ASCIA‐P51: SAFETY OF 300IR 5‐GRASS POLLEN SUBLINGUAL TABLET FOR THE TREATMENT OF GRASS POLLEN‐INDUCED ALLERGIC RHINOCONJUNCTIVITIS IN ADULTS AND PEDIATRIC SUBJECTS WITH INTERMITTENT ASTHMA

Abstract

Background: Allergic asthma is frequently associated with grass polleninduced allergic rhinoconjunctivitis (ARC). Here we present the safety experience across the development program for the 300IR 5‐grass pollen sublingual tablet by asthma status. Methods: Subjects with medically confirmed grass pollen‐induced ARC were included in one of seven double‐blind studies. Those with intermittent asthma not requiring treatment other than inhaled beta‐2 agonists (GINA treatment Step 1) could participate. Adverse events (AEs) pooled from the studies were analyzed descriptively. Asthma status was recorded at randomization. Results: The analysis included 1,878 adults and 312 pediatric subjects. Of these, 328 (17%) adults (300IR = 179, Placebo = 149) and 66 (21%) pediatrics (300IR = 32, Placebo = 34) had intermittent asthma at baseline. Percentages of actively‐treated subjects reporting drug‐related AEs were similar in those with and without asthma (adults: 59% vs. 58%; pediatrics: 53% for both). In both subsets, the respective incidences of AEs leading to discontinuation (mostly application‐site reactions) were 6.7% vs. 4.3% (adults) and 3.1% vs. 4.9% (pediatrics). Of the subjects with asthma, 60 adults (300IR: 31/179 [17%]; Placebo: 29/149 [19%]) and 29 pediatrics (300IR: 14/32 [44%]; Placebo: 15/34 [44%]) reported an AE of asthma or a related symptom during treatment. Two actively‐treated participants (including one pediatric) and 9 who received placebo (including one pediatric) were administered oral corticosteroids as treatment for an AE suggestive of asthma. There were no serious drug‐related AEs in any subject with asthma who received 300IR. Conclusion: Treatment with 5‐grass pollen sublingual tablet had a similar safety and tolerability profile in adults and children whether they had or not intermittent asthma.