Maintenance Therapy for Lupus Nephritis Study Results Favor Mycophenolate Mofetil

In patients with lupus nephritis who have a response to induction therapy, mycophenolate mofetil is superior to azathioprine in maintaining a renal response to treatment and in preventing relapse, according to the results of a study reported in The New England Journal of Medicine. In a 36-month, randomized, double-blind, double-dummy, phase 3 study, Dooley and associates¹ compared oral mycophenolate mofetil (2 g/d) and oral azathioprine (2 mg/kg/d) in patients who met response criteria during a 6-month induction trial. The primary efficacy end point was the time to treatment failure, defined as death, end-stage renal disease, doubling of the serum creatinine level, renal flare, or rescue therapy for lupus nephritis. Secondary assessments included the time to the individual components of treatment failure and adverse events.

Mycophenolate mofetil was superior to azathioprine with respect to the primary end point, time to treatment failure, and time to renal flare and time to rescue therapy. Treatment failure rates were 16.4% of patients in the mycophenolate mofetil group, compared with 32.4% in the azathioprine group. Adverse events, mostly minor infections and GI disorders, occurred in more than 95% of the patients in both groups. Serious adverse events occurred in 33.3% of patients in the azathioprine group, compared with 23.5% of those in the mycophenolate mofetil group.

The authors noted that there are few data on maintenance therapy for lupus nephritis and that a suboptimal response to treatment in patients with class 3, 4, or 5 lupus nephritis increases the risk of end-stage renal disease.

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References

1. Dooley MA, Jayne D, Ginzler EM, et al; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011;365:1886-1895.