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Surgery a reasonable alternative to biologics in some Crohn’s patients
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Laparoscopic ileocecal resection may be an alternative to biologic therapy in patients with limited, non-stricturing ileocecal Crohn’s disease who failed conventional therapies, according to the results of a randomized controlled trial.
“Effectiveness of laparoscopic ileocecal resection and infliximab [Remicade, Janssen] in restoring quality of life has previously been shown, but no randomized controlled trials had compared these strategies directly,” Willem A. Bemelman, MD, of the department of surgery at the Academic Medical Center in Amsterdam, and colleagues wrote. “We showed that laparoscopic ileocecal resection did not improve quality-of-life scores to a significantly greater extent than infliximab treatment, but results in similar quality-of-life scores and is not associated with more serious adverse events.”
In the open-label study, Bemelman and colleagues randomly assigned adults with non-stricturing ileocecal Crohn’s disease who failed conventional therapy to undergo the surgery (n = 73) or receive infliximab therapy (n = 70) at 29 centers in the Netherlands and the U.K. between 2008 and 2015. They excluded patients with a diseased terminal ileum longer than 40 cm or abdominal abscesses.
After a year, QOL measured by the IBD Questionnaire (the primary endpoint) was not significantly different between groups, nor was general QOL measured by the SF-36 survey and its physical and mental component scores.
Average number of sick days taken at work were significantly higher in the surgery group (3.4 vs. 1.4 days; P < .0001), but the number of days patients were unable to participate in their social lives were comparable, as were hospital visits and body image.
Four patients in the surgery group experienced a serious complication related to the procedure, and two patients who received infliximab experienced a treatment-related serious adverse event.
Finally, during a median follow-up of 4 years, 37% of patients who received infliximab required a resection, while 26% of the resection group later required anti-TNF therapy.
“On the basis of these data, we believe that laparoscopic ileocecal resection should be offered as an alternative to infliximab therapy in patients with limited, non-stricturing, ileocecal Crohn’s disease that does not respond to conventional therapy,” Bemelman and colleagues concluded. – by Adam Leitenberger
Disclosures: Bemelman reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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