Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
Long-term Results of Drug Treatment for Crohn's Disease Strictures.
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Lovett Grace C, Schulberg Julien D, Hamilton Amy L, Wright Emily K, Holt Bronte A, Sutherland Tom R, Ross Alyson L, Kamm Michael A
Аннотация
BACKGROUND & AIMS: 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 40 mg fortnightly plus thiopurine, with dose increase at 4 and/or 8 months if evidence of persisting inflammation, or standard dose adalimumab monotherapy. Baseline stricture magnetic resonance imaging risk score was assessed: prestenotic dilation ≥30 mm, stricture length >50 mm, and bowel wall thickness ≥10 mm (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 randomized to the intensive and 25 to the standard treatment arm, with 64 of 77 (83%) completing at least 12 months of therapy, whereas 13 patients (17%) withdrew: 8 for surgical treatment and 5 for other reasons. Following study completion at 12 months, 12 of 77 patients (16%) required endoscopic dilation, and 22 of 77 patients (29%) required surgery. Clinical responders had a lower rate of surgical resection compared with nonresponders (20% vs 52%; P < .001). The stricture magnetic resonance imaging risk score predicted surgery-free survival (odds ratio, 2.34; 95% confidence interval, 1.32-4.16; P = .004).
CONCLUSIONS: The clinical response to adalimumab is durable in a majority of patients beyond 4 years of therapy. In patients with symptomatic Crohn's disease strictures, drug treatment is a viable initial treatment. Stricture Definition and Treatment (STRIDENT) Drug Therapy Study: Clinicaltrials.gov, Number: NCT03220841.
METHODS: Patients with symptomatic Crohn's disease strictures were randomized 2:1 to high-dose adalimumab induction followed by 40 mg fortnightly plus thiopurine, with dose increase at 4 and/or 8 months if evidence of persisting inflammation, or standard dose adalimumab monotherapy. Baseline stricture magnetic resonance imaging risk score was assessed: prestenotic dilation ≥30 mm, stricture length >50 mm, and bowel wall thickness ≥10 mm (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 randomized to the intensive and 25 to the standard treatment arm, with 64 of 77 (83%) completing at least 12 months of therapy, whereas 13 patients (17%) withdrew: 8 for surgical treatment and 5 for other reasons. Following study completion at 12 months, 12 of 77 patients (16%) required endoscopic dilation, and 22 of 77 patients (29%) required surgery. Clinical responders had a lower rate of surgical resection compared with nonresponders (20% vs 52%; P < .001). The stricture magnetic resonance imaging risk score predicted surgery-free survival (odds ratio, 2.34; 95% confidence interval, 1.32-4.16; P = .004).
CONCLUSIONS: The clinical response to adalimumab is durable in a majority of patients beyond 4 years of therapy. In patients with symptomatic Crohn's disease strictures, drug treatment is a viable initial treatment. Stricture Definition and Treatment (STRIDENT) Drug Therapy Study: Clinicaltrials.gov, Number: NCT03220841.