A Post Hoc Analysis of Atopic Dermatitis of the Head and Neck and Other Body Regions from the Amlitelimab STREAM-AD Phase 2b Study

Amlitelimab (SAR445229, KY1005), a nondepleting anti-OX40 ligand monoclonal antibody, reduced lesions and pruritus in phase 2a and 2b trials in adults with moderate-to-severe atopic dermatitis (AD). Here, efficacy and durability of amlitelimab across body regions were evaluated, given that unmet needs remain for treatment of head and neck AD. STREAM-AD phase 2b trial data were used in this post hoc analysis. Patients were randomized 1:1:1:1:1 to receive amlitelimab subcutaneously (250 mg with 500-mg loading dose, 250 mg, 125 mg, or 62.5 mg) or placebo every 4 weeks from weeks 0 to 24 (part 1). In part 2, clinical responders (patients achieving Investigator Global Assessment 0/1 and/or ≥ 75% reduction in Eczema Area and Severity Index [EASI-75] at week 24) were re-randomized 3:1 to withdraw from amlitelimab or continue their pre-week 24 amlitelimab dose through week 52. EASI subscores and signs were evaluated for head and neck, trunk, lower extremities, and upper extremities. Part 1 included 390 randomized patients; 190 continued to part 2. In part 1, all EASI body region subscores were reduced with all amlitelimab doses at week 24 (P ≤ 0.01). Additionally, the four EASI signs—erythema, edema, excoriation, and lichenification—were reduced with amlitelimab vs. placebo. Greater proportions of patients achieved EASI-75 per body region with all amlitelimab doses, compared to placebo (P ≤ 0.05). At week 52, clinical responders maintained improvements in each body region achieved in part 1, regardless of treatment continuation or withdrawal. Improvements in AD signs and severity were observed with amlitelimab across all body regions. Notably, clinical responses were sustained following treatment withdrawal, supporting the potential for extended dosing intervals and durable off-treatment efficacy. Amlitelimab may be a treatment option for hard-to-treat head and neck AD that disproportionately impairs quality of life. ClinicalTrials.gov Identifier NCT05131477. Atopic dermatitis (AD, or eczema) is a common chronic disease driven by an overactive immune system, leading to severely itchy, inflamed, and damaged skin. Amlitelimab, a medication that is being evaluated in clinical trials but has not yet been approved, is injected under the skin and targets OX40 ligand. OX40 ligand is a part of the immune system that is not targeted by current approved therapies. A previously reported clinical trial evaluated the effect of amlitelimab given every 4 weeks in adult patients with moderate-to-severe AD. In this report, data from the clinical trial were used to assess how different body regions responded to amlitelimab therapy. All body regions (head and neck, trunk, upper extremities, and lower extremities) showed improvements with all doses of amlitelimab by week 24 of treatment. The four signs associated with AD were also improved with amlitelimab across these body regions. These signs are redness, swelling, excoriation (scratch marks), and lichenification (leathery appearance). If by week 24 the skin cleared up or eczema area and severity greatly improved, patients were able to enter part 2 of the study. In part 2, they were randomly assigned to either stop receiving amlitelimab or to continue through week 52. Importantly, both groups maintained body region improvements achieved by week 24 at similar rates regardless of whether they stopped or continued treatment. This may indicate that patients can sustain improvements achieved with amlitelimab treatment even when amlitelimab is administered less frequently than every 4 weeks or discontinued entirely.

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