Dermatology

Clinicians should incorporate at least one of three validated instruments to measure signs of atopic dermatitis (AD) in their clinical practice, the authors of a new consensus statement recommended.

These include the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment for AD (vIGAAD), and the Investigator’s Global Assessment (IGA) multiplied by or measured concurrently with a body surface area (BSA) assessment.

The recommendations are part of a consensus statement based on an updated systematic review conducted by the Harmonizing Outcome Measures for Eczema Clinical Practice (HOME-CP) initiative, whose goal is to identify validated, feasible outcome instruments designed to measure AD in the clinical setting. In the statement, which was published in JAMA Dermatology on May 22, 2024, corresponding author Eric L. Simpson, MD, MCR, professor of dermatology at Oregon Health & Science University, Portland, and coauthors described HOME-CP as “a ‘pick-and-choose’ list of valid and feasible OMIs [outcome measure instruments] that can be incorporated into the practice setting depending on the particular need of that clinic or health system.”

For the effort, the authors implemented a mixed methods design and incorporated systematic reviews and qualitative consensus methods modeled after the HOME core outcome set initiative, which developed a set of consensus-based core outcome sets for clinical trials and clinical practice. In October of 2022, a daylong in-person consensus exercise was held in Montreal, Canada, where attendees met to reach consensus on recommended instruments to measure AD clinical signs in clinical practice, based on an updated systematic review evaluating the validity of clinical signs instruments.

The review included 22 studies describing 16 instruments that assessed AD clinical signs and an additional 12 variants of instruments. The meeting was attended by 34 individuals from 13 countries, including patient and patient advocate research partners, health care professionals, researchers, methodologists, and industry representatives. Consensus was defined as less than 30% disagreement.

Following their daylong consensus exercise, the stakeholders reached consensus on recommendations to use the EASI, the vIGAAD, and an IGA multiplied or measured alongside a BSA measurement to measure the domain of clinical signs of AD in the clinical practice setting. “The use of multiple IGAs, most with insufficient validation, and the diverse methods used to assess BSA prevented participants from making specific recommendations for the exact IGA/BSA instrument,” the authors wrote. “We recommend that clinicians include at least one of the recommended instruments in their clinical practices and in documentation.” 

They explained that the ideal method of measuring BSA was difficult to assess “because multiple techniques exist for its measurement, including regional percentages, the Rule of Nines, or the handprint method. Most studies did not report which method was performed, and to our knowledge, no studies have been performed in patients with AD that have formally compared them.”

During the consensus exercise, the authors noted, several clinicians “expressed concern whether the EASI was feasible for universal use in clinical practice given its complexity, long completion time, and documentation/calculation requirements.” But clinicians who commonly perform the EASI in clinical practice said that the time it takes to complete this measure “has dropped substantially and now is not a considerable burden,” they wrote, adding that, “studies have shown that with trained investigators, EASI completion times can be as low as nearly 2 minutes.”

The authors acknowledged certain limitations of their recommendations, including the lack of input from primary care clinicians. “It is unknown whether ClinROMs [clinician-reported outcome measures] for AD clinical signs are used in the primary care setting, especially given the large amount of conditions that are managed simultaneously and the ever-increasing number of primary care documentation requirements,” they wrote.

Robert Sidbury, MD, MPH, chief of the division of dermatology at Seattle Children’s Hospital, who was asked to comment on the consensus statement, said that with the advent of new, improved, and more expensive medications for AD, “it is ever more important that [the clinical] assessment is reliable and reproducible.”

Insurers “are understandably less willing to rubber-stamp approval of more expensive medications without a reliable standard by which to justify such decisions,” he added. “This is even more important in a disease state like atopic dermatitis that lacks a reliable biomarker. Therefore, one or several practical, reliable, validated severity metrics will help standardize and improve AD care.”

Dr. Sidbury, who cochaired the 2023 American Academy of Dermatology guidelines of care for the management of AD in adults with phototherapy and systemic therapies, added that the instruments evaluated in the review “can be challenging for anyone,” not just primary care providers. “The EASI isn’t that easy, and while there is a learning curve and it ultimately does, like anything, become more efficient in the gathering, it is unclear if non-AD researchers will be willing to invest the time” to routinely use it, he said.

Dr. Simpson and several coauthors reported receiving grants and personal fees from multiple pharmaceutical companies. Dr. Sidbury reported that he serves as an investigator for Regeneron, Galderma, UCB, Castle, and Pfizer; is a consultant for LEO, Lilly, Arcutis, Dermavant, and Pierre Fabre; and a speaker for Beiersdorf.

A version of this article appeared on Medscape.com .

Clinicians should incorporate at least one of three validated instruments to measure signs of atopic dermatitis (AD) in their clinical practice, the authors of a new consensus statement recommended.

These include the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment for AD (vIGAAD), and the Investigator’s Global Assessment (IGA) multiplied by or measured concurrently with a body surface area (BSA) assessment.

The recommendations are part of a consensus statement based on an updated systematic review conducted by the Harmonizing Outcome Measures for Eczema Clinical Practice (HOME-CP) initiative, whose goal is to identify validated, feasible outcome instruments designed to measure AD in the clinical setting. In the statement, which was published in JAMA Dermatology on May 22, 2024, corresponding author Eric L. Simpson, MD, MCR, professor of dermatology at Oregon Health & Science University, Portland, and coauthors described HOME-CP as “a ‘pick-and-choose’ list of valid and feasible OMIs [outcome measure instruments] that can be incorporated into the practice setting depending on the particular need of that clinic or health system.”

For the effort, the authors implemented a mixed methods design and incorporated systematic reviews and qualitative consensus methods modeled after the HOME core outcome set initiative, which developed a set of consensus-based core outcome sets for clinical trials and clinical practice. In October of 2022, a daylong in-person consensus exercise was held in Montreal, Canada, where attendees met to reach consensus on recommended instruments to measure AD clinical signs in clinical practice, based on an updated systematic review evaluating the validity of clinical signs instruments.

The review included 22 studies describing 16 instruments that assessed AD clinical signs and an additional 12 variants of instruments. The meeting was attended by 34 individuals from 13 countries, including patient and patient advocate research partners, health care professionals, researchers, methodologists, and industry representatives. Consensus was defined as less than 30% disagreement.

Following their daylong consensus exercise, the stakeholders reached consensus on recommendations to use the EASI, the vIGAAD, and an IGA multiplied or measured alongside a BSA measurement to measure the domain of clinical signs of AD in the clinical practice setting. “The use of multiple IGAs, most with insufficient validation, and the diverse methods used to assess BSA prevented participants from making specific recommendations for the exact IGA/BSA instrument,” the authors wrote. “We recommend that clinicians include at least one of the recommended instruments in their clinical practices and in documentation.” 

They explained that the ideal method of measuring BSA was difficult to assess “because multiple techniques exist for its measurement, including regional percentages, the Rule of Nines, or the handprint method. Most studies did not report which method was performed, and to our knowledge, no studies have been performed in patients with AD that have formally compared them.”

During the consensus exercise, the authors noted, several clinicians “expressed concern whether the EASI was feasible for universal use in clinical practice given its complexity, long completion time, and documentation/calculation requirements.” But clinicians who commonly perform the EASI in clinical practice said that the time it takes to complete this measure “has dropped substantially and now is not a considerable burden,” they wrote, adding that, “studies have shown that with trained investigators, EASI completion times can be as low as nearly 2 minutes.”

The authors acknowledged certain limitations of their recommendations, including the lack of input from primary care clinicians. “It is unknown whether ClinROMs [clinician-reported outcome measures] for AD clinical signs are used in the primary care setting, especially given the large amount of conditions that are managed simultaneously and the ever-increasing number of primary care documentation requirements,” they wrote.

Robert Sidbury, MD, MPH, chief of the division of dermatology at Seattle Children’s Hospital, who was asked to comment on the consensus statement, said that with the advent of new, improved, and more expensive medications for AD, “it is ever more important that [the clinical] assessment is reliable and reproducible.”

Insurers “are understandably less willing to rubber-stamp approval of more expensive medications without a reliable standard by which to justify such decisions,” he added. “This is even more important in a disease state like atopic dermatitis that lacks a reliable biomarker. Therefore, one or several practical, reliable, validated severity metrics will help standardize and improve AD care.”

Dr. Sidbury, who cochaired the 2023 American Academy of Dermatology guidelines of care for the management of AD in adults with phototherapy and systemic therapies, added that the instruments evaluated in the review “can be challenging for anyone,” not just primary care providers. “The EASI isn’t that easy, and while there is a learning curve and it ultimately does, like anything, become more efficient in the gathering, it is unclear if non-AD researchers will be willing to invest the time” to routinely use it, he said.

Dr. Simpson and several coauthors reported receiving grants and personal fees from multiple pharmaceutical companies. Dr. Sidbury reported that he serves as an investigator for Regeneron, Galderma, UCB, Castle, and Pfizer; is a consultant for LEO, Lilly, Arcutis, Dermavant, and Pierre Fabre; and a speaker for Beiersdorf.

A version of this article appeared on Medscape.com .

Clinicians should incorporate at least one of three validated instruments to measure signs of atopic dermatitis (AD) in their clinical practice, the authors of a new consensus statement recommended.

These include the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment for AD (vIGAAD), and the Investigator’s Global Assessment (IGA) multiplied by or measured concurrently with a body surface area (BSA) assessment.

The recommendations are part of a consensus statement based on an updated systematic review conducted by the Harmonizing Outcome Measures for Eczema Clinical Practice (HOME-CP) initiative, whose goal is to identify validated, feasible outcome instruments designed to measure AD in the clinical setting. In the statement, which was published in JAMA Dermatology on May 22, 2024, corresponding author Eric L. Simpson, MD, MCR, professor of dermatology at Oregon Health & Science University, Portland, and coauthors described HOME-CP as “a ‘pick-and-choose’ list of valid and feasible OMIs [outcome measure instruments] that can be incorporated into the practice setting depending on the particular need of that clinic or health system.”

For the effort, the authors implemented a mixed methods design and incorporated systematic reviews and qualitative consensus methods modeled after the HOME core outcome set initiative, which developed a set of consensus-based core outcome sets for clinical trials and clinical practice. In October of 2022, a daylong in-person consensus exercise was held in Montreal, Canada, where attendees met to reach consensus on recommended instruments to measure AD clinical signs in clinical practice, based on an updated systematic review evaluating the validity of clinical signs instruments.

The review included 22 studies describing 16 instruments that assessed AD clinical signs and an additional 12 variants of instruments. The meeting was attended by 34 individuals from 13 countries, including patient and patient advocate research partners, health care professionals, researchers, methodologists, and industry representatives. Consensus was defined as less than 30% disagreement.

Following their daylong consensus exercise, the stakeholders reached consensus on recommendations to use the EASI, the vIGAAD, and an IGA multiplied or measured alongside a BSA measurement to measure the domain of clinical signs of AD in the clinical practice setting. “The use of multiple IGAs, most with insufficient validation, and the diverse methods used to assess BSA prevented participants from making specific recommendations for the exact IGA/BSA instrument,” the authors wrote. “We recommend that clinicians include at least one of the recommended instruments in their clinical practices and in documentation.” 

They explained that the ideal method of measuring BSA was difficult to assess “because multiple techniques exist for its measurement, including regional percentages, the Rule of Nines, or the handprint method. Most studies did not report which method was performed, and to our knowledge, no studies have been performed in patients with AD that have formally compared them.”

During the consensus exercise, the authors noted, several clinicians “expressed concern whether the EASI was feasible for universal use in clinical practice given its complexity, long completion time, and documentation/calculation requirements.” But clinicians who commonly perform the EASI in clinical practice said that the time it takes to complete this measure “has dropped substantially and now is not a considerable burden,” they wrote, adding that, “studies have shown that with trained investigators, EASI completion times can be as low as nearly 2 minutes.”

The authors acknowledged certain limitations of their recommendations, including the lack of input from primary care clinicians. “It is unknown whether ClinROMs [clinician-reported outcome measures] for AD clinical signs are used in the primary care setting, especially given the large amount of conditions that are managed simultaneously and the ever-increasing number of primary care documentation requirements,” they wrote.

Robert Sidbury, MD, MPH, chief of the division of dermatology at Seattle Children’s Hospital, who was asked to comment on the consensus statement, said that with the advent of new, improved, and more expensive medications for AD, “it is ever more important that [the clinical] assessment is reliable and reproducible.”

Insurers “are understandably less willing to rubber-stamp approval of more expensive medications without a reliable standard by which to justify such decisions,” he added. “This is even more important in a disease state like atopic dermatitis that lacks a reliable biomarker. Therefore, one or several practical, reliable, validated severity metrics will help standardize and improve AD care.”

Dr. Sidbury, who cochaired the 2023 American Academy of Dermatology guidelines of care for the management of AD in adults with phototherapy and systemic therapies, added that the instruments evaluated in the review “can be challenging for anyone,” not just primary care providers. “The EASI isn’t that easy, and while there is a learning curve and it ultimately does, like anything, become more efficient in the gathering, it is unclear if non-AD researchers will be willing to invest the time” to routinely use it, he said.

Dr. Simpson and several coauthors reported receiving grants and personal fees from multiple pharmaceutical companies. Dr. Sidbury reported that he serves as an investigator for Regeneron, Galderma, UCB, Castle, and Pfizer; is a consultant for LEO, Lilly, Arcutis, Dermavant, and Pierre Fabre; and a speaker for Beiersdorf.

A version of this article appeared on Medscape.com .

TOPLINE:

A new study found that use of e-cigarettes by parents was associated with an increased risk for atopic dermatitis (AD) in children.

METHODOLOGY:

• AD is one of the most common inflammatory conditions in children and is linked to environmental risk factors, such as exposure to secondhand smoke and prenatal exposure to tobacco.
• To address the effect of e-cigarettes use on children, researchers conducted a cross-sectional analysis of data from the 2014-2018 National Health Interview Survey, a nationally representative sample of the US population.
• The analysis included 48,637,111 individuals (mean age, 8.4 years), with 6,354,515 (13%) indicating a history of AD (mean age, 8 years).

TAKEAWAY:

• The prevalence of parental e-cigarette use was 18.0% among individuals with AD, compared with 14.4% among those without AD.
• This corresponded to a 24% higher risk for AD associated with parental e-cigarette use (adjusted odds ratio, 1.24; 95% CI, 1.08-1.42).
• The association between e-cigarette use and AD in children held regardless of parent’s sex.

IN PRACTICE:

“Our results suggest that parental e-cigarette use was associated with pediatric AD,” the authors concluded. They noted that the authors of a previous study that associated e-cigarette use with AD in adults postulated that the cause was “the inflammatory state created by” e-cigarettes.

SOURCE:

This study, led by Gun Min Youn, Department of Dermatology, Stanford University School of Medicine, Stanford, California, was published online in JAMA Dermatology.

LIMITATIONS:

The cross-sectional survey design limited the ability to draw causal inferences. Defining e-cigarette use as a single past instance could affect the strength of the findings. Only past-year e-cigarette use was considered. Furthermore, data on pediatric cigarette or e-cigarette use, a potential confounder, were unavailable.

DISCLOSURES:

The study did not disclose funding information. One author reported receiving consultation fees outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

A new study found that use of e-cigarettes by parents was associated with an increased risk for atopic dermatitis (AD) in children.

METHODOLOGY:

• AD is one of the most common inflammatory conditions in children and is linked to environmental risk factors, such as exposure to secondhand smoke and prenatal exposure to tobacco.
• To address the effect of e-cigarettes use on children, researchers conducted a cross-sectional analysis of data from the 2014-2018 National Health Interview Survey, a nationally representative sample of the US population.
• The analysis included 48,637,111 individuals (mean age, 8.4 years), with 6,354,515 (13%) indicating a history of AD (mean age, 8 years).

TAKEAWAY:

• The prevalence of parental e-cigarette use was 18.0% among individuals with AD, compared with 14.4% among those without AD.
• This corresponded to a 24% higher risk for AD associated with parental e-cigarette use (adjusted odds ratio, 1.24; 95% CI, 1.08-1.42).
• The association between e-cigarette use and AD in children held regardless of parent’s sex.

IN PRACTICE:

“Our results suggest that parental e-cigarette use was associated with pediatric AD,” the authors concluded. They noted that the authors of a previous study that associated e-cigarette use with AD in adults postulated that the cause was “the inflammatory state created by” e-cigarettes.

SOURCE:

This study, led by Gun Min Youn, Department of Dermatology, Stanford University School of Medicine, Stanford, California, was published online in JAMA Dermatology.

LIMITATIONS:

The cross-sectional survey design limited the ability to draw causal inferences. Defining e-cigarette use as a single past instance could affect the strength of the findings. Only past-year e-cigarette use was considered. Furthermore, data on pediatric cigarette or e-cigarette use, a potential confounder, were unavailable.

DISCLOSURES:

The study did not disclose funding information. One author reported receiving consultation fees outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

A new study found that use of e-cigarettes by parents was associated with an increased risk for atopic dermatitis (AD) in children.

METHODOLOGY:

• AD is one of the most common inflammatory conditions in children and is linked to environmental risk factors, such as exposure to secondhand smoke and prenatal exposure to tobacco.
• To address the effect of e-cigarettes use on children, researchers conducted a cross-sectional analysis of data from the 2014-2018 National Health Interview Survey, a nationally representative sample of the US population.
• The analysis included 48,637,111 individuals (mean age, 8.4 years), with 6,354,515 (13%) indicating a history of AD (mean age, 8 years).

TAKEAWAY:

• The prevalence of parental e-cigarette use was 18.0% among individuals with AD, compared with 14.4% among those without AD.
• This corresponded to a 24% higher risk for AD associated with parental e-cigarette use (adjusted odds ratio, 1.24; 95% CI, 1.08-1.42).
• The association between e-cigarette use and AD in children held regardless of parent’s sex.

IN PRACTICE:

“Our results suggest that parental e-cigarette use was associated with pediatric AD,” the authors concluded. They noted that the authors of a previous study that associated e-cigarette use with AD in adults postulated that the cause was “the inflammatory state created by” e-cigarettes.

SOURCE:

This study, led by Gun Min Youn, Department of Dermatology, Stanford University School of Medicine, Stanford, California, was published online in JAMA Dermatology.

LIMITATIONS:

The cross-sectional survey design limited the ability to draw causal inferences. Defining e-cigarette use as a single past instance could affect the strength of the findings. Only past-year e-cigarette use was considered. Furthermore, data on pediatric cigarette or e-cigarette use, a potential confounder, were unavailable.

DISCLOSURES:

The study did not disclose funding information. One author reported receiving consultation fees outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

TOPLINE:

An early serum cortisol concentration of > 237 nmol/L (> 8.6 μg/dL) has been validated as a safe and useful screening test with 100% specificity for predicting recovery of the hypothalamic-pituitary-adrenal (HPA) axis in patients on tapering regimes from long‐term chronic glucocorticoid therapy (CGT).

METHODOLOGY:

• A retrospective review of 250-µg Synacthen test (SST) results performed in patients on tapering CGT doses from a single-center rheumatology department over 12 months.
• A total of 60 SSTs were performed in 58 patients, all in the morning (7-12 AM) after withholding CGT for 48 hours.
• Peripheral blood was sampled for cortisol at baseline, 30 minutes, and 60 minutes.
• Adrenal insufficiency (AI) was defined as a peak serum cortisol concentration.

TAKEAWAY:

• The mean duration of CGT (all prednisolone) was 63 months, prescribed primarily for giant cell arteritis/polymyalgia rheumatica (48%) and inflammatory arthritis (18%), with a mean daily dose of 3.4 mg at the time of SST.
• With the investigators’ previously reported basal serum cortisol concentration of > 237 nmol/L (> 8.6 μg/dL) used to confirm an intact HPA axis, no patient with AI would have been missed, but 37 of 51 (73%) unnecessary SSTs in euadrenal patients would have been avoided.
• A basal serum cortisol concentration of > 227 nmol/L had a specificity of 100% for predicting passing the SST, while a basal serum cortisol concentration of ≤ 55 nmol/L had a 100% sensitivity for predicting failure.
• A mean daily prednisolone dosing at the time of SST in patients with AI was significantly higher than that with normal SSTs (5.7 vs 2.9 mg, respectively; P = .01).

IN PRACTICE:

“This offers a more rapid, convenient, and cost‐effective screening method for patients requiring biochemical assessment of the HPA axis with the potential for significant resource savings without any adverse impact on patient safety,” the authors wrote.

SOURCE:

The study was conducted by Ella Sharma, of the Department of Endocrinology, Royal Victoria Infirmary, Newcastle upon Tyne, UK, and colleagues and published online on May 19, 2024, as a letter in Clinical Endocrinology.

LIMITATIONS:

Not provided.

DISCLOSURES: 

Not provided.
 

A version of this article appeared on Medscape.com.

TOPLINE:

An early serum cortisol concentration of > 237 nmol/L (> 8.6 μg/dL) has been validated as a safe and useful screening test with 100% specificity for predicting recovery of the hypothalamic-pituitary-adrenal (HPA) axis in patients on tapering regimes from long‐term chronic glucocorticoid therapy (CGT).

METHODOLOGY:

• A retrospective review of 250-µg Synacthen test (SST) results performed in patients on tapering CGT doses from a single-center rheumatology department over 12 months.
• A total of 60 SSTs were performed in 58 patients, all in the morning (7-12 AM) after withholding CGT for 48 hours.
• Peripheral blood was sampled for cortisol at baseline, 30 minutes, and 60 minutes.
• Adrenal insufficiency (AI) was defined as a peak serum cortisol concentration.

TAKEAWAY:

• The mean duration of CGT (all prednisolone) was 63 months, prescribed primarily for giant cell arteritis/polymyalgia rheumatica (48%) and inflammatory arthritis (18%), with a mean daily dose of 3.4 mg at the time of SST.
• With the investigators’ previously reported basal serum cortisol concentration of > 237 nmol/L (> 8.6 μg/dL) used to confirm an intact HPA axis, no patient with AI would have been missed, but 37 of 51 (73%) unnecessary SSTs in euadrenal patients would have been avoided.
• A basal serum cortisol concentration of > 227 nmol/L had a specificity of 100% for predicting passing the SST, while a basal serum cortisol concentration of ≤ 55 nmol/L had a 100% sensitivity for predicting failure.
• A mean daily prednisolone dosing at the time of SST in patients with AI was significantly higher than that with normal SSTs (5.7 vs 2.9 mg, respectively; P = .01).

IN PRACTICE:

“This offers a more rapid, convenient, and cost‐effective screening method for patients requiring biochemical assessment of the HPA axis with the potential for significant resource savings without any adverse impact on patient safety,” the authors wrote.

SOURCE:

The study was conducted by Ella Sharma, of the Department of Endocrinology, Royal Victoria Infirmary, Newcastle upon Tyne, UK, and colleagues and published online on May 19, 2024, as a letter in Clinical Endocrinology.

LIMITATIONS:

Not provided.

DISCLOSURES: 

Not provided.
 

A version of this article appeared on Medscape.com.

TOPLINE:

An early serum cortisol concentration of > 237 nmol/L (> 8.6 μg/dL) has been validated as a safe and useful screening test with 100% specificity for predicting recovery of the hypothalamic-pituitary-adrenal (HPA) axis in patients on tapering regimes from long‐term chronic glucocorticoid therapy (CGT).

METHODOLOGY:

• A retrospective review of 250-µg Synacthen test (SST) results performed in patients on tapering CGT doses from a single-center rheumatology department over 12 months.
• A total of 60 SSTs were performed in 58 patients, all in the morning (7-12 AM) after withholding CGT for 48 hours.
• Peripheral blood was sampled for cortisol at baseline, 30 minutes, and 60 minutes.
• Adrenal insufficiency (AI) was defined as a peak serum cortisol concentration.

TAKEAWAY:

• The mean duration of CGT (all prednisolone) was 63 months, prescribed primarily for giant cell arteritis/polymyalgia rheumatica (48%) and inflammatory arthritis (18%), with a mean daily dose of 3.4 mg at the time of SST.
• With the investigators’ previously reported basal serum cortisol concentration of > 237 nmol/L (> 8.6 μg/dL) used to confirm an intact HPA axis, no patient with AI would have been missed, but 37 of 51 (73%) unnecessary SSTs in euadrenal patients would have been avoided.
• A basal serum cortisol concentration of > 227 nmol/L had a specificity of 100% for predicting passing the SST, while a basal serum cortisol concentration of ≤ 55 nmol/L had a 100% sensitivity for predicting failure.
• A mean daily prednisolone dosing at the time of SST in patients with AI was significantly higher than that with normal SSTs (5.7 vs 2.9 mg, respectively; P = .01).

IN PRACTICE:

“This offers a more rapid, convenient, and cost‐effective screening method for patients requiring biochemical assessment of the HPA axis with the potential for significant resource savings without any adverse impact on patient safety,” the authors wrote.

SOURCE:

The study was conducted by Ella Sharma, of the Department of Endocrinology, Royal Victoria Infirmary, Newcastle upon Tyne, UK, and colleagues and published online on May 19, 2024, as a letter in Clinical Endocrinology.

LIMITATIONS:

Not provided.

DISCLOSURES: 

Not provided.
 

A version of this article appeared on Medscape.com.

PARIS — While anaphylaxis requires immediate adrenaline administration through autoinjection, the use of this treatment is not optimal. Therefore, the development of new adrenaline formulations (such as for intranasal, sublingual, and transcutaneous routes) aims to facilitate the drug’s use and reduce persistent delays in administration by patients and caregivers. An overview of the research was presented at the 19th French-speaking Congress of Allergology.

Anaphylaxis is a severe and potentially fatal immediate hypersensitivity reaction with highly variable and dynamic clinical presentations. It requires prompt recognition for immediate treatment with intramuscular (IM) adrenaline (at the anterolateral aspect of the mid-thigh).

One might think that this reflex is acquired, but in France, while the number of prescribed adrenaline autoinjection (AAI) devices has been increasing for a decade, reaching 965,944 units in 2022, this first-line treatment is underused. Anapen (150, 300, and 500 µg), EpiPen (150 and 300 µg), Jext (150 µg and 300 µg), and Emerade (150, 300, and 500 µg) are the four products marketed in France in 2024.

“Only 17.3% of individuals presenting to the emergency department in the Lorraine region used it in 2015,” said Catherine Neukirch, MD, a pneumologist at Hôpital Bichat–Claude Bernard in Paris, France, with rates of 11.3% for children and 20.3% for adults.
 

Anaphylaxis Incidence Increasing

Approximately 0.3% (95% CI, 0.1-0.5) of the population will experience an anaphylaxis episode in their lifetime. Incidence in Europe, across all causes, is estimated between 1.5 and 7.9 cases per 100,000 inhabitants per year. Although anaphylaxis is on the rise, its associated mortality remains low, ranging between 0.05 and 0.51 per million per year for drugs, between 0.03 and 0.32 per million per year for foods, and between 0.09 and 0.13 per million per year for hymenopteran venoms.

Data from the European Anaphylaxis Registry indicate that anaphylaxis manifests rapidly after allergen exposure: 55% of cases occur within 10 minutes and 80% within 30 minutes. In addition, a biphasic reaction, which can occur up to 72 hours after exposure, is observed in < 5% of cases.

While a delay in adrenaline use is associated with risk for increased morbidity and mortality, AAI significantly reduces error rates compared with manual treatments involving ampoules, needles, and syringes. It also reduces the associated panic risks. However, there are multiple barriers to adrenaline use. The clinical symptoms of anaphylaxis may be misleading, especially if it occurs without cutaneous and urticarial manifestations but with only acute bronchospasm. It may present as isolated laryngeal edema without digestive involvement, hypotension, or other respiratory problems.

Other limitations to adrenaline use include technical difficulties and the possibility of incorrect administration, the need for appropriate needle sizes for patients with obesity, needle phobia, potential adverse effects of adrenaline injections, failure to carry two autoinjectors, constraints related to storage and bulky transport, as well as the need for training and practice.

“These factors contribute to underuse of adrenaline by patients and caregivers,” said Dr. Neukirch, which results in delays in necessary administration.
 

Adrenaline Treatment Criteria?

An analysis published in 2023 based on pharmacovigilance data from 30 regional French centers from 1984 to 2022 included 42 reported cases (average age, 33 years; 26% children) of reactions to AAI, which probably is an underestimate. About 40% of AAI uses occurred during anaphylaxis. The remaining 60% were triggered outside of reactions. The main reasons were accidental injections, mainly in the fingers, and cases of not triggering the autoinjector, underlining the importance of patient education.

In 2015, the European Medicines Agency required pharmacological studies for injectable adrenaline on healthy volunteers. These studies include ultrasound measurements of bolus injection, pharmacokinetics (ie, absorption, distribution, metabolism, and excretion), and pharmacodynamics (ie, the effect of the drug and the mechanism of action in the body), with precise evaluation of cardiovascular effects (eg, systolic and diastolic blood pressures and heart rate).

Among the information collected with the different products, ultrasound studies have shown a different localization of the adrenaline bolus (ie, in muscle in patients with normal BMI and mostly in adipose tissue in patients with BMI indicating overweight and obesity). The consequences of this finding are still unknown.

In a study with 500 µg Anapen, women with overweight or obesity showed different pharmacokinetic or pharmacodynamic profiles from those in men with normal weight, with an increase in the area under the curve (0-240 min) and marked changes in the heart rate time curve.

IM administration of 0.5 mg produces rapid pharmacokinetic effects in patients with normal weight, overweight, or obesity, with a delay for the second peak in the latter case. This delay perhaps results from initial local vasoconstriction due to adrenaline.

The early peak plasma concentration occurs at 5-10 minutes for AAI, with a faster speed for Anapen and EpiPen.

Moreover, needle size is not the most important factor. Rather, it is the strength and speed of injection, which can vary depending on the AAI.

Also, the optimal plasma concentration of adrenaline to treat anaphylaxis is not known; studies cannot be conducted during anaphylaxis. In terms of pharmacokinetics, a small series discovered that increased skin or muscle thickness delays the absorption of EpiPen AAI.
 

Intranasal Adrenaline

To facilitate rapid adrenaline use and convince reluctant patients to carry and use adrenaline, intranasal, sublingual, or transcutaneous forms are under development.

Three intranasal forms of adrenaline are already well advanced, including Neffy from ARS Pharma, epinephrine sprays from Bryn Pharma and Hikma, and Oxero from Oragoo, which contains dry powder.

A comparison of intranasal adrenaline Neffy and AAI shows that the former has satisfactory pharmacokinetic and pharmacodynamic effects.

In a phase 1 randomized crossover study of 42 healthy adults comparing the pharmacokinetic effects of Neffy adrenaline (2 mg) and EpiPen (0.3 mg), as well as IM epinephrine 0.3 mg, several observations were made. For a single dose, the maximum concentration (Cmax) of Neffy was lower than that of EpiPen.

However, with repeated doses administered 10 minutes apart, the Cmax of Neffy was higher than that of EpiPen. At this stage, pharmacodynamic responses to intranasal products are at least comparable with those of approved injectable products.

A comparison of the pharmacodynamic effects, such as systolic and diastolic blood pressures and heart rate, of Neffy adrenaline and AAI concluded that the profile of Neffy is comparable with that of EpiPen and superior to that of IM epinephrine.

In patients with a history of allergic rhinitis, adrenaline Cmax appears to be increased, while time to peak plasma concentration (Tmax) is reduced. Low blood pressure does not prevent Neffy absorption. Neffy is currently under review by the American and European health authorities.

Intranasal absorption of dry powder adrenaline appears to be faster than that of EpiPen, thus offering a clinical advantage in the short therapeutic window for anaphylaxis treatment.

In an open-label trial conducted on 12 adults with seasonal allergic rhinitis without asthma, the pharmacokinetics, pharmacodynamics, and safety of adrenaline were compared between FMXIN002 (1.6 and 3.2 mg), which was administered intranasally with or without nasal allergen challenge, and IM EpiPen 0.3 mg. Pharmacokinetics varied by patient. Nevertheless, nasal FMXIN002 had a shorter Tmax, a doubled Cmax after the allergen challenge peak, and a higher area under the curve in the 8 hours following administration compared with EpiPen. Pharmacodynamic effects comparable with those of EpiPen were noted at 15 minutes to 4 hours after administration. The tolerance was good, with mild and local side effects. The powder seems to deposit slightly better in the nasal cavity. It remains stable for 6 months at a temperature of 40 °C and relative humidity of 75% and for 2 years at a temperature of 25 °C and relative humidity of 60%.
 

Sublingual Adrenaline Film

AQST-109 is a sublingual film that is intended to allow rapid administration of epinephrine 1, which is a prodrug of adrenaline. The product is the size of a postage stamp, weighs < 30 g, and dissolves on contact with the tongue.

The EPIPHAST II study was a phase 1, multiperiod, crossover study conducted on 24 healthy adults (age, 24-49 years) who were randomly assigned to receive either 12 or 0.3 mg of AQST-109  of manual IM adrenaline in the first two periods. All participants received 0.3 mg of EpiPen in the last period.

EpiPen 0.3 mg resulted in a higher Cmax than AQST-109 12 mg. AQST-109 12 mg had the fastest median Tmax of 12 minutes. The areas under the curve of AQST-109 12 mg fell between those of EpiPen 0.3 mg and manual IM adrenaline 0.3 mg.

Early increases in systolic blood pressure, diastolic blood pressure, and heart rate were observed with AQST-109 12 mg. Changes were more pronounced with AQST-109 12 mg despite a higher Cmax with EpiPen 0.3 mg.

Part 3 of the EPIPHAST study evaluated the impact of food exposure (ie, a peanut butter sandwich) on the pharmacokinetics of AQST-109 12 mg in 24 healthy adults. Oral food residues did not significantly affect pharmacodynamic parameters, and no treatment-related adverse events were reported.

Researchers concluded that AQST-109 12 mg absorption would not be altered by “real” situations if used during meals. “These results suggest that the sublingual adrenaline film could be promising in real situations,” said Dr. Neukirch, especially in cases of food allergy with recent ingestion of the allergenic food.
 

Transcutaneous Adrenaline

A transcutaneous form of adrenaline that uses the Zeneo device developed by Crossject, a company based in Dijon, France, comes in the form of an AAI that requires no needle. This project, funded by the European Union, uses a gas generator to propel the drug at very high speed through the skin in 50 milliseconds. This method allows for extended drug storage.

Dr. Neukirch reported financial relationships with Viatris, Stallergènes, ALK, Astrazeneca, Sanofi, GSK, and Novartis.

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

PARIS — While anaphylaxis requires immediate adrenaline administration through autoinjection, the use of this treatment is not optimal. Therefore, the development of new adrenaline formulations (such as for intranasal, sublingual, and transcutaneous routes) aims to facilitate the drug’s use and reduce persistent delays in administration by patients and caregivers. An overview of the research was presented at the 19th French-speaking Congress of Allergology.

Anaphylaxis is a severe and potentially fatal immediate hypersensitivity reaction with highly variable and dynamic clinical presentations. It requires prompt recognition for immediate treatment with intramuscular (IM) adrenaline (at the anterolateral aspect of the mid-thigh).

One might think that this reflex is acquired, but in France, while the number of prescribed adrenaline autoinjection (AAI) devices has been increasing for a decade, reaching 965,944 units in 2022, this first-line treatment is underused. Anapen (150, 300, and 500 µg), EpiPen (150 and 300 µg), Jext (150 µg and 300 µg), and Emerade (150, 300, and 500 µg) are the four products marketed in France in 2024.

“Only 17.3% of individuals presenting to the emergency department in the Lorraine region used it in 2015,” said Catherine Neukirch, MD, a pneumologist at Hôpital Bichat–Claude Bernard in Paris, France, with rates of 11.3% for children and 20.3% for adults.
 

Anaphylaxis Incidence Increasing

Approximately 0.3% (95% CI, 0.1-0.5) of the population will experience an anaphylaxis episode in their lifetime. Incidence in Europe, across all causes, is estimated between 1.5 and 7.9 cases per 100,000 inhabitants per year. Although anaphylaxis is on the rise, its associated mortality remains low, ranging between 0.05 and 0.51 per million per year for drugs, between 0.03 and 0.32 per million per year for foods, and between 0.09 and 0.13 per million per year for hymenopteran venoms.

Data from the European Anaphylaxis Registry indicate that anaphylaxis manifests rapidly after allergen exposure: 55% of cases occur within 10 minutes and 80% within 30 minutes. In addition, a biphasic reaction, which can occur up to 72 hours after exposure, is observed in < 5% of cases.

While a delay in adrenaline use is associated with risk for increased morbidity and mortality, AAI significantly reduces error rates compared with manual treatments involving ampoules, needles, and syringes. It also reduces the associated panic risks. However, there are multiple barriers to adrenaline use. The clinical symptoms of anaphylaxis may be misleading, especially if it occurs without cutaneous and urticarial manifestations but with only acute bronchospasm. It may present as isolated laryngeal edema without digestive involvement, hypotension, or other respiratory problems.

Other limitations to adrenaline use include technical difficulties and the possibility of incorrect administration, the need for appropriate needle sizes for patients with obesity, needle phobia, potential adverse effects of adrenaline injections, failure to carry two autoinjectors, constraints related to storage and bulky transport, as well as the need for training and practice.

“These factors contribute to underuse of adrenaline by patients and caregivers,” said Dr. Neukirch, which results in delays in necessary administration.
 

Adrenaline Treatment Criteria?

An analysis published in 2023 based on pharmacovigilance data from 30 regional French centers from 1984 to 2022 included 42 reported cases (average age, 33 years; 26% children) of reactions to AAI, which probably is an underestimate. About 40% of AAI uses occurred during anaphylaxis. The remaining 60% were triggered outside of reactions. The main reasons were accidental injections, mainly in the fingers, and cases of not triggering the autoinjector, underlining the importance of patient education.

In 2015, the European Medicines Agency required pharmacological studies for injectable adrenaline on healthy volunteers. These studies include ultrasound measurements of bolus injection, pharmacokinetics (ie, absorption, distribution, metabolism, and excretion), and pharmacodynamics (ie, the effect of the drug and the mechanism of action in the body), with precise evaluation of cardiovascular effects (eg, systolic and diastolic blood pressures and heart rate).

Among the information collected with the different products, ultrasound studies have shown a different localization of the adrenaline bolus (ie, in muscle in patients with normal BMI and mostly in adipose tissue in patients with BMI indicating overweight and obesity). The consequences of this finding are still unknown.

In a study with 500 µg Anapen, women with overweight or obesity showed different pharmacokinetic or pharmacodynamic profiles from those in men with normal weight, with an increase in the area under the curve (0-240 min) and marked changes in the heart rate time curve.

IM administration of 0.5 mg produces rapid pharmacokinetic effects in patients with normal weight, overweight, or obesity, with a delay for the second peak in the latter case. This delay perhaps results from initial local vasoconstriction due to adrenaline.

The early peak plasma concentration occurs at 5-10 minutes for AAI, with a faster speed for Anapen and EpiPen.

Moreover, needle size is not the most important factor. Rather, it is the strength and speed of injection, which can vary depending on the AAI.

Also, the optimal plasma concentration of adrenaline to treat anaphylaxis is not known; studies cannot be conducted during anaphylaxis. In terms of pharmacokinetics, a small series discovered that increased skin or muscle thickness delays the absorption of EpiPen AAI.
 

Intranasal Adrenaline

To facilitate rapid adrenaline use and convince reluctant patients to carry and use adrenaline, intranasal, sublingual, or transcutaneous forms are under development.

Three intranasal forms of adrenaline are already well advanced, including Neffy from ARS Pharma, epinephrine sprays from Bryn Pharma and Hikma, and Oxero from Oragoo, which contains dry powder.

A comparison of intranasal adrenaline Neffy and AAI shows that the former has satisfactory pharmacokinetic and pharmacodynamic effects.

In a phase 1 randomized crossover study of 42 healthy adults comparing the pharmacokinetic effects of Neffy adrenaline (2 mg) and EpiPen (0.3 mg), as well as IM epinephrine 0.3 mg, several observations were made. For a single dose, the maximum concentration (Cmax) of Neffy was lower than that of EpiPen.

However, with repeated doses administered 10 minutes apart, the Cmax of Neffy was higher than that of EpiPen. At this stage, pharmacodynamic responses to intranasal products are at least comparable with those of approved injectable products.

A comparison of the pharmacodynamic effects, such as systolic and diastolic blood pressures and heart rate, of Neffy adrenaline and AAI concluded that the profile of Neffy is comparable with that of EpiPen and superior to that of IM epinephrine.

In patients with a history of allergic rhinitis, adrenaline Cmax appears to be increased, while time to peak plasma concentration (Tmax) is reduced. Low blood pressure does not prevent Neffy absorption. Neffy is currently under review by the American and European health authorities.

Intranasal absorption of dry powder adrenaline appears to be faster than that of EpiPen, thus offering a clinical advantage in the short therapeutic window for anaphylaxis treatment.

In an open-label trial conducted on 12 adults with seasonal allergic rhinitis without asthma, the pharmacokinetics, pharmacodynamics, and safety of adrenaline were compared between FMXIN002 (1.6 and 3.2 mg), which was administered intranasally with or without nasal allergen challenge, and IM EpiPen 0.3 mg. Pharmacokinetics varied by patient. Nevertheless, nasal FMXIN002 had a shorter Tmax, a doubled Cmax after the allergen challenge peak, and a higher area under the curve in the 8 hours following administration compared with EpiPen. Pharmacodynamic effects comparable with those of EpiPen were noted at 15 minutes to 4 hours after administration. The tolerance was good, with mild and local side effects. The powder seems to deposit slightly better in the nasal cavity. It remains stable for 6 months at a temperature of 40 °C and relative humidity of 75% and for 2 years at a temperature of 25 °C and relative humidity of 60%.
 

Sublingual Adrenaline Film

AQST-109 is a sublingual film that is intended to allow rapid administration of epinephrine 1, which is a prodrug of adrenaline. The product is the size of a postage stamp, weighs < 30 g, and dissolves on contact with the tongue.

The EPIPHAST II study was a phase 1, multiperiod, crossover study conducted on 24 healthy adults (age, 24-49 years) who were randomly assigned to receive either 12 or 0.3 mg of AQST-109  of manual IM adrenaline in the first two periods. All participants received 0.3 mg of EpiPen in the last period.

EpiPen 0.3 mg resulted in a higher Cmax than AQST-109 12 mg. AQST-109 12 mg had the fastest median Tmax of 12 minutes. The areas under the curve of AQST-109 12 mg fell between those of EpiPen 0.3 mg and manual IM adrenaline 0.3 mg.

Early increases in systolic blood pressure, diastolic blood pressure, and heart rate were observed with AQST-109 12 mg. Changes were more pronounced with AQST-109 12 mg despite a higher Cmax with EpiPen 0.3 mg.

Part 3 of the EPIPHAST study evaluated the impact of food exposure (ie, a peanut butter sandwich) on the pharmacokinetics of AQST-109 12 mg in 24 healthy adults. Oral food residues did not significantly affect pharmacodynamic parameters, and no treatment-related adverse events were reported.

Researchers concluded that AQST-109 12 mg absorption would not be altered by “real” situations if used during meals. “These results suggest that the sublingual adrenaline film could be promising in real situations,” said Dr. Neukirch, especially in cases of food allergy with recent ingestion of the allergenic food.
 

Transcutaneous Adrenaline

A transcutaneous form of adrenaline that uses the Zeneo device developed by Crossject, a company based in Dijon, France, comes in the form of an AAI that requires no needle. This project, funded by the European Union, uses a gas generator to propel the drug at very high speed through the skin in 50 milliseconds. This method allows for extended drug storage.

Dr. Neukirch reported financial relationships with Viatris, Stallergènes, ALK, Astrazeneca, Sanofi, GSK, and Novartis.

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

PARIS — While anaphylaxis requires immediate adrenaline administration through autoinjection, the use of this treatment is not optimal. Therefore, the development of new adrenaline formulations (such as for intranasal, sublingual, and transcutaneous routes) aims to facilitate the drug’s use and reduce persistent delays in administration by patients and caregivers. An overview of the research was presented at the 19th French-speaking Congress of Allergology.

Anaphylaxis is a severe and potentially fatal immediate hypersensitivity reaction with highly variable and dynamic clinical presentations. It requires prompt recognition for immediate treatment with intramuscular (IM) adrenaline (at the anterolateral aspect of the mid-thigh).

One might think that this reflex is acquired, but in France, while the number of prescribed adrenaline autoinjection (AAI) devices has been increasing for a decade, reaching 965,944 units in 2022, this first-line treatment is underused. Anapen (150, 300, and 500 µg), EpiPen (150 and 300 µg), Jext (150 µg and 300 µg), and Emerade (150, 300, and 500 µg) are the four products marketed in France in 2024.

“Only 17.3% of individuals presenting to the emergency department in the Lorraine region used it in 2015,” said Catherine Neukirch, MD, a pneumologist at Hôpital Bichat–Claude Bernard in Paris, France, with rates of 11.3% for children and 20.3% for adults.
 

Anaphylaxis Incidence Increasing

Approximately 0.3% (95% CI, 0.1-0.5) of the population will experience an anaphylaxis episode in their lifetime. Incidence in Europe, across all causes, is estimated between 1.5 and 7.9 cases per 100,000 inhabitants per year. Although anaphylaxis is on the rise, its associated mortality remains low, ranging between 0.05 and 0.51 per million per year for drugs, between 0.03 and 0.32 per million per year for foods, and between 0.09 and 0.13 per million per year for hymenopteran venoms.

Data from the European Anaphylaxis Registry indicate that anaphylaxis manifests rapidly after allergen exposure: 55% of cases occur within 10 minutes and 80% within 30 minutes. In addition, a biphasic reaction, which can occur up to 72 hours after exposure, is observed in < 5% of cases.

While a delay in adrenaline use is associated with risk for increased morbidity and mortality, AAI significantly reduces error rates compared with manual treatments involving ampoules, needles, and syringes. It also reduces the associated panic risks. However, there are multiple barriers to adrenaline use. The clinical symptoms of anaphylaxis may be misleading, especially if it occurs without cutaneous and urticarial manifestations but with only acute bronchospasm. It may present as isolated laryngeal edema without digestive involvement, hypotension, or other respiratory problems.

Other limitations to adrenaline use include technical difficulties and the possibility of incorrect administration, the need for appropriate needle sizes for patients with obesity, needle phobia, potential adverse effects of adrenaline injections, failure to carry two autoinjectors, constraints related to storage and bulky transport, as well as the need for training and practice.

“These factors contribute to underuse of adrenaline by patients and caregivers,” said Dr. Neukirch, which results in delays in necessary administration.
 

Adrenaline Treatment Criteria?

An analysis published in 2023 based on pharmacovigilance data from 30 regional French centers from 1984 to 2022 included 42 reported cases (average age, 33 years; 26% children) of reactions to AAI, which probably is an underestimate. About 40% of AAI uses occurred during anaphylaxis. The remaining 60% were triggered outside of reactions. The main reasons were accidental injections, mainly in the fingers, and cases of not triggering the autoinjector, underlining the importance of patient education.

In 2015, the European Medicines Agency required pharmacological studies for injectable adrenaline on healthy volunteers. These studies include ultrasound measurements of bolus injection, pharmacokinetics (ie, absorption, distribution, metabolism, and excretion), and pharmacodynamics (ie, the effect of the drug and the mechanism of action in the body), with precise evaluation of cardiovascular effects (eg, systolic and diastolic blood pressures and heart rate).

Among the information collected with the different products, ultrasound studies have shown a different localization of the adrenaline bolus (ie, in muscle in patients with normal BMI and mostly in adipose tissue in patients with BMI indicating overweight and obesity). The consequences of this finding are still unknown.

In a study with 500 µg Anapen, women with overweight or obesity showed different pharmacokinetic or pharmacodynamic profiles from those in men with normal weight, with an increase in the area under the curve (0-240 min) and marked changes in the heart rate time curve.

IM administration of 0.5 mg produces rapid pharmacokinetic effects in patients with normal weight, overweight, or obesity, with a delay for the second peak in the latter case. This delay perhaps results from initial local vasoconstriction due to adrenaline.

The early peak plasma concentration occurs at 5-10 minutes for AAI, with a faster speed for Anapen and EpiPen.

Moreover, needle size is not the most important factor. Rather, it is the strength and speed of injection, which can vary depending on the AAI.

Also, the optimal plasma concentration of adrenaline to treat anaphylaxis is not known; studies cannot be conducted during anaphylaxis. In terms of pharmacokinetics, a small series discovered that increased skin or muscle thickness delays the absorption of EpiPen AAI.
 

Intranasal Adrenaline

To facilitate rapid adrenaline use and convince reluctant patients to carry and use adrenaline, intranasal, sublingual, or transcutaneous forms are under development.

Three intranasal forms of adrenaline are already well advanced, including Neffy from ARS Pharma, epinephrine sprays from Bryn Pharma and Hikma, and Oxero from Oragoo, which contains dry powder.

A comparison of intranasal adrenaline Neffy and AAI shows that the former has satisfactory pharmacokinetic and pharmacodynamic effects.

In a phase 1 randomized crossover study of 42 healthy adults comparing the pharmacokinetic effects of Neffy adrenaline (2 mg) and EpiPen (0.3 mg), as well as IM epinephrine 0.3 mg, several observations were made. For a single dose, the maximum concentration (Cmax) of Neffy was lower than that of EpiPen.

However, with repeated doses administered 10 minutes apart, the Cmax of Neffy was higher than that of EpiPen. At this stage, pharmacodynamic responses to intranasal products are at least comparable with those of approved injectable products.

A comparison of the pharmacodynamic effects, such as systolic and diastolic blood pressures and heart rate, of Neffy adrenaline and AAI concluded that the profile of Neffy is comparable with that of EpiPen and superior to that of IM epinephrine.

In patients with a history of allergic rhinitis, adrenaline Cmax appears to be increased, while time to peak plasma concentration (Tmax) is reduced. Low blood pressure does not prevent Neffy absorption. Neffy is currently under review by the American and European health authorities.

Intranasal absorption of dry powder adrenaline appears to be faster than that of EpiPen, thus offering a clinical advantage in the short therapeutic window for anaphylaxis treatment.

In an open-label trial conducted on 12 adults with seasonal allergic rhinitis without asthma, the pharmacokinetics, pharmacodynamics, and safety of adrenaline were compared between FMXIN002 (1.6 and 3.2 mg), which was administered intranasally with or without nasal allergen challenge, and IM EpiPen 0.3 mg. Pharmacokinetics varied by patient. Nevertheless, nasal FMXIN002 had a shorter Tmax, a doubled Cmax after the allergen challenge peak, and a higher area under the curve in the 8 hours following administration compared with EpiPen. Pharmacodynamic effects comparable with those of EpiPen were noted at 15 minutes to 4 hours after administration. The tolerance was good, with mild and local side effects. The powder seems to deposit slightly better in the nasal cavity. It remains stable for 6 months at a temperature of 40 °C and relative humidity of 75% and for 2 years at a temperature of 25 °C and relative humidity of 60%.
 

Sublingual Adrenaline Film

AQST-109 is a sublingual film that is intended to allow rapid administration of epinephrine 1, which is a prodrug of adrenaline. The product is the size of a postage stamp, weighs < 30 g, and dissolves on contact with the tongue.

The EPIPHAST II study was a phase 1, multiperiod, crossover study conducted on 24 healthy adults (age, 24-49 years) who were randomly assigned to receive either 12 or 0.3 mg of AQST-109  of manual IM adrenaline in the first two periods. All participants received 0.3 mg of EpiPen in the last period.

EpiPen 0.3 mg resulted in a higher Cmax than AQST-109 12 mg. AQST-109 12 mg had the fastest median Tmax of 12 minutes. The areas under the curve of AQST-109 12 mg fell between those of EpiPen 0.3 mg and manual IM adrenaline 0.3 mg.

Early increases in systolic blood pressure, diastolic blood pressure, and heart rate were observed with AQST-109 12 mg. Changes were more pronounced with AQST-109 12 mg despite a higher Cmax with EpiPen 0.3 mg.

Part 3 of the EPIPHAST study evaluated the impact of food exposure (ie, a peanut butter sandwich) on the pharmacokinetics of AQST-109 12 mg in 24 healthy adults. Oral food residues did not significantly affect pharmacodynamic parameters, and no treatment-related adverse events were reported.

Researchers concluded that AQST-109 12 mg absorption would not be altered by “real” situations if used during meals. “These results suggest that the sublingual adrenaline film could be promising in real situations,” said Dr. Neukirch, especially in cases of food allergy with recent ingestion of the allergenic food.
 

Transcutaneous Adrenaline

A transcutaneous form of adrenaline that uses the Zeneo device developed by Crossject, a company based in Dijon, France, comes in the form of an AAI that requires no needle. This project, funded by the European Union, uses a gas generator to propel the drug at very high speed through the skin in 50 milliseconds. This method allows for extended drug storage.

Dr. Neukirch reported financial relationships with Viatris, Stallergènes, ALK, Astrazeneca, Sanofi, GSK, and Novartis.

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

PHOENIX — Immunosuppression is an independent risk factor for poorer outcomes in patients with cutaneous squamous cell carcinoma (cSCC), according to new research that was presented at the American College of Mohs Surgery (ACMS) 2024 annual meeting.

Even though immunosuppression is strongly associated with an increased risk for cSCC, studies to date have generally not shown it to be an independent risk factor for metastasis and disease-specific death (DSD), after accounting for primary tumor stage.

“Solid organ transplant puts patients at risk for developing cutaneous squamous cell carcinoma, and it’s more likely to have aggressive features,” said study author Jason Klein, MD, PhD, a dermatology resident at University of Texas Southwestern Medical Center, Dallas. “But it’s still not known if immunosuppression is an independent risk factor.”

Other groups “have tried to tackle this, but they have all primarily been single-institution data,” he noted, adding that “results so far have been tipping the scale towards immunosuppression not being an independent risk factor” for worse outcomes.

Immunosuppressed individuals face a greater risk for cSCC than the general population and often present with more aggressive, multifocal disease. However, Dr. Klein explained that a previous retrospective study comprising a cohort of approximately 7600 tumors from two centers reported that immunosuppression was not an independent risk factor for both tumor metastasis and cancer-specific death after adjusting for tumor characteristics.

Tipped the Scale

Therefore, the goal of the current study was to repeat this analysis but in a much larger retrospective cohort. Dr. Klein and his colleagues pooled cSCC data from 12 dermatology centers (11 academic and one private) that were located in the United States, Spain, and Brazil. The cohort included 4392 patients (3769 immunocompetent patients and 623 immunosuppressed patients) with 19,237 tumors (15,191 immunocompetent and 4046 immunosuppressed). Study endpoints included local recurrence, metastasis (nodal, satellite/in-transit, and distant), DSD, and “major poor outcomes” (defined as metastasis and DSD combined).

About 30% of the immunosuppressed patients were organ transplant recipients (OTR) and 10% had chronic lymphocytic leukemia (CLL). Half of the immunocompetent patients (50.3%) underwent Mohs surgery as the primary treatment, as did 58.2% of the immunosuppressed patients.

On multivariable analysis, significant predictors of “major poor outcomes” included immunosuppression (subdistribution hazard ratio [SHR], 1.3; P = .04), Brigham and Women’s Hospital tumor stage (SHR 6.7 for T2a, 18.1 for T2b, and 37.2 for T3; P < .001 for all), location on the head/neck (SHR, 2.1; P < .001), and adjuvant radiation (SHR, 1.6; P < .001).

But when metastasis and DSD were evaluated separately, immunosuppression was only predictive of DSD (SHR, 1.7; P = .008) but not metastasis (SHR, 1.2; P = .21). Dr. Klein explained that they also conducted a separate subanalysis limited to OTR and patients with CLL, which demonstrated that immunosuppression was no longer a significant predictor of “major poor outcomes” (SHR, 0.9; P = .66 for OTR; SHR, 1.4; P = .25 for CLL).

“Organ transplant status and CLL were not independent risk factors for major poor outcomes,” he said. “But in summary, we may be tipping the scale to immunosuppression being a risk factor.”

Asked to comment on the findings, Naissan O. Wesley, MD, director of Mohs surgery, Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California, stated that “this larger scale study presented at this meeting was important to further confirm what we see in everyday practice, that immunosuppression may lead to poorer outcomes in patients with cutaneous squamous cell carcinoma.”

Also weighing in on the data, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery, at the Icahn School of Medicine at Mount Sinai, New York City, noted that the treatment of cSCC in high-risk patients has been challenging because of the historical lack of data and large studies to guide management.

“The authors provide a large cohort to help stratify which patients are most at risk for poor outcomes, which can inform our decision to refer for neoadjuvant or adjuvant treatment and multi-disciplinary management,” he said. “This is the first step in being able to optimize cure in these patients.”

The study was independently supported. Dr. Klein, Dr. Lewin, and Dr. Wesley reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

PHOENIX — Immunosuppression is an independent risk factor for poorer outcomes in patients with cutaneous squamous cell carcinoma (cSCC), according to new research that was presented at the American College of Mohs Surgery (ACMS) 2024 annual meeting.

Even though immunosuppression is strongly associated with an increased risk for cSCC, studies to date have generally not shown it to be an independent risk factor for metastasis and disease-specific death (DSD), after accounting for primary tumor stage.

“Solid organ transplant puts patients at risk for developing cutaneous squamous cell carcinoma, and it’s more likely to have aggressive features,” said study author Jason Klein, MD, PhD, a dermatology resident at University of Texas Southwestern Medical Center, Dallas. “But it’s still not known if immunosuppression is an independent risk factor.”

Other groups “have tried to tackle this, but they have all primarily been single-institution data,” he noted, adding that “results so far have been tipping the scale towards immunosuppression not being an independent risk factor” for worse outcomes.

Immunosuppressed individuals face a greater risk for cSCC than the general population and often present with more aggressive, multifocal disease. However, Dr. Klein explained that a previous retrospective study comprising a cohort of approximately 7600 tumors from two centers reported that immunosuppression was not an independent risk factor for both tumor metastasis and cancer-specific death after adjusting for tumor characteristics.

Tipped the Scale

Therefore, the goal of the current study was to repeat this analysis but in a much larger retrospective cohort. Dr. Klein and his colleagues pooled cSCC data from 12 dermatology centers (11 academic and one private) that were located in the United States, Spain, and Brazil. The cohort included 4392 patients (3769 immunocompetent patients and 623 immunosuppressed patients) with 19,237 tumors (15,191 immunocompetent and 4046 immunosuppressed). Study endpoints included local recurrence, metastasis (nodal, satellite/in-transit, and distant), DSD, and “major poor outcomes” (defined as metastasis and DSD combined).

About 30% of the immunosuppressed patients were organ transplant recipients (OTR) and 10% had chronic lymphocytic leukemia (CLL). Half of the immunocompetent patients (50.3%) underwent Mohs surgery as the primary treatment, as did 58.2% of the immunosuppressed patients.

On multivariable analysis, significant predictors of “major poor outcomes” included immunosuppression (subdistribution hazard ratio [SHR], 1.3; P = .04), Brigham and Women’s Hospital tumor stage (SHR 6.7 for T2a, 18.1 for T2b, and 37.2 for T3; P < .001 for all), location on the head/neck (SHR, 2.1; P < .001), and adjuvant radiation (SHR, 1.6; P < .001).

But when metastasis and DSD were evaluated separately, immunosuppression was only predictive of DSD (SHR, 1.7; P = .008) but not metastasis (SHR, 1.2; P = .21). Dr. Klein explained that they also conducted a separate subanalysis limited to OTR and patients with CLL, which demonstrated that immunosuppression was no longer a significant predictor of “major poor outcomes” (SHR, 0.9; P = .66 for OTR; SHR, 1.4; P = .25 for CLL).

“Organ transplant status and CLL were not independent risk factors for major poor outcomes,” he said. “But in summary, we may be tipping the scale to immunosuppression being a risk factor.”

Asked to comment on the findings, Naissan O. Wesley, MD, director of Mohs surgery, Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California, stated that “this larger scale study presented at this meeting was important to further confirm what we see in everyday practice, that immunosuppression may lead to poorer outcomes in patients with cutaneous squamous cell carcinoma.”

Also weighing in on the data, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery, at the Icahn School of Medicine at Mount Sinai, New York City, noted that the treatment of cSCC in high-risk patients has been challenging because of the historical lack of data and large studies to guide management.

“The authors provide a large cohort to help stratify which patients are most at risk for poor outcomes, which can inform our decision to refer for neoadjuvant or adjuvant treatment and multi-disciplinary management,” he said. “This is the first step in being able to optimize cure in these patients.”

The study was independently supported. Dr. Klein, Dr. Lewin, and Dr. Wesley reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

PHOENIX — Immunosuppression is an independent risk factor for poorer outcomes in patients with cutaneous squamous cell carcinoma (cSCC), according to new research that was presented at the American College of Mohs Surgery (ACMS) 2024 annual meeting.

Even though immunosuppression is strongly associated with an increased risk for cSCC, studies to date have generally not shown it to be an independent risk factor for metastasis and disease-specific death (DSD), after accounting for primary tumor stage.

“Solid organ transplant puts patients at risk for developing cutaneous squamous cell carcinoma, and it’s more likely to have aggressive features,” said study author Jason Klein, MD, PhD, a dermatology resident at University of Texas Southwestern Medical Center, Dallas. “But it’s still not known if immunosuppression is an independent risk factor.”

Other groups “have tried to tackle this, but they have all primarily been single-institution data,” he noted, adding that “results so far have been tipping the scale towards immunosuppression not being an independent risk factor” for worse outcomes.

Immunosuppressed individuals face a greater risk for cSCC than the general population and often present with more aggressive, multifocal disease. However, Dr. Klein explained that a previous retrospective study comprising a cohort of approximately 7600 tumors from two centers reported that immunosuppression was not an independent risk factor for both tumor metastasis and cancer-specific death after adjusting for tumor characteristics.

Tipped the Scale

Therefore, the goal of the current study was to repeat this analysis but in a much larger retrospective cohort. Dr. Klein and his colleagues pooled cSCC data from 12 dermatology centers (11 academic and one private) that were located in the United States, Spain, and Brazil. The cohort included 4392 patients (3769 immunocompetent patients and 623 immunosuppressed patients) with 19,237 tumors (15,191 immunocompetent and 4046 immunosuppressed). Study endpoints included local recurrence, metastasis (nodal, satellite/in-transit, and distant), DSD, and “major poor outcomes” (defined as metastasis and DSD combined).

About 30% of the immunosuppressed patients were organ transplant recipients (OTR) and 10% had chronic lymphocytic leukemia (CLL). Half of the immunocompetent patients (50.3%) underwent Mohs surgery as the primary treatment, as did 58.2% of the immunosuppressed patients.

On multivariable analysis, significant predictors of “major poor outcomes” included immunosuppression (subdistribution hazard ratio [SHR], 1.3; P = .04), Brigham and Women’s Hospital tumor stage (SHR 6.7 for T2a, 18.1 for T2b, and 37.2 for T3; P < .001 for all), location on the head/neck (SHR, 2.1; P < .001), and adjuvant radiation (SHR, 1.6; P < .001).

But when metastasis and DSD were evaluated separately, immunosuppression was only predictive of DSD (SHR, 1.7; P = .008) but not metastasis (SHR, 1.2; P = .21). Dr. Klein explained that they also conducted a separate subanalysis limited to OTR and patients with CLL, which demonstrated that immunosuppression was no longer a significant predictor of “major poor outcomes” (SHR, 0.9; P = .66 for OTR; SHR, 1.4; P = .25 for CLL).

“Organ transplant status and CLL were not independent risk factors for major poor outcomes,” he said. “But in summary, we may be tipping the scale to immunosuppression being a risk factor.”

Asked to comment on the findings, Naissan O. Wesley, MD, director of Mohs surgery, Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California, stated that “this larger scale study presented at this meeting was important to further confirm what we see in everyday practice, that immunosuppression may lead to poorer outcomes in patients with cutaneous squamous cell carcinoma.”

Also weighing in on the data, Jesse M. Lewin, MD, chief of Mohs micrographic and dermatologic surgery, at the Icahn School of Medicine at Mount Sinai, New York City, noted that the treatment of cSCC in high-risk patients has been challenging because of the historical lack of data and large studies to guide management.

“The authors provide a large cohort to help stratify which patients are most at risk for poor outcomes, which can inform our decision to refer for neoadjuvant or adjuvant treatment and multi-disciplinary management,” he said. “This is the first step in being able to optimize cure in these patients.”

The study was independently supported. Dr. Klein, Dr. Lewin, and Dr. Wesley reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Supporters of home phototherapy for patients with plaque and guttate psoriasis had plenty to cheer about at the annual meeting of the American Academy of Dermatology (AAD) in March. There, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, presented results from the LITE study, a trial that tested the hypothesis that narrowband ultraviolet B phototherapy of psoriasis at home is noninferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. While smaller studies have drawn similar conclusions, LITE was the largest trial of its kind to show what many dermatologists have suspected for years: Home phototherapy can be an effective first-line treatment for patients with moderate to severe psoriasis.

The co-primary outcomes in the LITE study were a Physician’s Global Assessment (PGA) score of 0/1 (clear, almost clear) and a Dermatology Life Quality Index (DLQI) score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. Following 12 weeks of treatment, 25.6% of patients in the office-based phototherapy group achieved a PGA score of 0/1 compared with 32.8% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data). Similarly, 33.6% of patients in the office-based phototherapy group achieved a DLQI score of 5 or less compared with 52.4% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data).

Courtesy Dr. Gelfand

A Safe and Effective Option

“I think that it’s important for physicians, insurance companies, and patients with psoriasis to understand that this is a very safe and effective form of therapy,” Craig A. Elmets, MD, professor of dermatology at The University of Alabama at Birmingham, said in an interview. “For people who are not interested in systemic medications or who have contraindications to systemic medications, phototherapy would be ideal,” added Dr. Elmets, first author of the joint AAD–National Psoriasis Foundation (NPF) guidelines for the management and treatment of psoriasis with phototherapy, published in 2019.

Factors beyond efficacy support the role of home phototherapy, Dr. Gelfand said, including the fact that it costs 10-100 times less than biologics for psoriasis and that office-based phototherapy is not available in 90% of counties in the United States. However, insurance coverage of home phototherapy “is highly variable because until the LITE study, there was no large-scale US data to support its use,” he told this news organization.

“Also, insurance companies are broken up into two parts: Durable medical goods and the medical side such as pharmacy costs, and they are siloed. The durable medical goods side views phototherapy as expensive, while the pharmacy side views it as dirt cheap. This is part of the problem with our health system. A lot of things are siloed and don’t make any sense,” said Dr. Gelfand, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania. By working with the NPF and payers, he added, “we’re hoping ... to transform the way insurance companies think about covering home phototherapy.”

In the meantime, he and Dr. Elmets shared practical ways to optimize access to home phototherapy for psoriasis patients:

Have the discussion. Patients “rarely bring this up as an option,” Dr. Elmets said, so the onus is on clinicians to talk about it. In his view, the ideal candidate “is averse to using systemic agents but whose disease is beyond the point where topical medicines alone will work. One of the advantages of phototherapy is that it doesn’t have immunosuppressive effects.”

Clinicians and patients can learn about the efficacy and safety of phototherapy for psoriasis, including home-based options, on the NPF’s web site and by reading the 2019 joint AAD-NPF guidelines.

Shared decision-making is key. “When a patient comes in, I’ll discuss what their treatment options are and [we] will decide upon a course of action based on their unique needs and preferences [and] if it’s medically appropriate, meaning they have the type of psoriasis likely to respond to phototherapy,” Dr. Gelfand said. A patient with psoriasis mainly on the fingernails or genitals “is not a good candidate for phototherapy. If it’s on the trunk or extremities, that patient would be a good candidate.”

Home phototherapy candidates also must be willing and able to operate a machine and have dedicated space in their dwelling for it (most units are about the size of a door). Patients also have to be reliable, follow directions, and come back in person for follow-up appointments “so we can assess their response to treatment and fine-tune things as necessary and make sure they’re not developing any skin damage,” Dr. Gelfand said.

Educate yourself about existing options. Home phototherapy units from manufacturers such as Daavlin, National Biological Corporation, and SolRx range between $1200 and $6000 in cost, Dr. Gelfand said. He and his colleagues used the Daavlin 7 series in the LITE study. That unit features an integrated dosimetry system that delivers the correct dose of energy based on parameters that the prescribing clinician recommends. Settings are based on the patient’s skin type and how much the prescriber wants to increase the dose for each treatment. “The machine does the rest,” he said. “It knows what dose to give, so they get the same dosing as they would in an office situation.”

Smaller home-based phototherapy units designed to treat the hands and feet are available. So are handheld units to treat the scalp. “These can be a nice option for patients who have a few spots, but if the disease is moderate to severe, then it’s going to be pretty laborious to [use them],” Dr. Elmets said.

Remember that phototherapy is not a cure-all. According to the joint AAD-NPF guidelines, most phototherapy regimens require treatments two to three times per week for 10-14 weeks. Once patients achieve their home phototherapy treatment goal, Dr. Elmets often recommends treatments one to two times per week for maintenance.

“Patients with psoriasis have a lifetime condition,” he noted. “There are certainly cases where people have gone on phototherapy, cleared, and then stopped for a period of time. If they flare up, they can always go back to phototherapy. Usually, people who are on phototherapy use some type of topical agents to touch up areas that are resistant.”

Expect pushback from insurers on coverage. While Medicare and some integrated health plans cover home phototherapy, expect to spend time writing letters or placing phone calls to insurance companies to convince them why they should cover home phototherapy for candidate psoriasis patients. “Usually there’s a lot of letter writing and a long delay in getting approval,” Dr. Elmets said.

Dr. Elmets and Dr. Gelfand reported no relevant financial relationships. The LITE study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices.

A version of this article appeared on Medscape.com.

Supporters of home phototherapy for patients with plaque and guttate psoriasis had plenty to cheer about at the annual meeting of the American Academy of Dermatology (AAD) in March. There, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, presented results from the LITE study, a trial that tested the hypothesis that narrowband ultraviolet B phototherapy of psoriasis at home is noninferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. While smaller studies have drawn similar conclusions, LITE was the largest trial of its kind to show what many dermatologists have suspected for years: Home phototherapy can be an effective first-line treatment for patients with moderate to severe psoriasis.

The co-primary outcomes in the LITE study were a Physician’s Global Assessment (PGA) score of 0/1 (clear, almost clear) and a Dermatology Life Quality Index (DLQI) score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. Following 12 weeks of treatment, 25.6% of patients in the office-based phototherapy group achieved a PGA score of 0/1 compared with 32.8% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data). Similarly, 33.6% of patients in the office-based phototherapy group achieved a DLQI score of 5 or less compared with 52.4% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data).

Courtesy Dr. Gelfand

A Safe and Effective Option

“I think that it’s important for physicians, insurance companies, and patients with psoriasis to understand that this is a very safe and effective form of therapy,” Craig A. Elmets, MD, professor of dermatology at The University of Alabama at Birmingham, said in an interview. “For people who are not interested in systemic medications or who have contraindications to systemic medications, phototherapy would be ideal,” added Dr. Elmets, first author of the joint AAD–National Psoriasis Foundation (NPF) guidelines for the management and treatment of psoriasis with phototherapy, published in 2019.

Factors beyond efficacy support the role of home phototherapy, Dr. Gelfand said, including the fact that it costs 10-100 times less than biologics for psoriasis and that office-based phototherapy is not available in 90% of counties in the United States. However, insurance coverage of home phototherapy “is highly variable because until the LITE study, there was no large-scale US data to support its use,” he told this news organization.

“Also, insurance companies are broken up into two parts: Durable medical goods and the medical side such as pharmacy costs, and they are siloed. The durable medical goods side views phototherapy as expensive, while the pharmacy side views it as dirt cheap. This is part of the problem with our health system. A lot of things are siloed and don’t make any sense,” said Dr. Gelfand, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania. By working with the NPF and payers, he added, “we’re hoping ... to transform the way insurance companies think about covering home phototherapy.”

In the meantime, he and Dr. Elmets shared practical ways to optimize access to home phototherapy for psoriasis patients:

Have the discussion. Patients “rarely bring this up as an option,” Dr. Elmets said, so the onus is on clinicians to talk about it. In his view, the ideal candidate “is averse to using systemic agents but whose disease is beyond the point where topical medicines alone will work. One of the advantages of phototherapy is that it doesn’t have immunosuppressive effects.”

Clinicians and patients can learn about the efficacy and safety of phototherapy for psoriasis, including home-based options, on the NPF’s web site and by reading the 2019 joint AAD-NPF guidelines.

Shared decision-making is key. “When a patient comes in, I’ll discuss what their treatment options are and [we] will decide upon a course of action based on their unique needs and preferences [and] if it’s medically appropriate, meaning they have the type of psoriasis likely to respond to phototherapy,” Dr. Gelfand said. A patient with psoriasis mainly on the fingernails or genitals “is not a good candidate for phototherapy. If it’s on the trunk or extremities, that patient would be a good candidate.”

Home phototherapy candidates also must be willing and able to operate a machine and have dedicated space in their dwelling for it (most units are about the size of a door). Patients also have to be reliable, follow directions, and come back in person for follow-up appointments “so we can assess their response to treatment and fine-tune things as necessary and make sure they’re not developing any skin damage,” Dr. Gelfand said.

Educate yourself about existing options. Home phototherapy units from manufacturers such as Daavlin, National Biological Corporation, and SolRx range between $1200 and $6000 in cost, Dr. Gelfand said. He and his colleagues used the Daavlin 7 series in the LITE study. That unit features an integrated dosimetry system that delivers the correct dose of energy based on parameters that the prescribing clinician recommends. Settings are based on the patient’s skin type and how much the prescriber wants to increase the dose for each treatment. “The machine does the rest,” he said. “It knows what dose to give, so they get the same dosing as they would in an office situation.”

Smaller home-based phototherapy units designed to treat the hands and feet are available. So are handheld units to treat the scalp. “These can be a nice option for patients who have a few spots, but if the disease is moderate to severe, then it’s going to be pretty laborious to [use them],” Dr. Elmets said.

Remember that phototherapy is not a cure-all. According to the joint AAD-NPF guidelines, most phototherapy regimens require treatments two to three times per week for 10-14 weeks. Once patients achieve their home phototherapy treatment goal, Dr. Elmets often recommends treatments one to two times per week for maintenance.

“Patients with psoriasis have a lifetime condition,” he noted. “There are certainly cases where people have gone on phototherapy, cleared, and then stopped for a period of time. If they flare up, they can always go back to phototherapy. Usually, people who are on phototherapy use some type of topical agents to touch up areas that are resistant.”

Expect pushback from insurers on coverage. While Medicare and some integrated health plans cover home phototherapy, expect to spend time writing letters or placing phone calls to insurance companies to convince them why they should cover home phototherapy for candidate psoriasis patients. “Usually there’s a lot of letter writing and a long delay in getting approval,” Dr. Elmets said.

Dr. Elmets and Dr. Gelfand reported no relevant financial relationships. The LITE study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices.

A version of this article appeared on Medscape.com.

Supporters of home phototherapy for patients with plaque and guttate psoriasis had plenty to cheer about at the annual meeting of the American Academy of Dermatology (AAD) in March. There, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, presented results from the LITE study, a trial that tested the hypothesis that narrowband ultraviolet B phototherapy of psoriasis at home is noninferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. While smaller studies have drawn similar conclusions, LITE was the largest trial of its kind to show what many dermatologists have suspected for years: Home phototherapy can be an effective first-line treatment for patients with moderate to severe psoriasis.

The co-primary outcomes in the LITE study were a Physician’s Global Assessment (PGA) score of 0/1 (clear, almost clear) and a Dermatology Life Quality Index (DLQI) score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. Following 12 weeks of treatment, 25.6% of patients in the office-based phototherapy group achieved a PGA score of 0/1 compared with 32.8% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data). Similarly, 33.6% of patients in the office-based phototherapy group achieved a DLQI score of 5 or less compared with 52.4% of patients in the home-based phototherapy group (P > .0001 for noninferiority, non-response imputation for missing data).

Courtesy Dr. Gelfand

A Safe and Effective Option

“I think that it’s important for physicians, insurance companies, and patients with psoriasis to understand that this is a very safe and effective form of therapy,” Craig A. Elmets, MD, professor of dermatology at The University of Alabama at Birmingham, said in an interview. “For people who are not interested in systemic medications or who have contraindications to systemic medications, phototherapy would be ideal,” added Dr. Elmets, first author of the joint AAD–National Psoriasis Foundation (NPF) guidelines for the management and treatment of psoriasis with phototherapy, published in 2019.

Factors beyond efficacy support the role of home phototherapy, Dr. Gelfand said, including the fact that it costs 10-100 times less than biologics for psoriasis and that office-based phototherapy is not available in 90% of counties in the United States. However, insurance coverage of home phototherapy “is highly variable because until the LITE study, there was no large-scale US data to support its use,” he told this news organization.

“Also, insurance companies are broken up into two parts: Durable medical goods and the medical side such as pharmacy costs, and they are siloed. The durable medical goods side views phototherapy as expensive, while the pharmacy side views it as dirt cheap. This is part of the problem with our health system. A lot of things are siloed and don’t make any sense,” said Dr. Gelfand, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania. By working with the NPF and payers, he added, “we’re hoping ... to transform the way insurance companies think about covering home phototherapy.”

In the meantime, he and Dr. Elmets shared practical ways to optimize access to home phototherapy for psoriasis patients:

Have the discussion. Patients “rarely bring this up as an option,” Dr. Elmets said, so the onus is on clinicians to talk about it. In his view, the ideal candidate “is averse to using systemic agents but whose disease is beyond the point where topical medicines alone will work. One of the advantages of phototherapy is that it doesn’t have immunosuppressive effects.”

Clinicians and patients can learn about the efficacy and safety of phototherapy for psoriasis, including home-based options, on the NPF’s web site and by reading the 2019 joint AAD-NPF guidelines.

Shared decision-making is key. “When a patient comes in, I’ll discuss what their treatment options are and [we] will decide upon a course of action based on their unique needs and preferences [and] if it’s medically appropriate, meaning they have the type of psoriasis likely to respond to phototherapy,” Dr. Gelfand said. A patient with psoriasis mainly on the fingernails or genitals “is not a good candidate for phototherapy. If it’s on the trunk or extremities, that patient would be a good candidate.”

Home phototherapy candidates also must be willing and able to operate a machine and have dedicated space in their dwelling for it (most units are about the size of a door). Patients also have to be reliable, follow directions, and come back in person for follow-up appointments “so we can assess their response to treatment and fine-tune things as necessary and make sure they’re not developing any skin damage,” Dr. Gelfand said.

Educate yourself about existing options. Home phototherapy units from manufacturers such as Daavlin, National Biological Corporation, and SolRx range between $1200 and $6000 in cost, Dr. Gelfand said. He and his colleagues used the Daavlin 7 series in the LITE study. That unit features an integrated dosimetry system that delivers the correct dose of energy based on parameters that the prescribing clinician recommends. Settings are based on the patient’s skin type and how much the prescriber wants to increase the dose for each treatment. “The machine does the rest,” he said. “It knows what dose to give, so they get the same dosing as they would in an office situation.”

Smaller home-based phototherapy units designed to treat the hands and feet are available. So are handheld units to treat the scalp. “These can be a nice option for patients who have a few spots, but if the disease is moderate to severe, then it’s going to be pretty laborious to [use them],” Dr. Elmets said.

Remember that phototherapy is not a cure-all. According to the joint AAD-NPF guidelines, most phototherapy regimens require treatments two to three times per week for 10-14 weeks. Once patients achieve their home phototherapy treatment goal, Dr. Elmets often recommends treatments one to two times per week for maintenance.

“Patients with psoriasis have a lifetime condition,” he noted. “There are certainly cases where people have gone on phototherapy, cleared, and then stopped for a period of time. If they flare up, they can always go back to phototherapy. Usually, people who are on phototherapy use some type of topical agents to touch up areas that are resistant.”

Expect pushback from insurers on coverage. While Medicare and some integrated health plans cover home phototherapy, expect to spend time writing letters or placing phone calls to insurance companies to convince them why they should cover home phototherapy for candidate psoriasis patients. “Usually there’s a lot of letter writing and a long delay in getting approval,” Dr. Elmets said.

Dr. Elmets and Dr. Gelfand reported no relevant financial relationships. The LITE study was funded by the Patient-Centered Outcomes Research Institute. Research partners included the National Psoriasis Foundation and Daavlin, which provided the home phototherapy machines and covered the cost of shipping the devices.

A version of this article appeared on Medscape.com.

PHOENIX — Immunotherapy has revolutionized outcomes for patients with metastatic Merkel cell carcinoma (MCC). However, findings from a new study suggest that many patients who are eligible for immunotherapy are not receiving this treatment, despite guideline recommendations, and survival outcomes are better at high-volume centers.

The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.

MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.

“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”

Real World vs Clinical Trials

Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.

The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.

“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”

Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.

Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.

From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.

Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
 

Implications Going Forward

Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”

Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.

Fox Chase Cancer Center

“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”

Dr. Cheraghlou and Dr. Farma had no disclosures.

A version of this article appeared on Medscape.com.

PHOENIX — Immunotherapy has revolutionized outcomes for patients with metastatic Merkel cell carcinoma (MCC). However, findings from a new study suggest that many patients who are eligible for immunotherapy are not receiving this treatment, despite guideline recommendations, and survival outcomes are better at high-volume centers.

The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.

MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.

“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”

Real World vs Clinical Trials

Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.

The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.

“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”

Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.

Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.

From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.

Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
 

Implications Going Forward

Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”

Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.

Fox Chase Cancer Center

“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”

Dr. Cheraghlou and Dr. Farma had no disclosures.

A version of this article appeared on Medscape.com.

PHOENIX — Immunotherapy has revolutionized outcomes for patients with metastatic Merkel cell carcinoma (MCC). However, findings from a new study suggest that many patients who are eligible for immunotherapy are not receiving this treatment, despite guideline recommendations, and survival outcomes are better at high-volume centers.

The study has important implications, said study author Shayan Cheraghlou, MD, an incoming fellow in Mohs surgery at New York University, New York City. “We can see that in a real-world setting, these agents have an impact on survival,” he said. “We also found high-volume centers were significantly more likely to use the agents than low-volume centers.” He presented the findings at the annual meeting of the American College of Mohs Surgery.

MCC is a neuroendocrine skin cancer with a high rate of mortality, and even though it remains relatively rare, its incidence has been rising rapidly since the late 1990s and continues to increase. There were no approved treatments available until 2017, when the US Food and Drug Administration (FDA) approved the immunotherapy drug avelumab (Bavencio) to treat advanced MCC. Two years later, pembrolizumab (Keytruda) also received regulatory approval for MCC, and these two agents have revolutionized outcomes.

“In clinical trial settings, these agents led to significant and durable responses, and they are now the recommended treatments in guidelines for metastatic Merkel cell carcinoma,” said Dr. Cheraghlou. “However, we don’t have data as to how they are being used in the real-world setting and if survival outcomes are similar.”

Real World vs Clinical Trials

Real-world outcomes can differ from clinical trial data, and the adoption of novel therapeutics can be gradual. The goal of this study was to see if clinical trial data matched what was being observed in actual clinical use and if the agents were being used uniformly in centers across the United States.

The authors used data from the National Cancer Database that included patients diagnosed with cancer from 2004 to 2019 and identified 1017 adult cases of metastatic MCC. They then looked at the association of a variety of patient characteristics, tumors, and system factors with the likelihood of receiving systemic treatment for their disease.

“Our first finding was maybe the least surprising,” he said. “Patients who received these therapeutic agents had significantly improved survival compared to those who have not.”

Those who received immunotherapy had a 35% decrease in the risk for death per year compared with those who did not. The 1-, 3-, and 5-year survival rates were 47.2%, 21.8%, and 16.5%, respectively, for patients who did not receive immunotherapy compared with 62.7%, 34.4%, and 23.6%, respectively, for those who were treated with these agents.

Dr. Cheraghlou noted that they started to get some “surprising” findings when they looked at utilization data. “While it has been increasing over time, it is not as high as it should be,” he emphasized.

From 2017 to 2019, 54.2% of patients with metastatic MCC received immunotherapy. The data also showed an increase in use from 45.1% in 2017 to 63.0% in 2019. “This is an effective treatment for aggressive malignancy, so we have to ask why more patients aren’t getting them,” said Dr. Cheraghlou.

Their findings did suggest one possible reason, and that was that high-volume centers were significantly more likely to use the agents than low-volume centers. Centers that were in the top percentile for MCC case volume were three times as likely to use immunotherapy for MCC compared with other institutions. “So, if you have metastatic Merkel cell carcinoma and go to a low volume center, you may be less likely to get potential lifesaving treatment,” he noted.
 

Implications Going Forward

Dr. Cheraghlou concluded his presentation by pointing out that this study has important implications. The data showed that in a real-world setting, these agents have an impact on survival, but all eligible patients do not have access. “In other countries, there are established referral patterns for all patients with aggressive rare malignancies and really all cancers,” he added. “But in the US, cancer care is more decentralized. Studies like this and others show that high-volume centers have much better outcomes for aggressive rare malignancies, and we should be looking at why this is the case and mitigating these disparities and outcomes.”

Commenting on the study results, Jeffrey M. Farma, MD, co-director of the Melanoma and Skin Cancer Program and professor of surgical oncology at Fox Chase Cancer Center, Philadelphia, referred to the two immunotherapies that have been approved for MCC since 2017, which have demonstrated a survival benefit and improved outcomes in patients with metastatic MCC.

Fox Chase Cancer Center

“In their study, immunotherapy was associated with improved outcomes,” said Dr. Farma. “This study highlights the continued lag of implementation of guidelines when new therapies are approved, and that for rare cancers like Merkel cell carcinoma, being treated at high-volume centers and the regionalization of care can lead to improved outcomes for patients.”

Dr. Cheraghlou and Dr. Farma had no disclosures.

A version of this article appeared on Medscape.com.

PHOENIX — The use of radiotherapy has been steadily increasing by dermatologists, according to new findings from a study analyzing trends in Medicare claims from 2016 to 2021. More specifically, the persistent growth in the use of superficial radiotherapy (SRT) devices and electronic brachytherapy (eBT) to treat nonmelanoma skin cancer (NMSC) has exceeded that of traditional procedures among dermatologists using these modalities, according to Christian Gronbeck, MD, a resident in dermatology at the University of Connecticut Health Center, Farmington.

“These services increased substantially over the study period,” Dr. Gronbeck said at the annual meeting of the American College of Mohs Surgery, where he presented the results of the study. “Our findings suggest that those using eBT/SRT were frequently general dermatologists and non-fellowship–trained Mohs surgeons who have less formalized surgical training.”

He also noted that billing for these services also rose substantially, which is being driven by growing utilization and an increased SRT payment rate.

Surgical approaches are standard for most NMSC cases, but some patients are not good surgical candidates because of medical comorbidities and/or other factors, and radiotherapy is emerging as a potential treatment option for those patients. Traditionally, radiotherapy was administered by radiation oncologists, but with the growing availability of SRT devices and the introduction of eBT, dermatologists are now treating patients with these modalities.

“It is a potential treatment option for nonmelanoma skin cancer and keloids, and these lower energy devices can be used in the outpatient setting,” said Dr. Gronbeck. “Treatment typically involves a series of fractions over a period of several weeks. There has been recent growth in the use of radiotherapy despite this being a secondary option in skin cancer, primarily when surgery is contraindicated.”

Steady Expansion of Use

Dr. Gronbeck and colleagues sought to gain a better understanding of the use of SRT and eBT for NMSC among dermatologists, as well as trends in cost. Data were obtained from the 2016-2021 Medicare Public Use Files to evaluate the trend in the volume of Medicare Part B claims for eBT (CPT 0394T) and SRT (CPT 77401) by dermatologists, and they also looked at related billable services for radiotherapy.

Of 12,050 dermatologists, 293 (2.4%) were identified as utilizing eBT or SRT in 2021, representing a 75.4% increase from 2016. The usage of both eBT and SRT increased by 59.6% and 148.4%, respectively, from 2016 to 2021.

There were notable geographic differences in the utilization of radiotherapy. “Florida, California, Texas, and Arizona had the highest utilization,” Dr. Gronbeck said, although during the study period, utilization increased in other states, including North Carolina and Alabama.

When looking at geographic regions as a whole, the highest number of dermatologists using radiotherapy were located in the South (n = 143, 50.9%), followed by the West (n = 69, 23.6%). Utilization was more common in metro areas than in nonmetro/rural areas (86% vs 14%).

Differences were also noted among dermatologists. Those who performed eBT/SRT than those who did not were significantly more likely to have had 15 or more years of independent practice (70.1% vs 48.6%), be in a small private dermatology practice (62.7% vs 47.5%), and be non–fellowship-trained Mohs surgeons (33.5% vs 10.2%). Dermatologists utilizing radiotherapy were also more likely to treat Medicare beneficiaries who were older, with a mean age over 75 years (39.3% vs 31.1%) and a mean hierarchical condition category (HCC) score, above the national average (55.2% vs 44.6%).

Dr. Gronbeck and colleagues also looked at cost. The number of direct payments for eBT/SRT payments increased throughout the study period, from 3,678,224 in 2016 to 11,680,925 in 2021, nearly a 218% increase. The change in payments for services related to eBT/SRT, such as radiotherapy simulation, radiotherapy dosing, and ultrasound guidance, increased by 621.4% during this same timeframe.

Radiotherapy in dermatology has primarily been assessed through retrospective studies. “Our findings suggest that eBT and SRT are more frequently utilized by dermatologists managing older and sicker patients, but further studies are needed to identify whether these interventions are truly addressing poor surgical candidates,” Dr. Gronbeck said.

The Centers for Medicare & Medicaid Services (CMS) has recently proposed changes in Medicare coverage in seven states for Image-Guided Superficial Radiation Therapy (image-guided SRT or IGSRT) for the treatment of NMSC. The proposed local coverage determination, or LCD, if finalized in its current form, would affect residents in North Carolina, South Carolina, Virginia, West Virginia, Alabama, Georgia, and Tennessee.

“These changes would mean more restrictive coverage,” said Dr. Gronbeck, and further support the need for “improved clinical data and development of guidelines to support evidence-based utilization.”

Surgical Management Standard, but SRT Has a Role

Asked to comment on the findings, Seemal R. Desai, MD, president of the American Academy of Dermatology (AAD), who was not involved with the study, reiterated that according to this abstract, efficacy has mainly been assessed through retrospective studies, and results are likely inferior to Mohs surgery, require multiple treatment visits, and are associated with significant costs. More study is needed for the use of radiation therapy in dermatology, he told this news organization.

A version of this article appeared on Medscape.com.

PHOENIX — The use of radiotherapy has been steadily increasing by dermatologists, according to new findings from a study analyzing trends in Medicare claims from 2016 to 2021. More specifically, the persistent growth in the use of superficial radiotherapy (SRT) devices and electronic brachytherapy (eBT) to treat nonmelanoma skin cancer (NMSC) has exceeded that of traditional procedures among dermatologists using these modalities, according to Christian Gronbeck, MD, a resident in dermatology at the University of Connecticut Health Center, Farmington.

“These services increased substantially over the study period,” Dr. Gronbeck said at the annual meeting of the American College of Mohs Surgery, where he presented the results of the study. “Our findings suggest that those using eBT/SRT were frequently general dermatologists and non-fellowship–trained Mohs surgeons who have less formalized surgical training.”

He also noted that billing for these services also rose substantially, which is being driven by growing utilization and an increased SRT payment rate.

Surgical approaches are standard for most NMSC cases, but some patients are not good surgical candidates because of medical comorbidities and/or other factors, and radiotherapy is emerging as a potential treatment option for those patients. Traditionally, radiotherapy was administered by radiation oncologists, but with the growing availability of SRT devices and the introduction of eBT, dermatologists are now treating patients with these modalities.

“It is a potential treatment option for nonmelanoma skin cancer and keloids, and these lower energy devices can be used in the outpatient setting,” said Dr. Gronbeck. “Treatment typically involves a series of fractions over a period of several weeks. There has been recent growth in the use of radiotherapy despite this being a secondary option in skin cancer, primarily when surgery is contraindicated.”

Steady Expansion of Use

Dr. Gronbeck and colleagues sought to gain a better understanding of the use of SRT and eBT for NMSC among dermatologists, as well as trends in cost. Data were obtained from the 2016-2021 Medicare Public Use Files to evaluate the trend in the volume of Medicare Part B claims for eBT (CPT 0394T) and SRT (CPT 77401) by dermatologists, and they also looked at related billable services for radiotherapy.

Of 12,050 dermatologists, 293 (2.4%) were identified as utilizing eBT or SRT in 2021, representing a 75.4% increase from 2016. The usage of both eBT and SRT increased by 59.6% and 148.4%, respectively, from 2016 to 2021.

There were notable geographic differences in the utilization of radiotherapy. “Florida, California, Texas, and Arizona had the highest utilization,” Dr. Gronbeck said, although during the study period, utilization increased in other states, including North Carolina and Alabama.

When looking at geographic regions as a whole, the highest number of dermatologists using radiotherapy were located in the South (n = 143, 50.9%), followed by the West (n = 69, 23.6%). Utilization was more common in metro areas than in nonmetro/rural areas (86% vs 14%).

Differences were also noted among dermatologists. Those who performed eBT/SRT than those who did not were significantly more likely to have had 15 or more years of independent practice (70.1% vs 48.6%), be in a small private dermatology practice (62.7% vs 47.5%), and be non–fellowship-trained Mohs surgeons (33.5% vs 10.2%). Dermatologists utilizing radiotherapy were also more likely to treat Medicare beneficiaries who were older, with a mean age over 75 years (39.3% vs 31.1%) and a mean hierarchical condition category (HCC) score, above the national average (55.2% vs 44.6%).

Dr. Gronbeck and colleagues also looked at cost. The number of direct payments for eBT/SRT payments increased throughout the study period, from 3,678,224 in 2016 to 11,680,925 in 2021, nearly a 218% increase. The change in payments for services related to eBT/SRT, such as radiotherapy simulation, radiotherapy dosing, and ultrasound guidance, increased by 621.4% during this same timeframe.

Radiotherapy in dermatology has primarily been assessed through retrospective studies. “Our findings suggest that eBT and SRT are more frequently utilized by dermatologists managing older and sicker patients, but further studies are needed to identify whether these interventions are truly addressing poor surgical candidates,” Dr. Gronbeck said.

The Centers for Medicare & Medicaid Services (CMS) has recently proposed changes in Medicare coverage in seven states for Image-Guided Superficial Radiation Therapy (image-guided SRT or IGSRT) for the treatment of NMSC. The proposed local coverage determination, or LCD, if finalized in its current form, would affect residents in North Carolina, South Carolina, Virginia, West Virginia, Alabama, Georgia, and Tennessee.

“These changes would mean more restrictive coverage,” said Dr. Gronbeck, and further support the need for “improved clinical data and development of guidelines to support evidence-based utilization.”

Surgical Management Standard, but SRT Has a Role

Asked to comment on the findings, Seemal R. Desai, MD, president of the American Academy of Dermatology (AAD), who was not involved with the study, reiterated that according to this abstract, efficacy has mainly been assessed through retrospective studies, and results are likely inferior to Mohs surgery, require multiple treatment visits, and are associated with significant costs. More study is needed for the use of radiation therapy in dermatology, he told this news organization.

A version of this article appeared on Medscape.com.

PHOENIX — The use of radiotherapy has been steadily increasing by dermatologists, according to new findings from a study analyzing trends in Medicare claims from 2016 to 2021. More specifically, the persistent growth in the use of superficial radiotherapy (SRT) devices and electronic brachytherapy (eBT) to treat nonmelanoma skin cancer (NMSC) has exceeded that of traditional procedures among dermatologists using these modalities, according to Christian Gronbeck, MD, a resident in dermatology at the University of Connecticut Health Center, Farmington.

“These services increased substantially over the study period,” Dr. Gronbeck said at the annual meeting of the American College of Mohs Surgery, where he presented the results of the study. “Our findings suggest that those using eBT/SRT were frequently general dermatologists and non-fellowship–trained Mohs surgeons who have less formalized surgical training.”

He also noted that billing for these services also rose substantially, which is being driven by growing utilization and an increased SRT payment rate.

Surgical approaches are standard for most NMSC cases, but some patients are not good surgical candidates because of medical comorbidities and/or other factors, and radiotherapy is emerging as a potential treatment option for those patients. Traditionally, radiotherapy was administered by radiation oncologists, but with the growing availability of SRT devices and the introduction of eBT, dermatologists are now treating patients with these modalities.

“It is a potential treatment option for nonmelanoma skin cancer and keloids, and these lower energy devices can be used in the outpatient setting,” said Dr. Gronbeck. “Treatment typically involves a series of fractions over a period of several weeks. There has been recent growth in the use of radiotherapy despite this being a secondary option in skin cancer, primarily when surgery is contraindicated.”

Steady Expansion of Use

Dr. Gronbeck and colleagues sought to gain a better understanding of the use of SRT and eBT for NMSC among dermatologists, as well as trends in cost. Data were obtained from the 2016-2021 Medicare Public Use Files to evaluate the trend in the volume of Medicare Part B claims for eBT (CPT 0394T) and SRT (CPT 77401) by dermatologists, and they also looked at related billable services for radiotherapy.

Of 12,050 dermatologists, 293 (2.4%) were identified as utilizing eBT or SRT in 2021, representing a 75.4% increase from 2016. The usage of both eBT and SRT increased by 59.6% and 148.4%, respectively, from 2016 to 2021.

There were notable geographic differences in the utilization of radiotherapy. “Florida, California, Texas, and Arizona had the highest utilization,” Dr. Gronbeck said, although during the study period, utilization increased in other states, including North Carolina and Alabama.

When looking at geographic regions as a whole, the highest number of dermatologists using radiotherapy were located in the South (n = 143, 50.9%), followed by the West (n = 69, 23.6%). Utilization was more common in metro areas than in nonmetro/rural areas (86% vs 14%).

Differences were also noted among dermatologists. Those who performed eBT/SRT than those who did not were significantly more likely to have had 15 or more years of independent practice (70.1% vs 48.6%), be in a small private dermatology practice (62.7% vs 47.5%), and be non–fellowship-trained Mohs surgeons (33.5% vs 10.2%). Dermatologists utilizing radiotherapy were also more likely to treat Medicare beneficiaries who were older, with a mean age over 75 years (39.3% vs 31.1%) and a mean hierarchical condition category (HCC) score, above the national average (55.2% vs 44.6%).

Dr. Gronbeck and colleagues also looked at cost. The number of direct payments for eBT/SRT payments increased throughout the study period, from 3,678,224 in 2016 to 11,680,925 in 2021, nearly a 218% increase. The change in payments for services related to eBT/SRT, such as radiotherapy simulation, radiotherapy dosing, and ultrasound guidance, increased by 621.4% during this same timeframe.

Radiotherapy in dermatology has primarily been assessed through retrospective studies. “Our findings suggest that eBT and SRT are more frequently utilized by dermatologists managing older and sicker patients, but further studies are needed to identify whether these interventions are truly addressing poor surgical candidates,” Dr. Gronbeck said.

The Centers for Medicare & Medicaid Services (CMS) has recently proposed changes in Medicare coverage in seven states for Image-Guided Superficial Radiation Therapy (image-guided SRT or IGSRT) for the treatment of NMSC. The proposed local coverage determination, or LCD, if finalized in its current form, would affect residents in North Carolina, South Carolina, Virginia, West Virginia, Alabama, Georgia, and Tennessee.

“These changes would mean more restrictive coverage,” said Dr. Gronbeck, and further support the need for “improved clinical data and development of guidelines to support evidence-based utilization.”

Surgical Management Standard, but SRT Has a Role

Asked to comment on the findings, Seemal R. Desai, MD, president of the American Academy of Dermatology (AAD), who was not involved with the study, reiterated that according to this abstract, efficacy has mainly been assessed through retrospective studies, and results are likely inferior to Mohs surgery, require multiple treatment visits, and are associated with significant costs. More study is needed for the use of radiation therapy in dermatology, he told this news organization.

A version of this article appeared on Medscape.com.

Atopic dermatitis (AD) among older individuals presented most frequently on the extensor surfaces and trunk, with lichenification and nummular lesions being the most frequent rash characteristics, in a retrospective study of almost 800 patients aged 60 years and older.

The researchers reviewed charts of patients aged 60 years and older who were seen at either a private or county dermatology clinic in Houston between 2009 and 2020 and had been diagnosed with AD by a dermatologist. The findings of their cross-sectional study further supports that AD in this age group “presents as a unique phenotype compared to AD in younger ages, which may inform dermatologists’ diagnosis of AD in these patients” they wrote.

The 791 patients in the study had an average age of 69.3 years, were predominantly women (60.1%), and were racially diverse, with almost 40% being non-Hispanic White individuals. Others were non-Hispanic Black individuals (21.8%), Hispanics (20.4%), and non-Hispanic Asian/Pacific Islanders (11.7%).

Use of topicals, mainly topical corticosteroids (92.2%), was the most frequent treatment prescribed. Oral corticosteroids and antihistamines were “frequent systemic treatments” in this population, prescribed to 10.4% and 12.1%, respectively, “likely due to management prior to a diagnosis of AD by a dermatologist,” wrote first author Hannah Y. Wang, Baylor College of Medicine, Houston, and her coauthors, including Soo Jung Kim, MD, PhD, of the department of dermatology at Baylor.

Other treatments included dupilumab in 5.4%, systemic immunosuppressants (including methotrexate, cyclosporine, and mycophenolate) in 5.4%, and UVB-phototherapy in 2.7%.

Approximately 40% of the patients had a history of allergic rhinitis, while 20% had a history of asthma. Lichenification was noted in 14.5% of patients and nummular lesions in almost 13%. Other rash characteristics — ichthyosis and hyperpigmented patches — were less frequent, seen in 9.7% and 9.1%, respectively.

AD in this older population was most commonly documented on the extensors (49.9%) and the trunk (46%) and less commonly on the hands (19.8%) and feet (9%) — a distribution that is similar to past reports, the authors wrote.

Asked to comment on the findings, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization that the data relating to clinical morphology are consistent with past reports and with his own experiences. Lichenification is a “tell-tale sign of chronic disease” and may indicate undertreatment, and the frequency of nummular plaques is unsurprising because “nummular dermatitis as an independent eczema tends to occur more so in the elderly.”

A version of this article appeared on Medscape.com.

Atopic dermatitis (AD) among older individuals presented most frequently on the extensor surfaces and trunk, with lichenification and nummular lesions being the most frequent rash characteristics, in a retrospective study of almost 800 patients aged 60 years and older.

The researchers reviewed charts of patients aged 60 years and older who were seen at either a private or county dermatology clinic in Houston between 2009 and 2020 and had been diagnosed with AD by a dermatologist. The findings of their cross-sectional study further supports that AD in this age group “presents as a unique phenotype compared to AD in younger ages, which may inform dermatologists’ diagnosis of AD in these patients” they wrote.

The 791 patients in the study had an average age of 69.3 years, were predominantly women (60.1%), and were racially diverse, with almost 40% being non-Hispanic White individuals. Others were non-Hispanic Black individuals (21.8%), Hispanics (20.4%), and non-Hispanic Asian/Pacific Islanders (11.7%).

Use of topicals, mainly topical corticosteroids (92.2%), was the most frequent treatment prescribed. Oral corticosteroids and antihistamines were “frequent systemic treatments” in this population, prescribed to 10.4% and 12.1%, respectively, “likely due to management prior to a diagnosis of AD by a dermatologist,” wrote first author Hannah Y. Wang, Baylor College of Medicine, Houston, and her coauthors, including Soo Jung Kim, MD, PhD, of the department of dermatology at Baylor.

Other treatments included dupilumab in 5.4%, systemic immunosuppressants (including methotrexate, cyclosporine, and mycophenolate) in 5.4%, and UVB-phototherapy in 2.7%.

Approximately 40% of the patients had a history of allergic rhinitis, while 20% had a history of asthma. Lichenification was noted in 14.5% of patients and nummular lesions in almost 13%. Other rash characteristics — ichthyosis and hyperpigmented patches — were less frequent, seen in 9.7% and 9.1%, respectively.

AD in this older population was most commonly documented on the extensors (49.9%) and the trunk (46%) and less commonly on the hands (19.8%) and feet (9%) — a distribution that is similar to past reports, the authors wrote.

Asked to comment on the findings, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization that the data relating to clinical morphology are consistent with past reports and with his own experiences. Lichenification is a “tell-tale sign of chronic disease” and may indicate undertreatment, and the frequency of nummular plaques is unsurprising because “nummular dermatitis as an independent eczema tends to occur more so in the elderly.”

A version of this article appeared on Medscape.com.

Atopic dermatitis (AD) among older individuals presented most frequently on the extensor surfaces and trunk, with lichenification and nummular lesions being the most frequent rash characteristics, in a retrospective study of almost 800 patients aged 60 years and older.

The researchers reviewed charts of patients aged 60 years and older who were seen at either a private or county dermatology clinic in Houston between 2009 and 2020 and had been diagnosed with AD by a dermatologist. The findings of their cross-sectional study further supports that AD in this age group “presents as a unique phenotype compared to AD in younger ages, which may inform dermatologists’ diagnosis of AD in these patients” they wrote.

The 791 patients in the study had an average age of 69.3 years, were predominantly women (60.1%), and were racially diverse, with almost 40% being non-Hispanic White individuals. Others were non-Hispanic Black individuals (21.8%), Hispanics (20.4%), and non-Hispanic Asian/Pacific Islanders (11.7%).

Use of topicals, mainly topical corticosteroids (92.2%), was the most frequent treatment prescribed. Oral corticosteroids and antihistamines were “frequent systemic treatments” in this population, prescribed to 10.4% and 12.1%, respectively, “likely due to management prior to a diagnosis of AD by a dermatologist,” wrote first author Hannah Y. Wang, Baylor College of Medicine, Houston, and her coauthors, including Soo Jung Kim, MD, PhD, of the department of dermatology at Baylor.

Other treatments included dupilumab in 5.4%, systemic immunosuppressants (including methotrexate, cyclosporine, and mycophenolate) in 5.4%, and UVB-phototherapy in 2.7%.

Approximately 40% of the patients had a history of allergic rhinitis, while 20% had a history of asthma. Lichenification was noted in 14.5% of patients and nummular lesions in almost 13%. Other rash characteristics — ichthyosis and hyperpigmented patches — were less frequent, seen in 9.7% and 9.1%, respectively.

AD in this older population was most commonly documented on the extensors (49.9%) and the trunk (46%) and less commonly on the hands (19.8%) and feet (9%) — a distribution that is similar to past reports, the authors wrote.

Asked to comment on the findings, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, told this news organization that the data relating to clinical morphology are consistent with past reports and with his own experiences. Lichenification is a “tell-tale sign of chronic disease” and may indicate undertreatment, and the frequency of nummular plaques is unsurprising because “nummular dermatitis as an independent eczema tends to occur more so in the elderly.”

A version of this article appeared on Medscape.com.

Treatment options for individuals with early-stage hidradenitis suppurativa (HS) vary depending on patient preference and how clinicians define “early” HS. This can be challenging because to date, no Food and Drug Administration–approved treatments exist for early-stage HS and only two biologics exist for moderate to severe disease.

“For someone with occasional nodules and abscesses, we often use antibiotics and topical antiseptics,” Christopher Sayed, MD, a dermatologist at the HS and Follicular Disorders Clinic at the University of North Carolina, Chapel Hill, told this news organization. “We may use these daily for weeks or months or just provide them to use for 1-2 weeks at a time for intermittent flares if a patient doesn’t want to take a pill every day,” he said. “For women, hormonal options like oral contraceptive pills and spironolactone can be a great option” if they don’t mind taking a daily pill.

Topical options that Jennifer L. Hsiao, MD, reaches for in her role as director of the HS clinic at the University of Southern California, Los Angeles, include chlorhexidine wash, topical clindamycin, and topical resorcinol. Systemic medications include oral antibiotics such as doxycycline or clindamycin, while hormonal options include oral contraceptives and/or spironolactone for women and finasteride for men.

Metformin Among Options to Consider

According to Dr. Hsiao, other treatment options to consider trying in patients with mild HS include metformin, “especially in patients who also have prediabetes, PCOS, or obesity;” isotretinoin if the patient has concomitant severe acne; botulinum toxin injections; apremilast or topical roflumilast, and antihyperhidrosis medications such as prescription aluminum chloride topicals, glycopyrronium wipes, and glycopyrrolate.

Recommending lifestyle modifications such as smoking cessation and weight loss for patients diagnosed with early-stage HS is “challenging,” Dr. Sayed said, “because the evidence on different triggers and lifestyle modifications isn’t very strong. There can also be a lot of stigmas around weight and smoking in HS, and it can alienate patients to go straight to these topics in the first visit.”

Early Data on Ruxolitinib Cream Promising

At the 2024 annual meeting of the American Academy of Dermatology, researchers reported on the results of a phase 2 study, which found that topical 1.5% ruxolitinib, a Janus kinase (JAK) inhibitor (currently FDA-approved for atopic dermatitis) was effective in reducing abscess and inflammatory nodule count in patients with mild HS. “There is a major need for this kind of option, and the early results are promising,” said Dr. Sayed, who was not involved with the study. “It’s very difficult to get this covered for patients currently since it is off label for HS. We’ve gotten it for a few patients, and one has really liked it, but it’s unclear how consistent the others were with their use, and their level of improvement was not clear to me.”

For mild HS, he added, “the most important area in which we’ve seen growing evidence is around hair removal lasers such as Nd:YAG and alexandrite lasers. Improving access for patients is a major priority in the coming years.”

According to Dr. Hsiao, other approaches being studied for treating mild HS include a topical aryl hydrocarbon receptor agonist known as AT193, and oral medications, such as phosphodiesterase-4 inhibitors. Laser therapies are also being studied, “such as fractional ablative CO₂ laser therapy combined with topical triamcinolone,” she said. “However, the majority of ongoing HS trials are for moderate to severe disease, so there is certainly a need for more investigation into mild HS treatment approaches.”

Dr. Sayed disclosed that he is secretary of the HS Foundation and a member of the European HS Foundation. He has served as a consultant for AbbVie, Alumis, AstraZeneca, Incyte, InflaRx, Novartis, Sanofi, Sonoma Biotherapeutics, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Chemocentryx, Incyte, InflaRx, Novartis, and UCB. Dr. Hsiao disclosed that she is a member of the board of directors for the HS Foundation and has served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, Sanofi Regeneron, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

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

Treatment options for individuals with early-stage hidradenitis suppurativa (HS) vary depending on patient preference and how clinicians define “early” HS. This can be challenging because to date, no Food and Drug Administration–approved treatments exist for early-stage HS and only two biologics exist for moderate to severe disease.

“For someone with occasional nodules and abscesses, we often use antibiotics and topical antiseptics,” Christopher Sayed, MD, a dermatologist at the HS and Follicular Disorders Clinic at the University of North Carolina, Chapel Hill, told this news organization. “We may use these daily for weeks or months or just provide them to use for 1-2 weeks at a time for intermittent flares if a patient doesn’t want to take a pill every day,” he said. “For women, hormonal options like oral contraceptive pills and spironolactone can be a great option” if they don’t mind taking a daily pill.

Topical options that Jennifer L. Hsiao, MD, reaches for in her role as director of the HS clinic at the University of Southern California, Los Angeles, include chlorhexidine wash, topical clindamycin, and topical resorcinol. Systemic medications include oral antibiotics such as doxycycline or clindamycin, while hormonal options include oral contraceptives and/or spironolactone for women and finasteride for men.

Metformin Among Options to Consider

According to Dr. Hsiao, other treatment options to consider trying in patients with mild HS include metformin, “especially in patients who also have prediabetes, PCOS, or obesity;” isotretinoin if the patient has concomitant severe acne; botulinum toxin injections; apremilast or topical roflumilast, and antihyperhidrosis medications such as prescription aluminum chloride topicals, glycopyrronium wipes, and glycopyrrolate.

Recommending lifestyle modifications such as smoking cessation and weight loss for patients diagnosed with early-stage HS is “challenging,” Dr. Sayed said, “because the evidence on different triggers and lifestyle modifications isn’t very strong. There can also be a lot of stigmas around weight and smoking in HS, and it can alienate patients to go straight to these topics in the first visit.”

Early Data on Ruxolitinib Cream Promising

At the 2024 annual meeting of the American Academy of Dermatology, researchers reported on the results of a phase 2 study, which found that topical 1.5% ruxolitinib, a Janus kinase (JAK) inhibitor (currently FDA-approved for atopic dermatitis) was effective in reducing abscess and inflammatory nodule count in patients with mild HS. “There is a major need for this kind of option, and the early results are promising,” said Dr. Sayed, who was not involved with the study. “It’s very difficult to get this covered for patients currently since it is off label for HS. We’ve gotten it for a few patients, and one has really liked it, but it’s unclear how consistent the others were with their use, and their level of improvement was not clear to me.”

For mild HS, he added, “the most important area in which we’ve seen growing evidence is around hair removal lasers such as Nd:YAG and alexandrite lasers. Improving access for patients is a major priority in the coming years.”

According to Dr. Hsiao, other approaches being studied for treating mild HS include a topical aryl hydrocarbon receptor agonist known as AT193, and oral medications, such as phosphodiesterase-4 inhibitors. Laser therapies are also being studied, “such as fractional ablative CO₂ laser therapy combined with topical triamcinolone,” she said. “However, the majority of ongoing HS trials are for moderate to severe disease, so there is certainly a need for more investigation into mild HS treatment approaches.”

Dr. Sayed disclosed that he is secretary of the HS Foundation and a member of the European HS Foundation. He has served as a consultant for AbbVie, Alumis, AstraZeneca, Incyte, InflaRx, Novartis, Sanofi, Sonoma Biotherapeutics, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Chemocentryx, Incyte, InflaRx, Novartis, and UCB. Dr. Hsiao disclosed that she is a member of the board of directors for the HS Foundation and has served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, Sanofi Regeneron, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

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

Treatment options for individuals with early-stage hidradenitis suppurativa (HS) vary depending on patient preference and how clinicians define “early” HS. This can be challenging because to date, no Food and Drug Administration–approved treatments exist for early-stage HS and only two biologics exist for moderate to severe disease.

“For someone with occasional nodules and abscesses, we often use antibiotics and topical antiseptics,” Christopher Sayed, MD, a dermatologist at the HS and Follicular Disorders Clinic at the University of North Carolina, Chapel Hill, told this news organization. “We may use these daily for weeks or months or just provide them to use for 1-2 weeks at a time for intermittent flares if a patient doesn’t want to take a pill every day,” he said. “For women, hormonal options like oral contraceptive pills and spironolactone can be a great option” if they don’t mind taking a daily pill.

Topical options that Jennifer L. Hsiao, MD, reaches for in her role as director of the HS clinic at the University of Southern California, Los Angeles, include chlorhexidine wash, topical clindamycin, and topical resorcinol. Systemic medications include oral antibiotics such as doxycycline or clindamycin, while hormonal options include oral contraceptives and/or spironolactone for women and finasteride for men.

Metformin Among Options to Consider

According to Dr. Hsiao, other treatment options to consider trying in patients with mild HS include metformin, “especially in patients who also have prediabetes, PCOS, or obesity;” isotretinoin if the patient has concomitant severe acne; botulinum toxin injections; apremilast or topical roflumilast, and antihyperhidrosis medications such as prescription aluminum chloride topicals, glycopyrronium wipes, and glycopyrrolate.

Recommending lifestyle modifications such as smoking cessation and weight loss for patients diagnosed with early-stage HS is “challenging,” Dr. Sayed said, “because the evidence on different triggers and lifestyle modifications isn’t very strong. There can also be a lot of stigmas around weight and smoking in HS, and it can alienate patients to go straight to these topics in the first visit.”

Early Data on Ruxolitinib Cream Promising

At the 2024 annual meeting of the American Academy of Dermatology, researchers reported on the results of a phase 2 study, which found that topical 1.5% ruxolitinib, a Janus kinase (JAK) inhibitor (currently FDA-approved for atopic dermatitis) was effective in reducing abscess and inflammatory nodule count in patients with mild HS. “There is a major need for this kind of option, and the early results are promising,” said Dr. Sayed, who was not involved with the study. “It’s very difficult to get this covered for patients currently since it is off label for HS. We’ve gotten it for a few patients, and one has really liked it, but it’s unclear how consistent the others were with their use, and their level of improvement was not clear to me.”

For mild HS, he added, “the most important area in which we’ve seen growing evidence is around hair removal lasers such as Nd:YAG and alexandrite lasers. Improving access for patients is a major priority in the coming years.”

According to Dr. Hsiao, other approaches being studied for treating mild HS include a topical aryl hydrocarbon receptor agonist known as AT193, and oral medications, such as phosphodiesterase-4 inhibitors. Laser therapies are also being studied, “such as fractional ablative CO₂ laser therapy combined with topical triamcinolone,” she said. “However, the majority of ongoing HS trials are for moderate to severe disease, so there is certainly a need for more investigation into mild HS treatment approaches.”

Dr. Sayed disclosed that he is secretary of the HS Foundation and a member of the European HS Foundation. He has served as a consultant for AbbVie, Alumis, AstraZeneca, Incyte, InflaRx, Novartis, Sanofi, Sonoma Biotherapeutics, and UCB; as a speaker for AbbVie, Novartis, and UCB; and as an investigator for Chemocentryx, Incyte, InflaRx, Novartis, and UCB. Dr. Hsiao disclosed that she is a member of the board of directors for the HS Foundation and has served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie, Novartis, Sanofi Regeneron, and UCB; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

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