In the Journals

Stelara appears safe before surgery in Crohn’s disease

Amy L. Lightner, MD
Amy L. Lightner

New research from the Journal of Crohn’s & Colitis showed that patients with Crohn’s disease who received Stelara before abdominal surgery showed no increase in risk for postoperative infectious complications compared with patients treated with anti-tumor necrosis factor agents.

Stelara (ustekinumab, Janssen) “has been recently approved by the FDA for the treatment of Crohn’s disease,” Amy L. Lightner, MD, study author and surgeon at the Mayo Clinic, told Healio Gastroenterology and Liver Disease. “Given that some biologics have been associated with an increase in postoperative outcomes, we sought to determine if preoperative use of ustekinumab was associated with a significant increase in postoperative outcomes.”

Given the limited number of surgical patients treated with ustekinumab, Lightner and colleagues formed a consortium between the Mayo Clinic in Rochester Minn., University of Chicago, Cedars Sinai in Los Angeles, Pennsylvania State Hershey Medical Center, University Hospital Leuven in Belgium and Humanitas University in Milan Italy, “to gather a larger cohort of patients and better answer our question,” she said.

They performed a retrospective chart review and compared the rates of 30-day postoperative surgical site infection (SSI) between 44 patients treated with ustekinumab (61% women; median age, 35 years) and 169 patients treated with anti-TNFs within 12 weeks prior to a major abdominal surgery between January 2015 and May 2017. The groups were similar except those treated with anti-TNFs more often received combination therapy with an immunomodulator (P = .006).

Both groups showed statistically similar rates of postoperative SSI (13% vs. 20%) and hospital readmission (18% vs. 10%). However, patients treated with ustekinumab did show higher rates of returning to the operating room (16% vs. 5%; P = .01).

Multivariable analysis revealed no significant predictors of postoperative SSI.

“No significant difference was found in postoperative surgical site infections or hospital readmissions,” Lightner said. “These findings suggest that ustekinumab treatment within 12 weeks of surgery does not appear to increase the risk of postoperative SSI above that of CD patients treated with anti-TNF medications.”

However, Lightner and colleagues noted that the small number of patients included in the study requires further research in a larger cohort to confirm these findings. – by Adam Leitenberger

Disclosures: Lightner reports she is a consultant for Takeda. Please see the full study for a list of all other authors’ relevant financial disclosures.

Amy L. Lightner, MD
Amy L. Lightner

New research from the Journal of Crohn’s & Colitis showed that patients with Crohn’s disease who received Stelara before abdominal surgery showed no increase in risk for postoperative infectious complications compared with patients treated with anti-tumor necrosis factor agents.

Stelara (ustekinumab, Janssen) “has been recently approved by the FDA for the treatment of Crohn’s disease,” Amy L. Lightner, MD, study author and surgeon at the Mayo Clinic, told Healio Gastroenterology and Liver Disease. “Given that some biologics have been associated with an increase in postoperative outcomes, we sought to determine if preoperative use of ustekinumab was associated with a significant increase in postoperative outcomes.”

Given the limited number of surgical patients treated with ustekinumab, Lightner and colleagues formed a consortium between the Mayo Clinic in Rochester Minn., University of Chicago, Cedars Sinai in Los Angeles, Pennsylvania State Hershey Medical Center, University Hospital Leuven in Belgium and Humanitas University in Milan Italy, “to gather a larger cohort of patients and better answer our question,” she said.

They performed a retrospective chart review and compared the rates of 30-day postoperative surgical site infection (SSI) between 44 patients treated with ustekinumab (61% women; median age, 35 years) and 169 patients treated with anti-TNFs within 12 weeks prior to a major abdominal surgery between January 2015 and May 2017. The groups were similar except those treated with anti-TNFs more often received combination therapy with an immunomodulator (P = .006).

Both groups showed statistically similar rates of postoperative SSI (13% vs. 20%) and hospital readmission (18% vs. 10%). However, patients treated with ustekinumab did show higher rates of returning to the operating room (16% vs. 5%; P = .01).

Multivariable analysis revealed no significant predictors of postoperative SSI.

“No significant difference was found in postoperative surgical site infections or hospital readmissions,” Lightner said. “These findings suggest that ustekinumab treatment within 12 weeks of surgery does not appear to increase the risk of postoperative SSI above that of CD patients treated with anti-TNF medications.”

However, Lightner and colleagues noted that the small number of patients included in the study requires further research in a larger cohort to confirm these findings. – by Adam Leitenberger

Disclosures: Lightner reports she is a consultant for Takeda. Please see the full study for a list of all other authors’ relevant financial disclosures.