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

Matthew Greenhawt¹, Deborah Albright², Sara Anvari³, Nicolette Arends⁴, Peter D Arkwright⁵, Philippe Bégin⁶, Katharina Blümchen⁷, Terri Brown-Whitehorn⁸, Heather Cassell⁹, Edmond S Chan¹⁰, Christina E Ciaccio¹¹, Antoine Deschildre¹², Amandine Divaret-Chauveau¹³, Stacy Dorris¹⁴, Morna Dorsey¹⁵, George Du Toit¹⁶, Thomas Eiwegger¹⁷, Michel Erlewyn-Lajeunesse¹⁸, David M Fleischer¹⁹, Lara S Ford²⁰, Maria Garcia-Lloret²¹, Jonathan O'B Hourihane²², Nicola Jay²³, Stacie M Jones²⁴, Edwin H Kim²⁵, Kirsten Kloepfer²⁶, Stephanie Leonard²⁷, Guillaume Lezmi²⁸, Jay Lieberman²⁹, Jeanne Lomas³⁰, Melanie Makhija³¹, Michael O'Sullivan³², Christopher Parrish³³, Jane Peake³⁴, Kirsten P Perrett³⁵, Daniel Petroni³⁶, Jacqueline A Pongracic³¹, Patrick Quinn³⁷, Rachel G Robison³⁸, Georgiana Sanders³⁹, Lynda Schneider⁴⁰, Hemant Sharma⁴¹, Sayantani B Sindher⁴², Juan Trujillo⁴³, Paul J Turner⁴⁴, Katherine Tuttle⁴⁵, Julia Upton⁴⁶, Pooja Varshney⁴⁷, Brian P Vickery⁴⁸, Christian Vogelberg⁴⁹, Brynn Wainstein⁵⁰, Julie Wang⁵¹, Robert Wood⁵², Katharine J Bee⁵³, Dianne E Campbell⁵⁴, Todd D Green⁵⁵, Rihab Rouissi⁵³, Henry T Bahnson⁵³, Timothée Bois⁵³, Hugh A Sampson⁵¹, A Wesley Burks²⁵

Affiliations

¹ Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo. Electronic address: Matthew.Greenhawt@childrenscolorado.org.
² UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pa.
³ Department of Pediatrics, Division of Immunology, Allergy, and Retrovirology, Texas Children's Hospital/Baylor College of Medicine, Houston, Texas.
⁴ Department of Pediatrics, Division of Allergy and Pulmonology, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.
⁵ Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, United Kingdom.
⁶ Section of Allergy, Immunology, and Rheumatology, Department of Pediatrics, CHU Sainte-Justine and Université de Montréal, Montreal, QC, Canada.
⁷ Department of Pediatrics, Division of Pneumology, Allergology, Infectious Diseases and Gastroenterology, Goethe University Frankfurt, Frankfurt, Germany.
⁸ Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.
⁹ Pediatric Allergy and Immunology, Banner-University Medical Center, Tucson, Ariz.
¹⁰ Department of Pediatrics, Division of Allergy, British Columbia Children's Hospital, the University of British Columbia, Vancouver, BC, Canada.
¹¹ Departments of Pediatrics and Medicine, the University of Chicago, Chicago, Ill.
¹² Université de Lille, INSERM Unit 1019, CNRS UMR 9017, CHU Lille, Institut Pasteur de Lille, Center for Infection and Immunity of Lille, Lille, France.
¹³ Pediatric Allergy Unit, Children's Hospital, Centre Hospitalier Universitaire de Nancy, Vandœuvre-lès-Nancy, France; EA 3450 DevAH, Faculty of Medicine, Université de Lorraine, Vandœuvre-lès-Nancy, France.
¹⁴ Department of Pediatrics, Division of Allergy Immunology and Pulmonology, Vanderbilt University Medical Center, Nashville, Tenn.
¹⁵ University of California San Francisco, San Francisco, Calif.
¹⁶ Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
¹⁷ Division of Paediatrics and Adolescent Medicine, University Hospital St Pölten, St Pölten, Austria; Karl Landsteiner University of Health Sciences, Krems an der Donau, Austria; Division of Clinical Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada; Department of Immunology, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
¹⁸ Paediatric Allergy and Immunology, Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
¹⁹ Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo.
²⁰ The Children's Hospital at Westmead, University of Sydney, Sydney, NSW, Australia.
²¹ Department of Pediatrics, UCLA David Geffen School of Medicine, Los Angeles, Calif.
²² Pediatrics and Child Health, Royal College of Surgeons in Ireland and Children's Health Ireland, Dublin, Ireland.
²³ Sheffield Children's NHS Foundation Trust, Sheffield, United Kingdom.
²⁴ Department of Pediatrics, Division of Allergy and Immunology, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
²⁵ Department of Pediatrics, Division of Pediatric Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill, NC.
²⁶ Division of Pulmonology, Allergy/Immunology and Sleep Medicine, Indiana University and Riley Hospital for Children at Indiana University Health, Indianapolis, Ind.
²⁷ Department of Pediatrics, University of California San Diego, San Diego, Calif.
²⁸ Department of Pediatric Pulmonology and Allergy, AP-HP, Hôpital Necker-Enfants Malades, Université Paris Cité, Paris, France.
²⁹ Department of Pediatrics, the University of Tennessee Health Science Center and Le Bonheur Children's Hospital, Memphis, Tenn.
³⁰ Division of Pediatric Allergy and Immunology, University of Rochester, Clarence, NY.
³¹ Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Ill.
³² Immunology Department, Perth Children's Hospital and Honorary Research Associate, Telethon Kids Institute, Nedlands, WA, Australia.
³³ Departments of Pediatrics and Internal Medicine, Division of Allergy and Immunology, the University of Texas Southwestern Medical Center and Children's Medical Center, Dallas, Texas.
³⁴ Queensland Paediatric Immunology and Allergy Service, Queensland Children's Hospital and University of Queensland, Brisbane, QLD, Australia.
³⁵ National Allergy Centre of Excellence, Population Allergy Group, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia.
³⁶ Seattle Allergy and Asthma Research Institute, Seattle, Wash; Clinical Development, BioCryst Pharmaceuticals, Inc, Durham, NC.
³⁷ Department of Allergy and Clinical Immunology, Women's and Children's Hospital, North Adelaide, SA, Australia.
³⁸ Department of Pediatrics, Division of Allergy Immunology and Pulmonology, Vanderbilt University Medical Center, Nashville, Tenn; Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Ill.
³⁹ Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan, Ann Arbor, Mich.
⁴⁰ Allergy and Asthma Program, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, Mass.
⁴¹ Division of Allergy and Immunology, Children's National Hospital, Washington, DC.
⁴² Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, Calif.
⁴³ HRB Clinical Research Facility University College Cork, Irish Centre for Maternal and Child Health Research (INFANT), Cork University Hospital, University College Cork, Cork, Ireland.
⁴⁴ Paediatric Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College London, London, United Kingdom.
⁴⁵ Division of Pediatric Allergy and Immunology, University of Rochester School of Medicine and Dentistry, Golisano Children's Hospital, Rochester, NY.
⁴⁶ Department of Paediatrics, Division of Immunology and Allergy, the Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
⁴⁷ Department of Pediatrics, Dell Medical School at the University of Texas at Austin, Dell Children's Medical Center, Austin, Texas.
⁴⁸ Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, Ga.
⁴⁹ Department Pediatric Pneumology and Allergology, University Hospital Dresden and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
⁵⁰ Department of Immunology, Sydney Children's Hospital, Randwick, NSW, Australia; School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia.
⁵¹ Department of Pediatrics, Division of Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY.
⁵² Julie and Neil Reinhard Pediatric Allergy and Immunology, Pediatrics and International Health, Eudowood Division of Allergy, Immunology, and Rheumatology, Pediatric Clinical Research Unit, Institute for Clinical and Translational Research, the Johns Hopkins University School of Medicine, Baltimore, Md.
⁵³ DBV Technologies SA, Montrouge, France.
⁵⁴ The Children's Hospital at Westmead, University of Sydney, Sydney, NSW, Australia; DBV Technologies SA, Montrouge, France.
⁵⁵ UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pa; DBV Technologies SA, Montrouge, France.

PMID: 39956162
DOI: 10.1016/j.jaip.2025.02.004

Free article

Clinical Trial

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

Matthew Greenhawt et al. J Allergy Clin Immunol Pract. 2025 May.

Free article

. 2025 May;13(5):1176-1187.e7.

doi: 10.1016/j.jaip.2025.02.004. Epub 2025 Feb 14.

Authors

Affiliations

¹ Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo. Electronic address: Matthew.Greenhawt@childrenscolorado.org.
² UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pa.
³ Department of Pediatrics, Division of Immunology, Allergy, and Retrovirology, Texas Children's Hospital/Baylor College of Medicine, Houston, Texas.
⁴ Department of Pediatrics, Division of Allergy and Pulmonology, Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands.
⁵ Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, United Kingdom.
⁶ Section of Allergy, Immunology, and Rheumatology, Department of Pediatrics, CHU Sainte-Justine and Université de Montréal, Montreal, QC, Canada.
⁷ Department of Pediatrics, Division of Pneumology, Allergology, Infectious Diseases and Gastroenterology, Goethe University Frankfurt, Frankfurt, Germany.
⁸ Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.
⁹ Pediatric Allergy and Immunology, Banner-University Medical Center, Tucson, Ariz.
¹⁰ Department of Pediatrics, Division of Allergy, British Columbia Children's Hospital, the University of British Columbia, Vancouver, BC, Canada.
¹¹ Departments of Pediatrics and Medicine, the University of Chicago, Chicago, Ill.
¹² Université de Lille, INSERM Unit 1019, CNRS UMR 9017, CHU Lille, Institut Pasteur de Lille, Center for Infection and Immunity of Lille, Lille, France.
¹³ Pediatric Allergy Unit, Children's Hospital, Centre Hospitalier Universitaire de Nancy, Vandœuvre-lès-Nancy, France; EA 3450 DevAH, Faculty of Medicine, Université de Lorraine, Vandœuvre-lès-Nancy, France.
¹⁴ Department of Pediatrics, Division of Allergy Immunology and Pulmonology, Vanderbilt University Medical Center, Nashville, Tenn.
¹⁵ University of California San Francisco, San Francisco, Calif.
¹⁶ Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
¹⁷ Division of Paediatrics and Adolescent Medicine, University Hospital St Pölten, St Pölten, Austria; Karl Landsteiner University of Health Sciences, Krems an der Donau, Austria; Division of Clinical Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada; Department of Immunology, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
¹⁸ Paediatric Allergy and Immunology, Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
¹⁹ Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo.
²⁰ The Children's Hospital at Westmead, University of Sydney, Sydney, NSW, Australia.
²¹ Department of Pediatrics, UCLA David Geffen School of Medicine, Los Angeles, Calif.
²² Pediatrics and Child Health, Royal College of Surgeons in Ireland and Children's Health Ireland, Dublin, Ireland.
²³ Sheffield Children's NHS Foundation Trust, Sheffield, United Kingdom.
²⁴ Department of Pediatrics, Division of Allergy and Immunology, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
²⁵ Department of Pediatrics, Division of Pediatric Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill, NC.
²⁶ Division of Pulmonology, Allergy/Immunology and Sleep Medicine, Indiana University and Riley Hospital for Children at Indiana University Health, Indianapolis, Ind.
²⁷ Department of Pediatrics, University of California San Diego, San Diego, Calif.
²⁸ Department of Pediatric Pulmonology and Allergy, AP-HP, Hôpital Necker-Enfants Malades, Université Paris Cité, Paris, France.
²⁹ Department of Pediatrics, the University of Tennessee Health Science Center and Le Bonheur Children's Hospital, Memphis, Tenn.
³⁰ Division of Pediatric Allergy and Immunology, University of Rochester, Clarence, NY.
³¹ Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Ill.
³² Immunology Department, Perth Children's Hospital and Honorary Research Associate, Telethon Kids Institute, Nedlands, WA, Australia.
³³ Departments of Pediatrics and Internal Medicine, Division of Allergy and Immunology, the University of Texas Southwestern Medical Center and Children's Medical Center, Dallas, Texas.
³⁴ Queensland Paediatric Immunology and Allergy Service, Queensland Children's Hospital and University of Queensland, Brisbane, QLD, Australia.
³⁵ National Allergy Centre of Excellence, Population Allergy Group, Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, VIC, Australia.
³⁶ Seattle Allergy and Asthma Research Institute, Seattle, Wash; Clinical Development, BioCryst Pharmaceuticals, Inc, Durham, NC.
³⁷ Department of Allergy and Clinical Immunology, Women's and Children's Hospital, North Adelaide, SA, Australia.
³⁸ Department of Pediatrics, Division of Allergy Immunology and Pulmonology, Vanderbilt University Medical Center, Nashville, Tenn; Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Ill.
³⁹ Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan, Ann Arbor, Mich.
⁴⁰ Allergy and Asthma Program, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, Mass.
⁴¹ Division of Allergy and Immunology, Children's National Hospital, Washington, DC.
⁴² Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, Calif.
⁴³ HRB Clinical Research Facility University College Cork, Irish Centre for Maternal and Child Health Research (INFANT), Cork University Hospital, University College Cork, Cork, Ireland.
⁴⁴ Paediatric Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College London, London, United Kingdom.
⁴⁵ Division of Pediatric Allergy and Immunology, University of Rochester School of Medicine and Dentistry, Golisano Children's Hospital, Rochester, NY.
⁴⁶ Department of Paediatrics, Division of Immunology and Allergy, the Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
⁴⁷ Department of Pediatrics, Dell Medical School at the University of Texas at Austin, Dell Children's Medical Center, Austin, Texas.
⁴⁸ Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, Ga.
⁴⁹ Department Pediatric Pneumology and Allergology, University Hospital Dresden and Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
⁵⁰ Department of Immunology, Sydney Children's Hospital, Randwick, NSW, Australia; School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia.
⁵¹ Department of Pediatrics, Division of Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY.
⁵² Julie and Neil Reinhard Pediatric Allergy and Immunology, Pediatrics and International Health, Eudowood Division of Allergy, Immunology, and Rheumatology, Pediatric Clinical Research Unit, Institute for Clinical and Translational Research, the Johns Hopkins University School of Medicine, Baltimore, Md.
⁵³ DBV Technologies SA, Montrouge, France.
⁵⁴ The Children's Hospital at Westmead, University of Sydney, Sydney, NSW, Australia; DBV Technologies SA, Montrouge, France.
⁵⁵ UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pa; DBV Technologies SA, Montrouge, France.

PMID: 39956162
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.

Keywords: Anaphylaxis; Desensitization; Epicutaneous immunotherapy; Open-label study; Peanut allergy; Pediatrics; VIASKIN patch.

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

Affiliations

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

Authors

Affiliations

Abstract

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical