Cited by 89Systemic Lupus Erythematosus ResearchSystemic Sclerosis and Related DiseasesRenal Transplantation Outcomes and Treatments

Enteric-coated mycophenolate sodium versus azathioprine in patients with active systemic lupus erythematosus: a randomised clinical trial

Ordi-Ros, Josep, Sáez-Comet, Luis, Pérez-Conesa, Mercedes, Vidal, Xavier, Mitjavila, Francesca, Castro Salomó, Antoni, Cuquet Pedragosa, Jordi, Ortiz-Santamaria, Vera +2 more·2017·Annals of the Rheumatic Diseases

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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Crossref · 10.1136/annrheumdis-2016-210882

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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.”

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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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