Clinical efficacy and safety of preseasonal sublingual immunotherapy with grass pollen carbamylated allergoid in rhinitic patients. A double-blind, placebo-controlled study

Ag, Palma-Carlos; Santos, Amélia Spínola; Ferreira, Mário B.; Pregal, A.Lopes; Palma-Carlos, M L; Bruno, M.; Falagiani, P.; Riva, G

doi:10.1157/13094026

Cited by 41 publications

(19 citation statements)

References 20 publications

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“…The duration of SLIT courses varied from 3 months (minimum duration) to 3 years (maximum duration). The administration regimen was preseasonal in three studies (27,32,44), co-seasonal in three (15,42,47), and continuous in eight trials (30,35,38,39,41,43,46,54), despite the allergen was seasonal. In the remaining 27 trials the adopted regimen was precoseasonal.…”

Section: Literature Analysismentioning

confidence: 99%

Administration regimens for sublingual immunotherapy to pollen allergens: What do we know?

Lombardi

Incorvaia²,

Braga

et al. 2009

Allergy

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The modalities of administration of sublingual immunotherapy (SLIT), including dosing, build‐up phase, duration of the treatment, and frequency of the maintenance dose are largely variable. In the case of pollen (SLIT), the complexity increases, since preseasonal, coseasonal and pre‐coseasonal regimens can be used. The administration regimens are of relevance from a practical point of view, but can also have economic implications. We review herein the available literature (randomized double blind controlled studies) on pollen SLIT, in order to derive experimentally‐supported suggestions about the regimens of administration that should be preferred.

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Section: Literature Analysismentioning

confidence: 99%

Administration regimens for sublingual immunotherapy to pollen allergens: What do we know?

Lombardi

Incorvaia²,

Braga

et al. 2009

Allergy

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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%

“…Few or no local AEs were reported (12% in the active group in Palma-Carlos et al), and no systemic AEs were observed (43).…”

Section: Safetymentioning

confidence: 93%

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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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“…However, the risk of inducing side effects, sometimes associated with the injection of the above products [28], has led allergen manufacturers to explore safer therapeutic modalities. KCNO-modified allergens have proven useful for developing original, safe and effective products such as monomeric allergoids [18,29,30,31,32,33,34,35,36]. An analogous approach has been performed on DP pollen extract.…”

Section: Discussionmentioning

confidence: 99%

Date Palm Pollen Allergoid: Characterization of Its Chemical-Physical and Immunological Properties

Mistrello

Harfi

Roncarolo

et al. 2007

Int Arch Allergy Immunol

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Background: Date palm (DP) pollen can cause allergic symptoms in people living in different countries. Specific immunotherapy with allergenic extracts by subcutaneous route is effective to cure allergic people. However, the risk of side effects has led to explore safer therapeutic modalities. The aim of our work was to evaluate IgE cross-reactivity between DP and autochthonous palm (European fan palm, EFP) pollen extracts, to chemically modify DP extract with potassium cyanate in order to obtain an allergoid, and to characterize it. Methods: By radioallergosorbent test inhibition, immunoblotting (IB) and skin prick test, in vitro and in vivo allergenic activities of native and modified DP extracts were compared. By SDS-PAGE and IB, we compared the protein profile and IgE-binding capacity of both native and modified DP, as well as of EFP extracts. By IB inhibition, IgE cross-reactivity of native DP and EFP extracts was evaluated. By ELISA, the capacity of modified DP-induced IgG to react with native DP extract was determined. Results: Radioallergosorbent test inhibition, IB and skin prick test results demonstrated that modified DP was significantly less allergenic than native DP extract. The SDS-PAGE profile showed that potassium cyanate treatment of DP extract did not alter the molecular weight of its components. In addition, no difference was observed between native DP and EFP extracts. Subsequent IB inhibition data evidenced the existence of a strong IgE cross-reactivity between native DP and EFP extracts. ELISA results indicated that the administration of modified DP in mice was able to induce specific IgG also recognizing native DP extract. Conclusions: Modified DP extract (allergoid) seems to be a good candidate for immunotherapy of patients affected by specific allergy.

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Clinical efficacy and safety of preseasonal sublingual immunotherapy with grass pollen carbamylated allergoid in rhinitic patients. A double-blind, placebo-controlled study

Abstract: The results of this study show that the allergoid SLIT is safe and effective in decreasing symptom scores and drug use in rhinitic patients allergic to grass pollen.

Cited by 41 publications

References 20 publications

Administration regimens for sublingual immunotherapy to pollen allergens: What do we know?

Administration regimens for sublingual immunotherapy to pollen allergens: What do we know?

Towards evidence‐based medicine in specific grass pollen immunotherapy

Date Palm Pollen Allergoid: Characterization of Its Chemical-Physical and Immunological Properties

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