TY - JOUR
T1 - Risk of Postoperative Complications among Inflammatory Bowel Disease Patients Treated Preoperatively with Vedolizumab
AU - Yamada, Akihiro
AU - Komaki, Yuga
AU - Patel, Nayan
AU - Komaki, Fukiko
AU - Aelvoet, Arthur S.
AU - Tran, Anthony L.
AU - Pekow, Joel
AU - Dalal, Sushila
AU - Cohen, Russell D.
AU - Cannon, Lisa
AU - Umanskiy, Konstantin
AU - Smith, Radhika
AU - Hurst, Roger
AU - Hyman, Neil
AU - Rubin, David T.
AU - Sakuraba, Atsushi
N1 - Funding Information:
Guarantor of the article: Atsushi Sakuraba, M.D., Ph.D. Specific author contribution: A.Y., Y.K. and F.K., analysis of data and drafting of manuscript; N.Y., analysis of data and approval of manuscript; A.S.A., A.L.T., J.P., S.D., R.D.C., L.C., K.U., R.S., R.H., N.H. and D.T.R., critical review and approval of manuscript; A.S., study concept and design, analysis of data and writing of manuscript. Financial support: None. Potential competing interests: A.Y., F.K., N.P., A.S.A., A.L.T., K.U., R.S., R.H., N.H. and D.T.R.; none. Y.K. was supported by the Pediatric Oncology Research Fellowship of the Children’s Cancer Association of Japan. J.P.; research grants from Takeda and Abbvie. S.D.; investigator initiated research grant from Pfizer. R.D.C.; consultant and/or scientific advisory board for Abbvie, Celgene, Entera Health, Hospira, Janssen, Pfizer, Sandoz Biopharmaceuticals, Takeda, and UCB Pharma. Speaker’s bureau for Abbvie, and Takeda. A.S.; collaborative research with Abbvie.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - Objectives:Vedolizumab is increasingly used to treat patients with ulcerative colitis (UC) and Crohn's disease (CD), however, its safety during the perioperative period remains unclear. We compared the 30-day postoperative complications among patients treated preoperatively with vedolizumab, anti-tumor necrosis factor (TNF)-α agents or non-biological therapy.Methods:The retrospective study cohort was comprised of patients receiving vedolizumab, anti-TNF-α agents or non-biological therapy within 4 weeks of surgery. The rates of 30-day postoperative complications were compared between groups using univariate and multivariate analysis. Propensity score-matched analysis was performed to compare the outcome between groups.Results:Among 443 patients (64 vedolizumab, 129 anti-TNF-α agents, and 250 non-biological therapy), a total of 144 patients experienced postoperative complications (32%). In multivariate analysis, age >65 (odds ratio (OR) 3.56, 95% confidence interval (CI) 1.30-9.76) and low-albumin (OR 2.26, 95% CI 1.28-4.00) were associated with increased risk of 30-day postoperative complications. For infectious complications, steroid use (OR 3.67, 95% CI 1.57-8.57, P=0.003) and low hemoglobin (OR 3.03, 95% CI 1.32-6.96, P=0.009) were associated with increased risk in multivariate analysis. Propensity score matched analysis demonstrated that the risks of postoperative complications were not different among patients preoperatively receiving vedolizumab, anti-TNF-α agents or non-biological therapy (UC, P=0.40; CD, P=0.35).Conclusions:In the present study, preoperative vedolizumab exposure did not affect the risk of 30-day postoperative complications in UC and CD. Further, larger studies are required to confirm our findings.
AB - Objectives:Vedolizumab is increasingly used to treat patients with ulcerative colitis (UC) and Crohn's disease (CD), however, its safety during the perioperative period remains unclear. We compared the 30-day postoperative complications among patients treated preoperatively with vedolizumab, anti-tumor necrosis factor (TNF)-α agents or non-biological therapy.Methods:The retrospective study cohort was comprised of patients receiving vedolizumab, anti-TNF-α agents or non-biological therapy within 4 weeks of surgery. The rates of 30-day postoperative complications were compared between groups using univariate and multivariate analysis. Propensity score-matched analysis was performed to compare the outcome between groups.Results:Among 443 patients (64 vedolizumab, 129 anti-TNF-α agents, and 250 non-biological therapy), a total of 144 patients experienced postoperative complications (32%). In multivariate analysis, age >65 (odds ratio (OR) 3.56, 95% confidence interval (CI) 1.30-9.76) and low-albumin (OR 2.26, 95% CI 1.28-4.00) were associated with increased risk of 30-day postoperative complications. For infectious complications, steroid use (OR 3.67, 95% CI 1.57-8.57, P=0.003) and low hemoglobin (OR 3.03, 95% CI 1.32-6.96, P=0.009) were associated with increased risk in multivariate analysis. Propensity score matched analysis demonstrated that the risks of postoperative complications were not different among patients preoperatively receiving vedolizumab, anti-TNF-α agents or non-biological therapy (UC, P=0.40; CD, P=0.35).Conclusions:In the present study, preoperative vedolizumab exposure did not affect the risk of 30-day postoperative complications in UC and CD. Further, larger studies are required to confirm our findings.
UR - http://www.scopus.com/inward/record.url?scp=85028869546&partnerID=8YFLogxK
U2 - 10.1038/ajg.2017.201
DO - 10.1038/ajg.2017.201
M3 - Article
C2 - 28719595
AN - SCOPUS:85028869546
SN - 0002-9270
VL - 112
SP - 1423
EP - 1429
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 9
ER -