Internal Medicine News

Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

A version of this article first appeared on Medscape.com.

Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

A version of this article first appeared on Medscape.com.

Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

A version of this article first appeared on Medscape.com.

TOPLINE:

Black women in the United States have higher breast cancer (BC) mortality rates than White women across tumor subtypes. The greatest disparity in BC-specific survival was observed in those with hormone receptor-positive (HR+), human epidermal growth factor 2–negative (HER2−) tumors, with Black women having a 50% higher risk for death.

METHODOLOGY:

• US Black women have a 40% higher risk for death from BC than White women, and many cancer specialists believe that disparities are worse among more treatable subtypes, such as HR+ tumors.
• Researchers conducted a systematic review and meta-analysis of 18 US studies published during 2009-2022 that included 228,885 women (34,262 Black women; 182,466 White women) and examined racial differences in BC survival by subtype.
• The analysis included hormone receptor and HER2/neu status to define subtypes: HR+ HER2+, HR+ HER2−, HR− HER2+, and HR− HER2−.
• Random-effects models were used to generate pooled relative risks and 95% CI for BC-specific survival and overall survival.
• The primary outcome was BC-specific survival, with overall survival as a secondary analysis.

TAKEAWAY:

• Black women had a higher risk for BC death across all tumor subtypes than White women, with the greatest disparity observed in HR+ HER2− tumors (hazard ratio [HR], 1.50; 95% CI, 1.30-1.72).
• The risk for BC death was also higher for Black women with HR+ HER2+ tumors (HR, 1.34; 95% CI, 1.10-1.64); HR− HER2+ tumors (HR, 1.20; 95% CI, 1.00-1.43); and HR− HER2− tumors (HR, 1.17; 95% CI, 1.10-1.25).
• Overall survival was poorer for Black women across all subtypes, although estimates for HR− HER2+ tumors did not reach statistical significance.
• In analysis of two subtypes with significant heterogeneity among studies, adjustments for socioeconomic status and number of Black participants explained about half and all the variance for HR+ HER2− and HR− HER2+ tumors, respectively.

IN PRACTICE:

“These results suggest there are both subtype-specific and subtype-independent mechanisms that contribute to disparities in breast cancer survival between Black and White women, which require multilevel interventions to address and achieve health equity,” wrote the authors.

SOURCE:

The study was led by Juliana M. Torres, Dana-Farber/Harvard Cancer Center, CURE Program, Boston. It was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study’s limitations included potential heterogeneity between studies as indicated by significant heterogeneity in some analyses. The use of different subtype definitions and potential overlap in data sets may have also affected the results. Many included studies did not capture the extent to which treatments were completed or detection and treatment of recurrences. Additionally, the study’s findings may not fully capture socioeconomic inequality and other unmeasured factors contributing to disparities. The racial and ethnic disparities analysis focused only on Black and White women.

DISCLOSURES:

Individual authors disclosed financial relationships with Pfizer, Healthix, Merck, AstraZeneca, LabCorp, and Takeda. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Black women in the United States have higher breast cancer (BC) mortality rates than White women across tumor subtypes. The greatest disparity in BC-specific survival was observed in those with hormone receptor-positive (HR+), human epidermal growth factor 2–negative (HER2−) tumors, with Black women having a 50% higher risk for death.

METHODOLOGY:

• US Black women have a 40% higher risk for death from BC than White women, and many cancer specialists believe that disparities are worse among more treatable subtypes, such as HR+ tumors.
• Researchers conducted a systematic review and meta-analysis of 18 US studies published during 2009-2022 that included 228,885 women (34,262 Black women; 182,466 White women) and examined racial differences in BC survival by subtype.
• The analysis included hormone receptor and HER2/neu status to define subtypes: HR+ HER2+, HR+ HER2−, HR− HER2+, and HR− HER2−.
• Random-effects models were used to generate pooled relative risks and 95% CI for BC-specific survival and overall survival.
• The primary outcome was BC-specific survival, with overall survival as a secondary analysis.

TAKEAWAY:

• Black women had a higher risk for BC death across all tumor subtypes than White women, with the greatest disparity observed in HR+ HER2− tumors (hazard ratio [HR], 1.50; 95% CI, 1.30-1.72).
• The risk for BC death was also higher for Black women with HR+ HER2+ tumors (HR, 1.34; 95% CI, 1.10-1.64); HR− HER2+ tumors (HR, 1.20; 95% CI, 1.00-1.43); and HR− HER2− tumors (HR, 1.17; 95% CI, 1.10-1.25).
• Overall survival was poorer for Black women across all subtypes, although estimates for HR− HER2+ tumors did not reach statistical significance.
• In analysis of two subtypes with significant heterogeneity among studies, adjustments for socioeconomic status and number of Black participants explained about half and all the variance for HR+ HER2− and HR− HER2+ tumors, respectively.

IN PRACTICE:

“These results suggest there are both subtype-specific and subtype-independent mechanisms that contribute to disparities in breast cancer survival between Black and White women, which require multilevel interventions to address and achieve health equity,” wrote the authors.

SOURCE:

The study was led by Juliana M. Torres, Dana-Farber/Harvard Cancer Center, CURE Program, Boston. It was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study’s limitations included potential heterogeneity between studies as indicated by significant heterogeneity in some analyses. The use of different subtype definitions and potential overlap in data sets may have also affected the results. Many included studies did not capture the extent to which treatments were completed or detection and treatment of recurrences. Additionally, the study’s findings may not fully capture socioeconomic inequality and other unmeasured factors contributing to disparities. The racial and ethnic disparities analysis focused only on Black and White women.

DISCLOSURES:

Individual authors disclosed financial relationships with Pfizer, Healthix, Merck, AstraZeneca, LabCorp, and Takeda. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Black women in the United States have higher breast cancer (BC) mortality rates than White women across tumor subtypes. The greatest disparity in BC-specific survival was observed in those with hormone receptor-positive (HR+), human epidermal growth factor 2–negative (HER2−) tumors, with Black women having a 50% higher risk for death.

METHODOLOGY:

• US Black women have a 40% higher risk for death from BC than White women, and many cancer specialists believe that disparities are worse among more treatable subtypes, such as HR+ tumors.
• Researchers conducted a systematic review and meta-analysis of 18 US studies published during 2009-2022 that included 228,885 women (34,262 Black women; 182,466 White women) and examined racial differences in BC survival by subtype.
• The analysis included hormone receptor and HER2/neu status to define subtypes: HR+ HER2+, HR+ HER2−, HR− HER2+, and HR− HER2−.
• Random-effects models were used to generate pooled relative risks and 95% CI for BC-specific survival and overall survival.
• The primary outcome was BC-specific survival, with overall survival as a secondary analysis.

TAKEAWAY:

• Black women had a higher risk for BC death across all tumor subtypes than White women, with the greatest disparity observed in HR+ HER2− tumors (hazard ratio [HR], 1.50; 95% CI, 1.30-1.72).
• The risk for BC death was also higher for Black women with HR+ HER2+ tumors (HR, 1.34; 95% CI, 1.10-1.64); HR− HER2+ tumors (HR, 1.20; 95% CI, 1.00-1.43); and HR− HER2− tumors (HR, 1.17; 95% CI, 1.10-1.25).
• Overall survival was poorer for Black women across all subtypes, although estimates for HR− HER2+ tumors did not reach statistical significance.
• In analysis of two subtypes with significant heterogeneity among studies, adjustments for socioeconomic status and number of Black participants explained about half and all the variance for HR+ HER2− and HR− HER2+ tumors, respectively.

IN PRACTICE:

“These results suggest there are both subtype-specific and subtype-independent mechanisms that contribute to disparities in breast cancer survival between Black and White women, which require multilevel interventions to address and achieve health equity,” wrote the authors.

SOURCE:

The study was led by Juliana M. Torres, Dana-Farber/Harvard Cancer Center, CURE Program, Boston. It was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study’s limitations included potential heterogeneity between studies as indicated by significant heterogeneity in some analyses. The use of different subtype definitions and potential overlap in data sets may have also affected the results. Many included studies did not capture the extent to which treatments were completed or detection and treatment of recurrences. Additionally, the study’s findings may not fully capture socioeconomic inequality and other unmeasured factors contributing to disparities. The racial and ethnic disparities analysis focused only on Black and White women.

DISCLOSURES:

Individual authors disclosed financial relationships with Pfizer, Healthix, Merck, AstraZeneca, LabCorp, and Takeda. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved ribociclib (Kisqali, Novartis) in combination with an aromatase inhibitor for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stages II and III breast cancer at high risk for recurrence following surgery.

FDA also approved ribociclib and the aromatase inhibitor letrozole packaged together (Kisqali Femara Co-Pack, Novartis) for the same indication.

A rival cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib (Verzenio, Eli Lilly) carries a similar adjuvant indication, but use of this agent requires patients to be lymph node–positive.

There’s no such restriction for the new ribociclib indication, which “allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people,” lead investigator Dennis J. Slamon, MD, breast oncologist at the University of California Los Angeless, said in a Novartis press release.

The new indication joins ribociclib’s previous approval for advanced or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or fulvestrant.

The current approval was based on data from the NATALEE trial. NATALEE randomized 5101 patients with early-stage HR-positive, HER2-negative disease to either 400 mg ribociclib with an aromatase inhibitor or to an aromatase inhibitor alone following surgery. 

Invasive disease-free survival at 36 months was 90.7% in the ribociclib arm vs 87.6% with aromatase inhibitor monotherapy (hazard ratio [HR], 0.749; P = .0006). The trial included patients with and without lymph node involvement.

At 4 years (well beyond NATALEE’s 3-year treatment window), the ribociclib group continued to do better, with an invasive disease-free survival rate of 88.5% vs 83.6% in the control arm.

Overall survival data remain immature but with a trend towards improved survival in the ribociclib arm (HR, 0.715; P < .0001), according to a recent report from the 2024 European Society for Medical Oncology Congress.

There were no new safety signals in the trial. Adverse events in the ribociclib group included neutropenia (62.5% overall; 44.3% grade 3/4), liver-related events (26.4% overall; 8.6% grade 3/4), QT prolongation (5.3% overall; 1.0% grade 3/4), and interstitial lung disease/pneumonitis (1.5% overall; 0.0% grade 3/4), according to Novartis.

Ribociclib dosing for the adjuvant indication is lower than for metastatic disease, but patients are on the same schedule — two 200 mg tablets once daily for 21 days followed by 7 days off in 28-day cycles. Treatment continues for 3 years.

Forty-two 200 mg tablets cost about $15,000, according to drugs.com. A patient assistance program is available through Novartis.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved ribociclib (Kisqali, Novartis) in combination with an aromatase inhibitor for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stages II and III breast cancer at high risk for recurrence following surgery.

FDA also approved ribociclib and the aromatase inhibitor letrozole packaged together (Kisqali Femara Co-Pack, Novartis) for the same indication.

A rival cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib (Verzenio, Eli Lilly) carries a similar adjuvant indication, but use of this agent requires patients to be lymph node–positive.

There’s no such restriction for the new ribociclib indication, which “allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people,” lead investigator Dennis J. Slamon, MD, breast oncologist at the University of California Los Angeless, said in a Novartis press release.

The new indication joins ribociclib’s previous approval for advanced or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or fulvestrant.

The current approval was based on data from the NATALEE trial. NATALEE randomized 5101 patients with early-stage HR-positive, HER2-negative disease to either 400 mg ribociclib with an aromatase inhibitor or to an aromatase inhibitor alone following surgery. 

Invasive disease-free survival at 36 months was 90.7% in the ribociclib arm vs 87.6% with aromatase inhibitor monotherapy (hazard ratio [HR], 0.749; P = .0006). The trial included patients with and without lymph node involvement.

At 4 years (well beyond NATALEE’s 3-year treatment window), the ribociclib group continued to do better, with an invasive disease-free survival rate of 88.5% vs 83.6% in the control arm.

Overall survival data remain immature but with a trend towards improved survival in the ribociclib arm (HR, 0.715; P < .0001), according to a recent report from the 2024 European Society for Medical Oncology Congress.

There were no new safety signals in the trial. Adverse events in the ribociclib group included neutropenia (62.5% overall; 44.3% grade 3/4), liver-related events (26.4% overall; 8.6% grade 3/4), QT prolongation (5.3% overall; 1.0% grade 3/4), and interstitial lung disease/pneumonitis (1.5% overall; 0.0% grade 3/4), according to Novartis.

Ribociclib dosing for the adjuvant indication is lower than for metastatic disease, but patients are on the same schedule — two 200 mg tablets once daily for 21 days followed by 7 days off in 28-day cycles. Treatment continues for 3 years.

Forty-two 200 mg tablets cost about $15,000, according to drugs.com. A patient assistance program is available through Novartis.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved ribociclib (Kisqali, Novartis) in combination with an aromatase inhibitor for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stages II and III breast cancer at high risk for recurrence following surgery.

FDA also approved ribociclib and the aromatase inhibitor letrozole packaged together (Kisqali Femara Co-Pack, Novartis) for the same indication.

A rival cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib (Verzenio, Eli Lilly) carries a similar adjuvant indication, but use of this agent requires patients to be lymph node–positive.

There’s no such restriction for the new ribociclib indication, which “allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people,” lead investigator Dennis J. Slamon, MD, breast oncologist at the University of California Los Angeless, said in a Novartis press release.

The new indication joins ribociclib’s previous approval for advanced or metastatic HR-positive, HER2-negative breast cancer in combination with an aromatase inhibitor or fulvestrant.

The current approval was based on data from the NATALEE trial. NATALEE randomized 5101 patients with early-stage HR-positive, HER2-negative disease to either 400 mg ribociclib with an aromatase inhibitor or to an aromatase inhibitor alone following surgery. 

Invasive disease-free survival at 36 months was 90.7% in the ribociclib arm vs 87.6% with aromatase inhibitor monotherapy (hazard ratio [HR], 0.749; P = .0006). The trial included patients with and without lymph node involvement.

At 4 years (well beyond NATALEE’s 3-year treatment window), the ribociclib group continued to do better, with an invasive disease-free survival rate of 88.5% vs 83.6% in the control arm.

Overall survival data remain immature but with a trend towards improved survival in the ribociclib arm (HR, 0.715; P < .0001), according to a recent report from the 2024 European Society for Medical Oncology Congress.

There were no new safety signals in the trial. Adverse events in the ribociclib group included neutropenia (62.5% overall; 44.3% grade 3/4), liver-related events (26.4% overall; 8.6% grade 3/4), QT prolongation (5.3% overall; 1.0% grade 3/4), and interstitial lung disease/pneumonitis (1.5% overall; 0.0% grade 3/4), according to Novartis.

Ribociclib dosing for the adjuvant indication is lower than for metastatic disease, but patients are on the same schedule — two 200 mg tablets once daily for 21 days followed by 7 days off in 28-day cycles. Treatment continues for 3 years.

Forty-two 200 mg tablets cost about $15,000, according to drugs.com. A patient assistance program is available through Novartis.
 

A version of this article appeared on Medscape.com.

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

An epilepsy drug sold in Europe as Ospolot and also known as sulthiame showed promise in reducing sleep disordered breathing and other symptoms of obstructive sleep apnea (OSA), based on data from nearly 300 individuals presented in a late-breaking study at the annual congress of the European Respiratory Society.

“Current therapies are mechanical and based on the notion of an airway splint,” presenting author Jan Hedner, MD, professor of respiratory medicine at Sahlgrenska University Hospital and the University of Gothenburg, both in Sweden, said in an interview. “In other words, applying an airflow at elevated pressure [continuous positive airway pressure] or advancing the jaw with a dental device. Adherence to this type of therapy is limited. In the case of continuous positive airway pressure [CPAP], it is < 50% after 3-4 years of therapy.” Therefore, there is a need for a better-tolerated therapy, such as a drug, and possibly a combination of mechanical and pharmaceutical therapies.

The use of medication has emerged as a viable option for OSA, with a high rate of compliance and acceptable safety profile, Dr. Hedner said in his presentation.

“Modified carbonic anhydrase activity may be a pathophysiological mechanism in OSA,” said Dr. Hedner. Sulthiame, a carbonic anhydrase inhibitor, showed safety and effectiveness for improving OSA in a previous phase 2b trial.

In the current study, the researchers sought to determine the most effective dose of sulthiame for patients with OSA. They randomized 298 adults with OSA who could not accept or tolerate oral splints or CPAP to 100 mg, 200 mg, or 300 mg of sulthiame daily (74, 74, and 75 patients, respectively) or placebo (75 patients).

The mean age of the patients was 56 years, 26.2% were women, and the average apnea-hypopnea index (AHI3a) at baseline was 29 n/h. Patients were treated at centers in Spain, France, Belgium, Germany, and the Czech Republic. Baseline demographics and clinical characteristics were similar among the treatment groups.

The primary endpoint was the change in AHI3a from baseline to 15 weeks, and significant changes occurred in patients who received the 100-mg, 200-mg, and 300-mg doses, with decreases of 17.8%, 34.8%, and 39.9%, respectively.

Peak efficacy occurred in the range of 200-300 mg and was similar for patients with moderate or severe OSA, Dr. Hedner said in his presentation.

Notably, in a post hoc analysis, apnea improved by 47.1% at a 300-mg dose when the AHI4 measure (apnea/hypopnea with ≥ 4% O₂ desaturation) was used in a placebo-adjusted dose-dependent reduction, the researchers wrote. The changes in AHI4 from baseline in this analysis also were significant for 200 mg and 100 mg doses (36.8% and 26.2%, respectively).

Patients underwent polysomnography at baseline and at weeks 4 and 12.

Mean overnight oxygen saturation also improved significantly from baseline with doses of 200 mg and 300 mg, compared with placebo (P < .0001 for both).

In addition, scores on the Epworth Sleepiness Scale (ESS) improved from baseline to week 15 in all dosage groups, and the subgroup of patients with ESS scores of ≥ 11 at baseline showed even greater improvement in ESS, Dr. Hedner said in his presentation.

Total arousal index and sleep quality also improved from baseline compared with placebo, and no clinically relevant reduction in REM sleep was noted, Dr. Hedner added.

Treatment-emergent adverse events were in line with the known safety profile of sulthiame and included paresthesia, headache, fatigue, and nausea; these were mainly moderate and dose-dependent, with no evidence of cardiovascular safety issues, he said.

Although the study results were not surprising given previous research, the investigators were pleased with the potency of the therapy. “We are also happy about potential added values such as a blood pressure lowering effect, which is beneficial in this group of patients; however, we need to further study these mechanisms in detail,” Dr. Hedner noted.

The study findings were limited by the relatively small scale, and larger studies on long-term efficacy and tolerability are also needed, he said.

“The current study was a dose-finding study, and we now have useful information on most suitable dose,” he said.

However, the results support sulthiame as an effective, well-tolerated, and promising novel candidate for drug therapy in patients with OSA, worthy of phase 3 studies, Dr. Hedner said.
 

Oral Option Could Be Game-Changer, But Not Yet

The gold standard of treatment for OSA is a CPAP machine, but the effectiveness is limited by patient tolerance, Q. Afifa Shamim-Uzzaman, MD, an associate professor and a sleep medicine specialist at the University of Michigan, Ann Arbor, said in an interview.

“Presently, there are no effective pharmacological treatments for OSA — having a pill that treats OSA would be a total game changer and huge advance for the treatment of OSA and the field of sleep medicine,” said Dr. Shamim-Uzzaman, who was not involved in the study. “More patients may be able to obtain treatment for OSA and thereby reduce the potential complications of untreated OSA.

“Carbonic anhydrase inhibitors such as acetazolamide and sulthiame have been studied with limited success for the treatment of other forms of sleep disordered breathing such as central sleep apnea [CSA] but have shown less efficacy for OSA and are presently not recommended in the treatment of OSA by the American Academy of Sleep Medicine,” Dr. Shamim-Uzzaman said.

Recently, emerging evidence about different phenotypes of OSA suggests that nonanatomic features (such as high loop gain) may play a role in patients with OSA, not only in those with CSA, she said. Whether carbonic anhydrase inhibitors could play a greater role in treating sleep apnea in patients with predominantly nonanatomic pathophysiologic traits remains to be seen.

The sulthiame data are promising, but more research is needed, Dr. Shamim-Uzzaman said. Although patients in the highest dose group showed a reduction in AHI of nearly 40%, they still would have moderate OSA, and the OSA did not appear to decrease to a normal range in any of the treatment groups.

“More research is needed to identify which types of patients would be responders to this form of therapy, to understand if these effects are maintained long term (beyond 15 weeks), to evaluate patient-centered outcomes, especially in different sleep apnea subgroups (such as phenotypes with high loop gain vs those without), and to assess interactions with other therapies,” she said.

The study was supported by manufacturer Desitin. Dr. Hedner disclosed serving as a consultant to AstraZeneca, Bayer, CereusScience, Jazz Pharmaceuticals, MSD, Weinmann, Desitin, SomnoMed, and Itamar Medical; serving on the speakers’ bureau for Almirall, AstraZeneca, Jazz Pharmaceuticals, ResMed, Philips Respironics, and Weinmann; and receiving grants or research support from Bayer, ResMed, Philips Respironics, and SomnoMed. He also disclosed shared ownership of intellectual property related to sleep apnea therapy. Dr. Shamim-Uzzaman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

HUNTINGTON BEACH, CALIFORNIA — If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

HUNTINGTON BEACH, CALIFORNIA — If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

HUNTINGTON BEACH, CALIFORNIA — If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

Whooping cough is surging in the United States, with four times as many cases reported so far this year, compared to all of 2023. 

The CDC said 14,569 cases had been reported as of Sept. 14, compared to 3475 in all of 2023. 

There were 291 new cases reported for the week ending Sept. 14, with New York having the most cases, 44, followed by Ohio, Pennsylvania, and Oklahoma with 38 each. That’s the most cases in a single week since 2015.

Whooping cough, also called pertussis, is a respiratory illness spread through coughing, sneezing, or breathing very close to another person. Babies are given the DTaP vaccine to protect against whooping cough, diphtheria, and tetanus. Because the vaccine effectiveness wanes faster for whooping cough than the two other illnesses, boosters are recommended every decade or so.
 

Why the Whooping Cough Vaccine Is Important

Whooping cough is a very contagious bacteria, so vaccination is an important step to avoid it.

But many children in their tweens aren’t getting boosters, and that age group is driving the whooping cough outbreak.

“With the increase in vaccine hesitancy that has been going on since the COVID-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” Tina Tan, MD, president-elect of the Infectious Diseases Society of America, told NBC News.

Also, people are not social distancing the way they did during the height of the COVID pandemic, when whooping cough numbers went down.

“Levels of pertussis dropped dramatically when we were all masking, and now this huge increase is getting us back to pre-pandemic levels, and probably a little above that,” Thomas Murray, MD, a Yale Medicine pediatric infectious diseases specialist, said in a news release from the school. “It’s a contagious respiratory virus that can spread fairly quickly through the population.”

FDA advisers were scheduled to meet Sept. 20 to discuss developing more effective boosters for whooping cough.
 

A version of this article appeared on WebMD.com.

Whooping cough is surging in the United States, with four times as many cases reported so far this year, compared to all of 2023. 

The CDC said 14,569 cases had been reported as of Sept. 14, compared to 3475 in all of 2023. 

There were 291 new cases reported for the week ending Sept. 14, with New York having the most cases, 44, followed by Ohio, Pennsylvania, and Oklahoma with 38 each. That’s the most cases in a single week since 2015.

Whooping cough, also called pertussis, is a respiratory illness spread through coughing, sneezing, or breathing very close to another person. Babies are given the DTaP vaccine to protect against whooping cough, diphtheria, and tetanus. Because the vaccine effectiveness wanes faster for whooping cough than the two other illnesses, boosters are recommended every decade or so.
 

Why the Whooping Cough Vaccine Is Important

Whooping cough is a very contagious bacteria, so vaccination is an important step to avoid it.

But many children in their tweens aren’t getting boosters, and that age group is driving the whooping cough outbreak.

“With the increase in vaccine hesitancy that has been going on since the COVID-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” Tina Tan, MD, president-elect of the Infectious Diseases Society of America, told NBC News.

Also, people are not social distancing the way they did during the height of the COVID pandemic, when whooping cough numbers went down.

“Levels of pertussis dropped dramatically when we were all masking, and now this huge increase is getting us back to pre-pandemic levels, and probably a little above that,” Thomas Murray, MD, a Yale Medicine pediatric infectious diseases specialist, said in a news release from the school. “It’s a contagious respiratory virus that can spread fairly quickly through the population.”

FDA advisers were scheduled to meet Sept. 20 to discuss developing more effective boosters for whooping cough.
 

A version of this article appeared on WebMD.com.

Whooping cough is surging in the United States, with four times as many cases reported so far this year, compared to all of 2023. 

The CDC said 14,569 cases had been reported as of Sept. 14, compared to 3475 in all of 2023. 

There were 291 new cases reported for the week ending Sept. 14, with New York having the most cases, 44, followed by Ohio, Pennsylvania, and Oklahoma with 38 each. That’s the most cases in a single week since 2015.

Whooping cough, also called pertussis, is a respiratory illness spread through coughing, sneezing, or breathing very close to another person. Babies are given the DTaP vaccine to protect against whooping cough, diphtheria, and tetanus. Because the vaccine effectiveness wanes faster for whooping cough than the two other illnesses, boosters are recommended every decade or so.
 

Why the Whooping Cough Vaccine Is Important

Whooping cough is a very contagious bacteria, so vaccination is an important step to avoid it.

But many children in their tweens aren’t getting boosters, and that age group is driving the whooping cough outbreak.

“With the increase in vaccine hesitancy that has been going on since the COVID-19 pandemic, we’re seeing outbreaks occurring in kids who are not vaccinated,” Tina Tan, MD, president-elect of the Infectious Diseases Society of America, told NBC News.

Also, people are not social distancing the way they did during the height of the COVID pandemic, when whooping cough numbers went down.

“Levels of pertussis dropped dramatically when we were all masking, and now this huge increase is getting us back to pre-pandemic levels, and probably a little above that,” Thomas Murray, MD, a Yale Medicine pediatric infectious diseases specialist, said in a news release from the school. “It’s a contagious respiratory virus that can spread fairly quickly through the population.”

FDA advisers were scheduled to meet Sept. 20 to discuss developing more effective boosters for whooping cough.
 

A version of this article appeared on WebMD.com.