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Long-Term, Open-Label Extension Study of the Efficacy and Safety of Epicutaneous Immunotherapy for Peanut Allergy in Children: PEOPLE 3-Year Results. The Journal of allergy and clinical immunology Fleischer, D. M., Shreffler, W. G., Campbell, D. E., Green, T. D., Anvari, S., Assa'ad, A., Begin, P., Beyer, K., Bird, J. A., Brown-Whitehorn, T., Byrne, A., Chan, E. S., Cheema, A., Chinthrajah, S., Chong, H., Davis, C. M., Ford, L. S., Gagnon, R., Greenhawt, M., O'B Hourihane, J., Jones, S. M., Kim, E. H., Lange, L., Lanser, B. J., Leonard, S., Mahler, V., Maronna, A., Nowak-Wegrzyn, A., Oriel, R. C., O'Sullivan, M., Petroni, D., Pongracic, J. A., Prescott, S. L., Schneider, L. C., Smith, P., Staab, D., Sussman, G., Wood, R., Yang, W. H., Lambert, R., Peillon, A., Bois, T., Sampson, H. A. 2020

Abstract

BACKGROUND: We previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 mug, daily epicutaneous peanut protein; DBV712 250mug) in a 12-month randomized controlled study (PEPITES) of peanut-allergic children aged 4-11 years.OBJECTIVE: To assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) open-label extension PEOPLE study.METHODS: Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250mug, subjects who had received DBV712 250mug in PEPITES underwent Month-36 double-blind, placebo-controlled, food challenge (DBPCFC) with an optional Month-38 sustained unresponsiveness (SU) assessment.RESULTS: 198 (93%) of 213 eligible subjects who had received DBV712 250mug in PEPITES entered PEOPLE, of whom 141 (71%) had assessable DBPCFC at Month 36. At Month 36, 51.8% (73/141) of subjects reached an eliciting dose (ED) of =1000 mg, compared with 40.4% (57/141) at Month 12. 75.9% (107/141) demonstrated increased ED compared to baseline. 13.5% (19/141) tolerated the full DBPCFC of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. 18 subjects underwent an optional SU assessment; 14/18 (77.8%) maintained an ED of =1000 mg at Month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%).CONCLUSION: These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.

View details for DOI 10.1016/j.jaci.2020.06.028

View details for PubMedID 32659313