Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trialResearch in context
Summary: Background: Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child’s quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targe...
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Elsevier
2025-01-01
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| Series: | The Lancet Regional Health. Europe |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666776224003053 |
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| author | Antje Schuster Davide Caimmi Hendrik Nolte Silviya Novakova Jan Mikler Majken Hougaard Foss-Skiftesvik Anne Sofie Østerdal Andrzej Emeryk Remi Gagnon Oliver Pfaar |
| author_facet | Antje Schuster Davide Caimmi Hendrik Nolte Silviya Novakova Jan Mikler Majken Hougaard Foss-Skiftesvik Anne Sofie Østerdal Andrzej Emeryk Remi Gagnon Oliver Pfaar |
| author_sort | Antje Schuster |
| collection | DOAJ |
| description | Summary: Background: Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child’s quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children. Methods: Phase III, randomised, double-blind, placebo-controlled trial in younger children (5–11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22. Findings: A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%). Interpretation: The trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5–11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children. Funding: ALK-Abellό, Hørsholm, Denmark. |
| format | Article |
| id | doaj-art-e51f49be073144aaaad2fb6addd8dd41 |
| institution | OA Journals |
| issn | 2666-7762 |
| language | English |
| publishDate | 2025-01-01 |
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| series | The Lancet Regional Health. Europe |
| spelling | doaj-art-e51f49be073144aaaad2fb6addd8dd412025-08-20T02:27:43ZengElsevierThe Lancet Regional Health. Europe2666-77622025-01-014810113610.1016/j.lanepe.2024.101136Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trialResearch in contextAntje Schuster0Davide Caimmi1Hendrik Nolte2Silviya Novakova3Jan Mikler4Majken Hougaard Foss-Skiftesvik5Anne Sofie Østerdal6Andrzej Emeryk7Remi Gagnon8Oliver Pfaar9Center for Paediatric and Adolescent Medicine, University Medical Center, Düsseldorf, GermanyAllergy Unit, CHU de Montpellier, Université de Montpellier, Montpellier 34295, France; IDESP, UMR A11-INSERM, Université de Montpellier, Montpellier 34093, FranceALK-Abellό, Hørsholm, DenmarkAllergy Unit, Internal Consulting Department, St George University Hospital, Plovdiv, BulgariaPediatric Clinic, University Hospital in Martin and Jessenius Medical Faculty in Martin, Commenius University, Bratislava, SlovakiaALK-Abellό, Hørsholm, DenmarkALK-Abellό, Hørsholm, DenmarkDepartment of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, PolandClinique Spécialisée en Allergie de la Capitale, 2600 Boul Laurier, Bureau 880, Quebec, QC G1V 4W2, CanadaDepartment of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany; Corresponding author. Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Baldingerstraße, Marburg D-35043, Germany.Summary: Background: Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child’s quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children. Methods: Phase III, randomised, double-blind, placebo-controlled trial in younger children (5–11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22. Findings: A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%). Interpretation: The trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5–11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children. Funding: ALK-Abellό, Hørsholm, Denmark.http://www.sciencedirect.com/science/article/pii/S2666776224003053Allergic rhinitisAllergen immunotherapyHouse dust mitePaediatricSLIT-tablet |
| spellingShingle | Antje Schuster Davide Caimmi Hendrik Nolte Silviya Novakova Jan Mikler Majken Hougaard Foss-Skiftesvik Anne Sofie Østerdal Andrzej Emeryk Remi Gagnon Oliver Pfaar Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trialResearch in context The Lancet Regional Health. Europe Allergic rhinitis Allergen immunotherapy House dust mite Paediatric SLIT-tablet |
| title | Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trialResearch in context |
| title_full | Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trialResearch in context |
| title_fullStr | Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trialResearch in context |
| title_full_unstemmed | Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trialResearch in context |
| title_short | Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trialResearch in context |
| title_sort | efficacy and safety of sq house dust mite sublingual immunotherapy tablet 12 sq hdm in children with allergic rhinitis rhinoconjunctivitis with or without asthma mt 12 a randomised double blind placebo controlled phase iii trialresearch in context |
| topic | Allergic rhinitis Allergen immunotherapy House dust mite Paediatric SLIT-tablet |
| url | http://www.sciencedirect.com/science/article/pii/S2666776224003053 |
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