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House dust mite SCIT reduces asthma risk and significantly improves long-term rhinitis and asthma control -- a RWE study
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  • Marek Jutel,
  • Ludger Klimek,
  • Hartmut Richter,
  • Bernd Brüggenjürgen,
  • Vogelberg C
Marek Jutel
MED Medical Research Institute

Corresponding Author:[email protected]

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Ludger Klimek
Center for Rhinology and Allergology
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Hartmut Richter
Medical University
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Bernd Brüggenjürgen
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Vogelberg C
Universitatsklinikum Carl Gustav Carus
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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.
08 May 2023Submitted to Allergy
08 May 2023Submission Checks Completed
08 May 2023Assigned to Editor
08 May 2023Review(s) Completed, Editorial Evaluation Pending
08 May 2023Reviewer(s) Assigned
17 Aug 2023Editorial Decision: Revise Minor
03 Oct 20231st Revision Received
03 Oct 2023Assigned to Editor
03 Oct 2023Submission Checks Completed
03 Oct 2023Review(s) Completed, Editorial Evaluation Pending
06 Oct 2023Reviewer(s) Assigned
24 Oct 2023Editorial Decision: Revise Minor
22 Nov 20232nd Revision Received
22 Nov 2023Submission Checks Completed
22 Nov 2023Assigned to Editor
22 Nov 2023Review(s) Completed, Editorial Evaluation Pending