Safety of the SQ Tree Sublingual Immunotherapy Tablet: Pooled safety
analysis of clinical trials
Abstract
Background: The SQ tree SLIT-tablet has recently been approved
for treatment of tree pollen allergy. Health care workers should be
provided with detailed safety data for clinical use. Objective:
To assess the tolerability and safety of the SQ tree SLIT-tablet in
adults and adolescents. Methods: Safety data were pooled from
two phase-II and one phase-III double-blinded, randomized,
placebo-controlled trials including adults and adolescents with allergic
rhinitis and/or conjunctivitis treated before and during one pollen
season once-daily with the SQ tree SLIT-tablet (12 SQ-Bet) or placebo.
Results: The most frequently reported 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 PFS subjects (45%) than in subjects without PFS (29%).
A greater proportion of PFS subjects interrupted treatment (19%) than
subjects without PFS (7%). 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.