135(p ≤ 0.009) [ 7 ]. Subsequently infliximab received FDA approval for the treatment
of moderate-to-severe UC and endorsement by the American Gastroenterology
Association as an agent to treat hospitalized patients with severe UC [ 4 ]. When
disease surpasses medical salvage, restorative proctocolectomy (RP) and ileal
pouch-anal anastomosis (IPAA) become the procedure of choice. Determining one-,
two-, or three-stage RP is based on the severity of systemic illness and degree of
inflammation. Two-stage procedure is defined as a total proctocolectomy and ileal
pouch construction with covering loop ileostomy and then subsequent closure of
ileostomy marking the second stage. Three-stage procedure is frequently utilized in
acutely ill patients on high-dose steroids, immunomodulators, or severe colon and
rectal inflammation [ 16 ]. Similar to Crohn’s disease, the question regarding safety
of preoperative anti-TNF agents and risk of postoperative complications emerged
after the introduction of infliximab for moderate-to-severe UC. Thus, multiple stud-
ies were designed in the attempt to answer this question.
One of the initial studies to investigate the influence of infliximab on surgical
morbidity started at Cedars-Sinai Medical Center in 2007, 2 years after infliximab
received FDA approval for moderate-to-severe UC [ 4 ]. Between October 2000 and
October 2005, 30-day postoperative morbidity and mortality were recorded after
two-stage proctocolectomy with ileal pouch-anal anastomosis (IPAA) or if neces-
sary subtotal colectomy (STC). Complications were divided into medical and sur-
gical, with medical complications being divided into major and minor. Major
adverse effects included pneumonia, deep vein thrombosis, pancreatitis, acute
renal failure, and cerebrovascular accident, whereas minor complications encom-
passed dehydration, superficial thrombophlebitis, pyoderma gangrenosum, and
urinary retention. A preponderance of patients undergoing surgery were preopera-
tively diagnosed with pancolitis, and all were exposed to IV steroids. The study
group is comprised of 17 patients exposed to infliximab preoperatively compared
to 134 controls.
Results of the study revealed no statistical significance in medical (p = 0.99),
surgical (p = 0.3), or overall infectious (p = 0.2) complications. The bulk under-
went IPAA (112 patients, 69%) compared to STC (39 patients, 31%); however,
when comparing surgical approaches, no statistical difference in medical, surgi-
cal, or infectious complications was seen. In addition, the aim of this study was to
investigate the influence of infliximab with other immunosuppressive agents, such
as 6-MP or cyclosporine (CsA). Whereas no significant difference in complica-
tion rates were observed in 6-MP + infliximab compared to infliximab alone, the
groups receiving infliximab plus CsA demonstrated an overall 80% complication
rate, specifically infectious, when compared to infliximab monotherapy. The
authors concluded that preoperative infliximab use alone may not influence
30-day mortality; however, one should consider infectious complication risks
when combining with CsA [ 4 ].
At the Mayo Clinic in Rochester, Minnesota, short-term (within 30 days)
postoperative complications were measured between 2002 and 2005 on chronic
ulcerative colitis patients exposed to infliximab preceding IPAA; the complica-
tion rates for anastomotic leak, pelvic abscess, and wound infection were
9 Use of Biologics in Crohn’s Disease and Ulcerative Colitis Prior to Surgery