Christensen Robin, Heitmann Berit L, Andersen Karina Winther, Nielsen Ole Haagen, Sørensen Signe Bek, Jawhara Mohamad, Bygum Anette, Hvid Lone, Grauslund Jakob, Wied Jimmi, Glerup Henning, Fredberg Ulrich, Villadsen Jan Alexander, Kjær Søren Geill, Fallingborg Jan, Moghadd Seyed A G R, Knudsen Torben, Brodersen Jacob, Frøjk Jesper, Dahlerup Jens Frederik, Bojesen Anders Bo, Sorensen Grith Lykke, Thiel Steffen, Færgeman Nils J, Brandslund Ivan, Bennike Tue Bjerg, Stensballe Allan, Schmidt Erik Berg, Franke Andre, Ellinghaus David, Rosenstiel Philip, Raes Jeroen, Boye Mette, Werner Lars, Nielsen Charlotte Lindgaard, Munk Heidi Lausten, Nexøe Anders Bathum, Ellingsen Torkell, Holmskov Uffe, Kjeldsen Jens, Andersen Vibeke
Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark.
Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark.
BMJ Open. 2018 Feb 8;8(2):e018166. doi: 10.1136/bmjopen-2017-018166.
Chronic inflammatory diseases (CIDs) are frequently treated with biological medications, specifically tumour necrosis factor inhibitors (TNFi)). These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to one-third of patients do not, however, respond to biologics, and lifestyle factors are assumed to affect treatment outcomes. Little is known about the effects of dietary lifestyle as a prognostic factor that may enable personalised medicine. The primary outcome of this multidisciplinary collaborative study will be to identify dietary lifestyle factors that support optimal treatment outcomes.
This prospective cohort study will enrol 320 patients with CID who are prescribed a TNFi between June 2017 and March 2019. Included among the patients with CID will be patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis. At baseline (pretreatment), patient characteristics will be assessed using patient-reported outcome measures, clinical assessments of disease activity, quality of life and lifestyle, in addition to registry data on comorbidity and concomitant medication(s). In accordance with current Danish standards, follow-up will be conducted 14-16 weeks after treatment initiation. For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. The major outcome of the analyses will be to detect variability in treatment effectiveness between patients with different lifestyle characteristics.
The principle goal of this project is to improve the quality of life of patients suffering from CID by providing evidence to support dietary and other lifestyle recommendations that may improve clinical outcomes. The study is approved by the Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.
NCT03173144; Pre-results.
慢性炎症性疾病（CIDs）通常使用生物药物进行治疗，特别是肿瘤坏死因子抑制剂（TNFi）。这些药物抑制促炎分子肿瘤坏死因子α，该分子在这些疾病的病因中起着重要作用。然而，高达三分之一的患者对生物制剂无反应，并且生活方式因素被认为会影响治疗效果。关于饮食生活方式作为一种可能实现个性化医疗的预后因素的影响，人们知之甚少。这项多学科合作研究的主要结果将是确定支持最佳治疗效果的饮食生活方式因素。
这项前瞻性队列研究将招募320名在2017年6月至2019年3月期间被处方使用TNFi的CID患者。CID患者包括炎症性肠病（克罗恩病和溃疡性结肠炎）、风湿性疾病（类风湿关节炎、轴性脊柱关节炎、银屑病关节炎）、炎症性皮肤病（银屑病、化脓性汗腺炎）和非感染性葡萄膜炎患者。在基线（治疗前），除了关于合并症和伴随用药的登记数据外，还将使用患者报告的结局指标、疾病活动的临床评估、生活质量和生活方式来评估患者特征。根据丹麦现行标准，将在治疗开始后14 - 16周进行随访。对于每种疾病，成功治疗反应的评估将基于既定的主要和次要终点，包括疾病特异性核心结局指标集。分析的主要结果将是检测不同生活方式特征患者之间治疗效果的差异。
本项目的主要目标是通过提供证据支持可能改善临床结局的饮食和其他生活方式建议，来提高CID患者的生活质量。该研究已获得伦理委员会（S - 20160124）和丹麦数据保护局（2008 - 58 - 035）的批准。研究结果将通过同行评审期刊、患者协会以及在国际会议上的报告进行传播。
NCT03173144；预结果。
