Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen–induced rhinoconjunctivitis

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Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen–induced rhinoconjunctivitis Alain Didier, MD, Margitta Worm, MD, Friedrich Horak, MD, Gordon Sussman, MD, Olivier de Beaumont, MD, Martine Le Gall, Michel Melac, MD, Hans-Jorgen Malling, MD Journal of Allergy and Clinical Immunology Volume 128, Issue 3, Pages 559-566 (September 2011) DOI: 10.1016/j.jaci.2011.06.022 Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Study design. The circled R represents randomization to the 3 treatment arms. The actual time of the pollen season in each year is represented by the shaded bar. Journal of Allergy and Clinical Immunology 2011 128, 559-566DOI: (10.1016/j.jaci.2011.06.022) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Subject disposition during the 3 treatment years. FAS, Full analysis set (only for year 3). Journal of Allergy and Clinical Immunology 2011 128, 559-566DOI: (10.1016/j.jaci.2011.06.022) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Most common (≥5%) treatment-related adverse events by intensity: incidence for seasons 1 to 3. Treatment-related adverse events are those considered by the investigator to be at least possibly related to the study treatment. TEAEs are events starting on or after the first administration at each treatment period, including the days of first and last administration of the investigational product. Adverse events are presented separately for the groups having received 2 or 4 months of active treatment and the placebo group. The 2-month treatment group had a shorter preseasonal treatment period, and these patients received placebo for the 2 months before the start of their active treatment; therefore they are presented separately as a 2-month placebo period and a 2-month active period. The placebo group used for efficacy comparisons received placebo during the entire 4 months before and then during the pollen season and is indicated for safety as 4 months of placebo. AC, Active treatment; PL, placebo. Journal of Allergy and Clinical Immunology 2011 128, 559-566DOI: (10.1016/j.jaci.2011.06.022) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions