Safety of epicutaneous immunotherapy for the treatment of peanut allergy: A phase 1 study using the Viaskin patch Stacie M. Jones, MD, Wence K. Agbotounou,

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Presentation transcript:

Safety of epicutaneous immunotherapy for the treatment of peanut allergy: A phase 1 study using the Viaskin patch Stacie M. Jones, MD, Wence K. Agbotounou, PhD, David M. Fleischer, MD, A. Wesley Burks, MD, Robert D. Pesek, MD, Michael W. Harris, MD, Laurent Martin, PharmD, Claude Thebault, MD, Charles Ruban, MS, Pierre-Henri Benhamou, MD Journal of Allergy and Clinical Immunology Volume 137, Issue 4, Pages 1258-1261.e10 (April 2016) DOI: 10.1016/j.jaci.2016.01.008 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Reporting of TEAEs. Percentages of subjects reporting at least 1 nonlocal TEAE grouped by severity of PA are shown. Journal of Allergy and Clinical Immunology 2016 137, 1258-1261.e10DOI: (10.1016/j.jaci.2016.01.008) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Incidence of L-TEAEs. A, Percentage of subjects reporting L-TEAEs, as defined by symptom profile and grouped by severity of PA. B, Number of subjects reporting at least 1 L-TEAE during 24 hours of dosing of Viaskin Peanut, as defined by symptom profile and grouped by severity of PA and Viaskin Peanut dose. C, Number of subjects reporting at least 1 L-TEAE for subjects dosing at 48 hours with Viaskin Peanut, as defined by symptom profile and grouped by severity of PA and Viaskin dose. Journal of Allergy and Clinical Immunology 2016 137, 1258-1261.e10DOI: (10.1016/j.jaci.2016.01.008) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Study design schematic. Subjects were enrolled in dosing cohorts of 5 subjects in sequence, as indicated by numeric designation of dosing cohorts (boxes 1-20). Enrollment of each dosing cohort and age group progressed only after DSMB safety review. Adults with nonsevere allergy were enrolled (boxes 1-8), followed by adolescents (boxes 9-12), adults with severe allergy (boxes 13-18), and finally children (boxes 19-20). Journal of Allergy and Clinical Immunology 2016 137, 1258-1261.e10DOI: (10.1016/j.jaci.2016.01.008) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Incidence of non–L-TEAEs by system organ class and severity of PA. The proportion of subjects reporting non–L-TEAEs grouped by system organ classification and severity of PA is shown. Journal of Allergy and Clinical Immunology 2016 137, 1258-1261.e10DOI: (10.1016/j.jaci.2016.01.008) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions