Enteric-coated mycophenolate sodium versus azathioprine in patients with active systemic lupus erythematosus: a randomised clinical trial
Abstract
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.
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In a recent randomised, open-label trial in extrarenal SLE, enteric-coated mycophenolate sodium was superior to azathioprine in achieving remission and reducing flares.
“In a recent randomised, open-label trial in extrarenal SLE, enteric-coated mycophenolate sodium (EC-MPS) was superior to AZA in achieving remission and reducing flares.”
From 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus (2019) · cites this paper as [54]
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Advances in the pharmacological management of systemic lupus erythematosus
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Systemischer Lupus erythematodes (SLE) – neue Klassifikationskriterien
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Systemischer Lupus erythematodes
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Systemischer Lupus Erythematodes (SLE) (engl. Systemic lupus erythematosus)
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Immunosuppressive drug therapy
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Systemischer Lupus erythematodes: Strukturierte Diagnostik – Erfolg versprechende Therapie
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Was ist gesichert in der Therapie des systemischen Lupus erythematodes?
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Neue Wirkstoffe ermöglichen gute Krankheitskontrolle
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Systemischer Lupus Erythematodes 2023
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Head-to-Head-Studien bei Kollagenosen und Vaskulitiden
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Was ist gesichert in der Therapie des systemischen Lupus erythematodes?
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Lupus Arthritis: What We Know and What Remains Unknown?
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Updates on the Evaluation of Lupus Arthritis
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- Authors
- Ordi-Ros, J., Sáez-Comet, L., Pérez-Conesa, M., Vidal, X., Mitjavila, F., Castro Salomó, A., Cuquet Pedragosa, J., Ortiz-Santamaria, V., Mauri Plana, M., & Cortés-Hernández, J.
- Affiliations
- Hospital Universitario Miguel Servet (ES)
- Vall d'Hebron Hospital Universitari (ES)
- Bellvitge University Hospital (ES)
- Vall d'Hebron Institut de Recerca (ES)
- Corresponding author
- Cortés-Hernández, Josefina
- Venue
- Annals of the Rheumatic Diseases
- Publisher
- Elsevier BV
- Published
- 2017-09
- Volume
- 76
- Issue
- 9
- Pages
- 1575-1582
- ISSN
- 0003-4967 (ISSN-L)
- OpenAlex
- W2609479377
- Cited by
- 89
- References
- 41
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 20 · 2023: 8 · 2022: 4 · 2021: 13 · 2020: 10 · 2019: 10 · 2018: 8 · 2017: 1
- FWCI
- 6.93
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of the Rheumatic Diseases (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Instituto de Salud Carlos III
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Pathology and Forensic Medicine › Systemic Sclerosis and Related Diseases
- Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
- Keywords
- systemic lupus erythematosus, mycophenolate sodium, azathioprine, immunosuppressive therapy, clinical remission, disease flares, corticosteroid tapering, adverse events, SLEDAI-2000, BILAG, prednisone, antimalarial drugs, treatment safety and efficacy comparison, relapse after remission
- MeSH terms
- Adult, Antimalarials, Azathioprine, Drug Therapy, Combination, Female, Glucocorticoids, Humans, Immunosuppressive Agents, Lupus Erythematosus, Systemic, Male, Middle Aged, Mycophenolic Acid, Prednisone, Remission Induction, Tablets, Enteric-Coated
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