Title :

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

Author(s) :

Jourde-Chiche, Noemie [Auteur]
Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research [C2VN]
Costedoat-Chalumeau, Nathalie [Auteur]
Baumstarck, Karine [Auteur]
Loundou, Anderson [Auteur]
Bouillet, Laurence [Auteur]
Burtey, Stéphane [Auteur]
Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research [C2VN]
Caudwell, Valérie [Auteur]
Chiche, Laurent [Auteur]
Couzi, Lionel [Auteur]
Daniel, Laurent [Auteur]
Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research [C2VN]
Deligny, Christophe [Auteur]
Dussol, Bertrand [Auteur]
Faguer, Stanislas [Auteur]
Gobert, Pierre [Auteur]
Gondran, Guillaume [Auteur]
Huart, Antoine [Auteur]
Hummel, Aurélie [Auteur]
Kalbacher, Emilie [Auteur]
Karras, Adexandre [Auteur]
Lambert, Marc [Auteur]
Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167 [RID-AGE]
Le Guern, Véronique [Auteur]
Lebourg, Ludivine [Auteur]
Loubière, Sandrine [Auteur]
Maillard-Lefebvre, Hélène [Auteur]
Maurier, François [Auteur]
Pha, Micheline [Auteur]
Queyrel, Viviane [Auteur]
Remy, Philippe [Auteur]
Sarrot-Reynauld, Françoise [Auteur]
Verhelst, David [Auteur]
Hachulla, Eric [Auteur]
Institute for Translational Research in Inflammation - U 1286 [INFINITE]
Amoura, Zahir [Auteur]
Daugas, Eric [Auteur]

Journal title :

Annals of the Rheumatic Diseases

Pages :

1420-1427

Publisher :

BMJ Publishing Group

Publication date :

2022-10

ISSN :

0003-4967

English keyword(s) :

Lupus Nephritis
Hydroxychloroquine
Glucocorticoids
Lupus Erythematosus
Systemic
Outcome Assessment
Health Care

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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, ...
Show more >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 .Show less >

Language :

Anglais

Popular science :

Non

Collections :

• Facteurs de risque et déterminants moléculaires des maladies liées au vieillissement (RID-AGE) - U1167

Source :

Harvested from HAL