Researchers conducting the RA BIODAM study have successfully generated an extensive list of resources, in the form of clinical imaging and biosamples, intended to expedite the identification and validation of biomarkers representing radiographic damage in rheumatoid arthritis (RA) according to a study in the Journal of Rheumatology.
The purpose of the RA BIODAM study (NCT01476956) was to set a benchmark for the design, implementation, and analysis of studies attempting to validate prognostic parameters — including biomarkers — predictive of radiographic progression in RA. Investigators of the study published details on the study design, baseline characteristics of recruited patients, study treatments, primary clinical outcomes, and radiographic progression over follow up.
Patients included in the multicenter, multinational, prospective, observational study were consecutively recruited from global rheumatology outpatient clinics. Complete baseline data were available for 571 patients recruited between October 2011 and May 2017.
The overall patient population was comprised of a majority of women (76%) with a mean age of 55.7 years and 6.5 years mean disease duration. At baseline, active disease in patients included a mean of 8.4 swollen joints, 13.6 tender joints, a Disease Activity Score in 28 Joints of 5.2 and a Disease Activity Score in 44 Joints of 3.8. Just under 80% of patients were positive for either rheumatoid factor or anticitrullinated peptide antibody.
Investigators obtained serum, urine, and radiographs from 90.3%, 89.3%, and 82.1% of visits, respectively. Ultrasound scores were obtained over 1034 visits, with 130 patients undergoing at least 1 assessment at 11 study sites.
In terms of treatment, over the study period, a stable percentage (about 90%) of patients was treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs); biologic DMARD use increased from 41% to 52% over time. Of the 24.9% of patients who were csDMARD-naïve, 5.3% also started tumor necrosis factor inhibitor (TNFi) therapy during the follow-up period, whereas 7% of those who were already being treated with csDMARDs at baseline began TNFis.
At baseline, 40.5% of patients were being treated with TNFi therapy; of these, 195 were taking concomitant csDMARDs. Among these patients, 36 switched to an alternative TNFi, and 26 switched to a non-TNFi bDMARD. The percentage of patients taking oral steroids decreased from 45% to 26% from baseline to follow up.
Both disease activity score and health assessment questionnaire scores decreased through the first 6 months of treatment, and the percentage of patients achieving both disease activity score and American College of Rheumatology remission gradually increased over 2 years.
Finally, 442 patients had available radiographic data from baseline and 1 year; 406 patients had available data from baseline and 2 years. The smallest detectable change for radiographic progression was 2.6 vDHm-SHS units; a progression of >2.6 units was noted in 10.9% of patients at 1 year and 22.4% of patients at 2 years.
One study limitation is the potential for bias; according to investigators, these patients may reflect a “relatively refractory cohort of patients with inadequate responses to treatment and more likely to demonstrate radiographic progression.”
“The resources generated in RA BIODAM will be made available to the research community to help expedite the identification and validation of such biomarkers,” the researchers concluded.
Disclosure: One study author declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Maksymowych WP, FitzGerald O, Østergaard M, et al. The international RA BIODAM cohort for validation of soluble biomarkers in rheumatoid arthritis: cohort description [published online September 1, 2019]. J Rheumatol. doi: 10.3899.jrheum.190302