Background : Allergic asthma is frequently associated with grass pollen-induced allergic rhinoconjunctivitis. Aims and objectives : To present the safety experience with the 5-grass pollen extract sublingual tablet in patients with and without asthma. Methods : Patients with asthma controlled by GINA step 1 therapy were eligible for participation in the development program for rhinoconjunctivitis. Safety data were pooled from 8 randomised, DBPC trials: 6 natural field studies in which treatment was administered 2 or 4 months pre- and co-seasonally and 2 studies conducted outside the pollen season. Adverse events (AEs) were analysed descriptively. AE terms were screened for those suggestive of asthma (e.g. asthma, cough, dyspnoea, and wheeze). The associated AE reports were reviewed in patients with asthma at randomisation. Results : 2200 adults and 312 children/adolescents were included in the safety database. Of these, 1514 received active treatment and 998 placebo. Asthma as an AE was reported at a similar incidence in the active (3.6%) and placebo (4.7%) groups. 425 (17%) participants had intermittent asthma at baseline. The safety profile was similar in patients with and without asthma. Overall, 99 patients with asthma (Active 53/242;22% and Placebo 46/183;25%) reported an AE of asthma or a related symptom during treatment. Three participants in the active group and 10 in the placebo group were administered oral corticosteroids as treatment for an AE suggestive of asthma. Conclusion : The 5-grass pollen sublingual tablet has a favourable safety and tolerability profile in patients with intermittent asthma.
