Leflunomide as good as azathioprine in lupus nephritis maintenance therapy: study

Previous studies have compared mycophenolate mofetil and azathioprine as maintenance therapy for lupus nephritis (LN). Leflunomide is an immunosuppressant widely used in the treatment of rheumatoid arthritis. The aim of this investigator-initiated study was to compare the efficacy and safety of leflunomide versus azathioprine as maintenance therapy for lupus nephritis

270 adult patients with biopsy-confirmed active lupus nephritis from 7 Chinese Rheumatology Centres were enrolled. All patients received induction therapy with 6–9 months of intravenous cyclophosphamide plus glucocorticoids. Patients who achieved complete response (CR) or partial response (PR) were randomised to receive prednisone in combination with leflunomide or azathioprine as maintenance therapy for 36 months. The primary efficacy endpoint was the time to kidney flare. Secondary outcomes included clinical parameters, extrarenal flare and adverse effects.

Results:

• A total of 215 patients were randomly allocated to the leflunomide group (n=108) and the azathioprine group (n=107).
• Kidney flares were observed in 17 (15.7%) leflunomide-treated patients and 19 (17.8%) azathioprine-treated patients.
• Time to kidney flare did not statistically differ
• 24-hour proteinuria, serum creatinine, serum albumin, serum C3 and serum C4 improved similarly. The extrarenal flare occurred in two patients from the azathioprine group and one patient from the leflunomide group.
• The incidence of adverse events was similar in the 2 groups: leflunomide 56.5% and azathioprine 58.9%.

The efficacy and safety profile of leflunomide is non-inferior to azathioprine for maintenance therapy of lupus nephritis. Leflunomide may provide a new candidate for maintenance therapy in patients with lupus nephritis.

Reference:

Qiong Fu et al. Leflunomide versus azathioprine for maintenance therapy of lupus nephritis: a prospective, multicentre, randomised trial and long-term follow-up. 2022;doi:10.1136/ard-2022-222486.