Trial reportLupus science & medicine2021
Risk of psychiatric disorders and all-cause mortality with belimumab therapy in patients with systemic lupus erythematosus: a meta-analysis of randomised controlled trials.
Trial report in Lupus science & medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.
- Effects of telitacicept and belimumab on systemic lupus erythematosus: a systematic review and meta-analysis.Scientific reports · 2025Pooled it
- Artificial intelligence-assisted interventions for perioperative anesthetic management: a systematic review and meta-analysis.BMC anesthesiology · 2024Pooled it
- Determinants of neuropsychiatric flares in patients with systemic lupus erythematosus: results from five phase III trials of belimumab.Rheumatology (Oxford, England) · 2024Trial
- Thorough assessment of the effectiveness of belimumab in a large Spanish multicenter cohort of systemic lupus erythematosus patients.Rheumatology (Oxford, England) · 2025Article
- B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single-arm cohort study of telitacicept.MedComm · 2024Article
- Automated mental health screening in pediatric lupus: associations with disease features and treatment.Frontiers in pediatrics · 2024Article
- Targeted Therapy for SLE-What Works, What Doesn't, What's Next.Journal of clinical medicine · 2023Review
- Impact of Belimumab on Patient-Reported Outcomes in Systemic Lupus Erythematosus: Insights from Clinical Trials and Real-World Evidence.Patient related outcome measures · 2023Review
- Belimumab for systemic lupus erythematosus - Focus on lupus nephritis.Human vaccines & immunotherapeutics · 2022Review
- B cells in systemic lupus erythematosus: Targets of new therapies and surveillance tools.Frontiers in medicine · 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
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate the risk of psychiatric disorders and all-cause mortality associated with belimumab therapy in patients with SLE.
methodsA literature search of four electronic bibliographic databases, including PubMed, EMBASE, Scopus and Cochrane databases, was conducted for randomised controlled trials (RCTs) reporting adverse reactions between belimumab and placebo. OR and 95% CI were calculated using the Mantel-Haenszel method with fixed-effects or random-effects model, depending on the heterogeneity test.
resultsIn total, 11 eligible RCTs including 8824 patients with SLE were randomised into belimumab (5160 patients with 5552 patient-years) and placebo (3664 patients with 3985 patient-years) groups, respectively. Overall, no increased risk was identified with belimumab therapy at all dosages compared with placebo in patients with SLE regarding all psychiatric disorders (OR 0.89, 95% CI 0.64 to 1.23, I
conclusionBelimumab therapy overall does not increase psychiatric events and all-cause mortality risks, whereas the results from Belimumab Assessment of Safety in SLE Study are suggestive of increased risk of psychiatric adverse events with belimumab exposure. Consequently, post-marketing data are needed to ascertain its psychiatric safety, especially serious mental disorders.
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Registered trials
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.