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SAN DIEGO – An investigational human monoclonal antibody suggested a new approach to asthma treatment by showing evidence of anti-inflammatory activity and partial attenuation of early and late asthmatic responses in a proof-of-concept study of 31 patients with mild asthma.
Patients were randomized to intravenous treatment with AMG 157 or placebo for up to 3 months before undergoing allergen-induced challenge and testing. AMG 157 binds human thymic stromal lymphopoietin (TSLP), an epithelial cell–derived cytokine that might be important in initiating allergic inflammation, and prevents receptor interaction.
By day 84, the maximum percentage decrease in the forced expiratory volume at 1 second (FEV1) during late asthmatic response (3-7 hours after allergy challenge) was 46% smaller in the treatment group, vs. placebo, a significant difference, Gail M. Gauvreau, Ph.D., and her associates reported at an international conference of the American Thoracic Society.
Among secondary outcomes, the area under the curve (AUC) of the time-adjusted percent decrease in FEV1 during the early asthmatic response was significantly smaller in the treatment group than the control group on day 84. Patients who got AMG 157 showed significantly lower levels of blood and sputum eosinophils before and after allergy challenge and in the fraction of exhaled nitric oxide.
Adverse events were reported in 15 patients on AMG 157 and 12 patients on placebo. No serious adverse events were seen, reported Dr. Gauvreau of the Firestone Institute of Respiratory Health at McMaster University, Hamilton, Ont.
The study was published online by the New England Journal of Medicine (2014 May 20 [doi: 10.1056/NEJMoa1402895]). "This proof-of-concept study suggests that TSLP is a pivotal cytokine not only in allergen-induced airway responses but also in persistent airway inflammation in patients with allergic asthma," the investigators wrote.
The company that is developing AMG 157 has started a phase II clinical trial, Dr. Gauvreau said in an interview at the meeting.
The population of mild asthmatics in the proof-of-concept study is not the kind of patient who might use this treatment, she said, but this potential treatment pathway offers hope for a new therapy for patients with steroid-resistant asthma.
Amgen, which is developing AMG 157, funded the study and analyzed the data. Many of the researchers reported financial associations with Amgen and other companies.
On Twitter @sherryboschert
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Dr. Eric Gartman, FCCP, comments: For our most difficult-to-control asthma patients, we are longing for an effective and more directed alternative to systemic corticosteroids. While this agent has yet to be studied in the appropriate population, any advancement in the science of developing therapies against novel targets in asthma is a needed step in the right direction.
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Dr. Eric Gartman, FCCP, comments: For our most difficult-to-control asthma patients, we are longing for an effective and more directed alternative to systemic corticosteroids. While this agent has yet to be studied in the appropriate population, any advancement in the science of developing therapies against novel targets in asthma is a needed step in the right direction.
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Dr. Eric Gartman, FCCP, comments: For our most difficult-to-control asthma patients, we are longing for an effective and more directed alternative to systemic corticosteroids. While this agent has yet to be studied in the appropriate population, any advancement in the science of developing therapies against novel targets in asthma is a needed step in the right direction.
SAN DIEGO – An investigational human monoclonal antibody suggested a new approach to asthma treatment by showing evidence of anti-inflammatory activity and partial attenuation of early and late asthmatic responses in a proof-of-concept study of 31 patients with mild asthma.
Patients were randomized to intravenous treatment with AMG 157 or placebo for up to 3 months before undergoing allergen-induced challenge and testing. AMG 157 binds human thymic stromal lymphopoietin (TSLP), an epithelial cell–derived cytokine that might be important in initiating allergic inflammation, and prevents receptor interaction.
By day 84, the maximum percentage decrease in the forced expiratory volume at 1 second (FEV1) during late asthmatic response (3-7 hours after allergy challenge) was 46% smaller in the treatment group, vs. placebo, a significant difference, Gail M. Gauvreau, Ph.D., and her associates reported at an international conference of the American Thoracic Society.
Among secondary outcomes, the area under the curve (AUC) of the time-adjusted percent decrease in FEV1 during the early asthmatic response was significantly smaller in the treatment group than the control group on day 84. Patients who got AMG 157 showed significantly lower levels of blood and sputum eosinophils before and after allergy challenge and in the fraction of exhaled nitric oxide.
Adverse events were reported in 15 patients on AMG 157 and 12 patients on placebo. No serious adverse events were seen, reported Dr. Gauvreau of the Firestone Institute of Respiratory Health at McMaster University, Hamilton, Ont.
The study was published online by the New England Journal of Medicine (2014 May 20 [doi: 10.1056/NEJMoa1402895]). "This proof-of-concept study suggests that TSLP is a pivotal cytokine not only in allergen-induced airway responses but also in persistent airway inflammation in patients with allergic asthma," the investigators wrote.
The company that is developing AMG 157 has started a phase II clinical trial, Dr. Gauvreau said in an interview at the meeting.
The population of mild asthmatics in the proof-of-concept study is not the kind of patient who might use this treatment, she said, but this potential treatment pathway offers hope for a new therapy for patients with steroid-resistant asthma.
Amgen, which is developing AMG 157, funded the study and analyzed the data. Many of the researchers reported financial associations with Amgen and other companies.
On Twitter @sherryboschert
SAN DIEGO – An investigational human monoclonal antibody suggested a new approach to asthma treatment by showing evidence of anti-inflammatory activity and partial attenuation of early and late asthmatic responses in a proof-of-concept study of 31 patients with mild asthma.
Patients were randomized to intravenous treatment with AMG 157 or placebo for up to 3 months before undergoing allergen-induced challenge and testing. AMG 157 binds human thymic stromal lymphopoietin (TSLP), an epithelial cell–derived cytokine that might be important in initiating allergic inflammation, and prevents receptor interaction.
By day 84, the maximum percentage decrease in the forced expiratory volume at 1 second (FEV1) during late asthmatic response (3-7 hours after allergy challenge) was 46% smaller in the treatment group, vs. placebo, a significant difference, Gail M. Gauvreau, Ph.D., and her associates reported at an international conference of the American Thoracic Society.
Among secondary outcomes, the area under the curve (AUC) of the time-adjusted percent decrease in FEV1 during the early asthmatic response was significantly smaller in the treatment group than the control group on day 84. Patients who got AMG 157 showed significantly lower levels of blood and sputum eosinophils before and after allergy challenge and in the fraction of exhaled nitric oxide.
Adverse events were reported in 15 patients on AMG 157 and 12 patients on placebo. No serious adverse events were seen, reported Dr. Gauvreau of the Firestone Institute of Respiratory Health at McMaster University, Hamilton, Ont.
The study was published online by the New England Journal of Medicine (2014 May 20 [doi: 10.1056/NEJMoa1402895]). "This proof-of-concept study suggests that TSLP is a pivotal cytokine not only in allergen-induced airway responses but also in persistent airway inflammation in patients with allergic asthma," the investigators wrote.
The company that is developing AMG 157 has started a phase II clinical trial, Dr. Gauvreau said in an interview at the meeting.
The population of mild asthmatics in the proof-of-concept study is not the kind of patient who might use this treatment, she said, but this potential treatment pathway offers hope for a new therapy for patients with steroid-resistant asthma.
Amgen, which is developing AMG 157, funded the study and analyzed the data. Many of the researchers reported financial associations with Amgen and other companies.
On Twitter @sherryboschert
Key clinical point: A proof-of-concept study suggests that there may be a new asthma treatment pathway, to be tested next in a phase II clinical trial.
Major finding: The maximum percentage decrease in the FEV1 3-7 hours after allergy challenge was 46% smaller in the treatment group, compared with placebo on day 84 (P = .02)
Data source: A double-blind, placebo-controlled study of 31 patients with mild asthma treated with 3 months of intravenous AMG 157 or placebo assessed after allergen challenge.
Disclosures: Amgen, which is developing AMG 157, funded the study and analyzed the data. Dr. Gauvreau reported financial associations with Amgen and three other companies. Fourteen of her coinvestigators reported financial associations with Amgen and multiple other companies.
