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Published on: June 4, 2017
Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents
Susanne Halken1, Lone Agertoft, Jürgen Seidenberg
1Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.
Insights
Sublingual immunotherapy (SLIT) tablets effectively reduced grass pollen allergy symptoms in children and adolescents. This treatment demonstrated high patient satisfaction and safety during peak pollen seasons.
Area of Science:
- Allergy and Immunology
- Pharmacology
- Clinical Medicine
Background:
- Sublingual immunotherapy (SLIT) is an established treatment for allergic rhinoconjunctivitis.
- Previous studies demonstrated the efficacy and safety of five-grass pollen 300IR SLIT tablets in pediatric patients.
- Additional data were needed to assess efficacy at pollen peak, by age group, and impact on symptoms, medication use, satisfaction, and compliance.
Purpose of the Study:
- To evaluate the efficacy and safety of five-grass pollen 300IR SLIT tablets in children and adolescents with grass pollen-allergic rhinoconjunctivitis.
- To assess treatment outcomes during the entire pollen season and specifically at the pollen peak.
- To analyze efficacy across different age groups and its effect on nasal and ocular symptoms, rescue medication use, patient satisfaction, and treatment compliance.
Main Methods:
- A multinational, randomized, double-blind, placebo-controlled study.
- Inclusion of children (5-11 yr) and adolescents (12-17 yr) with grass pollen-allergic rhinoconjunctivitis.
- Daily administration of 300IR five-grass pollen SLIT tablets or placebo in a pre- and co-seasonal protocol (4 months pre-season).
Main Results:
- Five-grass pollen 300IR SLIT demonstrated significant efficacy throughout the pollen season (p = 0.0010) and at pollen peak (p = 0.0009).
- Significant reductions in both nasal (p = 0.0183) and ocular (p < 0.0001) symptoms were observed in the SLIT group compared to placebo.
- The SLIT group showed statistically lower rescue medication use (p < 0.05), higher patient satisfaction (83.2% vs. 68.1%, p = 0.0030), and high compliance (93.9%).
Conclusions:
- Five-grass pollen 300IR SLIT tablets are effective and safe for treating grass pollen-allergic rhinoconjunctivitis in children and adolescents.
- The treatment provides benefits throughout the pollen season, including during peak allergen exposure.
- SLIT improves symptom control, reduces the need for rescue medication, and enhances patient satisfaction and adherence.
Abstract:
The efficacy and safety of five-grass pollen 300IR sublingual immunotherapy (SLIT) tablets (Stallergènes SA, France) have previously been demonstrated in paediatric patients. This report presents additional data concerning efficacy at pollen peak, efficacy and safety according to age, nasal and ocular symptoms, use of rescue medication, satisfaction with treatment and compliance. Children (5-11 yr) and adolescents (12-17 yr) with grass pollen-allergic rhinoconjunctivitis were included in a multinational, randomized, double-blind, placebo-controlled study and received either a 300IR five-grass pollen tablet or placebo daily in a pre- (4 months) and co-seasonal protocol. The severity of six symptoms (sneezing, rhinorrhoea, nasal congestion, nasal and ocular pruritis, and tearing) was scored, and rescue medication use was recorded daily during the pollen season. Patient satisfaction was recorded at the season end. A total of 161 children and 117 adolescents were evaluated (n = 267). 300IR SLIT was effective over the whole season (p = 0.0010) and at the pollen peak (p = 0.0009). The adjusted mean difference between 300IR and placebo groups was significant for both nasal (p = 0.0183) and ocular (p < 0.0001) symptoms. Rescue medication use was statistically lower in the SLIT group during the pollen season and at the pollen peak (both p < 0.05). More patients in the SLIT group were satisfied with their treatment compared to placebo (83.2% vs. 68.1%, p = 0.0030), and compliance was high (SLIT 93.9% of patients were compliant, placebo 94.8% of patients were compliant). SLIT was well tolerated by children and adolescents. 300IR five-grass pollen tablets are effective and safe during the pollen season and at the pollen peak in children and adolescents with grass pollen rhinoconjunctivitis.
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