Assessment of Short-Term Changes Induced by a Dermatophagoides pteronyssinus Extract on Asthmatic Patients. Randomised, Double-Blind, Placebo-Controlled Trial

Vidal, Carmen; Tabar, A. I.; Figueroa, Javier; Navarro, J. A.; Sanchez, C Puente; Orovitg, A.; Armisén, Margarita; Echechipía, S.; Joral, Alejandro; Lizarza, Susana; Lizaso, Ma Teresa; Rodríguez, Virginia Carbajosa; Torre, Fernando De la

doi:10.2174/156720111794479871

Cited by 5 publications

(3 citation statements)

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“…Recently, Tabar AI et al [30] reported similar results, achieving a CTI of 1.44 (95 % CI, 1.04 ‐ 1.98) after 6 weeks of immunotherapy. Likewise, clinical trials led by Martínez‐Cocera [35] and Vidal [36] showed similar reductions in skin reactivity after a short course of AIT with allergen extract derived from Phleum pratense and house dust mites, respectively.…”

Section: Discussionmentioning

confidence: 77%

Exploratory study of tolerability and immunological effect of a short up‐dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea

Moreno‐Aguilar

Pedro

Millán

et al. 2015

Clinical & Translational All

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BackgroundA new subcutaneous specific immunotherapy (SCIT) product adsorbed on aluminium hydroxide has been developed with a short and simplified up-dosing phase, containing a biologically standardized allergen pollen extract from Olea europaea.ObjectiveTo assess the tolerability profile of the updosing phase and its immunological effect, in terms of specific IgG4 and IgE levels and immediate skin reactivity.Material and methodsThe study was an exploratory, multi-centre, open-label, single-arm, phase II/III clinical trial. Adults with a clinical history of allergic rhinoconjunctivitis with/without asthma due to sensitization to olive pollen were selected. Five up-dosing doses (300, 600, 3000, 6000 and 15000SQ+) were administered at weekly intervals, followed by a maintenance dose (15000SQ+) after 2 weeks. Adverse events were collected during the 30 min observation period after injections, after a telephone contact 2 days after each visit, and after reviewing the subjects’ diary. IgG4 and IgE levels and immediate skin reactivity were evaluated at the beginning and at the end of the trial.ResultsNinety-three subjects were included in the trial (mean age, 35.7 ± 10.3 years; women, 66.7 %). A total of 95 adverse drug reactions, all mild in intensity and non-serious, were reported during the trial: 85 local in 34.4 % subjects, 9 systemic in 4.3 % subjects and one non-specific (grade 0). Within 6 weeks, significant changes in IgG4 and IgE levels and in immediate skin reactivity to Olea europaea were accomplished.ConclusionThis new SCIT derived from pollen of Olea europaea presented a good tolerability profile and induced significant immunological responses already after a 6 week treatment. However, the non-controlled design may limit the interpretation of these results.Trial registrationEudraCT no: 2011-004852-20; ClinicalTrials.gov Identifier: NCT01674595.

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Section: Discussionmentioning

confidence: 77%

Exploratory study of tolerability and immunological effect of a short up‐dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea

Moreno‐Aguilar

Pedro

Millán

et al. 2015

Clinical & Translational All

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“…The majority of trials reported on the short‐term effectiveness of AIT with only one SLIT trial reporting on long‐term effectiveness. The 54 SCIT trials (reported in 57 papers) included 2305 patients . and the 34 SLIT trials (reported in 36 papers) included 5108 patients.…”

Section: Resultsmentioning

confidence: 99%

Allergen immunotherapy for allergic asthma: A systematic review and meta‐analysis

Dhami¹,

Κακούρου

Asamoah

et al. 2017

Allergy

300

240

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“…Longer SCIT duration was also associated to a clear immunomodulatory effect [91] and with significant reductions in rhinitis and asthma scores [92] in adults with HDM-allergic asthma. However, in patients with persistent mild-moderate allergic asthma due to sensitisation to D. pteronyssinus, a 4-months SCIT was capable of inducing in vivo and in vitro changes, but these changes were not reflected in improved clinical outcomes [93]. These results are reassuring about the mid-and long-term efficacy of SCIT on HDM-related allergic asthma, and the need of long-term treatment to achieve clinical benefit.…”

Section: Subcutaneous Immunotherapymentioning

confidence: 87%

Specific allergen immunotherapy for the treatment of allergic asthma: a review of current evidence

Domínguez‐Ortega

Delgado

Blanco

et al. 2017

J Investig Allergol Clin Immunol

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Asthma is frequently associated with atopy, characterized by the production of specific immunoglobulin E in response to environmental allergens. Currently, two types of allergen immunotherapy (AIT) are used in clinical practice: subcutaneous and sublingual immunotherapy, both accepted as key components of the therapeutic repertoire for allergic rhinitis and conjunctivitis. However, their role in asthma remains controversial. The present document is aimed at providing the clinicians with a review of the evidence on the use of AIT in asthma, focusing on the most relevant aspects of its mechanism of action, its efficacy, and existing data on safety, tolerability, and cost-effectivity, both in pediatric and adult populations. A systematic search of MEDLINE, Cochrane, and Clinical Trials databases from 2000 to April of 2016 was carried out by a panel of experts from the Spanish Allergy and Clinical Immunology Scientific Society. Relevant studies prior to the year 2000 included in ulterior systematic reviews were also considered. More than 4000 articles were identified during the search and 241 were selected to retrieve available evidence on AIT, which was graded according to the Oxford classification. All the group members reviewed the resulting text until the final version reached the consensual agreement. A summary of recommendations on the more relevant topics are proposed. The role of AIT as a valuable therapeutic strategy for prevention of exacerbation and progressive decline in lung function is highlighted. Future research should include specific tools for asthma evaluation when assessing AIT effectiveness in asthmatic patients. ResumenEl asma se asocia frecuentemente con alergia, entendida ésta como la producción de IgE específica frente a alérgenos ambientales. Actualmente, existen dos tipos de inmunoterapia específica con alérgenos (ITE) para la práctica clínica habitual: subcutánea y sublingual, ambas indicadas en el tratamiento de la rinitis y la conjuntivitis alérgicas. Sin embargo, su papel en el asma resulta todavía controvertido. Dominguez-Ortega J, et al.

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Assessment of Short-Term Changes Induced by a Dermatophagoides pteronyssinus Extract on Asthmatic Patients. Randomised, Double-Blind, Placebo-Controlled Trial

Abstract: After just 4 months of treatment, SCIT was capable of inducing in vivo and in vitro changes, but these changes were not reflected in improved clinical outcome within the first 4 months of therapy.

Cited by 5 publications

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Exploratory study of tolerability and immunological effect of a short up‐dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea

Exploratory study of tolerability and immunological effect of a short up‐dosing immunotherapy phase with a standardised allergen extract derived from pollen of Olea europaea

Allergen immunotherapy for allergic asthma: A systematic review and meta‐analysis

Specific allergen immunotherapy for the treatment of allergic asthma: a review of current evidence

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