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

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:143

Article

Biedermann, Tilo¹  Kuna, Piotr²  Panzner, Petr³  Valovirta, Erkka^4,5  Andersson, Morgan⁶  de Blay, Frederic⁷  Thrane, Dorthe⁸  Jacobsen, Sanja Hald⁸  Stage, Brian Sonne⁸  Winther, Lone⁹ 

[1] Tech Univ Munich, Dept Dermatol & Allergol, Biedersteiner Str 29, D-80802 Munich, Germany

[2] Med Univ Lodz, Barlicki Univ Hosp, Div Internal Med Asthma & Allergy, Lodz, Poland

[3] Charles Univ Prague, Fac Med Pilsen, Dept Immunol & Allergol, Prague, Czech Republic

[4] Univ Turku, Dept Pulm Dis & Clin Allergol, Turku, Finland

[5] Terveystalo Allergy Clin, Turku, Finland

[6] Skane Univ Hosp, Dept Otorhinolaryngol Head & Neck Surg, Lund, Sweden

[7] Univ Strasbourg, Univ Hosp Strasbourg, Federat Translat Med Chest Dis Dept, Strasbourg, France

[8] ALK Abello, Global Clin Dev, Horsholm, Denmark

[9] Gentofte Univ Hosp, Dept Dermato Allergol, Allergy Clin, Copenhagen, Denmark

关键词: Allergic rhinoconjunctivitis;    allergy immunotherapy;    birch pollen;    clinical efficacy;    clinical trial;    safety;    sublingual immunotherapy tablet;    total combined score;    tree pollen;   

DOI  :  10.1016/j.jaci.2018.12.1001

来源: Elsevier

【 摘 要 】

Background: The SQ tree sublingual immunotherapy (SLIT)tablet (ALK-Abello, Horsholm, Denmark) is developed for treatment of tree pollen-induced allergic rhinoconjunctivitis (ARC). Objective: The aim of this pivotal phase III trial was to demonstrate the efficacy and safety of the SQ tree SLIT-tablet. Methods: This was a randomized, double-blind, placebo-controlled trial with 634 subjects (12-65 years) with moderate-to-severe ARC despite use of symptom-relieving medication. Eligible subjects were randomized 1:1 to active or placebo treatment. The primary end point was the average daily ARC total combined score (TCS) during the birch pollen season (BPS) analyzed for subjects with diary data during the BPS. Secondary end points included average daily symptom scores (DSS) during the BPS, average TCS and DSS during the tree pollen season (TPS), and average daily medication scores (DMS) in the BPS and TPS. Results: The primary and key secondary end points demonstrated statistically significant and clinically relevant effects of the SQ tree SLIT-tablet compared with placebo. For the BPS, absolute (relative) differences from placebo were 3.02 (40%) for TCS, 1.32 (37%) for DSS, and 1.58 (49%) for DMS (all P < .0001). For the TPS, absolute (relative) differences from placebo were 2.27 (37%) for TCS, 0.99 (33%) for DSS, and 1.20 (47%) for DMS (all P < .0001). Treatment was well tolerated. The most frequently reported treatment-related adverse events were mild or moderate local reactions related to sublingual administration. Conclusion: The trial demonstrated the efficacy and safety of the SQ tree SLIT-tablet compared with placebo during the BPS and TPS in adolescents and adults with birch pollen-induced ARC (EudraCT 2015-004821-15).

【 授权许可】

Free