Grass Pollen Tablet AEs Spontaneously Resolve in Pediatric Allergic Rhinitis
The most common adverse drug reactions associated with the grass pollen tablet included throat irritation, oral paresthesia, and oral pruritus.
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SEATTLE — In immunotherapy-naive children with grass pollen-induced allergic rhinitis treated with a sublingual 300IR 5-grass pollen tablet, adverse drug reactions (ADRs) occurred in approximately half of patients but typically resolved within a week of treatment, according to research presented at the 2018 Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology held in Seattle, November 15-19, 2018.
A total of 307 children aged 5 to 9 years (mean age, 7.1 years) with grass pollen-induced allergic rhinitis with and without conjunctivitis who were seen at multiple centers and who had not been previously treated with immunotherapy were enrolled in the observational study (ClinicalTrials.gov Identifier: NCT02295969). Participants were prescribed a 3-day dose escalation of a daily 300IR tablet. Researchers assessed for ADRs throughout the first 30 treatment days following informed consent.
Approximately 56% (n=173) of patients experienced ADRs within the first month of treatment. The majority of reactions involved the application site. Overall, most of the patients reporting ADRs (93%) resolved spontaneously and without intervention. The majority of patients (83%) experienced the first ADR within the first week of taking the drug. In the entire cohort, the median time to ADR onset was 3.0 days. The median duration of each ADR that occurred within 24 hours of treatment initiation was 4.7 days.
The most common ADRs associated with the daily 300IR tablet included throat irritation, oral paresthesia, and oral pruritus, with a median onset time of 2.5 days, 2.0 days, and 2.0 days, respectively. ADR recurrence was reported in 26% of patients (n=45), with the most common recurrences including throat irritation (12%), oral paresthesia (5%) and tongue pruritus (3.5%). Recurrent ADRs also resolved quickly; each of the most common ADR recurrences lasted a median of 1 day, 2 days, and 4 hours, respectively.
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Geng B, Gerstlauer M, Szepfalusi Z, de Blic J. Pediatric observational study of 300IR 5-grass tablet in grass pollen-induced allergic rhinoconjunctivitis: further safety data. Presented at: the Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology; November 15-19, 2018; Seattle, WA. Poster P113.