Capsule Endoscopy-Guided Proactive Treat-to-Target Versus Continued Standard Care in Patients With Quiescent Crohn's Disease: A Randomized Controlled Trial

Abstract

Background & aims: Optimal treat-to-target strategies for Crohn's disease (CD) are still being sought. The value of video capsule endoscopy (VCE) to guide proactive treat-to-target optimization in CD was examined.

Methods: A randomized controlled trial of patients with small bowel-involved (L1/L3) CD in corticosteroid-free clinical remission (Crohn's Disease Activity Index < 150). Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) ≥ 350 were designated "high risk" and randomized to either treat-to-target treatment optimization or continued standard care. Treat-to-target was optimized by means of repeat VCE results every 6 months. Patients with LS < 350 ("low risk") continued standard care. The primary outcome was the rate of disease exacerbation (Crohn's Disease Activity Index increase > 70 points and score > 150 or hospitalization/surgery) in high-risk standard care vs treat-to-target groups at 24 months.

Results: Of 118 patients screened, 60 were enrolled. Treatment intensification in patients in the high-risk group allocated to proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20). The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio, 0.14; 95% CI, 0.04-0.57; P = .006). Mucosal healing was significantly more common among the treat-to-target group when determined by a cutoff LS < 350 (odds ratio, 4.5; 95% CI, 1.7-17.4; nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350. Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225-900 vs 225, 135-600, respectively; P = .07). Of 221 VCEs ingested, there was a single (0.4%) temporarily retained spontaneously resolved event.

Conclusions: A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care.

Clinicaltrials: gov, Number: NCT03555058.

Keywords: Capsule Endoscopy; Crohn's Disease; Inflammatory Bowel Disease; Treatment.