Journal
IMMUNOTHERAPY
Volume 13, Issue 16, Pages -Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/imt-2021-0173
Keywords
Actair; allergic rhinitis; effectiveness and safety; house dust mite; interim analysis; postmarketing survey; sublingual immunotherapy tablet
Categories
Funding
- Shionogi & Co. Ltd. (Osaka, Japan)
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The study conducted a postmarketing drug-use survey on registered outpatients and found that the house dust mite sublingual tablet demonstrated good safety and effectiveness in real-world conditions after 2 years of continuous use, significantly improving the severity score of rhinitis.
Background: The efficacy and safety of a house dust mite sublingual tablet (HDM-tab) have been demonstrated in clinical trials, but the findings must be confirmed in real-world use among more widespread patient populations. Materials & methods: A postmarketing drug-use survey is assessing the drug's safety and effectiveness during routine use for up to 4 years. This 2-year interim analysis reports data collected up to March 2020. Results: Of 545 registered outpatients, 526 were evaluable for safety and 371 for effectiveness. Most common adverse drug reactions were local reactions. Mean rhinitis severity score decreased from 2.5 +/- 0.8 at baseline to 1.4 +/- 0.9, 1.1 +/- 0.8 and 1.0 +/- 0.8 at 6 months, 1 year and 2 years, respectively. Conclusion: The HDM tab appears to be safe and effective in real-world conditions during 2 years of continuous use.
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