ArticleJournal of gastroenterology and hepatology2022
Safety and efficacy of long-term tofacitinib treatment in East Asian patients with ulcerative colitis in OCTAVE Open.
Article in Journal of gastroenterology and hepatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled 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
- Adverse Events Associated with Advanced Therapy Compared with Conventional Therapy in Patients with Inflammatory Bowel Disease: A Common Data Model Analysis.Gut and liver · 2026Observational
- 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
- Safety and efficacy of long-term filgotinib treatment in Japanese patients with ulcerative colitis: an interim subgroup analysis of the SELECTION long-term extension study.Crohn's & colitis 360 · 2026Article
- Long-Term Safety of Tofacitinib for Treatment of Moderate-to-Severe Ulcerative Colitis: Three Years of Korean National Data.Journal of Korean medical science · 2025Article
- Post-marketing Surveillance of Tofacitinib in Patients With Ulcerative Colitis in Japan: A Post Hoc Analysis of Safety and Effectiveness by Prior Biologic Status.Crohn's & colitis 360 · 2025Article
- Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data.Journal of gastroenterology · 2025Observational
- 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
- Etrasimod for ulcerative colitis: evaluating phase III results.Nature reviews. Gastroenterology & hepatology · 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
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Authors and funding
12 authors.
Funding
Abstract
BACKGROUND AND
aimTofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present safety and efficacy data from patients from East Asia (Japan, Korea, and Taiwan) in OCTAVE Open, an open-label, long-term extension study.
methodsPatients in remission at OCTAVE Open baseline received tofacitinib 5 mg twice daily (BID); all others received tofacitinib 10 mg BID. Proportions and IRs (unique patients with events/100 patient-years) were calculated for adverse events (AEs) of special interest. Efficacy endpoints were evaluated up to 36 months.
resultsIn OCTAVE Open, 105/944 patients were from East Asia (tofacitinib 5 mg BID, n = 22; tofacitinib 10 mg BID, n = 83). Overall, 87.6% and 24.8% of patients had AEs and serious AEs, respectively; IRs (95% CI) for AEs of special interest were herpes zoster (HZ; non-serious and serious), 6.07 (3.40-10.02); serious infections, 1.47 (0.40-3.76); opportunistic infections, 1.91 (0.62-4.45); major cardiovascular adverse events, 0.37 (0.01-2.04); malignancies (excluding non-melanoma skin cancer [NMSC]), 0.37 (0.01-2.04); and NMSC, 0.00 (0.00-1.35). No deaths, venous thromboembolic events, or gastrointestinal perforations occurred. At month 36, 68.2% and 54.2% of patients had a clinical response, 68.2% and 53.0% had endoscopic improvement, and 63.6% and 49.4% were in remission with tofacitinib 5 and 10 mg BID, respectively.
conclusionsThe HZ IR in East Asian patients was numerically higher versus the global study population; excluding HZ, tofacitinib safety and efficacy were consistent with the global study population.
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