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.
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.