The Experts below are selected from a list of 4782 Experts worldwide ranked by ideXlab platform
S. Hedgecock - One of the best experts on this subject based on the ideXlab platform.
-
benefits of omalizumab as add on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy gina 2002 step 4 treatment innovate
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
-
the effect of treatment with omalizumab an anti ige antibody on Asthma exacerbations and emergency medical visits in patients with Severe Persistent Asthma
Allergy, 2005Co-Authors: Jean Bousquet, P. Cabrera, Neville Berkman, Roland Buhl, Stephen T. Holgate, Sally E. Wenzel, Howard Fox, S. Hedgecock, M. Blogg, G. Della CioppaAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite treatment according to current Asthma management guidelines have a significant unmet medical need. Such patients are at high risk of serious exacerbations and Asthma-related mortality. Methods: Here, we pooled data from seven studies to determine the effect of omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, on Asthma exacerbations in patients with Severe Persistent Asthma. Omalizumab was added to current Asthma therapy and compared with placebo (in five double-blind studies) or with current Asthma therapy alone (in two open-label studies). The studies included 4308 patients (2511 treated with omalizumab), 93% of whom had Severe Persistent Asthma according to the Global Initiative for Asthma (GINA) 2002 classification. Using the Poisson regression model, results were calculated as the ratio of treatment effect (omalizumab : control) on the standardized exacerbation rate per year. Results: Omalizumab significantly reduced the rate of Asthma exacerbations by 38% (P < 0.0001 vs control) and the rate of total emergency visits by 47% (P < 0.0001 vs control). Analysis of demographic subgroups showed that the efficacy of omalizumab on Asthma exacerbations was unaffected by patient age, gender, baseline serum IgE (split by median) or by 2- or 4-weekly dosing schedule, although benefit in absolute terms appeared to be greatest in patients with more Severe Asthma, defined by a lower value of percentage predicted forced expiratory volume in 1 s (FEV1) at baseline. Conclusions: These results suggest that omalizumab may fulfil an important need in patients with Severe Persistent Asthma, many of whom are not adequately controlled on current therapy.
-
The effect of treatment with omalizumab, an anti-IgE antibody, on Asthma exacerbations and emergency medical visits in patients with Severe Persistent Asthma
Allergy, 2005Co-Authors: Jean Bousquet, P. Cabrera, Neville Berkman, Roland Buhl, Stephen T. Holgate, Sally E. Wenzel, Howard Fox, S. Hedgecock, M. Blogg, G. Della CioppaAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite treatment according to current Asthma management guidelines have a significant unmet medical need. Such patients are at high risk of serious exacerbations and Asthma-related mortality. Methods: Here, we pooled data from seven studies to determine the effect of omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, on Asthma exacerbations in patients with Severe Persistent Asthma. Omalizumab was added to current Asthma therapy and compared with placebo (in five double-blind studies) or with current Asthma therapy alone (in two open-label studies). The studies included 4308 patients (2511 treated with omalizumab), 93% of whom had Severe Persistent Asthma according to the Global Initiative for Asthma (GINA) 2002 classification. Using the Poisson regression model, results were calculated as the ratio of treatment effect (omalizumab : control) on the standardized exacerbation rate per year. Results: Omalizumab significantly reduced the rate of Asthma exacerbations by 38% (P
-
Benefits of omalizumab as add‐on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
Jean Bousquet - One of the best experts on this subject based on the ideXlab platform.
-
A randomized, double-blind, placebo-controlled study of tumor necrosis factor-α blockade in Severe Persistent Asthma
American journal of respiratory and critical care medicine, 2009Co-Authors: Sally E. Wenzel, William W. Busse, Jean Bousquet, Stephen T. Holgate, Peter J. Barnes, Eugene R. Bleecker, Sven Erik Dahlén, Deborah A. Meyers, Klaus F. Rabe, Adam AntczakAbstract:Rationale The treatment effect of golimumab, a human monoclonal antibody against tumor necrosis factor (TNF)-alpha, in Severe Persistent Asthma is unknown. Objectives To assess the safety and efficacy of golimumab in a large population of patients with uncontrolled, Severe Persistent Asthma. Methods From 2004 to 2006, 309 patients with Severe and uncontrolled Asthma, despite high-dose inhaled corticosteroids and long-acting beta(2) agonists, were randomized 1:1:1:1 to monthly subcutaneous injections of placebo or golimumab (50, 100, or 200 mg) through Week 52. Coprimary endpoints were the change from baseline through Week 24 in prebronchodilator percent-predicted FEV(1) and the number of Severe Asthma exacerbations through Week 24. Measurements and main results No significant differences were observed for the change in percent-predicted FEV1 (least squares mean: placebo, 2.44 [95% confidence interval (CI) -0.574 to 5.461]; combined 100-mg and 200-mg, 2.91 [0.696-5.116]) or Severe exacerbations (mean +/- SD: placebo, 0.5 +/- 1.07 vs. combined 100-mg and 200-mg 0.5 +/- 0.97) through week 24. Through Week 24, 2.6% of patients treated with placebo vs. 19.5% of those treated with golimumab discontinued the study agent, and 1.3% and 7.8% discontinued study participation, respectively. An unfavorable risk-benefit profile led to early discontinuation of study-agent administration after the Week-24 database lock. Through Week 76, 20.5% of patients treated with placebo and 30.3% of patients treated with golimumab experienced serious adverse events, with serious infections occurring more frequently in golimumab-treated patients. One death and all eight malignancies occurred in the active groups. Conclusions Overall, treatment with golimumab did not demonstrate a favorable risk-benefit profile in this study population of patients with Severe Persistent Asthma. Clinical trial registered with www.clinicaltrials.gov (NCT00207740).
-
the effect of treatment with omalizumab an anti ige antibody on Asthma exacerbations and emergency medical visits in patients with Severe Persistent Asthma
Allergy, 2005Co-Authors: Jean Bousquet, P. Cabrera, Neville Berkman, Roland Buhl, Stephen T. Holgate, Sally E. Wenzel, Howard Fox, S. Hedgecock, M. Blogg, G. Della CioppaAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite treatment according to current Asthma management guidelines have a significant unmet medical need. Such patients are at high risk of serious exacerbations and Asthma-related mortality. Methods: Here, we pooled data from seven studies to determine the effect of omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, on Asthma exacerbations in patients with Severe Persistent Asthma. Omalizumab was added to current Asthma therapy and compared with placebo (in five double-blind studies) or with current Asthma therapy alone (in two open-label studies). The studies included 4308 patients (2511 treated with omalizumab), 93% of whom had Severe Persistent Asthma according to the Global Initiative for Asthma (GINA) 2002 classification. Using the Poisson regression model, results were calculated as the ratio of treatment effect (omalizumab : control) on the standardized exacerbation rate per year. Results: Omalizumab significantly reduced the rate of Asthma exacerbations by 38% (P < 0.0001 vs control) and the rate of total emergency visits by 47% (P < 0.0001 vs control). Analysis of demographic subgroups showed that the efficacy of omalizumab on Asthma exacerbations was unaffected by patient age, gender, baseline serum IgE (split by median) or by 2- or 4-weekly dosing schedule, although benefit in absolute terms appeared to be greatest in patients with more Severe Asthma, defined by a lower value of percentage predicted forced expiratory volume in 1 s (FEV1) at baseline. Conclusions: These results suggest that omalizumab may fulfil an important need in patients with Severe Persistent Asthma, many of whom are not adequately controlled on current therapy.
-
benefits of omalizumab as add on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy gina 2002 step 4 treatment innovate
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
-
The effect of treatment with omalizumab, an anti-IgE antibody, on Asthma exacerbations and emergency medical visits in patients with Severe Persistent Asthma
Allergy, 2005Co-Authors: Jean Bousquet, P. Cabrera, Neville Berkman, Roland Buhl, Stephen T. Holgate, Sally E. Wenzel, Howard Fox, S. Hedgecock, M. Blogg, G. Della CioppaAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite treatment according to current Asthma management guidelines have a significant unmet medical need. Such patients are at high risk of serious exacerbations and Asthma-related mortality. Methods: Here, we pooled data from seven studies to determine the effect of omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, on Asthma exacerbations in patients with Severe Persistent Asthma. Omalizumab was added to current Asthma therapy and compared with placebo (in five double-blind studies) or with current Asthma therapy alone (in two open-label studies). The studies included 4308 patients (2511 treated with omalizumab), 93% of whom had Severe Persistent Asthma according to the Global Initiative for Asthma (GINA) 2002 classification. Using the Poisson regression model, results were calculated as the ratio of treatment effect (omalizumab : control) on the standardized exacerbation rate per year. Results: Omalizumab significantly reduced the rate of Asthma exacerbations by 38% (P
-
Benefits of omalizumab as add‐on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
Marc Humbert - One of the best experts on this subject based on the ideXlab platform.
-
benefits of omalizumab as add on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy gina 2002 step 4 treatment innovate
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
-
Benefits of omalizumab as add‐on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
Jon G Ayres - One of the best experts on this subject based on the ideXlab platform.
-
benefits of omalizumab as add on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy gina 2002 step 4 treatment innovate
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
-
Benefits of omalizumab as add‐on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
K M Beeh - One of the best experts on this subject based on the ideXlab platform.
-
benefits of omalizumab as add on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy gina 2002 step 4 treatment innovate
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.
-
Benefits of omalizumab as add‐on therapy in patients with Severe Persistent Asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE
Allergy, 2005Co-Authors: Marc Humbert, Jean Bousquet, Richard Beasley, Jon G Ayres, Raymond G Slavin, Jeanlouis Hebert, K M Beeh, S Ramos, Giorgio Walter Canonica, S. HedgecockAbstract:Background: Patients with Severe Persistent Asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant Asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Methods: Following a run-in phase, patients (12–75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. Results: A total of 419 patients were included in the efficacy analyses. The clinically significant Asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant Asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced Severe Asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved Asthma-related quality of life, morning peak expiratory flow and Asthma symptom scores. The incidence of adverse events was similar between treatment groups. Conclusions: In patients with inadequately controlled Severe Persistent Asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant Asthma exacerbations, Severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled Severe Persistent Asthma who have a significant unmet need despite best available therapy.