High dose cyclophosphamide performs better than monthly dose cyclophosphamide in quality of life measures

• Published in: Lupus 2008-12, Vol.17 (12), p.1079-1085
• Main Authors: Dussán, KB, Magder, L, Brodsky, RA, Jones, RJ, Petri, M
• Format: Article
• Language: English
• Subjects: Adult; Clinical trials; Cyclophosphamide - administration & dosage; Disability Evaluation; Dose-Response Relationship, Drug; Drug dosages; Emotions; Female; Humans; Immunosuppressive Agents - administration & dosage; Injections, Intravenous; Lupus; Lupus Erythematosus, Systemic - drug therapy; Lupus Erythematosus, Systemic - physiopathology; Lupus Erythematosus, Systemic - psychology; Male; Medical prognosis; Medicine; Middle Aged; Motor Activity; Nervous system; Oncology; Quality of Life; Rheumatology; Severity of Illness Index
• ISSN: 0961-2033; 1477-0962
• DOI: 10.1177/0961203308093828

In spite of current therapies, the overall health status of patients with SLE is poor. High-dose cyclophosphamide (50 mg/kg for 4 days) with or without stem-cell rescue has been introduced as a new therapy for severe SLE, including renal and central nervous system (CNS)-SLE. Long-term durable responses have been found to be 40%. A randomised clinical trial was completed comparing high-dose cyclophosphamide with monthly intravenous cyclophosphamide (750 mg/m squared bovine serum albumin) in patients with SLE who need cyclophosphamide for the first time. The primary outcome of the trial was complete clinical response. In this report, we compare the treatment groups with respect to quality of life. The patients in this study had a mean age of 35.3 ± 10.1 years, were of Caucasian (35%), African-American (51%), Hispanic (8%) and Asian (6%) people, and 88% were women. The organ leading to treatment was renal lupus in 29%, CNS-lupus in 45% and other organs in 26%. Quality of life was measured at each visit using the Medical Outcome Study Short-Form 36 (SF-36). At 6 months, the patients in the high-dose cyclophosphamide trial arm had significantly greater improvement than patients in the monthly intravenous cyclophosphamide arm (P = 0.026; P = 0.0082, respectively) in the categories of general health and social functioning. At 18 months, the improvement in the role-physical score was significantly greater in the high-dose cyclophosphamide trial arm than in the monthly-dose cyclophosphamide arm (P = 0.025). At the end of the two and a half-year study, there were no significant differences between the groups with respect to changes in SF-36. By pooling the groups, at 30 months, there was a statistically significant (P