Anal Dysplasia in Patients With Inflammatory Bowel Disease
Anal Dysplasia in Patients With Inflammatory Bowel Disease
The rationale for this study is that the risk of anal dysplasia in patients with inflammatory
 bowel disease (IBD) as compared to the general population has yet to be investigated
 prospectively. There have only been a few articles examining this relationship - preliminary
 results have suggested that patients with IBD are at increased risk for abnormal anal pap
 smears. As high grade anal dysplasia is strongly associated with an increased risk of anal
 carcinoma, it is important to identify all high risk groups that might benefit from routine
 screening. This pilot study aims to determine whether patients with IBD in our Bronx
 population have an increased risk of abnormal anal Pap smears. We hypothesize that there will
 be an increased incidence of abnormal anal pap smears in patients with IBD who have been
 treated with immunosuppressants, given that chronic immunosuppression is related to increased
 HPV infection.
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.