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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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
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Abstract	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.
AbstractList	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. Summary Introduction 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. Method 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). Results 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). Conclusion 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. 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.INTRODUCTIONIn 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).METHODThe 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).RESULTSThe 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.CONCLUSIONIn 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.
Author	Seitzberg, D. de Blay, F. Canonica, G.W. Ginko, T. Riis, B. Kuna, P. Prieto, L.
Author_xml	– sequence: 1 givenname: F. surname: de Blay fullname: de Blay, F. email: Frederic.DEBLAY@chru-strasbourg.fr organization: Chest Disease Department, University Hospital of Strasbourg, Federation of Translational Medicine, EA 3072, 67091 Strasbourg University, France – sequence: 2 givenname: P. surname: Kuna fullname: Kuna, P. organization: Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, ul. Kopcińskiego 22, 90-153 Łódź, Poland – sequence: 3 givenname: L. surname: Prieto fullname: Prieto, L. organization: Departamento de Medicina, Universidad de Valencia, Av. Blásco Ibáñez, 15, 46010 Valencia, Spain – sequence: 4 givenname: T. surname: Ginko fullname: Ginko, T. organization: Private Practice, Vorgebirgsstraße 43, 53119 Bonn, Germany – sequence: 5 givenname: D. surname: Seitzberg fullname: Seitzberg, D. organization: Global Clinical Development, ALK, Bøge Allé 6-8, 2970 Hørsholm, Denmark – sequence: 6 givenname: B. surname: Riis fullname: Riis, B. organization: Global Clinical Development, ALK, Bøge Allé 6-8, 2970 Hørsholm, Denmark – sequence: 7 givenname: G.W. surname: Canonica fullname: Canonica, G.W. organization: Allergy & Respiratory Dis. Clinic, DIMI, University of Genova, IRCCS AOU San Martino, Largo R. Benzi 10, 16132 Genova, Italy
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Snippet	In a double-blind, placebo-controlled trial (EudraCT identifier: 2006-001795-20), the standardised quality (SQ) house dust mite (HDM) sublingual immunotherapy... Summary Introduction In a double-blind, placebo-controlled trial (EudraCT identifier: 2006-001795-20), the standardised quality (SQ) house dust mite (HDM)...
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SubjectTerms	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
Title	SQ HDM SLIT-tablet (ALK) in treatment of asthma – Post hoc results from a randomised trial
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