Citation

BibTex format

@article{Greenhawt:2025:10.1016/j.jaip.2025.02.004,
author = {Greenhawt, M and Albright, D and Anvari, S and Arends, N and Arkwright, PD and Bégin, P and Blümchen, K and Brown-Whitehorn, T and Cassell, H and Chan, ES and Ciaccio, CE and Deschildre, A and Divaret-Chauveau, A and Dorris, S and Dorsey, M and Du, Toit G and Eiwegger, T and Erlewyn-Lajeunesse, M and Fleischer, DM and Ford, LS and Garcia-Lloret, M and OB, Hourihane J and Jay, N and Jones, SM and Kim, EH and Kloepfer, K and Leonard, S and Lezmi, G and Lieberman, J and Lomas, J and Makhija, M and OSullivan, M and Parrish, C and Peake, J and Perrett, KP and Petroni, D and Pongracic, JA and Quinn, P and Robison, RG and Sanders, G and Schneider, L and Sharma, H and Sindher, SB and Trujillo, J and Turner, PJ and Tuttle, K and Upton, J and Varshney, P and Vickery, BP and Vogelberg, C and Wainstein, B and Wang, J and Wood, R and Bee, KJ and Campbell, DE and Green, TD and Rouissi, R and Bahnson, HT and Bois, T and Sampson, HA and Burks, AW},
doi = {10.1016/j.jaip.2025.02.004},
journal = {The Journal of Allergy and Clinical Immunology: In Practice},
pages = {1176--1187.e7},
title = {Efficacy and safety of epicutaneous immunotherapy in peanut-allergic toddlers: open-label extension to EPITOPE},
url = {http://dx.doi.org/10.1016/j.jaip.2025.02.004},
volume = {13},
year = {2025}
}
Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundThe pivotal phase 3 EPITOPE trial, a 12-month, double-blind, placebo-controlled study of epicutaneous immunotherapy with the VIASKIN patch containing 250 μg of peanut protein (VP250), previously reported significant treatment response versus placebo in peanut-allergic toddlers aged 1 through 3 years.ObjectiveTo assess the interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study.MethodsEligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFCs) and safety assessments; here we report the first-year OLE (year 2) results.ResultsA total of 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 versus 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.ConclusionsTwo years of VP250 in young peanut-allergic children demonstrated continued increases in treatment effect without new safety signals. This supports the potential of VP250 as a safe and effective treatment for peanut allergy in young children.Clinicaltrials.govNCT03859700.
AU  - Greenhawt,M
AU  - Albright,D
AU  - Anvari,S
AU  - Arends,N
AU  - Arkwright,PD
AU  - Bégin,P
AU  - Blümchen,K
AU  - Brown-Whitehorn,T
AU  - Cassell,H
AU  - Chan,ES
AU  - Ciaccio,CE
AU  - Deschildre,A
AU  - Divaret-Chauveau,A
AU  - Dorris,S
AU  - Dorsey,M
AU  - Du,Toit G
AU  - Eiwegger,T
AU  - Erlewyn-Lajeunesse,M
AU  - Fleischer,DM
AU  - Ford,LS
AU  - Garcia-Lloret,M
AU  - OB,Hourihane J
AU  - Jay,N
AU  - Jones,SM
AU  - Kim,EH
AU  - Kloepfer,K
AU  - Leonard,S
AU  - Lezmi,G
AU  - Lieberman,J
AU  - Lomas,J
AU  - Makhija,M
AU  - OSullivan,M
AU  - Parrish,C
AU  - Peake,J
AU  - Perrett,KP
AU  - Petroni,D
AU  - Pongracic,JA
AU  - Quinn,P
AU  - Robison,RG
AU  - Sanders,G
AU  - Schneider,L
AU  - Sharma,H
AU  - Sindher,SB
AU  - Trujillo,J
AU  - Turner,PJ
AU  - Tuttle,K
AU  - Upton,J
AU  - Varshney,P
AU  - Vickery,BP
AU  - Vogelberg,C
AU  - Wainstein,B
AU  - Wang,J
AU  - Wood,R
AU  - Bee,KJ
AU  - Campbell,DE
AU  - Green,TD
AU  - Rouissi,R
AU  - Bahnson,HT
AU  - Bois,T
AU  - Sampson,HA
AU  - Burks,AW
DO  - 10.1016/j.jaip.2025.02.004
EP  - 1187
PY  - 2025///
SN  - 2213-2198
SP  - 1176
TI  - Efficacy and safety of epicutaneous immunotherapy in peanut-allergic toddlers: open-label extension to EPITOPE
T2  - The Journal of Allergy and Clinical Immunology: In Practice
UR  - http://dx.doi.org/10.1016/j.jaip.2025.02.004
UR  - https://doi.org/10.1016/j.jaip.2025.02.004
VL  - 13
ER  -
Download