Efficacy and safety of lebrikizumab, a high-affinity interleukin 13 inhibitor, in adults with moderate to severe atopic dermatitis: A phase 2b randomized clinical trial
JAMA Mar 02, 2020
Guttman-Yassky E, Blauvelt A, Eichenfield LF, et al. - A phase 2b, double-blind, placebo-controlled, dose-ranging randomized clinical trial was designed to assess the efficacy and safety of lebrikizumab, a novel, high-affinity, monoclonal antibody targeting IL-13 that selectively prevents formation of the IL-13Rα1/IL-4Rα heterodimer receptor signaling complex, in adults with moderate to severe atopic dermatitis (AD). This trial of lebrikizumab injections every 4 weeks or every 2 weeks was carried out between January 23, 2018, and May 23, 2019, at 57 US centers. Individuals were assigned randomly in 2:3:3:3 ratio to placebo every 2 weeks or to subcutaneous injections of lebrikizumab at the following doses: 125 mg every 4 weeks (250-mg loading dose [LD]), 250 mg every 4 weeks (500-mg LD), or 250 mg every 2 weeks (500-mg LD at baseline and week 2). The data indicated that lebrikizumab provided rapid, dose-dependent efficacy across a broad range of clinical manifestations in adult patients with moderate to severe AD and demonstrated a favorable safety profile during 16 weeks of treatment. The evidence support the central role of IL-13 in AD pathophysiology. The lebrikizumab may meaningfully advance the standard of care for moderate to severe AD, whether these findings replicate in phase 3 studies.
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