Efficacy and safety of the SQ house dust mite sublingual immunotherapy tablet in Japanese adults and adolescents with house dust mite–induced allergic.

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Efficacy and safety of the SQ house dust mite sublingual immunotherapy tablet in Japanese adults and adolescents with house dust mite–induced allergic rhinitis Kimihiro Okubo, MD, PhD, Keisuke Masuyama, MD, PhD, Toru Imai, MD, PhD, Kazuhiro Okamiya, MSc, Brian Sonne Stage, MSc, Dorthe Seitzberg, MSc, PhD, Akiyoshi Konno, MD, PhD Journal of Allergy and Clinical Immunology Volume 139, Issue 6, Pages 1840-1848.e10 (June 2017) DOI: 10.1016/j.jaci.2016.09.043 Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Trial design. Subjects were asked to follow a 2-step updosing regimen at the beginning of the treatment period. The electronic diary collected 14 days of data during the run-in period and 5 times after updosing until the end of the primary evaluation period comprising the last 8 weeks of the treatment period. Black boxes represent electronic diary periods. Journal of Allergy and Clinical Immunology 2017 139, 1840-1848.e10DOI: (10.1016/j.jaci.2016.09.043) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Subject disposition. Journal of Allergy and Clinical Immunology 2017 139, 1840-1848.e10DOI: (10.1016/j.jaci.2016.09.043) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Adjusted means with 95% CIs of AR symptom scores throughout the 52-week treatment period (primary evaluation period: weeks 44-52) (A) and each symptom score during the primary evaluation period (weeks 44-52) (B). *Statistically significant difference from the placebo group (FAS). Journal of Allergy and Clinical Immunology 2017 139, 1840-1848.e10DOI: (10.1016/j.jaci.2016.09.043) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Comparison of TCRSs between the adult (18-64 years) and adolescent (12-17 years) populations during the primary evaluation period (FAS) (A) and incidence of ADRs with severity (B). *Statistically significant difference from placebo in TCRSs as confirmatory results (see Table II). #Statistically significant difference from placebo in TCRSs for post hoc analysis. Journal of Allergy and Clinical Immunology 2017 139, 1840-1848.e10DOI: (10.1016/j.jaci.2016.09.043) Copyright © 2016 American Academy of Allergy, Asthma & Immunology Terms and Conditions