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The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

The Food and Drug Administration has expanded an emergency use authorization (EUA), allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.

According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both initial doses of Pfizer’s COVID-19 vaccine, and 35.3% have received their first dose.

Pfizer’s vaccine trial involving 4,500 children showed few side effects among children younger than 12 who received a booster, or third dose, according to a company statement.

Pfizer asked the FDA for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.

A study done by the New York State Department of Health showed the effectiveness of Pfizer’s two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was given to children 5 to 11 during the Omicron surge. A CDC study published in March also showed that the Pfizer shot reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.

To some experts, this data suggest an even greater need for children under 12 to be eligible for a third dose.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.

The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices is set to meet on May 19 to discuss boosters in this age group.

FDA advisory panels plan to meet next month to discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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

The Pfizer-BioNTech mRNA vaccine (Comirnaty) showed a good safety profile with minimal short-term side effects and no negative impact on disease activity in a cohort of adolescents and young adults with rheumatic diseases, according to research presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance, held virtually this year.

Only 3% of patients experience a severe transient adverse event, according to Merav Heshin-Bekenstein, MD, of Dana-Dwek Children’s Hospital at the Tel Aviv Sourasky Medical Center in Israel. The findings were published in Rheumatology.

Courtesy Dr. Heshin-Bekenstein

“We found that the mRNA Pfizer vaccine was immunogenic and induced an adequate humoral immune response in adolescent patients,” Dr. Heshin-Bekenstein told CARRA attendees. “It was definitely comparable to healthy controls and practically all patients were seropositive following the second vaccine, except for one patient with long-standing systemic sclerosis.”

The findings were not necessarily surprising but were encouraging to Melissa S. Oliver, MD, assistant professor of clinical pediatrics in the division of pediatric rheumatology at Indiana University, Indianapolis. Dr. Oliver wasn’t part of the study team.

“We know that the COVID vaccines in healthy adolescents have shown good efficacy with minimal side effects, and it’s good to see that this study showed that in those with rheumatic diseases on immunosuppressive therapy,” Dr. Oliver told this news organization.

Until now, the data on COVID-19 vaccines in teens with rheumatic illnesses has been limited, she said, so “many pediatric rheumatologists only have the data from adult studies to go on or personal experience with their own cohort of patients.”

But the high immunogenicity seen in the study was a pleasant surprise to Beth H. Rutstein, MD, assistant professor of clinical pediatrics in the division of rheumatology at Children’s Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania.

“I was both surprised and thrilled with Dr. Heshin-Bekenstein’s findings suggesting near-universal seroconversion for patients with rheumatic disease regardless of underlying diagnosis or immunomodulatory therapy regimen, as much of the adult data has suggested a poorer seroconversion rate” and lower antibody titers in adults with similar illnesses, Dr. Rutstein said in an interview.

The study “provides essential reassurance that vaccination against COVID-19 does not increase the risk of disease flare or worsen disease severity scores,” said Dr. Rutstein, who was not associated with the research. “Rather than speaking purely anecdotally with our patients and their families, we can refer to the science – which is always more reassuring for both our patients and ourselves.”
 

Study included diverse conditions and therapies

Risk factors for poor outcomes with COVID-19 in children include obesity, cardiovascular disease, chronic lung disease, diabetes, and asthma, Dr. Heshin-Bekenstein told CARRA attendees. Multisystem inflammatory syndrome in children (MIS-C) and long COVID are also potential complications of COVID-19 with less understood risk factors.

Although COVID-19 is most often mild in children, certain severe, systemic rheumatic diseases increase hospitalization risk, including systemic lupus erythematosus (SLE) and vasculitis. Evidence has also shown that COVID-19 infection increases the risk of disease flare in teens with juvenile-onset rheumatic diseases, so it’s “crucial to prevent COVID-19 disease in this population,” Dr. Heshin-Bekenstein said.

Her study therefore aimed to assess the safety and immunogenicity of the Pfizer mRNA vaccine for teens with juvenile-onset rheumatic diseases and those taking immunomodulatory medications. The international prospective multicenter study ran from April to November 2021 at three pediatric rheumatology clinics in Israel and one in Slovenia. Endpoints included short-term side effects, vaccination impact on clinical disease activity, immunogenicity at 2-9 weeks after the second dose, and, secondarily, efficacy against COVID-19 infection.

The 91 participants included adolescents aged 12-18 and young adults aged 18-21. Nearly half of the participants (46%) had juvenile idiopathic arthritis (JIA), and 14% had SLE. Other participants’ conditions included systemic vasculitis, idiopathic uveitis, inflammatory bowel disease–related arthritis, systemic or localized scleroderma, juvenile dermatomyositis, or an autoinflammatory disease. Participants’ mean disease duration was 4.8 years.  

The researchers compared the patients with a control group of 40 individuals with similar demographics but without rheumatic disease. The researchers used the LIAISON quantitative assay to assess serum IgG antibody levels against the SARS-CoV-2 spike protein in both groups.

Eight in 10 participants with rheumatic disease were taking an immunomodulatory medication, including a conventional synthetic disease-modifying antirheumatic drug (csDMARD) in 40%, a biologic DMARD in 37%, tumor necrosis factor (TNF) inhibitors in 32%, hydroxychloroquine (HCQ) in 19%, glucocorticoids in 14%, and mycophenolate in 11%. A smaller proportion were on other biologics: JAK inhibitors in 6.6%, anti-CD20 drugs in 4.4%, and an IL-6 inhibitor in 1%.
 

Side effects similar in both groups

None of the side effects reported by participants were statistically different between those with rheumatic disease and the control group. Localized pain was the most common side effect, reported by 73%-79% of participants after each dose. About twice as many participants with rheumatic disease experienced muscle aches and joint pains, compared with the control group, but the differences were not significant. Fever occurred more often in those with rheumatic disease (6%, five cases) than without (3%, one case). One-third of those with rheumatic disease felt tiredness, compared with 20% of the control group.

None of the healthy controls were hospitalized after vaccination, but three rheumatic patients were, including two after the first dose. Both were 17 years old, had systemic vasculitis with granulomatosis with polyangiitis (GPA), and were taking rituximab (Rituxan). One patient experienced acute onset of chronic renal failure, fever, dehydration, and high C-reactive protein within hours of vaccination. The other experienced new onset of pulmonary hemorrhage a week after vaccination.

In addition, a 14-year-old female with lupus, taking only HCQ, went to the emergency department with fever, headache, vomiting, and joint pain 1 day after the second vaccine dose. She had normal inflammatory markers and no change in disease activity score, and she was discharged with low-dose steroids tapered after 2 weeks.
 

Immune response high in patients with rheumatic disease

Immunogenicity was similar in both groups, with 97% seropositivity in the rheumatic disease group and 100% in the control group. Average IgG titers were 242 in the rheumatic group and 388 in the control group (P < .0001). Seropositivity was 88% in those taking mycophenolate with another drug (100% with mycophenolate monotherapy), 90% with HCQ, 94% with any csDMARDs and another drug (100% with csDMARD monotherapy), and 100% for all other drugs. During 3 months’ follow-up after vaccination, there were no COVID-19 cases among the participants.

Dr. Heshin-Bekenstein noted that their results showed better immunogenicity in teens, compared with adults, for two specific drugs. Seropositivity in teens taking methotrexate (Rheumatrex, Trexall) or rituximab was 100% in this study, compared with 84% in adults taking methotrexate and 39% in adults taking rituximab in a previous study. However, only three patients in this study were taking rituximab, and only seven were taking methotrexate.

The study’s heterogenous population was both a strength and a weakness of the study. “Due to the diversity of rheumatic diseases and medications included in this cohort, it was not possible to draw significant conclusions regarding the impact of the immunomodulatory medications and type of disease” on titers, Dr. Heshin-Bekenstein told attendees.

Still, “I think as pediatric rheumatologists, we can feel reassured in recommending the COVID-19 vaccine to our patients,” Dr. Oliver said. “I will add that every patient is different, and everyone should have a conversation with their physician about receiving the COVID-19 vaccine.” Dr. Oliver said she discusses vaccination, including COVID vaccination, with every patient, and it’s been challenging to address concerns in the midst of so much misinformation circulating about the vaccine.

These findings do raise questions about whether it’s still necessary to hold immunomodulatory medications to get the vaccine,” Dr. Rutstein said.

“Many families are nervous to pause their medications before and after the vaccine as is currently recommended for many therapies by the American College of Rheumatology, and I do share that concern for some of my patients with more clinically unstable disease, so I try to work with each family to decide on best timing and have delayed or deferred the series until some patients are on a steady dose of a new immunomodulatory medication if it has been recently started,” Dr. Rutstein said. “This is one of the reasons why Dr. Heshin-Bekenstein’s study is so important – we may be holding medications that can be safely continued and even further decrease the risk of disease flare.”

None of the physicians have disclosed any relevant financial relationships.

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

The Pfizer-BioNTech mRNA vaccine (Comirnaty) showed a good safety profile with minimal short-term side effects and no negative impact on disease activity in a cohort of adolescents and young adults with rheumatic diseases, according to research presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance, held virtually this year.

Only 3% of patients experience a severe transient adverse event, according to Merav Heshin-Bekenstein, MD, of Dana-Dwek Children’s Hospital at the Tel Aviv Sourasky Medical Center in Israel. The findings were published in Rheumatology.

Courtesy Dr. Heshin-Bekenstein

“We found that the mRNA Pfizer vaccine was immunogenic and induced an adequate humoral immune response in adolescent patients,” Dr. Heshin-Bekenstein told CARRA attendees. “It was definitely comparable to healthy controls and practically all patients were seropositive following the second vaccine, except for one patient with long-standing systemic sclerosis.”

The findings were not necessarily surprising but were encouraging to Melissa S. Oliver, MD, assistant professor of clinical pediatrics in the division of pediatric rheumatology at Indiana University, Indianapolis. Dr. Oliver wasn’t part of the study team.

“We know that the COVID vaccines in healthy adolescents have shown good efficacy with minimal side effects, and it’s good to see that this study showed that in those with rheumatic diseases on immunosuppressive therapy,” Dr. Oliver told this news organization.

Until now, the data on COVID-19 vaccines in teens with rheumatic illnesses has been limited, she said, so “many pediatric rheumatologists only have the data from adult studies to go on or personal experience with their own cohort of patients.”

But the high immunogenicity seen in the study was a pleasant surprise to Beth H. Rutstein, MD, assistant professor of clinical pediatrics in the division of rheumatology at Children’s Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania.

“I was both surprised and thrilled with Dr. Heshin-Bekenstein’s findings suggesting near-universal seroconversion for patients with rheumatic disease regardless of underlying diagnosis or immunomodulatory therapy regimen, as much of the adult data has suggested a poorer seroconversion rate” and lower antibody titers in adults with similar illnesses, Dr. Rutstein said in an interview.

The study “provides essential reassurance that vaccination against COVID-19 does not increase the risk of disease flare or worsen disease severity scores,” said Dr. Rutstein, who was not associated with the research. “Rather than speaking purely anecdotally with our patients and their families, we can refer to the science – which is always more reassuring for both our patients and ourselves.”
 

Study included diverse conditions and therapies

Risk factors for poor outcomes with COVID-19 in children include obesity, cardiovascular disease, chronic lung disease, diabetes, and asthma, Dr. Heshin-Bekenstein told CARRA attendees. Multisystem inflammatory syndrome in children (MIS-C) and long COVID are also potential complications of COVID-19 with less understood risk factors.

Although COVID-19 is most often mild in children, certain severe, systemic rheumatic diseases increase hospitalization risk, including systemic lupus erythematosus (SLE) and vasculitis. Evidence has also shown that COVID-19 infection increases the risk of disease flare in teens with juvenile-onset rheumatic diseases, so it’s “crucial to prevent COVID-19 disease in this population,” Dr. Heshin-Bekenstein said.

Her study therefore aimed to assess the safety and immunogenicity of the Pfizer mRNA vaccine for teens with juvenile-onset rheumatic diseases and those taking immunomodulatory medications. The international prospective multicenter study ran from April to November 2021 at three pediatric rheumatology clinics in Israel and one in Slovenia. Endpoints included short-term side effects, vaccination impact on clinical disease activity, immunogenicity at 2-9 weeks after the second dose, and, secondarily, efficacy against COVID-19 infection.

The 91 participants included adolescents aged 12-18 and young adults aged 18-21. Nearly half of the participants (46%) had juvenile idiopathic arthritis (JIA), and 14% had SLE. Other participants’ conditions included systemic vasculitis, idiopathic uveitis, inflammatory bowel disease–related arthritis, systemic or localized scleroderma, juvenile dermatomyositis, or an autoinflammatory disease. Participants’ mean disease duration was 4.8 years.  

The researchers compared the patients with a control group of 40 individuals with similar demographics but without rheumatic disease. The researchers used the LIAISON quantitative assay to assess serum IgG antibody levels against the SARS-CoV-2 spike protein in both groups.

Eight in 10 participants with rheumatic disease were taking an immunomodulatory medication, including a conventional synthetic disease-modifying antirheumatic drug (csDMARD) in 40%, a biologic DMARD in 37%, tumor necrosis factor (TNF) inhibitors in 32%, hydroxychloroquine (HCQ) in 19%, glucocorticoids in 14%, and mycophenolate in 11%. A smaller proportion were on other biologics: JAK inhibitors in 6.6%, anti-CD20 drugs in 4.4%, and an IL-6 inhibitor in 1%.
 

Side effects similar in both groups

None of the side effects reported by participants were statistically different between those with rheumatic disease and the control group. Localized pain was the most common side effect, reported by 73%-79% of participants after each dose. About twice as many participants with rheumatic disease experienced muscle aches and joint pains, compared with the control group, but the differences were not significant. Fever occurred more often in those with rheumatic disease (6%, five cases) than without (3%, one case). One-third of those with rheumatic disease felt tiredness, compared with 20% of the control group.

None of the healthy controls were hospitalized after vaccination, but three rheumatic patients were, including two after the first dose. Both were 17 years old, had systemic vasculitis with granulomatosis with polyangiitis (GPA), and were taking rituximab (Rituxan). One patient experienced acute onset of chronic renal failure, fever, dehydration, and high C-reactive protein within hours of vaccination. The other experienced new onset of pulmonary hemorrhage a week after vaccination.

In addition, a 14-year-old female with lupus, taking only HCQ, went to the emergency department with fever, headache, vomiting, and joint pain 1 day after the second vaccine dose. She had normal inflammatory markers and no change in disease activity score, and she was discharged with low-dose steroids tapered after 2 weeks.
 

Immune response high in patients with rheumatic disease

Immunogenicity was similar in both groups, with 97% seropositivity in the rheumatic disease group and 100% in the control group. Average IgG titers were 242 in the rheumatic group and 388 in the control group (P < .0001). Seropositivity was 88% in those taking mycophenolate with another drug (100% with mycophenolate monotherapy), 90% with HCQ, 94% with any csDMARDs and another drug (100% with csDMARD monotherapy), and 100% for all other drugs. During 3 months’ follow-up after vaccination, there were no COVID-19 cases among the participants.

Dr. Heshin-Bekenstein noted that their results showed better immunogenicity in teens, compared with adults, for two specific drugs. Seropositivity in teens taking methotrexate (Rheumatrex, Trexall) or rituximab was 100% in this study, compared with 84% in adults taking methotrexate and 39% in adults taking rituximab in a previous study. However, only three patients in this study were taking rituximab, and only seven were taking methotrexate.

The study’s heterogenous population was both a strength and a weakness of the study. “Due to the diversity of rheumatic diseases and medications included in this cohort, it was not possible to draw significant conclusions regarding the impact of the immunomodulatory medications and type of disease” on titers, Dr. Heshin-Bekenstein told attendees.

Still, “I think as pediatric rheumatologists, we can feel reassured in recommending the COVID-19 vaccine to our patients,” Dr. Oliver said. “I will add that every patient is different, and everyone should have a conversation with their physician about receiving the COVID-19 vaccine.” Dr. Oliver said she discusses vaccination, including COVID vaccination, with every patient, and it’s been challenging to address concerns in the midst of so much misinformation circulating about the vaccine.

These findings do raise questions about whether it’s still necessary to hold immunomodulatory medications to get the vaccine,” Dr. Rutstein said.

“Many families are nervous to pause their medications before and after the vaccine as is currently recommended for many therapies by the American College of Rheumatology, and I do share that concern for some of my patients with more clinically unstable disease, so I try to work with each family to decide on best timing and have delayed or deferred the series until some patients are on a steady dose of a new immunomodulatory medication if it has been recently started,” Dr. Rutstein said. “This is one of the reasons why Dr. Heshin-Bekenstein’s study is so important – we may be holding medications that can be safely continued and even further decrease the risk of disease flare.”

None of the physicians have disclosed any relevant financial relationships.

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

The Pfizer-BioNTech mRNA vaccine (Comirnaty) showed a good safety profile with minimal short-term side effects and no negative impact on disease activity in a cohort of adolescents and young adults with rheumatic diseases, according to research presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance, held virtually this year.

Only 3% of patients experience a severe transient adverse event, according to Merav Heshin-Bekenstein, MD, of Dana-Dwek Children’s Hospital at the Tel Aviv Sourasky Medical Center in Israel. The findings were published in Rheumatology.

Courtesy Dr. Heshin-Bekenstein

“We found that the mRNA Pfizer vaccine was immunogenic and induced an adequate humoral immune response in adolescent patients,” Dr. Heshin-Bekenstein told CARRA attendees. “It was definitely comparable to healthy controls and practically all patients were seropositive following the second vaccine, except for one patient with long-standing systemic sclerosis.”

The findings were not necessarily surprising but were encouraging to Melissa S. Oliver, MD, assistant professor of clinical pediatrics in the division of pediatric rheumatology at Indiana University, Indianapolis. Dr. Oliver wasn’t part of the study team.

“We know that the COVID vaccines in healthy adolescents have shown good efficacy with minimal side effects, and it’s good to see that this study showed that in those with rheumatic diseases on immunosuppressive therapy,” Dr. Oliver told this news organization.

Until now, the data on COVID-19 vaccines in teens with rheumatic illnesses has been limited, she said, so “many pediatric rheumatologists only have the data from adult studies to go on or personal experience with their own cohort of patients.”

But the high immunogenicity seen in the study was a pleasant surprise to Beth H. Rutstein, MD, assistant professor of clinical pediatrics in the division of rheumatology at Children’s Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania.

“I was both surprised and thrilled with Dr. Heshin-Bekenstein’s findings suggesting near-universal seroconversion for patients with rheumatic disease regardless of underlying diagnosis or immunomodulatory therapy regimen, as much of the adult data has suggested a poorer seroconversion rate” and lower antibody titers in adults with similar illnesses, Dr. Rutstein said in an interview.

The study “provides essential reassurance that vaccination against COVID-19 does not increase the risk of disease flare or worsen disease severity scores,” said Dr. Rutstein, who was not associated with the research. “Rather than speaking purely anecdotally with our patients and their families, we can refer to the science – which is always more reassuring for both our patients and ourselves.”
 

Study included diverse conditions and therapies

Risk factors for poor outcomes with COVID-19 in children include obesity, cardiovascular disease, chronic lung disease, diabetes, and asthma, Dr. Heshin-Bekenstein told CARRA attendees. Multisystem inflammatory syndrome in children (MIS-C) and long COVID are also potential complications of COVID-19 with less understood risk factors.

Although COVID-19 is most often mild in children, certain severe, systemic rheumatic diseases increase hospitalization risk, including systemic lupus erythematosus (SLE) and vasculitis. Evidence has also shown that COVID-19 infection increases the risk of disease flare in teens with juvenile-onset rheumatic diseases, so it’s “crucial to prevent COVID-19 disease in this population,” Dr. Heshin-Bekenstein said.

Her study therefore aimed to assess the safety and immunogenicity of the Pfizer mRNA vaccine for teens with juvenile-onset rheumatic diseases and those taking immunomodulatory medications. The international prospective multicenter study ran from April to November 2021 at three pediatric rheumatology clinics in Israel and one in Slovenia. Endpoints included short-term side effects, vaccination impact on clinical disease activity, immunogenicity at 2-9 weeks after the second dose, and, secondarily, efficacy against COVID-19 infection.

The 91 participants included adolescents aged 12-18 and young adults aged 18-21. Nearly half of the participants (46%) had juvenile idiopathic arthritis (JIA), and 14% had SLE. Other participants’ conditions included systemic vasculitis, idiopathic uveitis, inflammatory bowel disease–related arthritis, systemic or localized scleroderma, juvenile dermatomyositis, or an autoinflammatory disease. Participants’ mean disease duration was 4.8 years.  

The researchers compared the patients with a control group of 40 individuals with similar demographics but without rheumatic disease. The researchers used the LIAISON quantitative assay to assess serum IgG antibody levels against the SARS-CoV-2 spike protein in both groups.

Eight in 10 participants with rheumatic disease were taking an immunomodulatory medication, including a conventional synthetic disease-modifying antirheumatic drug (csDMARD) in 40%, a biologic DMARD in 37%, tumor necrosis factor (TNF) inhibitors in 32%, hydroxychloroquine (HCQ) in 19%, glucocorticoids in 14%, and mycophenolate in 11%. A smaller proportion were on other biologics: JAK inhibitors in 6.6%, anti-CD20 drugs in 4.4%, and an IL-6 inhibitor in 1%.
 

Side effects similar in both groups

None of the side effects reported by participants were statistically different between those with rheumatic disease and the control group. Localized pain was the most common side effect, reported by 73%-79% of participants after each dose. About twice as many participants with rheumatic disease experienced muscle aches and joint pains, compared with the control group, but the differences were not significant. Fever occurred more often in those with rheumatic disease (6%, five cases) than without (3%, one case). One-third of those with rheumatic disease felt tiredness, compared with 20% of the control group.

None of the healthy controls were hospitalized after vaccination, but three rheumatic patients were, including two after the first dose. Both were 17 years old, had systemic vasculitis with granulomatosis with polyangiitis (GPA), and were taking rituximab (Rituxan). One patient experienced acute onset of chronic renal failure, fever, dehydration, and high C-reactive protein within hours of vaccination. The other experienced new onset of pulmonary hemorrhage a week after vaccination.

In addition, a 14-year-old female with lupus, taking only HCQ, went to the emergency department with fever, headache, vomiting, and joint pain 1 day after the second vaccine dose. She had normal inflammatory markers and no change in disease activity score, and she was discharged with low-dose steroids tapered after 2 weeks.
 

Immune response high in patients with rheumatic disease

Immunogenicity was similar in both groups, with 97% seropositivity in the rheumatic disease group and 100% in the control group. Average IgG titers were 242 in the rheumatic group and 388 in the control group (P < .0001). Seropositivity was 88% in those taking mycophenolate with another drug (100% with mycophenolate monotherapy), 90% with HCQ, 94% with any csDMARDs and another drug (100% with csDMARD monotherapy), and 100% for all other drugs. During 3 months’ follow-up after vaccination, there were no COVID-19 cases among the participants.

Dr. Heshin-Bekenstein noted that their results showed better immunogenicity in teens, compared with adults, for two specific drugs. Seropositivity in teens taking methotrexate (Rheumatrex, Trexall) or rituximab was 100% in this study, compared with 84% in adults taking methotrexate and 39% in adults taking rituximab in a previous study. However, only three patients in this study were taking rituximab, and only seven were taking methotrexate.

The study’s heterogenous population was both a strength and a weakness of the study. “Due to the diversity of rheumatic diseases and medications included in this cohort, it was not possible to draw significant conclusions regarding the impact of the immunomodulatory medications and type of disease” on titers, Dr. Heshin-Bekenstein told attendees.

Still, “I think as pediatric rheumatologists, we can feel reassured in recommending the COVID-19 vaccine to our patients,” Dr. Oliver said. “I will add that every patient is different, and everyone should have a conversation with their physician about receiving the COVID-19 vaccine.” Dr. Oliver said she discusses vaccination, including COVID vaccination, with every patient, and it’s been challenging to address concerns in the midst of so much misinformation circulating about the vaccine.

These findings do raise questions about whether it’s still necessary to hold immunomodulatory medications to get the vaccine,” Dr. Rutstein said.

“Many families are nervous to pause their medications before and after the vaccine as is currently recommended for many therapies by the American College of Rheumatology, and I do share that concern for some of my patients with more clinically unstable disease, so I try to work with each family to decide on best timing and have delayed or deferred the series until some patients are on a steady dose of a new immunomodulatory medication if it has been recently started,” Dr. Rutstein said. “This is one of the reasons why Dr. Heshin-Bekenstein’s study is so important – we may be holding medications that can be safely continued and even further decrease the risk of disease flare.”

None of the physicians have disclosed any relevant financial relationships.

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

An investigative synthetic cannabinoid receptor type 2 (CB2) agonist, lenabasum, was associated with greater improvements than placebo in patients with skin-predominant dermatomyositis – some of it statistically significant – in a phase 2, double-blind, randomized, controlled study.

Patients taking lenabasum experienced greater reductions in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) – a validated outcome designed to assess inflammatory skin involvement in the rare autoimmune disease – and improvements in patient-reported and biomarker outcomes, compared with those on placebo, dermatologist Victoria P. Werth, MD, and coinvestigators reported.

Courtesy RegionalDerm.com

And in a recently completed phase 3 trial, reported by the manufacturer, a subpopulation of patients with active skin disease and no active muscle disease again showed greater reductions in CDASI activity scores – a secondary outcome in the trial.

However, the phase 3 DETERMINE trial produced negative findings overall. It enrolled a more heterogeneous group of patients – including those with both muscle weakness and skin involvement – and its primary outcome measure was a broader composite measure, the Total Improvement Score. The trial failed to meet this primary endpoint, Corbus Pharmaceuticals, the developer of lenabasum, announced in a press release in June 2021.

The phase 3 results are “frustrating” for patients with symptomatic and refractory skin manifestations of dermatomyositis (DM), given the promising findings from the phase 2 trial and from an open-label extension study, said Dr. Werth, professor of dermatology and medicine, University of Pennsylvania, Philadelphia, and principal investigator and coprincipal investigator of the phase 2 and phase 3 studies, respectively.

Dr. Werth is scheduled to present the results from the phase 3 trial at the annual European Alliance of Associations for Rheumatology meeting in June.

“With lenabasum, we have a therapy that doesn’t work for every patient, but does work for quite a number of them,” Dr. Werth said in an interview. “It’s oral, it’s not really that immunosuppressing, and there aren’t many side effects. Right now, patients are often being managed with steroids ... we really need treatments that are not as toxic.”

Robert Spiera, MD, a rheumatologist who led trials of lenabasum for treatment of diffuse cutaneous systemic sclerosis (dcSSc), agreed. “The CB2 agonist strategy is appealing because it’s nonimmunosuppressing and has both anti-inflammatory and antifibrotic properties,” he said in an interview. “I wouldn’t want to give up on it ... especially [for patients] with scleroderma and dermatomyositis who are treated with substantial drugs that are associated with morbidity.”

Lenabasum, he said, has proven to be “incredibly safe, and incredibly safe in the long term.”

While the phase 2 trial of the drug for dcSSc showed clear benefit over placebo, the phase 3 trial did not meet its primary endpoint using the American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis.

It allowed background immunosuppressant therapy to reflect real-world clinical practice, and “there was such a high response rate to [that therapy, largely mycophenolate] that there was little room to show benefit beyond that,” said Dr. Spiera, director of the vasculitis and scleroderma program, Hospital for Special Surgery, New York.

The drug led to more improvement in the small subset of participants who were not receiving background immunotherapy during the trial, he noted.

Corbus is currently “seeking a partnership to further explore the drug” for treatment in different subpopulations, according to a company spokesperson. Results of a phase 2 trial of lenabasum for the treatment of systemic lupus erythematosus – with a pain rating as the primary outcome measure – are expected soon.
 

Phase 2 findings

The single-center phase 2 trial of lenabasum for DM enrolled 22 adults with minimal muscle involvement as evidenced by normal maximal resistance on muscle testing at entry and throughout the study. Most were taking immunosuppressant medication, and all had CDASI scores of at least 20, with mean scores in the severe range (> 26). Symptoms registered on patient-reported outcome measures were moderate to severe.

Patients received a half-dose of lenabasum (20 mg daily) for 1 month and a full dose (20 mg twice daily) for 2 months, or placebo, and were followed for an additional month without dosing.

Starting at day 43 – approximately 2 weeks after the dose was increased – there was “a trend for the change from baseline CDASI to be greater” in the lenabasum group, compared with those on placebo, Dr. Werth and colleagues reported. The differences reached statistical significance on day 113 (P = .038), a month after patients discontinued lenabasum, “suggesting that the modulation of the inflammatory response by lenabasum continued beyond its last dose.”

Five of the 11 patients treated with lenabasum (45%), and none of those on placebo, achieved at least a 40% reduction in the CDASI activity score by the end of the study.

Patients in the lenabasum group also had greater improvement in the Skindex-29 Symptoms scores – an objective measure of itch – and improvements in other secondary efficacy outcomes, including pain, though these did not reach statistical significance.

Skin biopsies before and after treatment showed significant reductions in inflammatory cytokines relevant to DM pathogenesis. Patients treated with the CB2 agonist had a downward trend in the CD4+ T cell population, which correlated with decreased CDASI activity scores, for instance, and a decrease in IL-31 protein expression, which correlated with decreased Skindex-29 Symptoms scores, the investigators reported.

There were no serious adverse events related to the CB2 agonist, and no treatment discontinuations.

The main part of the phase 2 trial, conducted from 2015 to 2017, was followed by a 3-year, open-label extension, in which 20 of the 22 patients took lenabasum 20 mg twice a day. The drug continued to be safe and well tolerated, and the CDASI activity score and other outcomes improved through year 1 and remained stable thereafter, according to a poster presented by Dr. Werth at the 2021 EULAR meeting.

After 1 year in the open-label extension, 60%-70% of patients had achieved mild skin disease, and 75% had achieved at least a 40% reduction in CDASI activity.

“A lot of patients, even if they weren’t completely cleared, were much happier in terms of their itch,” said Dr. Werth, also chief of dermatology, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia. “It’s been difficult for a lot of them now that they’re off the long-term extension ... a lot of them are flaring.”

The future

In the lab, with funding from the National Institutes of Health, Dr. Werth is continuing to investigate how lenabasum may be working in DM. A paper just published in the open access journal Arthritis Research & Therapy describes CB2 receptor distribution and up-regulation on key immune cells in the skin and blood, and how, in DM skin, its highest expression is on dendritic cells.

Through both mechanistic and more clinical research, “it’s important to understand the characteristics of the people [lenabasum] worked in or didn’t work in,” she said. 

And in clinical trials, it’s important to capture meaningful improvement from the patient perspective. “It may be,” she noted, “that more global, systemic assessments are not the way to go for autoimmune skin disease.”

For dcSSc, Dr. Spiera said, it’s possible that a CB2 agonist may be helpful for patients who have been on immunosuppressants, particularly mycophenolate, for more than 6 months “and are still struggling.”

The phase 2 trial in DM was funded by the National Institutes of Health, the Department of Veterans Affairs, and Corbus Pharmaceuticals. The phase 3 trials in DM and in dcSSc were funded by Corbus. Dr. Werth disclosed grant support from Corbus and several other pharmaceutical companies. Dr. Spiera disclosed that he has received grant support or consulting fees from Roche-Genentech, GlaxoSmithKline, and several other pharmaceutical companies.

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

An investigative synthetic cannabinoid receptor type 2 (CB2) agonist, lenabasum, was associated with greater improvements than placebo in patients with skin-predominant dermatomyositis – some of it statistically significant – in a phase 2, double-blind, randomized, controlled study.

Patients taking lenabasum experienced greater reductions in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) – a validated outcome designed to assess inflammatory skin involvement in the rare autoimmune disease – and improvements in patient-reported and biomarker outcomes, compared with those on placebo, dermatologist Victoria P. Werth, MD, and coinvestigators reported.

Courtesy RegionalDerm.com

And in a recently completed phase 3 trial, reported by the manufacturer, a subpopulation of patients with active skin disease and no active muscle disease again showed greater reductions in CDASI activity scores – a secondary outcome in the trial.

However, the phase 3 DETERMINE trial produced negative findings overall. It enrolled a more heterogeneous group of patients – including those with both muscle weakness and skin involvement – and its primary outcome measure was a broader composite measure, the Total Improvement Score. The trial failed to meet this primary endpoint, Corbus Pharmaceuticals, the developer of lenabasum, announced in a press release in June 2021.

The phase 3 results are “frustrating” for patients with symptomatic and refractory skin manifestations of dermatomyositis (DM), given the promising findings from the phase 2 trial and from an open-label extension study, said Dr. Werth, professor of dermatology and medicine, University of Pennsylvania, Philadelphia, and principal investigator and coprincipal investigator of the phase 2 and phase 3 studies, respectively.

Dr. Werth is scheduled to present the results from the phase 3 trial at the annual European Alliance of Associations for Rheumatology meeting in June.

“With lenabasum, we have a therapy that doesn’t work for every patient, but does work for quite a number of them,” Dr. Werth said in an interview. “It’s oral, it’s not really that immunosuppressing, and there aren’t many side effects. Right now, patients are often being managed with steroids ... we really need treatments that are not as toxic.”

Robert Spiera, MD, a rheumatologist who led trials of lenabasum for treatment of diffuse cutaneous systemic sclerosis (dcSSc), agreed. “The CB2 agonist strategy is appealing because it’s nonimmunosuppressing and has both anti-inflammatory and antifibrotic properties,” he said in an interview. “I wouldn’t want to give up on it ... especially [for patients] with scleroderma and dermatomyositis who are treated with substantial drugs that are associated with morbidity.”

Lenabasum, he said, has proven to be “incredibly safe, and incredibly safe in the long term.”

While the phase 2 trial of the drug for dcSSc showed clear benefit over placebo, the phase 3 trial did not meet its primary endpoint using the American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis.

It allowed background immunosuppressant therapy to reflect real-world clinical practice, and “there was such a high response rate to [that therapy, largely mycophenolate] that there was little room to show benefit beyond that,” said Dr. Spiera, director of the vasculitis and scleroderma program, Hospital for Special Surgery, New York.

The drug led to more improvement in the small subset of participants who were not receiving background immunotherapy during the trial, he noted.

Corbus is currently “seeking a partnership to further explore the drug” for treatment in different subpopulations, according to a company spokesperson. Results of a phase 2 trial of lenabasum for the treatment of systemic lupus erythematosus – with a pain rating as the primary outcome measure – are expected soon.
 

Phase 2 findings

The single-center phase 2 trial of lenabasum for DM enrolled 22 adults with minimal muscle involvement as evidenced by normal maximal resistance on muscle testing at entry and throughout the study. Most were taking immunosuppressant medication, and all had CDASI scores of at least 20, with mean scores in the severe range (> 26). Symptoms registered on patient-reported outcome measures were moderate to severe.

Patients received a half-dose of lenabasum (20 mg daily) for 1 month and a full dose (20 mg twice daily) for 2 months, or placebo, and were followed for an additional month without dosing.

Starting at day 43 – approximately 2 weeks after the dose was increased – there was “a trend for the change from baseline CDASI to be greater” in the lenabasum group, compared with those on placebo, Dr. Werth and colleagues reported. The differences reached statistical significance on day 113 (P = .038), a month after patients discontinued lenabasum, “suggesting that the modulation of the inflammatory response by lenabasum continued beyond its last dose.”

Five of the 11 patients treated with lenabasum (45%), and none of those on placebo, achieved at least a 40% reduction in the CDASI activity score by the end of the study.

Patients in the lenabasum group also had greater improvement in the Skindex-29 Symptoms scores – an objective measure of itch – and improvements in other secondary efficacy outcomes, including pain, though these did not reach statistical significance.

Skin biopsies before and after treatment showed significant reductions in inflammatory cytokines relevant to DM pathogenesis. Patients treated with the CB2 agonist had a downward trend in the CD4+ T cell population, which correlated with decreased CDASI activity scores, for instance, and a decrease in IL-31 protein expression, which correlated with decreased Skindex-29 Symptoms scores, the investigators reported.

There were no serious adverse events related to the CB2 agonist, and no treatment discontinuations.

The main part of the phase 2 trial, conducted from 2015 to 2017, was followed by a 3-year, open-label extension, in which 20 of the 22 patients took lenabasum 20 mg twice a day. The drug continued to be safe and well tolerated, and the CDASI activity score and other outcomes improved through year 1 and remained stable thereafter, according to a poster presented by Dr. Werth at the 2021 EULAR meeting.

After 1 year in the open-label extension, 60%-70% of patients had achieved mild skin disease, and 75% had achieved at least a 40% reduction in CDASI activity.

“A lot of patients, even if they weren’t completely cleared, were much happier in terms of their itch,” said Dr. Werth, also chief of dermatology, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia. “It’s been difficult for a lot of them now that they’re off the long-term extension ... a lot of them are flaring.”

The future

In the lab, with funding from the National Institutes of Health, Dr. Werth is continuing to investigate how lenabasum may be working in DM. A paper just published in the open access journal Arthritis Research & Therapy describes CB2 receptor distribution and up-regulation on key immune cells in the skin and blood, and how, in DM skin, its highest expression is on dendritic cells.

Through both mechanistic and more clinical research, “it’s important to understand the characteristics of the people [lenabasum] worked in or didn’t work in,” she said. 

And in clinical trials, it’s important to capture meaningful improvement from the patient perspective. “It may be,” she noted, “that more global, systemic assessments are not the way to go for autoimmune skin disease.”

For dcSSc, Dr. Spiera said, it’s possible that a CB2 agonist may be helpful for patients who have been on immunosuppressants, particularly mycophenolate, for more than 6 months “and are still struggling.”

The phase 2 trial in DM was funded by the National Institutes of Health, the Department of Veterans Affairs, and Corbus Pharmaceuticals. The phase 3 trials in DM and in dcSSc were funded by Corbus. Dr. Werth disclosed grant support from Corbus and several other pharmaceutical companies. Dr. Spiera disclosed that he has received grant support or consulting fees from Roche-Genentech, GlaxoSmithKline, and several other pharmaceutical companies.

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

An investigative synthetic cannabinoid receptor type 2 (CB2) agonist, lenabasum, was associated with greater improvements than placebo in patients with skin-predominant dermatomyositis – some of it statistically significant – in a phase 2, double-blind, randomized, controlled study.

Patients taking lenabasum experienced greater reductions in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) – a validated outcome designed to assess inflammatory skin involvement in the rare autoimmune disease – and improvements in patient-reported and biomarker outcomes, compared with those on placebo, dermatologist Victoria P. Werth, MD, and coinvestigators reported.

Courtesy RegionalDerm.com

And in a recently completed phase 3 trial, reported by the manufacturer, a subpopulation of patients with active skin disease and no active muscle disease again showed greater reductions in CDASI activity scores – a secondary outcome in the trial.

However, the phase 3 DETERMINE trial produced negative findings overall. It enrolled a more heterogeneous group of patients – including those with both muscle weakness and skin involvement – and its primary outcome measure was a broader composite measure, the Total Improvement Score. The trial failed to meet this primary endpoint, Corbus Pharmaceuticals, the developer of lenabasum, announced in a press release in June 2021.

The phase 3 results are “frustrating” for patients with symptomatic and refractory skin manifestations of dermatomyositis (DM), given the promising findings from the phase 2 trial and from an open-label extension study, said Dr. Werth, professor of dermatology and medicine, University of Pennsylvania, Philadelphia, and principal investigator and coprincipal investigator of the phase 2 and phase 3 studies, respectively.

Dr. Werth is scheduled to present the results from the phase 3 trial at the annual European Alliance of Associations for Rheumatology meeting in June.

“With lenabasum, we have a therapy that doesn’t work for every patient, but does work for quite a number of them,” Dr. Werth said in an interview. “It’s oral, it’s not really that immunosuppressing, and there aren’t many side effects. Right now, patients are often being managed with steroids ... we really need treatments that are not as toxic.”

Robert Spiera, MD, a rheumatologist who led trials of lenabasum for treatment of diffuse cutaneous systemic sclerosis (dcSSc), agreed. “The CB2 agonist strategy is appealing because it’s nonimmunosuppressing and has both anti-inflammatory and antifibrotic properties,” he said in an interview. “I wouldn’t want to give up on it ... especially [for patients] with scleroderma and dermatomyositis who are treated with substantial drugs that are associated with morbidity.”

Lenabasum, he said, has proven to be “incredibly safe, and incredibly safe in the long term.”

While the phase 2 trial of the drug for dcSSc showed clear benefit over placebo, the phase 3 trial did not meet its primary endpoint using the American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis.

It allowed background immunosuppressant therapy to reflect real-world clinical practice, and “there was such a high response rate to [that therapy, largely mycophenolate] that there was little room to show benefit beyond that,” said Dr. Spiera, director of the vasculitis and scleroderma program, Hospital for Special Surgery, New York.

The drug led to more improvement in the small subset of participants who were not receiving background immunotherapy during the trial, he noted.

Corbus is currently “seeking a partnership to further explore the drug” for treatment in different subpopulations, according to a company spokesperson. Results of a phase 2 trial of lenabasum for the treatment of systemic lupus erythematosus – with a pain rating as the primary outcome measure – are expected soon.
 

Phase 2 findings

The single-center phase 2 trial of lenabasum for DM enrolled 22 adults with minimal muscle involvement as evidenced by normal maximal resistance on muscle testing at entry and throughout the study. Most were taking immunosuppressant medication, and all had CDASI scores of at least 20, with mean scores in the severe range (> 26). Symptoms registered on patient-reported outcome measures were moderate to severe.

Patients received a half-dose of lenabasum (20 mg daily) for 1 month and a full dose (20 mg twice daily) for 2 months, or placebo, and were followed for an additional month without dosing.

Starting at day 43 – approximately 2 weeks after the dose was increased – there was “a trend for the change from baseline CDASI to be greater” in the lenabasum group, compared with those on placebo, Dr. Werth and colleagues reported. The differences reached statistical significance on day 113 (P = .038), a month after patients discontinued lenabasum, “suggesting that the modulation of the inflammatory response by lenabasum continued beyond its last dose.”

Five of the 11 patients treated with lenabasum (45%), and none of those on placebo, achieved at least a 40% reduction in the CDASI activity score by the end of the study.

Patients in the lenabasum group also had greater improvement in the Skindex-29 Symptoms scores – an objective measure of itch – and improvements in other secondary efficacy outcomes, including pain, though these did not reach statistical significance.

Skin biopsies before and after treatment showed significant reductions in inflammatory cytokines relevant to DM pathogenesis. Patients treated with the CB2 agonist had a downward trend in the CD4+ T cell population, which correlated with decreased CDASI activity scores, for instance, and a decrease in IL-31 protein expression, which correlated with decreased Skindex-29 Symptoms scores, the investigators reported.

There were no serious adverse events related to the CB2 agonist, and no treatment discontinuations.

The main part of the phase 2 trial, conducted from 2015 to 2017, was followed by a 3-year, open-label extension, in which 20 of the 22 patients took lenabasum 20 mg twice a day. The drug continued to be safe and well tolerated, and the CDASI activity score and other outcomes improved through year 1 and remained stable thereafter, according to a poster presented by Dr. Werth at the 2021 EULAR meeting.

After 1 year in the open-label extension, 60%-70% of patients had achieved mild skin disease, and 75% had achieved at least a 40% reduction in CDASI activity.

“A lot of patients, even if they weren’t completely cleared, were much happier in terms of their itch,” said Dr. Werth, also chief of dermatology, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia. “It’s been difficult for a lot of them now that they’re off the long-term extension ... a lot of them are flaring.”

The future

In the lab, with funding from the National Institutes of Health, Dr. Werth is continuing to investigate how lenabasum may be working in DM. A paper just published in the open access journal Arthritis Research & Therapy describes CB2 receptor distribution and up-regulation on key immune cells in the skin and blood, and how, in DM skin, its highest expression is on dendritic cells.

Through both mechanistic and more clinical research, “it’s important to understand the characteristics of the people [lenabasum] worked in or didn’t work in,” she said. 

And in clinical trials, it’s important to capture meaningful improvement from the patient perspective. “It may be,” she noted, “that more global, systemic assessments are not the way to go for autoimmune skin disease.”

For dcSSc, Dr. Spiera said, it’s possible that a CB2 agonist may be helpful for patients who have been on immunosuppressants, particularly mycophenolate, for more than 6 months “and are still struggling.”

The phase 2 trial in DM was funded by the National Institutes of Health, the Department of Veterans Affairs, and Corbus Pharmaceuticals. The phase 3 trials in DM and in dcSSc were funded by Corbus. Dr. Werth disclosed grant support from Corbus and several other pharmaceutical companies. Dr. Spiera disclosed that he has received grant support or consulting fees from Roche-Genentech, GlaxoSmithKline, and several other pharmaceutical companies.

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

Patients with psoriasis have a significantly increased risk of severe and rare infections, compared with the general population, according to a population-based cohort study of nearly 95,000 patients.

Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.

Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.

The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.

Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.

For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.

The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.

When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).

Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.

The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.

Data show need for clinician vigilance

Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”

There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.

The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”

As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”

The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.

Patients with psoriasis have a significantly increased risk of severe and rare infections, compared with the general population, according to a population-based cohort study of nearly 95,000 patients.

Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.

Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.

The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.

Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.

For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.

The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.

When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).

Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.

The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.

Data show need for clinician vigilance

Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”

There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.

The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”

As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”

The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.

Patients with psoriasis have a significantly increased risk of severe and rare infections, compared with the general population, according to a population-based cohort study of nearly 95,000 patients.

Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.

Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.

The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.

Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.

For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.

The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.

When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).

Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.

The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.

Data show need for clinician vigilance

Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”

There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.

The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”

As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”

The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.