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

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

doi:10.1016/j.waojou.2024.100924

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

World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.

Authors

Margitta Worm¹, Pascal Demoly², Yoshitaka Okamoto³, Carmen Vidal⁴, Katia Daghildjian⁵, Kwok Yan⁶, Thomas B Casale⁷, Karl-Christian Bergmann⁸

Affiliations

¹ Division of Allergy and Immunology, Department of Dermatology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
² Division of Allergy, Department of Pulmonology, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier and IDESP UMR UA11, University of Montpellier - Inserm, Montpellier, France.
³ Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine, Chiba University and Chiba Rosai Hospital, Chiba, Japan.
⁴ Allergy Department, Complejo Hospitalario Universitario de Santiago, Faculty of Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain.
⁵ Global Medical Affairs Department, Stallergenes Greer, Antony, France.
⁶ Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, Australia.
⁷ Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA.
⁸ Institute of Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Abstract

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.

Keywords: Allergic; Antigens; Asthma; Dermatophagoides; Dust mite allergy; Perennial; Rhinitis; Sublingual immunotherapy/adverse effects.

Associated data

ClinicalTrials.gov/NCT01527188
ClinicalTrials.gov/NCT02443805
ClinicalTrials.gov/NCT00674700
ClinicalTrials.gov/NCT01199133