Amlitelimab Shows Long-Term Safety and Efficacy in Atopic Dermatitis in new trial
A new study published in The Journal of Allergy and Clinical Immunology revealed that amlitelimab was a safe and effective treatment for moderate-to-severe atopic dermatitis (AD). They found that over a 68-week period, patients experienced sustained therapeutic responses even after treatment ended, highlighting the long-term benefits of amlitelimab.
This study involved 390 adult patients in Part 1 and 190 in Part 2. Amlitelimab was administered subcutaneously every 4 weeks at varying doses (62.5 mg, 125 mg, 250 mg, and 250 mg with an initial 500 mg loading dose) versus placebo over a 24-week period in Part 1. In Part 2, responders were re-randomized 3:1 to either stop treatment or continue for an additional 28 weeks.
The primary endpoint, percentage change in the Eczema Area and Severity Index (EASI) score from baseline to week 16, showed statistically significant reductions across all amlitelimab dosing groups when compared to placebo (P < .001). This strong efficacy was further substantiated at week 24, where the patients demonstrated robust clinical responses based on Investigator Global Assessment scores of 0 or 1, or at least a 75% reduction in EASI scores.
Also, many patients who discontinued amlitelimab after week 24 maintained their clinical improvements through week 52. Over 80% of those who sustained their response off-treatment had serum amlitelimab concentrations well below the therapeutic threshold of 4 μg/mL for several weeks before week 52. This finding illuminates the potential of amlitelimab for disease modification rather than mere symptom suppression.
Biomarker analysis supported the reductions in AD-related biomarkers observed during Part 1 remained stable through the end of Part 2, which suggested a durable immunological effect. Amlitelimab was well tolerated throughout the 52-week study, with no major safety signals reported.
Overall, these findings offer hope for a new, mechanism-driven approach to managing T-cell–driven inflammation in AD. If confirmed with future trials, amlitelimab could redefine long-term treatment strategies for this burdensome skin condition. Amlitelimab not only significantly improves atopic dermatitis symptoms but also maintains clinical remission in many patients up to 28 weeks after stopping therapy, which highlighted its potential as a disease-modifying treatment.
Source:
Weidinger, S., Blauvelt, A., Papp, K. A., Reich, A., Lee, C.-H., Worm, M., Lynde, C., Kataoka, Y., Foley, P., Wei, X., Wong, W., Solente, A.-C., Weber, C., Adelman, S., Davey, S., Hurbin, F., Rynkiewicz, N., Yen, K., O’Malley, J. T., & Bernigaud, C. (2025). Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. The Journal of Allergy and Clinical Immunology, 155(4), 1264–1275. https://doi.org/10.1016/j.jaci.2024.10.031
