Safety of Timothy Grass Sublingual Immunotherapy Tablet in Children: Pooled Analyses of Clinical Trials

Halken, Susanne; Roberts, Graham; Valovirta, Erkka; Nolte, Hendrik; Hulstrøm, Veronica; Blaiss, Michael S.

doi:10.1016/j.jaip.2020.01.008

Cited by 15 publications

(15 citation statements)

References 29 publications

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“…The results confirm previous safety findings with other SQ sublingual immunotherapy tablets. A grass SLIT‐tablet showed a similar safety profile dominated by local allergic application‐site reactions primarily in the oral cavity and throat of mild or moderate severity with an early onset and transient and self‐resolving AEs 17,18 . Also, the safety profile of a house dust mite SLIT‐tablet revealed transient, mild local allergic reactions representing the most commonly occurring adverse reactions 19 …”

Section: Discussionmentioning

confidence: 97%

“…The studies included in the present pooled safety analysis were all short‐term studies conducted during one pollen season. No long‐term studies have been conducted with the SQ tree SLIT‐tablet; however, long‐term studies with the grass SLIT‐tablet have revealed a favourable safety profile and long‐term treatment effect 18,25 …”

Section: Discussionmentioning

confidence: 99%

“…No longterm studies have been conducted with the SQ tree SLIT-tablet; however, long-term studies with the grass SLIT-tablet have revealed a favourable safety profile and long-term treatment effect. 18,25…”

Section: Discussionmentioning

confidence: 99%

“…A grass SLIT-tablet showed a similar safety profile dominated by local allergic application-site reactions primarily in the oral cavity and throat of mild or moderate severity with an early onset and transient and self-resolving AEs. 17,18 Also, the safety profile of a house dust mite SLIT-tablet revealed transient, mild local allergic reactions representing the most commonly occurring adverse reactions. 19 Around 70% of individuals with birch pollen allergy develop pollen food syndrome (PFS), 1 and in the present study, 64% of subjects The present data suggest no increased risk of asthma events among all subjects treated with 12 SQ-Bet.…”

Section: Discussionmentioning

confidence: 99%

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

Biedermann

Couroux

Grève

et al. 2021

Allergy

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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.

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

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

Biedermann

Couroux

Grève

et al. 2021

Allergy

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“…It has been estimated that SLIT is used in 45 % of patients receiving allergen immunotherapy 7 , and the safety profile of SLIT appears to be favourable when compared with subcutaneous immunotherapy (SCIT) [7][8][9][10] . Anaphylactic reactions occur with SLIT as well as SCIT products, but they are more frequently observed with SCIT products.…”

Section: Introductionmentioning

confidence: 99%

Safety of the SQ Tree Sublingual Immunotherapy Tablet: Pooled safety analysis of clinical trials

Biedermann

Couroux

Greve³

et al. 2020

Preprint

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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. TitleSafety of the SQ Tree Sublingual Immunotherapy Tablet: Pooled safety analysis of clinical trials [title is 97 characters including spaces (should be less than 100).] Short running titleSafety of the SQ tree SLIT-tablet 34 characters including spaces (less than 50 characters).

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Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations?

Field

Blaiss

2020

Curr Allergy Asthma Rep

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Safety of Timothy Grass Sublingual Immunotherapy Tablet in Children: Pooled Analyses of Clinical Trials

Cited by 15 publications

References 29 publications

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

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

Safety of the SQ Tree Sublingual Immunotherapy Tablet: Pooled safety analysis of clinical trials

Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations?

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