A double‐blind, placebo‐controlled trial by the sublingual route of immunotherapy with a standardized grass pollen extract

Sabbah, Asmaa; Hassoun, S; Sellin, J. Le; André, C.; Sicard, H.

doi:10.1111/j.1398-9995.1994.tb02273.x

Cited by 154 publications

(104 citation statements)

References 17 publications

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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%

“…Likewise, cumulative doses in single-season studies ranged from 294 to 3390 lg (29,30). These variations may have contributed to the heterogeneity of the trial outcomes, with variously (i) a significant difference in favour of SIT in the median total symptom score over the whole pollen season (33), (ii) an effect on medication scores (29), (iii) an effect on symptom scores for the pollen peak or at certain time points (27,28), (iv) an improvement in investigator-assessed allergic complaints only (30) or (v) no SIT effect on efficacy parameters (31). The role of asthma status was mentioned by de Blay et al (32) in a population of 118 randomized subjects; although no significant, overall effects of SIT on efficacy scores were apparent, a subgroup analysis revealed a significant (P < 0.045) symptom reduction in nonasthmatic patients.…”

Section: Slit Grass Pollen Natural Extracts (Drops)mentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%

Section: Slit Grass Pollen Natural Extracts (Drops)mentioning

confidence: 99%

Towards evidence‐based medicine in specific grass pollen immunotherapy

Calderón

Mösges

Hellmich

et al. 2010

Allergy

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“…With improvements in pharmaceutic technology, new formulations (tablets, capsules, etc.) of allergenic extracts which do not have to be injected and can be self-administered by patients using alternative routes (nasal, buccal including sublingual ) are now widely used (2,27). It is likely that the therapeutic action of these products is linked to the ability of allergenic components to pass through the mucosal barrier.…”

Section: Discussionmentioning

confidence: 99%

Monomeric chemically modified allergens: immunologic and Physicochemical characterigation

Mistrello

Brenna

Roncarolo

et al. 1996

Allergy

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Allergenic extracts (Der p, grass, and Parietarin) or single allergens such as Par j I (the major allergen of Parietaria) and ovalbumin (OA), a food allergen widely used in animal models, were chemically modified by reaction with potassium cyanate (KCNO), which transforms the &‐amino group of the lysine of proteinaceous allergens into ureido groups. KCNO‐modified (carbamylated) allergens have low allergenic potency, as demonstrated in vitro (RAST inhibition) and in vivo (passive cutaneous anaphylaxis). When used to immunize rabbits, carbamylated allergens still induce IgG antibodies able to cross‐react with native allergens (immunoblotting experiments). An interesting feature distinguishing carbamylated allergens from other chemically modified allergens is the preservation of the native monomeric dimension as demonstrated by SDS‐PAGE analysis. Results are discussed from the perspective of clinical application of carbamylated allergens.

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“…In this issue of Allergy, yet another study of sublingual IT is reported (18). Unfortunately, it does not clarify the issue of efficacy because most of the above critique applies to the study.…”

mentioning

confidence: 99%

Local immunotherapy is not documented for clinical use

Björkstén

1994

Allergy

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A double‐blind, placebo‐controlled trial by the sublingual route of immunotherapy with a standardized grass pollen extract

Cited by 154 publications

References 17 publications

Towards evidence‐based medicine in specific grass pollen immunotherapy

Towards evidence‐based medicine in specific grass pollen immunotherapy

Monomeric chemically modified allergens: immunologic and Physicochemical characterigation

Local immunotherapy is not documented for clinical use

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