Cimzia Versus Mesalamine for Crohn's Recurrence

Crohn's disease is an autoimmune, pan-intestinal disease which can affect any portion of the
alimentary tract, but which has a preference for the small intestine, the colon, and the
anus. It is now well established that Crohn's disease most commonly presents with an
ileocolic distribution, followed by involvement of the small intestine, the colon, and the
anus. Treatment for Crohn's disease is principally medical, reserving surgery to address
complications from the disease which cannot be adequately resolved with medication alone. The
single greatest challenge in treating this incurable disease is dealing with its recurrence
rate. The cumulative probability of disease recurrence is quite high, with 75% of Crohn's
patients requiring abdominal surgery at some point during their life.

Following surgery, recurrence rates are significant, varying depending on the manner in which
recurrence is defined. With regard to clinical recurrences, where the recrudescence of the
disease is associated with symptoms caused by new intestinal lesions, the recurrence rate is
10-20% per year.In some instances, clinical recurrences can appear within 3 months of
surgery. Taking into account the need for additional surgery as defining a "surgical
recurrence", reoperation rates for Crohn's disease range from 16% to 65% 10 years after a
previous surgery. When recurrence is viewed from the vantage point of evidence of new Crohn's
disease activity based on radiographic studies, radiographic recurrences range from 41-60%
over the first 10 years following surgery. One of the most common measures of recurrence has
become demonstrating evidence of new Crohn's disease activity based on colonoscopy. This
endoscopic recurrence has consistently been shown to be as high as 50-75% at 3 months after
surgery, and 50-90% at 12 months. It is widely accepted by physicians treating Crohn's
patients that the appearance of endoscopic lesions has prognostic significance, as endoscopic
evidence of Crohn's disease temporally precedes radiographic, clinical and surgical
recurrences.

The role that Cimzia should play in preventing recurrence of Crohn's disease following
ileocolectomy for Crohn's disease remains to be determined, as does its relative advantages
and disadvantages compared to the use of mesalamine.

Inclusion Criteria:

- Patients ≥18 years of age or older with Crohn's disease of any phenotype (luminal
disease, perforating disease, stricturing disease) with an ileocolic distribution.

- Ileocolic Crohn's disease severe enough to require ileocolectomy (either open or
laparoscopic).

Exclusion Criteria:

- Patients younger than 18 years of age, as there is little data on pediatric patients
and since the Colorectal Surgery service only treats patients 18 years of age or
older.

- Patients undergoing an ileocolectomy for any reason besides Crohn's disease.

- Patients requiring a stoma.

- Patients with short-bowel syndrome.

- Patients who are incarcerated, due to difficulties with frequent clinic visits given
their incarceration and transportation issues.

- Patients who received previous anti-TNF therapy from infliximab or adalimumab within
three months of surgery, or patients who have a history of a severe hypersensitivity
reaction to infliximab or adalimumab

- Patients with a positive PPD and a suspicious finding on a chest x-ray suggestive of
tuberculosis, or any patient with a history of tuberculosis.

- Patients who require postoperative therapy besides either mesalamine or certolizumab
(steroids, antibiotics, and immunomodulator therapy would not be permitted starting at
4 weeks after ileocolectomy).

- Patients with significant psychiatric disorders (i.e. schizophrenia) and those with
significant cognitive disorders, due to the difficulties with this patient group
remaining compliant with frequent clinic visits, and due to the difficulty evaluating
quality of life measures in these patients.

- Patients with a history of malignancy.

- Patients with a history of any demyelinating neurologic disease or a history of
seizures.

- Patients with a history of severe congestive heart failure.

- Patients with a history of hepatitis B or C virus.

- Patients who are pregnant or who become pregnant.

- Involvement in any other clinical studies which use study medications.

- The subject has a condition, which, in the opinion of the investigator, would
compromise the study or well-being of the subject or prevent the subject from meeting
or performing the study requirements.