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

David M. Fleischer; Wayne G. Shreffler; Dianne E. Campbell; Todd D. Green; Sara Anvari; Amal Assa'ad; Philippe Bégin; Kirsten Beyer; J. Andrew Bird; Terri Brown-Whitehorn; Aideen Byrne; Edmond S. Chan; Amarjit Cheema; Sharon Chinthrajah; Hey Jin Chong; Carla M. Davis; Lara S. Ford; Rémi Gagnon; Matthew Greenhawt; Jonathan O.B. Hourihane; Stacie M. Jones; Edwin H. Kim; Lars Lange; Bruce J. Lanser; Stephanie Leonard; Vera Mahler; Andreas Maronna; Anna Nowak-Wegrzyn; Roxanne C. Oriel; Michael O'Sullivan; Daniel Petroni; Jacqueline A. Pongracic; Susan L. Prescott; Lynda C. Schneider; Peter Smith; Doris Staab; Gordon Sussman; Robert Wood; William H. Yang; Romain Lambert; Aurélie Peillon; Timothée Bois; Hugh A. Sampson

doi:10.1016/j.jaci.2020.06.028

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

David M. Fleischer^*, Wayne G. Shreffler, Dianne E. Campbell, Todd D. Green, Sara Anvari, Amal Assa'ad, Philippe Bégin, Kirsten Beyer, J. Andrew Bird, Terri Brown-Whitehorn, Aideen Byrne, Edmond S. Chan, Amarjit Cheema, Sharon Chinthrajah, Hey Jin Chong, Carla M. Davis, Lara S. Ford, Rémi Gagnon, Matthew Greenhawt, Jonathan O.B. HourihaneStacie M. Jones, Edwin H. Kim, Lars Lange, Bruce J. Lanser, Stephanie Leonard, Vera Mahler, Andreas Maronna, Anna Nowak-Wegrzyn, Roxanne C. Oriel, Michael O'Sullivan, Daniel Petroni, Jacqueline A. Pongracic, Susan L. Prescott, Lynda C. Schneider, Peter Smith, Doris Staab, Gordon Sussman, Robert Wood, William H. Yang, Romain Lambert, Aurélie Peillon, Timothée Bois, Hugh A. Sampson

^*Corresponding author for this work

Pediatrics

Research output: Contribution to journal › Article › peer-review

65 Scopus citations

Abstract

Background: 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). Objective: 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. Methods: 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. Results: 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%). Conclusions: 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.

Original language	English (US)
Pages (from-to)	863-874
Number of pages	12
Journal	Journal of Allergy and Clinical Immunology
Volume	146
Issue number	4
DOIs	https://doi.org/10.1016/j.jaci.2020.06.028
State	Published - Oct 2020

Keywords

EPIT
Peanut allergy
desensitization
eliciting dose
epicutaneous immunotherapy
food allergy
immunotherapy
sustained unresponsiveness

ASJC Scopus subject areas

Immunology and Allergy
Immunology

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10.1016/j.jaci.2020.06.028

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Fleischer, D. M., Shreffler, W. G., Campbell, D. E., Green, T. D., Anvari, S., Assa'ad, A., Bégin, P., Beyer, K., Bird, J. A., Brown-Whitehorn, T., Byrne, A., Chan, E. S., Cheema, A., Chinthrajah, S., Chong, H. J., Davis, C. M., Ford, L. S., Gagnon, R., Greenhawt, M., ... Sampson, H. A. (2020). Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results. Journal of Allergy and Clinical Immunology, 146(4), 863-874. https://doi.org/10.1016/j.jaci.2020.06.028

@article{a4fd240178bc49db80896ad654b19a7b,

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

abstract = "Background: 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). Objective: 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. Methods: 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. Results: 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%). Conclusions: 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.",

keywords = "EPIT, Peanut allergy, desensitization, eliciting dose, epicutaneous immunotherapy, food allergy, immunotherapy, sustained unresponsiveness",

author = "Fleischer, {David M.} and Shreffler, {Wayne G.} and Campbell, {Dianne E.} and Green, {Todd D.} and Sara Anvari and Amal Assa'ad and Philippe B{\'e}gin and Kirsten Beyer and Bird, {J. Andrew} and Terri Brown-Whitehorn and Aideen Byrne and Chan, {Edmond S.} and Amarjit Cheema and Sharon Chinthrajah and Chong, {Hey Jin} and Davis, {Carla M.} and Ford, {Lara S.} and R{\'e}mi Gagnon and Matthew Greenhawt and Hourihane, {Jonathan O.B.} and Jones, {Stacie M.} and Kim, {Edwin H.} and Lars Lange and Lanser, {Bruce J.} and Stephanie Leonard and Vera Mahler and Andreas Maronna and Anna Nowak-Wegrzyn and Oriel, {Roxanne C.} and Michael O'Sullivan and Daniel Petroni and Pongracic, {Jacqueline A.} and Prescott, {Susan L.} and Schneider, {Lynda C.} and Peter Smith and Doris Staab and Gordon Sussman and Robert Wood and Yang, {William H.} and Romain Lambert and Aur{\'e}lie Peillon and Timoth{\'e}e Bois and Sampson, {Hugh A.}",

note = "Publisher Copyright: {\textcopyright} 2020 The Authors",

year = "2020",

month = oct,

doi = "10.1016/j.jaci.2020.06.028",

language = "English (US)",

volume = "146",

pages = "863--874",

journal = "Journal of Allergy and Clinical Immunology",

issn = "0091-6749",

publisher = "Mosby Inc.",

number = "4",

}

Fleischer, DM, Shreffler, WG, Campbell, DE, Green, TD, Anvari, S, Assa'ad, A, Bégin, P, Beyer, K, Bird, JA, Brown-Whitehorn, T, Byrne, A, Chan, ES, Cheema, A, Chinthrajah, S, Chong, HJ, Davis, CM, Ford, LS, Gagnon, R, Greenhawt, M, Hourihane, JOB, Jones, SM, Kim, EH, Lange, L, Lanser, BJ, Leonard, S, Mahler, V, Maronna, A, Nowak-Wegrzyn, A, Oriel, RC, O'Sullivan, M, Petroni, D, Pongracic, JA, Prescott, SL, Schneider, LC, Smith, P, Staab, D, Sussman, G, Wood, R, Yang, WH, Lambert, R, Peillon, A, Bois, T & Sampson, HA 2020, 'Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results', Journal of Allergy and Clinical Immunology, vol. 146, no. 4, pp. 863-874. https://doi.org/10.1016/j.jaci.2020.06.028

Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results. / Fleischer, David M.; Shreffler, Wayne G.; Campbell, Dianne E. et al.
In: Journal of Allergy and Clinical Immunology, Vol. 146, No. 4, 10.2020, p. 863-874.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children

T2 - PEOPLE 3-year results

AU - Fleischer, David M.

AU - Shreffler, Wayne G.

AU - Campbell, Dianne E.

AU - Green, Todd D.

AU - Anvari, Sara

AU - Assa'ad, Amal

AU - Bégin, Philippe

AU - Beyer, Kirsten

AU - Bird, J. Andrew

AU - Brown-Whitehorn, Terri

AU - Byrne, Aideen

AU - Chan, Edmond S.

AU - Cheema, Amarjit

AU - Chinthrajah, Sharon

AU - Chong, Hey Jin

AU - Davis, Carla M.

AU - Ford, Lara S.

AU - Gagnon, Rémi

AU - Greenhawt, Matthew

AU - Hourihane, Jonathan O.B.

AU - Jones, Stacie M.

AU - Kim, Edwin H.

AU - Lange, Lars

AU - Lanser, Bruce J.

AU - Leonard, Stephanie

AU - Mahler, Vera

AU - Maronna, Andreas

AU - Nowak-Wegrzyn, Anna

AU - Oriel, Roxanne C.

AU - O'Sullivan, Michael

AU - Petroni, Daniel

AU - Pongracic, Jacqueline A.

AU - Prescott, Susan L.

AU - Schneider, Lynda C.

AU - Smith, Peter

AU - Staab, Doris

AU - Sussman, Gordon

AU - Wood, Robert

AU - Yang, William H.

AU - Lambert, Romain

AU - Peillon, Aurélie

AU - Bois, Timothée

AU - Sampson, Hugh A.

PY - 2020/10

Y1 - 2020/10

N2 - Background: 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). Objective: 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. Methods: 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. Results: 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%). Conclusions: 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.

AB - Background: 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). Objective: 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. Methods: 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. Results: 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%). Conclusions: 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.

KW - EPIT

KW - Peanut allergy

KW - desensitization

KW - eliciting dose

KW - epicutaneous immunotherapy

KW - food allergy

KW - immunotherapy

KW - sustained unresponsiveness

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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

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