ArticleJournal of Crohn's & colitis2023
Major Adverse Cardiovascular Events by Baseline Cardiovascular Risk in Patients with Ulcerative Colitis Treated with Tofacitinib: Data from the OCTAVE Clinical Programme.
Article 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. It is linked to 5 registered trials, which are not on this map. Cited by 12 papers.
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
Who cites it
12 citing papers in PubMed, 21 citations in OpenAlex.
- 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
- Optimizing Janus kinase inhibitor therapy for ulcerative colitis: a real-world perspective.Intestinal research · 2026Review
- Metabolic Disorders and Inflammatory Bowel Diseases.Gut and liver · 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
- Identifying Risk Factors of Major Adverse Cardiac Events in Patients With Ulcerative Colitis: A Retrospective Japanese Claims Data Analysis.Journal of gastroenterology and hepatology · 2025Article
- Performance of ASCVD Risk Prediction Models in Individuals With Inflammatory Bowel Disease: A UK Biobank Study.Inflammatory bowel diseases · 2025Article
- Review: Risk Stratification of Patients With Ulcerative Colitis for Treatment With Tofacitinib.Crohn's & colitis 360 · 2024Article
- Dietary Determinants of Metabolic and Gut Microbial Health in Patients with Inflammatory Bowel Disease.Nutrients · 2024Article
- Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure.United European gastroenterology journal · 2024Article
- Cardiovascular Comorbidities and Inflammatory Bowel Disease: Causes and Consequences.Gastroenterology & hepatology · 2024Article
- Inflammatory bowel disease and cardiac function: a systematic review of literature with meta-analysis.Therapeutic advances in gastroenterology · 2024Article
- Risk of dyslipidemia and major adverse cardiac events with tofacitinibFrontiers in pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 8 institutions in 6 countries.
Funding
Abstract
BACKGROUND AND
aimsPatients with inflammatory bowel disease have increased risk of atherosclerotic cardiovascular [CV] disease [ASCVD]. Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis [UC]. We report major adverse CV events [MACE] in the UC OCTAVE programme, stratified by baseline CV risk.
methodsRates of MACE were analysed by baseline [first tofacitinib exposure] CV risk profile: prior ASCVD, or 10-year ASCVD risk categories [low, borderline, intermediate, high].
resultsOf 1157 patients [2814.4 patient-years of exposure; ≤7.8 years' tofacitinib treatment], 4% had prior ASCVD and 83% had no prior ASCVD and low-borderline baseline 10-year ASCVD risk. Eight [0.7%] patients developed MACE; one had prior ASCVD. Incidence rates [unique patients with events/100 patient-years of exposure; 95% confidence intervals] for MACE were: 0.95 [0.02-5.27] in patients with prior ASCVD; and 1.81 [0.05-10.07], 1.54 [0.42-3.95], 0.00 [0.00-2.85], and 0.09 [0.01-0.32] in patients without prior ASCVD and with high, intermediate, -borderline, and low baseline 10-year ASCVD risk, respectively. For the 5/7 patients with MACE and without prior ASCVD, 10-year ASCVD risk scores were numerically higher [>1%] prior to MACE versus at baseline, primarily due to increasing age.
conclusionsMost patients receiving tofacitinib in the UC OCTAVE programme had low baseline 10-year ASCVD risk. MACE were more frequent in patients with prior ASCVD and higher baseline CV risk. This analysis demonstrates potential associations between baseline CV risk and MACE in patients with UC, suggesting CV risk should be assessed individually in clinical practice. 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.