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.
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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.