EPITOPE trial found that an epicutaneous immunotherapy patch having 250 ug peanut protein has shown a significant response, and there were very low treatment-related anaphylaxis and discontinuations among peanut-allergic children aged 1-3 years. The trial results were published in the journal Annals of Allergy, Asthma & Immunology.
Peanut allergy is very common in children and there are no approved peanut allergy treatments that can be used for children <4 years old. Hence researchers conducted a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of epicutaneous immunotherapy with a patch containing 250 µg peanut protein among peanut-allergic children ages 1-3 years.
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In the EPITOPE trial, peanut-allergic children developing symptoms that met the stopping criteria during a double-blind, placebo-controlled food challenge (DBPCFC) were given an eliciting dose (ED) of ≤300 mg peanut protein. They were randomized for 2:1 to 12 months of daily treatment with the peanut patch or placebo patch. There were 244 participants in the peanut patch group and 118 participants in the placebo group with a median age of 2.5 years and nearly 68.8% were male. The primary outcome was the percent difference in responders between active and placebo, based on DBPCFC ED at baseline and 12 months. Treatment-emergent adverse event (TEAE) rate was used to assess the safety.
Results:
Of 362 participants randomized, 84.8% completed treatment.
The primary efficacy endpoint was met by 67% receiving active peanut patches vs. 33.5% receiving placebo (difference=33.4%; [p<0.001]).
Additional peanut protein ED ≥1000 mg was received by 64.2% active vs. 29.6% placebo recipients (difference=34.7%; [p<0.001]).
Mild or moderate application site reactions were the major TEAEs.
Serious TEAEs occurred in 8.6% of peanut patches vs. 2.5% of placebo recipients.
Treatment-related anaphylaxis was experienced by 1.6% (n=4) of peanut patch subjects.
Nearly 3.3% (n=8) of peanut patch subjects discontinued due to a TEAE.
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Thus, the trial showed a statistically significant response for twelve months of epicutaneous immunotherapy patch having 250 µg peanut protein when compared with a placebo among peanut-allergic children aged 1-3 years and also with lower rates of treatment-related anaphylaxis and discontinuations due to TEAEs.
Further reading: Burks A, Sindher S, Wang J, et al. EPITOPE study results: phase 3, randomized, double-blind, placebo-controlled study of epicutaneous immunotherapy in peanut-allergic toddlers. Ann Allergy Asthma Immunol. 2022;125(5):S12. doi: 10.1016/j.anai.2022.08.540