D2.218 - Effectiveness of the 300IR house dust mite sublingual tablet according to the patients’ sensitisation and allergy profile in the real-world, non-interventional VORAN study

The efficacy and safety of the 300IR house dust mite (HDM) sublingual (SLIT) tablet has been shown in randomised controlled studies in HDM-induced allergic rhinoconjunctivitis (ARC), whether patients were mono- or poly-sensitised (MS/PS) and/or mono- or poly-allergic (MA/PA). Here we investigated the effectiveness of the 300IR HDM SLIT-tablet in subgroups of patients according to their baseline sensitisation and allergy profile in the real-world, non-interventional study VORAN.

This large prospective, multicentre, observational study conducted in Germany and Austria included adults and adolescents ≥12 years with moderate to severe HDM ARC with controlled allergic asthma (AA) or without AA. In MS/PS and/or MA/PA patients, severity of symptoms, use of symptomatic medication, impact of HDM allergy on sleep (10-point Likert scale: 0 - not at all to 10 - extremely), and patient well-being were explored during the first treatment year.

Of the 782 analysable patients, 63.3% were PS (of whom 69.3%, 60.2% and 42.7% co-sensitised to grasses/rye, tree pollen, and animal dander, respectively) and 47.9% were PA (of whom 65.9%, 57.3%, and 31.7% with concomitant allergy to grass, tree pollen and animal dander, respectively).

At baseline (Visit 1), patients were affected by moderate to severe nasal and eye symptoms in similar proportions whichever their sensitisation and allergy profile, while PS/PA reported more moderate to severe lung symptoms than their mono-S/-A counterparts (Table). PS/PA patients took slightly more symptomatic ARC medication (mainly antihistamines) than MS/MA. HDM allergy impaired sleep in >90.0% of cases, regardless of the patient profile.

At the end of the first treatment year, most patients in all subgroups (76%–90%) reported either being free of symptoms or experiencing improvement in nasal, eye and lung symptoms without marked differences between the groups. Symptomatic medication use decreased, with more than 5/10 patients able to discontinue any ARC medication (oral antihistamines: 75.9%–79.5%, nasal corticosteroids: 56.1%–70.4%). Treatment led to improved sleep in ≥75% of patients. More than 90% of patients assessed their well-being as much better or somewhat better.

In this large real-world study, the 300IR HDM SLIT-tablet effectively reduced allergic symptoms and symptomatic medication use and improved sleep in adults and adolescents in all subgroups.