The effect of belimumab on mucocutaneous and vasculitis manifestations in patients with systemic lupus erythematosus: A large pooled post hoc analysis.

IF 1.9 4区 医学 Q3 RHEUMATOLOGY
Lupus Pub Date : 2025-06-01 Epub Date: 2025-05-05 DOI:10.1177/09612033251337130
Susan Manzi, Jorge Sánchez-Guerrero, Naoto Yokogawa, Joerg Wenzel, Josephine C Ocran-Appiah, Julia Hn Harris, Munther Khamashta, Bernard Rubin, Norma Lynn Fox, Roger A Levy, Victoria P Werth
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引用次数: 0

Abstract

ObjectiveTo investigate the effects of belimumab (BEL) on systemic lupus erythematosus (SLE) mucocutaneous and vasculitis manifestations.MethodsThis post hoc, integrated Belimumab Summary of Lupus Efficacy (Be-SLE) analysis pooled data from five international Phase 3, randomized, placebo (PBO)-controlled BEL trials (BLISS-52 [NCT00424476; conducted in 2007-2009], BLISS-76 [NCT00410384; 2007-2009], BLISS-SC [NCT01484496; 2011-2015], North East Asia [NCT01345253; 2011-2015], EMBRACE [NCT01632241; 2013-2018]). Adults with active SLE and Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score ≥6 (BLISS-52, BLISS-76) or ≥8 (BLISS-SC, North East Asia, EMBRACE), randomized to BEL (10 mg/kg/month intravenously or 200 mg/week subcutaneously) or PBO, plus standard therapy (ST) were included. Mucocutaneous and vasculitis manifestations (listed below) were measured (baseline and every 4 weeks) for 52 weeks using SELENA-SLEDAI and British Isles Lupus Assessment Group (BILAG).ResultsOf 3086 patients (BEL, n = 1869; PBO, n = 1217), 85% (BEL and PBO) by SELENA-SLEDAI and 58% (BEL) and 62% (PBO) by BILAG (moderate or severe activity) had mucocutaneous manifestations, and <10% had vasculitis at baseline. At Week 52, significantly more BEL-treated than PBO-treated patients demonstrated improvements in SELENA-SLEDAI (59% vs 49%; p < .0001) and BILAG (54% vs 43%; p < .0001) mucocutaneous domains. Significant differences between-treatment favored BEL at Week 52 for resolution of all SELENA-SLEDAI items (vasculitis, rash, alopecia, and mucosal ulcers), and nine of 20 BILAG items (mild maculopapular eruption, localized active discoid lesions, mild alopecia, small mucosal ulceration, malar erythema, subcutaneous nodules, swollen fingers, major cutaneous vasculitis including ulcers, and minor cutaneous vasculitis).ConclusionPatients with SLE treated with BEL plus ST experienced significant improvements in most mucocutaneous and vasculitis manifestations compared with patients receiving PBO plus ST. These data provide additional support for the use of BEL in SLE and show that it is associated with skin improvements.

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贝利单抗对系统性红斑狼疮患者粘膜皮肤和血管炎表现的影响:一项大型汇总事后分析。
目的探讨贝利单抗(belimumab, BEL)对系统性红斑狼疮(SLE)粘膜皮肤及血管炎表现的影响。这项事后综合贝利单抗狼疮疗效总结(Be-SLE)分析汇集了5项国际3期随机安慰剂(PBO)对照BEL试验的数据(BLISS-52 [NCT00424476;2007-2009年进行的],BLISS-76 [NCT00410384;2007-2009], BLISS-SC [NCT01484496, 2011-2015],东北亚[NCT01345253;2011-2015],拥抱[nct01632241;2013 - 2018])。国家评估-SLE疾病活动性指数(SELENA-SLEDAI)评分≥6 (BLISS-52, BLISS-76)或≥8 (BLISS-SC,东北亚,EMBRACE),随机分为BEL(静脉注射10mg /kg/月或皮下注射200mg /周)或PBO加标准治疗(ST)。使用SELENA-SLEDAI和不列颠群岛狼疮评估小组(BILAG)测量皮肤粘膜和血管炎表现(如下所列)(基线,每4周),持续52周。结果3086例患者(BEL, n = 1869;SELENA-SLEDAI组的PBO, n = 1217)、85% (BEL和PBO), BILAG组的58% (BEL)和62% (PBO)(中度或重度活动)有皮肤粘膜表现,p < 0.0001)和BILAG组(54% vs 43%;P < 0.0001)粘膜皮肤域。在第52周,BEL治疗在所有SELENA-SLEDAI项目(血管炎、皮疹、脱发和粘膜溃疡)和20个BILAG项目中的9个(轻度斑疹丘疹、局部活动性盘状病变、轻度脱发、小粘膜溃疡、颈部红斑、皮下结节、肿胀的手指、包括溃疡在内的主要皮肤血管炎和轻微皮肤血管炎)的解决上有显著差异。结论与接受PBO + ST治疗的SLE患者相比,BEL + ST治疗的SLE患者在大多数皮肤粘膜炎和血管炎表现上有显著改善。这些数据为BEL在SLE中的应用提供了额外的支持,并表明BEL与皮肤改善有关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Lupus
Lupus 医学-风湿病学
CiteScore
4.20
自引率
11.50%
发文量
225
审稿时长
1 months
期刊介绍: The only fully peer reviewed international journal devoted exclusively to lupus (and related disease) research. Lupus includes the most promising new clinical and laboratory-based studies from leading specialists in all lupus-related disciplines. Invaluable reading, with extended coverage, lupus-related disciplines include: Rheumatology, Dermatology, Immunology, Obstetrics, Psychiatry and Cardiovascular Research…
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