Surgery an alternative to infliximab for some people with Crohn's disease

Last Updated: 2017-09-20

By Marilynn Larkin

NEW YORK (Reuters Health) - Laparoscopic ileocecal resection is a "reasonable alternative" to infliximab in people with limited, non-stricturing ileocecal Crohn's disease (CD) for whom conventional treatment fails, researchers in the Netherlands suggest.

Dr. Willem Bemelman of Academisch Medisch Centrum in Amsterdam and colleagues conducted a multicenter, open-label randomized trial comparing laparoscopic ileocecal resection with infliximab in patients with active CD of the terminal ileum who had not responded to at least three months of conventional therapy with steroids, thiopurines or methotrexate.

The primary outcome was quality of life, as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, as measured by the Short Form-36 health survey and its component subscales, and other factors.

Between 2008 and 2015, 143 patients (mean age, 27; 33% men) from the Netherlands and the UK were randomly assigned either to undergo resection or to receive infliximab.

As reported in The Lancet Gastroenterology and Hepatology, online August 21, after correction for baseline differences, mean scores at 12 months were 178.1 in the resection group versus 172.0 in the infliximab group for the IBDQ, and 112.1 versus 106.5 for the total SF-36 score. Both between-groups differences were not statistically significant.

Mean scores at 12 months for the SF-36 physical and mental component subscales were 47.7 and 49.5 for the resection group versus 44.6 and 46.1 in the infliximab group. Only the physical subcomponent showed a significant advantage with resection.

Other measures included mean number of days of sick leave (3.4 with resection vs. 1.4 with infliximab); days not able to take part in social life (1.8 vs. 1.1); days of scheduled hospital admission (6.5 vs. 6.8); and the number of patients who had unscheduled hospital admissions (13 vs. 15).

Serious surgical intervention-related complications occurred in four patients in the resection group, whereas two patients in the infliximab group had treatment-related serious adverse events.

During a median follow-up of four years, 37% of the infliximab group underwent resection and 26% of the resection group received anti-TNF therapy.

Three experts not involved in the study provided their views in emails to Reuters Health.

Dr. Louis Cohen of Mount Sinai Hospital in New York City called the study "critically important," noting that "due to perceived concerns about the risks of surgery, the entrenched dogma of Crohn's therapy has been that surgery follows a failure in medical therapy."

"That 75% of patients in the surgical group were free of biologic medications during follow-up almost certainly suggests other potential benefits . . . related to cost, something the authors hint at but do not report in this study," he observed.

"I am thrilled to see these two treatments compared in such a well-designed study, as I believe the study confirms suspicions that many physicians who care for Crohn's patients have - namely, that surgery can provide a safe and effective therapy for certain patients and offer them perhaps a more direct path to a durable remission," he concluded.

Dr. David Rubin, Chief of the Section of Gastroenterology, Hepatology, and Nutrition at the University of Chicago Medicine, agreed: "For some patients, as difficult as it may seem, a surgical intervention early in their disease will enable better control and, as this study shows, an excellent quality of life later."

"I often explain to patients that one of the most significant advances in the management of CD has been our ability to prevent it after an expert surgical resection," he said. "There is more work to be done to better understand which patients would benefit most from this approach. Nonetheless, this study provides us with the information necessary to have informed discussions with our patients about treatment options."

Dr. Robin Rothstein, of the Lewis Katz School of Medicine at Temple University in Philadelphia, said that despite the "interesting" findings, "it is premature to suggest that surgery is a good alternative to medical treatment for patients with Crohn's disease."

"Prior studies have demonstrated a reduction in the rate of surgery, hospitalization and complications of disease with . . . biologic therapy," she observed. "Additionally, early intervention with these treatments may reduce the development of complications of disease."

"A major issue with this study is that there is no objective measure of disease," Dr. Rothstein continued. Future studies should include "imaging studies of the bowel or endoscopic procedures to directly evaluate disease activity."

"There are significant costs with the use of biologic therapy," she acknowledged. "Their use has become a leading factor in the overall expense in treating patients with IBD."

"However," she concluded, "this has to be balanced with the cost of surgery, lost income from time off and the cost of subsequent care, as many patients will continue to need treatment."

Dr. Bemelman did not respond to requests for comment.

SOURCE: http://bit.ly/2wsPcnn

Lancet Gastroenterol Hepatol 2017.