Timothy grass SLIT-tablet is safe and well tolerated in children with allergic rhinoconjunctivitis
Published online: January 15, 2020
Allergic rhinoconjunctivitis (ARC) impacts children physically, mentally, and socially. Allergy immunotherapy (AIT) modifies the pathologic mechanisms of ARC, resulting in long-term decreases in symptoms and symptom-relieving pharmacotherapy use. AIT can also prevent the onset of asthma. Sublingual immunotherapy (SLIT)-tablets are a form of AIT that can be administered at home after the first dose, providing a convenient alternative to the in-clinic administration that is required for subcutaneous immunotherapy (SCIT). Fear of needles may also make SCIT unappealing for children. It is recommended to administer SLIT-tablets daily for at least 3 years. There is a need for increased evidence and awareness of SLIT-tablets as an alternative to SCIT. Because short-term and long-term safety and tolerability of a treatment are always of key concern to patients, caregivers, and healthcare providers, Nolte et al published results of a pooled safety analysis for the timothy grass SLIT-tablet in children in The Journal of Allergy and Clinical Immunology: In Practice.
Data from 1818 children and adolescents aged 18 years and younger in 9 randomized, double-blind, placebo-controlled clinical trials conducted in Europe and the US were included in the pooled analysis. Participants in all trials had timothy grass-induced allergic rhinitis with or without conjunctivitis, and in all but one trial participants were allowed to have non-severe asthma treated with short-acting beta-agonist alone or low-dose inhaled corticosteroid. Children in all 9 trials received the timothy grass SLIT-tablet or placebo daily and were treated for up to 3 years.
The frequency of any adverse events (AEs) with timothy grass SLIT-tablet was similar to placebo (86% and 83%, respectively) and of treatment-related AEs was higher than placebo (59% and 23%, respectively). Treatment-related AEs were primarily localized allergic reactions and most (98%) were mild-to-moderate in severity. The two most common treatment-related AEs with SLIT-tablet were oral pruritus (33%) and throat irritation (19%), which had a median onset of 1 day, a duration of 15 to 20 minutes, and a recurrence of 14.5 and 5 days, respectively. In all, 8% of children in the SLIT-tablet and 2% in the placebo groups discontinued due to AEs. There were 7 serious AEs assessed as related to SLIT-tablet, 1 systemic allergic reaction (severe reaction), and 3 epinephrine administrations. There were no anaphylactic reactions, eosinophilic esophagitis events, or serious airway obstructions. There were no notable differences in the safety profile across geographic regions or between children with and without asthma. There were no observed risks of long-term cumulative safety findings.
The data from this pooled analysis indicates that up to 3 years of timothy grass SLIT-tablet treatment is safe and well tolerated in children. Most of the side effects are early, mild, and transient localized allergic reactions, although severe systemic allergic reactions can occur, and the first dose should be administered in a healthcare setting.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.