TY - JOUR
T1 - Vedolizumab and early postoperative complications in nonintestinal surgery
T2 - a case-matched analysis
AU - Kotze, Paulo Gustavo
AU - Ma, Christopher
AU - Mckenna, Nicholas
AU - Almutairdi, Abdulelah
AU - Kaplan, Gilaad G.
AU - Raffals, Laura E.
AU - Loftus, Edward V.
AU - Panaccione, Remo
AU - Lightner, Amy L.
N1 - Publisher Copyright:
© The Author(s), 2018.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - Background: Vedolizumab (VDZ) is a gut-specific α4-β7 integrin antagonist that has demonstrated efficacy in Crohn’s disease (CD) and ulcerative colitis (UC). The safety of VDZ in the perioperative period remains unclear. The aim of this study was to evaluate postoperative complications and perioperative safety in VDZ-treated patients undergoing nonintestinal operations. Methods: A case-matched study was performed at two inflammatory bowel disease (IBD) referral centers. Adult patients with CD and UC who underwent a nonintestinal surgical procedure during treatment with VDZ were included. Patients who had their last VDZ infusion up to 12 weeks before the procedure were considered exposed and were matched in a 1:1 ratio to patients without VDZ therapy, according to type of surgical procedure, age, and sex. The primary outcome was overall risk of early postoperative infectious complications (up to 30 days after surgery), readmissions, reoperations, surgical site infections, and other infections. The VDZ and control groups were subsequently compared using the Pearson χ2 test and Wilcoxon rank sum. Results: We identified 34 patients treated with VDZ who underwent 36 nonintestinal surgical procedures. These patients were matched with 36 control procedures. Postoperative complications were not different between the VDZ-treated and control cohorts for all outcomes analyzed: infectious complications occurred in 14% versus 8% (p = 0.45), superficial surgical site infections 6% versus 0% (p = 0.15), reoperations 6% versus 3% (p = 0.56) and readmissions 11% versus 6% (p = 0.37). Conclusions: VDZ-treated patients with IBD undergoing nonintestinal procedures did not have an increased risk of overall postoperative infections or other complications compared with matched controls.
AB - Background: Vedolizumab (VDZ) is a gut-specific α4-β7 integrin antagonist that has demonstrated efficacy in Crohn’s disease (CD) and ulcerative colitis (UC). The safety of VDZ in the perioperative period remains unclear. The aim of this study was to evaluate postoperative complications and perioperative safety in VDZ-treated patients undergoing nonintestinal operations. Methods: A case-matched study was performed at two inflammatory bowel disease (IBD) referral centers. Adult patients with CD and UC who underwent a nonintestinal surgical procedure during treatment with VDZ were included. Patients who had their last VDZ infusion up to 12 weeks before the procedure were considered exposed and were matched in a 1:1 ratio to patients without VDZ therapy, according to type of surgical procedure, age, and sex. The primary outcome was overall risk of early postoperative infectious complications (up to 30 days after surgery), readmissions, reoperations, surgical site infections, and other infections. The VDZ and control groups were subsequently compared using the Pearson χ2 test and Wilcoxon rank sum. Results: We identified 34 patients treated with VDZ who underwent 36 nonintestinal surgical procedures. These patients were matched with 36 control procedures. Postoperative complications were not different between the VDZ-treated and control cohorts for all outcomes analyzed: infectious complications occurred in 14% versus 8% (p = 0.45), superficial surgical site infections 6% versus 0% (p = 0.15), reoperations 6% versus 3% (p = 0.56) and readmissions 11% versus 6% (p = 0.37). Conclusions: VDZ-treated patients with IBD undergoing nonintestinal procedures did not have an increased risk of overall postoperative infections or other complications compared with matched controls.
KW - antibodies
KW - infection
KW - inflammatory bowel diseases
KW - integrins
KW - monoclonal
KW - postoperative complications
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U2 - 10.1177/1756284818783614
DO - 10.1177/1756284818783614
M3 - Article
AN - SCOPUS:85054798519
SN - 1756-283X
VL - 11
JO - Therapeutic Advances in Gastroenterology
JF - Therapeutic Advances in Gastroenterology
ER -