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| |  Children and Adolescents With Grass-Pollen-Allergic Rhinoconjunctivitis Benefit Similarly From 5-Grass Sublingual Monotherapy: Presented at EAACI By Judith Moser, MD WARSAW, Poland -- June 11, 2009 -- Children and adolescents with grass-pollen-allergic rhinoconjunctivitis benefit similarly from treatment with a 5-grass pollen sublingual monotherapy (SLIT) tablet at a potency level of 300 on the index of reactivity (300IR), according to results of a phase 3 trial presented here at the 28th Congress of the European Academy of Allergy and Clinical Immunology (EAACI). Additionally, there were no significant differences in safety profiles between the age classes. The efficacy and safety of a 5-grass pollen 300IR SLIT tablet has recently been confirmed in this population, and researchers wished to determine the role of paediatric age on the efficacy and safety of this therapy as a pre- and co-seasonal treatment. “Children were randomised into 2 age categories -- 5 to 11 years and 12 to 17 years,” reported Jürgen Seidenberg, MD, Clinic of Pediatric Pulmonology and Allergy, Elisabeth Children’s Hospital, Klinikum Oldenburg, Oldenburg, Germany, who presented results of the phase 3 study here at a poster session on June 9. Two hundred seventy-eight children and adolescents with grass-pollen-related rhinoconjunctivitis were included. The intention-to-treat population comprised 266 participants. Treatment was performed with once-daily 5-grass pollen 300 IR SLIT tablets (n = 131) or placebo tablets (n = 135) taken 4 months prior to and then throughout the pollen season. Each symptom was evaluated by the patients on a daily basis (with parental assistance for the youngest) on a 4-point scale from 0 (absent) to 3 (severe). “Efficacy was similar in both age groups,” said Dr. Seidenberg. “The median improvement in the average rhinoconjunctivitis total symptom score was 39.4% in the younger group and 35% in the older group.” In both age categories, the average rhinoconjunctivitis total symptom score was lower in the 300IR group than in the placebo group (12 to 17 years: 3.77 and 4.98, respectively; 5 to 11 years: 2.94 and 4.08, respectively). The difference between treatment and placebo tablets was significant for rhinorrhoea (P = .038), nasal congestion (P = .0012), ocular pruritus (P < .0001), and watery eyes (P = .0008). Improvements in sneezing and nasal pruritus were not statistically significant. Side effects were assessed according to age, as well, and no difference was seen between the younger and the older children in this respect. “We did a minor subanalysis within the age group of 5 to 11 years, and found similar safety profiles in the age groups 5 to 8 and 8 to 11,” Dr. Seidenberg added. The most frequent treatment-emergent adverse events were local reactions, which were expected, and were generally mild or moderate in intensity. Funding for this study was provided by Stallergenes GmbH. [Presentation title: Efficacy and Safety of a 300IR Five-Grass Pollen SLIT Tablet in Children and Adolescents With Grass Pollen Rhinoconjunctivitis. Abstract 334]
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