TY - JOUR
T1 - Biologics and 30-Day Postoperative Complications after Abdominal Operations for Crohn's Disease
T2 - Are There Differences in the Safety Profiles?
AU - Lightner, Amy L.
AU - McKenna, Nicholas P.
AU - Alsughayer, Ahmad
AU - Harmsen, William S.
AU - Taparra, Kekoa
AU - Parker, Maile E.
AU - Raffals, Laura E.
AU - Loftus, Edward V.
N1 - Funding Information:
Funding/Support: None reported. Financial Disclosure: Dr Lightner received consultant fees from Takeda; Dr Loftus received research support from UCB, Takeda, Janssen, AbbVie, Amgen, Pfizer, Genentech, Seres Therapeutics, Receptos, Gilead, Celgene, Medimmune, and Robarts Clinical Trials and is a consultant for UCB, Takeda, Janssen, AbbVie, Amgen, Pfizer, Eli Lilly, Celltrion Healthcare, Ltd, and Napo Pharmaceuticals.
Publisher Copyright:
© 2019 The ASCRS.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - BACKGROUND: The evidence regarding the association of preoperative biologic exposure and postoperative outcomes remains controversial for both antitumor necrosis factor agents and vedolizumab and largely unknown for ustekinumab. OBJECTIVE: The purpose of this study was to determine differences in the rates of 30-day postoperative overall infectious complications and intra-abdominal septic complications among the 3 classes of biologic therapies as compared with no biologic therapy. DESIGN: This was a retrospective review. SETTINGS: The study was conducted at an IBD referral center. PATIENTS: Adult patients with Crohn's disease who received an antitumor necrosis factor, vedolizumab, ustekinumab, or no biologic therapy within 12 weeks of a major abdominal operation between May 20, 2014, and December 31, 2017, were included. MAIN OUTCOMES MEASURES: Thirty-day overall postoperative infectious complications and intra-abdominal septic complications were measured. RESULTS: A total of 712 patients with Crohn's disease were included; 272 patients were exposed to an antitumor necrosis factor agents, 127 to vedolizumab, 38 to ustekinumab, and 275 to no biologic therapy within the 12 weeks before an abdominal operation. Patients exposed to a biologic were more likely to be taking a concurrent immunomodulator, but there was no difference in concurrent corticosteroid usage. The particular class of biologic was not independently associated with total overall infectious complications. Vedolizumab was associated with an increased rate of intra-abdominal sepsis on univariate analysis but not on multivariable analysis. Combination immunosuppression was associated with both an increased rate of overall postoperative infectious complications and intra-abdominal sepsis. LIMITATIONS: The study was limited by its retrospective design and single-center data. CONCLUSIONS: The overall rate of total infectious complications or intra-abdominal septic complications was not increased based on preoperative exposure to a particular class of biologic. Rates increased with combination immunosuppression of biologic therapy with corticosteroids and previous abdominal resection.
AB - BACKGROUND: The evidence regarding the association of preoperative biologic exposure and postoperative outcomes remains controversial for both antitumor necrosis factor agents and vedolizumab and largely unknown for ustekinumab. OBJECTIVE: The purpose of this study was to determine differences in the rates of 30-day postoperative overall infectious complications and intra-abdominal septic complications among the 3 classes of biologic therapies as compared with no biologic therapy. DESIGN: This was a retrospective review. SETTINGS: The study was conducted at an IBD referral center. PATIENTS: Adult patients with Crohn's disease who received an antitumor necrosis factor, vedolizumab, ustekinumab, or no biologic therapy within 12 weeks of a major abdominal operation between May 20, 2014, and December 31, 2017, were included. MAIN OUTCOMES MEASURES: Thirty-day overall postoperative infectious complications and intra-abdominal septic complications were measured. RESULTS: A total of 712 patients with Crohn's disease were included; 272 patients were exposed to an antitumor necrosis factor agents, 127 to vedolizumab, 38 to ustekinumab, and 275 to no biologic therapy within the 12 weeks before an abdominal operation. Patients exposed to a biologic were more likely to be taking a concurrent immunomodulator, but there was no difference in concurrent corticosteroid usage. The particular class of biologic was not independently associated with total overall infectious complications. Vedolizumab was associated with an increased rate of intra-abdominal sepsis on univariate analysis but not on multivariable analysis. Combination immunosuppression was associated with both an increased rate of overall postoperative infectious complications and intra-abdominal sepsis. LIMITATIONS: The study was limited by its retrospective design and single-center data. CONCLUSIONS: The overall rate of total infectious complications or intra-abdominal septic complications was not increased based on preoperative exposure to a particular class of biologic. Rates increased with combination immunosuppression of biologic therapy with corticosteroids and previous abdominal resection.
KW - Antitumor necrosis factor
KW - Biologics
KW - Crohn's disease
KW - Postoperative outcomes
KW - Ustekinumab
KW - Veolizumab
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UR - http://www.scopus.com/inward/citedby.url?scp=85073126309&partnerID=8YFLogxK
U2 - 10.1097/DCR.0000000000001482
DO - 10.1097/DCR.0000000000001482
M3 - Article
C2 - 31567927
AN - SCOPUS:85073126309
SN - 0012-3706
VL - 62
SP - 1352
EP - 1362
JO - Diseases of the Colon and Rectum
JF - Diseases of the Colon and Rectum
IS - 11
ER -