D3.213 - Sustained effectiveness of the 300 IR house dust mite sublingual tablet over 2 treatment years in a real-world data setting – results of a non-interventional study

The real-world, non-interventional VORAN study demonstrated the effectiveness of the 300 IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet in HDM-induced allergic rhinoconjunctivitis (ARC) during the first treatment year (Y1)¹. In a subset of patients, follow-up continues for up to three years, the recommended treatment duration for allergen immunotherapy (AIT). Results from an interim analysis conducted at the end of treatment year 2 (Y2) are presented.

¹Pfaar et al. Allergy 2025;80(S114):S233

This prospective, multi-center, observational study included adults and adolescents (≥ 12 years) with moderate-to-severe HDM-induced ARC, with or without concomitant asthma. Assessments were conducted at up to 5 visits (V) in Y1 (approximately every 3 months) and once at the end of Y2. ARC symptom severity (4-point scale), ARC symptomatic medication use (yes/no), the impact of HDM allergy on sleep (11-point Likert scale), and overall patient well-being (4-point scale) were evaluated.

The analysis included 195 patients (91% adults; mean age 36.9 years; 52% male; 54% polysensitized; 38% polyallergic; 18% with asthma).

At baseline (Table), 87% of patients reported moderate-to-severe nasal symptoms and 41% moderate-to-severe eye symptoms. More than 85% used ARC symptomatic medication, mainly oral antihistamines (oAH) and nasal corticosteroids (NCS). Sleep was impacted due to HDM ARC in more than 97% of patients.

At the end of Y2 (V6), nasal symptoms improved or resolved in 93% of patients, eye symptoms in 83%, and breathing problems/lung symptoms in 84%. By V6, ARC symptomatic medication use decreased to 48%, with more than half of patients stopping all ARC symptomatic treatment (oAH: 84%, NCS: 68%). Sleep improved in > 80% of patients. Overall well-being was rated as somewhat or much better by 97% of patients at V6 (Table).

Treatment effects appeared from V2 onward, increased throughout Y1, and were sustained through the end of Y2 (Table).

Results were largely similar in patients with vs. without asthma and mono- vs. polysensitized patients.

In this real-world setting, the 300 IR HDM SLIT tablet progressively reduced the severity of allergic symptoms and ARC symptomatic medication use, and improved sleep over a two-year treatment period. Robust early improvements, evident within the first three months and consolidated during Y1, were sustained through Y2, suggesting the potential for continued benefit in Y3.