Background: Patients with proliferative lupus Bakery Tools nephritis are at risk of frequent relapses.Whether low- dose prednisone prevents relapses is uncertain.Objectives: We undertook a pilot RCT to determine the feasibility of a larger trial.Design: Pilot randomized controlled trial.Setting: Single center Canadian outpatient nephrology clinic.
Patients: Participants with systemic lupus erythematosus (SLE) and a history of class III or IV lupus nephritis that achieved at least partial remission and remained on prednisone were eligible.Measurements: Feasibility: proportion of eligible patients randomized and adherence to tapering regimen.Clinical: occurrence of renal or major non-renal flare of SLE.Methods: We conducted a blinded, two-parallel-group randomized controlled trial of prednisone 7.5 mg/day (continuation) compared to a matching placebo (withdrawal).
Results: Of nineteen eligible patients screened, 15 (79%) were recruited and randomized; 8 to prednisone continuation and seven to withdrawal.All participants adhered to the tapering protocol to their assigned withdrawal or low-dose maintenance target.Over 36 months, the primary outcome occurred in four (50%) patients in the continuation group (three renal and one major non-renal flare), compared with one patient (14%) in the withdrawal group (one renal flare).Three participants Oral Care (38%) in the continuation group had minor flares, while no patients in the withdrawal group did.Limitations: This pilot RCT was small and not designed to assess the efficacy or safety of maintenance with low-dose prednisone.
Conclusions: The high proportion of eligible patients recruited, and success of protocol adherence suggest a large trial of prednisone maintenance therapy compared to withdrawal is feasible.Trial registration: Current Controlled Trials ISRCTN31327267.