ArticleAlimentary pharmacology & therapeutics2022
Worldwide post-marketing safety surveillance experience with tofacitinib in ulcerative colitis.
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 17 papers, 1 of them a synthesis 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
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review.Journal of managed care & specialty pharmacy · 2024Pooled it
- 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
- Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.Inflammatory bowel diseases · 2023Trial
- Smad7 Antisense Oligonucleotide-Based Therapy in Crohn's Disease: Is it Time to Re-Evaluate?Molecular diagnosis & therapy · 2022Trial
- Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data.Journal of gastroenterology · 2025Observational
- JAK Inhibitor and Crohn's Disease.Biomedicines · 2025Review
- Advanced Combination Therapy with Biologics and Upadacitinib in Refractory Inflammatory Bowel Disease: A Retrospective Study from Taiwan.Journal of inflammation research · 2025Article
- Predictors of Efficacy of Janus Kinase Inhibitors in Patients Affected by Ulcerative Colitis.Journal of clinical medicine · 2024Review
- Disproportional signal of pericarditis with biological diseasemodifying antirheumatic drugs (bDMARDs) in patients with ankylosing spondylitis: a disproportionality analysis in the FAERS database.Frontiers in pharmacology · 2024Article
- Shared Immune Associations Between COVID-19 and Inflammatory Bowel Disease: A Cross-Sectional Observational Study in Shanghai, China.Journal of inflammation research · 2024Article
- Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis.Rheumatology and therapy · 2023Article
- Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting.Inflammatory bowel diseases · 2023Article
- Review
- Ustekinumab in ulcerative colitis- insights from the real-world data.United European gastroenterology journal · 2022Article
- Bridging Efficacy of Tofacitinib Immediate-Release to Extended-Release Formulations for Treatment of Ulcerative Colitis: Application of a Model-Informed Drug Development Approach.Clinical pharmacology in drug development · 2022Article
- Worldwide post-marketing safety surveillance experience with tofacitinib in ulcerative colitis.Alimentary pharmacology & therapeutics · 2022Article
- User's guide to JAK inhibitors in inflammatory bowel disease.Current research in pharmacology and drug discovery · 2022Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Post-marketing surveillance (PMS) is an important part of monitoring adverse events (AEs).
aimsTo report an analysis of PMS case safety reports for tofacitinib in patients with UC
methodsWorldwide tofacitinib PMS reports received in the Pfizer safety database from 30 May 2018 (first regulatory approval) to 25 August 2020 were analysed. The type and estimated reporting rate (RR) of serious AEs of interest, including infection, gastrointestinal, vascular, respiratory, neoplasm and cardiac events, were reviewed. Patient-years of exposure (PY) was estimated based on worldwide sales data and the calculated daily regimens of tofacitinib 5 or 10 mg twice daily, immediate- or extended-release formulations.
resultsDuring the 27-month reporting period, worldwide post-marketing exposure to tofacitinib was 8916 PY. Overall, 4226 case reports were received and included 12 103 AEs, of which 1839 were serious AEs (SAEs). Among the cases reported, 1141 (27.0%) included an SAE and 18 (0.4%) were fatal. The RR (per 100 PY) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 3.28 for infections, 1.26 for vascular disorders, 0.74 for respiratory disorders, 0.55 for neoplasms and 0.50 for cardiac disorders.
conclusionsThe types of AEs were consistent with those reported in tofacitinib clinical trials. Most reported AEs were non-serious. Limitations of PMS reports and reliance on estimated RRs due to lack of precise values for exposure, required for incidence rate calculation, should be considered when interpreting these results.
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