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Safety and efficacy of eblasakimab, an IL-13Rα1 monoclonal antibody, in adults with moderate-to-severe atopic dermatitis: a phase 1b, multiple-ascending dose study

J Am Acad Dermatol. 2023 Oct 20:S0190-9622(23)03029-3. doi: 10.1016/j.jaad.2023.10.026. Online ahead of print.


BACKGROUND: Eblasakimab, an interleukin (IL)-13 receptor α1 antagonist, blocks IL-4 and IL-13 signaling through the type 2 receptor.

OBJECTIVE: The safety and efficacy of eblasakimab was evaluated in adults with moderate-to-severe atopic dermatitis (AD).

METHODS: In this phase 1b randomized, double-blinded study, 52 patients with moderate-to-severe AD received weekly subcutaneous injections of eblasakimab 200, 400, or 600 mg, or placebo for 8 weeks. Primary outcome was the incidence of treatment-emergent adverse events (TEAEs). Secondary outcomes included percentage change in the Eczema Area and Severity Index (EASI) from baseline; EASI improvement of at least 50%, 75%, or 90% from baseline; and percentage change in the peak-pruritus numeric rating scale score from baseline.

RESULTS: TEAEs were reported in 47% placebo and 71% eblasakimab patients; most were considered mild or moderate and did not lead to study discontinuation. At week 8 eblasakimab 600 mg showed statistically significant improvement in mean percentage change in EASI vs. placebo (-65% vs. -27%, P=0.014). Other key secondary physician- and patient-reported end points were met.

LIMITATIONS: Longer studies are required to confirm eblasakimab safety and efficacy in AD patients.

CONCLUSIONS: Treatment of adults with moderate-to-severe AD with eblasakimab was well-tolerated and associated with significant clinical improvements vs. placebo.

PMID:37866456 | DOI:10.1016/j.jaad.2023.10.026

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