1. Efficacy of belimumab in patients with systemic lupus erythematosus from North East Asia: Results of exploratory subgroup analyses.
- Author
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Zheng J, Gu J, Su Y, Li Y, Li X, Xiong C, Cao H, Quasny H, Chu M, Curtis P, DeRose K, Kurrasch R, Meizlik P, Roth DA, and Zhang F
- Subjects
- Humans, Male, Female, Treatment Outcome, Double-Blind Method, Adult, Asia, Eastern, Antibodies, Monoclonal, Humanized therapeutic use, Lupus Erythematosus, Systemic drug therapy, Immunosuppressive Agents therapeutic use
- Abstract
Objectives: To assess belimumab efficacy in patients from North East Asia (NEA) with systemic lupus erythematosus (SLE) in baseline demographic/disease characteristic subgroups., Methods: This analysis of patient subgroups from BLISS-NEA (GSK Study 113750; NCT01345253) studied adults with SLE randomized to belimumab (10 mg/kg intravenous) or placebo. Primary endpoint, SLE Responder Index 4 (SRI-4) response rate at Week 52, was analysed in subgroups defined by gender, country, prednisone-equivalent dose, concomitant medications, Safety of Estrogens in Lupus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score, complement (C) levels, anti-double-stranded deoxyribonucleic acid (dsDNA) positivity, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index score., Results: Patients (overall population: N = 677; belimumab: n = 451, placebo: n = 226) were from China (76.4%), Korea (14.8%), and Japan (8.9%). The mean age was 32.1 years; 92.9% were female. In the overall population, more belimumab (53.8%) than placebo (40.1%) patients were SRI-4 Week 52 responders (p = .0001). SRI-4 response rates by subgroups were generally consistent with the overall population. A greater response with belimumab was seen in patients with a baseline SELENA-SLEDAI score ≥10 versus ≤9 and patients with low C3/C4 levels and anti-dsDNA positive at baseline versus those 'NOT' (low C3 and/or C4 and anti-dsDNA positive)., Conclusions: These findings continue to support the efficacy of belimumab in SLE., (© The Author(s) 2022. Published by Oxford University Press on behalf of Japan College of Rheumatology.)
- Published
- 2023
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