PT  - JOURNAL ARTICLE
AU  - Qiong Fu
AU  - Chunmei Wu
AU  - Min Dai
AU  - Suli Wang
AU  - Jianhua Xu
AU  - Lie Dai
AU  - Zhijun Li
AU  - Lan He
AU  - Xiaochun Zhu
AU  - Lingyun Sun
AU  - Liangjing Lu
AU  - Chunde Bao
TI  - Leflunomide versus azathioprine for maintenance therapy of lupus nephritis: a prospective, multicentre, randomised trial and long-term follow-up
AID  - 10.1136/ard-2022-222486
DP  - 2022 Nov 01
TA  - Annals of the Rheumatic Diseases
PG  - 1549--1555
VI  - 81
IP  - 11
4099  - http://ard.bmj.com/content/81/11/1549.short
4100  - http://ard.bmj.com/content/81/11/1549.full
SO  - Ann Rheum Dis2022 Nov 01; 81
AB  - Objectives 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 LN.Methods 270 adult patients with biopsy-confirmed active LN 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 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 (leflunomide: 16 months vs azathioprine: 14 months, p=0.676). 24-hour proteinuria, serum creatinine, serum albumin, serum C3 and serum C4 improved similarly. 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%.Conclusions The efficacy and safety profile of leflunomide are non-inferior to azathioprine for maintenance therapy of LN. Leflunomide may provide a new candidate for maintenance therapy in patients with LN.Trial registration number NCT01172002.Data are available upon reasonable request.