Trial reportRMD open2025
Outcomes of patients with systemic lupus erythematosus treated with belimumab: a post hoc efficacy analysis of five phase III clinical trials by British Isles Lupus Assessment Group-based Combined Lupus Assessment criteria.
Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis 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
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Biomarker-stratified efficacy and safety of biologics in systemic lupus erythematosus: a systematic review and meta-analysis.Lupus science & medicine · 2026Pooled it
- Advances in the treatment of systemic lupus erythematosus: Biologicals, small-molecular agents, and cell-depleting therapies coming to the clinic.Journal of internal medicine · 2026Review
- Review
- Can disease activity and treatment responses be captured by a core set of domains in SLE clinical trials? An analysis of phase III belimumab trial data.Lupus science & medicine · 2026Article
- Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo determine belimumab efficacy assessed using the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) in patients with systemic lupus erythematosus (SLE) from phase III belimumab randomised controlled trials (RCTs).
methodsA post hoc analysis was carried out on five RCTs in active adult SLE: four with intravenous (BLISS-52, BLISS-76, BLISS-NEA, EMBRACE) and one with subcutaneous belimumab (BLISS-SC). The 52-week landmark assessments were analysed across trials. Treatment response was defined according to BICLA criteria (BILAG improvement; no worsening of disease activity based on BILAG and Systemic Lupus Erythematosus Disease Activity Index-2K; no deterioration in Physician's Global Assessment ≥0.3 (scale: 0-3); no treatment failure).
resultsA total of 3086 patients received belimumab (n=1869) or placebo (n=1217). BICLA response frequencies at week 52 were greater with belimumab vs placebo in BLISS-52 (OR (95% CI): 1.49 (1.05-2.12); p=0.024), BLISS-NEA (1.62 (1.12-2.33); p=0.010) and BLISS-SC (1.89 (1.39-2.57); p<0.001). A highly significant difference was observed in the pooled population (1.47 (1.25-1.72); p<0.001; adjusted for trial variance). Belimumab yielded greater BICLA response frequencies than placebo irrespective of baseline glucocorticoid dose (>7.5 or ≤7.5 mg/day of a prednisone equivalent), in patients with baseline SLEDAI-2K≥10 and in patients with positive anti-double-stranded (ds)DNA and/or low C3/C4 levels at baseline. Belimumab combined with anti-malarials yielded greater frequency of BICLA response attainment.
conclusionsIn this analysis of five RCTs evaluating belimumab in SLE, belimumab conferred superiority over placebo to yield BICLA response in the overall study population and in subgroups of patients with high global or serological activity at baseline. The benefit of belimumab was more prominent when combined with anti-malarials.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.