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1 Ultra-Rush Specific Immune Therapy with Depigmented and Polymerized Allergen Extracts is Effective and Safe in Patients With Severe SAR Highly Sensitized against Pollen Allergens

1 Ultra-Rush Specific Immune Therapy with Depigmented and Polymerized Allergen Extracts is... ABSTRACTS Abstracts of the XXII World Allergy Congress, 4–8 December, 2012 Cancu´n, Mexico Methods: 301 (PP) patients with confirmed rhinitis and/or rhinoconjunctivitis ORAL ABSTRACT SESSION were treated in a double-blind study with 4 doses of 100 DPP/mL, 1000 DPP/ ALLERGEN IMMUNOTHERAPY 1 mL, 5000 DPP/mL and 10.000 DPP/mL allergen extract over 22 weeks in Germany, Poland, and Lithuania. A 1-day build-up phase applying 0.1 mL and 2 times 0.2 mL allergen extract was followed by a maintenance period applying 0.5 mL in 3 to 4 weeks intervals. Before treatment a CPT was Ultra-Rush Specific Immune Therapy with Depigmented and performed with semi-logarithmically increasing doses up to 10,000 SQ-U/mL Polymerized Allergen Extracts is Effective and Safe in Patients of native birch extract, after treatment the CPT was repeated with doses up to With Severe SAR Highly Sensitized against Pollen Allergens 100,000 SQ-U/mL. The main parameter was the percentage of patients with Michaela Gruber, and Ulrich Amon, MD. PsoriSol Clinic for Dermatology an increase of allergen extract to provoke a positive CPT after SIT. Secondary & Allergy, Hersbrcuk, Germany. parameters were specific IgE, IgG1 and IgG4 as well as safety. The main Background: Procedures for specific immune therapy (SIT) vary widely. We parameter was investigated using a hierarchic test procedure comparing the were interested whether a pre-seasonal ultra-rush treatment with depigmented highest dose against the lowest, if statistically significant testing the next and polymerized allergen extracts is effective and safe in patients with severe lower dose against the lowest until the difference was no longer significant. SAR. Results: An increase in allergen amount to provoke a positive CPT after SIT Methods: 31 pts (21 f, 10 m, mean age 39.7 years, range: 17–69 years) with was reached in 37.5% of the 100 DPP/mL, 50.7% of the 1000 DPP/mL, severe SAR and partial asthma attacks (31.3%) during pollen season (mean 54.9% of the 5000 DPP/mL and 55.8% of the 10,000 DPP/mL group. Results total IgE level 152 kU/L, range: 5–5113 kU/L; mean Phadia CAP class 3.7 compared to the lowest dose were statistically significant for the 5000 DPP/ and 3.5 against birch pollen and Bet v1, resp.; mean Phadia CAP class 3.7 mL (P ¼ 0.0236) and 10,000 DPP/mL group (P ¼ 0.0159). Specific IgEs and 3.3 against grass pollen and Phl p1,5, resp.) were treated with an ultra- remained stable in all groups whereas specific IgG1 and IgG4 showed dose- rush schedule receiving the maximum dose of 0.2 plus 0.3 mL of a allergen dependent increases. Grade 1 systemic reactions occurred in 18% (100 DPP/ extract (DepiQuick, Novartis, Germany) on day one, followed by further mL), 14.8% (1000 DPP/mL), 17.4% (5000 DPP/mL) and 25.3% (10,000 injecting the maximum dose of 0.5 mL at weekly intervals for 5 weeks. DPP/mL) of patients. Patients were interviewed by a questionnaire 2 months after the pollen season. Conclusions: We determined increased allergen amounts to obtain a positive Results: 75.8% of patients reported a good or very good effect of SIT with CPT after SIT from 1000 to 10,000 DPP/mL depigmented polymerized birch respect to their symptoms during the pollen season after having received only pollen extract. The 5000 DPP/mL dose extract suggest a good benefit/risk one cycle of ultra-rush SIT; 18.4 did not notice any effect after the first cycle; ratio with the potential for further development. one patient reported an increase of symptoms. 56.5% of patients did use less anti-allergic medication in comparison with their mean need before SIT; in 18.8% the need of medication was comparable to the year before. In 77.8% of all cases ultra-rush SIT was well tolerated subjectively. Local swelling at the injection site was reported in 25.9% (immediate) and 42.4% (delayed); 4 patients felt a mild discomfort after injection with pruritus, fatigue, or Double-blind Study of the Use of Transfer Factor (TF) Combined dizziness, respectively. The systemic symptoms disappeared spontaneously With Sublingual Immunotherapy in Management of Patients without medication. With Allergic Rhinitis in Mexican Population Conclusions: Even for patients with clinically severe SAR and high specific 1 2 María Isabel Rojo Gutiérrez, Misael Gonzalez-Ibarra, QFB, Teresa Sandoval, sensitization against birch or grass pollen the pre-seasonal ultra-rush SIT 3 1 1 2 QFB, and Jaime Mellado-Abrego, MD . Allergy; Allergy and Immunology; regimen with depigmented, polymerized allergen extracts showed a good Investigation, Juarez Hospital, Mexico City, Mexico. efficacy and tolerability. Background: Allergic diseases affect 20% of world population and allergic rhinitis (AR) is the most common, alone or associated with asthma. Antigen- specific immunotherapy has been world-desensitizing type studied showing that it is capable of modifying the natural history of the disease through changes in the immune response increasing the role of clones of lymphocytes T helper type Dose Optimizing Study of a Depigmented Polymerized Allergen I (LTh1) and inhibiting the activity of type 2 (LTh2). Dialyzable leukocyte Extract of Birch Pollen by Means of Conjunctival extract or transfer factor (TF) has shown the same stimulatory effect. Provocation Test Objective: Evaluate the synergistic effect of TF associated with SLIT in 1 2 1 Angelika Sager, MD, and Margitta Worm . Medical Department, LETI patients with RA. Pharma GmbH, Witten, Germany; Dermatology, Charite University Clinic, Material and Methods: We studied 94 patients with RA. We included Berlin, Germany. randomized into 2 groups (47 each one) both received antigen-specific Background: Clinical efficacy of a depigmented polymerized birch pollen sublingual immunotherapy (SLITAE) and also in group 1 was given oral TF extract has been shown in 2 large phase III studies with 1000 DPP/mL. To Unit at one 200 mg monthly for 3 months, and group 2 placebo. We used date dose-response studies are required to show optimal efficacy at a defined a control group only to compared the normal results. All patients underwent allergen dose. The conjunctival provocation test (CPT) is a possible outcome complete blood count (BHC), immunoglobulins, quantification of cell-type parameter and from the regulatory authorities accepted test procedure. lymphocyte CD3, CD4, CD8, interleukin (IL2, IL4, IL5, IL10, TNF and S18 WAO Journal February 2012 Copyright @ World Allergy Organization. Unauthorized reproduction of this article is prohibited. 2012 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png World Allergy Organization Journal Wolters Kluwer Health

1 Ultra-Rush Specific Immune Therapy with Depigmented and Polymerized Allergen Extracts is Effective and Safe in Patients With Severe SAR Highly Sensitized against Pollen Allergens

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Abstract

ABSTRACTS Abstracts of the XXII World Allergy Congress, 4–8 December, 2012 Cancu´n, Mexico Methods: 301 (PP) patients with confirmed rhinitis and/or rhinoconjunctivitis ORAL ABSTRACT SESSION were treated in a double-blind study with 4 doses of 100 DPP/mL, 1000 DPP/ ALLERGEN IMMUNOTHERAPY 1 mL, 5000 DPP/mL and 10.000 DPP/mL allergen extract over 22 weeks in Germany, Poland, and Lithuania. A 1-day build-up phase applying 0.1 mL and 2 times 0.2 mL allergen extract was followed by a maintenance period applying 0.5 mL in 3 to 4 weeks intervals. Before treatment a CPT was Ultra-Rush Specific Immune Therapy with Depigmented and performed with semi-logarithmically increasing doses up to 10,000 SQ-U/mL Polymerized Allergen Extracts is Effective and Safe in Patients of native birch extract, after treatment the CPT was repeated with doses up to With Severe SAR Highly Sensitized against Pollen Allergens 100,000 SQ-U/mL. The main parameter was the percentage of patients with Michaela Gruber, and Ulrich Amon, MD. PsoriSol Clinic for Dermatology an increase of allergen extract to provoke a positive CPT after SIT. Secondary & Allergy, Hersbrcuk, Germany. parameters were specific IgE, IgG1 and IgG4 as well as safety. The main Background: Procedures for specific immune therapy (SIT) vary widely. We parameter was investigated using a hierarchic test procedure comparing the were interested whether a pre-seasonal ultra-rush treatment with depigmented highest dose against the lowest, if statistically significant testing the next and polymerized allergen extracts is effective and safe in patients with severe lower dose against the lowest until the difference was no longer significant. SAR. Results: An increase in allergen amount to provoke a positive CPT after SIT Methods: 31 pts (21 f, 10 m, mean age 39.7 years, range: 17–69 years) with was reached in 37.5% of the 100 DPP/mL, 50.7% of the 1000 DPP/mL, severe SAR and partial asthma attacks (31.3%) during pollen season (mean 54.9% of the 5000 DPP/mL and 55.8% of the 10,000 DPP/mL group. Results total IgE level 152 kU/L, range: 5–5113 kU/L; mean Phadia CAP class 3.7 compared to the lowest dose were statistically significant for the 5000 DPP/ and 3.5 against birch pollen and Bet v1, resp.; mean Phadia CAP class 3.7 mL (P ¼ 0.0236) and 10,000 DPP/mL group (P ¼ 0.0159). Specific IgEs and 3.3 against grass pollen and Phl p1,5, resp.) were treated with an ultra- remained stable in all groups whereas specific IgG1 and IgG4 showed dose- rush schedule receiving the maximum dose of 0.2 plus 0.3 mL of a allergen dependent increases. Grade 1 systemic reactions occurred in 18% (100 DPP/ extract (DepiQuick, Novartis, Germany) on day one, followed by further mL), 14.8% (1000 DPP/mL), 17.4% (5000 DPP/mL) and 25.3% (10,000 injecting the maximum dose of 0.5 mL at weekly intervals for 5 weeks. DPP/mL) of patients. Patients were interviewed by a questionnaire 2 months after the pollen season. Conclusions: We determined increased allergen amounts to obtain a positive Results: 75.8% of patients reported a good or very good effect of SIT with CPT after SIT from 1000 to 10,000 DPP/mL depigmented polymerized birch respect to their symptoms during the pollen season after having received only pollen extract. The 5000 DPP/mL dose extract suggest a good benefit/risk one cycle of ultra-rush SIT; 18.4 did not notice any effect after the first cycle; ratio with the potential for further development. one patient reported an increase of symptoms. 56.5% of patients did use less anti-allergic medication in comparison with their mean need before SIT; in 18.8% the need of medication was comparable to the year before. In 77.8% of all cases ultra-rush SIT was well tolerated subjectively. Local swelling at the injection site was reported in 25.9% (immediate) and 42.4% (delayed); 4 patients felt a mild discomfort after injection with pruritus, fatigue, or Double-blind Study of the Use of Transfer Factor (TF) Combined dizziness, respectively. The systemic symptoms disappeared spontaneously With Sublingual Immunotherapy in Management of Patients without medication. With Allergic Rhinitis in Mexican Population Conclusions: Even for patients with clinically severe SAR and high specific 1 2 María Isabel Rojo Gutiérrez, Misael Gonzalez-Ibarra, QFB, Teresa Sandoval, sensitization against birch or grass pollen the pre-seasonal ultra-rush SIT 3 1 1 2 QFB, and Jaime Mellado-Abrego, MD . Allergy; Allergy and Immunology; regimen with depigmented, polymerized allergen extracts showed a good Investigation, Juarez Hospital, Mexico City, Mexico. efficacy and tolerability. Background: Allergic diseases affect 20% of world population and allergic rhinitis (AR) is the most common, alone or associated with asthma. Antigen- specific immunotherapy has been world-desensitizing type studied showing that it is capable of modifying the natural history of the disease through changes in the immune response increasing the role of clones of lymphocytes T helper type Dose Optimizing Study of a Depigmented Polymerized Allergen I (LTh1) and inhibiting the activity of type 2 (LTh2). Dialyzable leukocyte Extract of Birch Pollen by Means of Conjunctival extract or transfer factor (TF) has shown the same stimulatory effect. Provocation Test Objective: Evaluate the synergistic effect of TF associated with SLIT in 1 2 1 Angelika Sager, MD, and Margitta Worm . Medical Department, LETI patients with RA. Pharma GmbH, Witten, Germany; Dermatology, Charite University Clinic, Material and Methods: We studied 94 patients with RA. We included Berlin, Germany. randomized into 2 groups (47 each one) both received antigen-specific Background: Clinical efficacy of a depigmented polymerized birch pollen sublingual immunotherapy (SLITAE) and also in group 1 was given oral TF extract has been shown in 2 large phase III studies with 1000 DPP/mL. To Unit at one 200 mg monthly for 3 months, and group 2 placebo. We used date dose-response studies are required to show optimal efficacy at a defined a control group only to compared the normal results. All patients underwent allergen dose. The conjunctival provocation test (CPT) is a possible outcome complete blood count (BHC), immunoglobulins, quantification of cell-type parameter and from the regulatory authorities accepted test procedure. lymphocyte CD3, CD4, CD8, interleukin (IL2, IL4, IL5, IL10, TNF and S18 WAO Journal February 2012 Copyright @ World Allergy Organization. Unauthorized reproduction of this article is prohibited. 2012

Journal

World Allergy Organization JournalWolters Kluwer Health

Published: Feb 1, 2012

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