Tomokazu Matsuoka1, David I Bernstein2, Keisuke Masuyama1, Hendrik Nolte3, Kazuhiro Okamiya4, Dorthe Seitzberg3, Harold S Nelson5. 1. Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, Graduate Faculty of Interdisciplinary Research, University of Yamanashi, Yamanashi, Japan. 2. Bernstein Clinical Research Center and Division of Allergy and Immunology, University of Cincinnati, Cincinnati, OH, USA. 3. Research and Development, ALK, Hørsholm, Denmark. 4. Clinical Development Department, Torii Pharmaceutical Co. Ltd., Tokyo, Japan. 5. Division of Allergy/Immunology, Department of Medicine National Jewish Health, Denver, CO, USA.
Abstract
BACKGROUND:House dust mite (HDM) respiratory allergy is a common and burdensome disease in children and adolescents. There are few HDM allergy immunotherapy trials in children with perennial allergic rhinitis. This post hoc analysis used pooled data to evaluate efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT) tablet in adolescents (12-17 years). METHODS: In two double-blind, placebo-controlled trials conducted in North America and Japan, respectively, subjects aged 12+ years with HDM allergic rhinitis were randomized to up to 1 year of treatment. The primary end-point in both trials was the average total combined rhinitis score (TCRS) during the last 8 weeks of treatment in the active group compared with placebo. Data from subjects aged 12-17 years were pooled (N=395). RESULTS: In the pooled adolescent subpopulation, average TCRS improved 22% with 12 SQ HDM vs placebo (absolute treatment difference of 1.04; P<.01). Rhinitis daily symptom score (DSS), conjunctivitis DSS and rhinitis daily medication score (DMS) were also significantly improved vs placebo in the pooled adolescent subpopulation (all P<.05). There were no new safety signals for adolescents. The frequency of adverse events was similar in adolescents and adults with the majority being mild application site-related events. CONCLUSIONS: Treatment with 12 SQ HDM appears to be effective and well tolerated in adolescents with HDM allergic rhinitis.
RCT Entities:
BACKGROUND: House dust mite (HDM) respiratory allergy is a common and burdensome disease in children and adolescents. There are few HDM allergy immunotherapy trials in children with perennial allergic rhinitis. This post hoc analysis used pooled data to evaluate efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT) tablet in adolescents (12-17 years). METHODS: In two double-blind, placebo-controlled trials conducted in North America and Japan, respectively, subjects aged 12+ years with HDM allergic rhinitis were randomized to up to 1 year of treatment. The primary end-point in both trials was the average total combined rhinitis score (TCRS) during the last 8 weeks of treatment in the active group compared with placebo. Data from subjects aged 12-17 years were pooled (N=395). RESULTS: In the pooled adolescent subpopulation, average TCRS improved 22% with 12 SQ HDM vs placebo (absolute treatment difference of 1.04; P<.01). Rhinitis daily symptom score (DSS), conjunctivitis DSS and rhinitis daily medication score (DMS) were also significantly improved vs placebo in the pooled adolescent subpopulation (all P<.05). There were no new safety signals for adolescents. The frequency of adverse events was similar in adolescents and adults with the majority being mild application site-related events. CONCLUSIONS: Treatment with 12 SQ HDM appears to be effective and well tolerated in adolescents with HDM allergic rhinitis.
Authors: J Bousquet; C A Akdis; C Grattan; P A Eigenmann; K Hoffmann-Sommergruber; P W Hellings; I Agache Journal: Clin Transl Allergy Date: 2018-11-27 Impact factor: 5.871
Authors: Maria De Filippo; Martina Votto; Lucia Caminiti; Ilenia Panasiti; Francesco Carella; Giovanna De Castro; Massimo Landi; Roberta Olcese; Mario Vernich; Gian Luigi Marseglia; Giorgio Ciprandi; Salvatore Barberi Journal: Pediatr Allergy Immunol Date: 2022-01 Impact factor: 5.464