贝里穆马布
医学
耐受性
不利影响
内科学
临床终点
痹症科
系统性红斑狼疮
红斑狼疮
子群分析
临床试验
疾病
免疫学
B细胞激活因子
抗体
置信区间
B细胞
作者
Yoshiya Tanaka,Paula Curtis,Kathleen DeRose,Regina Kurrasch,Kyoko Kinoshita,Rika Tanaka,Yumi Yamazaki,David A. Roth
摘要
ABSTRACT Objectives Evaluate long-term safety, tolerability, and efficacy of belimumab in Japanese patients with systemic lupus erythematosus (SLE). Methods This was a subgroup analysis of Japanese patients who completed studies BEL113750 or BEL112341 and were enrolled in a Phase 3, open-label extension study (BEL114333; NCT01597622). Eligible patients received intravenous belimumab 10 mg/kg every 28 days for ≤7 years. Primary endpoint: safety and tolerability. Secondary endpoints included SLE Responder Index (SRI)-4 response rate, SRI-4 components, severe SLE flare, and use of corticosteroids/other SLE-related treatments. Analyses were based on observed data from first belimumab dose received in either parent or current study through to study end. Results Of 71 Japanese patients enrolled, 69.0% completed the study. Overall, 98.6% patients had adverse events (AEs); 32.4% had serious AEs. The proportion of SRI-4 responders increased progressively (Year 1, Week 24: 40.9% [27/66]; Year 7, Week 48: 84.6% [11/13]) as did the proportion of Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index responders. The proportion of patients with no worsening in PGA (91.2–100.0%) and no new organ damage (92.6–100.0%) remained stable over time. Severe SLE flare was experienced by 11.3% (8/71) of patients. Corticosteroid and immunosuppressant use decreased over time. Conclusions Favourable safety profile and treatment responses with belimumab were maintained for ≤7 years in Japanese patients with SLE.
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