Pediatric inflammatory bowel disease (IBD) patients on vedolizumab who undergo surgery may be at increased risk of postoperative complications, a new study in 31 patients suggests.
"Pediatric patients who have severe disease who get vedolizumab tend to have a number of complications, and most specifically they have an increase in mucocutaneous separation at the stoma," Dr. Lori A. Zimmerman of Boston Children's Hospital, the first author of the new study, told Reuters Health in an interview.
The findings were published online December 16 in the Journal of Pediatric Surgery.
Dr. Zimmerman and her colleagues conducted the study after observing that some patients on vedolizumab did not do well after surgery. "This was a newer medication that we had just started using, so we decided to review our experience and see if it was just with one or two patients or if it was a consistent problem."
The U.S. Food and Drug Administration approved vedolizumab (Entyvio, Takeda) for treating IBD in adults in 2014. The drug works by inhibiting leukocyte migration to the gut, Dr. Zimmerman noted, which is important for wound healing.
She and her colleagues, from 2014 to 2016, identified 31 children with Crohn's disease (CD) and ulcerative colitis (UC) who were treated with vedolizumab at their hospital; 13 required surgery. Sixteen vedolizumab-naive patients who underwent diverting ileostomy served as a control group.
Post-op complications occurred in eight, or 62%, of the surgery patients on vedolizumab: three with mucocutaneous separation of the stoma, three who required hospital readmission for pain/dehydration, and one each with bowel obstruction at the ostomy and intraoperative colonic perforation.
Four of the 16 controls (25%) had complications after surgery, including readmission for ileus and for high stoma output with mucocutaneous separation.
"There was not a statistically significant difference, but there certainly seemed to be a trend, and the biggest trend was with this mucocutaneous separation of the stoma," Dr. Zimmerman said.
Studies of vedolizumab have shown benefit for patients with UC or colonic Crohn's, she noted, but the medication takes up to 12 weeks to work. "I think the effect in Crohn's disease is a little bit more questionable," the researcher said, noting that initial trials of the drug have excluded patients who had surgery.
"What I've taken home from this study is that if I have a really severely ill Crohn's or colitis patient, my recommendation would have been to move forward with colectomy," Dr. Zimmerman said. "I would discuss with them that vedolizumab is an option, that it's likely only going to cause more complications down the road, either from the medication itself or from waiting too long when clearly the path forward is surgery."
"In pediatrics especially, we try to optimize medical management as much as possible," she added, "but sometimes surgery is the right option for a patient."
"Patient safety is Takeda's primary concern, and we are committed to the continuous monitoring and evaluation of safety information globally for Takeda products," a company representative told Reuters Health in an email. "The safety and efficacy of vedolizumab in patients <18 years of age has not yet been established, and is not approved for use in people under the age of 18."
"In Phase 3 trials involving vedolizumab in an adult population, no clear difference was observed in the incidence of postoperative adverse events between vedolizumab and placebo," the Takeda representative went on to say. "The benefit risk balance of vedolizumab use in authorized populations has not changed, and our prescribing and patient information accurately reflects our current understanding of the safety profile of vedolizumab."
