← Issue №4/ week of Jul 26, 2026/IBD

Risk of serious infection, myocardial infarction, stroke, and thromboembolic events in patients in the United States with ulcerative colitis treated with tofacitinib compared with biologic treatments.

From GI Signals issue №4: what this paper found, what it changes, and where it sits against the current standard of care, reviewed by Simon Mathews, MD.

IBD retrospective · n=62,596 · Jul 28, 2026 · Inflamm Bowel Dis · IF 4.5

Risk of serious infection, myocardial infarction, stroke, and thromboembolic events in patients in the United States with ulcerative colitis treated with tofacitinib compared with biologic treatments.

New evidenceulcerative colitisJAK inhibitorsbiologicsepidemiology
Clinical takeawayIn patients with UC (including those with prior biologic exposure), tofacitinib showed no significant difference in serious infections, MI/stroke, or VTE risk compared to biologics in this claims analysis. Safety decisions should weigh all risks, not just these endpoints.
What it foundNo significant differences in serious infections (IR 2.62 vs 2.45-3.25/100 PY), MI/stroke (IR 0.13 vs 0.17-0.19/100 PY), or VTE (IR 0.17 vs 0.16-0.33/100 PY) between tofacitinib and biologics (ustekinumab, vedolizumab, TNFis) in UC.
ContextContrasts with prior concerns about tofacitinib's safety profile (e.g., FDA warnings on VTE risk). Reassures that real-world risks for these specific outcomes align with biologics.
Reinforcessuggested applicable standard· ACG Clinical Guideline Update: Ulcerative Colitis in Adults, Am J Gastroenterol 2025;120(6):1187-1224; AGA Living Guideline on Pharmacological Management of Moderate-to-Severe UC, Gastroenterology 2024 (panel review March 2026, no changes)

Decision at stakepositioning tofacitinib in advanced therapy for ulcerative colitis

Confirm ulcerative colitis with endoscopy showing continuous colonic inflammation from the rectum plus histology, after excluding infection with two-step CDI testing.

From our summary of this standard, unedited — the part the paper bears on. marks omitted text. Our wording, not the guideline's; read the source for its own text.

Our full summary of this standard

Confirm ulcerative colitis with endoscopy showing continuous colonic inflammation from the rectum plus histology, after excluding infection with two-step CDI testing. Treat mild-moderate disease with 5-ASA by route and extent (suppository for proctitis, enema for left-sided, oral plus rectal for extensive); if 5-ASA fails, treat as moderate-to-severe rather than stepping up gradually. Position advanced therapy by EFFICACY TIER, not by an anti-TNF-first rule. Advanced-therapy-naive, higher efficacy: infliximab, vedolizumab, ozanimod, etrasimod, upadacitinib, risankizumab, guselkumab; intermediate: golimumab, ustekinumab, tofacitinib, filgotinib, mirikizumab; lower: adalimumab. PREVIOUSLY TNF-EXPOSED, higher efficacy: tofacitinib, upadacitinib, ustekinumab; lower: adalimumab, vedolizumab, ozanimod, etrasimod - S1P modulators are weakest in exactly this group. Do not cycle within the anti-TNF class after primary non-response; switch mechanism. Apply treat-to-target (STRIDE-II) to endoscopic improvement (MES 0-1). Screen for acute severe UC by Truelove-Witts and admit for IV steroids. Begin CRC surveillance 8-10 years after DIAGNOSIS for extensive or left-sided disease; isolated proctitis follows average-risk screening.

ACG Clinical Guideline Update: Ulcerative Colitis in Adults, Am J Gastroenterol 2025;120(6):1187-1224; AGA Living Guideline on Pharmacological Management of Moderate-to-Severe UC, Gastroenterology 2024 (panel review March 2026, no changes) ↗
Rubin DT … Dubinsky MC · Inflammatory Bowel Diseases · IF 4.5 · PubMed ↗Permalink
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