Safety of 6-mercaptopurine Use in the Elderly Inflammatory Bowel Disease Population

Abstract

Purpose: The population of elderly patients with inflammatory bowel disease (IBD) is increasing in part to the aging population as well as newly diagnosed IBD patients at an older age. Elderly patients are under-represented in clinical trials that investigate medical and surgical therapy for IBD. The aim of this study was to investigate long term safety with the use of the immunomodulator, 6-mercaptopurine.TableMethods: Thirty two patients above the age of 60 with either a diagnosis of Ulcerative Colitis (UC) or Crohn's disease (CD) were reviewed for demographics, dosage and most common adverse events. The study defined patient's aged 60 years or older as “elderly”. A comparison of the dosage, side effect profile and duration of therapy was examined. Results: Of the twenty nine patients (20 female, 9 male; mean age 70.3 years), 14 had CD and 15 had UC. All were on 6-MP at dosages ranging from 50mg to 150 mg. Of the twenty nine patients, 11 had a single documented side effect, 5 had more than one side effect and 13 were without side effects. Only one patient became pancytopenic. The average duration of therapy was 44 months. None exhibited newly diagnosed malignancies or episodes of pancreatitis. The most common adverse event was anemia (34%), whereby 70% of cases were with dosages greater than 50 mg. Leukopenia and elevated liver enzymes were the next most common side effects. All the patients were managed appropriately with individual side effects and none of the patients were discontinued from therapy. Conclusion: This is the first study reporting the safety profile of long-term 6-MP usage in the elderly IBD population (> 60 years). Our experience of 29 elderly patients on immunomodulator therapy revealed that elderly patients tolerated their medications reasonably well with a side effect profile that can be managed conservatively. Periodic monitoring of CBC, serum creatinine and hepatic profile is still warranted in this population with comorbid diseases and on multiple medications. Disclosure: Dr Seymour Katz - Speaker's Bureau: Proctor & Gamble, Abbott, UCB; Consultant/Scientific Advisor: Proctor & Gamble, Abbott, UCB; Research/Clinical Trial Support: Abbott, Proctor & Gamble, Pfizer, Élan, Bristol Meyers, Hutchison, Otsuka, Prometheus, Eisai, Millenium.