Amlitelimab Shows Long-Term Safety and Efficacy in Atopic Dermatitis in new trial

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