Efficacy and safety of the <scp>SQ</scp>‐standardized grass allergy immunotherapy tablet in mono‐ and polysensitized subjects

Nelson, Harold S.; Blaiss, Michael S.; Nolte, Hendrik; Würtz, Sidse Ørnbjerg; Andersen, Jens S.; Durham, Stephen R.

doi:10.1111/all.12074

Cited by 83 publications

(47 citation statements)

References 15 publications

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“…This is consistent with a recent pooled post hoc analysis including several studies on the SQ grass SLIT-tablet, suggesting that the observed effects were not dependent on sensitization status. 35 The presence of clinical symptoms to another perennial allergen to which the subject is regularly exposed was an exclusion criterion because other indoor sensitizations might interfere during efficacy assessment periods.…”

Section: Discussionmentioning

confidence: 99%

Effective treatment of house dust mite–induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial

Demoly

Emminger²,

Rehm

et al. 2016

Journal of Allergy and Clinical Immunology

201

150

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Section: Discussionmentioning

confidence: 99%

Effective treatment of house dust mite–induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial

Demoly

Emminger²,

Rehm

et al. 2016

Journal of Allergy and Clinical Immunology

201

150

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“…148 Consequently, consideration needs to be given as to whether patients are (i) clinically monoallergic (where only 1 allergen is driving symptoms) and polysensitized or (ii) poly-allergic (symptoms with overlapping exposure to multiple different allergens) and polysensitized. Immunotherapy with a single allergen extract is effective in the first, 149 while immunotherapy has been shown to be ineffective 150 or less effective in the last situation. 151 This may be apparent from the history or may need investigation with component-resolved diagnostics or assessment with nasal or conjunctival provocation challenges where the clinician is experienced in these diagnostic procedures.…”

Section: Polysensitized Patientsmentioning

confidence: 99%

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

Roberts

Pfaar

Akdiş

et al. 2017

Allergy

Self Cite

561

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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“…Pooled data from six randomized, double-blind, placebo controlled trials was used to compare the efficacy and safety of treatment with timothy SLIT tablets in mono-and polysensitized subjects [50]. Eighty percent of subjects in the studies were polysensitized.…”

Section: Drug Profilementioning

confidence: 99%

Oral/sublingualPhleum pretensegrass tablet (Grazax/Grastek) to treat allergic rhinitis in the USA

Nelson

2014

Expert Review of Clinical Immunology

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With the approval of two grass tablets and one ragweed tablet for sublingual immunotherapy (SLIT) by the US FDA in April 2014, the practice of allergy immunotherapy (AIT) in the USA has dramatically changed. Until this time, there were no approved allergen extracts for sublingual administration and physicians who prescribed SLIT for their patients did so without full knowledge of proper dosing or assurance of its safety. Now sublingual allergen tablets are available that have proven safe and effective doses. This article describes, in detail, the studies that have been conducted with a timothy grass SLIT tablet and draws some comparisons to the alternative 5-grass SLIT tablet. It also attempts to predict what will be the impact of the introduction of these tablets on the practice of AIT in the USA over the next few years.

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Efficacy and safety of the SQ‐standardized grass allergy immunotherapy tablet in mono‐ and polysensitized subjects

Cited by 83 publications

References 15 publications

Effective treatment of house dust mite–induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial

Effective treatment of house dust mite–induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial

EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis

Oral/sublingualPhleum pretensegrass tablet (Grazax/Grastek) to treat allergic rhinitis in the USA

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