An observational, real‐life safety study of a 5‐grass pollen sublingual tablet in children and adolescents

Eberle, Peter; Brueck, Helmut; Gall, Ralph; Hadler, Meike; Sieber, Jochen; Karagiannis, E.

doi:10.1111/pai.12298

Cited by 18 publications

(23 citation statements)

References 19 publications

(29 reference statements)

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“…Longitudinal studies and meta-analyses in adults (112) showed that a SLIT tablet containing five-grass pollens 300-IR is well tolerated and effective in reducing AR and conjunctivitis symptoms. Studies in pediatric populations have confirmed these benefits of preand co-seasonal treatments (113,114). Significant effects were identified on symptom scores and medication scores in treated patients compared with the placebo group (115).…”

Section: Allergen-specific Immunotherapymentioning

confidence: 85%

Asthma and allergic rhinitis in childhood: what's new

Mastrorilli

Posa

Cipriani

et al. 2016

Pediatric Allergy Immunology

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Novel approaches are currently offered for the diagnostic workup and therapeutic management of allergic rhinitis and asthma. New predictive biomarkers of allergy and asthma are available. Primary and secondary prevention, earlier intervention, and modification of the natural history of allergic rhinitis and asthma are being intensively investigated. This review highlights advances in the understanding of the etiology, diagnosis, and management of atopic airway diseases in childhood, as well as prenatal and early-life risk factors and strategies for prevention.

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Section: Allergen-specific Immunotherapymentioning

confidence: 85%

Asthma and allergic rhinitis in childhood: what's new

Mastrorilli

Posa

Cipriani

et al. 2016

Pediatric Allergy Immunology

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show abstract

“…Non-interventional studies are, for example, suitable for investigating under real-life conditions the safety and tolerability of a drug that has been authorized for use. Two previous real-life studies have been performed with the 5-grass pollen tablet [19, 20]. These studies, one in children/adolescents and one in adults, were principally concerned with safety/tolerability.…”

Section: Introductionmentioning

confidence: 99%

Management of Grass Pollen Allergy with 5-Grass Pollen Tablet: Results of a 2-Year Real-Life Study

Shah‐Hosseini

Krudewig

Hadler³

et al. 2017

Adv Ther

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IntroductionAllergen immunotherapy is the only treatment option for allergic rhinitis with disease-altering potential. It was the objective of this study to assess the effectiveness and tolerability of a 5-grass pollen tablet in a large population of non-selected grass pollen allergic patients, i.e. patients with different clinical profiles in daily clinical practice.MethodsIn a 2-year, prospective, open-label, multicenter, non-controlled, observational study patients were included from 327 centers across Germany. Rhinoconjunctivitis symptoms, symptomatic medication intake and adverse events were recorded.ResultsA total of 1482 patients aged 4–75 years were included. During the 2-year period of 5-grass pollen tablet therapy, mean rhinoconjunctivitis score decreased significantly in the overall study population by 65.5% (P < 0.001). The percentage of patients taking symptomatic medication decreased from 83.8% to 42.7%. Mean 2-year improvements in rhinoconjunctivitis scores and decreases in the percentage of patients taking symptomatic medication were broadly similar in adults, adolescents and children, in patients with polyallergy versus monoallergy, and in patients with/without asthma. Among polyallergic patients, concomitant application of another specific immunotherapy did not impair treatment outcomes. Adverse drug reactions, predominantly affecting the local application area, occurred in 15.4% of the overall patient population (n = 229). No cases of anaphylaxis or epinephrine use were documented.ConclusionThis study indicates that sublingual immunotherapy with the 5-grass pollen tablet is well tolerated and provides sustained effectiveness over 2 years in patients with different clinical profiles, producing a significant decrease in allergic symptoms and a reduction in the use of symptomatic medication.FundingStallergenes GmbH.

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“…Specially in childhood, SLIT offers practical advantages over subcutaneous therapy because injections can be avoided, the treatment is generally well tolerated [147], and the risk of severe allergic reactions seems to be negligible [148][149][150][151], even when multiple allergens [152,153] or ultra-rush and/or high-dose regimens [154,155] are used. In addition, SLIT can be administered at home rather than at a health center, thus facilitating, theoretically at least, compliance.…”

Section: Pediatric Populationsmentioning

confidence: 99%

Specific allergen immunotherapy for the treatment of allergic asthma: a review of current evidence

Domínguez‐Ortega

Delgado

Blanco

et al. 2017

J Investig Allergol Clin Immunol

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Asthma is frequently associated with atopy, characterized by the production of specific immunoglobulin E in response to environmental allergens. Currently, two types of allergen immunotherapy (AIT) are used in clinical practice: subcutaneous and sublingual immunotherapy, both accepted as key components of the therapeutic repertoire for allergic rhinitis and conjunctivitis. However, their role in asthma remains controversial. The present document is aimed at providing the clinicians with a review of the evidence on the use of AIT in asthma, focusing on the most relevant aspects of its mechanism of action, its efficacy, and existing data on safety, tolerability, and cost-effectivity, both in pediatric and adult populations. A systematic search of MEDLINE, Cochrane, and Clinical Trials databases from 2000 to April of 2016 was carried out by a panel of experts from the Spanish Allergy and Clinical Immunology Scientific Society. Relevant studies prior to the year 2000 included in ulterior systematic reviews were also considered. More than 4000 articles were identified during the search and 241 were selected to retrieve available evidence on AIT, which was graded according to the Oxford classification. All the group members reviewed the resulting text until the final version reached the consensual agreement. A summary of recommendations on the more relevant topics are proposed. The role of AIT as a valuable therapeutic strategy for prevention of exacerbation and progressive decline in lung function is highlighted. Future research should include specific tools for asthma evaluation when assessing AIT effectiveness in asthmatic patients. ResumenEl asma se asocia frecuentemente con alergia, entendida ésta como la producción de IgE específica frente a alérgenos ambientales. Actualmente, existen dos tipos de inmunoterapia específica con alérgenos (ITE) para la práctica clínica habitual: subcutánea y sublingual, ambas indicadas en el tratamiento de la rinitis y la conjuntivitis alérgicas. Sin embargo, su papel en el asma resulta todavía controvertido. Dominguez-Ortega J, et al.

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An observational, real‐life safety study of a 5‐grass pollen sublingual tablet in children and adolescents

Abstract: In clinical practice, pre- and coseasonal treatment with a 5-grass pollen sublingual tablet is safe and well tolerated in children and adolescents.

Cited by 18 publications

References 19 publications

Asthma and allergic rhinitis in childhood: what's new

Asthma and allergic rhinitis in childhood: what's new

Management of Grass Pollen Allergy with 5-Grass Pollen Tablet: Results of a 2-Year Real-Life Study

Specific allergen immunotherapy for the treatment of allergic asthma: a review of current evidence

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