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  • Azathioprine versus mycophenolate mofetil for long-term immunosuppression in lupus nephritis: results from the MAINTAIN Nephritis Trial

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Clinical and epidemiological research
Extended report
Azathioprine versus mycophenolate mofetil for long-term immunosuppression in lupus nephritis: results from the MAINTAIN Nephritis Trial
  1. Frédéric A Houssiau1,
  2. David D'Cruz2,
  3. Shirish Sangle2,
  4. Philippe Remy3,
  5. Carlos Vasconcelos4,
  6. Radmila Petrovic5,
  7. Christoph Fiehn6,
  8. Enrique de Ramon Garrido7,
  9. Inge-Magrethe Gilboe8,
  10. Maria Tektonidou9,
  11. Daniel Blockmans10,
  12. Isabelle Ravelingien11,
  13. Véronique le Guern12,
  14. Geneviève Depresseux1,
  15. Loïc Guillevin12,
  16. Ricard Cervera13,
  17. the MAINTAIN Nephritis Trial Group
  1. 1Rheumatology Department, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
  2. 2Louise Coote Lupus Unit, St Thomas' Hospital, London, UK
  3. 3Nephrology Department, Hôpital Henri Mondor, Créteil, France
  4. 4Clinical Immunology Unit, Hospital Santo Antonio, ICBAS, Porto, Portugal
  5. 5Institute of Rheumatology, University of Belgrade, Belgrade, Serbia
  6. 6Center for Rheumatic Diseases, Baden-Baden, Germany
  7. 7General Internal Medicine, Hospital Regional Universitario Carlos Haya, Malaga, Spain
  8. 8Rheumatology Department, Rikshospitalet University Hospital, Oslo, Norway
  9. 9Department of Pathophysiology, National University of Athens, Athens, Greece
  10. 10General Internal Medicine Department, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
  11. 11Rheumatology Department, Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium
  12. 12General Internal Medicine Department, Hôpital Cochin, Paris, France
  13. 13Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Catalonia, Spain
  1. Correspondence to Professor Frédéric A Houssiau, Rheumatology Department, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Saint-Luc University Hospital, Avenue Hippocrate, 10, Brussels 1200, Belgium; frederic.houssiau{at}uclouvain.be

Abstract

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.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ard.bmj.com/info/unlocked.dtl

http://dx.doi.org/10.1136/ard.2010.131995

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    Footnotes

    • The members of the MAINTAIN Nephritis Trial group are the coauthors and: Daniel Abramowicz, Nephrology Department, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium; Fabiola Atzeni, Unita Operativa di Reumatologia, Ospedale Luigi Sacco, Milan, Italy; Maria Giovanna Danieli, Istituto di Clinica Medica Generale, Universia Degli Study di Ancona, Torrette di Ancona, Italy; Luc De Clercq, Rheumatology Department, Sint-Augustinus Ziekenhuis, Wilrijk, Belgium; Filip de Keyser, Rheumatology Department, UZ Gent, University of Ghent, Ghent, Belgium; Michel Delahousse, Service de Nephrologie, Hôpital Foch, Paris, France; Gerard Espinosa, Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Catalonia, Spain; Marc Golstein, Service de Rheumatologie, Cliniques Saint-Jean, Brussels, Belgium; Marco Hirsch, Luxembourg, Grand Duchy of Luxembourg; Alexandre Karras, Service de Néphrologie, Hôpital Européen Georges Pompidou, Paris, France; Philippe Lang, Nephrology Department, Hôpital Henri Mondor, Créteil, France; Martine Marchal, Service de Néphrologie, Hôpital de Tivoli, La Louvière, Belgium; Antonio Marinho, Clinical Immunology Unit, Hospital Santo Antonio, ICBAS, Porto, Portugal; Regina Max, Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany; Patrick Peeters, Nephrology Department, UZ Gent, University of Ghent, Ghent, Belgium; Peter Petera, Zentrum für Diagnostik und Therapie rheumatischer Erkrankungen, Krankenhaus Lainz, Wien, Austria; Thomas Quémeneur; Centre Hospitalier Régional Universitaire de Lille, Lille, France; Frank Raeman, Rheumatology Department, Jan Palfijn Hospital, Merksem, Belgium; Piercarlo Sarzi-Puttini, Unita Operativa di Reumatologia, Ospedale Luigi Sacco, Milan, Italy; Lucia Valiente de Santis, General Internal Medicine, Hospital Regional Universitario Carlos Haya, Malaga, Spain; Luc Verresen, Nephrology Department, Ziekenhuis Oost-Limburg, Genk, Belgium; Laurence Weiss, Département d'Immunologie, Hôpital Européen Georges Pompidou, Paris, France; René Westhovens, Rheumatology Department, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.

    • Patient consent Obtained.

    • Ethics approval This study was conducted with the approval of the Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Belgium.

    • Competing interests None.

    • Provenance and peer review Not commissioned; externally peer reviewed.