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Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis  Karl-Christian Bergmann, MD, Pascal Demoly,

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Presentation on theme: "Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis  Karl-Christian Bergmann, MD, Pascal Demoly,"— Presentation transcript:

1 Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis  Karl-Christian Bergmann, MD, Pascal Demoly, MD, PhD, Margitta Worm, MD, Wytske J. Fokkens, MD, PhD, Teresa Carrillo, MD, PhD, Ana I. Tabar, MD, PhD, Hélène Nguyen, PharmD, Armelle Montagut, Robert K. Zeldin, MD  Journal of Allergy and Clinical Immunology  Volume 133, Issue 6, Pages e6 (June 2014) DOI: /j.jaci Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

2 Fig 1 Study design. Participants recorded the occurrence and severity of their symptoms and use of rescue medications during screening (7 days) and once randomized at months 2, 4, 6, 15, and 18 (14 days) and during the primary periods (months 8-12 and months 20-24). Primary periods were defined from October 1 to December 31 of each study year. Journal of Allergy and Clinical Immunology  , e6DOI: ( /j.jaci ) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

3 Fig 2 Symptom and rescue medication scores (FASYear1); ARTSS (A), ARMS (B), and ARSS (C). Observations for all variables were available for 136 participants in the 500IR group, 141 participants in the 300IR group, and 153 participants in the placebo group, except for ocular itching (131, 139, and 148 participants, respectively). *P < .05 (analysis of covariance, each of the 2 active groups vs the placebo group). Journal of Allergy and Clinical Immunology  , e6DOI: ( /j.jaci ) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

4 Fig 3 AAdSS (FASYear1 and FASYear2). Fourteen-day diaries were collected after each time point visit (months 2-10 and months 15-20) or preceding the month 12 and month 24 visits. Mean baseline ARTSSs (no rescue medication allowed) were 7.26 (500IR group), 6.94 (300IR group), and 6.79 (placebo group). *P < .05 (repeated-measures analysis of covariance mixed model, each of the 2 active groups vs the placebo group). Journal of Allergy and Clinical Immunology  , e6DOI: ( /j.jaci ) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

5 Fig 4 Symptom and rescue medication scores (FASYear2); AAdSS (A), ARTSS (B), ARMS (C) and ARSS (D). Observations for all variables were available for 120 participants in the 500IR group, 132 participants in the 300IR group, and 137 participants in the placebo group, except for ocular itching (117, 131, and 134 participants, respectively). *P < .05 (analysis of covariance, each of the 2 active groups vs the placebo group). Journal of Allergy and Clinical Immunology  , e6DOI: ( /j.jaci ) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

6 Fig E1 Participants' disposition. Participants were randomized to one of the 3 groups, treated for approximately 12 months, and followed for the subsequent 12-month, immunotherapy-free period. Safety set year 1 was comprised of all participants who received at least 1 dose of investigational product. Safety set year 2 was comprised of all participants who completed year 1. Journal of Allergy and Clinical Immunology  , e6DOI: ( /j.jaci ) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

7 Fig E2 Immunologic markers (FASYear2). Serum specific IgE levels for D pteronyssinus (A) and D farinae (B) and serum specific IgG4 levels for D pteronyssinus (C) and D farinae (D) at baseline, month 12, and month 24. Journal of Allergy and Clinical Immunology  , e6DOI: ( /j.jaci ) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

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