Clinical Trial

. 2023 May 11;388(19):1755-1766.

doi: 10.1056/NEJMoa2212895.

Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy

Matthew Greenhawt¹, Sayantani B Sindher¹, Julie Wang¹, Michael O'Sullivan¹, George du Toit¹, Edwin H Kim¹, Deborah Albright¹, Sara Anvari¹, Nicolette Arends¹, Peter D Arkwright¹, Philippe Bégin¹, Katharina Blumchen¹, Thierry Bourrier¹, Terri Brown-Whitehorn¹, Heather Cassell¹, Edmond S Chan¹, Christina E Ciaccio¹, Antoine Deschildre¹, Amandine Divaret-Chauveau¹, Stacy L Dorris¹, Morna J Dorsey¹, Thomas Eiwegger¹, Michel Erlewyn-Lajeunesse¹, David M Fleischer¹, Lara S Ford¹, Maria Garcia-Lloret¹, Lisa Giovannini-Chami¹, Jonathan O Hourihane¹, Nicola Jay¹, Stacie M Jones¹, Leigh Ann Kerns¹, Kirsten M Kloepfer¹, Stephanie Leonard¹, Guillaume Lezmi¹, Jay A Lieberman¹, Jeanne Lomas¹, Melanie Makhija¹, Christopher Parrish¹, Jane Peake¹, Kirsten P Perrett¹, Daniel Petroni¹, Wolfgang Pfützner¹, Jacqueline A Pongracic¹, Patrick Quinn¹, Rachel G Robison¹, Georgiana Sanders¹, Lynda Schneider¹, Hemant P Sharma¹, Juan Trujillo¹, Paul J Turner¹, Katherine Tuttle¹, Julia E Upton¹, Pooja Varshney¹, Brian P Vickery¹, Christian Vogelberg¹, Brynn Wainstein¹, Robert A Wood¹, Katharine J Bee¹, Dianne E Campbell¹, Todd D Green¹, Rihab Rouissi¹, Aurélie Peillon¹, Henry T Bahnson¹, Timothée Bois¹, Hugh A Sampson¹, A Wesley Burks¹

Affiliations

Affiliation

¹ From the Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (M.G., D.M.F.); the Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford (S.B.S.), the University of California, San Francisco, San Francisco (M.J.D.), the David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (M.G.-L.), the University of California, San Diego, La Jolla (S.L.), and Rady Children's Hospital San Diego, San Diego (S.L.) - all in California; the Department of Pediatrics, Division of Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York (J.W., H.A.S.); the Department of Immunology, Perth Children's Hospital, and Telethon Kids Institute, Nedlands, WA (M.O.), Westmead Children's Hospital, Westmead, NSW (L.S.F., D.E.C.), Queensland Children's Hospital, University of Queensland, South Brisbane (J.P.), Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC (K.P.P.), Women's and Children's Hospital, North Adelaide, SA (P.Q.), and Sydney Children's Hospital, Randwick, NSW (B.W.) - all in Australia; Guy's and St. Thomas' NHS Foundation Trust (G.T.), and the National Heart and Lung Institute, Imperial College London (P.J.T.), London, the Lydia Becker Institute of Immunology and Inflammation, University of Manchester and Royal Manchester Children's Hospital, Manchester (P.D.A.), University Hospital Southampton NHS Foundation Trust, Southampton (M.E.-L.), and Sheffield Children's NHS Foundation Trust, Sheffield (N.J.) - all in the United Kingdom; the Division of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill (E.H.K., A.W.B.); UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (D.A., T.D.G.); Baylor College of Medicine, Houston (S.A.), UT Southwestern Medical Center and Children's Medical Center, Dallas (C.P.), and Dell Medical School at the University of Texas, Dell Children's Medical Center of Central Texas, Austin (P.V.) - all in Texas; Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands (N.A.); Centre Hospitalier Universitaire (CHU) Sainte-Justine, Montreal (P.B.), British Columbia Children's Hospital, University of British Columbia, Vancouver (E.S.C.), the Translational Medicine Program, Research Institute, and the Department of Immunology (T.E.), and the Division of Immunology and Allergy, Department of Paediatrics (J.E.M.U.), Hospital for Sick Children, University of Toronto, Toronto - all in Canada; the Department of Children and Adolescent Medicine, Division of Pneumology, Allergology and Cystic Fibrosis, University Hospital Frankfurt, Goethe University, Frankfurt (K.B.), Philipps-Universität Marburg, Marburg (W.P.), and Universitätsklinikum Carl Gustav Carus, Dresden (C.V.) - all in Germany; Hôpitaux Pédiatriques de Nice CHU Lenval, Nice (T. Bourrier, L.G.-C.), Université de Lille, CHU Lille, Pediatric Pulmonology and Allergy Unit, Hôpital Jeanne de Flandre, Lille (A.D.), the Pediatric Allergy Unit, Children's Hospital, University Hospital of Nancy, and EA3450 Development, Adaptation and Handicap, Faculty of Medicine, University of Lorraine, Nancy (A.D.-C.), the Department of Pediatric Pulmonology and Allergy, Assistance Publique-Hôpitaux de Paris, Hôpital Necker-Enfants Malades, and University of Paris Cité, Paris (G.L.), and DBV Technologies, Montrouge (K.J.B., D.E.C., T.D.G., R.R., A.P., H.T.B., T. Bois, H.A.S.) - all in France; Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia (T.B.-W.); University of Arizona Medical Center, Tucson (H.C.); University of Chicago (C.E.C.), Northwestern University Feinberg School of Medicine (M.M.), and Ann and Robert H. Lurie Children's Hospital of Chicago (M.M., J.A.P., R.G.R.) - all in Chicago; the University of Tennessee Health Science Center, Memphis (J.A.L.); Vanderbilt University Medical Center, Nashville (S.L.D., R.G.R.); Karl Landsteiner University of Health Sciences, Krems, and the Department of Pediatric and Adolescent Medicine, University Hospital St. Pölten, St. Pölten - both in Austria (T.E.); Paediatrics and Child Health and the INFANT Center (J.O.H.) and the HRB Clinical Research Facility and the INFANT Research Center (J.T.), University College Cork, Cork University Hospital, Cork, and Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin (J.O.H.) - both in Ireland; University of Arkansas for Medical Sciences and Arkansas Children's Hospital - both in Little Rock (S.M.J.); Cleveland Clinic, Cleveland (L.A.K.); the Division of Pulmonary, Allergy, and Sleep Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis (K.M.K.); University of Rochester, Rochester, NY (J.L., K.T.); Seattle Allergy and Asthma Research Institute, Seattle (D.P.); University of Michigan, Ann Arbor (G.S.); Boston Children's Hospital, Boston (L.S.); Children's National Health System, Washington, DC (H.P.S.); Emory University, Atlanta (B.P.V.); and Johns Hopkins Hospital, Baltimore (R.A.W.).

PMID: 37163622
DOI: 10.1056/NEJMoa2212895

Clinical Trial

Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy

Matthew Greenhawt et al. N Engl J Med. 2023.

. 2023 May 11;388(19):1755-1766.

doi: 10.1056/NEJMoa2212895.

Authors

Affiliation

¹ From the Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (M.G., D.M.F.); the Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford (S.B.S.), the University of California, San Francisco, San Francisco (M.J.D.), the David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (M.G.-L.), the University of California, San Diego, La Jolla (S.L.), and Rady Children's Hospital San Diego, San Diego (S.L.) - all in California; the Department of Pediatrics, Division of Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York (J.W., H.A.S.); the Department of Immunology, Perth Children's Hospital, and Telethon Kids Institute, Nedlands, WA (M.O.), Westmead Children's Hospital, Westmead, NSW (L.S.F., D.E.C.), Queensland Children's Hospital, University of Queensland, South Brisbane (J.P.), Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC (K.P.P.), Women's and Children's Hospital, North Adelaide, SA (P.Q.), and Sydney Children's Hospital, Randwick, NSW (B.W.) - all in Australia; Guy's and St. Thomas' NHS Foundation Trust (G.T.), and the National Heart and Lung Institute, Imperial College London (P.J.T.), London, the Lydia Becker Institute of Immunology and Inflammation, University of Manchester and Royal Manchester Children's Hospital, Manchester (P.D.A.), University Hospital Southampton NHS Foundation Trust, Southampton (M.E.-L.), and Sheffield Children's NHS Foundation Trust, Sheffield (N.J.) - all in the United Kingdom; the Division of Pediatric Allergy and Immunology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill (E.H.K., A.W.B.); UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (D.A., T.D.G.); Baylor College of Medicine, Houston (S.A.), UT Southwestern Medical Center and Children's Medical Center, Dallas (C.P.), and Dell Medical School at the University of Texas, Dell Children's Medical Center of Central Texas, Austin (P.V.) - all in Texas; Erasmus MC Sophia Children's Hospital, Rotterdam, the Netherlands (N.A.); Centre Hospitalier Universitaire (CHU) Sainte-Justine, Montreal (P.B.), British Columbia Children's Hospital, University of British Columbia, Vancouver (E.S.C.), the Translational Medicine Program, Research Institute, and the Department of Immunology (T.E.), and the Division of Immunology and Allergy, Department of Paediatrics (J.E.M.U.), Hospital for Sick Children, University of Toronto, Toronto - all in Canada; the Department of Children and Adolescent Medicine, Division of Pneumology, Allergology and Cystic Fibrosis, University Hospital Frankfurt, Goethe University, Frankfurt (K.B.), Philipps-Universität Marburg, Marburg (W.P.), and Universitätsklinikum Carl Gustav Carus, Dresden (C.V.) - all in Germany; Hôpitaux Pédiatriques de Nice CHU Lenval, Nice (T. Bourrier, L.G.-C.), Université de Lille, CHU Lille, Pediatric Pulmonology and Allergy Unit, Hôpital Jeanne de Flandre, Lille (A.D.), the Pediatric Allergy Unit, Children's Hospital, University Hospital of Nancy, and EA3450 Development, Adaptation and Handicap, Faculty of Medicine, University of Lorraine, Nancy (A.D.-C.), the Department of Pediatric Pulmonology and Allergy, Assistance Publique-Hôpitaux de Paris, Hôpital Necker-Enfants Malades, and University of Paris Cité, Paris (G.L.), and DBV Technologies, Montrouge (K.J.B., D.E.C., T.D.G., R.R., A.P., H.T.B., T. Bois, H.A.S.) - all in France; Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia (T.B.-W.); University of Arizona Medical Center, Tucson (H.C.); University of Chicago (C.E.C.), Northwestern University Feinberg School of Medicine (M.M.), and Ann and Robert H. Lurie Children's Hospital of Chicago (M.M., J.A.P., R.G.R.) - all in Chicago; the University of Tennessee Health Science Center, Memphis (J.A.L.); Vanderbilt University Medical Center, Nashville (S.L.D., R.G.R.); Karl Landsteiner University of Health Sciences, Krems, and the Department of Pediatric and Adolescent Medicine, University Hospital St. Pölten, St. Pölten - both in Austria (T.E.); Paediatrics and Child Health and the INFANT Center (J.O.H.) and the HRB Clinical Research Facility and the INFANT Research Center (J.T.), University College Cork, Cork University Hospital, Cork, and Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin (J.O.H.) - both in Ireland; University of Arkansas for Medical Sciences and Arkansas Children's Hospital - both in Little Rock (S.M.J.); Cleveland Clinic, Cleveland (L.A.K.); the Division of Pulmonary, Allergy, and Sleep Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis (K.M.K.); University of Rochester, Rochester, NY (J.L., K.T.); Seattle Allergy and Asthma Research Institute, Seattle (D.P.); University of Michigan, Ann Arbor (G.S.); Boston Children's Hospital, Boston (L.S.); Children's National Health System, Washington, DC (H.P.S.); Emory University, Atlanta (B.P.V.); and Johns Hopkins Hospital, Baltimore (R.A.W.).

PMID: 37163622
DOI: 10.1056/NEJMoa2212895

Abstract

Background: No approved treatment for peanut allergy exists for children younger than 4 years of age, and the efficacy and safety of epicutaneous immunotherapy with a peanut patch in toddlers with peanut allergy are unknown.

Methods: We conducted this phase 3, multicenter, double-blind, randomized, placebo-controlled trial involving children 1 to 3 years of age with peanut allergy confirmed by a double-blind, placebo-controlled food challenge. Patients who had an eliciting dose (the dose necessary to elicit an allergic reaction) of 300 mg or less of peanut protein were assigned in a 2:1 ratio to receive epicutaneous immunotherapy delivered by means of a peanut patch (intervention group) or to receive placebo administered daily for 12 months. The primary end point was a treatment response as measured by the eliciting dose of peanut protein at 12 months. Safety was assessed according to the occurrence of adverse events during the use of the peanut patch or placebo.

Results: Of the 362 patients who underwent randomization, 84.8% completed the trial. The primary efficacy end point result was observed in 67.0% of children in the intervention group as compared with 33.5% of those in the placebo group (risk difference, 33.4 percentage points; 95% confidence interval, 22.4 to 44.5; P<0.001). Adverse events that occurred during the use of the intervention or placebo, irrespective of relatedness, were observed in 100% of the patients in the intervention group and 99.2% in the placebo group. Serious adverse events occurred in 8.6% of the patients in the intervention group and 2.5% of those in the placebo group; anaphylaxis occurred in 7.8% and 3.4%, respectively. Serious treatment-related adverse events occurred in 0.4% of patients in the intervention group and none in the placebo group. Treatment-related anaphylaxis occurred in 1.6% in the intervention group and none in the placebo group.

Conclusions: In this trial involving children 1 to 3 years of age with peanut allergy, epicutaneous immunotherapy for 12 months was superior to placebo in desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms. (Funded by DBV Technologies; EPITOPE ClinicalTrials.gov number, NCT03211247.).

Trial registration: ClinicalTrials.gov NCT03211247 NCT03859700.

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Epicutaneous immunotherapy with Viaskin^™ Peanut in toddlers: a plain language summary.
Stukus DR, Gupta R, Mack D, Mandelbaum L, Siri D, Hernandez-Trujillo V, Sampson HA. Stukus DR, et al. Immunotherapy. 2024 Jan;16(1):5-13. doi: 10.2217/imt-2023-0201. Epub 2023 Dec 19. Immunotherapy. 2024. PMID: 38112107

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Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy

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Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy

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Medical