Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden/Department of Medicine and Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.
Department of Medicine, Karolinska Institutet, Solna, Sweden.
Mult Scler. 2018 Jul;24(8):1087-1095. doi: 10.1177/1352458517713668. Epub 2017 Jun 26.
To compare treatment effectiveness and persistence in relapsing-remitting multiple sclerosis patients who initiated rituximab versus glatiramer acetate (GA) or interferon-beta (IFN-β).
A total of 461 patients from the Swedish MS registry in the rituximab arm were propensity score matched on a 1:2 basis with 922 patients from the IFN-β/GA comparator, between April 2005 and November 2015. Annualised relapse rate (ARR) was compared using the Poisson method. A marginal Cox model was used to analyse time to first relapse, 3-month confirmed disability progression and treatment discontinuation in the matched sample. A signed-rank test was used to compare Expanded Disability Status Scale (EDSS) change from baseline.
Rituximab was associated with a reduction in ARR (0.003; 95% confidence interval (CI) = 0.001, 0.009) relative to IFN-β/GA (0.026; 95% CI = 0.020, 0.033) ( p < 0.001). Rituximab was associated with an 87% reduction in the relapse rate (hazard ratio (HR) = 0.13; 95% CI = 0.04, 0.41) and an 85% reduction in the discontinuation rate (HR = 0.15; 95% CI = 0.11, 0.20) relative to IFN-β/GA. EDSS regression from baseline was greater in the rituximab group at 12 and 24 months.
Rituximab appears to be superior to first-generation disease-modifying treatments (DMTs) with respect to relapse control and tolerability, whereas superiority on disability outcomes is less clear.
比较在复发缓解型多发性硬化症患者中,起始使用利妥昔单抗与使用那他珠单抗/干扰素-β(IFN-β)相比的治疗效果和持续时间。
2005 年 4 月至 2015 年 11 月,在利妥昔单抗组中,共有 461 例患者来自瑞典多发性硬化症注册中心,按照 1:2 的比例与 IFN-β/GA 对照比较组中的 922 例患者进行倾向评分匹配。使用泊松法比较年复发率(ARR)。在匹配样本中,使用边缘 Cox 模型分析首次复发、3 个月确认的残疾进展和治疗中断的时间。使用符号秩检验比较从基线开始的扩展残疾状况量表(EDSS)变化。
与 IFN-β/GA(0.026;95%置信区间(CI)=0.020,0.033)相比,利妥昔单抗与 ARR 降低相关(0.003;95%CI=0.001,0.009)(p<0.001)。与 IFN-β/GA 相比,利妥昔单抗使复发率降低 87%(风险比(HR)=0.13;95%CI=0.04,0.41),使停药率降低 85%(HR=0.15;95%CI=0.11,0.20)。与基线相比,在 12 个月和 24 个月时,利妥昔单抗组的 EDSS 从基线回归更为显著。
与第一代疾病修正治疗(DMT)相比,利妥昔单抗在控制复发和耐受性方面似乎更优,而在残疾结局方面的优势则不太明确。