EFFICACY WITH TREE SUBLINGUAL IMMUNOTHERAPY TABLET DURING OAK POLLEN SEASON IN CHILDREN WITH ALLERGIC RHINITIS/RHINOCONJUNCTIVITIS

• Published in: Annals of allergy, asthma, & immunology Vol. 133; no. 6; p. S18
• Main Authors: Nolte, H., Gappa, M., Pfaar, O., Bennett, J. Kress, Hargreaves, K., Dalgaard, T.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01-11-2024
• ISSN: 1081-1206
• DOI: 10.1016/j.anai.2024.08.083

Oak pollen, a member of the birch homologous group, is an important cause of allergic rhinitis and/or conjunctivitis (AR/C) in the US. The efficacy and safety of the tree sublingual immunotherapy (SLIT)-tablet during oak pollen season was determined in children with AR/C.
Children (N=952) ages 5-17 years with moderate-to-severe tree AR/C were randomized to either daily tree SLIT-tablet or placebo for up to 12 months in a phase 3, double-blind trial (EudraCT2020-004372-17). Subjects had free access to symptom-relieving medication. The primary endpoint was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during birch pollen season (BPS). The average TCS during oak pollen season (OPS) was a secondary endpoint.
During BPS, the TCS improved by 21.9% (95% CI: 10.6-31.9) versus placebo (mean difference=1.3; p=0.0004). During OPS, the TCS improved with tree SLIT-tablet by 25.6% (13.9, 36.0) versus placebo (mean difference=1.5; p<0.0001), the DSS improved by 17.8% (5.2, 28.9; p=0.008) and the DMS improved by 39.9% (23.2, 53.7; p<0.0001; Figure).
Most (>99%) treatment-related adverse events were mild-to-moderate and were primarily local application site reactions; 2.7% of subjects discontinued the tree SLIT-tablet due to adverse events. No eosinophilic esophagitis cases were reported. One subject experienced symptoms of an anaphylactic reaction within 4 minutes after the first tree SLIT-tablet dose, was treated with epinephrine, and recovered within 2 hours.
A significant clinical effect during birch and oak pollen seasons with the tree SLIT-tablet was demonstrated in children with AR/C. Treatment was generally well tolerated.