MDedge Rheumatology

Here are the stories our MDedge editors across specialties think you need to know about today:

Comorbidities increase COVID-19 deaths by factor of 12

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the CDC.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females.

The pandemic “continues to affect all populations and result in severe outcomes including death,” noted the CDC, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.” Read more.

Preventive services coalition recommends routine anxiety screening for women

Women and girls aged 13 years and older with no current diagnosis of anxiety should be screened routinely for anxiety, according to a new recommendation from the Women’s Preventive Services Initiative.

The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault.

“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.” Read more.

High-fat, high-sugar diet may promote adult acne

A diet higher in fat, sugar, and milk was associated with having acne in a cross-sectional study of approximately 24,000 adults in France.

Although acne patients may believe that eating certain foods exacerbates acne, data on the effects of nutrition on acne, including associations between acne and a high-glycemic diet, are limited and have produced conflicting results, noted investigators.

“The results of our study appear to support the hypothesis that the Western diet (rich in animal products and fatty and sugary foods) is associated with the presence of acne in adulthood,” the researchers concluded.
 

Population study supports migraine-dementia link

Preliminary results from a population-based cohort study support previous reports that migraine is a midlife risk factor for dementia later in life, but further determined that migraine with aura and frequent hospital contacts significantly increased dementia risk after age 60 years, according to results from a Danish registry presented at the virtual annual meeting of the American Headache Society.

The preliminary findings revealed that the median age at diagnosis was 49 years and about 70% of the migraine population were women. “There was a 50% higher dementia rate in individuals who had any migraine diagnosis,” Dr. Islamoska said.

“To the best of our knowledge, no previous national register–based studies have investigated the risk of dementia among individuals who suffer from migraine with aura,” Dr. Sabrina Islamoska said.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Comorbidities increase COVID-19 deaths by factor of 12

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the CDC.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females.

The pandemic “continues to affect all populations and result in severe outcomes including death,” noted the CDC, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.” Read more.

Preventive services coalition recommends routine anxiety screening for women

Women and girls aged 13 years and older with no current diagnosis of anxiety should be screened routinely for anxiety, according to a new recommendation from the Women’s Preventive Services Initiative.

The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault.

“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.” Read more.

High-fat, high-sugar diet may promote adult acne

A diet higher in fat, sugar, and milk was associated with having acne in a cross-sectional study of approximately 24,000 adults in France.

Although acne patients may believe that eating certain foods exacerbates acne, data on the effects of nutrition on acne, including associations between acne and a high-glycemic diet, are limited and have produced conflicting results, noted investigators.

“The results of our study appear to support the hypothesis that the Western diet (rich in animal products and fatty and sugary foods) is associated with the presence of acne in adulthood,” the researchers concluded.
 

Population study supports migraine-dementia link

Preliminary results from a population-based cohort study support previous reports that migraine is a midlife risk factor for dementia later in life, but further determined that migraine with aura and frequent hospital contacts significantly increased dementia risk after age 60 years, according to results from a Danish registry presented at the virtual annual meeting of the American Headache Society.

The preliminary findings revealed that the median age at diagnosis was 49 years and about 70% of the migraine population were women. “There was a 50% higher dementia rate in individuals who had any migraine diagnosis,” Dr. Islamoska said.

“To the best of our knowledge, no previous national register–based studies have investigated the risk of dementia among individuals who suffer from migraine with aura,” Dr. Sabrina Islamoska said.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Comorbidities increase COVID-19 deaths by factor of 12

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the CDC.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females.

The pandemic “continues to affect all populations and result in severe outcomes including death,” noted the CDC, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.” Read more.

Preventive services coalition recommends routine anxiety screening for women

Women and girls aged 13 years and older with no current diagnosis of anxiety should be screened routinely for anxiety, according to a new recommendation from the Women’s Preventive Services Initiative.

The lifetime prevalence of anxiety disorders in women in the United States is 40%, approximately twice that of men, and anxiety can be a manifestation of underlying issues including posttraumatic stress, sexual harassment, and assault.

“The WPSI based its rationale for anxiety screening on several considerations,” the researchers noted. “Anxiety disorders are the most prevalent mental health disorders in women, and the problems created by untreated anxiety can impair function in all areas of a woman’s life.” Read more.

High-fat, high-sugar diet may promote adult acne

A diet higher in fat, sugar, and milk was associated with having acne in a cross-sectional study of approximately 24,000 adults in France.

Although acne patients may believe that eating certain foods exacerbates acne, data on the effects of nutrition on acne, including associations between acne and a high-glycemic diet, are limited and have produced conflicting results, noted investigators.

“The results of our study appear to support the hypothesis that the Western diet (rich in animal products and fatty and sugary foods) is associated with the presence of acne in adulthood,” the researchers concluded.
 

Population study supports migraine-dementia link

Preliminary results from a population-based cohort study support previous reports that migraine is a midlife risk factor for dementia later in life, but further determined that migraine with aura and frequent hospital contacts significantly increased dementia risk after age 60 years, according to results from a Danish registry presented at the virtual annual meeting of the American Headache Society.

The preliminary findings revealed that the median age at diagnosis was 49 years and about 70% of the migraine population were women. “There was a 50% higher dementia rate in individuals who had any migraine diagnosis,” Dr. Islamoska said.

“To the best of our knowledge, no previous national register–based studies have investigated the risk of dementia among individuals who suffer from migraine with aura,” Dr. Sabrina Islamoska said.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.

FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.

A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.

The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.

Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

lfranki@mdedge.com

The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.

FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.

A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.

The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.

Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

lfranki@mdedge.com

The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis.

FDA approval was based on results of the 2-year PREVENT trial, a randomized, double-blind, placebo-controlled, phase 3 study in 555 adults with active nr-axSpA who received a loading dose of 150 mg secukinumab subcutaneously weekly for 4 weeks, then maintenance dosing with 150 mg secukinumab monthly; 150 mg secukinumab monthly with no loading dose; or placebo. Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index, had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor (TNF) inhibitor or had an inadequate response to no more than one TNF inhibitor. A total of 501 patients had not previously taken a biologic medication.

A significantly greater proportion of biologic-naive patients taking secukinumab in both active treatment arm met the trial’s primary endpoint of at least a 40% improvement in the Assessment of Spondyloarthritis International Society response criteria versus placebo after 52 weeks. Both loading and nonloading arms saw significant improvements in Ankylosing Spondylitis Quality of Life scores, compared with those in the placebo group.

The safety profile of secukinumab in PREVENT was shown to be consistent with previous clinical trials, with no new safety signals detected.

Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, also received European Medicines Agency approval for the treatment of nr-axSpA in April 2020. It is already approved by the FDA for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

lfranki@mdedge.com

The global COVID-19 pandemic has escalated everyone’s stress levels, especially clinicians caring for hospitalized patients. New pressures have added to everyday stress, new studies have revised prior patient care recommendations, and the world generally seems upside down. What can a busy hospitalist do to maintain a modicum of sanity in all the craziness?

The stressors facing hospitalists

Uncertainty

Of all the burdens COVID-19 has unleashed, the biggest may be uncertainty. Not only is there unease about the virus itself, there also is legitimate concern about the future of medicine, said Elizabeth Harry, MD, SFHM, a hospitalist and senior director of clinical affairs at the University of Colorado Hospital in Aurora.

“What does it look like after an event like this, particularly in areas like academic medicine and teaching our next generation and getting funding for research? And how do we continue to produce physicians that can provide excellent care?” she asked.

There is also uncertainty in the best way to care for patients, said Eileen Barrett, MD, MPH, SFHM, a hospitalist at the University of New Mexico, Albuquerque.

“There are some models that are emerging to predict who will have a worse outcome, but they’re still not great models, so we have uncertainty for a given patient.” And, she noted, as the science continues to evolve, there exists a constant worry that “you might have inadvertently caused someone harm.”

The financial implications of the pandemic are creating uncertainty too. “When you fund a health care system with elective procedures and you can’t do those, and instead have to shift to the most essential services, a lot of places are seeing a massive deficit, which is going to affect staff morale and some physician offices are going to close,” said Elisabeth Poorman, MD, MPH, a primary care and internal medicine physician and chair of the King County Medical Society Physician Wellness Committee in Seattle.
 

Fear

When the pandemic began in the United States, “fear of the unknown was perhaps the scariest part, particularly as it pertained to personal protective equipment,” said Mark Rudolph, MD, SFHM, chief experience officer and vice president of patient experience and physician development at Sound Physicians in Tacoma, Wash. “For most clinicians, this is the first time that they are themselves in harm’s way while they do their jobs. And worse, they risk bringing the virus home to their families. That is the concern I hear most.”

Anxiety

Worrying about being able to provide excellent patient care is a big stressor, especially since this is the heart and soul of why most hospitalists have gone into their line of work.

“Part of providing excellent care to your patients is providing excellent supportive care to their families,” Dr. Harry said. “There’s some dissonance there in not being able to allow the family to come visit, but wanting to keep them safe, and it feels really hard to support your patients and support their families in the best way. It can feel like you’re just watching and waiting to see what will happen, and that we don’t have a lot of agency over which direction things take.”

There is concern for health care team members as well, Dr. Harry added. “Physicians care a lot about their teams and how they’re doing. I think there’s a sense of esprit de corps among folks and worry for each other there.”
 

Guilt

Although you may be at the hospital all day, you may feel guilty when you are not providing direct patient care. Or maybe you or someone on your team has an immunodeficiency and can’t be on the front line. Perhaps one of your team members contracted COVID-19 and you did not. Whatever the case, guilt is another emotion that is rampant among hospitalists right now, Dr. Barrett said.

Burnout

Unfortunately, burnout is a potential reality in times of high stress. “Burnout is dynamic,” said Dr. Poorman. “It’s a process by which your emotional and cognitive reserves are exhausted. The people with the highest burnout are the ones who are still trying to provide the standard of care, or above the standard of care in dysfunctional systems.”

Dr. Harry noted that burnout presents in different ways for different people, but Dr. Rudolph added that it’s crucial for hospitalist team members to watch for signs of burnout so they can intervene and/or get help for their colleagues.

Warning signs in yourself or others that burnout could be on the horizon include:

• Fatigue/exhaustion – Whether emotional or physical (or both), this can become a problem if it “just doesn’t seem to go away despite rest and time away from work,” said Dr. Rudolph.
• Behavioral changes – Any behavior that’s out of the ordinary may be a red flag, like lashing out at someone at work.
• Overwork – Working too much can be caused by an inability to let go of patient care, Dr. Barrett said.
• Not working enough – This may include avoiding tasks and having difficulty meeting deadlines.
• Maladaptive coping behaviors – Excessive consumption of alcohol or drugs is a common coping mechanism. “Even excessive consumption of news is something that people are using to numb out a little bit,” said Dr. Harry.
• Depersonalization – “This is where you start to look at patients, colleagues, or administrators as ‘them’ and you can’t connect as deeply,” Dr. Harry said. “Part of that’s protective and a normal thing to do during a big trauma like this, but it’s also incredibly distancing. Any language that people start using that feels like ‘us’ or ‘them’ is a warning sign.”
• Disengagement – Many people disengage from their work, but Dr. Poorman said physicians tend to disengage from other parts of their lives, such as exercise and family interaction.

Protecting yourself while supporting others

Like the illustration of putting the oxygen mask on yourself first so you can help others, it’s important to protect your own mental and physical health as you support your fellow physicians. Here’s what the experts suggest.

Focus on basic needs

“When you’re in the midst of a trauma, which we are, you don’t want to open all of that up and go to the depths of your thoughts about the grief of all of it because it can actually make the trauma worse,” said Dr. Harry. “There’s a lot of literature that debriefing is really helpful after the event, but if you do it during the event, it can be really dangerous.”

Instead, she said, the goal should be focusing on your basic needs and what you need to do to get through each day, like keeping you and your family in good health. “What is your purpose? Staying connected to why you do this and staying focused on the present is really important,” Dr. Harry noted.

Do your best to get a good night’s sleep, exercise as much as you can, talk to others, and see a mental health provider if your anxiety is too high, advises Dr. Barrett. “Even avoiding blue light from phones and screens within 2 hours of bedtime, parking further away from the hospital and walking, and taking the stairs are things that add up in a big way.”
 

Keep up your normal routine

“Right now, it’s really critical for clinicians to keep up components of their routine that feel ‘normal,’ ” Dr. Rudolph said. “Whether it’s exercise, playing board games with their kids, or spending time on a hobby, it’s critical to allow yourself these comfortable, predictable, and rewarding detours.”

Set limits

People under stress tend to find unhealthy ways to cope. Instead, try being intentional about what you are consuming by putting limits on things like your news, alcohol consumption, and the number of hours you work, said Dr. Harry.

Implement a culture of wellness

Dr. Barrett believes in creating the work culture we want to be in, one that ensures people have psychological safety, allows them to ask for help, encourages them to disconnect completely from work, and makes them feel valued and listened to. She likes the example of “the pause,” which is called by a team member right after a patient expires.

“It’s a 30-second moment of silence where we reflect on the patient, their loved ones, and every member of the health care team who helped support and treat them,” said Dr. Barrett. “At the conclusion, you say: ‘Thank you. Is there anything you need to be able to go back to the care of other patients?’ Because it’s unnatural to have this terrible thing that happened and then just act like nothing happened.”
 

Target resources

Be proactive and know where to find resources before you need them, advised Dr. Harry. “Most institutions have free mental health resources, either through their employee assistance programs or HR, plus there’s lots of national organizations that are offering free resources to health care providers.”

Focus on what you can control

Separating what is under your control from what is not is a struggle for everyone, Dr. Poorman said, but it’s helpful to think about the ways you can have an impact and what you’re able to control.

“There was a woman who was diagnosed with early-onset Parkinson’s that I heard giving an interview at the beginning of this pandemic,” she said. “It was the most helpful advice I got, which was: ‘Think of the next good thing you can do.’ You can’t fix everything, so what’s the next good thing you can do?”
 

Maintain connectivity

Make sure you are utilizing your support circle and staying connected. “That sense of connection is incredibly protective on multiple fronts for depression, for burnout, for suicide ideation, etc.,” Dr. Harry said.

“It doesn’t matter if it’s your teammates at work, your family at home, your best friend from medical school – whomever you can debrief with, vent with, and just share your thoughts and feelings with, these outlets are critical for all of us to process our emotions and diffuse stress and anxiety,” said Dr. Rudolph.

Dr. Poorman is concerned that there could be a spike in physician suicides caused by increased stress, so she also encourages talking openly about what is going on and about getting help when it’s necessary. “Many of us are afraid to seek care because we can actually have our ability to practice medicine questioned, but now is not the time for heroes. Now is the time for people who are willing to recognize their own strengths and limitations to take care of one another.”
 

Be compassionate toward others

Keep in mind that everyone is stressed out and offer empathy and compassion. “I think everybody’s struggling to try to figure this out and the more that we can give each other the benefit of the doubt and a little grace, the more protective that is,” said Dr. Harry.

Listening is meaningful too. “Recognizing opportunities to validate and acknowledge the feelings that are being shared with you by your colleagues is critical,” Dr. Rudolph said. “We all need to know that we’re not alone, that our thoughts and feelings are okay, and when we share a difficult story, the value of someone saying something as simple as, ‘wow, that sounds like it was really hard,’ is immense.”
 

Be compassionate toward yourself

Try to give yourself a break and be as compassionate with yourself as you would with others. It’s okay that you’re not getting in shape, publishing prolifically, or redesigning your house right now.

“There’s a lot of data linking lack of self-compassion to burnout,” said Dr. Harry. She says there are courses on self-compassion available that help you work on being kinder to yourself.
 

Get a “battle buddy”

The American Medical Association has a free “buddy system” program called PeerRx to help physicians cope during the pandemic. Dr. Rudolph said that now is a great time to use this military-developed intervention in which each team member checks in with a chosen partner at agreed-upon intervals.

For example, “You can tell that person: ‘If I don’t call my family for a week that’s a red flag for me.’ And then you hold each other accountable to those things,” Dr. Harry said.

The buddy system is another way to harness that sense of connection that is so vital to our health and well-being.

“The simple act of showing that you care … can make all the difference when you’re doing this kind of work that is both challenging and dangerous,” said Dr. Rudolph.

The global COVID-19 pandemic has escalated everyone’s stress levels, especially clinicians caring for hospitalized patients. New pressures have added to everyday stress, new studies have revised prior patient care recommendations, and the world generally seems upside down. What can a busy hospitalist do to maintain a modicum of sanity in all the craziness?

The stressors facing hospitalists

Uncertainty

Of all the burdens COVID-19 has unleashed, the biggest may be uncertainty. Not only is there unease about the virus itself, there also is legitimate concern about the future of medicine, said Elizabeth Harry, MD, SFHM, a hospitalist and senior director of clinical affairs at the University of Colorado Hospital in Aurora.

“What does it look like after an event like this, particularly in areas like academic medicine and teaching our next generation and getting funding for research? And how do we continue to produce physicians that can provide excellent care?” she asked.

There is also uncertainty in the best way to care for patients, said Eileen Barrett, MD, MPH, SFHM, a hospitalist at the University of New Mexico, Albuquerque.

“There are some models that are emerging to predict who will have a worse outcome, but they’re still not great models, so we have uncertainty for a given patient.” And, she noted, as the science continues to evolve, there exists a constant worry that “you might have inadvertently caused someone harm.”

The financial implications of the pandemic are creating uncertainty too. “When you fund a health care system with elective procedures and you can’t do those, and instead have to shift to the most essential services, a lot of places are seeing a massive deficit, which is going to affect staff morale and some physician offices are going to close,” said Elisabeth Poorman, MD, MPH, a primary care and internal medicine physician and chair of the King County Medical Society Physician Wellness Committee in Seattle.
 

Fear

When the pandemic began in the United States, “fear of the unknown was perhaps the scariest part, particularly as it pertained to personal protective equipment,” said Mark Rudolph, MD, SFHM, chief experience officer and vice president of patient experience and physician development at Sound Physicians in Tacoma, Wash. “For most clinicians, this is the first time that they are themselves in harm’s way while they do their jobs. And worse, they risk bringing the virus home to their families. That is the concern I hear most.”

Anxiety

Worrying about being able to provide excellent patient care is a big stressor, especially since this is the heart and soul of why most hospitalists have gone into their line of work.

“Part of providing excellent care to your patients is providing excellent supportive care to their families,” Dr. Harry said. “There’s some dissonance there in not being able to allow the family to come visit, but wanting to keep them safe, and it feels really hard to support your patients and support their families in the best way. It can feel like you’re just watching and waiting to see what will happen, and that we don’t have a lot of agency over which direction things take.”

There is concern for health care team members as well, Dr. Harry added. “Physicians care a lot about their teams and how they’re doing. I think there’s a sense of esprit de corps among folks and worry for each other there.”
 

Guilt

Although you may be at the hospital all day, you may feel guilty when you are not providing direct patient care. Or maybe you or someone on your team has an immunodeficiency and can’t be on the front line. Perhaps one of your team members contracted COVID-19 and you did not. Whatever the case, guilt is another emotion that is rampant among hospitalists right now, Dr. Barrett said.

Burnout

Unfortunately, burnout is a potential reality in times of high stress. “Burnout is dynamic,” said Dr. Poorman. “It’s a process by which your emotional and cognitive reserves are exhausted. The people with the highest burnout are the ones who are still trying to provide the standard of care, or above the standard of care in dysfunctional systems.”

Dr. Harry noted that burnout presents in different ways for different people, but Dr. Rudolph added that it’s crucial for hospitalist team members to watch for signs of burnout so they can intervene and/or get help for their colleagues.

Warning signs in yourself or others that burnout could be on the horizon include:

• Fatigue/exhaustion – Whether emotional or physical (or both), this can become a problem if it “just doesn’t seem to go away despite rest and time away from work,” said Dr. Rudolph.
• Behavioral changes – Any behavior that’s out of the ordinary may be a red flag, like lashing out at someone at work.
• Overwork – Working too much can be caused by an inability to let go of patient care, Dr. Barrett said.
• Not working enough – This may include avoiding tasks and having difficulty meeting deadlines.
• Maladaptive coping behaviors – Excessive consumption of alcohol or drugs is a common coping mechanism. “Even excessive consumption of news is something that people are using to numb out a little bit,” said Dr. Harry.
• Depersonalization – “This is where you start to look at patients, colleagues, or administrators as ‘them’ and you can’t connect as deeply,” Dr. Harry said. “Part of that’s protective and a normal thing to do during a big trauma like this, but it’s also incredibly distancing. Any language that people start using that feels like ‘us’ or ‘them’ is a warning sign.”
• Disengagement – Many people disengage from their work, but Dr. Poorman said physicians tend to disengage from other parts of their lives, such as exercise and family interaction.

Protecting yourself while supporting others

Like the illustration of putting the oxygen mask on yourself first so you can help others, it’s important to protect your own mental and physical health as you support your fellow physicians. Here’s what the experts suggest.

Focus on basic needs

“When you’re in the midst of a trauma, which we are, you don’t want to open all of that up and go to the depths of your thoughts about the grief of all of it because it can actually make the trauma worse,” said Dr. Harry. “There’s a lot of literature that debriefing is really helpful after the event, but if you do it during the event, it can be really dangerous.”

Instead, she said, the goal should be focusing on your basic needs and what you need to do to get through each day, like keeping you and your family in good health. “What is your purpose? Staying connected to why you do this and staying focused on the present is really important,” Dr. Harry noted.

Do your best to get a good night’s sleep, exercise as much as you can, talk to others, and see a mental health provider if your anxiety is too high, advises Dr. Barrett. “Even avoiding blue light from phones and screens within 2 hours of bedtime, parking further away from the hospital and walking, and taking the stairs are things that add up in a big way.”
 

Keep up your normal routine

“Right now, it’s really critical for clinicians to keep up components of their routine that feel ‘normal,’ ” Dr. Rudolph said. “Whether it’s exercise, playing board games with their kids, or spending time on a hobby, it’s critical to allow yourself these comfortable, predictable, and rewarding detours.”

Set limits

People under stress tend to find unhealthy ways to cope. Instead, try being intentional about what you are consuming by putting limits on things like your news, alcohol consumption, and the number of hours you work, said Dr. Harry.

Implement a culture of wellness

Dr. Barrett believes in creating the work culture we want to be in, one that ensures people have psychological safety, allows them to ask for help, encourages them to disconnect completely from work, and makes them feel valued and listened to. She likes the example of “the pause,” which is called by a team member right after a patient expires.

“It’s a 30-second moment of silence where we reflect on the patient, their loved ones, and every member of the health care team who helped support and treat them,” said Dr. Barrett. “At the conclusion, you say: ‘Thank you. Is there anything you need to be able to go back to the care of other patients?’ Because it’s unnatural to have this terrible thing that happened and then just act like nothing happened.”
 

Target resources

Be proactive and know where to find resources before you need them, advised Dr. Harry. “Most institutions have free mental health resources, either through their employee assistance programs or HR, plus there’s lots of national organizations that are offering free resources to health care providers.”

Focus on what you can control

Separating what is under your control from what is not is a struggle for everyone, Dr. Poorman said, but it’s helpful to think about the ways you can have an impact and what you’re able to control.

“There was a woman who was diagnosed with early-onset Parkinson’s that I heard giving an interview at the beginning of this pandemic,” she said. “It was the most helpful advice I got, which was: ‘Think of the next good thing you can do.’ You can’t fix everything, so what’s the next good thing you can do?”
 

Maintain connectivity

Make sure you are utilizing your support circle and staying connected. “That sense of connection is incredibly protective on multiple fronts for depression, for burnout, for suicide ideation, etc.,” Dr. Harry said.

“It doesn’t matter if it’s your teammates at work, your family at home, your best friend from medical school – whomever you can debrief with, vent with, and just share your thoughts and feelings with, these outlets are critical for all of us to process our emotions and diffuse stress and anxiety,” said Dr. Rudolph.

Dr. Poorman is concerned that there could be a spike in physician suicides caused by increased stress, so she also encourages talking openly about what is going on and about getting help when it’s necessary. “Many of us are afraid to seek care because we can actually have our ability to practice medicine questioned, but now is not the time for heroes. Now is the time for people who are willing to recognize their own strengths and limitations to take care of one another.”
 

Be compassionate toward others

Keep in mind that everyone is stressed out and offer empathy and compassion. “I think everybody’s struggling to try to figure this out and the more that we can give each other the benefit of the doubt and a little grace, the more protective that is,” said Dr. Harry.

Listening is meaningful too. “Recognizing opportunities to validate and acknowledge the feelings that are being shared with you by your colleagues is critical,” Dr. Rudolph said. “We all need to know that we’re not alone, that our thoughts and feelings are okay, and when we share a difficult story, the value of someone saying something as simple as, ‘wow, that sounds like it was really hard,’ is immense.”
 

Be compassionate toward yourself

Try to give yourself a break and be as compassionate with yourself as you would with others. It’s okay that you’re not getting in shape, publishing prolifically, or redesigning your house right now.

“There’s a lot of data linking lack of self-compassion to burnout,” said Dr. Harry. She says there are courses on self-compassion available that help you work on being kinder to yourself.
 

Get a “battle buddy”

The American Medical Association has a free “buddy system” program called PeerRx to help physicians cope during the pandemic. Dr. Rudolph said that now is a great time to use this military-developed intervention in which each team member checks in with a chosen partner at agreed-upon intervals.

For example, “You can tell that person: ‘If I don’t call my family for a week that’s a red flag for me.’ And then you hold each other accountable to those things,” Dr. Harry said.

The buddy system is another way to harness that sense of connection that is so vital to our health and well-being.

“The simple act of showing that you care … can make all the difference when you’re doing this kind of work that is both challenging and dangerous,” said Dr. Rudolph.

The global COVID-19 pandemic has escalated everyone’s stress levels, especially clinicians caring for hospitalized patients. New pressures have added to everyday stress, new studies have revised prior patient care recommendations, and the world generally seems upside down. What can a busy hospitalist do to maintain a modicum of sanity in all the craziness?

The stressors facing hospitalists

Uncertainty

Of all the burdens COVID-19 has unleashed, the biggest may be uncertainty. Not only is there unease about the virus itself, there also is legitimate concern about the future of medicine, said Elizabeth Harry, MD, SFHM, a hospitalist and senior director of clinical affairs at the University of Colorado Hospital in Aurora.

“What does it look like after an event like this, particularly in areas like academic medicine and teaching our next generation and getting funding for research? And how do we continue to produce physicians that can provide excellent care?” she asked.

There is also uncertainty in the best way to care for patients, said Eileen Barrett, MD, MPH, SFHM, a hospitalist at the University of New Mexico, Albuquerque.

“There are some models that are emerging to predict who will have a worse outcome, but they’re still not great models, so we have uncertainty for a given patient.” And, she noted, as the science continues to evolve, there exists a constant worry that “you might have inadvertently caused someone harm.”

The financial implications of the pandemic are creating uncertainty too. “When you fund a health care system with elective procedures and you can’t do those, and instead have to shift to the most essential services, a lot of places are seeing a massive deficit, which is going to affect staff morale and some physician offices are going to close,” said Elisabeth Poorman, MD, MPH, a primary care and internal medicine physician and chair of the King County Medical Society Physician Wellness Committee in Seattle.
 

Fear

When the pandemic began in the United States, “fear of the unknown was perhaps the scariest part, particularly as it pertained to personal protective equipment,” said Mark Rudolph, MD, SFHM, chief experience officer and vice president of patient experience and physician development at Sound Physicians in Tacoma, Wash. “For most clinicians, this is the first time that they are themselves in harm’s way while they do their jobs. And worse, they risk bringing the virus home to their families. That is the concern I hear most.”

Anxiety

Worrying about being able to provide excellent patient care is a big stressor, especially since this is the heart and soul of why most hospitalists have gone into their line of work.

“Part of providing excellent care to your patients is providing excellent supportive care to their families,” Dr. Harry said. “There’s some dissonance there in not being able to allow the family to come visit, but wanting to keep them safe, and it feels really hard to support your patients and support their families in the best way. It can feel like you’re just watching and waiting to see what will happen, and that we don’t have a lot of agency over which direction things take.”

There is concern for health care team members as well, Dr. Harry added. “Physicians care a lot about their teams and how they’re doing. I think there’s a sense of esprit de corps among folks and worry for each other there.”
 

Guilt

Although you may be at the hospital all day, you may feel guilty when you are not providing direct patient care. Or maybe you or someone on your team has an immunodeficiency and can’t be on the front line. Perhaps one of your team members contracted COVID-19 and you did not. Whatever the case, guilt is another emotion that is rampant among hospitalists right now, Dr. Barrett said.

Burnout

Unfortunately, burnout is a potential reality in times of high stress. “Burnout is dynamic,” said Dr. Poorman. “It’s a process by which your emotional and cognitive reserves are exhausted. The people with the highest burnout are the ones who are still trying to provide the standard of care, or above the standard of care in dysfunctional systems.”

Dr. Harry noted that burnout presents in different ways for different people, but Dr. Rudolph added that it’s crucial for hospitalist team members to watch for signs of burnout so they can intervene and/or get help for their colleagues.

Warning signs in yourself or others that burnout could be on the horizon include:

• Fatigue/exhaustion – Whether emotional or physical (or both), this can become a problem if it “just doesn’t seem to go away despite rest and time away from work,” said Dr. Rudolph.
• Behavioral changes – Any behavior that’s out of the ordinary may be a red flag, like lashing out at someone at work.
• Overwork – Working too much can be caused by an inability to let go of patient care, Dr. Barrett said.
• Not working enough – This may include avoiding tasks and having difficulty meeting deadlines.
• Maladaptive coping behaviors – Excessive consumption of alcohol or drugs is a common coping mechanism. “Even excessive consumption of news is something that people are using to numb out a little bit,” said Dr. Harry.
• Depersonalization – “This is where you start to look at patients, colleagues, or administrators as ‘them’ and you can’t connect as deeply,” Dr. Harry said. “Part of that’s protective and a normal thing to do during a big trauma like this, but it’s also incredibly distancing. Any language that people start using that feels like ‘us’ or ‘them’ is a warning sign.”
• Disengagement – Many people disengage from their work, but Dr. Poorman said physicians tend to disengage from other parts of their lives, such as exercise and family interaction.

Protecting yourself while supporting others

Like the illustration of putting the oxygen mask on yourself first so you can help others, it’s important to protect your own mental and physical health as you support your fellow physicians. Here’s what the experts suggest.

Focus on basic needs

“When you’re in the midst of a trauma, which we are, you don’t want to open all of that up and go to the depths of your thoughts about the grief of all of it because it can actually make the trauma worse,” said Dr. Harry. “There’s a lot of literature that debriefing is really helpful after the event, but if you do it during the event, it can be really dangerous.”

Instead, she said, the goal should be focusing on your basic needs and what you need to do to get through each day, like keeping you and your family in good health. “What is your purpose? Staying connected to why you do this and staying focused on the present is really important,” Dr. Harry noted.

Do your best to get a good night’s sleep, exercise as much as you can, talk to others, and see a mental health provider if your anxiety is too high, advises Dr. Barrett. “Even avoiding blue light from phones and screens within 2 hours of bedtime, parking further away from the hospital and walking, and taking the stairs are things that add up in a big way.”
 

Keep up your normal routine

“Right now, it’s really critical for clinicians to keep up components of their routine that feel ‘normal,’ ” Dr. Rudolph said. “Whether it’s exercise, playing board games with their kids, or spending time on a hobby, it’s critical to allow yourself these comfortable, predictable, and rewarding detours.”

Set limits

People under stress tend to find unhealthy ways to cope. Instead, try being intentional about what you are consuming by putting limits on things like your news, alcohol consumption, and the number of hours you work, said Dr. Harry.

Implement a culture of wellness

Dr. Barrett believes in creating the work culture we want to be in, one that ensures people have psychological safety, allows them to ask for help, encourages them to disconnect completely from work, and makes them feel valued and listened to. She likes the example of “the pause,” which is called by a team member right after a patient expires.

“It’s a 30-second moment of silence where we reflect on the patient, their loved ones, and every member of the health care team who helped support and treat them,” said Dr. Barrett. “At the conclusion, you say: ‘Thank you. Is there anything you need to be able to go back to the care of other patients?’ Because it’s unnatural to have this terrible thing that happened and then just act like nothing happened.”
 

Target resources

Be proactive and know where to find resources before you need them, advised Dr. Harry. “Most institutions have free mental health resources, either through their employee assistance programs or HR, plus there’s lots of national organizations that are offering free resources to health care providers.”

Focus on what you can control

Separating what is under your control from what is not is a struggle for everyone, Dr. Poorman said, but it’s helpful to think about the ways you can have an impact and what you’re able to control.

“There was a woman who was diagnosed with early-onset Parkinson’s that I heard giving an interview at the beginning of this pandemic,” she said. “It was the most helpful advice I got, which was: ‘Think of the next good thing you can do.’ You can’t fix everything, so what’s the next good thing you can do?”
 

Maintain connectivity

Make sure you are utilizing your support circle and staying connected. “That sense of connection is incredibly protective on multiple fronts for depression, for burnout, for suicide ideation, etc.,” Dr. Harry said.

“It doesn’t matter if it’s your teammates at work, your family at home, your best friend from medical school – whomever you can debrief with, vent with, and just share your thoughts and feelings with, these outlets are critical for all of us to process our emotions and diffuse stress and anxiety,” said Dr. Rudolph.

Dr. Poorman is concerned that there could be a spike in physician suicides caused by increased stress, so she also encourages talking openly about what is going on and about getting help when it’s necessary. “Many of us are afraid to seek care because we can actually have our ability to practice medicine questioned, but now is not the time for heroes. Now is the time for people who are willing to recognize their own strengths and limitations to take care of one another.”
 

Be compassionate toward others

Keep in mind that everyone is stressed out and offer empathy and compassion. “I think everybody’s struggling to try to figure this out and the more that we can give each other the benefit of the doubt and a little grace, the more protective that is,” said Dr. Harry.

Listening is meaningful too. “Recognizing opportunities to validate and acknowledge the feelings that are being shared with you by your colleagues is critical,” Dr. Rudolph said. “We all need to know that we’re not alone, that our thoughts and feelings are okay, and when we share a difficult story, the value of someone saying something as simple as, ‘wow, that sounds like it was really hard,’ is immense.”
 

Be compassionate toward yourself

Try to give yourself a break and be as compassionate with yourself as you would with others. It’s okay that you’re not getting in shape, publishing prolifically, or redesigning your house right now.

“There’s a lot of data linking lack of self-compassion to burnout,” said Dr. Harry. She says there are courses on self-compassion available that help you work on being kinder to yourself.
 

Get a “battle buddy”

The American Medical Association has a free “buddy system” program called PeerRx to help physicians cope during the pandemic. Dr. Rudolph said that now is a great time to use this military-developed intervention in which each team member checks in with a chosen partner at agreed-upon intervals.

For example, “You can tell that person: ‘If I don’t call my family for a week that’s a red flag for me.’ And then you hold each other accountable to those things,” Dr. Harry said.

The buddy system is another way to harness that sense of connection that is so vital to our health and well-being.

“The simple act of showing that you care … can make all the difference when you’re doing this kind of work that is both challenging and dangerous,” said Dr. Rudolph.

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the Centers for Disease Control and Prevention.

Among those with underlying conditions such as cardiovascular disease or diabetes, 45.4% of patients with COVID-19 were hospitalized, versus 7.6% of patients without an underlying condition, said Erin K. Stokes, MPH, and associates of the CDC COVID-19 Emergency Response team.

The difference in deaths was even greater over the study period of Jan. 22–May 30, 2020: 19.5% of COVID-19 patients with underlying conditions died, compared with 1.6% of those with no underlying condition. The gap narrowed, however, for ICU admissions, with corresponding rates of 8.5% and 1.5%, the investigators reported June 15 in the Morbidity and Mortality Weekly Report.

“The COVID-19 pandemic continues to be severe, particularly in certain population groups,” they said.

The cumulative incidence of laboratory-confirmed cases up to May 30, for instance, was nearly twice as high for those aged 80 years and over (902 per 100,000 population) than for those aged 70-79 years (464.2 per 100,000). Those aged 50-59 years had the second-highest incidence, 550.5 per 100,000, Ms. Stokes and associates said.

“Among cases with known race and ethnicity, 33% of persons were Hispanic, 22% were black, and 1.3% were [American Indian/Alaska Native]. These findings suggest that persons in these groups, who account for 18%, 13%, and 0.7% of the U.S. population, respectively, are disproportionately affected by the COVID-19 pandemic,” they wrote.

Another source of disparity: “Incidence among males and females was similar overall, [but] severe outcomes were more commonly reported among males,” the investigators noted. Cumulative incidence was 401.1 per 100,000 for males and 406.0 for females, but 6.0% of male patients died, compared with 4.8% of females.

As of May 30, a total of 1,761,503 cases and 103,700 deaths had been reported to the CDC. Of those cases, approximately 1.3 million were included in the analysis, with data on individual underlying health conditions available for 287,320 (22%). The split on those cases was 198,879 with health conditions and 88,411 without, the CDC data show.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females, Ms. Stokes and associates said.

The pandemic “is an ongoing public health crisis in the United States that continues to affect all populations and result in severe outcomes including death,” they said, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.”

rfranki@mdedge.com

SOURCE: Stokes EK et al. MMWR. 2020 Jun 15;69(early release):1-7.

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the Centers for Disease Control and Prevention.

Among those with underlying conditions such as cardiovascular disease or diabetes, 45.4% of patients with COVID-19 were hospitalized, versus 7.6% of patients without an underlying condition, said Erin K. Stokes, MPH, and associates of the CDC COVID-19 Emergency Response team.

The difference in deaths was even greater over the study period of Jan. 22–May 30, 2020: 19.5% of COVID-19 patients with underlying conditions died, compared with 1.6% of those with no underlying condition. The gap narrowed, however, for ICU admissions, with corresponding rates of 8.5% and 1.5%, the investigators reported June 15 in the Morbidity and Mortality Weekly Report.

“The COVID-19 pandemic continues to be severe, particularly in certain population groups,” they said.

The cumulative incidence of laboratory-confirmed cases up to May 30, for instance, was nearly twice as high for those aged 80 years and over (902 per 100,000 population) than for those aged 70-79 years (464.2 per 100,000). Those aged 50-59 years had the second-highest incidence, 550.5 per 100,000, Ms. Stokes and associates said.

“Among cases with known race and ethnicity, 33% of persons were Hispanic, 22% were black, and 1.3% were [American Indian/Alaska Native]. These findings suggest that persons in these groups, who account for 18%, 13%, and 0.7% of the U.S. population, respectively, are disproportionately affected by the COVID-19 pandemic,” they wrote.

Another source of disparity: “Incidence among males and females was similar overall, [but] severe outcomes were more commonly reported among males,” the investigators noted. Cumulative incidence was 401.1 per 100,000 for males and 406.0 for females, but 6.0% of male patients died, compared with 4.8% of females.

As of May 30, a total of 1,761,503 cases and 103,700 deaths had been reported to the CDC. Of those cases, approximately 1.3 million were included in the analysis, with data on individual underlying health conditions available for 287,320 (22%). The split on those cases was 198,879 with health conditions and 88,411 without, the CDC data show.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females, Ms. Stokes and associates said.

The pandemic “is an ongoing public health crisis in the United States that continues to affect all populations and result in severe outcomes including death,” they said, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.”

rfranki@mdedge.com

SOURCE: Stokes EK et al. MMWR. 2020 Jun 15;69(early release):1-7.

COVID-19 patients with an underlying condition are 6 times as likely to be hospitalized and 12 times as likely to die, compared with those who have no such condition, according to the Centers for Disease Control and Prevention.

Among those with underlying conditions such as cardiovascular disease or diabetes, 45.4% of patients with COVID-19 were hospitalized, versus 7.6% of patients without an underlying condition, said Erin K. Stokes, MPH, and associates of the CDC COVID-19 Emergency Response team.

The difference in deaths was even greater over the study period of Jan. 22–May 30, 2020: 19.5% of COVID-19 patients with underlying conditions died, compared with 1.6% of those with no underlying condition. The gap narrowed, however, for ICU admissions, with corresponding rates of 8.5% and 1.5%, the investigators reported June 15 in the Morbidity and Mortality Weekly Report.

“The COVID-19 pandemic continues to be severe, particularly in certain population groups,” they said.

The cumulative incidence of laboratory-confirmed cases up to May 30, for instance, was nearly twice as high for those aged 80 years and over (902 per 100,000 population) than for those aged 70-79 years (464.2 per 100,000). Those aged 50-59 years had the second-highest incidence, 550.5 per 100,000, Ms. Stokes and associates said.

“Among cases with known race and ethnicity, 33% of persons were Hispanic, 22% were black, and 1.3% were [American Indian/Alaska Native]. These findings suggest that persons in these groups, who account for 18%, 13%, and 0.7% of the U.S. population, respectively, are disproportionately affected by the COVID-19 pandemic,” they wrote.

Another source of disparity: “Incidence among males and females was similar overall, [but] severe outcomes were more commonly reported among males,” the investigators noted. Cumulative incidence was 401.1 per 100,000 for males and 406.0 for females, but 6.0% of male patients died, compared with 4.8% of females.

As of May 30, a total of 1,761,503 cases and 103,700 deaths had been reported to the CDC. Of those cases, approximately 1.3 million were included in the analysis, with data on individual underlying health conditions available for 287,320 (22%). The split on those cases was 198,879 with health conditions and 88,411 without, the CDC data show.

The most frequently reported underlying conditions were cardiovascular disease (32%), diabetes (30%), chronic lung disease (18%), and renal disease (7.6%), and there were no significant differences between males and females, Ms. Stokes and associates said.

The pandemic “is an ongoing public health crisis in the United States that continues to affect all populations and result in severe outcomes including death,” they said, emphasizing “the continued need for community mitigation strategies, especially for vulnerable populations, to slow COVID-19 transmission.”

rfranki@mdedge.com

SOURCE: Stokes EK et al. MMWR. 2020 Jun 15;69(early release):1-7.

The results from a pair of clinical trials should help to take the guesswork out of starting and stopping the tumor necrosis factor inhibitor etanercept (Enbrel) in patients with nonradiographic axial spondyloarthritis (nr-axSpA). The trials were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.

Optimal use of etanercept in this disease is still being defined, according to the investigators. Its effects, if any, when given very early in the disease course is unclear, and guidance is conflicting when it comes to stopping the drug after inactive disease is achieved.

In the Dutch randomized controlled PrevAS trial of 80 patients with suspected very early nr-axSpA, initiating etanercept instead of placebo did not significantly improve the odds of achieving a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16.

And in the multinational, open-label, phase 4 RE-EMBARK trial, three-quarters of the 119 patients with nr-axSpA who achieved inactive disease on etanercept and stopped the drug experienced a flare within 40 weeks. However, the majority were able to regain disease inactivity after restarting the drug.
 

Findings in context

“We all have some patients like this [PrevAS population] where we strongly believe they have axial spondyloarthritis but do not fully qualify,” Nigil Haroon MD, PhD, said in an interview. “From a clinical decision-making process, we may diagnose these patients with axial spondyloarthritis, but due to restrictions in access to medications, we have difficulty accessing biologic medications for them. Hence, this study has practical implications.”

“It has already been shown in other, much larger studies that, even in patients who satisfy the criteria of axial spondyloarthritis, those who are MRI and CRP [C-reactive protein] negative are unlikely to respond, so the results are not surprising,” commented Dr. Haroon, who is codirector of the spondylitis program at the University Health Network and associate professor of medicine and rheumatology at the University of Toronto.

Although intended to be a population with suspected very early disease, several of the PrevAS patients would have met ASAS criteria for the disease at baseline, Dr. Haroon cautioned. In addition, the small sample size precluded subgroup analyses.

“The overall conclusion should be, this is a negative study, rather than state there was a trend to better improvement on etanercept. Although there are practical implications, as mentioned, I don’t think this study, with the numbers and the results presented, will change clinical practice,” he said.

The question of stopping biologics in nr-axSpA was previously addressed in the ABILITY-3 randomized trial of adalimumab (Humira), which found that flares were significantly more common with stopping versus continuing the drug and only about half of patients were able to get back in remission by restarting the drug, according to Dr. Haroon.

However, the RE-EMBARK and ABILITY-3 studies differed in both design and patient population, he noted. For example, the mean disease duration was only about 2 years in the former study, compared with 7 years in the latter.

The initial 59% rate of attaining inactive disease on etanercept in RE-EMBARK was “impressive,” Dr. Haroon said, “but as this was an open-label study, higher values are expected.”

“The message in both studies is that stopping biologics completely is not a good idea as the majority of patients, 70%-75%, will relapse within a short period,” he concluded. “However, it should be kept in mind that these [RE-EMBARK] patients received biologic only for a short 24-week period. This study does not answer the question of whether nonradiographic axial spondyloarthritis patients with sustained inactive disease can be taken off biologics abruptly without a taper over time.”

Details of the studies

In the PrevAS trial, Tamara Rusman, a PhD candidate in Rheumatology at the VU University Medical Center Amsterdam and coinvestigators studied patients meeting Calin criteria for inflammatory back pain who had high disease activity plus either HLA-B27 positivity with at least one feature of axial spondyloarthritis or HLA-B27 negativity with two features.

This population is of interest because “most studies have included only patients with nonradiographic axial spondyloarthritis with a positive MRI of the sacroiliac joints and/or an elevated C-reactive protein level,” she noted.

Results showed that, during 16 weeks of treatment, etanercept users had a nonsignficantly higher rate of achieving an ASAS 20 response with etanercept versus placebo users (17% vs. 11%; hazard ratio, 2.1; P = .2). The etanercept group also had a somewhat higher rate of response as defined by the Ankylosing Spondylitis Disease Activity Score CRP (ASDAS-CRP) criterion (25% vs. 13%; hazard ratio, 1.1; P = .8).

“Based on these data, early treatment in inflammatory back pain patients prone to develop axial spondyloarthritis seems not to be useful,” Ms. Rusman concluded. “However, monitoring of these patients should be continued since they remain a risk group for developing axial spondyloarthritis.”

In the RE-EMBARK trial, investigators led by Filip Van den Bosch, MD, PhD, Rheumatology Head-of-Clinic at Ghent (Belgium) University Hospital, started with a cohort of 208 patients with nr-axSpA who were given etanercept and background NSAIDs for 24 weeks.

“Current guidelines do not agree on whether a TNF-blocking agent or another biological DMARD should be tapered once a status of low disease activity or remission is achieved,” he noted.

Overall, 59% of the patients achieved inactive disease (defined as an ASDAS-CRP < 1.3) and discontinued etanercept.

During the next 40 weeks, 24% of these patients maintained inactive disease with only the background NSAID therapy. Among the 75% who experienced a flare, defined as an ASDAS with erythrocyte sedimentation rate (ASDAS-ESR) score of 2.1 or greater, the median time to flare was 16.1 weeks. Fully 62% of this group were able to regain disease inactivity within 12 weeks of restarting etanercept.

In a comparative analysis, relative to the RE-EMBARK patients discontinuing etanercept, similar patients who continued etanercept on the companion EMBARK trial had a longer time to flare (P < .0001) and an 85% lower risk of this outcome.

“There were no new safety signals identified, and as expected, the number of treatment-emergent adverse events dropped during the drug-free period and, interestingly, remained stable over retreatment,” Dr. Van den Bosch noted.

“Temporarily discontinuing etanercept may be an option for some patients with stable inactive nonradiographic axial spondyloarthritis,” he concluded.

The PrevAS trial was financially supported by Pfizer and ReumaNederland. Ms. Rusman declared no relevant conflicts of interest; four coauthors reported financial relationship(s) with Pfizer and other pharmaceutical companies. The RE-EMBARK trial was sponsored by Pfizer. Dr. Van den Bosch disclosed receiving grant/research support from AbbVie, Merck, and UCB, and consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. Four coauthors reported financial ties to Pfizer and other pharmaceutical companies, and five coauthors were employees and shareholders of Pfizer.

SOURCES: Rusman T et al. Ann Rheum Dis. 2020;79[suppl 1]:72-3; and Van den Bosch F et al. Ann Rheum Dis. 2020;79[suppl 1]:70.

The results from a pair of clinical trials should help to take the guesswork out of starting and stopping the tumor necrosis factor inhibitor etanercept (Enbrel) in patients with nonradiographic axial spondyloarthritis (nr-axSpA). The trials were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.

Optimal use of etanercept in this disease is still being defined, according to the investigators. Its effects, if any, when given very early in the disease course is unclear, and guidance is conflicting when it comes to stopping the drug after inactive disease is achieved.

In the Dutch randomized controlled PrevAS trial of 80 patients with suspected very early nr-axSpA, initiating etanercept instead of placebo did not significantly improve the odds of achieving a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16.

And in the multinational, open-label, phase 4 RE-EMBARK trial, three-quarters of the 119 patients with nr-axSpA who achieved inactive disease on etanercept and stopped the drug experienced a flare within 40 weeks. However, the majority were able to regain disease inactivity after restarting the drug.
 

Findings in context

“We all have some patients like this [PrevAS population] where we strongly believe they have axial spondyloarthritis but do not fully qualify,” Nigil Haroon MD, PhD, said in an interview. “From a clinical decision-making process, we may diagnose these patients with axial spondyloarthritis, but due to restrictions in access to medications, we have difficulty accessing biologic medications for them. Hence, this study has practical implications.”

“It has already been shown in other, much larger studies that, even in patients who satisfy the criteria of axial spondyloarthritis, those who are MRI and CRP [C-reactive protein] negative are unlikely to respond, so the results are not surprising,” commented Dr. Haroon, who is codirector of the spondylitis program at the University Health Network and associate professor of medicine and rheumatology at the University of Toronto.

Although intended to be a population with suspected very early disease, several of the PrevAS patients would have met ASAS criteria for the disease at baseline, Dr. Haroon cautioned. In addition, the small sample size precluded subgroup analyses.

“The overall conclusion should be, this is a negative study, rather than state there was a trend to better improvement on etanercept. Although there are practical implications, as mentioned, I don’t think this study, with the numbers and the results presented, will change clinical practice,” he said.

The question of stopping biologics in nr-axSpA was previously addressed in the ABILITY-3 randomized trial of adalimumab (Humira), which found that flares were significantly more common with stopping versus continuing the drug and only about half of patients were able to get back in remission by restarting the drug, according to Dr. Haroon.

However, the RE-EMBARK and ABILITY-3 studies differed in both design and patient population, he noted. For example, the mean disease duration was only about 2 years in the former study, compared with 7 years in the latter.

The initial 59% rate of attaining inactive disease on etanercept in RE-EMBARK was “impressive,” Dr. Haroon said, “but as this was an open-label study, higher values are expected.”

“The message in both studies is that stopping biologics completely is not a good idea as the majority of patients, 70%-75%, will relapse within a short period,” he concluded. “However, it should be kept in mind that these [RE-EMBARK] patients received biologic only for a short 24-week period. This study does not answer the question of whether nonradiographic axial spondyloarthritis patients with sustained inactive disease can be taken off biologics abruptly without a taper over time.”

Details of the studies

In the PrevAS trial, Tamara Rusman, a PhD candidate in Rheumatology at the VU University Medical Center Amsterdam and coinvestigators studied patients meeting Calin criteria for inflammatory back pain who had high disease activity plus either HLA-B27 positivity with at least one feature of axial spondyloarthritis or HLA-B27 negativity with two features.

This population is of interest because “most studies have included only patients with nonradiographic axial spondyloarthritis with a positive MRI of the sacroiliac joints and/or an elevated C-reactive protein level,” she noted.

Results showed that, during 16 weeks of treatment, etanercept users had a nonsignficantly higher rate of achieving an ASAS 20 response with etanercept versus placebo users (17% vs. 11%; hazard ratio, 2.1; P = .2). The etanercept group also had a somewhat higher rate of response as defined by the Ankylosing Spondylitis Disease Activity Score CRP (ASDAS-CRP) criterion (25% vs. 13%; hazard ratio, 1.1; P = .8).

“Based on these data, early treatment in inflammatory back pain patients prone to develop axial spondyloarthritis seems not to be useful,” Ms. Rusman concluded. “However, monitoring of these patients should be continued since they remain a risk group for developing axial spondyloarthritis.”

In the RE-EMBARK trial, investigators led by Filip Van den Bosch, MD, PhD, Rheumatology Head-of-Clinic at Ghent (Belgium) University Hospital, started with a cohort of 208 patients with nr-axSpA who were given etanercept and background NSAIDs for 24 weeks.

“Current guidelines do not agree on whether a TNF-blocking agent or another biological DMARD should be tapered once a status of low disease activity or remission is achieved,” he noted.

Overall, 59% of the patients achieved inactive disease (defined as an ASDAS-CRP < 1.3) and discontinued etanercept.

During the next 40 weeks, 24% of these patients maintained inactive disease with only the background NSAID therapy. Among the 75% who experienced a flare, defined as an ASDAS with erythrocyte sedimentation rate (ASDAS-ESR) score of 2.1 or greater, the median time to flare was 16.1 weeks. Fully 62% of this group were able to regain disease inactivity within 12 weeks of restarting etanercept.

In a comparative analysis, relative to the RE-EMBARK patients discontinuing etanercept, similar patients who continued etanercept on the companion EMBARK trial had a longer time to flare (P < .0001) and an 85% lower risk of this outcome.

“There were no new safety signals identified, and as expected, the number of treatment-emergent adverse events dropped during the drug-free period and, interestingly, remained stable over retreatment,” Dr. Van den Bosch noted.

“Temporarily discontinuing etanercept may be an option for some patients with stable inactive nonradiographic axial spondyloarthritis,” he concluded.

The PrevAS trial was financially supported by Pfizer and ReumaNederland. Ms. Rusman declared no relevant conflicts of interest; four coauthors reported financial relationship(s) with Pfizer and other pharmaceutical companies. The RE-EMBARK trial was sponsored by Pfizer. Dr. Van den Bosch disclosed receiving grant/research support from AbbVie, Merck, and UCB, and consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. Four coauthors reported financial ties to Pfizer and other pharmaceutical companies, and five coauthors were employees and shareholders of Pfizer.

SOURCES: Rusman T et al. Ann Rheum Dis. 2020;79[suppl 1]:72-3; and Van den Bosch F et al. Ann Rheum Dis. 2020;79[suppl 1]:70.

The results from a pair of clinical trials should help to take the guesswork out of starting and stopping the tumor necrosis factor inhibitor etanercept (Enbrel) in patients with nonradiographic axial spondyloarthritis (nr-axSpA). The trials were reported at the annual European Congress of Rheumatology, held online this year due to COVID-19.

Optimal use of etanercept in this disease is still being defined, according to the investigators. Its effects, if any, when given very early in the disease course is unclear, and guidance is conflicting when it comes to stopping the drug after inactive disease is achieved.

In the Dutch randomized controlled PrevAS trial of 80 patients with suspected very early nr-axSpA, initiating etanercept instead of placebo did not significantly improve the odds of achieving a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16.

And in the multinational, open-label, phase 4 RE-EMBARK trial, three-quarters of the 119 patients with nr-axSpA who achieved inactive disease on etanercept and stopped the drug experienced a flare within 40 weeks. However, the majority were able to regain disease inactivity after restarting the drug.
 

Findings in context

“We all have some patients like this [PrevAS population] where we strongly believe they have axial spondyloarthritis but do not fully qualify,” Nigil Haroon MD, PhD, said in an interview. “From a clinical decision-making process, we may diagnose these patients with axial spondyloarthritis, but due to restrictions in access to medications, we have difficulty accessing biologic medications for them. Hence, this study has practical implications.”

“It has already been shown in other, much larger studies that, even in patients who satisfy the criteria of axial spondyloarthritis, those who are MRI and CRP [C-reactive protein] negative are unlikely to respond, so the results are not surprising,” commented Dr. Haroon, who is codirector of the spondylitis program at the University Health Network and associate professor of medicine and rheumatology at the University of Toronto.

Although intended to be a population with suspected very early disease, several of the PrevAS patients would have met ASAS criteria for the disease at baseline, Dr. Haroon cautioned. In addition, the small sample size precluded subgroup analyses.

“The overall conclusion should be, this is a negative study, rather than state there was a trend to better improvement on etanercept. Although there are practical implications, as mentioned, I don’t think this study, with the numbers and the results presented, will change clinical practice,” he said.

The question of stopping biologics in nr-axSpA was previously addressed in the ABILITY-3 randomized trial of adalimumab (Humira), which found that flares were significantly more common with stopping versus continuing the drug and only about half of patients were able to get back in remission by restarting the drug, according to Dr. Haroon.

However, the RE-EMBARK and ABILITY-3 studies differed in both design and patient population, he noted. For example, the mean disease duration was only about 2 years in the former study, compared with 7 years in the latter.

The initial 59% rate of attaining inactive disease on etanercept in RE-EMBARK was “impressive,” Dr. Haroon said, “but as this was an open-label study, higher values are expected.”

“The message in both studies is that stopping biologics completely is not a good idea as the majority of patients, 70%-75%, will relapse within a short period,” he concluded. “However, it should be kept in mind that these [RE-EMBARK] patients received biologic only for a short 24-week period. This study does not answer the question of whether nonradiographic axial spondyloarthritis patients with sustained inactive disease can be taken off biologics abruptly without a taper over time.”

Details of the studies

In the PrevAS trial, Tamara Rusman, a PhD candidate in Rheumatology at the VU University Medical Center Amsterdam and coinvestigators studied patients meeting Calin criteria for inflammatory back pain who had high disease activity plus either HLA-B27 positivity with at least one feature of axial spondyloarthritis or HLA-B27 negativity with two features.

This population is of interest because “most studies have included only patients with nonradiographic axial spondyloarthritis with a positive MRI of the sacroiliac joints and/or an elevated C-reactive protein level,” she noted.

Results showed that, during 16 weeks of treatment, etanercept users had a nonsignficantly higher rate of achieving an ASAS 20 response with etanercept versus placebo users (17% vs. 11%; hazard ratio, 2.1; P = .2). The etanercept group also had a somewhat higher rate of response as defined by the Ankylosing Spondylitis Disease Activity Score CRP (ASDAS-CRP) criterion (25% vs. 13%; hazard ratio, 1.1; P = .8).

“Based on these data, early treatment in inflammatory back pain patients prone to develop axial spondyloarthritis seems not to be useful,” Ms. Rusman concluded. “However, monitoring of these patients should be continued since they remain a risk group for developing axial spondyloarthritis.”

In the RE-EMBARK trial, investigators led by Filip Van den Bosch, MD, PhD, Rheumatology Head-of-Clinic at Ghent (Belgium) University Hospital, started with a cohort of 208 patients with nr-axSpA who were given etanercept and background NSAIDs for 24 weeks.

“Current guidelines do not agree on whether a TNF-blocking agent or another biological DMARD should be tapered once a status of low disease activity or remission is achieved,” he noted.

Overall, 59% of the patients achieved inactive disease (defined as an ASDAS-CRP < 1.3) and discontinued etanercept.

During the next 40 weeks, 24% of these patients maintained inactive disease with only the background NSAID therapy. Among the 75% who experienced a flare, defined as an ASDAS with erythrocyte sedimentation rate (ASDAS-ESR) score of 2.1 or greater, the median time to flare was 16.1 weeks. Fully 62% of this group were able to regain disease inactivity within 12 weeks of restarting etanercept.

In a comparative analysis, relative to the RE-EMBARK patients discontinuing etanercept, similar patients who continued etanercept on the companion EMBARK trial had a longer time to flare (P < .0001) and an 85% lower risk of this outcome.

“There were no new safety signals identified, and as expected, the number of treatment-emergent adverse events dropped during the drug-free period and, interestingly, remained stable over retreatment,” Dr. Van den Bosch noted.

“Temporarily discontinuing etanercept may be an option for some patients with stable inactive nonradiographic axial spondyloarthritis,” he concluded.

The PrevAS trial was financially supported by Pfizer and ReumaNederland. Ms. Rusman declared no relevant conflicts of interest; four coauthors reported financial relationship(s) with Pfizer and other pharmaceutical companies. The RE-EMBARK trial was sponsored by Pfizer. Dr. Van den Bosch disclosed receiving grant/research support from AbbVie, Merck, and UCB, and consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. Four coauthors reported financial ties to Pfizer and other pharmaceutical companies, and five coauthors were employees and shareholders of Pfizer.

SOURCES: Rusman T et al. Ann Rheum Dis. 2020;79[suppl 1]:72-3; and Van den Bosch F et al. Ann Rheum Dis. 2020;79[suppl 1]:70.

With new daily coronavirus cases rising in at least two dozen states, an explosion of new infections in Arizona is stretching some hospitals and alarming public health experts who link the surge in cases to the state’s lifting of a stay-at-home order a month ago.

Arizona has emerged as one of the country’s newest coronavirus hot spots, with the weekly average of daily cases more than doubling from 2 weeks ago. The total number of people hospitalized is climbing, too.

Over the past week, Arizona has seen an average of more than 1,300 new COVID-19 cases each day.

After the state’s largest hospital system warned about a shortage of ICU beds, Arizona Gov. Doug Ducey, a Republican, pushed back on claims that the health care system could soon be overwhelmed.

“The entire time we’ve been focused on a possible worst-case scenario with surge capacity for hospital beds, ICU beds and ventilators,” Ducey told reporters on Thursday. “Those are not needed or necessary right now.”

While he acknowledged a spike in positive cases, Ducey said a second stay-at-home order was “not under discussion.”

“We put the stay-at-home order there so we could prepare for what we are going through,” he said.

Some states have reopened more slowly with a set of specific benchmarks for different regions, but Arizona took a more aggressive approach.

The state began easing restrictions on businesses in early May and lifted its statewide lockdown order after May 15. Under Arizona’s reopening plan, businesses are advised to follow federal guidance on social distancing.

There is also no requirement for everyone to wear masks in public.

Public health experts agree: The timing of this spike reflects the state’s reopening.

“Perhaps, Arizona will be a warning sign to other areas,” said Katherine Ellingson, an epidemiologist at the University of Arizona. “We never had that consistent downward trend that would signal it’s time to reopen and we have everything in place to do it safely.”

Before Arizona lifted its stay-at-home order, only about 5% of COVID-19 tests registered as positive. On Monday, that number was around 16%.

A slower reopening gives public health agencies time to identify whether cases are rising and then respond with contact tracing and isolating those who are infected.

“With a fast, rapid reopening, we don’t have the time to mobilize those resources,” said Ellingson.

Maricopa County, home to about 60% of the state’s population, has ramped up contact tracing in recent weeks, but it may not have enough capacity if the surge in cases continues.

Dr. Peter Hotez said the spike in Arizona, as well as in parts of Texas such as Houston, Dallas and Austin, is the consequence of removing restrictions too quickly and without a public health system that can keep pace.

“It was just ‘open it up’ and then more or less business as usual, with a little bit of window dressing,” said Hotez, the dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston. “This is not an abstract number of cases. We’re seeing people pile into intensive care units.”

Arizona’s governor has also faced criticism from the mayors of Arizona’s two biggest cities for not putting in place more stringent requirements.

“There is a pandemic and it’s spreading uncontrollably,” said Tucson Mayor Regina Romero, a Democrat. Ducey, she said, “is just putting up his hands and saying ‘the spread is happening and we just have to go about our business.’”

And the governor’s executive order forbids local governments from implementing their own extra measures, which adds to Romero’s frustration. Texas has a similar measure.

“What he did was pretty much tie the hands of mayors and public health officials,” Romero said.

Arizona’s hospital industry has tried to tamp down fears that it’s on the verge of a crisis. Hospitals are still performing elective surgeries.

“It’s very unfortunate because hospitals right now in Arizona are quite busy with elective procedures,” said Saskia Popescu, a Phoenix-based epidemiologist with George Mason University. “You throw in increasing cases of COVID, and that’s going to very much stress your hospital systems.”

Phoenix’s triple-digit summer temperatures actually may fuel the spread of the virus. People forgo outdoor activities and retreat to air-conditioned indoor spaces, where the risk of transmitting the virus goes up significantly.

“My concern is we’re going to see a lot more people in close quarters for prolonged periods of time,” Popescu said.

Since the stay-at-home order was lifted, Popescu and others say they’ve seen people returning to a pre-pandemic mindset, neglecting to wear masks or maintain social distance. Videos of crowded bars have only propelled these fears.

On Thursday, however, Arizona’s top doctor stressed there were also dangers to keeping the state on lockdown, including the mental health effects of loneliness and isolation.

“We know that it’s in the community. We are not going to be able to stop the spread. And so we can’t stop living as well,” said Dr. Cara Christ, health director for the Arizona Department of Health Services.

But Dr. Quinn Snyder, an emergency medicine physician in Mesa, Arizona, said there needs to be more consistent messaging on public health measures like wearing masks.

“Frankly, I just think a wholesale reevaluation of where we’re at is critical right now, but I can tell you that we’re not doing nearly enough,” said Snyder, who has seen the uptick in seriously ill COVID-19 patients firsthand.

“If we continue to head down this path, the virus will press our health care facilities beyond capacity, where we’re going to have to be making tough decisions like who gets a ventilator and who doesn’t.”

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

With new daily coronavirus cases rising in at least two dozen states, an explosion of new infections in Arizona is stretching some hospitals and alarming public health experts who link the surge in cases to the state’s lifting of a stay-at-home order a month ago.

Arizona has emerged as one of the country’s newest coronavirus hot spots, with the weekly average of daily cases more than doubling from 2 weeks ago. The total number of people hospitalized is climbing, too.

Over the past week, Arizona has seen an average of more than 1,300 new COVID-19 cases each day.

After the state’s largest hospital system warned about a shortage of ICU beds, Arizona Gov. Doug Ducey, a Republican, pushed back on claims that the health care system could soon be overwhelmed.

“The entire time we’ve been focused on a possible worst-case scenario with surge capacity for hospital beds, ICU beds and ventilators,” Ducey told reporters on Thursday. “Those are not needed or necessary right now.”

While he acknowledged a spike in positive cases, Ducey said a second stay-at-home order was “not under discussion.”

“We put the stay-at-home order there so we could prepare for what we are going through,” he said.

Some states have reopened more slowly with a set of specific benchmarks for different regions, but Arizona took a more aggressive approach.

The state began easing restrictions on businesses in early May and lifted its statewide lockdown order after May 15. Under Arizona’s reopening plan, businesses are advised to follow federal guidance on social distancing.

There is also no requirement for everyone to wear masks in public.

Public health experts agree: The timing of this spike reflects the state’s reopening.

“Perhaps, Arizona will be a warning sign to other areas,” said Katherine Ellingson, an epidemiologist at the University of Arizona. “We never had that consistent downward trend that would signal it’s time to reopen and we have everything in place to do it safely.”

Before Arizona lifted its stay-at-home order, only about 5% of COVID-19 tests registered as positive. On Monday, that number was around 16%.

A slower reopening gives public health agencies time to identify whether cases are rising and then respond with contact tracing and isolating those who are infected.

“With a fast, rapid reopening, we don’t have the time to mobilize those resources,” said Ellingson.

Maricopa County, home to about 60% of the state’s population, has ramped up contact tracing in recent weeks, but it may not have enough capacity if the surge in cases continues.

Dr. Peter Hotez said the spike in Arizona, as well as in parts of Texas such as Houston, Dallas and Austin, is the consequence of removing restrictions too quickly and without a public health system that can keep pace.

“It was just ‘open it up’ and then more or less business as usual, with a little bit of window dressing,” said Hotez, the dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston. “This is not an abstract number of cases. We’re seeing people pile into intensive care units.”

Arizona’s governor has also faced criticism from the mayors of Arizona’s two biggest cities for not putting in place more stringent requirements.

“There is a pandemic and it’s spreading uncontrollably,” said Tucson Mayor Regina Romero, a Democrat. Ducey, she said, “is just putting up his hands and saying ‘the spread is happening and we just have to go about our business.’”

And the governor’s executive order forbids local governments from implementing their own extra measures, which adds to Romero’s frustration. Texas has a similar measure.

“What he did was pretty much tie the hands of mayors and public health officials,” Romero said.

Arizona’s hospital industry has tried to tamp down fears that it’s on the verge of a crisis. Hospitals are still performing elective surgeries.

“It’s very unfortunate because hospitals right now in Arizona are quite busy with elective procedures,” said Saskia Popescu, a Phoenix-based epidemiologist with George Mason University. “You throw in increasing cases of COVID, and that’s going to very much stress your hospital systems.”

Phoenix’s triple-digit summer temperatures actually may fuel the spread of the virus. People forgo outdoor activities and retreat to air-conditioned indoor spaces, where the risk of transmitting the virus goes up significantly.

“My concern is we’re going to see a lot more people in close quarters for prolonged periods of time,” Popescu said.

Since the stay-at-home order was lifted, Popescu and others say they’ve seen people returning to a pre-pandemic mindset, neglecting to wear masks or maintain social distance. Videos of crowded bars have only propelled these fears.

On Thursday, however, Arizona’s top doctor stressed there were also dangers to keeping the state on lockdown, including the mental health effects of loneliness and isolation.

“We know that it’s in the community. We are not going to be able to stop the spread. And so we can’t stop living as well,” said Dr. Cara Christ, health director for the Arizona Department of Health Services.

But Dr. Quinn Snyder, an emergency medicine physician in Mesa, Arizona, said there needs to be more consistent messaging on public health measures like wearing masks.

“Frankly, I just think a wholesale reevaluation of where we’re at is critical right now, but I can tell you that we’re not doing nearly enough,” said Snyder, who has seen the uptick in seriously ill COVID-19 patients firsthand.

“If we continue to head down this path, the virus will press our health care facilities beyond capacity, where we’re going to have to be making tough decisions like who gets a ventilator and who doesn’t.”

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

With new daily coronavirus cases rising in at least two dozen states, an explosion of new infections in Arizona is stretching some hospitals and alarming public health experts who link the surge in cases to the state’s lifting of a stay-at-home order a month ago.

Arizona has emerged as one of the country’s newest coronavirus hot spots, with the weekly average of daily cases more than doubling from 2 weeks ago. The total number of people hospitalized is climbing, too.

Over the past week, Arizona has seen an average of more than 1,300 new COVID-19 cases each day.

After the state’s largest hospital system warned about a shortage of ICU beds, Arizona Gov. Doug Ducey, a Republican, pushed back on claims that the health care system could soon be overwhelmed.

“The entire time we’ve been focused on a possible worst-case scenario with surge capacity for hospital beds, ICU beds and ventilators,” Ducey told reporters on Thursday. “Those are not needed or necessary right now.”

While he acknowledged a spike in positive cases, Ducey said a second stay-at-home order was “not under discussion.”

“We put the stay-at-home order there so we could prepare for what we are going through,” he said.

Some states have reopened more slowly with a set of specific benchmarks for different regions, but Arizona took a more aggressive approach.

The state began easing restrictions on businesses in early May and lifted its statewide lockdown order after May 15. Under Arizona’s reopening plan, businesses are advised to follow federal guidance on social distancing.

There is also no requirement for everyone to wear masks in public.

Public health experts agree: The timing of this spike reflects the state’s reopening.

“Perhaps, Arizona will be a warning sign to other areas,” said Katherine Ellingson, an epidemiologist at the University of Arizona. “We never had that consistent downward trend that would signal it’s time to reopen and we have everything in place to do it safely.”

Before Arizona lifted its stay-at-home order, only about 5% of COVID-19 tests registered as positive. On Monday, that number was around 16%.

A slower reopening gives public health agencies time to identify whether cases are rising and then respond with contact tracing and isolating those who are infected.

“With a fast, rapid reopening, we don’t have the time to mobilize those resources,” said Ellingson.

Maricopa County, home to about 60% of the state’s population, has ramped up contact tracing in recent weeks, but it may not have enough capacity if the surge in cases continues.

Dr. Peter Hotez said the spike in Arizona, as well as in parts of Texas such as Houston, Dallas and Austin, is the consequence of removing restrictions too quickly and without a public health system that can keep pace.

“It was just ‘open it up’ and then more or less business as usual, with a little bit of window dressing,” said Hotez, the dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston. “This is not an abstract number of cases. We’re seeing people pile into intensive care units.”

Arizona’s governor has also faced criticism from the mayors of Arizona’s two biggest cities for not putting in place more stringent requirements.

“There is a pandemic and it’s spreading uncontrollably,” said Tucson Mayor Regina Romero, a Democrat. Ducey, she said, “is just putting up his hands and saying ‘the spread is happening and we just have to go about our business.’”

And the governor’s executive order forbids local governments from implementing their own extra measures, which adds to Romero’s frustration. Texas has a similar measure.

“What he did was pretty much tie the hands of mayors and public health officials,” Romero said.

Arizona’s hospital industry has tried to tamp down fears that it’s on the verge of a crisis. Hospitals are still performing elective surgeries.

“It’s very unfortunate because hospitals right now in Arizona are quite busy with elective procedures,” said Saskia Popescu, a Phoenix-based epidemiologist with George Mason University. “You throw in increasing cases of COVID, and that’s going to very much stress your hospital systems.”

Phoenix’s triple-digit summer temperatures actually may fuel the spread of the virus. People forgo outdoor activities and retreat to air-conditioned indoor spaces, where the risk of transmitting the virus goes up significantly.

“My concern is we’re going to see a lot more people in close quarters for prolonged periods of time,” Popescu said.

Since the stay-at-home order was lifted, Popescu and others say they’ve seen people returning to a pre-pandemic mindset, neglecting to wear masks or maintain social distance. Videos of crowded bars have only propelled these fears.

On Thursday, however, Arizona’s top doctor stressed there were also dangers to keeping the state on lockdown, including the mental health effects of loneliness and isolation.

“We know that it’s in the community. We are not going to be able to stop the spread. And so we can’t stop living as well,” said Dr. Cara Christ, health director for the Arizona Department of Health Services.

But Dr. Quinn Snyder, an emergency medicine physician in Mesa, Arizona, said there needs to be more consistent messaging on public health measures like wearing masks.

“Frankly, I just think a wholesale reevaluation of where we’re at is critical right now, but I can tell you that we’re not doing nearly enough,” said Snyder, who has seen the uptick in seriously ill COVID-19 patients firsthand.

“If we continue to head down this path, the virus will press our health care facilities beyond capacity, where we’re going to have to be making tough decisions like who gets a ventilator and who doesn’t.”

A version of this article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

A proactive long-term strategy of maintenance therapy involving twice-weekly application of combined calcipotriene and betamethasone dipropionate spray foam was safe and effective in patients with moderate plaque psoriasis in the international, randomized PSO-LONG clinical trial, Mark Lebwohl, MD, reported at the virtual annual meeting of the American Academy of Dermatology.

The median time to first relapse – the primary study endpoint – was 56 days in patients randomized to the twice-weekly fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam (Enstilar), a significantly better outcome than the median 30 days for controls assigned to foam vehicle. Moreover, it took 169 days for 75% of patients on the combination foam to experience their first relapse: three times longer than in controls, added Dr. Lebwohl, principal investigator for PSO-LONG and professor and chair of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

The positive results “could have been predicted,” he said in an interview. “But what really distinguishes this study from others is that no one before has ever done a placebo-controlled, double-blind trial with a topical steroid that lasted a year. This is a first, and we’ve shown that if you limit treatment to twice a week you get dramatic improvements in efficacy at no cost in terms of safety.”

The combination spray foam is approved by the Food and Drug Administration as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid. However, psoriasis is a chronic disease. The PSO-LONG trial was designed to study the impact of a for-now still-investigational long-term maintenance treatment strategy.

The open-label run-in period of the study included 640 adults with plaque psoriasis, 82% of whom had moderate disease at baseline as rated by Physician Global Assessment (PGA). Participants applied the combination foam once daily for 4 weeks. At that point, 80% of them had achieved a PGA rating of clear or almost clear with at least a two-grade improvement from baseline; these 521 responders were then randomized to 52 weeks of double-blind treatment with the combination foam or vehicle foam. Anyone who relapsed went on 4 weeks of once-daily active treatment with the combination foam, then returned to their original treatment arm.

The risk of a first relapse during the course of 1 year was 43% lower with the combination foam than in controls. The relapse rate over the year was 46% lower. Patients in the active treatment arm spent an average of 256.5 days in remission during the year, compared with 222 days in controls.

“That’s more than 1 month more time in remission during the year with active treatment. And remember, if patients flared, they went on daily therapy for a month,” the dermatologist noted.

The rate of treatment-related adverse events was similar in the two groups at 2.8 events per 100 patient-years in the combination foam arm and 4.5 per 100 patient-years in controls. The twice-weekly active treatment group had no increase in stretch marks, telangiectasias, skin atrophy, serum calcium, or abnormalities of the hypothalamic-pituitary-adrenal axis.

Although the combination foam is approved for daily use for a maximum of 1 month in adolescents and adults, PSO-LONG was restricted to adults.

“I think that what will happen in the marketplace is that the data obtained from this adult study will likely be applied to younger patients,” Dr. Lebwohl predicted.

He reported receiving an institutional research grant to conduct the trial from LEO Pharma, the study sponsor, as well as serving as a consultant to and researcher for the company.

bjancin@mdedge.com

A proactive long-term strategy of maintenance therapy involving twice-weekly application of combined calcipotriene and betamethasone dipropionate spray foam was safe and effective in patients with moderate plaque psoriasis in the international, randomized PSO-LONG clinical trial, Mark Lebwohl, MD, reported at the virtual annual meeting of the American Academy of Dermatology.

The median time to first relapse – the primary study endpoint – was 56 days in patients randomized to the twice-weekly fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam (Enstilar), a significantly better outcome than the median 30 days for controls assigned to foam vehicle. Moreover, it took 169 days for 75% of patients on the combination foam to experience their first relapse: three times longer than in controls, added Dr. Lebwohl, principal investigator for PSO-LONG and professor and chair of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

The positive results “could have been predicted,” he said in an interview. “But what really distinguishes this study from others is that no one before has ever done a placebo-controlled, double-blind trial with a topical steroid that lasted a year. This is a first, and we’ve shown that if you limit treatment to twice a week you get dramatic improvements in efficacy at no cost in terms of safety.”

The combination spray foam is approved by the Food and Drug Administration as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid. However, psoriasis is a chronic disease. The PSO-LONG trial was designed to study the impact of a for-now still-investigational long-term maintenance treatment strategy.

The open-label run-in period of the study included 640 adults with plaque psoriasis, 82% of whom had moderate disease at baseline as rated by Physician Global Assessment (PGA). Participants applied the combination foam once daily for 4 weeks. At that point, 80% of them had achieved a PGA rating of clear or almost clear with at least a two-grade improvement from baseline; these 521 responders were then randomized to 52 weeks of double-blind treatment with the combination foam or vehicle foam. Anyone who relapsed went on 4 weeks of once-daily active treatment with the combination foam, then returned to their original treatment arm.

The risk of a first relapse during the course of 1 year was 43% lower with the combination foam than in controls. The relapse rate over the year was 46% lower. Patients in the active treatment arm spent an average of 256.5 days in remission during the year, compared with 222 days in controls.

“That’s more than 1 month more time in remission during the year with active treatment. And remember, if patients flared, they went on daily therapy for a month,” the dermatologist noted.

The rate of treatment-related adverse events was similar in the two groups at 2.8 events per 100 patient-years in the combination foam arm and 4.5 per 100 patient-years in controls. The twice-weekly active treatment group had no increase in stretch marks, telangiectasias, skin atrophy, serum calcium, or abnormalities of the hypothalamic-pituitary-adrenal axis.

Although the combination foam is approved for daily use for a maximum of 1 month in adolescents and adults, PSO-LONG was restricted to adults.

“I think that what will happen in the marketplace is that the data obtained from this adult study will likely be applied to younger patients,” Dr. Lebwohl predicted.

He reported receiving an institutional research grant to conduct the trial from LEO Pharma, the study sponsor, as well as serving as a consultant to and researcher for the company.

bjancin@mdedge.com

A proactive long-term strategy of maintenance therapy involving twice-weekly application of combined calcipotriene and betamethasone dipropionate spray foam was safe and effective in patients with moderate plaque psoriasis in the international, randomized PSO-LONG clinical trial, Mark Lebwohl, MD, reported at the virtual annual meeting of the American Academy of Dermatology.

The median time to first relapse – the primary study endpoint – was 56 days in patients randomized to the twice-weekly fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam (Enstilar), a significantly better outcome than the median 30 days for controls assigned to foam vehicle. Moreover, it took 169 days for 75% of patients on the combination foam to experience their first relapse: three times longer than in controls, added Dr. Lebwohl, principal investigator for PSO-LONG and professor and chair of the department of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

The positive results “could have been predicted,” he said in an interview. “But what really distinguishes this study from others is that no one before has ever done a placebo-controlled, double-blind trial with a topical steroid that lasted a year. This is a first, and we’ve shown that if you limit treatment to twice a week you get dramatic improvements in efficacy at no cost in terms of safety.”

The combination spray foam is approved by the Food and Drug Administration as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid. However, psoriasis is a chronic disease. The PSO-LONG trial was designed to study the impact of a for-now still-investigational long-term maintenance treatment strategy.

The open-label run-in period of the study included 640 adults with plaque psoriasis, 82% of whom had moderate disease at baseline as rated by Physician Global Assessment (PGA). Participants applied the combination foam once daily for 4 weeks. At that point, 80% of them had achieved a PGA rating of clear or almost clear with at least a two-grade improvement from baseline; these 521 responders were then randomized to 52 weeks of double-blind treatment with the combination foam or vehicle foam. Anyone who relapsed went on 4 weeks of once-daily active treatment with the combination foam, then returned to their original treatment arm.

The risk of a first relapse during the course of 1 year was 43% lower with the combination foam than in controls. The relapse rate over the year was 46% lower. Patients in the active treatment arm spent an average of 256.5 days in remission during the year, compared with 222 days in controls.

“That’s more than 1 month more time in remission during the year with active treatment. And remember, if patients flared, they went on daily therapy for a month,” the dermatologist noted.

The rate of treatment-related adverse events was similar in the two groups at 2.8 events per 100 patient-years in the combination foam arm and 4.5 per 100 patient-years in controls. The twice-weekly active treatment group had no increase in stretch marks, telangiectasias, skin atrophy, serum calcium, or abnormalities of the hypothalamic-pituitary-adrenal axis.

Although the combination foam is approved for daily use for a maximum of 1 month in adolescents and adults, PSO-LONG was restricted to adults.

“I think that what will happen in the marketplace is that the data obtained from this adult study will likely be applied to younger patients,” Dr. Lebwohl predicted.

He reported receiving an institutional research grant to conduct the trial from LEO Pharma, the study sponsor, as well as serving as a consultant to and researcher for the company.

bjancin@mdedge.com

Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.

copyright/Jupiterimages/Getty Images

And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.

“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.

Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.

“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
 

SWAN study: White women consume the most dairy

As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.

The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.

A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.

“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.

“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.

They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.

There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
 

Findings on dairy and bone are inconsistent

The authors caution that several factors should be taken into account when considering these new findings.

“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.

Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.

They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.

But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.

In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.

Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”

The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.

We “may need to look at different types of dairy products,” he said.

Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
 

Vitamin D data were not available; dairy may help in this respect

Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.

Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.

A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.

Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.

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

Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.

copyright/Jupiterimages/Getty Images

And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.

“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.

Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.

“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
 

SWAN study: White women consume the most dairy

As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.

The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.

A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.

“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.

“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.

They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.

There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
 

Findings on dairy and bone are inconsistent

The authors caution that several factors should be taken into account when considering these new findings.

“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.

Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.

They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.

But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.

In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.

Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”

The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.

We “may need to look at different types of dairy products,” he said.

Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
 

Vitamin D data were not available; dairy may help in this respect

Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.

Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.

A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.

Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.

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

Dairy consumption does not improve bone mineral density (BMD) or reduce the risk of osteoporotic fracture in women starting menopause, a new analysis of the Study of Women’s Health Across the Nation (SWAN) indicates.

copyright/Jupiterimages/Getty Images

And this was regardless of baseline menopausal status, say Taylor Wallace, PhD, of George Mason University, Fairfax, Va., and colleagues in their article published online in Menopause.

“Our previous work indicated a potential premenopausal critical window in regard to the effectiveness of calcium supplements,” they noted.

Clifford Rosen, MD, professor of medicine, Tufts University, Boston, said in an interview that he believes the study reinforces earlier work that dairy intake in women aged 45-55 years does not affect the rate of bone loss or fractures.

“The SWAN study is longitudinal and with sufficient numbers to support their conclusion,” Dr. Rosen said.
 

SWAN study: White women consume the most dairy

As dairy is known to be one of the foremost sources of calcium, along with other bone beneficial nutrients, Dr. Wallace and colleagues decided to examine intake of this food type with long-term bone health using the SWAN data.

The SWAN bone substudy started in 1996 and involved 3,302 pre- or early perimenopausal women aged 42-53 years. The sample size for the annualized rate of BMD loss and fracture analysis involved 1955 women.

A modified food frequency questionnaire was used at baseline, at visit 5, and again at visit 9 to record daily dairy consumption, among many other food items.

“Women were classified into four dairy groups based on this cumulative average dairy intake,” Wallace and colleagues note. Intake was grouped into < 0.5 servings/day; 0.5 to < 1.5 servings/day; 1.5 to < 2.5 servings/day, and ≥ 2.5 servings/day.

“Non-Hispanic white individuals were more likely to consume higher amounts of dairy compared to African American, Chinese, and Japanese individuals,” the authors noted.

They found no significant differences for baseline age, body mass index, femoral neck and lumbar spine BMD, calcium supplement use, or fracture history by dairy intake group.

There were also no differences in the hazard ratios or relative risk of nontraumatic fractures by frequency of daily dairy intake.
 

Findings on dairy and bone are inconsistent

The authors caution that several factors should be taken into account when considering these new findings.

“First, dairy intake was low [overall] among SWAN participants, with 65% reporting consumption of < 1.5 servings/day,” they point out.

Dairy intake was also “particularly low” among racial groups other than whites, which may be due to higher rates of lactose intolerance among ethnic minorities, they speculate.

They previously reported that the use of calcium dietary supplements in SWAN was associated with a lower annualized rate of femoral neck BMD loss as well as BMD loss at the lumbar spine over 10 years of follow-up, mainly in women who were premenopausal at baseline.

But no associations were observed in the risk of bone fracture in any women in that analysis, regardless of menopausal status.

In this new analysis, there were no significant differences in calcium supplement use across the dairy intake groups.

Dr. Wallace and colleagues also noted that the relevance of dairy product intake for bone health has been in question as some observational studies have even “suggested consumption to be associated with an increased risk of fractures.”

The lead author of one of these studies, Karl Michaelsson, MD, PhD, of Uppsala (Sweden) University, said in an interview that his study had looked only at milk intake, and the lack of benefit on bone health from high milk consumption may not apply to all dairy products.

We “may need to look at different types of dairy products,” he said.

Summing up, Stephanie Faubion, MD, MBA, medical director of the North American Menopause Society, said the new SWAN findings do add to the evidence base, “albeit inconsistent ... suggesting a lack of benefit from dairy intake on BMD and fracture risk.”
 

Vitamin D data were not available; dairy may help in this respect

Dr. Rosen also noted that no information was available on vitamin D levels in patients involved in SWAN, which he believes is a limitation of the study.

Nevertheless, “it is important to recognize that elderly individuals who increase their dairy intake may have health benefits as recognized in the Nurses’ Health Study, possibly due to increased protein intake, higher vitamin D levels, or greater calcium intake,” he observed.

A randomized trial of enhanced dairy intake in long-term care residents is currently underway, which should provide answers for a much more vulnerable population than those in the SWAN cohort, Dr. Rosen concluded.

Dr. Wallace has reported serving on the scientific advisory board of the Vitamin Shoppe and has received research support from the National Dairy Council and scientific consulting fees from several food companies. Dr. Rosen has reported no relevant financial relationships.

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

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at pdnews@mdedge.com.
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
 

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at pdnews@mdedge.com.
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
 

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at pdnews@mdedge.com.
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.