House dust mite SCIT reduces asthma risk and significantly improves long‐term rhinitis and asthma control—A RWE study

• Published in: Allergy (Copenhagen) Vol. 79; no. 4; pp. 1042 - 1051
• Main Authors: Jutel, Marek, Klimek, Ludger, Richter, Hartmut, Brüggenjürgen, Bernd, Vogelberg, Christian
• Format: Journal Article
• Language: English
• Published: Denmark Blackwell Publishing Ltd 01.04.2024
• Subjects: Adolescent; Adolescents; Adult; allergen immunotherapy; Allergens; Allergic rhinitis; Animals; Antigens, Dermatophagoides; Asthma; Asthma - epidemiology; Asthma - etiology; Asthma - prevention & control; Child; Clinical trials; cohort studies; Dermatophagoides pteronyssinus; Desensitization, Immunologic - methods; drug therapy; dust mites; Germany; health services; house dust mite; Humans; Immunotherapy; long‐term effect; markets; Prescriptions; Pyroglyphidae; real‐world evidence; Retrospective Studies; Rhinitis; Rhinitis, Allergic - epidemiology; Rhinitis, Allergic - etiology; Rhinitis, Allergic - prevention & control; risk; risk reduction; subcutaneous immunotherapy; Germany; long‐term effect; real‐world evidence; allergen immunotherapy; house dust mite; subcutaneous immunotherapy
• ISSN: 0105-4538; 1398-9995; 1398-9995
• DOI: 10.1111/all.16052

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. Aim of this analysis was to provide a per product analysis on effectiveness of mite AIT as it is demanded by international guidelines on AIT. Methods Subjects between 5 and 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 In total, 892 subjects (608 adults and 284 children/adolescents) were included in the SCIT group and 2676 subjects (1824 adults and 852 children/adolescents) in the non‐AIT group. During the follow‐up period after at least 2 years of SCIT, the number of prescriptions in the SCIT group was reduced by 62.8% (p < .0001) for AR medication and by 42.4% for asthma medication (p = .0003). New‐onset asthma risk was significantly reduced in the SCIT vs non‐AIT group by 27.0% (p = .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 prolonged compared to the non‐AIT group (p = .0010). Conclusion In this first product based RWD analysis on SCIT with a native HDM product, patients aged 5 to 70 years benefited from AIT in the long term in terms of reduced progression of AR and asthma after at least 2 years of treatment. The effects seemed to last for up to 6 years after treatment termination. A significantly reduced risk of asthma onset was observed, starting after 15 months of treatment. This study presents 6‐years follow‐up results for real‐world effectiveness of HDM SCIT compared to non‐AIT in Germany based on a retrospective claims database analysis. During the follow‐up period after at least two years of SCIT, the number of prescriptions in the SCIT group reduces by 62.8% for allergic rhinitis medication and by 42.4% for asthma medication. Compared to non‐AIT, HDM SCIT reduces the probability of asthma onset and the number of patients developing asthma from allergic rhinitis over time.Abbreviations: AIT, Allergen immunotherapy; HDM, house dust mite; SCIT, subcutaneous immunotherapy.