Intensive drug therapy vs standard drug therapy for symptomatic intestinal Crohns disease strictures (STRIDENT): An open-label, single-center, randomized controlled trial
The Lancet: Gastroenterology & Hepatology Dec 11, 2021
Schulberg JD, Wright EK, Holt BA, et al. - The most common structural complication of Crohn's disease is strictures, which are mainly treated with surgery and endoscopic balloon dilation. As most strictures have an inflammatory component, researchers herein examined whether drug treatment can induce response in strictures and whether intensive drug therapy is more effective than standard drug therapy.
In this open-label, single-center, randomized controlled trial, researchers included patients with a de novo or postoperative anastomotic intestinal stricture on MRI or ileocolonoscopy, symptoms consistent with chronic or subacute intestinal obstruction (postprandial abdominal pain in the presence of a confirmed stricture), and evidence of active intestinal inflammation.
Either intensive high-dose adalimumab (160 mg adalimumab once per week for 4 weeks followed by 40 mg every 2 weeks, with escalation of dose at 4 months and 8 months if assessment of disease activity indicated active inflammation) plus thiopurine (initial dose of azathioprine 2·5 mg/kg or mercaptopurine 1·5 mg/kg, with dose adjustment based on thiopurine metabolite testing) or standard adalimumab monotherapy (160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks) was provided to 77 patients; 52 received intensive adalimumab plus thiopurine treatment and 25 received standard adalimumab treatment.
Drug treatment induced response in Crohn's disease strictures.
Improvement in symptoms and stricture morphology occurred in all patients.
There occurred less treatment failure, a reduction in stricture-associated inflammation, and greater improvement in stricture morphology in correlation with treat-to-target therapy intensification, although these differences were not significantly different from standard therapy.
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