The American Academy of Dermatology (AAD) has released updated guidelines on the management of atopic dermatitis with topical therapies in adults.

Developed by a multidisciplinary workgroup, strong recommendations were made for both prescription and nonprescription therapies in which the benefits clearly outweighed the potential risks. These included moisturizers, topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment), topical costicosteroids, topical phosphodiesterase-4 inhibitors (crisaborole 2% ointment), and topical Janus kinase inhibitors (ruxolitinib 1.5% cream).

The experts also conditionally recommended bathing for the treatment and maintenance of atopic dermatitis and wet wrap therapy for adult patients with moderate to severe disease experiencing a flare.  

Due to the low certainty of evidence, the workgroup conditionally recommended against the use topical antimicrobials, antiseptics, and antihistamines. The experts noted that bleach baths or topical sodium hypochlorite may be suggested to reduce diseases severity in patients with moderate to severe atopic dermatitis and clinical signs of secondary bacterial infection.

“Atopic dermatitis is the most common type of eczema, and it can interfere with a person’s daily life without proper treatment,” said board-certified dermatologist Robert Sidbury, MD, MPH, FAAD, co-chair of the AAD’s Atopic Dermatitis Guideline Workgroup. “The guidelines provide evidence-based recommendations for dermatologists to use in caring for their adult atopic dermatitis patients with topical treatments, which have come a long way since the guidelines were last revised in 2014. This update reflects the latest advances in topical medications that are now available to help adults with atopic dermatitis.”

The full guidelines can be viewed here.

References

1. American Academy of Dermatology issues updated guidelines for the management of atopic dermatitis in adults with topical therapies. News release. January 12, 2023. https://www.prnewswire.com/news-releases/american-academy-of-dermatology-issues-updated-guidelines-for-the-management-of-atopic-dermatitis-in-adults-with-topical-therapies-301720824.html.
2. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. Published online January 11, 2023. Journal of the American Academy of Dermatology. doi.org/10.1016/j.jaad.2022.12.029

Andrew Alexis, MD, MPH, from Weill Cornell Medicine in New York City, and colleagues conducted ADmirable, a phase 3b, open-label, 24-week study to evaluate lebrikizumab in adults and adolescents with atopic dermatitis and skin of color. Interim data were presented for 50 patients aged 12 years and older with Fitzpatrick Phototype IV to VI. Self-reported race of the patients was 80% Black/African-American, 14% Asian, and 6% American Indian/Alaska Native. Patients were administered a 500mg loading dose of lebrikizumab at baseline and week 2 followed by a 250mg dose every 2 weeks up until week 16.

The researchers found that at week 16, 68.3% of patients achieved a 75% or greater reduction in the Eczema Area and Severity Index (EASI 75) and 39.0% achieved an Investigator’s Global Assessment of 0 or 1 with 2-point or greater improvement. The mean change and percentage change in the EASI were –22.2 and –79.1%, respectively; the corresponding changes in the Pruritis Numeric Rating Scale were –4.0 and –53.9%. Improvement in mean percentage change for hypopigmented and hyperpigmented lesions was also identified on the PDCA-Derm, a new scale used to describe postinflammatory lesions compared to unaffected skin. No serious adverse events were reported.

“People with skin of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis, and a lengthier timeframe to find appropriate treatment,” Alexis said in a statement. “They also have been historically underrepresented in clinical trials, which means we have lacked data pertaining to the treatment of patients with skin of color. With these initial results, [we are] taking a step toward investigating the needs of people with skin of color affected by atopic dermatitis.”

Several authors disclosed ties to Eli Lilly, which manufactures lebrikizumab and funded the study.

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HealthDay News — Adults with atopic dermatitis (AD) have an increased risk for developing melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC), with significantly higher risks seen for moderate-to-severe versus mild AD, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 17 to 21 in New Orleans.

Margaret Y. Huang, from the Keck School of Medicine at the University of Southern California in Los Angeles, and colleagues examined the risk for developing melanoma, SCC, and BCC among adults with AD in a retrospective cohort study using a claims database for 2007 to 2021. Data were included for 60 million adults aged 18 years or older with and without a diagnosis of AD who subsequently developed melanoma, SCC, or BCC.

The researchers found that adults with AD had significantly higher risks for developing melanoma, SCC, and BCC compared with those without AD (relative risks 1.23, 1.27, and 1.28, respectively) after adjustment for confounding variables. Adults with moderate-to-severe AD had a significantly higher risk for developing melanoma, SCC, and BCC compared with those with mild AD (relative risks, 1.11, 1.25, and 1.17, respectively).

“In conclusion, our findings support an increased risk of melanoma, SCC, and BCC development in adult patients with AD regardless of AD severity,” the authors write. “More mechanistic studies are necessary to understand AD and the development of skin cancers.”

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Positive topline results were announced from a phase 3 trial evaluating the efficacy and safety of ruxolitinib cream in pediatric patients with atopic dermatitis.

The randomized, double-blind, vehicle-controlled TRuE-AD3 study (ClinicalTrials.gov Identifier: NCT04921969) included over 300 children 2 to less than 12 years of age who were diagnosed with atopic dermatitis for at least 3 months and were candidates for topical therapy. Study participants were randomly assigned 2:2:1 to receive ruxolitinib cream 0.75%, ruxolitinib cream 1.5%, or vehicle administered twice daily for 8 weeks. 

Results showed that a significantly greater proportion of patients treated with ruxolitinib cream achieved Investigator’s Global Assessment Treatment Success (IGA-TS; primary endpoint) at week 8 compared with those who received vehicle. IGA-TS was defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at week 8.

The safety profile of ruxolitinib cream was consistent with that seen in previous studies. There were no new safety signals observed in this patient population. Participants who completed the efficacy assessments at week 8 with no additional safety concerns were eligible to continue into a 44-week long-term safety treatment extension period.

“We have already seen the benefit that ruxolitinib cream can have among adult and adolescent patients with atopic dermatitis in the TRuE-AD1 and TRuE-AD2 studies, and this new positive data reinforces the potential of ruxolitinib cream to offer children a much-needed effective, non-steroidal topical therapy,” said Jim Lee, MD, Group Vice President, Inflammation & AutoImmunity, Incyte. “We look forward to discussing these data with regulatory agencies to determine next steps.”

Ruxolitinib cream 1.5%, a Janus kinase (JAK) inhibitor, is currently marketed under the brand name Opzelura for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

HealthDay News — Atopic dermatitis (AD) in adulthood is associated with an increased risk for venous thromboembolism (VTE), according to a study published online May 31 in JAMA Dermatology.

Tai-Li Chen, MD, from Taipei Veterans General Hospital in Taiwan, and colleagues examined the risk for incident VTE among patients with AD. The analysis included 284,858 matched participants (142,429 participants with AD newly diagnosed between 2003 and 2017).

The researchers found that 0.7% of participants in the AD group and 0.6% in the non-AD cohort developed VTE, with incidence rates of 1.05 and 0.82 per 1000 person-years, respectively. Compared with adults without AD, adults with AD had a significantly increased risk for incident VTE (hazard ratio, 1.28). Specifically, AD was associated with higher risks for deep vein thrombosis (hazard ratio, 1.26) and pulmonary embolism (hazard ratio, 1.30).

“The results of this cohort study suggest that AD in adulthood is associated with an increased risk of VTE; however, the absolute risk difference of VTE between adults with and without AD appears small,” the authors write. “Nevertheless, cardiovascular examination and imperative management may be considered for adults with AD who present with symptoms suggestive of VTE. Future research is warranted to elucidate the pathophysiology underlying the association between AD and VTE.”

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HealthDay News — For children and young people with severe atopic dermatitis (AD), ciclosporin (CyA) and methotrexate (MTX) are both effective over 36 weeks, according to a study published online September 19 in the British Journal of Dermatology.

Carsten Flohr, PhD, from Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, and colleagues compared the safety and efficacy of CyA vs MTX in children and young people with severe AD. Eligible participants were aged 2 to 16 years and were unresponsive to potent topical treatment. One hundred three participants were randomly assigned to oral CyA (4mg/kg/day) or MTX (0.4mg/kg/week) for 36 weeks (52 and 51 patients, respectively).

The researchers observed greater improvement in disease severity by 12 weeks with CyA (mean difference Objective Severity Scoring of Atopic Dermatitis [o-SCORAD], −5.69). A 50 percent decrease in o-SCORAD (o-SCORAD-50) was reached by more participants in the CyA than MTX arm at 12 weeks (odds ratio, 2.60). MTX was superior by 60 weeks (odds ratio, 0.33); a trend was also seen for o-SCORAD-75, 50 percent reduction from baseline in the Eczema Area and Severity Index (EASI-50), and EASI-75. The CyA arm had higher participant-reported flares posttreatment (odds ratio, 3.22). Improvement in quality of life was seen with both treatments and was sustained after cessation of treatment. Both treatments had comparable frequency of adverse events.

“The TREAT trial demonstrated that both CyA and MTX are effective well-tolerated treatments for children and young people with severe AD,” the authors write. “CyA acts more quickly, while MTX induces better disease control after treatment discontinuation.”

Several authors disclosed ties to the pharmaceutical industry.

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(HealthDay News) — In two January data briefs published by the U.S. Centers for Disease Control and Prevention National Center for Health Statistics, data are presented regarding the prevalence of seasonal allergy, eczema, and food allergy among children and adults in 2021.

Benjamin Zablotsky, PhD, from the National Center for Health Statistics in Hyattsville, Maryland, and colleagues used data from the 2021 National Health Interview Survey (NHIS) to describe the percentage of children who had diagnosed seasonal allergy, eczema, or food allergy. The researchers found that 18.9%, 10.8% and 5.8% had a seasonal allergy, eczema, and a food allergy, respectively, in 2021. The likelihood of having a seasonal allergy was higher for boys than girls (20.0% vs 17.7%). There was variation observed by age in the percentage of children with eczema (10.4%, 12.1%, and 9.8% in children aged 0 to 5, 6 to 11, and 12 to 17 years, respectively). The likelihood of having a food allergy was increased for non-Hispanic Black versus non-Hispanic White and Hispanic children.

Amanda E. Ng, MPH, and Peter Boersma, MPH, both from the National Center for Health Statistics, used 2021 NHIS data to describe the prevalence of seasonal allergy, eczema, or food allergy among adults. The researchers found that 25.7%, 7.3%, and 6.2% of adults had a seasonal allergy, eczema, and a food allergy, respectively, in 2021. Compared with Hispanic, non-Hispanic Black, and non-Hispanic Asian adults, the percentage of adults with a seasonal allergy was higher in non-Hispanic White adults. Women were more likely than men to have eczema (8.9% vs 5.7%). With increasing age, the prevalence of food allergy decreased.

“For all three allergies, women were more likely than men to have a diagnosed allergy,” Ng and Boersma write.

Data Brief – Children

Data Brief – Adults

The Food and Drug Administration (FDA) has expanded the approval of Cibinqo^® (abrocitinib) to include patients 12 to less than 18 years of age with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of other therapies is inadvisable. Previously, the treatment was approved only for adults 18 years of age and older.

The approval was based on data from previous studies that included 124 adolescent patients, as well as the phase 3 JADE TEEN study (ClinicalTrials.gov Identifier: NCT03796676), which compared the efficacy and safety of abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, to placebo in 285 patients 12 to less than 18 years of age with moderate to severe atopic dermatitis. Patients were randomly assigned to receive abrocitinib 100mg, 200mg or placebo orally once daily for 12 weeks while on background topical therapy. 

The coprimary end points were the proportion of patients who achieved an Investigator’s Global Assessment (IGA) of clear (0) or almost clear (1) and a ≥2 point reduction from baseline at week 12; and the proportion of patients who achieved ≥75% change from baseline in the Eczema Area and Severity Index (EASI75) score at week 12. 

Results from JADE TEEN showed that 39% and 46% of patients treated with abrocitinib 100mg and 200mg, respectively, achieved an IGA 0 or 1 response compared with 24% of patients treated with placebo. At week 12, 71% and 64% of patients treated with abrocitinib 100mg and 200mg, respectively, achieved an EASI-75 response compared with 41% of patients treated with placebo.

Additionally, a greater proportion of patients treated with abrocitinib 100mg and 200mg achieved at least a 4-point decrease from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) score at week 2 compared with placebo (13% and 25% vs 8%, respectively).

“As an efficacious once-daily pill, we believe that Cibinqo offers an important new treatment option for adolescents burdened by uncontrolled symptoms of atopic dermatitis,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “Encouraged by an increasing uptake in the adult population, we look forward to bringing this important new oral medicine to adolescents who have yet to find relief from this inflammatory skin condition with current options.”

The safety profile of abrocitinib in adolescents was consistent with that seen in previous studies in the adult population. Cibinqo carries a Boxed Warning regarding the potential for serious infection, malignancy, major adverse cardiovascular events, thrombosis, and death associated with JAK inhibitors. The treatment is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

Cibinqo is supplied as 50mg, 100mg, and 200mg tablets. 

References

1. FDA approves Pfizer’s supplemental New Drug Application for Cibinqo^® (abrocitinib). News release. Pfizer. Accessed February 10, 2023. https://www.businesswire.com/news/home/20230210005281/en/FDA-Approves-Pfizers-Supplemental-New-Drug-Application-for-CIBINQO%C2%AE-abrocitinib.
2. Cibinqo. Package insert. Pfizer; 2023. Accessed February 10, 2023. https://labeling.pfizer.com/ShowLabeling.aspx?id=16652.

Sheng-Pei Wang, MD, MPH, from the University of California San Francisco, and colleagues identified 18 studies with evidence for an impact of AD by leveraging an existing framework for 10 climatic hazards related to greenhouse gas emissions.

The researchers found that evidence for aggravation of AD was seen for most climatic hazards, with the impact ranging from direct effects, such as particulate matter-induced AD exacerbations from wildfires, to indirect effects, such as drought-induced food insecurity and migration. Maps were created to compare the past, present, and future projected burden of climatic hazards to the global prevalence of AD. There was a lack of data, especially in regions most likely to experience climatic hazards.

“Our study adds to the research on climate change by providing clarity about the extent of research on climatic hazards and AD, including the research gaps and lack of evidence in the locations most impacted now and projected to be most impacted in the future,” the authors write.

Several authors disclosed ties to the biopharmaceutical, dermatological, and other industries.

Abstract/Full Text

Positive topline results were announced from a phase 3 study evaluating roflumilast cream, a topical phosphodiesterase-4 inhibitor, in patients with mild to moderate atopic dermatitis. 

The INTEGUMENT-2 trial (ClinicalTrials.gov Identifier: NCT04773600) included 683 patients 6 years of age and older with mild to moderate atopic dermatitis involving at least 3% body surface area. Patients were randomly assigned to receive either roflumilast cream 0.15% or vehicle applied once daily for 4 weeks. The primary endpoint of the study was Investigator Global Assessment (IGA) success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4.

Findings demonstrated that 28.9% of patients treated with roflumilast cream met the primary endpoint achieving IGA success at week 4 compared with 12% of those treated with vehicle (P <.0001). 

Results also showed that 42% of patients treated with roflumilast cream achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) at week 4 compared with 19.7% of those treated with vehicle (P <.0001). Moreover, a greater proportion of patients in the roflumilast arm achieved a 4-point reduction in Worst Itch Numeric Scale (WI-NRS) at week 4 compared with those in the vehicle arm (30.2% vs 12.4%, respectively; P <.01).

As for safety, roflumilast cream was well tolerated with most treatment emergent adverse events (TEAEs) being mild to moderate in severity. The most common TEAEs for roflumilast cream were headache, nausea, vomiting, diarrhea, and upper respiratory tract infection.

Topline results from an identical phase 3 trial, INTEGUMENT-1 trial (ClinicalTrials.gov Identifier: NCT04845620), were announced in November 2022. The Company plans to file a supplemental New Drug Application with the Food and Drug Administration (FDA) for the atopic dermatitis indication in the second half of 2023.

Roflumilast cream 0.3% is currently marketed under the brand name Zoryve for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Reference

Arcutis announces positive topline results from second atopic dermatitis pivotal phase 3 trial of roflumilast cream in adults and children aged 6 and older. News release. Arcutis. Accessed December 12, 2022. https://www.globenewswire.com/news-release/2022/12/12/2571826/0/en/Arcutis-Announces-Positive-Topline-Results-from-Second-Atopic-Dermatitis-Pivotal-Phase-3-Trial-of-Roflumilast-Cream-in-Adults-and-Children-Aged-6-and-Older.html.

Positive topline results were announced from a second phase 3 study evaluating delgocitinib cream in adult patients with moderate to severe chronic hand eczema. 

The phase 3 DELTA 2 study (ClinicalTrials.gov Identifier: NCT04872101) compared delgocitinib cream, a topical pan-Janus kinase (JAK) inhibitor, to vehicle in patients with moderate to severe chronic hand eczema. The primary endpoint was the Investigator’s Global Assessment for chronic hand eczema (IGA-CHE) treatment success at week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement from baseline.

Compared with vehicle cream, treatment with delgocitinib cream was associated with a statistically significant improvement in chronic hand eczema at week 16. Additionally, a significantly larger proportion of patients treated with delgocitinib cream had early symptom relief compared with those treated with vehicle cream. 

Detailed results from DELTA-2 will be submitted for scientific presentation and publication at a later date. Findings from DELTA-2 confirm the positive results previously reported from the DELTA-1 trial.

“It is incredibly exciting to see the level of consistency that our DELTA 2 results show in line with the positive DELTA-1 results announced late last year”, said Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. “These results bring us one step closer towards establishing delgocitinib as a best-in-class innovative topical treatment for patients affected by this hard-to-treat disease.”

Reference

LEO Pharma announces positive phase 3 topline results from DELTA 2 trial with delgocitinib cream in adults with moderate to severe chronic hand eczema (CHE), confirming the positive results of the recent DELTA 1 Trial. News release. LEO Pharma. Accessed February 13, 2023. https://www.businesswire.com/news/home/20230209005440/en/LEO-Pharma-Announces-Positive-Phase-3-Topline-Results-From-DELTA-2-Trial-With-Delgocitinib-Cream-in-Adults-With-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-Confirming-the-Positive-Results-of-the-Recent-DELTA-1-Trial.

The updated labeling is based on data from the phase 3 LIBERTY-AD-HAFT trial (ClinicalTrials.gov Identifier: NCT04417894), which evaluated the efficacy and safety of dupilumab, an interleukin-4 receptor alpha antagonist, in patients 12 years of age and older with atopic dermatitis with uncontrolled moderate to severe hand and/or foot involvement. Study participants were randomly assigned to receive dupilumab subcutaneously once every 2 weeks (n=67) or placebo (n=66).

Findings showed that 40% of patients treated with dupilumab met the primary endpoint, achieving an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) on the hands and feet at week 16, compared with 17% of those who received placebo. Moreover, 52% of dupilumab-treated patients experienced a clinically meaningful reduction in itch on the hands and feet compared with 14% of the placebo group (improvement of weekly averaged hand and foot Peak Pruritus Numeric Rating Scale score ≥4 points from baseline to week 16). 

“Living with atopic dermatitis on your most essential body areas like the hands and feet can make daily activities including walking and writing incredibly burdensome even in the case where disease symptoms are mild elsewhere,” said Naimish Patel, MD, Head of Global Development, Immunology and Inflammation at Sanofi. “Unfortunately, treating atopic dermatitis on the hands and feet has historically been difficult and there have been no phase 3 trials evaluating a biologic in this population of patients. Having these data added for this difficult-to-treat population is important for physicians looking for tools to treat these patients and reinforces the already well-established efficacy and safety of Dupixent in atopic dermatitis overall.”

The prescribing information for Eucrisa^® (crisaborole) ointment has been updated to include data related to long-term, once daily dosing of the product.

Eucrisa, a phosphodiesterase 4 inhibitor, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. The ointment is applied twice daily to affected areas. Once clinical effect is achieved, reducing application of the product to once daily administration may now be considered, according to the updated labeling.

This dosing update was supported by data from the phase 3 CrisADe CONTROL trial (ClinicalTrials.gov Identifier: NCT04040192), which evaluated long-term maintenance treatment with once-daily crisaborole ointment in patients 3 months of age and older who previously responded to twice-daily treatment (defined as an Investigator’s Static Global Assessment [ISGA] grade of clear [0] or almost clear [1] with a ≥2-grade improvement from baseline and ≥50% reduction from baseline on the Eczema Area and Severity Index) in an open-label run-in period.

Study participants were randomly assigned 1:1 into a double-blind period to receive crisaborole ointment once daily (n=135) or vehicle (n=135) for 52 weeks or until they developed a flare. The primary efficacy endpoint was the duration of flare-free maintenance (from randomization to first flare or last ISGA assessment). The primary safety assessment was the number of participants with treatment-emergent adverse events.

Results showed that the median time of flare-free maintenance was 111 days for patients treated with crisaborole and 30 days for patients who received vehicle (P =.0034). Findings also showed crisaborole-treated patients had more flare-free days (234.0 vs. 199.4, respectively; P =.0346) and fewer flares (0.95 vs. 1.36, respectively; P =.0042) than patients in the vehicle arm. Treatment with crisaborole was reported to be well tolerated with no new safety signals observed over the 52-week period.

Eucrisa is supplied as an ointment containing 20mg of crisaborole per gram in a 60g and 100g tube.

The sNDA is supported by data from the phase 3 INTEGUMENT-1 (ClinicalTrials.gov Identifier: NCT04773587) and INTEGUMENT-2 (ClinicalTrials.gov Identifier: NCT04773600) trials, which evaluated the efficacy and safety of roflumilast cream 0.15% in patients 6 years of age and older with mild to moderate atopic dermatitis involving at least 3% body surface area.

Study participants were randomly assigned to receive either roflumilast cream 0.15% or vehicle applied once daily for 4 weeks. The primary endpoint of the study was Investigator Global Assessment (IGA) success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4.

In INTEGUMENT-1 (N=654), 32% of patients treated with roflumilast cream achieved IGA success vs 15.2% of patients who received vehicle (P <.0001), while in INTEGUMENT-2 (N=683), 28.9% of roflumilast-treated patients met the primary endpoint compared with 12% of the vehicle group (P <.0001). The most common adverse reactions reported were headache, nausea, application site pain, diarrhea, and vomiting.

“With this filing acceptance, we are one step closer to potentially providing a new topical option for the millions of Americans living with atopic dermatitis,” said Frank Watanabe, president and chief executive officer at Arcutis. “Given the prevalence of this disease in both children and adults, as well as the need for better long-term management, we believe once-daily, steroid-free roflumilast cream has the potential to become the new standard of care in atopic dermatitis.”

A regulatory decision is expected on July 7, 2024.

Roflumilast cream 0.3% is currently marketed under the brand name Zoryve for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.