Effective treatment of house dust mite–induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial

• Published in: Journal of allergy and clinical immunology Vol. 137; no. 2; pp. 444 - 451.e8
• Main Authors: Demoly, Pascal, Emminger, Waltraud, Rehm, Dorte, Backer, Vibeke, Tommerup, Lene, Kleine-Tebbe, Jörg
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2016; Elsevier Limited; Elsevier
• Subjects: Adolescent; Adult; Aged; allergen immunotherapy; Allergens - administration & dosage; Allergens - immunology; allergic rhinitis; Allergies; Allergology; allergy; Allergy and Immunology; Allergy immunotherapy; Animals; Antigens, Dermatophagoides - immunology; Asthma; Dermatophagoides pteronyssinus; Drug therapy; Female; house dust mite; Humans; Immunology; Immunotherapy; Life Sciences; Male; Middle Aged; Population; Pyroglyphidae - immunology; Rhinitis Quality of Life Questionnaire; Rhinitis, Allergic - immunology; Rhinitis, Allergic - therapy; rhinoconjunctivitis; Risk Factors; sublingual immunotherapy; Sublingual Immunotherapy - methods; sublingual immunotherapy tablet; Time Factors; total combined rhinitis score; Treatment Outcome; Young Adult; PP; total combined rhinitis score; RQLQ; SLIT; allergen immunotherapy; house dust mite; AE; LME; Allergy immunotherapy; Rhinitis Quality of Life Questionnaire; allergy; AIT; IMP; ICH; rhinoconjunctivitis; HDM; AR; sublingual immunotherapy tablet; TCRS; ICS; FAS; sublingual immunotherapy; allergic rhinitis; FAS-MI; Investigational medicinal product; Sublingual allergy immunotherapy; Per protocol; Full analysis set with multiple imputation of missing data; Full analysis set, observed data; Inhaled corticosteroid; Adverse event; Linear mixed effect; International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use; Rhinitis Quality of Life Questionnaire with Standardised Activities
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2015.06.036

The SQ HDM SLIT-tablet (ALK) has been developed for treatment of house dust mite (HDM)–induced respiratory allergic disease. This trial investigated the efficacy and safety of the SQ HDM SLIT-tablet in adults with moderate-to-severe HDM-induced allergic rhinitis (AR). The trial was a randomized, double-blind, placebo-controlled phase III trial conducted in 12 European countries including 992 adults with moderate-to-severe HDM-induced AR despite treatment with pharmacotherapy. Subjects were randomized 1:1:1 to 1 year of daily treatment with placebo, 6 SQ-HDM, or 12 SQ-HDM. The primary end point was the total combined rhinitis score (ie, the sum of rhinitis symptom and medication scores) during the efficacy assessment period (approximately the last 8 weeks of the treatment period). Key secondary end points were rhinitis symptoms, medication scores, quality of life, and the combined rhinoconjunctivitis score. Analysis of the primary end point (observed data) demonstrated absolute reductions in total combined rhinitis score of 1.18 (P = .002) and 1.22 (P = .001) compared with placebo for 6 SQ-HDM and 12 SQ-HDM, respectively. The statistically significant treatment effect was evident from 14 weeks of treatment onward. For all key secondary end points, efficacy was confirmed for 12 SQ-HDM, with statistically significant reductions of rhinitis symptoms and medication scores, improved quality of life, and a reduced combined rhinoconjunctivitis score in the efficacy assessment period compared with placebo. The treatment was well tolerated. The trial confirmed the efficacy and favorable safety profile of both 6 SQ-HDM and 12 SQ-HDM in adults with HDM-induced AR. The treatment effect was present from 14 weeks of treatment onward.