A controlled dose-response study of immunotherapy with standardized, partially purified extract of house dust mite: Clinical efficacy and side effects

Haugaard, L.; Dahl, Ronald; Jacobsen, Lars

doi:10.1016/0091-6749(93)90190-q

Cited by 176 publications

(145 citation statements)

References 43 publications

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“…This test has also been used to document conjunctival response to AIT (67), with results highly comparable to those observed in NPT (68) and bronchial inhalation challenge testing (69). In one longterm trial on grass pollen AIT, there was a 10-to 30-fold decrease in immediate conjunctival allergen sensitivity that paralleled clinical improvement and persisted for 3 years after discontinuation of AIT (70).…”

Section: Advantagesmentioning

confidence: 90%

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Pfaar

Démoly

Wijk

et al. 2014

Allergy

377

442

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Background: Allergen immunotherapy (AIT) has been thoroughly documented in randomized controlled trials (RCTs). It is the only immune-modifying and causal treatment available for patients suffering from IgE-mediated diseases such as allergic rhinoconjunctivitis, allergic asthma and insect sting allergy. However, there is a high degree of clinical and methodological heterogeneity among the endpoints in clinical studies on AIT, for both subcutaneous and sublingual immunotherapy (SCIT and SLIT). At present, there are no commonly accepted standards for defining the optimal outcome parameters to be used for both primary and secondary endpoints. Methods: As elaborated by a Task Force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) Immunotherapy Interest Group, this Position Paper evaluates the currently used outcome parameters in different RCTs and also aims to provide recommendations for the optimal endpoints in future AIT trials for allergic rhinoconjunctivitis. Results: Based on a thorough literature review, the TF members have outlined recommendations for nine domains of clinical outcome measures. As the primary outcome, the TF recommends a homogeneous combined symptom and medication score (CSMS) as a simple and standardized method that balances both symptoms and the need for antiallergic medication in an equally weighted manner. All outcomes, grouped into nine domains, are reviewed. Conclusion: A standardized and globally harmonized method for analysing the clinical efficacy of AIT products in RCTs is required. The EAACI TF highlights the CSMS as the primary endpoint for future RCTs in AIT for allergic rhinoconjunctivitis.

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Section: Advantagesmentioning

confidence: 90%

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Pfaar

Démoly

Wijk

et al. 2014

Allergy

377

442

View full text Add to dashboard Cite

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“…In parallel, it has been shown that increasing the dose of allergenic extract increases the rate of adverse events (5,(15)(16). In fact, with SCIT, the maintenance dose is usually identified as "the vaccine dose that can induce a significant clinical effect without causing appreciable side effects" (1).…”

Section: Discussionmentioning

confidence: 99%

The Clinical Efficacy of a Sublingual Monomeric Allergoid at Different Maintenance Doses: A Randomized Controlled Trial

Marogna

Colombo²,

Cerra³

et al. 2010

Int J Immunopathol Pharmacol

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Sublingual immunotherapy is widely recognized as a viable treatment for allergic rhinitis and asthma, but the optimal dosage is still under debate, expecially with modified allergens. We assessed the clinical effects of a monomeric allergoid across 3 different maintenance doses in mite-monosensitized patients with rhinitis and intermittent asthma. Eighty-nine patients allergic to HDM were randomized to 3 maintenance doses of monomeric allergoid (Lais®, Lofarma) or medications only. All the patients recorded their symptoms and rescue drug consumption in a diary card from November to February. Additionally, nasal eosinophil count, spirometry and methacholine bronchial challenge were performed at the beginning of the study and after 3 years. The symptom scores showed a clear improvement in all the three active arms versus baseline and versus the controls, irrespective of the dose. Likewise, a similar improvement versus baseline was seen for nasal inflammation and bronchial hyperreactivity. The SLIT with monomeric allergoids produces clinically significant results across a wide range of doses. The absence of significant side effects, even at high doses, is probably due to their low level of allergenicity.

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“…The clinical benefit of a mite extract containing 7 µg of Der p 1 per injection in the maintenance phase (Der p 1 is a major allergen of the house-dust mite Dermatophagoides pteronyssinus) cannot be significantly augmented by raising the dose to 21 µg of Der p 1, although this does lead to an increase in adverse effects. The efficacy of 0.7 µg of Der p 1 was in the range of placebo (25). Circa 8 µg of group 5 allergen in a grasspollen tablet is about as effective as placebo, and three times this dose (25 µg per day) yields the maximum effect, without any further benefit from still higher doses (26).…”

Section: Dose-dependence Of the Immunological Effect-the Definition Omentioning

confidence: 89%

Specific Immunotherapy

Klimek¹,

Kopp²,

Virchow³

2013

Deutsches Ärzteblatt International

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A controlled dose-response study of immunotherapy with standardized, partially purified extract of house dust mite: Clinical efficacy and side effects

Cited by 176 publications

References 43 publications

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper

The Clinical Efficacy of a Sublingual Monomeric Allergoid at Different Maintenance Doses: A Randomized Controlled Trial

Specific Immunotherapy

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