Safety of using the 300 IR tablet containing house dust mite allergens for sublingual immunotherapy Review: Worm M, Demoly P, Okamoto Y et al. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data.

Main Article Content

Andrzej Bożek

Abstract

A meta-analysis assessing the safety of 300 IR SLIT-HDM tablets demonstrated good tolerability in adults, adolescents, and children with allergic rhinitis, with or without concomitant asthma. The analysis included eight randomized clinical trials and post-marketing pharmacovigilance data covering over 235,000 patients. The most frequently reported adverse events were mild to moderate local reactions, primarily occurring in the first weeks of therapy. Severe reactions were rare and effectively managed with symptomatic treatment. The study results confirm that 300 IR HDM SLIT tablet has a favorable safety profile consistent with previous scientific observations and international recommendations.

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How to Cite
Bożek, A. (2025). Safety of using the 300 IR tablet containing house dust mite allergens for sublingual immunotherapy. Alergoprofil, 20(4), 9-12. https://doi.org/10.24292/01.AP.204100525
Section
THERAPY

References

1. Pfaar O, Ankermann T, Augustin M et al. Guideline on allergen immunotherapy in IgE-mediated allergic diseases: S2K Guideline of the German Society of Allergology and Clinical Immunology (DGAKI), Society of Pediatric Allergology and Environmental Medicine (GPA), Medical Association of German Allergologists (AeDA), Austrian Society of Allergology and Immunology (ÖGAI), Swiss Society for Allergology and Immunology (SSAI), German Dermatological Society (DDG), German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), German Society of Pediatrics and Adolescent Medicine (DGKJ), Society of Pediatric Pulmonology (GPP), German Respiratory Society (DGP), German Professional Association of Otolaryngologists (BVHNO), German Association of Paediatric and Adolescent Care Specialists (BVKJ), Federal Association of Pneumologists, Sleep and Respiratory Physicians (BdP), Professional Association of German Dermatologists (BVDD). Allergol Select. 2022; 1: 67-232. http://doi.org/10.5414/ALX02331E.
2. Creticos PS, Gunaydin FE, Nolte H et al. Allergen Immunotherapy: The Evidence Supporting the Efficacy and Safety of Subcutaneous Immunotherapy and Sublingual Forms of Immunotherapy for Allergic Rhinitis/Conjunctivitis and Asthma. J Allergy Clin Immunol Pract. 2024; 12(6): 1415-27. http://doi.org/10.1016/j.jaip.2024.04.034.
3.Li X, Shang J, Liu J et al. A meta-analysis investigating the efficacy and safety of allergen-specific immunotherapy in the management of respiratory allergies. J Asthma. 2024; 61(10): 1337-46. http://doi.org/10.1080/02770903.2024.2349604.
4. Bousquet J, Pfaar O, Agache I et al. ARIA-EAACI care pathways for allergen immunotherapy in respiratory allergy. Clin Transl Allergy. 2021; 11(4): e12014. http://doi.org/10.1002/clt2.12014.
5. Okamoto Y, Kato M, Ishii K et al. Safety and effectiveness of a 300 IR house dust mite sublingual tablet: descriptive 4-year final analysis of a post-marketing surveillance in Japan. Immunotherapy. 2023; 15(16): 1401-14. http://doi.org/10.2217/imt-2023-0100.
6. Turner PJ, Ansotegui IJ, Campbell DE et al.; WAO Anaphylaxis Committee and WAO Allergen Immunotherapy Committee. Updated grading system for systemic allergic reactions: Joint Statement of the World Allergy Organization Anaphylaxis Committee and Allergen Immunotherapy Committee. World Allergy Organ J. 2024; 17(3): 100876. http://doi.org/10.1016/j.waojou.2024.100876.
7. Horn A, Bernstein DI, Okubo K et al. House dust mite sublingual immunotherapy tablet safety in adolescents with allergic rhinoconjunctivitis: Worldwide clinical trial results. Ann Allergy Asthma Immunol. 2023; 130(6): 797-804.e2. http://doi.org/10.1016/j.anai.2023.03.006.
8. Demoly P, Corren J, Creticos P et al. A 300 IR sublingual tablet is an effective, safe treatment for house dust mite-induced allergic rhinitis: An international, double-blind, placebo- controlled, randomized phase III clinical trial. J Allergy Clin Immunol. 2021; 147(3): 1020-30.e10. http://doi.org/10.1016/j.jaci.2020.07.036.
9. Worm M, Demoly P, Okamoto Y et al. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024; 17(7): 100924. http://doi.org/10.1016/j.waojou.2024.100924.