Leflunomide compares favourably with azathioprine as maintenance therapy for LN

In the maintenance treatment of patients with lupus nephritis (LN), leflunomide is as effective and safe as azathioprine, according to a study.

The study included 270 adult patients with biopsy-confirmed active LN, enrolled from seven Chinese rheumatology clinics. All patients were initially treated with 6–9 months of intravenous cyclophosphamide plus glucocorticoids. Those who achieved complete response (CR) or partial response (PR) were then randomized to receive prednisone in combination with either leflunomide (n=108; mean age 30.8 years, 90.7 percent female) or azathioprine (n=107; mean age 33.2 years, 86.0 percent female) in the maintenance setting for 36 months.

A total of 137 patients (63.7 percent) completed the 36 months of maintenance treatment: 72 (66.7 percent) in the leflunomide group and 65 (60.1 percent) in the azathioprine group. Most patients received 20 mg/day of leflunomide or 100 mg/day of azathioprine. The mean dosage of glucocorticoids at baseline was approximately 10 mg/day (prednisone or equivalent), with the dosage lowered to 7.5 mg/day and to further 5 mg/day afterward.

Kidney flares occurred in 17 (15.7 percent) leflunomide-treated patients and 19 (17.8 percent) azathioprine-treated patients. The primary efficacy endpoint of the time to kidney flare was comparable between the two groups (16 vs 14 months, respectively; p=0.676).

Likewise, there were no marked between-group differences in secondary outcomes including clinical parameters, extrarenal flare, and adverse effects. Parameters such as 24-hour proteinuria, serum creatinine, serum albumin, serum C3, and serum C4 improved similarly.

Two patients from the azathioprine group and one from the leflunomide group experienced extrarenal flare. The incidence of adverse events was similar in the two groups: 56.5 percent with leflunomide and 58.9 percent with azathioprine.

The findings suggest that leflunomide may provide a new candidate for maintenance therapy in patients with LN.