Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: Treatment of non-renal manifestations in systemic lupus erythematosus (SLE) remains challenging. To date, available data on the efficacy, safety and steroid-sparing effects of non-biological therapies is limited and provided mainly by small open-label studies and few randomized controlled trials (RCTs). The aim of the study is to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPs) compared with azathioprine (AZA) for active non-renal SLE.
Methods: This is a 24-month randomized, superiority, open-label, multicenter study (ClinicalTrials.gov: NCT01112215). Adults age ≥18 years with moderate-to-severe active SLE disease were recruited from 13 Hospitals in Spain. Patients were stratified by centre and SLEDAI-2k score (6-9 vs. ≥10) and randomized (1:1) to receive oral EC-MPs (target dose: 1440 mg/day) or azathioprine (target dose: 2 mg/Kg, according to TPMT levels when available), in addition to background therapy with oral prednisone and antimalarial agents. To have a ≥80% statistical power to detect a ~20% difference in clinical response between the 2 study groups, assuming a clinical response in the AZA group at 2 years of 40-50% we calculated we needed 120 patients in each group with a two-sided significance level of 0.05. Statistical analysis was by intention-to-treat. Rates of complete remission (CR) at 3 and 24 months were the primary endpoints. Secondary endpoints included time to CR, rate and time to BILAG A/B or BILAG A flares, reduction of corticosteroids and adverse events.
Results: A total of 240 patients were included. More patients in the EC-MPs group than in the azathioprine group achieved CR at 3 (32.5% vs. 19.2%, p=0.027) and 24 months (71.2% vs. 48.3%, p=0.0005). Time to CR was shorter in the EC-MPs group (hazard ratio, 1.43; 95% CI, 1.07 to 1.91; P=0.017). BILAG A/B flares were observed in 86 (71.7%) AZA-treated and 60 (50%) EC-MPs-treated patients (p=0.001). Time to first flare was longer with EC-MFs (hazard ratio, 1.81; 95% CI, 1.3 to 2.56; p=0.0004). New BILAG A flares occurred in 26 (21.7%) AZA-treated and 10 (8.3%) EC-MPs-treated patients (p=0.004). Time to severe flare was longer in the EC-MPs group (hazard ratio, 2.84; 95% CI, 1.37 to 5.89; p=0.0029). Steroid reduction was superior in the EC-MPS group (p=0.024). Adverse events did not differ between groups except for leukopenia in the AZA group.
Conclusion: EC-MPs was superior to AZA for treating active disease and preventing relapse in non-renal SLE patients.
To cite this abstract in AMA style:Cortés-Hernández J, Sáez-Comet L, Pérez-Conesa M, Rubio Rivas M, Mitjavila F, Castro Salomó A, Parra S, Cuquet Pedragosa J, Ortiz-Santamaría V, Mauri Plana M, Bujan-Rivas S, Suñé Martin P, Vidal X, Ordi-Ros J. Enteric-Coated Mycophenolate Sodium Versus Azathioprine for Patients with Moderate/Severe Active Systemic Lupus Erythematosus: Results from a Phase 3, Randomized, Parallel, Multicentre Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/enteric-coated-mycophenolate-sodium-versus-azathioprine-for-patients-with-moderatesevere-active-systemic-lupus-erythematosus-results-from-a-phase-3-randomized-parallel-multicentre-study/. Accessed December 2, 2020.
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