LOS ANGELES – Overall, 44% of inflammatory bowel disease (IBD) patients on vedolizumab had some form of infectious complication following intra-abdominal or anorectal surgery, results from a small single-center study suggest.
According to lead study author Dr. Samuel Eisenstein, there are currently no published surgical outcomes of patients receiving vedolizumab, an integrin receptor antagonist which was approved in May 2014 for the treatment of adults with moderate to severe ulcerative colitis as well as those with moderate to severe Crohn’s disease. “We’re not trying to alienate people who are proponents of the medication,” Dr. Eisenstein said in an interview in advance of the annual meeting of the American Society of Colon and Rectal Surgeons. “It’s an effective medication for treating Crohn’s and ulcerative colitis. We need to have a high index of suspicion that patients may have complications after these surgeries and to treat them with caution until we have better data.”
Dr. Samuel Eisenstein
Dr. Eisenstein and his associates in the section of colon and rectal surgery at Moores Cancer Center, University of California, San Diego, Health System, retrospectively analyzed the medical records of 26 patients with IBD who underwent intra-abdominal or anorectal surgery at the center following treatment with vedolizumab. The patients underwent a total of 36 operations: 27 that were intra-abdominal and 9 that were anorectal. Their mean age was 31 years and 46% were female.
Dr. Eisenstein reported that 17 of the 26 patients (65%) had a Clavien-Dindo grade II or greater complication following 19 operations. In all, 26 complications occurred following these 19 operations, and 53% were infectious in nature. The overall rate of infectious complications following any operation was 44%. In addition, the rate of anastomotic leak was 15%, and two patients died from culture-negative sepsis following abdominal surgery, for an overall mortality rate of 7.7%.
The researchers also observed that there were 23 visits to the emergency room following surgery and 10 hospital readmissions. The only preoperative characteristics that differed significantly between patients who had complications and those who did not were level of hemoglobin (10.6 g/dL vs. 11.9 g/dL, respectively; P = .02) and platelet count (349 vs. 287 K/mm3; P = .025). No differences in the rate of complications were observed based on the number of biologic medications each patient failed prior to the initiation of vedolizumab (P = .718). Compared with patients who had no postoperative complications, those who did were more likely to have undergone intra-abdominal surgery (17 vs. 10 patients; P = .034), require postoperative transfusion (4 vs. none; P = .045), visit the emergency department (10 vs. none; P less than .001), or require hospital readmission (10 vs. none; P less than .001).
Dr. Eisenstein acknowledged certain limitations of the study including its small sample size, single-center, retrospective design, and the potential for selection bias. “The patients who were getting vedolizumab are the patients who failed all of the anti-TNFs, so we’re really selecting patients with the worst, most medically refractory disease,” he noted. “Because of that we can’t say for sure [if the complications] are due to their severity of disease or due to the medication itself.”
The data are “preliminary and retrospectively analyzed, but there is some concern that patients on these types of medications may have an increased risk of postoperative complications,” he concluded. “What we really need are bigger studies. To that end, we are actually starting an IBD collaborative based on some of the findings we have here, because we really want to analyze these data over a much larger population of patients.”
The researchers reported having no financial disclosures.