Akkoc Nurullah, Khan Muhammad A
Department of Rheumatology, Faculty of Medicine, Dokuz Eylul University, Balcova, 35340, Izmir, Turkey.
Case Western Reserve University, Cleveland, OH, USA.
Clin Rheumatol. 2016 Jun;35(6):1415-23. doi: 10.1007/s10067-016-3261-6. Epub 2016 Apr 19.
The relationship between ankylosing spondylitis and the recently proposed entity called axial spondyloarthritis with its radiographic and non-radiographic forms that have been defined by the Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis (axSpA), is currently being debated. The Food and Drug Agency (FDA) had criticized the ASAS criteria and the studies which used these criteria to enroll patients in a clinical trial of certolizumab and adalimumab for the treatment of non-radiographic axial spondyloarthritis. The primary aim of classification criteria is to create homogenous patient populations for basic and clinical research. But the multi-arm construct of the ASAS criteria is a potential source of heterogeneity reducing their utility. Criteria sets should be regarded as dynamic concepts open to modifications or updates as our knowledge advances. We provide evidence to conclude that it is time to modify the ASAS Criteria for axSpA, and we propose some of the steps that can be taken to start moving forward in improving the validity of these criteria.
强直性脊柱炎与最近提出的轴向型脊柱关节炎这一概念之间的关系目前仍在讨论中，轴向型脊柱关节炎有放射学阳性和放射学阴性两种形式，由国际脊柱关节炎评估协会（ASAS）的轴向型脊柱关节炎（axSpA）标准所定义。美国食品药品监督管理局（FDA）曾批评ASAS标准以及那些使用这些标准将患者纳入赛妥珠单抗和阿达木单抗治疗非放射学阳性轴向型脊柱关节炎临床试验的研究。分类标准的主要目的是为基础研究和临床研究创建同质化的患者群体。但ASAS标准的多臂结构是异质性的一个潜在来源，降低了其效用。随着我们知识的进步，标准集应被视为一个动态概念，随时可以修改或更新。我们提供证据得出结论，是时候修改ASAS的axSpA标准了，并且我们提出了一些可以采取的步骤，以便在提高这些标准的有效性方面向前迈进。
