那他珠单抗治疗非洲裔复发型多发性硬化症患者的疗效：AFFIRM和SENTINEL数据分析
Efficacy of natalizumab therapy in patients of African descent with relapsing multiple sclerosis: analysis of AFFIRM and SENTINEL data.
作者信息
Cree Bruce A C, Stuart William H, Tornatore Carlo S, Jeffery Douglas R, Pace Amy L, Cha Choon H
机构信息
UCSF Multiple Sclerosis Center, Department of Neurology, University of California, San Francisco, 94117, USA.
出版信息
Arch Neurol. 2011 Apr;68(4):464-8. doi: 10.1001/archneurol.2011.45.
BACKGROUND
Patients with multiple sclerosis (MS) who are of African descent experience a more aggressive disease course than patients who are of white race/ethnicity. In phase 3 clinical trials (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] and Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis [SENTINEL]), natalizumab use significantly improved clinical and magnetic resonance imaging outcomes over 2 years in patients with relapsing MS. Because patients of African descent may be less responsive to interferon beta treatment than patients of white race/ethnicity, the efficacy of natalizumab therapy in this population is clinically important.
OBJECTIVE
To evaluate the efficacy of natalizumab use in patients of African descent with relapsing MS.
DESIGN
Post hoc analysis.
SETTING
Academic research.
PATIENTS
Patients of African descent with relapsing MS who received natalizumab or placebo in the phase 3 AFFIRM study and those who received natalizumab plus intramuscular interferon beta-1a or placebo plus intramuscular interferon beta-1a in the phase 3 SENTINEL study.
MAIN OUTCOME MEASURE
Efficacy of natalizumab use in patients of African descent with relapsing MS who participated in the AFFIRM or SENTINEL trial.
RESULTS
Forty-nine patients of African descent participated in AFFIRM (n = 10) or SENTINEL (n = 39). Demographic and baseline disease characteristics were similar between patients treated with natalizumab (n = 21) or placebo (n = 28). Natalizumab therapy significantly reduced the annualized MS relapse rate by 60% (0.21 vs 0.53 in the placebo group, P = .02). Compared with placebo use, natalizumab therapy also significantly reduced the accumulation of lesions observed on magnetic resonance imaging over 2 years: the mean number of gadolinium-enhancing lesions was reduced by 79% (0.19 vs 0.91, P = .03), and the mean number of new or enlarged T2-weighted lesions was reduced by 90% (0.88 vs 8.52, P = .008).
CONCLUSION
Natalizumab therapy significantly improved the relapse rate and accumulation of brain lesions in patients of African descent with relapsing MS.
背景
非裔多发性硬化症（MS）患者的疾病进程比白种人患者更为侵袭性。在3期临床试验（那他珠单抗治疗复发缓解型多发性硬化症的安全性和有效性[AFFIRM]以及那他珠单抗联合干扰素β-1a治疗复发缓解型多发性硬化症患者的安全性和有效性[SENTINEL]）中，那他珠单抗的使用在2年时间里显著改善了复发型MS患者的临床和磁共振成像结果。由于非裔患者可能比白种人患者对干扰素β治疗的反应性更低，那他珠单抗治疗在该人群中的疗效具有重要临床意义。
目的
评估那他珠单抗在复发型MS非裔患者中的疗效。
设计
事后分析。
地点
学术研究机构。
患者
在3期AFFIRM研究中接受那他珠单抗或安慰剂治疗的复发型MS非裔患者，以及在3期SENTINEL研究中接受那他珠单抗加肌肉注射干扰素β-1a或安慰剂加肌肉注射干扰素β-1a治疗的复发型MS非裔患者。
主要观察指标
参与AFFIRM或SENTINEL试验的复发型MS非裔患者使用那他珠单抗的疗效。
结果
49名非裔患者参与了AFFIRM（n = 10）或SENTINEL（n = 39）试验。接受那他珠单抗治疗的患者（n = 21）和接受安慰剂治疗的患者（n = 28）在人口统计学和基线疾病特征方面相似。那他珠单抗治疗使MS年化复发率显著降低了60%（安慰剂组为0.53，那他珠单抗组为0.21，P = 0.02）。与使用安慰剂相比，那他珠单抗治疗还显著减少了2年内磁共振成像观察到的病灶累积：钆增强病灶的平均数量减少了79%（分别为0.19和0.91，P = 0.03），新的或扩大的T2加权病灶的平均数量减少了90%（分别为0.
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