Delayed Ustekinumab and Adalimumab Responders Have Similar Outcomes as Early Responders in Biologic-Naïve Crohn's Disease.

Abstract

Differences in one-year outcomes among early and delayed responders have been demonstrated with some therapies in ulcerative colitis. However, it is unclear whether similar differences exist in patients with Crohn's disease (CD) treated with biologic therapies. This was a post-hoc analysis of patient-level data from the SEAVUE clinical trial program. Ustekinumab and adalimumab-treated patients with clinical response at week 8, defined as a reduction in CDAI score of at least 100 points from baseline or Crohn's Disease Activity Index (CDAI) score < 150, were deemed early responders and their outcomes were compared with delayed responders (week 8 non-responders who subsequently responded at week 16) and non-responders (no response at week 8 or 16). The primary outcome assessed was clinical remission (CR) at week 56, defined as CDAI < 150. There were 373 participants (187 treated with ustekinumab and 186 treated with adalimumab) included in this analysis. The overall rate of delayed clinical response was low in SEAVUE (13.1%). No differences were observed for week 56 CR among early vs. delayed responders to ustekinumab or adalimumab, nor were there significant differences for secondary outcomes assessed. Delayed responders to ustekinumab and adalimumab had a significant decline in CRP by week 8 as compared to non-responders. Among moderate-severe CD patients, early and delayed responders to adalimumab and ustekinumab have similar one-year clinical outcomes. Biomarker decline can be observed through the initial 8 weeks of therapy in patients who will eventually be delayed responders which may help differentiate from non-responders.