Objectives

This study aimed to compare the efficacy of low-dose prednisolone with conventional high-dose regimen in proliferative lupus nephritis (LN) for remission.

Methods

This open-label randomized clinical trial was conducted in the Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. A total of 32 LN patients were randomized into low-dose (experimental) and high-dose (control) groups. All subjects received standard dose of intravenous (I/V) methylprednisolone and pulse I/V cyclophosphamide. Oral prednisolone, 0.5 mg/kg/d and 1 mg/kg/d were given to experimental and control groups respectively for initially 4 weeks then tapered. The patients were followed for 24 weeks. The rates of renal remission (complete and partial) were assessed at 24 weeks. The disease activity, biochemical markers, and quality of life were evaluated at baseline and at 24 weeks.

Results

Complete renal remission was achieved by 66.7% of patients in each group (P = .99). Renal remission (partial/complete) was achieved by 86.7% and 83.3% of patients in the prednisolone low-dose group and high-dose group respectively (P = .99). In between groups, no significant difference was observed in the improvement of active urinary sediments, serum creatinine level, anti-double-stranded DNA level, complements level, disease activity and Short Form-12 score. The prednisolone dose-related adverse events like cushingoid facies, abdominal stria, infections and serious adverse events like death occurred more in the high-dose prednisolone group.

Conclusions

It has been observed that low-dose prednisolone regimen may be effective in LN. Steroid dose-related side effects and rate of infections were lower in this group.