820:
Limitations in Current Peanut Oral Immunotherapy (POIT) Practices in the U.S.
Monday, March 5, 2018
South Hall A2 (Convention Center)
Michael S. Blaiss, MD FAAAAI, Stephen A. Tilles, MD FAAAAI, Jay A. Lieberman, MD FAAAAI, Marie Cassese, Nicholas Georgitseas, Aditya Venugopal, PhD, Ellen Zigmont, PharmD, Kristin Bennett, Daniel Petroni, MD PhD
RATIONALE: Peanut allergy is a major U.S. health care burden. While current guidelines do not recommend POIT, some practices offer it in response to patient/caregiver dissatisfaction with peanut avoidance and other practitioners are studying POIT through ongoing clinical research. We sought to understand the limitations that currently prevent POIT from being widely used.

METHODS: Qualitative, in-depth phone interviews were conducted with 28 community and academic allergists and 6 nurse food allergy specialists across the U.S. between April and June 2016. Interviewed clinicians managed >100 peanut allergy patients/year. For perspectives on POIT, we interviewed 14 allergists who offer POIT in clinical studies or self-developed protocols; the remaining 14 allergists were POIT-naive.

RESULTS:

Both physicians offering and not offering POIT identified several limitations in the currently utilized POIT treatment regimens of peanut allergy, including:

  • Lack of a medicinal product meeting the required standards for FDA-approval
  • Lack of standardized dosing regimens
  • Medical-legal implications of offering non-FDA approved POIT
  • Unclear defined criteria for appropriate patient selection
  • Insufficient long-term safety and efficacy data
  • Lack of correlation between maintenance POIT dosing and level of protection

Those interviewed recognized that robust, Phase 3 clinical development programs with a sufficient number of patients, using standardized protocols and a characterized OIT product, with long-term follow up, could address several of these limitations.

CONCLUSIONS: Several limitations have been identified with currently offered POIT regimens in the U.S.; many of these are being explored in ongoing Phase 3 clinical trials evaluating characterized oral products and standardized dosing regimens.