Peer-reviewed article
Efficacy and safety of the tree sublingual immunotherapy tablet in the subpopulation of Canadian children with allergic rhinitis and/or conjunctivitis: phase III trial results.
Gagnon R, Dalgaard T, Ortving GS, Gappa M, Nolte H ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This peer-reviewed clinical trial reports on the efficacy and safety of a tree pollen sublingual immunotherapy tablet in Canadian children aged 5-17 with allergic rhinitis and conjunctivitis. The study was a phase III double-blind randomized controlled trial that measured symptom reduction over a 52-week period. The treatment showed statistically significant symptom reductions compared to placebo in multiple pollen seasons, with good tolerability. However, this research addresses allergic disease management rather than core child well-being domains.
Key points
- The tree SLIT-tablet reduced average total combined symptom scores by 26.8-50.6% versus placebo depending on pollen season in the Canadian subpopulation (n=87)
- Reductions in both daily symptom scores and daily medication scores were observed with treatment
- The intervention was well tolerated with no safety concerns reported in the trial population
- Results were statistically significant for tree pollen season, oak pollen season, and pure oak pollen season endpoints
- The trial included 87 Canadian children and adolescents as part of a larger international phase III study (N=952)
Limitations
This is a treatment efficacy study for allergic disease management and does not evaluate interventions addressing core dimensions of child well-being such as survival, development, protection, or participation. The document provides no information on how allergic rhinitis/conjunctivitis affects broader child health outcomes or quality of life.
Abstract
Background Pollen from birch and other trees in the birch homologous group (e.g., oak) is a common trigger of allergic rhinitis and/or conjunctivitis (AR/C) in Canada. The efficacy and safety of the tree sublingual immunotherapy (SLIT)-tablet in children with AR/C was evaluated post hoc in the Canadian subpopulation of a phase III, double-blind trial (EudraCT2020-004372-17). Methods Children and adolescents aged 5-17 years with moderate-to-severe tree AR/C were randomized to either daily tree SLIT-tablet or placebo for up to 52 weeks. Participants 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). Average TCS during tree pollen season (TPS, consisting of birch, alder, hazel, and oak pollen seasons), oak pollen season (OPS), and pure OPS (excluding days from birch, alder, or hazel pollen seasons) were also analyzed. Results In the Canadian subpopulation (n = 87), treatment with the tree SLIT-tablet reduced the average TCS by 26.8% versus placebo during BPS (absolute difference [95% CI] = 1.89 [-0.71, 4.49], p = 0.138), 32.0% during TPS (absolute difference = 2.14 [-0.03, 4.32], p = 0.042), 46.6% during OPS (absolute difference = 3.70 [0.98, 6.42], p = 0.004), and 50.6% during pure OPS (absolute difference = 4.20 [1.12, 7.27], p = 0.005). Reductions in DSS and DMS with tree SLIT-tablet versus placebo were also observed. In the total trial population (N = 952), tree SLIT-tablet treatment reduced the average TCS by 19.2% versus placebo during BPS (absolute difference = 1.13 [0.42, 1.84], p = 0.002), 16.8% during TPS (absolute difference = 0.76 [0.26, 1.26], p = 0.003), 23.4% during OPS (absolute difference = 1.32 [0.60, 2.05], p < 0.001), and 19.9% during pure OPS (absolute difference = 1.03 [0.27, 1.80], p = 0.009). The tree SLIT-tablet was well tolerated in the total trial and Canadian subgroup populations. Conclusions The tree SLIT-tablet demonstrated favorable efficacy and was well tolerated in Canadian children and adolescents with AR/C. Clinical trial registration EudraCT 2020-004372-17 and NCT04878354.