麻豆传媒

For inflammatory bowel disease (IBD) patients undergoing intra-abdominal surgery, exposure to tumor necrosis factor (TNF) inhibitors in the weeks beforehand was not associated with more postoperative infectious complications, a prospective study found.

In the study of close to 1,000 patients, infections within 30 days of surgery were no different between those who had exposure to TNF inhibitors in the prior 12 weeks and those who did not (18.1% vs 20.2%, respectively), which held up in a multivariable analysis that adjusted for demographics, steroid use, and disease type (OR 1.05, 95% CI 0.72-1.54), reported Benjamin Cohen, MD, of the Cleveland Clinic in Ohio, and colleagues.

Surgical site infections (SSIs) were also not significantly higher in the TNF inhibitor-exposed group (12.0% vs 12.6%; OR 1.25, 95% CI 0.79-1.96), nor were there differences in 30-day readmissions, need for reoperation, postoperative ileus, or length of hospital stay between the two groups, according to the findings in .

"Preoperative use of TNFi [TNF inhibitor] should not affect surgical decisions in most IBD patients," the group concluded, noting that neither the use of TNF inhibitors nor detectable serum concentrations of the drug were independent risk factors for infection.

"There is no reason to delay Crohn's disease surgery if a patient is on a TNF inhibitor, and there is no need to perform a diverting ileostomy just because a patient is on a TNFi," said Miguel Regueiro, MD, also of the Cleveland Clinic, but who was not involved in this study.

"A common surgical practice had been to create a temporary diverting ileostomy in patients on a TNFi due to a concern over postoperative infections," he told 麻豆传媒.

Despite effective regimens for moderate to severe ulcerative colitis and Crohn's disease, need for surgery remains high, Cohen's group noted, and roughly half of patients present with recent TNF inhibitor exposure before surgery.

Due to the lack of a large prospective study, it remained controversial whether preoperative use of immunosuppressive therapies raised infection risk. Two French prospective studies -- and -- that assessed preoperative TNF inhibitor use and its association with postoperative infectious complications after ileocolic resection in Crohn's disease found conflicting results.

The current study -- PUCCINI (Study to Determine Risk Factors for Post-operative Infection in Inflammatory Bowel Disease) -- is the largest prospective data to date to evaluate this potential risk.

included 947 IBD patients who were undergoing intra-abdominal surgery from September 2014 through June 2017 at one of 17 sites of the Crohn's & Colitis Foundation Clinical Research Alliance, including 640 patients with Crohn's disease and 307 with ulcerative colitis.

Of those, 382 were exposed to TNF inhibitors within the prior 12 weeks -- mostly infliximab (Remicade) and adalimumab (Humira) -- and the remaining 565 patients (unexposed group) either had no TNF inhibitor exposure at all (n=224) or it was outside the 12-week window (n=341).

Overall, 52% of the patients were men, median age was 39 years, and the average disease duration was 10 years. One-third had a prior bowel resection, and 18% had prior abdominal surgery. The most common comorbidities included anemia or a blood disease in roughly one-fourth of patients, depression in 17%, hypertension in 12%, and osteoarthritis/degenerative arthritis in 9%. Within 2 weeks of surgery, 41% used systemic corticosteroids and 42% had used antibiotics.

Those recently exposed to TNF inhibitors tended to be younger (39 vs 43 years in the unexposed group), have a shorter disease duration (11 vs 14 years), and a lower self-reported comorbidity score. Hospitalizations within the past 30 days were higher in the TNF inhibitor-exposed group (22% vs 15%), while fewer had prior bowel resections (28% vs 39%).

In the TNF inhibitor-exposed group, 6.3% had superficial incisional infections, 1.6% had deep incisional infections, and 4.2% had SSIs in the organ space. For the unexposed group, these rates were 5.3%, 1.9%, and 5.3%, respectively (P=0.889).

For non-infectious postoperative complications, venous thromboembolism was significantly associated with preoperative TNF inhibitor use, even after adjusting for preoperative corticosteroids (OR 2.64, 95% CI 1.10-6.37).

The authors acknowledged some limitations to the data, including non-consecutive patient enrollment, and that the inclusion of primarily academic centers may affect generalizability.

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