MMF for SLE
Trial question
What is the role of mycophenolate mofetil in patients with new-onset SLE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
86.0% female
14.0% male
N = 130
130 patients (112 female, 18 male).
Inclusion criteria: patients with new-onset SLE and a high titer of anti-dsDNA without major organ involvement.
Key exclusion criteria: prior SLE treatment; liver and kidney dysfunction; cancer; recent infection or hematologic diseases not caused by SLE; pregnancy.
Interventions
N=65 mycophenolate mofetil (oral mycophenolate mofetil 500 mg BID plus prednisone 0.5 mg/kg/day and hydroxychloroquine sulfate 5 mg/kg/day for 96 weeks).
N=65 prednisone and hydroxychloroquine (oral prednisone at a starting dose of 0.5 mg/kg/day and oral hydroxychloroquine 5 mg/kg/day for 96 weeks).
Primary outcome
Overall flares of systemic lupus erythematosus
43.1%
63.1%
63.1 %
47.3 %
31.6 %
15.8 %
0.0 %
Mycophenolate
mofetil
Prednisone and
hydroxychloroquine
Significant
decrease ▼
NNT = 5
Significant decrease in overall flares of SLE (43.1% vs. 63.1%; RR 0.68, 95% CI 0.49 to 0.96).
Secondary outcomes
Significant decrease in severe flares of lupus nephritis (1.5% vs. 13.8%; RR 0.11, 95% CI 0.01 to 0.85).
Significant decrease in new or worsening severe flares of SLE (10.8% vs. 27.7%; RR 0.39, 95% CI 0.17 to 0.87).
No significant difference in new or worsening mild-to-moderate arthritic flares (26.2% vs. 30.8%; RR 0.85, 95% CI 0.49 to 1.47).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with new-onset SLE and a high titer of anti-dsDNA without major organ involvement, mycophenolate mofetil was superior to prednisone and hydroxychloroquine with respect to overall flares of SLE.
Reference
Yijun You, Zhuochao Zhou, Fan Wang et al. Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2432131.
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