Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results

• Published in: Journal of allergy and clinical immunology Vol. 146; no. 4; pp. 863 - 874
• Main Authors: Fleischer, David M., Shreffler, Wayne G., Campbell, Dianne E., Green, Todd D., Anvari, Sara, Assa’ad, Amal, Bégin, Philippe, Beyer, Kirsten, Bird, J. Andrew, Brown-Whitehorn, Terri, Byrne, Aideen, Chan, Edmond S., Cheema, Amarjit, Chinthrajah, Sharon, Chong, Hey Jin, Davis, Carla M., Ford, Lara S., Gagnon, Rémi, Greenhawt, Matthew, Hourihane, Jonathan O’B., Jones, Stacie M., Kim, Edwin H., Lange, Lars, Lanser, Bruce J., Leonard, Stephanie, Mahler, Vera, Maronna, Andreas, Nowak-Wegrzyn, Anna, Oriel, Roxanne C., O’Sullivan, Michael, Petroni, Daniel, Pongracic, Jacqueline A., Prescott, Susan L., Schneider, Lynda C., Smith, Peter, Staab, Doris, Sussman, Gordon, Wood, Robert, Yang, William H., Lambert, Romain, Peillon, Aurélie, Bois, Timothée, Sampson, Hugh A.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2020
• Subjects: Administration, Cutaneous; Adolescent; Allergens - administration & dosage; Allergens - immunology; Biomarkers; Child; Child, Preschool; desensitization; Desensitization, Immunologic - adverse effects; Desensitization, Immunologic - methods; eliciting dose; epicutaneous immunotherapy; EPIT; Female; Follow-Up Studies; food allergy; Humans; Immunoglobulin E - immunology; immunotherapy; Male; Peanut allergy; Peanut Hypersensitivity - immunology; Peanut Hypersensitivity - therapy; sustained unresponsiveness; Treatment Outcome; PP; sIgE; SU; AE; HRQL; epicutaneous immunotherapy; IQR; food allergy; desensitization; mLOCF; eliciting dose; TEAE; CRD; Peanut allergy; EPIT; immunotherapy; sustained unresponsiveness; DBPCFC; ED
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2020.06.028

The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study. Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment. Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose 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 were low (1%). 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.