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.