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Allergoid

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Margitta Worm – 1st expert on this subject based on the ideXlab platform

  • dose response relationship of a new timothy grass pollen Allergoid in comparison with a 6 grass pollen Allergoid
    Clinical & Experimental Allergy, 2017
    Co-Authors: Oliver Pfaar, Jens M. Hohlfeld, B. Hauswald, Bernhard Homey, Nico Hunzelmann, Sibylle Schliemann, P. Velling, B Alkadah, Margitta Worm

    Abstract:

    Background
    Subcutaneous allergen immunotherapy with grass pollen Allergoids has been proven to be effective and safe in the treatment of patients with allergic rhinoconjunctivitis. Based on the extensive cross-reactivity among Pooideae species, it has been suggested that grass pollen extracts could be prepared from a single species, rather than from a multiple species mixture.

    Objective
    To find the optimal dose of a Phleum pratense Allergoid preparation and compare its efficacy and safety to a 6-grass pollen Allergoid preparation.

    Methods
    In this double-blind, placebo-controlled study (EudraCT: 2011-000674-58), 3 doses of Phleum pratense Allergoid (1800 Therapeutic Units (TU), standard dose 6000 TU, and 18000 TU) were compared with placebo and the marketed 6-grass pollen Allergoid (6000 TU). In a preseasonal dosing regimen, 102 patients were randomized to 5 treatment groups and received 9 subcutaneous injections. The primary efficacy endpoint was the change in wheal size (late phase reaction, LPR) in response to the intracutaneous testing (ICT) before and after treatment, comparing the active Allergoids to placebo. Secondary outcomes were the change in Total Nasal Symptom Score (TNSS) assessed in the allergen exposure chamber (AEC), the changes in Phleum pratense-serum specific IgG4, and the incidence of adverse events (AEs).

    Results
    All 3 doses of the Phleum pratense and the 6-grass pollen Allergoid preparations were significantly superior to placebo for the primary outcome, whereas there were no significant differences in the change in TNSS. Compared to the standard dose, the high dose of Phleum pratense did not produce any additional significant benefit, but showed a slight increase in AEs. Yet this increase in AEs was lower than for the 6-grass pollen preparation.

    Conclusions & Clinical Relevance
    The standard dose of the new Phleum pratense Allergoid was comparable to the marketed 6-grass pollen preparation at equal dose for the parameters measured.

    This article is protected by copyright. All rights reserved.

  • Dose‐response relationship of a new Timothy grass pollen Allergoid in comparison with a 6‐grass pollen Allergoid
    Clinical & Experimental Allergy, 2017
    Co-Authors: Oliver Pfaar, Jens M. Hohlfeld, B. Al‐kadah, B. Hauswald, Bernhard Homey, Nico Hunzelmann, Sibylle Schliemann, P. Velling, Margitta Worm, Ludger Klimek

    Abstract:

    Background
    Subcutaneous allergen immunotherapy with grass pollen Allergoids has been proven to be effective and safe in the treatment of patients with allergic rhinoconjunctivitis. Based on the extensive cross-reactivity among Pooideae species, it has been suggested that grass pollen extracts could be prepared from a single species, rather than from a multiple species mixture.

    Objective
    To find the optimal dose of a Phleum pratense Allergoid preparation and compare its efficacy and safety to a 6-grass pollen Allergoid preparation.

    Methods
    In this double-blind, placebo-controlled study (EudraCT: 2011-000674-58), 3 doses of Phleum pratense Allergoid (1800 Therapeutic Units (TU), standard dose 6000 TU, and 18000 TU) were compared with placebo and the marketed 6-grass pollen Allergoid (6000 TU). In a preseasonal dosing regimen, 102 patients were randomized to 5 treatment groups and received 9 subcutaneous injections. The primary efficacy endpoint was the change in wheal size (late phase reaction, LPR) in response to the intracutaneous testing (ICT) before and after treatment, comparing the active Allergoids to placebo. Secondary outcomes were the change in Total Nasal Symptom Score (TNSS) assessed in the allergen exposure chamber (AEC), the changes in Phleum pratense-serum specific IgG4, and the incidence of adverse events (AEs).

    Results
    All 3 doses of the Phleum pratense and the 6-grass pollen Allergoid preparations were significantly superior to placebo for the primary outcome, whereas there were no significant differences in the change in TNSS. Compared to the standard dose, the high dose of Phleum pratense did not produce any additional significant benefit, but showed a slight increase in AEs. Yet this increase in AEs was lower than for the 6-grass pollen preparation.

    Conclusions & Clinical Relevance
    The standard dose of the new Phleum pratense Allergoid was comparable to the marketed 6-grass pollen preparation at equal dose for the parameters measured.

    This article is protected by copyright. All rights reserved.

  • the impact on allergy related cells of a birch pollen Allergoid with and without monophosphoryl lipid a in comparison with the native equivalent
    International Archives of Allergy and Immunology, 2017
    Co-Authors: Margitta Worm, Dennis Ernst, M Kraller, M Babina

    Abstract:

    Background: The clinical efficacy and safety of Allergoid immunotherapy have been demonstrated in clinical trials. However, simultaneous monitoring of the immunol

Giorgio Walter Canonica – 2nd expert on this subject based on the ideXlab platform

  • the clinical efficacy of a sublingual monomeric Allergoid at different maintenance doses a randomized controlled trial
    International Journal of Immunopathology and Pharmacology, 2010
    Co-Authors: Maurizio Marogna, Paolo Falagiani, F Colombo, C Cerra, M E Bruno, Alessandro Massolo, Giorgio Walter Canonica, G Passalacqua

    Abstract:

    : Sublingual immunotherapy is widely recognized as a viable treatment for allergic rhinitis and asthma, but the optimal dosage is still under debate, especially 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 allergeni city.

  • pharmacokinetics of der p 2 allergen and derived monomeric Allergoid in allergic volunteers
    International Archives of Allergy and Immunology, 2005
    Co-Authors: Marcello Bagnasco, Paolo Falagiani, Giorgio Walter Canonica, G Mistrello, Vania Altrinetti, Giampaola Pesce, M Caputo, Giovanni Passalacqua

    Abstract:

    BACKGROUND: Presently, sublingual immunotherapy is widely used as an alternative to the injection route for respiratory allergy, but its pharmacokinetics in humans is poorly known, and data are available only for Par j 1 allergen. We aimed at assessing the biodistribution of iodine-123-radiolabelled Der p 2 in allergic volunteers. METHODS: Purified Der p 2 and its monomeric Allergoid were radiolabelled with iodine-123 and administered sublingually to 7 allergic volunteers. The subjects were allowed to swallow 6 min after administration. Dynamic (up to 10 min) and static scintigraphic images (30 min, 1, 2, 3 and 20 h) were recorded, and blood samples were obtained at different time points to measure the plasma radioactivity and to assess the presence of circulating radiolabelled species by gel chromatography. RESULTS: The local pharmacokinetics did not differ between allergen and Allergoid. Plasma radioactivity began to increase only after swallowing and peaked at 1-2 h. Both the allergen and the Allergoid persisted in the mouth for several hours, and traces could be detectable up to 20 h. At radioactivity plasma peak, gel chromatography showed that a fraction of the Allergoid, but not the allergen, was absorbed as an intact molecule. CONCLUSIONS: These results indicate that the pharmacokinetics of sublingual administration is independent of the allergen used and characterized by the long persistence in the mouth. The contribution of enteric absorption of the Allergoid in the mechanism of action of sublingual immunotherapy remains to be defined.

  • quantitative assessment of the adherence to Allergoid sublingual immunotherapy in patients with house dust mite sensitization the insit study
    The Journal of Allergy and Clinical Immunology, 2004
    Co-Authors: Carlo Lombardi, Paolo Falagiani, G Passalacqua, F Gani, Massimo Landi, S Gargioni, Giorgio Walter Canonica

    Abstract:

    Abstract Rationale Sublingual Immunotherapy (SLIT) is a viable alternative to conventional immunotherapy, but some concerns exist about the adherence to SLIT, and few experimental data exist about this topic. We aimed at quantifying the adherence to the SLIT in patients with mite allergy. Methods We performed a multicenter study (INSIT) to assess the adherence, given as Allergoid SLIT in tablets (Lais, Lofarma, Italy), in patients with mite allergy. Patients underwent random telephonic interviews, during which they were asked to immediately count the remaining tablets. The adherence was measured by assessing the reported number of remaining tablets versus that expected, based on the administration schedule. Demographic and socio-economic data and clinical scores were also recorded. Results Forty-one patients (16 male: 15-65 yrs, mean age: 36.3), 19 with rhino-conjunctivitis and 22 with concomitant asthma were enrolled in the first year of the study. Allergoid SLIT was given continuously and the compliance was assessed at the end of 1 year of treatment. There were two dropouts: one lack of efficacy, one onset of nasal polyps. In the remaining 39 patients, the adherence was 3.929/4.056 tablets (96.8%). Sporadically omitted doses (less than 1 tablet/month) were reported by 6 patients (14.6%). No systemic or local side-effects were reported. We also observed a statistically significant improvement of rhinoconjunctivitis and asthma symptoms score and medication consumption. The compliance was in general lower in patients frequently travelling for business reasons. Conclusions The preliminary results of this ongoing study show that the adherence to Allergoid SLIT is satisfactory, despite it is self-administered.

Zeynep Misirligil – 3rd expert on this subject based on the ideXlab platform

  • Short-term preseasonal immunotherapy: Is early clinical efficacy related to the basophil response?
    International Archives of Allergy and Immunology, 2014
    Co-Authors: Şahin Kaya Özdemir, B. A. Sin, Deniz Güloʇlu, Aydan Ikincioʇullari, Zeynep Gencturk, Zeynep Misirligil

    Abstract:

    BACKGROUND: An aluminum hydroxide-adsorbed depot Allergoid preparation of six-grass pollen allergens has been developed for short-term preseasonal immunotherapy in pollinosis. However, only limited knowledge exists about its immunological and clinical effects. The aim of this study was to evaluate the basophil response, which can explain early clinical findings of short-term preseasonal Allergoid immunotherapy in allergic rhinitis.\n\nMETHODS: In a double-blind, placebo-controlled study, 31 patients allergic to grass pollens received one course of short-term preseasonal Allergoid immunotherapy or placebo. Immunogenicity was assessed by the levels of specific IgG4, IgE antibodies and an allergen-induced CD203c basophil activation test. The primary clinical end point was the combined symptom and medication score/average combined score (ACS).\n\nRESULTS: There was a 52.9% difference in ACS between the treatment and placebo groups in favor of immunotherapy (p = 0.01). Active treatment induced Phleum pratense-specific IgG4 and IgE antibodies (p < 0.05). A decrease in allergen-induced basophil activation at submaximal allergen concentrations was demonstrated at the end of immunotherapy and at the peak of the grass pollen season after immunotherapy.\n\nCONCLUSIONS: This study shows that grass pollen-allergic patients treated with one course of short-term preseasonal Allergoid immunotherapy exhibit a decrease in allergen-induced basophil activation, an increase in allergen-specific IgG4 antibodies and early clinical improvement.