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Previous Volume 353:2219-2228 November 24, 2005 Number 21 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by McCune, W. J. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Since anecdotal series and small, prospective, controlled trials suggest that mycophenolate mofetil may be effective for treating lupus nephritis, larger trials are desirable.

Methods We conducted a 24-week randomized, open-label, noninferiority trial comparing oral mycophenolate mofetil (initial dose, 1000 mg per day, increased to 3000 mg per day) with monthly intravenous cyclophosphamide (0.5 g per square meter of body-surface area, increased to 1.0 g per square meter) as induction therapy for active lupus nephritis. A change to the alternative regimen was allowed at 12 weeks in patients who did not have an early response. The study protocol specified adjunctive care and the use and tapering of corticosteroids. The primary end point was complete remission at 24 weeks (normalization of abnormal renal measurements and maintenance of baseline normal measurements). A secondary end point was partial remission at 24 weeks.

Results Of 140 patients recruited, 71 were randomly assigned to receive mycophenolate mofetil and 69 were randomly assigned to receive cyclophosphamide. At 12 weeks, 56 patients receiving mycophenolate mofetil and 42 receiving cyclophosphamide had satisfactory early responses. In the intention-to-treat analysis, 16 of the 71 patients (22.5 percent) receiving mycophenolate mofetil and 4 of the 69 patients receiving cyclophosphamide (5.8 percent) had complete remission, for an absolute difference of 16.7 percentage points (95 percent confidence interval, 5.6 to 27.9 percentage points; P=0.005), meeting the prespecified criteria for noninferiority and demonstrating the superiority of mycophenolate mofetil to cyclophosphamide. Partial remission occurred in 21 of the 71 patients (29.6 percent) and 17 of the 69 patients (24.6 percent), respectively (P=0.51). Three patients assigned to cyclophosphamide died, two during protocol therapy. Fewer severe infections and hospitalizations but more diarrhea occurred among those receiving mycophenolate.

Conclusions In this 24-week trial, mycophenolate mofetil was more effective than intravenous cyclophosphamide in inducing remission of lupus nephritis and had a more favorable safety profile.

Source Information

From the Division of Rheumatology, State University of New York Downstate Medical Center, Brooklyn (E.M.G., C.A.); the Department of Medicine, University of North Carolina, Chapel Hill (M.A.D.); the Division of Biostatistics, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, N.Y. (M.Y.K.); Hospital for Joint Diseases of New York University School of Medicine, New York (J.B.); the Department of Clinical Pharmacology, Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the Department of Medicine, Johns Hopkins School of Medicine, Baltimore (M.P.); the Medical University of South Carolina, Charleston (G.S.G.); Cedars–Sinai Medical Center, Los Angeles (D.J.W., M.H.W.); and the Division of Nephrology, Columbia University Medical Center, New York (G.B.A.).

Address reprint requests to Dr. Ginzler at the Division of Rheumatology, SUNY Downstate Medical Center, 450 Clarkson Ave., Box 42, Brooklyn, NY 11203, or at ellen.ginzler{at}downstate.edu.

Full Text of this Article

Related Letters:

Mycophenolate Mofetil or Intravenous Cyclophosphamide in Lupus Nephritis
Karassa F. B., Killen J. P., Ginzler E. M., Dooley M. A., Kim M. Y.
Extract | Full Text | PDF  
N Engl J Med 2006; 354:764-765, Feb 16, 2006. Correspondence

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