ArticleUnited European gastroenterology journal2025
Gastrointestinal Perforations Associated With JAK Inhibitors: A Disproportionality Analysis of the FDA Adverse Event Reporting System.
Article in United European gastroenterology journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- STAT3 signaling inhibitors for cancer treatment.Trends in pharmacological sciences · 2026Review
- Achievement and Maintenance of Disease Targets with Upadacitinib in Rheumatoid Arthritis: 2-Year Outcomes from the UPHOLD Real-World Study.Rheumatology and therapy · 2026Article
- Pediatric health: mechanistic insights into inflammatory diseases and emerging therapeutic pathway-targeted approaches.Translational pediatrics · 2026Review
- Critical Intestinal Perforations in Pediatric Immunocompromised Patients: A Case-Based Review.Pediatric reports · 2026Article
- Real-world clinical experience with upadacitinib in a cohort of Italian patients with axial spondyloarthritis.Frontiers in pharmacology · 2026Article
- Differential risk of adverse drug reactions with baricitinib across age groups: integrating real-world pharmacovigilance and genetic causal inference.Therapeutic advances in drug safety · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGastrointestinal perforations have been reported in a small number of rheumatoid arthritis (RA) patients treated with Janus kinase (JAK) inhibitors in clinical trials. However, large-scale postmarketing data repositories are needed to further investigate this potentially rare but serious adverse event.
methodsA retrospective, pharmacovigilance study of the FDA adverse event reporting system (July 2014 to September 2023) assessing the reporting of gastrointestinal perforations following JAK inhibitors compared to biological disease-modifying antirheumatic drugs (bDMARDs) in RA patients. The adjusted reporting odds ratio (adj.ROR) was calculated using a multivariable logistic regression model.
resultsOf 399,983 RA patients included in the study, 76,446 were treated with JAK inhibitors (tofacitinib, n = 52,365; upadacitinib, n = 21,856; baricitinib, n = 2225) and 323,537 were treated with bDMARDs (TNF inhibitors, rituximab, and abatacept). Overall, 230 cases of gastrointestinal perforation following JAK inhibitors were identified, with a median time of 9 (IQR: 4-22) months from treatment initiation. Compared with bDMARDs, JAK inhibitors were associated with a higher-than-expected reporting of gastrointestinal perforations (adj.ROR = 1.98[1.69-2.31]). Increased reporting of gastrointestinal perforations was observed among recipients of JAK inhibitors or bDMARDs who used steroids or non-steroidal anti-inflammatory drugs concurrently (adj.ROR = 2.82 [2.41-3.31]). Perforations of both the upper and lower gastrointestinal tract were significantly over-reported (n = 51, adj.ROR = 1.55 [1.12-2.14], n = 143, adj.ROR = 1.78 [1.46-2.17], respectively). Furthermore, the safety signal was significant across all JAK inhibitors: tofacitinib (n = 125, adj.ROR = 1.52 [1.25-1.85]), upadacitinib (n = 84, adj.ROR = 2.73 [2.17-3.44]), and baricitinib (n = 21, adj.ROR = 5.38 [3.46-8.37]).
conclusionIn this global pharmacovigilance study, all JAK inhibitors were associated with increased reporting of gastrointestinal perforations compared with bDMARDs in RA patients. Until more data on IBD patients emerge, careful surveillance and increased clinicians' awareness should also be advocated for this population.
Indexed as
Identifiers
What OpenQuestion holds
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.