Real-world Evidence Comparing Tofacitinib and Vedolizumab in Anti-TNF-experienced Patients With Ulcerative Colitis

Area of Science:

• Gastroenterology
• Immunology
• Pharmacology

Background:

• Anti-tumor necrosis factor (anti-TNF) inhibitors are standard first-line treatments for ulcerative colitis (UC).
• Patients with UC often experience loss of response or intolerance to anti-TNF therapies over time.
• Switching to alternative treatments like tofacitinib or vedolizumab is common in advanced UC management.

Purpose of the Study:

• To compare the real-world effectiveness and safety of initiating tofacitinib versus vedolizumab in UC patients with prior anti-TNF exposure.
• To evaluate treatment persistence, hospitalization rates, and colectomy rates between the two drug classes.

Main Methods:

• A retrospective cohort study utilizing secondary data from a large US health insurer.
• Included UC patients newly initiating tofacitinib or vedolizumab after anti-TNF therapy.
• Propensity score stratification was used to control for confounding factors.

Main Results:

• Tofacitinib initiation was associated with significantly lower treatment persistence (>52 weeks) compared to vedolizumab (aRR 0.77; 95% CI, 0.60-0.99).
• No statistically significant differences were observed in secondary outcomes including all-cause hospitalization, total abdominal colectomy, or hospitalization for infection between the two groups.

Conclusions:

• Tofacitinib initiators showed lower treatment persistence than vedolizumab initiators among anti-TNF-experienced UC patients.
• These real-world findings contrast with some studies suggesting tofacitinib superiority.
• Head-to-head randomized controlled trials are recommended for definitive clinical guidance.