PT  - JOURNAL ARTICLE
AU  - Frédéric A Houssiau
AU  - David D'Cruz
AU  - Shirish Sangle
AU  - Philippe Remy
AU  - Carlos Vasconcelos
AU  - Radmila Petrovic
AU  - Christoph Fiehn
AU  - Enrique de Ramon Garrido
AU  - Inge-Magrethe Gilboe
AU  - Maria Tektonidou
AU  - Daniel Blockmans
AU  - Isabelle Ravelingien
AU  - Véronique le Guern
AU  - Geneviève Depresseux
AU  - Loïc Guillevin
AU  - Ricard Cervera
AU  - the MAINTAIN Nephritis Trial Group
TI  - Azathioprine versus mycophenolate mofetil for long-term immunosuppression in lupus nephritis: results from the MAINTAIN Nephritis Trial
AID  - 10.1136/ard.2010.131995
DP  - 2010 Dec 01
TA  - Annals of the Rheumatic Diseases
PG  - 2083--2089
VI  - 69
IP  - 12
4099  - http://ard.bmj.com/content/69/12/2083.short
4100  - http://ard.bmj.com/content/69/12/2083.full
SO  - Ann Rheum Dis2010 Dec 01; 69
AB  - Background Long-term immunosuppressive treatment does not efficiently prevent relapses of lupus nephritis (LN). This investigator-initiated randomised trial tested whether mycophenolate mofetil (MMF) was superior to azathioprine (AZA) as maintenance treatment. Methods A total of 105 patients with lupus with proliferative LN were included. All received three daily intravenous pulses of 750 mg methylprednisolone, followed by oral glucocorticoids and six fortnightly cyclophosphamide intravenous pulses of 500 mg. Based on randomisation performed at baseline, AZA (target dose: 2 mg/kg/day) or MMF (target dose: 2 g/day) was given at week 12. Analyses were by intent to treat. Time to renal flare was the primary end point. Mean (SD) follow-up of the intent-to-treat population was 48 (14) months. Results The baseline clinical, biological and pathological characteristics of patients allocated to AZA or MMF did not differ. Renal flares were observed in 13 (25%) AZA-treated and 10 (19%) MMF-treated patients. Time to renal flare, to severe systemic flare, to benign flare and to renal remission did not statistically differ. Over a 3-year period, 24 h proteinuria, serum creatinine, serum albumin, serum C3, haemoglobin and global disease activity scores improved similarly in both groups. Doubling of serum creatinine occurred in four AZA-treated and three MMF-treated patients. Adverse events did not differ between the groups except for haematological cytopenias, which were statistically more frequent in the AZA group (p=0.03) but led only one patient to drop out. Conclusions Fewer renal flares were observed in patients receiving MMF but the difference did not reach statistical significance.