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USPSTF Draft Recommendations Support More Options for Osteoporosis Screening, Seek More Research in Men
An influential US panel may largely reaffirm its current recommendation in favor of screening older women to prevent osteoporotic fractures, while also repeating its call for more research to try to determine whether men would benefit from this kind of routine testing.
The US Preventive Services Task Force (USPSTF) on June 11 released a draft update of its recommendations on osteoporosis screening. The task force will accept comments on the draft through July 8. Federal law gives the USPSTF recommendations extra clout, requiring insurers to cover — without co-pay — services that get top marks “A” or “B” from the task force.
The task force intends to maintain a “B” recommendation on screening of older women, indicating that the evidence gathered to date suggests a moderate net benefit. But the draft includes a shift in the approach to this screening.
The USPSTF proposed saying that it recommends screening for osteoporosis in both women aged 65 years and older and postmenopausal women younger than 65 years who are at an increased risk for an osteoporotic fracture. The current recommendation, finalized in 2018, advises “screening for osteoporosis with bone measurement testing [emphasis added]” for these groups.
The proposed change in language — dropping the phrase “with bone measurement testing” — is intended to expand flexibility for clinicians, Esa Davis, MD, MPH, a member of USPSTF and a professor at the University of Maryland School of Medicine, Baltimore, told this news organization.
“It provides them with more options instead of telling them, ‘You have to do it this way,’ ” Dr. Davis said.
The task force’s draft recommendation is not meant to apply to people with secondary osteoporosis due to an underlying medical condition such as cancer, metabolic bone diseases or hyperthyroidism, or chronic use of a medication associated with bone loss.
Rajesh K. Jain, MD, who was not involved with the USPSTF work, read the draft recommendations at the request of this news organization. In an email, he said he generally agreed with the decision to largely stick to the 2018 recommendations for women.
He also noted that there’s still a lack of a clear direction for physicians about assessing osteoporosis risk in men. But multiple randomized control trials of osteoporosis drugs seem to suggest these medicines work for both sexes, said Dr. Jain, who is the endocrinology fellowship program director at University of Chicago Medicine, Chicago.
The USPSTF draft also would reiterate the current “I” grade about screening men for osteoporosis.
An “I” grade means the task force found the current body of available evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men.
“Since there is no recommendation right now, it would have seemed sensible to include a recommendation to screen men with prior fracture or other risk factors for osteoporosis, much like they do for younger women,” Dr. Jain said.
Insufficient Evidence
The USPSTF’s “I” grade is different from a “D” grade, which is what the task force uses to recommend against the use of a service.
A “D” grade means the USPSTF says there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. (The USPSTF makes it easy to search online for grades given to preventive services, including those that got a “D.”)
The USPSTF is calling for more studies on the benefits and harms of screening for osteoporosis to prevent fractures and related morbidity and mortality in men.
“Men do get osteoporosis,” Dr. Davis said. “But unfortunately, the evidence isn’t there” to allow USPSTF to make a recommendation on screening approaches.
“Any man who has concerns about bone health should certainly talk to his clinician and figure out what is the best form of screening” he might want to do, she said.
There’s been a growing interest in the question of whether to screen men for osteoporosis and bone health. For example, Osteoporosis Canada last year updated a guideline to emphasize the need to assess older patients of both sexes for the risk for fractures. But the Canadian Task Force on Preventive Health Care in 2023 came to a conclusion in line with the USPSTF draft.
The Canadian task force recommended against routine screening in men, while adding that clinicians should be alert to changes in health that may indicate the patient has experienced or is at a higher risk for fragility fracture.
Risk Factors, Concerns About Tests
The USPSTF said that risk factors associated with fragility fractures are similar in men and women. These include:
- Increasing age
- Low body mass index
- Excessive alcohol intake
- Current smoking
- Chronic corticosteroid use
- History of prior fractures, falls within the past year, cerebrovascular accident, and diabetes
- Hypogonadism
The process of updating the USPSTF recommendations can serve as a chance to expand public awareness about osteoporosis, as many men may not know to raise the question of their fracture risk during medical appointments, Dr. Davis said.
“Clinicians need to be aware of the risk factors and to be able to have conversations with men,” she said.
Dr. Davis also cautioned about the need to be aware of limitations with clinical risk assessment tools. In the draft recommendation statement, the USPSTF noted that some tools and approaches may be less likely to identify Black, Hispanic, and Asian people as high risk, and subsequently, clinicians may be less likely to offer treatment to them compared with White people of the same age, bone mineral density, and clinical risk profile.
Dr. Davis had no relevant financial relationships. Dr. Jain received research funding from the Amgen Foundation.
A version of this article appeared on Medscape.com.
An influential US panel may largely reaffirm its current recommendation in favor of screening older women to prevent osteoporotic fractures, while also repeating its call for more research to try to determine whether men would benefit from this kind of routine testing.
The US Preventive Services Task Force (USPSTF) on June 11 released a draft update of its recommendations on osteoporosis screening. The task force will accept comments on the draft through July 8. Federal law gives the USPSTF recommendations extra clout, requiring insurers to cover — without co-pay — services that get top marks “A” or “B” from the task force.
The task force intends to maintain a “B” recommendation on screening of older women, indicating that the evidence gathered to date suggests a moderate net benefit. But the draft includes a shift in the approach to this screening.
The USPSTF proposed saying that it recommends screening for osteoporosis in both women aged 65 years and older and postmenopausal women younger than 65 years who are at an increased risk for an osteoporotic fracture. The current recommendation, finalized in 2018, advises “screening for osteoporosis with bone measurement testing [emphasis added]” for these groups.
The proposed change in language — dropping the phrase “with bone measurement testing” — is intended to expand flexibility for clinicians, Esa Davis, MD, MPH, a member of USPSTF and a professor at the University of Maryland School of Medicine, Baltimore, told this news organization.
“It provides them with more options instead of telling them, ‘You have to do it this way,’ ” Dr. Davis said.
The task force’s draft recommendation is not meant to apply to people with secondary osteoporosis due to an underlying medical condition such as cancer, metabolic bone diseases or hyperthyroidism, or chronic use of a medication associated with bone loss.
Rajesh K. Jain, MD, who was not involved with the USPSTF work, read the draft recommendations at the request of this news organization. In an email, he said he generally agreed with the decision to largely stick to the 2018 recommendations for women.
He also noted that there’s still a lack of a clear direction for physicians about assessing osteoporosis risk in men. But multiple randomized control trials of osteoporosis drugs seem to suggest these medicines work for both sexes, said Dr. Jain, who is the endocrinology fellowship program director at University of Chicago Medicine, Chicago.
The USPSTF draft also would reiterate the current “I” grade about screening men for osteoporosis.
An “I” grade means the task force found the current body of available evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men.
“Since there is no recommendation right now, it would have seemed sensible to include a recommendation to screen men with prior fracture or other risk factors for osteoporosis, much like they do for younger women,” Dr. Jain said.
Insufficient Evidence
The USPSTF’s “I” grade is different from a “D” grade, which is what the task force uses to recommend against the use of a service.
A “D” grade means the USPSTF says there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. (The USPSTF makes it easy to search online for grades given to preventive services, including those that got a “D.”)
The USPSTF is calling for more studies on the benefits and harms of screening for osteoporosis to prevent fractures and related morbidity and mortality in men.
“Men do get osteoporosis,” Dr. Davis said. “But unfortunately, the evidence isn’t there” to allow USPSTF to make a recommendation on screening approaches.
“Any man who has concerns about bone health should certainly talk to his clinician and figure out what is the best form of screening” he might want to do, she said.
There’s been a growing interest in the question of whether to screen men for osteoporosis and bone health. For example, Osteoporosis Canada last year updated a guideline to emphasize the need to assess older patients of both sexes for the risk for fractures. But the Canadian Task Force on Preventive Health Care in 2023 came to a conclusion in line with the USPSTF draft.
The Canadian task force recommended against routine screening in men, while adding that clinicians should be alert to changes in health that may indicate the patient has experienced or is at a higher risk for fragility fracture.
Risk Factors, Concerns About Tests
The USPSTF said that risk factors associated with fragility fractures are similar in men and women. These include:
- Increasing age
- Low body mass index
- Excessive alcohol intake
- Current smoking
- Chronic corticosteroid use
- History of prior fractures, falls within the past year, cerebrovascular accident, and diabetes
- Hypogonadism
The process of updating the USPSTF recommendations can serve as a chance to expand public awareness about osteoporosis, as many men may not know to raise the question of their fracture risk during medical appointments, Dr. Davis said.
“Clinicians need to be aware of the risk factors and to be able to have conversations with men,” she said.
Dr. Davis also cautioned about the need to be aware of limitations with clinical risk assessment tools. In the draft recommendation statement, the USPSTF noted that some tools and approaches may be less likely to identify Black, Hispanic, and Asian people as high risk, and subsequently, clinicians may be less likely to offer treatment to them compared with White people of the same age, bone mineral density, and clinical risk profile.
Dr. Davis had no relevant financial relationships. Dr. Jain received research funding from the Amgen Foundation.
A version of this article appeared on Medscape.com.
An influential US panel may largely reaffirm its current recommendation in favor of screening older women to prevent osteoporotic fractures, while also repeating its call for more research to try to determine whether men would benefit from this kind of routine testing.
The US Preventive Services Task Force (USPSTF) on June 11 released a draft update of its recommendations on osteoporosis screening. The task force will accept comments on the draft through July 8. Federal law gives the USPSTF recommendations extra clout, requiring insurers to cover — without co-pay — services that get top marks “A” or “B” from the task force.
The task force intends to maintain a “B” recommendation on screening of older women, indicating that the evidence gathered to date suggests a moderate net benefit. But the draft includes a shift in the approach to this screening.
The USPSTF proposed saying that it recommends screening for osteoporosis in both women aged 65 years and older and postmenopausal women younger than 65 years who are at an increased risk for an osteoporotic fracture. The current recommendation, finalized in 2018, advises “screening for osteoporosis with bone measurement testing [emphasis added]” for these groups.
The proposed change in language — dropping the phrase “with bone measurement testing” — is intended to expand flexibility for clinicians, Esa Davis, MD, MPH, a member of USPSTF and a professor at the University of Maryland School of Medicine, Baltimore, told this news organization.
“It provides them with more options instead of telling them, ‘You have to do it this way,’ ” Dr. Davis said.
The task force’s draft recommendation is not meant to apply to people with secondary osteoporosis due to an underlying medical condition such as cancer, metabolic bone diseases or hyperthyroidism, or chronic use of a medication associated with bone loss.
Rajesh K. Jain, MD, who was not involved with the USPSTF work, read the draft recommendations at the request of this news organization. In an email, he said he generally agreed with the decision to largely stick to the 2018 recommendations for women.
He also noted that there’s still a lack of a clear direction for physicians about assessing osteoporosis risk in men. But multiple randomized control trials of osteoporosis drugs seem to suggest these medicines work for both sexes, said Dr. Jain, who is the endocrinology fellowship program director at University of Chicago Medicine, Chicago.
The USPSTF draft also would reiterate the current “I” grade about screening men for osteoporosis.
An “I” grade means the task force found the current body of available evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men.
“Since there is no recommendation right now, it would have seemed sensible to include a recommendation to screen men with prior fracture or other risk factors for osteoporosis, much like they do for younger women,” Dr. Jain said.
Insufficient Evidence
The USPSTF’s “I” grade is different from a “D” grade, which is what the task force uses to recommend against the use of a service.
A “D” grade means the USPSTF says there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. (The USPSTF makes it easy to search online for grades given to preventive services, including those that got a “D.”)
The USPSTF is calling for more studies on the benefits and harms of screening for osteoporosis to prevent fractures and related morbidity and mortality in men.
“Men do get osteoporosis,” Dr. Davis said. “But unfortunately, the evidence isn’t there” to allow USPSTF to make a recommendation on screening approaches.
“Any man who has concerns about bone health should certainly talk to his clinician and figure out what is the best form of screening” he might want to do, she said.
There’s been a growing interest in the question of whether to screen men for osteoporosis and bone health. For example, Osteoporosis Canada last year updated a guideline to emphasize the need to assess older patients of both sexes for the risk for fractures. But the Canadian Task Force on Preventive Health Care in 2023 came to a conclusion in line with the USPSTF draft.
The Canadian task force recommended against routine screening in men, while adding that clinicians should be alert to changes in health that may indicate the patient has experienced or is at a higher risk for fragility fracture.
Risk Factors, Concerns About Tests
The USPSTF said that risk factors associated with fragility fractures are similar in men and women. These include:
- Increasing age
- Low body mass index
- Excessive alcohol intake
- Current smoking
- Chronic corticosteroid use
- History of prior fractures, falls within the past year, cerebrovascular accident, and diabetes
- Hypogonadism
The process of updating the USPSTF recommendations can serve as a chance to expand public awareness about osteoporosis, as many men may not know to raise the question of their fracture risk during medical appointments, Dr. Davis said.
“Clinicians need to be aware of the risk factors and to be able to have conversations with men,” she said.
Dr. Davis also cautioned about the need to be aware of limitations with clinical risk assessment tools. In the draft recommendation statement, the USPSTF noted that some tools and approaches may be less likely to identify Black, Hispanic, and Asian people as high risk, and subsequently, clinicians may be less likely to offer treatment to them compared with White people of the same age, bone mineral density, and clinical risk profile.
Dr. Davis had no relevant financial relationships. Dr. Jain received research funding from the Amgen Foundation.
A version of this article appeared on Medscape.com.
Having More Tender Than Swollen Joints Worsens Outcomes in Early Rheumatoid Arthritis
TOPLINE:
Having more tender than swollen joints is linked to worse patient-reported outcomes (PROs), particularly in pain interference, social participation, and fatigue, in patients with rheumatoid arthritis (RA).
METHODOLOGY:
- In early RA, understanding the impact of tender-swollen joint differences (TSJDs) on PROs across multiple domains of health-related quality of life is important to customize personalized therapeutic strategies.
- This study evaluated the impact of TSJDs on PROs over 1 year in 547 patients (mean age, 56 years; 70% women; mean symptom duration, 5.3 months) with early RA across 18 centers in Canada between January 2016 and August 2022.
- TSJDs were assessed for 28 joints (six large and 22 small) at baseline and at 3-, 6-, and 12-month visits using the PRO Measurement Information System (PROMIS-29), covering seven domains of health. Higher PROMIS T-scores indicated better health outcomes.
TAKEAWAY:
- A one-point increase of TSJD was significantly associated with worse PROMIS T-scores in physical function (adjusted regression coefficient [β], −0.27; 95% CI, −0.39 to −0.15) and social participation (β, −0.34; 95% CI, −0.50 to −0.19).
- A one-point increase in TSJD was also linked to worsened PROMIS symptoms in pain interference (β, 0.49), fatigue (β, 0.34), sleep problems (β, 0.29), anxiety (β, 0.23), and depression (β, 0.20).
- Large-joint TSJD was particularly associated with worse PROs than small-joint TSJD.
- The sensitivity analysis validated the reliability of the primary findings regarding the association between joint counts and PROs evaluated by PROMIS-29, even when accounting for C-reactive protein levels in various scenarios or assumptions.
IN PRACTICE:
“Patients with more tender than swollen joints may experience worsening of all seven domains of health, especially pain interference, social participation, and fatigue. Rheumatologists should be alerted to their patients with early RA having more tender than swollen joints, particularly in large joints,” the authors wrote.
SOURCE:
The study was led by Charis F. Meng, MD, Division of Rheumatology, Hospital for Special Surgery, New York. It was published online on May 1, 2024, in Journal of Clinical Rheumatology.
LIMITATIONS:
The study was observational with missing data, which could have impacted the reliability of the results. Most participants were women and White individuals, which could restrict the generalizability of results. The absence of ultrasound for synovitis limited the clinical assessment of patients with RA for information beyond physical examination alone.
DISCLOSURES:
The study was supported and funded by the Inflammatory Arthritis Center and Division of Rheumatology at the Hospital for Special Surgery, New York. One author reported receiving funding from the National Institutes of Health.
A version of this article appeared on Medscape.com.
TOPLINE:
Having more tender than swollen joints is linked to worse patient-reported outcomes (PROs), particularly in pain interference, social participation, and fatigue, in patients with rheumatoid arthritis (RA).
METHODOLOGY:
- In early RA, understanding the impact of tender-swollen joint differences (TSJDs) on PROs across multiple domains of health-related quality of life is important to customize personalized therapeutic strategies.
- This study evaluated the impact of TSJDs on PROs over 1 year in 547 patients (mean age, 56 years; 70% women; mean symptom duration, 5.3 months) with early RA across 18 centers in Canada between January 2016 and August 2022.
- TSJDs were assessed for 28 joints (six large and 22 small) at baseline and at 3-, 6-, and 12-month visits using the PRO Measurement Information System (PROMIS-29), covering seven domains of health. Higher PROMIS T-scores indicated better health outcomes.
TAKEAWAY:
- A one-point increase of TSJD was significantly associated with worse PROMIS T-scores in physical function (adjusted regression coefficient [β], −0.27; 95% CI, −0.39 to −0.15) and social participation (β, −0.34; 95% CI, −0.50 to −0.19).
- A one-point increase in TSJD was also linked to worsened PROMIS symptoms in pain interference (β, 0.49), fatigue (β, 0.34), sleep problems (β, 0.29), anxiety (β, 0.23), and depression (β, 0.20).
- Large-joint TSJD was particularly associated with worse PROs than small-joint TSJD.
- The sensitivity analysis validated the reliability of the primary findings regarding the association between joint counts and PROs evaluated by PROMIS-29, even when accounting for C-reactive protein levels in various scenarios or assumptions.
IN PRACTICE:
“Patients with more tender than swollen joints may experience worsening of all seven domains of health, especially pain interference, social participation, and fatigue. Rheumatologists should be alerted to their patients with early RA having more tender than swollen joints, particularly in large joints,” the authors wrote.
SOURCE:
The study was led by Charis F. Meng, MD, Division of Rheumatology, Hospital for Special Surgery, New York. It was published online on May 1, 2024, in Journal of Clinical Rheumatology.
LIMITATIONS:
The study was observational with missing data, which could have impacted the reliability of the results. Most participants were women and White individuals, which could restrict the generalizability of results. The absence of ultrasound for synovitis limited the clinical assessment of patients with RA for information beyond physical examination alone.
DISCLOSURES:
The study was supported and funded by the Inflammatory Arthritis Center and Division of Rheumatology at the Hospital for Special Surgery, New York. One author reported receiving funding from the National Institutes of Health.
A version of this article appeared on Medscape.com.
TOPLINE:
Having more tender than swollen joints is linked to worse patient-reported outcomes (PROs), particularly in pain interference, social participation, and fatigue, in patients with rheumatoid arthritis (RA).
METHODOLOGY:
- In early RA, understanding the impact of tender-swollen joint differences (TSJDs) on PROs across multiple domains of health-related quality of life is important to customize personalized therapeutic strategies.
- This study evaluated the impact of TSJDs on PROs over 1 year in 547 patients (mean age, 56 years; 70% women; mean symptom duration, 5.3 months) with early RA across 18 centers in Canada between January 2016 and August 2022.
- TSJDs were assessed for 28 joints (six large and 22 small) at baseline and at 3-, 6-, and 12-month visits using the PRO Measurement Information System (PROMIS-29), covering seven domains of health. Higher PROMIS T-scores indicated better health outcomes.
TAKEAWAY:
- A one-point increase of TSJD was significantly associated with worse PROMIS T-scores in physical function (adjusted regression coefficient [β], −0.27; 95% CI, −0.39 to −0.15) and social participation (β, −0.34; 95% CI, −0.50 to −0.19).
- A one-point increase in TSJD was also linked to worsened PROMIS symptoms in pain interference (β, 0.49), fatigue (β, 0.34), sleep problems (β, 0.29), anxiety (β, 0.23), and depression (β, 0.20).
- Large-joint TSJD was particularly associated with worse PROs than small-joint TSJD.
- The sensitivity analysis validated the reliability of the primary findings regarding the association between joint counts and PROs evaluated by PROMIS-29, even when accounting for C-reactive protein levels in various scenarios or assumptions.
IN PRACTICE:
“Patients with more tender than swollen joints may experience worsening of all seven domains of health, especially pain interference, social participation, and fatigue. Rheumatologists should be alerted to their patients with early RA having more tender than swollen joints, particularly in large joints,” the authors wrote.
SOURCE:
The study was led by Charis F. Meng, MD, Division of Rheumatology, Hospital for Special Surgery, New York. It was published online on May 1, 2024, in Journal of Clinical Rheumatology.
LIMITATIONS:
The study was observational with missing data, which could have impacted the reliability of the results. Most participants were women and White individuals, which could restrict the generalizability of results. The absence of ultrasound for synovitis limited the clinical assessment of patients with RA for information beyond physical examination alone.
DISCLOSURES:
The study was supported and funded by the Inflammatory Arthritis Center and Division of Rheumatology at the Hospital for Special Surgery, New York. One author reported receiving funding from the National Institutes of Health.
A version of this article appeared on Medscape.com.
National Academies Issue New Broad Definition of Long COVID
A new broadly inclusive definition of long COVID from the National Academies of Sciences, Engineering, and Medicine (NASEM) has been developed with the aim of improving consistency, documentation, and treatment for both adults and children.
According to the 2024 NASEM definition of long COVID issued on June 11, 2024, “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”
People with long COVID may present with one or more of a long list of symptoms, such as shortness of breath, rapid heartbeat, extreme fatigue, post-exertional malaise, or sleep disturbance and with single or multiple diagnosable conditions, including interstitial lung disease, arrhythmias, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), diabetes, or autoimmune disorders. The condition can exacerbate preexisting health conditions or present as new ones.
The definition does not require laboratory confirmation or other proof of initial infection. Long COVID can follow SARS-CoV-2 infection of any severity, including asymptomatic infections, whether or not they were initially recognized.
Several working definitions and terms for long COVID had previously been proposed, including those from the World Health Organization (WHO) and the US Centers for Disease Control and Prevention, but no common definition or terminology had been established.
The new definition was developed at the request of the Administration for Strategic Preparedness and Response and the Office of the Assistant Secretary for Health (OASH). It was written by a multi-stakeholder panel convened by NASEM, which recommended that the new definition be universally adopted by the federal government, clinical societies and associations, public health practitioners, clinicians, payers, the drug industry, and others using the term long COVID.
Recent surveys suggest that approximately 7% of Americans have experienced or are experiencing long COVID. “It’s millions of people,” panel chair Harvey V. Fineberg, MD, president of the Gordon and Betty Moore Foundation, told this news organization.
The new definition “does not erase the problem of clinical judgment ... But we think this definition has the real advantage of elevating to the clinician’s mind the real likelihood in the current environment of prevalence of this virus that a presenting patient’s strange symptoms are both real and maybe related as an expression of long COVID,” Dr. Fineberg noted.
One way this new definition differs from previous ones such as WHO’s, he said, is “they talk about a diagnosis of exclusion. One of the important points in our definition is that other diagnosable conditions like ME/CFS or POTS can be part of the picture of long COVID. They are not alternative. They are, in fact, an expression of long COVID.”
Indeed, the NASEM report also introduces the term infection-associated chronic condition (IACC). This was important, Dr. Fineberg said, “because it’s the larger family of conditions of which long COVID is a part. It emphasizes a relatedness of long COVID to other conditions that can follow from a variety of infections. We also adopted the term ‘disease state’ to convey the seriousness and reality of this condition in the lives of patients.”
Comments on New Definition
In a statement provided to this news organization, Lucinda Bateman, MD, and Brayden Yellman, MD, co-medical directors of the Bateman-Horne Center in Salt Lake City, said that “describing long COVID as an IACC ... not only meets the NASEM goal of allowing clinicians, researchers, and public health officials to meaningfully identify and serve all persons who suffer illness or disability in the wake of a SARS-CoV-2 infection, but also draws direct comparison to other known IACC’s (such as ME/CFS, post-treatment Lyme, POTS) that have been plaguing many for decades.”
Dr. Fineberg noted another important aspect of the NASEM report: “Our definition includes an explicit statement on equity, explaining that long COVID can affect anyone, young and old, different races, different ages, different sexes, different genders, different orientations, different socioeconomic conditions ... This does not mean that every single person is at equal risk. There are risk factors, but the important point is the universal nature of this as a condition.”
Two clinical directors of long COVID programs who were contacted by this news organization praised the new definition. Zijian Chen, MD, director of Mount Sinai’s Center for Post-COVID Care, New York, said that it’s “very similar to the definition that we have used for our clinical practice since 2020. It is very important that the broad definition helps to be inclusive of all patients that may be affected. The inclusion of children as a consideration is important as well, since there is routinely less focus on children because they tend to have less disease frequency ... The creation of a unified definition helps both with clinical practice and research.”
Nisha Viswanathan, MD, director of the long COVID program at the University of California, Los Angeles, said: “I think they left it intentionally broad for the medical practitioner to not necessarily use the definition to rule out individuals, but to perhaps use more of a clinical gestalt to help rule in this diagnosis ... I think this definition is providing clarity to health care providers on what exactly would be falling under the long-COVID diagnosis header.”
Dr. Viswanathan also said that she anticipates this definition to help patients make their case in filing disability claims. “Because long COVID has not previously had a good fleshed-out definition, it was very easy for disability providers to reject claims for patients who continue to have symptoms ... I actually think this might help our patients ultimately in their attempt to be able to have the ability to care for themselves when they’re disabled enough to not be able to work.”
Written into the report is the expectation that the definition “will evolve as new evidence emerges and the understanding of long COVID matures.” The writing committee calls for reexamination in “no more than 3 years.” Factors that would prompt a reevaluation could include improved testing methods, discovery of medical factors and/or biomarkers that distinguish long COVID from other conditions, and new treatments.
Meanwhile, Dr. Fineberg told this news organization, “If this definition adds to the readiness, awareness, openness, and response to the patient with long COVID, it will have done its job.”
Dr. Fineberg, Dr. Bateman, Dr. Yellman, Dr. Viswanathan, and Dr. Chen have no relevant disclosures.
A version of this article appeared on Medscape.com.
A new broadly inclusive definition of long COVID from the National Academies of Sciences, Engineering, and Medicine (NASEM) has been developed with the aim of improving consistency, documentation, and treatment for both adults and children.
According to the 2024 NASEM definition of long COVID issued on June 11, 2024, “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”
People with long COVID may present with one or more of a long list of symptoms, such as shortness of breath, rapid heartbeat, extreme fatigue, post-exertional malaise, or sleep disturbance and with single or multiple diagnosable conditions, including interstitial lung disease, arrhythmias, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), diabetes, or autoimmune disorders. The condition can exacerbate preexisting health conditions or present as new ones.
The definition does not require laboratory confirmation or other proof of initial infection. Long COVID can follow SARS-CoV-2 infection of any severity, including asymptomatic infections, whether or not they were initially recognized.
Several working definitions and terms for long COVID had previously been proposed, including those from the World Health Organization (WHO) and the US Centers for Disease Control and Prevention, but no common definition or terminology had been established.
The new definition was developed at the request of the Administration for Strategic Preparedness and Response and the Office of the Assistant Secretary for Health (OASH). It was written by a multi-stakeholder panel convened by NASEM, which recommended that the new definition be universally adopted by the federal government, clinical societies and associations, public health practitioners, clinicians, payers, the drug industry, and others using the term long COVID.
Recent surveys suggest that approximately 7% of Americans have experienced or are experiencing long COVID. “It’s millions of people,” panel chair Harvey V. Fineberg, MD, president of the Gordon and Betty Moore Foundation, told this news organization.
The new definition “does not erase the problem of clinical judgment ... But we think this definition has the real advantage of elevating to the clinician’s mind the real likelihood in the current environment of prevalence of this virus that a presenting patient’s strange symptoms are both real and maybe related as an expression of long COVID,” Dr. Fineberg noted.
One way this new definition differs from previous ones such as WHO’s, he said, is “they talk about a diagnosis of exclusion. One of the important points in our definition is that other diagnosable conditions like ME/CFS or POTS can be part of the picture of long COVID. They are not alternative. They are, in fact, an expression of long COVID.”
Indeed, the NASEM report also introduces the term infection-associated chronic condition (IACC). This was important, Dr. Fineberg said, “because it’s the larger family of conditions of which long COVID is a part. It emphasizes a relatedness of long COVID to other conditions that can follow from a variety of infections. We also adopted the term ‘disease state’ to convey the seriousness and reality of this condition in the lives of patients.”
Comments on New Definition
In a statement provided to this news organization, Lucinda Bateman, MD, and Brayden Yellman, MD, co-medical directors of the Bateman-Horne Center in Salt Lake City, said that “describing long COVID as an IACC ... not only meets the NASEM goal of allowing clinicians, researchers, and public health officials to meaningfully identify and serve all persons who suffer illness or disability in the wake of a SARS-CoV-2 infection, but also draws direct comparison to other known IACC’s (such as ME/CFS, post-treatment Lyme, POTS) that have been plaguing many for decades.”
Dr. Fineberg noted another important aspect of the NASEM report: “Our definition includes an explicit statement on equity, explaining that long COVID can affect anyone, young and old, different races, different ages, different sexes, different genders, different orientations, different socioeconomic conditions ... This does not mean that every single person is at equal risk. There are risk factors, but the important point is the universal nature of this as a condition.”
Two clinical directors of long COVID programs who were contacted by this news organization praised the new definition. Zijian Chen, MD, director of Mount Sinai’s Center for Post-COVID Care, New York, said that it’s “very similar to the definition that we have used for our clinical practice since 2020. It is very important that the broad definition helps to be inclusive of all patients that may be affected. The inclusion of children as a consideration is important as well, since there is routinely less focus on children because they tend to have less disease frequency ... The creation of a unified definition helps both with clinical practice and research.”
Nisha Viswanathan, MD, director of the long COVID program at the University of California, Los Angeles, said: “I think they left it intentionally broad for the medical practitioner to not necessarily use the definition to rule out individuals, but to perhaps use more of a clinical gestalt to help rule in this diagnosis ... I think this definition is providing clarity to health care providers on what exactly would be falling under the long-COVID diagnosis header.”
Dr. Viswanathan also said that she anticipates this definition to help patients make their case in filing disability claims. “Because long COVID has not previously had a good fleshed-out definition, it was very easy for disability providers to reject claims for patients who continue to have symptoms ... I actually think this might help our patients ultimately in their attempt to be able to have the ability to care for themselves when they’re disabled enough to not be able to work.”
Written into the report is the expectation that the definition “will evolve as new evidence emerges and the understanding of long COVID matures.” The writing committee calls for reexamination in “no more than 3 years.” Factors that would prompt a reevaluation could include improved testing methods, discovery of medical factors and/or biomarkers that distinguish long COVID from other conditions, and new treatments.
Meanwhile, Dr. Fineberg told this news organization, “If this definition adds to the readiness, awareness, openness, and response to the patient with long COVID, it will have done its job.”
Dr. Fineberg, Dr. Bateman, Dr. Yellman, Dr. Viswanathan, and Dr. Chen have no relevant disclosures.
A version of this article appeared on Medscape.com.
A new broadly inclusive definition of long COVID from the National Academies of Sciences, Engineering, and Medicine (NASEM) has been developed with the aim of improving consistency, documentation, and treatment for both adults and children.
According to the 2024 NASEM definition of long COVID issued on June 11, 2024, “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”
People with long COVID may present with one or more of a long list of symptoms, such as shortness of breath, rapid heartbeat, extreme fatigue, post-exertional malaise, or sleep disturbance and with single or multiple diagnosable conditions, including interstitial lung disease, arrhythmias, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), diabetes, or autoimmune disorders. The condition can exacerbate preexisting health conditions or present as new ones.
The definition does not require laboratory confirmation or other proof of initial infection. Long COVID can follow SARS-CoV-2 infection of any severity, including asymptomatic infections, whether or not they were initially recognized.
Several working definitions and terms for long COVID had previously been proposed, including those from the World Health Organization (WHO) and the US Centers for Disease Control and Prevention, but no common definition or terminology had been established.
The new definition was developed at the request of the Administration for Strategic Preparedness and Response and the Office of the Assistant Secretary for Health (OASH). It was written by a multi-stakeholder panel convened by NASEM, which recommended that the new definition be universally adopted by the federal government, clinical societies and associations, public health practitioners, clinicians, payers, the drug industry, and others using the term long COVID.
Recent surveys suggest that approximately 7% of Americans have experienced or are experiencing long COVID. “It’s millions of people,” panel chair Harvey V. Fineberg, MD, president of the Gordon and Betty Moore Foundation, told this news organization.
The new definition “does not erase the problem of clinical judgment ... But we think this definition has the real advantage of elevating to the clinician’s mind the real likelihood in the current environment of prevalence of this virus that a presenting patient’s strange symptoms are both real and maybe related as an expression of long COVID,” Dr. Fineberg noted.
One way this new definition differs from previous ones such as WHO’s, he said, is “they talk about a diagnosis of exclusion. One of the important points in our definition is that other diagnosable conditions like ME/CFS or POTS can be part of the picture of long COVID. They are not alternative. They are, in fact, an expression of long COVID.”
Indeed, the NASEM report also introduces the term infection-associated chronic condition (IACC). This was important, Dr. Fineberg said, “because it’s the larger family of conditions of which long COVID is a part. It emphasizes a relatedness of long COVID to other conditions that can follow from a variety of infections. We also adopted the term ‘disease state’ to convey the seriousness and reality of this condition in the lives of patients.”
Comments on New Definition
In a statement provided to this news organization, Lucinda Bateman, MD, and Brayden Yellman, MD, co-medical directors of the Bateman-Horne Center in Salt Lake City, said that “describing long COVID as an IACC ... not only meets the NASEM goal of allowing clinicians, researchers, and public health officials to meaningfully identify and serve all persons who suffer illness or disability in the wake of a SARS-CoV-2 infection, but also draws direct comparison to other known IACC’s (such as ME/CFS, post-treatment Lyme, POTS) that have been plaguing many for decades.”
Dr. Fineberg noted another important aspect of the NASEM report: “Our definition includes an explicit statement on equity, explaining that long COVID can affect anyone, young and old, different races, different ages, different sexes, different genders, different orientations, different socioeconomic conditions ... This does not mean that every single person is at equal risk. There are risk factors, but the important point is the universal nature of this as a condition.”
Two clinical directors of long COVID programs who were contacted by this news organization praised the new definition. Zijian Chen, MD, director of Mount Sinai’s Center for Post-COVID Care, New York, said that it’s “very similar to the definition that we have used for our clinical practice since 2020. It is very important that the broad definition helps to be inclusive of all patients that may be affected. The inclusion of children as a consideration is important as well, since there is routinely less focus on children because they tend to have less disease frequency ... The creation of a unified definition helps both with clinical practice and research.”
Nisha Viswanathan, MD, director of the long COVID program at the University of California, Los Angeles, said: “I think they left it intentionally broad for the medical practitioner to not necessarily use the definition to rule out individuals, but to perhaps use more of a clinical gestalt to help rule in this diagnosis ... I think this definition is providing clarity to health care providers on what exactly would be falling under the long-COVID diagnosis header.”
Dr. Viswanathan also said that she anticipates this definition to help patients make their case in filing disability claims. “Because long COVID has not previously had a good fleshed-out definition, it was very easy for disability providers to reject claims for patients who continue to have symptoms ... I actually think this might help our patients ultimately in their attempt to be able to have the ability to care for themselves when they’re disabled enough to not be able to work.”
Written into the report is the expectation that the definition “will evolve as new evidence emerges and the understanding of long COVID matures.” The writing committee calls for reexamination in “no more than 3 years.” Factors that would prompt a reevaluation could include improved testing methods, discovery of medical factors and/or biomarkers that distinguish long COVID from other conditions, and new treatments.
Meanwhile, Dr. Fineberg told this news organization, “If this definition adds to the readiness, awareness, openness, and response to the patient with long COVID, it will have done its job.”
Dr. Fineberg, Dr. Bateman, Dr. Yellman, Dr. Viswanathan, and Dr. Chen have no relevant disclosures.
A version of this article appeared on Medscape.com.
High-Frequency Electric Nerve Block Shows Promise in Postamputation Pain Management
TOPLINE:
in a new study, presenting a potential new therapeutic option for amputees.
METHODOLOGY:
- The study enrolled 180 patients with unilateral lower limb amputations who were experiencing severe post-procedure pain.
- Participants were randomized 1:1 to receive 3 months of treatment with either a high-frequency nerve block (Altius; Neuros Medical) or an active sham.
- Effectiveness was measured by the percentage of participants achieving at least a 50% reduction in pain in more than half of the treatment sessions.
- The researchers attempted to control for variables including pain type and baseline pain intensity.
TAKEAWAY:
- A total of 24.7% of patients in the group that received the nerve block were responders at 30 minutes post-treatment, significantly higher than 7.1% in the control group (P = .002).
- The rate of response rose to 46.8% in the treatment group at 120 minutes, compared with 22.2% in the sham group (P = .001).
- Patients who received the nerve block reported a greater improvement in their score on the Brief Pain Inventory than those in the sham arm — 2.3 ± 0.29 vs 1.3 ± 0.26, respectively (P = .01).
- Use of opioids trended toward a greater reduction in the treatment group, although that finding was not statistically significant.
IN PRACTICE:
The results suggested “high-frequency electric nerve block could be a viable option for managing chronic post-amputation pain, potentially improving patients’ quality of life and reducing reliance on opioids,” the authors wrote. “The study addresses a critical gap in treatment options for amputees suffering from persistent pain, offering evidence for a novel therapeutic approach.”
“We have never seen a study of this magnitude and rigor in this patient population,” said lead author Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, in a press release about the data. “The data demonstrated clear and lasting benefit of treatment for pain reduction and functional outcomes at 3 months, creating great optimism for the long-term study results. These findings represent a significant advancement for an at-risk and underserved patient population in desperate need of reliable and effective treatment.”
SOURCE:
The study was led by Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, and was published online in the Journal of Pain Research.
LIMITATIONS:
The sample size of 180 participants may limit the generalizability of the findings to all amputees. A 3-month duration for assessing treatment efficacy may not capture long-term outcomes and effects. The active-sham control design, while rigorous, may not fully account for the placebo effects inherent in pain perception studies.
DISCLOSURES:
The QUEST study was funded by Neuros Medical Inc. Dr. Kapural reported personal fees from various medical companies, unrelated to this work. No other conflicts of interest were reported in this work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
in a new study, presenting a potential new therapeutic option for amputees.
METHODOLOGY:
- The study enrolled 180 patients with unilateral lower limb amputations who were experiencing severe post-procedure pain.
- Participants were randomized 1:1 to receive 3 months of treatment with either a high-frequency nerve block (Altius; Neuros Medical) or an active sham.
- Effectiveness was measured by the percentage of participants achieving at least a 50% reduction in pain in more than half of the treatment sessions.
- The researchers attempted to control for variables including pain type and baseline pain intensity.
TAKEAWAY:
- A total of 24.7% of patients in the group that received the nerve block were responders at 30 minutes post-treatment, significantly higher than 7.1% in the control group (P = .002).
- The rate of response rose to 46.8% in the treatment group at 120 minutes, compared with 22.2% in the sham group (P = .001).
- Patients who received the nerve block reported a greater improvement in their score on the Brief Pain Inventory than those in the sham arm — 2.3 ± 0.29 vs 1.3 ± 0.26, respectively (P = .01).
- Use of opioids trended toward a greater reduction in the treatment group, although that finding was not statistically significant.
IN PRACTICE:
The results suggested “high-frequency electric nerve block could be a viable option for managing chronic post-amputation pain, potentially improving patients’ quality of life and reducing reliance on opioids,” the authors wrote. “The study addresses a critical gap in treatment options for amputees suffering from persistent pain, offering evidence for a novel therapeutic approach.”
“We have never seen a study of this magnitude and rigor in this patient population,” said lead author Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, in a press release about the data. “The data demonstrated clear and lasting benefit of treatment for pain reduction and functional outcomes at 3 months, creating great optimism for the long-term study results. These findings represent a significant advancement for an at-risk and underserved patient population in desperate need of reliable and effective treatment.”
SOURCE:
The study was led by Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, and was published online in the Journal of Pain Research.
LIMITATIONS:
The sample size of 180 participants may limit the generalizability of the findings to all amputees. A 3-month duration for assessing treatment efficacy may not capture long-term outcomes and effects. The active-sham control design, while rigorous, may not fully account for the placebo effects inherent in pain perception studies.
DISCLOSURES:
The QUEST study was funded by Neuros Medical Inc. Dr. Kapural reported personal fees from various medical companies, unrelated to this work. No other conflicts of interest were reported in this work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
in a new study, presenting a potential new therapeutic option for amputees.
METHODOLOGY:
- The study enrolled 180 patients with unilateral lower limb amputations who were experiencing severe post-procedure pain.
- Participants were randomized 1:1 to receive 3 months of treatment with either a high-frequency nerve block (Altius; Neuros Medical) or an active sham.
- Effectiveness was measured by the percentage of participants achieving at least a 50% reduction in pain in more than half of the treatment sessions.
- The researchers attempted to control for variables including pain type and baseline pain intensity.
TAKEAWAY:
- A total of 24.7% of patients in the group that received the nerve block were responders at 30 minutes post-treatment, significantly higher than 7.1% in the control group (P = .002).
- The rate of response rose to 46.8% in the treatment group at 120 minutes, compared with 22.2% in the sham group (P = .001).
- Patients who received the nerve block reported a greater improvement in their score on the Brief Pain Inventory than those in the sham arm — 2.3 ± 0.29 vs 1.3 ± 0.26, respectively (P = .01).
- Use of opioids trended toward a greater reduction in the treatment group, although that finding was not statistically significant.
IN PRACTICE:
The results suggested “high-frequency electric nerve block could be a viable option for managing chronic post-amputation pain, potentially improving patients’ quality of life and reducing reliance on opioids,” the authors wrote. “The study addresses a critical gap in treatment options for amputees suffering from persistent pain, offering evidence for a novel therapeutic approach.”
“We have never seen a study of this magnitude and rigor in this patient population,” said lead author Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, in a press release about the data. “The data demonstrated clear and lasting benefit of treatment for pain reduction and functional outcomes at 3 months, creating great optimism for the long-term study results. These findings represent a significant advancement for an at-risk and underserved patient population in desperate need of reliable and effective treatment.”
SOURCE:
The study was led by Leonardo Kapural, MD, PhD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, and was published online in the Journal of Pain Research.
LIMITATIONS:
The sample size of 180 participants may limit the generalizability of the findings to all amputees. A 3-month duration for assessing treatment efficacy may not capture long-term outcomes and effects. The active-sham control design, while rigorous, may not fully account for the placebo effects inherent in pain perception studies.
DISCLOSURES:
The QUEST study was funded by Neuros Medical Inc. Dr. Kapural reported personal fees from various medical companies, unrelated to this work. No other conflicts of interest were reported in this work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
Cosmetic Tattoo Ingredients Associated With Contact Dermatitis
TOPLINE:
, but the ability to identify these allergies in patients is limited.
METHODOLOGY:
- While the allergenic potential of pigments in traditional tattoos has been documented, there is less clarity about pigments used in inks contained in cosmetic tattoos, also known as permanent makeup, and their association with ACD.
- Researchers conducted an Internet search and identified 974 individual permanent makeup ink products sold in the United States and also identified 79 unique pigments in those products.
- They evaluated the safety data sheets of these products and performed a PubMed search to identify documented ACD cases related to these pigments.
TAKEAWAY:
- Of the 79 pigments, 20 contained inorganic metals, which included iron, aluminum, silicone, chromium, copper, titanium, molybdenum, and manganese.
- Organic pigments were more common: 59 of the remaining pigments were organic compounds, mostly azo, quinacridone, or anthraquinone dyes, including 4 black pigments made from carbon only.
- A literature search identified 29 cases where patients had developed ACD thought to be caused by at least one of the 79 pigments identified by the authors of the current study and included 10 of the 79 pigments (12%).
- In 18 of the 29 cases in the literature, patch testing to the suspected pigment had been performed; in 3 cases, ACD was suspected without confirmatory testing.
IN PRACTICE:
Permanent makeup is becoming more popular, and there have been reports of ACD related to pigments contained in the inks, the authors wrote. “Traditional patch testing methods may not be useful in confirming the presence of a pigment allergy, even if one is suspect,” they added. “Consumers and patch testing physicians would benefit from better labeling of tattoo inks and the development of protocols designed to specifically test for tattoo pigment allergies.”
SOURCE:
The study was led by Sarah Rigali, MS, of Rosalind Franklin University, Chicago Medical School, Chicago, and coauthors from the Department of Dermatology, Northwestern University, Chicago, published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study is limited by incomplete safety data sheets. So, many brands of permanent makeup ink could not be investigated. In addition, some pigments may not be fully disclosed in ingredient lists and precise ink content measurements were not available.
DISCLOSURES:
The study reported receiving no funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
, but the ability to identify these allergies in patients is limited.
METHODOLOGY:
- While the allergenic potential of pigments in traditional tattoos has been documented, there is less clarity about pigments used in inks contained in cosmetic tattoos, also known as permanent makeup, and their association with ACD.
- Researchers conducted an Internet search and identified 974 individual permanent makeup ink products sold in the United States and also identified 79 unique pigments in those products.
- They evaluated the safety data sheets of these products and performed a PubMed search to identify documented ACD cases related to these pigments.
TAKEAWAY:
- Of the 79 pigments, 20 contained inorganic metals, which included iron, aluminum, silicone, chromium, copper, titanium, molybdenum, and manganese.
- Organic pigments were more common: 59 of the remaining pigments were organic compounds, mostly azo, quinacridone, or anthraquinone dyes, including 4 black pigments made from carbon only.
- A literature search identified 29 cases where patients had developed ACD thought to be caused by at least one of the 79 pigments identified by the authors of the current study and included 10 of the 79 pigments (12%).
- In 18 of the 29 cases in the literature, patch testing to the suspected pigment had been performed; in 3 cases, ACD was suspected without confirmatory testing.
IN PRACTICE:
Permanent makeup is becoming more popular, and there have been reports of ACD related to pigments contained in the inks, the authors wrote. “Traditional patch testing methods may not be useful in confirming the presence of a pigment allergy, even if one is suspect,” they added. “Consumers and patch testing physicians would benefit from better labeling of tattoo inks and the development of protocols designed to specifically test for tattoo pigment allergies.”
SOURCE:
The study was led by Sarah Rigali, MS, of Rosalind Franklin University, Chicago Medical School, Chicago, and coauthors from the Department of Dermatology, Northwestern University, Chicago, published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study is limited by incomplete safety data sheets. So, many brands of permanent makeup ink could not be investigated. In addition, some pigments may not be fully disclosed in ingredient lists and precise ink content measurements were not available.
DISCLOSURES:
The study reported receiving no funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
, but the ability to identify these allergies in patients is limited.
METHODOLOGY:
- While the allergenic potential of pigments in traditional tattoos has been documented, there is less clarity about pigments used in inks contained in cosmetic tattoos, also known as permanent makeup, and their association with ACD.
- Researchers conducted an Internet search and identified 974 individual permanent makeup ink products sold in the United States and also identified 79 unique pigments in those products.
- They evaluated the safety data sheets of these products and performed a PubMed search to identify documented ACD cases related to these pigments.
TAKEAWAY:
- Of the 79 pigments, 20 contained inorganic metals, which included iron, aluminum, silicone, chromium, copper, titanium, molybdenum, and manganese.
- Organic pigments were more common: 59 of the remaining pigments were organic compounds, mostly azo, quinacridone, or anthraquinone dyes, including 4 black pigments made from carbon only.
- A literature search identified 29 cases where patients had developed ACD thought to be caused by at least one of the 79 pigments identified by the authors of the current study and included 10 of the 79 pigments (12%).
- In 18 of the 29 cases in the literature, patch testing to the suspected pigment had been performed; in 3 cases, ACD was suspected without confirmatory testing.
IN PRACTICE:
Permanent makeup is becoming more popular, and there have been reports of ACD related to pigments contained in the inks, the authors wrote. “Traditional patch testing methods may not be useful in confirming the presence of a pigment allergy, even if one is suspect,” they added. “Consumers and patch testing physicians would benefit from better labeling of tattoo inks and the development of protocols designed to specifically test for tattoo pigment allergies.”
SOURCE:
The study was led by Sarah Rigali, MS, of Rosalind Franklin University, Chicago Medical School, Chicago, and coauthors from the Department of Dermatology, Northwestern University, Chicago, published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The study is limited by incomplete safety data sheets. So, many brands of permanent makeup ink could not be investigated. In addition, some pigments may not be fully disclosed in ingredient lists and precise ink content measurements were not available.
DISCLOSURES:
The study reported receiving no funding. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
Study Highlights Melanoma Survival Disparities in Rural vs Urban Settings
, results from an analysis of data from the National Cancer Institute showed.
“Melanoma is currently the fifth most common malignancy in the United States, with approximately 106,000 new cases and 7180 reported deaths occurring in 2021,” the study’s first author, Mitchell Taylor, MD, a dermatology research fellow at the University of Nebraska, Omaha, and colleagues wrote in the abstract, which was presented during a poster session at the annual meeting of the Society for Investigative Dermatology. “Rural areas have been shown to bear a higher melanoma disease burden, yet there is a paucity of national-level studies examining these disparities.”
To characterize the rural population diagnosed with cutaneous melanoma and assess associated disparities in the United States, the researchers queried the NCI’s Surveillance, Epidemiology, and End Results database to identify individuals diagnosed with cutaneous melanoma from 2000 to 2020 (International Classification of Diseases, 3rd Edition, 8720/3 — 8780/3; Primary Site codes C44.0-C44.9). They drew from US Office of Management and Budget terminology to define and categorize rural and urban communities.
Among 391,047 patients included during the study period, binary logistic regression analysis revealed that patients in rural areas had a greater odds of being older, from ages 50 to 75 years (odds ratio [OR], 1.10; P < .001); had annual incomes < $70,000 (OR, 16.80; P < .001); had tumors located on the head and neck (OR, 1.24; P < .001); and presented with regional/distant disease (OR, 1.13; P < .001).
As for disease-specific survival, patients living in rural areas had significantly reduced survival compared with those living in urban areas (a mean of 207.3 vs 216.3 months, respectively; P < .001). Multivariate Cox regression revealed that living in a rural setting was significantly associated with reduced disease-specific survival (hazard ratio [HR], 1.10; P < .001), as was having head and neck tumors (HR, 1.41; P < .001).“Overall, this study underscores a significant decrease in disease-specific survival among rural patients diagnosed with cutaneous melanoma and establishes a significant association between rural living and high-risk primary tumor locations, particularly the head and neck,” the authors concluded.
Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, Colorado, who was asked to comment on the results, said the findings echo the results of a recent study which characterized melanoma rates among non-Hispanic American Indian/Alaska Native individuals from 1999 to 2019.
“I suspect this decreased disease-specific survival highlights the issues our rural-residing patients face with access to dermatology care,” Dr. Kohn told this news organization. “Dermatologists are able to detect thinner melanomas than patients [and] are preferentially concentrated in metropolitan areas. Dermatologists are also the most skilled and knowledgeable to screen, diagnose, and manage melanomas. Having fewer dermatologists in rural areas impedes melanoma care for our rural-residing patients.”
Neither the researchers nor Dr. Kohn reported any relevant disclosures.
A version of this article first appeared on Medscape.com.
, results from an analysis of data from the National Cancer Institute showed.
“Melanoma is currently the fifth most common malignancy in the United States, with approximately 106,000 new cases and 7180 reported deaths occurring in 2021,” the study’s first author, Mitchell Taylor, MD, a dermatology research fellow at the University of Nebraska, Omaha, and colleagues wrote in the abstract, which was presented during a poster session at the annual meeting of the Society for Investigative Dermatology. “Rural areas have been shown to bear a higher melanoma disease burden, yet there is a paucity of national-level studies examining these disparities.”
To characterize the rural population diagnosed with cutaneous melanoma and assess associated disparities in the United States, the researchers queried the NCI’s Surveillance, Epidemiology, and End Results database to identify individuals diagnosed with cutaneous melanoma from 2000 to 2020 (International Classification of Diseases, 3rd Edition, 8720/3 — 8780/3; Primary Site codes C44.0-C44.9). They drew from US Office of Management and Budget terminology to define and categorize rural and urban communities.
Among 391,047 patients included during the study period, binary logistic regression analysis revealed that patients in rural areas had a greater odds of being older, from ages 50 to 75 years (odds ratio [OR], 1.10; P < .001); had annual incomes < $70,000 (OR, 16.80; P < .001); had tumors located on the head and neck (OR, 1.24; P < .001); and presented with regional/distant disease (OR, 1.13; P < .001).
As for disease-specific survival, patients living in rural areas had significantly reduced survival compared with those living in urban areas (a mean of 207.3 vs 216.3 months, respectively; P < .001). Multivariate Cox regression revealed that living in a rural setting was significantly associated with reduced disease-specific survival (hazard ratio [HR], 1.10; P < .001), as was having head and neck tumors (HR, 1.41; P < .001).“Overall, this study underscores a significant decrease in disease-specific survival among rural patients diagnosed with cutaneous melanoma and establishes a significant association between rural living and high-risk primary tumor locations, particularly the head and neck,” the authors concluded.
Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, Colorado, who was asked to comment on the results, said the findings echo the results of a recent study which characterized melanoma rates among non-Hispanic American Indian/Alaska Native individuals from 1999 to 2019.
“I suspect this decreased disease-specific survival highlights the issues our rural-residing patients face with access to dermatology care,” Dr. Kohn told this news organization. “Dermatologists are able to detect thinner melanomas than patients [and] are preferentially concentrated in metropolitan areas. Dermatologists are also the most skilled and knowledgeable to screen, diagnose, and manage melanomas. Having fewer dermatologists in rural areas impedes melanoma care for our rural-residing patients.”
Neither the researchers nor Dr. Kohn reported any relevant disclosures.
A version of this article first appeared on Medscape.com.
, results from an analysis of data from the National Cancer Institute showed.
“Melanoma is currently the fifth most common malignancy in the United States, with approximately 106,000 new cases and 7180 reported deaths occurring in 2021,” the study’s first author, Mitchell Taylor, MD, a dermatology research fellow at the University of Nebraska, Omaha, and colleagues wrote in the abstract, which was presented during a poster session at the annual meeting of the Society for Investigative Dermatology. “Rural areas have been shown to bear a higher melanoma disease burden, yet there is a paucity of national-level studies examining these disparities.”
To characterize the rural population diagnosed with cutaneous melanoma and assess associated disparities in the United States, the researchers queried the NCI’s Surveillance, Epidemiology, and End Results database to identify individuals diagnosed with cutaneous melanoma from 2000 to 2020 (International Classification of Diseases, 3rd Edition, 8720/3 — 8780/3; Primary Site codes C44.0-C44.9). They drew from US Office of Management and Budget terminology to define and categorize rural and urban communities.
Among 391,047 patients included during the study period, binary logistic regression analysis revealed that patients in rural areas had a greater odds of being older, from ages 50 to 75 years (odds ratio [OR], 1.10; P < .001); had annual incomes < $70,000 (OR, 16.80; P < .001); had tumors located on the head and neck (OR, 1.24; P < .001); and presented with regional/distant disease (OR, 1.13; P < .001).
As for disease-specific survival, patients living in rural areas had significantly reduced survival compared with those living in urban areas (a mean of 207.3 vs 216.3 months, respectively; P < .001). Multivariate Cox regression revealed that living in a rural setting was significantly associated with reduced disease-specific survival (hazard ratio [HR], 1.10; P < .001), as was having head and neck tumors (HR, 1.41; P < .001).“Overall, this study underscores a significant decrease in disease-specific survival among rural patients diagnosed with cutaneous melanoma and establishes a significant association between rural living and high-risk primary tumor locations, particularly the head and neck,” the authors concluded.
Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, Colorado, who was asked to comment on the results, said the findings echo the results of a recent study which characterized melanoma rates among non-Hispanic American Indian/Alaska Native individuals from 1999 to 2019.
“I suspect this decreased disease-specific survival highlights the issues our rural-residing patients face with access to dermatology care,” Dr. Kohn told this news organization. “Dermatologists are able to detect thinner melanomas than patients [and] are preferentially concentrated in metropolitan areas. Dermatologists are also the most skilled and knowledgeable to screen, diagnose, and manage melanomas. Having fewer dermatologists in rural areas impedes melanoma care for our rural-residing patients.”
Neither the researchers nor Dr. Kohn reported any relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM SID 2024
Features of Merkel Cell in Hispanic Patients Explored
. In addition, the most affected site was the upper limb/shoulder, which differs from what has been reported in previous studies.
Those are key findings from a retrospective study of national cancer data that was presented during a poster session at the annual meeting of the Society for Investigative Dermatology.
“Merkel cell carcinoma is an infrequent and aggressive form of neuroendocrine skin cancer that mainly impacts individuals of White ethnicity, with a general occurrence rate of 0.7 instances per 100,000 person-years,” one of the study authors, Luis J. Borda, MD, chief dermatology resident at Eastern Virginia Medical School, Norfolk, Virginia, told this news organization. The incidence of MCC is increasing among all racial groups, especially in the Hispanic population, he added.
To determine how age, sex, and primary site of MCC differ in White vs non-White Hispanic patients, the researchers evaluated the 22 population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program from 2000 through 2020. They reported categorical variables as counts and percentages and used chi-square test with Yates’s correction to assess the association between categorical variables.
Of the 17,920 MCCs identified by the researchers, 40 (0.22%) were in non-White Hispanic patients. Compared with the White patients with MCC, significantly fewer non-White Hispanic patients were age 70 years or older (50% vs 72.1%, respectively; P < .001), and MCC was more common in female non-White Hispanic patients (23, or 57.5%), while White patients with MCC were predominantly male (11,309, or 63.2%; P < .05). “This suggests that MCC in non-White Hispanic patients may involve different risk factors related to age beyond just cumulative UV exposure and aging-related immunosenescence, which may additionally account for the higher prevalence of females in this cohort, as historically male outdoor occupation has resulted in increased lifetime cumulative UV exposure,” Dr. Borda said.
The head and neck were the most common sites of disease involvement in White patients (41.9% vs 27.5% in non-White Hispanic patients; P = .09), while the upper limb and shoulder were the most common sites of disease involvement in non-White Hispanic patients (37.5% vs 23.8% in White patients; P = .06). This finding “differs from previous studies showing head/neck being the most common site in Hispanics,” Dr. Borda said, adding that this could be a result of White patients not being included in the Hispanic cohort in this study. “Because non-White Hispanic patients have darker skin, they may have proportionally more cases on sun-protected skin, as is described by the present data, suggesting that they are less likely to have UV-driven MCC.”
The study “highlights distinct demographic and clinical characteristics of MCC among non-White Hispanic patients compared to their White counterparts, emphasizing the importance of considering race/ethnicity in understanding the epidemiology of this rare but increasingly prevalent cancer,” Dr. Borda said. He and his co-authors are planning to do further research on the increasing incidence of MCC in non-White Hispanic patients and on staging at diagnosis compared to White patients.
Dr. Borda acknowledged certain limitations of the analysis, including the small sample size in the non-White Hispanic group, the retrospective nature of SEER data, selection bias, and the potential for underreporting. He and his co-authors reported having no financial disclosures.
A version of this article first appeared on Medscape.com.
. In addition, the most affected site was the upper limb/shoulder, which differs from what has been reported in previous studies.
Those are key findings from a retrospective study of national cancer data that was presented during a poster session at the annual meeting of the Society for Investigative Dermatology.
“Merkel cell carcinoma is an infrequent and aggressive form of neuroendocrine skin cancer that mainly impacts individuals of White ethnicity, with a general occurrence rate of 0.7 instances per 100,000 person-years,” one of the study authors, Luis J. Borda, MD, chief dermatology resident at Eastern Virginia Medical School, Norfolk, Virginia, told this news organization. The incidence of MCC is increasing among all racial groups, especially in the Hispanic population, he added.
To determine how age, sex, and primary site of MCC differ in White vs non-White Hispanic patients, the researchers evaluated the 22 population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program from 2000 through 2020. They reported categorical variables as counts and percentages and used chi-square test with Yates’s correction to assess the association between categorical variables.
Of the 17,920 MCCs identified by the researchers, 40 (0.22%) were in non-White Hispanic patients. Compared with the White patients with MCC, significantly fewer non-White Hispanic patients were age 70 years or older (50% vs 72.1%, respectively; P < .001), and MCC was more common in female non-White Hispanic patients (23, or 57.5%), while White patients with MCC were predominantly male (11,309, or 63.2%; P < .05). “This suggests that MCC in non-White Hispanic patients may involve different risk factors related to age beyond just cumulative UV exposure and aging-related immunosenescence, which may additionally account for the higher prevalence of females in this cohort, as historically male outdoor occupation has resulted in increased lifetime cumulative UV exposure,” Dr. Borda said.
The head and neck were the most common sites of disease involvement in White patients (41.9% vs 27.5% in non-White Hispanic patients; P = .09), while the upper limb and shoulder were the most common sites of disease involvement in non-White Hispanic patients (37.5% vs 23.8% in White patients; P = .06). This finding “differs from previous studies showing head/neck being the most common site in Hispanics,” Dr. Borda said, adding that this could be a result of White patients not being included in the Hispanic cohort in this study. “Because non-White Hispanic patients have darker skin, they may have proportionally more cases on sun-protected skin, as is described by the present data, suggesting that they are less likely to have UV-driven MCC.”
The study “highlights distinct demographic and clinical characteristics of MCC among non-White Hispanic patients compared to their White counterparts, emphasizing the importance of considering race/ethnicity in understanding the epidemiology of this rare but increasingly prevalent cancer,” Dr. Borda said. He and his co-authors are planning to do further research on the increasing incidence of MCC in non-White Hispanic patients and on staging at diagnosis compared to White patients.
Dr. Borda acknowledged certain limitations of the analysis, including the small sample size in the non-White Hispanic group, the retrospective nature of SEER data, selection bias, and the potential for underreporting. He and his co-authors reported having no financial disclosures.
A version of this article first appeared on Medscape.com.
. In addition, the most affected site was the upper limb/shoulder, which differs from what has been reported in previous studies.
Those are key findings from a retrospective study of national cancer data that was presented during a poster session at the annual meeting of the Society for Investigative Dermatology.
“Merkel cell carcinoma is an infrequent and aggressive form of neuroendocrine skin cancer that mainly impacts individuals of White ethnicity, with a general occurrence rate of 0.7 instances per 100,000 person-years,” one of the study authors, Luis J. Borda, MD, chief dermatology resident at Eastern Virginia Medical School, Norfolk, Virginia, told this news organization. The incidence of MCC is increasing among all racial groups, especially in the Hispanic population, he added.
To determine how age, sex, and primary site of MCC differ in White vs non-White Hispanic patients, the researchers evaluated the 22 population-based cancer registries of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program from 2000 through 2020. They reported categorical variables as counts and percentages and used chi-square test with Yates’s correction to assess the association between categorical variables.
Of the 17,920 MCCs identified by the researchers, 40 (0.22%) were in non-White Hispanic patients. Compared with the White patients with MCC, significantly fewer non-White Hispanic patients were age 70 years or older (50% vs 72.1%, respectively; P < .001), and MCC was more common in female non-White Hispanic patients (23, or 57.5%), while White patients with MCC were predominantly male (11,309, or 63.2%; P < .05). “This suggests that MCC in non-White Hispanic patients may involve different risk factors related to age beyond just cumulative UV exposure and aging-related immunosenescence, which may additionally account for the higher prevalence of females in this cohort, as historically male outdoor occupation has resulted in increased lifetime cumulative UV exposure,” Dr. Borda said.
The head and neck were the most common sites of disease involvement in White patients (41.9% vs 27.5% in non-White Hispanic patients; P = .09), while the upper limb and shoulder were the most common sites of disease involvement in non-White Hispanic patients (37.5% vs 23.8% in White patients; P = .06). This finding “differs from previous studies showing head/neck being the most common site in Hispanics,” Dr. Borda said, adding that this could be a result of White patients not being included in the Hispanic cohort in this study. “Because non-White Hispanic patients have darker skin, they may have proportionally more cases on sun-protected skin, as is described by the present data, suggesting that they are less likely to have UV-driven MCC.”
The study “highlights distinct demographic and clinical characteristics of MCC among non-White Hispanic patients compared to their White counterparts, emphasizing the importance of considering race/ethnicity in understanding the epidemiology of this rare but increasingly prevalent cancer,” Dr. Borda said. He and his co-authors are planning to do further research on the increasing incidence of MCC in non-White Hispanic patients and on staging at diagnosis compared to White patients.
Dr. Borda acknowledged certain limitations of the analysis, including the small sample size in the non-White Hispanic group, the retrospective nature of SEER data, selection bias, and the potential for underreporting. He and his co-authors reported having no financial disclosures.
A version of this article first appeared on Medscape.com.
FROM SID 2024
MDs’ One-Word Summary of Long COVID Progress: ‘Frustration’
Stuart Malcolm, MD, a primary care physician who practices in Oregon and northern California, started seeing patients with long COVID early in the pandemic. Back then, he was frustrated by the obstacles and lack of standard diagnostic tests and treatments. Four years later, well, he still is.
“Something I learned the last few years is the logistics to get people care is really, really hard,” he said. “There’s a lot of frustration. It’s mostly frustration.”
For long COVID doctors and patients, there has been little to no progress addressing the challenges, leaving many discouraged. Researchers and clinicians now have a greater understanding of what health agencies formally call post-COVID condition, but the wide spectrum of symptoms, slow progress in launching pharmacologic clinical trials, and the research toward understanding the underlying causes mean standardized diagnostic tests and definitive treatments remain elusive.
“The frustration is that we aren’t able to help everyone with our current knowledge base. And I think the frustration lies not just with us physicians but also with patients because they’re at the point where if they tried everything, literally everything and haven’t gotten better,” said Zijian Chen, MD, director of the Mount Sinai Center for Post-COVID Care in New York City.
Wanted: More Funding, More Doctors, More Clinics
Between 10% and 20% of the estimated hundreds of millions of people infected worldwide with SARS-CoV-2 in the first 2 years went on to develop long-term symptoms. While many recover over time, doctors who have treated long COVID since 2020 said they see some patients still wrestling with the condition after 4 years.
The latest Centers for Disease Control and Prevention Household Pulse Survey, taken between March 5 and April 1, 2024, estimated that nearly 7% of the adult population — more than 18 million people — currently have long COVID. Data from other countries also suggest that millions have been living with long COVID for years now, and hundreds of thousands have seen their day-to-day activities significantly affected.
There is an urgent need for more funding, long COVID clinicians, multidisciplinary clinics, and education for non–long COVID physicians and specialists, doctors said. Instead, funding remains limited, clinics are closing, wait times are “horrendously long,” patients are left in limbo, and physicians are burning out.
“What’s changed in some ways is that there’s even less access to COVID rehab, which sounds crazy because there was very little to begin with,” said Alexandra Rendely, MD, a physical medicine and rehabilitation physician with the interdisciplinary Toronto Rehab, a part of the University Health Network of teaching hospitals in Toronto, Ontario, Canada.
“Patients are still being diagnosed every day, yet the resources available are becoming less and less.”
COVID-19 money earmarked during the pandemic was mostly limited to temporary emergency measures. As those funds dwindled, governments and institutions have decreased financial support. The Long COVID Moonshot campaign, organized by patients with long COVID, is pushing Congress to support $1 billion in annual research funding to close the financial chasm.
The Clinical Trial Conundrum
While long COVID clinics have come a long way in helping patients, gaps remain. Doctors may be unwilling to prescribe off-label treatments without proper clinical trials due to the potential risks and liabilities involved or due to the controversial or unconventional nature of the therapies, said Dr. Malcolm, who left his primary care practice more than 2 years ago to focus on long COVID.
In the absence of standard treatments, Dr. Malcolm and other doctors said they must take a trial-and-error approach in treating patients with long COVID that centers on addressing symptoms and not the underlying condition.
“There are actually a lot of treatments and a lot of them are not curative, but they can help people,” he said.
Dr. Malcolm, who is a medical director at Real Time Health Monitoring, a private clinic in the San Francisco Bay Area that specializes in long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), said it was important for him to be with a clinical team that understood and was supportive of his treatment decisions and was able to offer clinical support for those treatments if needed.
For physicians looking for clinical data before prescribing certain medications, the wait may be long. More than $1.5 billion in US federal funding has been earmarked to study long COVID, but the National Institutes of Health (NIH) has faced criticism from patients and scientists alike for its slow progress and emphasis on observational studies instead of research that could unravel the biological roots of long COVID. Among the clinical trials announced by the NIH’s RECOVER initiative, only a handful involve studying pharmaceutical treatments.
A 2023 editorial published in The Lancet called out the “dismal state of clinical research relative to the substantial burden of [long COVID]” and said, “we are clearly lacking tested pharmacological interventions that treat the underlying pathophysiology.” At the time of publication, it noted that of the 386 long COVID trials listed on ClinicalTrials.gov, only 12 were actually testing pharmacologic interventions.
There are also diagnostic and insurance barriers. The specialized tests that can detect long COVID anomalies are neither commonly known by primary care practitioners nor easily requested at the local lab, can be expensive, and are typically not covered by insurance, Dr. Malcolm explained.
Patients with long COVID also have the added barrier of being unable to advocate as easily because of their energy limitations, doctors said. Patients may appear outwardly fine, but fatigue and brain fog are among the many problems that cannot be measured in appearances. The condition has upended lives, some losing jobs, even homes, and the mental toll is why there is a “not insignificant” suicide rate.
One Patient’s 4-Year Journey
Charlie McCone, 34, used to be a tennis player and an active musician. But he’s spent the past 4 years mostly housebound, grappling with the aftermath of a SARS-CoV-2 infection he contracted in March 2020. He went from biking daily to work 10 miles and back to having at most 2 hours of energy per day.
In the first year alone, Mr. McCone saw more than two dozen doctors and specialists. The conditions now associated with long COVID, like ME/CFS, mast cell activation syndrome (a condition in which a patient experiences episodes of allergic symptoms such as hives, swelling, low blood pressure, and difficulty breathing), or dysautonomia (conditions that affect the autonomic nervous system, which controls automatic processes in the body) were not on physicians’ radars.
Then in 2021, he became bedbound for more than half a year after a Delta variant reinfection. He developed neurologic symptoms, including incapacitating fatigue, post-exertional malaise (where symptoms worsened after minimal physical or mental activity), left-sided weakness, and cognitive impairment. He stopped working altogether. But the worst was the shortness of breath he felt 24/7, even at rest. A battery of lab tests revealed nothing abnormal. He tried numerous drugs and the classic respiratory treatments.
Mr. McCone eventually connected with Dr. Malcolm over X and developed what he describes as an effective patient-doctor collaboration. When studies came out suggesting microclots were a common issue with patients with long COVID and positive outcomes were reported from anticoagulant therapy, they knew it could be one of the answers.
“After 3 weeks on [the antiplatelet drug], I was like, oh my god, my lungs are finally opening up,” said Mr. McCone. He has taken the medication for more than a year and a half, and some days he doesn’t even think about his respiratory symptoms.
“That trial-and-error process is just really long and hard and costly,” said Dr. Malcolm.
Today, fatigue and cognitive stamina are Mr. McCone’s main challenges, and he is far from recovered.
“[I had a] very fulfilling, happy life and now, it’s hard to think about. I’ve come a long way with my mental health and all this, but I’ve lost 4 years,” Mr. McCone said. “The prospect of me being here when I’m 40 seems very real ... so it’s pretty devastating.”
Lessons Learned, Hope Amid Ongoing Research
Despite the daunting obstacle, doctors said the science has come a long way for a new disease. We now know long COVID is likely caused by a combination of triggers, including viral reservoir in the tissue, inflammation, autoimmunity, and microclots; severity of infection is not necessarily an accurate risk factor predictor — long COVID can strike even those who had a mild infection; upward of 200 symptoms have been identified; and we know more about potential biomarkers that could lead to better diagnostic tools.
Unlike many other diseases and conditions with standard treatment protocols, long COVID treatments are typically aimed at addressing individual symptoms.
“It is very detailed and individualized to the patient’s specific symptoms and to the patient’s specific needs,” Dr. Rendely said. Symptoms can also fluctuate, relapse, or wax and wane, for example, so what ails a patient at their first doctor’s appointment could be completely different at the next appointment 2 months later.
Doctors are still hopeful the RECOVER research, which includes trials that look at autonomic and cognitive dysfunctions, will pave the way for more effective long COVID therapies. In Canada, Dr. Rendely is also eying the RECLAIM trial that is currently testing the effectiveness of pentoxifylline, which helps blood flow, and ibudilast, an anti-inflammatory drug.
Doctors are also hopeful when they see patients who have made “tremendous gains” or even full recoveries through their clinics. “It’s a new diagnosis, so I always tell my patients to think of this as a journey because I’m learning along with you,” said Jai Marathe, MD, an infectious disease physician at Boston Medical Center and an assistant professor of infectious diseases at Boston University Chobanian & Avedisian School of Medicine.
“Now we have 4 years of experience, but at the same time, no two long COVID patients are alike.”
Long COVID has also changed the way physicians view healthcare and how they practice medicine.
“I am a completely different person than I used to be because of this illness, and I don’t even have it. That is how profoundly it has affected how I view the universe,” said Dr. Malcolm. “I’ve been doing this for 4 years, and I’m very hopeful. But I don’t think about this in terms of months anymore. I think about this in terms of years.”
A version of this article first appeared on Medscape.com.
Stuart Malcolm, MD, a primary care physician who practices in Oregon and northern California, started seeing patients with long COVID early in the pandemic. Back then, he was frustrated by the obstacles and lack of standard diagnostic tests and treatments. Four years later, well, he still is.
“Something I learned the last few years is the logistics to get people care is really, really hard,” he said. “There’s a lot of frustration. It’s mostly frustration.”
For long COVID doctors and patients, there has been little to no progress addressing the challenges, leaving many discouraged. Researchers and clinicians now have a greater understanding of what health agencies formally call post-COVID condition, but the wide spectrum of symptoms, slow progress in launching pharmacologic clinical trials, and the research toward understanding the underlying causes mean standardized diagnostic tests and definitive treatments remain elusive.
“The frustration is that we aren’t able to help everyone with our current knowledge base. And I think the frustration lies not just with us physicians but also with patients because they’re at the point where if they tried everything, literally everything and haven’t gotten better,” said Zijian Chen, MD, director of the Mount Sinai Center for Post-COVID Care in New York City.
Wanted: More Funding, More Doctors, More Clinics
Between 10% and 20% of the estimated hundreds of millions of people infected worldwide with SARS-CoV-2 in the first 2 years went on to develop long-term symptoms. While many recover over time, doctors who have treated long COVID since 2020 said they see some patients still wrestling with the condition after 4 years.
The latest Centers for Disease Control and Prevention Household Pulse Survey, taken between March 5 and April 1, 2024, estimated that nearly 7% of the adult population — more than 18 million people — currently have long COVID. Data from other countries also suggest that millions have been living with long COVID for years now, and hundreds of thousands have seen their day-to-day activities significantly affected.
There is an urgent need for more funding, long COVID clinicians, multidisciplinary clinics, and education for non–long COVID physicians and specialists, doctors said. Instead, funding remains limited, clinics are closing, wait times are “horrendously long,” patients are left in limbo, and physicians are burning out.
“What’s changed in some ways is that there’s even less access to COVID rehab, which sounds crazy because there was very little to begin with,” said Alexandra Rendely, MD, a physical medicine and rehabilitation physician with the interdisciplinary Toronto Rehab, a part of the University Health Network of teaching hospitals in Toronto, Ontario, Canada.
“Patients are still being diagnosed every day, yet the resources available are becoming less and less.”
COVID-19 money earmarked during the pandemic was mostly limited to temporary emergency measures. As those funds dwindled, governments and institutions have decreased financial support. The Long COVID Moonshot campaign, organized by patients with long COVID, is pushing Congress to support $1 billion in annual research funding to close the financial chasm.
The Clinical Trial Conundrum
While long COVID clinics have come a long way in helping patients, gaps remain. Doctors may be unwilling to prescribe off-label treatments without proper clinical trials due to the potential risks and liabilities involved or due to the controversial or unconventional nature of the therapies, said Dr. Malcolm, who left his primary care practice more than 2 years ago to focus on long COVID.
In the absence of standard treatments, Dr. Malcolm and other doctors said they must take a trial-and-error approach in treating patients with long COVID that centers on addressing symptoms and not the underlying condition.
“There are actually a lot of treatments and a lot of them are not curative, but they can help people,” he said.
Dr. Malcolm, who is a medical director at Real Time Health Monitoring, a private clinic in the San Francisco Bay Area that specializes in long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), said it was important for him to be with a clinical team that understood and was supportive of his treatment decisions and was able to offer clinical support for those treatments if needed.
For physicians looking for clinical data before prescribing certain medications, the wait may be long. More than $1.5 billion in US federal funding has been earmarked to study long COVID, but the National Institutes of Health (NIH) has faced criticism from patients and scientists alike for its slow progress and emphasis on observational studies instead of research that could unravel the biological roots of long COVID. Among the clinical trials announced by the NIH’s RECOVER initiative, only a handful involve studying pharmaceutical treatments.
A 2023 editorial published in The Lancet called out the “dismal state of clinical research relative to the substantial burden of [long COVID]” and said, “we are clearly lacking tested pharmacological interventions that treat the underlying pathophysiology.” At the time of publication, it noted that of the 386 long COVID trials listed on ClinicalTrials.gov, only 12 were actually testing pharmacologic interventions.
There are also diagnostic and insurance barriers. The specialized tests that can detect long COVID anomalies are neither commonly known by primary care practitioners nor easily requested at the local lab, can be expensive, and are typically not covered by insurance, Dr. Malcolm explained.
Patients with long COVID also have the added barrier of being unable to advocate as easily because of their energy limitations, doctors said. Patients may appear outwardly fine, but fatigue and brain fog are among the many problems that cannot be measured in appearances. The condition has upended lives, some losing jobs, even homes, and the mental toll is why there is a “not insignificant” suicide rate.
One Patient’s 4-Year Journey
Charlie McCone, 34, used to be a tennis player and an active musician. But he’s spent the past 4 years mostly housebound, grappling with the aftermath of a SARS-CoV-2 infection he contracted in March 2020. He went from biking daily to work 10 miles and back to having at most 2 hours of energy per day.
In the first year alone, Mr. McCone saw more than two dozen doctors and specialists. The conditions now associated with long COVID, like ME/CFS, mast cell activation syndrome (a condition in which a patient experiences episodes of allergic symptoms such as hives, swelling, low blood pressure, and difficulty breathing), or dysautonomia (conditions that affect the autonomic nervous system, which controls automatic processes in the body) were not on physicians’ radars.
Then in 2021, he became bedbound for more than half a year after a Delta variant reinfection. He developed neurologic symptoms, including incapacitating fatigue, post-exertional malaise (where symptoms worsened after minimal physical or mental activity), left-sided weakness, and cognitive impairment. He stopped working altogether. But the worst was the shortness of breath he felt 24/7, even at rest. A battery of lab tests revealed nothing abnormal. He tried numerous drugs and the classic respiratory treatments.
Mr. McCone eventually connected with Dr. Malcolm over X and developed what he describes as an effective patient-doctor collaboration. When studies came out suggesting microclots were a common issue with patients with long COVID and positive outcomes were reported from anticoagulant therapy, they knew it could be one of the answers.
“After 3 weeks on [the antiplatelet drug], I was like, oh my god, my lungs are finally opening up,” said Mr. McCone. He has taken the medication for more than a year and a half, and some days he doesn’t even think about his respiratory symptoms.
“That trial-and-error process is just really long and hard and costly,” said Dr. Malcolm.
Today, fatigue and cognitive stamina are Mr. McCone’s main challenges, and he is far from recovered.
“[I had a] very fulfilling, happy life and now, it’s hard to think about. I’ve come a long way with my mental health and all this, but I’ve lost 4 years,” Mr. McCone said. “The prospect of me being here when I’m 40 seems very real ... so it’s pretty devastating.”
Lessons Learned, Hope Amid Ongoing Research
Despite the daunting obstacle, doctors said the science has come a long way for a new disease. We now know long COVID is likely caused by a combination of triggers, including viral reservoir in the tissue, inflammation, autoimmunity, and microclots; severity of infection is not necessarily an accurate risk factor predictor — long COVID can strike even those who had a mild infection; upward of 200 symptoms have been identified; and we know more about potential biomarkers that could lead to better diagnostic tools.
Unlike many other diseases and conditions with standard treatment protocols, long COVID treatments are typically aimed at addressing individual symptoms.
“It is very detailed and individualized to the patient’s specific symptoms and to the patient’s specific needs,” Dr. Rendely said. Symptoms can also fluctuate, relapse, or wax and wane, for example, so what ails a patient at their first doctor’s appointment could be completely different at the next appointment 2 months later.
Doctors are still hopeful the RECOVER research, which includes trials that look at autonomic and cognitive dysfunctions, will pave the way for more effective long COVID therapies. In Canada, Dr. Rendely is also eying the RECLAIM trial that is currently testing the effectiveness of pentoxifylline, which helps blood flow, and ibudilast, an anti-inflammatory drug.
Doctors are also hopeful when they see patients who have made “tremendous gains” or even full recoveries through their clinics. “It’s a new diagnosis, so I always tell my patients to think of this as a journey because I’m learning along with you,” said Jai Marathe, MD, an infectious disease physician at Boston Medical Center and an assistant professor of infectious diseases at Boston University Chobanian & Avedisian School of Medicine.
“Now we have 4 years of experience, but at the same time, no two long COVID patients are alike.”
Long COVID has also changed the way physicians view healthcare and how they practice medicine.
“I am a completely different person than I used to be because of this illness, and I don’t even have it. That is how profoundly it has affected how I view the universe,” said Dr. Malcolm. “I’ve been doing this for 4 years, and I’m very hopeful. But I don’t think about this in terms of months anymore. I think about this in terms of years.”
A version of this article first appeared on Medscape.com.
Stuart Malcolm, MD, a primary care physician who practices in Oregon and northern California, started seeing patients with long COVID early in the pandemic. Back then, he was frustrated by the obstacles and lack of standard diagnostic tests and treatments. Four years later, well, he still is.
“Something I learned the last few years is the logistics to get people care is really, really hard,” he said. “There’s a lot of frustration. It’s mostly frustration.”
For long COVID doctors and patients, there has been little to no progress addressing the challenges, leaving many discouraged. Researchers and clinicians now have a greater understanding of what health agencies formally call post-COVID condition, but the wide spectrum of symptoms, slow progress in launching pharmacologic clinical trials, and the research toward understanding the underlying causes mean standardized diagnostic tests and definitive treatments remain elusive.
“The frustration is that we aren’t able to help everyone with our current knowledge base. And I think the frustration lies not just with us physicians but also with patients because they’re at the point where if they tried everything, literally everything and haven’t gotten better,” said Zijian Chen, MD, director of the Mount Sinai Center for Post-COVID Care in New York City.
Wanted: More Funding, More Doctors, More Clinics
Between 10% and 20% of the estimated hundreds of millions of people infected worldwide with SARS-CoV-2 in the first 2 years went on to develop long-term symptoms. While many recover over time, doctors who have treated long COVID since 2020 said they see some patients still wrestling with the condition after 4 years.
The latest Centers for Disease Control and Prevention Household Pulse Survey, taken between March 5 and April 1, 2024, estimated that nearly 7% of the adult population — more than 18 million people — currently have long COVID. Data from other countries also suggest that millions have been living with long COVID for years now, and hundreds of thousands have seen their day-to-day activities significantly affected.
There is an urgent need for more funding, long COVID clinicians, multidisciplinary clinics, and education for non–long COVID physicians and specialists, doctors said. Instead, funding remains limited, clinics are closing, wait times are “horrendously long,” patients are left in limbo, and physicians are burning out.
“What’s changed in some ways is that there’s even less access to COVID rehab, which sounds crazy because there was very little to begin with,” said Alexandra Rendely, MD, a physical medicine and rehabilitation physician with the interdisciplinary Toronto Rehab, a part of the University Health Network of teaching hospitals in Toronto, Ontario, Canada.
“Patients are still being diagnosed every day, yet the resources available are becoming less and less.”
COVID-19 money earmarked during the pandemic was mostly limited to temporary emergency measures. As those funds dwindled, governments and institutions have decreased financial support. The Long COVID Moonshot campaign, organized by patients with long COVID, is pushing Congress to support $1 billion in annual research funding to close the financial chasm.
The Clinical Trial Conundrum
While long COVID clinics have come a long way in helping patients, gaps remain. Doctors may be unwilling to prescribe off-label treatments without proper clinical trials due to the potential risks and liabilities involved or due to the controversial or unconventional nature of the therapies, said Dr. Malcolm, who left his primary care practice more than 2 years ago to focus on long COVID.
In the absence of standard treatments, Dr. Malcolm and other doctors said they must take a trial-and-error approach in treating patients with long COVID that centers on addressing symptoms and not the underlying condition.
“There are actually a lot of treatments and a lot of them are not curative, but they can help people,” he said.
Dr. Malcolm, who is a medical director at Real Time Health Monitoring, a private clinic in the San Francisco Bay Area that specializes in long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), said it was important for him to be with a clinical team that understood and was supportive of his treatment decisions and was able to offer clinical support for those treatments if needed.
For physicians looking for clinical data before prescribing certain medications, the wait may be long. More than $1.5 billion in US federal funding has been earmarked to study long COVID, but the National Institutes of Health (NIH) has faced criticism from patients and scientists alike for its slow progress and emphasis on observational studies instead of research that could unravel the biological roots of long COVID. Among the clinical trials announced by the NIH’s RECOVER initiative, only a handful involve studying pharmaceutical treatments.
A 2023 editorial published in The Lancet called out the “dismal state of clinical research relative to the substantial burden of [long COVID]” and said, “we are clearly lacking tested pharmacological interventions that treat the underlying pathophysiology.” At the time of publication, it noted that of the 386 long COVID trials listed on ClinicalTrials.gov, only 12 were actually testing pharmacologic interventions.
There are also diagnostic and insurance barriers. The specialized tests that can detect long COVID anomalies are neither commonly known by primary care practitioners nor easily requested at the local lab, can be expensive, and are typically not covered by insurance, Dr. Malcolm explained.
Patients with long COVID also have the added barrier of being unable to advocate as easily because of their energy limitations, doctors said. Patients may appear outwardly fine, but fatigue and brain fog are among the many problems that cannot be measured in appearances. The condition has upended lives, some losing jobs, even homes, and the mental toll is why there is a “not insignificant” suicide rate.
One Patient’s 4-Year Journey
Charlie McCone, 34, used to be a tennis player and an active musician. But he’s spent the past 4 years mostly housebound, grappling with the aftermath of a SARS-CoV-2 infection he contracted in March 2020. He went from biking daily to work 10 miles and back to having at most 2 hours of energy per day.
In the first year alone, Mr. McCone saw more than two dozen doctors and specialists. The conditions now associated with long COVID, like ME/CFS, mast cell activation syndrome (a condition in which a patient experiences episodes of allergic symptoms such as hives, swelling, low blood pressure, and difficulty breathing), or dysautonomia (conditions that affect the autonomic nervous system, which controls automatic processes in the body) were not on physicians’ radars.
Then in 2021, he became bedbound for more than half a year after a Delta variant reinfection. He developed neurologic symptoms, including incapacitating fatigue, post-exertional malaise (where symptoms worsened after minimal physical or mental activity), left-sided weakness, and cognitive impairment. He stopped working altogether. But the worst was the shortness of breath he felt 24/7, even at rest. A battery of lab tests revealed nothing abnormal. He tried numerous drugs and the classic respiratory treatments.
Mr. McCone eventually connected with Dr. Malcolm over X and developed what he describes as an effective patient-doctor collaboration. When studies came out suggesting microclots were a common issue with patients with long COVID and positive outcomes were reported from anticoagulant therapy, they knew it could be one of the answers.
“After 3 weeks on [the antiplatelet drug], I was like, oh my god, my lungs are finally opening up,” said Mr. McCone. He has taken the medication for more than a year and a half, and some days he doesn’t even think about his respiratory symptoms.
“That trial-and-error process is just really long and hard and costly,” said Dr. Malcolm.
Today, fatigue and cognitive stamina are Mr. McCone’s main challenges, and he is far from recovered.
“[I had a] very fulfilling, happy life and now, it’s hard to think about. I’ve come a long way with my mental health and all this, but I’ve lost 4 years,” Mr. McCone said. “The prospect of me being here when I’m 40 seems very real ... so it’s pretty devastating.”
Lessons Learned, Hope Amid Ongoing Research
Despite the daunting obstacle, doctors said the science has come a long way for a new disease. We now know long COVID is likely caused by a combination of triggers, including viral reservoir in the tissue, inflammation, autoimmunity, and microclots; severity of infection is not necessarily an accurate risk factor predictor — long COVID can strike even those who had a mild infection; upward of 200 symptoms have been identified; and we know more about potential biomarkers that could lead to better diagnostic tools.
Unlike many other diseases and conditions with standard treatment protocols, long COVID treatments are typically aimed at addressing individual symptoms.
“It is very detailed and individualized to the patient’s specific symptoms and to the patient’s specific needs,” Dr. Rendely said. Symptoms can also fluctuate, relapse, or wax and wane, for example, so what ails a patient at their first doctor’s appointment could be completely different at the next appointment 2 months later.
Doctors are still hopeful the RECOVER research, which includes trials that look at autonomic and cognitive dysfunctions, will pave the way for more effective long COVID therapies. In Canada, Dr. Rendely is also eying the RECLAIM trial that is currently testing the effectiveness of pentoxifylline, which helps blood flow, and ibudilast, an anti-inflammatory drug.
Doctors are also hopeful when they see patients who have made “tremendous gains” or even full recoveries through their clinics. “It’s a new diagnosis, so I always tell my patients to think of this as a journey because I’m learning along with you,” said Jai Marathe, MD, an infectious disease physician at Boston Medical Center and an assistant professor of infectious diseases at Boston University Chobanian & Avedisian School of Medicine.
“Now we have 4 years of experience, but at the same time, no two long COVID patients are alike.”
Long COVID has also changed the way physicians view healthcare and how they practice medicine.
“I am a completely different person than I used to be because of this illness, and I don’t even have it. That is how profoundly it has affected how I view the universe,” said Dr. Malcolm. “I’ve been doing this for 4 years, and I’m very hopeful. But I don’t think about this in terms of months anymore. I think about this in terms of years.”
A version of this article first appeared on Medscape.com.
Study Finds Isotretinoin Effective for Acne in Transgender Patients on Hormone Rx
TOPLINE:
, but more information is needed on dosing and barriers to treatment.
METHODOLOGY:
- Acne can be a side effect of masculinizing hormone therapy for transmasculine individuals. While isotretinoin is an effective treatment option for acne, its effectiveness and safety in transgender and gender-diverse individuals are not well understood.
- This retrospective case series included 55 patients (mean age, 25.4 years) undergoing masculinizing hormone therapy at four medical centers, who were prescribed isotretinoin for acne associated with treatment.
- Isotretinoin treatment was started a median of 22.1 months after hormone therapy was initiated and continued for a median of 6 months with a median cumulative dose of 132.7 mg/kg.
- Researchers assessed acne improvement, clearance, recurrence, adverse effects, and reasons for treatment discontinuation.
TAKEAWAY:
- Overall, 48 patients (87.3%) experienced improvement, and 26 (47.3%) achieved clearance during treatment. A higher proportion of patients experienced improvement (97% vs 72.7%) and achieved clearance (63.6% vs 22.7%) with cumulative doses of ≥ 120 mg/kg than those who received cumulative doses < 120 mg/kg.
- The risk for recurrence was 20% (in four patients) among 20 patients who achieved clearance and had any subsequent health care encounters, with a mean follow-up time of 734.3 days.
- Common adverse effects included dryness (80%), joint pain (14.5%), and headaches (10.9%). Other adverse effects included nose bleeds (9.1%) and depression (5.5%).
- Of the 22 patients with a cumulative dose < 120 mg/kg, 14 (63.6%) were lost to follow-up; among those not lost to follow-up, 2 patients discontinued treatment because of transfer of care, 1 because of adverse effects, and 1 because of gender-affirming surgery, with concerns about wound healing.
IN PRACTICE:
“Although isotretinoin appears to be an effective treatment option for acne among individuals undergoing masculinizing hormone therapy, further efforts are needed to understand optimal dosing and treatment barriers to improve outcomes in transgender and gender-diverse individuals receiving testosterone,” the authors concluded.
SOURCE:
The study, led by James Choe, BS, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, was published online in JAMA Dermatology.
LIMITATIONS:
The study population was limited to four centers, and variability in clinician- and patient-reported acne outcomes and missing information could affect the reliability of data. Because of the small sample size, the association of masculinizing hormone therapy regimens with outcomes could not be evaluated.
DISCLOSURES:
One author is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Three authors reported receiving grants or personal fees from various sources. The other authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
, but more information is needed on dosing and barriers to treatment.
METHODOLOGY:
- Acne can be a side effect of masculinizing hormone therapy for transmasculine individuals. While isotretinoin is an effective treatment option for acne, its effectiveness and safety in transgender and gender-diverse individuals are not well understood.
- This retrospective case series included 55 patients (mean age, 25.4 years) undergoing masculinizing hormone therapy at four medical centers, who were prescribed isotretinoin for acne associated with treatment.
- Isotretinoin treatment was started a median of 22.1 months after hormone therapy was initiated and continued for a median of 6 months with a median cumulative dose of 132.7 mg/kg.
- Researchers assessed acne improvement, clearance, recurrence, adverse effects, and reasons for treatment discontinuation.
TAKEAWAY:
- Overall, 48 patients (87.3%) experienced improvement, and 26 (47.3%) achieved clearance during treatment. A higher proportion of patients experienced improvement (97% vs 72.7%) and achieved clearance (63.6% vs 22.7%) with cumulative doses of ≥ 120 mg/kg than those who received cumulative doses < 120 mg/kg.
- The risk for recurrence was 20% (in four patients) among 20 patients who achieved clearance and had any subsequent health care encounters, with a mean follow-up time of 734.3 days.
- Common adverse effects included dryness (80%), joint pain (14.5%), and headaches (10.9%). Other adverse effects included nose bleeds (9.1%) and depression (5.5%).
- Of the 22 patients with a cumulative dose < 120 mg/kg, 14 (63.6%) were lost to follow-up; among those not lost to follow-up, 2 patients discontinued treatment because of transfer of care, 1 because of adverse effects, and 1 because of gender-affirming surgery, with concerns about wound healing.
IN PRACTICE:
“Although isotretinoin appears to be an effective treatment option for acne among individuals undergoing masculinizing hormone therapy, further efforts are needed to understand optimal dosing and treatment barriers to improve outcomes in transgender and gender-diverse individuals receiving testosterone,” the authors concluded.
SOURCE:
The study, led by James Choe, BS, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, was published online in JAMA Dermatology.
LIMITATIONS:
The study population was limited to four centers, and variability in clinician- and patient-reported acne outcomes and missing information could affect the reliability of data. Because of the small sample size, the association of masculinizing hormone therapy regimens with outcomes could not be evaluated.
DISCLOSURES:
One author is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Three authors reported receiving grants or personal fees from various sources. The other authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
, but more information is needed on dosing and barriers to treatment.
METHODOLOGY:
- Acne can be a side effect of masculinizing hormone therapy for transmasculine individuals. While isotretinoin is an effective treatment option for acne, its effectiveness and safety in transgender and gender-diverse individuals are not well understood.
- This retrospective case series included 55 patients (mean age, 25.4 years) undergoing masculinizing hormone therapy at four medical centers, who were prescribed isotretinoin for acne associated with treatment.
- Isotretinoin treatment was started a median of 22.1 months after hormone therapy was initiated and continued for a median of 6 months with a median cumulative dose of 132.7 mg/kg.
- Researchers assessed acne improvement, clearance, recurrence, adverse effects, and reasons for treatment discontinuation.
TAKEAWAY:
- Overall, 48 patients (87.3%) experienced improvement, and 26 (47.3%) achieved clearance during treatment. A higher proportion of patients experienced improvement (97% vs 72.7%) and achieved clearance (63.6% vs 22.7%) with cumulative doses of ≥ 120 mg/kg than those who received cumulative doses < 120 mg/kg.
- The risk for recurrence was 20% (in four patients) among 20 patients who achieved clearance and had any subsequent health care encounters, with a mean follow-up time of 734.3 days.
- Common adverse effects included dryness (80%), joint pain (14.5%), and headaches (10.9%). Other adverse effects included nose bleeds (9.1%) and depression (5.5%).
- Of the 22 patients with a cumulative dose < 120 mg/kg, 14 (63.6%) were lost to follow-up; among those not lost to follow-up, 2 patients discontinued treatment because of transfer of care, 1 because of adverse effects, and 1 because of gender-affirming surgery, with concerns about wound healing.
IN PRACTICE:
“Although isotretinoin appears to be an effective treatment option for acne among individuals undergoing masculinizing hormone therapy, further efforts are needed to understand optimal dosing and treatment barriers to improve outcomes in transgender and gender-diverse individuals receiving testosterone,” the authors concluded.
SOURCE:
The study, led by James Choe, BS, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, was published online in JAMA Dermatology.
LIMITATIONS:
The study population was limited to four centers, and variability in clinician- and patient-reported acne outcomes and missing information could affect the reliability of data. Because of the small sample size, the association of masculinizing hormone therapy regimens with outcomes could not be evaluated.
DISCLOSURES:
One author is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Three authors reported receiving grants or personal fees from various sources. The other authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.