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.