Clinical Quiz: Roflumilast Cream, INTEGUMENT, and Atopic Dermatitis

Atopic dermatitis affects approximately 10 to 20% of children and up to 10% of adults worldwide, with many experiencing moderate-to-severe disease with a significant impact on quality of life. Despite its prevalence, effective treatment options have historically been limited, particularly for patients who do not respond to topical corticosteroids or conventional systemic therapies. Until recently, therapeutic advancements have been slow, leaving many patients with persistent symptoms and few alternatives.

However, in 2024 alone, 4 therapies—roflumilast cream (Zoryve), lebrikizumab (Ebglyss), nemolizumab (Nemluvio), and tapinarof cream 1% (Vtama)—received approvals for atopic dermatitis in different populations, marking a significant expansion of available treatment options.

On July 09, 2024, the US Food and Drug Administration (FDA) approved the supplemental new drug application for roflumilast cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. This approval was based on positive results from 3 phase 3 studies, as well as a Phase 2 dose-ranging study, and two Phase 1 pharmacokinetic studies. The phase 3 INTEGUMENT-1 and -2 studies each met their primary endpoint of 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 (P <.001).

This quiz is 1 of 4 in a series designed to reinforce knowledge of the data supporting these new treatments. By engaging with these quizzes, clinicians can better understand how these therapies fit into clinical practice and improve patient outcomes.

Test your knowledge below on pooled data from INTEGUMENT-1 and INTEGUMENT-2 trials and stay up to date with the latest clinical advancements in atopic dermatitis treatment.

1. True or False: The INTEGUMENT trials represent the first large-scale, randomized Phase 3 studies evaluating a PDE4 inhibitor in mild to moderate atopic dermatitis.

References:

1. Laughter MR, Maymone MBC, Mashayekhi S, et al. The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990-2017. Br J Dermatol. 2021;184(2):304-309. doi:10.1111/bjd.19580.

2. Choragudi S, Yosipovitch G. Trends in the Prevalence of Eczema Among US Children by Age, Sex, Race, and Ethnicity From 1997 to 2018. JAMA Dermatol. 2023;159(4):454-456. doi:10.1001/jamadermatol.2022.6647.

3. Arcutis Biotherapeutics. FDA approves Arcutis’ ZORYVE® (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age. Arcutis Biotherapeutics. July 9, 2024. Accessed March 25, 2025. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-15-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-down-to-6-years-of-age/.

4. Eli Lilly and Company. FDA approves Lilly’s EBGLYSSTM (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. Eli Lilly and Company. September 13, 2024. Accessed March 25, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and.

5. Organon. FDA approves VTAMA® (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. Organon. December 16, 2024. Accessed March 25, 2025. https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/.

6. Galderma. Galderma receives U.S. FDA approval for Nemluvio® (Nemolizumab) for patients with moderate-to-severe atopic dermatitis. Galderma. December 14, 2024. Accessed March 25, 2025. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic.

7. Simpson EL, Eichenfield LF, Alonso-Llamazares J, et al. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024;160(11):1161–1170. doi:10.1001/jamadermatol.2024.3121.