Endoscopic Response to Subcutaneous Infliximab Across All Segments of the Colon and Terminal Ileum
Background:
Endoscopic healing (EH) is associated with positive outcomes in Crohn’s disease (CD). Although patterns of EH vary for different therapeutic agents, most show a lower efficacy in the terminal ileum relative to other parts of the intestine. We investigated EH in patients who received subcutaneous (SC) infliximab (IFX) maintenance treatment (CT-P13 SC) during the Phase 3 LIBERTY-CD study (NCT03945019) to analyze the efficacy of SC IFX by intestinal segment.
Methods:
LIBERTY-CD demonstrated superiority of CT-P13 SC 120 mg every 2 weeks (Q2W) vs placebo (PBO) after intravenous IFX induction in clinical remission and endoscopic response at Week (W) 54. This post hoc analysis evaluated Simple Endoscopic Score for Crohn’s Disease (SES-CD) values at screening, W22 and W54 for the 5 ileocolonic segments (rectum; left, transverse and right colon; terminal ileum). Rates of EH, defined as SES-CD=0, or endoscopic response (ER), defined as ≥50% decrease in baseline SES-CD, were evaluated in each segment with baseline abnormalities (segmental SES-CD ≥1). Results were analyzed descriptively.
Results:
At baseline (CT-P13 SC: n=231, PBO: n=112), the left colon was the most frequently affected segment (187/343; 54.5%), followed by the right colon (185/343; 53.9%), rectum (163/343; 47.5%), terminal ileum (156/343; 45.5%), and transverse colon (134/343; 39.1%). At W54, EH rates were higher with CT-P13 SC vs PBO across all segments (p≤0.01). EH rates in the terminal ileum at W22 and W54 were 56.6% vs 33.3% and 56.8% vs 23.3% in the CT-P13 SC and PBO arms, respectively (<italic>P<</italic> 0.01). ER rates were also significantly higher in the CT-P13 SC vs PBO arms across all segments at W22 and W54 (p≤0.01), with W54 rates in the terminal ileum of 69.3% and 30.2% in the CT-P13 SC and PBO arms, respectively (<italic>P<</italic> 0.001). In terminal ileum, patients with disease duration of < 2 years achieved higher rates of ER than those with ≥2 years (85.1% vs 65.0%, p=0.0435).
Conclusions:
SC IFX led to high and consistent EH and ER rates across all segments, including the terminal ileum. Early observation of EH and ER at W22 underscores the effectiveness of SC IFX treatment. Early treatment with SC IFX may lead to higher rates of ER in patients with active ileal lesions.
