FDA Approves Roflumilast for Atopic Dermatitis in Patients 6 Years and Older


Roflumilast is approved as a once daily and steroid-free cream for rapid disease clearance and significant reduction in itch and for long-term disease control.

The FDA has approved a supplemental new drug application for roflumilast cream, 0.15%, (Zoryve; Arcutis Biotherapeutics Inc) for the treatment of mild to moderate atopic dermatitis (AD) in adults and pediatric patients 6 years and older. Roflumilast was approved as a once daily and steroid-free cream for rapid disease clearance and significant reduction in itch and for long-term disease control.1

Atopic Dermatitis, FDA Approval | Image Credit: InfiniteStudio - stock.adobe.com

Image Credit: InfiniteStudio - stock.adobe.com

“The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares,” Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice chair of the department of dermatology at UC San Diego School of Medicine, said in a news release. “[Roflumilast] rapidly improves and controls disease, including itch, the most bothersome reported symptom. In clinical trials, 9 in 10 patients saw some improvement at 4 weeks, with 69% of patients demonstrating a clinically meaningful improvement of at least an EASI-50.”1

Eichenfield added that roflumilast is a safe and effective steroid-free treatment option, without the risks associated with topical and systemic steroids.1

The approval was supported by 3 phase 3 studies, 1 phase 2 dose-ranging study, and 2 phase 1 pharmacokinetic studies. In the INTEGUMENT-1 and INTEGUMENT-2 studies, the investigators found that the once daily treatment met multiple efficacy end points by 4 weeks with favorable safety and tolerability in the patient population. Patients with an Eczema Area and Severity Index (EASI) score of 5 or greater and a Validated Investigator Global Assessment-AD (vIGA-AD) score of either mild or moderate were included in the study.1,2

Investigators found in a pooled analysis of both studies that there was a greater percentage of those using roflumilast that achieved the primary end point of vIGA-AD success, defined as clear or almost clear and a 2 or greater grade improvement at baseline, at week 4 at 31.4% compared with 14.1% for those treated with the vehicle. The percentage of patients that achieved vIGA-AD of clear or almost clear was 41.1% and 21.4%, respectively, and the percentage of individuals achieving a 75% reduction in EASI at 42.7% compared with 20.6%, respectively.2

Itch improvement was also reported as early as 24 hours and the percentage with baseline Worst Itch-Numeric Rating Scale of 4 or more and achieved a 4-point reduction was 31.9% for roflumilast compared with 16.6% with the vehicle, according to the authors. Both arms had low incidences of treatment-emergent and serious adverse events, including those that lead to discontinuation.2

Furthermore, in the INTEGUMENT-OLE study, 658 individuals from INTEGUMENT-1 or INTEGUMENT-2 continued with the extension. At any time after 4 weeks, individuals who achieved vIGA-AD score of clear with the once daily application, individuals switched to twice weekly application.1

“People suffering from AD experience intense itch, rash, and sensitive skin, which warrant effective, safe, and well-tolerated treatments,” Jonathan Silverberg, MD, PhD, MPH, professor of dermatology, and the director of clinical research and contact dermatitis at The George Washington University School of Medicine and Health Sciences, said in the news release. “[Roflumilast] was developed with the AD patient in mind, to deliver the drug in a moisturizing vehicle that is formulated without common sensitizers or irritants and does not further disrupt the abnormal skin barrier. It’s also important to note that in clinical trials [roflumilast] monotherapy provided safe and effective long-term disease control to AD patients.”1

1.FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age. News release. Arcutis Biotherapeutics. July 9, 2024. Accessed July 10, 2024. https://www.globenewswire.com/en/news-release/2024/07/09/2910781/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-15-for-the-Treatment-of-Atopic-Dermatitis-in-Adults-and-Children-Down-to-6-Years-of-Age.html#
2. Eichenfield L, Boguniewicz M, Simpson E, Blauvelt A, et al. Once-Daily Roflumilast Cream 0.15% for Atopic Dermatitis: Pooled Results from INTERGUMENT-1/2 Phase 3 Trials. Ann Allergy Asthma Immunol. 2023. doi:https://doi.org/10.1016/j.anai.2023.08.273
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