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

Biedermann, Tilo; Couroux, Peter; Grève, T.; Mäkelä, Mika J.

doi:10.1111/all.14882

Cited by 4 publications

(5 citation statements)

References 25 publications

(56 reference statements)

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“…Forty‐three percent of the participants in the LNIT group experienced local reactions, such as sneezing, mild rhinorrhea, nasal congestion, itching, and a local burning sensation. This rate was comparable with local reactions caused by SLIT (39%−47%) 52,53 . Nickelsen et al 30,31 and Cirla et al 40 reported a high incidence of local AEs.…”

Section: Discussionsupporting

confidence: 67%

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Local nasal immunotherapy for allergic rhinitis: A systematic review and meta‐analysis

Kasemsuk

Ngaotepprutaram

Kanjanawasee

et al. 2022

Int Forum Allergy Rhinol

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Introduction Local nasal immunotherapy (LNIT), an alternative noninjection immunotherapy method, is theoretically an efficient method for inducing immunotolerance directly in the affected organ. LNIT is more convenient and less invasive than injection immunotherapy, with fewer systemic reactions. The development of adjuvants to overcome LNIT's limitations raises the possibility of it being an alternative allergen immunotherapy. Objectives To evaluate the clinical and immunological efficacy and safety of LNIT for patients with allergic rhinitis. Methods A systematic search for randomized controlled trials comparing LNIT and placebo was performed using OVID Medline and Embase. Outcomes were total nasal symptom score (TNSS), symptom–medication score (SMS), medication score, immunological assessment, and nasal provocation threshold. Data were pooled for meta‐analysis. Results A total of 20 studies with 698 participants were included. The LNIT group had greater posttreatment improvement in TNSS, SMS, and medication score than control (TNSS: standardized mean difference [SMD], –1.37 [95% confidence interval [CI], –2.04 to –0.69]; SMS: SMD, –1.55 [95% CI, –2.83 to –0.28]; and medication score: SMD, –1.09 [95% CI, –1.35 to –0.83]). Immunological assessments showed no significant differences in serum‐specific IgE (mean difference [MD], 6.35; 95% CI, –4.62 to 17.31), nasal IgE (MD, –0.59; 95% CI, –1.99 to 0.81), or nasal eosinophil cationic protein (MD, 7.63; 95% CI, –18.65 to 33.91). Only serum IgG significantly increased with LNIT (MD, 0.45; 95% CI, 0.20, 0.70). Posttreatment, nasal provocation threshold was higher with LNIT (MD, 27.30; 95% CI, 10.13–44.46). No significant adverse events were reported. Conclusions LNIT is a safe alternative allergen immunotherapy route without significant adverse events. It improves clinical symptoms, reduces medication usage, and increases the nasal provocation threshold.

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Section: Discussionsupporting

confidence: 67%

“…This rate was comparable with local reactions caused by SLIT (39%−47%). 52,53 Nickelsen et al 30,31 and Cirla et al 40 reported a high incidence of local AEs. This high incidence could be attributable to the variation of the report degree accepted by each article without the same report standard.…”

Section: Discussionmentioning

confidence: 99%

Local nasal immunotherapy for allergic rhinitis: A systematic review and meta‐analysis

Kasemsuk

Ngaotepprutaram

Kanjanawasee

et al. 2022

Int Forum Allergy Rhinol

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“…These extracts are manufactured from one or more natural allergen sources including pollens, arthropods (mites), animal sources, and venom from Hymenoptera species, and related allergens sources are often used as homologous mixtures [ 8 9 ]. Manufacturing aspects in the production of extracts such as purity, quality, representativeness of the components as well as their storage are important to ensure effectiveness and safety in AIT [ 8 10 ]. Differences in the production of natural allergen extracts frequently occur and this heterogeneity in quality could generate different findings in the clinical and molecular outcomes of AIT [ 11 ].…”

Section: Overview Of Ait Featuresmentioning

confidence: 99%

Mechanisms and biomarkers of successful allergen-specific immunotherapy

López

Imam

Satitsuksanoa

et al. 2022

Asia Pacific Allergy

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Allergen-specific immunotherapy (AIT) is considered the only curative treatment for allergic diseases mediated by immunoglobulin E (IgE). Currently, the route of administration depends both on the different types of causal allergens and on its effectiveness and safety profile. Several studies have reported the mechanisms and changes in humoral and cellular response underlying AIT; however, the full picture remains unknown. Knowledge of who can benefit from this type of treatment is urgently needed due to the patient safety risks and costs of AIT. In vivo or in vitro biomarkers have become a strategy to predict clinical outcomes in precision medicine. There are currently no standardized biomarkers that allow determining successful responses to AIT, however, some studies have found differences between responders and nonresponders. In addition, different candidates have been postulated that may have the potential to become biomarkers. In this review, we aim to summarize the findings to date related to biomarkers in different IgE-mediated allergic diseases (respiratory, food, and venom allergy) with the potential to define who will benefit from AIT.

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“…In general, treatment with the SQ tree SLIT‐tablet was well tolerated. The most frequently reported treatment‐related adverse events (AEs) were mild‐to‐moderate oral pruritus and throat irritation as local reactions related to the sublingual administration 14 …”

Section: Introductionmentioning

confidence: 99%

“…The most frequently reported treatment-related adverse events (AEs) were mild-to-moderate oral pruritus and throat irritation as local reactions related to the sublingual administration. 14 In clinical trials, patients were solely treated with the tree SLITtablet. In real-life, since many patients are poly-allergic to tree and grass pollen, co-administration of tree-and grass-AIT is common.…”

mentioning

confidence: 99%

Treatment with the SQ tree sublingual immunotherapy tablet is safe and well tolerated in real‐life

Pfaar,

Wolf,

Reiber

et al. 2024

Clinical & Translational All

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BackgroundThe SQ tree sublingual immunotherapy (SLIT)‐tablet is authorised for treatment of allergic rhinoconjunctivitis with or without asthma in trees of the birch homologous group in 21 European countries. The primary objective of this study was to explore the safety in real‐life.MethodsIn a prospective, non‐interventional post‐authorisation safety study (EUPAS31470), adverse events (AEs) and adverse drug reactions (ADRs) at first administration and follow‐up visits, symptoms, medication use, and pollen food syndrome were recorded by physicians in 6 European countries during the first 4–6 months of treatment.ResultsADRs with the SQ tree SLIT‐tablet were reported in 57.7% of 1069 total patients (median age 36.0 years, 53.7% female) during the entire observation period (severity, mild‐to‐moderate: 70.1%, severe: 4.7%, serious: 0.7%) and in 45.9% after first administration. ADRs were not increased with pollen exposure at first administration. With coadministration of the SQ tree and grass SLIT‐tablet AEs were reported in 73.8% of patients and in 52.8% with the SQ tree SLIT‐tablet alone. Nasal and eye symptoms improved in 86.9% and 80.9% of patients and use of symptomatic medication in 76.0%. PFS with symptoms was reported in 43.0% of patients at baseline and in 4.3% at the individual last visit.ConclusionsThe results of this non‐interventional safety study with the SQ tree SLIT‐tablet confirm the safety profile from placebo‐controlled clinical trials and support effectiveness in real‐life according to the published efficacy data. Safety was not impaired by pollen exposure at first administration or co‐administration with other SLIT‐tablets.

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

Cited by 4 publications

References 25 publications

Local nasal immunotherapy for allergic rhinitis: A systematic review and meta‐analysis

Local nasal immunotherapy for allergic rhinitis: A systematic review and meta‐analysis

Mechanisms and biomarkers of successful allergen-specific immunotherapy

Treatment with the SQ tree sublingual immunotherapy tablet is safe and well tolerated in real‐life

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