Tolerability of mycophenolate mofetil in patients with systemic lupus erythematosus

Objective. To quantify the adverse events (AE) associated with mycophenolate mofetil (MMF) in patients with systemic lupus erythematosus (SLE), to examine the relationship between AE and dosage of MMF, and to assess the overall tolerability of MMF in SLE patients. Methods. A consecutive cohort of adults with SLE who received MMF between October 1996 and June 1999 was identified. Charts were reviewed for baseline data, AE, MMF dosing characteristics, and clinical response at baseline, 3 months, and at final followup or drug discontinuation. Results. The 54 SLE patients were followed for a mean of 12.4 ± 7.0 person-months. Baseline characteristics: 92.6% female, 72.2% white, mean age 38.3 years, and a mean of 9.6 years since diagnosis. Twenty-one of 54 patients (38.9%) had a total of 28 gastrointestinal AE. Twenty-four of 54 (44.4%) patients had a total of 37 infections, only one of which required hospitalization. Leukopenia occurred 3 times but never required dose adjustment. AE occurred at a similar rate at all MMF doses. Kaplan-Meier estimates show most drug discontinuation occurred in the first 2.5 months and 73% of patients were still on the drug at 12 months. Sixteen of 54 patients discontinued MMF because of AE (n = 9), lack of efficacy (n = 3), pregnancy (n = 2), and administrative reasons (n = 2). Clinical improvement in patients was noted with significant decreases in disease activity measured by the SLEDAI and prednisone dose at 3 months and at final followup. Conclusion. The majority of patients tolerated MMF. A range of doses was tolerated and associated with clinical improvement, suggesting that a flexible dosing schedule should be considered when using MMF in patients with SLE.