A Proposal for a Study on Treatment Selection and Lifestyle Recommendations in Chronic Inflammatory Diseases: A Danish Multidisciplinary Collaboration on Prognostic Factors and Personalised Medicine.

Vibeke Andersen,Jesper Frøjk,David Ellinghaus,Jeroen Raes,Jimmi Wied,Jan Fallingborg,Lars Werner,Henning Glerup,Anette Bygum,Philip Rosenstiel,Steffen Thiel,Mohamad Jawhara,Torkell Ellingsen,Mette Boye,Allan Stensballe,Jens Kjeldsen,Ulrich Fredberg,Torben Knudsen,Jakob Grauslund,Uffe Holmskov,Robin Christensen,Ivan Brandslund,Jacob Broder Brodersen ,Søren G Kjær ,Anders Bo Bojesen ,Berit Lilienthal Heitmann ,Grith Lykke Sørensen ,Ole Haagen Nielsen ,Nils J Færgeman ,Kjeld Andersen ,Seyed A G R Moghadd ,Jan Alexander Villadsen ,Lars G Hvid ,Erik Berg Schmidt ,André Franke ,Charlotte Lindgaard Nielsen ,Jens Frederik Dahlerup

doi:10.3390/nu9050499

Abstract

Chronic inflammatory diseases (CIDs), including Crohn’s disease and ulcerative colitis (inflammatory bowel diseases, IBD), rheumatoid arthritis, psoriasis, psoriatic arthritis, spondyloarthritides, hidradenitis suppurativa, and immune-mediated uveitis, are treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF) (i.e., TNF inhibitors). Approximately one-third of the patients do not respond to the treatment. Genetics and lifestyle may affect the treatment results. The aims of this multidisciplinary collaboration are to identify (1) molecular signatures of prognostic value to help tailor treatment decisions to an individual likely to initiate TNF inhibitor therapy, followed by (2) lifestyle factors that support achievement of optimised treatment outcome. This report describes the establishment of a cohort that aims to obtain this information. Clinical data including lifestyle and treatment response and biological specimens (blood, faeces, urine, and, in IBD patients, intestinal biopsies) are sampled prior to and while on TNF inhibitor therapy. Both hypothesis-driven and data-driven analyses will be performed according to pre-specified protocols including pathway analyses resulting from candidate gene expression analyses and global approaches (e.g., metabolomics, metagenomics, proteomics). The final purpose is to improve the lives of patients suffering from CIDs, by providing tools facilitating treatment selection and dietary recommendations likely to improve the clinical outcome.

Highlights

Inflammatory bowel disease (IBD), encompassing Crohn’s Disease (CD) and ulcerative colitis (UC), is a member of a large family of diseases of the immune system that results in chronic inflammatory diseases (CIDs)
We recently proposed a mechanism whereby fibre intake may affect an anti-tumour necrosis factor-α (TNF) response [71]
If we focus on the contrast between groups, for a comparison of two independent binomial proportions using Pearson’s Chi-square statistic with a Chi-square approximation with a two-sided significance level of 0.05 (p < 0.05), a total sample size of 318 assuming an allocation ratio of 1 to 2 has an approximate power of 0.924 (i.e., >90% statistical power) when the proportions responding are 60%

Summary

Introduction

Inflammatory bowel disease (IBD), encompassing Crohn’s Disease (CD) and ulcerative colitis (UC), is a member of a large family of diseases of the immune system that results in chronic inflammatory diseases (CIDs). CIDs have a large impact on individual patients and society. They are recurring, lifelong, potentially early onset illnesses that substantially affect the life quality of the patients and their families [1,2,3]. CIDs are frequent; IBD affects up to 0.5% of the population in the Western world [26] and RA and PsO have global prevalences of 0.3–1.0% and

Methods

Results

Discussion

Conclusion