ArticleRheumatology (Oxford, England)2025
Belimumab efficacy in mucocutaneous manifestations of systemic lupus erythematosus: a large post hoc analysis of five phase III clinical trials.
Article in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The 2026 British Society for Rheumatology guideline for the management of children, young people and adults with systemic lupus erythematosus.Rheumatology (Oxford, England) · 2026Guideline
- Biomarker-stratified efficacy and safety of biologics in systemic lupus erythematosus: a systematic review and meta-analysis.Lupus science & medicine · 2026Pooled it
- Belimumab for mucocutaneous manifestations in systemic lupus erythematosus: a systematic review and meta-analysis of trials and pooledAnnals of medicine and surgery (2012) · 2026Article
- Belimumab induces early and sustained resolution of lupus thrombocytopenia.Lupus science & medicine · 2026Article
- Therapeutic Approaches for Cutaneous Lupus Erythematosus: a Changing Landscape of Clinical Trials.Journal of inflammation research · 2026Review
- Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025Review
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
objectiveTo determine the efficacy of belimumab on mucocutaneous manifestations of SLE in a large integrative analysis.
methodsUsing data from five phase III clinical trials (BLISS-52; BLISS-76; BLISS-NEA; EMBRACE; BLISS-SC; N = 3086), we investigated the effect of belimumab vs. placebo on top of standard therapy on inducing improvement in mucocutaneous BILAG (mcBILAG) and mucocutaneous SLE Disease Activity Index 2000 (mcSLEDAI-2K), and on preventing mcBILAG flares. We employed logistic and Cox regression analysis, adjusting for trial variance.
resultsBelimumab was superior to placebo in inducing mcBILAG (week-52 OR: 1.29; 95% CI: 1.07-1.57; P = 0.008) and mcSLEDAI-2K (week-52 OR: 1.37; 95% CI: 1.16-1.62; P< 0.001) improvement, as well as in inducing sustained (≥2 visits, maintained through week 52) mcBILAG (HR: 1.23; 95% CI: 1.07-1.41; P = 0.003) and mcSLEDAI-2K (HR: 1.24; 95% CI: 1.17-1.31; P < 0.001) improvement. These associations held true for patients with SLEDAI-2K ≥10 and positive anti-dsDNA levels at baseline, but not their counter groups. Belimumab prevented mcBILAG flares to a greater extent than placebo in patients with positive anti-dsDNA levels (HR: 0.70; 95% CI: 0.50-0.98; P = 0.035) and with a near-significant separation in patients with baseline SLEDAI-2K ≥10 (HR: 0.71; 95% CI: 0.51-1.00; P = 0.050), whereas no difference was seen in their counter groups.
conclusionBelimumab is superior to placebo in inducing improvement and in preventing flares in the mucocutaneous domain of SLE, especially in patients with high disease activity and in serologically active patients.
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