Background: Combined treatment with probiotic and peanut oral
immunotherapy (PPOIT) was shown to induce sustained unresponsiveness
(SU) in a proof-of-concept randomized trial. Additional data on safety
and long-term outcomes are needed. This study aimed to evaluate the
safety and long-term effects of PPOIT in children with peanut allergy.
Methods: Open-label study of 20 children aged 1-12 years with
challenge-confirmed peanut allergy; all children received 18-months of
PPOIT. Efficacy endpoints were desensitization, 8-week SU, and
persistence of 8-week SU at 3-years post-treatment, assessed by
double-blind placebo-controlled food challenge (cumulative 4950mg peanut
protein). Treatment emergent adverse events and relationship to study
treatment were recorded. Immunologic measures and health related quality
of life (HRQL) were evaluated at screening, end-of-treatment and 3-years
post-treatment. Results: Sixteen children (75%) completed
treatment. By intention-to-treat analysis, 75% (15/20) achieved
desensitization and 60% (12/20) achieved 8-week SU. Ten of 12
participants with SU at end-of-treatment consented to the 3-year SU
challenge; 6 (60%) had persistence of SU. PPOIT was associated with
significantly reduced peanut skin prick test wheal size and serum peanut
specific-IgE levels at end-of-treatment, 12-months and 3-years
post-treatment. There were no serious adverse events. HRQL scores
improved (exceeding the Minimal Clinically Important Difference of 0.45)
at 12-months post-treatment with benefit sustained at 3-years
post-treatment. Conclusions: Eighteen months of PPOIT induced
high rates of desensitization and SU, and SU persisted to 3-years
post-treatment in a majority of initial responders. PPOIT led to
long-lasting suppression of peanut sIgE and long-lasting clinically
important improvement in HRQL.
Long-Term Effects of Neonatal Hypoxia-Ischemia on Structural and Physiological Integrity of the Eye and Visual Pathway by Multimodal MRI
