WEANING OF MAINTENANCE IMMUNOSUPPRESSIVE THERAPY IN LUPUS NEPHRITIS (WIN-LUPUS): A MULTICENTER RANDOMIZED CONTROLLED TRIAL
Authors: N. Jourde-Chiche et al.
The optimal duration of maintenance immunosuppression for proliferative lupus nephritis is unknown. The French WIN-Lupus trial tested whether discontinuation of immunosuppression (IST) after 2-3 years in proliferative lupus nephritis was non-inferior to IST continuation for 2 more years.
Patients on maintenance therapy with azathioprine or mycophenolate mofetil for a minimum of 2 years and a maximum of 3 years, and who were taking hydroxychloroquine, were randomized (1:1) between 2 groups: continuation and discontinuation of IST. The primary endpoint was the relapse rate of nephritis at 24 months after randomization.
96 were randomized in the trial: 48 in the IST continuation group, 48 in the IST discontinuation group. In the per-protocol population, a relapse of proliferative lupus nephritis occurred in 5/40 (10.4%) patients with IST continuation, and in 12/44 (25%) patients with IST discontinuation. Non-inferiority was not demonstrated for relapse rate. Severe SLE flares (renal or extra-renal) were less frequent in patients with IST continuation compared to IST discontinuation (5/40 vs 14/44 patients, p=0.035). Adverse events did not differ between groups.
This study shows that discontinuing immunosuppression after 2 to 3 years of maintenance therapy is associated with a higher risk of severe SLE flare than the continuation of immunosuppression for another 2 years, indicating that patients with lupus nephritis may benefit from long term IST.