Jones Gareth T, Macfarlane Gary J, Forrest Keenan Karen, McNamee Paul, Neilson Aileen R, Siebert Stefan, Burden A David, Kay Lesley, Helliwell Philip S
Epidemiology Group, Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Health Sciences Building, 1st floor, Foresterhill, Aberdeen, AB25 2ZD, UK.
Health Economics Research Unit, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.
BMC Rheumatol. 2021 May 17;5(1):19. doi: 10.1186/s41927-021-00189-0.
Psoriatic arthritis (PsA) presents a unique clinical challenge. Affecting joints, skin, nails, and other organs, it is associated with various comorbidities and has a significant impact on quality of life, social participation and working life. While biologic and other targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) have revolutionised therapy, questions remain about the long-term safety of these agents, and their effectiveness and cost-effectiveness in the real-world clinical setting.
METHODS/DESIGN: The British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA) is a prospective registry of patients with PsA, recruited from across Great Britain, who are (a) commencing a bDMARD/tsDMARD; or (b) naïve to all bDMARDs/tsDMARDs. Ethical approval was given by the NHS West of Scotland Research Ethics Committee 3 (reference: 18/WS/0126). Clinical data are extracted from participants' medical records, including symptom onset and diagnosis, joint, skin and nail symptoms, dactylitis and enthesitis. Physical measurements (height, weight and 66/68 joint counts) and a detailed drug history are taken. Participants are also asked to complete questionnaires comprising instruments relating to general health and quality of life, axial disease, sleep and fatigue, impact of disease, functional status, mental health, other symptoms, and occupational status. The study duration is 5 years in the first instance, and all participants are followed up annually until the end of the study. Participants commencing a bDMARD/tsDMARD are also followed up three and six months after the start of therapy. Disease activity, including C-reactive protein, is assessed at each visit; and participants from some centres are invited to donate blood and urine samples for the creation of a biobank.
Complementing data from randomised trials, results from this study will contribute to the evidence base underpinning the clinical management of psoriatic arthritis. Various analyses will determine the effectiveness and safety of bDMARDs/tsDMARDs in the real-world, will examine the clinical and biological predictors of treatment response, and will provide real-world data on the cost-effectiveness of these therapies, as well as providing informative data important to patients such as quality of life and occupational outcomes.
The full study protocol is registered on the Open Science Framework ( https://osf.io/jzs8n ).
银屑病关节炎（PsA）带来了独特的临床挑战。它会影响关节、皮肤、指甲和其他器官，与多种合并症相关，对生活质量、社会参与和工作生活有重大影响。虽然生物制剂和其他靶向合成改善病情抗风湿药物（bDMARDs和tsDMARDs）彻底改变了治疗方法，但这些药物的长期安全性以及它们在实际临床环境中的有效性和成本效益仍存在疑问。
方法/设计：英国风湿病学会银屑病关节炎登记处（BSR-PsA）是一个PsA患者的前瞻性登记处，招募自英国各地，这些患者（a）开始使用bDMARD/tsDMARD；或（b）从未使用过所有bDMARDs/tsDMARDs。苏格兰西部国民保健服务研究伦理委员会3给予了伦理批准（参考号：18/WS/0126）。临床数据从参与者的病历中提取，包括症状发作和诊断、关节、皮肤和指甲症状、指（趾）炎和附着点炎。进行身体测量（身高、体重和66/68关节计数）并记录详细的用药史。还要求参与者完成问卷，问卷包括与总体健康和生活质量、轴向疾病、睡眠和疲劳、疾病影响、功能状态、心理健康、其他症状以及职业状况相关的量表。研究期最初为5年，所有参与者每年接受随访直至研究结束。开始使用bDMARD/tsDMARD的参与者在治疗开始后3个月和6个月也接受随访。每次就诊时评估疾病活动，包括C反应蛋白；并邀请一些中心的参与者捐献血液和尿液样本以建立生物样本库。
补充随机试验的数据，本研究的结果将有助于为银屑病关节炎的临床管理提供证据基础。各种分析将确定bDMARDs/tsDMARDs在实际应用中的有效性和安全性，将研究治疗反应的临床和生物学预测因素，并将提供这些疗法成本效益的实际数据，以及提供对患者重要的信息性数据，如生活质量和职业结果。
完整的研究方案已在开放科学框架（https://osf.io/jzs8n）上注册。
