Journal article
The effect of belimumab on mucocutaneous and vasculitis manifestations in patients with systemic lupus erythematosus: A large pooled post hoc analysis
Lupus, v 34(7), pp 666-678
05 May 2025
PMID: 40322925
Featured in Collection : UN Sustainable Development Goals @ Drexel
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,
= 1869; PBO,
= 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%;
< .0001) and BILAG (54% vs 43%;
< .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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Details
- Title
- The effect of belimumab on mucocutaneous and vasculitis manifestations in patients with systemic lupus erythematosus: A large pooled post hoc analysis
- Creators
- Susan Manzi - Drexel University, General Internal MedicineJorge Sánchez-Guerrero - Toronto Western HospitalNaoto Yokogawa - Tokyo Metropolitan Tama Medical CenterJoerg Wenzel - University Hospital BonnJosephine C Ocran-Appiah - Clinical Science, GSK, Respiratory and Immunology Clinical Research and Early Programs, Philadelphia, PA, USAJulia Hn Harris - Immunology Biostatistics, GSK, London, UKMunther Khamashta - Dubai Medical CollegeBernard Rubin - US Medical Affairs and Immuno-inflammation, GSK, Durham, NC, USANorma Lynn Fox - Clinical Development, GSK, Collegeville, PA, USARoger A Levy - GlaxoSmithKline (United States)Victoria P Werth - University of Pennsylvania
- Publication Details
- Lupus, v 34(7), pp 666-678
- Publisher
- Sage Journals; Sage Journals
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- General Internal Medicine
- Web of Science ID
- WOS:001481196800001
- Scopus ID
- 2-s2.0-105004447734
- Other Identifier
- 991022051146604721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Rheumatology