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Efficacy, safety, and pharmacodynamic effects of the Bruton’s tyrosine kinase inhibitor, fenebrutinib (GDC-0853), in systemic lupus erythematosus

Arthritis & Rheumatology Jun 01, 2021

Isenberg D, Furie R, Jones NS, et al. - A randomized, placebo-controlled, multi-center phase II study was designed to explore the effectiveness, safety, and pharmacodynamics of fenebrutinib (FEN). Researchers randomized individuals with moderate-to-severely active systemic lupus erythematosus on background standard of care therapy to placebo, FEN 150 mg QD, or FEN 200 mg BID arms. A total of 260 individuals were included from 44 sites in 12 countries, with the majority from Latin America, the USA, and Western Europe. This study’s findings demonstrate that while FEN had an acceptable safety profile, the primary endpoint, SRI-4, was not met despite evidence of strong pathway inhibition.

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