Anal Dysplasia in Patients With Inflammatory Bowel Disease

IBD patients on and off immunosuppression will be identified from gastroenterology fellow
clinics. After patients express interest in the study, a study coordinator will provide an
overview of the study and obtain consent prior to initiating any research related procedures.
Anal Pap smears and Digene Hybrid Capture 2 High-Risk HPV DNA Tests will be performed on each
study patient.

Medications will be documented for all IBD subjects and controls. Patient characteristics
that will be documented will include IBD diagnosis, area of involvement (small bowel vs.
large bowel, rectal involvement), type and duration of immunosuppressant use, smoking status,
family history of any dysplasia (including anus), and reproductive risk factors. Data will be
reported by subjects in subject interviews and through questionnaires.

For the purposes of analysis, subjects will be divided into two groups: IBD patients on
immunosuppression and IBD patients not on immunosuppression. Results will be recorded in
relation to exposure to immunosuppressive agents including prednisone, purine analogs
(azathioprine/6MP), methotrexate, and infliximab. Immunosuppression will be defined as a
history of at least three months of azathioprine/6MP, eight consecutive weeks of prednisone
greater than 15mg per day, a cumulative dose of greater than 100mg of methotrexate, or at
least one infusion of infliximab within 8 weeks of the date of the anal Pap smear. Since this
is a pilot project, we will recruit a minimum of 20 subjects to each group.

Abnormalities will be classified in standard Bethesda classifications as atypical squamous
cells of undetermined significance (ASCUS), low grade squamous intraepithelial lesion (LSIL),
high grade squamous intraepithelial lesion (HSIL) or carcinoma. The pathologist reading the
Pap smears will be blinded to the patient status (IBD versus control) and immunomodulator
history.

Inclusion Criteria:

- i. Women and men between the ages of 18-65 with a history of inflammatory bowel
disease confirmed histologically and on immunosuppression defined as at least three
months of azathioprine/6MP, eight consecutive weeks of prednisone greater than 15mg
per day, a cumulative dose of greater than 100mg of methotrexate, or at least one
infusion of infliximab within 8 weeks of the date of the anal Pap smear.

ii. Women and men between the ages of 18-65 with a history of inflammatory bowel disease
confirmed histologically and not on immunosuppression (defined as above)

Exclusion Criteria:

- i. Patients with HIV, transplant recipients, men who have sex with men as they already
represent high risk groups ii. Women with a history of an abnormal cervical Pap test
within the past 2 years.

iii. Patients with active proctitis as defined by an abnormal sigmoidoscopy or colonoscopy,
rectal bleeding or tenesmus.