D3.184 - Treatment with the 300 IR house dust mite sublingual tablet is safe and well tolerated in adults and adolescents in a real-world data setting – results of a non-interventional post authorization safety study
Background
The efficacy and safety of the 300 IR house dust mite (HDM) sublingual tablet have been demonstrated in double-blind, placebo-controlled (DBPC) clinical trials. Following approval in 21 European countries, this non-interventional post authorization safety study (PASS) explored treatment with the 300 IR HDM SLIT tablet in a real-world data (RWD) setting in Germany and Austria.
Method
This large prospective, multi-center PASS (VORAN study; EUPAS 44205) investigated 300 IR HDM SLIT tablet treatment in adults and adolescents aged 12 to 17 years suffering from moderate to severe HDM-induced allergic rhinoconjunctivitis (ARC) with or without concomitant controlled asthma. The primary objective was to assess safety and tolerability during the patients’ first year of treatment. Adverse events/adverse drug reactions and tolerability were recorded by physicians in up to 5 visits.
Results
782 patients were included in the analyses (710 adults, 71 adolescents; mean age 35.9 years, 51.0% female, 63.3% polysensitized, 47.9% polyallergic, 20.8% with concomitant asthma).
Adverse drug reactions (ADRs) were reported in 153 patients (19.6%) during the entire observation period. In 0.8% of patients ADRs were considered as serious.
The majority of ADRs were gastrointestinal disorders, including local reactions at the application site, reported in 15.7% of all patients (most common ADRs, affecting ≥ 1.5% of all patients: oedema mouth, lip oedema, paraesthesia oral, dyspepsia), and respiratory disorders, affecting 6.9% of all patients (most common ADRs: throat irritation). The severity of ADRs was assessed as mild-to-moderate in the majority of patients with ADRs, severe ADRs were reported in 4.7% of all patients. During the observation period, 10.0% of all patients discontinued treatment due to ADRs.
Overall, treatment was well tolerated, with 93.2% rating tolerability as very good or good at the individual patient’s last visit.
Results were largely similar between adults and adolescents (see Tab. 1).
Conclusion
In this RWD analysis, treatment with the 300 IR HDM SLIT tablet was well-tolerated and safe in adults and adolescents suffering from HDM-induced ARC with or without concomitant asthma, confirming the results of DBPC clinical trials.
