Multiple Sclerosis Center, University of Cagliari/ATS Sardegna, Via Is Guadazzonis, 2, 09126, Cagliari, Italy.
J Neurol. 2019 Jun;266(6):1405-1411. doi: 10.1007/s00415-019-09272-6. Epub 2019 Mar 12.
No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing-remitting MS.
Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events. EDSS scores before alemtuzumab and at the last follow-up were compared by Wilcoxon test. Time to first relapse was analysed after dividing the cohort on the basis of previous treatment.
Ninety patients were enrolled [women 74.4%; naïve 7; mean follow-up 27 months (SD 23)]. The EDSS was reduced from a median of 2.5 (IQR 1.5-4) before alemtuzumab to 2.0 (IQR 1.5-3.5) after (p = 0.025). The time to first relapse was shorter in patients shifting from a second-line therapy (p = 0.011). Over 2 years, 43.7% had no evidence of disease activity. We observed infusion-related reactions in 95.5% patients, including 11.1% with pneumonitis, thyroiditis in 11%, and thrombocytopenia in 3.3%.
We confirmed the clinical and MRI efficacy of alemtuzumab in the clinical setting and the frequency of infusion-related reactions. Compared with that in clinical trials, higher number of patients developed pneumonitis during infusion.
尚无关于阿仑单抗的上市后随机临床试验,且真实世界数据有限。我们旨在分析单中心队列中复发缓解型多发性硬化症患者使用阿仑单抗的疗效和安全性。
纳入接受阿仑单抗治疗的患者。我们收集了以下数据:年龄、性别、多发性硬化症病史、扩展残疾状态量表(EDSS)评分、复发情况、阿仑单抗治疗后的磁共振成像(MRI)参数以及不良事件。采用 Wilcoxon 检验比较阿仑单抗治疗前和最后一次随访时的 EDSS 评分。根据既往治疗情况将队列分组,分析首次复发时间。
共纳入 90 例患者[女性 74.4%;初治患者 7 例;平均随访 27 个月(SD 23 个月)]。阿仑单抗治疗前 EDSS 中位数为 2.5(IQR 1.5-4),治疗后降至 2.0(IQR 1.5-3.5)(p=0.025)。从二线治疗转为一线治疗的患者首次复发时间更短(p=0.011)。超过 2 年,43.7%的患者无疾病活动证据。我们观察到 95.5%的患者出现了输注相关反应,包括 11.1%的肺炎、11%的甲状腺炎和 3.3%的血小板减少症。
我们在临床环境中证实了阿仑单抗的临床和 MRI 疗效以及输注相关反应的频率。与临床试验相比,更多患者在输注期间发生了肺炎。