P-132 YI Experience with Low-Dose Mycophenolate for the Inflammatory Bowel Disease Population

Abstract

BACKGROUND: Thiopurines (azathioprine/6-mercaptopurine) are the first-line immunomodulators for inflammatory bowel disease (IBD). Mycophenolate has been used as an alternative in patients intolerant to conventional thiopurine therapy but there is a paucity of data supporting the use of this medication for IBD. METHOD(S): Patients treated with mycophenolate for IBD were identified from over a 14 year period (1998-2012) from a single academic center using an electronic medical record. Charts were reviewed for demographic data, history of medical treatment for IBD including mycophenolate exposure, and adverse reactions to these medications. Patients treated with mycophenolate for conditions other than IBD such as immunosuppression for post-solid organ transplantation were excluded. RESULT(S): Sixty-four patients were identified with IBD (19 ulcerative colitis, 44 Crohn's disease, 1 indeterminate colitis) that has been treated with mycophenolate during the study period. Ninety-five percent (n = 61/64) were treated with thiopurines prior to mycophenolate. Four patients died during the study period, 7 patients were lost to follow-up, and 27 patients discontinued mycophenolate. Mycophenolate therapy averaged 45.5 months (3.8 years) per patient for a total 242.7 patient-years. The mean maximum daily dosage was 1,540 mg. Sixty-nine percent (n = 44/64) were started on mycophenolate because of thiopurine intolerance (e.g., pancreatitis, leucopenia, side effects) and 23% (n = 15/64) were started on mycophenolate because of thiopurine ineffectiveness. Forty-one percent (n = 26/64) remained on mycophenolate therapy at the study conclusion, with a mean length of treatment of 5.3 years for these patients. Twenty-seven patients discontinued mycophenolate with 6 patients stopping due to advancing to surgery, 5 due to ineffectiveness, 4 due to gastrointestinal symptoms (i.e., nausea, vomiting, diarrhea). Two patients stopped because of medication cost. CONCLUSION(S): Most patients treated with mycophenolate at our institution received the drug after failing or demonstrating intolerance to a thiopurine. Lowdose mycophenolate appeared safe and well tolerated in this group and was not associated with serious adverse outcomes. Further randomized controlled clinical trials with mycophenolate for IBD should be considered, given the clinical need for alternative immunomodulators for patients with thiopurine intolerance.