Trial reportJournal of Crohn's & colitis2021
Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme.
Trial report in Journal of Crohn's & colitis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Inflammatory bowel disease therapeutics: a bibliometric analysis of tofacitinib research in ulcerative colitis.Frontiers in pharmacology · 2025Pooled it
- Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.Inflammatory bowel diseases · 2023Trial
- Herpesviridae Reactivation and Therapeutic Outcomes in Patients with Ulcerative Colitis Treated with Tofacitinib.Journal of clinical medicine · 2026Article
- 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
- Network Meta-Analysis: Efficacy of Biological Therapies and Small Molecules as Maintenance Therapy in Ulcerative Colitis.Alimentary pharmacology & therapeutics · 2025Article
- Advanced Combination Therapy with Biologics and Upadacitinib in Refractory Inflammatory Bowel Disease: A Retrospective Study from Taiwan.Journal of inflammation research · 2025Article
- Managing Risks with Newer Oral Small Molecules in Patients with Inflammatory Bowel Diseases.Current gastroenterology reports · 2024Review
- 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
- Predictors of Efficacy of Janus Kinase Inhibitors in Patients Affected by Ulcerative Colitis.Journal of clinical medicine · 2024Review
- Inflammatory bowel disease in pregnancy and breastfeeding.Nature reviews. Gastroenterology & hepatology · 2023Review
- Impact of Concomitant Corticosteroids on Tofacitinib Induction Efficacy and Infection Rates in Ulcerative Colitis.Digestive diseases and sciences · 2023Article
- The Use of JAK/STAT Inhibitors in Chronic Inflammatory Disorders.Journal of clinical medicine · 2023Review
- Review
- Review
- Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program.Inflammatory bowel diseases · 2023Article
- Safety and efficacy of long-term tofacitinib treatment in East Asian patients with ulcerative colitis in OCTAVE Open.Journal of gastroenterology and hepatology · 2022Article
- Review article: guide to tofacitinib dosing in patients with ulcerative colitis.Alimentary pharmacology & therapeutics · 2022Review
- Positioning Filgotinib in the Treatment Algorithm of Moderate to Severe Ulcerative Colitis.Journal of Crohn's & colitis · 2022Review
- Worldwide post-marketing safety surveillance experience with tofacitinib in ulcerative colitis.Alimentary pharmacology & therapeutics · 2022Article
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 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsTofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We report integrated analyses of infections in the Phase [P]2 and P3 OCTAVE programmes.
methodsThree cohorts were analysed: Induction [P2/3 induction studies]; Maintenance [P3 maintenance study]; and Overall [all tofacitinib-treated patients in induction, maintenance, or ongoing, open-label, long-term extension studies; as of May 2019]. Proportions and incidence rates [IRs; unique patients with events/100 patient-years] of serious infections [SIs], herpes zoster [HZ] [non-serious and serious], and opportunistic infections [OIs] are reported [censored at time of event].
resultsIn the Induction Cohort [N = 1220], no patients receiving placebo and eight [0.9%] receiving tofacitinib 10 mg twice daily [BID] developed SIs. Maintenance Cohort [N = 592] SI IRs (95% confidence interval [CI]) were 1.94 [0.23-7.00] for placebo and 1.35 [0.16-4.87] and 0.64 [0.02-3.54] for tofacitinib 5 and 10 mg BID, respectively; HZ IRs were 0.97 [0.02-5.42], 2.05 [0.42-6.00], and 6.64 [3.19-12.22], respectively. In the Overall Cohort [N = 1157; 82.9% predominantly received tofacitinib 10 mg BID], SI, HZ, and non-HZ OI IRs were 1.70 [1.24-2.27], 3.48 [2.79-4.30], and 0.15 [0.04-0.38], respectively. No SIs resulted in death.
conclusionsDuring induction, SIs were more frequent with tofacitinib versus placebo. SIs were generally infrequent in the Maintenance and Overall Cohorts, with rates comparable between treatment groups. Maintenance Cohort HZ IR was numerically higher with tofacitinib 10 mg BID versus 5 mg BID. Overall Cohort HZ IRs remained stable over time. Non-HZ OIs and viral infections were rare.
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Registered trials
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