Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial - Aix-Marseille Université Access content directly
Journal Articles Annals of the Rheumatic Diseases Year : 2022

Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial

Nathalie Costedoat-Chalumeau
Karine Baumstarck
  • Function : Author
Anderson Loundou
  • Function : Author
Laurence Bouillet
  • Function : Author
Valérie Caudwell
  • Function : Author
Laurent Chiche
  • Function : Author
Lionel Couzi
  • Function : Author
Christophe Deligny
  • Function : Author
Bertrand Dussol
  • Function : Author
Stanislas Faguer
Pierre Gobert
  • Function : Author
Guillaume Gondran
  • Function : Author
Antoine Huart
  • Function : Author
Aurélie Hummel
  • Function : Author
Emilie Kalbacher
  • Function : Author
Adexandre Karras
  • Function : Author
Véronique Le Guern
  • Function : Author
Ludivine Lebourg
  • Function : Author
Sandrine Loubière
  • Function : Author
Hélène Maillard-Lefebvre
  • Function : Author
François Maurier
  • Function : Author
Micheline Pha
  • Function : Author
Viviane Queyrel
  • Function : Author
Philippe Remy
  • Function : Author
Françoise Sarrot-Reynauld
  • Function : Author
David Verhelst
  • Function : Author
Zahir Amoura
  • Function : Author
Eric Daugas

Abstract

Objectives Lupus nephritis (LN) is a frequent complication of systemic lupus erythematosus (SLE). Severe (proliferative) forms of LN are treated with induction immunosuppressive therapy (IST), followed by maintenance IST, to target remission and avoid relapses. The optimal duration of maintenance IST is unknown. The WIN-Lupus trial tested whether IST discontinuation after 2‒3 years was non-inferior to IST continuation for two more years in proliferative LN. Methods WIN-Lupus was an investigator-initiated multicentre randomised controlled trial. Patients receiving maintenance IST with azathioprine or mycophenolate mofetil for 2–3 years, and hydroxychloroquine, were randomised (1:1) into two groups: (1) IST continuation and (2) IST discontinuation. The primary endpoint was the relapse rate of proliferative LN at 24 months. Main secondary endpoints were the rate of severe SLE flares, survival without renal relapse or severe flare, adverse events. Results Between 2011 and 2016, 96 patients (out of 200 planned) were randomised in WIN-Lupus: IST continuation group (n=48), IST discontinuation group (n=48). Relapse of proliferative LN occurred in 5/40 (12.5%) patients with IST continuation and in 12/44 (27.3%) patients with IST discontinuation (difference 14.8% (95% CI −1.9 to 31.5)). Non-inferiority was not demonstrated for relapse rate; time to relapse did not differ between the groups. Severe SLE flares (renal or extrarenal) were less frequent in patients with IST continuation (5/40 vs 14/44 patients; p=0.035). Adverse events did not differ between the groups. Conclusions Non-inferiority of maintenance IST discontinuation after 2‒3 years was not demonstrated for renal relapse. IST discontinuation was associated with a higher risk of severe SLE flares. Trial registration number NCT01284725 .
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hal-03800914 , version 1 (16-11-2023)

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Noemie Jourde-Chiche, Nathalie Costedoat-Chalumeau, Karine Baumstarck, Anderson Loundou, Laurence Bouillet, et al.. Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial. Annals of the Rheumatic Diseases, 2022, 81 (10), pp.1420-1427. ⟨10.1136/annrheumdis-2022-222435⟩. ⟨hal-03800914⟩
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