Chronic Inflammatory Disease, Lifestyle and Treatment Response

Summary

Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis are treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and lifestyle is assumed to affect the treatment outcome. However, little is known on the effects of lifestyle as a prognostic factor (possibly enabling personalised medicine). The aims of this multidisciplinary collaboration are to identify lifestyle factors that support individualised forecasting of optimised treatment outcome on these costly drugs.

This prospective cohort study will enrol CID patients assigned for biologic treatment. At baseline (Pre-treatment), patient characteristics are assessed using patient-reported outcome measures and clinical assessments on disease activity, quality of life, and lifestyle together with registry data on comorbidity and medication. Follow-up will be conducted at week 14-16 after treatment initiation (according to the current Danish standards). Evaluation of a successful treatment outcome response will - for each disease - be based on most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients with specific lifestyle characteristics.

The overarching goal of this project is to improve the lives of patients suffering from CID, by providing evidence to support dietary recommendations likely to improve the clinical outcome.

The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient associations, and presented at national and international conferences.

Conditions

• Autoimmune Diseases
• Inflammatory Bowel Diseases
• Crohn Disease (CD)
• Colitis, Ulcerative (UC)
• Arthritis, Rheumatoid (RA)
• Spondylarthropathies
• Arthritis, Psoriatic (PsA)
• Psoriasis
• Hidradenitis Suppurativa (HS)
• Uveitis

Interventions

OTHER

Primary exposure variable

1. Upper tertile (33.3% of the total sample) based on the ratio: fibre/meat intake is associated with better treatment outcome 2. Low intake of red and processed meat (defined as below the lower tertile \[33.3% of the total sample\]) and high intake of dietary fibres (defined as those above the upper tertile \[33.3% of the total sample\]) are independently associated with better treatment outcome, and their synergy (interaction between the factors meat and fibres) gives the best treatment outcome

OTHER

Other (exploratory) exposure variables

* Lifestyle factors independently or combined (red and processed meat, vegetable, dietary fibre, cereals, gluten, legumes, red wine, dairy products, physical activity, smoking, total protein/ fat, protein/ fat from red and processed meat, glucemic index) * Pretreatment lifestyle-associated biomarkers * Combinations of lifestyle factors and lifestyle-associated biomarkers * Gene-environment interaction analyses * Pretreatment levels of inflammatory molecules

Sponsors & Collaborators

• Hospital of Southern Jutland

  collaborator OTHER

• University Hospital Bispebjerg and Frederiksberg

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Aalborg University

  collaborator OTHER

• University of Kiel

  collaborator OTHER

• Colitis-Crohn Foreningen

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Regionshospitalet Silkeborg

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• The Danish Psoriasis Association

  collaborator UNKNOWN

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Vibeke Andersen, Prof · University of Southern Denmark

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-21

Primary Completion

2020-07-22

Completion

2021-04-30

Countries

• Denmark

Study Locations