Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Department of Medicine, Yonsei University College of Medicine, Seoul, Korea.
Yonsei Med J. 2020 Aug;61(8):712-719. doi: 10.3349/ymj.2020.61.8.712.
There has been no extensive study to compare the efficacy between rituximab originator (Mabthera®) and its biosimilar (Truxima®) for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). Here, we investigated the clinical effects of rituximab on poor outcomes of MPA and GPA in Korean patients, and compared those between Mabthera® and Truxima®.
We retrospectively reviewed the medical records of a total of 139 patients, including 97 MPA patients and 42 GPA patients. At diagnosis, antineutrophil cytoplasmic antibody positivity and comorbidities were assessed. During follow-up, all-cause mortality, relapse, end-stage renal disease, cerebrovascular accident and acute coronary syndrome were evaluated as poor outcomes. In this study, rituximab was used as either Mabthera® or Truxima®.
The median age at diagnosis was 60.1 years and 46 patients were men (97 MPA and 42 GPA patients). Among poor outcomes, patients receiving rituximab exhibited a significantly lower cumulative relapse-free survival rate compared to those not receiving rituximab (=0.002). Nevertheless, rituximab use did not make any difference in other poor outcomes of MPA and GPA except for relapse, which might be a rebuttal to the fact that rituximab use after relapse eventually led to better prognosis. There were no significant differences in variables at diagnosis and during follow-up between patients receiving Mabthera® and those receiving Truxima®. Patients receiving Truxima® exhibited a similar pattern of the cumulative survival rates of each poor outcome to those receiving Mabthera®.
Truxima® prevents poor outcomes of MPA and GPA as effectively as does Mabthera®.
目前尚无广泛的研究比较利妥昔单抗原研药（美罗华）及其生物类似药（曲妥珠单抗）治疗显微镜下多血管炎（MPA）和肉芽肿性多血管炎（GPA）的疗效。本研究旨在探讨利妥昔单抗治疗韩国 MPA 和 GPA 不良结局的临床疗效，并比较美罗华和曲妥珠单抗的疗效。
我们回顾性分析了共 139 例患者的病历资料，其中 MPA 患者 97 例，GPA 患者 42 例。在诊断时，评估抗中性粒细胞胞质抗体阳性和合并症。在随访期间，评估全因死亡率、复发、终末期肾病、卒中和急性冠脉综合征作为不良结局。在本研究中，利妥昔单抗使用原研药（美罗华）或生物类似药（曲妥珠单抗）。
诊断时的中位年龄为 60.1 岁，46 例为男性（97 例 MPA 和 42 例 GPA 患者）。在不良结局中，与未使用利妥昔单抗的患者相比，使用利妥昔单抗的患者累积无复发生存率显著降低（=0.002）。然而，除了复发，利妥昔单抗的使用对 MPA 和 GPA 的其他不良结局没有影响，这可能反驳了这样一个事实，即复发后使用利妥昔单抗最终导致了更好的预后。使用美罗华和曲妥珠单抗的患者在诊断时和随访期间的变量没有显著差异。使用曲妥珠单抗的患者各不良结局的累积生存率与使用美罗华的患者相似。
曲妥珠单抗与美罗华一样，能有效预防 MPA 和 GPA 的不良结局。
