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Immunomodulator Adjunctive Effects in Treatment of Allergic Diseases
S56 Abstracts
SATURDAY
217
Immunomodulator Adjunctive Effects in Treatment of Allergic Diseases M. Rudenko1, L. Siziakina1, E. Urban1, L. Du Buske2; 1Research Institute of Clinical Immunology and Allergology, Rostov-on-Don, RUSSIAN FEDERATION, 2Immunological Research Institute of New England, Gardner, MA. RATIONALE: The efficacy of a new immunomodulator as treatment of patients with allergy and concomitant immunodeficiency (SID) was assessed in a double-blind placebo-controlled study. METHODS: Immunologic assessment including CD3, CD4/CD8, CD20, HLA-DR positive cells, total and specific IgE, and lymphocyte blast transformation with mitogen (FGA) and specific allergen was performed on 300 patients age 16-29 years who were divided into three clinical groups: bronchial asthma (BA), atopic dermatitis (AD), and pollen allergy (PA) associated rhinoconjunctivitis. Patients were then randomized into two subgroups: immunomodulator-treated (IM) and placebo treated controls (P). BA was assessed by spirometry, AD by SCORAD index, and PA by the Duchaine scale. All groups received standard therapy, the IM subgroups also being treated with 20 days of rectal suppositories containing 6 mg of copolymer N-oxy1,4-ethylenepiperazine-N-carboxyethyl-1,4ethylenepiperazinium bromide, whereas the P subgroups received placebo suppositories. Standard therapy of BA was 250 mcg per day of inhaled glucocorticosteroid; of AD was topical agents and antihistamines; and of PA was specific immunotherapy (SIT). RESULTS: Initially there were reduced CD31: 51.3362.49%, CD41: 30.0661.55%, CD81: 17.0660.07%, and CD161: 7.996015% cells, with IgG: 9.4560.3g/l, IgA: 1.2160.1g/l, and Th1: 8.0661.01% cells along with increased CD201: 8.561.3%, and HLADR1: 21.2651% cells, total IgE: 446.32697.5 g/l, asIgE: 2.260.34 g/l, and increased Th2: 3.5660.67% cells, with excess blast transformation(RBTL) with specific allergen and mitogen. After one year of IM treatment, all patients demonstrated positive trends including CD31: 70.161.9%, CD4/CD8: 1.860.2%, CD201: 8.362.4%, and HLA-DR1: 1262.2% cells, and RBTL FGA/allergen: 49.64616.7/1.7860.6. The IM subgroup BA peak flows increased 10-20%, AD SCORAD decreased from 75.361 to 34.261.5%, and PA Duchaine scale decreased from 4.5360.24 to 3.6360.16, all statistically significant versus P control subgroups (p<0.05). There was also a decrease in the duration and frequency of infectious episodes in the IM groups from 1462 to 563 times per year. CONCLUSIONS: IM added to standard therapy may improve clinical and immunologic parameters of BA, AD and PA while reducing concomitant infectious illnesses.
218
Influence Of Anti-IgE On Nasal Polyps G. Rasp; Katharinenhospital, Stuttgart, GERMANY. RATIONALE: Nasal Polyps are often associated with Asthma and elevated IgE. Since there is the possibility of removing IgE by Anti-IgE antibody, there may be an influence on nasal polyps. Especially in nasal polyps, own data suggest local IgE production in the nasal mucosa. METHODS: In a preliminary study, four patients with moderate to severe allergic asthma and recurrent nasal polyps were included and treated with Anti-IgE (Omalizumab) as recommended by the manufacturer. In addition to their asthma control measures and monitoring, patients were monitored by nasal videoendoscopy every 4 weeks. RESULTS: Nasal polyps remained the same or shrinked during therapy. The mean stage decreased about 20% as measured by size related to existing anatomic landmarks. Patients also reported subjective impressions of decreased secretion and enhanced olfaction. CONCLUSIONS: In this open study, there are first hints of a possible positive effect of Anti-IgE on nasal polyps. It is not yet evaluated, whether local synthesis of IgE needs to be included in Anti-IgE dosing schedules. Controlled studies are necessary to further evaluate these hypotheses.
J ALLERGY CLIN IMMUNOL JANUARY 2007
219
Use of a Multimedia Presentation to Increase Knowledge and Safety of Allergen Immunotherapy P. Hemmers, S. Amara, B. Silverman, A. T. Schneider; Long Island College Hospital, Brooklyn, NY. RATIONALE: Allergen immunotherapy (IT) is a valuable tool for treatment of atopic diseases. Patient knowledge and compliance are mandatory for optimal benefit and safety. Unfortunately, previous studies have shown grave lack of knowledge and numerous misconceptions. The goal of our study is to evaluate the efficacy of a video education tool. METHODS: Patients presenting to Long Island College Hospital Asthma & Allergy Center and an adjacent private office for IT, were given an initial questionnaire to assess their knowledge (e.g. benefits, risks). Patients then reviewed these issues with their doctor. Next, half of the patients were randomized to watch a brief video discussing the basics of IT, in the context of a mock patient encounter. Finally, the questionnaire was repeated at the subsequent visit. RESULTS: Sixty-two patients completed both pre and post intervention questionnaires (56% of 111 enrolled). The average pre-intervention score was 10.3 (57%; clinic 5 9.8 and private 5 10.5 [p 5 0.11]). Only 27% of patients were aware that IT might have some potential risk beyond a cutaneous reaction. The video intervention group improved an average of 1.5 questions (8%) over placebo (p 5 0.0148). This difference was greater for the private patients (1.8, p 5 0.0167) than clinic patients (1.3, p 5 0.274). CONCLUSIONS: In concordance with prior studies, baseline knowledge in all patients was poor. Our video intervention provided a statistically significant increase in patient knowledge over physician discussion alone. Future studies investigating the use of video education to increase knowledge must also include safety and compliance outcomes.
220
Sublingual Immunotherapy with Allergoid Tablets: A Double Blind Placebo Controlled Assay A. G. Palma-Carlos; Clinical Allergy Immunology Center, Lisbon, PORTUGAL. RATIONALE: Sublingual immunotherapy (SLIT) is gaining wide acceptance in Europe as an alternative to SIT. Allergoid tablets can increase compliance of patients. A double blind trial has been done in grass pollens allergic patients. METHODS: 33 patients only allergic to grass pollens have been enrolled after obtaining informed consent and approval of the ethical committee of the institution. After randomization 17 patients were included in the active ground and 16 in the placebo poli vaccine and placebo were given as tablets (Lofarma, Milan, Italy) three times a week by the sublingual swallow method increasing progressively during 14 weeks before pollen season. Patients were followed during 2 consecutive years. Nasal provocation tests with the same allergen were done before immunotherapy and after 1 or 2 years of treatment. Symptom scores and allowed rescue medication (nasal steroids) scores were registered each year. RESULTS: Between vaccine and placebo the scores for rhinorrea sneezing and conjunctivitis were significantly decreased. Between the second and the first year of treatment the scores for allergoid tablets, rhinorrea snnezing and conjunctvitis scores were significantly decreased. Nasal steroid consumption were also significantly decreased in the active group during the pollen season. Only two light mouth pruritus were reported in the active group. Symptomatic score after nasal challenge was decreased after 2 years of treatment. CONCLUSION: Pre-seasonal immunotherapy of grass pollen rhinitis/ conjunctivitis with a sublingual monomeric grass pollen allergoid in tablets was significantly effective after 2 years improving rhinorrea, sneezing and conjunctivitis and reducing rescue medication. Compliance and tolerability were optimal. Funding: Clinical Allergy Immunology Center
SATURDAY
217
Immunomodulator Adjunctive Effects in Treatment of Allergic Diseases M. Rudenko1, L. Siziakina1, E. Urban1, L. Du Buske2; 1Research Institute of Clinical Immunology and Allergology, Rostov-on-Don, RUSSIAN FEDERATION, 2Immunological Research Institute of New England, Gardner, MA. RATIONALE: The efficacy of a new immunomodulator as treatment of patients with allergy and concomitant immunodeficiency (SID) was assessed in a double-blind placebo-controlled study. METHODS: Immunologic assessment including CD3, CD4/CD8, CD20, HLA-DR positive cells, total and specific IgE, and lymphocyte blast transformation with mitogen (FGA) and specific allergen was performed on 300 patients age 16-29 years who were divided into three clinical groups: bronchial asthma (BA), atopic dermatitis (AD), and pollen allergy (PA) associated rhinoconjunctivitis. Patients were then randomized into two subgroups: immunomodulator-treated (IM) and placebo treated controls (P). BA was assessed by spirometry, AD by SCORAD index, and PA by the Duchaine scale. All groups received standard therapy, the IM subgroups also being treated with 20 days of rectal suppositories containing 6 mg of copolymer N-oxy1,4-ethylenepiperazine-N-carboxyethyl-1,4ethylenepiperazinium bromide, whereas the P subgroups received placebo suppositories. Standard therapy of BA was 250 mcg per day of inhaled glucocorticosteroid; of AD was topical agents and antihistamines; and of PA was specific immunotherapy (SIT). RESULTS: Initially there were reduced CD31: 51.3362.49%, CD41: 30.0661.55%, CD81: 17.0660.07%, and CD161: 7.996015% cells, with IgG: 9.4560.3g/l, IgA: 1.2160.1g/l, and Th1: 8.0661.01% cells along with increased CD201: 8.561.3%, and HLADR1: 21.2651% cells, total IgE: 446.32697.5 g/l, asIgE: 2.260.34 g/l, and increased Th2: 3.5660.67% cells, with excess blast transformation(RBTL) with specific allergen and mitogen. After one year of IM treatment, all patients demonstrated positive trends including CD31: 70.161.9%, CD4/CD8: 1.860.2%, CD201: 8.362.4%, and HLA-DR1: 1262.2% cells, and RBTL FGA/allergen: 49.64616.7/1.7860.6. The IM subgroup BA peak flows increased 10-20%, AD SCORAD decreased from 75.361 to 34.261.5%, and PA Duchaine scale decreased from 4.5360.24 to 3.6360.16, all statistically significant versus P control subgroups (p<0.05). There was also a decrease in the duration and frequency of infectious episodes in the IM groups from 1462 to 563 times per year. CONCLUSIONS: IM added to standard therapy may improve clinical and immunologic parameters of BA, AD and PA while reducing concomitant infectious illnesses.
218
Influence Of Anti-IgE On Nasal Polyps G. Rasp; Katharinenhospital, Stuttgart, GERMANY. RATIONALE: Nasal Polyps are often associated with Asthma and elevated IgE. Since there is the possibility of removing IgE by Anti-IgE antibody, there may be an influence on nasal polyps. Especially in nasal polyps, own data suggest local IgE production in the nasal mucosa. METHODS: In a preliminary study, four patients with moderate to severe allergic asthma and recurrent nasal polyps were included and treated with Anti-IgE (Omalizumab) as recommended by the manufacturer. In addition to their asthma control measures and monitoring, patients were monitored by nasal videoendoscopy every 4 weeks. RESULTS: Nasal polyps remained the same or shrinked during therapy. The mean stage decreased about 20% as measured by size related to existing anatomic landmarks. Patients also reported subjective impressions of decreased secretion and enhanced olfaction. CONCLUSIONS: In this open study, there are first hints of a possible positive effect of Anti-IgE on nasal polyps. It is not yet evaluated, whether local synthesis of IgE needs to be included in Anti-IgE dosing schedules. Controlled studies are necessary to further evaluate these hypotheses.
J ALLERGY CLIN IMMUNOL JANUARY 2007
219
Use of a Multimedia Presentation to Increase Knowledge and Safety of Allergen Immunotherapy P. Hemmers, S. Amara, B. Silverman, A. T. Schneider; Long Island College Hospital, Brooklyn, NY. RATIONALE: Allergen immunotherapy (IT) is a valuable tool for treatment of atopic diseases. Patient knowledge and compliance are mandatory for optimal benefit and safety. Unfortunately, previous studies have shown grave lack of knowledge and numerous misconceptions. The goal of our study is to evaluate the efficacy of a video education tool. METHODS: Patients presenting to Long Island College Hospital Asthma & Allergy Center and an adjacent private office for IT, were given an initial questionnaire to assess their knowledge (e.g. benefits, risks). Patients then reviewed these issues with their doctor. Next, half of the patients were randomized to watch a brief video discussing the basics of IT, in the context of a mock patient encounter. Finally, the questionnaire was repeated at the subsequent visit. RESULTS: Sixty-two patients completed both pre and post intervention questionnaires (56% of 111 enrolled). The average pre-intervention score was 10.3 (57%; clinic 5 9.8 and private 5 10.5 [p 5 0.11]). Only 27% of patients were aware that IT might have some potential risk beyond a cutaneous reaction. The video intervention group improved an average of 1.5 questions (8%) over placebo (p 5 0.0148). This difference was greater for the private patients (1.8, p 5 0.0167) than clinic patients (1.3, p 5 0.274). CONCLUSIONS: In concordance with prior studies, baseline knowledge in all patients was poor. Our video intervention provided a statistically significant increase in patient knowledge over physician discussion alone. Future studies investigating the use of video education to increase knowledge must also include safety and compliance outcomes.
220
Sublingual Immunotherapy with Allergoid Tablets: A Double Blind Placebo Controlled Assay A. G. Palma-Carlos; Clinical Allergy Immunology Center, Lisbon, PORTUGAL. RATIONALE: Sublingual immunotherapy (SLIT) is gaining wide acceptance in Europe as an alternative to SIT. Allergoid tablets can increase compliance of patients. A double blind trial has been done in grass pollens allergic patients. METHODS: 33 patients only allergic to grass pollens have been enrolled after obtaining informed consent and approval of the ethical committee of the institution. After randomization 17 patients were included in the active ground and 16 in the placebo poli vaccine and placebo were given as tablets (Lofarma, Milan, Italy) three times a week by the sublingual swallow method increasing progressively during 14 weeks before pollen season. Patients were followed during 2 consecutive years. Nasal provocation tests with the same allergen were done before immunotherapy and after 1 or 2 years of treatment. Symptom scores and allowed rescue medication (nasal steroids) scores were registered each year. RESULTS: Between vaccine and placebo the scores for rhinorrea sneezing and conjunctivitis were significantly decreased. Between the second and the first year of treatment the scores for allergoid tablets, rhinorrea snnezing and conjunctvitis scores were significantly decreased. Nasal steroid consumption were also significantly decreased in the active group during the pollen season. Only two light mouth pruritus were reported in the active group. Symptomatic score after nasal challenge was decreased after 2 years of treatment. CONCLUSION: Pre-seasonal immunotherapy of grass pollen rhinitis/ conjunctivitis with a sublingual monomeric grass pollen allergoid in tablets was significantly effective after 2 years improving rhinorrea, sneezing and conjunctivitis and reducing rescue medication. Compliance and tolerability were optimal. Funding: Clinical Allergy Immunology Center