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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.
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.
Allergy - European Journal of Allergy and Clinical Immunology
Safety of the SQ Tree Sublingual Immunotherapy Tablet: Pooled safety analysis of clinical trials
Tilo Biedermann et al.
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