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Implications of Evolving Disease Classification for Drug Approval in Juvenile Idiopathic Arthritis.
Pediatric Drugs ( IF 3.7 ) Pub Date : 2022-04-01 , DOI: 10.1007/s40272-022-00496-0
Siobhan M Case 1, 2 , Peter A Nigrovic 1, 2
Affiliation  

The classification of inflammatory arthritis incorporates a sharp divide between diseases of childhood onset, grouped together as juvenile idiopathic arthritis, and diseases such as rheumatoid arthritis that begin by definition in adulthood. An important consequence of this divide is that regulatory authorities and many rheumatologists regard pediatric and adult arthritides as truly different, with the implication that drugs should be evaluated separately for each category. However, it is now clear that most forms of arthritis transcend the pediatric/adult boundary and that agents generally exhibit comparable success irrespective of age of onset, offering new opportunities in drug development and regulation focused on pharmacology and safety rather than efficacy. This paradigm shift will enable advances in arthritis treatment, originating either with adults or children, to translate more rapidly across the age spectrum.

中文翻译:

不断变化的疾病分类对幼年特发性关节炎药物批准的影响。

炎症性关节炎的分类将儿童期发病的疾病(统称为幼年特发性关节炎)与根据定义在成年期开始的类风湿性关节炎等疾病区分开来。这种分歧的一个重要后果是,监管机构和许多风湿病学家认为儿童和成人关节炎确实不同,这意味着应该针对每个类别分别评估药物。然而,现在很明显,大多数形式的关节炎超越了儿童/成人的界限,并且无论发病年龄如何,药物通常都表现出相当的成功,这为药物开发和监管提供了新的机会,重点关注药理学和安全性而不是疗效。这种范式转变将使关节炎治疗的进步(无论是源自成人还是儿童)能够在整个年龄段中更快地转化。
更新日期:2022-04-01
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