Background: The German Therapy Allergen Ordinance (TAO) triggered an ongoing upheaval in the market for house dust mite (HDM) allergen immunotherapy (AIT) products. Three HDM subcutaneous AIT (SCIT) products hold approval in Germany and therefore will be available after the scheduled completion of the TAO procedure in 2026. In general, data from clinical trials on the long-term effectiveness of HDM AIT are rare. We evaluated real-world data (RWD) in a retrospective, observational cohort study based on a longitudinal claims database including 60% of all German statutory healthcare prescriptions to show the long-term effectiveness of one of these products in daily life. Methods: Subjects between 5 to 70 years receiving their first (index) prescription of SCIT with a native HDM product (SCIT group) between 2009 and 2013 were included. The exactly 3:1 matched control group received prescriptions for only symptomatic AR medication (non-AIT group); the evaluation period for up to 6 years of follow-up ended in February 2017. Study endpoints were the progression of allergic rhinitis (AR) and asthma, asthma occurrence and time to the onset of asthma after at least 2 treatment years. Results: 892 subjects (608 adults, 284 children/adolescents) were included in the SCIT group and 2676 subjects (1824 adults, 852 children/adolescents) in the non-AIT group. During the follow-up period after at least two years of SCIT, the number of prescriptions in the SCIT group was reduced by 62.8% (p<0.0001) for AR medication and by 42.4% for asthma medication (p=0.0003). New‐onset asthma risk was significantly reduced in the SCIT vs non‐AIT group by 27.0% (p=0.0212). The asthma preventive effect of SCIT occurred 15 months after start of the treatment. In the SCIT group, the time to onset of asthma was reduced compared to the non-AIT group (p=0.0010). Conclusion: In this RWD analysis patients aged between 5 to 70 years benefited from SCIT with a native HDM product in terms of the reduced progression of AR and asthma after at least 2 years of treatment in the long term. The effects lasted for up to six years after treatment termination. A significantly reduced risk of asthma onset was observed, starting after 15 months of treatment.

Background: Allergen immunotherapy (AIT) may have a long-term disease modifying effect. The aim of this study is to demonstrate the long-term benefit of MCT®-associated allergoid pollen SCIT (MCT®-associated -AIT) on allergic rhinitis (AR) and asthma in clinical practice. Methods: In this retrospective Real-World-Evidence (RWE) study the impact of AIT on the progression of AR and onset of need for asthma medication was analyzed using a German longitudinal database. Anonymized prescription data of AR patients and exactly matched control patients aged from 5-65 years were analyzed. Results: Significantly less patients treated with MCT®-associated-AIT did receive prescriptions for symptomatic AR medication in the follow up period vs. control group (OR: 0.27; p < 0.001). Further, significantly less asthmatic patients under MCT®-associated-AIT did receive prescriptions for asthma medications (OR: 0.48; p = 0.004). In addition, the prescriptions of AR and asthma medication for MCT®-associated-AIT patients were significantly reduced in the follow-up vs. baseline and control group (24.2% and 35.6%, respectively, p < 0.001).The probability of asthma medication onset in non-asthmatic patients during follow-up was significantly reduced for AIT patients compared to controls (OR: 0.77, p = 0.001). All endpoints were significant for children/adolescents and adults in the individual analyses. Conclusions: This study gives evidence for long-term benefits up to 9.5 years of MCT®-associated-AIT on the need for AR and new-onset asthma medication in AR patients and asthma medication in asthmatics in an RWE setting.