Watson Marion, Tillett William, Jadon Deepak, Massa M Sofia, Francis Anne, Gullick Nicola, Rombach Ines, Sinomati Yvonne, Tucker Laura, Coates Laura C
Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Royal National Hospital for Rheumatic Diseases, Bath, Somerset, UK.
Ther Adv Musculoskelet Dis. 2024 May 30;16:1759720X241240913. doi: 10.1177/1759720X241240913. eCollection 2024.
The aim of the Severe Psoriatic arthritis - Early intervEntion to control Disease trial is to compare outcomes in psoriatic arthritis (PsA) patients with poor prognostic factors treated with standard step-up conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), combination csDMARDs or a course of early biologics.
This multicentre UK trial was embedded within the MONITOR-PsA cohort, which uses a trial within cohort design.
Patients with newly diagnosed PsA and at least one poor prognostic factor (polyarthritis, C-reactive protein >5 mg/dL, health assessment questionnaire >1, radiographic erosions) were randomized equally and open-label to either standard care with 'step-up' csDMARD therapy, initial therapy with combination csDMARDs (methotrexate with either sulfasalazine or leflunomide) or to early biologics induction therapy (adalimumab plus methotrexate). The primary outcome is the PsA disease activity score at week 24.
Ethical approval for the study was granted by the South Central Research Ethics Committee (ref 18/SC/0107).
Treatment recommendations for PsA suggest more intensive therapy for those with poor prognostic factors but there are no studies that have previously used prognostic factors to guide therapy. Applying initial intensive therapy has shown improved outcomes in other inflammatory arthritides but has never been tried in PsA. Combination csDMARDs have shown some superiority over single therapies but there are limited data and concerns about side effects. Early use of biologics has also been shown to be superior to methotrexate but these drugs are costly and not usually funded first line. However, if a short course of biologics can rapidly suppress inflammation allowing treatment to be withdrawn and response maintained on methotrexate, this may be a cost-effective model for early use.
ClinicalTrials.gov (NCT03739853) and EudraCT (2017-004542-24).
重度银屑病关节炎-早期干预控制疾病试验的目的是比较银屑病关节炎（PsA）伴有不良预后因素的患者接受标准逐步常规合成改善病情抗风湿药物（csDMARDs）、联合csDMARDs或早期生物制剂疗程治疗后的结局。
这项英国多中心试验纳入了MONITOR-PsA队列，该队列采用队列内试验设计。
新诊断的PsA且至少有一项不良预后因素（多关节炎、C反应蛋白>5mg/dL、健康评估问卷>1、影像学侵蚀）的患者被等比例随机分组，并采用开放标签方式，分别接受“逐步升级”csDMARD治疗的标准治疗、联合csDMARDs（甲氨蝶呤联合柳氮磺胺吡啶或来氟米特）初始治疗或早期生物制剂诱导治疗（阿达木单抗加甲氨蝶呤）。主要结局是第24周时的PsA疾病活动评分。
该研究获得了中南研究伦理委员会的伦理批准（参考号18/SC/0107）。
PsA的治疗建议表明，对于有不良预后因素的患者应采用更强化的治疗，但此前尚无研究使用预后因素来指导治疗。在其他炎性关节炎中应用初始强化治疗已显示出改善的结局，但从未在PsA中尝试过。联合csDMARDs已显示出比单一疗法有一定优势，但数据有限且存在副作用问题。早期使用生物制剂也已显示优于甲氨蝶呤，但这些药物成本高昂且通常不在一线提供资金支持。然而，如果短期生物制剂疗程能够迅速抑制炎症，从而允许撤药并通过甲氨蝶呤维持反应，这可能是早期使用的一种具有成本效益的模式。
ClinicalTrials.gov（NCT03739853）和EudraCT（2017-004542-24）。
