Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.

In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.

“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

‘Alarming’ rates of exposure

Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.

Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”

These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.

Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.

To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.

Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.

Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.

This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.

The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.

“These results tell me these individuals are exposed to high levels of violence in their lifetime, which should be alarming,” said Dr. Motley.
 

Protectors or predators?

To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.

Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.

For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.

Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.

Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.

Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.

Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”

These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”

Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.

This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.

It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.

Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”

“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.

“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.

The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.

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

Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.

In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.

“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

‘Alarming’ rates of exposure

Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.

Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”

These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.

Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.

To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.

Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.

Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.

This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.

The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.

“These results tell me these individuals are exposed to high levels of violence in their lifetime, which should be alarming,” said Dr. Motley.
 

Protectors or predators?

To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.

Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.

For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.

Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.

Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.

Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.

Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”

These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”

Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.

This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.

It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.

Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”

“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.

“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.

The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.

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

Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.

In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.

“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

‘Alarming’ rates of exposure

Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.

Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”

These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.

Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.

To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.

Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.

Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.

This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.

The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.

“These results tell me these individuals are exposed to high levels of violence in their lifetime, which should be alarming,” said Dr. Motley.
 

Protectors or predators?

To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.

Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.

For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.

Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.

Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.

Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.

Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”

These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”

Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.

This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.

It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.

Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”

“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.

“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.

The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.

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

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

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

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

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

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

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

The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

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

The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

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

The Food and Drug Administration has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, deputy director of the division of cardiology and nephrology at the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction, based on results of the DAPA-HF trial.

This new approval in chronic kidney disease was based on results of the DAPA-CKD trial that was stopped early in March 2020 because of efficacy of the treatment.

DAPA-CKD randomly assigned 4,304 patients with CKD but without diabetes to receive either dapagliflozin or placebo. The full study results, reported at the 2020 annual congress of the European Society of Cardiology and simultaneously published in the New England Journal of Medicine, showed that, during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction, compared with placebo in the study’s primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate, compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death.

Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization.

“Farxiga was not studied, nor is expected to be effective, in treating chronic kidney disease among patients with autosomal dominant or recessive polycystic (characterized by multiple cysts) kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease,” the FDA statement noted.

Dapagliflozin should not be used by patients with a history of serious hypersensitivity reactions to this medication, or who are on dialysis, the agency added. “Serious, life-threatening cases of Fournier’s Gangrene have occurred in patients with diabetes taking Farxiga.”

Patients should consider taking a lower dose of insulin or insulin secretagogue to reduce hypoglycemic risk if they are also taking dapagliflozin. Treatment can also cause dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis, the announcement said. “Patients should be assessed for their volume status and kidney function before starting Farxiga.”

Dapagliflozin previously received Fast Track, Breakthrough Therapy, and Priority Review designations for this new indication.

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

Human leukocyte antigen (HLA)-mismatched hematopoetic stem cell microtransplantation (MST) has previously been evaluated in AML in combination with chemotherapy and suggests potential improvement in outcomes. Li et al evaluated MST combined with decitabine in patients with intermediate or high risk MDS compared to decitabine alone.  Out of 22 patients in the study, the cohort that received MST with decitabine had higher median OS (24 vs 14.2 months, p=0.04), although there was no statistical significant difference in overall response rate. There was no reported graft vs host disease, and adverse events were similar between the two groups. The main limitation of the study was the very small sample size; further prospective studies utilizing MST in MDS are needed to demonstrate benefit.

MDS patients often present with neutropenia and develop worsening neutropenia due to myelosuppression from HMA therapy, resulting in increased risk of infections including invasive fungal infection (IFI). Tey et al reported a retrospective analysis of the rate of IFI in patients with MDS or low blast count AML receiving azacitidine. Out of 117 patients, 61% received antifungal prophylaxis, either with posaconazole (n=70) or voriconazole (n=1). The IFI rate was 7.7% in the cohort with median time of onset of 74 days from start of azacitidine treatment (range 1-226); the IFI rate did not differ statistically between those receiving prophylaxis vs not (5.6% vs 10.9%, p=0.30). However, presence of neutropenia at three months of treatment was associated with increased IFI risk (HR 8.29, p=0.01), and IFI was associated with increased mortality in a multivariate analysis (HR 8.37, p<0.0001). Anti-fungal prophylaxis is currently standard practice for MDS patients who present or develop neutropenia; however, HMA treatment is associated with prolonged neutropenia due to myelosuppression and time to response. A more effective therapy with less myelosuppression is needed for treatment of MDS.

Human leukocyte antigen (HLA)-mismatched hematopoetic stem cell microtransplantation (MST) has previously been evaluated in AML in combination with chemotherapy and suggests potential improvement in outcomes. Li et al evaluated MST combined with decitabine in patients with intermediate or high risk MDS compared to decitabine alone.  Out of 22 patients in the study, the cohort that received MST with decitabine had higher median OS (24 vs 14.2 months, p=0.04), although there was no statistical significant difference in overall response rate. There was no reported graft vs host disease, and adverse events were similar between the two groups. The main limitation of the study was the very small sample size; further prospective studies utilizing MST in MDS are needed to demonstrate benefit.

MDS patients often present with neutropenia and develop worsening neutropenia due to myelosuppression from HMA therapy, resulting in increased risk of infections including invasive fungal infection (IFI). Tey et al reported a retrospective analysis of the rate of IFI in patients with MDS or low blast count AML receiving azacitidine. Out of 117 patients, 61% received antifungal prophylaxis, either with posaconazole (n=70) or voriconazole (n=1). The IFI rate was 7.7% in the cohort with median time of onset of 74 days from start of azacitidine treatment (range 1-226); the IFI rate did not differ statistically between those receiving prophylaxis vs not (5.6% vs 10.9%, p=0.30). However, presence of neutropenia at three months of treatment was associated with increased IFI risk (HR 8.29, p=0.01), and IFI was associated with increased mortality in a multivariate analysis (HR 8.37, p<0.0001). Anti-fungal prophylaxis is currently standard practice for MDS patients who present or develop neutropenia; however, HMA treatment is associated with prolonged neutropenia due to myelosuppression and time to response. A more effective therapy with less myelosuppression is needed for treatment of MDS.

Human leukocyte antigen (HLA)-mismatched hematopoetic stem cell microtransplantation (MST) has previously been evaluated in AML in combination with chemotherapy and suggests potential improvement in outcomes. Li et al evaluated MST combined with decitabine in patients with intermediate or high risk MDS compared to decitabine alone.  Out of 22 patients in the study, the cohort that received MST with decitabine had higher median OS (24 vs 14.2 months, p=0.04), although there was no statistical significant difference in overall response rate. There was no reported graft vs host disease, and adverse events were similar between the two groups. The main limitation of the study was the very small sample size; further prospective studies utilizing MST in MDS are needed to demonstrate benefit.

MDS patients often present with neutropenia and develop worsening neutropenia due to myelosuppression from HMA therapy, resulting in increased risk of infections including invasive fungal infection (IFI). Tey et al reported a retrospective analysis of the rate of IFI in patients with MDS or low blast count AML receiving azacitidine. Out of 117 patients, 61% received antifungal prophylaxis, either with posaconazole (n=70) or voriconazole (n=1). The IFI rate was 7.7% in the cohort with median time of onset of 74 days from start of azacitidine treatment (range 1-226); the IFI rate did not differ statistically between those receiving prophylaxis vs not (5.6% vs 10.9%, p=0.30). However, presence of neutropenia at three months of treatment was associated with increased IFI risk (HR 8.29, p=0.01), and IFI was associated with increased mortality in a multivariate analysis (HR 8.37, p<0.0001). Anti-fungal prophylaxis is currently standard practice for MDS patients who present or develop neutropenia; however, HMA treatment is associated with prolonged neutropenia due to myelosuppression and time to response. A more effective therapy with less myelosuppression is needed for treatment of MDS.

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

The Food and Drug Administration has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Olivier Le Moal/Getty Images

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Dr. Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals noted that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period of 2013-2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members – as well as the public health community – with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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

Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.

Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.

Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.