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Dose-related Effects of Ragweed Allergy Immunotherapy Tablet on Nasal and Ocular Symptoms of Allergic Rhinoconjunctivitis During the Peak Ragweed Pollen Seasons in Europe and North America
177
Post-treatment, Long-term Efficacy Of A 300IR Sublingual Tablet Of 5-grass Pollen Allergen Extract In Adults With Grass Pollen-induced Allergic Rhinoconjunctivitis: The Relationship With Disease Severity M. Worm1, A. Didier2, F. Horak3, H. Malling4, S. Soulie5, R. K. Zeldin5; 1 Allergie-Centrum-Charit, Klinik fr Dermatologie, Berlin, GERMANY, 2 Rangueil-Larrey Hospital, Toulouse, FRANCE, 3Allergy Centre Vienna, Vienna, AUSTRIA, 4National University Hospital, Copenhagen, DENMARK, 5Stallergenes, Antony, FRANCE. RATIONALE: The sustained efficacy (i.e., after 3 treatment years) of discontinuous treatment with 300IR sublingual tablet of 5-grass pollen allergen extract has been demonstrated in an ongoing, 5-year study. Here we report the relationship between disease severity and clinical efficacy over four consecutive grass pollen seasons. METHODS: 633 adults were randomized to placebo or 300IR pre- and co-seasonally for three grass pollen seasons starting 4 months [4M] or 2 months [2M] prior to the season each year and followed up during the subsequent, treatment-free, season. Average Adjusted Symptom Score (AASS, adjusting Rhinoconjunctivitis Total Symptom Score for rescue medication usage, range 0-18) was the primary efficacy endpoint. To evaluate the relationship with disease severity, pooled centers were ranked from lowest to highest mean AASS in the placebo group, and divided in three tertiles. As post hoc subgroup analyses, AASSs during the pollen period for each of the first 4 study years were analyzed by tertile using an ANCOVA model. RESULTS: For each study year, relative mean differences in AASS for active groups compared to Placebo in tertiles with medium and high mean AASS in placebo group were statistically significant while no significant differences were observed in the low tertile. For example, in year 4, relative mean differences in 4M vs. placebo in high, medium, and low disease severity tertiles were -34.0%, [[Unsupported Character - Codename -]] 28.3% and +14.3%, respectively. CONCLUSIONS: In each of three treatment seasons and the posttreatment season, the 300IR 5-grass-pollen tablet was most effective in populations with higher symptom severity.
178
Comparative Efficacy and Tolerability of Subcutaneous and Sublingual Allergen Specific Immunotherapy A. Blaziene1, A. Chomiciene1, L. M. DuBuske2; 1Vilnius University, Center of Pulmonology and Allergology, Vilnius, LITHUANIA, 2Immunology Research Institute of New England, Gardner, MA. RATIONALE: Allergen specific immunotherapy (ASIT) has been used for 100 years with efficacy confirmed of Subcutaneous Allergen Immunotherapy (SCIT) seen in numerous double-blind placebo controlled studies but recent evidence notes efficacy of sublingual immunotherapy (SLIT) which may be better tolerated than SCIT. This study assesses the efficacy and tolerability of both SCIT and SLIT in clinical practice. METHODS: 22 patients (13 females, 9 males) with allergic rhinitis or rhinoconjuctivitis (6 with mild asthma) were studied. Mean patient age was 3266 years. Duration of ASIT was 260.96 years. SCIT was used in 12 patients while SLIT was used in 10 patients (Stallergenes extracts). All patients were asked about symptom changes during ASIT (3 point system: worse, no change, better) and about adverse events. RESULTS: Nasal secretions and nasal obstruction decreased in 96% of patients, while sneezing and nasal itching decreased in 91% of patients. Itching and tearing of eyes decreased in 82%, and eye redness in 77% of patients. Asthma symptoms were less in 67 % of patients. Total symptom scores improved similarly in both SCIT and SLIT patients.1 patient from the SCIT group had local reaction after allergen extract injection and 1 patient from SLIT group had slight tongue edema after allergen extract administration in the initial phase of ASIT. CONCLUSIONS: Both SCIT and SLIT methods are effective and well tolerated in the treatment of allergic rhinoconjuctivitis and mild asthma.
179
Grass Pollen Inmunotherapy In Children: Safety Aspects M. I. Garcimartin, M. Vazquez de la Torre Gaspar, F. Ruano Perez, N. Blanca Lopez, E. Seoane Reula, M. De Diego, M. Canto Diez; Hospital Infanta Leonor, Madrid, Madrid, SPAIN. RATIONALE: Cluster schedules are an accelerated procedure to achieve maintenance dose and allow the administration of high allergen doses in a short time interval. We investigate the safety profile of cluster schedule with grass pollen (SCIT), in children with allergic rhinitis and/or asthma. METHODS: A total of 131 patients, aged 5 to 14 years (51 female and 80 male) with allergic rhinitis and/or asthma due to grass pollen were, included, in an open label prospective trial in a 3 years period (from 2008 to 2011), Grass pollen allergy was confirmed by clinical history, skin prick test and serum specific IgE. Patients received grass pollen SCIT, in a cluster schedule; up-dosing consisted in 6 inyections over 3 weeks, and for continuation the maintenance injections were given once a month The safety, is grade according to The World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System. RESULTS: The safety data of 3397 injections .were analyzed. The total numbers of systemic reactions were 6 or 0.17% of all injections, all of them in the up-dosing phase. Of this 2 were classified as immediate reactions and 4 were late-phase reactions. Of all systemic reactions 4 was classified as grade 1 reaction and 2 as grade 2. Grade 3, 4 or 5 reactions did not occur. The local hypersensitive reactions were 28 or 0.82% of all injections; 42.8% of them were in the maintenance phase. CONCLUSIONS: In this study the safety of cluster immunotherapy with grass pollen allergens is demonstrated for application in children.
180
Dose-related Effects of Ragweed Allergy Immunotherapy Tablet on Nasal and Ocular Symptoms of Allergic Rhinoconjunctivitis During the Peak Ragweed Pollen Seasons in Europe and North America J. Maloney1, H. Nolte1, K. Nekam2, P. Creticos3, G. Berman4, A. Kaur1, J. Hebert5; 1Merck Research Laboratories, Kenilworth, NJ, 2Hospital of the Hospitaller Brothers of St John of God, Budapest, HUNGARY, 3Johns Hopkins University School of Medicine, Baltimore, MD, 4Allergy & Asthma Specialists, Minneapolis, MN, 5Centre de Recherche Appliquee en Allergie de Quebec, Quebec, QC, CANADA. RATIONALE: Ragweed allergy is a significant problem in Europe and North America. Nasal and ocular symptoms of allergic rhinoconjunctivitis (ARC) are most pronounced during peak pollen exposure when traditional pharmacotherapy may be insufficient. Effects of a novel sublingual ragweed allergy immunotherapy tablet (AIT) on individual ARC symptoms were investigated in European and North American ragweed allergics. METHODS: Adult subjects (n5784) were randomized to daily ragweed AIT 1.5, 6, 12 Amb a 1-U (Amb) or placebo. Six symptoms were recorded daily (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/ itchy eyes, and watery eyes) and measured on a scale of 0 (no symptoms) to 3 (severe). Peak season (RS) was defined as the 15 consecutive days with the highest 15-day moving average pollen count. RESULTS: Peak season total nasal scores were 3.64, 3.45, 3.19, and 3.76 for 1.5, 6, and 12 Amb and placebo (12 Amb vs placebo, relative difference, -15.2%, diff5-0.57 points; P5.0260). Ocular scores were 1.47, 1.43, 1.24, and 1.61 for 1.5, 6, 12 Amb and placebo (12 Amb vs placebo, relative difference, -22.9%, diff5-0.37 points, P5.0086). Furthermore, significant effects (p<0.05) on blocked nose, itchy nose and all ocular symptoms were noted for 12 Amb. There were no reports of systemic allergic reactions. CONCLUSIONS: The results for the nasal and ocular symptoms during peak RS showed a dose-related response for the 12, 6, and 1.5 Amb ragweed AIT treatments. Once-daily ragweed AIT 12 Amb showed the larger difference indicating greater improvement in ARC symptoms for the higher dose of ragweed AIT.
SATURDAY
Abstracts AB47
J ALLERGY CLIN IMMUNOL VOLUME 129, NUMBER 2
Post-treatment, Long-term Efficacy Of A 300IR Sublingual Tablet Of 5-grass Pollen Allergen Extract In Adults With Grass Pollen-induced Allergic Rhinoconjunctivitis: The Relationship With Disease Severity M. Worm1, A. Didier2, F. Horak3, H. Malling4, S. Soulie5, R. K. Zeldin5; 1 Allergie-Centrum-Charit, Klinik fr Dermatologie, Berlin, GERMANY, 2 Rangueil-Larrey Hospital, Toulouse, FRANCE, 3Allergy Centre Vienna, Vienna, AUSTRIA, 4National University Hospital, Copenhagen, DENMARK, 5Stallergenes, Antony, FRANCE. RATIONALE: The sustained efficacy (i.e., after 3 treatment years) of discontinuous treatment with 300IR sublingual tablet of 5-grass pollen allergen extract has been demonstrated in an ongoing, 5-year study. Here we report the relationship between disease severity and clinical efficacy over four consecutive grass pollen seasons. METHODS: 633 adults were randomized to placebo or 300IR pre- and co-seasonally for three grass pollen seasons starting 4 months [4M] or 2 months [2M] prior to the season each year and followed up during the subsequent, treatment-free, season. Average Adjusted Symptom Score (AASS, adjusting Rhinoconjunctivitis Total Symptom Score for rescue medication usage, range 0-18) was the primary efficacy endpoint. To evaluate the relationship with disease severity, pooled centers were ranked from lowest to highest mean AASS in the placebo group, and divided in three tertiles. As post hoc subgroup analyses, AASSs during the pollen period for each of the first 4 study years were analyzed by tertile using an ANCOVA model. RESULTS: For each study year, relative mean differences in AASS for active groups compared to Placebo in tertiles with medium and high mean AASS in placebo group were statistically significant while no significant differences were observed in the low tertile. For example, in year 4, relative mean differences in 4M vs. placebo in high, medium, and low disease severity tertiles were -34.0%, [[Unsupported Character - Codename -]] 28.3% and +14.3%, respectively. CONCLUSIONS: In each of three treatment seasons and the posttreatment season, the 300IR 5-grass-pollen tablet was most effective in populations with higher symptom severity.
178
Comparative Efficacy and Tolerability of Subcutaneous and Sublingual Allergen Specific Immunotherapy A. Blaziene1, A. Chomiciene1, L. M. DuBuske2; 1Vilnius University, Center of Pulmonology and Allergology, Vilnius, LITHUANIA, 2Immunology Research Institute of New England, Gardner, MA. RATIONALE: Allergen specific immunotherapy (ASIT) has been used for 100 years with efficacy confirmed of Subcutaneous Allergen Immunotherapy (SCIT) seen in numerous double-blind placebo controlled studies but recent evidence notes efficacy of sublingual immunotherapy (SLIT) which may be better tolerated than SCIT. This study assesses the efficacy and tolerability of both SCIT and SLIT in clinical practice. METHODS: 22 patients (13 females, 9 males) with allergic rhinitis or rhinoconjuctivitis (6 with mild asthma) were studied. Mean patient age was 3266 years. Duration of ASIT was 260.96 years. SCIT was used in 12 patients while SLIT was used in 10 patients (Stallergenes extracts). All patients were asked about symptom changes during ASIT (3 point system: worse, no change, better) and about adverse events. RESULTS: Nasal secretions and nasal obstruction decreased in 96% of patients, while sneezing and nasal itching decreased in 91% of patients. Itching and tearing of eyes decreased in 82%, and eye redness in 77% of patients. Asthma symptoms were less in 67 % of patients. Total symptom scores improved similarly in both SCIT and SLIT patients.1 patient from the SCIT group had local reaction after allergen extract injection and 1 patient from SLIT group had slight tongue edema after allergen extract administration in the initial phase of ASIT. CONCLUSIONS: Both SCIT and SLIT methods are effective and well tolerated in the treatment of allergic rhinoconjuctivitis and mild asthma.
179
Grass Pollen Inmunotherapy In Children: Safety Aspects M. I. Garcimartin, M. Vazquez de la Torre Gaspar, F. Ruano Perez, N. Blanca Lopez, E. Seoane Reula, M. De Diego, M. Canto Diez; Hospital Infanta Leonor, Madrid, Madrid, SPAIN. RATIONALE: Cluster schedules are an accelerated procedure to achieve maintenance dose and allow the administration of high allergen doses in a short time interval. We investigate the safety profile of cluster schedule with grass pollen (SCIT), in children with allergic rhinitis and/or asthma. METHODS: A total of 131 patients, aged 5 to 14 years (51 female and 80 male) with allergic rhinitis and/or asthma due to grass pollen were, included, in an open label prospective trial in a 3 years period (from 2008 to 2011), Grass pollen allergy was confirmed by clinical history, skin prick test and serum specific IgE. Patients received grass pollen SCIT, in a cluster schedule; up-dosing consisted in 6 inyections over 3 weeks, and for continuation the maintenance injections were given once a month The safety, is grade according to The World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System. RESULTS: The safety data of 3397 injections .were analyzed. The total numbers of systemic reactions were 6 or 0.17% of all injections, all of them in the up-dosing phase. Of this 2 were classified as immediate reactions and 4 were late-phase reactions. Of all systemic reactions 4 was classified as grade 1 reaction and 2 as grade 2. Grade 3, 4 or 5 reactions did not occur. The local hypersensitive reactions were 28 or 0.82% of all injections; 42.8% of them were in the maintenance phase. CONCLUSIONS: In this study the safety of cluster immunotherapy with grass pollen allergens is demonstrated for application in children.
180
Dose-related Effects of Ragweed Allergy Immunotherapy Tablet on Nasal and Ocular Symptoms of Allergic Rhinoconjunctivitis During the Peak Ragweed Pollen Seasons in Europe and North America J. Maloney1, H. Nolte1, K. Nekam2, P. Creticos3, G. Berman4, A. Kaur1, J. Hebert5; 1Merck Research Laboratories, Kenilworth, NJ, 2Hospital of the Hospitaller Brothers of St John of God, Budapest, HUNGARY, 3Johns Hopkins University School of Medicine, Baltimore, MD, 4Allergy & Asthma Specialists, Minneapolis, MN, 5Centre de Recherche Appliquee en Allergie de Quebec, Quebec, QC, CANADA. RATIONALE: Ragweed allergy is a significant problem in Europe and North America. Nasal and ocular symptoms of allergic rhinoconjunctivitis (ARC) are most pronounced during peak pollen exposure when traditional pharmacotherapy may be insufficient. Effects of a novel sublingual ragweed allergy immunotherapy tablet (AIT) on individual ARC symptoms were investigated in European and North American ragweed allergics. METHODS: Adult subjects (n5784) were randomized to daily ragweed AIT 1.5, 6, 12 Amb a 1-U (Amb) or placebo. Six symptoms were recorded daily (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/ itchy eyes, and watery eyes) and measured on a scale of 0 (no symptoms) to 3 (severe). Peak season (RS) was defined as the 15 consecutive days with the highest 15-day moving average pollen count. RESULTS: Peak season total nasal scores were 3.64, 3.45, 3.19, and 3.76 for 1.5, 6, and 12 Amb and placebo (12 Amb vs placebo, relative difference, -15.2%, diff5-0.57 points; P5.0260). Ocular scores were 1.47, 1.43, 1.24, and 1.61 for 1.5, 6, 12 Amb and placebo (12 Amb vs placebo, relative difference, -22.9%, diff5-0.37 points, P5.0086). Furthermore, significant effects (p<0.05) on blocked nose, itchy nose and all ocular symptoms were noted for 12 Amb. There were no reports of systemic allergic reactions. CONCLUSIONS: The results for the nasal and ocular symptoms during peak RS showed a dose-related response for the 12, 6, and 1.5 Amb ragweed AIT treatments. Once-daily ragweed AIT 12 Amb showed the larger difference indicating greater improvement in ARC symptoms for the higher dose of ragweed AIT.
SATURDAY
Abstracts AB47
J ALLERGY CLIN IMMUNOL VOLUME 129, NUMBER 2