Leflunomide noninferior to azathioprine as lupus nephritis maintenance therapy
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Leflunomide is non-inferior to azathioprine in terms of safety and efficacy for lupus nephritis maintenance therapy, according to data published in the Annals of the Rheumatic Diseases.
“Although the kidney failure risk associated with [lupus nephritis (LN)] has substantially improved since the 1970s, the rate of kidney replacement therapy has remained consistent and appears to have increased since 2000,” Qiong Fu, MD, of the department of rheumatology at Renji Hospital in Shanghai, China, and co-authors wrote. “Therefore, there are still significant unmet needs in the management of LN.
“The results provided the first evidence supporting that [leflunomide (LEF)] may be an effective and safe choice for maintenance therapy in patients with LN,” they added.
To investigate the ability of leflunomide to maintain remission in patients with lupus nephritis, Fu and colleagues conducted a prospective, multicenter, randomized, open-label trial comparing leflunomide with azathioprine. The study took place in two phases. In the first, eligible patients received standard cyclophosphamide for induction therapy. After 6 to 9 months, patients who achieved a complete or partial response were admitted to the maintenance phase, where they were randomized to receive either leflunomide or azathioprine.
Patients were required to be aged 18 to 65 years, have systemic lupus erythematosus as defined by the American College of Rheumatology classification criteria, have biopsy-proven class three, four or five active lupus nephritis, demonstrate 24-hour proteinuria of 1g or more, and an SLE disease activity index score of eight or higher.
The study’s primary outcome measure was the time to kidney flare during 36 months of maintenance follow-up. Secondary endpoints included the number of patients who achieved complete resolution and other variables dependent on kidneys, including 24 hours proteinuria, serum creatinine and serum albumin over time, as well as frequency of extrarenal flares.
A total of 215 patients were randomized to the two groups. Kidney flares occurred and were seen in 17 (15.7%) patients treated with leflunomide and in 19 (17.8%) patients treated with azathioprine. There was no statistically significant difference between the groups in terms of time to kidney flares, the authors wrote. Additionally, there was no statistically significant difference between the groups regarding 24-hour proteinuria, serum creatinine, serum albumin, serum C3 and serum C4, according to the researchers. The rate of adverse events was 56.5% in the leflunomide group and 58.9% in the azathioprine group.
“The current study provides a relatively high level of evidence supporting LEF in the maintenance treatment of LN with comparable efficacy to the standardized regimen of [azathioprine (AZA)],” Fu and colleagues wrote. “To the best of our knowledge, this multicenter, randomized-controlled, open-label study is the first to report the non-inferiority of LEF to AZA for the maintenance therapy of LN in terms of its efficacy and safety profiles.”
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