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Durable clinical response of amlitelimab in moderate-to-severe atopic dermatitis

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Created On: 18/11/2025

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Key take away

Subcutaneous amlitelimab markedly improves atopic dermatitis symptoms by week 24 and maintains these benefits through week 52, even after treatment withdrawal.

Background

Amlitelimab, a fully human, nondepleting monoclonal antibody targeting OX40 ligand, has shown reductions in lesion severity and itch in adults with moderate-to-severe atopic dermatitis (AD) in earlier phase 2a and 2b studies. This study examined amlitelimab's efficacy and durability on clinical outcome assessments in the randomized STREAM-AD phase 2b trial.

Method

Adults suffering from moderate-to-severe AD who had an inadequate response to or could not use topical therapies were treated with subcutaneous amlitelimab (250 mg with a 500-mg loading dose, 250 mg, 125 mg, or 62.5 mg) or placebo every 4 weeks during Part 1 (Weeks 0–24; 1:1:1:1:1 randomization). In Part 2, those who met clinical response criteria at Week 24—defined as achieving Investigator Global Assessment (IGA) 0/1 and/or ≥75% improvement in the Eczema Area and Severity Index (EASI-75)—were rerandomized in a 3:1 ratio to either continue or withdraw from amlitelimab at their pre-Week 24 dose through Week 52.

Evaluated clinical outcomes included atopic dermatitis control tool, SCORing Atopic Dermatitis (SCORAD), patient-oriented eczema measure (POEM), dermatology life quality index (DLQI), and the affected body surface area.

Result

Of the 390 patients randomized in Part 1, 190 entered Part 2. All amlitelimab doses elicited remarkable improvements in clinical outcomes compared with placebo at week 24 (p < 0.05 for all measures). Most clinical responders at week 24 achieved meaningful improvements in clinical outcomes. By week 52, these gains were largely maintained in those who continued treatment as well as in those who discontinued amlitelimab, illustrating sustained clinical benefit over the 28-week Part 2 period.

Conclusion

Amlitelimab not only delivered rapid, meaningful improvements in AD symptoms but also maintained these benefits over time, even after treatment cessation. These findings reinforce amlitelimab’s persistent therapeutic effect and the practicality of extended dosing for a more convenient treatment regimen.