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determined [ 17 ]. Definition of perioperative treatment included exposure of ther-
apy with infliximab, corticosteroids, or immunomodulators up to 6 months
before surgery. Surgical inclusion was exclusive to IPAA, either two- or three-
stage procedures.
A total of 301 patients was included in the study—47 of whom received
infliximab. A higher percentage of the infliximab-treated arm suffered with
severe colitis (p = 0.02) with the main indication for surgery being medical
refractory disease. Although two- and three-stage IPAA were included in the
study, majority underwent two-stage procedure with closure of the ileostomy at
a mean of 3.1 months in both groups. A higher number of patients in the inflix-
imab-treated arm were exposed to corticosteroids (89% vs. 86%, p < 0.001), on
concurrent azathioprine (AZA) (91% vs. 44%, p < 0.0001), and treated with
combination of high-dose corticosteroids, ASA, and AZA (70% vs. 19.3%,
p < 0.001) [ 17 ].
Using univariate analysis, infliximab demonstrated an increase in pouch-specific
complications (OR = 3.5, 95% CI, 1.6–7.5). However, adjusting for age, severity of
colitis, and use of high-dose steroids and AZA/6-MP, there were no further increased
odds of pouch-specific complications. Rates of infectious complications (including
anastomotic leak, pelvic abscess, and wound infection) in the infliximab-treated
arm exceeded the control arm (28% vs. 10%, OR = 3.5; 95% CI, 1.6–7.5), as well
as anastomotic leaks and wound infections, without a significant difference in post-
operative fistula or anastomotic stricture frequency. The study concluded that preop-
erative exposure to infliximab significantly increased rate of postoperative infectious
complications, with nearly one in five experiencing adverse events. This becomes
important since anastomotic leaks and pelvic abscesses play an important role in
long-term pouch function [ 17 , 18 ].
At the Cleveland Clinic, early and late postoperative complications were ana-
lyzed between January 2000 and December 2006 on chronic UC patients exposed
to infliximab and matched controls undergoing two-stage restorative proctocolec-
tomy [ 16 ]. Early complications were defined as within 30 days after ileostomy clo-
sure, whereas late complications were those that developed after 30 days of
ileostomy closure (e.g., pouchitis, small bowel obstructions, and anastomotic stric-
tures). This study differed in that timing of infliximab did not have to meet inclu-
sion/exclusion criteria; timing ranged between 4 and 37 weeks, a median of
13.5 weeks and three infusions.
An aggregate of 85 patients received infliximab out of 523 total ileal pouches.
The extent and severity of colitis, in addition to steroid exposure preceding surgery
(11–20 mg) and immunomodulators, were comparable in the infliximab and non-
infliximab arms. Results of the study revealed a higher prevalence of pelvic sepsis
as an early complication (22% vs. 2%, p = 0.016), with parallel rates of postopera-
tive hemorrhage, venous thrombosis, and ileus. Later complications of pouchitis
were found at a higher prevalence in the infliximab exposed arm (39% vs. 15%,
p = 0.037), whereas overall late morbidity, small bowel obstruction, and IPAA stric-
tures were similar between the two groups.
A. Kamal and B. Lashner