Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE

Matthew Greenhawt; Deborah Albright; Sara Anvari; Nicolette Arends; Peter D Arkwright; Philippe Bégin; Katharina Blümchen; Terri Brown-Whitehorn; Heather Cassell; Edmond S Chan; Christina E Ciaccio; Antoine Deschildre; Amandine Divaret-Chauveau; Stacy Dorris; Morna Dorsey; George Du Toit; Thomas Eiwegger; Michel Erlewyn-Lajeunesse; David M Fleischer; Lara S Ford; Maria Garcia-Lloret; Jonathan O'B Hourihane; Nicola Jay; Stacie M Jones; Edwin H Kim; Kirsten Kloepfer; Stephanie Leonard; Guillaume Lezmi; Jay Lieberman; Jeanne Lomas; Melanie Makhija; Michael O'Sullivan; Christopher Parrish; Jane Peake; Kirsten P Perrett; Daniel Petroni; Jacqueline A Pongracic; Patrick Quinn; Rachel G Robison; Georgiana Sanders; Lynda Schneider; Hemant Sharma; Sayantani B Sindher; Juan Trujillo; Paul J Turner; Katherine Tuttle; Julia Upton; Pooja Varshney; Brian P Vickery; Christian Vogelberg; Brynn Wainstein; Julie Wang; Robert Wood; Katharine J Bee; Dianne E Campbell; Todd D Green; Rihab Rouissi; Henry T Bahnson; Timothée Bois; Hugh A Sampson; A Wesley Burks

doi:10.1016/j.jaip.2025.02.004

Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE

Matthew Greenhawt, Deborah Albright, Sara Anvari, Nicolette Arends, Peter D Arkwright, Philippe Bégin, Katharina Blümchen, Terri Brown-Whitehorn, Heather Cassell, Edmond S Chan, Christina E Ciaccio, Antoine Deschildre, Amandine Divaret-Chauveau, Stacy Dorris, Morna Dorsey, George Du Toit, Thomas Eiwegger, Michel Erlewyn-Lajeunesse, David M Fleischer, Lara S FordMaria Garcia-Lloret, Jonathan O'B Hourihane, Nicola Jay, Stacie M Jones, Edwin H Kim, Kirsten Kloepfer, Stephanie Leonard, Guillaume Lezmi, Jay Lieberman, Jeanne Lomas, Melanie Makhija, Michael O'Sullivan, Christopher Parrish, Jane Peake, Kirsten P Perrett, Daniel Petroni, Jacqueline A Pongracic, Patrick Quinn, Rachel G Robison, Georgiana Sanders, Lynda Schneider, Hemant Sharma, Sayantani B Sindher, Juan Trujillo, Paul J Turner, Katherine Tuttle, Julia Upton, Pooja Varshney, Brian P Vickery, Christian Vogelberg, Brynn Wainstein, Julie Wang, Robert Wood, Katharine J Bee, Dianne E Campbell, Todd D Green, Rihab Rouissi, Henry T Bahnson, Timothée Bois, Hugh A Sampson, A Wesley Burks

Research output: Journal article (peer-reviewed) › Journal article

Abstract

BACKGROUND: The pivotal phase 3 EPITOPE trial, a 12-month, double-blind, placebo-controlled study of epicutaneous immunotherapy with the VIASKIN® patch containing 250 μg peanut protein (VP250) previously reported significant treatment response vs placebo in peanut-allergic toddlers aged 1-through-3 years.

OBJECTIVE: To assess interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study.

METHODS: Eligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFC) and safety assessments; here we report the first year OLE (Year 2) results.

RESULTS: 266 EPITOPE participants enrolled in the OLE study; 244 underwent Month 24 DBPCFC (n=166 VP250; n=78 placebo). After 24 months of VP250, 81.3% reached an eliciting dose (ED) ≥1000 mg, 63.8% reached an ED ≥2000 mg, and 55.9% completed the DBPCFC (cumulative dose: 3444 mg) without meeting stopping criteria. No treatment-related anaphylaxis or serious treatment-related adverse events occurred during Year 2 in this treatment arm. Local application-site reactions occurred less frequently in Year 2 vs Year 1. In placebo-treated EPITOPE participants, outcomes after 1 year of open-label VP250 were consistent with EPITOPE treatment results: 62.7% reached an ED ≥1000 mg, 36.5% reached an ED ≥2000 mg, and 28.4% completed the DBPCFC without meeting stopping criteria; and there was 1 treatment-related anaphylaxis event.

CONCLUSIONS: Two years of VP250 in young peanut-allergic children demonstrated continued treatment effect increases without new safety signals. This supports the potential of VP250 as a safe and effective treatment for peanut allergy in young children.

Original language	English
Journal	Journal of Allergy and Clinical Immunology: In Practice
DOIs	https://doi.org/10.1016/j.jaip.2025.02.004
Publication status	E-pub ahead of print - 14 Feb 2025

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10.1016/j.jaip.2025.02.004

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Greenhawt, M., Albright, D., Anvari, S., Arends, N., Arkwright, P. D., Bégin, P., Blümchen, K., Brown-Whitehorn, T., Cassell, H., Chan, E. S., Ciaccio, C. E., Deschildre, A., Divaret-Chauveau, A., Dorris, S., Dorsey, M., Du Toit, G., Eiwegger, T., Erlewyn-Lajeunesse, M., Fleischer, D. M., ... Burks, A. W. (2025). Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE. Journal of Allergy and Clinical Immunology: In Practice. Advance online publication. https://doi.org/10.1016/j.jaip.2025.02.004

@article{f3a89e25b6044ee4895092e7790db3ff,

title = "Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE",

abstract = "BACKGROUND: The pivotal phase 3 EPITOPE trial, a 12-month, double-blind, placebo-controlled study of epicutaneous immunotherapy with the VIASKIN{\textregistered} patch containing 250 μg peanut protein (VP250) previously reported significant treatment response vs placebo in peanut-allergic toddlers aged 1-through-3 years.OBJECTIVE: To assess interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study.METHODS: Eligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFC) and safety assessments; here we report the first year OLE (Year 2) results.RESULTS: 266 EPITOPE participants enrolled in the OLE study; 244 underwent Month 24 DBPCFC (n=166 VP250; n=78 placebo). After 24 months of VP250, 81.3% reached an eliciting dose (ED) ≥1000 mg, 63.8% reached an ED ≥2000 mg, and 55.9% completed the DBPCFC (cumulative dose: 3444 mg) without meeting stopping criteria. No treatment-related anaphylaxis or serious treatment-related adverse events occurred during Year 2 in this treatment arm. Local application-site reactions occurred less frequently in Year 2 vs Year 1. In placebo-treated EPITOPE participants, outcomes after 1 year of open-label VP250 were consistent with EPITOPE treatment results: 62.7% reached an ED ≥1000 mg, 36.5% reached an ED ≥2000 mg, and 28.4% completed the DBPCFC without meeting stopping criteria; and there was 1 treatment-related anaphylaxis event.CONCLUSIONS: Two years of VP250 in young peanut-allergic children demonstrated continued treatment effect increases without new safety signals. This supports the potential of VP250 as a safe and effective treatment for peanut allergy in young children.",

author = "Matthew Greenhawt and Deborah Albright and Sara Anvari and Nicolette Arends and Arkwright, {Peter D} and Philippe B{\'e}gin and Katharina Bl{\"u}mchen and Terri Brown-Whitehorn and Heather Cassell and Chan, {Edmond S} and Ciaccio, {Christina E} and Antoine Deschildre and Amandine Divaret-Chauveau and Stacy Dorris and Morna Dorsey and {Du Toit}, George and Thomas Eiwegger and Michel Erlewyn-Lajeunesse and Fleischer, {David M} and Ford, {Lara S} and Maria Garcia-Lloret and {O'B Hourihane}, Jonathan and Nicola Jay and Jones, {Stacie M} and Kim, {Edwin H} and Kirsten Kloepfer and Stephanie Leonard and Guillaume Lezmi and Jay Lieberman and Jeanne Lomas and Melanie Makhija and Michael O'Sullivan and Christopher Parrish and Jane Peake and Perrett, {Kirsten P} and Daniel Petroni and Pongracic, {Jacqueline A} and Patrick Quinn and Robison, {Rachel G} and Georgiana Sanders and Lynda Schneider and Hemant Sharma and Sindher, {Sayantani B} and Juan Trujillo and Turner, {Paul J} and Katherine Tuttle and Julia Upton and Pooja Varshney and Vickery, {Brian P} and Christian Vogelberg and Brynn Wainstein and Julie Wang and Robert Wood and Bee, {Katharine J} and Campbell, {Dianne E} and Green, {Todd D} and Rihab Rouissi and Bahnson, {Henry T} and Timoth{\'e}e Bois and Sampson, {Hugh A} and Burks, {A Wesley}",

note = "Copyright {\textcopyright} 2025. Published by Elsevier Inc.",

year = "2025",

month = feb,

day = "14",

doi = "10.1016/j.jaip.2025.02.004",

language = "English",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "American Academy of Allergy, Asthma and Immunology",

}

Greenhawt, M, Albright, D, Anvari, S, Arends, N, Arkwright, PD, Bégin, P, Blümchen, K, Brown-Whitehorn, T, Cassell, H, Chan, ES, Ciaccio, CE, Deschildre, A, Divaret-Chauveau, A, Dorris, S, Dorsey, M, Du Toit, G, Eiwegger, T, Erlewyn-Lajeunesse, M, Fleischer, DM, Ford, LS, Garcia-Lloret, M, O'B Hourihane, J, Jay, N, Jones, SM, Kim, EH, Kloepfer, K, Leonard, S, Lezmi, G, Lieberman, J, Lomas, J, Makhija, M, O'Sullivan, M, Parrish, C, Peake, J, Perrett, KP, Petroni, D, Pongracic, JA, Quinn, P, Robison, RG, Sanders, G, Schneider, L, Sharma, H, Sindher, SB, Trujillo, J, Turner, PJ, Tuttle, K, Upton, J, Varshney, P, Vickery, BP, Vogelberg, C, Wainstein, B, Wang, J, Wood, R, Bee, KJ, Campbell, DE, Green, TD, Rouissi, R, Bahnson, HT, Bois, T, Sampson, HA & Burks, AW 2025, 'Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE', Journal of Allergy and Clinical Immunology: In Practice. https://doi.org/10.1016/j.jaip.2025.02.004

TY - JOUR

T1 - Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers

T2 - Open-Label Extension to EPITOPE

AU - Greenhawt, Matthew

AU - Albright, Deborah

AU - Anvari, Sara

AU - Arends, Nicolette

AU - Arkwright, Peter D

AU - Bégin, Philippe

AU - Blümchen, Katharina

AU - Brown-Whitehorn, Terri

AU - Cassell, Heather

AU - Chan, Edmond S

AU - Ciaccio, Christina E

AU - Deschildre, Antoine

AU - Divaret-Chauveau, Amandine

AU - Dorris, Stacy

AU - Dorsey, Morna

AU - Du Toit, George

AU - Eiwegger, Thomas

AU - Erlewyn-Lajeunesse, Michel

AU - Fleischer, David M

AU - Ford, Lara S

AU - Garcia-Lloret, Maria

AU - O'B Hourihane, Jonathan

AU - Jay, Nicola

AU - Jones, Stacie M

AU - Kim, Edwin H

AU - Kloepfer, Kirsten

AU - Leonard, Stephanie

AU - Lezmi, Guillaume

AU - Lieberman, Jay

AU - Lomas, Jeanne

AU - Makhija, Melanie

AU - O'Sullivan, Michael

AU - Parrish, Christopher

AU - Peake, Jane

AU - Perrett, Kirsten P

AU - Petroni, Daniel

AU - Pongracic, Jacqueline A

AU - Quinn, Patrick

AU - Robison, Rachel G

AU - Sanders, Georgiana

AU - Schneider, Lynda

AU - Sharma, Hemant

AU - Sindher, Sayantani B

AU - Trujillo, Juan

AU - Turner, Paul J

AU - Tuttle, Katherine

AU - Upton, Julia

AU - Varshney, Pooja

AU - Vickery, Brian P

AU - Vogelberg, Christian

AU - Wainstein, Brynn

AU - Wang, Julie

AU - Wood, Robert

AU - Bee, Katharine J

AU - Campbell, Dianne E

AU - Green, Todd D

AU - Rouissi, Rihab

AU - Bahnson, Henry T

AU - Bois, Timothée

AU - Sampson, Hugh A

AU - Burks, A Wesley

PY - 2025/2/14

Y1 - 2025/2/14

N2 - BACKGROUND: The pivotal phase 3 EPITOPE trial, a 12-month, double-blind, placebo-controlled study of epicutaneous immunotherapy with the VIASKIN® patch containing 250 μg peanut protein (VP250) previously reported significant treatment response vs placebo in peanut-allergic toddlers aged 1-through-3 years.OBJECTIVE: To assess interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study.METHODS: Eligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFC) and safety assessments; here we report the first year OLE (Year 2) results.RESULTS: 266 EPITOPE participants enrolled in the OLE study; 244 underwent Month 24 DBPCFC (n=166 VP250; n=78 placebo). After 24 months of VP250, 81.3% reached an eliciting dose (ED) ≥1000 mg, 63.8% reached an ED ≥2000 mg, and 55.9% completed the DBPCFC (cumulative dose: 3444 mg) without meeting stopping criteria. No treatment-related anaphylaxis or serious treatment-related adverse events occurred during Year 2 in this treatment arm. Local application-site reactions occurred less frequently in Year 2 vs Year 1. In placebo-treated EPITOPE participants, outcomes after 1 year of open-label VP250 were consistent with EPITOPE treatment results: 62.7% reached an ED ≥1000 mg, 36.5% reached an ED ≥2000 mg, and 28.4% completed the DBPCFC without meeting stopping criteria; and there was 1 treatment-related anaphylaxis event.CONCLUSIONS: Two years of VP250 in young peanut-allergic children demonstrated continued treatment effect increases without new safety signals. This supports the potential of VP250 as a safe and effective treatment for peanut allergy in young children.

AB - BACKGROUND: The pivotal phase 3 EPITOPE trial, a 12-month, double-blind, placebo-controlled study of epicutaneous immunotherapy with the VIASKIN® patch containing 250 μg peanut protein (VP250) previously reported significant treatment response vs placebo in peanut-allergic toddlers aged 1-through-3 years.OBJECTIVE: To assess interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study.METHODS: Eligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFC) and safety assessments; here we report the first year OLE (Year 2) results.RESULTS: 266 EPITOPE participants enrolled in the OLE study; 244 underwent Month 24 DBPCFC (n=166 VP250; n=78 placebo). After 24 months of VP250, 81.3% reached an eliciting dose (ED) ≥1000 mg, 63.8% reached an ED ≥2000 mg, and 55.9% completed the DBPCFC (cumulative dose: 3444 mg) without meeting stopping criteria. No treatment-related anaphylaxis or serious treatment-related adverse events occurred during Year 2 in this treatment arm. Local application-site reactions occurred less frequently in Year 2 vs Year 1. In placebo-treated EPITOPE participants, outcomes after 1 year of open-label VP250 were consistent with EPITOPE treatment results: 62.7% reached an ED ≥1000 mg, 36.5% reached an ED ≥2000 mg, and 28.4% completed the DBPCFC without meeting stopping criteria; and there was 1 treatment-related anaphylaxis event.CONCLUSIONS: Two years of VP250 in young peanut-allergic children demonstrated continued treatment effect increases without new safety signals. This supports the potential of VP250 as a safe and effective treatment for peanut allergy in young children.

U2 - 10.1016/j.jaip.2025.02.004

DO - 10.1016/j.jaip.2025.02.004

M3 - Journal article

C2 - 39956162

SN - 2213-2198

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

ER -

Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE

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