Week 2 Symptomatic Response with Vedolizumab as a Predictive Factor in Japanese Anti-TNFα-Naive Patients with Ulcerative Colitis: A post hoc Analysis of a Randomized, Placebo-Controlled Phase 3 Trial

Background and Aim: To evaluate the onset of symptomatic response with vedolizumab in patients with moderate-to-severe ulcerative colitis in Japan. Methods: Patients were randomized to receive vedolizumab 300 mg or placebo at Weeks 0, 2, and 6. Mayo subscores were analyzed in patients with baseline stool frequency (SF) >= 1 and rectal bleeding (RB) >= 1. In patients with baseline SF >= 2 and RB >= 1, the proportion who achieved SF <= 1 and RB = 0 was determined. Results: Patients were randomized to vedolizumab (n = 164) or placebo (n = 82). Decrease from baseline in mean SF subscore was greater with vedolizumab versus placebo from Week 2 (-6.6%; 95% confidence interval [CI], -16.2, 3.0), with a greater difference in anti-tumor necrosis factor (TNF)alpha-naive patients (vedolizumab vs. placebo, -13.2%; 95% CI, -29.7, 3.3). Mean percentage decrease from baseline RB subscore was numerically greater with vedolizumab versus placebo from Week 6 in anti-TNF alpha-naive patients (-10.7%; 95% CI, -33.0, 11.5). More patients in the anti-TNF alpha-naive subgroup achieved SF <= 1 and RB = 0 with vedolizumab versus placebo at Week 2 (14.8%; 95% CI, 2.5, 27.0) and Week 6 (20.3%; 95% CI, 4.4, 36.2). Patients with SF <= 1 and RB = 0 at Week 2 had higher clinical response, clinical remission, and mucosal healing rates at Week 10 than those without. Conclusions: Our results indicate that vedolizumab induces a rapid symptomatic response, particularly in anti-TNF alpha-naive patients, and suggest that early symptomatic improvement predicts treatment response at Week 10 (NCT02039505). (c) 2021 S. Karger AG, Basel

Automated summary

The study evaluated the onset of symptomatic response with vedolizumab in Japanese patients with moderate-to-severe ulcerative colitis. Results showed that vedolizumab induced a rapid symptomatic response, especially in anti-TNF alpha-naive patients, and early symptomatic improvement predicted treatment response at Week 10.