Comparative effect of pre‐coseasonal and continuous grass sublingual immunotherapy in children

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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“…91,92 Some heterogeneity between adult studies, low risk of severe systemic allergic side-effects. | 773…”

Section: Strength Of Recommendationmentioning

confidence: 99%

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

Roberts

Pfaar

Akdiş

et al. 2017

Allergy

524

705

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“…The different JC pollen counts in the 2 seasons make it difficult to compare treatment scores with certainty, and many of the patients in this study were not treated for 4 months prior to pollen dispersal in the 1st season. Recent studies have compared pre-coseasonal, coseasonal and continuous administration of SLIT [10,21]; however, it is difficult to conclude that continuous treatment over multiple seasons provides better efficacy. Most side effects in our study were mild and were related to the site of administration (mouth oedema, stomatitis and throat irritation).…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Sublingual Immunotherapy for Two Seasons in Patients with Japanese Cedar Pollinosis

Okamoto

Okubo

Yonekura

et al. 2015

Int Arch Allergy Immunol

107

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Background: Japanese cedar (JC) pollinosis is the most common seasonal allergic rhinitis in Japan. Standardized JC pollen extract is available for subcutaneous immunotherapy, but this treatment is limited by potentially serious side effects. The aim of this double-blind, randomized comparative study was to evaluate the efficacy and safety of standardized JC pollen extract in a new oral formulation (CEDARTOLEN®, Torii Pharmaceutical Co., Ltd., Tokyo, Japan) for sublingual immunotherapy (SLIT) for JC pollinosis. Methods: A total of 531 subjects with JC pollinosis were randomized into 2 groups at a ratio of 1:1 to receive daily sublingual administration of standardized JC pollen extract with a maintenance dose of 2,000 Japanese allergy units (JAU) or placebo for 2 consecutive pollen seasons. The efficacy was evaluated using the total nasal symptom and medication score (TNSMS) as the primary end point. Secondary end points included the total ocular symptom and medication score (TOSMS) and scores for individual symptoms and medication. Results: The TNSMS was significantly lower (p < 0.0001) in the SLIT group than in the placebo group in the peak symptom period by 18 and 30% in the first and second seasons, respectively. All secondary end points were also significantly lower in the SLIT group in both seasons. No systemic anaphylaxis occurred. Conclusions: SLIT with daily administration of standardized JC pollen extract was effective for improving nasal and ocular symptoms of JC pollinosis and reducing the use of relief medication. The JC pollen extract was well tolerated with only local adverse events.

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“…Twelve studies reported local reactions in 0.2% to 50% of patients receiving SLIT and 6% to 25% of patients receiving placebo. 22,25,[27][28][29][30][31][35][36][37] Systemic reactions were commonly reported in both the SLIT and placebo groups, but no life-threatening reactions, anaphylaxis, or deaths were reported in these trials. to least commonly reported, the symptoms or reactions were characterized as general, gastrointestinal, ocular, respiratory, and cutaneous.…”

Section: Safety Of Slit In Childrenmentioning

confidence: 99%

Allergen-Specific Immunotherapy for Pediatric Asthma and Rhinoconjunctivitis: A Systematic Review

Kim¹,

Lin²,

et al. 2013

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BACKGROUND AND OBJECTIVE: Subcutaneous immunotherapy (SCIT) is approved in the United States for the treatment of pediatric asthma and rhinitis; sublingual immunotherapy (SLIT) does not have regulatory approval but is used in clinical practice. The objective of this study was to systematically review the evidence regarding the efficacy and safety of SCIT and SLIT for the treatment of pediatric asthma and allergic rhinoconjunctivitis. METHODS:Two independent reviewers selected articles for inclusion, extracted data, and graded the strength of evidence for each clinical outcome. All studies were randomized controlled trials of children with allergic asthma or rhinoconjunctivitis treated with SCIT or an aqueous formulation of SLIT. Data sources were Medline, Embase, LILACS, CENTRAL, and the Cochrane Central Register of Controlled Trials through May 2012. RESULTS:In 13 trials, 920 children received SCIT or usual care; in 18 studies, 1583 children received SLIT or usual care. Three studies compared SCIT with SLIT head-to-head in 135 children. The strength of evidence is moderate that SCIT improves asthma and rhinitis symptoms and low that SCIT improves conjunctivitis symptoms and asthma medication scores. Strength of evidence is high that SLIT improves asthma symptoms and moderate that SLIT improves rhinitis and conjunctivitis symptoms and decreases medication usage. The evidence is low to support SCIT over SLIT for improving asthma or rhinitis symptoms or medication usage. Local reactions were frequent with SCIT and SLIT. There was 1 report of anaphylaxis with SCIT.CONCLUSIONS: Evidence supports the efficacy of both SCIT and SLIT for the treatment of asthma and rhinitis in children. Pediatrics

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Comparative effect of pre‐coseasonal and continuous grass sublingual immunotherapy in children

Abstract: Both protocols were effective compared with placebo and showed similar decreases for combined symptoms/medication score and all secondary endpoints, with the exception of nasal symptoms that were lower in the pre-coseasonal group.

Cited by 61 publications

References 23 publications

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

Efficacy and Safety of Sublingual Immunotherapy for Two Seasons in Patients with Japanese Cedar Pollinosis

Allergen-Specific Immunotherapy for Pediatric Asthma and Rhinoconjunctivitis: A Systematic Review

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