Am J Gastroenterol. 2024 Jul 1;119(7):1355-1364.doi: 10.14309/ajg.0000000000002654. Epub 2024 Jan 18.

Neeraj Narula ¹, Emily C L Wong ¹, Parambir S Dulai ², John K Marshall ¹, Vipul Jairath ³, Walter Reinisch ⁴

Author information

¹Division of Gastroenterology, Department of Medicine, and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.

²Division of Gastroenterology, Northwestern University, Chicago, Illinois, USA.

³Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.

⁴Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.

Abstract

Introduction: Differences in 1-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.

Methods: This was a post hoc analysis of patient-level data from the SEAVUE clinical trial program. Ustekinumab-treated and adalimumab-treated patients with clinical response at week 8, defined as a reduction in Crohn's Disease Activity Index (CDAI) score of at least 100 points from baseline or CDAI score <150, were deemed early responders and their outcomes were compared with delayed responders (week 8 nonresponders who subsequently responded at week 16) and nonresponders (no response at week 8 or 16). The primary outcome assessed was clinical remission at week 56, defined as CDAI <150.

Results: A total of 373 participants (187 treated with ustekinumab and 186 treated with adalimumab) were included in this analysis. The overall rate of delayed clinical response was low in the SEAVUE clinical trial program (13.1%). No differences were observed for week 56 clinical remission 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 C-reactive protein by week 8 when compared with nonresponders.

Discussion: Among patients with moderate-to-severe CD, early and delayed responders to adalimumab and ustekinumab have similar 1-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 nonresponders.