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Extended report
A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea

Abstract

Background Intravenous belimumab plus standard of care (SoC) is approved in the USA and Europe for treatment of active, autoantibody-positive systemic lupus erythematosus (SLE).

Methods This phase III, multicentre, randomised, double-blind, placebo-controlled study (BEL113750; NCT01345253) was conducted in 49 centres across China, Japan and South Korea (May 2011September 2015). Patients with SLE were randomised 2:1 to intravenous belimumab 10 mg/kg or placebo, plus SoC, every 4 weeks until Week 48. The primary endpoint was the SLE Responder Index (SRI) 4 response rate at Week 52. Secondary endpoints were the percentage of patients with ≥4 point reduction in Safety of Oestrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI), SRI7, time to first severe flare and number of days prednisone (or equivalent) dose ≤7.5 mg/day and/or reduced by 50% from baseline. Safety was assessed.

Results The modified intent-to-treat population included 677 patients (belimumab n=451, placebo n=226). At Week 52, the SRI4 response rate was higher with belimumab versus placebo (53.8% vs 40.1%; OR: 1.99 (95% CI: 1.40, 2.82; P=0.0001)). The percentages of patients with a ≥4 point reduction in SELENA-SLEDAI and an SRI7 response were significantly greater for belimumab versus placebo. Patients in the belimumab group had a 50% lower risk of experiencing a severe flare than those receiving placebo (P=0.0004). In patients with baseline prednisone dose >7.5 mg/day, there was a significant reduction in steroid use favouring belimumab (P=0.0228). The incidence of adverse events was similar between groups.

Conclusions In patients with SLE from North East Asia, belimumab significantly improved disease activity, while reducing prednisone use, with no new safety issues.

  • Systemic Lupus Erythematosus
  • Treatment
  • Disease Activity

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Footnotes

  • Handling editor Tore K Kvien

  • Contributors DB and DAR contributed to the study design, data analyses and interpretation. FZ, S-CB, YT and JZ contributed to the acquisition of data. MC, SE and DG contributed to data analyses and interpretation. All authors reviewed the manuscript and approved the final version for submission.

  • Funding This study was funded by GSK.

  • Competing interests DB, MC, SE, DG and DAR are employees of GSK and hold shares in the company. YT receives consulting fees, speaking fees and/or honoraria from AbbVie, Chugai, Daiichi-Sankyo, Bristol-Myers Squibb, Mitsubishi-Tanabe, Astellas, Takeda, Pfizer, Asahi-Kasei, YL Biologics, Sanofi, Janssen, Eli Lilly and GSK and has received research grants from Mitsubishi-Tanabe, Takeda, Daiichi-Sankyo, Chugai, Bristol-Myers Squibb, MSD, Astellas, AbbVie and Eisai.

  • Patient consent Obtained.

  • Ethics approval The study was conducted in accordance with the ethical principles of the Declaration of Helsinki, International Council for Harmonisation on Good Clinical Practice and the applicable country-specific regulatory requirements.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Presented at Data from this study have previously been presented at the American College of Rheumatology Annual Scientific meeting (ACR2016), the 12th International Congress on Systemic Lupus Erythematosus (LUPUS 2017) and the Japan College of Rheumatology 61st Annual Scientific Meeting (JCR 2017).

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