The following is a summary of “Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis,” published in the November 2024 issue of Allergy and Immunology by Weidinger et al.
Amlitelimab targets the OX40 ligand to reduce T-cell inflammation in atopic dermatitis (AD). It may offer effective control for moderate-to-severe AD.
Researchers conducted a retrospective study on the efficacy and safety of amlitelimab in adults with AD.
They conducted a 2-part, phase 2b, randomized, double-blind trial (NCT05131477) with subcutaneous amlitelimab given every 4 weeks at varying doses for 24 weeks. In Part 2, responders were reallocated 3:1 to either stop or continue amlitelimab for 28 weeks. The primary endpoint was the percent change in Eczema Area and Severity Index (EASI) from baseline to Week 16.
The results showed significant EASI reductions with amlitelimab vs. placebo (P<.001), with 390 and 190 patients enrolled in Parts 1 and 2, respectively. Clinical responses at Week 24 were sustained at Week 52, even after amlitelimab withdrawal. Over 80% of off-treatment responders had serum levels below 4 μg/mL before Week 52. Reductions in AD-related biomarkers during Part 1 were maintained through Part 2, and amlitelimab was well tolerated over 52 weeks.
They found that amlitelimab significantly reduced clinical and biomarker responses and was well tolerated over 52 weeks. They observed sustained responses in most patients even after 28 weeks of treatment withdrawal.
Source: jacionline.org/article/S0091-6749(24)01175-8/fulltext
