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Safety and effectiveness of a 300 IR house dust mite sublingual tablet: descriptive 4-year final analysis of a post-marketing surveillance in Japan

Yoshitaka Okamoto

Moe Kato

Kiyonori Ishii

Yumi Sato

Tomohisa Hata

Yuta Asaka

Yoshitaka Okamoto

https://orcid.org/0000-0001-9352-1582

Chiba University, Chiba, 260-8670 & Chiba Rosai Hospital, Chiba, 290-0003, Japan

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Moe Kato

Shionogi Pharmacovigilance Center Co., Ltd, Osaka, 541-0045, Japan

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Kiyonori Ishii

Shionogi Pharmacovigilance Center Co., Ltd, Osaka, 541-0045, Japan

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Yumi Sato

*Author for correspondence:

E-mail Address: yumi.sato@shionogi.co.jp

Medical Affairs Department, Shionogi & Co., Ltd, Osaka, 541-0045, Japan

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Tomohisa Hata

Pharmacovigilance Department, Shionogi & Co., Ltd, Osaka, 541-0042, Japan

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Yuta Asaka

Pharmacovigilance Department, Shionogi & Co., Ltd, Osaka, 541-0042, Japan

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Published Online:20 Sep 2023https://doi.org/10.2217/imt-2023-0100

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Abstract

Background: Data are limited for clinical outcomes with house dust mite (HDM) allergen immunotherapy beyond 2 years' observation. Materials & methods: A post-marketing drug-use survey assessed the safety and effectiveness of the 300 index of reactivity (IR) HDM tablet during use for up to 4 years in Japan. Results: 538 patients were evaluable for safety and 383 for effectiveness. Most adverse drug reactions (ADRs) occurred early and were local reactions; 5.6% of 249 total events were reported during years 2 to 4 as new ADRs after the interim analysis. The CAP-RAST score was identified as a potential risk factor for ADRs. The proportion of evaluable patients with severe allergic rhinitis symptoms decreased from 46.4% at baseline (n = 317) to 1.0% at 4 years (n = 104). Patients (n = 16) who discontinued 300 IR HDM tablet due to symptomatic improvement had sustained improvement relative to baseline 1 to 2 years later. Conclusion: Long-term use of the 300 IR HDM tablet is safe and effective.

Plain language summary

The 300 index of reactivity house dust mite (HDM) sublingual tablet (Actair^®) is a treatment option for people with HDM allergy. A Japanese study investigated the safety and effectiveness of the HDM sublingual tablet during its use for up to 4 years. Less than a third of patients (29%) reported adverse effects, mainly itching or irritation in the mouth. The percentage of patients with no allergic rhinitis symptoms increased from 0.3% before treatment to 57.7% after 4 years of use. The percentage of patients who perceived that their allergic rhinitis had improved ‘substantially’ compared with before treatment increased from 22.3% at 6 months to 73.5% at 4 years. Patients who ended treatment with the HDM sublingual tablet because their symptoms had improved continued to perceive benefit 1 to 2 years later.

Clinical Trial Registration: University hospital Medical Information Network (UMIN) Clinical Trials Registry identifier: UMIN000042840.

Tweetable abstract

Long-term use of the 300 IR HDM tablet is safe and effective.

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Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 15, No. 16

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History

Received 28 April 2023

Accepted 24 August 2023

Published online 20 September 2023

Published in print November 2023

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Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/suppl/10.2217/imt-2023-0100

Author contributions

T Hata, K Ishii, Y Asaka and M Kato were involved in developing the study protocol. All authors were involved in interpreting the results and participated in developing the manuscript and critical evaluation of the revisions. All authors read and approved the final manuscript for submission.

Acknowledgments

The authors sincerely thank all investigators, site staff and patients who contributed to this post-marketing drug-use survey. The authors also thank Ken-ichi Setsukinai (Shionogi & Co., Ltd.), and M Rees, S Scurati and J Cognet-Sice (Stallergenes Greer) for their critical appraisal of the manuscript and publication support.

Financial disclosure

The post-marketing drug-use survey of the 300 IR HDM tablet was funded by Shionogi & Co., Ltd (Osaka, Japan). Y Okamoto serves in an advisory role for Kirin Holdings Co., Ltd and Torii Pharmaceutical Co., Ltd; and has received honoraria from Meiji Seika Pharma Co., Ltd, Mitsubishi Tanabe Pharma Co., Novartis AG, ALK, Shionogi & Co., Ltd., and Torii Pharmaceutical Co., Ltd. M Kato and K Ishii are full-time employees of Shionogi Pharmacovigilance Center Co., Ltd. Y Sato, T Hata, and Y Asaka are full-time employees of Shionogi & Co., Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

Medical writing and editorial assistance were provided by Kerry Dechant, ISMPP CMPP™, on behalf of Content Ed Net with funding from Shionogi & Co., Ltd (Osaka, Japan).

Ethical conduct of research

This post-marketing drug-use survey was conducted in compliance with Good Post-marketing Study Practice according to ordinance by the Japanese Ministry of Health, Labour, and Welfare, in which the Pharmaceuticals and Medical Devices Agency requires evaluation of the safety and effectiveness of a drug in a real-world clinical setting. Institutional Review Board approval and informed consent were not required.

Open access

This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/

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