The standardised quality (SQ) treesublingual immunotherapy (SLIT)-tablet has recently been approved for treatment of tree pollen allergy. Health care workers should be providedwith detailed safety data for clinical use.
To assess the tolerability and safety of the SQ tree SLIT-tablet (12 SQ-Bet)in adults and adolescents.
Safety data were pooled fromthree double-blinded, randomized, placebo-controlled trials (2 phase-II/1 phase-III) including adults and adolescents 12-65 years with allergic rhinitis and/orconjunctivitis treated before and during one pollen season once-daily with 12 SQ-Bet (n=471) or placebo (n=458): EudraCTno:2012-000031-59; NCT02481856; EudraCT 2015-004821-15.
The most frequently reportedinvestigational 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.
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.

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