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Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA: Cohort Description

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Harvard

Maksymowych, WP, FitzGerald, O, Østergaard, M, Homik, J, van der Heijde, D, Lambert, RG, Elkayam, O, Ramiro, S, Thorne, C, Larché, MJ, Ferraccioli, G, Backhaus, M, Burmester, GR, Boire, G, Combe, B, Saraux, A, Dougados, M, Rossini, M, Govoni, M, Sinigaglia, L, Cantagrel, A, Allaart, R, Barnabe, C, Bingham, CO, Tak, PP, van Schaardenburg, D, Hammer, HB, Paschke, J, Dadashova, R, Hutchings, E, Sepriano, A & Landewé, R 2020, 'Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA: Cohort Description' Journal of Rheumatology, bind 47, nr. 6, s. 796-808. https://doi.org/10.3899/jrheum.190302

APA

CBE

Maksymowych WP, FitzGerald O, Østergaard M, Homik J, van der Heijde D, Lambert RG, Elkayam O, Ramiro S, Thorne C, Larché MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Allaart R, Barnabe C, Bingham CO, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Sepriano A, Landewé R. 2020. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA: Cohort Description. Journal of Rheumatology. 47(6):796-808. https://doi.org/10.3899/jrheum.190302

MLA

Vancouver

Author

Maksymowych, Walter P ; FitzGerald, Oliver ; Østergaard, Mikkel ; Homik, Joanne ; van der Heijde, Désirée ; Lambert, Robert G ; Elkayam, Ori ; Ramiro, Sofia ; Thorne, Carter ; Larché, Maggie J ; Ferraccioli, Gianfranco ; Backhaus, Marina ; Burmester, Gerd R ; Boire, Gilles ; Combe, Bernard ; Saraux, Alain ; Dougados, Maxime ; Rossini, Maurizio ; Govoni, Marcello ; Sinigaglia, Luigi ; Cantagrel, Alain ; Allaart, Renée ; Barnabe, Cheryl ; Bingham, Clifton O ; Tak, Paul P ; van Schaardenburg, Dirkjan ; Hammer, Hilde Berner ; Paschke, Joel ; Dadashova, Rana ; Hutchings, Edna ; Sepriano, Alexandre ; Landewé, Robert. / Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA : Cohort Description. I: Journal of Rheumatology. 2020 ; Bind 47, Nr. 6. s. 796-808.

Bibtex

@article{cf8d4651cc1d45e9b00bdd0cc6bb7f81,
title = "Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA: Cohort Description",
abstract = "OBJECTIVE: The Outcome Measures in Rheumatology Soluble Biomarker Working Group initiated an international, multicenter, prospective study, the Rheumatoid Arthritis (RA) BIODAM cohort, to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings.METHODS: Patients with RA from 38 sites in 10 countries starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp/van der Heijde score.RESULTS: A total of 571 patients were recruited and 439 (76.9{\%}) completed 2-year followup. At baseline, the majority was female (76{\%}), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, 44-joint count Disease Activity Score (DAS44) 3.8, 77.7{\%} rheumatoid factor-positive or anticitrullinated protein antibody-positive. Percentage of patients in DAS and American College of Rheumatology remission at 2 years was 52.2{\%} and 27.1{\%}, respectively. Percentage of patients with radiographic progression (> 0.5) at 1 and 2 years was 38.2{\%} and 59.9{\%}, respectively.CONCLUSION: The RA BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints. (Clinicaltrials.gov: NCT01476956, clinicaltrials.gov/ct2/show/NCT01476956).",
keywords = "Biomarker, Prognosis, Radiographic progression, Risk assessment",
author = "Maksymowych, {Walter P} and Oliver FitzGerald and Mikkel {\O}stergaard and Joanne Homik and {van der Heijde}, D{\'e}sir{\'e}e and Lambert, {Robert G} and Ori Elkayam and Sofia Ramiro and Carter Thorne and Larch{\'e}, {Maggie J} and Gianfranco Ferraccioli and Marina Backhaus and Burmester, {Gerd R} and Gilles Boire and Bernard Combe and Alain Saraux and Maxime Dougados and Maurizio Rossini and Marcello Govoni and Luigi Sinigaglia and Alain Cantagrel and Ren{\'e}e Allaart and Cheryl Barnabe and Bingham, {Clifton O} and Tak, {Paul P} and {van Schaardenburg}, Dirkjan and Hammer, {Hilde Berner} and Joel Paschke and Rana Dadashova and Edna Hutchings and Alexandre Sepriano and Robert Landew{\'e}",
year = "2020",
month = "6",
day = "1",
doi = "10.3899/jrheum.190302",
language = "English",
volume = "47",
pages = "796--808",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology Publishing Co. Ltd",
number = "6",

}

RIS

TY - JOUR

T1 - Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA

T2 - Cohort Description

AU - Maksymowych, Walter P

AU - FitzGerald, Oliver

AU - Østergaard, Mikkel

AU - Homik, Joanne

AU - van der Heijde, Désirée

AU - Lambert, Robert G

AU - Elkayam, Ori

AU - Ramiro, Sofia

AU - Thorne, Carter

AU - Larché, Maggie J

AU - Ferraccioli, Gianfranco

AU - Backhaus, Marina

AU - Burmester, Gerd R

AU - Boire, Gilles

AU - Combe, Bernard

AU - Saraux, Alain

AU - Dougados, Maxime

AU - Rossini, Maurizio

AU - Govoni, Marcello

AU - Sinigaglia, Luigi

AU - Cantagrel, Alain

AU - Allaart, Renée

AU - Barnabe, Cheryl

AU - Bingham, Clifton O

AU - Tak, Paul P

AU - van Schaardenburg, Dirkjan

AU - Hammer, Hilde Berner

AU - Paschke, Joel

AU - Dadashova, Rana

AU - Hutchings, Edna

AU - Sepriano, Alexandre

AU - Landewé, Robert

PY - 2020/6/1

Y1 - 2020/6/1

N2 - OBJECTIVE: The Outcome Measures in Rheumatology Soluble Biomarker Working Group initiated an international, multicenter, prospective study, the Rheumatoid Arthritis (RA) BIODAM cohort, to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings.METHODS: Patients with RA from 38 sites in 10 countries starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp/van der Heijde score.RESULTS: A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. At baseline, the majority was female (76%), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, 44-joint count Disease Activity Score (DAS44) 3.8, 77.7% rheumatoid factor-positive or anticitrullinated protein antibody-positive. Percentage of patients in DAS and American College of Rheumatology remission at 2 years was 52.2% and 27.1%, respectively. Percentage of patients with radiographic progression (> 0.5) at 1 and 2 years was 38.2% and 59.9%, respectively.CONCLUSION: The RA BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints. (Clinicaltrials.gov: NCT01476956, clinicaltrials.gov/ct2/show/NCT01476956).

AB - OBJECTIVE: The Outcome Measures in Rheumatology Soluble Biomarker Working Group initiated an international, multicenter, prospective study, the Rheumatoid Arthritis (RA) BIODAM cohort, to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings.METHODS: Patients with RA from 38 sites in 10 countries starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp/van der Heijde score.RESULTS: A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. At baseline, the majority was female (76%), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, 44-joint count Disease Activity Score (DAS44) 3.8, 77.7% rheumatoid factor-positive or anticitrullinated protein antibody-positive. Percentage of patients in DAS and American College of Rheumatology remission at 2 years was 52.2% and 27.1%, respectively. Percentage of patients with radiographic progression (> 0.5) at 1 and 2 years was 38.2% and 59.9%, respectively.CONCLUSION: The RA BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints. (Clinicaltrials.gov: NCT01476956, clinicaltrials.gov/ct2/show/NCT01476956).

KW - Biomarker

KW - Prognosis

KW - Radiographic progression

KW - Risk assessment

U2 - 10.3899/jrheum.190302

DO - 10.3899/jrheum.190302

M3 - Journal article

VL - 47

SP - 796

EP - 808

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 6

ER -

ID: 58908571