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Weaning of maintenance immunosuppressive therapy in lupus nephritis (WIN-Lupus): results of a multicentre randomised controlled trial
- Source :
- Annals of the Rheumatic Diseases, Annals of the Rheumatic Diseases, 2022, 81 (10), pp.1420-1427. ⟨10.1136/annrheumdis-2022-222435⟩
- Publication Year :
- 2022
- Publisher :
- BMJ, 2022.
-
Abstract
- International audience; ObjectivesLupus 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.MethodsWIN-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.ResultsBetween 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.ConclusionsNon-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 numberNCT01284725.
- Subjects :
- Immunosuppression Therapy
Lupus Erythematosus
Outcome Assessment
[SDV]Life Sciences [q-bio]
Systemic
Immunology
Weaning
Mycophenolic Acid
Lupus Nephritis
General Biochemistry, Genetics and Molecular Biology
Health Care
Treatment Outcome
Rheumatology
Recurrence
Azathioprine
Humans
Lupus Erythematosus, Systemic
Immunology and Allergy
Glucocorticoids
Immunosuppressive Agents
Hydroxychloroquine
Subjects
Details
- ISSN :
- 14682060 and 00034967
- Volume :
- 81
- Database :
- OpenAIRE
- Journal :
- Annals of the Rheumatic Diseases
- Accession number :
- edsair.doi.dedup.....e272eddcfbb3437f84c852b6c42cc9d6