ArticleAlimentary pharmacology & therapeutics2022
Safety and efficacy of tofacitinib for treatment of ulcerative colitis: final analysis of OCTAVE Open, an open-label, long-term extension study with up to 7.0 years of treatment.
Article in Alimentary pharmacology & therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 8 of them syntheses that pooled it.
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Who cites it
92 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- S1P receptor modulators for moderate-to-severe ulcerative colitis: a systematic review, meta-analysis, and trial sequential analysis.Journal of gastroenterology · 2026Pooled it
- Major cardiovascular event risk of advanced therapies in inflammatory bowel diseases: systematic review and meta-analysis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026Pooled it
- Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines on the Use of Small Molecules and IL-23 p19 Inhibitors in Ulcerative Colitis and Crohn's Disease.Journal of gastroenterology and hepatology · 2026Guideline
- Second United Arab Emirates consensus guidance on the diagnosis and management of inflammatory bowel disease.World journal of gastroenterology · 2025Pooled it
- Inflammatory bowel disease therapeutics: a bibliometric analysis of tofacitinib research in ulcerative colitis.Frontiers in pharmacology · 2025Pooled it
- Effectiveness of tofacitinib in patients with ulcerative colitis: an updated systematic review and meta-analysis of real-world studies.BMJ open gastroenterology · 2024Pooled it
- Efficacy and safety of Advanced Combination Treatment in immune-mediated inflammatory disease: A systematic review and meta-analysis of randomized controlled trials.Journal of autoimmunity · 2024Pooled it
- Herpes zoster in patients with inflammatory arthritides or ulcerative colitis treated with tofacitinib, baricitinib or upadacitinib: a systematic review of clinical trials and real-world studies.Rheumatology international · 2023Pooled it
- Trial
- Clostridium difficile Infection in Patients with Ulcerative Colitis Treated with Tofacitinib in the Ulcerative Colitis Program.Inflammatory bowel diseases · 2023Trial
- Disease Activity and Health-related Quality of Life Relationships with Work Productivity in Patients with Ulcerative Colitis in OCTAVE Induction 1 and 2 and OCTAVE Sustain.Journal of Crohn's & colitis · 2023Trial
- 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
- Prescribing Biologic Immune-Modifying Therapies for Patients with a History of Cancer: A Cross-Specialty Review.Current oncology (Toronto, Ont.) · 2026Review
- 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
- Extended High-Dose Tofacitinib Induction Improves Clinical Response in Ulcerative Colitis: A Multicenter Cohort Study.JGH open : an open access journal of gastroenterology and hepatology · 2026Article
- Safety and Efficacy of Upadacitinib in Patients with Inflammatory Bowel Disease After Liver Transplantation: A Case Series.Digestive diseases and sciences · 2026Observational
- Current Perspectives on the Inflammatory Bowel Disease Pathogenesis of Microbiota and the Gut-Brain Axis, and Emerging Therapeutics.Biomedicines · 2026Review
- Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a post hoc analysis of safety and effectiveness in older (≥65 years) and younger (<65 years) patients.Intestinal research · 2026Article
- Optimizing Janus kinase inhibitor therapy for ulcerative colitis: a real-world perspective.Intestinal research · 2026Review
- Filgotinib effectiveness and safety as second or third-line therapy in patients with ulcerative colitis: data from a real-world study.Intestinal research · 2026Article
32 more citing papers are in PubMed but not listed here.
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Authors and funding
13 authors.
Funding
Abstract
backgroundTofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We present final data from OCTAVE Open, an open-label, long-term extension study.
aimsThe primary objective of OCTAVE Open was to assess the safety and tolerability of long-term tofacitinib in patients with ulcerative colitis; evaluating efficacy was a secondary objective.
methodsEligible patients included OCTAVE Induction 1&2 non-responders and OCTAVE Sustain completers/treatment failures. Patients in remission at OCTAVE Open baseline received tofacitinib 5 mg b.d.; all others received 10 mg b.d. Incidence rates (unique patients with events/100 patient-years) for adverse events of special interest were calculated; ≤7.0 years of observation. Efficacy endpoints derived from Mayo score were reported ≤36 months (last scheduled endoscopy visit).
resultsIn OCTAVE Open, 769 of 944 patients (81.5%) initially received tofacitinib 10 mg b.d. Among all patients (2440.8 patient-years of exposure), incidence rates (IRs; 95% confidence intervals) for deaths and adverse events of special interest were: deaths, 0.25 (0.09-0.54); serious infections, 1.61 (1.14-2.20); herpes zoster (non-serious and serious), 3.16 (2.47-3.97); opportunistic infections, 0.87 (0.54-1.33); major adverse cardiovascular events, 0.16 (0.04-0.42); malignancies (excluding non-melanoma skin cancer), 1.03 (0.67-1.52); non-melanoma skin cancer, 0.75 (0.45-1.19); deep vein thrombosis, 0.04 (0.00-0.23); pulmonary embolism, 0.21 (0.07-0.48). At Month 36, 66.9% and 40.3% showed clinical response, 64.6% and 37.1% had endoscopic improvement, and 58.9% and 33.7% maintained or achieved remission, with tofacitinib 5 and 10 mg b.d. respectively.
conclusionTofacitinib demonstrated consistent safety up to 7.0 years. Data collected up to Month 36 support long-term efficacy beyond the 52-week maintenance study.
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