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In patients with Fabry disease (FD), treatment with enzyme replacement therapy (ERT), may trigger the formation of anti-drug antibodies (ADAs). The consequences of this immune reaction range from the transient appearance of clinically insignificant ADAs to the generation of neutralizing antibodies that negate the clinical benefit of the biotherapeutic agent, lead to side effects (such [...]

The aim of the analysis was to develop a phenomenological longitudinal population pharmacokinetics (PK)-anti-drug antibodies (ADA) model to enable an informed and quantitative framework for assessment of ADA influence. Data used were from seven clinical studies of avelumab across drug development phases in patients with several tumor types. ADA as covariate in a population PK [...]

Bacteriophage (phage) therapy is a promising alternative to antibiotics, yet phage-induced immune responses can affect treatment efficacy. However, current methods for assessing phage immunogenicity are limited, hindering the development of safer, more effective therapies. Here, we introduce the Bacteriophage Risk Index (BRI), a novel metric that quantifies phage immunogenic potential based on CpG dinucleotide frequency, [...]

BACKGROUND: As the use of anti-tumor necrosis factor-alpha (TNFalpha) therapies in Crohn disease (CD) is spread, the loss-of-response (LOR) to it is increasingly encountered. Discovering a pathological pathway and biomarkers that can predict LOR would assist in the management of patients with CD. In this article, we provide a comprehensive systematic review of studies assessing [...]

Administration of therapeutic protein products might potentially elicit an immune response via production of Anti-Drug Antibodies (ADA). This immune response can cause some clinical consequences ranging from mild to harmful for the patient, affecting the safety and efficacy of the drug. Therefore, assessment of Immunogenicity and the ability to follow possible associations between ADA assay [...]

Generic drugs have saved consumers billions of dollars in the United States. The demand for lower-cost and effective drugs, particularly for well-known peptide drugs like Ozempic and Wegovy (brand names for semaglutide), has resulted in a surge of generic drug development to address perceived shortages in the supply of the reference listed drugs (RLD). To [...]