Service Pharmacie, APHM, Hôpital de la Timone, Aix-Marseille University, Marseille, France Institute of NeuroPhysiopathology (INP), CNRS, Aix-Marseille University, Marseille, France.
Pôle de Neurosciences Cliniques, Service de Neurologie, APHM, Hôpital de la Timone, Aix-Marseille University, Marseille, France.
Mult Scler. 2021 Apr;27(4):585-592. doi: 10.1177/1352458520912170. Epub 2020 Mar 17.
Rituximab's originator MabThera or Rituxan has demonstrated high efficacy in multiple sclerosis (MS). Because of the patent expiration, rituximab biosimilars have been developed. However, because a biosimilar is not the exact copy of the originator, the efficacy and safety of a biosimilar may significantly differ.
To compare the efficacy and safety of the biosimilar Truxima and the originator MabThera in MS.
Consecutive MS patients receiving MabThera or Truxima were prospectively followed during 1 year after treatment introduction. Allocation to each treatment depended on the period of introduction and not the physician's choice. Lymphocyte count, clinical and magnetic resonance imaging (MRI) activity, Expanded Disability Status Scale (EDSS), and adverse events were compared.
In total, 105 and 40 patients received MabThera and Truxima, respectively. The two groups did not differ in baseline characteristics. Effect on CD19+ lymphocytes and disease activity were similar during follow-up. EDSS remained stable, with no difference between groups. Adverse events were similar between groups.
The efficacy and safety of the rituximab biosimilar Truxima seem equivalent to the originator MabThera in MS patients. Truxima could represent a relatively cheap and safe therapeutic alternative to MabThera and could improve access to highly efficient therapy for MS in low- or middle-income countries.
利妥昔单抗的原研药美罗华或利妥昔单抗在多发性硬化症（MS）中显示出了很高的疗效。由于专利到期，利妥昔单抗生物类似药已经被开发出来。然而，由于生物类似药不是原研药的完全复制，其疗效和安全性可能会有显著差异。
比较 MS 患者中利妥昔单抗生物类似药 Truxima 和原研药美罗华的疗效和安全性。
连续接受美罗华或 Truxima 治疗的 MS 患者在治疗开始后 1 年内进行前瞻性随访。每种药物的分配取决于引入的时间段，而不是医生的选择。比较淋巴细胞计数、临床和磁共振成像（MRI）活动、扩展残疾状态量表（EDSS）和不良反应。
共有 105 例和 40 例患者分别接受了美罗华和 Truxima 治疗。两组患者在基线特征方面没有差异。在随访期间，CD19+淋巴细胞和疾病活动的影响相似。EDSS 保持稳定，两组之间没有差异。两组之间的不良反应相似。
利妥昔单抗生物类似药 Truxima 在 MS 患者中的疗效和安全性似乎与原研药美罗华相当。Truxima 可能是一种相对便宜且安全的治疗选择，可以改善低收入和中等收入国家中 MS 患者获得高效治疗的机会。
