on the role of stigma as a barrier to screening,” they wrote.
One coauthor is supported by the cancer prevention and research training program at the University of Texas MD Anderson Cancer Center and the Cancer Prevention and Research Institute of Texas. No other disclosures were reported. Dr. Navuluri receives funding from the National Comprehensive Cancer Network for work on lung cancer screening.
Only 12.8% of eligible adults get CT screening for lung cancer, despite recommendations from the U.S. Preventive Services Task Force.
Kristin G. Maki, PhD, with Karmanos Cancer Institute, Wayne State University, Detroit, led a team that estimated lung cancer screening (LCS) from the 2021 Behavioral Risk Factor Surveillance System in four states (Maine, Michigan, New Jersey, and Rhode Island).
“Increasing LCS among eligible adults is a national priority,” the authors wrote in the study, published online in JAMA Network Open. Lung cancer remains the top cause of cancer in the United States and smoking accounts for approximately 90% of cases.
Screening much higher for other cancers
The authors pointed out that screening rates for eligible people are much higher for other cancers. Melzer and colleagues wrote in a 2021 editorial that breast and colon cancer screening rates are near 70% “despite combined annual death rates less than two-thirds that of lung cancer.”
The USPSTF updated its recommendations for lung cancer screening in March 2021.
Eligibility now includes anyone aged between 50 and 80 years who has smoked at least 20 pack-years and either still smokes or quit within the last 15 years.
The researchers found that, when comparing screening by health status, the highest odds for screening were seen in those who reported they were in poor health, which is concerning, the authors note, because those patients may not be healthy enough to benefit from treatment for their lung cancer.
The odds ratio for getting screening was 2.88 (95% confidence interval, 0.85-9.77) times higher than that of the reference group, which reported excellent health.
Rates differ by state
Consistent with previous studies, this analysis found that screening rates differed by state. Their analysis, for example, showed a higher likelihood of screening for respondents in Rhode Island, compared with Maine (OR, 1.96; 95% CI, 1.05-3.67; P = .03).
Patients who reported having a primary health professional were more than five times more likely to undergo screening, compared with those without one (OR, 5.62; 95% CI, 1.19-26.49).
The authors said their results also highlight the need for Medicare coverage for screening as those with public insurance had lower odds of screening than those with private insurance (OR, 0.81; 95% CI, 0.42-1.56).
Neelima Navuluri, MD, assistant professor in the division of pulmonary, allergy, and critical care at Duke University and the Duke Global Health Institute, both in Durham, N.C., pointed out that the study highlights age, smoking status, and health care access as key factors associated with lack of uptake.
Work needed on all levels
Dr. Navuluri said in an interview that multifaceted patient-, provider- and system-level interventions are needed to improve screening rates.
“For example, we need more community engagement to increase knowledge and awareness of eligibility for lung cancer screening,” she said.
She highlighted the need for interventions around improving and streamlining shared decision-making conversations about screening (a CMS requirement that does not exist for other cancer screening).
Emphasis is needed on younger age groups, people who currently smoke, and communities of color as well as policy to improve insurance coverage of screening, she said.
Dr. Navuluri, who also works with the Durham Veterans Affairs Medical Center, was lead author on a study published in JAMA Network Open on racial disparities in screening among veterans.
“We demonstrate similar findings related to age, smoking status, and poor health status,” she said. “We discuss the need for more qualitative studies to better understand the role of these factors as well as implementation studies to assess effectiveness of various interventions to improve disparities in lung cancer screening rates.”
“Research to identify facilitators for LCS among persons who currently smoke is needed, including a focus on the role of stigma as a barrier to screening,” they wrote.
One coauthor is supported by the cancer prevention and research training program at the University of Texas MD Anderson Cancer Center and the Cancer Prevention and Research Institute of Texas. No other disclosures were reported. Dr. Navuluri receives funding from the National Comprehensive Cancer Network for work on lung cancer screening.
FROM JAMA NETWORK OPEN
Risk threshold may help providers decide on rabies PEP
The model, reported in JAMA Network Open, could help clinicians, particularly those in primary care settings, to more rationally prescribe PEP to people concerned about a potential exposure to the rabies virus (RABV). In the United States, rabies PEP often is given without a comprehensive assessment that considers regional factors as well as species, nature of an attack, and the health and vaccination status of the animal.
Providers err on the side of caution, as rabies infection has a fatality rate near 100%. When exposures are low-risk, however, patients can rack up substantial out-of-pocket expenses or experience unnecessary adverse effects from the series of shots. Those can include injection site reactions, hypersensitivity reactions, and neurological complications.
The authors write that an estimated 55,000 people per year in the United States were treated for potential exposure to RABV in 2017 and 2018, at an estimated cost of more than $3,800 per person treated.
Researchers calculate risk threshold
The researchers, led by Kelly Charniga, PhD, MPH, an infectious disease epidemiologist with the U.S. Centers for Disease Control and Prevention in Atlanta, calculated positivity rates using more than 900,000 animal samples tested for RABV between 2011 and 2020. Other parameters were estimated from surveillance data and the literature and probabilities were estimated using Bayes’ rule.
A convenience sample of state public health officials in all states (excluding Hawaii) plus Washington and Puerto Rico was used to help determine a risk threshold for recommending PEP. Respondents were asked whether they would recommend PEP given 24 standardized exposure scenarios while accounting for local rabies epidemiology.
Their model establishes a risk threshold of 0.0004 for PEP administration, which represents the probability that an animal would test positive for RABV given that a person was exposed, and the probability that a person would die from rabies after exposure to a suspect rabid animal and no PEP. PEP should not be recommended with any value lower than that cutoff.
Alfred DeMaria, DPH, a consultant to the Massachusetts Department of Public Health in Boston, who was not involved with the study, said the work will be particularly helpful for primary care physicians, giving them confidence to not recommend PEP when infection is statistically highly unlikely and thereby to reduce unnecessary and costly measures.
“Concern about rabies is often based on a very unlikely scenario,” Dr. DeMaria said. He gave the example of people coming into primary care worried that they might have been exposed after comforting their dog who had been bitten in a fight with a wild animal.
“Has that ever happened in the history of the human species? Not that we know of,” he said.
Many people also think dogs and other domestic animals are a likely source of rabies, which is not the case in the United States, Dr. DeMaria said.
“In most cases, it is exposure to a raccoon, a skunk, or a bat,” he said. “Most calls are for potential bat exposure, especially in the summer when young bats are flying around and are not very savvy about avoiding humans.”
The authors note the difference between the animals likely to bite and the species that carry RABV: “The most common mammals involved in bite events in the U.S. are dogs, cats, and small rodents. These species, when healthy and provoked into biting, represent some of the lowest risk exposures evaluated in this model.”
The canine rabies variant virus was eliminated in the United States in 2004.
The study authors note that their model should not be used in other countries because “most rabies deaths globally are caused by domestic dogs.”
Health department consultation can reduce inappropriate treatment
Dr. DeMaria said the paper may also convince physicians to consult with their health department for a final recommendation.
The authors note that a 2020 study in Cook County, Ill., found patients who received PEP were about 90% less likely to receive inappropriate treatment if their clinician had consulted with a health department.
“Anything that puts the risk in a context, like this paper does, is helpful,” he said.
Most physicians in the United States will never see a patient with rabies, the authors write, but animal bites are common – resulting in hundreds of thousands of primary care and emergency department visits each year when physicians must decide whether to administer PEP.
The study authors and Dr. DeMaria report no relevant financial relationships.
The model, reported in JAMA Network Open, could help clinicians, particularly those in primary care settings, to more rationally prescribe PEP to people concerned about a potential exposure to the rabies virus (RABV). In the United States, rabies PEP often is given without a comprehensive assessment that considers regional factors as well as species, nature of an attack, and the health and vaccination status of the animal.
Providers err on the side of caution, as rabies infection has a fatality rate near 100%. When exposures are low-risk, however, patients can rack up substantial out-of-pocket expenses or experience unnecessary adverse effects from the series of shots. Those can include injection site reactions, hypersensitivity reactions, and neurological complications.
The authors write that an estimated 55,000 people per year in the United States were treated for potential exposure to RABV in 2017 and 2018, at an estimated cost of more than $3,800 per person treated.
Researchers calculate risk threshold
The researchers, led by Kelly Charniga, PhD, MPH, an infectious disease epidemiologist with the U.S. Centers for Disease Control and Prevention in Atlanta, calculated positivity rates using more than 900,000 animal samples tested for RABV between 2011 and 2020. Other parameters were estimated from surveillance data and the literature and probabilities were estimated using Bayes’ rule.
A convenience sample of state public health officials in all states (excluding Hawaii) plus Washington and Puerto Rico was used to help determine a risk threshold for recommending PEP. Respondents were asked whether they would recommend PEP given 24 standardized exposure scenarios while accounting for local rabies epidemiology.
Their model establishes a risk threshold of 0.0004 for PEP administration, which represents the probability that an animal would test positive for RABV given that a person was exposed, and the probability that a person would die from rabies after exposure to a suspect rabid animal and no PEP. PEP should not be recommended with any value lower than that cutoff.
Alfred DeMaria, DPH, a consultant to the Massachusetts Department of Public Health in Boston, who was not involved with the study, said the work will be particularly helpful for primary care physicians, giving them confidence to not recommend PEP when infection is statistically highly unlikely and thereby to reduce unnecessary and costly measures.
“Concern about rabies is often based on a very unlikely scenario,” Dr. DeMaria said. He gave the example of people coming into primary care worried that they might have been exposed after comforting their dog who had been bitten in a fight with a wild animal.
“Has that ever happened in the history of the human species? Not that we know of,” he said.
Many people also think dogs and other domestic animals are a likely source of rabies, which is not the case in the United States, Dr. DeMaria said.
“In most cases, it is exposure to a raccoon, a skunk, or a bat,” he said. “Most calls are for potential bat exposure, especially in the summer when young bats are flying around and are not very savvy about avoiding humans.”
The authors note the difference between the animals likely to bite and the species that carry RABV: “The most common mammals involved in bite events in the U.S. are dogs, cats, and small rodents. These species, when healthy and provoked into biting, represent some of the lowest risk exposures evaluated in this model.”
The canine rabies variant virus was eliminated in the United States in 2004.
The study authors note that their model should not be used in other countries because “most rabies deaths globally are caused by domestic dogs.”
Health department consultation can reduce inappropriate treatment
Dr. DeMaria said the paper may also convince physicians to consult with their health department for a final recommendation.
The authors note that a 2020 study in Cook County, Ill., found patients who received PEP were about 90% less likely to receive inappropriate treatment if their clinician had consulted with a health department.
“Anything that puts the risk in a context, like this paper does, is helpful,” he said.
Most physicians in the United States will never see a patient with rabies, the authors write, but animal bites are common – resulting in hundreds of thousands of primary care and emergency department visits each year when physicians must decide whether to administer PEP.
The study authors and Dr. DeMaria report no relevant financial relationships.
The model, reported in JAMA Network Open, could help clinicians, particularly those in primary care settings, to more rationally prescribe PEP to people concerned about a potential exposure to the rabies virus (RABV). In the United States, rabies PEP often is given without a comprehensive assessment that considers regional factors as well as species, nature of an attack, and the health and vaccination status of the animal.
Providers err on the side of caution, as rabies infection has a fatality rate near 100%. When exposures are low-risk, however, patients can rack up substantial out-of-pocket expenses or experience unnecessary adverse effects from the series of shots. Those can include injection site reactions, hypersensitivity reactions, and neurological complications.
The authors write that an estimated 55,000 people per year in the United States were treated for potential exposure to RABV in 2017 and 2018, at an estimated cost of more than $3,800 per person treated.
Researchers calculate risk threshold
The researchers, led by Kelly Charniga, PhD, MPH, an infectious disease epidemiologist with the U.S. Centers for Disease Control and Prevention in Atlanta, calculated positivity rates using more than 900,000 animal samples tested for RABV between 2011 and 2020. Other parameters were estimated from surveillance data and the literature and probabilities were estimated using Bayes’ rule.
A convenience sample of state public health officials in all states (excluding Hawaii) plus Washington and Puerto Rico was used to help determine a risk threshold for recommending PEP. Respondents were asked whether they would recommend PEP given 24 standardized exposure scenarios while accounting for local rabies epidemiology.
Their model establishes a risk threshold of 0.0004 for PEP administration, which represents the probability that an animal would test positive for RABV given that a person was exposed, and the probability that a person would die from rabies after exposure to a suspect rabid animal and no PEP. PEP should not be recommended with any value lower than that cutoff.
Alfred DeMaria, DPH, a consultant to the Massachusetts Department of Public Health in Boston, who was not involved with the study, said the work will be particularly helpful for primary care physicians, giving them confidence to not recommend PEP when infection is statistically highly unlikely and thereby to reduce unnecessary and costly measures.
“Concern about rabies is often based on a very unlikely scenario,” Dr. DeMaria said. He gave the example of people coming into primary care worried that they might have been exposed after comforting their dog who had been bitten in a fight with a wild animal.
“Has that ever happened in the history of the human species? Not that we know of,” he said.
Many people also think dogs and other domestic animals are a likely source of rabies, which is not the case in the United States, Dr. DeMaria said.
“In most cases, it is exposure to a raccoon, a skunk, or a bat,” he said. “Most calls are for potential bat exposure, especially in the summer when young bats are flying around and are not very savvy about avoiding humans.”
The authors note the difference between the animals likely to bite and the species that carry RABV: “The most common mammals involved in bite events in the U.S. are dogs, cats, and small rodents. These species, when healthy and provoked into biting, represent some of the lowest risk exposures evaluated in this model.”
The canine rabies variant virus was eliminated in the United States in 2004.
The study authors note that their model should not be used in other countries because “most rabies deaths globally are caused by domestic dogs.”
Health department consultation can reduce inappropriate treatment
Dr. DeMaria said the paper may also convince physicians to consult with their health department for a final recommendation.
The authors note that a 2020 study in Cook County, Ill., found patients who received PEP were about 90% less likely to receive inappropriate treatment if their clinician had consulted with a health department.
“Anything that puts the risk in a context, like this paper does, is helpful,” he said.
Most physicians in the United States will never see a patient with rabies, the authors write, but animal bites are common – resulting in hundreds of thousands of primary care and emergency department visits each year when physicians must decide whether to administer PEP.
The study authors and Dr. DeMaria report no relevant financial relationships.
FROM JAMA NETWORK
Kangaroo mother care may cut death risk for premature babies by a third
, according to new research published online in BMJ Global Health.
Starting the contact, which involves mothers carrying the newborn in a sling, within 24 hours of birth and continuing it for at least 8 hours a day both appear to amplify the effect on reducing mortality and infection, the paper states.
Sindhu Sivanandan, MD, with the department of neonatology at Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, and Mari Jeeva Sankar, MD, in the pediatrics department of the All India Institute of Medical Sciences, New Delhi, looked at existing studies to compare KMC with conventional care and to compare starting the intervention within 24 hours of birth versus a later start.
Their review looked at 31 trials that included 15,559 low-birthweight and preterm infants collectively. Of the 31 trials, 27 studies compared KMC with conventional care and four compared early with late initiation of KMC.
Mortality risk reduction
Analysis showed that, compared with conventional care, KMC appeared to cut mortality risk by 32% (relative risk, 0.68; 95% confidence interval, 0.53-0.86) during birth hospitalization or by 28 days after birth, while it seemed to reduce the risk of severe infection, such as sepsis, by 15% (RR, 0.85; 95% CI, 0.76-0.96; low-certainty evidence.)
That mortality-risk reduction was found regardless of gestational age or weight of the child at enrolment, time of starting KMC, and whether the intervention was started in a hospital or community.
The studies that had compared early with late-initiated KMC showed a reduction in neonatal mortality of 33%.
Low- and middle-income countries have the highest rates of premature births (gestational age of less than 37 weeks) and low birthweight (less than 2,500 grams). Premature births and low birthweight both are key causes of death and disability.
The World Health Organization recommends KMC as the standard of care among low birthweight infants after clinical stabilization. The American Academy of Pediatrics also promotes immediate KMC.
Relevance in the U.S.
Grace Chan, MD, MPH, PhD, an epidemiologist and pediatrician with the Harvard School of Public Health, Boston, said though the practice is promoted by the WHO and AAP, recommendations to families vary widely by providers.
She said the health benefits for KMC are numerous. One of the biggest is that skin-to-skin contact can help transfer heat to newborns who may have trouble regulating their own temperature. That is especially important in cold climates in places where there may be insufficient indoor heat.
She said it’s well-known that preterm babies are at higher risk for apnea, and listening to a mother’s heartbeat may stimulate the child to breathe regularly.
Additionally with KMC, there’s an inherent benefit of a mother or caregiver being able to see any change in a newborn’s color immediately when the baby is held so closely, as opposed to a nurse watching several babies at a time in a neonatal intensive care unit.
This is evidence that starting KMC right away is important, because the risk of death for premature and low-weight newborns is highest in the first 24 hours of life, Dr. Chan noted.
Barriers of time
There are some barriers, she noted, in that mothers or other caregivers caring for several young children may not have the time to carry a child in a sling for 8 or more hours at a time.
The authors conclude that their findings have policy implications, particularly for low- and middle-income countries: “KMC should be provided to all low birth weight and preterm infants irrespective of the settings – both health facilities and at home,” they wrote.
The authors caution that, “very low birth weight, extremely preterm neonates, and severely unstable neonates were often excluded from studies. More evidence is needed before extrapolating the study results in these high-risk groups.”
The study authors and Dr. Chan report no relevant financial relationships.
, according to new research published online in BMJ Global Health.
Starting the contact, which involves mothers carrying the newborn in a sling, within 24 hours of birth and continuing it for at least 8 hours a day both appear to amplify the effect on reducing mortality and infection, the paper states.
Sindhu Sivanandan, MD, with the department of neonatology at Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, and Mari Jeeva Sankar, MD, in the pediatrics department of the All India Institute of Medical Sciences, New Delhi, looked at existing studies to compare KMC with conventional care and to compare starting the intervention within 24 hours of birth versus a later start.
Their review looked at 31 trials that included 15,559 low-birthweight and preterm infants collectively. Of the 31 trials, 27 studies compared KMC with conventional care and four compared early with late initiation of KMC.
Mortality risk reduction
Analysis showed that, compared with conventional care, KMC appeared to cut mortality risk by 32% (relative risk, 0.68; 95% confidence interval, 0.53-0.86) during birth hospitalization or by 28 days after birth, while it seemed to reduce the risk of severe infection, such as sepsis, by 15% (RR, 0.85; 95% CI, 0.76-0.96; low-certainty evidence.)
That mortality-risk reduction was found regardless of gestational age or weight of the child at enrolment, time of starting KMC, and whether the intervention was started in a hospital or community.
The studies that had compared early with late-initiated KMC showed a reduction in neonatal mortality of 33%.
Low- and middle-income countries have the highest rates of premature births (gestational age of less than 37 weeks) and low birthweight (less than 2,500 grams). Premature births and low birthweight both are key causes of death and disability.
The World Health Organization recommends KMC as the standard of care among low birthweight infants after clinical stabilization. The American Academy of Pediatrics also promotes immediate KMC.
Relevance in the U.S.
Grace Chan, MD, MPH, PhD, an epidemiologist and pediatrician with the Harvard School of Public Health, Boston, said though the practice is promoted by the WHO and AAP, recommendations to families vary widely by providers.
She said the health benefits for KMC are numerous. One of the biggest is that skin-to-skin contact can help transfer heat to newborns who may have trouble regulating their own temperature. That is especially important in cold climates in places where there may be insufficient indoor heat.
She said it’s well-known that preterm babies are at higher risk for apnea, and listening to a mother’s heartbeat may stimulate the child to breathe regularly.
Additionally with KMC, there’s an inherent benefit of a mother or caregiver being able to see any change in a newborn’s color immediately when the baby is held so closely, as opposed to a nurse watching several babies at a time in a neonatal intensive care unit.
This is evidence that starting KMC right away is important, because the risk of death for premature and low-weight newborns is highest in the first 24 hours of life, Dr. Chan noted.
Barriers of time
There are some barriers, she noted, in that mothers or other caregivers caring for several young children may not have the time to carry a child in a sling for 8 or more hours at a time.
The authors conclude that their findings have policy implications, particularly for low- and middle-income countries: “KMC should be provided to all low birth weight and preterm infants irrespective of the settings – both health facilities and at home,” they wrote.
The authors caution that, “very low birth weight, extremely preterm neonates, and severely unstable neonates were often excluded from studies. More evidence is needed before extrapolating the study results in these high-risk groups.”
The study authors and Dr. Chan report no relevant financial relationships.
, according to new research published online in BMJ Global Health.
Starting the contact, which involves mothers carrying the newborn in a sling, within 24 hours of birth and continuing it for at least 8 hours a day both appear to amplify the effect on reducing mortality and infection, the paper states.
Sindhu Sivanandan, MD, with the department of neonatology at Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, and Mari Jeeva Sankar, MD, in the pediatrics department of the All India Institute of Medical Sciences, New Delhi, looked at existing studies to compare KMC with conventional care and to compare starting the intervention within 24 hours of birth versus a later start.
Their review looked at 31 trials that included 15,559 low-birthweight and preterm infants collectively. Of the 31 trials, 27 studies compared KMC with conventional care and four compared early with late initiation of KMC.
Mortality risk reduction
Analysis showed that, compared with conventional care, KMC appeared to cut mortality risk by 32% (relative risk, 0.68; 95% confidence interval, 0.53-0.86) during birth hospitalization or by 28 days after birth, while it seemed to reduce the risk of severe infection, such as sepsis, by 15% (RR, 0.85; 95% CI, 0.76-0.96; low-certainty evidence.)
That mortality-risk reduction was found regardless of gestational age or weight of the child at enrolment, time of starting KMC, and whether the intervention was started in a hospital or community.
The studies that had compared early with late-initiated KMC showed a reduction in neonatal mortality of 33%.
Low- and middle-income countries have the highest rates of premature births (gestational age of less than 37 weeks) and low birthweight (less than 2,500 grams). Premature births and low birthweight both are key causes of death and disability.
The World Health Organization recommends KMC as the standard of care among low birthweight infants after clinical stabilization. The American Academy of Pediatrics also promotes immediate KMC.
Relevance in the U.S.
Grace Chan, MD, MPH, PhD, an epidemiologist and pediatrician with the Harvard School of Public Health, Boston, said though the practice is promoted by the WHO and AAP, recommendations to families vary widely by providers.
She said the health benefits for KMC are numerous. One of the biggest is that skin-to-skin contact can help transfer heat to newborns who may have trouble regulating their own temperature. That is especially important in cold climates in places where there may be insufficient indoor heat.
She said it’s well-known that preterm babies are at higher risk for apnea, and listening to a mother’s heartbeat may stimulate the child to breathe regularly.
Additionally with KMC, there’s an inherent benefit of a mother or caregiver being able to see any change in a newborn’s color immediately when the baby is held so closely, as opposed to a nurse watching several babies at a time in a neonatal intensive care unit.
This is evidence that starting KMC right away is important, because the risk of death for premature and low-weight newborns is highest in the first 24 hours of life, Dr. Chan noted.
Barriers of time
There are some barriers, she noted, in that mothers or other caregivers caring for several young children may not have the time to carry a child in a sling for 8 or more hours at a time.
The authors conclude that their findings have policy implications, particularly for low- and middle-income countries: “KMC should be provided to all low birth weight and preterm infants irrespective of the settings – both health facilities and at home,” they wrote.
The authors caution that, “very low birth weight, extremely preterm neonates, and severely unstable neonates were often excluded from studies. More evidence is needed before extrapolating the study results in these high-risk groups.”
The study authors and Dr. Chan report no relevant financial relationships.
FROM BMJ GLOBAL HEALTH
Halting active inflammation key in treating PIH
CHICAGO –
Dr. Desai, clinical assistant professor in the department of dermatology at the University of Texas Southwestern Medical Center, Dallas, spoke at the Pigmentary Disorders Exchange Symposium, provided by MedscapeLive!
Like all dermatologists, he said at the meeting, he sees lots of acne cases. However, PIH is often the presenting reason for the visit in his practice, which focuses predominantly on skin of color.
“Most of my patients come in not even worried about the acne,” he said. “They come in wanting me to fix the dark spots.”
Inflammation persists
Dermatologists, Dr. Desai said, should educate patients with active PIH resulting from acne or other diseases that even though the condition has been labeled post- inflammatory hyperpigmentation, the inflammation continues to be a problem.
He said, while patients may think PIH is “just scars,” the inflammation is still active and the condition needs to be treated from a skin-lightening perspective but, more importantly, with a focus on halting the inflammation. “If you were to biopsy the areas of hyperpigmentation, you would find a high density of active inflammatory behaviors still present in the skin,” he said.
When treating patients, it’s critical to first treat the underlying skin condition aggressively, he said. “Things like topical retinoids and azelaic acid mechanistically actually make a lot more sense for PIH than even hydroquinone, in some cases, because these therapies are actually anti-inflammatory for many of the diseases we treat.”
Dr. Desai noted that, in patients with darker skin tones, even diseases like seborrheic dermatitis and plaque psoriasis can result in PIH, while in patients with lighter skin tones, the same diseases may leave some residual postinflammatory erythema.
“I think it’s very important, particularly when you’re treating a darker skin–toned patient, to arrest the erythema early on to prevent that further worsening of hyperpigmentation,” he said.
Biopsies important
In cases of PIH, determining the best treatment requires finding out where the pigment is and how deep it is, Dr. Desai said.
He noted dermatologists are often worried about doing biopsies, particularly in patients with darker skin, because of the risk of scarring and keloid formation for those more prone to keloids. The preference is also for a therapeutic effect without using invasive procedures.
“But particularly with PIH, in patients who have been therapeutically challenging, I don’t hesitate to do very small biopsies – 2- and 3-mm punch biopsies – particularly if they are from the head and neck area.”
He suggests doing biopsies on part of the ear, lower jaw line, or the neck area, as these areas tend to heal nicely. “You don’t have to be so concerned about the scarring if you counsel appropriately,” he said.
The biopsy can be valuable in determining whether a very expensive treatment will reach the intended target.
Topical retinoids play an important role as anti-inflammatories for PIH, Dr. Desai said.
He gave an example of a patient with Fitzpatrick skin type IV or V with chronic acne and extensive PIH. “Are you going to effectively tell that patient to apply 4% hydroquinone triple-combination compound across 30 different areas of PIH on their face? The answer is that’s really not very efficient or effective.”
That’s why therapies, such as retinoids, that target the pathogenesis of PIH, particularly the inflammatory component, are important, he added.
Psychological burden
PIH comes with significant stigma and loss of quality of life loss that can last many years.
During another presentation at the meeting, Susan C. Taylor, MD, professor and vice chair of diversity, equity and inclusion in the department of dermatology, at the University of Pennsylvania, Philadelphia, pointed out that in a 2016 study of 324 patients in seven Asian countries, acne-related PIH lasted longer than 1 year in 65.2% of patients and 5 years or longer in 22.3%, significantly affecting their quality of life.
Dr. Desai added that, in a paper recently published in the British Journal of Dermatology, on the impact of postacne hyperpigmentation in patients, the authors pointed out that the reported prevalence of PIH in patients with acne ranges between 45.5% and 87.2%, depending on skin phototype, and that in most cases, PIH takes more than a year to fade.
“Studies have demonstrated that patients with acne and resulting scarring often face stigmatization, leading to quality of life impairment, social withdrawal and body image disorders, which can further contribute to higher risk for depression and social anxiety,” the paper’s authors wrote.
Dr. Desai reported no financial disclosures relevant to his talk.
CHICAGO –
Dr. Desai, clinical assistant professor in the department of dermatology at the University of Texas Southwestern Medical Center, Dallas, spoke at the Pigmentary Disorders Exchange Symposium, provided by MedscapeLive!
Like all dermatologists, he said at the meeting, he sees lots of acne cases. However, PIH is often the presenting reason for the visit in his practice, which focuses predominantly on skin of color.
“Most of my patients come in not even worried about the acne,” he said. “They come in wanting me to fix the dark spots.”
Inflammation persists
Dermatologists, Dr. Desai said, should educate patients with active PIH resulting from acne or other diseases that even though the condition has been labeled post- inflammatory hyperpigmentation, the inflammation continues to be a problem.
He said, while patients may think PIH is “just scars,” the inflammation is still active and the condition needs to be treated from a skin-lightening perspective but, more importantly, with a focus on halting the inflammation. “If you were to biopsy the areas of hyperpigmentation, you would find a high density of active inflammatory behaviors still present in the skin,” he said.
When treating patients, it’s critical to first treat the underlying skin condition aggressively, he said. “Things like topical retinoids and azelaic acid mechanistically actually make a lot more sense for PIH than even hydroquinone, in some cases, because these therapies are actually anti-inflammatory for many of the diseases we treat.”
Dr. Desai noted that, in patients with darker skin tones, even diseases like seborrheic dermatitis and plaque psoriasis can result in PIH, while in patients with lighter skin tones, the same diseases may leave some residual postinflammatory erythema.
“I think it’s very important, particularly when you’re treating a darker skin–toned patient, to arrest the erythema early on to prevent that further worsening of hyperpigmentation,” he said.
Biopsies important
In cases of PIH, determining the best treatment requires finding out where the pigment is and how deep it is, Dr. Desai said.
He noted dermatologists are often worried about doing biopsies, particularly in patients with darker skin, because of the risk of scarring and keloid formation for those more prone to keloids. The preference is also for a therapeutic effect without using invasive procedures.
“But particularly with PIH, in patients who have been therapeutically challenging, I don’t hesitate to do very small biopsies – 2- and 3-mm punch biopsies – particularly if they are from the head and neck area.”
He suggests doing biopsies on part of the ear, lower jaw line, or the neck area, as these areas tend to heal nicely. “You don’t have to be so concerned about the scarring if you counsel appropriately,” he said.
The biopsy can be valuable in determining whether a very expensive treatment will reach the intended target.
Topical retinoids play an important role as anti-inflammatories for PIH, Dr. Desai said.
He gave an example of a patient with Fitzpatrick skin type IV or V with chronic acne and extensive PIH. “Are you going to effectively tell that patient to apply 4% hydroquinone triple-combination compound across 30 different areas of PIH on their face? The answer is that’s really not very efficient or effective.”
That’s why therapies, such as retinoids, that target the pathogenesis of PIH, particularly the inflammatory component, are important, he added.
Psychological burden
PIH comes with significant stigma and loss of quality of life loss that can last many years.
During another presentation at the meeting, Susan C. Taylor, MD, professor and vice chair of diversity, equity and inclusion in the department of dermatology, at the University of Pennsylvania, Philadelphia, pointed out that in a 2016 study of 324 patients in seven Asian countries, acne-related PIH lasted longer than 1 year in 65.2% of patients and 5 years or longer in 22.3%, significantly affecting their quality of life.
Dr. Desai added that, in a paper recently published in the British Journal of Dermatology, on the impact of postacne hyperpigmentation in patients, the authors pointed out that the reported prevalence of PIH in patients with acne ranges between 45.5% and 87.2%, depending on skin phototype, and that in most cases, PIH takes more than a year to fade.
“Studies have demonstrated that patients with acne and resulting scarring often face stigmatization, leading to quality of life impairment, social withdrawal and body image disorders, which can further contribute to higher risk for depression and social anxiety,” the paper’s authors wrote.
Dr. Desai reported no financial disclosures relevant to his talk.
CHICAGO –
Dr. Desai, clinical assistant professor in the department of dermatology at the University of Texas Southwestern Medical Center, Dallas, spoke at the Pigmentary Disorders Exchange Symposium, provided by MedscapeLive!
Like all dermatologists, he said at the meeting, he sees lots of acne cases. However, PIH is often the presenting reason for the visit in his practice, which focuses predominantly on skin of color.
“Most of my patients come in not even worried about the acne,” he said. “They come in wanting me to fix the dark spots.”
Inflammation persists
Dermatologists, Dr. Desai said, should educate patients with active PIH resulting from acne or other diseases that even though the condition has been labeled post- inflammatory hyperpigmentation, the inflammation continues to be a problem.
He said, while patients may think PIH is “just scars,” the inflammation is still active and the condition needs to be treated from a skin-lightening perspective but, more importantly, with a focus on halting the inflammation. “If you were to biopsy the areas of hyperpigmentation, you would find a high density of active inflammatory behaviors still present in the skin,” he said.
When treating patients, it’s critical to first treat the underlying skin condition aggressively, he said. “Things like topical retinoids and azelaic acid mechanistically actually make a lot more sense for PIH than even hydroquinone, in some cases, because these therapies are actually anti-inflammatory for many of the diseases we treat.”
Dr. Desai noted that, in patients with darker skin tones, even diseases like seborrheic dermatitis and plaque psoriasis can result in PIH, while in patients with lighter skin tones, the same diseases may leave some residual postinflammatory erythema.
“I think it’s very important, particularly when you’re treating a darker skin–toned patient, to arrest the erythema early on to prevent that further worsening of hyperpigmentation,” he said.
Biopsies important
In cases of PIH, determining the best treatment requires finding out where the pigment is and how deep it is, Dr. Desai said.
He noted dermatologists are often worried about doing biopsies, particularly in patients with darker skin, because of the risk of scarring and keloid formation for those more prone to keloids. The preference is also for a therapeutic effect without using invasive procedures.
“But particularly with PIH, in patients who have been therapeutically challenging, I don’t hesitate to do very small biopsies – 2- and 3-mm punch biopsies – particularly if they are from the head and neck area.”
He suggests doing biopsies on part of the ear, lower jaw line, or the neck area, as these areas tend to heal nicely. “You don’t have to be so concerned about the scarring if you counsel appropriately,” he said.
The biopsy can be valuable in determining whether a very expensive treatment will reach the intended target.
Topical retinoids play an important role as anti-inflammatories for PIH, Dr. Desai said.
He gave an example of a patient with Fitzpatrick skin type IV or V with chronic acne and extensive PIH. “Are you going to effectively tell that patient to apply 4% hydroquinone triple-combination compound across 30 different areas of PIH on their face? The answer is that’s really not very efficient or effective.”
That’s why therapies, such as retinoids, that target the pathogenesis of PIH, particularly the inflammatory component, are important, he added.
Psychological burden
PIH comes with significant stigma and loss of quality of life loss that can last many years.
During another presentation at the meeting, Susan C. Taylor, MD, professor and vice chair of diversity, equity and inclusion in the department of dermatology, at the University of Pennsylvania, Philadelphia, pointed out that in a 2016 study of 324 patients in seven Asian countries, acne-related PIH lasted longer than 1 year in 65.2% of patients and 5 years or longer in 22.3%, significantly affecting their quality of life.
Dr. Desai added that, in a paper recently published in the British Journal of Dermatology, on the impact of postacne hyperpigmentation in patients, the authors pointed out that the reported prevalence of PIH in patients with acne ranges between 45.5% and 87.2%, depending on skin phototype, and that in most cases, PIH takes more than a year to fade.
“Studies have demonstrated that patients with acne and resulting scarring often face stigmatization, leading to quality of life impairment, social withdrawal and body image disorders, which can further contribute to higher risk for depression and social anxiety,” the paper’s authors wrote.
Dr. Desai reported no financial disclosures relevant to his talk.
AT THE MEDSCAPELIVE! PIGMENTARY DISORDERS SYMPOSIUM
Macular dermal hyperpigmentation: Treatment tips from an expert
CHICAGO – based on cases she has treated in her practice.
Heather Woolery-Lloyd, MD, director of the skin of color division in the dermatology department at University of Miami, provided three general pointers.
- When in doubt, biopsy.
- For inflammatory disorders, always treat the inflammation in addition to the hyperpigmentation.
- Avoid long-term hydroquinone use in these patients.
Dr. Woolery-Lloyd also reviewed examples of what she has found successful in treating her patients with these conditions.
Lichen planus pigmentosus (LPP)
“It’s one of the hardest things that we treat,” said Dr. Woolery-Lloyd, who often sees cases of LPP in patients in their 30s, 40s, and 50s.
Lesions first appear as small, ill-defined oval-to-round macules, which later become confluent and form large areas of pigmentation. In different patients, the pigment on the face and neck, and sometimes on the forearms can be slate gray or brownish black.
In 2013, dermatologist N.C. Dlova, MD, at the University of KwaZulu‐Natal, Durban, South Africa, reported a link between frontal fibrosing alopecia and LPP in the British Journal of Dermatology. “I definitely see this connection in my practice,” said Dr. Woolery-Lloyd, noting that “both conditions often result in the loss of both eyebrows.”
She recommends always using a topical anti-inflammatory that is safe for the face. One combination she uses is azelaic acid 20% plus hydrocortisone 2.5%.
“We do use a lot of azelaic acid in my practice because it’s affordable,” she said, at the meeting, provided by MedscapeLive! She added that the hardest area to treat in women is around the chin.
Two other conditions, ashy dermatosis and erythema dyschromicum perstans (EDP), are similar. Ashy dermatosis mimics LPP but occurs more prominently on the trunk and extremities. EDP often has a preceding ring of erythema.
Dr. Woolery-Lloyd said the term EDP is often used to cover both EDP and ashy dermatosis in North America because “ashy” can have a negative connotation.
She noted there is no consensus on effective therapy for LPP, ashy dermatosis, or EDP.
A review of the literature on EDP, which included 16 studies on treatment outcomes, found the following:
- Narrow-band ultraviolet B and tacrolimus were effective treatments with minimal side effects.
- Clofazimine was effective, but had side effects, which, ironically, included pigmentary changes.
- Griseofulvin, isotretinoin, and dapsone were comparatively ineffective as lesions recurred after discontinuation.
- Lasers were largely ineffective and can also result in postinflammatory hyperpigmentation and fibrosis.
Ochronosis
Dr. Woolery-Lloyd said she may see one to two patients a year with ochronosis, which is characterized by paradoxical darkening of the skin with long-term hydroquinone use. It usually starts with redness followed by blue-black patches on the face where hydroquinone is applied. In severe cases, blue-black papules and nodules can occur.
“When I give a patient hydroquinone, I always say: ‘I don’t want to see any redness,’” Dr. Woolery-Lloyd said. “If you have any redness, please stop because ochronosis is typically preceded by this redness.”
But, she noted, “people will come in actively using hydroquinone, will have the dark brown or deep black papules or macules on their face, and then this background of redness because they are so inflamed.”
She said that ochronosis can occur in any skin type, not just in patients with darker skin tones. Dr. Woolery-Lloyd advised: “Do not hesitate to biopsy the face if ochronosis is suspected. I always biopsy ochronosis.”
There are two reasons for doing so, she explained. It can help with the diagnosis but it will also provide the patient with an incentive to stop using hydroquinone. “People who are using hydroquinone are addicted to it. They love it. They don’t want to stop. They keep using it despite the fact that their face is getting darker.” When they see a biopsy report, they may be convinced to stop.
Dr. Woolery-Lloyd said she does a 2-mm punch biopsy in the crow’s feet area because there’s almost always ochronosis in that area and it does not leave an obvious scar.
Eventually, she said, if the person stops using hydroquinone, it will clear up, “but it will take years.” Again, here she has had success with her “special formula” of azelaic acid 20% plus hydrocortisone 2.5%
“Don’t tell patients there’s no treatment. That’s the take-home,” she said.
Drug-induced facial hyperpigmentation
“I see this all the time in my African American patients,” Dr. Woolery-Lloyd said. The condition usually is characterized by dark brown hyperpigmentation on the face.
In this situation, the first question to ask is whether the patient is taking medication for hypertension, and the second question is whether it is “HCTZ.” It’s important to use the abbreviation for hydrochlorothiazide – the most common cause of drug-induced facial hyperpigmentation – because that’s what a patient sees on the bottle.
If they are taking HCTZ or another blood pressure medication associated with photosensitivity, they need to switch to a nonphotosensitizing antihypertensive agent (there are several options) and they should start treatment with a topical anti-inflammatory, Dr. Woolery-Lloyd said. Then, she suggests introducing hydrocortisone 2.5% cream and a hydroquinone-free skin brightener (azelaic acid, for example).
Importantly, with any of these conditions, Dr Woolery-Lloyd said, dermatologists should talk with patients about realistic expectations. “It takes a long time for dermal pigment to clear,” she emphasized.
Dr. Woolery-Lloyd has been a speaker for Ortho Dermatologics, L’Oreal, and EPI; has done research for Pfizer, Galderma, Allergan, Arcutis, Vyne, Merz, and Eirion; and has been on advisory boards for L’Oreal, Allergan, Ortho Dermatologics, Pfizer, and Merz.
CHICAGO – based on cases she has treated in her practice.
Heather Woolery-Lloyd, MD, director of the skin of color division in the dermatology department at University of Miami, provided three general pointers.
- When in doubt, biopsy.
- For inflammatory disorders, always treat the inflammation in addition to the hyperpigmentation.
- Avoid long-term hydroquinone use in these patients.
Dr. Woolery-Lloyd also reviewed examples of what she has found successful in treating her patients with these conditions.
Lichen planus pigmentosus (LPP)
“It’s one of the hardest things that we treat,” said Dr. Woolery-Lloyd, who often sees cases of LPP in patients in their 30s, 40s, and 50s.
Lesions first appear as small, ill-defined oval-to-round macules, which later become confluent and form large areas of pigmentation. In different patients, the pigment on the face and neck, and sometimes on the forearms can be slate gray or brownish black.
In 2013, dermatologist N.C. Dlova, MD, at the University of KwaZulu‐Natal, Durban, South Africa, reported a link between frontal fibrosing alopecia and LPP in the British Journal of Dermatology. “I definitely see this connection in my practice,” said Dr. Woolery-Lloyd, noting that “both conditions often result in the loss of both eyebrows.”
She recommends always using a topical anti-inflammatory that is safe for the face. One combination she uses is azelaic acid 20% plus hydrocortisone 2.5%.
“We do use a lot of azelaic acid in my practice because it’s affordable,” she said, at the meeting, provided by MedscapeLive! She added that the hardest area to treat in women is around the chin.
Two other conditions, ashy dermatosis and erythema dyschromicum perstans (EDP), are similar. Ashy dermatosis mimics LPP but occurs more prominently on the trunk and extremities. EDP often has a preceding ring of erythema.
Dr. Woolery-Lloyd said the term EDP is often used to cover both EDP and ashy dermatosis in North America because “ashy” can have a negative connotation.
She noted there is no consensus on effective therapy for LPP, ashy dermatosis, or EDP.
A review of the literature on EDP, which included 16 studies on treatment outcomes, found the following:
- Narrow-band ultraviolet B and tacrolimus were effective treatments with minimal side effects.
- Clofazimine was effective, but had side effects, which, ironically, included pigmentary changes.
- Griseofulvin, isotretinoin, and dapsone were comparatively ineffective as lesions recurred after discontinuation.
- Lasers were largely ineffective and can also result in postinflammatory hyperpigmentation and fibrosis.
Ochronosis
Dr. Woolery-Lloyd said she may see one to two patients a year with ochronosis, which is characterized by paradoxical darkening of the skin with long-term hydroquinone use. It usually starts with redness followed by blue-black patches on the face where hydroquinone is applied. In severe cases, blue-black papules and nodules can occur.
“When I give a patient hydroquinone, I always say: ‘I don’t want to see any redness,’” Dr. Woolery-Lloyd said. “If you have any redness, please stop because ochronosis is typically preceded by this redness.”
But, she noted, “people will come in actively using hydroquinone, will have the dark brown or deep black papules or macules on their face, and then this background of redness because they are so inflamed.”
She said that ochronosis can occur in any skin type, not just in patients with darker skin tones. Dr. Woolery-Lloyd advised: “Do not hesitate to biopsy the face if ochronosis is suspected. I always biopsy ochronosis.”
There are two reasons for doing so, she explained. It can help with the diagnosis but it will also provide the patient with an incentive to stop using hydroquinone. “People who are using hydroquinone are addicted to it. They love it. They don’t want to stop. They keep using it despite the fact that their face is getting darker.” When they see a biopsy report, they may be convinced to stop.
Dr. Woolery-Lloyd said she does a 2-mm punch biopsy in the crow’s feet area because there’s almost always ochronosis in that area and it does not leave an obvious scar.
Eventually, she said, if the person stops using hydroquinone, it will clear up, “but it will take years.” Again, here she has had success with her “special formula” of azelaic acid 20% plus hydrocortisone 2.5%
“Don’t tell patients there’s no treatment. That’s the take-home,” she said.
Drug-induced facial hyperpigmentation
“I see this all the time in my African American patients,” Dr. Woolery-Lloyd said. The condition usually is characterized by dark brown hyperpigmentation on the face.
In this situation, the first question to ask is whether the patient is taking medication for hypertension, and the second question is whether it is “HCTZ.” It’s important to use the abbreviation for hydrochlorothiazide – the most common cause of drug-induced facial hyperpigmentation – because that’s what a patient sees on the bottle.
If they are taking HCTZ or another blood pressure medication associated with photosensitivity, they need to switch to a nonphotosensitizing antihypertensive agent (there are several options) and they should start treatment with a topical anti-inflammatory, Dr. Woolery-Lloyd said. Then, she suggests introducing hydrocortisone 2.5% cream and a hydroquinone-free skin brightener (azelaic acid, for example).
Importantly, with any of these conditions, Dr Woolery-Lloyd said, dermatologists should talk with patients about realistic expectations. “It takes a long time for dermal pigment to clear,” she emphasized.
Dr. Woolery-Lloyd has been a speaker for Ortho Dermatologics, L’Oreal, and EPI; has done research for Pfizer, Galderma, Allergan, Arcutis, Vyne, Merz, and Eirion; and has been on advisory boards for L’Oreal, Allergan, Ortho Dermatologics, Pfizer, and Merz.
CHICAGO – based on cases she has treated in her practice.
Heather Woolery-Lloyd, MD, director of the skin of color division in the dermatology department at University of Miami, provided three general pointers.
- When in doubt, biopsy.
- For inflammatory disorders, always treat the inflammation in addition to the hyperpigmentation.
- Avoid long-term hydroquinone use in these patients.
Dr. Woolery-Lloyd also reviewed examples of what she has found successful in treating her patients with these conditions.
Lichen planus pigmentosus (LPP)
“It’s one of the hardest things that we treat,” said Dr. Woolery-Lloyd, who often sees cases of LPP in patients in their 30s, 40s, and 50s.
Lesions first appear as small, ill-defined oval-to-round macules, which later become confluent and form large areas of pigmentation. In different patients, the pigment on the face and neck, and sometimes on the forearms can be slate gray or brownish black.
In 2013, dermatologist N.C. Dlova, MD, at the University of KwaZulu‐Natal, Durban, South Africa, reported a link between frontal fibrosing alopecia and LPP in the British Journal of Dermatology. “I definitely see this connection in my practice,” said Dr. Woolery-Lloyd, noting that “both conditions often result in the loss of both eyebrows.”
She recommends always using a topical anti-inflammatory that is safe for the face. One combination she uses is azelaic acid 20% plus hydrocortisone 2.5%.
“We do use a lot of azelaic acid in my practice because it’s affordable,” she said, at the meeting, provided by MedscapeLive! She added that the hardest area to treat in women is around the chin.
Two other conditions, ashy dermatosis and erythema dyschromicum perstans (EDP), are similar. Ashy dermatosis mimics LPP but occurs more prominently on the trunk and extremities. EDP often has a preceding ring of erythema.
Dr. Woolery-Lloyd said the term EDP is often used to cover both EDP and ashy dermatosis in North America because “ashy” can have a negative connotation.
She noted there is no consensus on effective therapy for LPP, ashy dermatosis, or EDP.
A review of the literature on EDP, which included 16 studies on treatment outcomes, found the following:
- Narrow-band ultraviolet B and tacrolimus were effective treatments with minimal side effects.
- Clofazimine was effective, but had side effects, which, ironically, included pigmentary changes.
- Griseofulvin, isotretinoin, and dapsone were comparatively ineffective as lesions recurred after discontinuation.
- Lasers were largely ineffective and can also result in postinflammatory hyperpigmentation and fibrosis.
Ochronosis
Dr. Woolery-Lloyd said she may see one to two patients a year with ochronosis, which is characterized by paradoxical darkening of the skin with long-term hydroquinone use. It usually starts with redness followed by blue-black patches on the face where hydroquinone is applied. In severe cases, blue-black papules and nodules can occur.
“When I give a patient hydroquinone, I always say: ‘I don’t want to see any redness,’” Dr. Woolery-Lloyd said. “If you have any redness, please stop because ochronosis is typically preceded by this redness.”
But, she noted, “people will come in actively using hydroquinone, will have the dark brown or deep black papules or macules on their face, and then this background of redness because they are so inflamed.”
She said that ochronosis can occur in any skin type, not just in patients with darker skin tones. Dr. Woolery-Lloyd advised: “Do not hesitate to biopsy the face if ochronosis is suspected. I always biopsy ochronosis.”
There are two reasons for doing so, she explained. It can help with the diagnosis but it will also provide the patient with an incentive to stop using hydroquinone. “People who are using hydroquinone are addicted to it. They love it. They don’t want to stop. They keep using it despite the fact that their face is getting darker.” When they see a biopsy report, they may be convinced to stop.
Dr. Woolery-Lloyd said she does a 2-mm punch biopsy in the crow’s feet area because there’s almost always ochronosis in that area and it does not leave an obvious scar.
Eventually, she said, if the person stops using hydroquinone, it will clear up, “but it will take years.” Again, here she has had success with her “special formula” of azelaic acid 20% plus hydrocortisone 2.5%
“Don’t tell patients there’s no treatment. That’s the take-home,” she said.
Drug-induced facial hyperpigmentation
“I see this all the time in my African American patients,” Dr. Woolery-Lloyd said. The condition usually is characterized by dark brown hyperpigmentation on the face.
In this situation, the first question to ask is whether the patient is taking medication for hypertension, and the second question is whether it is “HCTZ.” It’s important to use the abbreviation for hydrochlorothiazide – the most common cause of drug-induced facial hyperpigmentation – because that’s what a patient sees on the bottle.
If they are taking HCTZ or another blood pressure medication associated with photosensitivity, they need to switch to a nonphotosensitizing antihypertensive agent (there are several options) and they should start treatment with a topical anti-inflammatory, Dr. Woolery-Lloyd said. Then, she suggests introducing hydrocortisone 2.5% cream and a hydroquinone-free skin brightener (azelaic acid, for example).
Importantly, with any of these conditions, Dr Woolery-Lloyd said, dermatologists should talk with patients about realistic expectations. “It takes a long time for dermal pigment to clear,” she emphasized.
Dr. Woolery-Lloyd has been a speaker for Ortho Dermatologics, L’Oreal, and EPI; has done research for Pfizer, Galderma, Allergan, Arcutis, Vyne, Merz, and Eirion; and has been on advisory boards for L’Oreal, Allergan, Ortho Dermatologics, Pfizer, and Merz.
AT THE MEDSCAPELIVE! PIGMENTARY DISORDERS SYMPOSIUM
Tips, contraindications for superficial chemical peels reviewed
CHICAGO – Heather Woolery-Lloyd, MD, says she’s generally “risk averse,” but when it comes to superficial chemical peels, she’s in her comfort zone.
Superficial peeling is “one of the most common cosmetic procedures that I do,” Dr. Woolery-Lloyd, director of the skin of color division in the dermatology department at the University of Miami, said at the Pigmentary Disorders Exchange Symposium.
In her practice, .
Contraindications are an active bacterial infection, open wounds, and active herpes simplex virus. “If someone looks like they even have a remnant of a cold sore, I tell them to come back,” she said.
Setting expectations for patients is critical, Dr. Woolery-Lloyd said, as a series of superficial peels is needed before the desired results are evident.
The peel she uses most is salicylic acid, a beta-hydroxy acid, at a strength of 20%-30%. “It’s very effective on our acne patients,” she said at the meeting, provided by MedscapeLIVE! “If you’re just starting with peels, I think this is a very safe one. You don’t have to time it, and you don’t have to neutralize it,” and at lower concentrations, is “very safe.”
Dr. Woolery-Lloyd provided these other tips during her presentation:
- Even superficial peels can be uncomfortable, she noted, so she keeps a fan nearby to use when needed to help with discomfort.
- Find the peel you’re comfortable with, master that peel, and don’t jump from peel to peel. Get familiar with the side effects and how to predict results.
- Stop retinoids up to 7 days before a peel. Consider placing the patient on hydroquinone before the chemical peel to decrease the risk of hyperpigmentation.
- Before the procedure, prep the skin with acetone or alcohol. Applying petrolatum helps protect around the eyes, alar crease, and other sensitive areas, “or anywhere you’re concerned about the depth of the peel.”
- Application with rough gauze helps avoid the waste that comes with makeup sponges soaking up the product. It also helps add exfoliation.
- Have everything ready before starting the procedure, including (depending on the peel), a neutralizer or soapless cleanser. Although peels are generally safe, you want to be able to remove one quickly, if needed, without having to leave the room.
- Start with the lowest concentration (salicylic acid or glycolic acid) then titrate up. Ask patients about any reactions they experienced with the previous peel before making the decision on the next concentration.
- For a peel to treat hyperpigmentation, she recommends one peel about every 4 weeks for a series of 5-6 peels.
- After a peel, the patient should use a mineral sunscreen; chemical sunscreens will sting.
Know your comfort zone
Conference chair Pearl Grimes, MD, director of The Vitiligo & Pigmentation Institute of Southern California in Los Angeles, said superficial peels are best for dermatologists new to peeling until they gain comfort with experience.
Superficial and medium-depth peels work well for mild to moderate photoaging, she said at the meeting.
“We know that in darker skin we have more intrinsic aging rather than photoaging. We have more textural changes, hyperpigmentation,” Dr. Grimes said.
For Fitzpatrick skin types I-III, she said, “you can do superficial, medium, and deep peels.” For darker skin types, “I typically stay in the superficial, medium range.”
She said that she uses retinoids to exfoliate before a superficial peel but added, “you’ve got to stop them early because retinoids can make a superficial peel a medium-depth peel.”
Taking photos is important before any procedure, she said, as is spending time with patients clarifying their outcome expectations.
“I love peeling,” Dr. Grimes said. “And it’s cost effective. If you don’t want to spend a ton of money, it’s amazing what you can achieve with chemical peeling.”
When asked by a member of the audience whether they avoid superficial peels in women who are pregnant or breastfeeding, both Dr. Woolery-Lloyd and Dr. Grimes said they do avoid them in those patients.
Dr. Grimes said she tells her patients, especially in the first trimester, “I am the most conservative woman on the planet. I do nothing during the first trimester.”
Dr. Woolery-Lloyd has been a speaker for Ortho Dermatologics, Loreal and EPI, and has done research for Pfizer, Galderma, Allergan, Arcutis, Vyne, Merz, and Eirion. She has been on advisory boards for Loreal, Allergan, Ortho Dermatologics, Pfize,r and Merz. Dr. Grimes reports grant/research Support from Clinuvel Pharmaceuticals, Incyte, Johnson & Johnson, LASEROPTEK, L’Oréal USA, Pfizer, Procter & Gamble, skinbetter science, and Versicolor Technologies, and is on the speakers bureau/receives honoraria for non-CME for Incyte and Procter & Gamble; and is a consultant or is on the advisory board for L’Oréal USA and Procter & Gamble. She has stock options in Versicolor Technologies.
CHICAGO – Heather Woolery-Lloyd, MD, says she’s generally “risk averse,” but when it comes to superficial chemical peels, she’s in her comfort zone.
Superficial peeling is “one of the most common cosmetic procedures that I do,” Dr. Woolery-Lloyd, director of the skin of color division in the dermatology department at the University of Miami, said at the Pigmentary Disorders Exchange Symposium.
In her practice, .
Contraindications are an active bacterial infection, open wounds, and active herpes simplex virus. “If someone looks like they even have a remnant of a cold sore, I tell them to come back,” she said.
Setting expectations for patients is critical, Dr. Woolery-Lloyd said, as a series of superficial peels is needed before the desired results are evident.
The peel she uses most is salicylic acid, a beta-hydroxy acid, at a strength of 20%-30%. “It’s very effective on our acne patients,” she said at the meeting, provided by MedscapeLIVE! “If you’re just starting with peels, I think this is a very safe one. You don’t have to time it, and you don’t have to neutralize it,” and at lower concentrations, is “very safe.”
Dr. Woolery-Lloyd provided these other tips during her presentation:
- Even superficial peels can be uncomfortable, she noted, so she keeps a fan nearby to use when needed to help with discomfort.
- Find the peel you’re comfortable with, master that peel, and don’t jump from peel to peel. Get familiar with the side effects and how to predict results.
- Stop retinoids up to 7 days before a peel. Consider placing the patient on hydroquinone before the chemical peel to decrease the risk of hyperpigmentation.
- Before the procedure, prep the skin with acetone or alcohol. Applying petrolatum helps protect around the eyes, alar crease, and other sensitive areas, “or anywhere you’re concerned about the depth of the peel.”
- Application with rough gauze helps avoid the waste that comes with makeup sponges soaking up the product. It also helps add exfoliation.
- Have everything ready before starting the procedure, including (depending on the peel), a neutralizer or soapless cleanser. Although peels are generally safe, you want to be able to remove one quickly, if needed, without having to leave the room.
- Start with the lowest concentration (salicylic acid or glycolic acid) then titrate up. Ask patients about any reactions they experienced with the previous peel before making the decision on the next concentration.
- For a peel to treat hyperpigmentation, she recommends one peel about every 4 weeks for a series of 5-6 peels.
- After a peel, the patient should use a mineral sunscreen; chemical sunscreens will sting.
Know your comfort zone
Conference chair Pearl Grimes, MD, director of The Vitiligo & Pigmentation Institute of Southern California in Los Angeles, said superficial peels are best for dermatologists new to peeling until they gain comfort with experience.
Superficial and medium-depth peels work well for mild to moderate photoaging, she said at the meeting.
“We know that in darker skin we have more intrinsic aging rather than photoaging. We have more textural changes, hyperpigmentation,” Dr. Grimes said.
For Fitzpatrick skin types I-III, she said, “you can do superficial, medium, and deep peels.” For darker skin types, “I typically stay in the superficial, medium range.”
She said that she uses retinoids to exfoliate before a superficial peel but added, “you’ve got to stop them early because retinoids can make a superficial peel a medium-depth peel.”
Taking photos is important before any procedure, she said, as is spending time with patients clarifying their outcome expectations.
“I love peeling,” Dr. Grimes said. “And it’s cost effective. If you don’t want to spend a ton of money, it’s amazing what you can achieve with chemical peeling.”
When asked by a member of the audience whether they avoid superficial peels in women who are pregnant or breastfeeding, both Dr. Woolery-Lloyd and Dr. Grimes said they do avoid them in those patients.
Dr. Grimes said she tells her patients, especially in the first trimester, “I am the most conservative woman on the planet. I do nothing during the first trimester.”
Dr. Woolery-Lloyd has been a speaker for Ortho Dermatologics, Loreal and EPI, and has done research for Pfizer, Galderma, Allergan, Arcutis, Vyne, Merz, and Eirion. She has been on advisory boards for Loreal, Allergan, Ortho Dermatologics, Pfize,r and Merz. Dr. Grimes reports grant/research Support from Clinuvel Pharmaceuticals, Incyte, Johnson & Johnson, LASEROPTEK, L’Oréal USA, Pfizer, Procter & Gamble, skinbetter science, and Versicolor Technologies, and is on the speakers bureau/receives honoraria for non-CME for Incyte and Procter & Gamble; and is a consultant or is on the advisory board for L’Oréal USA and Procter & Gamble. She has stock options in Versicolor Technologies.
CHICAGO – Heather Woolery-Lloyd, MD, says she’s generally “risk averse,” but when it comes to superficial chemical peels, she’s in her comfort zone.
Superficial peeling is “one of the most common cosmetic procedures that I do,” Dr. Woolery-Lloyd, director of the skin of color division in the dermatology department at the University of Miami, said at the Pigmentary Disorders Exchange Symposium.
In her practice, .
Contraindications are an active bacterial infection, open wounds, and active herpes simplex virus. “If someone looks like they even have a remnant of a cold sore, I tell them to come back,” she said.
Setting expectations for patients is critical, Dr. Woolery-Lloyd said, as a series of superficial peels is needed before the desired results are evident.
The peel she uses most is salicylic acid, a beta-hydroxy acid, at a strength of 20%-30%. “It’s very effective on our acne patients,” she said at the meeting, provided by MedscapeLIVE! “If you’re just starting with peels, I think this is a very safe one. You don’t have to time it, and you don’t have to neutralize it,” and at lower concentrations, is “very safe.”
Dr. Woolery-Lloyd provided these other tips during her presentation:
- Even superficial peels can be uncomfortable, she noted, so she keeps a fan nearby to use when needed to help with discomfort.
- Find the peel you’re comfortable with, master that peel, and don’t jump from peel to peel. Get familiar with the side effects and how to predict results.
- Stop retinoids up to 7 days before a peel. Consider placing the patient on hydroquinone before the chemical peel to decrease the risk of hyperpigmentation.
- Before the procedure, prep the skin with acetone or alcohol. Applying petrolatum helps protect around the eyes, alar crease, and other sensitive areas, “or anywhere you’re concerned about the depth of the peel.”
- Application with rough gauze helps avoid the waste that comes with makeup sponges soaking up the product. It also helps add exfoliation.
- Have everything ready before starting the procedure, including (depending on the peel), a neutralizer or soapless cleanser. Although peels are generally safe, you want to be able to remove one quickly, if needed, without having to leave the room.
- Start with the lowest concentration (salicylic acid or glycolic acid) then titrate up. Ask patients about any reactions they experienced with the previous peel before making the decision on the next concentration.
- For a peel to treat hyperpigmentation, she recommends one peel about every 4 weeks for a series of 5-6 peels.
- After a peel, the patient should use a mineral sunscreen; chemical sunscreens will sting.
Know your comfort zone
Conference chair Pearl Grimes, MD, director of The Vitiligo & Pigmentation Institute of Southern California in Los Angeles, said superficial peels are best for dermatologists new to peeling until they gain comfort with experience.
Superficial and medium-depth peels work well for mild to moderate photoaging, she said at the meeting.
“We know that in darker skin we have more intrinsic aging rather than photoaging. We have more textural changes, hyperpigmentation,” Dr. Grimes said.
For Fitzpatrick skin types I-III, she said, “you can do superficial, medium, and deep peels.” For darker skin types, “I typically stay in the superficial, medium range.”
She said that she uses retinoids to exfoliate before a superficial peel but added, “you’ve got to stop them early because retinoids can make a superficial peel a medium-depth peel.”
Taking photos is important before any procedure, she said, as is spending time with patients clarifying their outcome expectations.
“I love peeling,” Dr. Grimes said. “And it’s cost effective. If you don’t want to spend a ton of money, it’s amazing what you can achieve with chemical peeling.”
When asked by a member of the audience whether they avoid superficial peels in women who are pregnant or breastfeeding, both Dr. Woolery-Lloyd and Dr. Grimes said they do avoid them in those patients.
Dr. Grimes said she tells her patients, especially in the first trimester, “I am the most conservative woman on the planet. I do nothing during the first trimester.”
Dr. Woolery-Lloyd has been a speaker for Ortho Dermatologics, Loreal and EPI, and has done research for Pfizer, Galderma, Allergan, Arcutis, Vyne, Merz, and Eirion. She has been on advisory boards for Loreal, Allergan, Ortho Dermatologics, Pfize,r and Merz. Dr. Grimes reports grant/research Support from Clinuvel Pharmaceuticals, Incyte, Johnson & Johnson, LASEROPTEK, L’Oréal USA, Pfizer, Procter & Gamble, skinbetter science, and Versicolor Technologies, and is on the speakers bureau/receives honoraria for non-CME for Incyte and Procter & Gamble; and is a consultant or is on the advisory board for L’Oréal USA and Procter & Gamble. She has stock options in Versicolor Technologies.
AT THE MEDSCAPE LIVE! PIGMENTARY DISORDERS SYMPOSIUM
Primary care’s per-person costs for addressing social needs not covered by federal funding
The costs of providing evidence-based interventions in primary care to address social needs far exceed current federal funding streams, say the authors of a new analysis.
A microsimulation analysis by Sanjay Basu, MD, PhD, with Clinical Product Development, Waymark Care, San Francisco, and colleagues found that, as primary care practices are being asked to screen for social needs, the cost of providing evidence-based interventions for these needs averaged $60 per member/person per month (PMPM) (95% confidence interval, $55-$65).
However, less than half ($27) of the $60 cost had existing federal financing in place to pay for it. Of the $60, $5 was for screening and referral.
The study results were published in JAMA Internal Medicine.
The researchers looked at key social needs areas and found major gaps between what interventions cost and what’s covered by federal payers. They demonstrate the gaps in four key areas. Many people in the analysis have more than one need:
- Food insecurity: Cost was $23 PMPM and the proportion borne by existing federal payers was 61.6%.
- Housing insecurity: Cost was $3 PMPM; proportion borne by federal payers was 45.6%.
- Transportation insecurity: Cost was $0.1 PMPM; proportion borne by federal payers was 27.8%.
- Community-based care coordination: Cost was $0.6 PMPM; proportion borne by federal payers is 6.4%.
Gaps varied by type of center
Primary care practices were grouped into federally qualified health centers; non-FQHC urban practices in high-poverty areas; non-FQHC rural practices in high-poverty areas; and practices in lower-poverty areas. Gaps varied among the groups.
While disproportionate funding was available to populations seen at FQHCs, populations seen at non-FQHC practices in high-poverty areas had larger funding gaps.
The study population consisted of 19,225 patients seen in primary care practices; data on social needs were pulled from the National Center for Health Statistics from 2015 to 2018.
Dr. Basu said in an interview with the journal’s deputy editor, Mitchell Katz, MD, that new sustainable revenue streams need to be identified to close the gap. Primary care physicians should not be charged with tasks such as researching the best housing programs and food benefits.
“I can’t imagine fitting this into my primary care appointments,” he said.
Is primary care the best setting for addressing these needs?
In an accompanying comment, Jenifer Clapp, MPA, with the Office of Ambulatory Care and Population Health, NYC Health + Hospitals, New York, and colleagues wrote that the study raises the question of whether the health care setting is the right place for addressing social needs. Some aspects have to be addressed in health care, such as asking about the home environment for a patient with environmentally triggered asthma.
“But how involved should health care professionals be in identifying needs unrelated to illness and solving those needs?” Ms. Clapp and colleagues asked.
They wrote that the health care sector in the United States must address these needs because in the United States, unlike in many European countries, “there is an insufficient social service sector to address the basic human needs of children and working-age adults.”
Eligible but not enrolled
Importantly, both the study authors and editorialists pointed out, in many cases, intervening doesn’t mean paying for the social services, but helping patients enroll in the services for which they already qualify.
The study authors wrote that among people who had food and housing needs, most met the criteria for federally funded programs, but had low enrollment for reasons including inadequate program capacity.
For example, 78% of people with housing needs were eligible for federal programs but only 24% were enrolled, and 95.6% of people with food needs were eligible for programs but only 70.2% were enrolled in programs like the Supplemental Nutrition and Assistance Program and Women, Infants and Children.
Commentary coauthor Nichola Davis, MD, also with NYC Health + Hospitals, said one thing they’ve done at NYC Health + Hospitals is partner with community-based organizations that provide food navigators so when patients screen positive for food insecurity they can then be seen by a food navigator to pinpoint appropriate programs.
The referral for those who indicate food insecurity is automatically generated by the electronic health system and appears on the after-visit summary.
“At the bare minimum, the patient would leave with a list of resources,” Dr. Davis said.
One place primary care providers can make a difference
Dr. Katz said that the $60 cost per person is much lower than that for a service such as an MRI.
“We should be able to achieve that,” he said.
Will Bleser, PhD, MSPH, assistant research director of health care transformation for social needs and health equity at the Duke-Margolis Center for Health Policy, Washington, said it’s exciting to see the per-person cost for social needs quantified.
He pointed to existing revenue options that have been underutilized.
Through Medicare, he noted, if you are part of a Medicare Advantage plan, there is a program implemented in 2020 called Special Supplemental Benefits for the Chronically Ill. “That authorizes Medicare Advantage plans to offer non–primarily health-related services through Medicare Advantage to individuals who meet certain chronic illness conditions.”
Non–primarily health-related services may include meals, transportation, and pest control, for example, the Centers for Medicare & Medicaid Services notes.
Also, within the shared-savings program of traditional Medicare, if an accountable care organization is providing quality care under the cost target and is reaping the savings, “you could use those bonuses to do things that you couldn’t do under the normal Medicare fee schedule like address social needs,” Dr. Bleser said.
Medicaid, he said, offers the most opportunities to address social needs through the health system. One policy mechanism within Medicaid is the Section 1115 Waiver, where states can propose to provide new services as long as they comply with the core rules of Medicaid and meet certain qualifications.
Avoiding checking boxes with no benefit to patients
Ms. Clapp and colleagues noted that whether health care professionals agree that social needs can or should be addressed in primary care, CMS will mandate social needs screening and reporting for all hospitalized adults starting in 2024. Additionally, the Joint Commission will require health care systems to gauge social needs and report on resources.
“We need to ensure that these mandates do not become administrative checkboxes that frustrate clinical staff and ratchet up health care costs with no benefit to patients,” they wrote.
Dr. Basu reported receiving personal fees from the University of California, Healthright360, Waymark and Collective Health outside the submitted work; he has a patent issued for a multimodel member outreach system; and a patent pending for operationalizing predicted changes in risk based on interventions. A coauthor reported grants from the North Carolina Department of Health and Human Services, Blue Cross Blue Shield of North Carolina, and personal fees from several nonprofit organizations outside the submitted work. Another coauthor reported personal fees from ZealCare outside the submitted work.
The costs of providing evidence-based interventions in primary care to address social needs far exceed current federal funding streams, say the authors of a new analysis.
A microsimulation analysis by Sanjay Basu, MD, PhD, with Clinical Product Development, Waymark Care, San Francisco, and colleagues found that, as primary care practices are being asked to screen for social needs, the cost of providing evidence-based interventions for these needs averaged $60 per member/person per month (PMPM) (95% confidence interval, $55-$65).
However, less than half ($27) of the $60 cost had existing federal financing in place to pay for it. Of the $60, $5 was for screening and referral.
The study results were published in JAMA Internal Medicine.
The researchers looked at key social needs areas and found major gaps between what interventions cost and what’s covered by federal payers. They demonstrate the gaps in four key areas. Many people in the analysis have more than one need:
- Food insecurity: Cost was $23 PMPM and the proportion borne by existing federal payers was 61.6%.
- Housing insecurity: Cost was $3 PMPM; proportion borne by federal payers was 45.6%.
- Transportation insecurity: Cost was $0.1 PMPM; proportion borne by federal payers was 27.8%.
- Community-based care coordination: Cost was $0.6 PMPM; proportion borne by federal payers is 6.4%.
Gaps varied by type of center
Primary care practices were grouped into federally qualified health centers; non-FQHC urban practices in high-poverty areas; non-FQHC rural practices in high-poverty areas; and practices in lower-poverty areas. Gaps varied among the groups.
While disproportionate funding was available to populations seen at FQHCs, populations seen at non-FQHC practices in high-poverty areas had larger funding gaps.
The study population consisted of 19,225 patients seen in primary care practices; data on social needs were pulled from the National Center for Health Statistics from 2015 to 2018.
Dr. Basu said in an interview with the journal’s deputy editor, Mitchell Katz, MD, that new sustainable revenue streams need to be identified to close the gap. Primary care physicians should not be charged with tasks such as researching the best housing programs and food benefits.
“I can’t imagine fitting this into my primary care appointments,” he said.
Is primary care the best setting for addressing these needs?
In an accompanying comment, Jenifer Clapp, MPA, with the Office of Ambulatory Care and Population Health, NYC Health + Hospitals, New York, and colleagues wrote that the study raises the question of whether the health care setting is the right place for addressing social needs. Some aspects have to be addressed in health care, such as asking about the home environment for a patient with environmentally triggered asthma.
“But how involved should health care professionals be in identifying needs unrelated to illness and solving those needs?” Ms. Clapp and colleagues asked.
They wrote that the health care sector in the United States must address these needs because in the United States, unlike in many European countries, “there is an insufficient social service sector to address the basic human needs of children and working-age adults.”
Eligible but not enrolled
Importantly, both the study authors and editorialists pointed out, in many cases, intervening doesn’t mean paying for the social services, but helping patients enroll in the services for which they already qualify.
The study authors wrote that among people who had food and housing needs, most met the criteria for federally funded programs, but had low enrollment for reasons including inadequate program capacity.
For example, 78% of people with housing needs were eligible for federal programs but only 24% were enrolled, and 95.6% of people with food needs were eligible for programs but only 70.2% were enrolled in programs like the Supplemental Nutrition and Assistance Program and Women, Infants and Children.
Commentary coauthor Nichola Davis, MD, also with NYC Health + Hospitals, said one thing they’ve done at NYC Health + Hospitals is partner with community-based organizations that provide food navigators so when patients screen positive for food insecurity they can then be seen by a food navigator to pinpoint appropriate programs.
The referral for those who indicate food insecurity is automatically generated by the electronic health system and appears on the after-visit summary.
“At the bare minimum, the patient would leave with a list of resources,” Dr. Davis said.
One place primary care providers can make a difference
Dr. Katz said that the $60 cost per person is much lower than that for a service such as an MRI.
“We should be able to achieve that,” he said.
Will Bleser, PhD, MSPH, assistant research director of health care transformation for social needs and health equity at the Duke-Margolis Center for Health Policy, Washington, said it’s exciting to see the per-person cost for social needs quantified.
He pointed to existing revenue options that have been underutilized.
Through Medicare, he noted, if you are part of a Medicare Advantage plan, there is a program implemented in 2020 called Special Supplemental Benefits for the Chronically Ill. “That authorizes Medicare Advantage plans to offer non–primarily health-related services through Medicare Advantage to individuals who meet certain chronic illness conditions.”
Non–primarily health-related services may include meals, transportation, and pest control, for example, the Centers for Medicare & Medicaid Services notes.
Also, within the shared-savings program of traditional Medicare, if an accountable care organization is providing quality care under the cost target and is reaping the savings, “you could use those bonuses to do things that you couldn’t do under the normal Medicare fee schedule like address social needs,” Dr. Bleser said.
Medicaid, he said, offers the most opportunities to address social needs through the health system. One policy mechanism within Medicaid is the Section 1115 Waiver, where states can propose to provide new services as long as they comply with the core rules of Medicaid and meet certain qualifications.
Avoiding checking boxes with no benefit to patients
Ms. Clapp and colleagues noted that whether health care professionals agree that social needs can or should be addressed in primary care, CMS will mandate social needs screening and reporting for all hospitalized adults starting in 2024. Additionally, the Joint Commission will require health care systems to gauge social needs and report on resources.
“We need to ensure that these mandates do not become administrative checkboxes that frustrate clinical staff and ratchet up health care costs with no benefit to patients,” they wrote.
Dr. Basu reported receiving personal fees from the University of California, Healthright360, Waymark and Collective Health outside the submitted work; he has a patent issued for a multimodel member outreach system; and a patent pending for operationalizing predicted changes in risk based on interventions. A coauthor reported grants from the North Carolina Department of Health and Human Services, Blue Cross Blue Shield of North Carolina, and personal fees from several nonprofit organizations outside the submitted work. Another coauthor reported personal fees from ZealCare outside the submitted work.
The costs of providing evidence-based interventions in primary care to address social needs far exceed current federal funding streams, say the authors of a new analysis.
A microsimulation analysis by Sanjay Basu, MD, PhD, with Clinical Product Development, Waymark Care, San Francisco, and colleagues found that, as primary care practices are being asked to screen for social needs, the cost of providing evidence-based interventions for these needs averaged $60 per member/person per month (PMPM) (95% confidence interval, $55-$65).
However, less than half ($27) of the $60 cost had existing federal financing in place to pay for it. Of the $60, $5 was for screening and referral.
The study results were published in JAMA Internal Medicine.
The researchers looked at key social needs areas and found major gaps between what interventions cost and what’s covered by federal payers. They demonstrate the gaps in four key areas. Many people in the analysis have more than one need:
- Food insecurity: Cost was $23 PMPM and the proportion borne by existing federal payers was 61.6%.
- Housing insecurity: Cost was $3 PMPM; proportion borne by federal payers was 45.6%.
- Transportation insecurity: Cost was $0.1 PMPM; proportion borne by federal payers was 27.8%.
- Community-based care coordination: Cost was $0.6 PMPM; proportion borne by federal payers is 6.4%.
Gaps varied by type of center
Primary care practices were grouped into federally qualified health centers; non-FQHC urban practices in high-poverty areas; non-FQHC rural practices in high-poverty areas; and practices in lower-poverty areas. Gaps varied among the groups.
While disproportionate funding was available to populations seen at FQHCs, populations seen at non-FQHC practices in high-poverty areas had larger funding gaps.
The study population consisted of 19,225 patients seen in primary care practices; data on social needs were pulled from the National Center for Health Statistics from 2015 to 2018.
Dr. Basu said in an interview with the journal’s deputy editor, Mitchell Katz, MD, that new sustainable revenue streams need to be identified to close the gap. Primary care physicians should not be charged with tasks such as researching the best housing programs and food benefits.
“I can’t imagine fitting this into my primary care appointments,” he said.
Is primary care the best setting for addressing these needs?
In an accompanying comment, Jenifer Clapp, MPA, with the Office of Ambulatory Care and Population Health, NYC Health + Hospitals, New York, and colleagues wrote that the study raises the question of whether the health care setting is the right place for addressing social needs. Some aspects have to be addressed in health care, such as asking about the home environment for a patient with environmentally triggered asthma.
“But how involved should health care professionals be in identifying needs unrelated to illness and solving those needs?” Ms. Clapp and colleagues asked.
They wrote that the health care sector in the United States must address these needs because in the United States, unlike in many European countries, “there is an insufficient social service sector to address the basic human needs of children and working-age adults.”
Eligible but not enrolled
Importantly, both the study authors and editorialists pointed out, in many cases, intervening doesn’t mean paying for the social services, but helping patients enroll in the services for which they already qualify.
The study authors wrote that among people who had food and housing needs, most met the criteria for federally funded programs, but had low enrollment for reasons including inadequate program capacity.
For example, 78% of people with housing needs were eligible for federal programs but only 24% were enrolled, and 95.6% of people with food needs were eligible for programs but only 70.2% were enrolled in programs like the Supplemental Nutrition and Assistance Program and Women, Infants and Children.
Commentary coauthor Nichola Davis, MD, also with NYC Health + Hospitals, said one thing they’ve done at NYC Health + Hospitals is partner with community-based organizations that provide food navigators so when patients screen positive for food insecurity they can then be seen by a food navigator to pinpoint appropriate programs.
The referral for those who indicate food insecurity is automatically generated by the electronic health system and appears on the after-visit summary.
“At the bare minimum, the patient would leave with a list of resources,” Dr. Davis said.
One place primary care providers can make a difference
Dr. Katz said that the $60 cost per person is much lower than that for a service such as an MRI.
“We should be able to achieve that,” he said.
Will Bleser, PhD, MSPH, assistant research director of health care transformation for social needs and health equity at the Duke-Margolis Center for Health Policy, Washington, said it’s exciting to see the per-person cost for social needs quantified.
He pointed to existing revenue options that have been underutilized.
Through Medicare, he noted, if you are part of a Medicare Advantage plan, there is a program implemented in 2020 called Special Supplemental Benefits for the Chronically Ill. “That authorizes Medicare Advantage plans to offer non–primarily health-related services through Medicare Advantage to individuals who meet certain chronic illness conditions.”
Non–primarily health-related services may include meals, transportation, and pest control, for example, the Centers for Medicare & Medicaid Services notes.
Also, within the shared-savings program of traditional Medicare, if an accountable care organization is providing quality care under the cost target and is reaping the savings, “you could use those bonuses to do things that you couldn’t do under the normal Medicare fee schedule like address social needs,” Dr. Bleser said.
Medicaid, he said, offers the most opportunities to address social needs through the health system. One policy mechanism within Medicaid is the Section 1115 Waiver, where states can propose to provide new services as long as they comply with the core rules of Medicaid and meet certain qualifications.
Avoiding checking boxes with no benefit to patients
Ms. Clapp and colleagues noted that whether health care professionals agree that social needs can or should be addressed in primary care, CMS will mandate social needs screening and reporting for all hospitalized adults starting in 2024. Additionally, the Joint Commission will require health care systems to gauge social needs and report on resources.
“We need to ensure that these mandates do not become administrative checkboxes that frustrate clinical staff and ratchet up health care costs with no benefit to patients,” they wrote.
Dr. Basu reported receiving personal fees from the University of California, Healthright360, Waymark and Collective Health outside the submitted work; he has a patent issued for a multimodel member outreach system; and a patent pending for operationalizing predicted changes in risk based on interventions. A coauthor reported grants from the North Carolina Department of Health and Human Services, Blue Cross Blue Shield of North Carolina, and personal fees from several nonprofit organizations outside the submitted work. Another coauthor reported personal fees from ZealCare outside the submitted work.
FROM JAMA INTERNAL MEDICINE
SPF is only the start when recommending sunscreens
CHICAGO – at the inaugural Pigmentary Disorders Exchange Symposium.
Among the first factors physicians should consider before recommending sunscreen are a patient’s Fitzpatrick skin type, risks for burning or tanning, underlying skin disorders, and medications the patient is taking, Dr. Taylor, professor of dermatology at the University of Pennsylvania, Philadelphia, said at the meeting, provided by MedscapeLIVE! If patients are on hypertensives, for example, medications can make them more photosensitive.
Consider skin type
Dr. Taylor said she was dismayed by the results of a recent study, which found that 43% of dermatologists who responded to a survey reported that they never, rarely, or only sometimes took a patient’s skin type into account when making sunscreen recommendations. The article is referenced in a 2022 expert panel consensus paper she coauthored on photoprotection “for skin of all color.” But she pointed out that considering skin type alone is inadequate.
Questions for patients in joint decision-making should include lifestyle and work choices such as whether they work inside or outside, and how much sun exposure they get in a typical day. Heat and humidity levels should also be considered as should a patient’s susceptibility to dyspigmentation. “That could be overall darkening of the skin, mottled hyperpigmentation, actinic dyspigmentation, and, of course, propensity for skin cancer,” she said.
Use differs by race
Dr. Taylor, who is also vice chair for diversity, equity and inclusion in the department of dermatology at the University of Pennsylvania, pointed out that sunscreen use differs considerably by race.
In study of 8,952 adults in the United States who reported that they were sun sensitive found that a subset of adults with skin of color were significantly less likely to use sunscreen when compared with non-Hispanic White adults: Non-Hispanic Black (adjusted odds ratio, 0.43); non-Hispanic Asian (aOR. 0.54); and Hispanic (aOR, 0.70) adults.
In the study, non-Hispanic Black and Hispanic adults were significantly less likely to use sunscreens with an SPF greater than 15. In addition, non-Hispanic Black, non-Hispanic Asian, and Hispanic adults were significantly more likely than non-Hispanic Whites to wear long sleeves when outside. Such differences are important to keep in mind when advising patients about sunscreens, she said.
Protection for lighter-colored skin
Dr. Taylor said that, for patients with lighter skin tones, “we really want to protect against ultraviolet B as well as ultraviolet A, particularly ultraviolet A2. Ultraviolet radiation is going to cause DNA damage.” Patients with Fitzpatrick skin types I, II, or III are most susceptible to the effects of UVB with sunburn inflammation, which will cause erythema and tanning, and immunosuppression.
“For those who are I, II, and III, we do want to recommend a broad-spectrum, photostable sunscreen with a critical wavelength of 370 nanometers, which is going to protect from both UVB and UVA2,” she said.
Sunscreen recommendations are meant to be paired with advice to avoid midday sun from 10 a.m. to 2 p.m., wearing protective clothing and accessories, and seeking shade, she noted.
Dr. Taylor said, for those patients with lighter skin who are more susceptible to photodamage and premature aging, physicians should recommend sunscreens that contain DNA repair enzymes such as photolyases and sunscreens that contain antioxidants that can prevent or reverse DNA damage. “The exogenous form of these lyases have been manufactured and added to sunscreens,” Dr. Taylor said. “They’re readily available in the United States. That is something to consider for patients with significant photodamage.”
Retinoids can also help alleviate or reverse photodamage, she added.
Protection for darker-colored skin
“Many people of color do not believe they need sunscreen,” Dr. Taylor said. But studies show that, although there may be more intrinsic protection, sunscreen is still needed.
Over 30 years ago, Halder and colleagues reported that melanin in skin of color can filter two to five times more UV radiation, and in a paper on the photoprotective role of melanin, Kaidbey and colleagues found that skin types V and VI had an intrinsic SPF of 13 when compared with those who have lighter complexions, which had an SPF of 3.
Sunburns seem to occur less frequently in people with skin of color, but that may be because erythema is less apparent in people with darker skin tones or because of differences in personal definitions of sunburn, Dr. Taylor said.
“Skin of color can and does sustain sunburns and sunscreen will help prevent that,” she said, adding that a recommendation of an SPF 30 is likely sufficient for these patients. Dr. Taylor noted that sunscreens for patients with darker skin often cost substantially more than those for lighter skin, and that should be considered in recommendations.
Tinted sunscreens
Dr. Taylor said that, while broad-spectrum photostable sunscreens protect against UVB and UVA 2, they don’t protect from visible light and UVA1. Two methods to add that protection are using inorganic tinted sunscreens that contain iron oxide or pigmentary titanium dioxide. Dr. Taylor was a coauthor of a practical guide to tinted sunscreens published in 2022.
“For iron oxide, we want a concentration of 3% or greater,” she said, adding that the percentage often is not known because if it is contained in a sunscreen, it is listed as an inactive ingredient.
Another method to address visible light and UVA1 is the use of antioxidant-containing sunscreens with vitamin E, vitamin C, or licochalcone A, Dr. Taylor said.
During the question-and-answer period following her presentation, Amit Pandya, MD, adjunct professor of dermatology at University of Texas Southwestern Medical Center, Dallas, asked why “every makeup, every sunscreen, just says iron oxide,” since it is known that visible light will cause pigmentation, especially in those with darker skin tones.
He urged pushing for a law that would require listing the percentage of iron oxide on products to assure it is sufficient, according to what the literature recommends.
Conference Chair Pearl Grimes, MD, director of the Vitiligo and Pigmentation Institute of Southern California, Los Angeles, said that she recommends tinted sunscreens almost exclusively for her patients, but those with darker skin colors struggle to match color.
Dr. Taylor referred to an analysis published in 2022 of 58 over-the counter sunscreens, which found that only 38% of tinted sunscreens was available in more than one shade, “which is a problem for many of our patients.” She said that providing samples with different hues and tactile sensations may help patients find the right product.
Dr. Taylor disclosed being on the advisory boards for AbbVie, Avita Medical, Beiersdorf, Biorez, Eli Lily, EPI Health, Evolus, Galderma, Hugel America, Johnson and Johnson, L’Oreal USA, MedScape, Pfizer, Scientis US, UCB, Vichy Laboratories. She is a consultant for Arcutis Biothermapeutics, Beiersdorf, Bristol-Myers Squibb, Cara Therapeutics, Dior, and Sanofi. She has done contracted research for Allergan Aesthetics, Concert Pharmaceuticals, Croma-Pharma, Eli Lilly, and Pfizer, and has an ownership interest in Armis Scientific, GloGetter, and Piction Health.
Medscape and this news organization are owned by the same parent company.
CHICAGO – at the inaugural Pigmentary Disorders Exchange Symposium.
Among the first factors physicians should consider before recommending sunscreen are a patient’s Fitzpatrick skin type, risks for burning or tanning, underlying skin disorders, and medications the patient is taking, Dr. Taylor, professor of dermatology at the University of Pennsylvania, Philadelphia, said at the meeting, provided by MedscapeLIVE! If patients are on hypertensives, for example, medications can make them more photosensitive.
Consider skin type
Dr. Taylor said she was dismayed by the results of a recent study, which found that 43% of dermatologists who responded to a survey reported that they never, rarely, or only sometimes took a patient’s skin type into account when making sunscreen recommendations. The article is referenced in a 2022 expert panel consensus paper she coauthored on photoprotection “for skin of all color.” But she pointed out that considering skin type alone is inadequate.
Questions for patients in joint decision-making should include lifestyle and work choices such as whether they work inside or outside, and how much sun exposure they get in a typical day. Heat and humidity levels should also be considered as should a patient’s susceptibility to dyspigmentation. “That could be overall darkening of the skin, mottled hyperpigmentation, actinic dyspigmentation, and, of course, propensity for skin cancer,” she said.
Use differs by race
Dr. Taylor, who is also vice chair for diversity, equity and inclusion in the department of dermatology at the University of Pennsylvania, pointed out that sunscreen use differs considerably by race.
In study of 8,952 adults in the United States who reported that they were sun sensitive found that a subset of adults with skin of color were significantly less likely to use sunscreen when compared with non-Hispanic White adults: Non-Hispanic Black (adjusted odds ratio, 0.43); non-Hispanic Asian (aOR. 0.54); and Hispanic (aOR, 0.70) adults.
In the study, non-Hispanic Black and Hispanic adults were significantly less likely to use sunscreens with an SPF greater than 15. In addition, non-Hispanic Black, non-Hispanic Asian, and Hispanic adults were significantly more likely than non-Hispanic Whites to wear long sleeves when outside. Such differences are important to keep in mind when advising patients about sunscreens, she said.
Protection for lighter-colored skin
Dr. Taylor said that, for patients with lighter skin tones, “we really want to protect against ultraviolet B as well as ultraviolet A, particularly ultraviolet A2. Ultraviolet radiation is going to cause DNA damage.” Patients with Fitzpatrick skin types I, II, or III are most susceptible to the effects of UVB with sunburn inflammation, which will cause erythema and tanning, and immunosuppression.
“For those who are I, II, and III, we do want to recommend a broad-spectrum, photostable sunscreen with a critical wavelength of 370 nanometers, which is going to protect from both UVB and UVA2,” she said.
Sunscreen recommendations are meant to be paired with advice to avoid midday sun from 10 a.m. to 2 p.m., wearing protective clothing and accessories, and seeking shade, she noted.
Dr. Taylor said, for those patients with lighter skin who are more susceptible to photodamage and premature aging, physicians should recommend sunscreens that contain DNA repair enzymes such as photolyases and sunscreens that contain antioxidants that can prevent or reverse DNA damage. “The exogenous form of these lyases have been manufactured and added to sunscreens,” Dr. Taylor said. “They’re readily available in the United States. That is something to consider for patients with significant photodamage.”
Retinoids can also help alleviate or reverse photodamage, she added.
Protection for darker-colored skin
“Many people of color do not believe they need sunscreen,” Dr. Taylor said. But studies show that, although there may be more intrinsic protection, sunscreen is still needed.
Over 30 years ago, Halder and colleagues reported that melanin in skin of color can filter two to five times more UV radiation, and in a paper on the photoprotective role of melanin, Kaidbey and colleagues found that skin types V and VI had an intrinsic SPF of 13 when compared with those who have lighter complexions, which had an SPF of 3.
Sunburns seem to occur less frequently in people with skin of color, but that may be because erythema is less apparent in people with darker skin tones or because of differences in personal definitions of sunburn, Dr. Taylor said.
“Skin of color can and does sustain sunburns and sunscreen will help prevent that,” she said, adding that a recommendation of an SPF 30 is likely sufficient for these patients. Dr. Taylor noted that sunscreens for patients with darker skin often cost substantially more than those for lighter skin, and that should be considered in recommendations.
Tinted sunscreens
Dr. Taylor said that, while broad-spectrum photostable sunscreens protect against UVB and UVA 2, they don’t protect from visible light and UVA1. Two methods to add that protection are using inorganic tinted sunscreens that contain iron oxide or pigmentary titanium dioxide. Dr. Taylor was a coauthor of a practical guide to tinted sunscreens published in 2022.
“For iron oxide, we want a concentration of 3% or greater,” she said, adding that the percentage often is not known because if it is contained in a sunscreen, it is listed as an inactive ingredient.
Another method to address visible light and UVA1 is the use of antioxidant-containing sunscreens with vitamin E, vitamin C, or licochalcone A, Dr. Taylor said.
During the question-and-answer period following her presentation, Amit Pandya, MD, adjunct professor of dermatology at University of Texas Southwestern Medical Center, Dallas, asked why “every makeup, every sunscreen, just says iron oxide,” since it is known that visible light will cause pigmentation, especially in those with darker skin tones.
He urged pushing for a law that would require listing the percentage of iron oxide on products to assure it is sufficient, according to what the literature recommends.
Conference Chair Pearl Grimes, MD, director of the Vitiligo and Pigmentation Institute of Southern California, Los Angeles, said that she recommends tinted sunscreens almost exclusively for her patients, but those with darker skin colors struggle to match color.
Dr. Taylor referred to an analysis published in 2022 of 58 over-the counter sunscreens, which found that only 38% of tinted sunscreens was available in more than one shade, “which is a problem for many of our patients.” She said that providing samples with different hues and tactile sensations may help patients find the right product.
Dr. Taylor disclosed being on the advisory boards for AbbVie, Avita Medical, Beiersdorf, Biorez, Eli Lily, EPI Health, Evolus, Galderma, Hugel America, Johnson and Johnson, L’Oreal USA, MedScape, Pfizer, Scientis US, UCB, Vichy Laboratories. She is a consultant for Arcutis Biothermapeutics, Beiersdorf, Bristol-Myers Squibb, Cara Therapeutics, Dior, and Sanofi. She has done contracted research for Allergan Aesthetics, Concert Pharmaceuticals, Croma-Pharma, Eli Lilly, and Pfizer, and has an ownership interest in Armis Scientific, GloGetter, and Piction Health.
Medscape and this news organization are owned by the same parent company.
CHICAGO – at the inaugural Pigmentary Disorders Exchange Symposium.
Among the first factors physicians should consider before recommending sunscreen are a patient’s Fitzpatrick skin type, risks for burning or tanning, underlying skin disorders, and medications the patient is taking, Dr. Taylor, professor of dermatology at the University of Pennsylvania, Philadelphia, said at the meeting, provided by MedscapeLIVE! If patients are on hypertensives, for example, medications can make them more photosensitive.
Consider skin type
Dr. Taylor said she was dismayed by the results of a recent study, which found that 43% of dermatologists who responded to a survey reported that they never, rarely, or only sometimes took a patient’s skin type into account when making sunscreen recommendations. The article is referenced in a 2022 expert panel consensus paper she coauthored on photoprotection “for skin of all color.” But she pointed out that considering skin type alone is inadequate.
Questions for patients in joint decision-making should include lifestyle and work choices such as whether they work inside or outside, and how much sun exposure they get in a typical day. Heat and humidity levels should also be considered as should a patient’s susceptibility to dyspigmentation. “That could be overall darkening of the skin, mottled hyperpigmentation, actinic dyspigmentation, and, of course, propensity for skin cancer,” she said.
Use differs by race
Dr. Taylor, who is also vice chair for diversity, equity and inclusion in the department of dermatology at the University of Pennsylvania, pointed out that sunscreen use differs considerably by race.
In study of 8,952 adults in the United States who reported that they were sun sensitive found that a subset of adults with skin of color were significantly less likely to use sunscreen when compared with non-Hispanic White adults: Non-Hispanic Black (adjusted odds ratio, 0.43); non-Hispanic Asian (aOR. 0.54); and Hispanic (aOR, 0.70) adults.
In the study, non-Hispanic Black and Hispanic adults were significantly less likely to use sunscreens with an SPF greater than 15. In addition, non-Hispanic Black, non-Hispanic Asian, and Hispanic adults were significantly more likely than non-Hispanic Whites to wear long sleeves when outside. Such differences are important to keep in mind when advising patients about sunscreens, she said.
Protection for lighter-colored skin
Dr. Taylor said that, for patients with lighter skin tones, “we really want to protect against ultraviolet B as well as ultraviolet A, particularly ultraviolet A2. Ultraviolet radiation is going to cause DNA damage.” Patients with Fitzpatrick skin types I, II, or III are most susceptible to the effects of UVB with sunburn inflammation, which will cause erythema and tanning, and immunosuppression.
“For those who are I, II, and III, we do want to recommend a broad-spectrum, photostable sunscreen with a critical wavelength of 370 nanometers, which is going to protect from both UVB and UVA2,” she said.
Sunscreen recommendations are meant to be paired with advice to avoid midday sun from 10 a.m. to 2 p.m., wearing protective clothing and accessories, and seeking shade, she noted.
Dr. Taylor said, for those patients with lighter skin who are more susceptible to photodamage and premature aging, physicians should recommend sunscreens that contain DNA repair enzymes such as photolyases and sunscreens that contain antioxidants that can prevent or reverse DNA damage. “The exogenous form of these lyases have been manufactured and added to sunscreens,” Dr. Taylor said. “They’re readily available in the United States. That is something to consider for patients with significant photodamage.”
Retinoids can also help alleviate or reverse photodamage, she added.
Protection for darker-colored skin
“Many people of color do not believe they need sunscreen,” Dr. Taylor said. But studies show that, although there may be more intrinsic protection, sunscreen is still needed.
Over 30 years ago, Halder and colleagues reported that melanin in skin of color can filter two to five times more UV radiation, and in a paper on the photoprotective role of melanin, Kaidbey and colleagues found that skin types V and VI had an intrinsic SPF of 13 when compared with those who have lighter complexions, which had an SPF of 3.
Sunburns seem to occur less frequently in people with skin of color, but that may be because erythema is less apparent in people with darker skin tones or because of differences in personal definitions of sunburn, Dr. Taylor said.
“Skin of color can and does sustain sunburns and sunscreen will help prevent that,” she said, adding that a recommendation of an SPF 30 is likely sufficient for these patients. Dr. Taylor noted that sunscreens for patients with darker skin often cost substantially more than those for lighter skin, and that should be considered in recommendations.
Tinted sunscreens
Dr. Taylor said that, while broad-spectrum photostable sunscreens protect against UVB and UVA 2, they don’t protect from visible light and UVA1. Two methods to add that protection are using inorganic tinted sunscreens that contain iron oxide or pigmentary titanium dioxide. Dr. Taylor was a coauthor of a practical guide to tinted sunscreens published in 2022.
“For iron oxide, we want a concentration of 3% or greater,” she said, adding that the percentage often is not known because if it is contained in a sunscreen, it is listed as an inactive ingredient.
Another method to address visible light and UVA1 is the use of antioxidant-containing sunscreens with vitamin E, vitamin C, or licochalcone A, Dr. Taylor said.
During the question-and-answer period following her presentation, Amit Pandya, MD, adjunct professor of dermatology at University of Texas Southwestern Medical Center, Dallas, asked why “every makeup, every sunscreen, just says iron oxide,” since it is known that visible light will cause pigmentation, especially in those with darker skin tones.
He urged pushing for a law that would require listing the percentage of iron oxide on products to assure it is sufficient, according to what the literature recommends.
Conference Chair Pearl Grimes, MD, director of the Vitiligo and Pigmentation Institute of Southern California, Los Angeles, said that she recommends tinted sunscreens almost exclusively for her patients, but those with darker skin colors struggle to match color.
Dr. Taylor referred to an analysis published in 2022 of 58 over-the counter sunscreens, which found that only 38% of tinted sunscreens was available in more than one shade, “which is a problem for many of our patients.” She said that providing samples with different hues and tactile sensations may help patients find the right product.
Dr. Taylor disclosed being on the advisory boards for AbbVie, Avita Medical, Beiersdorf, Biorez, Eli Lily, EPI Health, Evolus, Galderma, Hugel America, Johnson and Johnson, L’Oreal USA, MedScape, Pfizer, Scientis US, UCB, Vichy Laboratories. She is a consultant for Arcutis Biothermapeutics, Beiersdorf, Bristol-Myers Squibb, Cara Therapeutics, Dior, and Sanofi. She has done contracted research for Allergan Aesthetics, Concert Pharmaceuticals, Croma-Pharma, Eli Lilly, and Pfizer, and has an ownership interest in Armis Scientific, GloGetter, and Piction Health.
Medscape and this news organization are owned by the same parent company.
AT THE MEDSCAPELIVE! PIGMENTARY DISORDERS SYMPOSIUM
AxSpA remission on TNFi seen in half of patients with comorbid IBD
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.
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.
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.
AT SPARTAN 2023