ArticleUnited European gastroenterology journal2024
Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure.
Article in United European gastroenterology journal, 2024. 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 25 papers.
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
A phase 3b/4, multi-center, double-blind, randomized, parallel group study of tofacitinib (cp-690,550) in subjects with ulcerative colitis in stable remission
Who cites it
25 citing papers in PubMed.
- Risk of Myeloproliferative Neoplasms in Patients With Inflammatory Bowel Disease and Impact on Outcomes: A Multi-Centre Matched Analysis.Alimentary pharmacology & therapeutics · 2026Observational
- The JAK attack: transforming the management of ulcerative colitis in India.Intestinal research · 2026Review
- Optimizing Janus kinase inhibitor therapy for ulcerative colitis: a real-world perspective.Intestinal research · 2026Review
- Comparative Safety of Janus Kinase Inhibitors vs Tumor Necrosis Factor Antagonists in Patients With Inflammatory Bowel Diseases.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026Article
- Recent Advances in Molecular Targeted Therapy for Inflammatory Bowel Disease.Internal medicine (Tokyo, Japan) · 2026Review
- Optimal use and cycling strategies of Janus kinase inhibitors in ulcerative colitis: current evidence and clinical implications from the KASID Guidelines Task Force Team.Intestinal research · 2026Review
- Successful and Risk-Minimizing Treatment of Ulcerative Colitis by Positive Switch from JAK Inhibitors to Ustekinumab.Biologics : targets & therapy · 2026Article
- Drug-induced liver injury in inflammatory bowel disease: Challenges in diagnosis and monitoring.World journal of hepatology · 2025Review
- Value of tofacitinib extended induction therapy in patients with moderate-to-severe ulcerative colitis: A real-world 52-week follow-up study.World journal of gastroenterology · 2025Observational
- Toward Precision Medicine: Molecular Biomarkers of Response to Tofacitinib in Inflammatory Bowel Disease.Genes · 2025Review
- Long-Term Effectiveness and Safety of Tofacitinib in a Nationwide Veterans Affairs Cohort of Ulcerative Colitis Patients.Crohn's & colitis 360 · 2025Article
- JAK Inhibitor and Crohn's Disease.Biomedicines · 2025Review
- JAK Inhibitors and Risk of Cancer in IBD Patients.Cancers · 2025Review
- Advanced Therapies for Inflammatory Bowel Disease and Risk of Skin Cancer: What's New?Cancers · 2025Review
- Clinical Outcomes for Patients With Ulcerative Colitis in Cases of Withdrawal and Resumption of Janus Kinase Inhibitors: Multicenter Cohort Study.Crohn's & colitis 360 · 2025Article
- Tofacitinib for ulcerative colitis in Brazil: a multicenter observational study on effectiveness and safety.BMC gastroenterology · 2025Observational
- Cancer Risk in IBD Patients Treated with JAK Inhibitors: Reassuring Evidence from Trials and Real-World Data.Cancers · 2025Review
- Efficacy and Safety of Janus Kinase-Inhibitors in Ulcerative Colitis.Journal of clinical medicine · 2024Review
- [Small Molecule Therapy for Inflammatory Bowel Disease: JAK Inhibitors and S1PR Modulators].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024Review
- Inflammatory Bowel Disease and Colorectal Cancer.Cancers · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
BACKGROUND AND
aimsTofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We report an integrated summary of tofacitinib safety from the completed global UC clinical program (9.2 years maximum tofacitinib exposure).
methodsThis analysis included patients receiving tofacitinib 5 or 10 mg twice daily (b.i.d.) from completed phase 2/3 placebo-controlled studies, an open-label, long-term extension study and a randomized phase 3b/4 study. Proportions and incidence rates (IRs; unique patients with events/100 patient-years [PY] of exposure) were evaluated for deaths and adverse events (AEs) of special interest (AESI).
resultsOverall, 1157 patients received ≥1 dose of tofacitinib 5 or 10 mg b.i.d.; 938 (81.1%) were in the predominant dose tofacitinib 10 mg b.i.d. group; 552 (47.7%) received tofacitinib for ≥2 years; total exposure: 3202.0 PY; 994 (85.9%) experienced AEs; 254 (22.0%) experienced serious AEs. Median treatment duration: 1.7 (range 0.0-9.2) years. IRs (95% CI) for combined tofacitinib doses: deaths 0.24 (0.10-0.48); serious infections (SIs) 1.80 (1.37-2.32); herpes zoster (HZ; non-serious and serious) 3.24 (2.63-3.94); serious HZ 0.24 (0.10-0.48); opportunistic infections 0.96 (0.65-1.36); malignancies (excluding non-melanoma skin cancer [NMSC]) 0.88 (0.59-1.26); NMSC 0.71 (0.45-1.07); major adverse cardiovascular events 0.27 (0.12-0.52); deep vein thrombosis 0.06 (0.01-0.22); pulmonary embolism 0.18 (0.07-0.40); and gastrointestinal perforations 0.09 (0.02-0.27).
conclusionsExcept for HZ and SIs, IRs for AESI were <1 case/100 PY. Safety was consistent with previous analyses of shorter exposure and tofacitinib's known safety profile, including real-world data. CLINICALTRIALS: GOV: NCT00787202; NCT01465763; NCT01458951; NCT01458574; NCT01470612; NCT03281304.
Indexed as
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.