Federal Practitioner

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.

BOSTON – Among atopic dermatitis (AD) patients infected with COVID-19, those who received topical treatments were nearly five times more likely to be hospitalized compared with those on dupilumab monotherapy, results from a global registry demonstrated.

Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.

“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”

On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.

“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”

To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.

Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m², and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.

By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).

To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).

Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.

“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”

She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.

Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”

Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.

BOSTON – Among atopic dermatitis (AD) patients infected with COVID-19, those who received topical treatments were nearly five times more likely to be hospitalized compared with those on dupilumab monotherapy, results from a global registry demonstrated.

Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.

“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”

On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.

“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”

To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.

Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m², and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.

By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).

To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).

Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.

“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”

She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.

Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”

Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.

BOSTON – Among atopic dermatitis (AD) patients infected with COVID-19, those who received topical treatments were nearly five times more likely to be hospitalized compared with those on dupilumab monotherapy, results from a global registry demonstrated.

Moreover, combination systemic treatment, especially those that included systemic corticosteroids, was associated with the highest risk of COVID-19–related hospitalization.

“Patients with inflammatory skin diseases such as AD may be at higher risk of COVID-19,” Annelie H. Musters, MD, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. “Another factor to consider is that AD patients are often treated with systemic immunomodulatory therapy, including systemic corticosteroids and nonsteroidal immunosuppressants such as methotrexate, cyclosporin, biologics, and Janus kinase inhibitors. Different mechanisms of action and levels of immunosuppression may impart variable risks of serious infections.”

On the other hand, some degree of immunomodulation may have beneficial effects on the course of COVID-19 in AD patients, said Dr. Musters, of the department of dermatology at Academic Medical Center, University of Amsterdam. Targeting of specific immune pathways could reduce the development of a hyperinflammatory state in severe COVID-19. Dual blockade of interleukin (IL)-4 and IL-13 with dupilumab may have a protective effect in the context of COVID-19 infection, because expression of Th2 cytokines, including IL-4 and IL-13, may be increased during COVID-19.

“At the start of the pandemic, many of us were faced with important questions, like do systemic immunomodulatory treatments influence outcomes of COVID-19 in patients with AD?” she said. “Do patients on dupilumab or other novel systemics fare better than those on conventional systemic treatment?”

To answer these questions, she and her colleagues launched a web-based registry in April 2020 to investigate COVID-19 outcomes in patients with AD treated with or without systemic immunomodulatory treatments. For the registry, known as Surveillance Epidemiology of Coronavirus Under Research Exclusion for Atopic Dermatitis (SECURE-AD), clinicians in 27 countries used a web-based form to enter anonymized data after patients had fully recovered from COVID-19. Eligibility criteria included having proven or highly suspected COVID-19, and there were no restrictions on age nor the type of AD treatment they were receiving.

Dr. Musters reported results from 442 patients who were recruited between April 2, 2020, and Oct. 31, 2021. Their mean age was 35.6 years, their median body mass index was 23.7 kg/m², and there was an even sex distribution. Most patients were White and were recruited from Italy. Of the 442 patients, 216 (48.8%) received dupilumab monotherapy, 131 (29.6%) received topical treatments, and 14 (3.16%) received combination systemic treatments, including systemic corticosteroids. About 12% presented to the emergency department and 6% were hospitalized. Of those hospitalized, 2% required intensive care and/or ventilation, and no deaths have occurred in the registry to date.

By treatment group, hospitalization rates were highest among those on combination treatments (35.7%), followed by systemic corticosteroids (14.3%), topical treatments only (9.9%), other conventional systemics (3.6%), methotrexate (3.3%), and dupilumab (2.3%).

To further explore the differences between hospitalization rates in treatment groups, the researchers performed a multivariable logistic regression analysis, adjusted for age, sex, ethnicity, and comorbidity score. Compared with those who received dupilumab, the adjusted odds ratios (ORs) for hospitalization were highest among those who received topical treatments (OR, 4.95), followed by those who received systemic corticosteroids (OR, 2.81), and those who received other conventional systemic treatments (OR, 2.36).

Dr. Musters and colleagues also found that compared with patients on nonsteroidal immunosuppressive therapy, patients on combination systemic therapy had a significantly higher odds of hospitalization, specifically an OR of 45.75 for those on combination treatment including corticosteroids, an OR of 37.57 for those on combination treatment not including steroids, and an OR of 1.87 for those on systemic corticosteroids as monotherapy.

“Overall, the risk of COVID-19 complications appears to be low in patients with AD, even when treated with systemic immunomodulatory agents,” Dr. Musters concluded. “Dupilumab monotherapy was associated with lower odds of hospitalizations compared with other therapies. Moreover, combination systemic treatment, especially combinations including systemic corticosteroids, was associated with the highest risk of severe COVID-19.”

She added that other population-based study designs are more suitable to answer other important questions, such as whether the overall risk of COVID-19 in patients with AD is higher or lower compared to healthy controls.

Amy S. Paller, MD, professor and chair of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, characterized the results as reassuring. In this patient population, “we expected that dupilumab would not cause any problems,” she said. “We wouldn’t necessarily expect it to [confer] a benefit, but I think it’s because the patients who need a systemic medication are going on something that’s very targeted (dupilumab) rather than something that has a broader immunosuppressing function. It was interesting but not surprising that those on systemic steroids had more of a problem. Get them on something that’s very targeted if you can and don’t suppress the immune systems that might be handling COVID-19.”

Dr. Musters reported having no disclosures. Dr. Paller disclosed that she is consultant to and/or an investigator for many pharmaceutical companies.

The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.

Semaglutide is currently available as 0.5-mg and 1-mg doses.

Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.

The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.

As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.

Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.

SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.

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

The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.

Semaglutide is currently available as 0.5-mg and 1-mg doses.

Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.

The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.

As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.

Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.

SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.

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

The U.S. Food and Drug Administration has approved a higher 2-mg dose of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) for adults with type 2 diabetes, giving a higher-dose alternative to the previous maximum 1-mg dose of semaglutide, administered by subcutaneous injection once weekly.

Semaglutide is currently available as 0.5-mg and 1-mg doses.

Results from the pivotal SUSTAIN FORTE study of the 2-mg dose (which, like lower-dose semaglutide for type 2 diabetes, comes in a single-use pen injector) showed that when compared head-to-head with a 1-mg/week dose in a 40-week study with 961 randomized patients, the 2-mg regimen led to a significant average incremental reduction in A1c levels of 0.23 percentage points. The 2-mg dose also produced a significant incremental increase in weight loss, with patients losing 0.93 kg more on the higher dose.

The 2-mg dose gives patients with type 2 diabetes and clinicians an “additional option” when a bigger “shift” in blood glucose is needed, said Juan Pablo Frias, MD, National Research Institute, Los Angeles, California, who was lead investigator for SUSTAIN FORTE, in a written statement.

As well as reducing glucose levels, semaglutide has been shown to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known cardiovascular disease.

Semaglutide was approved as a 2.4-mg injectable dose, as Wegovy, in 2021 for weight loss in patients with overweight or obesity.

SUSTAIN FORTE and other trials of semaglutide were sponsored by Novo Nordisk. SURPASS-2 and other trials of tirzepatide were sponsored by Lilly. Dr. Frias was lead investigator for both SUSTAIN FORTE and SURPASS-2, as well as an investigator for other trials sponsored by Lilly, Novo Nordisk, and other companies.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

The Food and Drug Administration today authorized Americans over the age of 50 to receive a second COVID-19 booster shot, even though many top infectious disease experts questioned the need before the agency’s decision.

The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.

The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.

“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.

Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.

“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”

Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.

“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
 

To boost or not to boost

Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.

“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.

The current vaccine — with a booster — has prevented severe disease, he said.

An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.

A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.

A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.

Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.

And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.

“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
 

Booster confusion

The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.

Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.

What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.

The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).

The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.

That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.

Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.

The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.

Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”

There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.

“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”

Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.

“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”

Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
 

Supply issues?

Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.

That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.

Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.

On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”

But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”

Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”

Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.

He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”

Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”

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

DENVER – Neurocognitive and psychiatric symptoms of mental illness, including posttraumatic stress disorder, are alarmingly high among patients who have previously had COVID-19 – even among those who were not hospitalized with the virus, new research shows.

The findings are from an online survey of more than 800 respondents.

“Regardless of how long ago they had been infected with COVID-19, all respondents had persistent symptoms,” co-investigator Beth Patterson, MSc, adjunct clinical professor at McMaster University, MacAnxiety Research Centre, Hamilton, Ont., told this news organization.

“The take-home message for clinicians is to be aware that if you have patients who had COVID-19, it’s quite likely that they may also experience a psychiatric issue and that they may have reduced resilience and lower quality-of-life [issues],” Ms. Patterson said.

The survey results were presented here at the Anxiety and Depression Association of America (ADAA) Conference 2022.
 

100% report symptoms

The study included 827 respondents (81% women) to an online survey who had contracted COVID.

Using validated symptom severity scores, respondents were assessed for mental health and neurocognitive issues, as well as some physical and quality-of-life factors.

Remarkably, all participants (100%) reported having current, persistent symptoms of COVID. In addition, 88% (n = 729) reported persistent neurocognitive symptoms, even though only 15.5% reported they had been hospitalized for COVID.

Of those hospitalized, 28.9% were treated in the intensive care unit; 42.2% stayed in hospital for less than 1 week; and 13.3% remained hospitalized for at least 3 weeks.

Data were not available on how long it had been since the patients were diagnosed or hospitalized, but most participants (68%) said they had not returned to normal functioning since contracting COVID.

The most common persistent symptoms were fatigue (75.9%), brain fog (67.9%), difficulty concentrating (61%), and weakness (51.2%).

More than half of respondents reported neurocognitive symptoms, including poor memory (57.4%) and word-finding problems in processing information (46.9%). Only 11% reported no persistent neurocognitive symptoms.

A total of 41.7% of respondents reported anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale, and rates of depression were 61.4% as assessed with the Patient Health Questionnaire (PHQ-9).

Rates of probable posttraumatic stress disorder were 40.5% as assessed via the PTSD checklist (PCL-5).

Although it wasn’t possible to use diagnostic screens, the assessment scores suggest strikingly high rates of mental health disorders among the respondents, Ms. Patterson said.

“When we look at the mean scores on the validated scales, we see percentages of probable diagnoses that are staggeringly higher than you would find in the population,” she added.

Of note, about 44% of respondents reported having had mental health treatment in the past, and 33.7% were receiving current mental health treatment.

Although the study had no control group, the findings are consistent with larger studies that have had comparator groups, including research recently published in the BMJ.
 

Poor understanding of COVID’s fallout

In an editorial accompanying the BMJ study, Scott Weich, MD, Mental Health Research Unit, School of Health and Related Research, University of Sheffield, United Kingdom, emphasized the need to better understand the lingering mental health aspects of COVID-19 infection.

“Our attachment to syndromal phenotypes means that we have learned remarkably little about the causes of mental ill health – in this case psychopathology associated with a viral pandemic,” Dr. Weich writes.

Dr. Weich called for improved efforts to understanding long COVID, as well as the establishment of more effective responses to the mental health fallout from the pandemic.

Commenting on the current study, Dr. Weich elaborated on the challenges in disentangling the causes of mental health effects in illness.

“In terms of other viruses, etc., there is a long history of debate and pitched battles between those that attribute mental health effects to predominantly biological processes, [involving] immunological and other responses, and those who understand these responses are mediated by psychological and social processes,” he noted.

“The story of myalgic encephalomyelitis/chronic fatigue syndrome speaks volumes about these different positions, and how difficult it can be to find a middle ground,” he said.

“This has been going on for centuries and may never be fully resolved, at least until we have clearer and more definitive evidence of pathophysiology, though this seems incredibly elusive,” Dr. Weich said.

The authors and Dr. Weich have disclosed no relevant financial relationships.

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

DENVER – Neurocognitive and psychiatric symptoms of mental illness, including posttraumatic stress disorder, are alarmingly high among patients who have previously had COVID-19 – even among those who were not hospitalized with the virus, new research shows.

The findings are from an online survey of more than 800 respondents.

“Regardless of how long ago they had been infected with COVID-19, all respondents had persistent symptoms,” co-investigator Beth Patterson, MSc, adjunct clinical professor at McMaster University, MacAnxiety Research Centre, Hamilton, Ont., told this news organization.

“The take-home message for clinicians is to be aware that if you have patients who had COVID-19, it’s quite likely that they may also experience a psychiatric issue and that they may have reduced resilience and lower quality-of-life [issues],” Ms. Patterson said.

The survey results were presented here at the Anxiety and Depression Association of America (ADAA) Conference 2022.
 

100% report symptoms

The study included 827 respondents (81% women) to an online survey who had contracted COVID.

Using validated symptom severity scores, respondents were assessed for mental health and neurocognitive issues, as well as some physical and quality-of-life factors.

Remarkably, all participants (100%) reported having current, persistent symptoms of COVID. In addition, 88% (n = 729) reported persistent neurocognitive symptoms, even though only 15.5% reported they had been hospitalized for COVID.

Of those hospitalized, 28.9% were treated in the intensive care unit; 42.2% stayed in hospital for less than 1 week; and 13.3% remained hospitalized for at least 3 weeks.

Data were not available on how long it had been since the patients were diagnosed or hospitalized, but most participants (68%) said they had not returned to normal functioning since contracting COVID.

The most common persistent symptoms were fatigue (75.9%), brain fog (67.9%), difficulty concentrating (61%), and weakness (51.2%).

More than half of respondents reported neurocognitive symptoms, including poor memory (57.4%) and word-finding problems in processing information (46.9%). Only 11% reported no persistent neurocognitive symptoms.

A total of 41.7% of respondents reported anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale, and rates of depression were 61.4% as assessed with the Patient Health Questionnaire (PHQ-9).

Rates of probable posttraumatic stress disorder were 40.5% as assessed via the PTSD checklist (PCL-5).

Although it wasn’t possible to use diagnostic screens, the assessment scores suggest strikingly high rates of mental health disorders among the respondents, Ms. Patterson said.

“When we look at the mean scores on the validated scales, we see percentages of probable diagnoses that are staggeringly higher than you would find in the population,” she added.

Of note, about 44% of respondents reported having had mental health treatment in the past, and 33.7% were receiving current mental health treatment.

Although the study had no control group, the findings are consistent with larger studies that have had comparator groups, including research recently published in the BMJ.
 

Poor understanding of COVID’s fallout

In an editorial accompanying the BMJ study, Scott Weich, MD, Mental Health Research Unit, School of Health and Related Research, University of Sheffield, United Kingdom, emphasized the need to better understand the lingering mental health aspects of COVID-19 infection.

“Our attachment to syndromal phenotypes means that we have learned remarkably little about the causes of mental ill health – in this case psychopathology associated with a viral pandemic,” Dr. Weich writes.

Dr. Weich called for improved efforts to understanding long COVID, as well as the establishment of more effective responses to the mental health fallout from the pandemic.

Commenting on the current study, Dr. Weich elaborated on the challenges in disentangling the causes of mental health effects in illness.

“In terms of other viruses, etc., there is a long history of debate and pitched battles between those that attribute mental health effects to predominantly biological processes, [involving] immunological and other responses, and those who understand these responses are mediated by psychological and social processes,” he noted.

“The story of myalgic encephalomyelitis/chronic fatigue syndrome speaks volumes about these different positions, and how difficult it can be to find a middle ground,” he said.

“This has been going on for centuries and may never be fully resolved, at least until we have clearer and more definitive evidence of pathophysiology, though this seems incredibly elusive,” Dr. Weich said.

The authors and Dr. Weich have disclosed no relevant financial relationships.

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

DENVER – Neurocognitive and psychiatric symptoms of mental illness, including posttraumatic stress disorder, are alarmingly high among patients who have previously had COVID-19 – even among those who were not hospitalized with the virus, new research shows.

The findings are from an online survey of more than 800 respondents.

“Regardless of how long ago they had been infected with COVID-19, all respondents had persistent symptoms,” co-investigator Beth Patterson, MSc, adjunct clinical professor at McMaster University, MacAnxiety Research Centre, Hamilton, Ont., told this news organization.

“The take-home message for clinicians is to be aware that if you have patients who had COVID-19, it’s quite likely that they may also experience a psychiatric issue and that they may have reduced resilience and lower quality-of-life [issues],” Ms. Patterson said.

The survey results were presented here at the Anxiety and Depression Association of America (ADAA) Conference 2022.
 

100% report symptoms

The study included 827 respondents (81% women) to an online survey who had contracted COVID.

Using validated symptom severity scores, respondents were assessed for mental health and neurocognitive issues, as well as some physical and quality-of-life factors.

Remarkably, all participants (100%) reported having current, persistent symptoms of COVID. In addition, 88% (n = 729) reported persistent neurocognitive symptoms, even though only 15.5% reported they had been hospitalized for COVID.

Of those hospitalized, 28.9% were treated in the intensive care unit; 42.2% stayed in hospital for less than 1 week; and 13.3% remained hospitalized for at least 3 weeks.

Data were not available on how long it had been since the patients were diagnosed or hospitalized, but most participants (68%) said they had not returned to normal functioning since contracting COVID.

The most common persistent symptoms were fatigue (75.9%), brain fog (67.9%), difficulty concentrating (61%), and weakness (51.2%).

More than half of respondents reported neurocognitive symptoms, including poor memory (57.4%) and word-finding problems in processing information (46.9%). Only 11% reported no persistent neurocognitive symptoms.

A total of 41.7% of respondents reported anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale, and rates of depression were 61.4% as assessed with the Patient Health Questionnaire (PHQ-9).

Rates of probable posttraumatic stress disorder were 40.5% as assessed via the PTSD checklist (PCL-5).

Although it wasn’t possible to use diagnostic screens, the assessment scores suggest strikingly high rates of mental health disorders among the respondents, Ms. Patterson said.

“When we look at the mean scores on the validated scales, we see percentages of probable diagnoses that are staggeringly higher than you would find in the population,” she added.

Of note, about 44% of respondents reported having had mental health treatment in the past, and 33.7% were receiving current mental health treatment.

Although the study had no control group, the findings are consistent with larger studies that have had comparator groups, including research recently published in the BMJ.
 

Poor understanding of COVID’s fallout

In an editorial accompanying the BMJ study, Scott Weich, MD, Mental Health Research Unit, School of Health and Related Research, University of Sheffield, United Kingdom, emphasized the need to better understand the lingering mental health aspects of COVID-19 infection.

“Our attachment to syndromal phenotypes means that we have learned remarkably little about the causes of mental ill health – in this case psychopathology associated with a viral pandemic,” Dr. Weich writes.

Dr. Weich called for improved efforts to understanding long COVID, as well as the establishment of more effective responses to the mental health fallout from the pandemic.

Commenting on the current study, Dr. Weich elaborated on the challenges in disentangling the causes of mental health effects in illness.

“In terms of other viruses, etc., there is a long history of debate and pitched battles between those that attribute mental health effects to predominantly biological processes, [involving] immunological and other responses, and those who understand these responses are mediated by psychological and social processes,” he noted.

“The story of myalgic encephalomyelitis/chronic fatigue syndrome speaks volumes about these different positions, and how difficult it can be to find a middle ground,” he said.

“This has been going on for centuries and may never be fully resolved, at least until we have clearer and more definitive evidence of pathophysiology, though this seems incredibly elusive,” Dr. Weich said.

The authors and Dr. Weich have disclosed no relevant financial relationships.

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