Results from a randomized study support the clinical efficacy of low-dose leflunomide combined with prednisone for the treatment of proliferative lupus nephritis, according to study findings published in Clinical Rheumatology.

Researchers conducted a multicenter prospective study of 100 patients with proliferative lupus nephritis who were randomly assigned to receive either oral leflunomide or intravenous cyclophosphamide in combination with prednisone over 24 weeks. Leflunomide was administered at a dose of 40 mg daily for 3 days followed by 20 mg daily, while 0.8 to 1.0 g of cyclophosphamide was given monthly. As a primary end point, investigators captured the percentage of patients achieving either complete or partial remission at 24 weeks.

After statistical analysis, researchers found that after 24 weeks, 23% of participants receiving leflunomide and 27% of participants receiving intravenous cyclophosphamide had reached full remission (P =.64), while 56% and 42% of patients achieved partial remission (P =.16),  respectively. However, these differences did not reach statistical significance. Furthermore, no significant differences were seen in clinical parameters post-treatment between the groups.

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Primary study limitations included the small sample size and lack of blinding with therapy administration.

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“Compared with cyclophosphamide, low-dose leflunomide in combination with prednisone showed both effectiveness and safety in the induction therapy of proliferative lupus nephritis,” the researchers wrote.

“Long-term, randomized studies are needed to elucidate the efficacy and safety of leflunomide in treating lupus nephritis,” they concluded.

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Zhang M, Qi C, Zha Y, et al. Leflunomide versus cyclophosphamide in the induction treatment of proliferative lupus nephritis in Chinese patients: a randomized trial [published online November 13, 2018]. Clin Rheumatol. doi:10.1007/s10067-018-4348-z