Clinical Quiz: ARCADIA Trial Program, Nemolizumab for Moderate-to-Severe 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—nemolizumab (Nemluvio), roflumilast cream (Zoryve), lebrikizumab (Ebglyss), and tapinarof cream 1% (Vtama)—received approvals for atopic dermatitis in different populations, marking a significant expansion of available treatment options.

On December 14, 2024, the US Food and Drug Administration approved nemolizumab for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies. This approval was based on positive results from the phase 3 ARCADIA clinical trial program which evaluated the efficacy and safety of nemolizumab in combination with background TCS, with or without TCI, versus placebo in combination with TCS, with or without TCI, in 1,728 patients aged 12 years or older with moderate-to-severe atopic dermatitis. The phase 3 trial met its co-primary endpoints, which were clearance (0) or almost-clearance (1) of skin lesions when assessed using the Investigator’s Global Assessment score, and achieving a 75% reduction in the Eczema Area and Severity Index.

This quiz is 3 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.

Interested in dermatology? Learn more about the annual Revolutionizing Atopic Dermatitis (RAD) Conference, hosted by HCPLive, Dermatology Times, and our CE/CME partner Physicians’ Education Resource.

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

1. True or False: Nemolizumab directly inhibits interleukin-13 (IL-13) signaling, reducing both inflammation and pruritus in 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. 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.

4. 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/.

5. 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.

6. 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/.

7. Silverberg JI, Wollenberg A, Reich A, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi:10.1016/S0140-6736(24)01203-0.