The SQ tree SLIT-tablet is highly effective and well tolerated: Results from a randomized, double-blind, placebo-controlled phase III trial Tilo Biedermann,

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The SQ tree SLIT-tablet is highly effective and well tolerated: Results from a randomized, double-blind, placebo-controlled phase III trial Tilo Biedermann, MD, Piotr Kuna, MD, PhD, Petr Panzner, MD, PhD, Erkka Valovirta, MD, Morgan Andersson, MD, Frederic de Blay, MD, PhD, Dorthe Thrane, MSc, Sanja Hald Jacobsen, MSc, Brian Sonne Stage, MSc, Lone Winther, MD Journal of Allergy and Clinical Immunology Volume 143, Issue 3, Pages 1058-1066.e6 (March 2019) DOI: 10.1016/j.jaci.2018.12.1001 Copyright © 2019 The Authors Terms and Conditions

Journal of Allergy and Clinical Immunology 2019 143, 1058-1066 Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions

Fig 1 Trial design. Subjects were treated for at least 16 weeks before and during the 2017 TPS. Efficacy was assessed throughout the TPS. Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions

Fig 2 Subject disposition. *Primarily subjects who withdrew consent or were lost to follow-up before randomization. **Subjects with a valid value for the primary end point in the BPS. Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions

Fig 3 Primary and key secondary end points. Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions

Fig 4 Proportion of mild and severe days during the BPS. Mild days, Days without intake of antihistamine tablet/eyedrops and no single symptom scoring greater than 1; Odds ratio, SQ tree SLIT-tablet/placebo; Severe days, days with DSS of 6 or greater and 2 or more moderate or 1 severe symptom. Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions

Fig 5 Immunology. Change from baseline in birch-specific IgE and IgG4 levels. Adjusted means with 95% CIs are shown. *Statistically significant difference from placebo: P < .0001. Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions

Fig 6 Percentage of subjects with the most frequent treatment-related AEs (experienced by ≥ 5% of subjects treated with SQ tree SLIT-tablet). Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions

Fig E1 Post hoc analysis of average TCS, DMS, and DSS during the alder and hazel seasons. Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions

Fig E2 Median onset and duration of most frequent treatment-related AEs (experienced by ≥ 5% of subjects treated with SQ tree SLIT-tablet). Left, Median onset and duration of AE. Duration is given as time from onset until resolution (reoccurring AEs given from first to last day of appearance). Overlapping symbols indicate resolution on same day of occurrence. Right, Median onset of AE for AEs starting on the first day of treatment. Journal of Allergy and Clinical Immunology 2019 143, 1058-1066.e6DOI: (10.1016/j.jaci.2018.12.1001) Copyright © 2019 The Authors Terms and Conditions