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：

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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。