• Yoshiya Tanaka, Damon Bass, Myron Chu, Sally Egginton, Beulah Ji, Herbert Struemper, and David Roth.
• a The First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health Japan , Kitakyushu , Japan.
• Mod Rheumatol. 2019 May 1; 29 (3): 452-460.

ObjectivesTo assess the efficacy and safety of intravenous (IV) belimumab plus standard systemic lupus erythematosus (SLE) therapy standard of care (SoC) in Japanese patients with SLE.MethodsA Phase 3, multicenter, double-blind, placebo-controlled, 52-week study (BEL 113750; NCT01345253) in patients with SLE, randomized 2:1 to belimumab 10 mg/kg plus SoC or placebo plus SoC to Week 48.ResultsSixty of 707 randomized patients were enrolled from study centers in Japan (belimumab, n = 39; placebo, n = 21). In this cohort, more patients achieved SLE Responder Index 4 response at Week 52 in the belimumab group compared with placebo (46.2% [18/39] vs. 25.0% [5/20]; odds ratio, 2.57 [95% confidence interval: 0.78, 8.47]; p=.1204). Fewer patients receiving belimumab experienced a severe flare through Week 52, with longer median time to flare compared with placebo. More patients with baseline prednisone dose >7.5 mg/d receiving belimumab had a dose reduction of ≥25% from baseline to ≤7.5 mg/d during Weeks 40-52, compared with placebo. No new safety issues were identified within the Japanese cohort.ConclusionIn Japanese patients with SLE, belimumab improved disease activity, with efficacy and safety results similar and consistent to the pivotal Phase 3 trials, suggesting that belimumab is a potential treatment option in this population.

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