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ABP 501 for the treatment of rheumatoid arthritis

机译:ABP 501用于治疗类风湿性关节炎

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Introduction: Rheumatoid arthritis (RA) is an autoimmune disease, which has a negative impact on the ability to perform activities daily. Tumour necrosis factor ?(TNF) is a cytokine with diverse cellular effects, and a key regulator of the inflammatory response. ABP 501 is a biosimilar to adalimumab, a TNF inhibitor. Areas covered: In this review, we examined ABP 501, as a biosimilar candidate to adalimumab in the treatment of RA focusing on the available data. Current data indicate that ABP 501 is a highly similar alternative to adalimumab in terms of safety, efficacy, tolerability and immunogenicity. ABP 501 has already been approved by health authorities in Europe and the United States of America, as a subcutaneous (s.c.) therapy option for the treatment of patients with RA, but also for the full spectrum approved for its bio-originator adalimumab. Expert opinion: Current body of evidence suggests that all biologic activities have been demonstrated to be equivalent between ABP 501 and the originator, including binding rates and affinity to TNF, and also the effector functions such as antibody-dependent cell-mediated cytotoxicity (ADCC). Therefore, it is fully expected to have same efficacy and safety in all indications.
机译:简介:类风湿性关节炎(RA)是一种自身免疫性疾病,对每天进行活动的能力产生负面影响。肿瘤坏死因子?(TNF)是具有多种细胞效应的细胞因子,以及炎症反应的关键调节因子。 ABP 501是一种生物纤维单反血,是一种TNF抑制剂。所涵盖的区域:在本次审查中,我们在治疗RA关注可用数据的RA时,我们将ABP 501审查了ABP 501。当前数据表明ABP 501在安全性,疗效,耐受性和免疫原性方面是对Adalimalab的高度相似的替代品。 ABP 501已被欧洲和美利坚合众国的卫生当局批准,作为治疗RA患者的皮下(S.C.)治疗选择,但也用于批准其生物发布者Adalimalab的全谱。专家意见:目前的证据表明,所有生物学活动都证明了ABP 501和发起者之间的等同物,包括结合速率和对TNF的亲和力,以及依赖依赖性细胞介导的细胞毒性(ADCC)等效应功能。因此,在所有适应症中都有完全预期具有相同的功效和安全性。

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