Real-World Results of First-Line Advanced Therapies for Ulcerative Proctitis
According to findings of a study presented at the American College of Gastroenterology scientific meeting, vedolizumab may be more effective for achieving sustained remission and has higher treatment durability than anti-TNFs in bionaïve adults diagnosed with ulcerative proctitis (UP).
The investigators noted that patients with UP are often excluded from clinical trials. In this study, the researchers analyzed the records of patients with UP who initiated advanced therapies between January 2014 and June 2023 within a large academic health system. The diagnosis of UP was confirmed via endoscopic evidence of inflammation within 15 cm of the anal verge.
The primary outcome of this study was steroid-free clinical remission (SFCR) at 52 ± 4 weeks, defined as a clinical colitis activity index (SCCAI) score <2 or physician assessment if SCCAI data were unavailable. Secondary outcomes included treatment persistence at 52 weeks, SFCR at 12 ± 4 weeks, endoscopic response, and adverse events.
Of the 72 patients who initiated advanced therapies, most received either vedolizumab (47%) or anti-TNFs (44%), primarily adalimumab (69% of anti-TNFs). Smaller proportions of patients were treated with ustekinumab (4%), tofacitinib (3%), and ozanimod (1%).
After multivariable adjustment, vedolizumab demonstrated significantly higher odds of achieving SFCR at 52 weeks compared to anti-TNFs (OR 3.8, p=0.03). Kaplan-Meier and Cox regression analyses suggested lower persistence with anti-TNFs relative to vedolizumab, though this difference was not statistically significant (HR 1.8, p=0.20). Adalimumab specifically was associated with a higher likelihood of discontinuation than vedolizumab (HR 2.8, p=0.04). Reported adverse events were generally consistent with known safety profiles, with minor differences observed between therapy types.
This study suggests that vedolizumab may be more effective for achieving sustained remission and has higher treatment durability than anti-TNFs in bio-naïve UP patients. Further research with larger cohorts is warranted to better assess the effectiveness of advanced therapies in UP.
Reference
Dalal R, Clarke, L, Carlin A, et al. Real-world comparison of effectiveness, durability, and safety of first-line advanced therapies for ulcerative proctitis. Presented at: American College of Gastroenterology. October 25-30, 2024; Philadelphia, PA.
