Subcutaneous Allergen Immunotherapy in Adults Allergic to House Dust Mites: A Phase 3 Randomized Controlled Trial
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Le résumé fourni par la source
BACKGROUND: Subcutaneous allergen immunotherapy (SCIT) has a longstanding history as a safe and effective treatment. Nevertheless, to meet the European Medicines Agency's regulatory requirements for continued market authorization, its efficacy and safety must be confirmed in a pivotal Phase III trial. OBJECTIVE: Based on a successful Phase II dose-finding study, the aim was to confirm the safety and efficacy of a subcutaneous house dust mites (HDM) preparation in a randomized controlled trial using an optimal higher dose than the current maintenance dose. METHOD: Seven hundred sixty-seven subjects were randomized in a 1:1 ratio to 1-year treatment with SCIT-product at a dose of 50,000 AUeq/mL or placebo. Out of these, 682 subjects completed the study. The primary endpoint was assessed using the combined symptom and medication score (CSMS(n)), which focuses on nasal symptoms, as specified by the European Academy of Allergy and Clinical Immunology (EAACI). RESULTS: The primary endpoint showed a trend (p = 0.0767) with a mean treatment effect of -0.12 (95% CI, -0.3 to 0) toward a favorable change in mean CSMS(n) for active compared to placebo treatment. This treatment effect of 0.12 points did however not meet the prespecified minimal clinically relevant difference of 0.25 points. Among the 767 randomized patients, 539 had mild symptoms and 228 patients had moderate to severe HDM allergic symptoms, defined by a mean baseline daily symptom score (dSS(n)) of at least 2. Post hoc analysis of the clinical data, focusing on this subgroup of patients with moderate to severe symptoms, revealed a significant treatment effect for the primary endpoint, with a clinically meaningful reduction of -0.39 points (95% CI, -0.64 to -0.13; p = 0.0031) thereby surpassing the minimal prespecified difference of 0.25 points. No additional safety concerns were observed in the moderate to severe symptom group compared with the minor symptom group. CONCLUSION: Treatment with the tested SCIT-product at a dose of 50,000 AUeq/mL was safe and well tolerated. The primary outcome was not met, with no significant difference observed between the active and placebo groups. A likely explanation might be the inclusion of mainly patients with mild symptoms of rhino conjunctivitis (539 of in total 767 randomized subjects). Post hoc analysis, however, indicated that SCIT was effective in the subgroup of patients with moderate to severe disease, suggesting that the overall study outcome may have been influenced by the inclusion of a large proportion of patients with only mild symptoms of HDM-induced rhino-conjunctivitis. As a consequence, reconfirming efficacy requires adequate baseline symptom severity, especially in HDM allergic patients.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Subcutaneous Allergen Immunotherapy in Adults Allergic to House Dust Mites: A Phase 3 Randomized Controlled Trial
- Date Crossref
- 18/09/2025
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Augenstern pays non établi dans la noticeStructure de recherche
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HAL Allergy (Netherlands) pays non établi dans la noticeEntreprise
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Clinical Research Center for Hair and Skin Science pays non établi dans la noticeStructure de recherche
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Charité - Universitätsmedizin Berlin pays non établi dans la noticeÉtablissement de santé
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Philipps University of Marburg pays non établi dans la noticeUniversité ou école supérieure
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Wroclaw Medical University Department of Clinical Immunology pays non établi dans la noticeUniversité ou école supérieure
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Medical University of Silesia Clinical Department of Internal Diseases pays non établi dans la noticeUniversité ou école supérieure
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GGZ inGeest pays non établi dans la noticeOrganisme public
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Amsterdam University Medical Centers Department of Experimental Immunology pays non établi dans la noticeÉtablissement de santé
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ENT‐Dep University of Muenster Muenster Germany ENT-Dep pays non établi dans la noticeUniversité ou école supérieure
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HAL Allergy B.V. Leiden the Netherlands pays non établi dans la noticeInstitution
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Division of Allergy and Immunology pays non établi dans la noticeInstitution
Augenstern, HAL Allergy (Netherlands) et Clinical Research Center for Hair and Skin Science, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.