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Extended report
Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis
  1. Farah Tamirou1,
  2. David D'Cruz2,
  3. Shirish Sangle2,
  4. Philippe Remy3,
  5. Carlos Vasconcelos4,
  6. Christoph Fiehn5,
  7. Maria del Mar Ayala Guttierez6,
  8. Inge-Magrethe Gilboe7,
  9. Maria Tektonidou8,
  10. Daniel Blockmans9,
  11. Isabelle Ravelingien10,
  12. Véronique le Guern11,
  13. Geneviève Depresseux1,
  14. Loïc Guillevin11,
  15. Ricard Cervera12,
  16. Frédéric A Houssiau1
  17. and 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. 5ACURA Center for Rheumatic Diseases, Baden-Baden, Germany
    6. 6Department of General Internal Medicine, Hospital Regional Universitario Carlos Haya, Malaga, Spain
    7. 7Rheumatology Department, Rikshospitalet University Hospital, Oslo, Norway
    8. 8First Department of Internal Medicine, National University of Athens, Athens, Greece
    9. 9General Internal Medicine Department, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
    10. 10Rheumatology Department, Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium
    11. 11General Internal Medicine Department, Hôpital Cochin, Paris, France
    12. 12Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Catalonia, Spain
    1. Correspondance to Professor Frédéric A Houssiau, Rheumatology Department, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels 1200, Belgium; frederic.houssiau{at}uclouvain.be

    Abstract

    Objective To report the 10-year follow-up of the MAINTAIN Nephritis Trial comparing azathioprine (AZA) and mycophenolate mofetil (MMF) as maintenance therapy of proliferative lupus nephritis, and to test different definitions of early response as predictors of long-term renal outcome.

    Methods In 2014, data on survival, kidney function, 24 h proteinuria, renal flares and other outcomes were collected for the 105 patients randomised between 2002 and 2006, except in 13 lost to follow-up.

    Results Death (2 and 3 in the AZA and MMF groups, respectively) and end-stage renal disease (1 and 3, respectively) were rare events. Time to renal flare (22 and 19 flares in AZA and MMF groups, respectively) did not differ between AZA and MMF patients. Patients with good long-term renal outcome had a much more stringent early decrease of 24 h proteinuria compared with patients with poor outcome. The positive predictive value of a 24 h proteinuria <0.5 g/day at 3 months, 6 months and 12 months for a good long-term renal outcome was excellent (between 89% and 92%). Inclusion of renal function and urinalysis in the early response criteria did not impact the value of early proteinuria decrease as long-term prognostic marker.

    Conclusions The long-term follow-up data of the MAINTAIN Nephritis Trial do not indicate that MMF is superior to AZA as maintenance therapy in a Caucasian population suffering from proliferative lupus nephritis. Moreover, we confirm the excellent positive predictive value of an early proteinuria decrease for long-term renal outcome.

    Trial registration number NCT00204022.

    • Lupus Nephritis
    • Treatment
    • Outcomes research

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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