Mycophenolate in New-Onset SLE Save

How aggressively do you treat newly diagnosed new-onset systemic lupus erythematosus (SLE), or should you wait for organ involvement? A trial of early use of mycophenolate mofetil (MMF), in addition to prednisone and hydroxychloroquine, decreased severe flares and the development of renal involvement. 

A multicenter, blinded randomized clinical trial enrolled newly diagnosed, treatment-naive SLE patients who were required to have high titers of anti-dsDNA antibody, and no major organ involvement. All patients received daily prednisone (0.5 mg/kg/d) and hydroxychloroquine (5 mg/kg/d) and were then randomized to receive placebo or MMF (500 mg twice daily) (MMF group) for 96 weeks. The primary outcome was flares according to the SELENA-SLEDAI flare Index.

A total of 130 SLE patients were enrolled with a mean age of 34.5 years; 86% were women. At 92 weeks the outcomes showed:

• Severe flare significantly lower in the MMF group (11% vs controls 28%) (RR 0.39 [95% CI, 0.17-0.87]; P = .01)
• Lupus nephritis (LN) was signfificantly less frequent with MMF (1.5%) compared to controls (13.8%) (RR, 0.11; P = .008).
• Serious drug–related AEs were equal between groups. 

Early use of MMF may decrease the flare rates and the risk of future lupus nephritis in new-onset SLE, with a high titer of anti–double-stranded DNA antibody.