疗效和安全性比较研究:治疗丘疹性荨麻疹的生物仿制药利妥昔单抗与原研药利妥昔单抗的疗效比较研究。

IF 2.9 3区 医学 Q2 DERMATOLOGY
Sang Heon Shin, Jae Yeon Kim, Soo-Chan Kim, Jong Hoon Kim
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引用次数: 0

摘要

利妥昔单抗是一种针对 B 细胞 CD20 抗原的单克隆抗体。对于丘疹性荨麻疹,利妥昔单抗在中度至重度病例的类固醇保留治疗中非常有效。原研药利妥昔单抗已在丘疹性荨麻疹患者中显示出良好的治疗效果,但其高昂的成本仍是一个挑战。生物仿制药利妥昔单抗有望提供一种潜在的解决方案。然而,由于所有生物仿制药可能与原研药不完全相同,因此需要对生物仿制药和原研药的疗效和安全性进行比较研究。在这项研究中,我们比较了生物仿制药(Truxima)和原研药(MabThera)利妥昔单抗对丘疹性荨麻疹患者的治疗效果和安全性。最终,MabThera 组和 Truxima 组分别有 52 名和 72 名患者入组。除了静脉注射免疫球蛋白的比例外,两组患者的基线特征没有差异;为了比较疗效,对完全缓解时间、完全缓解前类固醇总摄入量以及利妥昔单抗治疗后6个月的类固醇总摄入量进行了调查,结果显示两组患者的疗效没有显著差异。Truxima可被视为治疗丘疹性荨麻疹的一种相对经济实惠的替代疗法,为适合使用MabThera治疗的患者提供了成本效益。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Comparative study of efficacy and safety: Biosimilar rituximab versus originator rituximab in the treatment of pemphigus

Comparative study of efficacy and safety: Biosimilar rituximab versus originator rituximab in the treatment of pemphigus

Rituximab is a monoclonal antibody that targets CD20 antigen in B cells. For pemphigus, rituximab has been highly effective in steroid-sparing therapy for moderate to severe cases. Originator rituximab has demonstrated favorable treatment effects in patients with pemphigus, but its high cost remains a challenge. Biosimilar rituximab is expected to offer a potential solution. However, it is required for the comparative study of efficacy and safety between biosimilar and originator because all biosimilars may not be identical to the originator. In this study, we compared the treatment effects and safety of biosimilar (Truxima) and originator (MabThera) rituximab in patients with pemphigus. A final cohort of 52 patients in the MabThera group and 72 patients in the Truxima group was enrolled. Except for the intravenous immunoglobulin administration rate, there were no differences in baseline characteristics between the two groups, and for the purpose of comparing efficacy, investigations into time to complete remission, total steroid intake to complete remission, and total steroid intake for 6 months following rituximab treatment revealed no significant differences between the two groups. Truxima can be considered a relatively affordable alternative treatment option for pemphigus, offering cost-effectiveness to patients who are indicated for the treatment with MabThera.

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来源期刊
Journal of Dermatology
Journal of Dermatology 医学-皮肤病学
CiteScore
4.60
自引率
9.70%
发文量
368
审稿时长
4-8 weeks
期刊介绍: The Journal of Dermatology is the official peer-reviewed publication of the Japanese Dermatological Association and the Asian Dermatological Association. The journal aims to provide a forum for the exchange of information about new and significant research in dermatology and to promote the discipline of dermatology in Japan and throughout the world. Research articles are supplemented by reviews, theoretical articles, special features, commentaries, book reviews and proceedings of workshops and conferences. Preliminary or short reports and letters to the editor of two printed pages or less will be published as soon as possible. Papers in all fields of dermatology will be considered.
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