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Extended High-Dose Tofacitinib Induction Improves Clinical Response in Ulcerative Colitis: A Multicenter Cohort Study
R Gilmore1,2, T Pham1,2, R G Fernandes1,2
1Department of Gastroenterology Mater Hospital Brisbane Australia.
Summary
Extended induction with tofacitinib (Tofacitinib) for ulcerative colitis (UC) showed improved clinical response at 16 and 52 weeks. This real-world Australian study found tofacitinib effective and safe for UC patients.
Area of Science:
- Gastroenterology
- Pharmacology
- Clinical Medicine
Background:
- Tofacitinib, a Janus Kinase (JAK) inhibitor, is approved for ulcerative colitis (UC).
- Optimal induction dosing for tofacitinib in UC remains unclear.
- Real-world data is crucial for understanding treatment effectiveness beyond clinical trials.
Purpose of the Study:
- To evaluate the effectiveness and safety of tofacitinib in a real-world Australian UC cohort.
- To compare standard 8-week induction with extended 16-week induction of tofacitinib.
- To analyze clinical, biochemical, endoscopic, and adverse event outcomes.
Main Methods:
- Multicenter study of 124 moderate-to-severe UC patients initiating tofacitinib.
- Data collected at baseline, weeks 8, 16, and 52.
- Outcomes stratified by standard (8-week) versus extended (16-week) induction therapy.
Main Results:
- Extended induction (60% of patients) showed significantly higher clinical response at week 16 (69% vs. 45%) and week 52 (75% vs. 54%) compared to standard induction (40% of patients).
- Overall clinical response rates were 70% at week 8, 60% at week 16, and 68% at week 52.
- Adverse events (AEs) and serious AEs occurred in 17% and 7% of patients, respectively, over 52 weeks. Herpes zoster was reported in 6% of patients.
Conclusions:
- Tofacitinib is effective in a real-world Australian UC population.
- Extended induction dosing (16 weeks) of tofacitinib resulted in significantly higher clinical response at 16 and 52 weeks.
- The safety profile of tofacitinib in this cohort was consistent with known data.
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