Saridas Furkan, Mercan Saridas Filiz, Koc Emine Rabia, Turan Omer Faruk
Bursa Uludag University, Faculty of Medicine, Department of Neurology, Turkey.
Bursa Uludag University, Faculty of Medicine, Department of Internal Medicine, Division of Endocrinology and Metabolism, Turkey.
Heliyon. 2024 Feb 22;10(5):e26900. doi: 10.1016/j.heliyon.2024.e26900. eCollection 2024 Mar 15.
Alemtuzumab (ATZ) is an anti-CD52 humanized monoclonal antibody indicated for treating highly active relapsing-remitting MS (RRMS). It alters the regulation of the immune system by depleting circulating lymphocytes. Changes in blood cell count, infusion-related reactions, and changes in vital parameters can be seen in the early period with ATZ.
Changes in blood tests, serum tests, vital parameters, and characteristics of infusion-associated reactions (IARs) observed during the first course of ATZ treatment and thereafter were evaluated.
The systolic blood pressure (SBP), diastolic blood pressure (DBP), fever, heart rate (HR), changes in blood and serum tests, and IARs developed after the first course of 23 patients with RRMS who received ATZ treatment were evaluated by comparing the results of 26 patients with RRMS who received only intravenous methylprednisolone.
Mean age was 36.60 ± 8.98, 73.9% female (n = 17), diagnosis time was 8.52 ± 3.64 years, pre-EDSS: 3.93 ± 1.80. No significant difference was found in vital parameters except for sub-febrile fever that developed on the first day. The number of white blood cells increased significantly after the first day. The hemoglobin level did not change. Lymphocyte (very high) and platelet (mild) counts decreased starting from the first days, and eosinophil (very high) and monocyte (moderate) counts decreased from the third day. There were no significant changes in liver enzymes, thyroid function tests, serum urea, creatinine, and lipid profile during 1-year follow-up. The IAR rate was 95.6% and occurred most frequently on the second and third days. The most common are dermatological findings (52%), headache (20%), pain (10%) and fatigue (8%).
Alemtuzumab has no appreciable effect on vital parameters during infusion. However, these changes are not clinically correlated, even if there is. Headache in the first days, dermatological (most common) findings, pain, and fatigue are seen in the following days. Most IARs can be resolved with symptomatic treatment and close follow-up. Lymphocytes, eosinophils, and monocytes are significantly reduced and return to baseline levels towards the end of the first year. The first year does not cause significant pathologies in other serum parameters. However, after the first year, watch out for associated autoimmune pathologies, especially thyroid involvement.
阿仑单抗（ATZ）是一种抗CD52人源化单克隆抗体，用于治疗高度活动性复发缓解型多发性硬化症（RRMS）。它通过消耗循环淋巴细胞来改变免疫系统的调节。在使用ATZ治疗的早期，可以观察到血细胞计数的变化、输液相关反应以及生命体征参数的变化。
评估在ATZ治疗的第一个疗程及之后观察到的血液检查、血清检查、生命体征参数变化以及输液相关反应（IAR）的特征。
通过比较23例接受ATZ治疗的RRMS患者在第一个疗程后出现的收缩压（SBP）、舒张压（DBP）、发热、心率（HR）、血液和血清检查变化以及IAR，与26例仅接受静脉注射甲基强的松龙的RRMS患者的结果进行评估。
平均年龄为36.60±8.98岁，女性占73.9%（n = 17），诊断时间为8.52±3.64年，EDSS评分前：3.93±1.80。除第一天出现低热外，生命体征参数未发现显著差异。第一天后白细胞数量显著增加。血红蛋白水平未改变。淋巴细胞（非常高）和血小板（轻度）计数从第一天开始下降，嗜酸性粒细胞（非常高）和单核细胞（中度）计数从第三天开始下降。在1年的随访期间，肝酶、甲状腺功能检查、血清尿素、肌酐和血脂谱均无显著变化。IAR发生率为95.6%，最常发生在第二天和第三天。最常见的是皮肤表现（52%）、头痛（20%）、疼痛（10%）和疲劳（8%）。
阿仑单抗在输液过程中对生命体征参数没有明显影响。然而，即使存在这些变化，它们在临床上也没有相关性。在开始几天出现头痛，随后几天出现皮肤表现（最常见）、疼痛和疲劳。大多数IAR可以通过对症治疗和密切随访得到解决。淋巴细胞、嗜酸性粒细胞和单核细胞显著减少，并在第一年末恢复到基线水平。第一年不会在其他血清参数中引起显著病变。然而，在第一年之后，要注意相关的自身免疫性病变，尤其是甲状腺受累情况。
