MDedge Dermatology

March 2024 proved to be a busy month for benzoyl peroxide in the media! We are now at almost 4 months since Valisure, an independent analytical laboratory located in Connecticut, filed a Citizen Petition on benzene in benzoyl peroxide drug products with the US Food and Drug Administration (FDA) on March 5, 2024.¹ This petition was filed shortly before the annual meeting of the American Academy of Dermatology was held in San Diego, California, creating quite a stir of concern in the dermatology world. Further information on the degradation of benzoyl peroxide with production of benzene was published in the medical literature in March 2024.² As benzene is recognized as a human carcinogen, manufacturing regulations exist to assure that it does not appear in topical products either through contamination or degradation over the course of a product’s shelf-life.³

As anticipated, several opinions and commentaries appeared quickly, both on video and in various articles. The American Acne & Rosacea Society (AARS) released a statement on this issue on March 20, 2024.⁴ The safety of the public is the overarching primary concern. This AARS statement does include some general suggestions related to benzoyl peroxide use based on the best assessment to date while awaiting further guidance from the FDA on this issue. Benzoyl peroxide is approved for use by the FDA as an over-the-counter (OTC) topical product for acne and also is in several FDA-approved prescription topical products.^5,6

The following reflects my personal viewpoint as both a dermatologist and a grandfather who has grandchildren who use acne products. My views are not necessarily those of AARS. Since early March 2024, I have read several documents and spoken to several dermatologists, scientists, and formulators with knowledge in this area, including contacts at Valisure. I was hoping to get to some reasonable definitive answer but have not been able to achieve this to my full satisfaction. There are many opinions and concerns, and each one makes sense based on the vantage point of the presenter. However, several unanswered questions remain related to what testing and data are currently required of companies to gain FDA approval of a benzoyl peroxide product, including:

• assessment of stability and degradation products (including benzene),
• validation of testing methods,
• the issue of benzoyl peroxide stability in commercial products, and
• the relevant magnitude of resultant benzene exposures, especially as we are all exposed to benzene from several sources each day.

I am certain that companies with benzoyl peroxide products will evaluate their already-approved products and also do further testing. However, in this situation, which impacts millions of people on so many levels, I feel there needs to be an organized approach to evaluate and resolve the issue, otherwise the likelihood of continued confusion and uncertainty is high. As the FDA is the approval body, I am hoping it will provide definitive guidance within a reasonable timeline so that clinicians, patients, and manufacturers of benzoyl peroxide can proceed with full confidence. Right now, we all remain in a state of limbo. It is time for less talk and more definitive action to sort out this issue.

March 2024 proved to be a busy month for benzoyl peroxide in the media! We are now at almost 4 months since Valisure, an independent analytical laboratory located in Connecticut, filed a Citizen Petition on benzene in benzoyl peroxide drug products with the US Food and Drug Administration (FDA) on March 5, 2024.¹ This petition was filed shortly before the annual meeting of the American Academy of Dermatology was held in San Diego, California, creating quite a stir of concern in the dermatology world. Further information on the degradation of benzoyl peroxide with production of benzene was published in the medical literature in March 2024.² As benzene is recognized as a human carcinogen, manufacturing regulations exist to assure that it does not appear in topical products either through contamination or degradation over the course of a product’s shelf-life.³

As anticipated, several opinions and commentaries appeared quickly, both on video and in various articles. The American Acne & Rosacea Society (AARS) released a statement on this issue on March 20, 2024.⁴ The safety of the public is the overarching primary concern. This AARS statement does include some general suggestions related to benzoyl peroxide use based on the best assessment to date while awaiting further guidance from the FDA on this issue. Benzoyl peroxide is approved for use by the FDA as an over-the-counter (OTC) topical product for acne and also is in several FDA-approved prescription topical products.^5,6

The following reflects my personal viewpoint as both a dermatologist and a grandfather who has grandchildren who use acne products. My views are not necessarily those of AARS. Since early March 2024, I have read several documents and spoken to several dermatologists, scientists, and formulators with knowledge in this area, including contacts at Valisure. I was hoping to get to some reasonable definitive answer but have not been able to achieve this to my full satisfaction. There are many opinions and concerns, and each one makes sense based on the vantage point of the presenter. However, several unanswered questions remain related to what testing and data are currently required of companies to gain FDA approval of a benzoyl peroxide product, including:

• assessment of stability and degradation products (including benzene),
• validation of testing methods,
• the issue of benzoyl peroxide stability in commercial products, and
• the relevant magnitude of resultant benzene exposures, especially as we are all exposed to benzene from several sources each day.

I am certain that companies with benzoyl peroxide products will evaluate their already-approved products and also do further testing. However, in this situation, which impacts millions of people on so many levels, I feel there needs to be an organized approach to evaluate and resolve the issue, otherwise the likelihood of continued confusion and uncertainty is high. As the FDA is the approval body, I am hoping it will provide definitive guidance within a reasonable timeline so that clinicians, patients, and manufacturers of benzoyl peroxide can proceed with full confidence. Right now, we all remain in a state of limbo. It is time for less talk and more definitive action to sort out this issue.

March 2024 proved to be a busy month for benzoyl peroxide in the media! We are now at almost 4 months since Valisure, an independent analytical laboratory located in Connecticut, filed a Citizen Petition on benzene in benzoyl peroxide drug products with the US Food and Drug Administration (FDA) on March 5, 2024.¹ This petition was filed shortly before the annual meeting of the American Academy of Dermatology was held in San Diego, California, creating quite a stir of concern in the dermatology world. Further information on the degradation of benzoyl peroxide with production of benzene was published in the medical literature in March 2024.² As benzene is recognized as a human carcinogen, manufacturing regulations exist to assure that it does not appear in topical products either through contamination or degradation over the course of a product’s shelf-life.³

As anticipated, several opinions and commentaries appeared quickly, both on video and in various articles. The American Acne & Rosacea Society (AARS) released a statement on this issue on March 20, 2024.⁴ The safety of the public is the overarching primary concern. This AARS statement does include some general suggestions related to benzoyl peroxide use based on the best assessment to date while awaiting further guidance from the FDA on this issue. Benzoyl peroxide is approved for use by the FDA as an over-the-counter (OTC) topical product for acne and also is in several FDA-approved prescription topical products.^5,6

The following reflects my personal viewpoint as both a dermatologist and a grandfather who has grandchildren who use acne products. My views are not necessarily those of AARS. Since early March 2024, I have read several documents and spoken to several dermatologists, scientists, and formulators with knowledge in this area, including contacts at Valisure. I was hoping to get to some reasonable definitive answer but have not been able to achieve this to my full satisfaction. There are many opinions and concerns, and each one makes sense based on the vantage point of the presenter. However, several unanswered questions remain related to what testing and data are currently required of companies to gain FDA approval of a benzoyl peroxide product, including:

• assessment of stability and degradation products (including benzene),
• validation of testing methods,
• the issue of benzoyl peroxide stability in commercial products, and
• the relevant magnitude of resultant benzene exposures, especially as we are all exposed to benzene from several sources each day.

I am certain that companies with benzoyl peroxide products will evaluate their already-approved products and also do further testing. However, in this situation, which impacts millions of people on so many levels, I feel there needs to be an organized approach to evaluate and resolve the issue, otherwise the likelihood of continued confusion and uncertainty is high. As the FDA is the approval body, I am hoping it will provide definitive guidance within a reasonable timeline so that clinicians, patients, and manufacturers of benzoyl peroxide can proceed with full confidence. Right now, we all remain in a state of limbo. It is time for less talk and more definitive action to sort out this issue.

The classification of severe alopecia areata (AA) and its treatment are evolving. Dr Ali Jabbari, from the University of Iowa, discusses factors that characterize severe AA and traces the expanded treatment options provided by the advent of Janus kinase (JAK) inhibitors.

Dr Jabbari reports on a modified AA severity scale, published in the Journal of American Academy of Dermatology, in which the presence of certain factors upgrade the level of severity. Factors include eyebrow/eyelash involvement and psychosocial comorbidities such as depression, anxiety, and social phobias. Traditional treatments for severe AA have relied largely on corticosteroids. Dr Jabbari explains how this treatment can be helpful for patients with limited disease, but may be burdensome for those with severe disease, in terms of injection pain and side effects of long-term use. Another option for patients with severe AA is the use of systemic immunosuppressants, but these are not as effective as newer treatments.

Dr Jabbari looks at two FDA-approved options for JAK inhibitors: baricitinib for patients aged 18 years or older and ritlecitinib for patients aged 12 years or older. He notes some of the potential side effects of these medications but concludes that JAK inhibitors are a safe option for treating patients with severe AA.

--

Ali Jabbari, MD, PhD, Chair, DEO, Roger I. Ceilley Associate Professor, Department of Dermatology, University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa

Ali Jabbari, MD, PhD, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: Pfizer; Inc.; Cage Bio

Received research grant from: National Institutes of Health; Department of Veterans Affairs; Pfizer; Inc

Scientific Advisory Board for: BiologicsMD

The classification of severe alopecia areata (AA) and its treatment are evolving. Dr Ali Jabbari, from the University of Iowa, discusses factors that characterize severe AA and traces the expanded treatment options provided by the advent of Janus kinase (JAK) inhibitors.

Dr Jabbari reports on a modified AA severity scale, published in the Journal of American Academy of Dermatology, in which the presence of certain factors upgrade the level of severity. Factors include eyebrow/eyelash involvement and psychosocial comorbidities such as depression, anxiety, and social phobias. Traditional treatments for severe AA have relied largely on corticosteroids. Dr Jabbari explains how this treatment can be helpful for patients with limited disease, but may be burdensome for those with severe disease, in terms of injection pain and side effects of long-term use. Another option for patients with severe AA is the use of systemic immunosuppressants, but these are not as effective as newer treatments.

Dr Jabbari looks at two FDA-approved options for JAK inhibitors: baricitinib for patients aged 18 years or older and ritlecitinib for patients aged 12 years or older. He notes some of the potential side effects of these medications but concludes that JAK inhibitors are a safe option for treating patients with severe AA.

--

Ali Jabbari, MD, PhD, Chair, DEO, Roger I. Ceilley Associate Professor, Department of Dermatology, University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa

Ali Jabbari, MD, PhD, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: Pfizer; Inc.; Cage Bio

Received research grant from: National Institutes of Health; Department of Veterans Affairs; Pfizer; Inc

Scientific Advisory Board for: BiologicsMD

The classification of severe alopecia areata (AA) and its treatment are evolving. Dr Ali Jabbari, from the University of Iowa, discusses factors that characterize severe AA and traces the expanded treatment options provided by the advent of Janus kinase (JAK) inhibitors.

Dr Jabbari reports on a modified AA severity scale, published in the Journal of American Academy of Dermatology, in which the presence of certain factors upgrade the level of severity. Factors include eyebrow/eyelash involvement and psychosocial comorbidities such as depression, anxiety, and social phobias. Traditional treatments for severe AA have relied largely on corticosteroids. Dr Jabbari explains how this treatment can be helpful for patients with limited disease, but may be burdensome for those with severe disease, in terms of injection pain and side effects of long-term use. Another option for patients with severe AA is the use of systemic immunosuppressants, but these are not as effective as newer treatments.

Dr Jabbari looks at two FDA-approved options for JAK inhibitors: baricitinib for patients aged 18 years or older and ritlecitinib for patients aged 12 years or older. He notes some of the potential side effects of these medications but concludes that JAK inhibitors are a safe option for treating patients with severe AA.

--

Ali Jabbari, MD, PhD, Chair, DEO, Roger I. Ceilley Associate Professor, Department of Dermatology, University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa

Ali Jabbari, MD, PhD, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: Pfizer; Inc.; Cage Bio

Received research grant from: National Institutes of Health; Department of Veterans Affairs; Pfizer; Inc

Scientific Advisory Board for: BiologicsMD

In a survey of adults with moderate to severe atopic dermatitis (AD) participating in a patient support program for upadacitinib in the United States, 86.8% reported that their itch was “very much” or “much” improved from taking the drug, while 7.8% rated their itch as minimally improved.

Also, 27.5% reported itch improvement within one day of taking upadacitinib (Rinvoq), an oral Janus kinase inhibitor that was approved to treat moderate to severe AD in adults and children aged ≥ 12 years in January 2022.

“We have a lot of data about upadacitinib from clinical trials, but sometimes there’s a concern that when you start using a medication in the real world, the effectiveness doesn’t match up with the efficacy observed in clinical trials,” the study’s first author, Jonathan I. Silverberg, MD, PhD, professor of dermatology at George Washington University, Washington, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session. “We always want to confirm or reaffirm clinical trial results with real-world data.”

Dr. Silverberg

In SCALE-UP, 6191 adults with moderate to severe AD participating in the patient support program for upadacitinib in the United States were invited to complete a one-time online survey about their experience with upadacitinib, including the degree of and time to itch improvement and skin clearance. The researchers reported on 204 patients who completed the survey questions, for a response rate of 3.3%. The mean age of respondents was 45.3 years, their mean age when diagnosed with AD was 30.3 years; 70.1% were women, and 37% were using topical corticosteroids. In addition, 68.6% were White individuals, 12.3% were Black individuals, 8.8% were Asian individuals or Pacific Islanders, and 0.5% were Native Americans/Alaska Natives.

Duration of upadacitinib treatment was 2-6 months for 50.5% of the patients and 7-12 months for the remaining patients. Starting upadacitinib dose was 15 mg for about 95% of patients and 30 mg for nearly 4% of patients. At the time of the survey, 79.4% of patients were receiving upadacitinib 15 mg once a day, and 19.6% were receiving upadacitinib 30 mg once a day.
 

Improvements in Itch, Skin Clearance

Nearly all experienced improvements in itch, with 86.8% reporting “very much” or “much” improved itch. Relief was rapid, with 87% noticing improvement in itch within 7 days and 27.5% noticing improvement within 1 day. “This is something I have clinically seen,” Dr. Silverberg said.

After receiving upadacitinib, 87% and 86% of patients indicated they were “extremely” or “very” satisfied with the degree and speed of itch improvement, respectively.

In findings related to skin clearance, 90.7% of respondents reported clearer skin after initiating upadacitinib, with 81.4% reporting “very much” or “much” clearer skin. Skin clearance occurred rapidly, with 30.8% of patients noticing clearer skin within 3 days of starting upadacitinib and 89.2% of patients noticing clearer skin within 14 days. The proportions of patients who were “extremely” or “very” satisfied with the degree and speed of skin clearance were 83.8% and 83.2%, respectively.

“What we’re seeing is that the real-world effectiveness [of upadacitinib] aligns with the clinical trial efficacy,” Dr. Silverberg told this news organization. “This study adds even more data to help inform shared decision-making discussion with our patients in trying to decide what medication is best for them.”

He acknowledged certain limitations of the survey, including the lack of a control group of other treatments for comparison, a low response rate, and the potential for response bias. “That said, I think the results remain important, but we value having even more real-world data in the future from prospective registries,” he said. “Those kinds of studies are ongoing, and we look forward to getting more real-world data readouts.”

AbbVie, the manufacturer of upadacitinib, funded the study. Dr. Silverberg reported having served as an advisor, consultant, speaker, and/or investigator for several pharmaceutical companies, including AbbVie. Two authors are AbbVie employees.

A version of this article appeared on Medscape.com.

In a survey of adults with moderate to severe atopic dermatitis (AD) participating in a patient support program for upadacitinib in the United States, 86.8% reported that their itch was “very much” or “much” improved from taking the drug, while 7.8% rated their itch as minimally improved.

Also, 27.5% reported itch improvement within one day of taking upadacitinib (Rinvoq), an oral Janus kinase inhibitor that was approved to treat moderate to severe AD in adults and children aged ≥ 12 years in January 2022.

“We have a lot of data about upadacitinib from clinical trials, but sometimes there’s a concern that when you start using a medication in the real world, the effectiveness doesn’t match up with the efficacy observed in clinical trials,” the study’s first author, Jonathan I. Silverberg, MD, PhD, professor of dermatology at George Washington University, Washington, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session. “We always want to confirm or reaffirm clinical trial results with real-world data.”

Dr. Silverberg

In SCALE-UP, 6191 adults with moderate to severe AD participating in the patient support program for upadacitinib in the United States were invited to complete a one-time online survey about their experience with upadacitinib, including the degree of and time to itch improvement and skin clearance. The researchers reported on 204 patients who completed the survey questions, for a response rate of 3.3%. The mean age of respondents was 45.3 years, their mean age when diagnosed with AD was 30.3 years; 70.1% were women, and 37% were using topical corticosteroids. In addition, 68.6% were White individuals, 12.3% were Black individuals, 8.8% were Asian individuals or Pacific Islanders, and 0.5% were Native Americans/Alaska Natives.

Duration of upadacitinib treatment was 2-6 months for 50.5% of the patients and 7-12 months for the remaining patients. Starting upadacitinib dose was 15 mg for about 95% of patients and 30 mg for nearly 4% of patients. At the time of the survey, 79.4% of patients were receiving upadacitinib 15 mg once a day, and 19.6% were receiving upadacitinib 30 mg once a day.
 

Improvements in Itch, Skin Clearance

Nearly all experienced improvements in itch, with 86.8% reporting “very much” or “much” improved itch. Relief was rapid, with 87% noticing improvement in itch within 7 days and 27.5% noticing improvement within 1 day. “This is something I have clinically seen,” Dr. Silverberg said.

After receiving upadacitinib, 87% and 86% of patients indicated they were “extremely” or “very” satisfied with the degree and speed of itch improvement, respectively.

In findings related to skin clearance, 90.7% of respondents reported clearer skin after initiating upadacitinib, with 81.4% reporting “very much” or “much” clearer skin. Skin clearance occurred rapidly, with 30.8% of patients noticing clearer skin within 3 days of starting upadacitinib and 89.2% of patients noticing clearer skin within 14 days. The proportions of patients who were “extremely” or “very” satisfied with the degree and speed of skin clearance were 83.8% and 83.2%, respectively.

“What we’re seeing is that the real-world effectiveness [of upadacitinib] aligns with the clinical trial efficacy,” Dr. Silverberg told this news organization. “This study adds even more data to help inform shared decision-making discussion with our patients in trying to decide what medication is best for them.”

He acknowledged certain limitations of the survey, including the lack of a control group of other treatments for comparison, a low response rate, and the potential for response bias. “That said, I think the results remain important, but we value having even more real-world data in the future from prospective registries,” he said. “Those kinds of studies are ongoing, and we look forward to getting more real-world data readouts.”

AbbVie, the manufacturer of upadacitinib, funded the study. Dr. Silverberg reported having served as an advisor, consultant, speaker, and/or investigator for several pharmaceutical companies, including AbbVie. Two authors are AbbVie employees.

A version of this article appeared on Medscape.com.

In a survey of adults with moderate to severe atopic dermatitis (AD) participating in a patient support program for upadacitinib in the United States, 86.8% reported that their itch was “very much” or “much” improved from taking the drug, while 7.8% rated their itch as minimally improved.

Also, 27.5% reported itch improvement within one day of taking upadacitinib (Rinvoq), an oral Janus kinase inhibitor that was approved to treat moderate to severe AD in adults and children aged ≥ 12 years in January 2022.

“We have a lot of data about upadacitinib from clinical trials, but sometimes there’s a concern that when you start using a medication in the real world, the effectiveness doesn’t match up with the efficacy observed in clinical trials,” the study’s first author, Jonathan I. Silverberg, MD, PhD, professor of dermatology at George Washington University, Washington, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session. “We always want to confirm or reaffirm clinical trial results with real-world data.”

Dr. Silverberg

In SCALE-UP, 6191 adults with moderate to severe AD participating in the patient support program for upadacitinib in the United States were invited to complete a one-time online survey about their experience with upadacitinib, including the degree of and time to itch improvement and skin clearance. The researchers reported on 204 patients who completed the survey questions, for a response rate of 3.3%. The mean age of respondents was 45.3 years, their mean age when diagnosed with AD was 30.3 years; 70.1% were women, and 37% were using topical corticosteroids. In addition, 68.6% were White individuals, 12.3% were Black individuals, 8.8% were Asian individuals or Pacific Islanders, and 0.5% were Native Americans/Alaska Natives.

Duration of upadacitinib treatment was 2-6 months for 50.5% of the patients and 7-12 months for the remaining patients. Starting upadacitinib dose was 15 mg for about 95% of patients and 30 mg for nearly 4% of patients. At the time of the survey, 79.4% of patients were receiving upadacitinib 15 mg once a day, and 19.6% were receiving upadacitinib 30 mg once a day.
 

Improvements in Itch, Skin Clearance

Nearly all experienced improvements in itch, with 86.8% reporting “very much” or “much” improved itch. Relief was rapid, with 87% noticing improvement in itch within 7 days and 27.5% noticing improvement within 1 day. “This is something I have clinically seen,” Dr. Silverberg said.

After receiving upadacitinib, 87% and 86% of patients indicated they were “extremely” or “very” satisfied with the degree and speed of itch improvement, respectively.

In findings related to skin clearance, 90.7% of respondents reported clearer skin after initiating upadacitinib, with 81.4% reporting “very much” or “much” clearer skin. Skin clearance occurred rapidly, with 30.8% of patients noticing clearer skin within 3 days of starting upadacitinib and 89.2% of patients noticing clearer skin within 14 days. The proportions of patients who were “extremely” or “very” satisfied with the degree and speed of skin clearance were 83.8% and 83.2%, respectively.

“What we’re seeing is that the real-world effectiveness [of upadacitinib] aligns with the clinical trial efficacy,” Dr. Silverberg told this news organization. “This study adds even more data to help inform shared decision-making discussion with our patients in trying to decide what medication is best for them.”

He acknowledged certain limitations of the survey, including the lack of a control group of other treatments for comparison, a low response rate, and the potential for response bias. “That said, I think the results remain important, but we value having even more real-world data in the future from prospective registries,” he said. “Those kinds of studies are ongoing, and we look forward to getting more real-world data readouts.”

AbbVie, the manufacturer of upadacitinib, funded the study. Dr. Silverberg reported having served as an advisor, consultant, speaker, and/or investigator for several pharmaceutical companies, including AbbVie. Two authors are AbbVie employees.

A version of this article appeared on Medscape.com.

Isotretinoin was introduced more than 3 decades ago and marked a major advancement in the treatment of severe refractory cystic acne. The most common adverse effects linked to isotretinoin usage are mucocutaneous in nature, manifesting as xerosis and cheilitis.¹ Skin fragility and poor wound healing also have been reported.^2-6 Current recommendations for avoiding these adverse effects include refraining from waxing, laser procedures, and other elective cutaneous procedures for at least 6 months.⁷ We present a case of isotretinoin-induced cutaneous fragility resulting in blistering and erosions on the palms of a competitive aerial trapeze artist.

Case Report

A 25-year-old woman presented for follow-up during week 12 of isotretinoin therapy (40 mg twice daily) prescribed for acne. She reported peeling of the skin on the palms following intense aerial acrobatic workouts. She had been a performing aerialist for many years and had never sustained a similar injury. The wounds were painful and led to decreased activity. She had no notable medical history. Physical examination of the palms revealed erosions in a distribution that corresponded to horizontal bar contact and friction (Figure). The patient was advised on proper wound care, application of emollients, and minimizing friction. She completed the course of isotretinoin and has continued aerialist activity without recurrence of skin fragility.

Comment

Skin fragility is a well-known adverse effect of isotretinoin therapy.⁸ Pavlis and Lieblich⁹ reported skin fragility in a young wrestler who experienced similar skin erosions due to isotretinoin therapy. The proposed mechanism of isotretinoin-induced skin fragility is multifactorial. It involves an apoptotic effect on sebocytes,⁵ which results in reduced stratum corneum hydration and an associated increase in transepidermal water loss.^6,10,11 Retinoids also are known to cause thinning of the skin, likely due to the disadhesion of both the epidermis and the stratum corneum, which was demonstrated by the easy removal of cornified cells through tape stripping in hairless mice treated with isotretinoin.¹² In further investigations, human patients and hairless mice treated with isotretinoin readily developed friction blisters through pencil eraser abrasion.¹³ Examination of the friction blisters using light and electron microscopy revealed fraying or loss of the stratum corneum and viable epidermis as well as loss of desmosomes and tonofilaments. Additionally, intracellular and intercellular deposits of an unidentified amorphous material were noted.¹³

Overall, the origin of skin fragility induced by isotretinoin is supported by its effect on sebocytes, increased transepidermal water loss, and profound disruption of the integrity of the epidermis, resulting in an elevated risk for inadvertent skin damage. Patients were encouraged to avoid cosmetic procedures in prior case reports,^14-16 and because our case demonstrates the risk for cutaneous injury in athletes due to isotretinoin-induced skin fragility, we propose an extension of these warnings to encompass athletes receiving isotretinoin treatment. Offering early guidance on wound prevention is of paramount importance in maintaining athletic performance and minimizing painful injuries.

Isotretinoin was introduced more than 3 decades ago and marked a major advancement in the treatment of severe refractory cystic acne. The most common adverse effects linked to isotretinoin usage are mucocutaneous in nature, manifesting as xerosis and cheilitis.¹ Skin fragility and poor wound healing also have been reported.^2-6 Current recommendations for avoiding these adverse effects include refraining from waxing, laser procedures, and other elective cutaneous procedures for at least 6 months.⁷ We present a case of isotretinoin-induced cutaneous fragility resulting in blistering and erosions on the palms of a competitive aerial trapeze artist.

Case Report

A 25-year-old woman presented for follow-up during week 12 of isotretinoin therapy (40 mg twice daily) prescribed for acne. She reported peeling of the skin on the palms following intense aerial acrobatic workouts. She had been a performing aerialist for many years and had never sustained a similar injury. The wounds were painful and led to decreased activity. She had no notable medical history. Physical examination of the palms revealed erosions in a distribution that corresponded to horizontal bar contact and friction (Figure). The patient was advised on proper wound care, application of emollients, and minimizing friction. She completed the course of isotretinoin and has continued aerialist activity without recurrence of skin fragility.

Comment

Skin fragility is a well-known adverse effect of isotretinoin therapy.⁸ Pavlis and Lieblich⁹ reported skin fragility in a young wrestler who experienced similar skin erosions due to isotretinoin therapy. The proposed mechanism of isotretinoin-induced skin fragility is multifactorial. It involves an apoptotic effect on sebocytes,⁵ which results in reduced stratum corneum hydration and an associated increase in transepidermal water loss.^6,10,11 Retinoids also are known to cause thinning of the skin, likely due to the disadhesion of both the epidermis and the stratum corneum, which was demonstrated by the easy removal of cornified cells through tape stripping in hairless mice treated with isotretinoin.¹² In further investigations, human patients and hairless mice treated with isotretinoin readily developed friction blisters through pencil eraser abrasion.¹³ Examination of the friction blisters using light and electron microscopy revealed fraying or loss of the stratum corneum and viable epidermis as well as loss of desmosomes and tonofilaments. Additionally, intracellular and intercellular deposits of an unidentified amorphous material were noted.¹³

Overall, the origin of skin fragility induced by isotretinoin is supported by its effect on sebocytes, increased transepidermal water loss, and profound disruption of the integrity of the epidermis, resulting in an elevated risk for inadvertent skin damage. Patients were encouraged to avoid cosmetic procedures in prior case reports,^14-16 and because our case demonstrates the risk for cutaneous injury in athletes due to isotretinoin-induced skin fragility, we propose an extension of these warnings to encompass athletes receiving isotretinoin treatment. Offering early guidance on wound prevention is of paramount importance in maintaining athletic performance and minimizing painful injuries.

Isotretinoin was introduced more than 3 decades ago and marked a major advancement in the treatment of severe refractory cystic acne. The most common adverse effects linked to isotretinoin usage are mucocutaneous in nature, manifesting as xerosis and cheilitis.¹ Skin fragility and poor wound healing also have been reported.^2-6 Current recommendations for avoiding these adverse effects include refraining from waxing, laser procedures, and other elective cutaneous procedures for at least 6 months.⁷ We present a case of isotretinoin-induced cutaneous fragility resulting in blistering and erosions on the palms of a competitive aerial trapeze artist.

Case Report

A 25-year-old woman presented for follow-up during week 12 of isotretinoin therapy (40 mg twice daily) prescribed for acne. She reported peeling of the skin on the palms following intense aerial acrobatic workouts. She had been a performing aerialist for many years and had never sustained a similar injury. The wounds were painful and led to decreased activity. She had no notable medical history. Physical examination of the palms revealed erosions in a distribution that corresponded to horizontal bar contact and friction (Figure). The patient was advised on proper wound care, application of emollients, and minimizing friction. She completed the course of isotretinoin and has continued aerialist activity without recurrence of skin fragility.

Comment

Skin fragility is a well-known adverse effect of isotretinoin therapy.⁸ Pavlis and Lieblich⁹ reported skin fragility in a young wrestler who experienced similar skin erosions due to isotretinoin therapy. The proposed mechanism of isotretinoin-induced skin fragility is multifactorial. It involves an apoptotic effect on sebocytes,⁵ which results in reduced stratum corneum hydration and an associated increase in transepidermal water loss.^6,10,11 Retinoids also are known to cause thinning of the skin, likely due to the disadhesion of both the epidermis and the stratum corneum, which was demonstrated by the easy removal of cornified cells through tape stripping in hairless mice treated with isotretinoin.¹² In further investigations, human patients and hairless mice treated with isotretinoin readily developed friction blisters through pencil eraser abrasion.¹³ Examination of the friction blisters using light and electron microscopy revealed fraying or loss of the stratum corneum and viable epidermis as well as loss of desmosomes and tonofilaments. Additionally, intracellular and intercellular deposits of an unidentified amorphous material were noted.¹³

Overall, the origin of skin fragility induced by isotretinoin is supported by its effect on sebocytes, increased transepidermal water loss, and profound disruption of the integrity of the epidermis, resulting in an elevated risk for inadvertent skin damage. Patients were encouraged to avoid cosmetic procedures in prior case reports,^14-16 and because our case demonstrates the risk for cutaneous injury in athletes due to isotretinoin-induced skin fragility, we propose an extension of these warnings to encompass athletes receiving isotretinoin treatment. Offering early guidance on wound prevention is of paramount importance in maintaining athletic performance and minimizing painful injuries.

Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorial, John A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorial, John A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorial, John A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Medicaid acceptance among pediatric dermatologists varies significantly by practice type and region, with the highest rate among academic practices.

METHODOLOGY:

• Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
• They collected physician and practice characteristics from the US Census American Community Survey data and a web search.

TAKEAWAY:

• A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
• Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
• Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
• Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).

IN PRACTICE:

“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
 

SOURCE:

The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
 

LIMITATIONS:

Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
 

DISCLOSURES:

The study funding source was not disclosed. One author was a consultant for AbbVie. Other 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 appeared on Medscape.com.

TOPLINE:

Medicaid acceptance among pediatric dermatologists varies significantly by practice type and region, with the highest rate among academic practices.

METHODOLOGY:

• Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
• They collected physician and practice characteristics from the US Census American Community Survey data and a web search.

TAKEAWAY:

• A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
• Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
• Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
• Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).

IN PRACTICE:

“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
 

SOURCE:

The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
 

LIMITATIONS:

Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
 

DISCLOSURES:

The study funding source was not disclosed. One author was a consultant for AbbVie. Other 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 appeared on Medscape.com.

TOPLINE:

Medicaid acceptance among pediatric dermatologists varies significantly by practice type and region, with the highest rate among academic practices.

METHODOLOGY:

• Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
• They collected physician and practice characteristics from the US Census American Community Survey data and a web search.

TAKEAWAY:

• A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
• Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
• Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
• Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).

IN PRACTICE:

“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
 

SOURCE:

The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
 

LIMITATIONS:

Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
 

DISCLOSURES:

The study funding source was not disclosed. One author was a consultant for AbbVie. Other 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 appeared on Medscape.com.

TOPLINE:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

METHODOLOGY:

• Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
• A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
• DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

• The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
• The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
• The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
• Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

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:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

METHODOLOGY:

• Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
• A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
• DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

• The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
• The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
• The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
• Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

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:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

METHODOLOGY:

• Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
• A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
• DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

• The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
• The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
• The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
• Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

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.

VIENNA — While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

VIENNA — While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

VIENNA — While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

Practice Gap

Epidermoid cysts are asymptomatic, well-circumscribed, mobile, subcutaneous masses that elevate the skin. Also known as epidermal, keratin, or infundibular cysts, epidermoid cysts are caused by proliferation of surface epidermoid cells within the dermis and can arise anywhere on the body, most commonly on the face, neck, and trunk.¹ Cutaneous cysts often contain fluid or semifluid contents and can be aesthetically displeasing or cause mild pain, prompting patients to seek removal. Definitive treatment of epidermoid cysts is complete surgical removal,² which can be performed in office in a sterile or clean manner by either dermatologists or primary care providers.

Prior to incision, a local anesthetic—commonly lidocaine with epinephrine—is injected in the region surrounding the cyst sac so as not to rupture the cyst wall. Maintaining the cyst wall throughout the procedure ensures total cyst removal and minimizes the risk for recurrence. However, it often is difficult to approximate the cyst border because it cannot be visualized prior to incision.

Throughout the duration of the procedure, cyst contents may suddenly spray out of the area and pose a risk to providers and their staff (Figure, A). Even with careful application around the periphery, either puncture or ­pericystic anesthesia between the cyst wall and the dermis can lead to splatter. Larger and wider peripheral anesthesia may not be possible given a shortage of ­lidocaine and a desire to minimize injection. Even with meticulous use of personal protective equipment in cutaneous surgery, infectious organisms found in ruptured cysts and abscesses may spray the surgical field.³ Therefore, it is in our best interest to minimize the trajectory of cyst spray contents.

The Tools

We have employed 2 simple techniques using equipment normally found on a standard surgical tray for easy safe injection of cysts. Supplies needed include 4×4-inch gauze pads, alcohol and chlorhexidine, a marker, all instruments necessary for cyst excision, and a small clear biohazard bag.

The Technique

Prior to covering the cyst, care is taken to locate the cyst opening. At times, a comedo or punctum can be seen overlying the cyst bulge. We mark the lumen and cyst opening with a surgical marker. If the pore is not easily identified, we draw an 8-mm circle around the mound of the cyst. 

One option is to apply a gauze pad over the cyst to allow for stabilization of the surgical field and blanket the area from splatter (Figure, B). Then we cover the cyst using antiseptic-soaked gauze as a protective barrier to avoid potentially contaminated spray. This tool can be constructed from a 4×4-inch gauze pad with the addition of alcohol and chlorhexidine. When the cyst is covered, the surgeon can inject the lesion and surrounding tissue without biohazard splatter.

Practice Implications

Outpatient surgical excision is a common effective procedure for epidermoid cysts. However, it is not uncommon for cyst contents to spray during the injection of anesthetic, posing a nuisance to the surgeon, health care staff, and patient. The technique of covering the lesion with antiseptic-soaked gauze or a small clear biohazard bag prevents cyst contents from spraying and reduces risk for contamination. In addition to these protective benefits, the use of readily available items replaces the need to order a splatter control shield.

Limitations—Although we seldom see spray using our technique, covering the cyst with gauze may disguise the region of interest and interfere with accurate incision. Marking the lesion prior to anesthesia administration or using a clear biohazard bag minimizes difficulty visualizing the cyst opening.

Practice Gap

Epidermoid cysts are asymptomatic, well-circumscribed, mobile, subcutaneous masses that elevate the skin. Also known as epidermal, keratin, or infundibular cysts, epidermoid cysts are caused by proliferation of surface epidermoid cells within the dermis and can arise anywhere on the body, most commonly on the face, neck, and trunk.¹ Cutaneous cysts often contain fluid or semifluid contents and can be aesthetically displeasing or cause mild pain, prompting patients to seek removal. Definitive treatment of epidermoid cysts is complete surgical removal,² which can be performed in office in a sterile or clean manner by either dermatologists or primary care providers.

Prior to incision, a local anesthetic—commonly lidocaine with epinephrine—is injected in the region surrounding the cyst sac so as not to rupture the cyst wall. Maintaining the cyst wall throughout the procedure ensures total cyst removal and minimizes the risk for recurrence. However, it often is difficult to approximate the cyst border because it cannot be visualized prior to incision.

Throughout the duration of the procedure, cyst contents may suddenly spray out of the area and pose a risk to providers and their staff (Figure, A). Even with careful application around the periphery, either puncture or ­pericystic anesthesia between the cyst wall and the dermis can lead to splatter. Larger and wider peripheral anesthesia may not be possible given a shortage of ­lidocaine and a desire to minimize injection. Even with meticulous use of personal protective equipment in cutaneous surgery, infectious organisms found in ruptured cysts and abscesses may spray the surgical field.³ Therefore, it is in our best interest to minimize the trajectory of cyst spray contents.

The Tools

We have employed 2 simple techniques using equipment normally found on a standard surgical tray for easy safe injection of cysts. Supplies needed include 4×4-inch gauze pads, alcohol and chlorhexidine, a marker, all instruments necessary for cyst excision, and a small clear biohazard bag.

The Technique

Prior to covering the cyst, care is taken to locate the cyst opening. At times, a comedo or punctum can be seen overlying the cyst bulge. We mark the lumen and cyst opening with a surgical marker. If the pore is not easily identified, we draw an 8-mm circle around the mound of the cyst. 

One option is to apply a gauze pad over the cyst to allow for stabilization of the surgical field and blanket the area from splatter (Figure, B). Then we cover the cyst using antiseptic-soaked gauze as a protective barrier to avoid potentially contaminated spray. This tool can be constructed from a 4×4-inch gauze pad with the addition of alcohol and chlorhexidine. When the cyst is covered, the surgeon can inject the lesion and surrounding tissue without biohazard splatter.

Practice Implications

Outpatient surgical excision is a common effective procedure for epidermoid cysts. However, it is not uncommon for cyst contents to spray during the injection of anesthetic, posing a nuisance to the surgeon, health care staff, and patient. The technique of covering the lesion with antiseptic-soaked gauze or a small clear biohazard bag prevents cyst contents from spraying and reduces risk for contamination. In addition to these protective benefits, the use of readily available items replaces the need to order a splatter control shield.

Limitations—Although we seldom see spray using our technique, covering the cyst with gauze may disguise the region of interest and interfere with accurate incision. Marking the lesion prior to anesthesia administration or using a clear biohazard bag minimizes difficulty visualizing the cyst opening.

Practice Gap

Epidermoid cysts are asymptomatic, well-circumscribed, mobile, subcutaneous masses that elevate the skin. Also known as epidermal, keratin, or infundibular cysts, epidermoid cysts are caused by proliferation of surface epidermoid cells within the dermis and can arise anywhere on the body, most commonly on the face, neck, and trunk.¹ Cutaneous cysts often contain fluid or semifluid contents and can be aesthetically displeasing or cause mild pain, prompting patients to seek removal. Definitive treatment of epidermoid cysts is complete surgical removal,² which can be performed in office in a sterile or clean manner by either dermatologists or primary care providers.

Prior to incision, a local anesthetic—commonly lidocaine with epinephrine—is injected in the region surrounding the cyst sac so as not to rupture the cyst wall. Maintaining the cyst wall throughout the procedure ensures total cyst removal and minimizes the risk for recurrence. However, it often is difficult to approximate the cyst border because it cannot be visualized prior to incision.

Throughout the duration of the procedure, cyst contents may suddenly spray out of the area and pose a risk to providers and their staff (Figure, A). Even with careful application around the periphery, either puncture or ­pericystic anesthesia between the cyst wall and the dermis can lead to splatter. Larger and wider peripheral anesthesia may not be possible given a shortage of ­lidocaine and a desire to minimize injection. Even with meticulous use of personal protective equipment in cutaneous surgery, infectious organisms found in ruptured cysts and abscesses may spray the surgical field.³ Therefore, it is in our best interest to minimize the trajectory of cyst spray contents.

The Tools

We have employed 2 simple techniques using equipment normally found on a standard surgical tray for easy safe injection of cysts. Supplies needed include 4×4-inch gauze pads, alcohol and chlorhexidine, a marker, all instruments necessary for cyst excision, and a small clear biohazard bag.

The Technique

Prior to covering the cyst, care is taken to locate the cyst opening. At times, a comedo or punctum can be seen overlying the cyst bulge. We mark the lumen and cyst opening with a surgical marker. If the pore is not easily identified, we draw an 8-mm circle around the mound of the cyst. 

One option is to apply a gauze pad over the cyst to allow for stabilization of the surgical field and blanket the area from splatter (Figure, B). Then we cover the cyst using antiseptic-soaked gauze as a protective barrier to avoid potentially contaminated spray. This tool can be constructed from a 4×4-inch gauze pad with the addition of alcohol and chlorhexidine. When the cyst is covered, the surgeon can inject the lesion and surrounding tissue without biohazard splatter.

Practice Implications

Outpatient surgical excision is a common effective procedure for epidermoid cysts. However, it is not uncommon for cyst contents to spray during the injection of anesthetic, posing a nuisance to the surgeon, health care staff, and patient. The technique of covering the lesion with antiseptic-soaked gauze or a small clear biohazard bag prevents cyst contents from spraying and reduces risk for contamination. In addition to these protective benefits, the use of readily available items replaces the need to order a splatter control shield.

Limitations—Although we seldom see spray using our technique, covering the cyst with gauze may disguise the region of interest and interfere with accurate incision. Marking the lesion prior to anesthesia administration or using a clear biohazard bag minimizes difficulty visualizing the cyst opening.

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

• Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
• Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

• Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
• Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

• Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
• Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.