PMID- 28450313
OWN - NLM
STAT- MEDLINE
DCOM- 20170821
LR  - 20220317
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Linking)
VI  - 76
IP  - 9
DP  - 2017 Sep
TI  - Enteric-coated mycophenolate sodium versus azathioprine in patients with active 
      systemic lupus erythematosus: a randomised clinical trial.
PG  - 1575-1582
LID - 10.1136/annrheumdis-2016-210882 [doi]
AB  - 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.
CI  - (c) Article author(s) (or their employer(s) unless otherwise stated in the text of 
      the article) 2017. All rights reserved. No commercial use is permitted unless 
      otherwise expressly granted.
FAU - Ordi-Ros, Josep
AU  - Ordi-Ros J
AD  - Autoimmune Disease Unit, Internal Medicine Department, Research Institute Vall 
      d'Hebron Hospital, Barcelona, Spain.
FAU - Saez-Comet, Luis
AU  - Saez-Comet L
AD  - Autoimmune Diseases Unit, Internal Medicine Department, Miguel Servet Hospital, 
      Zaragoza, Spain.
FAU - Perez-Conesa, Mercedes
AU  - Perez-Conesa M
AD  - Autoimmune Diseases Unit, Internal Medicine Department, Miguel Servet Hospital, 
      Zaragoza, Spain.
FAU - Vidal, Xavier
AU  - Vidal X
AD  - Clinical Pharmacology Department, Vall d'Hebron Hospital, Barcelona, Spain.
FAU - Mitjavila, Francesca
AU  - Mitjavila F
AD  - Internal Medicine Department, Bellvitge University Hospital, Barcelona, Spain.
FAU - Castro Salomo, Antoni
AU  - Castro Salomo A
AD  - Internal Medicine Department, Sant Joan de Reus University Hospital, Reus, Spain.
FAU - Cuquet Pedragosa, Jordi
AU  - Cuquet Pedragosa J
AD  - Internal Medicine Department, Granollers University Hospital, Granollers, Spain.
FAU - Ortiz-Santamaria, Vera
AU  - Ortiz-Santamaria V
AD  - Department of Rheumatology Unit, Granollers University Hospital, Granollers, 
      Spain.
FAU - Mauri Plana, Montserrat
AU  - Mauri Plana M
AD  - Internal Medicine Department, Mataro Hospital, Mataro, Spain.
FAU - Cortes-Hernandez, Josefina
AU  - Cortes-Hernandez J
AD  - Autoimmune Disease Unit, Internal Medicine Department, Research Institute Vall 
      d'Hebron Hospital, Barcelona, Spain.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170427
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antimalarials)
RN  - 0 (Glucocorticoids)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Tablets, Enteric-Coated)
RN  - HU9DX48N0T (Mycophenolic Acid)
RN  - MRK240IY2L (Azathioprine)
RN  - VB0R961HZT (Prednisone)
SB  - IM
MH  - Adult
MH  - Antimalarials/therapeutic use
MH  - Azathioprine/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glucocorticoids/therapeutic use
MH  - Humans
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Lupus Erythematosus, Systemic/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Mycophenolic Acid/*therapeutic use
MH  - Prednisone/therapeutic use
MH  - Remission Induction
MH  - Tablets, Enteric-Coated
OTO - NOTNLM
OT  - Outcomes research
OT  - Systemic Lupus Erythematosus
OT  - Treatment
COIS- Competing interests: None declared.
EDAT- 2017/04/30 06:00
MHDA- 2017/08/22 06:00
CRDT- 2017/04/29 06:00
PHST- 2016/11/27 00:00 [received]
PHST- 2017/03/29 00:00 [revised]
PHST- 2017/04/09 00:00 [accepted]
PHST- 2017/04/30 06:00 [pubmed]
PHST- 2017/08/22 06:00 [medline]
PHST- 2017/04/29 06:00 [entrez]
AID - annrheumdis-2016-210882 [pii]
AID - 10.1136/annrheumdis-2016-210882 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2017 Sep;76(9):1575-1582. doi: 10.1136/annrheumdis-2016-210882. 
      Epub 2017 Apr 27.