Abstract
Background: The standardized quality (SQ) tree sublingual immunotherapy (SLIT)-tablet has recently been approved for treatment of tree pollen allergy. Healthcare workers should be provided with detailed safety data for clinical use. Objective: To assess the tolerability and safety of the SQ tree SLIT-tablet (12 SQ-Bet) in adults and adolescents. Methods: Safety data were pooled from three double-blinded, randomized, placebo-controlled trials (2 phase-II/1 phase-III) including adults and adolescents 12–65 years with allergic rhinitis and/or conjunctivitis treated before and during one pollen season once-daily with 12 SQ-Bet (n = 471) or placebo (n = 458): EudraCT no: 2012-000031-59; NCT02481856; EudraCT 2015-004821-15. Results: The most frequently reported investigational medicinal product (IMP)-related AEs with 12 SQ-Bet were oral pruritis (39% of subjects) and throat irritation (29%). IMP-related AEs were mainly mild or moderate in severity, and the majority resolved without treatment and did not lead to treatment interruption/discontinuation. With 12 SQ-Bet, oral pruritus was more frequent among subjects with pollen food syndrome (PFS) (45%) than without PFS (29%). The 12 SQ-Bet did not seem to induce an increased risk of asthma: 7 events were reported in 7 subjects with 12 SQ-Bet and 11 in 10 subjects with placebo. No differences were seen in the risk of moderate-to-severe IMP-related AEs regardless of age, PFS status and asthma medical history. Conclusions: The 12 SQ tree SLIT-tablet was well tolerated in tree pollen allergic subjects with no major safety concerns detected. This safety profile supports daily at-home sublingual administration once the first dose is tolerated when administered under medical supervision.
Original language | English |
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Pages (from-to) | 3733-3742 |
Number of pages | 10 |
Journal | Allergy: European Journal of Allergy and Clinical Immunology |
Volume | 76 |
Issue number | 12 |
DOIs | |
State | Published - Dec 2021 |
Keywords
- allergy treatment
- food allergy
- pollen
- rhinitis
- vaccines