ARCADIA Data Highlight Long-Term Sleep, Itch Benefits of Nemolizumab in Atopic Dermatitis

With an FDA decision in moderate-to-severe atopic dermatitis expected before the end of the year, new ARCADIA data from the Maui Derm NP+PA Fall 2024 meeting is shedding further light on the effects of nemolizumab (Nemluvio) among this patient population.^1,2

In an analysis of data from the initial and maintenance phase of the ARCADIA program, results demonstrate that the use of the IL-31 inhibitor was associated with early response in itch and sustained improvement in itch and sleep responses maintained up to 48 weeks of treatment.¹

“Nemolizumab [every 4 weeks] with background [topical corticosteroids] or [topical calcineurin inhibitors] was well tolerated and led to clinically meaningful and statistically significant improvements in core signs and symptoms of [atopic dermatitis] in adults and adolescents with moderate-to-severe disease,” wrote investigators.¹

In February 2024, Galderma submitted a Biologics License Applications (BLA) to the FDA for nemolizumab in the treatment of prurigo nodularis and atopic dermatitis based on data from the OLYMPIA and ARCADIA programs, respectively. On August 13, 2024, Galderma announced the FDA approval of nemolizumab for adult patients with prurigo nodularis and, in the same release, pointed out its expectation of a regulatory decision regarding the BLA for use in moderate-to-severe atopic dermatitis by the end of the year.²

ARCADIA 1 and ARCADIA 2 were 48-week randomized, placebo-controlled double-blind, phase 3 studies designed to assess the effect of nemolizumab against placebo therapy during an initial 16-week treatment period and a 32-week maintenance period. Per trial protocol, patients aged 12 years or older with moderate-to-severe atopic dermatitis and pruritus were randomized in a 2:1 ratio to nemolizumab or placebo every 4 weeks in addition to background topical corticosteroids or topical calcineurin inhibitors of medium or low potency.^1,2,3

In October 2023, Galderma unveiled positive results from the trials demonstrating nemolizumab met the co-primary and all key secondary endpoints, including a statistically significant effect on investigator’s global assessment (IGA) score and Eczema Area and Severity Index (EASI). At the time of the presentation at EADV Congress 2023, Galderma highlighted a statistically significant effect on rate of patients achieving a 4-point reduction in peak-pruritus numerical rating scale (PP-NRS) at 16 weeks.³

At Maui Derm NP+PA Fall 2024, Jonathan Silverberg, MD, PhD, professor of dermatology and director of clinical research at the George Washington University School of Medicine and Health Science, presented data from an analysis evaluating the efficacy of nemolizumab on itch and sleep responses using SCORing Atopic Dermatitis (SCORAD) visual analog scale (VAS) Pruritus and SCORAD VAS Sleep loss, respectively.¹

Results indicated response rates for a 4-point improvement in SCORAD VAS Pruritus were maintained in both the nemolizumab every 4 weeks (72.8%, P <.0001) and nemolizumab every 8 weeks groups (66.9%, P <.001) relative to placebo groups (49.1%). Similar results were seen with regard to response rates for 4-point improvement in weekly average Peak Pruritus NRS with nemolizumab every 4 weeks (76.2%; P <.0001) and nemolizumab every 8 weeks (59.7%; P <.01) relative to placebo (41.0%).¹

Data from the analysis suggested response rates for 4-point improvement in SCORAD VAS Sleep loss were also maintained in the nemolizumab every 4 weeks (61.5%; P<.001) and nemolizumab every 8 weeks (56.2%; P<.05) groups relative to the placebo groups (43.2%). Further analysis indicated rates of 4-point improvement in weekly average Sleep Disturbance NRS were maintained in the nemolizumab every 4 weeks (57.7%; P <.01), nemolizumab every 8 weeks (50.1%) relative to placebo groups (39.0%).¹

“Resolution of itch and sleep disturbance was rapid and sustained through [week 16],” investigators concluded.¹

References:

1. JI Silverberg, D Thaçi, KA Papp, et al. Nemolizumab improves skin lesions, itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis: Results from two identical phase 3 multinational studies (ARCADIA 1 and ARCADIA 2). Abstract presented at Maui Derm NP+PA Fall 2024. Nashville, TN. September 15-18, 2024.
2. Smith T. FDA approves nemolizumab for treatment of prurigo nodularis. HCP Live. August 13, 2024. Accessed September 16, 2024. https://www.hcplive.com/view/fda-approves-nemolizumab-treatment-prurigo-nodularis.
3. Smith T. Positive phase 3 results announced for nemolizumab treatment of atopic dermatitis, prurigo nodularis. HCP Live. October 11, 2023. Accessed September 16, 2024. https://www.hcplive.com/view/positive-phase-3-results-announced-nemolizumab-treatment-atopic-dermatitis-prurigo-nodularis.