Safety of 300IR 5-Grass Tablet in Children with Grass Pollen-Induced Allergic Rhinoconjunctivitis: Results of an Observational, Post-Marketing Safety Study
Monday, March 5, 2018
South Hall A2 (Convention Center)
Michael Gertslauer, MD, Zsolt Szepfalusi, MD, David B.K. Golden, MD FAAAAI, Agnès Viatte, Michel Melac, MD, Kathy Abiteboul, PharmD, Jacques de Blic, MD
Rationale: We report safety data of 300IR 5-grass pollen tablet* from a post-marketing study conducted in grass pollen-allergic children in Europe. Methods: This multicenter, observational study included allergy immunotherapy-naïve children 5 to 9 years old with grass pollen-induced allergic rhinitis (AR) with/without conjunctivitis prescribed with 300IR tablet daily. Patients whose parent/legal guardian provided written consent were followed for safety and tolerability during the first 30 treatment days. Adverse reactions (ADRs) were analyzed descriptively. Results: 307 children (mean age: 7.1 years, SD: 1.42) were enrolled in 2015-2016: 71% were males, 70% polysensitized. The mean duration of their AR was 2 years. 76% had conjunctivitis, 36% had asthma. Over the first treatment month, 173 (56%) patients reported ADRs, most frequently application-site reactions (e.g., throat irritation, oral pruritus, oral paresthesia), mild in 73% of ADRs, moderate in 24%. ADRs occurred in 20% patients on Day 1, 14% on Day 2, 34% within Day 3-Day 10. 16 (5.2%) patients discontinued due to ADRs: application-site reactions in 3.3%. Two patients reported serious reactions. One experienced oral pruritus, mild urticaria and asthmatic attack (grade II anaphylaxis, Day 5), received oral antihistamine/inhaled salbutamol and resumed treatment. The other developed severe lip and eye swelling (angioedema, Day 26) resolved within six hours with IV antihistamine/corticosteroid. She was hospitalized overnight. No epinephrine use nor ICU was reported. Conclusions: Over the first treatment month, the safety profile of the 300IR tablet in 5 to 9-year-old children was consistent with that previously observed in pre- and post-marketing settings. *The US indication is for patients 10-65.