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

Curtis, Jeffrey R.; Wright, Grace; Strand, Vibeke; Davis, Charles S.; Hitraya, Elena; Sasso, Eric H.

doi:10.1002/art.39981

Cited by 9 publications

(10 citation statements)

References 21 publications

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“…These cohorts were the only ones where every patient was randomized to receive a biologic treatment for the entire time analyzed, making their results complementary to those of the other cohorts. A prior report 16,17 analyzed the relationship between radiographic progression and MBDA scores in AMPLE differently from the present study, where we re-analyzed published data from AMPLE 16,17 in terms of the percentage of progressors within each disease activity category 28 . The associations we found between MBDA score and radiographic progression in AMPLE resembled those obtained in the Leiden, OPERA and SWEFOT cohorts, even though in AMPLE the overall rates of progression were lower than in the other three cohorts and the risk for radiographic progression in AMPLE was analyzed using MBDA scores from the end of Year 1, rather than baselinean approach that, although not ideal, has been used previously 29 and was predicated here on the unavailability of patient-level data from AMPLE.…”

Section: Discussionmentioning

confidence: 99%

Predicting risk for radiographic damage in rheumatoid arthritis: comparative analysis of the multi-biomarker disease activity score and conventional measures of disease activity in multiple studies

Curtis

Brahe

Østergaard

et al. 2019

Current Medical Research and Opinion

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Objective: To compare the multi-biomarker disease activity (MBDA) score with the DAS28-CRP and CRP for predicting risk of radiographic progression in patients with rheumatoid arthritis. Methods: Published studies of the MBDA score and radiographic progression with 100 patients per cohort were evaluated. Rates of radiographic progression over 1 year were determined across the low/moderate/high categories for MBDA score (low/moderate/high: <30, 30-44, >44), DAS28-CRP (low/ moderate/high: 2.67, >2.67-4.09, >4.09) and CRP (low/moderate/high: 10, >10-30, >30 mg/L), with positive and negative predictive value (PPV, NPV) and relative risk (RR) determined for high vs. not-high (i.e. low and moderate combined) categories. Patient-level data from studies having all three measures was pooled to: (1) determine a combined RR for radiographic progression in the high vs. not-high categories for each measure; and (2) compare the predictive ability of MBDA score vs. DAS28-CRP by comparing the rates of radiographic progression observed in subgroups created by cross-classifying the high and not-high categories of each measure. Results: Five cohorts were identified for inclusion (total N¼929). In each, radiographic progression was more frequent with increasing MBDA scores. Among the three cohorts with requisite data, PPVs were generally similar using categories of MBDA score, DAS28-CRP or CRP but NPVs were greater for MBDA score (93-97%) than DAS28-CRP or CRP (77-87%). RRs for radiographic progression were greater when based on categories of MBDA score than DAS28-CRP or CRP and the combined RR was greater for MBDA score (4.6, p < .0001) than DAS28-CRP (1.7, p ¼ .02) or CRP (1.7, p ¼ .002). For patients cross-classified by MBDA score and DAS28-CRP, high vs. not-high MBDA score significantly predicted radiographic progression independently of DAS28-CRP. Conclusions: High and not-high MBDA scores were associated with increased and low risk, respectively, for radiographic progression over one year. MBDA score was a better predictor of radiographic progression than DAS28-CRP or CRP.

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Section: Discussionmentioning

confidence: 99%

Predicting risk for radiographic damage in rheumatoid arthritis: comparative analysis of the multi-biomarker disease activity score and conventional measures of disease activity in multiple studies

Curtis

Brahe

Østergaard

et al. 2019

Current Medical Research and Opinion

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“…Upon further analysis, high levels of CRP, SAA, MMP-3, CXCL13 and hepcidin predicted ACR20 responses to sarilumab. Several of these markers are included in the multi-biomarker disease activity (MBDA) score which is associated with disease activity but has not been evaluated for differential response to specific biologic therapies [27,28]. Baseline levels of markers associated with anaemia of chronic disease did not predict efficacy (except hepcidin); however, these markers were associated with changes in several PROs.…”

Section: Discussionmentioning

confidence: 99%

Sarilumab and adalimumab differential effects on bone remodelling and cardiovascular risk biomarkers, and predictions of treatment outcomes

et al. 2020

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Background: Interleukin-6 (IL-6) is a pleiotropic cytokine that plays a key role in the pathogenesis of rheumatoid arthritis. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptor-α to inhibit IL-6 signalling. The aim of this study was to compare the effects of sarilumab and adalimumab (a tumour necrosis factor alpha inhibitor) monotherapy on levels of circulating biomarkers associated with the acute-phase response, bone remodelling, atherothrombosis, anaemia of chronic disease and markers purported to reflect synovial lymphoid and myeloid cell infiltrates, as well as the potential of these biomarkers to differentially predict clinical and patient-reported outcomes with sarilumab vs. adalimumab. Methods: In this post hoc analysis, serum samples were analysed at baseline and prespecified post-treatment timepoints up to week 24 in adults with moderate-to-severe active rheumatoid arthritis intolerant of or inadequate responders to methotrexate from the MONARCH trial (NCT02332590). Results: Greater reductions in C-reactive protein (CRP; − 94.0% vs.-24.0%), serum amyloid A (SAA; − 83.2% vs.-17.4%), total receptor activator of nuclear factor-κB ligand (RANKL; − 18.3% vs. 10.5%) and lipoprotein (a) (− 41.0% vs.-2.8%) were observed at week 24 with sarilumab vs. adalimumab, respectively (adjusted p < 0.0001). Greater increases in procollagen type 1 N-terminal propeptide (P1NP) were observed with sarilumab vs. adalimumab at week 24 (22.8% vs. 6.2%, p = 0.027). Patients with high baseline SAA, CRP and matrix metalloproteinase-3 (MMP-3) were more likely to achieve clinical efficacy, including American College of Rheumatology 20% improvement criteria and Disease Activity Score (28 joints)-CRP < 3.2, and report improvements in patient-reported outcomes, including Health Assessment Questionnaire-Disability Index and pain visual analogue scale, with sarilumab than adalimumab. Conclusion: Sarilumab was associated with greater positive effects on bone remodelling and decreases in biomarkers of the acute-phase response, synovial inflammation and cardiovascular risk vs. adalimumab. High baseline concentrations of SAA, CRP and MMP-3 are predictive of clinical and patient-reported outcome responses to sarilumab treatment and prospective validation is warranted to confirm these results.

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“…This evaluation score is called the multi-biomarkers disease activity test (MBDA), which determine the disease activity via biomarkers such as CRP, VCAM-1, IL-6, anti-MMP1 as well as EGF and VEGF-A, which give a better RA evaluation compared to the other test [ 114 ]. Of note, it was reported that the Vectra DA test, a RA diagnostic test that measures 12 biomarkers in combination including VCAM-1, EGF, VEGF-A, IL-6, MMP-1, MMP-3, TNF-R1, YKL-40, Leptin, Resistin, SAA (serum amyloid) and CRP produced more accurate results in measuring the disease activity of the patients who are receiving RA treatment [ 115 , 116 ].…”

Section: Immune Cell Related Biomarker and Vaccine Development Formentioning

confidence: 99%

Pathogenic Role of Immune Cells in Rheumatoid Arthritis: Implications in Clinical Treatment and Biomarker Development

Yap

Tee

Wong

et al. 2018

Cells

330

242

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Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disorder that affects synovial joints, both small and large joints, in a symmetric pattern. This disorder usually does not directly cause death but significantly reduces the quality of life and life expectancy of patients if left untreated. There is no cure for RA but, patients are usually on long-term disease modifying anti-rheumatic drugs (DMARDs) to suppress the joint inflammation, to minimize joint damage, to preserve joint function, and to keep the disease in remission. RA is strongly associated with various immune cells and each of the cell type contributes differently to the disease pathogenesis. Several types of immunomodulatory molecules mainly cytokines secreted from immune cells mediate pathogenesis of RA, hence complicating the disease treatment and management. There are various treatments for RA depending on the severity of the disease and more importantly, the patient’s response towards the given drugs. Early diagnosis of RA and treatment with (DMARDs) are known to significantly improve the treatment outcome of patients. Sensitive biomarkers are crucial in early detection of disease as well as to monitor the disease activity and progress. This review aims to discuss the pathogenic role of various immune cells and immunological molecules in RA. This review also highlights the importance of understanding the immune cells in treating RA and in exploring novel biomarkers.

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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

Cited by 9 publications

References 21 publications

Predicting risk for radiographic damage in rheumatoid arthritis: comparative analysis of the multi-biomarker disease activity score and conventional measures of disease activity in multiple studies

Predicting risk for radiographic damage in rheumatoid arthritis: comparative analysis of the multi-biomarker disease activity score and conventional measures of disease activity in multiple studies

Sarilumab and adalimumab differential effects on bone remodelling and cardiovascular risk biomarkers, and predictions of treatment outcomes

Pathogenic Role of Immune Cells in Rheumatoid Arthritis: Implications in Clinical Treatment and Biomarker Development

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