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Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223.
Journal of Neurology ( IF 4.8 ) Pub Date : 2020-06-24 , DOI: 10.1007/s00415-020-09983-1
Brian Steingo 1 , Yaser Al Malik 2 , Ann D Bass 3 , Regina Berkovich 4, 5 , Matthew Carraro 6 , Óscar Fernández 7 , Carolina Ionete 8 , Luca Massacesi 9 , Sven G Meuth 10 , Dimos D Mitsikostas 11 , Gabriel Pardo 12 , Renata Faria Simm 13 , Anthony Traboulsee 14 , Zia Choudhry 15 , Nadia Daizadeh 15 , D Alastair S Compston 16 ,
Affiliation  

Background

In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing–remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656).

Methods

In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies.

Results

Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients had stable or improved Expanded Disability Status Scale scores, and 69% were free of 6-month confirmed disability worsening. In Year 12, 73% of patients were free of MRI disease activity. Cumulatively throughout the extensions (Years 7–12), 34% of patients had no evidence of disease activity. Adverse event (AE) incidence declined through Year 12. Infusion-associated reactions peaked at first course and declined thereafter. Cumulative thyroid AE incidence was 50%; one immune thrombocytopenia event occurred, and there were no autoimmune nephropathy cases.

Conclusions

Alemtuzumab efficacy was maintained over 12 years in CAMMS223 patients, with 73% receiving no more than three courses. The safety profile in this cohort was consistent with other alemtuzumab clinical trials.



中文翻译:

Alemtuzumab在RRMS患者中的长期疗效和安全性:CAMMS223的12年随访。

背景

在CAMMS223 2期试验(NCT00050778)中,与未经治疗的复发缓解型MS患者相比,阿仑单抗在3年内显着改善了临床和MRI结果,优于皮下干扰素β-1a。在这里,我们评估了alemtuzumab在CAMMS223409扩展(NCT00930553)入组的CAMMS223患者中超过12年的疗效和安全性,并通过后续的TOPAZ扩展(NCT02255656)进行了随访。

方法

在CAMMS223中,患者接受了2个alemtuzumab疗程(12 mg /天;基线:5天; 12个月后:3天);22%的人接受了第三门课程。在开放标签的非随机扩展中,患者可以根据需要接受其他阿仑单抗或其他缓解疾病的疗法。

结果

在CAMMS223中治疗的108名用alemtuzumab治疗的患者中,有60名进入了CAMMS03409扩展名;33%的人总共接受了2个alemtuzumab疗程,73%的人在第12年接受了不超过3个疗程。在过去的12年中,年复发率是0.09,71%的患者具有稳定或改善的扩展残疾状况量表得分,而69%没有六个月确认的残疾恶化。在第12年,73%的患者没有MRI疾病活动。在整个扩展期(7-12年)中,累计有34%的患者没有疾病活动的迹象。到第12年,不良事件(AE)的发生率下降了。与输注相关的反应在第一个疗程达到高峰,然后下降。累积甲状腺AE发生率为50%;发生了1例免疫性血小板减少症事件,没有自身免疫性肾病病例。

结论

Alemtuzumab在CAMMS223患者中的疗效保持了12年以上,其中73%接受了不超过3个疗程。该队列的安全性与其他alemtuzumab临床试验一致。

更新日期:2020-06-24
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