PEDIATRIC OBSERVATIONAL STUDY OF 300IR 5-GRASS TABLET IN GRASS POLLEN–INDUCED ALLERGIC RHINOCONJUNCTIVITIS: FURTHER SAFETY DATA

Abstract

Introduction We report further safety data from a European post-marketing study of 300IR 5-grass pollen tablet* in grass pollen–allergic children. Methods Immunotherapy-naïve children (5-9 years) with grass pollen–induced allergic rhinitis (GP-AR) with/without conjunctivitis were prescribed 300IR tablet daily (3-day dose escalation) in this multicenter observational study (NCT02295969). After informed consent, patients were followed-up over the first 30 treatment days. Adverse drug reactions (ADRs) were analyzed descriptively. Results 307 children (mean age: 7.1 years) were enrolled. As previously reported, 173/307 (56%) patients had ADRs (generally application-site reactions) during the first treatment month. Of these 161/173 (93%) resolved spontaneously. In 143/173 (83%) patients, ADRs first occurred within one week of starting treatment. The median time to onset of most common ADRs was 3.0 days. Throat irritation, oral pruritus, and oral paresthesia occurred 2.5, 2.0, and 2.0 days (respective medians) following initiation. Median duration of ADRs arising within the first 24 hours was 4.7 days. ADR recurrences were reported in 45/173 (26%) patients. These were most frequently throat irritation (in 21/173 [12%]), oral paresthesia (in 9/173 [5%]) and tongue pruritus (in 6/173 [3.5%]) which resolved shortly after starting (median duration of 1 day, 2 days, and 4 hours, respectively). Conclusions Over the first treatment month for this pediatric GP-AR population, ADRs presented in approximately half of the patients, occurred within a few days after starting treatment, and generally resolved within a week. ADR recurrences were reported in approximately a quarter of the patients. We report further safety data from a European post-marketing study of 300IR 5-grass pollen tablet* in grass pollen–allergic children. Immunotherapy-naïve children (5-9 years) with grass pollen–induced allergic rhinitis (GP-AR) with/without conjunctivitis were prescribed 300IR tablet daily (3-day dose escalation) in this multicenter observational study (NCT02295969). After informed consent, patients were followed-up over the first 30 treatment days. Adverse drug reactions (ADRs) were analyzed descriptively. 307 children (mean age: 7.1 years) were enrolled. As previously reported, 173/307 (56%) patients had ADRs (generally application-site reactions) during the first treatment month. Of these 161/173 (93%) resolved spontaneously. In 143/173 (83%) patients, ADRs first occurred within one week of starting treatment. The median time to onset of most common ADRs was 3.0 days. Throat irritation, oral pruritus, and oral paresthesia occurred 2.5, 2.0, and 2.0 days (respective medians) following initiation. Median duration of ADRs arising within the first 24 hours was 4.7 days. ADR recurrences were reported in 45/173 (26%) patients. These were most frequently throat irritation (in 21/173 [12%]), oral paresthesia (in 9/173 [5%]) and tongue pruritus (in 6/173 [3.5%]) which resolved shortly after starting (median duration of 1 day, 2 days, and 4 hours, respectively). Over the first treatment month for this pediatric GP-AR population, ADRs presented in approximately half of the patients, occurred within a few days after starting treatment, and generally resolved within a week. ADR recurrences were reported in approximately a quarter of the patients.