부산대학교 도서관

This phase II, double-blind, placebo-controlled, 48-week trial enrolled 104 patients with relapsing-remitting multiple sclerosis (RRMS). Of these, 69 patients received IV rituximab 1000 mg on days 1 and 15, and 35 patients received placebo. The groups had an average disease duration of 6 years, median annualized relapse rate of 1, and a median EDSS (Expanded Disability Status Scale) of 2.5. More than three-fourths had been on prior immunotherapy with interferon-beta, glatiramer, or natalizumab. The primary end point was the total number of gadolinium-enhancing lesions on brain MRIs at weeks 12, 16, 20, and 24. Secondary clinical outcome measures were the proportion of relapses and annualized relapse rate. The number of total and new gadolinium-enhancing lesions was significantly reduced at week 24 by 91% in the rituximab group compared to placebo controls (p<0.001). The proportion of patients with relapses was reduced by over 50% at week 24 (14.5% vs. 34.3%, p=0.02) and week 48 (20.3% vs. 40.0%, p=0.04). Examining safety measures, 50 patients (92.6%) of rituximab-treated patients had mild to moderate infusion-associated adverse events, and 4 patients (7.4%) reported severe infusion reactions, which included headache, back pain, limb pain, pruritus, and rash. At week 48, 16 patients (24.6%) tested positive for human antichimeric antibodies against rituximab. [ABSTRACT FROM AUTHOR]