Preseasonal local allergoid immunotherapy to grass pollen in children: a double‐blind, placebo‐controlled, randomized trial

Caffarelli, Carlo; Sensi, L.; Marcucci, Francesco; Cavagni, Giovanni

doi:10.1034/j.1398-9995.2000.00655.x

Cited by 104 publications

(78 citation statements)

References 26 publications

(36 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Dose-dependent effects of LAIS with carbamylated allergoid was observed also for pollens at the dose of 3000AU/ week induced a greater statistically significant improvement of symptoms respect to IOOOAU/week after one year of treatment (19). In general, sublingual immunotherapy with monomeric allergoids is widely recognized as an effective treatment for allergic rhinoconjunctivitis (1), both in adults (3) and in children (4). These results are due to its specific characteristics that differentiates it from the other molecules used for specific immunotherapy.…”

Section: Discussionmentioning

confidence: 99%

Dose-Dependent Clinical and Immunological Efficacy of Sublingual Immunotherapy with Mite Monomeric Allergoid

Gioacchino

Cavallucci

Ballone

et al. 2012

Int J Immunopathol Pharmacol

View full text Add to dashboard Cite

Sublingual immunotherapy with monomeric carbamylated allergoid (LAIS) is an effective and well tolerated treatment of respiratory allergy. The aim of the present study was to correlate the efficacy of two maintenance doses (1000 AU vs 3000 AU) of LAIS with the immunological modulation of allergendriven Thl, Th2 and T regulatory cytokines produced in vitro by PBMCs, in patients suffering from mite allergic rhinitis. Forty-eight consecutive patients with mite allergic rhinitis were recruited. Patients were randomly assigned to group A (n=24) or group B (n=24), respectively receiving 1000 AU or 3000 AU weekly during one-year maintenance phase. Each patient was evaluated for rhinitis severity (ARIA protocol), and for drug consumption at the time ofthe inclusion and after 6 and 12 months oftreatment. Patients were also asked to report the perceived severity of the disease and the tolerability of the treatment in a visual analogical scale (VAS). Before and at the end of the treatment allergen-driven release of cytokines by PBMCs in vitro was measured. After J-year treatment, a statistically significant reduction of all clinical parameters was observed in all patients, associated with reduction of IL-4 and increase of INF-y secreted in vitro by mite-challenged PBMCs. Notably, the group treated with the higher dose showed significantly better clinical and immunological results. The efficacy of LAIS is correlated to the immune modulation in a clear dose-dependent effect.Sublingual specific immunotherapy with monomeric carbamylated allergoid (LAlS) is an effective and well tolerated treatment of respiratory allergy (1-5). The monomeric allergoid was obtained by carbamylation of the allergen with potassium cyanate at alkaline pH, a reaction that leads to a substantial substitution of the s-amino groups of the lysine residues within the protein. This simple chemical modification confers to the allergoid a series ofcharacteristics (6) which made it particularly appropriate for sublingual administration. Among them,thehypoallergenicity andthemonomericity, that

show abstract

Section: Discussionmentioning

confidence: 99%

Dose-Dependent Clinical and Immunological Efficacy of Sublingual Immunotherapy with Mite Monomeric Allergoid

Gioacchino

Cavallucci

Ballone

et al. 2012

Int J Immunopathol Pharmacol

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

“…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%

“…Study quality and treatment efficacy Only one adult study and one paediatric study were selected; both featured low sample sizes (17 and 24 SIT-treated subjects, respectively) (43,44). In a two-season study, PalmaCarlos et al (43) reported a significant season-to-season decrease in the symptom score for the active group only.…”

Section: Slit Allergoid Tabletsmentioning

confidence: 99%

Towards evidence‐based medicine in specific grass pollen immunotherapy

Calderón

Mösges

Hellmich

et al. 2010

Allergy

View full text Add to dashboard Cite

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 ...

show abstract

Preseasonal local allergoid immunotherapy to grass pollen in children: a double‐blind, placebo‐controlled, randomized trial

Abstract: Our results suggest that this immunotherapy is effective for the treatment of asthma due to grass pollen in children.

Cited by 104 publications

References 26 publications

Dose-Dependent Clinical and Immunological Efficacy of Sublingual Immunotherapy with Mite Monomeric Allergoid

Dose-Dependent Clinical and Immunological Efficacy of Sublingual Immunotherapy with Mite Monomeric Allergoid

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

Towards evidence‐based medicine in specific grass pollen immunotherapy

Contact Info

Product

Resources

About