Patient-Centered Outcomes of the First Approved Peanut Allergy Treatment

项目总结/文摘

PROJECT SUMMARY/ABSTRACT Jennifer Dantzer, MD MHS is an allergy and immunology physician-scientist at Johns Hopkins University, with a Master's Degree in Epidemiology. This K23 award will provide her valuable training towards her long-term career goal of being an independent investigator focused on patient centered outcomes (PCO) of food allergy treatments. Food allergy is a major public health disorder that affects at least 5.9 million American children and is increasing in prevalence. Historically, food allergy management has been based on strict allergen avoidance and recognition and treatment of allergic reactions. However, the burden of food avoidance and on-going uncertainty over possible accidental exposures can have a significant psychosocial impact on children and parents. The FDA approved the first treatment for peanut allergy, Palforzia, peanut oral immunotherapy (POIT), in January 2020, ushering in a new era for food allergy treatment. While this paradigm shift in food allergy management is monumental, there is significant uncertainty related to benefits/risks to the patient, treatment preferences, and patient-centered outcomes (PCO). This gap in our understanding lead to this project's overall objective to evaluate the patient perceived benefit of peanut allergy therapy and to better understand decision-making with regard to discontinuation and treatment preferences. Aim 1 will examine longitudinal change in child, adolescent, and caregiver food allergy related quality of life in a diverse, real-world population on and off POIT. In addition, the long-term benefit of POIT is dependent upon on-going treatment since stopping treatment causes the majority of patients to lose most or all protection. Aim 2 will use local and national data as well as interviews and questionnaires to determine the rates, potential predictors, and reasons for POIT discontinuation. Finally, Aim 3 will use a mixed methods approach to understand patient and parent preferences for PA treatment. This K23 award addresses the mission of NIAID to better understand and treat allergic diseases by using a novel approach and methods directed towards PCO research. The research will be completed within the highly supportive training environment at Johns Hopkins, with the guidance of a team of expert mentors with relevant expertise (Drs. Robert Wood, MD, Corinne Keet, MD PhD, Albert Wu, MD MPH, Cynthia Rand, PhD and John F.P. Bridges, PhD). The career development plan combines hands-on training, formal didactics, and outstanding mentorship in key areas of statistical analysis, epidemiology, and advanced techniques in PCO research. This plan will ensure a successful transition to independence. This K23 award will provide preliminary data and skills that are highly relevant and applicable to future R01 or U level grants. Findings have the potential to change clinical practice not only related to POIT, but also for future food allergy treatments, through enhanced benefit-risk assessment, best practice guidelines, and patient decision-making tools.