Benefits of leflunomide in systemic lupus erythematosus: a pilot observational study

The objective of this study was to retrospectively explore the safety and e fficacy of leflunomide (LEF) in outpatients with systemic lupus erythematos us (SLE). Eighteen SLE females received LEF, open label, 100 mg/day loading dose for 3 days followed by 20 mg per day. Patients were evaluated for safety and ef ficacy after 2-3 months of therapy. The mean age was 42.6 y and mean disease duration 7.9 y. ACR criteria were met by 15/18. Four patients stopped LEF during the observation period. Ten of 14 LEF-treated patients had subjective improvement with 9/14 patients ac hieving lower SLEDAI scores. The mean SLEDAI decreased by 2.1 (P = 0.005) a nd the mean ESR decreased by 9 mm/h (P = 0.02). Prednisone dosages could be reduced in 2/5 subjects without a flare. No organ-threatening or life-thre atening side effects were seen in our patients. Diarrhea occurred in seven patients (two stopped LEF), rash occurred in one patient (stopped LEF), one patient stopped LEF for reasons not related to therapy. Blood pressure was unchanged. Leflunomide was efficacious and safe in this cohort of SLE patients after 2 - 3 months of therapy. Placebo-controlled trials of longer duration are in dicated.