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.

Abstract

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)α-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-TNFα-naive patients (-10.7%; 95% CI, -33.0, 11.5). More patients in the anti-TNFα-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-TNFα-naive patients, and suggest that early symptomatic improvement predicts treatment response at Week 10 (NCT02039505).

• Authors: Masakazu Nagahori, Kenji Watanabe, Satoshi Motoya, Haruhiko Ogata, Takanori Kanai, Toshiyuki Matsui, Yasuo Suzuki, Philippe Pinton, Lyann Ursos, Shigeru Sakamoto, Mitsuhiro Shikamura, Tetsuharu Hori, Jovelle Fernandez, Toshifumi Hibi, Mamoru Watanabe
• Journal: Digestion (Digestion) Vol. 102 Issue 5 Pg. 742-752 ( 2021) ISSN: 1421-9867 [Electronic] Switzerland
• PMID: 33454706 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: The Author(s). Published by S. Karger AG, Basel.

Chemical References

• Antibodies, Monoclonal, Humanized
• Gastrointestinal Agents
• Tumor Necrosis Factor-alpha
• vedolizumab

Topics

• Antibodies, Monoclonal, Humanized
• Colitis, Ulcerative (drug therapy)
• Gastrointestinal Agents (adverse effects)
• Humans
• Japan
• Remission Induction
• Treatment Outcome
• Tumor Necrosis Factor-alpha