Mehra S, et al. - Experts intended to contemplate the efficacy and compare adverse effects of low and high dose intravenous cyclophosphamide (CYC) therapy in Indian patients with proliferative lupus nephritis. Findings shed light on substantially higher renal relapses in the low dose group when compared to the high dose group. It was deduced that high dose CYC was more effective in inducing remission with decreased renal relapses in the study cohort at 52 weeks.

Methods

• The scheme of this research was an open-label, parallel group, randomized controlled trial.
• The enrollment consisted of 75 candidates with class III/IV LN after obtaining informed consent.
• During this study, the low dose group (n = 38) received 6 × 500 mg CYC fortnightly and high dose group (n = 37) received 6 × 750 mg/m² CYC 4-weekly followed by azathioprine.
• Complete/partial/no response at 52 weeks served as the primary outcome.
• The secondary outcomes included renal and non-renal flares and adverse events.
• Herein, intention-to-treat analyses were carried out.

Results

• Complete/partial response (CR/PR) was achieved by 27 (73%) patients in high dose group vs 19 (50%) in low dose (p=0.04) at 52 weeks.
• Higher CR was discovered in the high dose vs low dose [24 (65%) vs 17 (44%)], which, however, was not statistically prominent.
• Data revealed markedly lower non-responders (NR) in the high dose group which was 10 (27%) vs low dose 19 (50%) (p=0.04).
• Additionally higher change was detected in the SLEDAI (Median, IQR) in the high dose 16 (7-20) than the low dose 10 (5.5-14) (p=0.04).
• Prominent alopecia and CYC-induced leucopenia were illustrated in high dose group.
• Findings disclosed considerably higher renal relapses in the low dose group vs high dose [9 (24%) vs 1(3%), (p=0.01)].