Two features are significantly associated with a higher risk for developing long COVID symptoms among people with inflammatory bowel disease (IBD), according to a large Danish population study.

People with Crohn’s disease (CD) who experienced adverse acute COVID-19, defined as requiring hospitalization, were nearly three times more likely to report persistent symptoms 12 weeks after acute infection.

“Long-term, persisting symptoms following COVID-19 is a frequently occurring problem, which is probably underappreciated. IBD specialists should therefore be aware of any of these symptoms and actively ask patients whether they have these problems,” lead author Mohamed Attauabi, MD, PhD, said in an interview.

Dr. Attauabi and colleagues also found that people with ulcerative colitis (UC) who discontinued immunosuppressive agents because of COVID-19 were 1.5 times more likely to experience long COVID symptoms, a result that surprised the researchers.

“This has not been shown before and remains to be confirmed,” said Dr. Attauabi, a fellow in the department of gastroenterology at Herlev Hospital at the University of Copenhagen.

Attauabi presented the results as a digital oral presentation at the 17th congress of the European Crohn’s and Colitis Organisation.
 

A closer look at IBD and COVID-19

Large, hospital-based studies of symptoms consistent with long COVID reveal a high prevalence of fatigue, sleep difficulties, and anxiety at 12 weeks or more post acute infection. However, these were not specific to people with CD or UC, Dr. Attauabi said.

“In patients with IBD, the risk of long-term sequelae of COVID-19 remains to be investigated,” he said.

Dr. Attauabi and colleagues studied 197 people with CD and 319 with UC, all of whom had polymerase chain reaction–confirmed COVID-19. Participants were prospectively enrolled in the population-based Danish IBD-COVID registry from January 28, 2020 to April 1, 2021. At a median of 5.1 months, a subset of 85 people with CD and 137 with UC agreed to report any post-COVID symptoms.

Older age, smoking, IBD disease activity, and presence of comorbidities were not associated with a significantly elevated risk of long COVID.

In a multivariate analysis, hospitalization for COVID-19 among people with CD was significantly associated with long COVID (odds ratio, 2.76; 95% confidence interval, 1.05-3.90; P = .04).

Furthermore, people with UC who stopped taking immunosuppressive agents also had a significantly higher risk (OR, 1.50; 95% CI, 1.07-10.22; P = .01).

“However, IBD medications such as systemic steroids were not associated with this outcome,” Dr. Attauabi said.
 

Fatigue most common long COVID symptom

Fatigue was the most common long COVID symptom, reported by 37% of patients with CD and 36% with UC.

Anosmia and ageusia were also common, reported by 29% and 28% of patients with CD, and 27% and 19% of those with UC, respectively.

“In our cohort of patients with UC or CD who developed COVID-19, the long-term health effects of COVID-19 did not appear to differ among patients with UC or CD nor according to IBD medications,” Dr. Attauabi said.

That is a “great study,” said session cochair Torsten Kucharzik, MD, PhD, head of internal medicine and gastroenterology at Lueneburg (Germany) Hospital.

When Dr. Kucharzik asked about smoking, Dr. Attauabi responded that they collected information on current and previous smoking, but they chose not to include the data because it was not statistically significant.

Dr. Attauabi has reported no relevant financial relationships. Dr. Kucharzik has reported receiving grants from Takeda and personal fees from companies including MSD/Essex, AbbVie, Falk Foundation, Biogen, Bristol-Myers Squibb, Arena, Celgene, Celltrion, Ferring, Janssen, Galapagos, Olympus, Mundipharma, Takeda, Amgen, Pfizer, Roche, and Vifor Pharma.

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

Two features are significantly associated with a higher risk for developing long COVID symptoms among people with inflammatory bowel disease (IBD), according to a large Danish population study.

People with Crohn’s disease (CD) who experienced adverse acute COVID-19, defined as requiring hospitalization, were nearly three times more likely to report persistent symptoms 12 weeks after acute infection.

“Long-term, persisting symptoms following COVID-19 is a frequently occurring problem, which is probably underappreciated. IBD specialists should therefore be aware of any of these symptoms and actively ask patients whether they have these problems,” lead author Mohamed Attauabi, MD, PhD, said in an interview.

Dr. Attauabi and colleagues also found that people with ulcerative colitis (UC) who discontinued immunosuppressive agents because of COVID-19 were 1.5 times more likely to experience long COVID symptoms, a result that surprised the researchers.

“This has not been shown before and remains to be confirmed,” said Dr. Attauabi, a fellow in the department of gastroenterology at Herlev Hospital at the University of Copenhagen.

Attauabi presented the results as a digital oral presentation at the 17th congress of the European Crohn’s and Colitis Organisation.
 

A closer look at IBD and COVID-19

Large, hospital-based studies of symptoms consistent with long COVID reveal a high prevalence of fatigue, sleep difficulties, and anxiety at 12 weeks or more post acute infection. However, these were not specific to people with CD or UC, Dr. Attauabi said.

“In patients with IBD, the risk of long-term sequelae of COVID-19 remains to be investigated,” he said.

Dr. Attauabi and colleagues studied 197 people with CD and 319 with UC, all of whom had polymerase chain reaction–confirmed COVID-19. Participants were prospectively enrolled in the population-based Danish IBD-COVID registry from January 28, 2020 to April 1, 2021. At a median of 5.1 months, a subset of 85 people with CD and 137 with UC agreed to report any post-COVID symptoms.

Older age, smoking, IBD disease activity, and presence of comorbidities were not associated with a significantly elevated risk of long COVID.

In a multivariate analysis, hospitalization for COVID-19 among people with CD was significantly associated with long COVID (odds ratio, 2.76; 95% confidence interval, 1.05-3.90; P = .04).

Furthermore, people with UC who stopped taking immunosuppressive agents also had a significantly higher risk (OR, 1.50; 95% CI, 1.07-10.22; P = .01).

“However, IBD medications such as systemic steroids were not associated with this outcome,” Dr. Attauabi said.
 

Fatigue most common long COVID symptom

Fatigue was the most common long COVID symptom, reported by 37% of patients with CD and 36% with UC.

Anosmia and ageusia were also common, reported by 29% and 28% of patients with CD, and 27% and 19% of those with UC, respectively.

“In our cohort of patients with UC or CD who developed COVID-19, the long-term health effects of COVID-19 did not appear to differ among patients with UC or CD nor according to IBD medications,” Dr. Attauabi said.

That is a “great study,” said session cochair Torsten Kucharzik, MD, PhD, head of internal medicine and gastroenterology at Lueneburg (Germany) Hospital.

When Dr. Kucharzik asked about smoking, Dr. Attauabi responded that they collected information on current and previous smoking, but they chose not to include the data because it was not statistically significant.

Dr. Attauabi has reported no relevant financial relationships. Dr. Kucharzik has reported receiving grants from Takeda and personal fees from companies including MSD/Essex, AbbVie, Falk Foundation, Biogen, Bristol-Myers Squibb, Arena, Celgene, Celltrion, Ferring, Janssen, Galapagos, Olympus, Mundipharma, Takeda, Amgen, Pfizer, Roche, and Vifor Pharma.

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

Two features are significantly associated with a higher risk for developing long COVID symptoms among people with inflammatory bowel disease (IBD), according to a large Danish population study.

People with Crohn’s disease (CD) who experienced adverse acute COVID-19, defined as requiring hospitalization, were nearly three times more likely to report persistent symptoms 12 weeks after acute infection.

“Long-term, persisting symptoms following COVID-19 is a frequently occurring problem, which is probably underappreciated. IBD specialists should therefore be aware of any of these symptoms and actively ask patients whether they have these problems,” lead author Mohamed Attauabi, MD, PhD, said in an interview.

Dr. Attauabi and colleagues also found that people with ulcerative colitis (UC) who discontinued immunosuppressive agents because of COVID-19 were 1.5 times more likely to experience long COVID symptoms, a result that surprised the researchers.

“This has not been shown before and remains to be confirmed,” said Dr. Attauabi, a fellow in the department of gastroenterology at Herlev Hospital at the University of Copenhagen.

Attauabi presented the results as a digital oral presentation at the 17th congress of the European Crohn’s and Colitis Organisation.
 

A closer look at IBD and COVID-19

Large, hospital-based studies of symptoms consistent with long COVID reveal a high prevalence of fatigue, sleep difficulties, and anxiety at 12 weeks or more post acute infection. However, these were not specific to people with CD or UC, Dr. Attauabi said.

“In patients with IBD, the risk of long-term sequelae of COVID-19 remains to be investigated,” he said.

Dr. Attauabi and colleagues studied 197 people with CD and 319 with UC, all of whom had polymerase chain reaction–confirmed COVID-19. Participants were prospectively enrolled in the population-based Danish IBD-COVID registry from January 28, 2020 to April 1, 2021. At a median of 5.1 months, a subset of 85 people with CD and 137 with UC agreed to report any post-COVID symptoms.

Older age, smoking, IBD disease activity, and presence of comorbidities were not associated with a significantly elevated risk of long COVID.

In a multivariate analysis, hospitalization for COVID-19 among people with CD was significantly associated with long COVID (odds ratio, 2.76; 95% confidence interval, 1.05-3.90; P = .04).

Furthermore, people with UC who stopped taking immunosuppressive agents also had a significantly higher risk (OR, 1.50; 95% CI, 1.07-10.22; P = .01).

“However, IBD medications such as systemic steroids were not associated with this outcome,” Dr. Attauabi said.
 

Fatigue most common long COVID symptom

Fatigue was the most common long COVID symptom, reported by 37% of patients with CD and 36% with UC.

Anosmia and ageusia were also common, reported by 29% and 28% of patients with CD, and 27% and 19% of those with UC, respectively.

“In our cohort of patients with UC or CD who developed COVID-19, the long-term health effects of COVID-19 did not appear to differ among patients with UC or CD nor according to IBD medications,” Dr. Attauabi said.

That is a “great study,” said session cochair Torsten Kucharzik, MD, PhD, head of internal medicine and gastroenterology at Lueneburg (Germany) Hospital.

When Dr. Kucharzik asked about smoking, Dr. Attauabi responded that they collected information on current and previous smoking, but they chose not to include the data because it was not statistically significant.

Dr. Attauabi has reported no relevant financial relationships. Dr. Kucharzik has reported receiving grants from Takeda and personal fees from companies including MSD/Essex, AbbVie, Falk Foundation, Biogen, Bristol-Myers Squibb, Arena, Celgene, Celltrion, Ferring, Janssen, Galapagos, Olympus, Mundipharma, Takeda, Amgen, Pfizer, Roche, and Vifor Pharma.

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

It’s January 1, 2022, as I write, and my CHEST presidency came to an end last night as the fireworks lit up the sky. With COVID-19 waxing and waning across the United States and around the world, I have been a wartime president. CHEST has not been able to do a number of the things that we would normally have done in person, including that there has not been an in-person CHEST annual meeting during my entire presidency. We have, nonetheless, achieved some important things that I will share with you.

If you’re a typical CHEST member, you probably don’t spend a lot of time wondering about CHEST’s finances, nor should you. Nevertheless, CHEST – your organization – does have to be fiscally responsible if we desire to continue our educational and research missions, and that is the job of your Board of Regents, your presidents, and your professional staff at the CHEST headquarters. I’m happy to tell you that your organization is in healthy financial condition, in spite of a challenging economic environment and, being forced into remote, online annual meetings and board reviews for 2 years. What that means to us and to you is that we get to maintain and improve our full array of educational activities, including our annual meeting, our journal, our board reviews, our hands-on courses at the CHEST headquarters, and our web content. And, we get to accelerate our advocacy activities for our patients and for the clinical folks who care for them (us!). CHEST is primed for emerging from this pandemic stronger, because we have had to make the most of every dollar we have, and more innovative, because that’s how we have done it. We are ready for new ways of interacting and for innovative new ways of delivering education, sponsoring research, fostering networking, and leading in the clinical arena of chest medicine.

During my time as CHEST President, many of us have become progressively more aware of the blatant inequities that continue in society – and, yes, even in medicine. Perhaps more than anything, it both saddens and angers me when anyone values or devalues someone else’s life because of the color of their skin, who they feel attracted to or love, the sex they were born with or their knowledge that nature gave them the wrong physical characteristics for their gender, what physical impairments they have, where they were born, where they were educated - or not, what language is their first language, or what opportunities they were presented with in their lives. Everyone deserves the opportunity to be who and what they are and to be respected for who they are, and everyone deserves the opportunity to excel. The strongest collaborations have diverse constituents with unified goals, and I want for CHEST to be among the strongest of professional collaborations. It has been deeply important to me during my presidency to champion these values, and we have worked hard to make CHEST an inclusive and diverse organization. Much remains to be done, but we did make some good progress this year.

We established a spirometry working group to look at the science around race-based adjustments for normal values, to call out if there are mistakes or omissions in that approach, and to propose the work that needs to be done to correct them. We invited the American Thoracic Society and the Canadian Thoracic Society to join us in this effort. Race is a social construct, not a physiologic principle, and some data suggest that apparent differences in physiology could actually reflect differences in socioeconomic status of study participants. In similar work, our nephrology colleagues demonstrated that apparent differences in normal glomerular filtration rate (GFR) are related to socio-economic and health care access issues; they called for labs to no longer report race-based norms for creatinine and GFR values. Our colleagues believe that race-based GFR norms have harmed patients by promoting delay in treatments aimed at preventing dialysis or by causing delays in the initiation of dialysis. In our world, asbestos companies have argued that African American and other populations of color should receive lower asbestosis settlements on the basis that they began with lower predicted lung function and, therefore, had been less damaged by exposure to asbestos. I am very interested to see our working group’s output. I think it could result in landmark changes in our evaluation and treatment of patients with lung diseases.

It’s January 1, 2022, as I write, and my CHEST presidency came to an end last night as the fireworks lit up the sky. With COVID-19 waxing and waning across the United States and around the world, I have been a wartime president. CHEST has not been able to do a number of the things that we would normally have done in person, including that there has not been an in-person CHEST annual meeting during my entire presidency. We have, nonetheless, achieved some important things that I will share with you.

If you’re a typical CHEST member, you probably don’t spend a lot of time wondering about CHEST’s finances, nor should you. Nevertheless, CHEST – your organization – does have to be fiscally responsible if we desire to continue our educational and research missions, and that is the job of your Board of Regents, your presidents, and your professional staff at the CHEST headquarters. I’m happy to tell you that your organization is in healthy financial condition, in spite of a challenging economic environment and, being forced into remote, online annual meetings and board reviews for 2 years. What that means to us and to you is that we get to maintain and improve our full array of educational activities, including our annual meeting, our journal, our board reviews, our hands-on courses at the CHEST headquarters, and our web content. And, we get to accelerate our advocacy activities for our patients and for the clinical folks who care for them (us!). CHEST is primed for emerging from this pandemic stronger, because we have had to make the most of every dollar we have, and more innovative, because that’s how we have done it. We are ready for new ways of interacting and for innovative new ways of delivering education, sponsoring research, fostering networking, and leading in the clinical arena of chest medicine.

During my time as CHEST President, many of us have become progressively more aware of the blatant inequities that continue in society – and, yes, even in medicine. Perhaps more than anything, it both saddens and angers me when anyone values or devalues someone else’s life because of the color of their skin, who they feel attracted to or love, the sex they were born with or their knowledge that nature gave them the wrong physical characteristics for their gender, what physical impairments they have, where they were born, where they were educated - or not, what language is their first language, or what opportunities they were presented with in their lives. Everyone deserves the opportunity to be who and what they are and to be respected for who they are, and everyone deserves the opportunity to excel. The strongest collaborations have diverse constituents with unified goals, and I want for CHEST to be among the strongest of professional collaborations. It has been deeply important to me during my presidency to champion these values, and we have worked hard to make CHEST an inclusive and diverse organization. Much remains to be done, but we did make some good progress this year.

We established a spirometry working group to look at the science around race-based adjustments for normal values, to call out if there are mistakes or omissions in that approach, and to propose the work that needs to be done to correct them. We invited the American Thoracic Society and the Canadian Thoracic Society to join us in this effort. Race is a social construct, not a physiologic principle, and some data suggest that apparent differences in physiology could actually reflect differences in socioeconomic status of study participants. In similar work, our nephrology colleagues demonstrated that apparent differences in normal glomerular filtration rate (GFR) are related to socio-economic and health care access issues; they called for labs to no longer report race-based norms for creatinine and GFR values. Our colleagues believe that race-based GFR norms have harmed patients by promoting delay in treatments aimed at preventing dialysis or by causing delays in the initiation of dialysis. In our world, asbestos companies have argued that African American and other populations of color should receive lower asbestosis settlements on the basis that they began with lower predicted lung function and, therefore, had been less damaged by exposure to asbestos. I am very interested to see our working group’s output. I think it could result in landmark changes in our evaluation and treatment of patients with lung diseases.

It’s January 1, 2022, as I write, and my CHEST presidency came to an end last night as the fireworks lit up the sky. With COVID-19 waxing and waning across the United States and around the world, I have been a wartime president. CHEST has not been able to do a number of the things that we would normally have done in person, including that there has not been an in-person CHEST annual meeting during my entire presidency. We have, nonetheless, achieved some important things that I will share with you.

If you’re a typical CHEST member, you probably don’t spend a lot of time wondering about CHEST’s finances, nor should you. Nevertheless, CHEST – your organization – does have to be fiscally responsible if we desire to continue our educational and research missions, and that is the job of your Board of Regents, your presidents, and your professional staff at the CHEST headquarters. I’m happy to tell you that your organization is in healthy financial condition, in spite of a challenging economic environment and, being forced into remote, online annual meetings and board reviews for 2 years. What that means to us and to you is that we get to maintain and improve our full array of educational activities, including our annual meeting, our journal, our board reviews, our hands-on courses at the CHEST headquarters, and our web content. And, we get to accelerate our advocacy activities for our patients and for the clinical folks who care for them (us!). CHEST is primed for emerging from this pandemic stronger, because we have had to make the most of every dollar we have, and more innovative, because that’s how we have done it. We are ready for new ways of interacting and for innovative new ways of delivering education, sponsoring research, fostering networking, and leading in the clinical arena of chest medicine.

During my time as CHEST President, many of us have become progressively more aware of the blatant inequities that continue in society – and, yes, even in medicine. Perhaps more than anything, it both saddens and angers me when anyone values or devalues someone else’s life because of the color of their skin, who they feel attracted to or love, the sex they were born with or their knowledge that nature gave them the wrong physical characteristics for their gender, what physical impairments they have, where they were born, where they were educated - or not, what language is their first language, or what opportunities they were presented with in their lives. Everyone deserves the opportunity to be who and what they are and to be respected for who they are, and everyone deserves the opportunity to excel. The strongest collaborations have diverse constituents with unified goals, and I want for CHEST to be among the strongest of professional collaborations. It has been deeply important to me during my presidency to champion these values, and we have worked hard to make CHEST an inclusive and diverse organization. Much remains to be done, but we did make some good progress this year.

We established a spirometry working group to look at the science around race-based adjustments for normal values, to call out if there are mistakes or omissions in that approach, and to propose the work that needs to be done to correct them. We invited the American Thoracic Society and the Canadian Thoracic Society to join us in this effort. Race is a social construct, not a physiologic principle, and some data suggest that apparent differences in physiology could actually reflect differences in socioeconomic status of study participants. In similar work, our nephrology colleagues demonstrated that apparent differences in normal glomerular filtration rate (GFR) are related to socio-economic and health care access issues; they called for labs to no longer report race-based norms for creatinine and GFR values. Our colleagues believe that race-based GFR norms have harmed patients by promoting delay in treatments aimed at preventing dialysis or by causing delays in the initiation of dialysis. In our world, asbestos companies have argued that African American and other populations of color should receive lower asbestosis settlements on the basis that they began with lower predicted lung function and, therefore, had been less damaged by exposure to asbestos. I am very interested to see our working group’s output. I think it could result in landmark changes in our evaluation and treatment of patients with lung diseases.

Spironolactone was not associated with any meaningful increase in the risk of breast cancer or other solid organ cancers in a systematic review and meta-analysis covering seven observational studies and a total population of over 4.5 million people.

The data, published in JAMA Dermatology, are “reassuring,” the authors reported, considering that the spironolactone label carries a Food and Drug Administration warning regarding possible tumorigenicity, which is based on animal studies of doses up to 150-fold greater than doses used for humans. The drug’s antiandrogenic properties have driven its off-label use as a treatment for acne, hidradenitis, androgenetic alopecia, and hirsutism.

Spironolactone, a synthetic 17-lactone steroid, is approved for the treatment of heart failure, edema and ascites, hypertension, and primary hyperaldosteronism. Off label, it is also frequently used in gender-affirming care and is included in Endocrine Society guidelines as part of hormonal regimens for transgender women, the authors noted.

The seven eligible studies looked at the occurrence of cancer in men and women who had any exposure to the drug, regardless of the primary indication. Sample sizes ranged from 18,035 to 2.3 million, and the mean age across all studies was 62.6-72 years.

The researchers synthesized the studies, mostly of European individuals, using random effects meta-analysis and found no statistically significant association between spironolactone use and risk of breast cancer (risk ratio, 1.04; 95% confidence interval, 0.86-1.22). Three of the seven studies investigated breast cancer.

There was also no significant association between spironolactone use and risk of ovarian cancer (two studies), bladder cancer (three studies), kidney cancer (two studies), gastric cancer (two studies), or esophageal cancer (two studies).

For prostate cancer, investigated in four studies, use of the drug was associated with decreased risk (RR, 0.79, 95% CI, 0.68-0.90).

Kanthi Bommareddy, MD, of the University of Miami and coauthors concluded that all studies were at low risk of bias after appraising each one using a scale that looks at selection bias, confounding bias, and detection and outcome bias.

In dermatology, the results should “help us to take a collective sigh of relief,” said Julie C. Harper, MD, of the Dermatology and Skin Care Center of Birmingham, Ala., who was asked to comment on the study. The drug has been “safe and effective in our clinics and it is affordable and accessible to our patients,” she said, but with the FDA’s warning and the drug’s antiandrogen capacity, “there has been concern that we might be putting our patients at increased risk of breast cancer [in particular].”

The pooling of seven large studies together and the finding of no substantive increased risk of cancer “gives us evidence and comfort that spironolactone does not increase the risk of cancer in our dermatology patients,” said Dr. Harper, a past president of the American Acne & Rosacea Society.

“With every passing year,” she noted, “dermatologists are prescribing more and more spironolactone for acne, hidradenitis, androgenetic alopecia, and hirsutism.”

Four of the seven studies stratified analyses by sex, and in those without stratification by sex, women accounted for 17.2%-54.4% of the samples.

The studies had long follow-up periods of 5-20 years, but certainty of the evidence was low and since many of the studies included mostly older individuals, “they may not generalize to younger populations, such as those treated with spironolactone for acne,” the investigators wrote.

The authors also noted they were unable to look for dose-dependent associations between spironolactone and cancer risk, and that confidence intervals for rarer cancers like ovarian cancer were wide. “We cannot entirely exclude the potential for a meaningful increase in cancer risk,” and future studies are needed, in populations that include younger patients and those with acne or hirsutism.

Dr. Bommareddy reported no disclosures. Other coauthors reported grants from the National Cancer Institute outside the submitted work, and personal fees as a Cancer Prevention and Research Institute of Texas Scholar in Cancer Research. There was no funding reported for the study. Dr. Harper said she had no disclosures.

Spironolactone was not associated with any meaningful increase in the risk of breast cancer or other solid organ cancers in a systematic review and meta-analysis covering seven observational studies and a total population of over 4.5 million people.

The data, published in JAMA Dermatology, are “reassuring,” the authors reported, considering that the spironolactone label carries a Food and Drug Administration warning regarding possible tumorigenicity, which is based on animal studies of doses up to 150-fold greater than doses used for humans. The drug’s antiandrogenic properties have driven its off-label use as a treatment for acne, hidradenitis, androgenetic alopecia, and hirsutism.

Spironolactone, a synthetic 17-lactone steroid, is approved for the treatment of heart failure, edema and ascites, hypertension, and primary hyperaldosteronism. Off label, it is also frequently used in gender-affirming care and is included in Endocrine Society guidelines as part of hormonal regimens for transgender women, the authors noted.

The seven eligible studies looked at the occurrence of cancer in men and women who had any exposure to the drug, regardless of the primary indication. Sample sizes ranged from 18,035 to 2.3 million, and the mean age across all studies was 62.6-72 years.

The researchers synthesized the studies, mostly of European individuals, using random effects meta-analysis and found no statistically significant association between spironolactone use and risk of breast cancer (risk ratio, 1.04; 95% confidence interval, 0.86-1.22). Three of the seven studies investigated breast cancer.

There was also no significant association between spironolactone use and risk of ovarian cancer (two studies), bladder cancer (three studies), kidney cancer (two studies), gastric cancer (two studies), or esophageal cancer (two studies).

For prostate cancer, investigated in four studies, use of the drug was associated with decreased risk (RR, 0.79, 95% CI, 0.68-0.90).

Kanthi Bommareddy, MD, of the University of Miami and coauthors concluded that all studies were at low risk of bias after appraising each one using a scale that looks at selection bias, confounding bias, and detection and outcome bias.

In dermatology, the results should “help us to take a collective sigh of relief,” said Julie C. Harper, MD, of the Dermatology and Skin Care Center of Birmingham, Ala., who was asked to comment on the study. The drug has been “safe and effective in our clinics and it is affordable and accessible to our patients,” she said, but with the FDA’s warning and the drug’s antiandrogen capacity, “there has been concern that we might be putting our patients at increased risk of breast cancer [in particular].”

The pooling of seven large studies together and the finding of no substantive increased risk of cancer “gives us evidence and comfort that spironolactone does not increase the risk of cancer in our dermatology patients,” said Dr. Harper, a past president of the American Acne & Rosacea Society.

“With every passing year,” she noted, “dermatologists are prescribing more and more spironolactone for acne, hidradenitis, androgenetic alopecia, and hirsutism.”

Four of the seven studies stratified analyses by sex, and in those without stratification by sex, women accounted for 17.2%-54.4% of the samples.

The studies had long follow-up periods of 5-20 years, but certainty of the evidence was low and since many of the studies included mostly older individuals, “they may not generalize to younger populations, such as those treated with spironolactone for acne,” the investigators wrote.

The authors also noted they were unable to look for dose-dependent associations between spironolactone and cancer risk, and that confidence intervals for rarer cancers like ovarian cancer were wide. “We cannot entirely exclude the potential for a meaningful increase in cancer risk,” and future studies are needed, in populations that include younger patients and those with acne or hirsutism.

Dr. Bommareddy reported no disclosures. Other coauthors reported grants from the National Cancer Institute outside the submitted work, and personal fees as a Cancer Prevention and Research Institute of Texas Scholar in Cancer Research. There was no funding reported for the study. Dr. Harper said she had no disclosures.

Spironolactone was not associated with any meaningful increase in the risk of breast cancer or other solid organ cancers in a systematic review and meta-analysis covering seven observational studies and a total population of over 4.5 million people.

The data, published in JAMA Dermatology, are “reassuring,” the authors reported, considering that the spironolactone label carries a Food and Drug Administration warning regarding possible tumorigenicity, which is based on animal studies of doses up to 150-fold greater than doses used for humans. The drug’s antiandrogenic properties have driven its off-label use as a treatment for acne, hidradenitis, androgenetic alopecia, and hirsutism.

Spironolactone, a synthetic 17-lactone steroid, is approved for the treatment of heart failure, edema and ascites, hypertension, and primary hyperaldosteronism. Off label, it is also frequently used in gender-affirming care and is included in Endocrine Society guidelines as part of hormonal regimens for transgender women, the authors noted.

The seven eligible studies looked at the occurrence of cancer in men and women who had any exposure to the drug, regardless of the primary indication. Sample sizes ranged from 18,035 to 2.3 million, and the mean age across all studies was 62.6-72 years.

The researchers synthesized the studies, mostly of European individuals, using random effects meta-analysis and found no statistically significant association between spironolactone use and risk of breast cancer (risk ratio, 1.04; 95% confidence interval, 0.86-1.22). Three of the seven studies investigated breast cancer.

There was also no significant association between spironolactone use and risk of ovarian cancer (two studies), bladder cancer (three studies), kidney cancer (two studies), gastric cancer (two studies), or esophageal cancer (two studies).

For prostate cancer, investigated in four studies, use of the drug was associated with decreased risk (RR, 0.79, 95% CI, 0.68-0.90).

Kanthi Bommareddy, MD, of the University of Miami and coauthors concluded that all studies were at low risk of bias after appraising each one using a scale that looks at selection bias, confounding bias, and detection and outcome bias.

In dermatology, the results should “help us to take a collective sigh of relief,” said Julie C. Harper, MD, of the Dermatology and Skin Care Center of Birmingham, Ala., who was asked to comment on the study. The drug has been “safe and effective in our clinics and it is affordable and accessible to our patients,” she said, but with the FDA’s warning and the drug’s antiandrogen capacity, “there has been concern that we might be putting our patients at increased risk of breast cancer [in particular].”

The pooling of seven large studies together and the finding of no substantive increased risk of cancer “gives us evidence and comfort that spironolactone does not increase the risk of cancer in our dermatology patients,” said Dr. Harper, a past president of the American Acne & Rosacea Society.

“With every passing year,” she noted, “dermatologists are prescribing more and more spironolactone for acne, hidradenitis, androgenetic alopecia, and hirsutism.”

Four of the seven studies stratified analyses by sex, and in those without stratification by sex, women accounted for 17.2%-54.4% of the samples.

The studies had long follow-up periods of 5-20 years, but certainty of the evidence was low and since many of the studies included mostly older individuals, “they may not generalize to younger populations, such as those treated with spironolactone for acne,” the investigators wrote.

The authors also noted they were unable to look for dose-dependent associations between spironolactone and cancer risk, and that confidence intervals for rarer cancers like ovarian cancer were wide. “We cannot entirely exclude the potential for a meaningful increase in cancer risk,” and future studies are needed, in populations that include younger patients and those with acne or hirsutism.

Dr. Bommareddy reported no disclosures. Other coauthors reported grants from the National Cancer Institute outside the submitted work, and personal fees as a Cancer Prevention and Research Institute of Texas Scholar in Cancer Research. There was no funding reported for the study. Dr. Harper said she had no disclosures.

Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.

“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.

The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.

Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.

Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
 

Secondary outcomes

Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.

In all the secondary outcomes, there were no significant differences between groups.

Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).

The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
 

No difference by vaccine status

The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”

Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).

Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.

The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”

Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.

Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.

In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.

Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.

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

Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.

“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.

The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.

Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.

Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
 

Secondary outcomes

Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.

In all the secondary outcomes, there were no significant differences between groups.

Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).

The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
 

No difference by vaccine status

The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”

Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).

Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.

The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”

Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.

Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.

In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.

Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.

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

Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.

“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.

The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.

Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.

Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
 

Secondary outcomes

Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.

In all the secondary outcomes, there were no significant differences between groups.

Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).

The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
 

No difference by vaccine status

The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”

Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).

Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.

The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”

Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.

Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.

In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.

Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.

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

We’re proud to announce the 10 early-career physician-scientists selected as “Scholars” for the 2021-2023 AGA FORWARD Program: Fostering Opportunities Resulting in Workforce and Research Diversity, supported by NIH (1R25DK118761-01). This new cohort of Scholars will participate in a training and mentorship program designed to provide concrete and applicable skills to promote physician-scientists from underrepresented populations in the pursuit of successful careers.

“AGA is excited to announce our second cohort of FORWARD Program Scholars as we continue in our promise to inspire and cultivate the next generation of prominent, diverse leaders in gastroenterology and hepatology,” said Byron Cryer, MD, FORWARD Program cochair, AGA Equity Project cochair, and associate dean for the Office of Faculty Diversity & Development at UT Southwestern Medical Center, Dallas. “This class includes gastroenterology and hepatology’s most gifted leaders who are trailblazers for the future of academic medicine.”

• Muyiwa Awoniyi, MD, PhD
• Bubu Banini, MD, PhD
• Manuel Braga Neto, MD, PhD
• Jihane Benhammou, MD, PhD
• Cassandra Fritz, MD
• Joel Gabre, MD
• Rachel Issaka, MD, MAS
• Jeremy Louissaint, MD
• Vivian Ortiz, MD
• Nicolette Rodriguez, MD, MPH

Each Scholar has been paired with a top GI investigator for the duration of the program who will provide mentorship and help in developing the Scholar’s leadership skills and strengthening their research and management skills to ensure continued success in their careers. In addition to the GI mentors, the program will be introducing five “near-peer” mentors from the inaugural FORWARD cohort who will each serve as program guides for the current cohort Scholars. 

Learn more about this program at https://www.gastro.org/aga-leadership/initiatives-and-programs/forward-program.

We’re proud to announce the 10 early-career physician-scientists selected as “Scholars” for the 2021-2023 AGA FORWARD Program: Fostering Opportunities Resulting in Workforce and Research Diversity, supported by NIH (1R25DK118761-01). This new cohort of Scholars will participate in a training and mentorship program designed to provide concrete and applicable skills to promote physician-scientists from underrepresented populations in the pursuit of successful careers.

“AGA is excited to announce our second cohort of FORWARD Program Scholars as we continue in our promise to inspire and cultivate the next generation of prominent, diverse leaders in gastroenterology and hepatology,” said Byron Cryer, MD, FORWARD Program cochair, AGA Equity Project cochair, and associate dean for the Office of Faculty Diversity & Development at UT Southwestern Medical Center, Dallas. “This class includes gastroenterology and hepatology’s most gifted leaders who are trailblazers for the future of academic medicine.”

• Muyiwa Awoniyi, MD, PhD
• Bubu Banini, MD, PhD
• Manuel Braga Neto, MD, PhD
• Jihane Benhammou, MD, PhD
• Cassandra Fritz, MD
• Joel Gabre, MD
• Rachel Issaka, MD, MAS
• Jeremy Louissaint, MD
• Vivian Ortiz, MD
• Nicolette Rodriguez, MD, MPH

Each Scholar has been paired with a top GI investigator for the duration of the program who will provide mentorship and help in developing the Scholar’s leadership skills and strengthening their research and management skills to ensure continued success in their careers. In addition to the GI mentors, the program will be introducing five “near-peer” mentors from the inaugural FORWARD cohort who will each serve as program guides for the current cohort Scholars. 

Learn more about this program at https://www.gastro.org/aga-leadership/initiatives-and-programs/forward-program.

We’re proud to announce the 10 early-career physician-scientists selected as “Scholars” for the 2021-2023 AGA FORWARD Program: Fostering Opportunities Resulting in Workforce and Research Diversity, supported by NIH (1R25DK118761-01). This new cohort of Scholars will participate in a training and mentorship program designed to provide concrete and applicable skills to promote physician-scientists from underrepresented populations in the pursuit of successful careers.

“AGA is excited to announce our second cohort of FORWARD Program Scholars as we continue in our promise to inspire and cultivate the next generation of prominent, diverse leaders in gastroenterology and hepatology,” said Byron Cryer, MD, FORWARD Program cochair, AGA Equity Project cochair, and associate dean for the Office of Faculty Diversity & Development at UT Southwestern Medical Center, Dallas. “This class includes gastroenterology and hepatology’s most gifted leaders who are trailblazers for the future of academic medicine.”

• Muyiwa Awoniyi, MD, PhD
• Bubu Banini, MD, PhD
• Manuel Braga Neto, MD, PhD
• Jihane Benhammou, MD, PhD
• Cassandra Fritz, MD
• Joel Gabre, MD
• Rachel Issaka, MD, MAS
• Jeremy Louissaint, MD
• Vivian Ortiz, MD
• Nicolette Rodriguez, MD, MPH

Each Scholar has been paired with a top GI investigator for the duration of the program who will provide mentorship and help in developing the Scholar’s leadership skills and strengthening their research and management skills to ensure continued success in their careers. In addition to the GI mentors, the program will be introducing five “near-peer” mentors from the inaugural FORWARD cohort who will each serve as program guides for the current cohort Scholars. 

Learn more about this program at https://www.gastro.org/aga-leadership/initiatives-and-programs/forward-program.

Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

Starting this month, I will be joining Dr. Leslie S. Baumann as a cocontributor to the Cosmeceutical Critique column, and since this is my first column, I would like to formally introduce myself. I am a cosmetic and general dermatologist in private practice in Miami and a longtime skin care enthusiast. My path toward becoming a dermatologist began when I was working in New York City, my hometown, as a scientific researcher, fulfilling my passion for scientific inquiry. After realizing that I most enjoyed applying discoveries made in the lab directly to patient care, I decided to pursue medical school at New York University before completing a dermatology residency at the University of Miami, serving as Chief Resident during my final year. Although I was born and raised in New York, staying in Miami was an obvious decision for me. In addition to the tropical weather and amazing lifestyle, the medical community in Miami supports adventure, creativity, and innovation, which are key aspects that drew me to the University of Miami and continue to drive my personal evolution in private practice.

I now practice at Baumann Cosmetic & Research Institute alongside my mentor, Dr. Baumann. I truly have my dream job – I get to talk skin care and do a wide array of cosmetics procedures, perform skin surgeries, and solve complex medical dermatology cases all in a day’s work. My career sits at the intersection of my passions for science, critical thinking, beauty, aesthetics, and most importantly, engaging with patients.

For my first column, I want to provide a newly minted dermatologist’s perspective on cosmeceuticals. I will focus this discussion on the limited training in cosmeceuticals during residency and the importance of learning about cosmeceuticals, and I will provide a simple framework to approach the design of skin care regimens and utilization of cosmeceuticals in practice.

The focus of a dermatology residency is on medical and surgical skills. We become experts in diagnosing and treating conditions ranging from life-threatening drug reactions like Stevens-Johnson Syndrome to complex diseases like dermatomyositis, utilizing medications and treatments ranging from cyclosporine and methotrexate to biologics and intravenous immunoglobulin, and performing advanced skin surgeries utilizing flaps and grafts to repair defects.

The discipline of cosmetic dermatology, let alone cosmeceuticals, accounts for a fraction of our didactic and hands-on training. I completed a top dermatology residency program that prepared me to treat any dermatologic condition; however, I honestly felt like I didn’t have a strong understanding of cosmeceuticals and skin care and how to integrate them with prescription therapies when I completed residency, which is a sentiment shared by residents across the country. I remember a study break while preparing for my final board exam when I went into a tailspin for an entire day trying to decode an ingredient list of a new “antiaging serum” and researching its mechanisms of action and the clinical data supporting the active ingredients in the serum, which included bakuchiol and a blend of peptides. As a dermatologist who likes to treat and provide recommendations based on scientific rationale and data to deliver the highest level of care, I admit that I felt insecure not being as knowledgeable about cosmeceuticals as I was about more complex dermatology treatments. As both a cosmetic and general dermatologist, discussing skin care and cosmeceuticals independent of or in conjunction with medical management occurs daily, and I recognized that becoming an expert in this area is essential to becoming a top, well-rounded dermatologist.
 

A gap in cosmeceutical education in dermatology residency

Multiple studies have established that the field of cosmetic dermatology comprises a fraction of dermatology residency training. In 2013, Kirby et al. published a survey of dermatology instructors and chief residents across the country and found that only 67% of responders reported having received formal lectures on cosmetic dermatology.¹ In 2014, Bauer et al. published a survey of dermatology program directors assessing attitudes toward cosmetic dermatology and reported that only 38% of program directors believed that cosmetic dermatology should be a necessary aspect of residency training.² A survey sent to dermatology residents published in 2012 found that among respondents, more than 58% of residency programs have an “encouraging or somewhat encouraging” attitude toward teaching cosmetic dermatology, yet 22% of programs had a “somewhat discouraging” or “discouraging” attitude.³ While these noted studies have focused on procedural aspects of cosmetic dermatology training, Feetham et al. surveyed dermatology residents and faculty to assess attitudes toward and training on skin care and cosmeceuticals specifically. Among resident respondents, most (74.5%) reported their education on skin care and cosmeceuticals has been “too little or nonexistent” during residency and 76.5% “agree or strongly agree” that it should be part of their education.4 In contrast, 60% of faculty reported resident education on skin care and cosmeceuticals is “just the right amount or too much” (P < .001).

In my personal experience as a resident, discussing skin care was emphasized when treating patients with eczema, contact dermatitis, acne, and hair disorders, but otherwise, the majority of skin care discussions relied on having a stock list of recommended cleansers, moisturizers, and sunscreens. In regards to cosmeceuticals for facial skin specifically, there were only a handful of instances in which alternative ingredients, such as vitamin C for hyperpigmentation, were discussed and specific brands were mentioned. Upon reflection, I wish I had more opportunity to see the clinical benefits of cosmeceuticals first hand, just like when I observe dupilumab clear patients with severe atopic dermatitis, rather than reading about it in textbooks and journals.

While one hypothesis for programs’ limited attention given to cosmetic training may be that it detracts from medical training, the survey by Bauer et al. found that residents did not feel less prepared (94.9%) or less interested (97.4%) in medical dermatology as a result of their cosmetic training.² In addition, providers in an academic dermatology residency may limit discussions of skin care because of the high patient volume and because extensive skin care discussions will not impact insurance billings. Academic dermatology programs often service patients with more financial constraints, which further limits OTC cosmeceutical discussions. In my residency experience, I had the opportunity to regularly treat more severe and rare dermatologic cases than those I encounter in private practice; therefore, I spent more time focusing on systemic therapies, with fewer opportunities to dedicate time to cosmeceuticals.
 

Why skin care and cosmeceuticals should be an essential aspect of residency training

Discussing skin care and cosmeceuticals is a valuable aspect of medical and general dermatology, not just aesthetic dermatology. When treating general dermatologic conditions, guidance on proper skin care can improve both adherence and efficacy of medical treatments. For example, an acne study by de Lucas et al. demonstrated that adherence to adjuvant treatment of acne (such as the use of moisturizers) was associated not only with a 2.4-fold increase in the probability of adherence to pharmacological treatment, but also with a significant reduction in acne severity.⁵ Aside from skin care, cosmeceuticals themselves have efficacy in treating general dermatologic conditions. In the treatment of acne, topical niacinamide, a popular cosmeceutical ingredient, has been shown to have sebosuppressive and anti-inflammatory effects, addressing key aspects of acne pathogenesis.⁶ A double-blind study by Draelos et al. reported topical 2% niacinamide was effective in reducing the rate of sebum excretion in 50 Japanese patients over 4 weeks.⁶ In several double-blind studies that have compared twice daily application of 4% nicotinamide gel with the same application of 1% clindamycin gel in moderate inflammatory acne over 8 weeks, nicotinamide gel reduced the number of inflammatory papules and acne lesions to a level comparable with clindamycin gel.6 These studies support the use of niacinamide cosmeceutical products as an adjunctive treatment for acne.

With increased clinical data supporting cosmeceuticals, it can be expected that some cosmeceuticals will substitute traditional prescription medications in the dermatologists’ arsenal. For example, hydroquinone – both prescription strength and OTC 2% – is a workhorse in treating melasma; however, there is increasing interest in hydroquinone-free treatments, especially since OTC cosmeceuticals containing 2% hydroquinone were banned in 2020 because of safety concerns. Dermatologists will therefore need to provide guidance about hydroquinone alternatives for skin lightening, including soy, licorice extracts, kojic acid, arbutin, niacinamide, N-acetylglucosamine, and vitamin C, among others.⁷ Utilizing knowledge of a cosmeceutical’s mechanisms of action and clinical data, the dermatologist is in the best position to guide patients toward optimal ingredients and dispel cosmeceutical myths. Given that cosmeceuticals are not regulated by the Food and Drug Administration, it is even more important that the dermatologist serves as an authority on cosmeceuticals.
 

How to become a master skin care and cosmeceutical prescriber

A common pitfall I have observed among practitioners less experienced with aesthetic-focused skin care and cosmeceuticals is adapting a one-size-fits-all approach. In the one-size-fits-all approach, every patient concerned about aging gets the same vitamin C serum and retinoid, and every patient with hyperpigmentation gets the same hydroquinone prescription, for example. This approach, however, does not take into account unique differences in patients’ skin. Below

is the basic skin care framework that I follow, taught to me by Dr. Baumann. It utilizes an individualized approach based on the patient’s skin qualities to achieve optimal results.

Determine the patient’s skin type (dry vs. oily; sensitive vs. not sensitive; pigmentation issues vs. no hyperpigmentation; wrinkled and mature vs. nonwrinkled) and identify concerns (e.g., dark spots, redness, acne, dehydration).

Separate products into categories of cleansers, eye creams, moisturizers, sun protection, and treatments. Treatments refers to any additional products in a skin care regimen intended to ameliorate a particular condition (e.g., vitamin C for hyperpigmentation, retinoids for fine lines).

Choose products for each category in step 2 (cleansers, eye creams, moisturizers, sun protection, treatments) that are complementary to the patient’s skin type (determined in step 1) and aid the patient in meeting their particular skin goals. For example, a salicylic acid cleanser would be beneficial for a patient with oily skin and acne, but this same cleanser may be too drying and irritating for an acne patient with dry skin.

Ensure that chosen ingredients and products work together harmoniously. For example, while the acne patient may benefit from a salicylic acid cleanser and retinoid cream, using them in succession initially may be overly drying for some patients.

Spend the time to make sure patients understand the appropriate order of application and recognize when efficacy of a product is impacted by another product in the regimen. For example, a low pH cleanser can increase penetration of an ascorbic acid product that follows it in the regimen.

After establishing a basic skin care framework, the next step for beginners is learning about ingredients and their mechanisms of action and familiarizing themselves with scientific and clinical studies. Until cosmeceuticals become an integral part of the training curriculum, dermatologists can gain knowledge independently by reading literature and studies on cosmeceutical active ingredients and experimenting with consumer products. I look forward to regularly contributing to this column to further our awareness and understanding of the mechanisms of and data supporting cosmeceuticals so that we can better guide our patients.

Please feel free to email me at chloe@derm.net or message me on Instagram @DrChloeGoldman with ideas that you would like me to address in this column.
 

Dr. Goldman is a dermatologist in private practice in Miami, and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a new general dermatology practice. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other relevant disclosures.

References

1. Kirby JS et al. J Am Acad Dermatol. 2013;68(2):e23-8.

2. Bauer et al. JAMA Dermatol. 2014;150(2):125-9.

3. Group A et al. Dermatol Surg. 2012;38(12):1975-80.

4. Feetham HJ et al. J Cosmet Dermatol. 2018;17(2):220-6.

5. de Lucas R et al. BMC Dermatol. 2015;15:17.

6. Araviiskaia E and Dreno BJ. Eur Acad Dermatol Venereol. 2016;30(6):926-35.

7. Leyden JJ et al. J Eur Acad Dermatol Venereol. 2011;25(10):1140-5.

Starting this month, I will be joining Dr. Leslie S. Baumann as a cocontributor to the Cosmeceutical Critique column, and since this is my first column, I would like to formally introduce myself. I am a cosmetic and general dermatologist in private practice in Miami and a longtime skin care enthusiast. My path toward becoming a dermatologist began when I was working in New York City, my hometown, as a scientific researcher, fulfilling my passion for scientific inquiry. After realizing that I most enjoyed applying discoveries made in the lab directly to patient care, I decided to pursue medical school at New York University before completing a dermatology residency at the University of Miami, serving as Chief Resident during my final year. Although I was born and raised in New York, staying in Miami was an obvious decision for me. In addition to the tropical weather and amazing lifestyle, the medical community in Miami supports adventure, creativity, and innovation, which are key aspects that drew me to the University of Miami and continue to drive my personal evolution in private practice.

I now practice at Baumann Cosmetic & Research Institute alongside my mentor, Dr. Baumann. I truly have my dream job – I get to talk skin care and do a wide array of cosmetics procedures, perform skin surgeries, and solve complex medical dermatology cases all in a day’s work. My career sits at the intersection of my passions for science, critical thinking, beauty, aesthetics, and most importantly, engaging with patients.

For my first column, I want to provide a newly minted dermatologist’s perspective on cosmeceuticals. I will focus this discussion on the limited training in cosmeceuticals during residency and the importance of learning about cosmeceuticals, and I will provide a simple framework to approach the design of skin care regimens and utilization of cosmeceuticals in practice.

The focus of a dermatology residency is on medical and surgical skills. We become experts in diagnosing and treating conditions ranging from life-threatening drug reactions like Stevens-Johnson Syndrome to complex diseases like dermatomyositis, utilizing medications and treatments ranging from cyclosporine and methotrexate to biologics and intravenous immunoglobulin, and performing advanced skin surgeries utilizing flaps and grafts to repair defects.

The discipline of cosmetic dermatology, let alone cosmeceuticals, accounts for a fraction of our didactic and hands-on training. I completed a top dermatology residency program that prepared me to treat any dermatologic condition; however, I honestly felt like I didn’t have a strong understanding of cosmeceuticals and skin care and how to integrate them with prescription therapies when I completed residency, which is a sentiment shared by residents across the country. I remember a study break while preparing for my final board exam when I went into a tailspin for an entire day trying to decode an ingredient list of a new “antiaging serum” and researching its mechanisms of action and the clinical data supporting the active ingredients in the serum, which included bakuchiol and a blend of peptides. As a dermatologist who likes to treat and provide recommendations based on scientific rationale and data to deliver the highest level of care, I admit that I felt insecure not being as knowledgeable about cosmeceuticals as I was about more complex dermatology treatments. As both a cosmetic and general dermatologist, discussing skin care and cosmeceuticals independent of or in conjunction with medical management occurs daily, and I recognized that becoming an expert in this area is essential to becoming a top, well-rounded dermatologist.
 

A gap in cosmeceutical education in dermatology residency

Multiple studies have established that the field of cosmetic dermatology comprises a fraction of dermatology residency training. In 2013, Kirby et al. published a survey of dermatology instructors and chief residents across the country and found that only 67% of responders reported having received formal lectures on cosmetic dermatology.¹ In 2014, Bauer et al. published a survey of dermatology program directors assessing attitudes toward cosmetic dermatology and reported that only 38% of program directors believed that cosmetic dermatology should be a necessary aspect of residency training.² A survey sent to dermatology residents published in 2012 found that among respondents, more than 58% of residency programs have an “encouraging or somewhat encouraging” attitude toward teaching cosmetic dermatology, yet 22% of programs had a “somewhat discouraging” or “discouraging” attitude.³ While these noted studies have focused on procedural aspects of cosmetic dermatology training, Feetham et al. surveyed dermatology residents and faculty to assess attitudes toward and training on skin care and cosmeceuticals specifically. Among resident respondents, most (74.5%) reported their education on skin care and cosmeceuticals has been “too little or nonexistent” during residency and 76.5% “agree or strongly agree” that it should be part of their education.4 In contrast, 60% of faculty reported resident education on skin care and cosmeceuticals is “just the right amount or too much” (P < .001).

In my personal experience as a resident, discussing skin care was emphasized when treating patients with eczema, contact dermatitis, acne, and hair disorders, but otherwise, the majority of skin care discussions relied on having a stock list of recommended cleansers, moisturizers, and sunscreens. In regards to cosmeceuticals for facial skin specifically, there were only a handful of instances in which alternative ingredients, such as vitamin C for hyperpigmentation, were discussed and specific brands were mentioned. Upon reflection, I wish I had more opportunity to see the clinical benefits of cosmeceuticals first hand, just like when I observe dupilumab clear patients with severe atopic dermatitis, rather than reading about it in textbooks and journals.

While one hypothesis for programs’ limited attention given to cosmetic training may be that it detracts from medical training, the survey by Bauer et al. found that residents did not feel less prepared (94.9%) or less interested (97.4%) in medical dermatology as a result of their cosmetic training.² In addition, providers in an academic dermatology residency may limit discussions of skin care because of the high patient volume and because extensive skin care discussions will not impact insurance billings. Academic dermatology programs often service patients with more financial constraints, which further limits OTC cosmeceutical discussions. In my residency experience, I had the opportunity to regularly treat more severe and rare dermatologic cases than those I encounter in private practice; therefore, I spent more time focusing on systemic therapies, with fewer opportunities to dedicate time to cosmeceuticals.
 

Why skin care and cosmeceuticals should be an essential aspect of residency training

Discussing skin care and cosmeceuticals is a valuable aspect of medical and general dermatology, not just aesthetic dermatology. When treating general dermatologic conditions, guidance on proper skin care can improve both adherence and efficacy of medical treatments. For example, an acne study by de Lucas et al. demonstrated that adherence to adjuvant treatment of acne (such as the use of moisturizers) was associated not only with a 2.4-fold increase in the probability of adherence to pharmacological treatment, but also with a significant reduction in acne severity.⁵ Aside from skin care, cosmeceuticals themselves have efficacy in treating general dermatologic conditions. In the treatment of acne, topical niacinamide, a popular cosmeceutical ingredient, has been shown to have sebosuppressive and anti-inflammatory effects, addressing key aspects of acne pathogenesis.⁶ A double-blind study by Draelos et al. reported topical 2% niacinamide was effective in reducing the rate of sebum excretion in 50 Japanese patients over 4 weeks.⁶ In several double-blind studies that have compared twice daily application of 4% nicotinamide gel with the same application of 1% clindamycin gel in moderate inflammatory acne over 8 weeks, nicotinamide gel reduced the number of inflammatory papules and acne lesions to a level comparable with clindamycin gel.6 These studies support the use of niacinamide cosmeceutical products as an adjunctive treatment for acne.

With increased clinical data supporting cosmeceuticals, it can be expected that some cosmeceuticals will substitute traditional prescription medications in the dermatologists’ arsenal. For example, hydroquinone – both prescription strength and OTC 2% – is a workhorse in treating melasma; however, there is increasing interest in hydroquinone-free treatments, especially since OTC cosmeceuticals containing 2% hydroquinone were banned in 2020 because of safety concerns. Dermatologists will therefore need to provide guidance about hydroquinone alternatives for skin lightening, including soy, licorice extracts, kojic acid, arbutin, niacinamide, N-acetylglucosamine, and vitamin C, among others.⁷ Utilizing knowledge of a cosmeceutical’s mechanisms of action and clinical data, the dermatologist is in the best position to guide patients toward optimal ingredients and dispel cosmeceutical myths. Given that cosmeceuticals are not regulated by the Food and Drug Administration, it is even more important that the dermatologist serves as an authority on cosmeceuticals.
 

How to become a master skin care and cosmeceutical prescriber

A common pitfall I have observed among practitioners less experienced with aesthetic-focused skin care and cosmeceuticals is adapting a one-size-fits-all approach. In the one-size-fits-all approach, every patient concerned about aging gets the same vitamin C serum and retinoid, and every patient with hyperpigmentation gets the same hydroquinone prescription, for example. This approach, however, does not take into account unique differences in patients’ skin. Below

is the basic skin care framework that I follow, taught to me by Dr. Baumann. It utilizes an individualized approach based on the patient’s skin qualities to achieve optimal results.

Determine the patient’s skin type (dry vs. oily; sensitive vs. not sensitive; pigmentation issues vs. no hyperpigmentation; wrinkled and mature vs. nonwrinkled) and identify concerns (e.g., dark spots, redness, acne, dehydration).

Separate products into categories of cleansers, eye creams, moisturizers, sun protection, and treatments. Treatments refers to any additional products in a skin care regimen intended to ameliorate a particular condition (e.g., vitamin C for hyperpigmentation, retinoids for fine lines).

Choose products for each category in step 2 (cleansers, eye creams, moisturizers, sun protection, treatments) that are complementary to the patient’s skin type (determined in step 1) and aid the patient in meeting their particular skin goals. For example, a salicylic acid cleanser would be beneficial for a patient with oily skin and acne, but this same cleanser may be too drying and irritating for an acne patient with dry skin.

Ensure that chosen ingredients and products work together harmoniously. For example, while the acne patient may benefit from a salicylic acid cleanser and retinoid cream, using them in succession initially may be overly drying for some patients.

Spend the time to make sure patients understand the appropriate order of application and recognize when efficacy of a product is impacted by another product in the regimen. For example, a low pH cleanser can increase penetration of an ascorbic acid product that follows it in the regimen.

After establishing a basic skin care framework, the next step for beginners is learning about ingredients and their mechanisms of action and familiarizing themselves with scientific and clinical studies. Until cosmeceuticals become an integral part of the training curriculum, dermatologists can gain knowledge independently by reading literature and studies on cosmeceutical active ingredients and experimenting with consumer products. I look forward to regularly contributing to this column to further our awareness and understanding of the mechanisms of and data supporting cosmeceuticals so that we can better guide our patients.

Please feel free to email me at chloe@derm.net or message me on Instagram @DrChloeGoldman with ideas that you would like me to address in this column.
 

Dr. Goldman is a dermatologist in private practice in Miami, and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a new general dermatology practice. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other relevant disclosures.

References

1. Kirby JS et al. J Am Acad Dermatol. 2013;68(2):e23-8.

2. Bauer et al. JAMA Dermatol. 2014;150(2):125-9.

3. Group A et al. Dermatol Surg. 2012;38(12):1975-80.

4. Feetham HJ et al. J Cosmet Dermatol. 2018;17(2):220-6.

5. de Lucas R et al. BMC Dermatol. 2015;15:17.

6. Araviiskaia E and Dreno BJ. Eur Acad Dermatol Venereol. 2016;30(6):926-35.

7. Leyden JJ et al. J Eur Acad Dermatol Venereol. 2011;25(10):1140-5.

Starting this month, I will be joining Dr. Leslie S. Baumann as a cocontributor to the Cosmeceutical Critique column, and since this is my first column, I would like to formally introduce myself. I am a cosmetic and general dermatologist in private practice in Miami and a longtime skin care enthusiast. My path toward becoming a dermatologist began when I was working in New York City, my hometown, as a scientific researcher, fulfilling my passion for scientific inquiry. After realizing that I most enjoyed applying discoveries made in the lab directly to patient care, I decided to pursue medical school at New York University before completing a dermatology residency at the University of Miami, serving as Chief Resident during my final year. Although I was born and raised in New York, staying in Miami was an obvious decision for me. In addition to the tropical weather and amazing lifestyle, the medical community in Miami supports adventure, creativity, and innovation, which are key aspects that drew me to the University of Miami and continue to drive my personal evolution in private practice.

I now practice at Baumann Cosmetic & Research Institute alongside my mentor, Dr. Baumann. I truly have my dream job – I get to talk skin care and do a wide array of cosmetics procedures, perform skin surgeries, and solve complex medical dermatology cases all in a day’s work. My career sits at the intersection of my passions for science, critical thinking, beauty, aesthetics, and most importantly, engaging with patients.

For my first column, I want to provide a newly minted dermatologist’s perspective on cosmeceuticals. I will focus this discussion on the limited training in cosmeceuticals during residency and the importance of learning about cosmeceuticals, and I will provide a simple framework to approach the design of skin care regimens and utilization of cosmeceuticals in practice.

The focus of a dermatology residency is on medical and surgical skills. We become experts in diagnosing and treating conditions ranging from life-threatening drug reactions like Stevens-Johnson Syndrome to complex diseases like dermatomyositis, utilizing medications and treatments ranging from cyclosporine and methotrexate to biologics and intravenous immunoglobulin, and performing advanced skin surgeries utilizing flaps and grafts to repair defects.

The discipline of cosmetic dermatology, let alone cosmeceuticals, accounts for a fraction of our didactic and hands-on training. I completed a top dermatology residency program that prepared me to treat any dermatologic condition; however, I honestly felt like I didn’t have a strong understanding of cosmeceuticals and skin care and how to integrate them with prescription therapies when I completed residency, which is a sentiment shared by residents across the country. I remember a study break while preparing for my final board exam when I went into a tailspin for an entire day trying to decode an ingredient list of a new “antiaging serum” and researching its mechanisms of action and the clinical data supporting the active ingredients in the serum, which included bakuchiol and a blend of peptides. As a dermatologist who likes to treat and provide recommendations based on scientific rationale and data to deliver the highest level of care, I admit that I felt insecure not being as knowledgeable about cosmeceuticals as I was about more complex dermatology treatments. As both a cosmetic and general dermatologist, discussing skin care and cosmeceuticals independent of or in conjunction with medical management occurs daily, and I recognized that becoming an expert in this area is essential to becoming a top, well-rounded dermatologist.
 

A gap in cosmeceutical education in dermatology residency

Multiple studies have established that the field of cosmetic dermatology comprises a fraction of dermatology residency training. In 2013, Kirby et al. published a survey of dermatology instructors and chief residents across the country and found that only 67% of responders reported having received formal lectures on cosmetic dermatology.¹ In 2014, Bauer et al. published a survey of dermatology program directors assessing attitudes toward cosmetic dermatology and reported that only 38% of program directors believed that cosmetic dermatology should be a necessary aspect of residency training.² A survey sent to dermatology residents published in 2012 found that among respondents, more than 58% of residency programs have an “encouraging or somewhat encouraging” attitude toward teaching cosmetic dermatology, yet 22% of programs had a “somewhat discouraging” or “discouraging” attitude.³ While these noted studies have focused on procedural aspects of cosmetic dermatology training, Feetham et al. surveyed dermatology residents and faculty to assess attitudes toward and training on skin care and cosmeceuticals specifically. Among resident respondents, most (74.5%) reported their education on skin care and cosmeceuticals has been “too little or nonexistent” during residency and 76.5% “agree or strongly agree” that it should be part of their education.4 In contrast, 60% of faculty reported resident education on skin care and cosmeceuticals is “just the right amount or too much” (P < .001).

In my personal experience as a resident, discussing skin care was emphasized when treating patients with eczema, contact dermatitis, acne, and hair disorders, but otherwise, the majority of skin care discussions relied on having a stock list of recommended cleansers, moisturizers, and sunscreens. In regards to cosmeceuticals for facial skin specifically, there were only a handful of instances in which alternative ingredients, such as vitamin C for hyperpigmentation, were discussed and specific brands were mentioned. Upon reflection, I wish I had more opportunity to see the clinical benefits of cosmeceuticals first hand, just like when I observe dupilumab clear patients with severe atopic dermatitis, rather than reading about it in textbooks and journals.

While one hypothesis for programs’ limited attention given to cosmetic training may be that it detracts from medical training, the survey by Bauer et al. found that residents did not feel less prepared (94.9%) or less interested (97.4%) in medical dermatology as a result of their cosmetic training.² In addition, providers in an academic dermatology residency may limit discussions of skin care because of the high patient volume and because extensive skin care discussions will not impact insurance billings. Academic dermatology programs often service patients with more financial constraints, which further limits OTC cosmeceutical discussions. In my residency experience, I had the opportunity to regularly treat more severe and rare dermatologic cases than those I encounter in private practice; therefore, I spent more time focusing on systemic therapies, with fewer opportunities to dedicate time to cosmeceuticals.
 

Why skin care and cosmeceuticals should be an essential aspect of residency training

Discussing skin care and cosmeceuticals is a valuable aspect of medical and general dermatology, not just aesthetic dermatology. When treating general dermatologic conditions, guidance on proper skin care can improve both adherence and efficacy of medical treatments. For example, an acne study by de Lucas et al. demonstrated that adherence to adjuvant treatment of acne (such as the use of moisturizers) was associated not only with a 2.4-fold increase in the probability of adherence to pharmacological treatment, but also with a significant reduction in acne severity.⁵ Aside from skin care, cosmeceuticals themselves have efficacy in treating general dermatologic conditions. In the treatment of acne, topical niacinamide, a popular cosmeceutical ingredient, has been shown to have sebosuppressive and anti-inflammatory effects, addressing key aspects of acne pathogenesis.⁶ A double-blind study by Draelos et al. reported topical 2% niacinamide was effective in reducing the rate of sebum excretion in 50 Japanese patients over 4 weeks.⁶ In several double-blind studies that have compared twice daily application of 4% nicotinamide gel with the same application of 1% clindamycin gel in moderate inflammatory acne over 8 weeks, nicotinamide gel reduced the number of inflammatory papules and acne lesions to a level comparable with clindamycin gel.6 These studies support the use of niacinamide cosmeceutical products as an adjunctive treatment for acne.

With increased clinical data supporting cosmeceuticals, it can be expected that some cosmeceuticals will substitute traditional prescription medications in the dermatologists’ arsenal. For example, hydroquinone – both prescription strength and OTC 2% – is a workhorse in treating melasma; however, there is increasing interest in hydroquinone-free treatments, especially since OTC cosmeceuticals containing 2% hydroquinone were banned in 2020 because of safety concerns. Dermatologists will therefore need to provide guidance about hydroquinone alternatives for skin lightening, including soy, licorice extracts, kojic acid, arbutin, niacinamide, N-acetylglucosamine, and vitamin C, among others.⁷ Utilizing knowledge of a cosmeceutical’s mechanisms of action and clinical data, the dermatologist is in the best position to guide patients toward optimal ingredients and dispel cosmeceutical myths. Given that cosmeceuticals are not regulated by the Food and Drug Administration, it is even more important that the dermatologist serves as an authority on cosmeceuticals.
 

How to become a master skin care and cosmeceutical prescriber

A common pitfall I have observed among practitioners less experienced with aesthetic-focused skin care and cosmeceuticals is adapting a one-size-fits-all approach. In the one-size-fits-all approach, every patient concerned about aging gets the same vitamin C serum and retinoid, and every patient with hyperpigmentation gets the same hydroquinone prescription, for example. This approach, however, does not take into account unique differences in patients’ skin. Below

is the basic skin care framework that I follow, taught to me by Dr. Baumann. It utilizes an individualized approach based on the patient’s skin qualities to achieve optimal results.

Determine the patient’s skin type (dry vs. oily; sensitive vs. not sensitive; pigmentation issues vs. no hyperpigmentation; wrinkled and mature vs. nonwrinkled) and identify concerns (e.g., dark spots, redness, acne, dehydration).

Separate products into categories of cleansers, eye creams, moisturizers, sun protection, and treatments. Treatments refers to any additional products in a skin care regimen intended to ameliorate a particular condition (e.g., vitamin C for hyperpigmentation, retinoids for fine lines).

Choose products for each category in step 2 (cleansers, eye creams, moisturizers, sun protection, treatments) that are complementary to the patient’s skin type (determined in step 1) and aid the patient in meeting their particular skin goals. For example, a salicylic acid cleanser would be beneficial for a patient with oily skin and acne, but this same cleanser may be too drying and irritating for an acne patient with dry skin.

Ensure that chosen ingredients and products work together harmoniously. For example, while the acne patient may benefit from a salicylic acid cleanser and retinoid cream, using them in succession initially may be overly drying for some patients.

Spend the time to make sure patients understand the appropriate order of application and recognize when efficacy of a product is impacted by another product in the regimen. For example, a low pH cleanser can increase penetration of an ascorbic acid product that follows it in the regimen.

After establishing a basic skin care framework, the next step for beginners is learning about ingredients and their mechanisms of action and familiarizing themselves with scientific and clinical studies. Until cosmeceuticals become an integral part of the training curriculum, dermatologists can gain knowledge independently by reading literature and studies on cosmeceutical active ingredients and experimenting with consumer products. I look forward to regularly contributing to this column to further our awareness and understanding of the mechanisms of and data supporting cosmeceuticals so that we can better guide our patients.

Please feel free to email me at chloe@derm.net or message me on Instagram @DrChloeGoldman with ideas that you would like me to address in this column.
 

Dr. Goldman is a dermatologist in private practice in Miami, and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a new general dermatology practice. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other relevant disclosures.

References

1. Kirby JS et al. J Am Acad Dermatol. 2013;68(2):e23-8.

2. Bauer et al. JAMA Dermatol. 2014;150(2):125-9.

3. Group A et al. Dermatol Surg. 2012;38(12):1975-80.

4. Feetham HJ et al. J Cosmet Dermatol. 2018;17(2):220-6.

5. de Lucas R et al. BMC Dermatol. 2015;15:17.

6. Araviiskaia E and Dreno BJ. Eur Acad Dermatol Venereol. 2016;30(6):926-35.

7. Leyden JJ et al. J Eur Acad Dermatol Venereol. 2011;25(10):1140-5.

Oral tofacitinib (Xeljanz), a Janus kinase inhibitor, helped regrow hair in three-quarters of pediatric patients with alopecia areata (AA) in a small study conducted at the University of Colorado and published in Pediatric Dermatology.

The 11 pediatric patients, ages 8-18 years, all with a diagnosis of AA, were treated with tofacitinib. Eight patients, or nearly 73%, experienced hair regrowth, while the other three (27.3%) did not, as the investigators reported in the retrospective chart review.

“A success rate of 73% is very good,” said lead author Cory A. Dunnick, MD, professor of dermatology and director of clinical trials at the University of Colorado at Denver, Aurora. No serious adverse events occurred, and adverse events of any kind were limited, the researchers found.

“It is important to get information into the literature about potential treatments for severe alopecia areata because there is no [Food and Drug Administration]–approved therapy at the present time,” Dr. Dunnick told this news organization. Patients’ insurance plans often deny non–FDA-approved therapies unless there are data to support their use.

The researchers found no correlation between the dose, duration of treatment, or the presence of comorbidities and clinical response.

Oral tofacitinib has been shown to be effective and well tolerated for AA in adults, the researchers said. They referred to recent studies that have used JAK inhibitors, including tofacitinib, “in an effort to inhibit T-cell activation and halt disease progression in adult and pediatric patients” with AA.
 

Study details

Of the 11 patients evaluated, 6 had alopecia universalis, 1 had alopecia totalis, and 4 had patchy AA. Concomitant medical conditions known to be associated with AA affected four patients. These included atopic dermatitis, autoimmune hypothyroidism, and asthma. One patient reported having two brothers with AA.

The median disease duration was 6 years. “In my experience, JAK inhibitors are less effective for patients with longstanding – more than 10 years – alopecia totalis or alopecia universalis,” Dr. Dunnick said.

Previously, patients had been given methotrexate, oral prednisone, intralesional triamcinolone, topical corticosteroids, and topical diphenylcyclopropenone. During treatment with tofacitinib, 5 of the 11 patients also received topical steroid treatment.

The study was a retrospective chart review, so dosing was not standardized, the researchers said. Most took 5-10 mg twice daily. Median treatment time was 32 months, with a range of 5-39 months.

Patients with a complete or near complete clinical response were categorized as responders; subjectively, these were the patients who had persistent hair regrowth over more than 50% of affected areas. Five patients had complete regrowth of hair on the scalp, eyebrows, and body during treatment. Others had incomplete responses. For instance, one patient had improved growth of eyelashes and eyebrows but not on the scalp. Once the medication was increased to 15 mg daily, the patient had complete regrowth of body hair, eyelashes, and eyebrows but slow regrowth on the scalp after 1 year of treatment.

“Patients are very happy with regrowth of their hair,” Dr. Dunnick said, noting that severe AA affects self-esteem and quality of life.
 

Other research

In a retrospective study that looked at the effects of oral tofacitinib given to 14 preadolescent patients with AA, 9 experienced “clinically significant improvement” in their Severity of Alopecia Tool score. Three had complete remission, and seven (63.6%) had more than a 50% improvement in the score.

Mechanisms, concerns

The researchers of the current study explained that interferon signaling activity through the JAK pathways is a key mediator of the inflammation and cytotoxic T-cell response in AA. That modulation of the signaling may decrease disease progression, as the results of the current chart review suggest.

A main concern, the researchers wrote, is the potential for significant adverse events. Although this chart review did not find any, the researchers did see some transient lab abnormalities. One study found lab abnormalities in such measures as triglycerides and cholesterol.

Asked to comment on the study results, Brett King, MD, PHD, associate professor of dermatology at Yale University, New Haven, Conn., said that the study “is an important addition to a series of articles dating back to 2017 showing efficacy of tofacitinib in the pediatric age group.” The results are similar to those of previous studies, “showing that severe AA can be treated effectively with tofacitinib. Cumulatively, there is significant data to support treatment of this age group with JAK inhibitors,” he said.

At the 2021 European Academy of Dermatology and Venereology meeting, Dr. King presented the results of two phase 3 studies, which found that treatment with the oral JAK inhibitor baricitinib resulted in substantial hair growth in adults with AA. He and colleagues have also reported positive results of tofacitinib in treating AA in four children ages 8-10, with alopecia totalis and alopecia universalis, and in adolescents with AA.

Currently, three large, randomized, phase 3 clinical trials of other JAK inhibitors for AA are underway – ritlecitinib, baricitinib, and ruxolitinib – and the ritlecitinib trial includes adolescents (ages 12 years and older). “It is the results of these trials that we eagerly await, because FDA approval will bring greater access to these treatments,” Dr. King said.

Dr. Dunnick has disclosed no relevant financial relationships. Dr. King has served on advisory boards and/or is a consultant and/or a clinical trial investigator for AbbVie, Bristol-Myers Squibb, Concert Pharmaceuticals, Eli Lilly, Incyte, Pfizer, and others. He is on speaker bureaus for AbbVie, Incyte, Pfizer, and others.

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

Oral tofacitinib (Xeljanz), a Janus kinase inhibitor, helped regrow hair in three-quarters of pediatric patients with alopecia areata (AA) in a small study conducted at the University of Colorado and published in Pediatric Dermatology.

The 11 pediatric patients, ages 8-18 years, all with a diagnosis of AA, were treated with tofacitinib. Eight patients, or nearly 73%, experienced hair regrowth, while the other three (27.3%) did not, as the investigators reported in the retrospective chart review.

“A success rate of 73% is very good,” said lead author Cory A. Dunnick, MD, professor of dermatology and director of clinical trials at the University of Colorado at Denver, Aurora. No serious adverse events occurred, and adverse events of any kind were limited, the researchers found.

“It is important to get information into the literature about potential treatments for severe alopecia areata because there is no [Food and Drug Administration]–approved therapy at the present time,” Dr. Dunnick told this news organization. Patients’ insurance plans often deny non–FDA-approved therapies unless there are data to support their use.

The researchers found no correlation between the dose, duration of treatment, or the presence of comorbidities and clinical response.

Oral tofacitinib has been shown to be effective and well tolerated for AA in adults, the researchers said. They referred to recent studies that have used JAK inhibitors, including tofacitinib, “in an effort to inhibit T-cell activation and halt disease progression in adult and pediatric patients” with AA.
 

Study details

Of the 11 patients evaluated, 6 had alopecia universalis, 1 had alopecia totalis, and 4 had patchy AA. Concomitant medical conditions known to be associated with AA affected four patients. These included atopic dermatitis, autoimmune hypothyroidism, and asthma. One patient reported having two brothers with AA.

The median disease duration was 6 years. “In my experience, JAK inhibitors are less effective for patients with longstanding – more than 10 years – alopecia totalis or alopecia universalis,” Dr. Dunnick said.

Previously, patients had been given methotrexate, oral prednisone, intralesional triamcinolone, topical corticosteroids, and topical diphenylcyclopropenone. During treatment with tofacitinib, 5 of the 11 patients also received topical steroid treatment.

The study was a retrospective chart review, so dosing was not standardized, the researchers said. Most took 5-10 mg twice daily. Median treatment time was 32 months, with a range of 5-39 months.

Patients with a complete or near complete clinical response were categorized as responders; subjectively, these were the patients who had persistent hair regrowth over more than 50% of affected areas. Five patients had complete regrowth of hair on the scalp, eyebrows, and body during treatment. Others had incomplete responses. For instance, one patient had improved growth of eyelashes and eyebrows but not on the scalp. Once the medication was increased to 15 mg daily, the patient had complete regrowth of body hair, eyelashes, and eyebrows but slow regrowth on the scalp after 1 year of treatment.

“Patients are very happy with regrowth of their hair,” Dr. Dunnick said, noting that severe AA affects self-esteem and quality of life.
 

Other research

In a retrospective study that looked at the effects of oral tofacitinib given to 14 preadolescent patients with AA, 9 experienced “clinically significant improvement” in their Severity of Alopecia Tool score. Three had complete remission, and seven (63.6%) had more than a 50% improvement in the score.

Mechanisms, concerns

The researchers of the current study explained that interferon signaling activity through the JAK pathways is a key mediator of the inflammation and cytotoxic T-cell response in AA. That modulation of the signaling may decrease disease progression, as the results of the current chart review suggest.

A main concern, the researchers wrote, is the potential for significant adverse events. Although this chart review did not find any, the researchers did see some transient lab abnormalities. One study found lab abnormalities in such measures as triglycerides and cholesterol.

Asked to comment on the study results, Brett King, MD, PHD, associate professor of dermatology at Yale University, New Haven, Conn., said that the study “is an important addition to a series of articles dating back to 2017 showing efficacy of tofacitinib in the pediatric age group.” The results are similar to those of previous studies, “showing that severe AA can be treated effectively with tofacitinib. Cumulatively, there is significant data to support treatment of this age group with JAK inhibitors,” he said.

At the 2021 European Academy of Dermatology and Venereology meeting, Dr. King presented the results of two phase 3 studies, which found that treatment with the oral JAK inhibitor baricitinib resulted in substantial hair growth in adults with AA. He and colleagues have also reported positive results of tofacitinib in treating AA in four children ages 8-10, with alopecia totalis and alopecia universalis, and in adolescents with AA.

Currently, three large, randomized, phase 3 clinical trials of other JAK inhibitors for AA are underway – ritlecitinib, baricitinib, and ruxolitinib – and the ritlecitinib trial includes adolescents (ages 12 years and older). “It is the results of these trials that we eagerly await, because FDA approval will bring greater access to these treatments,” Dr. King said.

Dr. Dunnick has disclosed no relevant financial relationships. Dr. King has served on advisory boards and/or is a consultant and/or a clinical trial investigator for AbbVie, Bristol-Myers Squibb, Concert Pharmaceuticals, Eli Lilly, Incyte, Pfizer, and others. He is on speaker bureaus for AbbVie, Incyte, Pfizer, and others.

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

Oral tofacitinib (Xeljanz), a Janus kinase inhibitor, helped regrow hair in three-quarters of pediatric patients with alopecia areata (AA) in a small study conducted at the University of Colorado and published in Pediatric Dermatology.

The 11 pediatric patients, ages 8-18 years, all with a diagnosis of AA, were treated with tofacitinib. Eight patients, or nearly 73%, experienced hair regrowth, while the other three (27.3%) did not, as the investigators reported in the retrospective chart review.

“A success rate of 73% is very good,” said lead author Cory A. Dunnick, MD, professor of dermatology and director of clinical trials at the University of Colorado at Denver, Aurora. No serious adverse events occurred, and adverse events of any kind were limited, the researchers found.

“It is important to get information into the literature about potential treatments for severe alopecia areata because there is no [Food and Drug Administration]–approved therapy at the present time,” Dr. Dunnick told this news organization. Patients’ insurance plans often deny non–FDA-approved therapies unless there are data to support their use.

The researchers found no correlation between the dose, duration of treatment, or the presence of comorbidities and clinical response.

Oral tofacitinib has been shown to be effective and well tolerated for AA in adults, the researchers said. They referred to recent studies that have used JAK inhibitors, including tofacitinib, “in an effort to inhibit T-cell activation and halt disease progression in adult and pediatric patients” with AA.
 

Study details

Of the 11 patients evaluated, 6 had alopecia universalis, 1 had alopecia totalis, and 4 had patchy AA. Concomitant medical conditions known to be associated with AA affected four patients. These included atopic dermatitis, autoimmune hypothyroidism, and asthma. One patient reported having two brothers with AA.

The median disease duration was 6 years. “In my experience, JAK inhibitors are less effective for patients with longstanding – more than 10 years – alopecia totalis or alopecia universalis,” Dr. Dunnick said.

Previously, patients had been given methotrexate, oral prednisone, intralesional triamcinolone, topical corticosteroids, and topical diphenylcyclopropenone. During treatment with tofacitinib, 5 of the 11 patients also received topical steroid treatment.

The study was a retrospective chart review, so dosing was not standardized, the researchers said. Most took 5-10 mg twice daily. Median treatment time was 32 months, with a range of 5-39 months.

Patients with a complete or near complete clinical response were categorized as responders; subjectively, these were the patients who had persistent hair regrowth over more than 50% of affected areas. Five patients had complete regrowth of hair on the scalp, eyebrows, and body during treatment. Others had incomplete responses. For instance, one patient had improved growth of eyelashes and eyebrows but not on the scalp. Once the medication was increased to 15 mg daily, the patient had complete regrowth of body hair, eyelashes, and eyebrows but slow regrowth on the scalp after 1 year of treatment.

“Patients are very happy with regrowth of their hair,” Dr. Dunnick said, noting that severe AA affects self-esteem and quality of life.
 

Other research

In a retrospective study that looked at the effects of oral tofacitinib given to 14 preadolescent patients with AA, 9 experienced “clinically significant improvement” in their Severity of Alopecia Tool score. Three had complete remission, and seven (63.6%) had more than a 50% improvement in the score.

Mechanisms, concerns

The researchers of the current study explained that interferon signaling activity through the JAK pathways is a key mediator of the inflammation and cytotoxic T-cell response in AA. That modulation of the signaling may decrease disease progression, as the results of the current chart review suggest.

A main concern, the researchers wrote, is the potential for significant adverse events. Although this chart review did not find any, the researchers did see some transient lab abnormalities. One study found lab abnormalities in such measures as triglycerides and cholesterol.

Asked to comment on the study results, Brett King, MD, PHD, associate professor of dermatology at Yale University, New Haven, Conn., said that the study “is an important addition to a series of articles dating back to 2017 showing efficacy of tofacitinib in the pediatric age group.” The results are similar to those of previous studies, “showing that severe AA can be treated effectively with tofacitinib. Cumulatively, there is significant data to support treatment of this age group with JAK inhibitors,” he said.

At the 2021 European Academy of Dermatology and Venereology meeting, Dr. King presented the results of two phase 3 studies, which found that treatment with the oral JAK inhibitor baricitinib resulted in substantial hair growth in adults with AA. He and colleagues have also reported positive results of tofacitinib in treating AA in four children ages 8-10, with alopecia totalis and alopecia universalis, and in adolescents with AA.

Currently, three large, randomized, phase 3 clinical trials of other JAK inhibitors for AA are underway – ritlecitinib, baricitinib, and ruxolitinib – and the ritlecitinib trial includes adolescents (ages 12 years and older). “It is the results of these trials that we eagerly await, because FDA approval will bring greater access to these treatments,” Dr. King said.

Dr. Dunnick has disclosed no relevant financial relationships. Dr. King has served on advisory boards and/or is a consultant and/or a clinical trial investigator for AbbVie, Bristol-Myers Squibb, Concert Pharmaceuticals, Eli Lilly, Incyte, Pfizer, and others. He is on speaker bureaus for AbbVie, Incyte, Pfizer, and others.

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

One year into treatment with an every-6-month dose of the investigational drug lenacapavir (LEN, Gilead Sciences) in a dual-treatment combination, 88% of treatment-naive people living with HIV had undetectable viral loads.

The findings, presented at the Conference on Retroviruses and Opportunistic Infections, also showed the drug was well tolerated, with 2 of 182 people developing drug-resistant mutations to lenacapavir and one person developing a nodule at the injection site.

Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust, who was not involved in the trial, called the findings “hugely exciting,” especially given its unique mode of administration. Right now it’s formulated as a subcutaneous injection, not an intramuscular injection like cabotegravir and rilpivirine (Cabenuva, ViiV Healthcare).

“Clearly it’s incredibly exciting to have the option for a subcutaneous drug that could be given at home every 6 months,” Dr. Waters said in an interview. With phase 3 trials and long-term follow-up still to come, she said she’s looking forward to how the treatment evolves.

CALIBRATE is a phase 2, four-arm, open-label, active-control study. Of the 182 participants, 25 were randomized to the active control arm, in which participants took daily oral bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy, Gilead Sciences) as standard of care. The rest of the 182 participants were divided evenly between three arms. In one of those, treatment group three, participants took a daily oral version of 50-mg LEN with emtricitabine and tenofovir alafenamide (F/TAF, Descovy, Gilead Sciences).

The other two arms, treatment groups one and two, were the arms in which Samir K. Gupta, MD, of Indiana University, Indianapolis, and colleagues tried the twice-yearly subcutaneous shots of LEN (LEN SC). Participants in those arms underwent a 2-week lead-in period in which they took 600 mg of LEN orally on days 1 and 2 and then a 300-mg pill on day 8 before starting the shots on day 15. As currently formulated, LEN SC shots can be given into the stomach and are designed to be simple enough to administer at home.

“It’s like doing an insulin shot,” Dr. Gupta said in an interview.

In addition to LEN SC, participants in treatment group one took a daily Descovy lead-in and then engaged in dual therapy of LEN plus TAF. In group two, they took a daily Descovy lead-in and then switched to LEN SC plus bictegravir (BIC) daily at 28 weeks.

Study results presented at the meeting were the results at 54 weeks. Researchers had previously presented 28-week results for CALIBRATE at the International AIDS Society Conference on HIV Science 2021.

Of the participants, 7% were cisgender women, 52% were Black, and 45% were Latinx. A total of 15% of participants had baseline viral loads of more than 100,000 copies, and median CD4 counts were 437. None of the participants in either the active-control arm or the LEN SC plus Descovy group had a history of AIDS, defined as fewer than 200 cells/mcL. In the LEN SC plus Biktarvy group, two did, and there were six people with a history of AIDS in the oral LEN plus Descovy group.

At 54 weeks, 88% of participants in groups one and two – the LEN SC arms – had undetectable viral loads (viral loads below 50 copies/mL). Specifically, 90% of those in the LEN SC plus TAF arm had viral loads below 50 copies. Those taking LEN SC plus BIC had an 85% viral suppression rate. The best performing of all was the control arm, in which 92% had undetectable viral loads. The protocol didn’t allow for analysis of statistical significance between the arms, so it’s unclear if any of the treatments really surpassed the others, Dr. Gupta said.

When they looked only at people whose viral loads became undetectable early, by week 28, the results were slightly better, with 93% of people between the two subcutaneous arms having undetectable viral loads at week 54. Again, the results were slightly higher in the LEN SC plus TAF arm (94%) than the LEN SC plus BIC (92%). People taking daily oral LEN plus Descovy had the lowest rate of viral suppression, but it was still at 90% if they were virally suppressed early. Again, it’s unclear whether those differences were statistically significant.
 

Well tolerated, with a chance of a nodule

Regarding safety, LEN was well tolerated across treatment arms, though the oral LEN group had as many people develop resistance mutations as the other three groups combined. Still, that was only three people, with one each in the two subcutaneous arms and one in the control arm.

Two people developed resistance to LEN – one in the LEN SC plus BIC arm and one in the oral LEN plus Descovy arm. In the LEN SC plus BIC arm, the mutations Q67H and K70R emerged at week 10, following a mutation that’s common when people don’t take integrase inhibitors as they’re supposed to (M184M/I). This led Dr. Gupta to conclude that lack of adherence to the oral part of the regimen may have contributed to the development of resistance, rather than an issue with LEN SC itself.

In the oral LEN plus Descovy arm, mutation Q67H didn’t emerge until week 54, when pill counts and drug levels revealed that that participant hadn’t been taking his Descovy as prescribed. In both cases, viral loads in those participants returned to undetectable after switching to an integrase inhibitor–based three-drug regimen.

Most safety concerns were mild and included nausea, diarrhea, and vomiting. But that was for non–injection-site reactions. There were more side effects of that sort, with most of them being pain, hardening of the site, and swelling. But 11% of participants developed more serious side effects, including nodules. Only one nodule was considered a grade 3 reaction; that person didn’t leave the trial because of it.

“These phase 2 data from the ongoing CALIBRATE trial support the further evaluation of lenacapavir for treatment and prevention of HIV-1,” he said.
 

Finding the right partner

In short, the findings are promising, Dr. Gupta told this news organization . But the question now, as Gilead prepares to begin a phase 3 efficacy trial, is what would be a good combination with LEN SC?

“Lenacapavir in a two-drug regimen should work,” he said. “The question now, though, is you have to find a suitable, potent, second agent to pair it with.”

Indeed, the long-acting HIV treatment pipeline sustained a blow in December 2021 when the U.S. Food and Drug Administration halted all trials for Merck’s investigational, long-acting drug islatravir. This led Dr. Waters to tweet: “Is it just me or are the islatravir abstracts at #CROI2022 quite sad to read?” She ended the tweet with, “I just hope it recovers!”

Indeed, Merck and Gilead have entered into an agreement to codevelop lenacapavir and islatravir as a weekly oral tablet. Islatravir seemed like the obvious choice as a partner to lenacapavir if phase 3 trials are successful, said Dr. Gupta. But now, it’s anyone’s guess as to what will happen. And while it’s too soon to say that lenacapavir is a success, it does leave the field wondering about how to use LEN SC without another, equally long-acting agent.

“When I talk about LEN, I show a picture of a man standing solo at a party, leaning against the wall looking a bit lonely, with ‘lenacapavir’ written over his head,” she said in an interview. “Right now, lenacapavir is the only drug at the 6-monthly party. It’s going to need some other guests if that party is going to rock.”

The study was funded by Gilead Sciences. Dr. Gupta has received research funding from ViiV Healthcare and advisory board fees from Gilead Sciences and ViiV Healthcare. Dr. Waters has received speaker or advisory fees from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

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

One year into treatment with an every-6-month dose of the investigational drug lenacapavir (LEN, Gilead Sciences) in a dual-treatment combination, 88% of treatment-naive people living with HIV had undetectable viral loads.

The findings, presented at the Conference on Retroviruses and Opportunistic Infections, also showed the drug was well tolerated, with 2 of 182 people developing drug-resistant mutations to lenacapavir and one person developing a nodule at the injection site.

Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust, who was not involved in the trial, called the findings “hugely exciting,” especially given its unique mode of administration. Right now it’s formulated as a subcutaneous injection, not an intramuscular injection like cabotegravir and rilpivirine (Cabenuva, ViiV Healthcare).

“Clearly it’s incredibly exciting to have the option for a subcutaneous drug that could be given at home every 6 months,” Dr. Waters said in an interview. With phase 3 trials and long-term follow-up still to come, she said she’s looking forward to how the treatment evolves.

CALIBRATE is a phase 2, four-arm, open-label, active-control study. Of the 182 participants, 25 were randomized to the active control arm, in which participants took daily oral bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy, Gilead Sciences) as standard of care. The rest of the 182 participants were divided evenly between three arms. In one of those, treatment group three, participants took a daily oral version of 50-mg LEN with emtricitabine and tenofovir alafenamide (F/TAF, Descovy, Gilead Sciences).

The other two arms, treatment groups one and two, were the arms in which Samir K. Gupta, MD, of Indiana University, Indianapolis, and colleagues tried the twice-yearly subcutaneous shots of LEN (LEN SC). Participants in those arms underwent a 2-week lead-in period in which they took 600 mg of LEN orally on days 1 and 2 and then a 300-mg pill on day 8 before starting the shots on day 15. As currently formulated, LEN SC shots can be given into the stomach and are designed to be simple enough to administer at home.

“It’s like doing an insulin shot,” Dr. Gupta said in an interview.

In addition to LEN SC, participants in treatment group one took a daily Descovy lead-in and then engaged in dual therapy of LEN plus TAF. In group two, they took a daily Descovy lead-in and then switched to LEN SC plus bictegravir (BIC) daily at 28 weeks.

Study results presented at the meeting were the results at 54 weeks. Researchers had previously presented 28-week results for CALIBRATE at the International AIDS Society Conference on HIV Science 2021.

Of the participants, 7% were cisgender women, 52% were Black, and 45% were Latinx. A total of 15% of participants had baseline viral loads of more than 100,000 copies, and median CD4 counts were 437. None of the participants in either the active-control arm or the LEN SC plus Descovy group had a history of AIDS, defined as fewer than 200 cells/mcL. In the LEN SC plus Biktarvy group, two did, and there were six people with a history of AIDS in the oral LEN plus Descovy group.

At 54 weeks, 88% of participants in groups one and two – the LEN SC arms – had undetectable viral loads (viral loads below 50 copies/mL). Specifically, 90% of those in the LEN SC plus TAF arm had viral loads below 50 copies. Those taking LEN SC plus BIC had an 85% viral suppression rate. The best performing of all was the control arm, in which 92% had undetectable viral loads. The protocol didn’t allow for analysis of statistical significance between the arms, so it’s unclear if any of the treatments really surpassed the others, Dr. Gupta said.

When they looked only at people whose viral loads became undetectable early, by week 28, the results were slightly better, with 93% of people between the two subcutaneous arms having undetectable viral loads at week 54. Again, the results were slightly higher in the LEN SC plus TAF arm (94%) than the LEN SC plus BIC (92%). People taking daily oral LEN plus Descovy had the lowest rate of viral suppression, but it was still at 90% if they were virally suppressed early. Again, it’s unclear whether those differences were statistically significant.
 

Well tolerated, with a chance of a nodule

Regarding safety, LEN was well tolerated across treatment arms, though the oral LEN group had as many people develop resistance mutations as the other three groups combined. Still, that was only three people, with one each in the two subcutaneous arms and one in the control arm.

Two people developed resistance to LEN – one in the LEN SC plus BIC arm and one in the oral LEN plus Descovy arm. In the LEN SC plus BIC arm, the mutations Q67H and K70R emerged at week 10, following a mutation that’s common when people don’t take integrase inhibitors as they’re supposed to (M184M/I). This led Dr. Gupta to conclude that lack of adherence to the oral part of the regimen may have contributed to the development of resistance, rather than an issue with LEN SC itself.

In the oral LEN plus Descovy arm, mutation Q67H didn’t emerge until week 54, when pill counts and drug levels revealed that that participant hadn’t been taking his Descovy as prescribed. In both cases, viral loads in those participants returned to undetectable after switching to an integrase inhibitor–based three-drug regimen.

Most safety concerns were mild and included nausea, diarrhea, and vomiting. But that was for non–injection-site reactions. There were more side effects of that sort, with most of them being pain, hardening of the site, and swelling. But 11% of participants developed more serious side effects, including nodules. Only one nodule was considered a grade 3 reaction; that person didn’t leave the trial because of it.

“These phase 2 data from the ongoing CALIBRATE trial support the further evaluation of lenacapavir for treatment and prevention of HIV-1,” he said.
 

Finding the right partner

In short, the findings are promising, Dr. Gupta told this news organization . But the question now, as Gilead prepares to begin a phase 3 efficacy trial, is what would be a good combination with LEN SC?

“Lenacapavir in a two-drug regimen should work,” he said. “The question now, though, is you have to find a suitable, potent, second agent to pair it with.”

Indeed, the long-acting HIV treatment pipeline sustained a blow in December 2021 when the U.S. Food and Drug Administration halted all trials for Merck’s investigational, long-acting drug islatravir. This led Dr. Waters to tweet: “Is it just me or are the islatravir abstracts at #CROI2022 quite sad to read?” She ended the tweet with, “I just hope it recovers!”

Indeed, Merck and Gilead have entered into an agreement to codevelop lenacapavir and islatravir as a weekly oral tablet. Islatravir seemed like the obvious choice as a partner to lenacapavir if phase 3 trials are successful, said Dr. Gupta. But now, it’s anyone’s guess as to what will happen. And while it’s too soon to say that lenacapavir is a success, it does leave the field wondering about how to use LEN SC without another, equally long-acting agent.

“When I talk about LEN, I show a picture of a man standing solo at a party, leaning against the wall looking a bit lonely, with ‘lenacapavir’ written over his head,” she said in an interview. “Right now, lenacapavir is the only drug at the 6-monthly party. It’s going to need some other guests if that party is going to rock.”

The study was funded by Gilead Sciences. Dr. Gupta has received research funding from ViiV Healthcare and advisory board fees from Gilead Sciences and ViiV Healthcare. Dr. Waters has received speaker or advisory fees from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

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

One year into treatment with an every-6-month dose of the investigational drug lenacapavir (LEN, Gilead Sciences) in a dual-treatment combination, 88% of treatment-naive people living with HIV had undetectable viral loads.

The findings, presented at the Conference on Retroviruses and Opportunistic Infections, also showed the drug was well tolerated, with 2 of 182 people developing drug-resistant mutations to lenacapavir and one person developing a nodule at the injection site.

Laura Waters, MD, consulting physician in HIV and sexual health at Central and Northwest London NHS Trust, who was not involved in the trial, called the findings “hugely exciting,” especially given its unique mode of administration. Right now it’s formulated as a subcutaneous injection, not an intramuscular injection like cabotegravir and rilpivirine (Cabenuva, ViiV Healthcare).

“Clearly it’s incredibly exciting to have the option for a subcutaneous drug that could be given at home every 6 months,” Dr. Waters said in an interview. With phase 3 trials and long-term follow-up still to come, she said she’s looking forward to how the treatment evolves.

CALIBRATE is a phase 2, four-arm, open-label, active-control study. Of the 182 participants, 25 were randomized to the active control arm, in which participants took daily oral bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy, Gilead Sciences) as standard of care. The rest of the 182 participants were divided evenly between three arms. In one of those, treatment group three, participants took a daily oral version of 50-mg LEN with emtricitabine and tenofovir alafenamide (F/TAF, Descovy, Gilead Sciences).

The other two arms, treatment groups one and two, were the arms in which Samir K. Gupta, MD, of Indiana University, Indianapolis, and colleagues tried the twice-yearly subcutaneous shots of LEN (LEN SC). Participants in those arms underwent a 2-week lead-in period in which they took 600 mg of LEN orally on days 1 and 2 and then a 300-mg pill on day 8 before starting the shots on day 15. As currently formulated, LEN SC shots can be given into the stomach and are designed to be simple enough to administer at home.

“It’s like doing an insulin shot,” Dr. Gupta said in an interview.

In addition to LEN SC, participants in treatment group one took a daily Descovy lead-in and then engaged in dual therapy of LEN plus TAF. In group two, they took a daily Descovy lead-in and then switched to LEN SC plus bictegravir (BIC) daily at 28 weeks.

Study results presented at the meeting were the results at 54 weeks. Researchers had previously presented 28-week results for CALIBRATE at the International AIDS Society Conference on HIV Science 2021.

Of the participants, 7% were cisgender women, 52% were Black, and 45% were Latinx. A total of 15% of participants had baseline viral loads of more than 100,000 copies, and median CD4 counts were 437. None of the participants in either the active-control arm or the LEN SC plus Descovy group had a history of AIDS, defined as fewer than 200 cells/mcL. In the LEN SC plus Biktarvy group, two did, and there were six people with a history of AIDS in the oral LEN plus Descovy group.

At 54 weeks, 88% of participants in groups one and two – the LEN SC arms – had undetectable viral loads (viral loads below 50 copies/mL). Specifically, 90% of those in the LEN SC plus TAF arm had viral loads below 50 copies. Those taking LEN SC plus BIC had an 85% viral suppression rate. The best performing of all was the control arm, in which 92% had undetectable viral loads. The protocol didn’t allow for analysis of statistical significance between the arms, so it’s unclear if any of the treatments really surpassed the others, Dr. Gupta said.

When they looked only at people whose viral loads became undetectable early, by week 28, the results were slightly better, with 93% of people between the two subcutaneous arms having undetectable viral loads at week 54. Again, the results were slightly higher in the LEN SC plus TAF arm (94%) than the LEN SC plus BIC (92%). People taking daily oral LEN plus Descovy had the lowest rate of viral suppression, but it was still at 90% if they were virally suppressed early. Again, it’s unclear whether those differences were statistically significant.
 

Well tolerated, with a chance of a nodule

Regarding safety, LEN was well tolerated across treatment arms, though the oral LEN group had as many people develop resistance mutations as the other three groups combined. Still, that was only three people, with one each in the two subcutaneous arms and one in the control arm.

Two people developed resistance to LEN – one in the LEN SC plus BIC arm and one in the oral LEN plus Descovy arm. In the LEN SC plus BIC arm, the mutations Q67H and K70R emerged at week 10, following a mutation that’s common when people don’t take integrase inhibitors as they’re supposed to (M184M/I). This led Dr. Gupta to conclude that lack of adherence to the oral part of the regimen may have contributed to the development of resistance, rather than an issue with LEN SC itself.

In the oral LEN plus Descovy arm, mutation Q67H didn’t emerge until week 54, when pill counts and drug levels revealed that that participant hadn’t been taking his Descovy as prescribed. In both cases, viral loads in those participants returned to undetectable after switching to an integrase inhibitor–based three-drug regimen.

Most safety concerns were mild and included nausea, diarrhea, and vomiting. But that was for non–injection-site reactions. There were more side effects of that sort, with most of them being pain, hardening of the site, and swelling. But 11% of participants developed more serious side effects, including nodules. Only one nodule was considered a grade 3 reaction; that person didn’t leave the trial because of it.

“These phase 2 data from the ongoing CALIBRATE trial support the further evaluation of lenacapavir for treatment and prevention of HIV-1,” he said.
 

Finding the right partner

In short, the findings are promising, Dr. Gupta told this news organization . But the question now, as Gilead prepares to begin a phase 3 efficacy trial, is what would be a good combination with LEN SC?

“Lenacapavir in a two-drug regimen should work,” he said. “The question now, though, is you have to find a suitable, potent, second agent to pair it with.”

Indeed, the long-acting HIV treatment pipeline sustained a blow in December 2021 when the U.S. Food and Drug Administration halted all trials for Merck’s investigational, long-acting drug islatravir. This led Dr. Waters to tweet: “Is it just me or are the islatravir abstracts at #CROI2022 quite sad to read?” She ended the tweet with, “I just hope it recovers!”

Indeed, Merck and Gilead have entered into an agreement to codevelop lenacapavir and islatravir as a weekly oral tablet. Islatravir seemed like the obvious choice as a partner to lenacapavir if phase 3 trials are successful, said Dr. Gupta. But now, it’s anyone’s guess as to what will happen. And while it’s too soon to say that lenacapavir is a success, it does leave the field wondering about how to use LEN SC without another, equally long-acting agent.

“When I talk about LEN, I show a picture of a man standing solo at a party, leaning against the wall looking a bit lonely, with ‘lenacapavir’ written over his head,” she said in an interview. “Right now, lenacapavir is the only drug at the 6-monthly party. It’s going to need some other guests if that party is going to rock.”

The study was funded by Gilead Sciences. Dr. Gupta has received research funding from ViiV Healthcare and advisory board fees from Gilead Sciences and ViiV Healthcare. Dr. Waters has received speaker or advisory fees from Gilead Sciences, ViiV Healthcare, Merck, Janssen, Theratech, Sipla, and Mylan.

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

New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.

“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
 

The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.

Marc Bruxelle/Getty Images

The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.

The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.

Mario Olaya/Pixabay

In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.

The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.

“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.

Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.

Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.

“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.

Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.

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

New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.

“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
 

The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.

Marc Bruxelle/Getty Images

The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.

The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.

Mario Olaya/Pixabay

In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.

The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.

“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.

Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.

Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.

“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.

Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.

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

New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.

“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
 

The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.

Marc Bruxelle/Getty Images

The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.

The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.

Mario Olaya/Pixabay

In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.

The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.

“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.

Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.

Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.

“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.

Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.

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