To understand adverse reactions requiring epinephrine injection in the build-up phase of an oral immunotherapy clinical trial
Subjects, aged 7-55 years old (n=114), were enrolled into a randomized placebo-controlled peanut oral immunotherapy (OIT) study and trained on the proper use of epinephrine administration. Rate of epinephrine use was calculated as dose-related epinephrine administrations per 1000 doses taken, to account for continuing accrual of subjects into the trial. Pollen counts, temperature, and time of day dose was taken were studied to understand possible associations.
Of 36,000 total doses taken in the build-up phase since the study start, there have been 13 dose-related reactions and 7 accidental ingestions requiring epinephrine. Epinephrine was used at a rate of 0.3-0.4 epinephrine administrations per 1000 doses. This rate increased slightly during summer months. Of the 12 participants who required epinephrine, 85% were asthmatic and 69% had allergic rhinitis. In addition, the most frequent time of day in which taking the food allergen (FA) dose led to more severe reactions and use of epinephrine was between 22:00 and 24:00.
Preliminary data show a possible increase in the rate of reactions requiring epinephrine during the summer and/or during the late evening (time of FA dose). Further investigation is required to understand the mechanisms.