The Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) pilot trial

BACKGROUND: Patients with proliferative lupus 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 (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.