Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber

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Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber Michel Roux, MD, Philippe Devillier, MD, PhD, William H. Yang, MD, Armelle Montagut, MSc, Kathy Abiteboul, PharmD, Agnès Viatte, MSc, Robert K. Zeldin, MD Journal of Allergy and Clinical Immunology Volume 138, Issue 2, Pages 451-458.e5 (August 2016) DOI: 10.1016/j.jaci.2016.03.039 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Trial design. After the primary screening based on clinical history of HDM-associated allergic rhinitis, eligible subjects underwent a baseline HDM allergen challenge in an EEC. Those with symptom scores above the predefined threshold were randomized to 1 of the 4 treatment arms, and underwent 4 additional allergen challenges during the 6 treatment months. Journal of Allergy and Clinical Immunology 2016 138, 451-458.e5DOI: (10.1016/j.jaci.2016.03.039) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Subject disposition. *Recorded as withdrawal by subject. †Sponsor's decision to withdraw the subject. ‡Subject did not tolerate the chamber. Journal of Allergy and Clinical Immunology 2016 138, 451-458.e5DOI: (10.1016/j.jaci.2016.03.039) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Treatment efficacy. Change from baseline (ChBL) to end of treatment (after 6 months) in the AUC of RTSSs for the full 4 hours (0-4 h) (A) or the last 2 hours (2-4 h) (B) of allergen challenge. Change from baseline (ChBL) in the ARTSSs for the full 4 hours (0-4 h) (C) or the last 2 hours (2-4 h) (D) of allergen challenge. NS, Not significant. Journal of Allergy and Clinical Immunology 2016 138, 451-458.e5DOI: (10.1016/j.jaci.2016.03.039) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Assessment of RTSSs during HDM allergen challenge. Subjects were exposed to HDM allergens for 4 hours in the EEC. Rhinitis symptoms were recorded by the subjects at 13 time points, and RTSSs (range, 0-12) were derived at each time point. Journal of Allergy and Clinical Immunology 2016 138, 451-458.e5DOI: (10.1016/j.jaci.2016.03.039) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 5 Immunological markers. Serum-specific IgE (top panels) and IgG4 (bottom panels) levels for D pteronyssinus and D farinae at baseline and after 2, 4, and 6 months. Units: kU/L for IgE, μg/mL for IgG4. Journal of Allergy and Clinical Immunology 2016 138, 451-458.e5DOI: (10.1016/j.jaci.2016.03.039) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions