Patients who took Entyvio for the treatment of inflammatory bowel disease did not appear to have an increased risk for developing postoperative infections or other complications following nonintestinal surgery, according to research published in Therapeutic Advances in Gastroenterology.
Paulo Gustavo Kotze, MD,
of the IBD Outpatient Clinic at Cajuru University Hospital in Curitiba, Brazil, and colleagues wrote that the impact of Entyvio (vedolizumab, Takeda Pharmaceuticals) and other biologic agents on surgical outcomes has long been debated, and various studies on the topic have provided mixed results.
“The perioperative safety of [vedolizumab] in patients with IBD undergoing intestinal surgical procedures remains controversial, with conflicting data from different tertiary care centers as to whether preoperative [vedolizumab] exposure increases the risk of postoperative infectious complications in IBD surgery,” they wrote. “Data evaluating the real-world impact of [vedolizumab] in nonintestinal operations is lacking.”
Kotze and colleagues conducted a case-matched study at two IBD referral centers to evaluate the preoperative safety of vedolizumab therapy. They included adult patients with Crohn’s disease and ulcerative colitis who underwent surgery during treatment with vedolizumab and matched them 1:1 with patients without vedolizumab therapy according to type of surgical procedure, age and sex. The primary outcomes were overall risk for infectious complications up to 30 days after surgery, readmissions, reoperations, surgical site infections and other infections.
Investigators identified 34 patients treated with vedolizumab who underwent 36 nonintestinal surgeries and matched them with 36 control procedures.
When comparing the vedolizumab group with the control groups, they found no significantly different risk for infectious complications (14% vs. 8%; P = .45), superficial surgical site infections (6% vs. 0%; P = .15), reoperations (6% vs. 3%; P = .56) or readmissions (11% vs. 6%; P = .37).
“For now, there does not appear to be a need to undergo a washout period or delay in surgical intervention related to [vedolizumab] exposure,” Kotze and colleagues wrote. “This may be attributed to [vedolizumab’s] gut-selective mechanism, but further mechanistic research is needed.” – by Alex Young
Disclosures: Kotze reports financial ties to AbbVie, Janssen, Pfizer and Takeda. Please see the full study for all other authors’ relevant financial disclosures.