Liposome‐entrapped <i>D. pteronyssinus</i> vaccination in mild asthma patients: effect of 1‐year double‐blind, placebo‐controlled trial on inflammation, bronchial hyper‐responsiveness and immediate and late bronchial responses to the allergen

Álvarez, Miguel; Echechipía, S.; García, Blanca E.; Tabar, A. I.; Martín, S; Rico, Pilar; Olaguíbel, J M

doi:10.1046/j.1365-2222.2002.01514.x

Cited by 24 publications

(13 citation statements)

References 32 publications

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“…This confirms the results of other controlled trials investigating the effect of SIT administered by subcutaneous injection on methacholine responsiveness in subjects with respiratory allergy[7,30,31]. By contrast, other investigations identified a significant improvement in methacholine responsiveness after SIT with house dust mites[23,27] or pollen allergens[24,25]. Reasons to such discrepancies are not evident, but might be related to differences in patients' characteristics, to diversity in the disease activity in the subjects studied, to differences in the characteristics of the allergenic extract administered, or to important differences in the statistical analysis.…”

Section: Discussionsupporting

confidence: 87%

Effect of allergen-specific immunotherapy with purified Alt a1 on AMP responsiveness, exhaled nitric oxide and exhaled breath condensate pH: a randomized double blind study

Prieto

Palácios

Aldana

et al. 2010

All Asth Clin Immun

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BackgroundLittle information is available on the effect of allergen-specific immunotherapy on airway responsiveness and markers in exhaled air. The aims of this study were to assess the safety of immunotherapy with purified natural Alt a1 and its effect on airway responsiveness to direct and indirect bronchoconstrictor agents and markers in exhaled air.MethodsThis was a randomized double-blind trial. Subjects with allergic rhinitis with or without mild/moderate asthma sensitized to A alternata and who also had a positive skin prick test to Alt a1 were randomized to treatment with placebo (n = 18) or purified natural Alt a1 (n = 22) subcutaneously for 12 months. Bronchial responsiveness to adenosine 5'-monophosphate (AMP) and methacholine, exhaled nitric oxide (ENO), exhaled breath condensate (EBC) pH, and serum Alt a1-specific IgG4 antibodies were measured at baseline and after 6 and 12 months of treatment. Local and systemic adverse events were also registered.ResultsThe mean (95% CI) allergen-specific IgG4 value for the active treatment group increased from 0.07 μg/mL (0.03-0.11) at baseline to 1.21 μg/mL (0.69-1.73, P < 0.001) at 6 months and to 1.62 μg/mL (1.02-2.22, P < 0.001) at 12 months of treatment. In the placebo group, IgG4 value increased nonsignificantly from 0.09 μg/mL (0.06-0.12) at baseline to 0.13 μg/mL (0.07-0.18) at 6 months and to 0.11 μg/mL (0.07-0.15) at 12 months of treatment. Changes in the active treatment group were significantly higher than in the placebo group both at 6 months (P < 0.001) and at 12 months of treatment (P < 0.0001). However, changes in AMP and methacholine responsiveness, ENO and EBC pH levels were not significantly different between treatment groups. The overall incidence of adverse events was comparable between the treatment groups.ConclusionAlthough allergen-specific immunotherapy with purified natural Alt a1 is well tolerated and induces an allergen-specific IgG4 response, treatment is not associated with changes in AMP or methacholine responsiveness or with significant improvements in markers of inflammation in exhaled air. These findings suggest dissociation between the immunotherapy-induced increase in IgG4 levels and its effect on airway responsiveness and inflammation.

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Section: Discussionsupporting

confidence: 87%

Effect of allergen-specific immunotherapy with purified Alt a1 on AMP responsiveness, exhaled nitric oxide and exhaled breath condensate pH: a randomized double blind study

Prieto

Palácios

Aldana

et al. 2010

All Asth Clin Immun

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“…Nine studies reported on FEV1. Reporting of data was varied . (Table ) Data pooled from two studies indicated no clear evidence of benefit associated with AIT with an SMD of 0.41 (95% CI −0.46, 1.27; Fig.…”

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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“…At T12, before the allergen challenge, serum ECP levels increased in the placebo group and blood eosinophils showed a trend toward lower numbers in the active group. The immediate response and the changes in Mch‐DRS values, sputum eosinophils, and serum ECP levels, following the allergen challenge, were attenuated in the active group …”

Section: Evaluation Of the Body Of Evidencementioning

confidence: 94%

EAACI Guidelines on Allergen Immunotherapy: House dust mite‐driven allergic asthma

Agache

Lau

Akdiş

et al. 2019

Allergy

241

199

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blind placebo controlled; EAACI, European Academy of Allergy and Clinical Immunology; FEF 25-75, forced expiratory flow at 25-75% of the pulmonary volume; FEV1, forced expiratory volume in 1 second; GINA, Global Initiative for Asthma; GRADE, The Grading of Recommendations Assessment, Development and Evaluation; HCP, healthcare professional; HDM, house dust mites; ICS, inhaled corticosteroids; MEF 25, maximal expiratory flow at 25% of forced vital capacity; MEF 50, maximal expiratory flow at 50% of forced vital capacity; MEF 75, maximal expiratory flow at 75% of forced vital capacity; PD20, provocative dose causing a 20% drop in FEV1; QoL, quality of life; RCTs, randomized control trials; ROB, risk of bias; SCIT, subcutaneous allergen immunotherapy; SLIT, sublingual allergen immunotherapy; SmPC, Summary of product characteristics; WAO, World Allergy Organization; WHO, World Health Organization.Agache and Lau are joint first co-authorship. External peer-reviewers: AbstractAllergen immunotherapy (AIT) has been in use for the treatment of allergic disease for more than 100 years. Asthma treatment relies mainly on corticosteroids and other controllers recommended to achieve and maintain asthma control, prevent exacerbations, and improve quality of life. AIT is underused in asthma, both in children and in adults. Notably, patients with allergic asthma not adequately controlled on pharmacotherapy (including biologics) represent an unmet health need. The European Academy of Allergy and Clinical Immunology has developed a clinical practice guideline providing evidence-based recommendations for the use of house dust mites (HDM) AIT as add-on treatment for HDM-driven allergic asthma. This guideline was developed by a multi-disciplinary working group using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. HDM AIT was separately evaluated by route of administration and children and adults: subcutaneous (SCIT) and sublingual AIT (SLIT), drops, and tablets. Recommendations were formulated for each. The important prerequisites for successful treatment with HDM AIT are (a) selection of patients most likely to respond to AIT and (b) use of allergen extracts and desensitization protocols of proven efficacy. To date, only AITwith HDM SLIT-tablet has demonstrated a robust effect in adults for critical end points (exacerbations, asthma control, and safety). Thus, it is recommended as an add-on to regular asthma therapy for adults with controlled or partially controlled HDM-driven allergic asthma (conditional recommendation, moderate-quality evidence). HDM SCIT is recommended for adults and children, and SLIT drops are recommended for children with controlled HDM-driven allergic asthma as the add-on to regular asthma therapy to decrease symptoms and medication needs (conditional recommendation, low-quality evidence). K E Y W O R D Sallergen immunotherapy, allergy, asthma, asthma control, asthma exacerbations, GRADE, house dust mites, lung function

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Liposome‐entrapped D. pteronyssinus vaccination in mild asthma patients: effect of 1‐year double‐blind, placebo‐controlled trial on inflammation, bronchial hyper‐responsiveness and immediate and late bronchial responses to the allergen

Abstract: Liposome-entrapped D. Pteronyssinus vaccination: (i) protects mild asthma patients from the worsening of asthma due to sustained mite exposure; and (ii) reduces the functional and inflammatory changes induced by allergen bronchial provocation.

Cited by 24 publications

References 32 publications

Effect of allergen-specific immunotherapy with purified Alt a1 on AMP responsiveness, exhaled nitric oxide and exhaled breath condensate pH: a randomized double blind study

Effect of allergen-specific immunotherapy with purified Alt a1 on AMP responsiveness, exhaled nitric oxide and exhaled breath condensate pH: a randomized double blind study

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

EAACI Guidelines on Allergen Immunotherapy: House dust mite‐driven allergic asthma

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