Organ system improvements in Japanese patients with systemic lupus erythematosus treated with belimumab: A subgroup analysis from a phase 3 randomized placebo-controlled trial

Abstract

Objectives: To assess the effects of belimumab on disease activity across multiple organ domains in Japanese patients from the Phase 3 randomized, double-blind, North-East Asia study, BEL113750 (NCT01345253).

Methods: Patients, aged ≥18 years, with American College of Rheumatology-defined systemic lupus erythematosus (SLE) and a Safety of Estrogen in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score ≥8 at screening, on stable SLE treatment, were randomized 2:1 to receive intravenous belimumab 10 mg/kg or placebo, plus standard of care, on Days 0, 14, and 28, then 4-weekly until Week 48. Patients were assessed for SELENA-SLEDAI and British Isles Lupus Assessment Group (BILAG) organ system improvement/worsening between baseline and Week 52.

Results: Sixty patients (belimumab, n = 39; placebo, n = 21) were enrolled in Japan. Improvement was seen in a greater proportion of belimumab patients, compared with placebo, in most SELENA-SLEDAI and BILAG domains (significant for the mucocutaneous domain). Worsening occurred in SELENA-SLEDAI hematologic and renal systems (<7% both treatments) and in a number of BILAG systems: <11% (placebo) and <8% (belimumab), although the small sample size should be noted.

Conclusion: Organ system improvements were seen in more Japanese belimumab-treated than placebo-treated patients, providing further evidence supporting belimumab use in Japanese patients with SLE.

Keywords:

• Belimumab
• British Isles Lupus Assessment Group (BILAG)
• organ damage
• Safety of Estrogen in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI)
• systemic lupus erythematosus

Acknowledgments

The authors would like to acknowledge the following Japanese study investigators who helped to obtain study data for BEL113750.

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Conflicts of interest

Damon Bass, Sally Egginton, Beulah Ji, and David Roth are employees of GSK and hold shares in the company. Myron Chu was a GSK employee and held shares in the company at the time of study. Yoshiya Tanaka received 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.

Data availability

Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com.

Additional information

Funding

This study [BEL113750; NCT01345253] was funded by GlaxoSmithKline (GSK). Medical writing support was provided by Emma Hargreaves, MA, and Jennie McLean, PhD, of Fishawack Indicia Ltd, UK, and was funded by GSK.