Dermatology

TOPLINE:

The presence of an operational classification of drug interactions (ORCA) class 3 or 4 drug-drug interactions (DDIs) did not increase the risk for colchicine-related gastrointestinal adverse events or modify the effect of colchicine on death or hospitalization caused by COVID-19 infection in ambulatory patients.

METHODOLOGY:

• This secondary analysis of the COLCORONA trial aimed to evaluate if a potential DDI of colchicine was associated with changes in its pharmacokinetics or modified its clinical safety and efficacy in patients with COVID-19.
• Overall, 4432 ambulatory patients with COVID-19 (median age, 54 years; 54% women) were randomly assigned to receive colchicine 0.5 mg twice daily for 3 days and then 0.5 mg once daily for 27 days (n = 2205) or a placebo (n = 2227).
• All the participants had at least one high-risk criterion such as age ≥ 70 years, diabetes, heart failure, systolic blood pressure ≥ 150 mm Hg, respiratory disease, coronary disease, body temperature ≥ 38.4 °C within the last 48 hours, dyspnea, bicytopenia, pancytopenia, or high neutrophil count with low lymphocyte count.
• The medications that could interact with colchicine were determined and categorized under ORCA classes 1 (contraindicated), 2 (provisionally contraindicated), 3 (conditional use), or 4 (minimal risk).
• The primary outcome was any gastrointestinal adverse event assessed over a 30-day follow-up period.

TAKEAWAY:

• Among all the participants, 1% received medications with an ORCA class 2 interaction, 14% with a class 3 interaction, and 13% with a class 4 interaction; rosuvastatin (12%) and atorvastatin (10%) were the most common interacting medications.
• The odds of any gastrointestinal adverse event were 1.80 times and 1.68 times higher in the colchicine arm than in the placebo arm among those without and with a DDI, respectively, with the effect of colchicine being consistent regardless of the presence of drug interactions (P = .69 for interaction).
• Similarly, DDIs did not influence the effect of colchicine on combined risk for COVID-19 hospitalization or mortality (P = .80 for interaction).

IN PRACTICE:

“Once potential DDIs have been identified through screening, they must be tested,” Hemalkumar B. Mehta, PhD, and G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, wrote in an invited commentary published online in JAMA Network Open. “Theoretical DDIs may not translate into real-world harms,” they added.

SOURCE:

The study was led by Lama S. Alfehaid, PharmD, of Brigham and Women’s Hospital, Boston. It was published online in JAMA Network Open.

LIMITATIONS:

This study focused on the medications used by participants at baseline, which may not have captured all potential DDIs. The findings did not provide information on rare adverse events, such as rhabdomyolysis, which usually occur months after initiating drug therapy. Furthermore, all the study participants had confirmed SARS-CoV-2 infection, which may have increased their susceptibility to adverse reactions associated with the use of colchicine.

DISCLOSURES:

Some authors were supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute, American Heart Association, and other sources. The authors also declared serving on advisory boards or on the board of directors; receiving personal fees, grants, research support, or speaking fees; or having other ties with many pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The presence of an operational classification of drug interactions (ORCA) class 3 or 4 drug-drug interactions (DDIs) did not increase the risk for colchicine-related gastrointestinal adverse events or modify the effect of colchicine on death or hospitalization caused by COVID-19 infection in ambulatory patients.

METHODOLOGY:

• This secondary analysis of the COLCORONA trial aimed to evaluate if a potential DDI of colchicine was associated with changes in its pharmacokinetics or modified its clinical safety and efficacy in patients with COVID-19.
• Overall, 4432 ambulatory patients with COVID-19 (median age, 54 years; 54% women) were randomly assigned to receive colchicine 0.5 mg twice daily for 3 days and then 0.5 mg once daily for 27 days (n = 2205) or a placebo (n = 2227).
• All the participants had at least one high-risk criterion such as age ≥ 70 years, diabetes, heart failure, systolic blood pressure ≥ 150 mm Hg, respiratory disease, coronary disease, body temperature ≥ 38.4 °C within the last 48 hours, dyspnea, bicytopenia, pancytopenia, or high neutrophil count with low lymphocyte count.
• The medications that could interact with colchicine were determined and categorized under ORCA classes 1 (contraindicated), 2 (provisionally contraindicated), 3 (conditional use), or 4 (minimal risk).
• The primary outcome was any gastrointestinal adverse event assessed over a 30-day follow-up period.

TAKEAWAY:

• Among all the participants, 1% received medications with an ORCA class 2 interaction, 14% with a class 3 interaction, and 13% with a class 4 interaction; rosuvastatin (12%) and atorvastatin (10%) were the most common interacting medications.
• The odds of any gastrointestinal adverse event were 1.80 times and 1.68 times higher in the colchicine arm than in the placebo arm among those without and with a DDI, respectively, with the effect of colchicine being consistent regardless of the presence of drug interactions (P = .69 for interaction).
• Similarly, DDIs did not influence the effect of colchicine on combined risk for COVID-19 hospitalization or mortality (P = .80 for interaction).

IN PRACTICE:

“Once potential DDIs have been identified through screening, they must be tested,” Hemalkumar B. Mehta, PhD, and G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, wrote in an invited commentary published online in JAMA Network Open. “Theoretical DDIs may not translate into real-world harms,” they added.

SOURCE:

The study was led by Lama S. Alfehaid, PharmD, of Brigham and Women’s Hospital, Boston. It was published online in JAMA Network Open.

LIMITATIONS:

This study focused on the medications used by participants at baseline, which may not have captured all potential DDIs. The findings did not provide information on rare adverse events, such as rhabdomyolysis, which usually occur months after initiating drug therapy. Furthermore, all the study participants had confirmed SARS-CoV-2 infection, which may have increased their susceptibility to adverse reactions associated with the use of colchicine.

DISCLOSURES:

Some authors were supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute, American Heart Association, and other sources. The authors also declared serving on advisory boards or on the board of directors; receiving personal fees, grants, research support, or speaking fees; or having other ties with many pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The presence of an operational classification of drug interactions (ORCA) class 3 or 4 drug-drug interactions (DDIs) did not increase the risk for colchicine-related gastrointestinal adverse events or modify the effect of colchicine on death or hospitalization caused by COVID-19 infection in ambulatory patients.

METHODOLOGY:

• This secondary analysis of the COLCORONA trial aimed to evaluate if a potential DDI of colchicine was associated with changes in its pharmacokinetics or modified its clinical safety and efficacy in patients with COVID-19.
• Overall, 4432 ambulatory patients with COVID-19 (median age, 54 years; 54% women) were randomly assigned to receive colchicine 0.5 mg twice daily for 3 days and then 0.5 mg once daily for 27 days (n = 2205) or a placebo (n = 2227).
• All the participants had at least one high-risk criterion such as age ≥ 70 years, diabetes, heart failure, systolic blood pressure ≥ 150 mm Hg, respiratory disease, coronary disease, body temperature ≥ 38.4 °C within the last 48 hours, dyspnea, bicytopenia, pancytopenia, or high neutrophil count with low lymphocyte count.
• The medications that could interact with colchicine were determined and categorized under ORCA classes 1 (contraindicated), 2 (provisionally contraindicated), 3 (conditional use), or 4 (minimal risk).
• The primary outcome was any gastrointestinal adverse event assessed over a 30-day follow-up period.

TAKEAWAY:

• Among all the participants, 1% received medications with an ORCA class 2 interaction, 14% with a class 3 interaction, and 13% with a class 4 interaction; rosuvastatin (12%) and atorvastatin (10%) were the most common interacting medications.
• The odds of any gastrointestinal adverse event were 1.80 times and 1.68 times higher in the colchicine arm than in the placebo arm among those without and with a DDI, respectively, with the effect of colchicine being consistent regardless of the presence of drug interactions (P = .69 for interaction).
• Similarly, DDIs did not influence the effect of colchicine on combined risk for COVID-19 hospitalization or mortality (P = .80 for interaction).

IN PRACTICE:

“Once potential DDIs have been identified through screening, they must be tested,” Hemalkumar B. Mehta, PhD, and G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, wrote in an invited commentary published online in JAMA Network Open. “Theoretical DDIs may not translate into real-world harms,” they added.

SOURCE:

The study was led by Lama S. Alfehaid, PharmD, of Brigham and Women’s Hospital, Boston. It was published online in JAMA Network Open.

LIMITATIONS:

This study focused on the medications used by participants at baseline, which may not have captured all potential DDIs. The findings did not provide information on rare adverse events, such as rhabdomyolysis, which usually occur months after initiating drug therapy. Furthermore, all the study participants had confirmed SARS-CoV-2 infection, which may have increased their susceptibility to adverse reactions associated with the use of colchicine.

DISCLOSURES:

Some authors were supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute, American Heart Association, and other sources. The authors also declared serving on advisory boards or on the board of directors; receiving personal fees, grants, research support, or speaking fees; or having other ties with many pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

• Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
• Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
• In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

• Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
• Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
• The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
• Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

• Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
• Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
• This spike at higher temperatures is presumably due to air conditioning, the authors said.
• In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

• Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
• Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
• In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

• Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
• Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
• The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
• Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

• Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
• Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
• This spike at higher temperatures is presumably due to air conditioning, the authors said.
• In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

• Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
• Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
• In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

• Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
• Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
• The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
• Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

• Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
• Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
• This spike at higher temperatures is presumably due to air conditioning, the authors said.
• In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

CARLSBAD, CALIFORNIA — Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD, avoiding a presence on platforms like Facebook, X, Instagram, or YouTube means missing an opportunity to educate patients about dermatologic procedures and to dispel misinformation from nonmedical influencers.

“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”

courtesy Dr. Jessica G. Labadie

According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.

Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”

Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”

Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.

Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”

Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”

She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”

Dr. Labadie reported having no financial disclosures.

A version of this article appeared on Medscape.com.

CARLSBAD, CALIFORNIA — Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD, avoiding a presence on platforms like Facebook, X, Instagram, or YouTube means missing an opportunity to educate patients about dermatologic procedures and to dispel misinformation from nonmedical influencers.

“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”

courtesy Dr. Jessica G. Labadie

According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.

Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”

Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”

Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.

Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”

Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”

She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”

Dr. Labadie reported having no financial disclosures.

A version of this article appeared on Medscape.com.

CARLSBAD, CALIFORNIA — Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD, avoiding a presence on platforms like Facebook, X, Instagram, or YouTube means missing an opportunity to educate patients about dermatologic procedures and to dispel misinformation from nonmedical influencers.

“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”

courtesy Dr. Jessica G. Labadie

According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.

Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”

Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”

Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.

Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”

Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”

She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”

Dr. Labadie reported having no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Black children with vitiligo are significantly more likely to be diagnosed with psychiatric disorders, including depression, suicidal ideation, and disruptive behavior disorders, than matched controls who did not have vitiligo, according to a case-control study.

METHODOLOGY:

• Researchers conducted a retrospective, single-center, case-control study at Texas Children’s Hospital in Houston on 327 Black children with vitiligo and 981 matched controls without vitiligo.
• The average age of participants was 11.7 years, and 62% were girls.
• The study outcome was the prevalence of psychiatric conditions and rates of treatment (pharmacotherapy and/or psychotherapy) initiation for those conditions.

TAKEAWAY:

• Black children with vitiligo were more likely to be diagnosed with depression (odds ratio [OR], 3.63; P < .001), suicidal ideation (OR, 2.88; P = .005), disruptive behavior disorders (OR, 7.68; P < .001), eating disorders (OR, 15.22; P = .013), generalized anxiety disorder (OR, 2.61; P < .001), and substance abuse (OR, 2.67; P = .011).
• The likelihood of having a psychiatric comorbidity was not significantly different between children with segmental vitiligo and those with generalized vitiligo or between girls and boys.
• Among the patients with vitiligo and psychiatric comorbidities, treatment initiation rates were higher for depression (76.5%), disruptive behavior disorders (82.1%), and eating disorders (100%).
• Treatment initiation rates were lower in patients with vitiligo diagnosed with generalized anxiety disorder (55.3%) and substance abuse (61.5%). Treatment was not initiated in 14% patients with suicidal ideation.

IN PRACTICE:

“Pediatric dermatologists have an important role in screening for psychiatric comorbidities, and implementation of appropriate screening tools while treating vitiligo is likely to have a bidirectional positive impact,” the authors wrote, adding: “By better understanding psychiatric comorbidities of African American children with vitiligo, dermatologists can be more aware of pediatric mental health needs and provide appropriate referrals.”

SOURCE:

This study was led by Emily Strouphauer, BSA, Baylor College of Medicine, Houston, and was published online in JAAD International.

LIMITATIONS:

The study limitations were the retrospective design, small sample size, and heterogeneity in the control group.

DISCLOSURES:

The study did not receive any funding. The authors declared no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Black children with vitiligo are significantly more likely to be diagnosed with psychiatric disorders, including depression, suicidal ideation, and disruptive behavior disorders, than matched controls who did not have vitiligo, according to a case-control study.

METHODOLOGY:

• Researchers conducted a retrospective, single-center, case-control study at Texas Children’s Hospital in Houston on 327 Black children with vitiligo and 981 matched controls without vitiligo.
• The average age of participants was 11.7 years, and 62% were girls.
• The study outcome was the prevalence of psychiatric conditions and rates of treatment (pharmacotherapy and/or psychotherapy) initiation for those conditions.

TAKEAWAY:

• Black children with vitiligo were more likely to be diagnosed with depression (odds ratio [OR], 3.63; P < .001), suicidal ideation (OR, 2.88; P = .005), disruptive behavior disorders (OR, 7.68; P < .001), eating disorders (OR, 15.22; P = .013), generalized anxiety disorder (OR, 2.61; P < .001), and substance abuse (OR, 2.67; P = .011).
• The likelihood of having a psychiatric comorbidity was not significantly different between children with segmental vitiligo and those with generalized vitiligo or between girls and boys.
• Among the patients with vitiligo and psychiatric comorbidities, treatment initiation rates were higher for depression (76.5%), disruptive behavior disorders (82.1%), and eating disorders (100%).
• Treatment initiation rates were lower in patients with vitiligo diagnosed with generalized anxiety disorder (55.3%) and substance abuse (61.5%). Treatment was not initiated in 14% patients with suicidal ideation.

IN PRACTICE:

“Pediatric dermatologists have an important role in screening for psychiatric comorbidities, and implementation of appropriate screening tools while treating vitiligo is likely to have a bidirectional positive impact,” the authors wrote, adding: “By better understanding psychiatric comorbidities of African American children with vitiligo, dermatologists can be more aware of pediatric mental health needs and provide appropriate referrals.”

SOURCE:

This study was led by Emily Strouphauer, BSA, Baylor College of Medicine, Houston, and was published online in JAAD International.

LIMITATIONS:

The study limitations were the retrospective design, small sample size, and heterogeneity in the control group.

DISCLOSURES:

The study did not receive any funding. The authors declared no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Black children with vitiligo are significantly more likely to be diagnosed with psychiatric disorders, including depression, suicidal ideation, and disruptive behavior disorders, than matched controls who did not have vitiligo, according to a case-control study.

METHODOLOGY:

• Researchers conducted a retrospective, single-center, case-control study at Texas Children’s Hospital in Houston on 327 Black children with vitiligo and 981 matched controls without vitiligo.
• The average age of participants was 11.7 years, and 62% were girls.
• The study outcome was the prevalence of psychiatric conditions and rates of treatment (pharmacotherapy and/or psychotherapy) initiation for those conditions.

TAKEAWAY:

• Black children with vitiligo were more likely to be diagnosed with depression (odds ratio [OR], 3.63; P < .001), suicidal ideation (OR, 2.88; P = .005), disruptive behavior disorders (OR, 7.68; P < .001), eating disorders (OR, 15.22; P = .013), generalized anxiety disorder (OR, 2.61; P < .001), and substance abuse (OR, 2.67; P = .011).
• The likelihood of having a psychiatric comorbidity was not significantly different between children with segmental vitiligo and those with generalized vitiligo or between girls and boys.
• Among the patients with vitiligo and psychiatric comorbidities, treatment initiation rates were higher for depression (76.5%), disruptive behavior disorders (82.1%), and eating disorders (100%).
• Treatment initiation rates were lower in patients with vitiligo diagnosed with generalized anxiety disorder (55.3%) and substance abuse (61.5%). Treatment was not initiated in 14% patients with suicidal ideation.

IN PRACTICE:

“Pediatric dermatologists have an important role in screening for psychiatric comorbidities, and implementation of appropriate screening tools while treating vitiligo is likely to have a bidirectional positive impact,” the authors wrote, adding: “By better understanding psychiatric comorbidities of African American children with vitiligo, dermatologists can be more aware of pediatric mental health needs and provide appropriate referrals.”

SOURCE:

This study was led by Emily Strouphauer, BSA, Baylor College of Medicine, Houston, and was published online in JAAD International.

LIMITATIONS:

The study limitations were the retrospective design, small sample size, and heterogeneity in the control group.

DISCLOSURES:

The study did not receive any funding. The authors declared no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mobile images may be reliable for assessing cutaneous neurofibroma (cNF) features in patients with neurofibromatosis type 1 (NF1), according to a crowd-sourced registry study that also suggests correlations between cNF burden and quality of life (QoL), particularly the impact of facial severity on emotional well-being.

METHODOLOGY:

• To learn more about the association of cNFs with QoL, pain, and itch in patients with this rare disease, researchers enrolled 1016 individuals aged 40 years and older with NF1 who had at least one cNF, from May 2021 to December 2023, after reaching out to patient-led or NF1 advocacy organizations in 13 countries, including the United States.
• Participants provided demographic data, detailed photographs, and saliva samples for genetic sequencing, with 583 participants (mean age, 51.7 years; 65.9% women) submitting high-quality photographs from seven body regions at the time of the study analysis.
• A subset of 50 participants also underwent whole-body imaging.
• Four researchers independently rated the photographs for various cNF features, including general severity, number, size, facial severity, and subtypes.

TAKEAWAY:

• Based on evaluations by NF1 specialists, the agreement between mobile and whole-body images was “substantial” (74%-88% agreement) for the number of cNFs, general severity, and facial severity. Agreement between self-reported numbers of cNFs and investigator-rated numbers based on photographs was “minimal to fair.”
• Female sex, the number of cNFs, severity of cNFs on the face, and globular cNFs were associated with worse QoL (based on Skindex scores); severity of cNFs on the face had the strongest impact on overall QoL (P < .001).
• An increasing number of cNFs and worsening facial severity were strongly correlated with higher emotion subdomain scores.
• A higher number of cNFs, more severe cNFs on the face, and larger cNFs were all slightly associated with increased itch and pain (P < .01).

IN PRACTICE:

“To develop effective therapeutics, meaningful clinical outcomes that are tied with improvement in QoL for persons with NF1 must be clearly defined,” the authors wrote. The results of this study, they added, “suggested the benefit of this crowd-sourced resource by identifying the features of cNFs with the greatest association with QoL and symptoms of pain and itch in persons with NF1, highlighting new intervention strategies and features to target to most improve QoL in NF1.”

SOURCE:

The study was led by Michelle Jade Lin, BS, Stanford University School of Medicine, Redwood City, California, and was published online in JAMA Dermatology.

LIMITATIONS:

The study included only a small number of individuals from racial and ethnic minority groups and did not capture ethnicity information, which could have provided further insights into disease impact across different demographics.

DISCLOSURES:

This study was supported by Johns Hopkins University, Baltimore, and the Bloomberg Family Foundation. Ms. Lin reported support from the Stanford Medical Scholars Research Program. Three authors reported personal fees or grants outside this work. Other authors reported no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mobile images may be reliable for assessing cutaneous neurofibroma (cNF) features in patients with neurofibromatosis type 1 (NF1), according to a crowd-sourced registry study that also suggests correlations between cNF burden and quality of life (QoL), particularly the impact of facial severity on emotional well-being.

METHODOLOGY:

• To learn more about the association of cNFs with QoL, pain, and itch in patients with this rare disease, researchers enrolled 1016 individuals aged 40 years and older with NF1 who had at least one cNF, from May 2021 to December 2023, after reaching out to patient-led or NF1 advocacy organizations in 13 countries, including the United States.
• Participants provided demographic data, detailed photographs, and saliva samples for genetic sequencing, with 583 participants (mean age, 51.7 years; 65.9% women) submitting high-quality photographs from seven body regions at the time of the study analysis.
• A subset of 50 participants also underwent whole-body imaging.
• Four researchers independently rated the photographs for various cNF features, including general severity, number, size, facial severity, and subtypes.

TAKEAWAY:

• Based on evaluations by NF1 specialists, the agreement between mobile and whole-body images was “substantial” (74%-88% agreement) for the number of cNFs, general severity, and facial severity. Agreement between self-reported numbers of cNFs and investigator-rated numbers based on photographs was “minimal to fair.”
• Female sex, the number of cNFs, severity of cNFs on the face, and globular cNFs were associated with worse QoL (based on Skindex scores); severity of cNFs on the face had the strongest impact on overall QoL (P < .001).
• An increasing number of cNFs and worsening facial severity were strongly correlated with higher emotion subdomain scores.
• A higher number of cNFs, more severe cNFs on the face, and larger cNFs were all slightly associated with increased itch and pain (P < .01).

IN PRACTICE:

“To develop effective therapeutics, meaningful clinical outcomes that are tied with improvement in QoL for persons with NF1 must be clearly defined,” the authors wrote. The results of this study, they added, “suggested the benefit of this crowd-sourced resource by identifying the features of cNFs with the greatest association with QoL and symptoms of pain and itch in persons with NF1, highlighting new intervention strategies and features to target to most improve QoL in NF1.”

SOURCE:

The study was led by Michelle Jade Lin, BS, Stanford University School of Medicine, Redwood City, California, and was published online in JAMA Dermatology.

LIMITATIONS:

The study included only a small number of individuals from racial and ethnic minority groups and did not capture ethnicity information, which could have provided further insights into disease impact across different demographics.

DISCLOSURES:

This study was supported by Johns Hopkins University, Baltimore, and the Bloomberg Family Foundation. Ms. Lin reported support from the Stanford Medical Scholars Research Program. Three authors reported personal fees or grants outside this work. Other authors reported no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mobile images may be reliable for assessing cutaneous neurofibroma (cNF) features in patients with neurofibromatosis type 1 (NF1), according to a crowd-sourced registry study that also suggests correlations between cNF burden and quality of life (QoL), particularly the impact of facial severity on emotional well-being.

METHODOLOGY:

• To learn more about the association of cNFs with QoL, pain, and itch in patients with this rare disease, researchers enrolled 1016 individuals aged 40 years and older with NF1 who had at least one cNF, from May 2021 to December 2023, after reaching out to patient-led or NF1 advocacy organizations in 13 countries, including the United States.
• Participants provided demographic data, detailed photographs, and saliva samples for genetic sequencing, with 583 participants (mean age, 51.7 years; 65.9% women) submitting high-quality photographs from seven body regions at the time of the study analysis.
• A subset of 50 participants also underwent whole-body imaging.
• Four researchers independently rated the photographs for various cNF features, including general severity, number, size, facial severity, and subtypes.

TAKEAWAY:

• Based on evaluations by NF1 specialists, the agreement between mobile and whole-body images was “substantial” (74%-88% agreement) for the number of cNFs, general severity, and facial severity. Agreement between self-reported numbers of cNFs and investigator-rated numbers based on photographs was “minimal to fair.”
• Female sex, the number of cNFs, severity of cNFs on the face, and globular cNFs were associated with worse QoL (based on Skindex scores); severity of cNFs on the face had the strongest impact on overall QoL (P < .001).
• An increasing number of cNFs and worsening facial severity were strongly correlated with higher emotion subdomain scores.
• A higher number of cNFs, more severe cNFs on the face, and larger cNFs were all slightly associated with increased itch and pain (P < .01).

IN PRACTICE:

“To develop effective therapeutics, meaningful clinical outcomes that are tied with improvement in QoL for persons with NF1 must be clearly defined,” the authors wrote. The results of this study, they added, “suggested the benefit of this crowd-sourced resource by identifying the features of cNFs with the greatest association with QoL and symptoms of pain and itch in persons with NF1, highlighting new intervention strategies and features to target to most improve QoL in NF1.”

SOURCE:

The study was led by Michelle Jade Lin, BS, Stanford University School of Medicine, Redwood City, California, and was published online in JAMA Dermatology.

LIMITATIONS:

The study included only a small number of individuals from racial and ethnic minority groups and did not capture ethnicity information, which could have provided further insights into disease impact across different demographics.

DISCLOSURES:

This study was supported by Johns Hopkins University, Baltimore, and the Bloomberg Family Foundation. Ms. Lin reported support from the Stanford Medical Scholars Research Program. Three authors reported personal fees or grants outside this work. Other authors reported no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

A US government report showed how a Medicare policy change made the drug ustekinumab (Stelara) for autoimmune diseases much more expensive, a finding that experts say illustrates the need for reforms created by the Inflation Reduction Act of 2022 (IRA).

The topline findings of an August report from the Department of Health and Human Services (HHS) about ustekinumab may seem somewhat surprising and a bit counterintuitive.

Ustekinumab costs spiked as Medicare pushed patients to get their supply through the Part D pharmacy program. The aim of Part D is to make medicines more affordable and accessible for patients. It runs on a model of insurers to negotiate deals for pharmaceuticals.

Earlier, many patients who needed ustekinumab had the drug covered by Medicare Part B. For many years, Medicare Part B has been largely a passive purchaser of medicines. Part B covers drugs administered by physicians. Its longtime model has been to add a premium of 6% to the reported average sales price to reimburse physicians who buy and administer the drug for patients.

But it was Part D, the Medicare program based on insurers’ negotiating clout, that saw a spike in ustekinumab costs after patients were shifted out of Part B coverage, where the cost of the medicine fell.

The average reported Part B cost for an ustekinumab injection slipped from $14,450 in 2016 to $12,912 by 2023, according to the report from HHS’ Office of Inspector General (OIG).

The Part D cost jumped in the same period. It rose by 84% from $17,717 in 2016 to $32,559 by 2023.

The IRA is intended to curb these kinds of increases in the future for drugs covered by Medicare, said Stacie B. Dusetzina, PhD, professor of health policy at Vanderbilt University School of Medicine, Nashville, Tennessee. The law demands companies pay rebates to Medicare if they increase drug prices faster than consumer inflation.

“That should at least help with some of this price growth that over time has seemed quite egregious,” Dr. Dusetzina told this news organization.

The IRA contains several provisions intended to curb rising drug costs for people enrolled in Medicare, including allowing the federal government to directly negotiate on some medicines.

Ustekinumab is one of the first 10 medicines that are subject to negotiations. Medicare will select as many as 15 additional drugs covered under Part D for negotiation in 2025, another 15 Part B and D drugs in 2026, and up to 20 drugs every year after that.

Earlier in August, the Centers for Medicare & Medicaid Services (CMS) announced the results of its first drug negotiations, with prices set to take effect in 2026. The Part D price for a 30-day supply of ustekinumab will be $4695 in 2026, a 66% reduction from the list price last year of $13,836.

Even at the negotiated price, ustekinumab’s cost will be high enough to trigger a new cap on out-of-pocket Part D spending, Dr. Dusetzina said.

Starting in 2025, Part D will have a cap of $2000 on individuals’ out-of-pocket costs, with annual adjustments in future years.

“It may not be better for someone who was filling this on Part B, who had a supplement [that covered their share of the ustekinumab cost], but it will be better for a lot of people that it’s covered under Part D,” Dr. Dusetzina said. “The good news is that at least from a beneficiary affordability standpoint, they’re going to have some price protection.”

OIG noted that the US Food and Drug Administration has approved three competing biosimilar versions of ustekinumab. These could also potentially work to lower costs.
 

‘A Complicated and Not Particularly Transparent Process’

OIG said it expects to release a report later this year with more detail about the decision that shifted ustekinumab coverage from Part B to Part D.

First cleared for US sales in 2009, ustekinumab is approved for psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It can be given subcutaneously or intravenously.

Part B does not generally cover self-administered drugs. The infused version of ustekinumab has been covered under Medicare Part B since it reached the market.

“However, Part B coverage of the subcutaneous versions has been less straightforward,” OIG said in the report.

In 2020, Medicare administrative contractors — the units or affiliates of insurers that for decades have processed Part B claims for the traditional Medicare programs — determined that subcutaneous ustekinumab did not meet the criteria for coverage under Part B. Implementation of this change was delayed due to the COVID public health emergency but has since taken effect.

The shift in ustekinumab coverage to Part D eroded financial protections of many people on Medicare when Part B covered the drug.

Almost 9 in 10 people enrolled in Medicare Part B have supplemental insurance such as Medigap, employer coverage, or Medicaid to fully or partially cover their cost-sharing requirements, the OIG report said. That means Part B coverage shielded many patients from high ustekinumab costs. 

In contrast, patients who self-administered the drug at home under Part D coverage paid an average of almost $6000 out of pocket if they did not receive any type of financial assistance, OIG said.

“From a financial standpoint, as long as you have Part B coinsurance, it would be much cheaper to get the drug in your doctor’s office than getting it through a pharmacy, unless you qualify for the low-income subsidy,” OIG Regional Inspector General David Tawes, who supervised the team that produced the report, told this news organization.

OIG has previously reported that post–point-of-sale rebates paid by manufacturers sometimes lower the costs incurred by Part D plans by a significant margin. But this was not the case with ustekinumab. Instead, OIG said the gap between initial and actual costs of ustekinumab was reduced by less than one third even with rebates. Rebate information is considered confidential.

“The whole negotiation structure is a complicated and not particularly transparent process,” Mr. Tawes said.
 

Backchannel Discounts, Top-Line Prices

The IRA is bringing some more transparency to the process through negotiations, said Mariana P. Socal, MD, associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. Patients who buy medicines that have been through the CMS negotiation process will be able to see if they are being charged correctly.

Dr. Socal noted that there’s something of a disconnect in discussions of Part D between how insurers and consumers view prices. 

For Part D plans, the list prices represent the beginning of negotiations. They get rebates from drugmakers’ list prices for medicines, which insurers say work to lower premium costs. 

“For plans, those prices are unrealistic. They are simply a sticker price. But for patients, for the Medicare beneficiaries, these prices are very real” because they are used to set copays, Dr. Socal said.

Dr. Dusetzina reported receiving funding from Arnold Ventures and the Commonwealth Fund for research related to drug pricing. Dr. Socal reported receiving funding from Arnold Ventures. 

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

CARLSBAD, CALIFORNIA — The idea of using nonablative fractional lasers to reduce the risk of nonmelanoma skin cancer (NMSC) has gained support in recent years, and a key 2017 publication laid the groundwork for current approaches, according to Elizabeth Tanzi, MD.

In the article, which was published in Molecules, Mike Kemp, PhD, and Jeffrey Bryant Travers, MD, PhD, at Wright State University, Dayton, Ohio, and Dan F. Spandau, PhD, at Indiana University School of Medicine, Indianapolis, demonstrated that geriatric skin responds to ultraviolet B (UVB) differently than young skin because of differences in insulin-like growth factor 1 (IGF-1) levels produced by dermal fibroblasts.

“As we age, our fibroblasts become senescent, inactive,” Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington, DC, said at the Controversies and Conversations in Laser and Cosmetic Surgery symposium. “They don’t make as many growth factors, particularly IGF-1, and therefore we don’t stimulate the responses. We need more of our growth factors.”

In later, separate work, Dr. Travers, Dr. Spandau, and colleagues found that using dermabrasion or fractionated laser resurfacing to wound the skin can result in increased dermal IGF-1 levels and normalization of the abnormal pro-carcinogenic UV response associated with geriatric skin — a treatment that has the potential to prevent NMSC. That study “was the epiphany” for fostering interest among researchers in the field of lasers and medicine, Dr. Tanzi said.

In a retrospective cohort study, Mathew Avram, MD, JD, and colleagues reviewed patients with a history of facial keratinocyte carcinoma (KC) who were treated at Massachusetts General Hospital in Boston between 2005 and 2021. The study population included 43 patients treated with either the 1927- or the 1550-nm nonablative fractional laser (NAFL) and 52 matched controls. The rate of subsequent facial KC development was 20.9% in NAFL-treated patients and 40.4% in controls (relative risk, 0.52, P = .049). 

During a separate presentation at the meeting, Dr. Avram, director of lasers and cosmetics at Massachusetts General Hospital, Boston, said that, when he and his colleagues controlled for age, gender, and skin type, controls were 2.65 times more likely to develop new facial KC, compared with those treated with NAFL (P = .0169). “This enhanced effect was seen with the 1550-nm device, compared with the 1927-nm device. The study shows us that 1550-nm/1927-nm NAFL may have a protective effect for patients with a history of KC, but the role of each wavelength is to be determined. We also need a prospective, controlled study to verify the results.” 

In an ongoing study first presented at the 2023 annual meeting of the American Society for Dermatologic Surgery, Dr. Tanzi and colleagues enrolled 15 patients aged ≥ 55 years to evaluate the restoration of physiologic features and biomarkers in skin treated with 25% trichloroacetic acid (TCA), plus the 1550-nm or 1927-nm NAFL. Four sites on the back were treated and biopsies were taken at baseline and at 3 months post treatment. The protocol involved TCA 25% to speckled frost, with the 1550-nm device set to level 6 at 70 mJ and the 1927-nm device set to level 8 at 20 mJ. Immunohistochemical stains are still pending; however, physiologic changes were noted.

Three months after a single treatment, the 1927-nm treated areas showed statistically significant elongation of fibroblasts (consistent with younger fibroblasts) on histology. “Although not a large study, it supports the growing body of research that demonstrates we are improving the health of our patients’ skin with certain types of laser treatments, not just beautifying it,” Dr. Tanzi said. 

Dr. Tanzi disclosed being a member of the advisory board for AbbVie/Allergan and Sciton, and is a consultant for Alastin/Galderma, Candesant Biomedical, Cytrellis, Revance, and Solta Medical. Dr. Avram disclosed that he receives intellectual property royalties from and holds stock options in Cytrellis, and is a consultant to Allergan and holds stock options in BAI Biosciences, Sofwave, and La Jolla NanoMedical.

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

CARLSBAD, CALIFORNIA — The idea of using nonablative fractional lasers to reduce the risk of nonmelanoma skin cancer (NMSC) has gained support in recent years, and a key 2017 publication laid the groundwork for current approaches, according to Elizabeth Tanzi, MD.

In the article, which was published in Molecules, Mike Kemp, PhD, and Jeffrey Bryant Travers, MD, PhD, at Wright State University, Dayton, Ohio, and Dan F. Spandau, PhD, at Indiana University School of Medicine, Indianapolis, demonstrated that geriatric skin responds to ultraviolet B (UVB) differently than young skin because of differences in insulin-like growth factor 1 (IGF-1) levels produced by dermal fibroblasts.

“As we age, our fibroblasts become senescent, inactive,” Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington, DC, said at the Controversies and Conversations in Laser and Cosmetic Surgery symposium. “They don’t make as many growth factors, particularly IGF-1, and therefore we don’t stimulate the responses. We need more of our growth factors.”

In later, separate work, Dr. Travers, Dr. Spandau, and colleagues found that using dermabrasion or fractionated laser resurfacing to wound the skin can result in increased dermal IGF-1 levels and normalization of the abnormal pro-carcinogenic UV response associated with geriatric skin — a treatment that has the potential to prevent NMSC. That study “was the epiphany” for fostering interest among researchers in the field of lasers and medicine, Dr. Tanzi said.

In a retrospective cohort study, Mathew Avram, MD, JD, and colleagues reviewed patients with a history of facial keratinocyte carcinoma (KC) who were treated at Massachusetts General Hospital in Boston between 2005 and 2021. The study population included 43 patients treated with either the 1927- or the 1550-nm nonablative fractional laser (NAFL) and 52 matched controls. The rate of subsequent facial KC development was 20.9% in NAFL-treated patients and 40.4% in controls (relative risk, 0.52, P = .049). 

During a separate presentation at the meeting, Dr. Avram, director of lasers and cosmetics at Massachusetts General Hospital, Boston, said that, when he and his colleagues controlled for age, gender, and skin type, controls were 2.65 times more likely to develop new facial KC, compared with those treated with NAFL (P = .0169). “This enhanced effect was seen with the 1550-nm device, compared with the 1927-nm device. The study shows us that 1550-nm/1927-nm NAFL may have a protective effect for patients with a history of KC, but the role of each wavelength is to be determined. We also need a prospective, controlled study to verify the results.” 

In an ongoing study first presented at the 2023 annual meeting of the American Society for Dermatologic Surgery, Dr. Tanzi and colleagues enrolled 15 patients aged ≥ 55 years to evaluate the restoration of physiologic features and biomarkers in skin treated with 25% trichloroacetic acid (TCA), plus the 1550-nm or 1927-nm NAFL. Four sites on the back were treated and biopsies were taken at baseline and at 3 months post treatment. The protocol involved TCA 25% to speckled frost, with the 1550-nm device set to level 6 at 70 mJ and the 1927-nm device set to level 8 at 20 mJ. Immunohistochemical stains are still pending; however, physiologic changes were noted.

Three months after a single treatment, the 1927-nm treated areas showed statistically significant elongation of fibroblasts (consistent with younger fibroblasts) on histology. “Although not a large study, it supports the growing body of research that demonstrates we are improving the health of our patients’ skin with certain types of laser treatments, not just beautifying it,” Dr. Tanzi said. 

Dr. Tanzi disclosed being a member of the advisory board for AbbVie/Allergan and Sciton, and is a consultant for Alastin/Galderma, Candesant Biomedical, Cytrellis, Revance, and Solta Medical. Dr. Avram disclosed that he receives intellectual property royalties from and holds stock options in Cytrellis, and is a consultant to Allergan and holds stock options in BAI Biosciences, Sofwave, and La Jolla NanoMedical.

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

CARLSBAD, CALIFORNIA — The idea of using nonablative fractional lasers to reduce the risk of nonmelanoma skin cancer (NMSC) has gained support in recent years, and a key 2017 publication laid the groundwork for current approaches, according to Elizabeth Tanzi, MD.

In the article, which was published in Molecules, Mike Kemp, PhD, and Jeffrey Bryant Travers, MD, PhD, at Wright State University, Dayton, Ohio, and Dan F. Spandau, PhD, at Indiana University School of Medicine, Indianapolis, demonstrated that geriatric skin responds to ultraviolet B (UVB) differently than young skin because of differences in insulin-like growth factor 1 (IGF-1) levels produced by dermal fibroblasts.

“As we age, our fibroblasts become senescent, inactive,” Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington, DC, said at the Controversies and Conversations in Laser and Cosmetic Surgery symposium. “They don’t make as many growth factors, particularly IGF-1, and therefore we don’t stimulate the responses. We need more of our growth factors.”

In later, separate work, Dr. Travers, Dr. Spandau, and colleagues found that using dermabrasion or fractionated laser resurfacing to wound the skin can result in increased dermal IGF-1 levels and normalization of the abnormal pro-carcinogenic UV response associated with geriatric skin — a treatment that has the potential to prevent NMSC. That study “was the epiphany” for fostering interest among researchers in the field of lasers and medicine, Dr. Tanzi said.

In a retrospective cohort study, Mathew Avram, MD, JD, and colleagues reviewed patients with a history of facial keratinocyte carcinoma (KC) who were treated at Massachusetts General Hospital in Boston between 2005 and 2021. The study population included 43 patients treated with either the 1927- or the 1550-nm nonablative fractional laser (NAFL) and 52 matched controls. The rate of subsequent facial KC development was 20.9% in NAFL-treated patients and 40.4% in controls (relative risk, 0.52, P = .049). 

During a separate presentation at the meeting, Dr. Avram, director of lasers and cosmetics at Massachusetts General Hospital, Boston, said that, when he and his colleagues controlled for age, gender, and skin type, controls were 2.65 times more likely to develop new facial KC, compared with those treated with NAFL (P = .0169). “This enhanced effect was seen with the 1550-nm device, compared with the 1927-nm device. The study shows us that 1550-nm/1927-nm NAFL may have a protective effect for patients with a history of KC, but the role of each wavelength is to be determined. We also need a prospective, controlled study to verify the results.” 

In an ongoing study first presented at the 2023 annual meeting of the American Society for Dermatologic Surgery, Dr. Tanzi and colleagues enrolled 15 patients aged ≥ 55 years to evaluate the restoration of physiologic features and biomarkers in skin treated with 25% trichloroacetic acid (TCA), plus the 1550-nm or 1927-nm NAFL. Four sites on the back were treated and biopsies were taken at baseline and at 3 months post treatment. The protocol involved TCA 25% to speckled frost, with the 1550-nm device set to level 6 at 70 mJ and the 1927-nm device set to level 8 at 20 mJ. Immunohistochemical stains are still pending; however, physiologic changes were noted.

Three months after a single treatment, the 1927-nm treated areas showed statistically significant elongation of fibroblasts (consistent with younger fibroblasts) on histology. “Although not a large study, it supports the growing body of research that demonstrates we are improving the health of our patients’ skin with certain types of laser treatments, not just beautifying it,” Dr. Tanzi said. 

Dr. Tanzi disclosed being a member of the advisory board for AbbVie/Allergan and Sciton, and is a consultant for Alastin/Galderma, Candesant Biomedical, Cytrellis, Revance, and Solta Medical. Dr. Avram disclosed that he receives intellectual property royalties from and holds stock options in Cytrellis, and is a consultant to Allergan and holds stock options in BAI Biosciences, Sofwave, and La Jolla NanoMedical.

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

TOPLINE:

Quitting smoking significantly lowered the risk of developing hidradenitis suppurativa (HS), with this reduction becoming evident 3-4 years after cessation, in a cohort study from Korea.

METHODOLOGY:

• Researchers conducted a population-based cohort study using the Korean National Health Insurance Service database.
• A total of 6,230,189 participants in South Korea who underwent two consecutive biennial health examinations from 2004 to 2005 and 2006 to 2007 were included.
• Participants were categorized into six groups on the basis of their smoking status at both checkups: Sustained smokers, relapsed smokers, new smokers, smoking quitters, sustained ex-smokers, and never smokers.
• The primary outcome was the development of HS.

TAKEAWAY:

• A total of 3761 HS cases were detected during the 84,457,025 person-years of observation.
• Smoking quitters (adjusted hazard ratio [AHR], 0.68; 95% CI, 0.56-0.83), sustained ex-smokers (AHR, 0.67; 95% CI, 0.57-0.77), and never smokers (AHR, 0.57; 95% CI, 0.52-0.63) exhibited a reduced risk of developing HS compared with sustained smokers.
• The risk of developing HS varied over time, with smoking quitters showing no significant risk reduction compared with sustained smokers in the first 3 years. After 3 years, a statistically significant decrease in HS risk was observed among quitters, which persisted over time.
• At 3-6 years, the risk reduction in sustained quitters was comparable with that of never smokers (AHR, 0.58 and 0.63, respectively).

IN PRACTICE:

“Smoking cessation and maintaining a smoke-free lifestyle may be important preventive measures against the development of HS,” the authors concluded. In an accompanying editorial, Alexandra Charrow, MD, and Leandra A. Barnes, MD, of the departments of dermatology at Brigham and Women’s Hospital, Boston, and Stanford University, Palo Alto, California, respectively, wrote that while the study “importantly contributes to the understanding of the association of smoking tobacco and HS onset, prospective cohort studies in large, diverse cohorts of patients with HS may help dermatologists better understand the causal relationship between smoking and the onset or exacerbation of HS.” For now, they added, “dermatologists must continue to use comprehensive HS treatment strategies, including lifestyle modifications that promote overall health like smoking cessation, to improve the lives of those enduring HS.”

SOURCE:

The study was led by Seong Rae Kim, MD, Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea, and was published online, along with the editorial, on August 21 in JAMA Dermatology.

LIMITATIONS:

The study limitations include the potential for unexamined confounding factors like hereditary background, reliance on self-reported smoking status, and the exclusion of electronic cigarette use and nicotine replacement therapy. The predominantly male smoker population may limit generalizability, and delayed diagnosis of HS may not reflect the actual time of onset.

DISCLOSURES:

The study funding source was not disclosed. One study author reported various financial ties with pharmaceutical companies outside this work; other authors had no disclosures. Dr. Charrow’s disclosures included receiving personal fees from several pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Quitting smoking significantly lowered the risk of developing hidradenitis suppurativa (HS), with this reduction becoming evident 3-4 years after cessation, in a cohort study from Korea.

METHODOLOGY:

• Researchers conducted a population-based cohort study using the Korean National Health Insurance Service database.
• A total of 6,230,189 participants in South Korea who underwent two consecutive biennial health examinations from 2004 to 2005 and 2006 to 2007 were included.
• Participants were categorized into six groups on the basis of their smoking status at both checkups: Sustained smokers, relapsed smokers, new smokers, smoking quitters, sustained ex-smokers, and never smokers.
• The primary outcome was the development of HS.

TAKEAWAY:

• A total of 3761 HS cases were detected during the 84,457,025 person-years of observation.
• Smoking quitters (adjusted hazard ratio [AHR], 0.68; 95% CI, 0.56-0.83), sustained ex-smokers (AHR, 0.67; 95% CI, 0.57-0.77), and never smokers (AHR, 0.57; 95% CI, 0.52-0.63) exhibited a reduced risk of developing HS compared with sustained smokers.
• The risk of developing HS varied over time, with smoking quitters showing no significant risk reduction compared with sustained smokers in the first 3 years. After 3 years, a statistically significant decrease in HS risk was observed among quitters, which persisted over time.
• At 3-6 years, the risk reduction in sustained quitters was comparable with that of never smokers (AHR, 0.58 and 0.63, respectively).

IN PRACTICE:

“Smoking cessation and maintaining a smoke-free lifestyle may be important preventive measures against the development of HS,” the authors concluded. In an accompanying editorial, Alexandra Charrow, MD, and Leandra A. Barnes, MD, of the departments of dermatology at Brigham and Women’s Hospital, Boston, and Stanford University, Palo Alto, California, respectively, wrote that while the study “importantly contributes to the understanding of the association of smoking tobacco and HS onset, prospective cohort studies in large, diverse cohorts of patients with HS may help dermatologists better understand the causal relationship between smoking and the onset or exacerbation of HS.” For now, they added, “dermatologists must continue to use comprehensive HS treatment strategies, including lifestyle modifications that promote overall health like smoking cessation, to improve the lives of those enduring HS.”

SOURCE:

The study was led by Seong Rae Kim, MD, Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea, and was published online, along with the editorial, on August 21 in JAMA Dermatology.

LIMITATIONS:

The study limitations include the potential for unexamined confounding factors like hereditary background, reliance on self-reported smoking status, and the exclusion of electronic cigarette use and nicotine replacement therapy. The predominantly male smoker population may limit generalizability, and delayed diagnosis of HS may not reflect the actual time of onset.

DISCLOSURES:

The study funding source was not disclosed. One study author reported various financial ties with pharmaceutical companies outside this work; other authors had no disclosures. Dr. Charrow’s disclosures included receiving personal fees from several pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Quitting smoking significantly lowered the risk of developing hidradenitis suppurativa (HS), with this reduction becoming evident 3-4 years after cessation, in a cohort study from Korea.

METHODOLOGY:

• Researchers conducted a population-based cohort study using the Korean National Health Insurance Service database.
• A total of 6,230,189 participants in South Korea who underwent two consecutive biennial health examinations from 2004 to 2005 and 2006 to 2007 were included.
• Participants were categorized into six groups on the basis of their smoking status at both checkups: Sustained smokers, relapsed smokers, new smokers, smoking quitters, sustained ex-smokers, and never smokers.
• The primary outcome was the development of HS.

TAKEAWAY:

• A total of 3761 HS cases were detected during the 84,457,025 person-years of observation.
• Smoking quitters (adjusted hazard ratio [AHR], 0.68; 95% CI, 0.56-0.83), sustained ex-smokers (AHR, 0.67; 95% CI, 0.57-0.77), and never smokers (AHR, 0.57; 95% CI, 0.52-0.63) exhibited a reduced risk of developing HS compared with sustained smokers.
• The risk of developing HS varied over time, with smoking quitters showing no significant risk reduction compared with sustained smokers in the first 3 years. After 3 years, a statistically significant decrease in HS risk was observed among quitters, which persisted over time.
• At 3-6 years, the risk reduction in sustained quitters was comparable with that of never smokers (AHR, 0.58 and 0.63, respectively).

IN PRACTICE:

“Smoking cessation and maintaining a smoke-free lifestyle may be important preventive measures against the development of HS,” the authors concluded. In an accompanying editorial, Alexandra Charrow, MD, and Leandra A. Barnes, MD, of the departments of dermatology at Brigham and Women’s Hospital, Boston, and Stanford University, Palo Alto, California, respectively, wrote that while the study “importantly contributes to the understanding of the association of smoking tobacco and HS onset, prospective cohort studies in large, diverse cohorts of patients with HS may help dermatologists better understand the causal relationship between smoking and the onset or exacerbation of HS.” For now, they added, “dermatologists must continue to use comprehensive HS treatment strategies, including lifestyle modifications that promote overall health like smoking cessation, to improve the lives of those enduring HS.”

SOURCE:

The study was led by Seong Rae Kim, MD, Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea, and was published online, along with the editorial, on August 21 in JAMA Dermatology.

LIMITATIONS:

The study limitations include the potential for unexamined confounding factors like hereditary background, reliance on self-reported smoking status, and the exclusion of electronic cigarette use and nicotine replacement therapy. The predominantly male smoker population may limit generalizability, and delayed diagnosis of HS may not reflect the actual time of onset.

DISCLOSURES:

The study funding source was not disclosed. One study author reported various financial ties with pharmaceutical companies outside this work; other authors had no disclosures. Dr. Charrow’s disclosures included receiving personal fees from several pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Zasocitinib, a tyrosine kinase 2 (TYK2) inhibitor, at oral doses of ≥ 5 mg led to greater skin clearance than placebo over a period of 12 weeks, in a phase 2b study.
 

METHODOLOGY:

• Researchers performed a phase 2b, randomized, double-blind trial to assess the efficacy, safety, and tolerability of different doses of zasocitinib in adults with moderate to severe psoriasis (mean age, 47 years; 32% women) at 47 centers in the United States and eight centers in Canada. Most (83%) were White, 7% were Black, and 8% were Asian.
• A total of 287 patients were randomly assigned to receive one of the four oral doses of zasocitinib (2 mg, 5 mg, 15 mg, or 30 mg, once daily) or a matched placebo for 12 weeks, followed by a 4-week safety monitoring period.
• The primary outcome was the proportion of patients achieving a ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) from baseline at week 12.

TAKEAWAY:

• At week 12, PASI 75 was achieved by 18%, 44%, 68%, and 67% of patients receiving zasocitinib at doses of 2 mg, 5 mg, 15 mg, and 30 mg, respectively, vs 6% of patients receiving placebo.
• PASI 90 was achieved in 8%, 21%, 45%, and 46% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, and in no patients in the placebo group.
• At week 12, 10%, 27%, 49%, and 52% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, had no or mild disease (a score of 0 or 1) according to the Physician Global Assessment tool vs 4% in the placebo group.
• Treatment-emergent adverse events occurred in 53%-62% of patients in the zasocitinib groups compared with 44% in the placebo group. The most common were COVID-19, acne/acneiform dermatitis, and diarrhea. There were no reports of major adverse cardiovascular events, thromboembolic events, or opportunistic infections.

IN PRACTICE:

“Zasocitinib, an advanced, potent, and highly selective oral TYK2 inhibitor bioengineered to optimize target coverage and functional selectivity, achieved biologic-level efficacy with complete skin clearance observed after only a 12-week treatment period in up to one third of patients, with a low incidence of known tolerability issues and absence of serious toxic effects that are characteristic of [Janus kinase] 1-3 inhibition,” the authors wrote.

SOURCE:

The study was led by April W. Armstrong, MD, MPH, University of California, Los Angeles, and was published online on August 21, 2024, in JAMA Dermatology.
 

LIMITATIONS:

The study was limited by a relatively small sample size and a short duration. In addition, the inclusion of predominantly White patients may limit the generalizability of findings to a diverse population.
 

DISCLOSURES:

The study was funded by Nimbus Discovery, which includes Nimbus Therapeutics and Nimbus Lakshmi. Dr. Armstrong’s disclosures included receiving grants and/or personal fees from various pharmaceutical companies, including Nimbus Therapeutics and Nimbus. Three authors were employees of and reported holding equity, stocks, or shares in Nimbus. Several authors had disclosures related to pharmaceutical companies, including Nimbus.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Zasocitinib, a tyrosine kinase 2 (TYK2) inhibitor, at oral doses of ≥ 5 mg led to greater skin clearance than placebo over a period of 12 weeks, in a phase 2b study.
 

METHODOLOGY:

• Researchers performed a phase 2b, randomized, double-blind trial to assess the efficacy, safety, and tolerability of different doses of zasocitinib in adults with moderate to severe psoriasis (mean age, 47 years; 32% women) at 47 centers in the United States and eight centers in Canada. Most (83%) were White, 7% were Black, and 8% were Asian.
• A total of 287 patients were randomly assigned to receive one of the four oral doses of zasocitinib (2 mg, 5 mg, 15 mg, or 30 mg, once daily) or a matched placebo for 12 weeks, followed by a 4-week safety monitoring period.
• The primary outcome was the proportion of patients achieving a ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) from baseline at week 12.

TAKEAWAY:

• At week 12, PASI 75 was achieved by 18%, 44%, 68%, and 67% of patients receiving zasocitinib at doses of 2 mg, 5 mg, 15 mg, and 30 mg, respectively, vs 6% of patients receiving placebo.
• PASI 90 was achieved in 8%, 21%, 45%, and 46% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, and in no patients in the placebo group.
• At week 12, 10%, 27%, 49%, and 52% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, had no or mild disease (a score of 0 or 1) according to the Physician Global Assessment tool vs 4% in the placebo group.
• Treatment-emergent adverse events occurred in 53%-62% of patients in the zasocitinib groups compared with 44% in the placebo group. The most common were COVID-19, acne/acneiform dermatitis, and diarrhea. There were no reports of major adverse cardiovascular events, thromboembolic events, or opportunistic infections.

IN PRACTICE:

“Zasocitinib, an advanced, potent, and highly selective oral TYK2 inhibitor bioengineered to optimize target coverage and functional selectivity, achieved biologic-level efficacy with complete skin clearance observed after only a 12-week treatment period in up to one third of patients, with a low incidence of known tolerability issues and absence of serious toxic effects that are characteristic of [Janus kinase] 1-3 inhibition,” the authors wrote.

SOURCE:

The study was led by April W. Armstrong, MD, MPH, University of California, Los Angeles, and was published online on August 21, 2024, in JAMA Dermatology.
 

LIMITATIONS:

The study was limited by a relatively small sample size and a short duration. In addition, the inclusion of predominantly White patients may limit the generalizability of findings to a diverse population.
 

DISCLOSURES:

The study was funded by Nimbus Discovery, which includes Nimbus Therapeutics and Nimbus Lakshmi. Dr. Armstrong’s disclosures included receiving grants and/or personal fees from various pharmaceutical companies, including Nimbus Therapeutics and Nimbus. Three authors were employees of and reported holding equity, stocks, or shares in Nimbus. Several authors had disclosures related to pharmaceutical companies, including Nimbus.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Zasocitinib, a tyrosine kinase 2 (TYK2) inhibitor, at oral doses of ≥ 5 mg led to greater skin clearance than placebo over a period of 12 weeks, in a phase 2b study.
 

METHODOLOGY:

• Researchers performed a phase 2b, randomized, double-blind trial to assess the efficacy, safety, and tolerability of different doses of zasocitinib in adults with moderate to severe psoriasis (mean age, 47 years; 32% women) at 47 centers in the United States and eight centers in Canada. Most (83%) were White, 7% were Black, and 8% were Asian.
• A total of 287 patients were randomly assigned to receive one of the four oral doses of zasocitinib (2 mg, 5 mg, 15 mg, or 30 mg, once daily) or a matched placebo for 12 weeks, followed by a 4-week safety monitoring period.
• The primary outcome was the proportion of patients achieving a ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) from baseline at week 12.

TAKEAWAY:

• At week 12, PASI 75 was achieved by 18%, 44%, 68%, and 67% of patients receiving zasocitinib at doses of 2 mg, 5 mg, 15 mg, and 30 mg, respectively, vs 6% of patients receiving placebo.
• PASI 90 was achieved in 8%, 21%, 45%, and 46% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, and in no patients in the placebo group.
• At week 12, 10%, 27%, 49%, and 52% of patients receiving zasocitinib at 2 mg, 5 mg, 15 mg, and 30 mg, respectively, had no or mild disease (a score of 0 or 1) according to the Physician Global Assessment tool vs 4% in the placebo group.
• Treatment-emergent adverse events occurred in 53%-62% of patients in the zasocitinib groups compared with 44% in the placebo group. The most common were COVID-19, acne/acneiform dermatitis, and diarrhea. There were no reports of major adverse cardiovascular events, thromboembolic events, or opportunistic infections.

IN PRACTICE:

“Zasocitinib, an advanced, potent, and highly selective oral TYK2 inhibitor bioengineered to optimize target coverage and functional selectivity, achieved biologic-level efficacy with complete skin clearance observed after only a 12-week treatment period in up to one third of patients, with a low incidence of known tolerability issues and absence of serious toxic effects that are characteristic of [Janus kinase] 1-3 inhibition,” the authors wrote.

SOURCE:

The study was led by April W. Armstrong, MD, MPH, University of California, Los Angeles, and was published online on August 21, 2024, in JAMA Dermatology.
 

LIMITATIONS:

The study was limited by a relatively small sample size and a short duration. In addition, the inclusion of predominantly White patients may limit the generalizability of findings to a diverse population.
 

DISCLOSURES:

The study was funded by Nimbus Discovery, which includes Nimbus Therapeutics and Nimbus Lakshmi. Dr. Armstrong’s disclosures included receiving grants and/or personal fees from various pharmaceutical companies, including Nimbus Therapeutics and Nimbus. Three authors were employees of and reported holding equity, stocks, or shares in Nimbus. Several authors had disclosures related to pharmaceutical companies, including Nimbus.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.