Researchers Report Study Design and 2-Year Data From RA BIODAM Cohort

The RA BIODAM study has successfully resulted in the generation of an extensive list of clinical imaging and biosample resources that will ultimately result in expedited identification and validation of biomarkers in rheumatoid arthritis (RA), according to research results published in the Journal of Rheumatology. In the published study, the investigators described the research design and 2-year changes in clinical characteristics in an international cohort of patients with RA.

Researchers with the Outcome Measures in Rheumatology Soluble Biomarker Working Group reported the results of their international, multicenter, prospective study, the RA BIODAM (ClinicalTrials.gov Identifier: NCT01476956).

The primary objective of the RA BIODAM study was to collect data and create study resources that would allow researchers to analyze the independent predictive validity of soluble biomarkers that are high-priority candidates for predicting structural damage in RA.

The observational study included patients with RA who fulfilled the American College of Rheumatology/European League Against Rheumatism collaborative 2010 RA classification criteria and who were consecutively recruited beginning in October 2011. Complete baseline data were available for 571 patients recruited from 38 participating centers. Ultimately, the sample included a demographically typical cohort of patients with RA (76% women; mean age, 55.7 years; mean disease duration, 6.5 years; previous exposure to a conventional synthetic disease-modifying antirheumatic drug [csDMARD], 52%).

In terms of disease activity, patients generally had active disease at baseline, with a mean of 8.4 swollen joints and 13.6 tender joints. Mean Disease Activity Score in 28 joints was 5.2 and mean Disease Activity Score in 44 joints was 3.8. A majority of patients were positive for either rheumatoid factor or anticitrullinated protein antibodies (77.7%), with a mean C-reactive protein of 14.9 mg/L at baseline.

Those who completed a full 2-year follow-up generally had fewer comorbidities and lower levels of disease activity and were more likely to have received treatment with oral steroids at baseline.

Treatment percentages with csDMARDs were stable over time (approximately 90%), while the number of patients taking biologic DMARDs (bDMARDs) increased from 41% to 52%. In addition, 142 patients who were csDMARD-naive at baseline began csDMARD therapy; 5.3% of these patients were additionally treated with tumor necrosis factor inhibitor (TNFi) therapy during follow-up. Among the patients who were being treated with csDMARDs at baseline (34.2%), 7.0% were also started on TNFi therapy during follow-up.

At baseline, 40.5% (n=231) of patients were treated with TNFi therapy, of whom 195 were being treated with concomitant csDMARD therapy. Within this group, 36 switched to a different TNFi treatment and 26 switched to a non-TNFi bDMARD. Oral steroid use decreased from 45% at baseline to 26% at follow-up.

Over the first 6 months of treatment, both Disease Activity Scores and Health Assessment Questionnaire scores decreased. However, this trend was less evident in patients being treated with csDMARDs and subsequent TNFi therapy.

Radiographs from baseline to 1-year and to 2-year follow-up were available in 442 and 406 patients, respectively. Mean Sharp/van der Heijde scores at baseline, year 1, and year 2 were 17.2, 18.5, and 20.0, respectively. Radiographic progression of >0, >0.5, ≥3, and ≥5 Sharp/van der Heijde units was noted in 57.8%, 38.2%, 10.9%, and 6.1% of patients at year 1, and in 78.3%, 59.9%, 22.4%, and 10.1% at year 2, respectively.

Study limitations included potential bias in terms of the final cohort and loss of patients, precluding an opportunity for researchers to examine “physician- and patient-related factors associated with failure to adhere to the treatment strategy.”

“This is the first report of the data from RA BIODAM, which was an investigator-initiated 6-year international collaborative effort to compile a unique resource of clinical and imaging data with biosamples acquired according to an international consensus for the conduct of a prognostic study and standard operating procedures for the handling, transportation, and storage of biosamples,” the researchers wrote. “Our data demonstrate that the RA BIODAM Cohort is characteristic of patients with RA starting DMARD therapy in current clinical practice regarding both demographics and disease status and is therefore an appropriate cohort for the validation of biomarkers.”

Disclosure: This clinical trial was supported by AbbVie. Please see the original reference for a full list of authors’ disclosures.

Reference

Maksymowych WP, FitzGerald O, Østergaard M, et al. Outcomes and findings of the international rheumatoid arthritis (RA) BIODAM cohort for validation of soluble biomarkers in RA [published online February 15, 2020]. J Rheumatol. doi:10.3899/jrheum.190302