Safety of the standardized quality tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials

Tilo Biedermann, Peter Couroux, Tina Maria Greve, Mika Mäkelä

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

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 languageEnglish
Pages (from-to)3733-3742
Number of pages10
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume76
Issue number12
DOIs
StatePublished - Dec 2021

Keywords

  • allergy treatment
  • food allergy
  • pollen
  • rhinitis
  • vaccines

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