Trial reportLupus2016
Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care.
Trial report in Lupus, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00712933 (A Multi-Center, Continuation Trial of Belimumab), which is not on this map. Cited by 46 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057
Who cites it
46 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Beyond systemic lupus erythematosus: a systematic review on the use of belimumab in other connective tissue diseases and vasculitides.Clinical rheumatology · 2026Pooled it
- Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis.Annals of the rheumatic diseases · 2019Pooled it
- Trial
- Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.Rheumatology (Oxford, England) · 2020Trial
- Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: a randomised, double-blind, placebo-controlled trial.Annals of the rheumatic diseases · 2020Trial
- Trial
- Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States.Arthritis & rheumatology (Hoboken, N.J.) · 2018Trial
- Belimumab prevention against organ damage over 8 years and safety up to 13 years: three pooled open-label, long-term extension SLE studies.Lupus science & medicine · 2026Article
- Belimumab in Systemic Lupus Erythematosus: From B-Cell Biology to Disease Modification.Journal of clinical medicine · 2026Review
- Long-term outcomes of hydroxychloroquine dose reduction in Puerto Ricans with systemic lupus erythematosus: 6-year follow-up.Lupus science & medicine · 2026Article
- Immune ontogeny in childhood-onset systemic lupus erythematosus: effect of immune maturity on disease phenotype and therapeutic responses.Frontiers in immunology · 2026Review
- Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025Review
- Development and evaluation of a Register-Based Organ Damage Index in systemic lupus erythematosus: a nationwide, population-based study from Sweden.Lupus science & medicine · 2025Article
- Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis.Lupus science & medicine · 2025Article
- Efficacy of Belimumab on Different Joint and Skin Manifestations of Systemic Lupus Erythematosus: Real-Life Data from a New Multicentric, Nationwide Italian Cohort (BeRLiSS-JS 2.0).Biologics : targets & therapy · 2025Article
- Clinical and economic burden of organ damage among patients with systemic lupus erythematosus in a real-world setting in Germany.BMC rheumatology · 2024Article
- Predictive Factors of the Use of Rituximab and Belimumab in Spanish Lupus Patients.Medicina (Kaunas, Lithuania) · 2023Article
- The Safety and Efficacy of Rituximab and Belimumab in Systemic Lupus Erythematosus: A Systematic Review.Cureus · 2023Review
- Biological therapy in systemic lupus erythematosus, antiphospholipid syndrome, and Sjögren's syndrome: evidence- and practice-based guidance.Frontiers in immunology · 2023Review
- Belimumab for systemic lupus erythematosus - Focus on lupus nephritis.Human vaccines & immunotherapeutics · 2022Review
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
Abstract
objectiveTo examine long-term organ damage and safety following treatment with belimumab plus standard of care (SoC) in patients with systemic lupus erythematosus (SLE).
methodsPooled data were examined from two ongoing open-label studies that enrolled patients who completed BLISS-52 or BLISS-76. Patients received belimumab every four weeks plus SoC. SLICC Damage Index (SDI) values were assessed every 48 weeks (study years) following belimumab initiation (baseline). The primary endpoint was change in SDI from baseline at study years 5-6. Incidences of adverse events (AEs) were reported for the entire study period.
resultsThe modified intent-to-treat (MITT) population comprised 998 patients. At baseline, 940 (94.2%) were female, mean (SD) age was 38.7 (11.49) years, and disease duration was 6.7 (6.24) years. The mean (SD) SELENA-SLEDAI and SDI scores were 8.2 (4.18) and 0.7 (1.19), respectively; 411 (41.2%) patients had organ damage (SDI = 1: 235 (23.5%); SDI ≥ 2: 176 (17.6%)) prior to belimumab. A total of 427 (42.8%) patients withdrew overall; the most common reasons were patient request (16.8%) and AEs (8.5%).The mean (SD) change in SDI was +0.2 (0.48) at study years 5-6 (n = 403); 343 (85.1%) patients had no change from baseline in SDI score (SDI +1: 46 (11.4%), SDI +2: 13 (3.2%), SDI +3: 1 (0.2%)). Of patients without organ damage at baseline, 211/241 (87.6%) had no change in SDI and the mean change (SD) in SDI was +0.2 (0.44). Of patients with organ damage at baseline, 132/162 (81.5%) had no change in SDI and the mean (SD) change in SDI was +0.2 (0.53). The probability of not having a worsening in SDI score was 0.88 (95% CI: 0.85, 0.91) and 0.75 (0.67, 0.81) in those without and with baseline damage, respectively (post hoc analysis).Drug-related AEs were reported for 433 (43.4%) patients; infections/infestations (282, 28.3%) and gastrointestinal disorders (139, 13.9%) were the most common.
conclusionPatients with SLE treated with long-term belimumab plus SoC had a low incidence of organ damage accrual and no unexpected AEs. High-risk patients with pre-existing organ damage also had low accrual, suggesting a favorable effect on future damage development.
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