Delayed vs early response to ustekinumab, adalimumab shows similar outcomes in CD

Patients with moderate-to-severe Crohn’s disease (CD) with delayed response to adalimumab or ustekinumab display similar 1-year clinical outcomes to those with an early response, reports a study.

The analysis involved 373 participants: 187 treated with ustekinumab and 186 with adalimumab. The overall rate of delayed clinical response was low at 13.1 percent in the SEAVUE clinical trial program.

Week 56 clinical remission did not differ significantly between early and delayed responders to ustekinumab or adalimumab. Similarly, no significant differences were seen for the other outcomes. Of note, delayed responders to the study drugs showed a substantial decrease in C-reactive protein at week 8 relative to nonresponders.

“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 nonresponders,” the authors said.

This study was a post hoc analysis of patient-level data from the SEAVUE clinical trial program. Early responders included patients treated with ustekinumab or adalimumab who had clinical response at week 8, defined as a decline in CD Activity Index (CDAI) score of at least 100 points from baseline or a CDAI score of <150.

The authors compared these outcomes with those of delayed responders (week 8 nonresponders who subsequently responded at week 16) and nonresponders (no response at either week 8 or week 16). Clinical remission at week 56, defined as CDAI <150, was the primary outcome.