Efficacy and safety of epicutaneous immunotherapy in peanut-allergic toddlers: open-label extension to EPITOPE
Efficacy and safety of epicutaneous immunotherapy in peanut-allergic toddlers: open-label extension to EPITOPE
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 of peanut protein (VP250), previously reported significant treatment response versus placebo in peanut-allergic toddlers aged 1 through 3 years.
Objective: to assess the 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 (DBPCFCs) and safety assessments; here we report the first-year OLE (year 2) results.
Results: a 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.
Conclusions: two 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.gov: NCT03859700.
Anaphylaxis, Desensitization, Epicutaneous immunotherapy, Open-label study, Peanut allergy, Pediatrics, VIASKIN patch
1176-1187.e7
Greenhawt, Matthew
b360033f-d839-45c6-bafd-133cd5b9f71b
Albright, Deborah
d09b1300-114f-4329-a148-4807de2bee9f
Anvari, Sara
9b199a95-5f70-425e-83cd-98a713385cec
Erlewyn-Lajeunesse, Michel
e1763b6d-165b-45c5-9108-5dc8722220b9
6 May 2025
Greenhawt, Matthew
b360033f-d839-45c6-bafd-133cd5b9f71b
Albright, Deborah
d09b1300-114f-4329-a148-4807de2bee9f
Anvari, Sara
9b199a95-5f70-425e-83cd-98a713385cec
Erlewyn-Lajeunesse, Michel
e1763b6d-165b-45c5-9108-5dc8722220b9
Greenhawt, Matthew, Albright, Deborah and Anvari, Sara
,
et al.
(2025)
Efficacy and safety of epicutaneous immunotherapy in peanut-allergic toddlers: open-label extension to EPITOPE.
The journal of allergy and clinical immunology. In practice, 13 (5), .
(doi:10.1016/j.jaip.2025.02.004).
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 of peanut protein (VP250), previously reported significant treatment response versus placebo in peanut-allergic toddlers aged 1 through 3 years.
Objective: to assess the 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 (DBPCFCs) and safety assessments; here we report the first-year OLE (year 2) results.
Results: a 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.
Conclusions: two 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.gov: NCT03859700.
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Accepted/In Press date: 7 February 2025
e-pub ahead of print date: 14 February 2025
Published date: 6 May 2025
Keywords:
Anaphylaxis, Desensitization, Epicutaneous immunotherapy, Open-label study, Peanut allergy, Pediatrics, VIASKIN patch
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Local EPrints ID: 508708
URI: http://eprints.soton.ac.uk/id/eprint/508708
PURE UUID: ea1373ca-6176-4b2a-96f4-76f9f18c4404
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Date deposited: 30 Jan 2026 17:49
Last modified: 31 Jan 2026 05:52
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Author:
Matthew Greenhawt
Author:
Deborah Albright
Author:
Sara Anvari
Author:
Michel Erlewyn-Lajeunesse
Corporate Author: et al.
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