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A Didier - One of the best experts on this subject based on the ideXlab platform.
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five Grass Pollen sublingual immunotherapy tablet for the treatment of Grass Pollen induced allergic rhinoconjunctivitis 5 years of experience
Expert Review of Clinical Immunology, 2014Co-Authors: A Didier, Ulrich Wahn, Friedrich HorakAbstract:Oralair® (OA) (Stallergenes, Antony, France) is a unique pre- and co-seasonal 5-Grass-Pollen sublingual immunotherapy tablet launched in 2008, and now approved in 31 countries worldwide for the treatment of Grass-Pollen allergic rhinitis and rhinoconjunctivitis. OA is the first oral treatment with a consistent, well-balanced allergen extract that mimics natural exposure and sensitization. A wealth of data exists from over 5 years of clinical and real-world experience demonstrating the efficacy and safety of OA for Grass-Pollen-allergy treatment. OA is highly effective from the first Pollen season in all patient subgroups, including children and those with comorbid mild asthma, irrespective of sensitization status and symptom severity. OA also has sustained long-term benefits for symptom control and quality of life. This article provides an overview of the pharmacodynamics and pharmacology of OA; its efficacy, safety, tolerability and cost–effectiveness for the treatment of allergic rhinitis and rhinoconju...
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post treatment efficacy of discontinuous treatment with 300ir 5 Grass Pollen sublingual tablet in adults with Grass Pollen induced allergic rhinoconjunctivitis
Clinical & Experimental Allergy, 2013Co-Authors: A Didier, M. Worm, Michel Melac, Hansjorgen Malling, F Horak, Gordon Sussman, S Soulie, Robert K. ZeldinAbstract:BACKGROUND: Sustained efficacy over three Pollen seasons of pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet has been demonstrated in adults with moderate-severe Grass Pollen-associated allergic rhinoconjunctivitis. OBJECTIVE: To assess the efficacy of discontinuous treatment with 300IR 5-Grass Pollen sublingual tablet during the post-treatment Pollen season of this long-term study. METHODS: Adults aged 18-50, sensitized to Grass Pollen, with a history of allergic rhinoconjunctivitis for more than two Pollen seasons, and a retrospective rhinoconjunctivitis total symptom score ≥ 12 (0-18 scale), were randomized to receive Placebo or a 300IR tablet daily beginning either 4 months (4M) or 2 months (2M) prior to each Pollen season and continuing for its duration for three consecutive years. They were followed over the subsequent immunotherapy-free Pollen season. Post-treatment efficacy was evaluated using the Average Adjusted Symptom Score (AAdSS, adjusting the Rhinoconjunctivitis Total Symptom Score for rescue medication usage) during the post-treatment Pollen period. Secondary endpoints included Average Rhinoconjunctivitis Total Symptom Score (ARTSS), Average Rescue Medication Score (ARMS), overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and safety evaluation. Efficacy variables were analysed using ancova. RESULTS: Overall, 435 patients contributed to the Year 4 efficacy analyses. The Least-Squares (LS) mean differences (95% confidence interval) in AAdSS between active treatment and Placebo over the fourth Pollen period were -1.14 (-2.03; -0.26) (P = 0.0114) and -1.43 (-2.32; -0.53) (P = 0.0019) in the (4M) and (2M) groups, corresponding to -22.9% and -28.5% relative LS mean differences (vs. Placebo) respectively. The active groups also showed statistically significant differences compared to Placebo in ARTSS, ARMS and overall RQLQ score. No safety risk was identified during the post-treatment period. CONCLUSIONS AND CLINICAL RELEVANCE: Pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet administered discontinuously for three consecutive years is efficacious post-treatment, safe and well tolerated. Benefits of treatment were meaningful to patients.
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Post‐treatment efficacy of discontinuous treatment with 300IR 5‐Grass Pollen sublingual tablet in adults with Grass Pollen‐induced allergic rhinoconjunctivitis
Clinical & Experimental Allergy, 2013Co-Authors: A Didier, M. Worm, Friedrich Horak, Michel Melac, Hansjorgen Malling, Gordon Sussman, S Soulie, Robert K. ZeldinAbstract:BACKGROUND: Sustained efficacy over three Pollen seasons of pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet has been demonstrated in adults with moderate-severe Grass Pollen-associated allergic rhinoconjunctivitis. OBJECTIVE: To assess the efficacy of discontinuous treatment with 300IR 5-Grass Pollen sublingual tablet during the post-treatment Pollen season of this long-term study. METHODS: Adults aged 18-50, sensitized to Grass Pollen, with a history of allergic rhinoconjunctivitis for more than two Pollen seasons, and a retrospective rhinoconjunctivitis total symptom score ≥ 12 (0-18 scale), were randomized to receive Placebo or a 300IR tablet daily beginning either 4 months (4M) or 2 months (2M) prior to each Pollen season and continuing for its duration for three consecutive years. They were followed over the subsequent immunotherapy-free Pollen season. Post-treatment efficacy was evaluated using the Average Adjusted Symptom Score (AAdSS, adjusting the Rhinoconjunctivitis Total Symptom Score for rescue medication usage) during the post-treatment Pollen period. Secondary endpoints included Average Rhinoconjunctivitis Total Symptom Score (ARTSS), Average Rescue Medication Score (ARMS), overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and safety evaluation. Efficacy variables were analysed using ancova. RESULTS: Overall, 435 patients contributed to the Year 4 efficacy analyses. The Least-Squares (LS) mean differences (95% confidence interval) in AAdSS between active treatment and Placebo over the fourth Pollen period were -1.14 (-2.03; -0.26) (P = 0.0114) and -1.43 (-2.32; -0.53) (P = 0.0019) in the (4M) and (2M) groups, corresponding to -22.9% and -28.5% relative LS mean differences (vs. Placebo) respectively. The active groups also showed statistically significant differences compared to Placebo in ARTSS, ARMS and overall RQLQ score. No safety risk was identified during the post-treatment period. CONCLUSIONS AND CLINICAL RELEVANCE: Pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet administered discontinuously for three consecutive years is efficacious post-treatment, safe and well tolerated. Benefits of treatment were meaningful to patients.
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5 Posttreatment, Long-Term Clinical Efficacy of a 300 IR Sublingual Tablet of 5-Grass Pollen Allergen Extract in Adults With Grass Pollen Induced Allergic Rhinoconjunctivitis.
World Allergy Organization Journal, 2012Co-Authors: A Didier, Friedrich Horak, A. Montagut, Robert K. Zeldin, Hansjorgen Malling, Margitta Worm, Patricia Rodriguez, Michèle Lheritier-barrandAbstract:Background A 5-year study of adults with Grass-Pollen related rhinoconjunctivitis has demonstrated the sustained efficacy of discontinuous treatment with a 300 IR sublingual tablet of 5-Grass Pollen allergen extract, initiated 4 or 2 months before each Pollen season and continued for its duration for 3 consecutive years. Here we report on the persistence of efficacy during the first of 2 post-treatment Pollen seasons.
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sustained 3 year efficacy of pre and coseasonal 5 Grass Pollen sublingual immunotherapy tablets in patients with Grass Pollen induced rhinoconjunctivitis
The Journal of Allergy and Clinical Immunology, 2011Co-Authors: A Didier, Friedrich Horak, Olivier De Beaumont, Gordon Sussman, Margitta Worm, Martine Le Gall, M Melac, Hansjorgen MallingAbstract:Background Seasonal allergic rhinoconjunctivitis affects millions of persons. The efficacy of allergen sublingual immunotherapy (SLIT) was demonstrated in previous short-term studies. Objectives We sought to evaluate the sustained efficacy of 2 dosing regimens of a pre- and coseasonal treatment with 300 IR (index of reactivity) 5-Grass-Pollen SLIT tablets (Oralair) compared with placebo assessed by using the average adjusted symptom score (AAdSS) at season 3 in adults with Grass Pollen–induced rhinoconjunctivitis. Methods Six hundred thirty-three patients were treated for either 2 or 4 months before and then during the Grass Pollen season with active or placebo treatment for 3 consecutive seasons. The primary outcome was the AAdSS, a symptom score adjusted for rescue medication use, after 3 consecutive treatment seasons. Secondary outcomes were symptoms and rescue medication score, quality-of-life, and safety assessments. Results The mean AAdSS was reduced by 36.0% and 34.5% at season 3 in the 2- and 4-month pre- and coseasonal active treatment groups, respectively, compared with that in the placebo group ( P Conclusions Sustained efficacy of 2- and 4-month pre- and coseasonal treatment with the 300 IR tablet over 3 Pollen seasons was demonstrated, with reduction in symptoms and rescue medication use. The treatment was well tolerated. Adverse events decreased in number and intensity over the 3 seasons.
Friedrich Horak - One of the best experts on this subject based on the ideXlab platform.
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five Grass Pollen sublingual immunotherapy tablet for the treatment of Grass Pollen induced allergic rhinoconjunctivitis 5 years of experience
Expert Review of Clinical Immunology, 2014Co-Authors: A Didier, Ulrich Wahn, Friedrich HorakAbstract:Oralair® (OA) (Stallergenes, Antony, France) is a unique pre- and co-seasonal 5-Grass-Pollen sublingual immunotherapy tablet launched in 2008, and now approved in 31 countries worldwide for the treatment of Grass-Pollen allergic rhinitis and rhinoconjunctivitis. OA is the first oral treatment with a consistent, well-balanced allergen extract that mimics natural exposure and sensitization. A wealth of data exists from over 5 years of clinical and real-world experience demonstrating the efficacy and safety of OA for Grass-Pollen-allergy treatment. OA is highly effective from the first Pollen season in all patient subgroups, including children and those with comorbid mild asthma, irrespective of sensitization status and symptom severity. OA also has sustained long-term benefits for symptom control and quality of life. This article provides an overview of the pharmacodynamics and pharmacology of OA; its efficacy, safety, tolerability and cost–effectiveness for the treatment of allergic rhinitis and rhinoconju...
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Post‐treatment efficacy of discontinuous treatment with 300IR 5‐Grass Pollen sublingual tablet in adults with Grass Pollen‐induced allergic rhinoconjunctivitis
Clinical & Experimental Allergy, 2013Co-Authors: A Didier, M. Worm, Friedrich Horak, Michel Melac, Hansjorgen Malling, Gordon Sussman, S Soulie, Robert K. ZeldinAbstract:BACKGROUND: Sustained efficacy over three Pollen seasons of pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet has been demonstrated in adults with moderate-severe Grass Pollen-associated allergic rhinoconjunctivitis. OBJECTIVE: To assess the efficacy of discontinuous treatment with 300IR 5-Grass Pollen sublingual tablet during the post-treatment Pollen season of this long-term study. METHODS: Adults aged 18-50, sensitized to Grass Pollen, with a history of allergic rhinoconjunctivitis for more than two Pollen seasons, and a retrospective rhinoconjunctivitis total symptom score ≥ 12 (0-18 scale), were randomized to receive Placebo or a 300IR tablet daily beginning either 4 months (4M) or 2 months (2M) prior to each Pollen season and continuing for its duration for three consecutive years. They were followed over the subsequent immunotherapy-free Pollen season. Post-treatment efficacy was evaluated using the Average Adjusted Symptom Score (AAdSS, adjusting the Rhinoconjunctivitis Total Symptom Score for rescue medication usage) during the post-treatment Pollen period. Secondary endpoints included Average Rhinoconjunctivitis Total Symptom Score (ARTSS), Average Rescue Medication Score (ARMS), overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and safety evaluation. Efficacy variables were analysed using ancova. RESULTS: Overall, 435 patients contributed to the Year 4 efficacy analyses. The Least-Squares (LS) mean differences (95% confidence interval) in AAdSS between active treatment and Placebo over the fourth Pollen period were -1.14 (-2.03; -0.26) (P = 0.0114) and -1.43 (-2.32; -0.53) (P = 0.0019) in the (4M) and (2M) groups, corresponding to -22.9% and -28.5% relative LS mean differences (vs. Placebo) respectively. The active groups also showed statistically significant differences compared to Placebo in ARTSS, ARMS and overall RQLQ score. No safety risk was identified during the post-treatment period. CONCLUSIONS AND CLINICAL RELEVANCE: Pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet administered discontinuously for three consecutive years is efficacious post-treatment, safe and well tolerated. Benefits of treatment were meaningful to patients.
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5 Posttreatment, Long-Term Clinical Efficacy of a 300 IR Sublingual Tablet of 5-Grass Pollen Allergen Extract in Adults With Grass Pollen Induced Allergic Rhinoconjunctivitis.
World Allergy Organization Journal, 2012Co-Authors: A Didier, Friedrich Horak, A. Montagut, Robert K. Zeldin, Hansjorgen Malling, Margitta Worm, Patricia Rodriguez, Michèle Lheritier-barrandAbstract:Background A 5-year study of adults with Grass-Pollen related rhinoconjunctivitis has demonstrated the sustained efficacy of discontinuous treatment with a 300 IR sublingual tablet of 5-Grass Pollen allergen extract, initiated 4 or 2 months before each Pollen season and continued for its duration for 3 consecutive years. Here we report on the persistence of efficacy during the first of 2 post-treatment Pollen seasons.
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sustained 3 year efficacy of pre and coseasonal 5 Grass Pollen sublingual immunotherapy tablets in patients with Grass Pollen induced rhinoconjunctivitis
The Journal of Allergy and Clinical Immunology, 2011Co-Authors: A Didier, Friedrich Horak, Olivier De Beaumont, Gordon Sussman, Margitta Worm, Martine Le Gall, M Melac, Hansjorgen MallingAbstract:Background Seasonal allergic rhinoconjunctivitis affects millions of persons. The efficacy of allergen sublingual immunotherapy (SLIT) was demonstrated in previous short-term studies. Objectives We sought to evaluate the sustained efficacy of 2 dosing regimens of a pre- and coseasonal treatment with 300 IR (index of reactivity) 5-Grass-Pollen SLIT tablets (Oralair) compared with placebo assessed by using the average adjusted symptom score (AAdSS) at season 3 in adults with Grass Pollen–induced rhinoconjunctivitis. Methods Six hundred thirty-three patients were treated for either 2 or 4 months before and then during the Grass Pollen season with active or placebo treatment for 3 consecutive seasons. The primary outcome was the AAdSS, a symptom score adjusted for rescue medication use, after 3 consecutive treatment seasons. Secondary outcomes were symptoms and rescue medication score, quality-of-life, and safety assessments. Results The mean AAdSS was reduced by 36.0% and 34.5% at season 3 in the 2- and 4-month pre- and coseasonal active treatment groups, respectively, compared with that in the placebo group ( P Conclusions Sustained efficacy of 2- and 4-month pre- and coseasonal treatment with the 300 IR tablet over 3 Pollen seasons was demonstrated, with reduction in symptoms and rescue medication use. The treatment was well tolerated. Adverse events decreased in number and intensity over the 3 seasons.
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Different allergenic activity of Grass Pollen allergens revealed by skin testing
European Journal of Clinical Investigation, 2008Co-Authors: Kerstin Westritschnig, Susanne Spitzauer, Friedrich Horak, Ines Swoboda, Nadja Balic, Michael Kundi, Helmut Fiebig, Roland Suck, Oliver Cromwell, R ValentaAbstract:Background Grass Pollen is one of the most important allergen sources. The aim of this study was to compare the in vivo allergenic activity of two recently characterized major Grass Pollen allergens, Phl p 4 and Phl p 13, with three established major Grass Pollen allergens, Phl p 1, Phl p 2 and Phl p 5 as a basis for the formulation of a Grass Pollen allergy vaccine based on purified allergens. Material and methods Eighty-two Grass Pollen allergic patients were skin prick tested with serial dilutions of approximately equimolar concentrations of the purified allergens in a double-blind study. Results Phl p 4 and Phl p 13 were identified as major Grass Pollen allergens according to IgE binding frequency (Phl p 4: 85%; Phl p 13: 56%), but exhibited a five to nine-fold lower allergenic skin reactivity compared to Phl p 1, Phl p 2 or Phl p 5. Conclusion Our results indicate that Phl p 4 and Phl p 13 are not essential components for a therapeutic Grass Pollen vaccine and underpin the importance of evaluating the in vivo allergenic activity of individual allergens for the formulation of therapeutic vaccines based on purified allergens.
Hansjorgen Malling - One of the best experts on this subject based on the ideXlab platform.
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post treatment efficacy of discontinuous treatment with 300ir 5 Grass Pollen sublingual tablet in adults with Grass Pollen induced allergic rhinoconjunctivitis
Clinical & Experimental Allergy, 2013Co-Authors: A Didier, M. Worm, Michel Melac, Hansjorgen Malling, F Horak, Gordon Sussman, S Soulie, Robert K. ZeldinAbstract:BACKGROUND: Sustained efficacy over three Pollen seasons of pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet has been demonstrated in adults with moderate-severe Grass Pollen-associated allergic rhinoconjunctivitis. OBJECTIVE: To assess the efficacy of discontinuous treatment with 300IR 5-Grass Pollen sublingual tablet during the post-treatment Pollen season of this long-term study. METHODS: Adults aged 18-50, sensitized to Grass Pollen, with a history of allergic rhinoconjunctivitis for more than two Pollen seasons, and a retrospective rhinoconjunctivitis total symptom score ≥ 12 (0-18 scale), were randomized to receive Placebo or a 300IR tablet daily beginning either 4 months (4M) or 2 months (2M) prior to each Pollen season and continuing for its duration for three consecutive years. They were followed over the subsequent immunotherapy-free Pollen season. Post-treatment efficacy was evaluated using the Average Adjusted Symptom Score (AAdSS, adjusting the Rhinoconjunctivitis Total Symptom Score for rescue medication usage) during the post-treatment Pollen period. Secondary endpoints included Average Rhinoconjunctivitis Total Symptom Score (ARTSS), Average Rescue Medication Score (ARMS), overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and safety evaluation. Efficacy variables were analysed using ancova. RESULTS: Overall, 435 patients contributed to the Year 4 efficacy analyses. The Least-Squares (LS) mean differences (95% confidence interval) in AAdSS between active treatment and Placebo over the fourth Pollen period were -1.14 (-2.03; -0.26) (P = 0.0114) and -1.43 (-2.32; -0.53) (P = 0.0019) in the (4M) and (2M) groups, corresponding to -22.9% and -28.5% relative LS mean differences (vs. Placebo) respectively. The active groups also showed statistically significant differences compared to Placebo in ARTSS, ARMS and overall RQLQ score. No safety risk was identified during the post-treatment period. CONCLUSIONS AND CLINICAL RELEVANCE: Pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet administered discontinuously for three consecutive years is efficacious post-treatment, safe and well tolerated. Benefits of treatment were meaningful to patients.
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Post‐treatment efficacy of discontinuous treatment with 300IR 5‐Grass Pollen sublingual tablet in adults with Grass Pollen‐induced allergic rhinoconjunctivitis
Clinical & Experimental Allergy, 2013Co-Authors: A Didier, M. Worm, Friedrich Horak, Michel Melac, Hansjorgen Malling, Gordon Sussman, S Soulie, Robert K. ZeldinAbstract:BACKGROUND: Sustained efficacy over three Pollen seasons of pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet has been demonstrated in adults with moderate-severe Grass Pollen-associated allergic rhinoconjunctivitis. OBJECTIVE: To assess the efficacy of discontinuous treatment with 300IR 5-Grass Pollen sublingual tablet during the post-treatment Pollen season of this long-term study. METHODS: Adults aged 18-50, sensitized to Grass Pollen, with a history of allergic rhinoconjunctivitis for more than two Pollen seasons, and a retrospective rhinoconjunctivitis total symptom score ≥ 12 (0-18 scale), were randomized to receive Placebo or a 300IR tablet daily beginning either 4 months (4M) or 2 months (2M) prior to each Pollen season and continuing for its duration for three consecutive years. They were followed over the subsequent immunotherapy-free Pollen season. Post-treatment efficacy was evaluated using the Average Adjusted Symptom Score (AAdSS, adjusting the Rhinoconjunctivitis Total Symptom Score for rescue medication usage) during the post-treatment Pollen period. Secondary endpoints included Average Rhinoconjunctivitis Total Symptom Score (ARTSS), Average Rescue Medication Score (ARMS), overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and safety evaluation. Efficacy variables were analysed using ancova. RESULTS: Overall, 435 patients contributed to the Year 4 efficacy analyses. The Least-Squares (LS) mean differences (95% confidence interval) in AAdSS between active treatment and Placebo over the fourth Pollen period were -1.14 (-2.03; -0.26) (P = 0.0114) and -1.43 (-2.32; -0.53) (P = 0.0019) in the (4M) and (2M) groups, corresponding to -22.9% and -28.5% relative LS mean differences (vs. Placebo) respectively. The active groups also showed statistically significant differences compared to Placebo in ARTSS, ARMS and overall RQLQ score. No safety risk was identified during the post-treatment period. CONCLUSIONS AND CLINICAL RELEVANCE: Pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet administered discontinuously for three consecutive years is efficacious post-treatment, safe and well tolerated. Benefits of treatment were meaningful to patients.
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5 Posttreatment, Long-Term Clinical Efficacy of a 300 IR Sublingual Tablet of 5-Grass Pollen Allergen Extract in Adults With Grass Pollen Induced Allergic Rhinoconjunctivitis.
World Allergy Organization Journal, 2012Co-Authors: A Didier, Friedrich Horak, A. Montagut, Robert K. Zeldin, Hansjorgen Malling, Margitta Worm, Patricia Rodriguez, Michèle Lheritier-barrandAbstract:Background A 5-year study of adults with Grass-Pollen related rhinoconjunctivitis has demonstrated the sustained efficacy of discontinuous treatment with a 300 IR sublingual tablet of 5-Grass Pollen allergen extract, initiated 4 or 2 months before each Pollen season and continued for its duration for 3 consecutive years. Here we report on the persistence of efficacy during the first of 2 post-treatment Pollen seasons.
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sustained 3 year efficacy of pre and coseasonal 5 Grass Pollen sublingual immunotherapy tablets in patients with Grass Pollen induced rhinoconjunctivitis
The Journal of Allergy and Clinical Immunology, 2011Co-Authors: A Didier, Friedrich Horak, Olivier De Beaumont, Gordon Sussman, Margitta Worm, Martine Le Gall, M Melac, Hansjorgen MallingAbstract:Background Seasonal allergic rhinoconjunctivitis affects millions of persons. The efficacy of allergen sublingual immunotherapy (SLIT) was demonstrated in previous short-term studies. Objectives We sought to evaluate the sustained efficacy of 2 dosing regimens of a pre- and coseasonal treatment with 300 IR (index of reactivity) 5-Grass-Pollen SLIT tablets (Oralair) compared with placebo assessed by using the average adjusted symptom score (AAdSS) at season 3 in adults with Grass Pollen–induced rhinoconjunctivitis. Methods Six hundred thirty-three patients were treated for either 2 or 4 months before and then during the Grass Pollen season with active or placebo treatment for 3 consecutive seasons. The primary outcome was the AAdSS, a symptom score adjusted for rescue medication use, after 3 consecutive treatment seasons. Secondary outcomes were symptoms and rescue medication score, quality-of-life, and safety assessments. Results The mean AAdSS was reduced by 36.0% and 34.5% at season 3 in the 2- and 4-month pre- and coseasonal active treatment groups, respectively, compared with that in the placebo group ( P Conclusions Sustained efficacy of 2- and 4-month pre- and coseasonal treatment with the 300 IR tablet over 3 Pollen seasons was demonstrated, with reduction in symptoms and rescue medication use. The treatment was well tolerated. Adverse events decreased in number and intensity over the 3 seasons.
Oliver Pfaar - One of the best experts on this subject based on the ideXlab platform.
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ultra short course booster is effective in recurrent Grass Pollen induced allergic rhinoconjunctivitis
Allergy, 2018Co-Authors: Oliver Pfaar, S Lang, U Pieperfurst, Anatoli Astvatsatourov, F Gerich, L Klimek, Matthias F Kramer, Y Reydelet, Kija Shahhosseini, R MosgesAbstract:Background A relevant proportion of allergic rhinitis (AR) patients experience recurrent symptoms after successfully completing allergen immunotherapy (AIT). This prospective, controlled, non-interventional study used internationally standardised instruments to determine the clinical effects of a preseasonal, ultra-short-course booster AIT on clinical outcome parameters. Methods This two-arm study included patients aged ≥12 years with recurrent Grass Pollen–induced seasonal AR who had completed a successful course of any Grass Pollen AIT at least five years before enrolment. Overall, 56 patients received one preseasonal short-course booster AIT using tyrosine-absorbed Grass Pollen allergoids containing the adjuvant monophosphoryl lipid A (MPL®); 51 control patients received symptomatic medication. The combined symptom and medication score (CSMS) was recorded in the (peak) Grass Pollen season. Furthermore, concomitant (antiallergic) medication use, the patients'state of health, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) results, and safety/tolerability of the treatment were assessed. Results The CSMS in the peak Grass Pollen season was significantly lower in the booster AIT group (Δ=38.4%, P<0.01). Moreover, significantly more patients in this group used no concomitant antiallergic medication throughout the peak Grass Pollen season. Twice as many patients in the booster AIT group as in the control group reported having a better state of health than in the preceding season. RQLQ results showed significant differences favouring the booster AIT. The booster AIT was generally well tolerated, with only 2 patients reporting mild, grade 1 systemic adverse events. Conclusion Booster AIT using tyrosine-absorbed allergoids containing the adjuvant MPL® effectively prevents re-occurrence of symptoms in patients with Grass Pollen–induced AR. This article is protected by copyright. All rights reserved.
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Dose‐response relationship of a new Timothy Grass Pollen allergoid in comparison with a 6‐Grass Pollen allergoid
Clinical & Experimental Allergy, 2017Co-Authors: Oliver Pfaar, Jens M. Hohlfeld, B. Al‐kadah, B. Hauswald, Bernhard Homey, Nico Hunzelmann, S. Schliemann, P. Velling, M. Worm, Ludger KlimekAbstract: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.
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a randomized placebo controlled trial of rush preseasonal depigmented polymerized Grass Pollen immunotherapy
Allergy, 2012Co-Authors: Oliver Pfaar, Zoe Urry, David Robinson, A. Sager, Catherine M. Hawrylowicz, Matthias Bräutigam, D Richards, Ludger KlimekAbstract:To cite this article: Pfaar O, Urry Z, Robinson DS, Sager A, Richards D, Hawrylowicz CM, Brautigam M, Klimek L. A randomized placebo-controlled trial of rush preseasonal depigmented polymerized Grass Pollen immunotherapy. Allergy 2012; 67: 272–279. Abstract: Background: Specific subcutaneous immunotherapy (SCIT) for seasonal rhinoconjunctivitis with unmodified allergen extracts is effective, but limited by risk of side-effects and involves treatment over 3 years. We examined a depigmented polymerized Grass Pollen extract for immunogenicity and for clinical efficacy in a rush preseasonal regimen. Methods: Depigmented polymerized Grass Pollen extract was tested for proliferation and cytokine production by peripheral blood mononuclear cells. A prospective, double-blind, placebo-controlled trial of 195 Grass Pollen allergic patients treated with preseasonal rush immunotherapy using depigmented polymerized allergenic extract of mixed Grass Pollen was performed over 2 years. Primary outcome was combined symptom and medication score (SMS) during the peak of the second Grass Pollen season. Secondary outcomes included combined score over the whole season, during the first Grass Pollen season, individual symptom and medication scores, quality of life, well days/hell days and responder analysis. Adverse events were classified using the EAACI scale. Grass Pollen-specific IgE and IgG4 were measured before and during treatment. Results: Depigmented polymerized extract stimulated dose-dependent T-cell proliferation and cytokine production. Patients treated with preseasonal SCIT showed improved combined scores during peak season at year 2 (median 3.93, interquartile range 0.77–6.27 vs median 5.86 for placebo, 3.11–8.36, P < 0.01). Most secondary outcomes were significantly better for active treatment. Side-effects were minimal, with no grade 3 or 4 reactions. Conclusions: Depigmented polymerized Grass Pollen extract is immunogenic and clinically effective in rush preseasonal SCIT. This form of immunotherapy may be an attractive option for some patients.
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A randomized placebo-controlled trial of rush preseasonal depigmented polymerized Grass Pollen immunotherapy*
Allergy, 2011Co-Authors: Oliver Pfaar, Zoe Urry, David Robinson, A. Sager, David F. Richards, Catherine M. Hawrylowicz, Matthias Bräutigam, Ludger KlimekAbstract:To cite this article: Pfaar O, Urry Z, Robinson DS, Sager A, Richards D, Hawrylowicz CM, Brautigam M, Klimek L. A randomized placebo-controlled trial of rush preseasonal depigmented polymerized Grass Pollen immunotherapy. Allergy 2012; 67: 272–279. Abstract: Background: Specific subcutaneous immunotherapy (SCIT) for seasonal rhinoconjunctivitis with unmodified allergen extracts is effective, but limited by risk of side-effects and involves treatment over 3 years. We examined a depigmented polymerized Grass Pollen extract for immunogenicity and for clinical efficacy in a rush preseasonal regimen. Methods: Depigmented polymerized Grass Pollen extract was tested for proliferation and cytokine production by peripheral blood mononuclear cells. A prospective, double-blind, placebo-controlled trial of 195 Grass Pollen allergic patients treated with preseasonal rush immunotherapy using depigmented polymerized allergenic extract of mixed Grass Pollen was performed over 2 years. Primary outcome was combined symptom and medication score (SMS) during the peak of the second Grass Pollen season. Secondary outcomes included combined score over the whole season, during the first Grass Pollen season, individual symptom and medication scores, quality of life, well days/hell days and responder analysis. Adverse events were classified using the EAACI scale. Grass Pollen-specific IgE and IgG4 were measured before and during treatment. Results: Depigmented polymerized extract stimulated dose-dependent T-cell proliferation and cytokine production. Patients treated with preseasonal SCIT showed improved combined scores during peak season at year 2 (median 3.93, interquartile range 0.77–6.27 vs median 5.86 for placebo, 3.11–8.36, P
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Sustained clinical efficacy of sublingual immunotherapy with a high-dose Grass Pollen extract
European annals of allergy and clinical immunology, 2011Co-Authors: Piotr Kuna, Oliver Pfaar, Margitta Worm, Bolesław Samoliński, Leszek KlimekAbstract:Background: Sublingual immunotherapy (SLIT) with a high-dose 6-Grass Pollen SingleDose preparation was shown to be effective and safe in a 2-year randomized, double-blind, placebo-controlled trial. Objective: We evaluated the effect of the third year of SLIT in comparison to the second year. Methods: 46 Grass Pollen-allergic patients who had received active treatment for 3 consecutive years were included in the safety set. Diary data from 39 subjects were evaluated to calculate symptom and medication scores as well as 'well days'. Results: Symptoms and medication intake further decreased in the third year of SLIT during the Grass Pollen season in comparison to the previous years and the number of 'well days' increased accordingly. No serious adverse events occurred during the three years of SLIT. Conclusion: The third year of SLIT with the high-dose 6-Grass Pollen preparation results in sustained and even further increased clinical efficacy.
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post treatment efficacy of discontinuous treatment with 300ir 5 Grass Pollen sublingual tablet in adults with Grass Pollen induced allergic rhinoconjunctivitis
Clinical & Experimental Allergy, 2013Co-Authors: A Didier, M. Worm, Michel Melac, Hansjorgen Malling, F Horak, Gordon Sussman, S Soulie, Robert K. ZeldinAbstract:BACKGROUND: Sustained efficacy over three Pollen seasons of pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet has been demonstrated in adults with moderate-severe Grass Pollen-associated allergic rhinoconjunctivitis. OBJECTIVE: To assess the efficacy of discontinuous treatment with 300IR 5-Grass Pollen sublingual tablet during the post-treatment Pollen season of this long-term study. METHODS: Adults aged 18-50, sensitized to Grass Pollen, with a history of allergic rhinoconjunctivitis for more than two Pollen seasons, and a retrospective rhinoconjunctivitis total symptom score ≥ 12 (0-18 scale), were randomized to receive Placebo or a 300IR tablet daily beginning either 4 months (4M) or 2 months (2M) prior to each Pollen season and continuing for its duration for three consecutive years. They were followed over the subsequent immunotherapy-free Pollen season. Post-treatment efficacy was evaluated using the Average Adjusted Symptom Score (AAdSS, adjusting the Rhinoconjunctivitis Total Symptom Score for rescue medication usage) during the post-treatment Pollen period. Secondary endpoints included Average Rhinoconjunctivitis Total Symptom Score (ARTSS), Average Rescue Medication Score (ARMS), overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and safety evaluation. Efficacy variables were analysed using ancova. RESULTS: Overall, 435 patients contributed to the Year 4 efficacy analyses. The Least-Squares (LS) mean differences (95% confidence interval) in AAdSS between active treatment and Placebo over the fourth Pollen period were -1.14 (-2.03; -0.26) (P = 0.0114) and -1.43 (-2.32; -0.53) (P = 0.0019) in the (4M) and (2M) groups, corresponding to -22.9% and -28.5% relative LS mean differences (vs. Placebo) respectively. The active groups also showed statistically significant differences compared to Placebo in ARTSS, ARMS and overall RQLQ score. No safety risk was identified during the post-treatment period. CONCLUSIONS AND CLINICAL RELEVANCE: Pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet administered discontinuously for three consecutive years is efficacious post-treatment, safe and well tolerated. Benefits of treatment were meaningful to patients.
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Post‐treatment efficacy of discontinuous treatment with 300IR 5‐Grass Pollen sublingual tablet in adults with Grass Pollen‐induced allergic rhinoconjunctivitis
Clinical & Experimental Allergy, 2013Co-Authors: A Didier, M. Worm, Friedrich Horak, Michel Melac, Hansjorgen Malling, Gordon Sussman, S Soulie, Robert K. ZeldinAbstract:BACKGROUND: Sustained efficacy over three Pollen seasons of pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet has been demonstrated in adults with moderate-severe Grass Pollen-associated allergic rhinoconjunctivitis. OBJECTIVE: To assess the efficacy of discontinuous treatment with 300IR 5-Grass Pollen sublingual tablet during the post-treatment Pollen season of this long-term study. METHODS: Adults aged 18-50, sensitized to Grass Pollen, with a history of allergic rhinoconjunctivitis for more than two Pollen seasons, and a retrospective rhinoconjunctivitis total symptom score ≥ 12 (0-18 scale), were randomized to receive Placebo or a 300IR tablet daily beginning either 4 months (4M) or 2 months (2M) prior to each Pollen season and continuing for its duration for three consecutive years. They were followed over the subsequent immunotherapy-free Pollen season. Post-treatment efficacy was evaluated using the Average Adjusted Symptom Score (AAdSS, adjusting the Rhinoconjunctivitis Total Symptom Score for rescue medication usage) during the post-treatment Pollen period. Secondary endpoints included Average Rhinoconjunctivitis Total Symptom Score (ARTSS), Average Rescue Medication Score (ARMS), overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score and safety evaluation. Efficacy variables were analysed using ancova. RESULTS: Overall, 435 patients contributed to the Year 4 efficacy analyses. The Least-Squares (LS) mean differences (95% confidence interval) in AAdSS between active treatment and Placebo over the fourth Pollen period were -1.14 (-2.03; -0.26) (P = 0.0114) and -1.43 (-2.32; -0.53) (P = 0.0019) in the (4M) and (2M) groups, corresponding to -22.9% and -28.5% relative LS mean differences (vs. Placebo) respectively. The active groups also showed statistically significant differences compared to Placebo in ARTSS, ARMS and overall RQLQ score. No safety risk was identified during the post-treatment period. CONCLUSIONS AND CLINICAL RELEVANCE: Pre- and co-seasonal treatment with 300IR 5-Grass Pollen sublingual tablet administered discontinuously for three consecutive years is efficacious post-treatment, safe and well tolerated. Benefits of treatment were meaningful to patients.
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A Us Study Of 5-Grass Pollen Allergen Extract In Adults With Grass Pollen-induced Allergic Rhinoconjunctivitis - Results Of Secondary Efficacy Assessments
The Journal of Allergy and Clinical Immunology, 2012Co-Authors: Thomas B. Casale, A. Nayak, Peter Socrates Creticos, A. Montagut, Robert K. ZeldinAbstract:FEBRUARY 2012 AB46 Abstracts S A T U R D A Y 174 Improvement In Quality Of Life With Administration Of A 300 IR Sublingual Tablet Of 5-Grass Pollen Allergen Extract In Adults With Grass Pollen-induced Allergic Rhinoconjunctivitis F. Horak, A. Didier, M. Worm, H. Malling, K. Abiteboul, A. Montagut, R. K. Zeldin; Allergy Centre Vienna, Vienna, AUSTRIA, Rangueil-Larrey Hospital, Toulouse, FRANCE, Allergie-Centrum-Charit, Klinik fr Dermatologie, Venerologie und Allergologie, Berlin, GERMANY, National University Hospital, Copenhagen, DENMARK, Stallergenes, Antony, FRANCE. RATIONALE: In single season studies, preand co-seasonal administration of a 300 IR sublingual tablet of 5-Grass Pollen allergen extract improves quality of life (QoL). Here we report the Year 1 to Year 4 QoL results from an ongoing 5 year study. METHODS: 633 adults were randomized to placebo or 300 IR preand co-seasonally for three Grass Pollen seasons. Active treatment was initiated 4 months [4M] or 2 months [2M] before each season and continued for its duration. Patients were followed during the subsequent, treatment-free, Grass Pollen season. Each year, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ, responses to 28 questions, 7-point Likert scale with low score 5 better QoL) was completed before and midway through the Pollen season. An ANCOVA model was used to analyze differences vs. placebo. RESULTS: The LS mean changes from baseline in the placebo, 4M and 2Mgroupswere 1.67, 1.36 and 1.21 in Year 1, 1.45, 1.06 and 1.01 inYear 2, 1.36, 0.94 and 0.95 in Year 3 and 1.41, 0.95 and 0.88 in treatment-free, Y4. The relative LS mean QoL improvement in the 4M and 2M groups (vs. placebo) was 18.5% and 27.4% in Year 1, 27.0% and 30.6% in Year 2, 30.4% and 29.8% in Year 3 and 32.8% and 37.6% in Year 4, respectively (p
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5 Posttreatment, Long-Term Clinical Efficacy of a 300 IR Sublingual Tablet of 5-Grass Pollen Allergen Extract in Adults With Grass Pollen Induced Allergic Rhinoconjunctivitis.
World Allergy Organization Journal, 2012Co-Authors: A Didier, Friedrich Horak, A. Montagut, Robert K. Zeldin, Hansjorgen Malling, Margitta Worm, Patricia Rodriguez, Michèle Lheritier-barrandAbstract:Background A 5-year study of adults with Grass-Pollen related rhinoconjunctivitis has demonstrated the sustained efficacy of discontinuous treatment with a 300 IR sublingual tablet of 5-Grass Pollen allergen extract, initiated 4 or 2 months before each Pollen season and continued for its duration for 3 consecutive years. Here we report on the persistence of efficacy during the first of 2 post-treatment Pollen seasons.
