Impact of Amlitelimab (An Anti-OX40 Ligand Antibody) on Maintenance of Itch Response in Atopic Dermatitis: Results From the 52-Week STREAM-AD Phase 2b Study
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Keywords
atopic dermatiits, Amlitelimab, itch response, maintenance
Abstract
Background Amlitelimab is an anti-OX40 Ligand (OX40L) monoclonal antibody inhibiting OX40L-OX40 interactions. Here, we evaluated itch response in clinical responders at Week 24 who continued or withdrew from amlitelimab treatment for an additional 28 weeks in Part 2 of the Phase 2b STREAM-AD (NCT05131477) dose-ranging trial in adults with moderate-to-severe AD.
Methods STREAM-AD Part 2 included 190 clinical responders from Part 1, defined as those achieving EASI-75 and/or IGA 0/1 at Week 24. Participants were re-randomized 3:1 to withdraw treatment or continue pre-Week 24 dose (250mg with 500mg loading dose, n=34 [treatment withdrawal]/n=13 [continuing]; 250mg, n=28/n=12; 125mg, n=33/n=12; 62.5mg, n=35/n=7; placebo responders continuing placebo, n=16), and were followed to Week 52 for efficacy. In this post hoc analysis, proportions of patients with a ≥4-point reduction from baseline in Peak Pruritus Numerical Rating Scale (PPNRS≥4) were evaluated in clinical responders at Weeks 24 and 52.
Results Of the participants entering Part 2 who received amlitelimab in Part 1 (n=174), 46.6% (n=81) were PPNRS≥4 responders. Among these Week 24 PPNRS≥4 responders that continued (n=27) or withdrew (n=54) from amlitelimab during Part 2, 74.1% and 63.0% maintained PPNRS≥4 responses at Week 52, respectively.
Conclusion In the STREAM-AD Phase 2b trial, many patients treated with amlitelimab who demonstrated skin improvements also experienced improvements in itch at Week 24. A majority of the clinical responders who saw itch reduction at Week 24 maintained this reduction on- or off-amlitelimab for the 28-week withdrawal period, demonstrating durable and sustained itch responses following amlitelimab treatment.
References
2. Weidinger S, Bieber T, Cork MJ, et al. Safety and efficacy of amlitelimab, a fully human nondepleting, noncytotoxic anti-OX40 ligand monoclonal antibody, in atopic dermatitis: results of a phase IIa randomized placebo-controlled trial. Br J Dermatol. 2023;189(5):531-539. doi:10.1093/bjd/ljad240
3. Weidinger S, Blauvelt A, Papp KA, et al. Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2025;155(4):1264-1275. doi:10.1016/j.jaci.2024.10.031
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