Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
Trial registration number NCT03173144; Pre-results.
- lifestyle and chronic inflammatory disease
- biomarker and lifestyle
- personalized medicine
- patient related outcome measures
- treatment outcome
- western style diet
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Contributors VA, BLH and RC wrote the first draft. All other authors, KWA, OHN, SBS, MJ, AB, LH, JG, JW, HG, UF, JAV, SGK, JF, SAGRM, TK, JB, JF, JFD, ABB, GLS, ST, NJF, IB, TBB, AS, EBS, AF, DE, PR, JR, MB, LW, CLN, HLM, ABN, TK, JK and UH contributed to the conception and design of the study. All authors accepted the final submitted version.
Funding This project is part of a project that has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 733100” (P Rosenstiel, A Franke, J Raes, V Andersen). Funding has furthermore been received from Odense Patient data Explorative Network (OPEN) (OP-332, V Andersen), “Knudog Edith Eriksen’s Mindefond” (V Andersen), Region of Southern Denmark (V Andersen), University of Southern Denmark (V Andersen, U Holmskov). The Parker Institute, Bispebjerg and Frederiksberg Hospital (R Christensen, B L Heitmann) are supported by a core grant from the Oak Foundation (OCAY-13-309).
Competing interests All authors declare no conflict of interest. However, the following authors declare: B. Heitmann has received funding from ‘MatPrat’, the information office for Norwegian egg and meat; L. Hvid is on the advisory board for Abbvie A/S; J. Fallingborg is on the advisory boards for AbbVie A/S, MSD Denmark, Takeda Pharma A/S, and Ferring Pharmaceuticals A/S; V. Andersen receives compensation for consultancy and for being a member of the advisory board for MSD Denmark (Merck) and Janssen A/S. The funding sponsors had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.
Patient consent Not required.
Ethics approval Written informed consent will be obtained from participants before participation in the study. The project has been approved by The Regional Scientific Ethical Committee (S-20160124) and the Danish Data Protection Agency (2008-58-035). The procedures followed are in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975 with later amendments.
Provenance and peer review Not commissioned; externally peer reviewed.
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