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  • Leflunomide versus azathioprine for maintenance therapy of lupus nephritis: a prospective, multicentre, randomised trial and long-term follow-up

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Systemic lupus erythematosus
Leflunomide versus azathioprine for maintenance therapy of lupus nephritis: a prospective, multicentre, randomised trial and long-term follow-up
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  • Published on: 28 July 2022
    Leflunomide for lupus nephritis
    • Carlos Abud-Mendoza, Rheumatologist Hospital Central "Dr. Ignacio Morones Prieto" and Faculty of Medicine, Universidad Autónoma de San Luis Potosí , S.L.P., México

    Leflunomide for lupus nephritis
    Mycophenolate mofetil and azathioprine are drugs with proven efficacy for lupus nephritis (LN) treatment. In excellent prospective, randomised, open-label trial, Fu et al.1 emphasize the competitive clinical response between azathioprine and leflunomide in 215 adult patients with biopsy-confirmed active LN after cyclophosphamide and glucocorticoids, as maintenance therapy during 36 months.
    Both kidney flares and their onset time were similar, as well as their proteinuria, serum creatinine and complement levels response, with similar adverse events. AEs leading to permanent treatment discontinuation were 2/108 patients treated with leflunomide (20 mg/d) and 5/107 in the azathioprine group (100mg/d). Authors, also mentioned that leflunomide is associated with some other advantages, such as easy accessibility, long-term safety profile and cost effectiveness, particularly in developing countries.
    In Mexico, most of rheumatologist have vast experience with leflunomide as monotherapy for rheumatoid arthritis or combined with other csDMARD’s, most of them with good pregnancy outcomes, as has been reported recently, with no significant difference in malformations rates between leflunomide exposed and unexposed pregnancies.2 The cost of leflunomide is lower than azathioprine, equivalent to $10 USD every 4 to 6 weeks.
    Additionally, the potential benefit of leflunomide as LN remission induction treatment has been reported. Wang...

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    Conflict of Interest:
    None declared.
  • Published on: 6 July 2022
    Is leflunomide non-inferiorior to azathioprine in the maintenance treatment of lupus nephritis?
    • Laurent ARNAUD, Professor of Medicine Hôpitaux Universitaires de Strasbourg

    Dear Editor,
    We read with great interest the recent paper published in ARD by Fu et al.
    Based on their prospective open-label randomised control trial in 270 patients with active Class III/IV/V lupus nephritis, the authors conclude that the efficacy and safety profile of leflunomide is non-inferior to azathioprine for maintenance therapy of LN.
    Importantly, this study was designed as a non-inferiority trial with the non-inferiority margin set at 12% for the primary outcome (flare at 36 months of maintenance-phase follow-up), meaning that the lower bound of the two-sided 95% CI for the difference in flare rates between LEF and AZA (as reference) should exceed −12%. Unexpectedly for a non-inferiority trial, the difference between groups for all data was considered significant at p<0.05.
    Time to kidney flare was reported as not statistically different between the LEF group (17/108 patients, 15.7%; median time: 16 months) compared with that in the AZA group (19/107 patients, 17.8%; median time 14 months) during the 36 months of follow-up, yielding a Hazard Ratio (HR) of 0.89 (95%CI: 0.57-1.21), with the lower bound of the 95%CI below the non-inferiority margin (-12%) which should be interpreted as an inclusive non-inferiority trial.
    We therefore believe that the main conclusion of the authors is not supported by the data presented, and as leflunomide is currently not shown as non-inferior to azathioprine for the maintenance of LN.

    Conflict of Interest:
    None declared.