ArticleJournal of Crohn's & colitis2021
Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials.
Article 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. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers, 2 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 Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
A multi-center, open-label study of cp-690,550 in subjects with moderate to severe ulcerative colitis
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Cost-Effectiveness Analysis of Tofacitinib Compared with Biologics in Biologic-Naïve Patients with Moderate-to-Severe Ulcerative Colitis in Japan.PharmacoEconomics · 2023Pooled it
- Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies.Journal of Crohn's & colitis · 2024Trial
- Efficacy of Upadacitinib Retreatment or Dose Escalation After Loss of Response in Ulcerative Colitis: Data From the Open-Label Extension of the U-ACTIVATE Study.Gastro hep advances · 2026Article
- Vedolizumab in biologic-naïve ulcerative colitis: a multicenter real-world evaluation of clinical benefits and exploratory inflammatory indices.Frontiers in medicine · 2026Article
- 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
- The evolving understanding of histology as an endpoint in ulcerative colitis.Intestinal research · 2024Review
- Treatment endpoints in ulcerative colitis: Does one size fit all?World journal of gastrointestinal pharmacology and therapeutics · 2024Article
- Discontinuation of therapy in inflammatory bowel disease: Current views.World journal of clinical cases · 2024Review
- The Role of Tofacitinib in the Treatment of Acute Severe Colitis in Children.Journal of the Canadian Association of Gastroenterology · 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
- Exit strategies in inflammatory bowel disease: Looking beyond anti-tumor necrosis factors.World journal of clinical cases · 2023Review
- De-escalation of Therapy in Patients with Quiescent Inflammatory Bowel Disease.Gut and liver · 2023Review
- Review article: guide to tofacitinib dosing in patients with ulcerative colitis.Alimentary pharmacology & therapeutics · 2022Review
- Tofacitinib to Treat Severe Acute Refractory Colitis in a Teenager: Case Report and Review of the Literature.JPGN reports · 2022Article
- Persistence of treatment in patients with ulcerative colitis who responded to tofacitinib therapy: data from the open-label, long-term extension study, OCTAVE open.Alimentary pharmacology & therapeutics · 2022Article
- Research-Based Product Innovation to Address Critical Unmet Needs of Patients with Inflammatory Bowel Diseases.Inflammatory bowel diseases · 2021Article
- Tofacitinib for Biologic-Experienced Hospitalized Patients With Acute Severe Ulcerative Colitis: A Retrospective Case-Control Study.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021Article
- Efficacy of JAK inhibitors in Ulcerative Colitis.Journal of Crohn's & colitis · 2020Review
- IBD considerations in spondyloarthritis.Therapeutic advances in musculoskeletal disease · 2020Review
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 at 5 institutions in 2 countries.
Funding
Abstract
BACKGROUND AND
aimsTofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. Here, we evaluate the efficacy and safety of tofacitinib re-treatment following treatment interruption in patients with ulcerative colitis.
methodsHere, patients with clinical response to tofacitinib 10 mg b.d. induction therapy were randomised to receive placebo in OCTAVE Sustain. Those experiencing treatment failure after Week 8 of OCTAVE Sustain entered OCTAVE Open and re-initiated tofacitinib 10 mg b.d. [re-treatment subpopulation]; efficacy and safety data are presented up to Month 36 of OCTAVE Open.
resultsMedian time to treatment failure following interruption was 169 (95% confidence interval [CI], 94.0-179.0) and 123 [95% CI, 91.0-168.0] days for induction remitters, and induction responders but non-remitters, respectively. Following re-treatment with tofacitinib, rates (non-responder imputation after a patient discontinued; latest observation carried forward imputation after a patient advanced to a subsequent study [NRI-LOCF]) of clinical response, remission, and endoscopic improvement were 74.0%, 39.0%, and 55.0% at Month 2, and 48.5%, 37.4%, and 42.4% at Month 36, respectively. Among induction remitters and induction responders but non-remitters, clinical response rates at Month 36 were 60.6% and 42.4% [NRI-LOCF], respectively. Efficacy was recaptured regardless of prior tumour necrosis factor inhibitor failure status. The safety profile of tofacitinib 10 mg b.d. re-treatment was consistent with the overall cohort and demonstrated no new safety risks associated with exposure of ≤36 months.
conclusionsMedian time to treatment failure was numerically higher in induction remitters versus induction responders but non-remitters. Following treatment interruption, efficacy was safely and successfully recaptured with tofacitinib 10 mg b.d. re-treatment in a substantial proportion of patients [ClinicalTrials.gov: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.