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, vol. 47, no. 6, pp. 796-808.
https://doi.org/10.3899/jrheum.190302APA
Maksymowych, W. P., FitzGerald, O.
, Østergaard, M., Homik, J., van der Heijde, D., Lambert, R. G., ... 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.190302CBE
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.190302MLA
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. In:
Journal of Rheumatology. 2020 ; Vol. 47, No. 6. pp. 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 -
