House dust mite SCIT reduces asthma risk and significantly improves
long-term rhinitis and asthma control -- a RWE study
Abstract
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.