Andreasen Rikke Asmussen, Kristensen Lars Erik, Ellingsen Torkell, Christensen Robin, Baraliakos Xenofon, Wied Jimmi, Aalykke Claus, Ulstrup Thomas, Schiøttz-Christensen Berit, Horn Hans Christian, Emamifar Amir, Duerlund Bent, Fischer Lars, Hansen Inger Marie Jensen
Department of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg, Denmark.
Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
BMJ Open. 2017 Jul 10;7(7):e015536. doi: 10.1136/bmjopen-2016-015536.
Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-α inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical therapy. Chronic pain is common in patients with SpA and may still persist despite the lack of signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in SpA. The painDETECT Questionnaire (PDQ) is a screening tool developed to detect neuropathic pain components. The primary objective is to explore the prognostic value of the PDQ regarding treatment response in patients with axSpA 3 months after initiating a biological agent. Secondary aim is to evaluate the impact of extra-articular manifestations, comorbidities and patient-reported outcomes and elucidate if these factors influence treatment response.
We will include 60 participants (≥18 years of age) diagnosed with axSpA independent of main entity, who initiate or switch treatment of a biologic. Data will be collected at baseline and at endpoint following Danish clinical practice (≥3 months) of treatment with biologics. We will explore whether the PDQ and other phenotypical patient characteristics are prognostically important for response to biological therapy according to established response criteria like 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (50%) and Ankylosing Spondylitis Disease Activity Score.
The study is approved by the Region of Southern Denmark's Ethics committee (S-20160094) and has been designed in cooperation with patient representatives. The study is registered at clinicaltrials.gov (NCT02948608, pre-results). Dissemination will occur through publication(s) in international peer-reviewed journal(s).
脊柱关节炎（SpA）是一类异质性的风湿性疾病，主要表现为脊柱和骶髂关节的轴向炎症症状或主要为外周关节炎。轴向SpA（axSpA）的两个主要类型是强直性脊柱炎或非放射学axSpA（nr-axSpA）。肿瘤坏死因子-α抑制剂彻底改变了对非甾体抗炎药和物理治疗无反应的axSpA患者的治疗方式。慢性疼痛在SpA患者中很常见，即使没有炎症迹象也可能持续存在。这使得研究人员推测，中枢性疼痛敏化可能在SpA慢性疼痛的产生中起作用。疼痛DETECT问卷（PDQ）是一种用于检测神经性疼痛成分的筛查工具。主要目的是探讨PDQ对axSpA患者在开始使用生物制剂3个月后治疗反应的预后价值。次要目的是评估关节外表现、合并症和患者报告结局的影响，并阐明这些因素是否影响治疗反应。
我们将纳入60名（≥18岁）被诊断为axSpA（不考虑主要类型）且开始或转换生物制剂治疗的参与者。数据将在基线时以及按照丹麦生物制剂治疗临床实践（≥3个月）后的终点时收集。我们将根据既定的反应标准，如巴斯强直性脊柱炎疾病活动指数改善50%（50%）和强直性脊柱炎疾病活动评分，探讨PDQ和其他患者表型特征对生物治疗反应是否具有预后重要性。
该研究已获得丹麦南部地区伦理委员会批准（S-20160094），并与患者代表合作设计。该研究已在clinicaltrials.gov注册（NCT02948608，预结果）。传播将通过在国际同行评审期刊上发表文章来进行。
