Trial reportInflammatory bowel diseases2023
Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.
Trial report in Inflammatory bowel diseases, 2023. 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 16 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
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
16 citing papers in PubMed, 28 citations in OpenAlex.
- 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
- Review
- Outcomes of tofacitinib dose reduction in patients with ulcerative colitis in stable remission: a long-term follow-up of the randomized RIVETING trial.Crohn's & colitis 360 · 2026Article
- Herpes Zoster in Patients Treated with JAK Inhibitors for Immune-Mediated Inflammatory Diseases: Incidence, Associated Factors and Vaccination Uptake in a Real-World Cohort.Journal of clinical medicine · 2026Article
- Challenges and Treatment Strategies in Elderly Patients with Inflammatory Bowel Disease: A Systematic Review and Narrative Synthesis.Journal of personalized medicine · 2026Review
- Evolving Research Hotspots and Emerging Trends in Atopic Dermatitis and Inflammatory Bowel Disease: A Bibliometric Analysis.Clinical, cosmetic and investigational dermatology · 2026Article
- Propensity score-matched real-world comparative treatment outcomes of Janus kinase inhibitors for ulcerative colitis in patients with and without prior exposure to anti-tumor necrosis factor α antibody.Intestinal research · 2025Article
- 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
- [Small Molecule Therapy for Inflammatory Bowel Disease: JAK Inhibitors and S1PR Modulators].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024Review
- Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study.BMC gastroenterology · 2024Observational
- Biologics Versus JAK Inhibitors. Part II: Risk of Infections. A Narrative Review.Dermatology and therapy · 2024Review
- Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study.Intestinal research · 2024Article
- Tofacitinib use in ulcerative colitis: An expert consensus for day-to-day clinical practice.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024Article
- Review
- Patients' Preference on Advanced Therapy and Follow-Up Procedure for Inflammatory Bowel Disease in Japan: A Web-Based 3A Survey.Inflammatory intestinal diseasesArticle
- Research advancements and perspectives of inflammatory bowel disease: A comprehensive review.Science progressReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We report herpes zoster (HZ) incidence and risk factors in the tofacitinib UC clinical program (up to 7.8 years).
methodsProportions and incidence rates (IRs; unique patients with events/100 patient-years) of HZ were evaluated in 4 cohorts: Induction (phase 2 and 3 induction study data), Maintenance (phase 3 maintenance study data), Overall (data from all phase 2, 3, and open-label, long-term extension studies), and Overall plus interim 6-month phase 3b and 4 data. Herpes zoster risk factors were assessed by Cox regression analysis.
resultsIn the Induction and Maintenance Cohorts, IRs for HZ (nonserious and serious) were numerically higher with tofacitinib 10 mg twice daily (BID) vs placebo and tofacitinib 10 vs 5 mg BID, respectively. With all tofacitinib doses (5 or 10 mg BID), IRs (95% confidence intervals) for HZ in the Overall and Overall plus phase 3b/4 Cohorts (total exposure, 2814.4 and 2999.7 patient-years, respectively) were 3.38 (2.73-4.15) and 3.30 (2.67-4.04), respectively. In the Overall plus phase 3b/4 Cohort, >90% of HZ were nonserious; >90% were mild/moderate; >90% resolved without discontinuing tofacitinib; 0.6% of patients had multiple HZ events. Herpes zoster IRs were stable when analyzed by 6-month intervals up to >30 months. Herpes zoster risk factors included older age, lower weight, geographic region, and prior tumor necrosis factor inhibitor (TNFi) failure.
conclusionsMost HZ events were mild/moderate. Herpes zoster IRs remained stable over 7.8 years of exposure. Older age, lower weight, geographic region, and prior TNFi failure were associated with increased HZ risk. CLINICALTRIALS.GOV: NCT00787202;NCT01465763;NCT01458951;NCT01458574;NCT01470612;NCT03281304.
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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.