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 Govoni, Luigi Sinigaglia, Alain Cantagrel, Cheryl Barnabe, Clifton O. Bingham III, Paul P. Tak, Dirkjan van Schaardenburg, Hilde Berner Hammer, Joel Paschke, Rana Dadashova, Edna Hutchings, Alexandre Sepriano, and Robert Landewé
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) (First Release February 15 2020; J Rheumatol 2020;47:796–808; doi:10.3899/jrheum.190302)