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

Addressing racism in the maternal mortality crisis

The emerging racial disparities in COVID-19 incidence and outcomes in the United States are on a collision course with long-standing racial disparities in U.S. maternal care and mortality. “The saying is that ‘the virus doesn’t discriminate,’ but it understands our biases, right? So, the virus takes advantage of the weaknesses in our system,” said Joia A. Crear-Perry, MD, an ob.gyn. and founder and president of the National Birth Equity Collaborative, a New Orleans–based research, training, and advocacy organization working to optimize black maternal and infant health. This article is part of an ongoing feature series on the crisis in maternal mortality in the United States. Here we explore potential solutions for addressing the inequities as proposed by thought leaders and key stakeholders. Read more.

A ‘Beacon’ for physicians, nurses facing retaliation

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy. Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality. The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment supply and other matters of public concern related to coronavirus. “There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.” Read more.

COVID-19 ravages the Navajo Nation

The Navajo Nation has the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths. These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average rates of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%. “We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language), is a monster confronting the Navajo today. It has had significant impact on our nation and people,” Mary Hasbah Roessel, MD, a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., wrote in a commentary on MDedge. Read more.

Heart pump system authorized for COVID-19 patients

The Food and Drug Administration issued an emergency use authorization (EUA) for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation. The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m² for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including pulmonary embolism. Read more.

Deprescribing hypertension meds looks safe for older adults

Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure control, researchers concluded based on findings from a randomized multicenter trial. The study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” said James P. Sheppard, PhD, of University of Oxford (England). The report was published in JAMA. Read more.

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

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

Addressing racism in the maternal mortality crisis

The emerging racial disparities in COVID-19 incidence and outcomes in the United States are on a collision course with long-standing racial disparities in U.S. maternal care and mortality. “The saying is that ‘the virus doesn’t discriminate,’ but it understands our biases, right? So, the virus takes advantage of the weaknesses in our system,” said Joia A. Crear-Perry, MD, an ob.gyn. and founder and president of the National Birth Equity Collaborative, a New Orleans–based research, training, and advocacy organization working to optimize black maternal and infant health. This article is part of an ongoing feature series on the crisis in maternal mortality in the United States. Here we explore potential solutions for addressing the inequities as proposed by thought leaders and key stakeholders. Read more.

A ‘Beacon’ for physicians, nurses facing retaliation

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy. Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality. The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment supply and other matters of public concern related to coronavirus. “There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.” Read more.

COVID-19 ravages the Navajo Nation

The Navajo Nation has the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths. These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average rates of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%. “We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language), is a monster confronting the Navajo today. It has had significant impact on our nation and people,” Mary Hasbah Roessel, MD, a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., wrote in a commentary on MDedge. Read more.

Heart pump system authorized for COVID-19 patients

The Food and Drug Administration issued an emergency use authorization (EUA) for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation. The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m² for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including pulmonary embolism. Read more.

Deprescribing hypertension meds looks safe for older adults

Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure control, researchers concluded based on findings from a randomized multicenter trial. The study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” said James P. Sheppard, PhD, of University of Oxford (England). The report was published in JAMA. Read more.

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

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

Addressing racism in the maternal mortality crisis

The emerging racial disparities in COVID-19 incidence and outcomes in the United States are on a collision course with long-standing racial disparities in U.S. maternal care and mortality. “The saying is that ‘the virus doesn’t discriminate,’ but it understands our biases, right? So, the virus takes advantage of the weaknesses in our system,” said Joia A. Crear-Perry, MD, an ob.gyn. and founder and president of the National Birth Equity Collaborative, a New Orleans–based research, training, and advocacy organization working to optimize black maternal and infant health. This article is part of an ongoing feature series on the crisis in maternal mortality in the United States. Here we explore potential solutions for addressing the inequities as proposed by thought leaders and key stakeholders. Read more.

A ‘Beacon’ for physicians, nurses facing retaliation

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy. Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality. The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment supply and other matters of public concern related to coronavirus. “There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.” Read more.

COVID-19 ravages the Navajo Nation

The Navajo Nation has the most cases of the COVID-19 virus of any tribe in the United States, and numbers as of May 31, 2020, are 5,348, with 246 confirmed deaths. These devastating numbers, which might be leveling off, are associated with Navajo people having higher-than-average rates of diabetes, heart disease, and cancer. This is compounded with 30%-40% of homes having no electricity or running water, and a poverty rate of about 38%. “We endured and learned from each Naayee, hunger, and death to name a few adversities. The COVID-19 pandemic, or “Big Cough” (Dikos Nitsaa’igii -19 in Navajo language), is a monster confronting the Navajo today. It has had significant impact on our nation and people,” Mary Hasbah Roessel, MD, a Navajo board-certified psychiatrist practicing in Santa Fe, N.M., wrote in a commentary on MDedge. Read more.

Heart pump system authorized for COVID-19 patients

The Food and Drug Administration issued an emergency use authorization (EUA) for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation. The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m² for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including pulmonary embolism. Read more.

Deprescribing hypertension meds looks safe for older adults

Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure control, researchers concluded based on findings from a randomized multicenter trial. The study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” said James P. Sheppard, PhD, of University of Oxford (England). The report was published in JAMA. Read more.

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

In an update of the PREDIX-HER2 trial, trastuzumab emtansine (T-DM1) remained equivalent to standard neoadjuvant chemotherapy plus dual-targeted HER2 therapy in producing pathologic complete remissions (pCRs) among patients with HER2-positive, metastatic breast cancer.

The new data also suggest tumor-infiltrating lymphocytes (TILs) and dramatic improvements in PET-CT scans can predict favorable outcomes in both treatment groups. Though these findings will be useful for research purposes, they likely won’t influence routine clinical practice.

Thomas Hatschek, MD, PhD, of Karolinska Institutet in Stockholm, presented the updated results from PREDIX-HER2 during the European Society for Medical Oncology: Breast Cancer virtual meeting.

PREDIX-HER2 included patients with HER2-positive breast cancer and tumor size greater than 20 mm or lymph node metastases.

Patients received neoadjuvant therapy (NAT) with docetaxel and trastuzumab plus pertuzumab (DTP) or T-DM1 every 3 weeks for a planned total of six courses. The protocol permitted switching to the competing treatment for progression, lack of response, or drug-related severe toxicity.

Postoperatively, all patients received triweekly epirubicin plus cyclophosphamide – four courses for the T-DM1 arm and two courses for the DTP arm. All patients then received triweekly adjuvant trastuzumab for 11 courses. The 62% of patients whose tumors were hormone receptor (HR)–positive received standard endocrine therapy postoperatively.
 

Updated results, predictors of pCR

At the 2019 ASCO annual meeting, PREDIX-HER2 investigators reported that, when compared with DTP, T-DM1 produced the same likelihood of pCR with less toxicity (ASCO 2019, Abstract 501). Updated data presented at ESMO Breast Cancer 2020 showed similar results.

The pCR rate was 45.5% in the DTP arm and 43.9% in the T-DM1 arm (P = .824). pCR rates were higher for HR-negative tumors – 63.6% in the DTP arm and 59% in the T-DM1 arm – than for HR-positive tumors – 36.4% in the DTP arm and 33.9% in the TDM-1 arm.

Three patients had disease progression with T-DM1, and none progressed with DTP. However, almost twice as many patients switched from DTP to T-DM1, compared with the other sequence.

Dr. Hatschek reported that the presence of at least 10% TILs predicted pCR in both treatment groups. Among patients who achieved a pCR, 52.2% had at least 10% TILs in baseline biopsies, and 30.4% had less than 10% TILs.

In addition, a decrease of FDG maximum standardized uptake value by more than 75% on protocol-required PET-CT scans was highly predictive of pCR. Among patients who achieved a pCR, 70.3% had a maximum standardized uptake value decrease of more than 75%, and 22.5% had a decrease of 75% or less.

At median follow-up of 28.5 months, event-free survival was similar between the treatment arms. Overall, there were 13 cases of progression, relapse, contralateral breast cancer, distant metastases, or death from any cause. There were five such events in the DTP arm and eight in the TDM-1 arm.

Dr. Hatschek concluded that neoadjuvant T-DM1 may be as effective as standard NAT in all clinical subgroups evaluated. Both TILs and PET-CT showed the potential to predict pCR and merit further study in the NAT setting.
 

An imperfect surrogate

By definition, a surrogate is “one appointed to act in place of another.” In the case of PREDIX-HER2 and most other NAT studies in HER2-positive breast cancer patients, pCR is a surrogate for the endpoint about which doctors and patients really care – cancer-free survival.

As such, pCR is not a perfect surrogate. Reproducibly, pCR has been highly predictive of disease-free survival and overall survival, especially in the HR-negative subset of HER2-positive patients.

However, despite improvements with dual targeting of HER2 in the TRYPHAENA trial (Eur J Cancer. 2018;89:27-35) and the use of T-DM1 for patients failing to achieve pCR in the immediately practice-changing KATHERINE trial (N Engl J Med. 2019;380:617-28), eventual relapse is seen in 10%-20% of patients in various clinical-pathologic subgroups.

In PREDIX-HER2, the pCR rate for node-positive patients was considerably lower with T-DM1 than with DTP (54.1% vs. 38%), noted Valentina Guarneri, MD, of the University of Padova (Italy), in her discussion of the trial at ESMO Breast Cancer 2020.

Patients with larger initial tumor size and multiple involved axillary nodes at diagnosis remain at increased risk of death because of cancer relapse.

Central nervous system relapse remains a vexing problem. Among patients with triple-positive breast cancer, relapses may occur late, despite pCR.

Patients whose tumors transform from HER2 positive to HER2 negative with NAT, seen in approximately 8% of cases in the KATHERINE trial (ESMO Breast Cancer 2020, Abstract 96O), may be another poor-risk group.
 

Clinical implications

PREDIX-HER2 is an important study. At the early time point of 2.4 years (especially early since most patients were HR-positive), if pCR is achieved, event-free survival is excellent with T-DM1 or an aggressive multiagent cytotoxic combination plus dual HER2 targeting followed by anthracyclines.

It is ideal to have clinical-pathologic tests to distinguish those patients destined to achieve the surrogate endpoint of pCR from those who will not achieve it.

Despite linkage of TILs to improved outcome for triple-negative and HER2-enriched molecular subtypes (Lancet Oncol. 2018 Jan;19[1]:40-50), analysis of TILs is not standard practice in HER2-positive breast cancer in community settings. Optimal cutoffs are not well established, and TILs have not been linked to the choice of particular treatment options.

Currently, PET-CT scans are not part of National Comprehensive Cancer Network guidelines for pretreatment evaluation, except in patients for whom there is clinical suspicion of distant disease.

For those reasons, the main results of PREDIX-HER2 remain research tools that will focus our attention on the clinical-pathologic correlations Dr. Hatschek highlighted, but the results should have no influence on routine clinical practice at this time.

PREDIX-HER2 was funded by the Swedish Cancer Society, Radiumhemmet of Karolinska Institutet, Region Stockholm, and Roche Sweden. Dr. Hatschek disclosed relationships with Roche Sweden, Pfizer Sweden, and Pierre Fabre Sweden. Dr. Guarneri disclosed relationships with Roche, Novartis, and Eli Lilly.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Hatschek T et al. ESMO Breast Cancer 2020, Abstract 97O.

In an update of the PREDIX-HER2 trial, trastuzumab emtansine (T-DM1) remained equivalent to standard neoadjuvant chemotherapy plus dual-targeted HER2 therapy in producing pathologic complete remissions (pCRs) among patients with HER2-positive, metastatic breast cancer.

The new data also suggest tumor-infiltrating lymphocytes (TILs) and dramatic improvements in PET-CT scans can predict favorable outcomes in both treatment groups. Though these findings will be useful for research purposes, they likely won’t influence routine clinical practice.

Thomas Hatschek, MD, PhD, of Karolinska Institutet in Stockholm, presented the updated results from PREDIX-HER2 during the European Society for Medical Oncology: Breast Cancer virtual meeting.

PREDIX-HER2 included patients with HER2-positive breast cancer and tumor size greater than 20 mm or lymph node metastases.

Patients received neoadjuvant therapy (NAT) with docetaxel and trastuzumab plus pertuzumab (DTP) or T-DM1 every 3 weeks for a planned total of six courses. The protocol permitted switching to the competing treatment for progression, lack of response, or drug-related severe toxicity.

Postoperatively, all patients received triweekly epirubicin plus cyclophosphamide – four courses for the T-DM1 arm and two courses for the DTP arm. All patients then received triweekly adjuvant trastuzumab for 11 courses. The 62% of patients whose tumors were hormone receptor (HR)–positive received standard endocrine therapy postoperatively.
 

Updated results, predictors of pCR

At the 2019 ASCO annual meeting, PREDIX-HER2 investigators reported that, when compared with DTP, T-DM1 produced the same likelihood of pCR with less toxicity (ASCO 2019, Abstract 501). Updated data presented at ESMO Breast Cancer 2020 showed similar results.

The pCR rate was 45.5% in the DTP arm and 43.9% in the T-DM1 arm (P = .824). pCR rates were higher for HR-negative tumors – 63.6% in the DTP arm and 59% in the T-DM1 arm – than for HR-positive tumors – 36.4% in the DTP arm and 33.9% in the TDM-1 arm.

Three patients had disease progression with T-DM1, and none progressed with DTP. However, almost twice as many patients switched from DTP to T-DM1, compared with the other sequence.

Dr. Hatschek reported that the presence of at least 10% TILs predicted pCR in both treatment groups. Among patients who achieved a pCR, 52.2% had at least 10% TILs in baseline biopsies, and 30.4% had less than 10% TILs.

In addition, a decrease of FDG maximum standardized uptake value by more than 75% on protocol-required PET-CT scans was highly predictive of pCR. Among patients who achieved a pCR, 70.3% had a maximum standardized uptake value decrease of more than 75%, and 22.5% had a decrease of 75% or less.

At median follow-up of 28.5 months, event-free survival was similar between the treatment arms. Overall, there were 13 cases of progression, relapse, contralateral breast cancer, distant metastases, or death from any cause. There were five such events in the DTP arm and eight in the TDM-1 arm.

Dr. Hatschek concluded that neoadjuvant T-DM1 may be as effective as standard NAT in all clinical subgroups evaluated. Both TILs and PET-CT showed the potential to predict pCR and merit further study in the NAT setting.
 

An imperfect surrogate

By definition, a surrogate is “one appointed to act in place of another.” In the case of PREDIX-HER2 and most other NAT studies in HER2-positive breast cancer patients, pCR is a surrogate for the endpoint about which doctors and patients really care – cancer-free survival.

As such, pCR is not a perfect surrogate. Reproducibly, pCR has been highly predictive of disease-free survival and overall survival, especially in the HR-negative subset of HER2-positive patients.

However, despite improvements with dual targeting of HER2 in the TRYPHAENA trial (Eur J Cancer. 2018;89:27-35) and the use of T-DM1 for patients failing to achieve pCR in the immediately practice-changing KATHERINE trial (N Engl J Med. 2019;380:617-28), eventual relapse is seen in 10%-20% of patients in various clinical-pathologic subgroups.

In PREDIX-HER2, the pCR rate for node-positive patients was considerably lower with T-DM1 than with DTP (54.1% vs. 38%), noted Valentina Guarneri, MD, of the University of Padova (Italy), in her discussion of the trial at ESMO Breast Cancer 2020.

Patients with larger initial tumor size and multiple involved axillary nodes at diagnosis remain at increased risk of death because of cancer relapse.

Central nervous system relapse remains a vexing problem. Among patients with triple-positive breast cancer, relapses may occur late, despite pCR.

Patients whose tumors transform from HER2 positive to HER2 negative with NAT, seen in approximately 8% of cases in the KATHERINE trial (ESMO Breast Cancer 2020, Abstract 96O), may be another poor-risk group.
 

Clinical implications

PREDIX-HER2 is an important study. At the early time point of 2.4 years (especially early since most patients were HR-positive), if pCR is achieved, event-free survival is excellent with T-DM1 or an aggressive multiagent cytotoxic combination plus dual HER2 targeting followed by anthracyclines.

It is ideal to have clinical-pathologic tests to distinguish those patients destined to achieve the surrogate endpoint of pCR from those who will not achieve it.

Despite linkage of TILs to improved outcome for triple-negative and HER2-enriched molecular subtypes (Lancet Oncol. 2018 Jan;19[1]:40-50), analysis of TILs is not standard practice in HER2-positive breast cancer in community settings. Optimal cutoffs are not well established, and TILs have not been linked to the choice of particular treatment options.

Currently, PET-CT scans are not part of National Comprehensive Cancer Network guidelines for pretreatment evaluation, except in patients for whom there is clinical suspicion of distant disease.

For those reasons, the main results of PREDIX-HER2 remain research tools that will focus our attention on the clinical-pathologic correlations Dr. Hatschek highlighted, but the results should have no influence on routine clinical practice at this time.

PREDIX-HER2 was funded by the Swedish Cancer Society, Radiumhemmet of Karolinska Institutet, Region Stockholm, and Roche Sweden. Dr. Hatschek disclosed relationships with Roche Sweden, Pfizer Sweden, and Pierre Fabre Sweden. Dr. Guarneri disclosed relationships with Roche, Novartis, and Eli Lilly.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Hatschek T et al. ESMO Breast Cancer 2020, Abstract 97O.

In an update of the PREDIX-HER2 trial, trastuzumab emtansine (T-DM1) remained equivalent to standard neoadjuvant chemotherapy plus dual-targeted HER2 therapy in producing pathologic complete remissions (pCRs) among patients with HER2-positive, metastatic breast cancer.

The new data also suggest tumor-infiltrating lymphocytes (TILs) and dramatic improvements in PET-CT scans can predict favorable outcomes in both treatment groups. Though these findings will be useful for research purposes, they likely won’t influence routine clinical practice.

Thomas Hatschek, MD, PhD, of Karolinska Institutet in Stockholm, presented the updated results from PREDIX-HER2 during the European Society for Medical Oncology: Breast Cancer virtual meeting.

PREDIX-HER2 included patients with HER2-positive breast cancer and tumor size greater than 20 mm or lymph node metastases.

Patients received neoadjuvant therapy (NAT) with docetaxel and trastuzumab plus pertuzumab (DTP) or T-DM1 every 3 weeks for a planned total of six courses. The protocol permitted switching to the competing treatment for progression, lack of response, or drug-related severe toxicity.

Postoperatively, all patients received triweekly epirubicin plus cyclophosphamide – four courses for the T-DM1 arm and two courses for the DTP arm. All patients then received triweekly adjuvant trastuzumab for 11 courses. The 62% of patients whose tumors were hormone receptor (HR)–positive received standard endocrine therapy postoperatively.
 

Updated results, predictors of pCR

At the 2019 ASCO annual meeting, PREDIX-HER2 investigators reported that, when compared with DTP, T-DM1 produced the same likelihood of pCR with less toxicity (ASCO 2019, Abstract 501). Updated data presented at ESMO Breast Cancer 2020 showed similar results.

The pCR rate was 45.5% in the DTP arm and 43.9% in the T-DM1 arm (P = .824). pCR rates were higher for HR-negative tumors – 63.6% in the DTP arm and 59% in the T-DM1 arm – than for HR-positive tumors – 36.4% in the DTP arm and 33.9% in the TDM-1 arm.

Three patients had disease progression with T-DM1, and none progressed with DTP. However, almost twice as many patients switched from DTP to T-DM1, compared with the other sequence.

Dr. Hatschek reported that the presence of at least 10% TILs predicted pCR in both treatment groups. Among patients who achieved a pCR, 52.2% had at least 10% TILs in baseline biopsies, and 30.4% had less than 10% TILs.

In addition, a decrease of FDG maximum standardized uptake value by more than 75% on protocol-required PET-CT scans was highly predictive of pCR. Among patients who achieved a pCR, 70.3% had a maximum standardized uptake value decrease of more than 75%, and 22.5% had a decrease of 75% or less.

At median follow-up of 28.5 months, event-free survival was similar between the treatment arms. Overall, there were 13 cases of progression, relapse, contralateral breast cancer, distant metastases, or death from any cause. There were five such events in the DTP arm and eight in the TDM-1 arm.

Dr. Hatschek concluded that neoadjuvant T-DM1 may be as effective as standard NAT in all clinical subgroups evaluated. Both TILs and PET-CT showed the potential to predict pCR and merit further study in the NAT setting.
 

An imperfect surrogate

By definition, a surrogate is “one appointed to act in place of another.” In the case of PREDIX-HER2 and most other NAT studies in HER2-positive breast cancer patients, pCR is a surrogate for the endpoint about which doctors and patients really care – cancer-free survival.

As such, pCR is not a perfect surrogate. Reproducibly, pCR has been highly predictive of disease-free survival and overall survival, especially in the HR-negative subset of HER2-positive patients.

However, despite improvements with dual targeting of HER2 in the TRYPHAENA trial (Eur J Cancer. 2018;89:27-35) and the use of T-DM1 for patients failing to achieve pCR in the immediately practice-changing KATHERINE trial (N Engl J Med. 2019;380:617-28), eventual relapse is seen in 10%-20% of patients in various clinical-pathologic subgroups.

In PREDIX-HER2, the pCR rate for node-positive patients was considerably lower with T-DM1 than with DTP (54.1% vs. 38%), noted Valentina Guarneri, MD, of the University of Padova (Italy), in her discussion of the trial at ESMO Breast Cancer 2020.

Patients with larger initial tumor size and multiple involved axillary nodes at diagnosis remain at increased risk of death because of cancer relapse.

Central nervous system relapse remains a vexing problem. Among patients with triple-positive breast cancer, relapses may occur late, despite pCR.

Patients whose tumors transform from HER2 positive to HER2 negative with NAT, seen in approximately 8% of cases in the KATHERINE trial (ESMO Breast Cancer 2020, Abstract 96O), may be another poor-risk group.
 

Clinical implications

PREDIX-HER2 is an important study. At the early time point of 2.4 years (especially early since most patients were HR-positive), if pCR is achieved, event-free survival is excellent with T-DM1 or an aggressive multiagent cytotoxic combination plus dual HER2 targeting followed by anthracyclines.

It is ideal to have clinical-pathologic tests to distinguish those patients destined to achieve the surrogate endpoint of pCR from those who will not achieve it.

Despite linkage of TILs to improved outcome for triple-negative and HER2-enriched molecular subtypes (Lancet Oncol. 2018 Jan;19[1]:40-50), analysis of TILs is not standard practice in HER2-positive breast cancer in community settings. Optimal cutoffs are not well established, and TILs have not been linked to the choice of particular treatment options.

Currently, PET-CT scans are not part of National Comprehensive Cancer Network guidelines for pretreatment evaluation, except in patients for whom there is clinical suspicion of distant disease.

For those reasons, the main results of PREDIX-HER2 remain research tools that will focus our attention on the clinical-pathologic correlations Dr. Hatschek highlighted, but the results should have no influence on routine clinical practice at this time.

PREDIX-HER2 was funded by the Swedish Cancer Society, Radiumhemmet of Karolinska Institutet, Region Stockholm, and Roche Sweden. Dr. Hatschek disclosed relationships with Roche Sweden, Pfizer Sweden, and Pierre Fabre Sweden. Dr. Guarneri disclosed relationships with Roche, Novartis, and Eli Lilly.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Hatschek T et al. ESMO Breast Cancer 2020, Abstract 97O.

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

The Food and Drug Administration has approved ticagrelor (Brilinta/Brilique, AstraZeneca) for use with aspirin to cut the risk for a first myocardial infarction or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke, AstraZeneca announced today. 

Patients falling under the new indication do not need to have diabetes, although THEMIS had entered patients with diabetes and CAD, the latter defined as a 50% or greater narrowing of a coronary artery or a history of coronary revascularization but without a history of MI or stroke. 

The trial showed a significant reduction in the rate of the primary efficacy end point (P = .04), a composite of cardiovascular death, MI, and stroke. But the risk of TIMI (Thrombolysis in Myocardial Infarction) bleeding classification major bleeding was more than doubled in the ticagrelor group (P < .001) and the risk for intracranial hemorrhage went up 71% (P = .005). Net clinical benefit didn't differ significantly between the groups in an exploratory analysis. 

The benefit of dual-antiplatelet therapy with ticagrelor for the primary efficacy end point was even more pronounced in a prespecified THEMIS subanalysis of more than 11,000 patients with a history of percutaneous coronary intervention. In this group, the risk for  intracerebral hemorrhage didn't differ significantly between the groups, and the net clinical benefit favored ticagrelor by a significant 15%. 

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

The Food and Drug Administration has approved ticagrelor (Brilinta/Brilique, AstraZeneca) for use with aspirin to cut the risk for a first myocardial infarction or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke, AstraZeneca announced today. 

Patients falling under the new indication do not need to have diabetes, although THEMIS had entered patients with diabetes and CAD, the latter defined as a 50% or greater narrowing of a coronary artery or a history of coronary revascularization but without a history of MI or stroke. 

The trial showed a significant reduction in the rate of the primary efficacy end point (P = .04), a composite of cardiovascular death, MI, and stroke. But the risk of TIMI (Thrombolysis in Myocardial Infarction) bleeding classification major bleeding was more than doubled in the ticagrelor group (P < .001) and the risk for intracranial hemorrhage went up 71% (P = .005). Net clinical benefit didn't differ significantly between the groups in an exploratory analysis. 

The benefit of dual-antiplatelet therapy with ticagrelor for the primary efficacy end point was even more pronounced in a prespecified THEMIS subanalysis of more than 11,000 patients with a history of percutaneous coronary intervention. In this group, the risk for  intracerebral hemorrhage didn't differ significantly between the groups, and the net clinical benefit favored ticagrelor by a significant 15%. 

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

The Food and Drug Administration has approved ticagrelor (Brilinta/Brilique, AstraZeneca) for use with aspirin to cut the risk for a first myocardial infarction or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke, AstraZeneca announced today. 

Patients falling under the new indication do not need to have diabetes, although THEMIS had entered patients with diabetes and CAD, the latter defined as a 50% or greater narrowing of a coronary artery or a history of coronary revascularization but without a history of MI or stroke. 

The trial showed a significant reduction in the rate of the primary efficacy end point (P = .04), a composite of cardiovascular death, MI, and stroke. But the risk of TIMI (Thrombolysis in Myocardial Infarction) bleeding classification major bleeding was more than doubled in the ticagrelor group (P < .001) and the risk for intracranial hemorrhage went up 71% (P = .005). Net clinical benefit didn't differ significantly between the groups in an exploratory analysis. 

The benefit of dual-antiplatelet therapy with ticagrelor for the primary efficacy end point was even more pronounced in a prespecified THEMIS subanalysis of more than 11,000 patients with a history of percutaneous coronary intervention. In this group, the risk for  intracerebral hemorrhage didn't differ significantly between the groups, and the net clinical benefit favored ticagrelor by a significant 15%. 

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

Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure (BP) control, researchers concluded based on their randomized multicenter trial.

Deprescription of one of at least two antihypertensive meds in such patients was found noninferior to usual care in keeping systolic BP below 150 mm Hg at 12 weeks, in the study that randomly assigned only patients who were considered appropriate for BP-med reduction by their primary care physicians.

Major trials that have shaped some contemporary hypertension guidelines, notably SPRINT, in general have not included such older patients with hypertension along with other chronic conditions, such as diabetes or a history of stroke. So “it’s difficult to know whether their data are relevant for frail, multimorbid patients. In fact, the guidelines say you should use some clinical judgment when applying the results of SPRINT to the kind of patients seen in clinical practice,” James P. Sheppard, PhD, of University of Oxford (England) said in an interview.

The current study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” Dr. Sheppard said.

The trial is meant to provide something of an otherwise-scant evidence base for how to deprescribe antihypertensive medications, said Dr. Sheppard, who is lead author on the report published May 25 in JAMA.

Of the trial’s 282 patients randomly assigned to the drug-reduction group, 86.4% reached the primary endpoint goal of systolic BP less than 150 mm Hg, compared with 87.7% of the 287 patients on usual care, a difference which in adjusted analysis met the predetermined standard for noninferiority.

The intervention group reduced its number of antihypertensive agents by a mean of 0.6 per patient, which the authors described as “a modest reduction.” However, they noted, drugs that were taken away could be reintroduced as judged necessary by the physicians, yet most of the group sustained their reductions until the end of the 12 weeks.

Had the primary endpoint instead specified a threshold of 130 mm Hg for BP control, which is more consistent with SPRINT and some guidelines in the United States, “the deprescribing strategy would have failed to be considered noninferior to usual care” as calculated by the OPTIMISE authors themselves, observed an accompanying editorial.

The 150 mm Hg threshold chosen by the trialists for the primary endpoint, therefore, “was somewhat of a low bar,” wrote Eric D. Peterson, MD, MPH, of Duke University, Durham, N.C., and Michael W. Rich, MD, of Washington University School of Medicine, St. Louis, Mo.

“Here in the UK it wouldn’t be considered a low bar,” Dr. Sheppard said in an interview. The National Institute for Health and Care Excellence guidelines in Britain “recommends that you treat people over the age of 18 regardless of whether they have any other conditions and to 150 mm Hg systolic.”

The study’s general practitioners, he said, “did what we told them to do, and as a result, two-thirds of the patients were able to reduce their medications. If we had a lower threshold for treatment, it’s possible that more patients might have had medications reintroduced. I think you still could have potentially ended up with a noninferior result.”

Participating physicians were instructed to enroll only “patients who, in their opinion, might potentially benefit from medication reduction due to one or more of the following existing characteristics: polypharmacy, comorbidity, nonadherence or dislike of medicines, or frailty,” the report notes.

They chose which antihypertensives would be dropped for each patient and “were given a medication reduction algorithm to assist with this decision.” Physicians also followed a guide for monitoring for safety issues and were told to reintroduce medications if systolic BP exceeded 150 mm Hg or diastolic BP rose above 90 mm Hg for more than 1 week or in the event of adverse events or signs of accelerated hypertension, the group wrote.

In the deprescription group, the mean systolic BP rose 4.3 points from baseline to 12 weeks, from 129.4 to 133.7 mm Hg. For those given usual care, mean systolic BP went from 130.5 to 130.8 mm Hg. Adjusted, the mean change in systolic BP was 3.4 mm Hg greater (P = .005) in the intervention group. The corresponding adjusted mean change in diastolic BP was a 2.2 mm Hg increase in the intervention group (P = .001).

Although the difference seems minimal, wrote Dr. Peterson and Dr. Rich, “such differences in BP can potentially lead to long-term differences in outcomes at the population level.”

Also, they pointed out, only about 10% of patients screened for enrollment actually entered the study, which brings into question the study’s generalizability, and “patients in the trial had relatively well-controlled BP at baseline.”

Dr. Sheppard said patients in the original screened population, taken from a national database, were directly invited to participate en masse by conventional mail, based on broad inclusion criteria. Far more than the number needed were invited, and nearly all of those excluded from the study had simply not responded to the invitation.

As for greater increases in systolic and diastolic pressures in the deprescribing group, the OPTIMISE authors acknowledged that “caution should be exercised when adopting this approach in routine clinical practice.”

His own view, Dr. Sheppard said, “is that there are some patients who will definitely benefit from intensive blood pressure lowering like you saw in the SPRINT trial. And there’s other patients who will benefit from deprescribing and having a slightly higher target. Those sorts of things very much need to be individualized at the patient level.”

And ideally, he added, clinicians in practice should probably be even more selective in choosing patients for a deprescribing strategy, “and focus on people who are at the highest risk of adverse events.”

Dr. Sheppard has disclosed no relevant financial relationships; disclosures for the other authors are in the report. Dr. Peterson disclosed receiving personal fees from Cerner and Livongo and grants and personal fees from AstraZeneca, Janssen, and Amgen; Dr. Rick has disclosed no relevant financial relationships.

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

Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure (BP) control, researchers concluded based on their randomized multicenter trial.

Deprescription of one of at least two antihypertensive meds in such patients was found noninferior to usual care in keeping systolic BP below 150 mm Hg at 12 weeks, in the study that randomly assigned only patients who were considered appropriate for BP-med reduction by their primary care physicians.

Major trials that have shaped some contemporary hypertension guidelines, notably SPRINT, in general have not included such older patients with hypertension along with other chronic conditions, such as diabetes or a history of stroke. So “it’s difficult to know whether their data are relevant for frail, multimorbid patients. In fact, the guidelines say you should use some clinical judgment when applying the results of SPRINT to the kind of patients seen in clinical practice,” James P. Sheppard, PhD, of University of Oxford (England) said in an interview.

The current study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” Dr. Sheppard said.

The trial is meant to provide something of an otherwise-scant evidence base for how to deprescribe antihypertensive medications, said Dr. Sheppard, who is lead author on the report published May 25 in JAMA.

Of the trial’s 282 patients randomly assigned to the drug-reduction group, 86.4% reached the primary endpoint goal of systolic BP less than 150 mm Hg, compared with 87.7% of the 287 patients on usual care, a difference which in adjusted analysis met the predetermined standard for noninferiority.

The intervention group reduced its number of antihypertensive agents by a mean of 0.6 per patient, which the authors described as “a modest reduction.” However, they noted, drugs that were taken away could be reintroduced as judged necessary by the physicians, yet most of the group sustained their reductions until the end of the 12 weeks.

Had the primary endpoint instead specified a threshold of 130 mm Hg for BP control, which is more consistent with SPRINT and some guidelines in the United States, “the deprescribing strategy would have failed to be considered noninferior to usual care” as calculated by the OPTIMISE authors themselves, observed an accompanying editorial.

The 150 mm Hg threshold chosen by the trialists for the primary endpoint, therefore, “was somewhat of a low bar,” wrote Eric D. Peterson, MD, MPH, of Duke University, Durham, N.C., and Michael W. Rich, MD, of Washington University School of Medicine, St. Louis, Mo.

“Here in the UK it wouldn’t be considered a low bar,” Dr. Sheppard said in an interview. The National Institute for Health and Care Excellence guidelines in Britain “recommends that you treat people over the age of 18 regardless of whether they have any other conditions and to 150 mm Hg systolic.”

The study’s general practitioners, he said, “did what we told them to do, and as a result, two-thirds of the patients were able to reduce their medications. If we had a lower threshold for treatment, it’s possible that more patients might have had medications reintroduced. I think you still could have potentially ended up with a noninferior result.”

Participating physicians were instructed to enroll only “patients who, in their opinion, might potentially benefit from medication reduction due to one or more of the following existing characteristics: polypharmacy, comorbidity, nonadherence or dislike of medicines, or frailty,” the report notes.

They chose which antihypertensives would be dropped for each patient and “were given a medication reduction algorithm to assist with this decision.” Physicians also followed a guide for monitoring for safety issues and were told to reintroduce medications if systolic BP exceeded 150 mm Hg or diastolic BP rose above 90 mm Hg for more than 1 week or in the event of adverse events or signs of accelerated hypertension, the group wrote.

In the deprescription group, the mean systolic BP rose 4.3 points from baseline to 12 weeks, from 129.4 to 133.7 mm Hg. For those given usual care, mean systolic BP went from 130.5 to 130.8 mm Hg. Adjusted, the mean change in systolic BP was 3.4 mm Hg greater (P = .005) in the intervention group. The corresponding adjusted mean change in diastolic BP was a 2.2 mm Hg increase in the intervention group (P = .001).

Although the difference seems minimal, wrote Dr. Peterson and Dr. Rich, “such differences in BP can potentially lead to long-term differences in outcomes at the population level.”

Also, they pointed out, only about 10% of patients screened for enrollment actually entered the study, which brings into question the study’s generalizability, and “patients in the trial had relatively well-controlled BP at baseline.”

Dr. Sheppard said patients in the original screened population, taken from a national database, were directly invited to participate en masse by conventional mail, based on broad inclusion criteria. Far more than the number needed were invited, and nearly all of those excluded from the study had simply not responded to the invitation.

As for greater increases in systolic and diastolic pressures in the deprescribing group, the OPTIMISE authors acknowledged that “caution should be exercised when adopting this approach in routine clinical practice.”

His own view, Dr. Sheppard said, “is that there are some patients who will definitely benefit from intensive blood pressure lowering like you saw in the SPRINT trial. And there’s other patients who will benefit from deprescribing and having a slightly higher target. Those sorts of things very much need to be individualized at the patient level.”

And ideally, he added, clinicians in practice should probably be even more selective in choosing patients for a deprescribing strategy, “and focus on people who are at the highest risk of adverse events.”

Dr. Sheppard has disclosed no relevant financial relationships; disclosures for the other authors are in the report. Dr. Peterson disclosed receiving personal fees from Cerner and Livongo and grants and personal fees from AstraZeneca, Janssen, and Amgen; Dr. Rick has disclosed no relevant financial relationships.

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

Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure (BP) control, researchers concluded based on their randomized multicenter trial.

Deprescription of one of at least two antihypertensive meds in such patients was found noninferior to usual care in keeping systolic BP below 150 mm Hg at 12 weeks, in the study that randomly assigned only patients who were considered appropriate for BP-med reduction by their primary care physicians.

Major trials that have shaped some contemporary hypertension guidelines, notably SPRINT, in general have not included such older patients with hypertension along with other chronic conditions, such as diabetes or a history of stroke. So “it’s difficult to know whether their data are relevant for frail, multimorbid patients. In fact, the guidelines say you should use some clinical judgment when applying the results of SPRINT to the kind of patients seen in clinical practice,” James P. Sheppard, PhD, of University of Oxford (England) said in an interview.

The current study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” Dr. Sheppard said.

The trial is meant to provide something of an otherwise-scant evidence base for how to deprescribe antihypertensive medications, said Dr. Sheppard, who is lead author on the report published May 25 in JAMA.

Of the trial’s 282 patients randomly assigned to the drug-reduction group, 86.4% reached the primary endpoint goal of systolic BP less than 150 mm Hg, compared with 87.7% of the 287 patients on usual care, a difference which in adjusted analysis met the predetermined standard for noninferiority.

The intervention group reduced its number of antihypertensive agents by a mean of 0.6 per patient, which the authors described as “a modest reduction.” However, they noted, drugs that were taken away could be reintroduced as judged necessary by the physicians, yet most of the group sustained their reductions until the end of the 12 weeks.

Had the primary endpoint instead specified a threshold of 130 mm Hg for BP control, which is more consistent with SPRINT and some guidelines in the United States, “the deprescribing strategy would have failed to be considered noninferior to usual care” as calculated by the OPTIMISE authors themselves, observed an accompanying editorial.

The 150 mm Hg threshold chosen by the trialists for the primary endpoint, therefore, “was somewhat of a low bar,” wrote Eric D. Peterson, MD, MPH, of Duke University, Durham, N.C., and Michael W. Rich, MD, of Washington University School of Medicine, St. Louis, Mo.

“Here in the UK it wouldn’t be considered a low bar,” Dr. Sheppard said in an interview. The National Institute for Health and Care Excellence guidelines in Britain “recommends that you treat people over the age of 18 regardless of whether they have any other conditions and to 150 mm Hg systolic.”

The study’s general practitioners, he said, “did what we told them to do, and as a result, two-thirds of the patients were able to reduce their medications. If we had a lower threshold for treatment, it’s possible that more patients might have had medications reintroduced. I think you still could have potentially ended up with a noninferior result.”

Participating physicians were instructed to enroll only “patients who, in their opinion, might potentially benefit from medication reduction due to one or more of the following existing characteristics: polypharmacy, comorbidity, nonadherence or dislike of medicines, or frailty,” the report notes.

They chose which antihypertensives would be dropped for each patient and “were given a medication reduction algorithm to assist with this decision.” Physicians also followed a guide for monitoring for safety issues and were told to reintroduce medications if systolic BP exceeded 150 mm Hg or diastolic BP rose above 90 mm Hg for more than 1 week or in the event of adverse events or signs of accelerated hypertension, the group wrote.

In the deprescription group, the mean systolic BP rose 4.3 points from baseline to 12 weeks, from 129.4 to 133.7 mm Hg. For those given usual care, mean systolic BP went from 130.5 to 130.8 mm Hg. Adjusted, the mean change in systolic BP was 3.4 mm Hg greater (P = .005) in the intervention group. The corresponding adjusted mean change in diastolic BP was a 2.2 mm Hg increase in the intervention group (P = .001).

Although the difference seems minimal, wrote Dr. Peterson and Dr. Rich, “such differences in BP can potentially lead to long-term differences in outcomes at the population level.”

Also, they pointed out, only about 10% of patients screened for enrollment actually entered the study, which brings into question the study’s generalizability, and “patients in the trial had relatively well-controlled BP at baseline.”

Dr. Sheppard said patients in the original screened population, taken from a national database, were directly invited to participate en masse by conventional mail, based on broad inclusion criteria. Far more than the number needed were invited, and nearly all of those excluded from the study had simply not responded to the invitation.

As for greater increases in systolic and diastolic pressures in the deprescribing group, the OPTIMISE authors acknowledged that “caution should be exercised when adopting this approach in routine clinical practice.”

His own view, Dr. Sheppard said, “is that there are some patients who will definitely benefit from intensive blood pressure lowering like you saw in the SPRINT trial. And there’s other patients who will benefit from deprescribing and having a slightly higher target. Those sorts of things very much need to be individualized at the patient level.”

And ideally, he added, clinicians in practice should probably be even more selective in choosing patients for a deprescribing strategy, “and focus on people who are at the highest risk of adverse events.”

Dr. Sheppard has disclosed no relevant financial relationships; disclosures for the other authors are in the report. Dr. Peterson disclosed receiving personal fees from Cerner and Livongo and grants and personal fees from AstraZeneca, Janssen, and Amgen; Dr. Rick has disclosed no relevant financial relationships.

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

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.

Courtesy Dr. Sejal Hathi

Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.

“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”

The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.

In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.

Courtesy John Paul Schnapper-Casteras

“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
 

Letter highlights hospitals’ obligations

As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.

Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”

“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”

Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.

“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”

Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.

Workplace rights, legal options

Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.

“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”

In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.

Courtesy Sheel Tyle

“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.

Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.

“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”

While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.

Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.

“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”

[email protected]

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.

Courtesy Dr. Sejal Hathi

Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.

“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”

The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.

In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.

Courtesy John Paul Schnapper-Casteras

“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
 

Letter highlights hospitals’ obligations

As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.

Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”

“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”

Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.

“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”

Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.

Workplace rights, legal options

Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.

“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”

In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.

Courtesy Sheel Tyle

“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.

Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.

“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”

While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.

Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.

“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”

[email protected]

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.

Courtesy Dr. Sejal Hathi

Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.

“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”

The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.

In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.

Courtesy John Paul Schnapper-Casteras

“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
 

Letter highlights hospitals’ obligations

As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.

Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”

“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”

Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.

“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”

Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.

Workplace rights, legal options

Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.

“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”

In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.

Courtesy Sheel Tyle

“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.

Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.

“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”

While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.

Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.

“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”

[email protected]

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The US Department of Defense (DoD) has unveiled a plan for returning to normal operations. The plan is tied to “local conditions” and does not have specific dates for opening. Instead, the plan provides phase-by-phase guidance to commanders, supervisors, and employees to safely and effectively return to Pentagon Reservation offices. Along with guidelines for in-office and telework targets; vulnerable populations; entrance screening; and the status and cleaning of common areas, food courts, gyms and other facilities, the plan includes mandatory requirements regarding face coverings, social distancing, and symptomatic personnel throughout each phase.

Building on the 3-phase White House “Opening Up America Again” plan, the Joint Staff, military services, and the DoD COVID Task Force have developed a 5-phase plan. Currently, the department is at Phase Zero. The Pentagon Reservation Plan for Resilience and ‘Aligning with National Guidelines for Opening Up America Again’ “places the health and safety of our workforce first,” is “nested” within the White House, Office of Management and Budget, and Office of Personnel Management guidelines and plans. The goal is to allow the workforce to return to the Pentagon Reservation “in a controlled and steady manner.”

The DoD reported nearly 10,000 COVID-19 cases as of June 1, 2020, including 6,596 active-duty service members, 1,124 dependents, 1,516 civilians, and 649 DoD contractors. To date, 3 service members and 5 dependents have died of COVID-19, including Capt. Douglas Linn Hickok, a physician assistant and member of the New Jersey National Guard, who died March 28, 2020.

Since mid-March the DoD says it has taken “aggressive steps” to stop the spread of COVID-19, implementing health protection measures that resulted in a sustained transmission rate below that of the region at large. Teams have deep cleaned and sanitized more than 1 million square feet of office space on the Pentagon Reservation to US Centers for Disease Control and Prevention standards. And for the first time ever, according to the DoD, maximized telework options have enabled more than two-thirds of the Pentagon Reservation workforce to continue to work at alternate locations.

The criteria to enter Phase 1 require a downward trajectory of influenza-like illnesses reported with a 14-day period and a downward trajectory of COVID-like symptoms reported within a 14-day period. There must also be a downward trajectory of documented COVID-19 cases within a 14-day period or a downward trajectory of positive COVID-19 tests as a percentage of total tests within a 14-day period (flat or increasing volume of tests).

Finally, hospitals must treat all patients without crisis care and have a “robust” testing program in place for at-risk health care workers, including emerging antibody testing.

Those same criteria must be met between each phase of the plan. The “gates” for controlling moves from phase to phase are not tied to dates but are based on state, regional, and local public health conditions, availability of hospitals and testing capacity, and monitoring through the DoD’s Electronic Surveillance System for Early Notification of Community-based Epidemics (ESSENCE).

If the monitors detect a resurgence in the spread of COVID-19, the department will reassess its protection measures and workforce phase and respond appropriately. DoD service members and civilian employees are advised to talk with their commanders or supervisors to determine when it’s all right to return.

The US Department of Defense (DoD) has unveiled a plan for returning to normal operations. The plan is tied to “local conditions” and does not have specific dates for opening. Instead, the plan provides phase-by-phase guidance to commanders, supervisors, and employees to safely and effectively return to Pentagon Reservation offices. Along with guidelines for in-office and telework targets; vulnerable populations; entrance screening; and the status and cleaning of common areas, food courts, gyms and other facilities, the plan includes mandatory requirements regarding face coverings, social distancing, and symptomatic personnel throughout each phase.

Building on the 3-phase White House “Opening Up America Again” plan, the Joint Staff, military services, and the DoD COVID Task Force have developed a 5-phase plan. Currently, the department is at Phase Zero. The Pentagon Reservation Plan for Resilience and ‘Aligning with National Guidelines for Opening Up America Again’ “places the health and safety of our workforce first,” is “nested” within the White House, Office of Management and Budget, and Office of Personnel Management guidelines and plans. The goal is to allow the workforce to return to the Pentagon Reservation “in a controlled and steady manner.”

The DoD reported nearly 10,000 COVID-19 cases as of June 1, 2020, including 6,596 active-duty service members, 1,124 dependents, 1,516 civilians, and 649 DoD contractors. To date, 3 service members and 5 dependents have died of COVID-19, including Capt. Douglas Linn Hickok, a physician assistant and member of the New Jersey National Guard, who died March 28, 2020.

Since mid-March the DoD says it has taken “aggressive steps” to stop the spread of COVID-19, implementing health protection measures that resulted in a sustained transmission rate below that of the region at large. Teams have deep cleaned and sanitized more than 1 million square feet of office space on the Pentagon Reservation to US Centers for Disease Control and Prevention standards. And for the first time ever, according to the DoD, maximized telework options have enabled more than two-thirds of the Pentagon Reservation workforce to continue to work at alternate locations.

The criteria to enter Phase 1 require a downward trajectory of influenza-like illnesses reported with a 14-day period and a downward trajectory of COVID-like symptoms reported within a 14-day period. There must also be a downward trajectory of documented COVID-19 cases within a 14-day period or a downward trajectory of positive COVID-19 tests as a percentage of total tests within a 14-day period (flat or increasing volume of tests).

Finally, hospitals must treat all patients without crisis care and have a “robust” testing program in place for at-risk health care workers, including emerging antibody testing.

Those same criteria must be met between each phase of the plan. The “gates” for controlling moves from phase to phase are not tied to dates but are based on state, regional, and local public health conditions, availability of hospitals and testing capacity, and monitoring through the DoD’s Electronic Surveillance System for Early Notification of Community-based Epidemics (ESSENCE).

If the monitors detect a resurgence in the spread of COVID-19, the department will reassess its protection measures and workforce phase and respond appropriately. DoD service members and civilian employees are advised to talk with their commanders or supervisors to determine when it’s all right to return.

The US Department of Defense (DoD) has unveiled a plan for returning to normal operations. The plan is tied to “local conditions” and does not have specific dates for opening. Instead, the plan provides phase-by-phase guidance to commanders, supervisors, and employees to safely and effectively return to Pentagon Reservation offices. Along with guidelines for in-office and telework targets; vulnerable populations; entrance screening; and the status and cleaning of common areas, food courts, gyms and other facilities, the plan includes mandatory requirements regarding face coverings, social distancing, and symptomatic personnel throughout each phase.

Building on the 3-phase White House “Opening Up America Again” plan, the Joint Staff, military services, and the DoD COVID Task Force have developed a 5-phase plan. Currently, the department is at Phase Zero. The Pentagon Reservation Plan for Resilience and ‘Aligning with National Guidelines for Opening Up America Again’ “places the health and safety of our workforce first,” is “nested” within the White House, Office of Management and Budget, and Office of Personnel Management guidelines and plans. The goal is to allow the workforce to return to the Pentagon Reservation “in a controlled and steady manner.”

The DoD reported nearly 10,000 COVID-19 cases as of June 1, 2020, including 6,596 active-duty service members, 1,124 dependents, 1,516 civilians, and 649 DoD contractors. To date, 3 service members and 5 dependents have died of COVID-19, including Capt. Douglas Linn Hickok, a physician assistant and member of the New Jersey National Guard, who died March 28, 2020.

Since mid-March the DoD says it has taken “aggressive steps” to stop the spread of COVID-19, implementing health protection measures that resulted in a sustained transmission rate below that of the region at large. Teams have deep cleaned and sanitized more than 1 million square feet of office space on the Pentagon Reservation to US Centers for Disease Control and Prevention standards. And for the first time ever, according to the DoD, maximized telework options have enabled more than two-thirds of the Pentagon Reservation workforce to continue to work at alternate locations.

The criteria to enter Phase 1 require a downward trajectory of influenza-like illnesses reported with a 14-day period and a downward trajectory of COVID-like symptoms reported within a 14-day period. There must also be a downward trajectory of documented COVID-19 cases within a 14-day period or a downward trajectory of positive COVID-19 tests as a percentage of total tests within a 14-day period (flat or increasing volume of tests).

Finally, hospitals must treat all patients without crisis care and have a “robust” testing program in place for at-risk health care workers, including emerging antibody testing.

Those same criteria must be met between each phase of the plan. The “gates” for controlling moves from phase to phase are not tied to dates but are based on state, regional, and local public health conditions, availability of hospitals and testing capacity, and monitoring through the DoD’s Electronic Surveillance System for Early Notification of Community-based Epidemics (ESSENCE).

If the monitors detect a resurgence in the spread of COVID-19, the department will reassess its protection measures and workforce phase and respond appropriately. DoD service members and civilian employees are advised to talk with their commanders or supervisors to determine when it’s all right to return.

Hidradenitis suppurativa (HS) was associated with a significantly increased risk of any cancer as well as for several specific cancers in a population-based study of approximately 200,000 individuals in Korea.

HS is associated with severe comorbidities, and previous studies have suggested a link between HS and cancer development, wrote Joon Min Jung, MD, of the University of Ulsan College of Medicine, Seoul, Korea, and colleagues.

“The aberrant immune response and chronic inflammation in HS and genetic and environmental factors associated with the disease may all be factors in the development of cancer,” but large, population-based studies of cancer in HS patients are limited, they noted.

In a study published in JAMA Dermatology, the researchers reviewed data from 22,468 adults with HS and 179,734 matched controls, in the Korean National Health Insurance System, seen by physicians between January 2009 and December 2017. The average age of the participants was 34 years, and 64% were male.

Overall, HS patients had a significantly higher risk of cancer compared with controls, with an adjusted hazard ratio (aHR) of 1.28.

As for specific cancers, HS patients had a significantly higher risk for Hodgkin lymphoma (aHR 5.08), oral cavity and pharyngeal cancer (aHR 3.10), central nervous system cancer (aHR 2.40), nonmelanoma skin cancer (aHR 2.06), prostate cancer (aHR 2.05), and colorectal cancer (aHR 1.45).

The risk of any cancer was not significantly different between women with HS and female controls (after adjustment for comorbidities), but was significantly higher among men with HS compared with male controls, also after adjustment for comorbidities (aHR, 1.37). In addition, HS patients in both younger (less than 40 years) and older (aged 40 years and older) age groups had increased cancer risk compared with age-matched controls. Overall cancer risk and the risk of most cancer types were higher among HS patients with moderate to severe disease than in those with mild disease, with the exception of nonmelanoma skin cancer, prostate cancer, lymphoma, and leukemia.

“Overall cancer risk showed a tendency to increase with worsening HS severity, reinforcing the possibility of an association between HS and cancer development,” the researchers noted. “However, we could not identify tendencies in some specific cancers, such as nonmelanoma skin cancer, CNS cancer, and prostate cancer, because the number of occurrences of those cancers was too small in the group with moderate to severe HS.”

The study findings were limited by several factors including the potential underestimate of HS cases in the population and the inability of the study design to adjust for factors including smoking status, alcohol use, and obesity, the researchers noted. However, the results support an increased cancer risk in HS patients and suggest the need to promote lifestyle modifications to reduce risk, and to increase cancer surveillance in these patients, they said. “For early detection of skin cancer, more aggressive histologic examination and a high level of suspicion are required,” they added.

The study was supported by the National Research Foundation of Korea and the Korea Health Technology R&D Project. The researchers had no financial conflicts to disclose.

SOURCE: Jung JM et al. JAMA Dermatol. 2020 May 27. doi: 10.1001/jamadermatol.2020.1422.

Hidradenitis suppurativa (HS) was associated with a significantly increased risk of any cancer as well as for several specific cancers in a population-based study of approximately 200,000 individuals in Korea.

HS is associated with severe comorbidities, and previous studies have suggested a link between HS and cancer development, wrote Joon Min Jung, MD, of the University of Ulsan College of Medicine, Seoul, Korea, and colleagues.

“The aberrant immune response and chronic inflammation in HS and genetic and environmental factors associated with the disease may all be factors in the development of cancer,” but large, population-based studies of cancer in HS patients are limited, they noted.

In a study published in JAMA Dermatology, the researchers reviewed data from 22,468 adults with HS and 179,734 matched controls, in the Korean National Health Insurance System, seen by physicians between January 2009 and December 2017. The average age of the participants was 34 years, and 64% were male.

Overall, HS patients had a significantly higher risk of cancer compared with controls, with an adjusted hazard ratio (aHR) of 1.28.

As for specific cancers, HS patients had a significantly higher risk for Hodgkin lymphoma (aHR 5.08), oral cavity and pharyngeal cancer (aHR 3.10), central nervous system cancer (aHR 2.40), nonmelanoma skin cancer (aHR 2.06), prostate cancer (aHR 2.05), and colorectal cancer (aHR 1.45).

The risk of any cancer was not significantly different between women with HS and female controls (after adjustment for comorbidities), but was significantly higher among men with HS compared with male controls, also after adjustment for comorbidities (aHR, 1.37). In addition, HS patients in both younger (less than 40 years) and older (aged 40 years and older) age groups had increased cancer risk compared with age-matched controls. Overall cancer risk and the risk of most cancer types were higher among HS patients with moderate to severe disease than in those with mild disease, with the exception of nonmelanoma skin cancer, prostate cancer, lymphoma, and leukemia.

“Overall cancer risk showed a tendency to increase with worsening HS severity, reinforcing the possibility of an association between HS and cancer development,” the researchers noted. “However, we could not identify tendencies in some specific cancers, such as nonmelanoma skin cancer, CNS cancer, and prostate cancer, because the number of occurrences of those cancers was too small in the group with moderate to severe HS.”

The study findings were limited by several factors including the potential underestimate of HS cases in the population and the inability of the study design to adjust for factors including smoking status, alcohol use, and obesity, the researchers noted. However, the results support an increased cancer risk in HS patients and suggest the need to promote lifestyle modifications to reduce risk, and to increase cancer surveillance in these patients, they said. “For early detection of skin cancer, more aggressive histologic examination and a high level of suspicion are required,” they added.

The study was supported by the National Research Foundation of Korea and the Korea Health Technology R&D Project. The researchers had no financial conflicts to disclose.

SOURCE: Jung JM et al. JAMA Dermatol. 2020 May 27. doi: 10.1001/jamadermatol.2020.1422.

Hidradenitis suppurativa (HS) was associated with a significantly increased risk of any cancer as well as for several specific cancers in a population-based study of approximately 200,000 individuals in Korea.

HS is associated with severe comorbidities, and previous studies have suggested a link between HS and cancer development, wrote Joon Min Jung, MD, of the University of Ulsan College of Medicine, Seoul, Korea, and colleagues.

“The aberrant immune response and chronic inflammation in HS and genetic and environmental factors associated with the disease may all be factors in the development of cancer,” but large, population-based studies of cancer in HS patients are limited, they noted.

In a study published in JAMA Dermatology, the researchers reviewed data from 22,468 adults with HS and 179,734 matched controls, in the Korean National Health Insurance System, seen by physicians between January 2009 and December 2017. The average age of the participants was 34 years, and 64% were male.

Overall, HS patients had a significantly higher risk of cancer compared with controls, with an adjusted hazard ratio (aHR) of 1.28.

As for specific cancers, HS patients had a significantly higher risk for Hodgkin lymphoma (aHR 5.08), oral cavity and pharyngeal cancer (aHR 3.10), central nervous system cancer (aHR 2.40), nonmelanoma skin cancer (aHR 2.06), prostate cancer (aHR 2.05), and colorectal cancer (aHR 1.45).

The risk of any cancer was not significantly different between women with HS and female controls (after adjustment for comorbidities), but was significantly higher among men with HS compared with male controls, also after adjustment for comorbidities (aHR, 1.37). In addition, HS patients in both younger (less than 40 years) and older (aged 40 years and older) age groups had increased cancer risk compared with age-matched controls. Overall cancer risk and the risk of most cancer types were higher among HS patients with moderate to severe disease than in those with mild disease, with the exception of nonmelanoma skin cancer, prostate cancer, lymphoma, and leukemia.

“Overall cancer risk showed a tendency to increase with worsening HS severity, reinforcing the possibility of an association between HS and cancer development,” the researchers noted. “However, we could not identify tendencies in some specific cancers, such as nonmelanoma skin cancer, CNS cancer, and prostate cancer, because the number of occurrences of those cancers was too small in the group with moderate to severe HS.”

The study findings were limited by several factors including the potential underestimate of HS cases in the population and the inability of the study design to adjust for factors including smoking status, alcohol use, and obesity, the researchers noted. However, the results support an increased cancer risk in HS patients and suggest the need to promote lifestyle modifications to reduce risk, and to increase cancer surveillance in these patients, they said. “For early detection of skin cancer, more aggressive histologic examination and a high level of suspicion are required,” they added.

The study was supported by the National Research Foundation of Korea and the Korea Health Technology R&D Project. The researchers had no financial conflicts to disclose.

SOURCE: Jung JM et al. JAMA Dermatol. 2020 May 27. doi: 10.1001/jamadermatol.2020.1422.

Coronaviruses (CoVs) are among the most common causes of the common cold but also can lead to severe respiratory disease.¹ In recent years, CoVs have been responsible for outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), caused by SARS-CoV and MERS-CoV, respectively. Severe acute respiratory syndrome emerged from China in 2002, and MERS started in Saudi Arabia in 2012. In December 2019, several cases of unexplained pneumonia were reported in Wuhan, China.¹ A novel CoV--SARS-CoV-2--was isolated in these patients and is now known to cause coronavirus disease 19 (COVID-19).¹ Coronavirus disease 19 can cause acute respiratory distress and multiorgan failure.^1,2 It spread quickly throughout the world and was declared a pandemic by the World Health Organization on March 11, 2020. According to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html), there were approximately 14,500 COVID-19 cases diagnosed worldwide on February 1, 2020; by May 22, 2020, there were more than 5,159,600 cases. Thus, heightened measures for infection prevention and control were put in place around the globe in an attempt to slow the spread of disease.¹  

In this article, we describe the dermatologic implications of COVID-19, including the clinical manifestations of the disease, risk reduction techniques for patients and providers, personal protective equipment-associated adverse reactions, and the financial impact on dermatologists.  

Clinical Manifestations 

At the start of the COVID-19 outbreak, little was known about the skin manifestations of the disease. Providers speculated that COVID-19 could have nonspecific skin findings similar to many other viral illnesses.^3,4 Research throughout the pandemic has found many cutaneous manifestations of the disease.^3-6 A case report from Thailand described a patient who presented with petechiae in addition to fever and thrombocytopenia, which led to an initial misdiagnosis of Dengue fever; however, when the patient began having respiratory symptoms, the diagnosis of COVID-19 was discovered.⁵ Furthermore, a study from Italy (N=88) showed dermatologic findings in 20.4% (18/88) of patients, including erythematous rash (77.8% [14/18]), widespread urticaria (16.7% [3/18]), and chickenpoxlike vesicles (5.6% [1/18]). A recent study from Spain (N=375) found 5 cutaneous patterns associated with COVID-19: pseudochilblain--acral areas of erythema with vesicles and/or pustules--lesions (19%), vesicular eruptions (9%), urticarial lesions (19%), maculopapular eruptions (47%), and livedoid/necrotic lesions (6%).⁶ Pseudochilblain lesions appeared in younger patients, occurred later in the disease course, and were associated with less severe disease. Vesicular lesions often were found in middle-aged patients prior to the onset of other COVID-19 symptoms, and they were associated with intermediate disease severity. Urticarial and maculopapular lesions typically paralleled other COVID-19 symptoms in timing and were associated with more severe disease. Likewise, livedoid and necrotic lesions were associated with more severe disease; they occurred more frequently in older patients.⁶ Clinicians at Cleveland Clinic found similar cutaneous lesions in COVID-19 patients, including morbilliform rashes, acral purpura resembling perniosis, and livedoid lesions.³ Initial biopsies of these lesions pointed to viral exanthema and thrombotic vasculopathy as potential etiologies of morbilliform and livedoid lesions, respectively. Interestingly, patients may present with multiple cutaneous morphologies of the disease at the same time.³ The acral lesions ("COVID toes") have been popularized throughout the media and thus may be the best-known cutaneous manifestation of the disease at this time. New findings continuously arise, and further research is warranted as lesions that develop in hospitalized COVID-19 patients could be virus related or secondary to hospital-induced skin irritation, stressors, or medications.³ Importantly, clinicians should be aware of these cutaneous signs of COVID-19, especially when triaging patients.

Risk Reduction

The current health crisis could have a drastic impact on dermatology patients and providers. One factor that may increase COVID-19 risk in dermatology patients is immunosuppression. Many patients are on immunomodulators and biologics for skin conditions, which can cause immunosuppression directly and indirectly. Immunosuppression is a risk factor for severe disease in patients with COVID-19, so this population is at higher risk for serious infection.⁷ Telemedicine for nonemergent cases and follow-ups should be considered to decrease traffic in high-risk hospitals; to limit the number of people in waiting rooms; and to protect staff, providers, and patients alike.¹ Recommendations for teledermatology consultation during this time include the following: First, have patients take photographs of their skin lesions and send them remotely to the consulting physician. If the lesion is easily recognizable, treatment recommendations can be made remotely; if the diagnosis is ambiguous, the dermatologist can set up an in-person appointment.¹  

Personal Protective Equipment

Moreover, the current need to wear personal protective equipment (PPE) and wash hands frequently may lead to skin disease among health care providers. Facial rashes may arise from wearing masks and goggles, and repeated handwashing and wearing gloves may lead to hand dermatitis.⁸ One study examined adverse skin reactions among health care workers (N=322) during the SARS outbreak in 2003. More than one-third (35.5%) of staff members who wore masks regularly during the outbreak reported adverse skin reactions, including acne (59.6%), facial itching (51.4%), and rash (35.8%).⁸ The acne etiology likely is multifactorial. Masks increase heat and humidity in the covered facial region, which can cause acne flare-ups due to increased sebum production and Cutibacterium acnes growth.⁸ Additionally, tight N95 masks may occlude the pilosebaceous glands, causing acne to flare. In the SARS study, facial itchiness and rashes likely were due to irritant contact dermatitis to the N95 masks. All of the respondents with adverse skin reactions from masks developed them after using N95 masks; those who wore surgical masks did not report reactions.⁸ Because N95 masks are recommended for health care workers caring for patients with highly transmissible respiratory infections such as SARS and COVID-19, it will be difficult to avoid wearing them during the current crisis. For this reason, topical retinoids and topical benzoyl peroxide should be the first-line treatment of mask-induced acne, and moisturization and topical corticosteroids should be used for facial erythema. Additionally, 21.4% of respondents reported adverse skin reactions from latex gloves during the SARS outbreak, including dry skin, itchiness, rash, and wheals.⁸ These skin reactions may have been type I IgE-mediated hypersensitivity reactions or irritant contact dermatitis due to latex sensitization and frequent handwashing. No respondents reported skin reactions to plastic gloves.⁸ For this reason, health care providers should consider wearing plastic gloves in lieu of or under latex gloves to prevent hand dermatitis during this time. Moisturization, barrier creams, and topical corticosteroids also can help treat hand dermatitis. Frequently changing PPE may help prevent skin disease among the frontline health care workers,⁸ which posed a problem at the beginning of the COVID-19 outbreak as there was a PPE shortage. With industry and individuals coming together to make and donate PPE, it is now more widely available for our frontline providers.  

Financial Impact

Finally, the pandemic is having an immense financial impact on dermatology.⁹ At the onset of the outbreak, our role as health care providers was to help slow the spread of COVID-19; for this reason, most elective procedures were cancelled, and many outpatient clinics closed. Both elective procedures and outpatient visits are central to dermatology, so many dermatologists worked less or not at all during this time, leading to a loss of revenue. The goals of these measures were to reduce transmissibility of the disease, to prevent the health care system from being overwhelmed with critical COVID-19 cases, and to allocate resources to the frontline providers.⁹ Although these measures were beneficial for slowing the spread of disease, they were detrimental to some providers' and practices' financial stability. Many dermatology practices have begun to reopen with COVID-19 precautions in place. For example, practices are limiting the number of patients that can be in the office at one time, mandating temperature readings upon check-in, and requiring masks be worn throughout the entire visit. With continued recommendations for individuals to stay at home as much as possible, the number of patients being seen in dermatology clinics on a daily basis remains less than normal. One potential solution is telemedicine, which would allow patients' concerns to be addressed while keeping providers practicing with a normal patient volume during this time.⁹ Keeping providers financially afloat is vital for private practices to continue operating after the pandemic. Dermatology appointments are in high demand with long waiting lists during nonpandemic times; without dermatologists practicing at full capacity, there will be an accumulation of patients with dermatologic conditions with even longer waiting times after the pandemic. Telemedicine may help reduce this potential accumulation of patients and allow patients to be treated in a more timely manner while alleviating financial pressures for providers.

Final Thoughts

The COVID-19 pandemic has spread across the world, infecting millions of people. Although the trends have slowed, more than 106,100 cases are still being diagnosed daily according to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html). Patients with COVID-19 may present with a variety of cutaneous lesions. Wearing PPE to take care of COVID-19 patients may lead to skin irritation, so care should be taken to address these adverse skin reactions to maintain the safety of providers. Finally, dermatologists should consider telemedicine during this time to protect high-risk patients, prevent a postpandemic surge of patients, and alleviate financial stressors caused by COVID-19.

Coronaviruses (CoVs) are among the most common causes of the common cold but also can lead to severe respiratory disease.¹ In recent years, CoVs have been responsible for outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), caused by SARS-CoV and MERS-CoV, respectively. Severe acute respiratory syndrome emerged from China in 2002, and MERS started in Saudi Arabia in 2012. In December 2019, several cases of unexplained pneumonia were reported in Wuhan, China.¹ A novel CoV--SARS-CoV-2--was isolated in these patients and is now known to cause coronavirus disease 19 (COVID-19).¹ Coronavirus disease 19 can cause acute respiratory distress and multiorgan failure.^1,2 It spread quickly throughout the world and was declared a pandemic by the World Health Organization on March 11, 2020. According to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html), there were approximately 14,500 COVID-19 cases diagnosed worldwide on February 1, 2020; by May 22, 2020, there were more than 5,159,600 cases. Thus, heightened measures for infection prevention and control were put in place around the globe in an attempt to slow the spread of disease.¹  

In this article, we describe the dermatologic implications of COVID-19, including the clinical manifestations of the disease, risk reduction techniques for patients and providers, personal protective equipment-associated adverse reactions, and the financial impact on dermatologists.  

Clinical Manifestations 

At the start of the COVID-19 outbreak, little was known about the skin manifestations of the disease. Providers speculated that COVID-19 could have nonspecific skin findings similar to many other viral illnesses.^3,4 Research throughout the pandemic has found many cutaneous manifestations of the disease.^3-6 A case report from Thailand described a patient who presented with petechiae in addition to fever and thrombocytopenia, which led to an initial misdiagnosis of Dengue fever; however, when the patient began having respiratory symptoms, the diagnosis of COVID-19 was discovered.⁵ Furthermore, a study from Italy (N=88) showed dermatologic findings in 20.4% (18/88) of patients, including erythematous rash (77.8% [14/18]), widespread urticaria (16.7% [3/18]), and chickenpoxlike vesicles (5.6% [1/18]). A recent study from Spain (N=375) found 5 cutaneous patterns associated with COVID-19: pseudochilblain--acral areas of erythema with vesicles and/or pustules--lesions (19%), vesicular eruptions (9%), urticarial lesions (19%), maculopapular eruptions (47%), and livedoid/necrotic lesions (6%).⁶ Pseudochilblain lesions appeared in younger patients, occurred later in the disease course, and were associated with less severe disease. Vesicular lesions often were found in middle-aged patients prior to the onset of other COVID-19 symptoms, and they were associated with intermediate disease severity. Urticarial and maculopapular lesions typically paralleled other COVID-19 symptoms in timing and were associated with more severe disease. Likewise, livedoid and necrotic lesions were associated with more severe disease; they occurred more frequently in older patients.⁶ Clinicians at Cleveland Clinic found similar cutaneous lesions in COVID-19 patients, including morbilliform rashes, acral purpura resembling perniosis, and livedoid lesions.³ Initial biopsies of these lesions pointed to viral exanthema and thrombotic vasculopathy as potential etiologies of morbilliform and livedoid lesions, respectively. Interestingly, patients may present with multiple cutaneous morphologies of the disease at the same time.³ The acral lesions ("COVID toes") have been popularized throughout the media and thus may be the best-known cutaneous manifestation of the disease at this time. New findings continuously arise, and further research is warranted as lesions that develop in hospitalized COVID-19 patients could be virus related or secondary to hospital-induced skin irritation, stressors, or medications.³ Importantly, clinicians should be aware of these cutaneous signs of COVID-19, especially when triaging patients.

Risk Reduction

The current health crisis could have a drastic impact on dermatology patients and providers. One factor that may increase COVID-19 risk in dermatology patients is immunosuppression. Many patients are on immunomodulators and biologics for skin conditions, which can cause immunosuppression directly and indirectly. Immunosuppression is a risk factor for severe disease in patients with COVID-19, so this population is at higher risk for serious infection.⁷ Telemedicine for nonemergent cases and follow-ups should be considered to decrease traffic in high-risk hospitals; to limit the number of people in waiting rooms; and to protect staff, providers, and patients alike.¹ Recommendations for teledermatology consultation during this time include the following: First, have patients take photographs of their skin lesions and send them remotely to the consulting physician. If the lesion is easily recognizable, treatment recommendations can be made remotely; if the diagnosis is ambiguous, the dermatologist can set up an in-person appointment.¹  

Personal Protective Equipment

Moreover, the current need to wear personal protective equipment (PPE) and wash hands frequently may lead to skin disease among health care providers. Facial rashes may arise from wearing masks and goggles, and repeated handwashing and wearing gloves may lead to hand dermatitis.⁸ One study examined adverse skin reactions among health care workers (N=322) during the SARS outbreak in 2003. More than one-third (35.5%) of staff members who wore masks regularly during the outbreak reported adverse skin reactions, including acne (59.6%), facial itching (51.4%), and rash (35.8%).⁸ The acne etiology likely is multifactorial. Masks increase heat and humidity in the covered facial region, which can cause acne flare-ups due to increased sebum production and Cutibacterium acnes growth.⁸ Additionally, tight N95 masks may occlude the pilosebaceous glands, causing acne to flare. In the SARS study, facial itchiness and rashes likely were due to irritant contact dermatitis to the N95 masks. All of the respondents with adverse skin reactions from masks developed them after using N95 masks; those who wore surgical masks did not report reactions.⁸ Because N95 masks are recommended for health care workers caring for patients with highly transmissible respiratory infections such as SARS and COVID-19, it will be difficult to avoid wearing them during the current crisis. For this reason, topical retinoids and topical benzoyl peroxide should be the first-line treatment of mask-induced acne, and moisturization and topical corticosteroids should be used for facial erythema. Additionally, 21.4% of respondents reported adverse skin reactions from latex gloves during the SARS outbreak, including dry skin, itchiness, rash, and wheals.⁸ These skin reactions may have been type I IgE-mediated hypersensitivity reactions or irritant contact dermatitis due to latex sensitization and frequent handwashing. No respondents reported skin reactions to plastic gloves.⁸ For this reason, health care providers should consider wearing plastic gloves in lieu of or under latex gloves to prevent hand dermatitis during this time. Moisturization, barrier creams, and topical corticosteroids also can help treat hand dermatitis. Frequently changing PPE may help prevent skin disease among the frontline health care workers,⁸ which posed a problem at the beginning of the COVID-19 outbreak as there was a PPE shortage. With industry and individuals coming together to make and donate PPE, it is now more widely available for our frontline providers.  

Financial Impact

Finally, the pandemic is having an immense financial impact on dermatology.⁹ At the onset of the outbreak, our role as health care providers was to help slow the spread of COVID-19; for this reason, most elective procedures were cancelled, and many outpatient clinics closed. Both elective procedures and outpatient visits are central to dermatology, so many dermatologists worked less or not at all during this time, leading to a loss of revenue. The goals of these measures were to reduce transmissibility of the disease, to prevent the health care system from being overwhelmed with critical COVID-19 cases, and to allocate resources to the frontline providers.⁹ Although these measures were beneficial for slowing the spread of disease, they were detrimental to some providers' and practices' financial stability. Many dermatology practices have begun to reopen with COVID-19 precautions in place. For example, practices are limiting the number of patients that can be in the office at one time, mandating temperature readings upon check-in, and requiring masks be worn throughout the entire visit. With continued recommendations for individuals to stay at home as much as possible, the number of patients being seen in dermatology clinics on a daily basis remains less than normal. One potential solution is telemedicine, which would allow patients' concerns to be addressed while keeping providers practicing with a normal patient volume during this time.⁹ Keeping providers financially afloat is vital for private practices to continue operating after the pandemic. Dermatology appointments are in high demand with long waiting lists during nonpandemic times; without dermatologists practicing at full capacity, there will be an accumulation of patients with dermatologic conditions with even longer waiting times after the pandemic. Telemedicine may help reduce this potential accumulation of patients and allow patients to be treated in a more timely manner while alleviating financial pressures for providers.

Final Thoughts

The COVID-19 pandemic has spread across the world, infecting millions of people. Although the trends have slowed, more than 106,100 cases are still being diagnosed daily according to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html). Patients with COVID-19 may present with a variety of cutaneous lesions. Wearing PPE to take care of COVID-19 patients may lead to skin irritation, so care should be taken to address these adverse skin reactions to maintain the safety of providers. Finally, dermatologists should consider telemedicine during this time to protect high-risk patients, prevent a postpandemic surge of patients, and alleviate financial stressors caused by COVID-19.

Coronaviruses (CoVs) are among the most common causes of the common cold but also can lead to severe respiratory disease.¹ In recent years, CoVs have been responsible for outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), caused by SARS-CoV and MERS-CoV, respectively. Severe acute respiratory syndrome emerged from China in 2002, and MERS started in Saudi Arabia in 2012. In December 2019, several cases of unexplained pneumonia were reported in Wuhan, China.¹ A novel CoV--SARS-CoV-2--was isolated in these patients and is now known to cause coronavirus disease 19 (COVID-19).¹ Coronavirus disease 19 can cause acute respiratory distress and multiorgan failure.^1,2 It spread quickly throughout the world and was declared a pandemic by the World Health Organization on March 11, 2020. According to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html), there were approximately 14,500 COVID-19 cases diagnosed worldwide on February 1, 2020; by May 22, 2020, there were more than 5,159,600 cases. Thus, heightened measures for infection prevention and control were put in place around the globe in an attempt to slow the spread of disease.¹  

In this article, we describe the dermatologic implications of COVID-19, including the clinical manifestations of the disease, risk reduction techniques for patients and providers, personal protective equipment-associated adverse reactions, and the financial impact on dermatologists.  

Clinical Manifestations 

At the start of the COVID-19 outbreak, little was known about the skin manifestations of the disease. Providers speculated that COVID-19 could have nonspecific skin findings similar to many other viral illnesses.^3,4 Research throughout the pandemic has found many cutaneous manifestations of the disease.^3-6 A case report from Thailand described a patient who presented with petechiae in addition to fever and thrombocytopenia, which led to an initial misdiagnosis of Dengue fever; however, when the patient began having respiratory symptoms, the diagnosis of COVID-19 was discovered.⁵ Furthermore, a study from Italy (N=88) showed dermatologic findings in 20.4% (18/88) of patients, including erythematous rash (77.8% [14/18]), widespread urticaria (16.7% [3/18]), and chickenpoxlike vesicles (5.6% [1/18]). A recent study from Spain (N=375) found 5 cutaneous patterns associated with COVID-19: pseudochilblain--acral areas of erythema with vesicles and/or pustules--lesions (19%), vesicular eruptions (9%), urticarial lesions (19%), maculopapular eruptions (47%), and livedoid/necrotic lesions (6%).⁶ Pseudochilblain lesions appeared in younger patients, occurred later in the disease course, and were associated with less severe disease. Vesicular lesions often were found in middle-aged patients prior to the onset of other COVID-19 symptoms, and they were associated with intermediate disease severity. Urticarial and maculopapular lesions typically paralleled other COVID-19 symptoms in timing and were associated with more severe disease. Likewise, livedoid and necrotic lesions were associated with more severe disease; they occurred more frequently in older patients.⁶ Clinicians at Cleveland Clinic found similar cutaneous lesions in COVID-19 patients, including morbilliform rashes, acral purpura resembling perniosis, and livedoid lesions.³ Initial biopsies of these lesions pointed to viral exanthema and thrombotic vasculopathy as potential etiologies of morbilliform and livedoid lesions, respectively. Interestingly, patients may present with multiple cutaneous morphologies of the disease at the same time.³ The acral lesions ("COVID toes") have been popularized throughout the media and thus may be the best-known cutaneous manifestation of the disease at this time. New findings continuously arise, and further research is warranted as lesions that develop in hospitalized COVID-19 patients could be virus related or secondary to hospital-induced skin irritation, stressors, or medications.³ Importantly, clinicians should be aware of these cutaneous signs of COVID-19, especially when triaging patients.

Risk Reduction

The current health crisis could have a drastic impact on dermatology patients and providers. One factor that may increase COVID-19 risk in dermatology patients is immunosuppression. Many patients are on immunomodulators and biologics for skin conditions, which can cause immunosuppression directly and indirectly. Immunosuppression is a risk factor for severe disease in patients with COVID-19, so this population is at higher risk for serious infection.⁷ Telemedicine for nonemergent cases and follow-ups should be considered to decrease traffic in high-risk hospitals; to limit the number of people in waiting rooms; and to protect staff, providers, and patients alike.¹ Recommendations for teledermatology consultation during this time include the following: First, have patients take photographs of their skin lesions and send them remotely to the consulting physician. If the lesion is easily recognizable, treatment recommendations can be made remotely; if the diagnosis is ambiguous, the dermatologist can set up an in-person appointment.¹  

Personal Protective Equipment

Moreover, the current need to wear personal protective equipment (PPE) and wash hands frequently may lead to skin disease among health care providers. Facial rashes may arise from wearing masks and goggles, and repeated handwashing and wearing gloves may lead to hand dermatitis.⁸ One study examined adverse skin reactions among health care workers (N=322) during the SARS outbreak in 2003. More than one-third (35.5%) of staff members who wore masks regularly during the outbreak reported adverse skin reactions, including acne (59.6%), facial itching (51.4%), and rash (35.8%).⁸ The acne etiology likely is multifactorial. Masks increase heat and humidity in the covered facial region, which can cause acne flare-ups due to increased sebum production and Cutibacterium acnes growth.⁸ Additionally, tight N95 masks may occlude the pilosebaceous glands, causing acne to flare. In the SARS study, facial itchiness and rashes likely were due to irritant contact dermatitis to the N95 masks. All of the respondents with adverse skin reactions from masks developed them after using N95 masks; those who wore surgical masks did not report reactions.⁸ Because N95 masks are recommended for health care workers caring for patients with highly transmissible respiratory infections such as SARS and COVID-19, it will be difficult to avoid wearing them during the current crisis. For this reason, topical retinoids and topical benzoyl peroxide should be the first-line treatment of mask-induced acne, and moisturization and topical corticosteroids should be used for facial erythema. Additionally, 21.4% of respondents reported adverse skin reactions from latex gloves during the SARS outbreak, including dry skin, itchiness, rash, and wheals.⁸ These skin reactions may have been type I IgE-mediated hypersensitivity reactions or irritant contact dermatitis due to latex sensitization and frequent handwashing. No respondents reported skin reactions to plastic gloves.⁸ For this reason, health care providers should consider wearing plastic gloves in lieu of or under latex gloves to prevent hand dermatitis during this time. Moisturization, barrier creams, and topical corticosteroids also can help treat hand dermatitis. Frequently changing PPE may help prevent skin disease among the frontline health care workers,⁸ which posed a problem at the beginning of the COVID-19 outbreak as there was a PPE shortage. With industry and individuals coming together to make and donate PPE, it is now more widely available for our frontline providers.  

Financial Impact

Finally, the pandemic is having an immense financial impact on dermatology.⁹ At the onset of the outbreak, our role as health care providers was to help slow the spread of COVID-19; for this reason, most elective procedures were cancelled, and many outpatient clinics closed. Both elective procedures and outpatient visits are central to dermatology, so many dermatologists worked less or not at all during this time, leading to a loss of revenue. The goals of these measures were to reduce transmissibility of the disease, to prevent the health care system from being overwhelmed with critical COVID-19 cases, and to allocate resources to the frontline providers.⁹ Although these measures were beneficial for slowing the spread of disease, they were detrimental to some providers' and practices' financial stability. Many dermatology practices have begun to reopen with COVID-19 precautions in place. For example, practices are limiting the number of patients that can be in the office at one time, mandating temperature readings upon check-in, and requiring masks be worn throughout the entire visit. With continued recommendations for individuals to stay at home as much as possible, the number of patients being seen in dermatology clinics on a daily basis remains less than normal. One potential solution is telemedicine, which would allow patients' concerns to be addressed while keeping providers practicing with a normal patient volume during this time.⁹ Keeping providers financially afloat is vital for private practices to continue operating after the pandemic. Dermatology appointments are in high demand with long waiting lists during nonpandemic times; without dermatologists practicing at full capacity, there will be an accumulation of patients with dermatologic conditions with even longer waiting times after the pandemic. Telemedicine may help reduce this potential accumulation of patients and allow patients to be treated in a more timely manner while alleviating financial pressures for providers.

Final Thoughts

The COVID-19 pandemic has spread across the world, infecting millions of people. Although the trends have slowed, more than 106,100 cases are still being diagnosed daily according to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html). Patients with COVID-19 may present with a variety of cutaneous lesions. Wearing PPE to take care of COVID-19 patients may lead to skin irritation, so care should be taken to address these adverse skin reactions to maintain the safety of providers. Finally, dermatologists should consider telemedicine during this time to protect high-risk patients, prevent a postpandemic surge of patients, and alleviate financial stressors caused by COVID-19.