Objective To compare the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) versus azathioprine (AZA) in patients with active systemic lupus erythematosus (SLE) disease.
Methods A multicentre, 24-month, superiority, open-label, randomised controlled trial (NCT01112215) was conducted with 240 patients (120 per arm) receiving either EC-MPS (target dose: 1440 mg/day) or AZA (target dose: 2 mg/kg/day) in addition to prednisone and/or antimalarials. The primary endpoint was the proportion of patients achieving clinical remission, assessed by SLE Disease Activity Index 2000 (SLEDAI-2K) and British Isles Lupus Assessment Group (BILAG), at 3 and 24 months. Secondary endpoints included time to clinical remission, BILAG A and B flare rates, time to flare, corticosteroid reduction and adverse events (AEs).
Results Proportion of patients achieving clinical remission (clinical SLEDAI=0) was higher in the EC-MPS group at 3 (32.5% vs 19.2%; treatment difference, 13.3 (CI 2.3 to 24), p=0.034) and 24 months (71.2% vs 48.3%; treatment difference, 22.9 (CI 10.4 to 34.4), p<0.001). EC-MPS was superior with respect to time to clinical remission (HR 1.43; 95% CI 1.07 to 1.91; p=0.017). BILAG A/B and B flares occurred more frequently in the AZA group (71.7% vs 50%, p=0.001 and 21.67% vs 8.3%, p=0.004, respectively). EC-MPS was superior with respect to time to first BILAG A/B (HR 1.81; 95% CI 1.3 to 2.56; p=0.0004) and BILAG A flare (HR 2.84; 95% CI 1.37 to 5.89; p=0.003). AEs were similar in both groups except for leucopenia that occurred more frequently with AZA.
Conclusions EC-MPS was superior to AZA in treating SLE and preventing further relapses.
Trial registration number NCT01112215; Results.
- Systemic Lupus Erythematosus
- Outcomes research
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Contributors JOR and JCH had full access to all data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. JOR contributed to the design and execution of the study, interpretation, analysis of data and preparation of the manuscript. JCH, LSC, MPC, FM, ACS, JCP, VOS and MMP contributed to the design and execution of the study, acquisition, interpretation and analysis of data, and preparation of the manuscript. XV developed the statistical analysis plan, conducted the analysis of the data and revised the manuscript.
Competing interests None declared.
Patient consent Patient enrolled in the study signed the patient consent form approved by the Ethic Committee of Vall d’Hebron Hospital and by the Agencia Espaola del medicamento y productos sanitarios (AEMPS).
Provenance and peer review Not commissioned; externally peer reviewed.