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ACIP approves new influenza vaccine recommendations
FROM AN ACIP MEETING
by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) after a lengthy debate over specifics regarding recommendations for pregnant women.
The proposed recommendation that sparked the debate would change the wording of the previous recommendation for pregnant women to receive a seasonal inactivated vaccine (IIV) to “any licensed, recommended, and age-appropriate, trivalent or quadrivalent IIV or RIV [recombinant influenza vaccine] may be used.”
“I think there’s a subtle, but important difference here between making what would appear to be an affirmative statement that RIV is safe in pregnant women, versus just staying silent on it, and saying ‘we’re not saying you shouldn’t use it, but we don’t have enough data to affirmatively say it is safe,’ ” said Cindy Pellegrini, senior vice president of Public Policy and Government Affairs at the March of Dimes Foundation.
In response, members of the committee pointed out that the responsibility of determining safety lies with the Food and Drug Administration, which has already licensed the Flublok trivalent vaccine with expectations that the quadrivalent vaccine soon will follow.
While Lisa Grohskopf, MD, MPH, medical officer of the influenza division of the CDC, did acknowledge that there were more data on the safety of inactivated influenza vaccines, she asserted to the committee that “the general overall safety profile of Flublok in comparison to inactivated vaccines is reassuring.”
“For example, one concern that arises is reactogenicity and inflammation. [In terms of] overall reactogenicity in the studies where Flublok and inactivated vaccines have been compared, rates of the adverse and systemic reactions were similar,” Dr. Grohskopf said.
A motion was made to change the wording of the recommendation; however, the motion was not passed, and the eventual vote on the approval was conducted.
The ACIP also voted unanimously to change the safe age limit noted in influenza guidelines for use of Afluria (IIV3) from 9 years and older to 5 years and older. A footnote saying that the ACIP recommends Afluria for children 9 years and older will be removed.
This change, which mirrors the licensing Afluria has with the FDA, was based on research conducted by Seqirus that showed fever levels were the same for Afluria trivalent and quadrivalent vaccines in children 5 to 9 years old, both of which were less than historical vaccine rates.
The approved recommendations will be sent to the director of the CDC and the U.S. Department of Health and Human Services. Once reviewed and approved, the final recommendations will be published in the CDC’s Morbidity and Mortality Weekly Report. The committee members had no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
FROM AN ACIP MEETING
by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) after a lengthy debate over specifics regarding recommendations for pregnant women.
The proposed recommendation that sparked the debate would change the wording of the previous recommendation for pregnant women to receive a seasonal inactivated vaccine (IIV) to “any licensed, recommended, and age-appropriate, trivalent or quadrivalent IIV or RIV [recombinant influenza vaccine] may be used.”
“I think there’s a subtle, but important difference here between making what would appear to be an affirmative statement that RIV is safe in pregnant women, versus just staying silent on it, and saying ‘we’re not saying you shouldn’t use it, but we don’t have enough data to affirmatively say it is safe,’ ” said Cindy Pellegrini, senior vice president of Public Policy and Government Affairs at the March of Dimes Foundation.
In response, members of the committee pointed out that the responsibility of determining safety lies with the Food and Drug Administration, which has already licensed the Flublok trivalent vaccine with expectations that the quadrivalent vaccine soon will follow.
While Lisa Grohskopf, MD, MPH, medical officer of the influenza division of the CDC, did acknowledge that there were more data on the safety of inactivated influenza vaccines, she asserted to the committee that “the general overall safety profile of Flublok in comparison to inactivated vaccines is reassuring.”
“For example, one concern that arises is reactogenicity and inflammation. [In terms of] overall reactogenicity in the studies where Flublok and inactivated vaccines have been compared, rates of the adverse and systemic reactions were similar,” Dr. Grohskopf said.
A motion was made to change the wording of the recommendation; however, the motion was not passed, and the eventual vote on the approval was conducted.
The ACIP also voted unanimously to change the safe age limit noted in influenza guidelines for use of Afluria (IIV3) from 9 years and older to 5 years and older. A footnote saying that the ACIP recommends Afluria for children 9 years and older will be removed.
This change, which mirrors the licensing Afluria has with the FDA, was based on research conducted by Seqirus that showed fever levels were the same for Afluria trivalent and quadrivalent vaccines in children 5 to 9 years old, both of which were less than historical vaccine rates.
The approved recommendations will be sent to the director of the CDC and the U.S. Department of Health and Human Services. Once reviewed and approved, the final recommendations will be published in the CDC’s Morbidity and Mortality Weekly Report. The committee members had no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
FROM AN ACIP MEETING
by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) after a lengthy debate over specifics regarding recommendations for pregnant women.
The proposed recommendation that sparked the debate would change the wording of the previous recommendation for pregnant women to receive a seasonal inactivated vaccine (IIV) to “any licensed, recommended, and age-appropriate, trivalent or quadrivalent IIV or RIV [recombinant influenza vaccine] may be used.”
“I think there’s a subtle, but important difference here between making what would appear to be an affirmative statement that RIV is safe in pregnant women, versus just staying silent on it, and saying ‘we’re not saying you shouldn’t use it, but we don’t have enough data to affirmatively say it is safe,’ ” said Cindy Pellegrini, senior vice president of Public Policy and Government Affairs at the March of Dimes Foundation.
In response, members of the committee pointed out that the responsibility of determining safety lies with the Food and Drug Administration, which has already licensed the Flublok trivalent vaccine with expectations that the quadrivalent vaccine soon will follow.
While Lisa Grohskopf, MD, MPH, medical officer of the influenza division of the CDC, did acknowledge that there were more data on the safety of inactivated influenza vaccines, she asserted to the committee that “the general overall safety profile of Flublok in comparison to inactivated vaccines is reassuring.”
“For example, one concern that arises is reactogenicity and inflammation. [In terms of] overall reactogenicity in the studies where Flublok and inactivated vaccines have been compared, rates of the adverse and systemic reactions were similar,” Dr. Grohskopf said.
A motion was made to change the wording of the recommendation; however, the motion was not passed, and the eventual vote on the approval was conducted.
The ACIP also voted unanimously to change the safe age limit noted in influenza guidelines for use of Afluria (IIV3) from 9 years and older to 5 years and older. A footnote saying that the ACIP recommends Afluria for children 9 years and older will be removed.
This change, which mirrors the licensing Afluria has with the FDA, was based on research conducted by Seqirus that showed fever levels were the same for Afluria trivalent and quadrivalent vaccines in children 5 to 9 years old, both of which were less than historical vaccine rates.
The approved recommendations will be sent to the director of the CDC and the U.S. Department of Health and Human Services. Once reviewed and approved, the final recommendations will be published in the CDC’s Morbidity and Mortality Weekly Report. The committee members had no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
Histological changes noted, with topical application of cosmetic product, in small study
Histological changes were observed in skin treated with a product developed to target changes in the extracellular matrix associated with aging, in a study of six patients in their 60s.
The results were presented in a poster at the Summit in Aesthetic Medicine held by Global Academy for Medical Education.
The product, which contains tripeptide and hexapeptide ingredients, was applied to the forearms and preauricular regions of the participants, which were biopsied 3-8 weeks later. Compared with biopsies at baseline, the investigators found evidence of changes in the extracellular matrix, with “changes in collagen and elastin ... with mature old collagen replaced by freshened new collagen,” as well as “upregulated and redistributed elastin,” and “thickened epidermis with healthy cuboidal basal cells” that replaced flattened cells in the dermoepidermal junction, according to the poster
The study was limited by the small sample of patients, the authors noted. This study was sponsored by Alastin Skincare, the product’s manufacturer. The lead author, Antoanella Calame, MD, chief of dermatology at Scripps Memorial Hospital, La Jolla, California, disclosed consulting fees from Alastin. The other author, Alan Widgerow, MD, professor of plastic surgery at University of California, Irvine, is the chief medical officer of Alastin.
Global Academy and this news organization are owned the same company.
[email protected]
On Twitter @eaztweets
Histological changes were observed in skin treated with a product developed to target changes in the extracellular matrix associated with aging, in a study of six patients in their 60s.
The results were presented in a poster at the Summit in Aesthetic Medicine held by Global Academy for Medical Education.
The product, which contains tripeptide and hexapeptide ingredients, was applied to the forearms and preauricular regions of the participants, which were biopsied 3-8 weeks later. Compared with biopsies at baseline, the investigators found evidence of changes in the extracellular matrix, with “changes in collagen and elastin ... with mature old collagen replaced by freshened new collagen,” as well as “upregulated and redistributed elastin,” and “thickened epidermis with healthy cuboidal basal cells” that replaced flattened cells in the dermoepidermal junction, according to the poster
The study was limited by the small sample of patients, the authors noted. This study was sponsored by Alastin Skincare, the product’s manufacturer. The lead author, Antoanella Calame, MD, chief of dermatology at Scripps Memorial Hospital, La Jolla, California, disclosed consulting fees from Alastin. The other author, Alan Widgerow, MD, professor of plastic surgery at University of California, Irvine, is the chief medical officer of Alastin.
Global Academy and this news organization are owned the same company.
[email protected]
On Twitter @eaztweets
Histological changes were observed in skin treated with a product developed to target changes in the extracellular matrix associated with aging, in a study of six patients in their 60s.
The results were presented in a poster at the Summit in Aesthetic Medicine held by Global Academy for Medical Education.
The product, which contains tripeptide and hexapeptide ingredients, was applied to the forearms and preauricular regions of the participants, which were biopsied 3-8 weeks later. Compared with biopsies at baseline, the investigators found evidence of changes in the extracellular matrix, with “changes in collagen and elastin ... with mature old collagen replaced by freshened new collagen,” as well as “upregulated and redistributed elastin,” and “thickened epidermis with healthy cuboidal basal cells” that replaced flattened cells in the dermoepidermal junction, according to the poster
The study was limited by the small sample of patients, the authors noted. This study was sponsored by Alastin Skincare, the product’s manufacturer. The lead author, Antoanella Calame, MD, chief of dermatology at Scripps Memorial Hospital, La Jolla, California, disclosed consulting fees from Alastin. The other author, Alan Widgerow, MD, professor of plastic surgery at University of California, Irvine, is the chief medical officer of Alastin.
Global Academy and this news organization are owned the same company.
[email protected]
On Twitter @eaztweets
Benefits of topical product evaluated in patients undergoing laser treatment
The use of a combination product applied to treated areas before and after laser treatment of the face or decollete appeared to improve healing, compared with standard care, in a split-face study of 10 patients undergoing fractional CO2 laser treatment of the face and decollete.
The results were presented in a poster at the Summit in Aesthetic Medicine held by Global Academy for Medical Education. The product, manufactured by Alastin Skincare, is a topical formulation designed for use before and after laser therapy.
Before and after treatment, patients in the trial were given the topical treatment on one side of their faces or decollete and a standard treatment on the other, according to the poster.
Based on the blinded investigator ratings, the sides treated with the new product scored higher on day 4 for lentigines (P = .009), texture (P = .043), and Global Skin Quality (P = .051), according to Deanne Robinson, MD, director of the body sculpting center at the Connecticut Dermatology Group and the author of the study.
In addition, patients said they were more satisfied with the side treated with the product in terms of looking better and feeling better on that side (P = .05).
Dr. Robinson reported no financial conflicts. Global Academy and this news organization are owned the same company.
[email protected]
On Twitter @eaztweets
The use of a combination product applied to treated areas before and after laser treatment of the face or decollete appeared to improve healing, compared with standard care, in a split-face study of 10 patients undergoing fractional CO2 laser treatment of the face and decollete.
The results were presented in a poster at the Summit in Aesthetic Medicine held by Global Academy for Medical Education. The product, manufactured by Alastin Skincare, is a topical formulation designed for use before and after laser therapy.
Before and after treatment, patients in the trial were given the topical treatment on one side of their faces or decollete and a standard treatment on the other, according to the poster.
Based on the blinded investigator ratings, the sides treated with the new product scored higher on day 4 for lentigines (P = .009), texture (P = .043), and Global Skin Quality (P = .051), according to Deanne Robinson, MD, director of the body sculpting center at the Connecticut Dermatology Group and the author of the study.
In addition, patients said they were more satisfied with the side treated with the product in terms of looking better and feeling better on that side (P = .05).
Dr. Robinson reported no financial conflicts. Global Academy and this news organization are owned the same company.
[email protected]
On Twitter @eaztweets
The use of a combination product applied to treated areas before and after laser treatment of the face or decollete appeared to improve healing, compared with standard care, in a split-face study of 10 patients undergoing fractional CO2 laser treatment of the face and decollete.
The results were presented in a poster at the Summit in Aesthetic Medicine held by Global Academy for Medical Education. The product, manufactured by Alastin Skincare, is a topical formulation designed for use before and after laser therapy.
Before and after treatment, patients in the trial were given the topical treatment on one side of their faces or decollete and a standard treatment on the other, according to the poster.
Based on the blinded investigator ratings, the sides treated with the new product scored higher on day 4 for lentigines (P = .009), texture (P = .043), and Global Skin Quality (P = .051), according to Deanne Robinson, MD, director of the body sculpting center at the Connecticut Dermatology Group and the author of the study.
In addition, patients said they were more satisfied with the side treated with the product in terms of looking better and feeling better on that side (P = .05).
Dr. Robinson reported no financial conflicts. Global Academy and this news organization are owned the same company.
[email protected]
On Twitter @eaztweets
ACIP approves new hepatitis A vaccine draft recommendations
, including a focus on catch-up vaccines for adolescents and those over age 40 years.
While hepatitis A cases have dropped significantly since the vaccine’s debut – with the number of reported cases in 2015 dropping to 1,390, compared with 9,606 in 1971 – previous recommendations regarding catch-up vaccinations suggested patients should consider treatment, as opposed to catch-up vaccination.
Adult catch-up vaccines now are recommended to be considered in areas with increasing disease risks, an addition that was not part of the current recommendations but has been changed because of evidence that patients over 40 years old are more vulnerable to the virus and more likely to be hospitalized if infected, said Noele Nelson, MD, PhD, of the Division of Viral Hepatitis at the CDC.
“Increasing proportions of adults in the United States are susceptible to hepatitis A ... due to reduced exposure to virus early in life and significant serum prevalence in older adults greater and equal to 40 years,” said Dr. Nelson. “In addition, there is low two-dose vaccination coverage among adults, including high risk adults, and morbidity and mortality increases with age.”
Recommendations for pregnant women also have been updated with a more definitive message. Previous recommendations advised pregnant women to weigh the options of acquiring hepatitis A against possible adverse effects of the vaccine. But, new evidence was presented at the meeting: in a study of 139 pregnant women vaccinated between 1996 and 2015 who experienced adverse effects, only seven of the effects were considered serious, and no maternal or infant deaths were apparent. In light of this, the ACIP approved the recommendation change to advise all pregnant women to be vaccinated, if they have not already been so before pregnancy.
Updates also included recommendations for patients with chronic liver disease, who are considered to be members of a high-risk population. Newly approved recommendations include a section on epidemiology, which states that, while those with chronic liver disease are not at increased risk for hepatitis A virus infection unless they experience fecal-oral exposure to the virus, those with acute hepatitis A may be more at risk to develop more severe liver disease. Recommendations for those with chronic liver disease also include a statement advising patients to seek immunoglobulin, as well as a hepatitis A, vaccination as soon as possible after exposure.
The ACIP also approved a change in recommendations to advise all residents and caretakers of those living in a group home, specifically those caring for developmentally disabled patients, to be vaccinated because of the historically high endemic nature of such institutions.
Committee members hope these new recommendations will help the United States reach its goal of a national hepatitis A case ratio of 0.3/100,000 people and a hepatitis A vaccination rate of 85%.
If these recommendations are approved by the director of the CDC and the U.S. Health Department, as they usually are, they will be published in the CDC’s Weekly Morbidity and Mortality Report.
Members of the committee reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
, including a focus on catch-up vaccines for adolescents and those over age 40 years.
While hepatitis A cases have dropped significantly since the vaccine’s debut – with the number of reported cases in 2015 dropping to 1,390, compared with 9,606 in 1971 – previous recommendations regarding catch-up vaccinations suggested patients should consider treatment, as opposed to catch-up vaccination.
Adult catch-up vaccines now are recommended to be considered in areas with increasing disease risks, an addition that was not part of the current recommendations but has been changed because of evidence that patients over 40 years old are more vulnerable to the virus and more likely to be hospitalized if infected, said Noele Nelson, MD, PhD, of the Division of Viral Hepatitis at the CDC.
“Increasing proportions of adults in the United States are susceptible to hepatitis A ... due to reduced exposure to virus early in life and significant serum prevalence in older adults greater and equal to 40 years,” said Dr. Nelson. “In addition, there is low two-dose vaccination coverage among adults, including high risk adults, and morbidity and mortality increases with age.”
Recommendations for pregnant women also have been updated with a more definitive message. Previous recommendations advised pregnant women to weigh the options of acquiring hepatitis A against possible adverse effects of the vaccine. But, new evidence was presented at the meeting: in a study of 139 pregnant women vaccinated between 1996 and 2015 who experienced adverse effects, only seven of the effects were considered serious, and no maternal or infant deaths were apparent. In light of this, the ACIP approved the recommendation change to advise all pregnant women to be vaccinated, if they have not already been so before pregnancy.
Updates also included recommendations for patients with chronic liver disease, who are considered to be members of a high-risk population. Newly approved recommendations include a section on epidemiology, which states that, while those with chronic liver disease are not at increased risk for hepatitis A virus infection unless they experience fecal-oral exposure to the virus, those with acute hepatitis A may be more at risk to develop more severe liver disease. Recommendations for those with chronic liver disease also include a statement advising patients to seek immunoglobulin, as well as a hepatitis A, vaccination as soon as possible after exposure.
The ACIP also approved a change in recommendations to advise all residents and caretakers of those living in a group home, specifically those caring for developmentally disabled patients, to be vaccinated because of the historically high endemic nature of such institutions.
Committee members hope these new recommendations will help the United States reach its goal of a national hepatitis A case ratio of 0.3/100,000 people and a hepatitis A vaccination rate of 85%.
If these recommendations are approved by the director of the CDC and the U.S. Health Department, as they usually are, they will be published in the CDC’s Weekly Morbidity and Mortality Report.
Members of the committee reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
, including a focus on catch-up vaccines for adolescents and those over age 40 years.
While hepatitis A cases have dropped significantly since the vaccine’s debut – with the number of reported cases in 2015 dropping to 1,390, compared with 9,606 in 1971 – previous recommendations regarding catch-up vaccinations suggested patients should consider treatment, as opposed to catch-up vaccination.
Adult catch-up vaccines now are recommended to be considered in areas with increasing disease risks, an addition that was not part of the current recommendations but has been changed because of evidence that patients over 40 years old are more vulnerable to the virus and more likely to be hospitalized if infected, said Noele Nelson, MD, PhD, of the Division of Viral Hepatitis at the CDC.
“Increasing proportions of adults in the United States are susceptible to hepatitis A ... due to reduced exposure to virus early in life and significant serum prevalence in older adults greater and equal to 40 years,” said Dr. Nelson. “In addition, there is low two-dose vaccination coverage among adults, including high risk adults, and morbidity and mortality increases with age.”
Recommendations for pregnant women also have been updated with a more definitive message. Previous recommendations advised pregnant women to weigh the options of acquiring hepatitis A against possible adverse effects of the vaccine. But, new evidence was presented at the meeting: in a study of 139 pregnant women vaccinated between 1996 and 2015 who experienced adverse effects, only seven of the effects were considered serious, and no maternal or infant deaths were apparent. In light of this, the ACIP approved the recommendation change to advise all pregnant women to be vaccinated, if they have not already been so before pregnancy.
Updates also included recommendations for patients with chronic liver disease, who are considered to be members of a high-risk population. Newly approved recommendations include a section on epidemiology, which states that, while those with chronic liver disease are not at increased risk for hepatitis A virus infection unless they experience fecal-oral exposure to the virus, those with acute hepatitis A may be more at risk to develop more severe liver disease. Recommendations for those with chronic liver disease also include a statement advising patients to seek immunoglobulin, as well as a hepatitis A, vaccination as soon as possible after exposure.
The ACIP also approved a change in recommendations to advise all residents and caretakers of those living in a group home, specifically those caring for developmentally disabled patients, to be vaccinated because of the historically high endemic nature of such institutions.
Committee members hope these new recommendations will help the United States reach its goal of a national hepatitis A case ratio of 0.3/100,000 people and a hepatitis A vaccination rate of 85%.
If these recommendations are approved by the director of the CDC and the U.S. Health Department, as they usually are, they will be published in the CDC’s Weekly Morbidity and Mortality Report.
Members of the committee reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
FROM ACIP MEETING
Angiotensin II may improve vasopressors’ efficacy
WASHINGTON – Adding angiotensin II to available vasopressor therapies correlated with significantly improved arterial pressure in patients with catecholamine-resistant vasodilatory shock and less adverse effects, according to a study presented at the recent international conference of the American Thoracic Society.
In a double blind, controlled, phase III study, 70% of 163 patients given angiotensin II reached arterial pressure of at least 75 mm HG or improved by at least 10 mm Hg three hours later, compared with 23.4% of the 158 patients given a placebo (P less than .001).
Those in the angiotensin II group also saw a mean pressure increase of 12.5 mm Hg in the first 3 hours after initiating treatment, compared with 2.9 mm Hg in the placebo group (P less than .001), according to Ashish Khanna, MD, FCCP, of the Cleveland Clinic, and his fellow researchers (N Engl J Med. 2017 May 21. doi: 10.1056/NEJMoa1704154).
Current vasopressor therapies for vasodilatory patients are associated with dangerous side effects and a 30-day mortality rate of more than 50%, which is a major concern for patients who do not have many options to begin with, the researchers noted.
“Treatment options for patients with catecholamine-resistant vasodilatory shock are limited, and the treatments that are available are often associated with side effects,” said Dr. Khanna and his colleagues.
The researchers added the naturally occurring peptide hormone angiotensin II to vasodilatory patients’ treatment regimen in order to “more closely [mimic] natural physiologic responses to shock, which include increased secretion of catecholamines, vasopressin, and RAAS hormones.”
To test the efficacy of angiotensin II, researchers gathered patients with a median age of 64 years and a mean arterial pressure of 66.3 mm Hg.
Sepsis was the predominant cause of shock for 80.7% of the study’s participants.
Patients were injected with either 20 ng/kg of body weight per minute of angiotensin II or an equivalent dose of a placebo until mean arterial pressure reached 75 mm Hg. After 3 hours and 15 minutes of treatment, the dosages were adjusted to keep pressure between 65 and 75 mm Hg for the next 48 hours.
Among patients in the angiotensin II group, 67% of patients were able to decrease angiotensin II and vasopressor doses within 30 minutes of injection, according to researchers.
When researchers measured improvement using the cardiovascular Sequential Organ Failure Assessment, patients in the angiotensin II group saw an average decrease of 1.75 points, compared with 1.28 points in patients in the placebo group (P = .01) 48 hours after treatment.
The Sequential Organ Failure Assessment is scaled from 0-4, with higher scores indicating more severe organ failure.
When measuring for adverse affects, serious effects occurred in 60.7% of the angiotensin II patients, compared with in 67.1% of those in the placebo group.
At the 28-day mark, 75 angiotensin II patients (46.0%) died, compared with 85 patients (53.8%) of the placebo group.
This study was limited by the small sample size, “so the possibility of clinically important side effects attributable to angiotensin II therapy cannot be exuded,” the researches warned.
Also, the follow-up timeline of 28 days, may not have given researchers enough time to uncover the full extent of positive and negative long-term effects associated with angiotensin II.
This study was supported by La Jolla Pharmaceutical, from which multiple researchers reported receiving financial support in the form of personal fees and grants. Two of the researchers reported having patents related to administering angiotensin II and additional patents pending.
[email protected]
On Twitter @eaztweets
WASHINGTON – Adding angiotensin II to available vasopressor therapies correlated with significantly improved arterial pressure in patients with catecholamine-resistant vasodilatory shock and less adverse effects, according to a study presented at the recent international conference of the American Thoracic Society.
In a double blind, controlled, phase III study, 70% of 163 patients given angiotensin II reached arterial pressure of at least 75 mm HG or improved by at least 10 mm Hg three hours later, compared with 23.4% of the 158 patients given a placebo (P less than .001).
Those in the angiotensin II group also saw a mean pressure increase of 12.5 mm Hg in the first 3 hours after initiating treatment, compared with 2.9 mm Hg in the placebo group (P less than .001), according to Ashish Khanna, MD, FCCP, of the Cleveland Clinic, and his fellow researchers (N Engl J Med. 2017 May 21. doi: 10.1056/NEJMoa1704154).
Current vasopressor therapies for vasodilatory patients are associated with dangerous side effects and a 30-day mortality rate of more than 50%, which is a major concern for patients who do not have many options to begin with, the researchers noted.
“Treatment options for patients with catecholamine-resistant vasodilatory shock are limited, and the treatments that are available are often associated with side effects,” said Dr. Khanna and his colleagues.
The researchers added the naturally occurring peptide hormone angiotensin II to vasodilatory patients’ treatment regimen in order to “more closely [mimic] natural physiologic responses to shock, which include increased secretion of catecholamines, vasopressin, and RAAS hormones.”
To test the efficacy of angiotensin II, researchers gathered patients with a median age of 64 years and a mean arterial pressure of 66.3 mm Hg.
Sepsis was the predominant cause of shock for 80.7% of the study’s participants.
Patients were injected with either 20 ng/kg of body weight per minute of angiotensin II or an equivalent dose of a placebo until mean arterial pressure reached 75 mm Hg. After 3 hours and 15 minutes of treatment, the dosages were adjusted to keep pressure between 65 and 75 mm Hg for the next 48 hours.
Among patients in the angiotensin II group, 67% of patients were able to decrease angiotensin II and vasopressor doses within 30 minutes of injection, according to researchers.
When researchers measured improvement using the cardiovascular Sequential Organ Failure Assessment, patients in the angiotensin II group saw an average decrease of 1.75 points, compared with 1.28 points in patients in the placebo group (P = .01) 48 hours after treatment.
The Sequential Organ Failure Assessment is scaled from 0-4, with higher scores indicating more severe organ failure.
When measuring for adverse affects, serious effects occurred in 60.7% of the angiotensin II patients, compared with in 67.1% of those in the placebo group.
At the 28-day mark, 75 angiotensin II patients (46.0%) died, compared with 85 patients (53.8%) of the placebo group.
This study was limited by the small sample size, “so the possibility of clinically important side effects attributable to angiotensin II therapy cannot be exuded,” the researches warned.
Also, the follow-up timeline of 28 days, may not have given researchers enough time to uncover the full extent of positive and negative long-term effects associated with angiotensin II.
This study was supported by La Jolla Pharmaceutical, from which multiple researchers reported receiving financial support in the form of personal fees and grants. Two of the researchers reported having patents related to administering angiotensin II and additional patents pending.
[email protected]
On Twitter @eaztweets
WASHINGTON – Adding angiotensin II to available vasopressor therapies correlated with significantly improved arterial pressure in patients with catecholamine-resistant vasodilatory shock and less adverse effects, according to a study presented at the recent international conference of the American Thoracic Society.
In a double blind, controlled, phase III study, 70% of 163 patients given angiotensin II reached arterial pressure of at least 75 mm HG or improved by at least 10 mm Hg three hours later, compared with 23.4% of the 158 patients given a placebo (P less than .001).
Those in the angiotensin II group also saw a mean pressure increase of 12.5 mm Hg in the first 3 hours after initiating treatment, compared with 2.9 mm Hg in the placebo group (P less than .001), according to Ashish Khanna, MD, FCCP, of the Cleveland Clinic, and his fellow researchers (N Engl J Med. 2017 May 21. doi: 10.1056/NEJMoa1704154).
Current vasopressor therapies for vasodilatory patients are associated with dangerous side effects and a 30-day mortality rate of more than 50%, which is a major concern for patients who do not have many options to begin with, the researchers noted.
“Treatment options for patients with catecholamine-resistant vasodilatory shock are limited, and the treatments that are available are often associated with side effects,” said Dr. Khanna and his colleagues.
The researchers added the naturally occurring peptide hormone angiotensin II to vasodilatory patients’ treatment regimen in order to “more closely [mimic] natural physiologic responses to shock, which include increased secretion of catecholamines, vasopressin, and RAAS hormones.”
To test the efficacy of angiotensin II, researchers gathered patients with a median age of 64 years and a mean arterial pressure of 66.3 mm Hg.
Sepsis was the predominant cause of shock for 80.7% of the study’s participants.
Patients were injected with either 20 ng/kg of body weight per minute of angiotensin II or an equivalent dose of a placebo until mean arterial pressure reached 75 mm Hg. After 3 hours and 15 minutes of treatment, the dosages were adjusted to keep pressure between 65 and 75 mm Hg for the next 48 hours.
Among patients in the angiotensin II group, 67% of patients were able to decrease angiotensin II and vasopressor doses within 30 minutes of injection, according to researchers.
When researchers measured improvement using the cardiovascular Sequential Organ Failure Assessment, patients in the angiotensin II group saw an average decrease of 1.75 points, compared with 1.28 points in patients in the placebo group (P = .01) 48 hours after treatment.
The Sequential Organ Failure Assessment is scaled from 0-4, with higher scores indicating more severe organ failure.
When measuring for adverse affects, serious effects occurred in 60.7% of the angiotensin II patients, compared with in 67.1% of those in the placebo group.
At the 28-day mark, 75 angiotensin II patients (46.0%) died, compared with 85 patients (53.8%) of the placebo group.
This study was limited by the small sample size, “so the possibility of clinically important side effects attributable to angiotensin II therapy cannot be exuded,” the researches warned.
Also, the follow-up timeline of 28 days, may not have given researchers enough time to uncover the full extent of positive and negative long-term effects associated with angiotensin II.
This study was supported by La Jolla Pharmaceutical, from which multiple researchers reported receiving financial support in the form of personal fees and grants. Two of the researchers reported having patents related to administering angiotensin II and additional patents pending.
[email protected]
On Twitter @eaztweets
At ATS 2017
Key clinical point:
Major finding: In the first 3 hours, patients taking angiotensin II improved arterial pressure by an average of 12.5 mm Hg, compared with 2.9 mm Hg in patients taking the placebo (P less than .001)
Data source: Double blind, randomized, control trial of 321 patients with catecholamine-resistant vasodilatory shock collected from 75 intensive care units globally during May 2015-January 2017.
Disclosures: Multiple investigators reported receiving support from La Jolla Pharmaceutical and similar companies in the form of grants and/or personal fees. Two of the researchers reported having patents related to administering angiotensin II and additional patents pending.
CDC: First-trimester Zika infection had highest rate of birth defects
One in 12 infant or fetus born to mothers from the U.S. territories with laboratory-confirmed Zika infection during the first trimester had a birth defect possibly-associated with the infection, officials from the Centers for Disease Control and Prevention reported.
Overall, there were 3,930 pregnant women with laboratory evidence of possible Zika infection reported in the U.S. territories during Jan. 1, 2016-May 24, 2017. Of the 2,549 completed pregnancies, 122 resulted in a fetus or infant with possible Zika-related birth defects. The greatest number of birth defects was for maternal infections in the first trimester at 8%, followed by 5% in the second trimester, and 4% in the third trimester (MMWR. 2017, June 8. doi: 10.15585/mmwr.mm6623e1).
“These data indicate that Zika virus is associated with risks to pregnant women and their babies, even when the infection is identified later during pregnancy,” Dr. Schuchat said. “Although we are still learning about the full range of birth defects that can occur within a woman infected with Zika during pregnancy, we know that it causes brain abnormalities, vision problems, and other consequences of brain damage that might require long-term specialized care.”
In depth analysis of Zika side effects among the studied population found that 108 (89%) of the 122 fetuses or infants with infection confirmed by nucleic acid testing were diagnosed with brain abnormalities and/or microcephaly.
Researchers also found potential gaps in the evaluation of infants at birth with possible congenital Zika virus infections in the U.S. territories, according to Peggy Honein, PhD, a coleader of the CDC Pregnancy and Birth Defects Task Force.
“There are still opportunities to ensure every health care provider is aware of how to screen for exposure to Zika, the need for comprehensive evaluation of infants, and how to monitor and provide follow-up care,” Dr. Honein said. “Identification and follow-ups with laboratory evidence of Zika infection during pregnancy can facilitate timely and appropriate clinical intervention services and help assess their future needs.”
This research was limited by the size of the population analyzed, which was small and, therefore, may not be the full scope of the Zika population. The clinical guidance for infants was also changed in August of 2016, which may have affected reporting, officials said.
To help collect more accurate data, U.S. territories will begin using the same standard case definition as used by the U.S. states and Washington, DC starting June 22, 2017.
One of the investigators reported personal fees from Population Services International, Dexis Consulting Group, and Public Health Institute outside the submitted work. The other investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
One in 12 infant or fetus born to mothers from the U.S. territories with laboratory-confirmed Zika infection during the first trimester had a birth defect possibly-associated with the infection, officials from the Centers for Disease Control and Prevention reported.
Overall, there were 3,930 pregnant women with laboratory evidence of possible Zika infection reported in the U.S. territories during Jan. 1, 2016-May 24, 2017. Of the 2,549 completed pregnancies, 122 resulted in a fetus or infant with possible Zika-related birth defects. The greatest number of birth defects was for maternal infections in the first trimester at 8%, followed by 5% in the second trimester, and 4% in the third trimester (MMWR. 2017, June 8. doi: 10.15585/mmwr.mm6623e1).
“These data indicate that Zika virus is associated with risks to pregnant women and their babies, even when the infection is identified later during pregnancy,” Dr. Schuchat said. “Although we are still learning about the full range of birth defects that can occur within a woman infected with Zika during pregnancy, we know that it causes brain abnormalities, vision problems, and other consequences of brain damage that might require long-term specialized care.”
In depth analysis of Zika side effects among the studied population found that 108 (89%) of the 122 fetuses or infants with infection confirmed by nucleic acid testing were diagnosed with brain abnormalities and/or microcephaly.
Researchers also found potential gaps in the evaluation of infants at birth with possible congenital Zika virus infections in the U.S. territories, according to Peggy Honein, PhD, a coleader of the CDC Pregnancy and Birth Defects Task Force.
“There are still opportunities to ensure every health care provider is aware of how to screen for exposure to Zika, the need for comprehensive evaluation of infants, and how to monitor and provide follow-up care,” Dr. Honein said. “Identification and follow-ups with laboratory evidence of Zika infection during pregnancy can facilitate timely and appropriate clinical intervention services and help assess their future needs.”
This research was limited by the size of the population analyzed, which was small and, therefore, may not be the full scope of the Zika population. The clinical guidance for infants was also changed in August of 2016, which may have affected reporting, officials said.
To help collect more accurate data, U.S. territories will begin using the same standard case definition as used by the U.S. states and Washington, DC starting June 22, 2017.
One of the investigators reported personal fees from Population Services International, Dexis Consulting Group, and Public Health Institute outside the submitted work. The other investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
One in 12 infant or fetus born to mothers from the U.S. territories with laboratory-confirmed Zika infection during the first trimester had a birth defect possibly-associated with the infection, officials from the Centers for Disease Control and Prevention reported.
Overall, there were 3,930 pregnant women with laboratory evidence of possible Zika infection reported in the U.S. territories during Jan. 1, 2016-May 24, 2017. Of the 2,549 completed pregnancies, 122 resulted in a fetus or infant with possible Zika-related birth defects. The greatest number of birth defects was for maternal infections in the first trimester at 8%, followed by 5% in the second trimester, and 4% in the third trimester (MMWR. 2017, June 8. doi: 10.15585/mmwr.mm6623e1).
“These data indicate that Zika virus is associated with risks to pregnant women and their babies, even when the infection is identified later during pregnancy,” Dr. Schuchat said. “Although we are still learning about the full range of birth defects that can occur within a woman infected with Zika during pregnancy, we know that it causes brain abnormalities, vision problems, and other consequences of brain damage that might require long-term specialized care.”
In depth analysis of Zika side effects among the studied population found that 108 (89%) of the 122 fetuses or infants with infection confirmed by nucleic acid testing were diagnosed with brain abnormalities and/or microcephaly.
Researchers also found potential gaps in the evaluation of infants at birth with possible congenital Zika virus infections in the U.S. territories, according to Peggy Honein, PhD, a coleader of the CDC Pregnancy and Birth Defects Task Force.
“There are still opportunities to ensure every health care provider is aware of how to screen for exposure to Zika, the need for comprehensive evaluation of infants, and how to monitor and provide follow-up care,” Dr. Honein said. “Identification and follow-ups with laboratory evidence of Zika infection during pregnancy can facilitate timely and appropriate clinical intervention services and help assess their future needs.”
This research was limited by the size of the population analyzed, which was small and, therefore, may not be the full scope of the Zika population. The clinical guidance for infants was also changed in August of 2016, which may have affected reporting, officials said.
To help collect more accurate data, U.S. territories will begin using the same standard case definition as used by the U.S. states and Washington, DC starting June 22, 2017.
One of the investigators reported personal fees from Population Services International, Dexis Consulting Group, and Public Health Institute outside the submitted work. The other investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
FROM MMWR
Noninvasive therapy cut COPD readmissions
WASHINGTON – The addition of noninvasive ventilation to home oxygen therapy regimens correlated with increased time to readmission or death among patients with exacerbated chronic obstructive pulmonary diseases (COPD), according to a study presented at an international conference of the American Thoracic Society.
Among 116 patients observed with COPD, the 57 patients given home oxygen and noninvasive ventilation reported an average time to readmission of 4.3 months, compared with 1.4 months among the 59 patients given only home oxygen, according to Patrick B. Murphy, PhD, of St. Thomas’ Hospital, London (JAMA. 2017 May 21. doi: 10.1001/jama.2017.4451), who presented this research on the same day it was published in JAMA. 
Dr. Murphy said the findings are encouraging for patients with COPD suffering from exacerbations from the disease.
“Patients with established chronic respiratory failure secondary to COPD have poor outcomes with limited treatment options available,” the investigators noted. “The results of the current trial are reassuring, suggesting that home noninvasive ventilation added to home oxygen therapy in this population improved the overall clinical outcome without adding to the health burden of the patient.”
In this 12-month, phase III, multicenter, randomized clinical trial, the average age of the patients was 67 years, and the average body mass index was 21.6 mg/k2. The patients had an average partial pressure of carbon dioxide (PaCo2) level of 59, indicating persistent hypercapnia.
The investigators gave those in the intervention group one of three noninvasive home ventilators – nasal, oronasal, or total face mask – to use for a minimum of 6 hours nightly. Patients in both groups received 15 hours of oxygen therapy daily.
Doctors gathered data from patients after 6 weeks, 3 months, 6 months, and 12 months.
After 12 months, risk of readmission or death in the intervention group was 63.4%, while those in the oxygen-only group reported a risk of 80.4%. Despite a 17% risk reduction, a similar number of patients died during the experiment in both groups: five in the noninvasive intervention group and four in the control group, according to the investigators.
At the end of the trial, 16 patients (28%) in the intervention group and 19 (32%) in the control group died.
Dr. Murphy and his peers asserted that these deaths do not take away from the success of the treatment, as the focus of the study was to find a way to reduce readmissions, not necessarily mortality.
“The driver of the clinical improvement in the home oxygen therapy plus home noninvasive ventilation group was readmission avoidance with no significant difference in mortality,” they wrote. “This study has major clinical relevance because readmission avoidance is beneficial to the patient in terms of preservation of lung function and health-related quality of life, as well as providing a direct and indirect cost saving.”
The study was limited by the lack of a double-blind design; however, investigators said that a sham device may have made patients’ respiratory failure worse.
Some patients in the control group were later given ventilation treatment for safety reasons. Eighteen patients were given noninvasive ventilation, although reportedly after the primary endpoint was reached.
Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.
[email protected]
On Twitter @eaztweets
Vera A. De Palo, MD, FCCP, MBA, comments: A goal for any patient with a chronic disease is the best possible quality of life. Increasing hospital-free and exacerbation-free days helps to improve that quality of life. The authors report that the addition of noninvasive ventilation therapy increased the time to readmission due to COPD exacerbation. This adds another tool to the armamentarium to help improve outcomes for our COPD patients.
Vera A. De Palo, MD, FCCP, MBA, comments: A goal for any patient with a chronic disease is the best possible quality of life. Increasing hospital-free and exacerbation-free days helps to improve that quality of life. The authors report that the addition of noninvasive ventilation therapy increased the time to readmission due to COPD exacerbation. This adds another tool to the armamentarium to help improve outcomes for our COPD patients.
Vera A. De Palo, MD, FCCP, MBA, comments: A goal for any patient with a chronic disease is the best possible quality of life. Increasing hospital-free and exacerbation-free days helps to improve that quality of life. The authors report that the addition of noninvasive ventilation therapy increased the time to readmission due to COPD exacerbation. This adds another tool to the armamentarium to help improve outcomes for our COPD patients.
WASHINGTON – The addition of noninvasive ventilation to home oxygen therapy regimens correlated with increased time to readmission or death among patients with exacerbated chronic obstructive pulmonary diseases (COPD), according to a study presented at an international conference of the American Thoracic Society.
Among 116 patients observed with COPD, the 57 patients given home oxygen and noninvasive ventilation reported an average time to readmission of 4.3 months, compared with 1.4 months among the 59 patients given only home oxygen, according to Patrick B. Murphy, PhD, of St. Thomas’ Hospital, London (JAMA. 2017 May 21. doi: 10.1001/jama.2017.4451), who presented this research on the same day it was published in JAMA.
Dr. Murphy said the findings are encouraging for patients with COPD suffering from exacerbations from the disease.
“Patients with established chronic respiratory failure secondary to COPD have poor outcomes with limited treatment options available,” the investigators noted. “The results of the current trial are reassuring, suggesting that home noninvasive ventilation added to home oxygen therapy in this population improved the overall clinical outcome without adding to the health burden of the patient.”
In this 12-month, phase III, multicenter, randomized clinical trial, the average age of the patients was 67 years, and the average body mass index was 21.6 mg/k2. The patients had an average partial pressure of carbon dioxide (PaCo2) level of 59, indicating persistent hypercapnia.
The investigators gave those in the intervention group one of three noninvasive home ventilators – nasal, oronasal, or total face mask – to use for a minimum of 6 hours nightly. Patients in both groups received 15 hours of oxygen therapy daily.
Doctors gathered data from patients after 6 weeks, 3 months, 6 months, and 12 months.
After 12 months, risk of readmission or death in the intervention group was 63.4%, while those in the oxygen-only group reported a risk of 80.4%. Despite a 17% risk reduction, a similar number of patients died during the experiment in both groups: five in the noninvasive intervention group and four in the control group, according to the investigators.
At the end of the trial, 16 patients (28%) in the intervention group and 19 (32%) in the control group died.
Dr. Murphy and his peers asserted that these deaths do not take away from the success of the treatment, as the focus of the study was to find a way to reduce readmissions, not necessarily mortality.
“The driver of the clinical improvement in the home oxygen therapy plus home noninvasive ventilation group was readmission avoidance with no significant difference in mortality,” they wrote. “This study has major clinical relevance because readmission avoidance is beneficial to the patient in terms of preservation of lung function and health-related quality of life, as well as providing a direct and indirect cost saving.”
The study was limited by the lack of a double-blind design; however, investigators said that a sham device may have made patients’ respiratory failure worse.
Some patients in the control group were later given ventilation treatment for safety reasons. Eighteen patients were given noninvasive ventilation, although reportedly after the primary endpoint was reached.
Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.
[email protected]
On Twitter @eaztweets
WASHINGTON – The addition of noninvasive ventilation to home oxygen therapy regimens correlated with increased time to readmission or death among patients with exacerbated chronic obstructive pulmonary diseases (COPD), according to a study presented at an international conference of the American Thoracic Society.
Among 116 patients observed with COPD, the 57 patients given home oxygen and noninvasive ventilation reported an average time to readmission of 4.3 months, compared with 1.4 months among the 59 patients given only home oxygen, according to Patrick B. Murphy, PhD, of St. Thomas’ Hospital, London (JAMA. 2017 May 21. doi: 10.1001/jama.2017.4451), who presented this research on the same day it was published in JAMA.
Dr. Murphy said the findings are encouraging for patients with COPD suffering from exacerbations from the disease.
“Patients with established chronic respiratory failure secondary to COPD have poor outcomes with limited treatment options available,” the investigators noted. “The results of the current trial are reassuring, suggesting that home noninvasive ventilation added to home oxygen therapy in this population improved the overall clinical outcome without adding to the health burden of the patient.”
In this 12-month, phase III, multicenter, randomized clinical trial, the average age of the patients was 67 years, and the average body mass index was 21.6 mg/k2. The patients had an average partial pressure of carbon dioxide (PaCo2) level of 59, indicating persistent hypercapnia.
The investigators gave those in the intervention group one of three noninvasive home ventilators – nasal, oronasal, or total face mask – to use for a minimum of 6 hours nightly. Patients in both groups received 15 hours of oxygen therapy daily.
Doctors gathered data from patients after 6 weeks, 3 months, 6 months, and 12 months.
After 12 months, risk of readmission or death in the intervention group was 63.4%, while those in the oxygen-only group reported a risk of 80.4%. Despite a 17% risk reduction, a similar number of patients died during the experiment in both groups: five in the noninvasive intervention group and four in the control group, according to the investigators.
At the end of the trial, 16 patients (28%) in the intervention group and 19 (32%) in the control group died.
Dr. Murphy and his peers asserted that these deaths do not take away from the success of the treatment, as the focus of the study was to find a way to reduce readmissions, not necessarily mortality.
“The driver of the clinical improvement in the home oxygen therapy plus home noninvasive ventilation group was readmission avoidance with no significant difference in mortality,” they wrote. “This study has major clinical relevance because readmission avoidance is beneficial to the patient in terms of preservation of lung function and health-related quality of life, as well as providing a direct and indirect cost saving.”
The study was limited by the lack of a double-blind design; however, investigators said that a sham device may have made patients’ respiratory failure worse.
Some patients in the control group were later given ventilation treatment for safety reasons. Eighteen patients were given noninvasive ventilation, although reportedly after the primary endpoint was reached.
Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.
[email protected]
On Twitter @eaztweets
FROM ATS 2017
Key clinical point:
Major finding: The average time until readmission or death was 4.3 months for patients using both oxygen therapy and ventilation, compared with an average of 1.4 months for patients using only oxygen therapy.
Data source: Phase III, multicenter, randomized clinical trial of 116 COPD patients gathered from 13 U.K. medical centers between February, 2010, and April, 2015.
Disclosures: Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Patrick B. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.
Study: Antibiotic monotherapy fails 25% of CAP patients
WASHINGTON – A substantial failure rate of antibiotic monotherapy was found in patients with community acquired pneumonia (CAP), according to a presentation given at an international conference of the American Thoracic Society.
In a study of 413,801 patient records with confirmed CAP, an average of 25% of patients reported treatment failure, according to James A McKinnell, MD, an infectious disease specialist at LA BioMed and an assistant professor at the University of California, Los Angeles.
Adult outpatient records with a diagnosis of CAP and a prescription for antibiotics were gathered from the period of 2012-2015, with treatment failure defined as a refill or change in the medication prescribed, a visit to the emergency department, or a hospitalization, according to Dr. McKinnell and the other investigators.
When broken down, the failure rates in patients given beta-lactams (25.7%), macrolides (22.9%), tetracycline (22.5%), and fluoroquinolones (20.8%), were all found to increase when patients’ Charlson Comorbidity Index (CCI) score increased (odds ration [OR] = 1.16 [1.13-1.20] for CCI = 1, OR = 1.22 [1.18-1.26], for CCI = 2, OR = 1.44 [1.39-1.49], for CCI greater than or equal to 3).
These medications have been shown to be effective through the usual array of controlled tests. While these trials do confirm overall efficacy, they are not always accurate in predicting how they will affect individual patients, Dr. McKinnell noted.
“I want to know the best drug for my patient, [and] unfortunately randomized clinical trials are not completely generalizable,” Dr. McKinnell said during his presentation. “Pathogen distribution and resistance is different in a clinical trial compared to the patients we see, and there’s a measuring bias, so there’s a lot of limitations when just using clinical trials.”
When analyzing failure endpoints, the investigators found 79%, 73.4%, 80.8%, and 64% of patients switched their antibiotics while taking beta-lactams, macrolides, tetracycline, or fluoroquinolones, respectively. The investigators interpreted this as a sign that patient treatment plans must be better fitted for their personal circumstances.
This is where the idea of “big data” would apply; using large-scale, “real-world” data of current and previous CAP patients could be instrumental to test the benefits and limitations of certain treatment options on patients with certain comorbidities, according to Dr. McKinnell and his fellow investigators.
When breaking down comorbidities among patients, the investigators found that many of the comorbid conditions had a “significant predictor value” of treatment failure, according to Dr. McKinnell.
Investigators were not surprised that hemiplegia or paraplegia, which increased the odds of antibiotic failure by 33%, were independent factors; however, comorbidities such as peptic ulcer disease (OR: 1.15) was less expected, Dr. McKinnell noted.
When looking at the mortality rate of patients 18 years of age and older with treatment failure, 18.1% (10,087) died (P less than .0001), with an even higher mortality rate of 24.3% (3,299) among those at least 65 years of age, he said.
If big data studies could decrease the number of treatment failures, the implications would be significant in decreasing the number of mortalities, the investigators noted.
“Prescribers should be aware of those CAP patients most at risk for poor outcomes and consider these factors to guide a comprehensive treatment plan,” said Dr. McKinnell.
Cempra Pharmaceuticals funded the study. The researchers did not report any conflicts of interest during their presentation.
[email protected]
On Twitter @eaztweets
WASHINGTON – A substantial failure rate of antibiotic monotherapy was found in patients with community acquired pneumonia (CAP), according to a presentation given at an international conference of the American Thoracic Society.
In a study of 413,801 patient records with confirmed CAP, an average of 25% of patients reported treatment failure, according to James A McKinnell, MD, an infectious disease specialist at LA BioMed and an assistant professor at the University of California, Los Angeles.
Adult outpatient records with a diagnosis of CAP and a prescription for antibiotics were gathered from the period of 2012-2015, with treatment failure defined as a refill or change in the medication prescribed, a visit to the emergency department, or a hospitalization, according to Dr. McKinnell and the other investigators.
When broken down, the failure rates in patients given beta-lactams (25.7%), macrolides (22.9%), tetracycline (22.5%), and fluoroquinolones (20.8%), were all found to increase when patients’ Charlson Comorbidity Index (CCI) score increased (odds ration [OR] = 1.16 [1.13-1.20] for CCI = 1, OR = 1.22 [1.18-1.26], for CCI = 2, OR = 1.44 [1.39-1.49], for CCI greater than or equal to 3).
These medications have been shown to be effective through the usual array of controlled tests. While these trials do confirm overall efficacy, they are not always accurate in predicting how they will affect individual patients, Dr. McKinnell noted.
“I want to know the best drug for my patient, [and] unfortunately randomized clinical trials are not completely generalizable,” Dr. McKinnell said during his presentation. “Pathogen distribution and resistance is different in a clinical trial compared to the patients we see, and there’s a measuring bias, so there’s a lot of limitations when just using clinical trials.”
When analyzing failure endpoints, the investigators found 79%, 73.4%, 80.8%, and 64% of patients switched their antibiotics while taking beta-lactams, macrolides, tetracycline, or fluoroquinolones, respectively. The investigators interpreted this as a sign that patient treatment plans must be better fitted for their personal circumstances.
This is where the idea of “big data” would apply; using large-scale, “real-world” data of current and previous CAP patients could be instrumental to test the benefits and limitations of certain treatment options on patients with certain comorbidities, according to Dr. McKinnell and his fellow investigators.
When breaking down comorbidities among patients, the investigators found that many of the comorbid conditions had a “significant predictor value” of treatment failure, according to Dr. McKinnell.
Investigators were not surprised that hemiplegia or paraplegia, which increased the odds of antibiotic failure by 33%, were independent factors; however, comorbidities such as peptic ulcer disease (OR: 1.15) was less expected, Dr. McKinnell noted.
When looking at the mortality rate of patients 18 years of age and older with treatment failure, 18.1% (10,087) died (P less than .0001), with an even higher mortality rate of 24.3% (3,299) among those at least 65 years of age, he said.
If big data studies could decrease the number of treatment failures, the implications would be significant in decreasing the number of mortalities, the investigators noted.
“Prescribers should be aware of those CAP patients most at risk for poor outcomes and consider these factors to guide a comprehensive treatment plan,” said Dr. McKinnell.
Cempra Pharmaceuticals funded the study. The researchers did not report any conflicts of interest during their presentation.
[email protected]
On Twitter @eaztweets
WASHINGTON – A substantial failure rate of antibiotic monotherapy was found in patients with community acquired pneumonia (CAP), according to a presentation given at an international conference of the American Thoracic Society.
In a study of 413,801 patient records with confirmed CAP, an average of 25% of patients reported treatment failure, according to James A McKinnell, MD, an infectious disease specialist at LA BioMed and an assistant professor at the University of California, Los Angeles.
Adult outpatient records with a diagnosis of CAP and a prescription for antibiotics were gathered from the period of 2012-2015, with treatment failure defined as a refill or change in the medication prescribed, a visit to the emergency department, or a hospitalization, according to Dr. McKinnell and the other investigators.
When broken down, the failure rates in patients given beta-lactams (25.7%), macrolides (22.9%), tetracycline (22.5%), and fluoroquinolones (20.8%), were all found to increase when patients’ Charlson Comorbidity Index (CCI) score increased (odds ration [OR] = 1.16 [1.13-1.20] for CCI = 1, OR = 1.22 [1.18-1.26], for CCI = 2, OR = 1.44 [1.39-1.49], for CCI greater than or equal to 3).
These medications have been shown to be effective through the usual array of controlled tests. While these trials do confirm overall efficacy, they are not always accurate in predicting how they will affect individual patients, Dr. McKinnell noted.
“I want to know the best drug for my patient, [and] unfortunately randomized clinical trials are not completely generalizable,” Dr. McKinnell said during his presentation. “Pathogen distribution and resistance is different in a clinical trial compared to the patients we see, and there’s a measuring bias, so there’s a lot of limitations when just using clinical trials.”
When analyzing failure endpoints, the investigators found 79%, 73.4%, 80.8%, and 64% of patients switched their antibiotics while taking beta-lactams, macrolides, tetracycline, or fluoroquinolones, respectively. The investigators interpreted this as a sign that patient treatment plans must be better fitted for their personal circumstances.
This is where the idea of “big data” would apply; using large-scale, “real-world” data of current and previous CAP patients could be instrumental to test the benefits and limitations of certain treatment options on patients with certain comorbidities, according to Dr. McKinnell and his fellow investigators.
When breaking down comorbidities among patients, the investigators found that many of the comorbid conditions had a “significant predictor value” of treatment failure, according to Dr. McKinnell.
Investigators were not surprised that hemiplegia or paraplegia, which increased the odds of antibiotic failure by 33%, were independent factors; however, comorbidities such as peptic ulcer disease (OR: 1.15) was less expected, Dr. McKinnell noted.
When looking at the mortality rate of patients 18 years of age and older with treatment failure, 18.1% (10,087) died (P less than .0001), with an even higher mortality rate of 24.3% (3,299) among those at least 65 years of age, he said.
If big data studies could decrease the number of treatment failures, the implications would be significant in decreasing the number of mortalities, the investigators noted.
“Prescribers should be aware of those CAP patients most at risk for poor outcomes and consider these factors to guide a comprehensive treatment plan,” said Dr. McKinnell.
Cempra Pharmaceuticals funded the study. The researchers did not report any conflicts of interest during their presentation.
[email protected]
On Twitter @eaztweets
FROM ATS 2017
Key clinical point:
Major finding: On average, 25% of patients experienced treatment failure for antibiotic monotherapy, which was exacerbated by increasing Charlson comorbidity index scores (OR = 1.16 [1.13-1.20] for CCI = 1, OR = 1.22 [1.18-1.26] for CCI = 2, OR = 1.44 [1.39-1.49] for CCI greater than or equal to 3).
Data source: Retrospective study of 413,801 patients with CAP gathered from the commercial claims encounters database and the Medicare supplemental coordination benefits database between January 2011 and December 2015.
Disclosures: Cempra Pharmaceuticals funded the study. The researchers did not report any conflicts of interest during their presentation.
6MWTs improved following online pulmonary rehab
WASHINGTON – An online pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease (COPD) was not inferior to an in-person program, according to study findings presented at an international conference of the American Thoracic Society, Tuesday.
In a walking test conducted after all patients completed a 7-week program, participants in the online program, on average, increased their 6MWT (6-minute walking test) score by 23.8 m (P = .098) from baseline; this amount of improvement is much greater than the noninferiority threshold for this study. COPD assessment, hospital anxiety, respiratory function, and modified medical research council dyspnea scores of patients who participated in the online program were also not inferior to the scores of patients who participated in the in-person program.
If found to be a viable option, online options for COPD patients could be useful for treatment in those who would otherwise not have access to in-person rehabilitation sessions, said Tom Wilkinson, MD, PhD, of the University of Southhampton (England), in his presentation.
“The challenges for patients with COPD are quite real; there are factors which are limiting the access of treatments ... in the way of geography of where our patients live,” said Dr. Wilkinson. “[Also] some patients may be housebound or have social anxiety but would benefit from using programs more regularly.”
The study’s 90 participants were assigned to participate either in an online program designed as an in-home guide for pulmonary rehabilitation or in pulmonary rehabilitation sessions at a local facility, after a baseline 6-minute walking test, according to Dr. Wilkinson.
The average age of patients participating in the face-to-face program was 71 years, while the average age for the online group was 69 years. Both groups were predominantly male and former smokers.
Investigators designed the online program to mimic face-to-face sessions by integrating advice on exercises, and information about a patient’s condition, into the program. While the online program included five sessions per week of either exercise or education, the program for patients in the control group involved two facility sessions per week.
Dr. Wilkinson said the online form of rehabilitation used in this study would not only benefit patients, but would help hospitals financially.
An online application could be a helpful supplement for facilities that do not have the resources to hire additional workers or do not have the proper facility to conduct these sessions, he added.
Attendees expressed concern that the learning curve of an online platform could make participating in the program difficult for COPD patients.
Dr. Wilkinson said he and his team had taken that potential learning curve into account when designing the program, by including digital literacy programs and a service hotline.
This study was funded by a grant awarded through the U.K. small business research initiative. The investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
WASHINGTON – An online pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease (COPD) was not inferior to an in-person program, according to study findings presented at an international conference of the American Thoracic Society, Tuesday.
In a walking test conducted after all patients completed a 7-week program, participants in the online program, on average, increased their 6MWT (6-minute walking test) score by 23.8 m (P = .098) from baseline; this amount of improvement is much greater than the noninferiority threshold for this study. COPD assessment, hospital anxiety, respiratory function, and modified medical research council dyspnea scores of patients who participated in the online program were also not inferior to the scores of patients who participated in the in-person program.
If found to be a viable option, online options for COPD patients could be useful for treatment in those who would otherwise not have access to in-person rehabilitation sessions, said Tom Wilkinson, MD, PhD, of the University of Southhampton (England), in his presentation.
“The challenges for patients with COPD are quite real; there are factors which are limiting the access of treatments ... in the way of geography of where our patients live,” said Dr. Wilkinson. “[Also] some patients may be housebound or have social anxiety but would benefit from using programs more regularly.”
The study’s 90 participants were assigned to participate either in an online program designed as an in-home guide for pulmonary rehabilitation or in pulmonary rehabilitation sessions at a local facility, after a baseline 6-minute walking test, according to Dr. Wilkinson.
The average age of patients participating in the face-to-face program was 71 years, while the average age for the online group was 69 years. Both groups were predominantly male and former smokers.
Investigators designed the online program to mimic face-to-face sessions by integrating advice on exercises, and information about a patient’s condition, into the program. While the online program included five sessions per week of either exercise or education, the program for patients in the control group involved two facility sessions per week.
Dr. Wilkinson said the online form of rehabilitation used in this study would not only benefit patients, but would help hospitals financially.
An online application could be a helpful supplement for facilities that do not have the resources to hire additional workers or do not have the proper facility to conduct these sessions, he added.
Attendees expressed concern that the learning curve of an online platform could make participating in the program difficult for COPD patients.
Dr. Wilkinson said he and his team had taken that potential learning curve into account when designing the program, by including digital literacy programs and a service hotline.
This study was funded by a grant awarded through the U.K. small business research initiative. The investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
WASHINGTON – An online pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease (COPD) was not inferior to an in-person program, according to study findings presented at an international conference of the American Thoracic Society, Tuesday.
In a walking test conducted after all patients completed a 7-week program, participants in the online program, on average, increased their 6MWT (6-minute walking test) score by 23.8 m (P = .098) from baseline; this amount of improvement is much greater than the noninferiority threshold for this study. COPD assessment, hospital anxiety, respiratory function, and modified medical research council dyspnea scores of patients who participated in the online program were also not inferior to the scores of patients who participated in the in-person program.
If found to be a viable option, online options for COPD patients could be useful for treatment in those who would otherwise not have access to in-person rehabilitation sessions, said Tom Wilkinson, MD, PhD, of the University of Southhampton (England), in his presentation.
“The challenges for patients with COPD are quite real; there are factors which are limiting the access of treatments ... in the way of geography of where our patients live,” said Dr. Wilkinson. “[Also] some patients may be housebound or have social anxiety but would benefit from using programs more regularly.”
The study’s 90 participants were assigned to participate either in an online program designed as an in-home guide for pulmonary rehabilitation or in pulmonary rehabilitation sessions at a local facility, after a baseline 6-minute walking test, according to Dr. Wilkinson.
The average age of patients participating in the face-to-face program was 71 years, while the average age for the online group was 69 years. Both groups were predominantly male and former smokers.
Investigators designed the online program to mimic face-to-face sessions by integrating advice on exercises, and information about a patient’s condition, into the program. While the online program included five sessions per week of either exercise or education, the program for patients in the control group involved two facility sessions per week.
Dr. Wilkinson said the online form of rehabilitation used in this study would not only benefit patients, but would help hospitals financially.
An online application could be a helpful supplement for facilities that do not have the resources to hire additional workers or do not have the proper facility to conduct these sessions, he added.
Attendees expressed concern that the learning curve of an online platform could make participating in the program difficult for COPD patients.
Dr. Wilkinson said he and his team had taken that potential learning curve into account when designing the program, by including digital literacy programs and a service hotline.
This study was funded by a grant awarded through the U.K. small business research initiative. The investigators reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
Key clinical point:
Major finding: The 6-minute walking test scores for patients participating in an online pulmonary rehabilitation program improved by 23.8 m, on average (P = .098).
Data source: A single-blind, randomized controlled trial of 90 patients conducted through the Portsmouth Hospital.
Disclosures: This study was funded by a grant awarded through the U.K. small business research initiative. Investigators reported no relevant financial disclosures.
Biologic may reduce glucocorticoid use
WASHINGTON – The biologic benralizumab cut glucocorticoid dosage by nearly 75% among patients with severe, uncontrolled asthma, compared with a 25% reduction in dosage among patients using a placebo, according to a study.
In this three-armed, double-blind study of 220 patients, those administered benralizumab every 4 and 8 weeks were 4.09 (95% confidence interval, 2.22-7.57) and 4.12 (95% CI, 2.22-7.57) times as likely to see a reduction in glucocorticoid dose, compared with those in the placebo group, according to investigators (NEJM. 2017 May 21. doi: 10.1056/NEJMoa1703501).The study was presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Frequent or long-term use of systemic corticosteroids can lead to potentially life-threatening complications, including osteoporosis, diabetes, cardiovascular disease, and adrenal suppression,” Parameswaran Nair, MD, PhD, professor at McMaster University, Hamilton, Ont., said in a press release. “We need new, safe therapies that would replace the need for systemic corticosteroids for patients with severe asthma.”
To test benralizumab’s effectiveness, investigators measured a baseline level of glucocorticoid dosage of 220 patients with severe, uncontrolled asthma. Patients were then given one of three treatment options: one dose of benralizumab every 4 weeks, one dose of benralizumab every 8 weeks, or a placebo. All three treatments were decreased each time until minimal dosage was found while still maintaining asthma control. The average age of patients was around 50 years, with the majority of patients in both treatment groups and the placebo group having been female.
The researchers also analyzed patients’ accounts of any worsening asthma symptoms, which were recorded in an electronic asthma daily diary.
Along with the median 75% decrease in glucocorticoid dosage seen in both groups of patients receiving benralizumab, 24 patients (33%) in the 4-week group and 27 patients in the 8-week group (37%) showed a 90% reduction from their baseline glucocorticoid dosage. In contrast, only nine patients (12%) in the placebo group experienced a 90% drop in glucocorticoid use.
The researchers observed an additional finding suggesting benralizumab’s usefulness in a subgroup of patients with a baseline prednisone dose of less than 12.5 mg. These patients were more likely to stop taking their glucocorticoid dose if they were taking benralizumab instead of the placebo. Specifically, patients who took benralizumab every 4 weeks were 5.23 times more likely and those who took the biologic every 8 weeks were 4.19 times more likely to cease using glucocorticoids.
Similar to the current biologics used to treat severe eosinophilic asthma, mepolizumab and reslizumab, benralizumab is a form of a monoclonal antibody. Instead of targeting interleukin-5, benralizumab works against a subunit of the iterleukin-5 receptor. They investigators said this aspect of benralizumab may explain why it was successful in this study.
“Targeting of the alpha-subunit of the iterleukin-5 receptor with benralizumab has potential advantages over existing anti–interleukin-5 therapies,” according to Dr. Nier and fellow investigators. “By targeting the interleukin receptor rather than the cytokine, luminal depletion of eosinophils can occur, which may be related to greater clinical efficiency.”
The investigators noted that FEV1 levels seemed relatively unaffected by benralizumab.
This study was limited by the length of the trials, which lasted 28 weeks. Investigators also note that 20% of the original patients were not used in the final population.
This study was sponsored by, and organized in partnership with, AstraZeneca. All of the investigators reported having a financial or other type of relationship with AstraZeneca.
[email protected]
On Twitter @eaztweets
WASHINGTON – The biologic benralizumab cut glucocorticoid dosage by nearly 75% among patients with severe, uncontrolled asthma, compared with a 25% reduction in dosage among patients using a placebo, according to a study.
In this three-armed, double-blind study of 220 patients, those administered benralizumab every 4 and 8 weeks were 4.09 (95% confidence interval, 2.22-7.57) and 4.12 (95% CI, 2.22-7.57) times as likely to see a reduction in glucocorticoid dose, compared with those in the placebo group, according to investigators (NEJM. 2017 May 21. doi: 10.1056/NEJMoa1703501).The study was presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Frequent or long-term use of systemic corticosteroids can lead to potentially life-threatening complications, including osteoporosis, diabetes, cardiovascular disease, and adrenal suppression,” Parameswaran Nair, MD, PhD, professor at McMaster University, Hamilton, Ont., said in a press release. “We need new, safe therapies that would replace the need for systemic corticosteroids for patients with severe asthma.”
To test benralizumab’s effectiveness, investigators measured a baseline level of glucocorticoid dosage of 220 patients with severe, uncontrolled asthma. Patients were then given one of three treatment options: one dose of benralizumab every 4 weeks, one dose of benralizumab every 8 weeks, or a placebo. All three treatments were decreased each time until minimal dosage was found while still maintaining asthma control. The average age of patients was around 50 years, with the majority of patients in both treatment groups and the placebo group having been female.
The researchers also analyzed patients’ accounts of any worsening asthma symptoms, which were recorded in an electronic asthma daily diary.
Along with the median 75% decrease in glucocorticoid dosage seen in both groups of patients receiving benralizumab, 24 patients (33%) in the 4-week group and 27 patients in the 8-week group (37%) showed a 90% reduction from their baseline glucocorticoid dosage. In contrast, only nine patients (12%) in the placebo group experienced a 90% drop in glucocorticoid use.
The researchers observed an additional finding suggesting benralizumab’s usefulness in a subgroup of patients with a baseline prednisone dose of less than 12.5 mg. These patients were more likely to stop taking their glucocorticoid dose if they were taking benralizumab instead of the placebo. Specifically, patients who took benralizumab every 4 weeks were 5.23 times more likely and those who took the biologic every 8 weeks were 4.19 times more likely to cease using glucocorticoids.
Similar to the current biologics used to treat severe eosinophilic asthma, mepolizumab and reslizumab, benralizumab is a form of a monoclonal antibody. Instead of targeting interleukin-5, benralizumab works against a subunit of the iterleukin-5 receptor. They investigators said this aspect of benralizumab may explain why it was successful in this study.
“Targeting of the alpha-subunit of the iterleukin-5 receptor with benralizumab has potential advantages over existing anti–interleukin-5 therapies,” according to Dr. Nier and fellow investigators. “By targeting the interleukin receptor rather than the cytokine, luminal depletion of eosinophils can occur, which may be related to greater clinical efficiency.”
The investigators noted that FEV1 levels seemed relatively unaffected by benralizumab.
This study was limited by the length of the trials, which lasted 28 weeks. Investigators also note that 20% of the original patients were not used in the final population.
This study was sponsored by, and organized in partnership with, AstraZeneca. All of the investigators reported having a financial or other type of relationship with AstraZeneca.
[email protected]
On Twitter @eaztweets
WASHINGTON – The biologic benralizumab cut glucocorticoid dosage by nearly 75% among patients with severe, uncontrolled asthma, compared with a 25% reduction in dosage among patients using a placebo, according to a study.
In this three-armed, double-blind study of 220 patients, those administered benralizumab every 4 and 8 weeks were 4.09 (95% confidence interval, 2.22-7.57) and 4.12 (95% CI, 2.22-7.57) times as likely to see a reduction in glucocorticoid dose, compared with those in the placebo group, according to investigators (NEJM. 2017 May 21. doi: 10.1056/NEJMoa1703501).The study was presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Frequent or long-term use of systemic corticosteroids can lead to potentially life-threatening complications, including osteoporosis, diabetes, cardiovascular disease, and adrenal suppression,” Parameswaran Nair, MD, PhD, professor at McMaster University, Hamilton, Ont., said in a press release. “We need new, safe therapies that would replace the need for systemic corticosteroids for patients with severe asthma.”
To test benralizumab’s effectiveness, investigators measured a baseline level of glucocorticoid dosage of 220 patients with severe, uncontrolled asthma. Patients were then given one of three treatment options: one dose of benralizumab every 4 weeks, one dose of benralizumab every 8 weeks, or a placebo. All three treatments were decreased each time until minimal dosage was found while still maintaining asthma control. The average age of patients was around 50 years, with the majority of patients in both treatment groups and the placebo group having been female.
The researchers also analyzed patients’ accounts of any worsening asthma symptoms, which were recorded in an electronic asthma daily diary.
Along with the median 75% decrease in glucocorticoid dosage seen in both groups of patients receiving benralizumab, 24 patients (33%) in the 4-week group and 27 patients in the 8-week group (37%) showed a 90% reduction from their baseline glucocorticoid dosage. In contrast, only nine patients (12%) in the placebo group experienced a 90% drop in glucocorticoid use.
The researchers observed an additional finding suggesting benralizumab’s usefulness in a subgroup of patients with a baseline prednisone dose of less than 12.5 mg. These patients were more likely to stop taking their glucocorticoid dose if they were taking benralizumab instead of the placebo. Specifically, patients who took benralizumab every 4 weeks were 5.23 times more likely and those who took the biologic every 8 weeks were 4.19 times more likely to cease using glucocorticoids.
Similar to the current biologics used to treat severe eosinophilic asthma, mepolizumab and reslizumab, benralizumab is a form of a monoclonal antibody. Instead of targeting interleukin-5, benralizumab works against a subunit of the iterleukin-5 receptor. They investigators said this aspect of benralizumab may explain why it was successful in this study.
“Targeting of the alpha-subunit of the iterleukin-5 receptor with benralizumab has potential advantages over existing anti–interleukin-5 therapies,” according to Dr. Nier and fellow investigators. “By targeting the interleukin receptor rather than the cytokine, luminal depletion of eosinophils can occur, which may be related to greater clinical efficiency.”
The investigators noted that FEV1 levels seemed relatively unaffected by benralizumab.
This study was limited by the length of the trials, which lasted 28 weeks. Investigators also note that 20% of the original patients were not used in the final population.
This study was sponsored by, and organized in partnership with, AstraZeneca. All of the investigators reported having a financial or other type of relationship with AstraZeneca.
[email protected]
On Twitter @eaztweets
FROM ATS 2017
Key clinical point:
Major finding: Patients administered benralizumab averaged a 75% reduction rate in final glucocorticoid dosage, compared with 25% in the control group (P less than .001).
Data source: Randomized, double blind, placebo-controlled study of 220 patients with severe asthma given benralizumab every 4 weeks or every 8 weeks or a placebo between April 2014 and November 2015.
Disclosures: The study was sponsored by and designed in collaboration with AstraZeneca. All of the investigators reported having a financial or other type of relationship with AstraZeneca.