一项减少中轴性脊柱炎生物治疗剂量的随机对照试验:一项开放标签非劣效性研究的基本原理和方案以及文献综述

S. C. Chan, Ian Yue Kit Kwan, W. Shum, M. Yeung, H. Chung
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引用次数: 0

摘要

轴性脊柱炎(SpA)是一种主要累及脊柱和骶髂关节(SI)的炎性病症。生物疗法的发展彻底改变了SpA的治疗模式。这导致了临床结果的巨大改善,包括炎症抑制,症状缓解和功能改善。尽管它很有用,但关于最佳治疗时间的问题仍然没有答案。考虑到与生物疗法相关的成本以及与免疫抑制相关的潜在副作用,这一点尤为重要。目前,关于轴向SpA生物制剂治疗剂量减少的指南和数据尚未很好地建立。这项随机对照试验旨在研究轴向SpA患者生物剂量减少的可能性。主要的衡量标准是,与接受标准剂量治疗的参与者相比,接受生物制剂减量治疗的参与者中疾病突发的发生率。本研究还旨在评估抗药物抗体在疾病爆发中的作用、生物制剂减剂量对结构变化的影响以及生物制剂减剂量的成本效益。这项研究的结果将对临床决策和建立关于SpA生物制剂剂量减少的未来指南至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Randomized Controlled Trial of Dose Reduction of Biologic Therapy in Axial Spondyloarthritis: Rationale and Protocol of an Open-Label Non-inferiority Study and a Review of Literature
Axial spondyloarthritis (SpA) is a spectrum of inflammatory conditions predominantly involving the spine and sacroiliac (SI) joints. The development of biological therapies has revolutionized the treatment paradigm in SpA. This has led to a great improvement in clinical outcomes, including inflammation suppression, symptom alleviation, and functional improvement. Despite its usefulness, the question regarding the optimal duration of therapy remains unanswered. This is particularly important given the cost associated with biological therapies, and the potential side effects related to immune suppression. Currently, guideline and data regarding dose reduction of biologics treatment in axial SpA has not been well established. This randomized controlled trial aims to study the possibility of biologic dose reduction in patients with axial SpA. The primary measure will be the occurrence of disease flare up in participants undergoing biologics tapering compared with participants on standard dose of treatment. The study also aims to evaluate the role of anti-drug antibodies in disease flare, the effect of biologics dose reduction on structural changes, and the cost effectiveness of biologics dose reduction. The results of this study will be crucial for clinical decisions and establishing future guidelines regarding dose reduction of biologics in SpA.
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