D3.185 - The 300 IR house dust mite sublingual tablet is effective and well tolerated in patients with allergic rhinoconjunctivitis and concomitant allergic asthma in a real-world data setting
Background
The 300 IR house dust mite (HDM) sublingual tablet is indicated for HDM-induced allergic rhinoconjunctivitis (ARC). Clinical trials have shown efficacy and safety in HDM-induced ARC, irrespective of the concomitant presence of controlled allergic asthma (AA). To confirm this observation in a real-world data (RWD) analysis and to explore asthma outcomes, we analyzed data of a non-interventional study.
Method
In this prospective, multi-center RWD study (VORAN study; EUPAS 44205), effectiveness, safety and tolerability of the 300 IR HDM SLIT tablet in patients with ARC and concomitant asthma were assessed as an exploratory objective. Severity of ARC symptoms and lung symptoms/breathing problems, ARC and AA medication use, asthma control (according to GINA), adverse drug reactions (ADR), and tolerability were documented during the first treatment year.
Results
Of 782 analyzed patients (710 adults, 71 adolescents), 20.8% had ARC and AA (ARC+AA). At baseline, moderate-to-severe nasal, eye, and lung symptoms were present in 86.9%, 35.6%, and 64.4% of ARC+AA patients, respectively.
During observation, nasal and eye symptoms improved or resolved in 82.6% and 74.7% of ARC+AA patients, while lung symptoms improved or resolved in 80.8%.
At the final visit, medication use was reduced, with 36.7% of ARC+AA patients using ARC medication (vs. 81.3% at baseline) - mainly oral antihistamines (47.2% of ARC+AA patients using ARC medication vs. 74.6% at baseline) and nasal corticosteroids (61.1% vs. 51.5%). AA medication was used by 74.2% (vs. 85.8% at baseline), mainly inhaled corticosteroids (77.6% vs. 78.7%) and inhaled short-acting beta-sympathomimetics (SABA) (38.8% vs. 47.2%). 59.5% of ARC+AA patients using any ARC medication at baseline were able to stop it (oral antihistamines: 75.8%, nasal corticosteroids: 65.2%), and 21.3% were able to stop any AA medication (inhaled corticosteroids: 37.7%, SABA: 55.2%).
Asthma control improved in 48.5% of ARC+AA patients, with well-controlled cases rising from 25.7% to 66.7%.
ADRs occurred in 24.4% of patients, while 93.4% rated tolerability as good or very good at the individual patient’s last visit.
Conclusion
In this RWD analysis, treatment with the 300 IR HDM SLIT tablet was effective and well tolerated in patients with ARC+AA, showing improved ARC and lung symptoms, reduced ARC and AA medication use and improved asthma control.
