期刊
DIGESTION
卷 102, 期 5, 页码 742-752出版社
KARGER
DOI: 10.1159/000512235
关键词
Ulcerative colitis; Vedolizumab; Early symptomatic improvement
资金
- Takeda Pharmaceutical Co., Ltd.
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.
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
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