Safety and effectiveness of the 300 IR sublingual house dust mite allergen immunotherapy tablet: 2-year interim analysis of a specified drug-use survey

Abstract

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