VCE-guided strategy for quiescent CD

May 20, 2025

Issue 10

Clinical Question

Does a capsule endoscopy-guided treat-to-target strategy improve outcomes in quiescent Crohn’s disease?

Editor’s Bottom Line

These data provide further evidence in support of treat-to-target strategies for Crohn’s disease. Video capsule endoscopy can help to target treatment intensification.

Reference

Ben-Horin S, Lahat A, Ungar B, et al. Capsule Endoscopy–Guided Proactive Treat-to-Target Versus Continued Standard Care in Patients with Quiescent Crohn’s Disease: A Randomized Controlled Trial. Gastroenterology. Epub ahead of print March 17, 2025; https://www.gastrojournal.org/article

Synopsis

This randomized controlled trial examined whether video capsule endoscopy (VCE) could effectively guide a treat-to-target strategy for patients with quiescent Crohn’s disease (CD) to improve clinical outcomes.

Researchers from the Israeli IBD Research Nucleus (IIRN) enrolled 60 adult patients with small bowel-involved CD (L1/L3 by Montreal classification) who were in corticosteroid-free clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) <150. All participants underwent VCE at baseline, and those with a Lewis inflammatory score (LS) ≥350 were designated as “high risk” and randomized to either treat-to-target optimization (n=20) or continued standard care (n=20). Twenty patients had an LS <350 and were deemed “low risk,” continuing with standard care without intervention during the 24-month study. The treat-to-target strategy involved biologic dose escalation, initiating a biologic or switching biologics based on findings from repeat VCE performed every six months. Treatment was further optimized if the six-month follow-up VCE did not show a reduction of at least 225 points in LS or if LS remained ≥350. The primary outcome was clinical flare during the 24 months. Clinical flare was defined as a CDAI increase >70 points and a total score >150, or CD-related hospitalization/surgery.

Results showed that 25% of the high-risk treat-to-target patients had a clinical flare by 24 months, compared to 70% of the high-risk standard-care patients (Odds Ratio [OR]: 0.14; 95% Confidence Interval [CI], 0.04–0.57; p=0.006). Cox proportional regression analysis, accounting for use of biologics at or prior to enrollment as well as disease duration, confirmed this finding, with a 78% reduced risk of clinical flare among the high-risk treat-to-target group (Hazard Ratio: 0.22; 95% CI, 0.07–0.67; p=0.008).

Treatment intensification in the 20 high-risk treat-to-target patients included biologic dose escalation (n=11), starting a first biologic (n=8) or switching biologics (n=1). Nine of 20 patients in this group required additional treatment optimization during the study.

Rates of mucosal healing, defined as a total LS <450 and a worst-segment LS <350, were not significantly different between groups. However, an exploratory analysis examining the absence of significant mucosal inflammation (defined as a worst-segment with LS<350) showed this was significantly more likely among the treat-to-target high-risk group than the standard care high-risk group (OR: 4.5; 95% CI, 1.7–17.4; p=0.03).

Among both high and low risk patients continuing with standard care, baseline LS was numerically higher among those who subsequently experienced disease flares, compared to those who maintained remission (median baseline LS for those with subsequent clinical flare: 450; 95% CI, 225–900 vs. median LS of 225 for those with no subsequent flare; 95% CI, 135–600; p=0.07). In contrast, baseline C-reactive protein and fecal calprotectin levels were not significantly different between patients who experienced a flare and those who did not.

Details

Study Design: Randomized controlled trial
Funding: The Leona M. & Harry B. Helmsley Charitable Trust, with additional in-kind support from Medtronic, AbbVie, and Takeda Israel Ltd.
Allocation: Randomized
Setting: Multicenter
Level of Evidence: 1b