Effect of epicutaneous immunotherapy vs. placebo on reaction to peanut protein ingestion

Researchers conducted the PEPITES clinical trial to learn more about epicutaneous immunotherapy for peanut allergy and its effect on reactivity to peanut protein ingestion in affected children.

Researchers conducted the PEPITES clinical trial to learn more about epicutaneous immunotherapy for peanut allergy and its effect on reactivity to peanut protein ingestion in affected children. The randomized Phase III study, carried out in the United States and four other countries, compared treatment response rates in 238 participants who received 1 year of daily therapy via a peanut skin patch with 118 participants who received placebo. All of the participating children were aged 4–11 years; were diagnosed with peanut allergy; and, to avoid potentially life-threatening reactions, had no history of severe anaphylaxis or unstable chronic conditions, such as asthma. In the peanut-patch group, treatment response was documented in 35.3% of the children vs. 13.6% of the controls. Although the difference was statistically significant, it fell short of a prespecified criterion required to declare a positive trial result. A component of the primary outcome stipulated a threshold of 15% or more on the lower bound of a 95% confidence interval around the difference in responder rates; however, that measurement came in only at 12.4%. The clinical implications are uncertain.