Introduction: Lupus nephritis (LN) is a severe manifestation of systemic lupus erythematosus (SLE) that is usually treated with an extended course of intravenous (IV) cyclophosphamide (CYC). Given the side effects of this regimen, we evaluated the short-term efficacy and toxicity of a course of low-dose remission-inducing IV CYC followed by azathioprine (AZA) in a prospective controlled study among Egyptian patients with severe LN.
Patients and methods: In this single center, prospective clinical trial, we assigned 46 SLE patients with diffuse proliferative glomerulonephritis to either a high-dose (a maximum of 1 g/dose) of IV CYC (HD-CYC) for six monthly pulses followed by two quarterly pulses or a fixed low-dose (500 mg/dose) of IV CYC (LD-CYC) for six fortnightly pulses with a cumulative dose of 3 g. Each regimen was followed by AZA.
The objective: To compare between efficacy, potential toxicity and outcome of parenteral LD-CYC versus HD-CYC therapy for severe LN.
Results: Twenty patients (2 male and 18 female) received fortnightly fixed LD-CYC while 26 (5 male and 21 female) received monthly HD-CYC therapy. At the end of the study (1 year after starting therapy), there was no difference either in patients' or in renal survival in both groups. Significant improvement of disease activity (SLE disease activity index) as well as rise of serum albumin was noticed with both regimens. Renal relapse was observed in 11.5% of HD-CYC patients and in none of the LD-CYC therapy patients. Treatment failure was seen in 5% and 3.4% (P = NS) of LD-CYC and HD-CYC patients, respectively. Infection (pneumonia and cellulitis) occurred in five patients in the LD-CYC group and four patients of HD-CYC; again this difference was not statistically significant.
Conclusion: A remission-inducing regimen of LD-CYC (cumulative dose 3 g) followed by AZA for SLE patients with proliferative LN achieves clinical results comparable to those obtained with HD-CYC without serious infection in both regimens.