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.

journal_name

Mod Rheumatol

journal_title

Modern rheumatology

authors

Tanaka Y,Bass D,Chu M,Egginton S,Ji B,Roth D

doi

10.1080/14397595.2019.1630897

subject

Has Abstract

pub_date

2020-03-01 00:00:00

pages

313-320

issue

2

eissn

1439-7595

issn

1439-7609

journal_volume

30

pub_type

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