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Safety of the SQ Tree Sublingual Immunotherapy Tablet: Pooled safety analysis of clinical trials
  • +1
  • Tilo Biedermann,
  • Peter Couroux,
  • Tina Greve,
  • Mika Makela
Tilo Biedermann
Technische Universit√§t M√ľnchen
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Peter Couroux
Inflamax Research Inc
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Tina Greve
ALK
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Mika Makela
University of Helsinki, the Skin and Allergy Hospital
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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.

Peer review status:Published

23 Sep 2020Submitted to Allergy
26 Sep 2020Submission Checks Completed
26 Sep 2020Assigned to Editor
28 Sep 2020Reviewer(s) Assigned
16 Oct 2020Review(s) Completed, Editorial Evaluation Pending
16 Oct 2020Editorial Decision: Revise Minor
12 Feb 20211st Revision Received
13 Feb 2021Assigned to Editor
13 Feb 2021Submission Checks Completed
15 Feb 2021Reviewer(s) Assigned
19 Feb 2021Review(s) Completed, Editorial Evaluation Pending
26 Feb 2021Editorial Decision: Revise Minor
19 Mar 20212nd Revision Received
22 Mar 2021Submission Checks Completed
22 Mar 2021Assigned to Editor
25 Mar 2021Reviewer(s) Assigned
04 Apr 2021Review(s) Completed, Editorial Evaluation Pending
07 Apr 2021Editorial Decision: Accept
27 Apr 2021Published in Allergy. 10.1111/all.14882