ArticleDrug safety2020
Thromboembolic Safety Reporting of Tofacitinib and Baricitinib: An Analysis of the WHO VigiBase.
Article in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis 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
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.
- Cardiovascular safety of Janus kinase inhibitors in inflammatory bowel disease: a systematic review and network meta-analysis.Annals of medicine · 2025Pooled it
- Emerging therapeutic targets in non-infectious uveitis and scleritis.Frontiers in medicine · 2026Review
- Dual effects of JAK vs TNF inhibitors on osteoporosis, fractures and mortality in rheumatoid arthritis: a real-world cohort study.Frontiers in immunology · 2026Article
- Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase.Drug safety · 2025Article
- JAK inhibitor withdrawal causes a transient pro-inflammatory cascade: A potential mechanism for major adverse cardiac events.PloS one · 2025Article
- Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis.Rheumatology and therapy · 2023Article
- Branch retinal vein occlusion in a case of recalcitrant diffuse anterior scleritis treated with tofacitinib.Journal of ophthalmic inflammation and infection · 2023Article
- An Overview on Anti-COVID-19 Drug Achievements and Challenges Ahead.ACS pharmacology & translational science · 2023Review
- Janus Kinase Inhibitors: A New Tool for the Treatment of Axial Spondyloarthritis.International journal of molecular sciences · 2023Review
- Article
- A Case of Superficial Thrombo-occlusive Vascular Disease in a Patient With Rheumatoid Arthritis.Journal of rheumatic diseases · 2022Article
- Identification of novel off targets of baricitinib and tofacitinib by machine learning with a focus on thrombosis and viral infection.Scientific reports · 2022Article
- Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database.Scientific reports · 2022Observational
- Gut-Selective Design of Orally Administered Izencitinib (TD-1473) Limits Systemic Exposure and Effects of Janus Kinase Inhibition in Nonclinical Species.Toxicological sciences : an official journal of the Society of Toxicology · 2022Article
- Response to Correspondence: Baricitinib: Impact on Coronavirus Disease 2019 (COVID-19) Coagulopathy? Jorgensen et al.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Article
- The JAK-STAT pathway: an emerging target for cardiovascular disease in rheumatoid arthritis and myeloproliferative neoplasms.European heart journal · 2021Article
- Risk of venous thromboembolism associated with Janus kinase inhibitors for rheumatoid arthritis: case presentation and literature review.Clinical rheumatology · 2021Review
- Janus Kinase Inhibitors and Coronavirus Disease (COVID)-19: Rationale, Clinical Evidence and Safety Issues.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Authors' Reply to Moura et al.: "Safety of Janus Kinase Inhibitors in Older Patients: A Focus on the Thromboembolic Risk".Drugs & aging · 2021Article
- Update on the Safety Profile of Tofacitinib in Rheumatoid Arthritis from Clinical Trials to Real-World Studies: A Narrative Review.Rheumatology and therapy · 2021Review
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe Janus kinase (JAK) inhibitors tofacitinib and baricitinib are new treatments for rheumatic diseases. Recent concerns regarding the risk of thrombosis have led to warnings by competent authorities. We therefore aimed to examine the thromboembolic safety signal for tofacitinib and baricitinib.
methodsIndividual case safety reports (ICSRs) for tofacitinib and baricitinib were retrieved from the World Health Organization global database VigiBase in April 2019. Primary outcomes were deep vein thrombosis (DVT) and pulmonary thrombosis (PT) or pulmonary embolism (PE). Patient demographics were summarized and then stratified by outcome. Disproportionality analyses were conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals (CIs) worldwide, and stratified by either Europe or the US.
resultsIn both the tofacitinib (n = 40,017) and baricitinib (n = 2138) ICSRs, patients with reported DVT or PT/PE were older and had higher reporting of prothrombotic medications or antithrombotic treatments, suggesting a pre-existing thromboembolic risk/event. In Europe, tofacitinib was associated with increased reporting for DVT (ROR 2.37, 95% CI 1.23-4.56) and PT/PE (ROR 2.38. 95% CI 1.45-3.89). For baricitinib, a threefold increased reporting odds was observed for DVT (ROR 3.47, 95% CI 2.18-5.52) and PT/PE (ROR 3.44, 95% CI 2.43-4.88) in Europe. In the US, tofacitinib was only associated with an elevated ROR of PT (ROR 2.05, 95% CI 1.45-2.90) and no baricitinib ICSRs were reported.
conclusionThis study supports the current recommendation for cautious use of tofacitinib in patients with high thromboembolic risk. Moreover, with a similar patient profile and elevated reporting for baricitinib, a potential class effect of JAK inhibitors cannot be ruled out.
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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.