TrialWatch: Sanofi’s Leflunomide Effective Induction Treatment for Lupus Nephritis

Dec 12, 2018 | Lupus, lupus nephritis, Positive Results


A low dose of the immunosuppressant leflunomide is as safe and effective as the standard of care cyclophosphamide for induction treatment of patients with lupus nephritis based on the results of a Phase 2/3 trial in China. We provide a link to the trial findings below. Lupus Nephritis is a type of kidney inflammation and the most frequent complication in systematic lupus erythematosus (SLE) patients. The study included 100 patients, between 21 and 61 years old, with proliferative lupus nephritis, randomly assigned to either leflunomide or cyclophosphamide treatment, combined with prednisone. While leflunomide was given orally at a loading dose of 40 mg/day for three days followed by 20 mg/day for 24 weeks, cyclophosphamide was delivered monthly via intravenous infusion at a dosage of 0.8-1 grams. Prednisone was administered daily at a dose of 0.8-1 mg per kilogram of total weight for eight weeks, which was decreased by 5-10 mg every two weeks until 20 mg daily and then decreased by 2.5 mg every two weeks until a maintenance dose of 10 mg per day was reached. The study’s primary efficacy outcome was the frequency of complete remission and partial remission at 24 weeks. Complete remission was defined as urinary protein excretion of less than 0.3 g/day, with normal urinary sediment and serum albumin concentration, as well as stable renal function. Partial remission was defined as a decrease of urinary protein excretion by more than 50%, serum albumin level of 30 g/L or greater, and stable renal function. Secondary outcomes included assessments of urinary protein excretion, serum albumin — the most abundant protein in plasma — immune protein complement 3, antibodies targeting double-stranded DNA, SLEDAI score, blood platelet count, and liver function.


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