TY - JOUR
T1 - Identification of new biomarkers to promote personalised treatment of patients with inflammatory rheumatic disease
T2 - protocol for an open cohort study
AU - Kringelbach, Tina Marie
AU - Glintborg, Bente
AU - Hogdall, Estrid V
AU - Johansen, Julia Sidenius
AU - Hetland, Merete Lund
AU - Biomarker Protocol Study Group
A2 - Jørgensen, Niklas Rye
A2 - Sørensen, Inge Juul
A2 - Dreyer, Lene
A2 - Østergaard, Mikkel
A2 - Bliddal, Henning
A2 - Jacobsen, Søren
A2 - Pedersen, Susanne Juhl
A2 - Nielsen, Christoffer Tandrup
A2 - Jensen, Dorte Vendelbo
N1 - COPECARE
PY - 2018/2/1
Y1 - 2018/2/1
N2 - INTRODUCTION: The introduction of biological disease-modifying antirheumatic drugs (bDMARDs) has improved the treatment of inflammatory rheumatic diseases dramatically. However, bDMARD treatment failure occurs in 30%-40% of patients due to lack of effect or adverse events, and the tools to predict treatment outcomes in individual patients are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to (1) diagnose inflammatory rheumatic diseases early in the disease course with high sensitivity and specificity, (2) improve prognostication or (3) predict and monitor treatment effectiveness and tolerability for the individual patient.METHODS AND ANALYSIS: The present study is an observational and translational open cohort study with prospective collection of clinical data and biological materials (primarily blood) in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute with one cross-sectional blood sample and/or are enrolled for longitudinal follow-up on initiation of a new DMARD (blood sampling after 0, 3, 6, 12, 24, 36, 48, 60 months of treatment). Other biological materials will be collected when accessible and relevant. Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (July 2017), >5000 samples from approximately 3000 patients have been collected. Data will be analysed using appropriate statistical analyses.ETHICS AND DISSEMINATION: The protocol is approved by the Danish Ethics Committee and the Danish Data Protection Agency. Participants give written and oral informed consent. Biomarkers will be evaluated and published according to the Reporting Recommendations for Tumour Marker (REMARK) prognostic studies, Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines. Results will be published in peer-reviewed scientific journals and presented at international conferences.TRIAL REGISTRATION NUMBER: NCT03214263.
AB - INTRODUCTION: The introduction of biological disease-modifying antirheumatic drugs (bDMARDs) has improved the treatment of inflammatory rheumatic diseases dramatically. However, bDMARD treatment failure occurs in 30%-40% of patients due to lack of effect or adverse events, and the tools to predict treatment outcomes in individual patients are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to (1) diagnose inflammatory rheumatic diseases early in the disease course with high sensitivity and specificity, (2) improve prognostication or (3) predict and monitor treatment effectiveness and tolerability for the individual patient.METHODS AND ANALYSIS: The present study is an observational and translational open cohort study with prospective collection of clinical data and biological materials (primarily blood) in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute with one cross-sectional blood sample and/or are enrolled for longitudinal follow-up on initiation of a new DMARD (blood sampling after 0, 3, 6, 12, 24, 36, 48, 60 months of treatment). Other biological materials will be collected when accessible and relevant. Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (July 2017), >5000 samples from approximately 3000 patients have been collected. Data will be analysed using appropriate statistical analyses.ETHICS AND DISSEMINATION: The protocol is approved by the Danish Ethics Committee and the Danish Data Protection Agency. Participants give written and oral informed consent. Biomarkers will be evaluated and published according to the Reporting Recommendations for Tumour Marker (REMARK) prognostic studies, Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines. Results will be published in peer-reviewed scientific journals and presented at international conferences.TRIAL REGISTRATION NUMBER: NCT03214263.
KW - Adult
KW - Antirheumatic Agents/therapeutic use
KW - Cross-Sectional Studies
KW - Denmark
KW - Disease Progression
KW - Female
KW - Humans
KW - Inflammation/blood
KW - Male
KW - Precision Medicine/trends
KW - Predictive Value of Tests
KW - Prognosis
KW - Prospective Studies
KW - Rheumatic Diseases/blood
KW - Sensitivity and Specificity
KW - Translational Medical Research
U2 - 10.1136/bmjopen-2017-019325
DO - 10.1136/bmjopen-2017-019325
M3 - Journal article
C2 - 29391382
SN - 2044-6055
VL - 8
SP - e019325
JO - BMJ Open
JF - BMJ Open
IS - 2
ER -