Rheumatology News

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.

San Diego – The anabolic osteoporosis treatment abaloparatide (Tymlos, Radius Health) works in men as well as women, new data indicate.  

Findings from the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM) randomized, double-blind, placebo-controlled, phase 3 study were presented last week at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2022.

Abaloparatide, a subcutaneously administered parathyroid-hormone–related protein (PTHrP) analog, resulted in significant increases in bone mineral density by 12 months at the lumbar spine, total hip, and femoral neck, compared with placebo in men with osteoporosis, with no significant adverse effects.

“Osteoporosis is underdiagnosed in men. Abaloparatide is another option for an ignored population,” presenter Neil Binkley, MD, of the University of Wisconsin School of Medicine and Public Health Madison, said in an interview.

Abaloparatide was approved by the U.S. Food and Drug Administration in 2017 for the treatment of postmenopausal women at high risk for fracture due to a history of osteoporotic fracture or multiple fracture risk factors, or who haven’t responded to or are intolerant of other osteoporosis therapies.

While postmenopausal women have mainly been the focus in osteoporosis, men account for approximately 30% of the societal burden of osteoporosis and have greater fracture-related morbidity and mortality than women.

About one in four men over the age of 50 years will have a fragility fracture in their lifetime. Yet, they’re far less likely to be diagnosed or to be included in osteoporosis treatment trials, Dr. Binkley noted.

Asked to comment, session moderator Thanh D. Hoang, DO, told this news organization, “I think it’s a great option to treat osteoporosis, and now we have evidence for treating osteoporosis in men. Mostly the data have come from postmenopausal women.”
 

Screen men with hypogonadism or those taking steroids

“This new medication is an addition to the very limited number of treatments that we have when patients don’t respond to [initial] medications. To have another anabolic bone-forming medication is very, very good,” said Dr. Hoang, who is professor and program director of the Endocrinology Fellowship Program at Walter Reed National Military Medical Center, Bethesda, Maryland.

Radius Health filed a Supplemental New Drug Application with the FDA for abaloparatide (Tymlos) subcutaneous injection in men with osteoporosis at high risk for fracture in February. There is a 10-month review period.

Dr. Binkley advises bone screening for men who have conditions such as hypogonadism or who are taking glucocorticoids or chemotherapeutics.

But, he added, “I think that if we did nothing else good in the osteoporosis field, if we treated people after they fractured that would be a huge step forward. Even with a normal T score, when those people fracture, they [often] don’t have normal bone mineral density ... That’s a group of people we’re ignoring still. They’re not getting diagnosed, and they’re not getting treated.”

ATOM Study: Significant BMD increases at key sites

The approval of abaloparatide in women was based on the phase 3, 18-week ACTIVE trial of more than 2,000 high-risk women, in whom abaloparatide was associated with an 86% reduction in vertebral fracture incidence, compared with placebo, and also significantly greater reductions in nonvertebral fractures, compared with both placebo and teriparatide (Forteo, Eli Lilly).

The ATOM study involved a total of 228 men aged 40-85 years with primary or hypogonadism-associated osteoporosis randomized 2:1 to receive subcutaneous 80 μg abaloparatide or injected placebo daily for 12 months. All had T scores (based on male reference range) of ≤ −2.5 at the lumbar spine or hip, or ≤ −1.5 and with radiologic vertebral fracture or a history of low trauma nonvertebral fracture in the past 5 years, or T score ≤ −2.0 if older than 65 years.

Increases in bone mineral density from baseline were significantly greater with abaloparatide compared with placebo at the lumbar spine, total hip, and femoral neck at 3, 6, and 12 months. Mean percentage changes at 12 months were 8.5%, 2.1%, and 3.0%, for the three locations, respectively, compared with 1.2%, 0.01%, and 0.2% for placebo (all P ≤ .0001).

Three fractures occurred in those receiving placebo and one with abaloparatide.

For markers of bone turnover, median serum procollagen type I N-terminal propeptide (s-PINP) was 111.2 ng/mL after 1 month of abaloparatide treatment and 85.7 ng/mL at month 12. Median serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) was 0.48 ng/mL at month 6 and 0.45 ng/mL at month 12 in the abaloparatide group. Geometric mean relative to baseline s-PINP and s-CTX increased significantly at months 3, 6, and 12 (all P < .001 for relative treatment effect of abaloparatide vs. placebo).

The most commonly reported treatment-emergent adverse events were injection site erythema (12.8% vs. 5.1%), nasopharyngitis (8.7% vs. 7.6%), dizziness (8.7% vs. 1.3%), and arthralgia (6.7% vs. 1.3%), with abaloparatide versus placebo. Serious treatment-emergent adverse event rates were similar in both groups (5.4% vs. 5.1%). There was one death in the abaloparatide group, which was deemed unrelated to the drug.

Dr. Binkley has reported receiving consulting fees from Amgen and research support from Radius. Dr. Hoang has reported disclosures with Acella Pharmaceuticals and Horizon Therapeutics (no financial compensation).

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

San Diego – The anabolic osteoporosis treatment abaloparatide (Tymlos, Radius Health) works in men as well as women, new data indicate.  

Findings from the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM) randomized, double-blind, placebo-controlled, phase 3 study were presented last week at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2022.

Abaloparatide, a subcutaneously administered parathyroid-hormone–related protein (PTHrP) analog, resulted in significant increases in bone mineral density by 12 months at the lumbar spine, total hip, and femoral neck, compared with placebo in men with osteoporosis, with no significant adverse effects.

“Osteoporosis is underdiagnosed in men. Abaloparatide is another option for an ignored population,” presenter Neil Binkley, MD, of the University of Wisconsin School of Medicine and Public Health Madison, said in an interview.

Abaloparatide was approved by the U.S. Food and Drug Administration in 2017 for the treatment of postmenopausal women at high risk for fracture due to a history of osteoporotic fracture or multiple fracture risk factors, or who haven’t responded to or are intolerant of other osteoporosis therapies.

While postmenopausal women have mainly been the focus in osteoporosis, men account for approximately 30% of the societal burden of osteoporosis and have greater fracture-related morbidity and mortality than women.

About one in four men over the age of 50 years will have a fragility fracture in their lifetime. Yet, they’re far less likely to be diagnosed or to be included in osteoporosis treatment trials, Dr. Binkley noted.

Asked to comment, session moderator Thanh D. Hoang, DO, told this news organization, “I think it’s a great option to treat osteoporosis, and now we have evidence for treating osteoporosis in men. Mostly the data have come from postmenopausal women.”
 

Screen men with hypogonadism or those taking steroids

“This new medication is an addition to the very limited number of treatments that we have when patients don’t respond to [initial] medications. To have another anabolic bone-forming medication is very, very good,” said Dr. Hoang, who is professor and program director of the Endocrinology Fellowship Program at Walter Reed National Military Medical Center, Bethesda, Maryland.

Radius Health filed a Supplemental New Drug Application with the FDA for abaloparatide (Tymlos) subcutaneous injection in men with osteoporosis at high risk for fracture in February. There is a 10-month review period.

Dr. Binkley advises bone screening for men who have conditions such as hypogonadism or who are taking glucocorticoids or chemotherapeutics.

But, he added, “I think that if we did nothing else good in the osteoporosis field, if we treated people after they fractured that would be a huge step forward. Even with a normal T score, when those people fracture, they [often] don’t have normal bone mineral density ... That’s a group of people we’re ignoring still. They’re not getting diagnosed, and they’re not getting treated.”

ATOM Study: Significant BMD increases at key sites

The approval of abaloparatide in women was based on the phase 3, 18-week ACTIVE trial of more than 2,000 high-risk women, in whom abaloparatide was associated with an 86% reduction in vertebral fracture incidence, compared with placebo, and also significantly greater reductions in nonvertebral fractures, compared with both placebo and teriparatide (Forteo, Eli Lilly).

The ATOM study involved a total of 228 men aged 40-85 years with primary or hypogonadism-associated osteoporosis randomized 2:1 to receive subcutaneous 80 μg abaloparatide or injected placebo daily for 12 months. All had T scores (based on male reference range) of ≤ −2.5 at the lumbar spine or hip, or ≤ −1.5 and with radiologic vertebral fracture or a history of low trauma nonvertebral fracture in the past 5 years, or T score ≤ −2.0 if older than 65 years.

Increases in bone mineral density from baseline were significantly greater with abaloparatide compared with placebo at the lumbar spine, total hip, and femoral neck at 3, 6, and 12 months. Mean percentage changes at 12 months were 8.5%, 2.1%, and 3.0%, for the three locations, respectively, compared with 1.2%, 0.01%, and 0.2% for placebo (all P ≤ .0001).

Three fractures occurred in those receiving placebo and one with abaloparatide.

For markers of bone turnover, median serum procollagen type I N-terminal propeptide (s-PINP) was 111.2 ng/mL after 1 month of abaloparatide treatment and 85.7 ng/mL at month 12. Median serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) was 0.48 ng/mL at month 6 and 0.45 ng/mL at month 12 in the abaloparatide group. Geometric mean relative to baseline s-PINP and s-CTX increased significantly at months 3, 6, and 12 (all P < .001 for relative treatment effect of abaloparatide vs. placebo).

The most commonly reported treatment-emergent adverse events were injection site erythema (12.8% vs. 5.1%), nasopharyngitis (8.7% vs. 7.6%), dizziness (8.7% vs. 1.3%), and arthralgia (6.7% vs. 1.3%), with abaloparatide versus placebo. Serious treatment-emergent adverse event rates were similar in both groups (5.4% vs. 5.1%). There was one death in the abaloparatide group, which was deemed unrelated to the drug.

Dr. Binkley has reported receiving consulting fees from Amgen and research support from Radius. Dr. Hoang has reported disclosures with Acella Pharmaceuticals and Horizon Therapeutics (no financial compensation).

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

San Diego – The anabolic osteoporosis treatment abaloparatide (Tymlos, Radius Health) works in men as well as women, new data indicate.  

Findings from the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM) randomized, double-blind, placebo-controlled, phase 3 study were presented last week at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2022.

Abaloparatide, a subcutaneously administered parathyroid-hormone–related protein (PTHrP) analog, resulted in significant increases in bone mineral density by 12 months at the lumbar spine, total hip, and femoral neck, compared with placebo in men with osteoporosis, with no significant adverse effects.

“Osteoporosis is underdiagnosed in men. Abaloparatide is another option for an ignored population,” presenter Neil Binkley, MD, of the University of Wisconsin School of Medicine and Public Health Madison, said in an interview.

Abaloparatide was approved by the U.S. Food and Drug Administration in 2017 for the treatment of postmenopausal women at high risk for fracture due to a history of osteoporotic fracture or multiple fracture risk factors, or who haven’t responded to or are intolerant of other osteoporosis therapies.

While postmenopausal women have mainly been the focus in osteoporosis, men account for approximately 30% of the societal burden of osteoporosis and have greater fracture-related morbidity and mortality than women.

About one in four men over the age of 50 years will have a fragility fracture in their lifetime. Yet, they’re far less likely to be diagnosed or to be included in osteoporosis treatment trials, Dr. Binkley noted.

Asked to comment, session moderator Thanh D. Hoang, DO, told this news organization, “I think it’s a great option to treat osteoporosis, and now we have evidence for treating osteoporosis in men. Mostly the data have come from postmenopausal women.”
 

Screen men with hypogonadism or those taking steroids

“This new medication is an addition to the very limited number of treatments that we have when patients don’t respond to [initial] medications. To have another anabolic bone-forming medication is very, very good,” said Dr. Hoang, who is professor and program director of the Endocrinology Fellowship Program at Walter Reed National Military Medical Center, Bethesda, Maryland.

Radius Health filed a Supplemental New Drug Application with the FDA for abaloparatide (Tymlos) subcutaneous injection in men with osteoporosis at high risk for fracture in February. There is a 10-month review period.

Dr. Binkley advises bone screening for men who have conditions such as hypogonadism or who are taking glucocorticoids or chemotherapeutics.

But, he added, “I think that if we did nothing else good in the osteoporosis field, if we treated people after they fractured that would be a huge step forward. Even with a normal T score, when those people fracture, they [often] don’t have normal bone mineral density ... That’s a group of people we’re ignoring still. They’re not getting diagnosed, and they’re not getting treated.”

ATOM Study: Significant BMD increases at key sites

The approval of abaloparatide in women was based on the phase 3, 18-week ACTIVE trial of more than 2,000 high-risk women, in whom abaloparatide was associated with an 86% reduction in vertebral fracture incidence, compared with placebo, and also significantly greater reductions in nonvertebral fractures, compared with both placebo and teriparatide (Forteo, Eli Lilly).

The ATOM study involved a total of 228 men aged 40-85 years with primary or hypogonadism-associated osteoporosis randomized 2:1 to receive subcutaneous 80 μg abaloparatide or injected placebo daily for 12 months. All had T scores (based on male reference range) of ≤ −2.5 at the lumbar spine or hip, or ≤ −1.5 and with radiologic vertebral fracture or a history of low trauma nonvertebral fracture in the past 5 years, or T score ≤ −2.0 if older than 65 years.

Increases in bone mineral density from baseline were significantly greater with abaloparatide compared with placebo at the lumbar spine, total hip, and femoral neck at 3, 6, and 12 months. Mean percentage changes at 12 months were 8.5%, 2.1%, and 3.0%, for the three locations, respectively, compared with 1.2%, 0.01%, and 0.2% for placebo (all P ≤ .0001).

Three fractures occurred in those receiving placebo and one with abaloparatide.

For markers of bone turnover, median serum procollagen type I N-terminal propeptide (s-PINP) was 111.2 ng/mL after 1 month of abaloparatide treatment and 85.7 ng/mL at month 12. Median serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) was 0.48 ng/mL at month 6 and 0.45 ng/mL at month 12 in the abaloparatide group. Geometric mean relative to baseline s-PINP and s-CTX increased significantly at months 3, 6, and 12 (all P < .001 for relative treatment effect of abaloparatide vs. placebo).

The most commonly reported treatment-emergent adverse events were injection site erythema (12.8% vs. 5.1%), nasopharyngitis (8.7% vs. 7.6%), dizziness (8.7% vs. 1.3%), and arthralgia (6.7% vs. 1.3%), with abaloparatide versus placebo. Serious treatment-emergent adverse event rates were similar in both groups (5.4% vs. 5.1%). There was one death in the abaloparatide group, which was deemed unrelated to the drug.

Dr. Binkley has reported receiving consulting fees from Amgen and research support from Radius. Dr. Hoang has reported disclosures with Acella Pharmaceuticals and Horizon Therapeutics (no financial compensation).

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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