Long-term Results of Drug Treatment for Crohn's Disease Strictures.

Abstract

Background and aim: Recent controlled data from the STRIDENT study suggest that in the short-term drug treatment effectively relieves symptoms and improves bowel wall morphology. Here we present the long-term results of this clinical trial, identifying predictors of treatment outcomes.

Methods: Patients with symptomatic Crohn's disease strictures were randomized 2:1 to high dose adalimumab induction followed by 40mg fortnightly plus thiopurine, with dose increase at 4 and/or 8 months if evidence of persisting inflammation, or standard dose adalimumab monotherapy. Baseline stricture MRI risk score was assessed: pre-stenotic dilation ≥30mm, stricture length >50mm and bowel wall thickness ≥10mm (each factor assigned a score of 1). Patients were assessed at 12 months for clinical response (reduction in the 14-day obstructive symptom score). Follow up interviews were performed at a minimum of 4 years.

Results: In the initial 12-month study, 52 patients were randomised to the intensive and 25 to the standard treatment arm, with 64 of 77 (83%) completing at least 12 months of therapy while 13 (17%) withdrew: 8 for surgical treatment and 5 for other reasons. Following study completion at 12 months 12/77 (16%) patients required endoscopic dilation and 22/77 (29%) patients required surgery. Clinical responders had a lower rate of surgical resection compared to non-responders (20% vs 52%, P < 0.001). The stricture MRI risk score predicted surgery free survival (OR 2.34; 95%CI 1.32-4.16, P = 0.004).

Conclusion: The clinical response to adalimumab is durable in a majority of patients beyond four years of therapy. In patients with symptomatic Crohn's disease strictures, drug treatment is a viable initial treatment.