Trial reportJournal of Crohn's & colitis2023
Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme.
Trial report in Journal of Crohn's & colitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 5 registered trials, which are not on this map. Cited by 47 papers, 4 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.
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
Who cites it
47 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Major cardiovascular event risk of advanced therapies in inflammatory bowel diseases: systematic review and meta-analysis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026Pooled it
- Cardiovascular safety of Janus kinase inhibitors in inflammatory bowel disease: a systematic review and network meta-analysis.Annals of medicine · 2025Pooled it
- Effectiveness of tofacitinib in patients with ulcerative colitis: an updated systematic review and meta-analysis of real-world studies.BMJ open gastroenterology · 2024Pooled it
- Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Baseline Modified Mayo Score: A Post Hoc Analysis From the Phase 3 ELEVATE UC Clinical Program.Inflammatory bowel diseases · 2025Trial
- Risk of Myeloproliferative Neoplasms in Patients With Inflammatory Bowel Disease and Impact on Outcomes: A Multi-Centre Matched Analysis.Alimentary pharmacology & therapeutics · 2026Observational
- Review
- A JAK of two trades: beneficial or adverse effects of Janus kinase inhibition for plasma LDL-cholesterol and major adverse cardiovascular events in inflammatory bowel disease patients?Current opinion in lipidology · 2026Review
- Oral milk-derived exosomes loaded with tafatinib for anti-inflammatory therapy.International journal of pharmaceutics: X · 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
- Tofacitinib ameliorates Campylobacter-induced intestinal pathology by suppressing IFNγ producing ILCs and T cells.Mucosal immunology · 2025Article
- Update in Inflammatory Bowel Disease Management in the Elderly.Current gastroenterology reports · 2025Review
- Understanding the therapeutic toolkit for inflammatory bowel disease.Nature reviews. Gastroenterology & hepatology · 2025Review
- JAK Inhibitor and Crohn's Disease.Biomedicines · 2025Review
- JAK Inhibitors and Risk of Cancer in IBD Patients.Cancers · 2025Review
- Cancer Risk in IBD Patients Treated with JAK Inhibitors: Reassuring Evidence from Trials and Real-World Data.Cancers · 2025Review
- Modern Advanced Therapies for Inflammatory Bowel Diseases: Practical Considerations and Positioning.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025Review
- Small Molecules, Big Results: How JAK Inhibitors Have Transformed the Treatment of Patients with IBD.Digestive diseases and sciences · 2025Review
- Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis.BMJ open gastroenterology · 2025Article
- Consensus Statements on Assessments and Vaccinations Prior to Commencement of Advanced Therapies for the Treatment of Inflammatory Bowel Diseases.Alimentary pharmacology & therapeutics · 2025Article
Corrections and comments
- Erratum issued
Authors and funding
13 authors.
Funding
Abstract
BACKGROUND AND
aimsTofacitinib is an oral small molecule Janus kinase [JAK] inhibitor for the treatment of ulcerative colitis. We report an integrated summary of tofacitinib safety [exposure: ≤7.8 years] from the global clinical programme.
methodsPatients receiving tofacitinib 5 or 10 mg twice daily [BID] from completed phase [P]2/3 placebo-controlled studies, an open-label, long-term extension study [final data cut-off: August 24, 2020], and interim analysis of a P3b/4 study (interim data cut-off: February 20, 2020; Overall plus P3b/4 [2020] Cohort) were included. Proportions with adverse events [AEs] and serious AEs, and incidence rates [IRs; unique patients with events/100 patient-years] for deaths and AEs of special interest [AESI] were evaluated. Opportunistic infections, malignancies, major adverse cardiovascular events [MACE] and gastrointestinal perforations were adjudicated.
resultsIn total, 1157 patients received one or more dose of tofacitinib (mean duration: 946.9 days); 955/1157 [83%] received a predominant dose of 10 mg BID; 412/1157 [35.6%] received tofacitinib for >4 years; 992/1157 [85.7%] had AEs, 244/1157 [21.1%] had serious AEs and 134/1157 (11.6%) discontinued use due to AEs. IRs [95% confidence intervals] for all tofacitinib doses were: deaths, 0.23 [0.09-0.46]; serious infections, 1.69 [1.26-2.21]; herpes zoster [non-serious and serious], 3.30 [2.67-4.04]; opportunistic infections, 1.03 [0.70-1.46]; malignancies (excluding non-melanoma skin cancer [NMSC]), 0.84 [0.55-1.24]; NMSC, 0.73 [0.45-1.10]; MACE, 0.29 [0.13-0.55]; deep vein thrombosis, 0.03 [0.00-0.18]; pulmonary embolism, 0.19 [0.07-0.42]; gastrointestinal perforations, 0.10 [0.02-0.28].
conclusionsAESI IRs were stable to 7.8 years and generally <2.0 in the Overall plus P3b/4 [2020] Cohort, with the exception of herpes zoster [a known risk of tofacitinib treatment]. ClinicalTrials.gov:NCT00787202;NCT01465763;NCT01458951;NCT01458574;NCT01470612;NCT03281304JCC Topic/keyword selection: 3. Clinical trials.
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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.