Main idea: The safety profile of 5-grass tablet in pediatric allergic rhinitis patients aged 5 to 9 years was consistent with safety findings in older patients.
Although 5-grass pollen sublingual immunotherapy has a good safety profile in controlled clinical trials, additional safety information among pediatric patients in a real-world setting would be useful.
The objective of the study was to document the safety of 5-grass tablet among children aged 5 to 9 years with allergic rhinoconjunctivitis.
This multi-center, observational study included allergy immunotherapy-naïve 5- to 9-year-old children with grass pollen-induced allergic rhinoconjunctivitis prescribed with 5-grass tablet daily (3-day dose escalation to 300 indexes of reactivity [IR]). Patients were followed up daily for safety and tolerability over the first 30 treatment days.
Results: Three hundred seven children (mean age, 7.1 years) were enrolled. 58% were confirmed as polysensitized, and 36% had mild-to-moderate asthma. Of 307 patients 233 (76%), some patients had side effects including throat irritation, oral pruritus, oral paresthesia. 16 of 307 (5.2%) patients withdrew because of side effects. More than half of the side effects lasted less than 2 days.