Short-interval lower-dose intravenous cyclophosphamide as induction and maintenance therapy for lupus nephritis: a prospective observational study

Abstract

Cyclophosphamide (CYC) has long been considered a gold standard in inducing renal remission and preventing renal flares for patients with systemic lupus erythematosus (SLE). However, the rational use of CYC has not reached a consensus, such as the timing and length of treatment, the route of administration, and the ideal dosage. The objective of this study was to assess the efficacy and safety of short-interval lower-dose (SILD) intravenous (IV) CYC in the treatment of SLE. A total of 225 patients with lupus nephritis were randomly assigned to a 1-year trial, either the SILD group (12 fortnightly pulses at a fixed dose of 400 mg followed by 6 monthly pulses) or high-dose (HD) group (6 monthly pulses followed by two quarterly pulses at a dose of 0.5~1.0 g/m 2 ). At 6 months of treatment, 28 % (30/107) of patients in the SILD group reached a complete remission (CR), and 51.4 % (55/107) were in partial remission (PR), as compared with 32.7 % (35/107) and 45.8 % (49/107) in the HD group, respectively. Serum albumin, 24-h urinary protein, and the scores of disease activity were significantly improved in both groups at 6 months and maintained at the end of clinical trial. However, the SILD group showed much less menstrual disturbances (11.5 %), gastrointestinal adverse effects (5.3 %), and leukopenia (9.7 %) than the HD group (28.6, 26.8, and 19.8 %, respectively) at the end of clinical trial. The efficacy of the short-interval lower-dose (SILD) IV CYC regimen in the treatment of lupus nephritis is equivalent to that of the high-dose (HD) regimen, whereas the incidence of adverse events is much lower in the SILD group.

Systematic evaluation of different doses of cyclophosphamide induction therapy for lupus nephritis

“…In recent years, numerous clinical studies have shown that intermittent intravenous pulse therapy with low-dose CTX combined with glucocorticoid has a superior efficacy in the treatment of LN with less adverse reactions than high-dose regimens do. [ 6 – 8 ] To the best of our knowledge, our study is the first to investigate the efficacy and safety of different doses of CTX in the treatment of LN using a meta-analysis.…”

Comparison of short interval and low dose (SILD) with high dose of cyclophosphamide in the susceptibility to infection in SLE: a multicentrereal-world study

“…In recent years, many studies have demonstrated that SILD IV-CYC is also efficacious, and there was no difference between the SILD IV-CYC and HD IV-CYC groups in SLE disease control. 10 11 19 20 However, the side effects of long-term exposure to CYC have been shown to include infection, bone marrow damage, malignancy, ovarian dysfunction and haemorrhagic cystitis at any therapeutic dose. The infection occurring in associated with CYC treatment could be fatal for patients with SLE.…”

The GSTA1 polymorphism and cyclophosphamide therapy outcomes in lupus nephritis patients

“…A partial remission (PR) was defined as a value for urinary protein excretion that was 0.3-2.9 g per 24 h, with an ALB concentration of at least 30 g/L and stable renal function [9]. Complete or partial remission patients were classified into remission group, and other patients were classified into none-remission group.…”