Biologics And Clinical Immunology Cohort at Sinai

The study team proposes a twofold approach to determine how immunophenotype may affect the course of clinical immunological disease for patients receiving biologic therapy. First, the team intends to establish a biorepository and database that includes demographic, immunologic, exposure and clinical records. The registry will be set up to facilitate research across disease disciplines, and across other registries affiliated with ISMMS. Second, over time, the team aims to address specific and an increasing number of research questions focused on using novel diagnostics to increase the effectiveness of biologic treatment as outlined below. Most subjects will be recruited from the Mount Sinai Therapeutic Infusion Center (TIC), although others receiving infusions elsewhere or at home will be recruited from outpatient affiliated clinical practices during scheduled medical visits.

Specific Aims:

1. (Overarching) Build a repository of biological specimens, questionnaire data, and apply state-of-the-art assessment tools to assess the current immunological and clinical condition, and changes over time. Specimens and data will be collected in a manner that can readily incorporate new technology, new research questions, link to intelligent analytics, and provide a resource for future consortia across disciplines. An infrastructure will be created that includes a multi-disciplinary Steering Committee to facilitate spinoff research studies and harmonize protocols within the TIC and across the Sinai system, resolve procedural questions, and communicate updated policies to referring physicians.

Additional initial specific scientific aims related to responses to biologics prescribed as part of standard practice that will be considered in this proposal are to determine:

2 . Effects of anti-IgE therapy on IgE phenotypes, maturation and production, and clinical outcomes.