Trial reportAnnals of the rheumatic diseases2022
Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study.
Trial report in Annals of the rheumatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04772248 (Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis), which is not on this map. Cited by 92 papers, 3 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.
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
Who cites it
92 citing papers in PubMed, 3 syntheses or guidelines pooled it, 156 citations in OpenAlex.
- Therapeutic approaches for difficult-to-treat rheumatoid arthritis: a systematic literature review of current evidence.RMD open · 2026Pooled it
- Comparative Safety of JAK Inhibitors vs TNF Antagonists in Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Efficacy and safety of tofacitinib for chronic plaque psoriasis and psoriatic arthritis: a systematic review and meta-analysis of randomized controlled trials.Clinical rheumatology · 2024Pooled it
- Trial
- Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme.Annals of the rheumatic diseases · 2023Trial
- Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications.Advances in therapy · 2023Trial
- Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance.Annals of the rheumatic diseases · 2023Trial
- Waiting for JAK inhibitor safety data.RMD open · 2022Trial
- Observational
- Real-world evidence on JAK inhibitors in rheumatology practice: comparative safety, efficacy, and outcomes between JAK inhibitors.Clinical rheumatology · 2026Article
- Article
- Tofacitinib: New drug in the therapeutic armamentarium in ocular inflammation.Indian journal of ophthalmology · 2026Review
- Emulating Six Cardiovascular Outcome Trials of Antidiabetic Drugs in Individuals with Type 2 Diabetes: Analyses Based on Real-World Databases from Korea and Taiwan.Clinical pharmacology and therapeutics · 2026Article
- Global research trends and future directions for Janus kinase inhibitors in rheumatoid arthritis: a comprehensive bibliometric analysis.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Heart Failure in Rheumatoid Arthritis: Epidemiology, Pathogenesis, Diagnosis, Treatment, and Emerging Insights-A Comprehensive Review.Medicina (Kaunas, Lithuania) · 2026Review
- Cardiovascular and Thromboembolic Risk of Janus Kinase Inhibitors Compared to Other Disease-Modifying Drugs in Patients with Rheumatoid Arthritis: A Systematic Review and Meta-Analysis.Journal of personalized medicine · 2026Review
- Comparative Safety of Advanced Therapies for Crohn Disease.JAMA network open · 2026Article
- Emerging therapeutic targets in non-infectious uveitis and scleritis.Frontiers in medicine · 2026Review
- JAK inhibitors and adverse cardiovascular events: Class effect or molecule-specific risk?Frontiers in pharmacology · 2026Review
- From concept to practice: real-world safety of JAK inhibitors in rheumatoid arthritis treatment.Frontiers in medicine · 2026Review
32 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
objectivesRecent results from 'ORAL Surveillance' trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting.
methodsWe created two cohorts of patients with RA initiating treatment with tofacitinib or tumour necrosis factor inhibitors (TNFI) using deidentified data from Optum Clinformatics (2012-2020), IBM MarketScan (2012-2018) and Medicare (parts A, B and D, 2012-2017) claims databases: (1) A 'real-world evidence (RWE) cohort' consisting of routine care patients and (2) A 'randomised controlled trial (RCT)-duplicate cohort' mimicking inclusion and exclusion criteria of the ORAL surveillance trial to calibrate results against the trial findings. Cox proportional hazards models with propensity score fine stratification weighting were used to estimate HR and 95% CIs for composite outcome of myocardial infarction and stroke and accounting for 76 potential confounders. Database-specific effect estimates were pooled using fixed effects models with inverse-variance weighting.
resultsIn the RWE cohort, 102 263 patients were identified of whom 12 852 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) comparing tofacitinib with TNFI was 1.01 (0.83 to 1.23) in RWE cohort and 1.24 (0.90 to 1.69) in RCT-duplicate cohort which aligned closely with ORAL-surveillance results (HR: 1.33, 95% CI 0.91 to 1.94).
conclusionsWe did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib in patients with RA treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, although statistically non-significant, in patients with RA with cardiovascular risk factors. TRIAL REGISTRATION NUMBER: NCT04772248.
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Identifiers
What OpenQuestion holds
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.