RT Journal Article
SR Electronic
T1 Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.190302
DO 10.3899/jrheum.190302
A1 Walter P.  Maksymowych
A1 Oliver FitzGerald
A1 Mikkel Østergaard
A1 Joanne Homik
A1 Désirée  van der Heijde
A1 Robert G.  Lambert
A1 Ori Elkayam
A1 Sofia Ramiro
A1 J. Carter  Thorne
A1 Maggie J.  Larché
A1 Gianfranco Ferraccioli
A1 Marina Backhaus
A1 Gerd R.  Burmester
A1 Gilles Boire
A1 Bernard Combe
A1 Thierry Schaeverbeke
A1 Alain Saraux
A1 Maxime Dougados
A1 Maurizio Rossini
A1 Marcello Govoni
A1 Luigi Sinigaglia
A1 Alain Cantagrel
A1 Cheryl Barnabe
A1 Clifton O.  Bingham  III
A1 Paul P.  Tak
A1 Dirkjan  van Schaardenburg
A1 Hilde  Berner Hammer
A1 Joel Paschke
A1 Rana Dadashova
A1 Edna Hutchings
A1 Alexandre Sepriano
A1 Robert Landewé
YR 2019
UL http://www.jrheum.org/content/early/2020/02/10/jrheum.190302.abstract
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)