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

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. 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. 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. The HDM tab appears to be safe and effective in real-world conditions during 2 years of continuous use. : University hospital Medical Information Network (UMIN) Clinical Trials Registry identifier: