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COPENHAGEN – Half of patients with ileocecal Crohn’s disease who undergo ileocecal resection within a year of diagnosis remain off drug treatment 5 years post procedure, challenging the current paradigm of reserving surgery for complicated Crohn’s disease, show real-world data comparing outcomes of surgery with anti–tumor necrosis factor inhibitor (TNFi) therapy.
“These data show that resection of inflamed bowel in early ileocecal Crohn’s disease effectively resets the clock,” said Manasi Agrawal, MD, department of gastroenterology, Icahn School of Medicine at Mount Sinai, New York, and research associate, Center for Molecular Prediction of Inflammatory Bowel Disease, Aalborg University, Copenhagen, Denmark, who presented the findings at the annual congress of the European Crohn’s and Colitis Organisation.”These data are in accordance with the LIR!C study data and suggest that ileocecal resection could be a first-line therapeutic option in early ileal or ileocecal Crohn’s disease that could be discussed with our patients.”
While ileocecal resection is accepted as a therapeutic option in early Crohn’s disease, most clinicians reserve it for complicated disease that is refractory or intolerant to medication.
A radical shift in approach might be justified, said Jean-Frederic Colombel, MD, a study coinvestigator and gastroenterologist at Mount Sinai Hospital.
“These data can be transforming. It confirms that there may be a subset of patients with limited ileal Crohn’s disease that is uncomplicated and in whom surgery may be almost ‘curative’ because after follow-up there was no need for drug therapy. We need to reposition surgery as one possible option at diagnosis in patients with limited Crohn’s disease,” he said.
The 2017 LIR!C trial demonstrated comparable 1-year outcomes with ileocecal resection and anti-TNFi therapy in limited, nonstricturing ileocecal Crohn’s disease. A retrospective analysis of 5-year data from this trial, further reinforced ileocecal resection as a first-line option for limited Crohn’s disease, such that of those patients who underwent resection, 26% continued on anti-TNFi therapy, compared with 38% in those patients who took anti-TNFi therapy only. In addition, no patient in the resection group underwent subsequent surgery, whereas 48% of patients on anti-TNF underwent surgery.
Dr. Agrawal and coinvestigators decided that more conclusive, real-world data were needed and would help to determine whether ileocecal resection offered better patient outcomes than staying on anti-TNFi therapy.
The new findings are based on an analysis of 16,443 adults living with ileal Crohn’s disease and were diagnosed between 2003 and 2018. The data is based on an analysis of nationwide Danish registries. It included individuals who underwent
Ileocecal resection or received anti-TNF drugs within 1 year of diagnosis. Of the 16,443 patients diagnosed with Crohn’s disease over the study period, 1,279 had ileal or ileocecal disease and were included with 581 (3.5%) undergoing resection and 698 (4.2%) anti-TNFi index therapy.
Outcomes were compared between the two groups, and the proportions of individuals initiated on immunomodulator, anti-TNFi therapy, or no therapy at 5 years after their ileocecal resection were determined.
The primary outcome was CD-related hospitalization, systemic corticosteroid exposure, CD-related surgery, and perianal CD diagnosis. Crohn’s disease–related hospitalization, systemic corticosteroid use, Crohn’s disease–related surgery or perianal Crohn’s disease occurred in 273 versus 318 people in the ileocecal resection and anti-TNFi therapy groups respectively, equating to a 33% lower risk in the resection group. Of those patients who underwent ileocecal resection, 50.3% were on no treatment 5 years later; 47.5% and 17.1% were on immunomodulators and on anti-TNFi therapy respectively.
Resection was found to be associated with a statistically significant reduced risk of systemic corticosteroid use with an adjusted hazard ratio of 0.71 (95% confidence interval, 0.54-0.92). No statistically significant reduced risk was found for Crohn’s disease-related hospitalization (aHR, 0.79; 95% CI, 0.61-1.01) or perianal Crohn’s disease diagnosis (aHR, 0.70; 95% CI, 0.38-1.30). Adjustments were made for demographic and clinical variables, for example, age, sex, year of treatment, number of hospital contacts for an indication all in the year prior to index treatment.
In comparison with the proportion of resection patients at 5 years who were on no treatment, immunomodulators or anti-TNFi therapy, there are no data on the 5-year outcomes of those patients who began on anti-TNFi therapy, but patients typically continue unless they become intolerant or response starts to fail, Dr. Agrawal said.
Willem Bemelmen, MD, a colorectal surgeon from the University of Amsterdam who served as a moderator after the presentation said: “These results could lead to a paradigm shift in the management of patients with Crohn’s disease. Prior studies gave us early signals that surgery in Crohn’s disease might benefit the patients, but now with these larger scale data, with many patients, we might finally convince gastroenterologists to send patients in for early surgery.”