As per this pooled analysis comprising of 471 individuals with allergic rhinitis and/or conjunctivitis, the safety profile of the recently approved standardised quality tree sublingual immunotherapy tablet supported its everyday, at-home sublingual administration once the first dose is tolerated when used under proper guidance of a physician.

To estimate the tolerability and safety of European approved- standardised quality (SQ) tree sublingual immunotherapy (SLIT)-tablet (12 SQ-Bet) in people with allergic rhinitis and/or conjunctivitis.

Safety data were pooled from 3 randomized controlled trials (2 phase-II and 1 phase-III) comprising of 471 adults and adolescents in the age group of 12 to 65 years with allergic rhinitis and/or conjunctivitis treated before and through one pollen season with 12 SQ-Bet taken one time per day. The placebo group had 458 individuals.

With the use of 12 SQ-Bet, 39% patients reported having oral pruritis and 29% as having throat irritation deemed as the most commonly described investigational medicinal product (IMP)-linked adverse events (AEs). These were of mild or moderate severity, with majority of them resolving without any treatment and did not lead to treatment disturbance or withdrawal. Oral pruritus was more common among individuals with pollen food syndrome (PFS) (45%) as compared to without PFS (29%). Use of 12 SQ-Bet did not seem to provoke an increased asthma risk. 

12 SQ tree SLIT-tablet usage was regarded as well-tolerated in individuals with pollen allergies with no major AEs.