Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.
Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.
Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.
Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.
Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240