Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data

Margitta Worm, MD; Pascal Demoly, MD, PhD; Yoshitaka Okamoto, MD, PhD; Carmen Vidal, MD, PhD; Katia Daghildjian, PharmD, PhD; Kwok Yan, MD; Thomas B. Casale, MD; Karl-Christian Bergmann, MD, PhD

World Allergy Organization Journal (Jul 2024)

Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data

Margitta Worm, MD,
Pascal Demoly, MD, PhD,
Yoshitaka Okamoto, MD, PhD,
Carmen Vidal, MD, PhD,
Katia Daghildjian, PharmD, PhD,
Kwok Yan, MD,
Thomas B. Casale, MD,
Karl-Christian Bergmann, MD, PhD

Affiliations

Margitta Worm, MD: Division of Allergy and Immunology, Department of Dermatology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany; Corresponding author. Charité – Universitätsmedizin Berlin, Department of Dermatology and Allergy, Charitéplat 1, 10117 Berlin, Germany.
Pascal Demoly, MD, PhD: Division of Allergy, Department of Pulmonology, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier and IDESP UMR UA11, University of Montpellier - Inserm, Montpellier, France
Yoshitaka Okamoto, MD, PhD: Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine, Chiba University and Chiba Rosai Hospital, Chiba, Japan
Carmen Vidal, MD, PhD: Allergy Department, Complejo Hospitalario Universitario de Santiago, Faculty of Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain
Katia Daghildjian, PharmD, PhD: Global Medical Affairs Department, Stallergenes Greer, Antony, France
Kwok Yan, MD: Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, Australia
Thomas B. Casale, MD: Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA
Karl-Christian Bergmann, MD, PhD: Institute of Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany

Journal volume & issue: Vol. 17, no. 7
p. 100924

Abstract

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Background: The 300IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is approved for treatment of HDM-induced allergic rhinitis (AR). To provide a comprehensive review of the 300IR HDM-SLIT tablet safety profile based on randomized controlled trial (RCT) pooled data and post-marketing (PM) pharmacovigilance data. Methods: Subjects (5–65 years) with confirmed HDM-AR with or without controlled asthma were treated with 300IR or placebo in 8 RCTs. Reported treatment-emergent adverse events (TEAEs) were pooled and analyzed descriptively in subsets of adults/adolescents and children. Adverse reactions (ADRs) collected from spontaneous reporting and PM studies through a pharmacovigilance system since the first marketing authorization were also analyzed. Results: Across RCTs, 1853 subjects were treated with the 300IR HDM-SLIT tablet and 1846 with placebo. In both subsets of adults/adolescents and children whichever their asthma status, treatment-related TEAEs of higher incidence in active groups vs placebo were mostly consistent with mild or moderate local application-site reactions. They were mainly reported on the first days of treatment and decreased over time. 4 severe laryngopharyngeal reactions (2 requiring adrenaline/epinephrine) and 1 moderate eczema considered serious rapidly resolved with medications; no anaphylaxis was reported. In PM settings, ADRs reported in more than 235,000 patients were in line with RCT findings. Severe systemic reactions occurred rarely; 12 anaphylactic reactions resolved safely (5 with adrenaline). No new safety signal was raised. Conclusion: Safety data from RCTs and more than 7 years of real-life experience confirmed the favorable safety profile of 300IR HDM-SLIT tablet in patients across different regions, regardless of age and asthma status. Clinical trial registrations: NCT00674700; Retrospectively registered 06 May 2008.NCT01199133; Retrospectively registered 09 September 2010.NCT01527188; Retrospectively registered 01 February 2012.NCT02443805; Registered 29 April 2015/EudraCT 2014-004223-46; Registered 16 September 2015.jRCT2080221872/JapicCTI-121917; Registered 01 August 2012.jRCT2080222929/JapicCTI-15298; Registered 04 August 2015.

Published in World Allergy Organization Journal

ISSN: 1939-4551 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Immunologic diseases. Allergy
Website: https://www.sciencedirect.com/journal/world-allergy-organization-journal

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