Alemtuzumab more effective than interferon β-1a at 5-year follow-up of CAMMS223 Clinical Trial
Alemtuzumab more effective than interferon β-1a at 5-year follow-up of CAMMS223 Clinical Trial
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DOI：
10.1212/wnl.0b013e31824e8ee7
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发表时间：
2012-04-01
期刊：
影响因子：
9.9
通讯作者：
Compston, D. A. S.
中科院分区：
文献类型：
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作者：
Coles, A. J.;Fox, E.;Compston, D. A. S.
目的：报告CAMMS 223中比较Alemtuzumab与干扰素β-1a治疗早期活动性复发缓解型多发性硬化症（RRMS）的长期安全性和疗效结果。既往接受36 - 48个月的Alemtuzumab治疗对早期活动性RRMS复发和残疾的长期影响是什么？本研究提供的证据表明，阿仑单抗在降低复发率和残疾的积累相比，干扰素β-1a（IFN β-1a）通过延长随访（从基线到60个月）。方法：334例患者最初随机，198人参加了扩展阶段（151 [68%]阿仑单抗和47 [42%] IFN β-1a）。残疾、复发和安全性的评估与初始研究期间相同。分析从初始试验期基线至60个月的疗效结局。安全性数据延长超过60 months.Results：超过5年，阿仑单抗与IFN β-1a相比，残疾持续累积风险降低72%，复发率降低69%（均p < 0.0001）。Alemtuzumab组从基线至第60个月的年复发率为0.11，IFN β-1a组为0.35。完整的安全性随访反映了Alemtuzumab和IFN β-1a患者分别为988和376人-年。在7%的Alemtuzumab患者和3%的IFN β-1a患者中观察到严重感染，在30%的Alemtuzumab患者和4%的IFN β-1a患者中观察到甲状腺疾病。在初始研究期间，3%的Alemtuzumab患者和0.9%的IFN β-1a患者发生免疫性血小板减少症;在扩展期未报告其他事件。一名Alemtuzumab患者在第二个年度周期的Alemtuzumab治疗后39个月发生Goodpasture病。结论：通过延长随访，Alemtuzumab仍然比IFN β-1a显著更有效，其安全性特征与以前的报告一致。证据分类：这项研究提供了III类证据，证明Alemtuzumab比干扰素β-干扰素更有效。在一项评分者设盲、随机临床试验的长期随访中，1a在减少RRMS患者复发和残疾方面的作用，59.5%的患者参与了延长随访期。神经病学（R）2012;78：1069-1078
Objective: To report the long-term safety and efficacy results from CAMMS223 comparing alemtuzumab with interferon beta-1a in early, active relapsing-remitting multiple sclerosis (RRMS). What are the long-term effects of alemtuzumab treatment, received 36 to 48 months previously, on relapse and disability in early, active RRMS? This study provides evidence of the effectiveness of alemtuzumab in reducing the relapse rate and accumulation of disability compared with interferon beta-1a (IFN beta-1a) through extended follow-up (up to 60 months from baseline).Methods: Of 334 patients originally randomized, 198 participated in the extension phase (151 [68%] alemtuzumab and 47 [42%] IFN beta-1a). Disability, relapses, and safety were assessed as in the original study period. Efficacy outcomes were analyzed from baseline of the original trial period to 60 months. Safety data extended beyond 60 months.Results: Over 5 years, alemtuzumab lowered the risk of sustained accumulation of disability by 72% and the rate of relapse by 69% compared with IFN beta-1a (both p < 0.0001). The annualized relapse rate from baseline to month 60 was 0.11 for alemtuzumab and 0.35 for IFN beta-1a. Complete safety follow-up reflected 988 and 376 person-years for alemtuzumab and IFN beta-1a patients, respectively. Serious infections were seen in 7% of alemtuzumab patients and 3% of IFN beta-1a patients, and thyroid disorders were seen in 30% of alemtuzumab patients vs 4% of IFN beta-1a patients. Immune thrombocytopenia occurred in 3% of alemtuzumab patients and 0.9% of IFN beta-1a patients during the initial study period; no additional events were reported during the extension phase. One alemtuzumab patient developed Goodpasture disease 39 months after the second annual cycle of alemtuzumab.Conclusions: Through extended follow-up, alemtuzumab remained significantly more efficacious than IFN beta-1a, with a safety profile consistent with previous reports.Classification of Evidence: This study provides Class III evidence that alemtuzumab is more effective than interferon beta-1a in reducing relapses and disability in patients with RRMS in a long-term follow-up of a rater-blinded, randomized clinical trial with 59.5% of patients participating in the extended follow-up period. Neurology (R) 2012;78:1069-1078