Background

Pivotal studies have reported a significant proportion of patients achieving no evidence of disease activity (NEDA) after 2 cycles of treatment with alemtuzumab (ATZ), that can be maintained for several years. Long-term real-world evidence regarding ATZ as well as subsequent treatment trajectories is still scarce.

Objective

To analyze the effectiveness and safety of ATZ-treated patients in a tertiary care Belgian center.

Methods

A retrospective cohort study including 32 patients treated with ATZ between 2015 and 2021 was performed.

Results

32 patients received 2 ATZ courses with a mean follow-up (FU) duration of 5.6 years (range: 2.25–8.2). 21.75% patients were treatment naïve. 40.5% were previously treated with natalizumab or fingolimod. NEDA-3 was achieved in 61.3–85% of patients, with failure mostly attributed to recurrence of radiological disease activity. During FU, annualized relapse rates remained very low (0.06–0.14), disability improvement occurred in up to 40.5%, whereas disability worsening occurred in up to 13.5%. Retreatment risk was associated with younger age (< 45 years old, Odds Ratio 8.0, p = 0.02) and a higher number of previous DMTs (Hazard ratio 2.7, 95%CI 1.3–7.4, p = 0.02). Safety in our cohort was consistent with the known profile of ATZ. At the end of FU, 65.6% patients remained untreated after 2 or 3 courses of ATZ, while the remaining switched to anti-CD20 therapy or cladribine.

Conclusion

ATZ is a high efficacy therapy for active MS, providing long-term remission in a significant proportion of patients. Retreatment was more frequent in younger patients or patients having failed a higher number of previous DMTs.

中文翻译：

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阿仑单抗治疗患者的长期随访：比利时三级护理中心的回顾性研究

背景

关键研究报告称，相当比例的患者在接受阿仑单抗 (ATZ) 2 个周期治疗后没有出现疾病活动证据 (NEDA)，并且可以维持数年。关于 ATZ 以及后续治疗轨迹的长期现实证据仍然很少。

客观的

分析比利时三级护理中心接受 ATZ 治疗的患者的有效性和安全性。

方法

进行了一项回顾性队列研究，纳入了 2015 年至 2021 年间接受 ATZ 治疗的 32 名患者。

结果

32 名患者接受了 2 个 ATZ 疗程，平均随访 (FU) 持续时间为 5.6 年（范围：2.25-8.2）。 21.75% 的患者未接受过治疗。 40.5% 之前接受过那他珠单抗或芬戈莫德治疗。 61.3-85% 的患者达到了 NEDA-3，失败主要归因于放射学疾病活动的复发。在 FU 期间，年复发率仍然非常低（0.06-0.14），残疾改善率高达 40.5%，而残疾恶化率高达 13.5%。再治疗风险与年龄较小（< 45 岁，优势比 8.0，p  = 0.02）和既往 DMT 次数较多（风险比 2.7，95% CI 1.3-7.4，p  = 0.02）相关。我们队列的安全性与 ATZ 的已知特征一致。在 FU 结束时，65.6% 的患者在 2 或 3 个疗程的 ATZ 后仍未接受治疗，而其余患者则改用抗 CD20 治疗或克拉屈滨。

结论

ATZ 是一种治疗活动性多发性硬化症的高效疗法，可为相当一部分患者提供长期缓解。年轻患者或先前多次 DMT 失败的患者中，再治疗的频率更高。