Observational studyClinical drug investigation2020
Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database.
Observational study in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed, 5 citations in OpenAlex.
- Efficacy and safety of subcutaneous golimumab in Syrian patients with ankylosing spondylitis: A cohort study.The Journal of international medical research · 2026Observational
- The role of inflammatory biomarkers in the association between rheumatoid arthritis and depression: a Mendelian randomization study.Inflammopharmacology · 2023Article
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveGolimumab is a fully human anti-tumor necrosis factor monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This study estimated rates of prespecified outcomes in patients with RA, PsA or AS initiating golimumab versus matched patients initiating non-biologic systemic (NBS) medications.
methodsPatients enrolled in a US health plan with rheumatic disease who initiated a study medication were accrued between April 2009 and November 2014. Golimumab initiators were matched by propensity score to NBS initiators in a 1:4 ratio. Outcomes were identified through September 2015. As-treated, as-matched, and nested case-control (NCC) analyses were conducted in the matched cohorts. Sensitivity analyses evaluated the impact of residual confounding and nondifferential misclassification of exposure and outcomes.
resultsRisks of outcomes were similar between golimumab and NBS initiators. In the as-treated analysis, the rate ratio (RR) for depression was elevated during current golimumab use versus golimumab non-use in the NBS cohort [RR 1.45, 95% confidence interval (CI) 1.31-1.61]. This finding was not replicated in as-matched (RR 1.08, 95% CI 0.97-1.19) or NCC (odds ratio 1.01, 95% CI 0.78-1.31) analyses, which focused on incident cases. Sensitivity analyses suggest that depression was sensitive to misclassification, and the RR changed from greater than to less than one across a plausible range of specificity.
conclusionsThis study suggests that there is no association between exposure to golimumab and an increased risk of prespecified outcomes. Increased depression risk in the as-treated analysis was not replicated in other analyses and may be associated with residual imbalance in baseline history or severity of depression.
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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.