SQ HDM SLIT-tablet (ALK) in treatment of asthma – Post hoc results from a randomised trial

In a double-blind, placebo-controlled trial (EudraCT identifier: 2006-001795-20), the standardised quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) was investigated. The trial included 604 subjects, ≥14 years, with mild-moderate HDM allergic asthma. Subjects w...

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Bibliographic Details
Published in:Respiratory medicine Vol. 108; no. 10; pp. 1430 - 1437
Main Authors: de Blay, F., Kuna, P., Prieto, L., Ginko, T., Seitzberg, D., Riis, B., Canonica, G.W.
Format: Journal Article
Language:English
Published: England Elsevier Ltd 01.10.2014
Subjects:
Adult
Animals
Asthma
Asthma - drug therapy
Asthma - immunology
Asthma quality of life
Budesonide - administration & dosage
Double-Blind Method
Glucocorticoids - administration & dosage
House dust mite
Humans
ICS reduction
Pulmonary/Respiratory
Pyroglyphidae - immunology
Quality of Life
SLIT-tablet
Sublingual Immunotherapy - methods
Surveys and Questionnaires
Tablets - administration & dosage
Treatment Outcome
Asthma quality of life
ICS reduction
House dust mite
SLIT-tablet
Asthma
ISSN:0954-6111, 1532-3064, 1532-3064
Online Access:Get full text
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Summary:In a double-blind, placebo-controlled trial (EudraCT identifier: 2006-001795-20), the standardised quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) was investigated. The trial included 604 subjects, ≥14 years, with mild-moderate HDM allergic asthma. Subjects were randomised 1:1:1:1 to 1, 3 or 6 SQ-HDM or placebo once daily. The primary endpoint was reduction in inhaled corticosteroid (ICS) after one year. ICS reduction, asthma quality of life questionnaire (AQLQ) and asthma control questionnaire (ACQ) score was analysed post hoc in a subgroup with daily ICS use of 400–800 μg and ACQ score of 1–1.5, corresponding to partly controlled asthma (N = 108). The trial met its primary endpoint. In the subgroup, the difference between placebo and 6 SQ-HDM in change from baseline in daily ICS use was 327 μg (p < 0.0001), while it was 0.52 (p = 0.010) for AQLQ. The treatment effect on ICS reduction and AQLQ was increased for the subgroup versus the residual population (ICS reduction: p < 0.001); AQLQ: p = 0.044). In this subgroup, including only patients with partly controlled asthma, the benefit of 1 year of treatment with SQ HDM SLIT-tablet was significantly higher than for the less severe full population, both in terms of increased asthma control and improved quality of life.
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ISSN:0954-6111
1532-3064
1532-3064
DOI:10.1016/j.rmed.2014.07.017