Long-Term Outcomes of Early vs Delayed Responders to Vedolizumab and Adalimumab: A Post Hoc Analysis of the VARSITY Study.

INTRODUCTION: It is uncertain whether patients with ulcerative colitis (UC) and delayed symptomatic response to therapy have as robust and durable a response as earlier responders to therapy. We compared clinical outcomes of early and delayed responders to vedolizumab and adalimumab for patients with moderate-severe UC.

METHODS: This was a post hoc analysis of the VARSITY study. Patients with early partial Mayo score (PMS) remission (PMS ≤1 at week 4/6 of therapy) were compared with those with delayed PMS remission (PMS ≤1 at week 14 and not week 4/6). Differences in proportions of patients achieving week 52 clinical remission (CR) (PMS = 0), endoscopic improvement (EI) (Mayo endoscopic subscore ≤1), and histoendoscopic mucosal improvement (HEMI) (Mayo endoscopic subscore ≤1 and Geboes score highest grade <3.2) were assessed. Confounders were adjusted for using multivariate logistic regression.

RESULTS: A total of 147 vedolizumab-treated and 110 adalimumab-treated patients attained early or late PMS remission. Those who attained early PMS remission with vedolizumab were more likely to attain week 52 CR than participants with delayed PMS remission with vedolizumab (69.1% [67/97] vs 50.0% [25/50], aOR 2.43 [95% CI 1.11-5.33], P = 0.027). Week 52 HEMI was more likely among early vedolizumab PMS remitters (63.9% [62/97] vs 40.0% [20/50], aOR 2.60 [95% CI 1.20-5.62], P = 0.015). Week 52 EI was similar between early and delayed PMS remitters to vedolizumab. No differences were observed in week 52 CR, EI, or HEMI between early and delayed PMS remitters to adalimumab.

DISCUSSION: Patients with UC who achieve early PMS remission with vedolizumab have greater odds of week 52 remission compared with delayed responders.