Intensive drug therapy improves stricture-associated inflammation in CD
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Intensive drug therapy improved symptoms, stricture-associated inflammation and stricture morphology among patients with Crohn’s disease, according to research published in The Lancet Gastroenterology & Hepatology.
“Strictures are the most common structural complication of Crohn’s disease, seen in 10% to 28% of patients at diagnosis and a third of patients 5 years after a diagnosis. ... To date, no drug therapy investigated in randomized trials has been shown to influence the course of stricture development or prevent the need for surgery,” Julien D. Schulberg, MBBS, of the department of gastroenterology at St. Vincent’s Hospital in Melbourne, Australia, and colleagues wrote. “Furthermore, because of the assumption that drug therapy might cause further narrowing and intestinal obstruction as part of the healing process, patients with a known stricture have been excluded from biologic drug registration trials.”
In an open-label, single-center, randomized controlled trial, the Stricture Definition and Treatment study aimed to investigate stricture response to drug treatment and compare effectiveness between intensive drug therapy and standard drug therapy. Of 77 patients with CD and evidence of stricturing and inflammation, 52 patients underwent intensive Humira therapy (adalimumab, AbbVie; 160 mg once weekly for 4 weeks followed by 40 mg every 2 weeks with dose escalation at 4 months) with thiopurine treatment (initial dose of azathioprine 2.5 mg/kg or mercaptopurine 1.5 mg/kg, with dose adjustment) and 25 patients underwent standard adalimumab monotherapy (160 mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks). The primary outcome was decreased 14-day obstructive symptom score by at least 1 point compared with baseline.
At 12 months, researchers observed improvement in obstructive symptom score among 79% of patients in the intensive treatment group and 64% of patients in the standard treatment group (OR = 2.1; 95% CI, 0.73-6.01). Treatment failure occurred in 10% of patients in the intensive treatment group and 28% of patients in the standard treatment group (OR = 0.27; 95% CI, 0.08-0.97); four patients in each group required stricture surgery (OR = 0.44; 95% CI, 0.1-1.92).
Using the stricture MRI activity score, MRI analysis showed a greater than 25% improvement among 61% of patients in the intensive treatment group and 28% of patients in the standard treatment group (OR = 3.99; 95% CI, 1.41-11.26) with complete stricture resolution among 20% and 16% of patients, respectively (OR = 1.28; 95% CI, 0.36-4.57). Researchers additionally noted a greater than 25% improvement in bowel wall thickness using intestinal ultrasound among 51% of patients in the intensive treatment group vs. 33% of patients in the standard treatment group (OR = 2.1; 95% CI, 0.71-6.21).
“Crohn’s disease strictures are responsive to drug treatment. Most patients had improved symptoms and stricture morphology. Treat-to-target therapy intensification resulted in less treatment failure, a reduction in stricture-associated inflammation and greater improvement in stricture morphology, although these differences were not significantly different from standard therapy,” Schulberg and colleagues concluded. “Intensive therapy together with tight control of inflammation leads to the best outcomes.”
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