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The anti-OX40 antibody amlitelimab showed maintenance of response even after treatment discontinuation in the STREAM-AD study.
The anti-OX40 antibody amlitelimab showed remarkable maintenance of response even after treatment discontinuation in the STREAM-AD study. This observation might implicate an extension of the treatment interval.
Amlitelimab is a fully human, non-depleting anti-OX40 antibody that inhibits T-cell-dependent inflammation without T-cell depletion. In the phase 2b STREAM-AD study (NCT05131477), the agent showed clinically meaningful improvements in patients with atopic dermatitis (AD) at week 24 across 4 different doses. The objective of the second part of STREAM-AD was to explore the maintenance of clinical response over 28 weeks (from week 24 to week 52) with continued amlitelimab treatment or amlitelimab withdrawal (placebo) in clinical responders of study part 1, defined as participants achieving Eczema Area and Severity Index improvement by 75% (EASI75) and clear or almost clear skin in the Investigator’s Global Assessment (IGA 0/1) at week 24.
Of the 390 participants enrolled in part 1 of STREAM-AD, 190 entered part 2. Participants were rerandomized to withdraw from amlitelimab (n=130), continue amlitelimab in the pre-week 24 dose (n=44) every 4 weeks, or continue placebo (n=16), and were followed to week 52 for efficacy evaluations.
At week 52, a high percentage of clinical responders were seen in all groups, both on and off amlitelimab. In the non-responder-imputation analysis, 70.5% of the participants that continued their original amlitelimab dose and 60.6% of the pooled placebo participants still achieved IGA 0/1 and/or EASI75 response. Regardless of treatment discontinuation and rescue medication use, the corresponding overall percentages were 81.8% versus 74.6%, respectively. Those continuing treatment had numerically higher maintenance response rates.
As Stephan Weidinger, MD, PhD, pointed out, the high efficacy observed across the broad range of amlitelimab doses given every 4 weeks supports extended dosing of amlitelimab (eg, every 12 weeks).
Furthermore, AD-related biomarkers remained suppressed over 28 weeks; ≥95% of the drug was eliminated from serum for the last 8 weeks. The overall incidence of treatment-emergent adverse events was similar in part 1 and part 2 of the STREAM-AD study.
Medical writing support was provided by Dr. Susanne Kammerer.
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