Abstract
BackgroundA multi-biomarker disease activity (MBDA) score has been validated as an objective measure of disease activity in rheumatoid arthritis (RA) and shown to track response to treatment with several disease-modifying anti-rheumatic drugs (DMARDs). The objective of this study was to evaluate the ability of the MBDA score to track response to treatment with rituximab.MethodsData were used from 57 RA patients from three cohorts treated with rituximab 1000 mg and methylprednisolone 100 mg at days 1 and 15. The MBDA score was assessed in serum samples obtained at baseline and 6 months. Spearman’s rank correlation coefficients were calculated for baseline values, 6-month values, and change from baseline to 6 months (∆), between MBDA score and the following measures: disease activity score assessing 28 joints (DAS28) using erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP), ESR, (hs)CRP, swollen and tender joint counts assessing 28 joints (SJC28, TJC28), patient visual analogue scale for general health (VAS-GH), health assessment questionnaire (HAQ), and radiographic progression over 12 months using Sharp/van der Heijde score (SHS), as well as six bone turnover markers. Additionally, multivariable linear regression analyses were performed using these measures as dependent variable and the MBDA score as independent variable, with adjustment for relevant confounders. The association between ∆MBDA score and European League Against Rheumatism (EULAR) response at 6 months was assessed with adjustment for relevant confounders.ResultsAt baseline, the median MBDA score and DAS28-ESR were 54.0 (IQR 44.3–70.0) and 6.3 (IQR 5.4–7.1), respectively. MBDA scores correlated significantly with DAS28-ESR, DAS28-hsCRP, ESR and (hs)CRP at baseline and 6 months. ∆MBDA score correlated significantly with changes in these measures. ∆MBDA score was associated with EULAR good or moderate response (adjusted OR = 0.89, 95% CI = 0.81–0.98, p = 0.02). Neither baseline MBDA score nor ΔMBDA score correlated statistically significantly with ∆SHS (n = 11) or change in bone turnover markers (n = 23), although ∆SHS ≥ 5 was observed in 5 (56%) of nine patients with high MBDA scores.ConclusionsWe have shown, for the first time, that the MBDA score tracked disease activity in RA patients treated with rituximab and that change in MBDA score reflected the degree of treatment response.
Highlights
A multi-biomarker disease activity (MBDA) score has been validated as an objective measure of disease activity in rheumatoid arthritis (RA) and shown to track response to treatment with several disease-modifying antirheumatic drugs (DMARDs)
Study population and treatment protocol We used data from three prospective cohort studies in which adult, refractory RA patients were treated with rituximab because of active disease despite conventional treatment (e.g. a combination of DMARDs, including maximum tolerable doses of a conventional syntheticDMARD and/or tumour necrosis factor (TNF) inhibitor): one cohort from the Leiden University Medical Center (LUMC) [19] and one from the University Medical Center (UMC) Utrecht [20], both in the Netherlands, and the HORUS cohort in the United Kingdom [21]
We found significant correlations between the MBDA score and disease activity score assessing 28 joints (DAS28)-erythrocyte sedimentation rate (ESR) as well as DAS28-high-sensitivity C-reactive protein (hsCRP) at baseline and at 6 months, and between ΔMBDA score and ΔDAS28-ESR and ΔDAS28-hsCRP from baseline to 6 months in patients treated with rituximab
Summary
A multi-biomarker disease activity (MBDA) score has been validated as an objective measure of disease activity in rheumatoid arthritis (RA) and shown to track response to treatment with several disease-modifying antirheumatic drugs (DMARDs). The DAS28 has shortcomings that hamper its use in clinical practice [5]. It does not include the ankles or feet, whereas these are common sites of inflammation in RA. There is a need for an objective measure that reflects systemic disease activity and is sensitive to change. It would be of additional benefit if that measure could be used to predict radiographic progression
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