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ZRC3197(阿达木单抗生物类似药)在印度常见风湿性疾病患者中的真实世界安全性概况。

Real-life Safety Profile of ZRC3197 (Adalimumab Biosimilar) in Indian Patients with Common Rheumatic Diseases.

作者信息

Mathew Ashish J, Ganapati Arvind, T Sathish Kumar, Goel Ruchika, P Sandhya, Danda Debashish

机构信息

Clinical Immunology and Rheumatology.

Child Health - Pediatric Rheumatology, Christian Medical College, Vellore, Tamil Nadu.

出版信息

J Assoc Physicians India. 2017 May;65(5 Suppl):30-32.

Abstract

The advent of biologic therapies has brought in significant improvement in the outcome of patients suffering from chronic inflammatory arthritis. High costs and unavailability have however, limited their utility in some parts of the world. These limitations have been overcome to a good extent by the introduction of biosimilar versions of original products, which are gaining momentum, of late. Adalimumab (Humira®), a TNF-α inhibitor has been successfully used in patients with inflammatory arthritis for more than a decade now. ZRC3197 (Adalimumab Biosimilar) was developed in India and approved for use since 2014. Ongoing evaluation of safety in real-world setting outside the context of controlled clinical trials is pivotal in ensuring long-term safety of such biologic therapies. We share the real-life safety profile of biosimilar Adalimumab in patients with chronic inflammatory arthritis and other autoimmune conditions from a tertiary care centre in south India.

摘要

生物疗法的出现显著改善了慢性炎症性关节炎患者的治疗效果。然而,高昂的成本和难以获得性限制了它们在世界某些地区的应用。通过推出原创产品的生物类似药版本,这些限制在很大程度上得到了克服,生物类似药近来正获得越来越多的关注。阿达木单抗(修美乐®),一种TNF-α抑制剂,已经成功用于炎症性关节炎患者超过十年。ZRC3197(阿达木单抗生物类似药)在印度研发,并自2014年起获批使用。在非对照临床试验背景下的真实世界环境中持续评估安全性对于确保此类生物疗法的长期安全性至关重要。我们分享了来自印度南部一家三级护理中心的慢性炎症性关节炎和其他自身免疫性疾病患者使用生物类似药阿达木单抗的真实安全性概况。

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