6/28/23, 12:07 AM ALMS Pathway Feedback Search Clinical Topics Home Studies ALMS ALMS Disease Disease Lupus nephritis Systemic lupus erythematosus Trial question What is the role of mycophenolate mofetil in patients with class III to V lupus nephritis? Study design Multi-center Open label RCT Population Characteristics of study participants 85.0% female N = 370 15.0% male 370 patients (313 female, 57 male) Inclusion criteria: patients with class III to V lupus nephritis undergoing induction treatment Key exclusion criteria: insufficient proteinuria, concurrent infection or illness, pregnancy, prohibited concurrent medication, low WBC count, > 6 months from renal biopsy, or unwilling to provide consent Interventions N=185 mycophenolate mofetil (target dosage 3 g/d plus prednisone, tapered from a maximum starting dosage of 60 mg/d) N=185 intravenous cyclophosphamide (0.5 to 1.0 g/m in monthly pulses plus prednisone, tapered from a maximum starting dosage of 60 mg/d) https://web.pathway.md/studies/recwpUjish7yUdPcO 1/2 6/28/23, 12:07 AM ALMS Pathway Primary outcome Percentage of patients achieving urine protein/creatinine ratio reduction and stabilization or reduction in serum creatinine 56.2 % 56.2 53 42.2 % 28.1 % 14.1 % No significant difference 0.0 % Mycophenolate mofetil Intravenous cyclophosphamide No significant difference in the percentage of patients achieving urine protein/creatinine ratio reduction and stabilization or reduction in serum creatinine (56.2% vs. 53%; OR 1.2, 95% CI 0.8 to 1.8) Secondary outcomes No significant difference in the percentage of patients achieving normal serum creatinine at 24 weeks (70.3% vs. 67.6%; ARD 2.7, 95% CI -6.7 to 12.1) Safety outcomes No significant differences in rates of adverse events, serious adverse events, or infections. Conclusion In patients with class III to V lupus nephritis undergoing induction treatment, mycophenolate mofetil was not superior to intravenous cyclophosphamide with respect to the percentage of patients achieving urine protein/creatinine ratio reduction and stabilization or reduction in serum creatinine. Reference Appel GB, Contreras G, Dooley MA et al. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol. 2009 May;20(5):1103-12. Open reference URL https://web.pathway.md/studies/recwpUjish7yUdPcO 2/2