Pediatric inflammatory bowel disease (IBD) patients on vedolizumab who undergo surgery may be at increased risk of postoperative complications , a new study published in  Journal of Pediatric Surgery  suggests.

"Pediatric patients who have severe disease who get vedolizumab tend to have a number of complications, and most of them have an increase in mucocutaneous separation at the stoma," said Dr. Lori A. Zimmerman of Boston Children's Hospital.

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 US 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 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 8 ( 62% ) of the surgery patients on vedolizumab: 3 with mucocutaneous separation of the stoma, 3 who required hospital readmission for pain/dehydration, and one each with bowel obstruction at the ostomy and intraoperative colonic perforation, when compared to 25% of the controls.

"There was not a statistically significant difference, but there seemed to be a tendency, 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, he 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.

"If I have a 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 to go to cause more complications down the road."

"In pediatrics especially, we try to optimize medical management as much as possible," said first author Dr. Zimmerman. "But sometimes surgery is the right option for a patient," she added.

"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 reflects our current understanding of the safety profile of vedolizumab."