Sublingual immunotherapy: what have we learnt from the ‘big trials’?

Durham, Stephen R.

doi:10.1097/aci.0b013e3283196764

Cited by 46 publications

(29 citation statements)

References 45 publications

(43 reference statements)

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“…Negative publication bias is also possible although less likely following the introduction of regulatory requirements to register all clinical trials on a public database. In support of the conclusions of recent meta-analyses, recent data from large multi-centre trials of SLIT for seasonal rhinitis in adults (reviewed in [24]) and in children [25,26] have provided further evidence for the efficacy of SLIT at least for grass pollen-induced SAR (Table 1). …”

Section: Sublingual Immunotherapymentioning

confidence: 62%

“…Although four to seven pre-seasonal injections of allergoids appear to be efficacious, the optimal number of injections has yet to be defined. In the case of SLIT one study of sublingual grass tablet immunotherapy suggested that treatment should start at least 8 weeks before the season and be continued for at least 16 weeks [24]. There are only limited data on the long-term benefits of pre-seasonal immunotherapy but there is a single report of a placebo-controlled study of 3 years' treatment with SLIT which demonstrated persistent benefit for at least 1 year following cessation of immunotherapy [33].…”

Section: Sublingual Immunotherapymentioning

confidence: 99%

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Immunotherapy for allergic rhinitis

Walker¹,

Durham

Till

et al. 2011

Clin Experimental Allergy

145

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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Section: Sublingual Immunotherapymentioning

confidence: 62%

Section: Sublingual Immunotherapymentioning

confidence: 99%

Immunotherapy for allergic rhinitis

Walker¹,

Durham

Till

et al. 2011

Clin Experimental Allergy

145

125

View full text Add to dashboard Cite

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“…Today, there are properly configured powered studies that prove that such therapy is effective and safer than SCIT. 33 Likewise, the immunologic changes associated with SCIT also have been found with SLIT. 33,34 Many different investigators have played a role in investigating this new form of therapy.…”

Section: New Science and Forms Of Allergen Immunotherapymentioning

confidence: 94%

“…33 Likewise, the immunologic changes associated with SCIT also have been found with SLIT. 33,34 Many different investigators have played a role in investigating this new form of therapy. Two important documents published on this subject include the World Allergy Organization (WAO) article entitled "Sublingual Immunotherapy: WAO Position Paper 2009" 35 and the article entitled "Recommendations for Appropriate Sublingual Immunotherapy (SLIT) Clinical Trials."…”

Section: New Science and Forms Of Allergen Immunotherapymentioning

confidence: 94%

Historical perspectives of allergy and immunology and allergen immunotherapy

Lockey

2014

Annals of Allergy, Asthma & Immunology

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“…ITT, intention-to-treat; QoL, quality of life; SCIT, subcutaneous immunotherapy; SLIT, sublingual immunotherapy. *With at least 100 subjects in one or more active SIT arms and at least 100 in the control arm (according to Durham, 2008). With investigating centers in more than one country.…”

Section: Discussionmentioning

confidence: 99%

Towards evidence‐based medicine in specific grass pollen immunotherapy

Calderón

Mösges

Hellmich

et al. 2010

Allergy

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To cite this article: Calderon M, Mö sges R, Hellmich M, Demoly P. Towards evidence-based medicine in specific grass pollen immunotherapy. Allergy 2010; 65: 420-434.We performed a systematic, evidence-based medicine (EBM) review of double-blind, placebo-controlled randomized clinical trials (DBPC RCTs) of commercially available grass pollen-specific immunotherapy (SIT) modalities for the treatment of seasonal allergic rhinoconjunctivitis (SAR) in adults and children (1). This health problem affects as many as one in seven of the population in Western countries (2, 3), with grass pollen as one of the major triggers (4).Fundamental regulatory and technological changes are modifying the types of specific subcutaneous or sublingual SIT (SCIT and SLIT) product available to specialist practitioners. The European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) have issued guidelines affecting the clinical development of SIT products (5, 6). With the exception of Gramineae grass pollen extract SLIT tablets (currently being registered across Europe as pharmaceutical specialties), SIT products are sold as either unregistered, named patient preparations or nationally registered formulations. Hence, in many European countries, the specialist physician initiating grass pollen SIT has to choose (in collaboration with the patient) between nonregistered and registered modalities. To inform that choice, we used an EBM approach to assess commercially available immunotherapy modalities.Evidence-based medicine has been defined as 'the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient' (7) and 'the integration of the best available research evidence with clinical expertise and patient values ' (8 AbstractWhen initiating grass pollen immunotherapy for seasonal allergic rhinoconjunctivitis, specialist physicians in many European countries must choose between modalities of differing pharmaceutical and regulatory status. We applied an evidence-based medicine (EBM) approach to commercially available subcutaneous and sublingual Gramineae grass pollen immunotherapies (SCIT and SLIT) by evaluating study design, populations, pollen seasons, treatment doses and durations, efficacy, quality of life, safety and compliance. After searching MEDLINE, Embase and the Cochrane Library up until January 2009, we identified 33 randomized, double-blind, placebo-controlled trials (including seven paediatric trials) with a total of 440 specific immunotherapy (SIT)-treated subjects in seven trials (0 paediatric) for SCIT with natural pollen extracts, 168 in three trials (0 paediatric) for SCIT with allergoids, 906 in 16 trials (five paediatric) for natural extract SLIT drops, 41 in two trials (one paediatric) for allergoid SLIT tablets and 1605 in five trials (two paediatric) for natural extract SLIT tablets. Trial design and quality varied significantly within and between SIT modalities. The multinational, rigorous trials of natural extract SLIT ...

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Sublingual immunotherapy: what have we learnt from the ‘big trials’?

Abstract: Sublingual immunotherapy represents an effective and well tolerated treatment for seasonal allergic rhinoconjunctivitis in adults. Current ongoing paediatric trials and evaluation of long-term effects in adults will further define its role in therapy.

Cited by 46 publications

References 45 publications

Immunotherapy for allergic rhinitis

Immunotherapy for allergic rhinitis

Historical perspectives of allergy and immunology and allergen immunotherapy

Towards evidence‐based medicine in specific grass pollen immunotherapy

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