Novel Diagnostic Markers for Rheumatoid Arthritis Including Anti-CarP (Carbamylated Protein), Anti-Sa (Citrullinated Vimentin) and Anti-CEP1 (Citrullinated Enolase Peptide1) Are Frequently Positive in Diagnostic Profiles

Despite the diagnostic contribution of Anti-CCP 3.1 (cyclic citrullinated peptide) antibody and RF (rheumatoid factor) as classified by the 2010 ACR/EULAR RA criteria, approximately one-third of patients with rheumatoid arthritis (RA) are considered “seronegative.” Novel markers, Anti-CarP Anti-Sa, and Anti-CEP-1 were recently added in order to improve RA diagnosis and characterization. These autoantibodies may predict the development of RA and may be associated with more active disease and higher risk of developing joint erosions.

Therapeutic Drug Monitoring (TDM) of Hydroxychloroquine in Whole Blood: Analysis of Over 10,000 Patient Results Using Lab Developed Liquid Chromatography Tandem Mass Spectrometry

Hydroxychloroquine (HCQ), a mainstay SLE therapy, improves survival and reduces flares. Therapeutic drug monitoring (TDM) may be useful in 1) identifying and improving adherence issues, 2) titrating daily dose to achieve therapeutic benefits associated with whole blood HCQ >1000 ng/mL while 3) minimizing cumulative exposure by keeping levels <2000 ng/mL. Whole blood (WB) is the correct specimen because WB HCQ levels are higher than serum or plasma levels, more stable and reflective of the last month of HCQ ingestion, and are better correlated to efficacy and retinopathy risk.

Correlation of Anti-DFS70 Autoantibodies by ELISA with HEp-2 Cells DFS Pattern by IFA

Anti-DFS70 antibodies are associated with a dense-fine speckled (DFS) pattern by IFA while their clinical associations remain an immunological enigma. This study provides supporting evidence of the significant association between the DFS pattern by IFA and anti-DFS70 antibodies by ELISA and offers a potential algorithm to triage patients to exclude systemic autoimmune rheumatic diseases/ANA-associated rheumatic diseases (SARD/AARD).

Rheumatologic Disorder Diagnostic Testing Patterns: Real World Evidence from a National Laboratory Database

Rheumatologic disorders can take years to diagnose, often requiring a combination of specific symptoms, examination findings and laboratory testing, rather than a single test. Additionally, symptoms presenting in rheumatologic processes are often present in other common conditions, making diagnosis challenging. In this study, we sought to examine patterns of post-ANA testing using real world evidence to inform order guidance opportunities and help advance diagnosis.

Biologic Drug and Anti-Drug Antibody Monitoring: All 5 TNF-Inhibitors, Infliximab, Adalimumab, Golimumab, Etanercept and Certolizumab Pegol, in 63,930 Patient Samples

Biologic therapeutic drug monitoring (TDM) of TNF-inhibitor drug and anti-drug antibody provides patient-specific pharmacokinetic and immunogenic assessment and informs the very different medication decisions of whether to increase the same biologic or to switch drug, in- or out-of class.

Novel Markers for Rheumatoid Arthritis, Anti-CarP, Anti-Sa, and Anti-CEP1, Are More Frequently Positive and Higher in Titer in RA Patients with Higher Vectra® Disease Activity Scores

Autoantibodies against citrullinated and carbamylated proteins in RA patients may be associated with more active disease and higher risk of developing joint erosions, and Vectra® is a blood test that yields a RA disease activity (DA) score from 1 to 100 that is low, moderate or high. In this abstract, 120 patient samples were analyzed to assess the relationship of DA as measured by Vectra® Score and the presence of novel autoantibody markers with potential prognostic value.

Supporting preclinical and clinical studies through innovative biomarker analysis and solutions: Insights from a recent Japan symposium (Part 3)

Effective drug development is driven by robust clinical trials, which depend on collecting and analyzing individual biomarker data. Biomarker analysis is key to developing targeted, personalized therapies. However, given the diverse types of biomarkers and their context-dependent performance, validating biomarkers is still complex. Innovative solutions can help support biomarker analysis through a fit-for-purpose approach based on the context of use (CoU). Recently, at the Japan Symposium 2023, Dr. John Mu, head of immunology and immunotoxicology at Labcorp Early Development Research Laboratories, and Dr. Christopher Cooper, manager of science and reporting for immunotoxicology at Labcorp, discussed the considerations of biomarker analysis and CoU in delivering appropriate interpretation for preclinical and clinical studies at the symposium.

Correlation of Anti-Centromere Antibodies (ACA) Detection by Indirect Immunofluorescence (IFA) on HEp-2 Cells and by ELISA Demonstrates High Concordance but Highlights Advantage of IFA in Detecting ACA to All Centromere Protein (CENP) Antigens

Anti-centromere antibodies, first identified as a discrete speckled pattern on indirect immunofluorescence assay (IFA), are a hallmark of systemic sclerosis (SSc). In this abstract, an ELISA using both CENP-B and CENP-A is compared to the reference method, HEp-2 cell IFA, highlighting its high, but still less than 100%, sensitivity due to multiple centromere subcomponents.