Standardized quality (SQ) house dust mite sublingual immunotherapy tablet (ALK) reduces inhaled corticosteroid use while maintaining asthma control: A randomized, double-blind, placebo-controlled trial

• Published in: Journal of allergy and clinical immunology Vol. 134; no. 3; pp. 568 - 575.e7
• Main Authors: Mosbech, Holger, Deckelmann, Regina, de Blay, Fréderic, Pastorello, Elide Anna, Trebas-Pietras, Ewa, Andres, Luis Prieto, Malcus, Inga, Ljørring, Christian, Canonica, Giorgio Walter
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.09.2014; Elsevier; Elsevier Limited
• Subjects: Administration, Inhalation; Administration, Sublingual; Adolescent; Adrenal Cortex Hormones - therapeutic use; Adult; Allergies; Allergy; Allergy and Immunology; allergy immunotherapy; Animals; Antigens, Dermatophagoides - immunology; Antigens, Dermatophagoides - therapeutic use; Asthma; Asthma - immunology; Asthma - therapy; asthma control; Biological and medical sciences; Chronic obstructive pulmonary disease, asthma; Dermatophagoides pteronyssinus; Desensitization, Immunologic - methods; Desensitization, Immunologic - standards; Design; Disease Progression; Double-Blind Method; Drug Dosage Calculations; Drug therapy; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; house dust mite; Humans; Immunopathology; Immunotherapy; inhaled corticosteroid; Male; Medical sciences; Methods; Pneumology; Practice Patterns, Physicians' - standards; Practice Patterns, Physicians' - statistics & numerical data; Pyroglyphidae; Quality Control; Reference Standards; respiratory allergic disease; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; SLIT-tablet; Tablets - administration & dosage; Tablets - adverse effects; Treatment Outcome; PP; RDBPC; Allergy; SLIT; house dust mite; AE; allergy immunotherapy; SLIT-tablet; asthma; asthma control; AQLQ; AIT; inhaled corticosteroid; ACQ; ICH; HDM; respiratory allergic disease; GINA; immunotherapy; ICS; FAS; SCIT; SQ; Randomized, double-blind, placebo-controlled; Standardized quality; Asthma Quality of Life Questionnaire; International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; Subcutaneous allergy immunotherapy; Adverse event; Inhaled corticosteroids; Per-protocol; Asthma Control Questionnaire; Global Initiative for Asthma; Full analysis set; Sublingually administered allergy immunotherapy; Sublingual administration; Mite; Immunology; Immunotherapy; Quality; Bronchus disease; Tablet; Obstructive pulmonary disease; Anaplastic lymphoma kinase; Protooncogene; Lung disease; Corticosteroid; Immunopathology; Desensitization; Respiratory disease; Use; House dust; Randomized controlled trial; Asthma; Inhalation; Treatment; C-Onc gene; Double blind study
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2014.03.019

Investigations meeting current standards are limited for the effect of house dust mite (HDM) allergy immunotherapy in asthmatic patients. This trial investigated the efficacy and safety of a standardized quality (SQ; allergen standardization method proprietary to the trial sponsor) HDM SLIT-tablet (ALK, Hørsholm, Denmark) in adults and adolescents with HDM respiratory allergic disease. This publication reports the results of the endpoints related to asthma. Six hundred four subjects 14 years or older with HDM allergic rhinitis and mild-to-moderate asthma were randomized 1:1:1:1 to double-blind daily treatment with one of 3 active doses (1, 3, or 6 SQ-HDM) or placebo. Their use of inhaled corticosteroid (ICS) was standardized and adjusted at baseline and the end of treatment to the lowest dose providing asthma control. The primary end point was a reduction in ICS dose from the individual subject's baseline dose after 1 year of treatment. The primary analysis revealed a mean difference between 6 SQ-HDM and placebo in the reduction in daily ICS dose of 81 μg (P = .004). Relative mean and median reductions were 42% and 50% for 6 SQ-HDM and 15% and 25% for placebo, respectively. No statistically significant differences were observed for the other assessed asthma parameters, reflecting the intended controlled status of the trial subjects. The most common adverse events were local reactions in the mouth. The rate and severity of adverse events were higher for 3 and 6 SQ-HDM than for 1 SQ-HDM and placebo. Efficacy in mild-to-moderate asthma of 6 SQ-HDM relative to placebo was demonstrated by a moderate statistically significant reduction in the ICS dose required to maintain asthma control. All active doses were well tolerated.