Pretreatment multi-biomarker disease activity score and radiographic progression in early RA: results from the SWEFOT trial

Abstract

ObjectivesPrediction of radiographic progression (RP) in early rheumatoid arthritis (eRA) would be very useful for optimal choice among available therapies. We evaluated a multi-biomarker disease activity (MBDA) score, based on 12 serum biomarkers as a baseline predictor for 1-year RP in eRA.MethodsBaseline disease activity score based on erythrocyte sedimentation rate (DAS28-ESR), disease activity score based on C-reactive protein (DAS28-CRP), CRP, MBDA scores and DAS28-ESR at 3 months were analysed for 235 patients with eRA from the Swedish Farmacotherapy (SWEFOT) clinical trial. RP was defined as an increase in the Van der Heijde-modified Sharp score by more than five points over 1 year. Associations between baseline disease activity measures, the MBDA score, and 1-year RP were evaluated using univariate and multivariate logistic regression, adjusted for potential confounders.ResultsAmong 235 patients with eRA, 5 had low and 29 moderate MBDA scores at baseline. None of the former and only one of the latter group (3.4%) had RP during 1 year, while the proportion of patients with RP among those with high MBDA score was 20.9% (p=0.021). Among patients with low/moderate CRP, moderate DAS28-CRP or moderate DAS28-ESR at baseline, progression occurred in 14%, 15%, 14% and 15%, respectively. MBDA score was an independent predictor of RP as a continuous (OR=1.05, 95% CI 1.02 to 1.08) and dichotomised variable (high versus low/moderate, OR=3.86, 95% CI 1.04 to 14.26).ConclusionsIn patients with eRA, the MBDA score at baseline was a strong independent predictor of 1-year RP. These results suggest that when choosing initial treatment in eRA the MBDA test may be clinically useful to identify a subgroup of patients at low risk of RP.Trial registration numberWHO database at the Karolinska Institute: CT20080004; and clinicaltrials.gov: NCT00764725.

YKL‐40: The Search for New Biomarkers in Rheumatoid Arthritis

“…MBDA score is estimated by measuring the concentrations of 12 serum biomarkers. YKL-40 is a part of the established panel of parameters [60,61]. This fact conirms the potential signiicance of YKL-40 in the pathogenic route of RA.…”

Reanalysis of the Multi‐Biomarker Disease Activity Score for Assessing Disease Activity in the Abatacept Versus Adalimumab Comparison in Biologic‐Naive Rheumatoid Arthritis Subjects with Background Methotrexate Study: Comment on the Article by Fleischmann et al

“…We would encourage readers to make the distinction between the scientific validity of a diagnostic test and its clinical utility. There is already a sizable evidence base supporting the development and validation of the MBDA test in diverse RA patient cohorts (9)(10)(11)(12)(13)(18)(19)(20)(23)(24)(25). A prospective clinical trial is underway to rigorously evaluate its clinical utility and its potential role in RA patient management (26).…”

Brief Report: Enhancement of Patient Recruitment in Rheumatoid Arthritis Clinical Trials Using a Multi‐Biomarker Disease Activity Score as an Inclusion Criterion

“…However, the CRP level is often discordant with the level of disease activity, indicating that use of the CRP as an inclusion criterion may exclude patients who have active RA 4, 5, 6.…”

“…It provides an objective disease activity measure that complements clinically based RA assessment tools 6, 10, 11. The MBDA instrument is scored on a scale of 1–100, with disease activity categories of high (score >44), moderate (score 30–44), and low (score <30).…”