Unmet Needs in Spondyloarthritis: Pathogenesis, Clinical Trial Design, and Nonpharmacologic Therapy.

Laura C Coates,Georg Schett,Chenchen Wang,Pamela F Weiss
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Abstract

A program focused on pathogenesis, clinical trial design, and nonpharmacologic mind-body therapy for of spondyloarthritis (SpA) was presented at the Spondylitis Association of America Unmet Needs Conference IV. SpA pathogenesis is incompletely understood but involves a complex set of drivers, including genetics, biomechanical stress, and microbial factors. Affected tissues may include axial and peripheral joints, entheses, skin, uvea, and intestines. The specific role of key cytokines like interleukin (IL)-23, IL-17, and tumor necrosis factor in the phases of this inflammatory process remains unclear. New insights into pathogenesis will continue to generate targets for novel therapeutics. How to optimally evaluate those therapeutics in clinical trials, and for the various manifestations of SpA, remains less clear. Future trials need better generalizability, robust subgroup analyses to assess differential responses for distinct disease manifestations, a focus on comparative efficacy, and outcomes relevant to the clinician and the patient. Additionally, study designs need to leverage available technology to facilitate subject participation in trials. In view of the interplay between biologic, physical, and psychological aspects of disease, there is increasing attention to nonpharmacologic agents, with the aim of maximizing long-term health-related quality of life through the control of symptoms and inflammation. Recent studies provide encouraging evidence that mind-body interventions such as tai chi, qigong, yoga, and meditation have benefits for patients with SpA, particularly those with pain. The advances in our understanding of pathogenesis, novel therapeutics, and nonpharmacologic interventions have revolutionized the management of SpA, but numerous questions around optimal management remain.
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脊柱关节炎未满足的需求:发病机制、临床试验设计和非药物疗法。
在第四届美国脊柱炎协会未满足需求会议(Spondylitis Association of America Unmet Needs Conference IV)上,一个以脊柱关节炎(Spondyloarthritis,SpA)的发病机制、临床试验设计和非药物身心疗法为重点的项目进行了展示。脊柱关节炎的发病机制尚不完全清楚,但涉及一系列复杂的驱动因素,包括遗传、生物力学压力和微生物因素。受影响的组织可能包括轴向和外周关节、粘膜、皮肤、葡萄膜和肠道。白细胞介素(IL)-23、IL-17 和肿瘤坏死因子等关键细胞因子在这一炎症过程中的具体作用仍不清楚。对发病机制的新认识将继续为新型疗法提供目标。如何在临床试验中针对 SpA 的各种表现对这些疗法进行最佳评估,目前仍不太清楚。未来的试验需要更好的通用性、强大的亚组分析以评估不同疾病表现的不同反应、关注比较疗效以及与临床医生和患者相关的结果。此外,研究设计还需要利用现有技术来促进受试者参与试验。鉴于疾病在生物、生理和心理方面的相互作用,人们越来越关注非药物疗法,目的是通过控制症状和炎症,最大限度地提高长期健康相关生活质量。最近的研究提供了令人鼓舞的证据,表明太极拳、气功、瑜伽和冥想等身心干预措施对 SpA 患者,尤其是疼痛患者有益处。我们对发病机理、新型疗法和非药物干预措施的认识不断进步,使 SpA 的治疗发生了革命性的变化,但围绕最佳治疗的问题仍然很多。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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Prologue: Spondyloarthritis Unmet Research Needs Conference IV. Enhancing Equity in Clinical Research: A Multifaceted Proposal for Spondyloarthritis. Are There Disease Endotypes in Axial Spondyloarthritis and How Would We Define Them? Unmet Needs in Spondyloarthritis: Understanding and Managing Chronic Pain. Unmet Needs in Spondyloarthritis: Pathogenesis, Clinical Trial Design, and Nonpharmacologic Therapy.
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