ArticleAlimentary pharmacology & therapeutics2019
Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme.
Article in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 78 papers, 4 of them syntheses that pooled it.
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.
A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
A multi-center, open-label study of cp-690,550 in subjects with moderate to severe ulcerative colitis
Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Who cites it
78 citing papers in PubMed, 4 syntheses or guidelines pooled it, 164 citations in OpenAlex.
- Comparative Efficacy of Advanced Therapies for Management of Moderate-to-Severe Ulcerative Colitis: 2024 American Gastroenterological Association Evidence Synthesis.Gastroenterology · 2024Pooled it
- Efficacy and safety of the S1PR modulator etrasimod in the treatment of moderately to severely active ulcerative colitis during the induction phase: a systematic review and meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2024Pooled it
- Venous thrombotic events in psoriasis patients: a systematic review with meta-analysis.Annals of medicine · 2021Pooled it
- Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement.Annals of the rheumatic diseases · 2021Guideline
- Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme.Journal of Crohn's & colitis · 2023Trial
- Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study.Journal of Crohn's & colitis · 2021Trial
- Outcomes of Tofacitinib Dose Reduction in Patients with Ulcerative Colitis in Stable Remission from the Randomised RIVETING Trial.Journal of Crohn's & colitis · 2021Trial
- Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis.Clinical pharmacology in drug development · 2021Trial
- Temporal Trends in Janus Kinase Inhibitor (JAKi) Use Across Five European Countries: A DARWIN EU Network Study.Pharmacoepidemiology and drug safety · 2026Article
- Review
- Multicenter experience using tofacitinib for treatment of refractory pediatric inflammatory bowel diseases in the United States.Journal of pediatric gastroenterology and nutrition · 2026Article
- Anti-Ulcerative Colitis Tanzawaic Acids from a Marine Algicolous Fungus, Penicillium steckii SCSIO 41040.Marine drugs · 2026Article
- From Inflammation to Thrombosis: The Prothrombotic State and Cardiovascular Risk in Inflammatory Bowel Disease.Medicina (Kaunas, Lithuania) · 2026Review
- Biologic and small-molecule therapies for inflammatory bowel disease: mechanisms, comparative evidence and the emerging pipeline.Frontiers in pharmacology · 2026Review
- Tofacitinib does not affect platelet function or coagulation in patients with ulcerative colitis.Frontiers in immunology · 2026Article
- Coagulopathy and platelet abnormalities in patients with inflammatory bowel disease.The Korean journal of internal medicine · 2025Review
- Long-Term Safety of Tofacitinib for Treatment of Moderate-to-Severe Ulcerative Colitis: Three Years of Korean National Data.Journal of Korean medical science · 2025Article
- Direct inhibition of the TXNIP-NLRP3-GSDMD pathway reduces pyroptosis in colonocytes and alleviates ulcerative colitis in mice by the small compound PEITC.Acta pharmacologica Sinica · 2025Article
- IBD 2024: Charting a New Course in IBD Proceedings of the Takeda Symposium 22-23 November 2024 W Hotel, Brisbane, Queensland, Australia.Journal of gastroenterology and hepatology · 2025Article
- Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data.Journal of gastroenterology · 2025Observational
18 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
12 authors at 6 institutions in 4 countries.
Funding
Abstract
backgroundTofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC).
aimTo report incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the tofacitinib UC programme.
methodsDVT and PE were evaluated from one phase 2 and two phase 3 induction studies, one phase 3 maintenance study and an ongoing, open-label, long-term extension (OLE) study (September 2018 datacut). Data were analysed in induction, maintenance and overall (patients receiving ≥ 1 dose of tofacitinib 5 or 10 mg b.d. in any phase 2, 3 or OLE study) cohorts.
results1157 patients (2404 patient-years' exposure; ≤ 6.1 years' tofacitinib treatment) were evaluated in the overall cohort. In induction, one placebo-treated patient had DVT and one had PE; no tofacitinib-treated patients had DVT/PE. In maintenance, one placebo-treated patient had DVT and one had PE; no tofacitinib-treated patients had DVT/PE. In the overall cohort, one patient had DVT (incidence rate [patients with events/100 patient-years; 95% CI]: 0.04 [0.00-0.23]); four had PE (0.16 [0.04-0.41]); all received predominant dose tofacitinib 10 mg b.d.; all had venous thromboembolism risk factors alongside UC.
conclusionsIn this post hoc analysis of patients with UC, during tofacitinib exposure, one patient had DVT and four had PE, all during the OLE study, on predominant dose 10 mg b.d. (83% of overall cohort patients received predominant dose 10 mg b.d.) with venous thromboembolism risk factors. This analysis is limited by small sample size and limited drug exposure; further studies are needed. ClinicalTrials.gov: NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612.
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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.