To redevelop a neutralizing antibody (NAb) assay to be much more drug tolerant, have a large dynamic range and have high inhibition when using high levels of positive control (PC). Early assay data suggested that typical biotin labeling of the capture reagent (Drug 1, produced in a human cell line) was blocking it from binding with the PC or the detection target, and that the detection target was out competing the PC. Methodical biotin labeling experiments were performed at several challenge ratios and an Fc linker was added to the detection target.
View Article and Find Full Text PDFThe measurement of antidrug antibodies (ADA) in nonclinical studies provides limited value because the formation and incidence of nonclinical ADA does not translate to clinical experience. The formation and presence of ADA in nonclinical species can, however, correlate to reduced drug exposure and safety observations including vasculitis and immune complex disease. Generic ADA methods for humanized monoclonal antibody biotherapeutics mitigate the need to develop bespoke ADA methods during nonclinical drug development.
View Article and Find Full Text PDFInconsistent or careless responding is a significant threat to the validity of self-reported personality data. Using archival samples of undergraduate and community participants, we developed an inconsistent responding scale using items that appear on both the 60- and 100-item versions of the HEXACO Personality Inventory-Revised-two widely used measures of the HEXACO model of personality trait structure. We identified pairs of correlated HEXACO items in Sample 1 and created a total inconsistent responding score by summing absolute differences between each item pair.
View Article and Find Full Text PDFObjective: To determine the long-term outcome of Maori and Pacific Island children diagnosed with childhood onset lupus nephritis.
Method: A chart review was conducted of children diagnosed with biopsy proven lupus nephritis seen by the Starship Hospital and Kidz First paediatric rheumatology and/or Starship renal services between January 1992 and January 2018. Baseline and follow-up kidney histology, adherence and response to therapy including partial or full renal remission, refractory disease, end-stage kidney disease (ESKD) and mortality were determined.
Aim: To describe the incidence, demographics, diagnostic clinical manifestations and long-term outcomes of juvenile dermatomyositis (JDM) in Maori and Pacific Island compared to European children.
Methods: A chart review was conducted of children with JDM seen by the Starship Rheumatology service between 2000 and 2020. Diagnostic clinical manifestations, demographics, disease course and significant complications were collated.