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A study was carried to determine the onset of symptomatic response with vedolizumab in individuals suffering from moderate-to-severe ulcerative colitis.
Vedolizumab leads to a rapid
symptomatic response, specifically in anti-tumor necrosis factor (TNFα)-naive
ulcerative colitis patients, Early symptomatic improvement predicts the
therapeutic response at week 10.
A study was carried to determine
the onset of symptomatic response with vedolizumab in individuals suffering
from moderate-to-severe ulcerative colitis.
In this post hoc analysis of a
randomized, placebo-controlled phase III trial, participants were randomly
assigned to receive vedolizumab 300 mg (n = 164) or placebo (n = 82) at weeks
0, two, and six. Mayo subscores were assessed in individuals having baseline
stool frequency ≥1 and rectal bleeding ≥1. In subjects having baseline stool
frequency ≥2 and rectal bleeding ≥1, the percentage attaining stool frequency
≤1 and rectal bleeding = 0 was assessed.
From week two, the decline in mean stool frequency subscore from baseline was higher with vedolizumab compared to placebo (-6.6%), with a higher difference in anti-TNF α-naive patients (vedolizumab vs. placebo, -13.2%). From the sixth week, the mean percentage decline from baseline rectal bleeding subscore was numerically higher with vedolizumab compared to placebo in anti-TNFα-naive subjects (-10.7%).
More individuals in the
anti-TNFα-naive subgroup attained stool frequency ≤1 and rectal bleeding = 0
with vedolizumab compared to placebo at week 2 (14.8%) and week 6 (20.3%).
Individuals having stool frequency ≤1 and rectal bleeding = 0 at week two had
greater clinical remission and response,
and mucosal healing rates at week 10 in comparison with the devoid subjects.
In anti-TNFα-naive ulcerative colitis patients, vedolizumab
induces a prompt symptomatic response.
Digestion
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
Masakazu Nagahori et al.
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