Outcomes and findings of the international rheumatoid arthritis (RA) BIODAM cohort for validation of soluble biomarkers in RA

Walter P. Maksymowych*, Oliver FitzGerald, Mikkel Østergaard, Joanne Homik, Désirée Van Der Heijde, Robert G. Lambert, Ori Elkayam, Sofia Ramiro, J. Carter Thorne, Maggie J. Larché, Gianfranco Ferraccioli, Marina Backhaus, Gerd R. Burmester, Gilles Boire, Bernard Combe, Thierry Schaeverbeke, Alain Saraux, Maxime Dougados, Maurizio Rossini, Marcello GovoniLuigi Sinigaglia, Alain Cantagrel, Cheryl Barnabe, Clifton O. Bingham, Paul P. Tak, Dirkjan Van Schaardenburg, Hilde Berner Hammer, Joel Paschke, Rana Dadashova, Edna Hutchings, Alexandre Sepriano, Robert Landewé

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)796-808
Number of pages13
JournalJournal of Rheumatology
Volume47
Issue number6
DOIs
StatePublished - 1 Jun 2020
Externally publishedYes

Keywords

  • Biomarker
  • Prognosis
  • Radiographic progression
  • Risk assessment

Fingerprint

Dive into the research topics of 'Outcomes and findings of the international rheumatoid arthritis (RA) BIODAM cohort for validation of soluble biomarkers in RA'. Together they form a unique fingerprint.

Cite this