SP152COMPARISON OF TWO STEROID REGIMENS IN INDUCTION THERAPY OF PROLIFERATIVE LUPUS NEPHRITIS: A RANDOMISED CONTROLLED TRIAL

Abstract

INTRODUCTION AND AIMS: Corticosteroids are the mainstay of treatment of active lupus nephritis (LN). Different investigators have used oral prednisolone between 0.5‐1 mg/kg/day as the induction dose. The adverse effects of corticosteroids are dosedependent and have both short‐and long‐term complications. METHODS: The present pilot study is a randomized parallel‐group active‐controlled trial design conducted during the period of January 2015‐July 2017 (CTRI/2016/01/ 006488). Treatment‐naive biopsy‐proven LN [International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III, IV, III+Vor IV+V] patients were included. Patients with serum creatinine >2 mg/dl (176.8 mmol/L) and crescents in >50% of sampled glomeruli were excluded. The protocol consisted of oral prednisolone at 0.5 mg/kg/day (Regimen 1) or 1.0 mg/kg/day (Regimen 2) given for a period of 8 weeks followed by fixed tapering. All patients received methylprednisolone pulse of 750 mg/day for 3 days preceding oral steroids and the other induction agent was mycophenolate mofetil (2 g/day). Outcome: Primary‐Response rate as per Kidney Disease Improving Global Outcomes (KDIGO) criteria and Secondary: Complication rate. The sample size was 60 patients with a provision for interim analysis RESULTS: We analysed the outcomes of 18 patients (all females), 8 of them were on regimen 1 (0.5 mg/kg/day) and 10 received regimen 2 (1 mg/kg/day). The baseline parameters and outcome are mentioned in Table 1. The mean change in proteinuria was‐0.4360.9 g/day in regimen 1 vs.‐2.962.1 in regimen 2 (p=0.007). Two patients on regimen 1 and one patient on regimen 2 were started on alternative induction therapy with a change in steroid dosing at the 4th month of follow‐up due to worsening proteinuria. Adverse events, in the form of serious infections (herpes zoster in 2 and cellulitis in 1), were noted in the group receiving regimen 2 only. CONCLUSIONS: Low dose oral prednisolone is inferior to standard dose as induction therapy of less severe proliferative lupus nephritis (Table presented).