Randomized controlled trial of high-dose sublingual immunotherapy to treat seasonal allergic rhinitis

Smith, Helen; White, Peter; Annila, Ilkka; Poole, Jason; André, C.; Frew, Anthony J.

doi:10.1016/j.jaci.2004.06.058

Cited by 101 publications

(81 citation statements)

References 21 publications

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“…Wilson et al (1698) published a Cochrane Collaboration meta-analysis of SLIT in rhinitis and proposed that it was safe and effective. The Cochrane meta-analysis (1699) was followed by several studies which accorded with the results of the review (1103,(1700)(1701)(1702)(1703)(1704)(1705)(1706)(1707)(1708)(1709)(1710)(1711). Moreover, pivotal trials have been carried out and the results on over 600 patients showed convincingly that in grass pollen allergy, SLIT is safe and effective using tablets (1103,1712).…”

Section: Sublingual Immunotherapymentioning

confidence: 99%

Allergic Rhinitis and its Impact on Asthma (ARIA) 2008*

Bousquet¹,

Khaltaev²,

Cruz³

et al. 2008

Allergy

3,861

1,761

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Section: Sublingual Immunotherapymentioning

confidence: 99%

Allergic Rhinitis and its Impact on Asthma (ARIA) 2008*

Bousquet¹,

Khaltaev²,

Cruz³

et al. 2008

Allergy

3,861

1,761

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“…1). They comprised a total of 3160 SIT-treated participants [SCIT with natural extracts: 440 subjects in seven trials (17)(18)(19)(20)(21)(22)(23); SCIT with allergoids: 168 SIT-treated subjects in three trials (24)(25)(26); SLIT with natural extract drops: 906 SIT-treated subjects in 16 trials (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42); SLIT with allergoid tablets: 41 SIT-treated subjects in two trials (43,44); SLIT with natural extract tablets: 1605 SIT-treated subjects in five trials (45)(46)(47)(48)(49)(50)]. The main reasons for excluding studies were lack of double-blinding/ randomization, review articles, multiple allergen extracts, outcomes unrelated to efficacy and preparations that are not commercially available.…”

Section: Resultsmentioning

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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“…Such doses can be administered in view of the reassuring data on tolerability and safety of high-dose SLIT. The efficacy and safety of Staloral, as demonstrated by eight double-blind, placebo-controlled studies using doses up to 1125 times higher than those administered with SCIT, 17,[20][21][22][23][24][25][26] suggests that this allergen extract is an attractive therapeutic option for patients with seasonal allergies due to grass pollen.…”

Section: Resultsmentioning

confidence: 99%

“…Frati et al scores in adult patients [20][21][22][23][24] and children 17,21,25,26 treated with Staloral compared with placebo-treated controls. Table 2 reports the main data from the published studies evaluating Staloral for grass pollen allergy.…”

mentioning

confidence: 99%

Development of a sublingual allergy vaccine for grass pollinosis

Incorvaia¹

2010

DDDT

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Grass pollen is a very common cause of allergic rhinitis and asthma. The only treatment targeting the underlying causes of allergy is immunotherapy (IT). Sublingual immunotherapy (SLIT) has been introduced to solve the problem of systemic reactions to subcutaneous IT (SCIT). This article evaluates the characteristics of the allergen extract, Staloral, in terms of practical administration, effectiveness, safety, and mechanism of action. Efficacy data were obtained from double-blind, placebo-controlled studies using Staloral in patients sensitized to grass pollen, while practical administration, cost-effectiveness, and mechanism of action data were provided by well designed studies. The efficacy and safety of Staloral, as demonstrated by review of published studies which used doses up to 1125 times those administered with SCIT, shows that this allergen extract has optimal characteristics for treating patients with seasonal allergies due to grass pollens. The main mechanism of action is the interaction between dendritic cells of the oral mucosa and the subsequent tolerance induced in T-cells.

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Randomized controlled trial of high-dose sublingual immunotherapy to treat seasonal allergic rhinitis

Cited by 101 publications

References 21 publications

Allergic Rhinitis and its Impact on Asthma (ARIA) 2008*

Allergic Rhinitis and its Impact on Asthma (ARIA) 2008*

Towards evidence‐based medicine in specific grass pollen immunotherapy

Development of a sublingual allergy vaccine for grass pollinosis

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