Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents

Halken, Susanne; Agertoft, Lone; Seidenberg, J.; Bauer, Carl‐Peter; Payot, F.; Martín-Muñoz, M.F.; Bartkowiak-Emeryk, Małgorzata; Vereda, Andrea; Jean-Alphonse, S.; Mélac, M.; Gall, M. Le; Wahn, Ulrich

doi:10.1111/j.1399-3038.2010.01050.x

Cited by 60 publications

(48 citation statements)

References 27 publications

(45 reference statements)

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“…Notably, the incidence of treatment-emergent AEs remained comparable when split by age group, occurring in 86.2% of children (aged 5-11 years) and 82.7% of adolescents (aged 12-17 years) on active treatment, with corresponding values of 82.4 and 81.5%, respectively, for patients taking placebo [64].…”

Section: Infections and Infestationsmentioning

confidence: 94%

“…The most frequently reported AEs were oral pruritus, mouth edema and throat irritation, in 32.4, 12.9 and 7.9% of actively treated patients versus 1.4, 0 and 5.0% of placebo-treated patients. Treatment discontinuation due to AEs occurred in 5.3 and 1.5% of patients using 5-grass-pollen tablet or placebo, respectively [50,64].…”

Section: Infections and Infestationsmentioning

confidence: 99%

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Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience

Didier

Wahn

Horak

et al. 2014

Expert Review of Clinical Immunology

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OralairÒ (OA) (Stallergenes, Antony, France) is a unique pre-and co-seasonal 5-grass-pollen sublingual immunotherapy tablet launched in 2008, and now approved in 31 countries worldwide for the treatment of grass-pollen allergic rhinitis and rhinoconjunctivitis. OA is the first oral treatment with a consistent, well-balanced allergen extract that mimics natural exposure and sensitization. A wealth of data exists from over 5 years of clinical and realworld experience demonstrating the efficacy and safety of OA for grass-pollen-allergy treatment. OA is highly effective from the first pollen season in all patient subgroups, including children and those with comorbid mild asthma, irrespective of sensitization status and symptom severity. OA also has sustained long-term benefits for symptom control and quality of life. This article provides an overview of the pharmacodynamics and pharmacology of OA; its efficacy, safety, tolerability and cost-effectiveness for the treatment of allergic rhinitis and rhinoconjunctivitis and its role in clinical practice. Allergic rhinitis (AR) is a common chronic inflammatory illness, characterized by rhinorrhea, nasal congestion, sneezing, nasal and ocular pruritis and watery eyes [1]. Inhalation of allergens by sensitized individuals triggers the IgE-mediated release of inflammatory mediators and cytokines, leading to a rapid appearance of symptoms [2]. AR has historically been classified as 'seasonal' or 'perennial' depending on whether symptoms occur with seasonal exposure to aeroallergens or are present throughout the year. Seasonal AR is most commonly attributed to plant pollen and other outdoor allergens, while perennial AR is associated with indoor allergens, such as dust mites, mold, cockroaches and pet dander, although it can also be associated with pollen in areas where this is prevalent year-round [3,4].In 2001, the WHO-sponsored Allergic Rhinitis and its Impact on Asthma meeting produced guidelines proposing an alternative classification of the condition into 'intermittent' or 'persistent' AR, and grading symptoms as 'mild' or 'moderate/severe' [5]. Globally, the prevalence of seasonal ('hay fever') and perennial AR ranges from 7 to 42 and 1 to 13%, respectively, with the former being more common in children than adults [6]. The length of exposure to seasonal allergens is dependent on geographic location and climatic conditions [4]; in Europe, the main pollen season typically occurs from March to July, with slight variations according to latitude [7].Approximately 500 million people worldwide [6], including an estimated 30-60 million in the USA [4] 1309Drug Profile suffer from AR, and its prevalence is increasing in most countries [2]. It is estimated that from 10 to 30% of adults and up to 40% of the pediatric population have AR [3,9]. While AR does not directly lead to mortality, it places a considerable burden on affected individuals, who often have a reduced quality of life (QoL), compared with non-sufferers [10]. The physical symptoms of AR can cause sleep disturbance...

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Section: Infections and Infestationsmentioning

confidence: 94%

Section: Infections and Infestationsmentioning

confidence: 99%

Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience

Didier

Wahn

Horak

et al. 2014

Expert Review of Clinical Immunology

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“…They are commonly considered to be of mild intensity and self-limiting. 34,97 Nevertheless, these reactions may lead to cessation of treatment, …”

Section: 185mentioning

confidence: 99%

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

Roberts

Pfaar

Akdiş

et al. 2017

Allergy

576

705

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drawn on data from a systematic review of the literature, more recent published studies and multistakeholder expert clinical opinion. This Guideline is aimed at healthcare professionals who are encouraged to take the recommendations into account in the context of delivering clinical care. This Guideline is not a substitute for professional clinical judgment, which professionals need to exercise in the context of delivering personalised healthcare. AbstractAllergic rhinoconjunctivitis (AR) is an allergic disorder of the nose and eyes affecting about a fifth of the general population. Symptoms of AR can be controlled with allergen avoidance measures and pharmacotherapy. However, many patients continue to have ongoing symptoms and an impaired quality of life; pharmacotherapy may also induce some side-effects. Allergen immunotherapy (AIT) represents the only currently available treatment that targets the underlying pathophysiology, and it may have a disease-modifying effect. Either the subcutaneous (SCIT) or sublingual (SLIT) routes may be used. This Guideline has been prepared by the European Academy of Allergy and Clinical Immunology's (EAACI) Taskforce on AIT for AR and is part of the EAACI presidential project "EAACI Guidelines on Allergen Immunotherapy." It aims to provide evidence-based clinical recommendations and has been informed by a formal systematic review and meta-analysis. Its generation has followed the Appraisal of Guidelines for Research and Evaluation (AGREE II) approach.The process included involvement of the full range of stakeholders. In general, broad evidence for the clinical efficacy of AIT for AR exists but a product-specific evaluation of evidence is recommended. In general, SCIT and SLIT are recommended for both seasonal and perennial AR for its short-term benefit. The strongest evidence for long-term benefit is documented for grass AIT (especially for the grass 766 | ROBERTS, PFAAR ET AL. tablets) where long-term benefit is seen. To achieve long-term efficacy, it is recommended that a minimum of 3 years of therapy is used. Many gaps in the evidence base exist, particularly around long-term benefit and use in children. | ME TH ODOLOGYThis Guideline was produced using the Appraisal of Guidelines forResearch & Evaluation (AGREE II) approach, 17,18 a structured approach to guideline production (see Table S1). This is designed to ensure appropriate representation of the full range of stakeholders, a careful search for and critical appraisal of the relevant literature, a systematic approach to the formulation and presentation of recommendations and steps to ensure that the risk of bias is minimized at each step of the process. The process started on April 2015 beginning with detailed face-to-face discussions agreeing on the process and the key clinical areas to address, followed by face-to-face meetings, and regular web conferences in which professional and lay representatives participated. | Clarifying the scope and purpose of the guidelinesThe scope of this EAACI Guideline is multifaceted...

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“…SCIT [56][57][58][59] and SLIT [33,[60][61][62][63] improve the symptoms of AR. In children, there is also evidence that immunotherapy can prevent or at least delay the onset of asthma.…”

Section: Allergen Immunotherapy In Childrenmentioning

confidence: 99%

Immunotherapy for allergic rhinitis

Walker¹,

Durham

Till

et al. 2011

Clin Experimental Allergy

146

125

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SummaryAllergic rhinitis (AR) affects more than 20% of the population in the United Kingdom and western Europe and represents a major cause of morbidity that includes interference with usual daily activities and impairment of sleep quality. This guidance prepared by the Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI) is for the management of AR in patients that have failed to achieve adequate relief of symptoms despite treatment with intranasal corticosteroids and/or antihistamines. The guideline is based on evidence and is for use by both adult physicians and paediatricians practising allergy. During the development of these guidelines, all BSACI members were included in the consultation process using a web-based system. Their comments and suggestions were carefully considered by the SOCC. Where evidence was lacking, consensus was reached by the experts on the committee. Included in this guideline are indications and contraindications for immunotherapy, criteria for patient selection, the evidence for short-and long-term efficacy of subcutaneous and sublingual immunotherapy, and discussion on safety and the different modes of immunotherapy including, pre-seasonal and co-seasonal treatments. There are sections on children, allergen standardization, vaccines used in the United Kingdom, oral allergy syndrome, cost effectiveness of immunotherapy and practical considerations of undertaking immunotherapy including recommendations on who should undertake immunotherapy and dosing schedules. Finally, there is discussion on potential biomarkers of response to immunotherapy, the use of component-resolved diagnostics, novel approaches, alternative routes and potential areas for future research.Keywords aeroallergens, allergen, allergic rhinitis, allergen standardization, allergy to animals, allergy to house dust mites, asthma, BSACI, cat allergy, component-resolved diagnostics, cost effectiveness, dosing schedules, grass pollen, guideline, immunotherapy, oral allergy syndrome, perennial rhinitis, pollinosis, ragweed allergy, SAR, seasonal pollen induced rhinitis, subcutaneous immunotherapy, sublingual immunotherapy, tree pollen Submitted 19 February 2011; revised 6 May 2011; accepted 9 May 2011. Executive summaryUntreated rhinitis represents a major cause of morbidity that includes interference with usual daily activities and impaired sleep quality. Immunotherapy, both subcutaneous and sublingual, is an effective treatment for adults and children with severe allergic rhinitis (AR) that does not respond to conventional pharmacotherapy and allergen avoidance measures. The efficacy of immunotherapy depends on correct patient selection, the type of allergen and the product chosen for treatment. Each vaccine requires individual assessment before recommendation for routine use.

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Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents

Cited by 60 publications

References 27 publications

Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience

Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

Immunotherapy for allergic rhinitis

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