Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial Hendrik.

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Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial Hendrik Nolte, MD, PhD, David I. Bernstein, MD, Harold S. Nelson, MD, Jörg Kleine-Tebbe, MD, Gordon L. Sussman, MD, Dorthe Seitzberg, PhD, Dorte Rehm, Amarjot Kaur, PhD, Ziliang Li, PhD, Susan Lu, PharmD Journal of Allergy and Clinical Immunology Volume 138, Issue 6, Pages 1631-1638 (December 2016) DOI: 10.1016/j.jaci.2016.06.044 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Subject disposition. *Five subjects were cross-treated; 3 subjects were randomized to placebo and received 1 or more doses of 12 SQ-HDM, and 2 subjects were randomized to 12 SQ-HDM and received 1 or more doses of placebo. ASaT, All subjects as treated. Journal of Allergy and Clinical Immunology 2016 138, 1631-1638DOI: (10.1016/j.jaci.2016.06.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Efficacy outcome scores during approximately the last 8 weeks of treatment (full analysis set). Plots are medians (upper/lower quartiles) except for rhinitis DMSs, which are estimated means (95% CIs). Percentages indicate improvement in scores relative to placebo. *Nominal P values of less than .001 versus placebo. TCS, Total combined rhinoconjunctivitis symptom and medication score. Journal of Allergy and Clinical Immunology 2016 138, 1631-1638DOI: (10.1016/j.jaci.2016.06.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Change from baseline in immunologic parameters (log10 scale) for IgE (A) and IgG4 (B) by trial visit (full analysis set). Error bars indicate 95% CIs. †Only 400 subjects were selected to have immunologic samples analyzed. ‡End of trial ranged from 35 weeks to 52 weeks from randomization. LS, Least square. Journal of Allergy and Clinical Immunology 2016 138, 1631-1638DOI: (10.1016/j.jaci.2016.06.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Journal of Allergy and Clinical Immunology 2016 138, 1631-1638DOI: (10.1016/j.jaci.2016.06.044) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions