Federal Practitioner

Key clinical point: Sustained virologic response (SVR) decreases the risk for hepatic decompensation in patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) receiving nonsurgical treatment.

Major finding: Patients with SVR vs viremia had a significantly lower likelihood of hepatic decompensation (adjusted odds ratio 0.18; 95% CI 0.06-0.59).

Study details: Findings are from a multicenter, retrospective cohort study including adult patients with HCV cirrhosis and treatment-naive HCC who had active viremia (n = 431) or SVR before HCC diagnosis (n = 135).

Disclosures: This study was sponsored by the US National Institutes of Health. Some authors reported serving as consultants, advisory board members, speakers for, or receiving research funding or consulting fees from various sources.

Source: Parikh ND et al. Association between sustained virological response and clinical outcomes in patients with hepatitis C infection and hepatocellular carcinoma. Cancer. 2022 (Jul 7). Doi:  10.1002/cncr.34378

Key clinical point: Sustained virologic response (SVR) decreases the risk for hepatic decompensation in patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) receiving nonsurgical treatment.

Major finding: Patients with SVR vs viremia had a significantly lower likelihood of hepatic decompensation (adjusted odds ratio 0.18; 95% CI 0.06-0.59).

Study details: Findings are from a multicenter, retrospective cohort study including adult patients with HCV cirrhosis and treatment-naive HCC who had active viremia (n = 431) or SVR before HCC diagnosis (n = 135).

Disclosures: This study was sponsored by the US National Institutes of Health. Some authors reported serving as consultants, advisory board members, speakers for, or receiving research funding or consulting fees from various sources.

Source: Parikh ND et al. Association between sustained virological response and clinical outcomes in patients with hepatitis C infection and hepatocellular carcinoma. Cancer. 2022 (Jul 7). Doi:  10.1002/cncr.34378

Key clinical point: Sustained virologic response (SVR) decreases the risk for hepatic decompensation in patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) receiving nonsurgical treatment.

Major finding: Patients with SVR vs viremia had a significantly lower likelihood of hepatic decompensation (adjusted odds ratio 0.18; 95% CI 0.06-0.59).

Study details: Findings are from a multicenter, retrospective cohort study including adult patients with HCV cirrhosis and treatment-naive HCC who had active viremia (n = 431) or SVR before HCC diagnosis (n = 135).

Disclosures: This study was sponsored by the US National Institutes of Health. Some authors reported serving as consultants, advisory board members, speakers for, or receiving research funding or consulting fees from various sources.

Source: Parikh ND et al. Association between sustained virological response and clinical outcomes in patients with hepatitis C infection and hepatocellular carcinoma. Cancer. 2022 (Jul 7). Doi:  10.1002/cncr.34378

Key clinical point: Transplant waitlist mortality and dropout rates were not significantly different between patients with hepatocellular carcinoma (HCC) who received transarterial chemoembolization (TACE) and those who received radiofrequency ablation (RFA).

Major finding: TACE and RFA were associated with a comparable 5-year cumulative incidence of mortality or dropout in patients both within (13.4% and 12.9%, respectively; adjusted hazard ratio [aHR] 0.91; 95% CI 0.79-1.03) and outside (19.2% and 19.0%, respectively; aHR 1.29; 95% CI 0.79-2.09) the Milan criteria.

Study details: This retrospective study analyzed the data of 11,824 patients with HCC (within and outside the Milan criteria) from the Scientific Registry of Transplant Recipients who underwent RFA (n = 2449) or TACE (n = 9375).

Disclosures: This study was funded by the US National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

Source: Kolarich AR et al. Radiofrequency ablation versus trans-arterial chemoembolization in patients with HCC awaiting liver transplant: An analysis of the Scientific Registry of Transplant Recipients. J Vasc Interv Radiol. 2022 Jun 28. Doi: 10.1016/j.jvir.2022.06.016

Key clinical point: Transplant waitlist mortality and dropout rates were not significantly different between patients with hepatocellular carcinoma (HCC) who received transarterial chemoembolization (TACE) and those who received radiofrequency ablation (RFA).

Major finding: TACE and RFA were associated with a comparable 5-year cumulative incidence of mortality or dropout in patients both within (13.4% and 12.9%, respectively; adjusted hazard ratio [aHR] 0.91; 95% CI 0.79-1.03) and outside (19.2% and 19.0%, respectively; aHR 1.29; 95% CI 0.79-2.09) the Milan criteria.

Study details: This retrospective study analyzed the data of 11,824 patients with HCC (within and outside the Milan criteria) from the Scientific Registry of Transplant Recipients who underwent RFA (n = 2449) or TACE (n = 9375).

Disclosures: This study was funded by the US National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

Source: Kolarich AR et al. Radiofrequency ablation versus trans-arterial chemoembolization in patients with HCC awaiting liver transplant: An analysis of the Scientific Registry of Transplant Recipients. J Vasc Interv Radiol. 2022 Jun 28. Doi: 10.1016/j.jvir.2022.06.016

Key clinical point: Transplant waitlist mortality and dropout rates were not significantly different between patients with hepatocellular carcinoma (HCC) who received transarterial chemoembolization (TACE) and those who received radiofrequency ablation (RFA).

Major finding: TACE and RFA were associated with a comparable 5-year cumulative incidence of mortality or dropout in patients both within (13.4% and 12.9%, respectively; adjusted hazard ratio [aHR] 0.91; 95% CI 0.79-1.03) and outside (19.2% and 19.0%, respectively; aHR 1.29; 95% CI 0.79-2.09) the Milan criteria.

Study details: This retrospective study analyzed the data of 11,824 patients with HCC (within and outside the Milan criteria) from the Scientific Registry of Transplant Recipients who underwent RFA (n = 2449) or TACE (n = 9375).

Disclosures: This study was funded by the US National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

Source: Kolarich AR et al. Radiofrequency ablation versus trans-arterial chemoembolization in patients with HCC awaiting liver transplant: An analysis of the Scientific Registry of Transplant Recipients. J Vasc Interv Radiol. 2022 Jun 28. Doi: 10.1016/j.jvir.2022.06.016

Key clinical point: In systemic therapy-naive patients with advanced hepatocellular carcinoma (HCC), pembrolizumab monotherapy demonstrates promising antitumor efficacy and survival outcomes, with a safety profile similar to that of second-line pembrolizumab in advanced HCC.

Major finding: After a 27-month median follow-up, the objective response rate was 16% (95% CI 7%-29%). The median progression-free and overall survival were 4 (95% CI 2-8) and 17 (95% CI 8-23) months, respectively. Treatment-related adverse events of  grade ≥ 3 were observed in 16% of patients.

Study details: The data are derived from cohort 2 of the multicenter, phase 2 KEYNOTE-224 trial that included 51 systemic therapy-naive adult patients with advanced HCC who received 200 mg pembrolizumab every 3 weeks for ≤2 years.

Disclosures: This study was sponsored by Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., NJ. Some authors declared receiving grants, personal fees, or other support from various sources, including MSD.

Source: Verset G et al. Pembrolizumab monotherapy for previously untreated advanced hepatocellular carcinoma: Data from the open-label, phase II KEYNOTE-224 trial. Clin Cancer Res. 2022;28(12):2547–2554 (Jun 13). Doi: 10.1158/1078-0432.CCR-21-3807

Key clinical point: In systemic therapy-naive patients with advanced hepatocellular carcinoma (HCC), pembrolizumab monotherapy demonstrates promising antitumor efficacy and survival outcomes, with a safety profile similar to that of second-line pembrolizumab in advanced HCC.

Major finding: After a 27-month median follow-up, the objective response rate was 16% (95% CI 7%-29%). The median progression-free and overall survival were 4 (95% CI 2-8) and 17 (95% CI 8-23) months, respectively. Treatment-related adverse events of  grade ≥ 3 were observed in 16% of patients.

Study details: The data are derived from cohort 2 of the multicenter, phase 2 KEYNOTE-224 trial that included 51 systemic therapy-naive adult patients with advanced HCC who received 200 mg pembrolizumab every 3 weeks for ≤2 years.

Disclosures: This study was sponsored by Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., NJ. Some authors declared receiving grants, personal fees, or other support from various sources, including MSD.

Source: Verset G et al. Pembrolizumab monotherapy for previously untreated advanced hepatocellular carcinoma: Data from the open-label, phase II KEYNOTE-224 trial. Clin Cancer Res. 2022;28(12):2547–2554 (Jun 13). Doi: 10.1158/1078-0432.CCR-21-3807

Key clinical point: In systemic therapy-naive patients with advanced hepatocellular carcinoma (HCC), pembrolizumab monotherapy demonstrates promising antitumor efficacy and survival outcomes, with a safety profile similar to that of second-line pembrolizumab in advanced HCC.

Major finding: After a 27-month median follow-up, the objective response rate was 16% (95% CI 7%-29%). The median progression-free and overall survival were 4 (95% CI 2-8) and 17 (95% CI 8-23) months, respectively. Treatment-related adverse events of  grade ≥ 3 were observed in 16% of patients.

Study details: The data are derived from cohort 2 of the multicenter, phase 2 KEYNOTE-224 trial that included 51 systemic therapy-naive adult patients with advanced HCC who received 200 mg pembrolizumab every 3 weeks for ≤2 years.

Disclosures: This study was sponsored by Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., NJ. Some authors declared receiving grants, personal fees, or other support from various sources, including MSD.

Source: Verset G et al. Pembrolizumab monotherapy for previously untreated advanced hepatocellular carcinoma: Data from the open-label, phase II KEYNOTE-224 trial. Clin Cancer Res. 2022;28(12):2547–2554 (Jun 13). Doi: 10.1158/1078-0432.CCR-21-3807

Key clinical point: Cabozantinib plus atezolizumab significantly improved progression-free survival (PFS) but not overall survival (OS) in systemic therapy-naive patients with advanced hepatocellular carcinoma (HCC) unresponsive to curative or locoregional therapy.

Major finding: Patients receiving cabozantinib plus atezolizumab vs sorafenib had a significantly longer median PFS (6.8 vs 4.2 months; hazard ratio [HR] 0.63; P  =  .001) but a comparable median OS (15.4 vs 15.5 months; HR 0.90; P  =  .44).

Study details: Findings are from a multicenter, phase 3 trial, COSMIC-312, that included 837 systemic therapy-naive adult patients with HCC unresponsive to curative or locoregional therapy who were randomly assigned 2:1:1 to receive cabozantinib plus atezolizumab (n = 432), sorafenib (n = 217), or single-agent cabozantinib (n = 188).

Disclosures: This study was funded by Exelixis, USA, and Ipsen, France. Some authors reported being consultants, advisors, or speakers for or receiving research funding, personal fees, travel and accommodations, or other expenses from various sources, including Exelixis and Ipsen. Four authors reported employment (current or former), stock, and other ownership interests in Exelixis or Ipsen.

Source: Kelley RK et al. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): A multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 (Jul 4). Doi: 10.1016/S1470-2045(22)00326-6

Key clinical point: Cabozantinib plus atezolizumab significantly improved progression-free survival (PFS) but not overall survival (OS) in systemic therapy-naive patients with advanced hepatocellular carcinoma (HCC) unresponsive to curative or locoregional therapy.

Major finding: Patients receiving cabozantinib plus atezolizumab vs sorafenib had a significantly longer median PFS (6.8 vs 4.2 months; hazard ratio [HR] 0.63; P  =  .001) but a comparable median OS (15.4 vs 15.5 months; HR 0.90; P  =  .44).

Study details: Findings are from a multicenter, phase 3 trial, COSMIC-312, that included 837 systemic therapy-naive adult patients with HCC unresponsive to curative or locoregional therapy who were randomly assigned 2:1:1 to receive cabozantinib plus atezolizumab (n = 432), sorafenib (n = 217), or single-agent cabozantinib (n = 188).

Disclosures: This study was funded by Exelixis, USA, and Ipsen, France. Some authors reported being consultants, advisors, or speakers for or receiving research funding, personal fees, travel and accommodations, or other expenses from various sources, including Exelixis and Ipsen. Four authors reported employment (current or former), stock, and other ownership interests in Exelixis or Ipsen.

Source: Kelley RK et al. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): A multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 (Jul 4). Doi: 10.1016/S1470-2045(22)00326-6

Key clinical point: Cabozantinib plus atezolizumab significantly improved progression-free survival (PFS) but not overall survival (OS) in systemic therapy-naive patients with advanced hepatocellular carcinoma (HCC) unresponsive to curative or locoregional therapy.

Major finding: Patients receiving cabozantinib plus atezolizumab vs sorafenib had a significantly longer median PFS (6.8 vs 4.2 months; hazard ratio [HR] 0.63; P  =  .001) but a comparable median OS (15.4 vs 15.5 months; HR 0.90; P  =  .44).

Study details: Findings are from a multicenter, phase 3 trial, COSMIC-312, that included 837 systemic therapy-naive adult patients with HCC unresponsive to curative or locoregional therapy who were randomly assigned 2:1:1 to receive cabozantinib plus atezolizumab (n = 432), sorafenib (n = 217), or single-agent cabozantinib (n = 188).

Disclosures: This study was funded by Exelixis, USA, and Ipsen, France. Some authors reported being consultants, advisors, or speakers for or receiving research funding, personal fees, travel and accommodations, or other expenses from various sources, including Exelixis and Ipsen. Four authors reported employment (current or former), stock, and other ownership interests in Exelixis or Ipsen.

Source: Kelley RK et al. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): A multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 (Jul 4). Doi: 10.1016/S1470-2045(22)00326-6

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

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

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

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

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

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

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

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

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

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

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

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

A new study suggests that going beyond current guidance on moderate and vigorous physical activity levels may add years to one’s life.

Americans are advised to do a minimum of 150-300 minutes a week of moderate exercise or 75-150 minutes a week of vigorous exercise, or an equivalent combination of both, according to U.S. Department of Health and Human Services Physical Activity Guidelines.

Results from more than 100,000 U.S. adults followed for 30 years showed that individuals who performed double the currently recommended range of either moderate or vigorous physical activity weekly had the lowest long-term risk of mortality.

Adults who reported completing four times the minimum recommended activity levels saw no clear incremental mortality benefit but also no harm, according to the study, published in the journal Circulation.

“I think we’re worried more about the lower end and people that are not even doing the minimum, but this should be reassuring to people who like to do a lot of exercise,” senior author Edward Giovannucci, MD, ScD, with the Harvard T.H. Chan School of Public Health, Boston, told this news organization.

Some studies have suggested that long-term, high-intensity exercise (e.g., marathons, triathlons, and long-distance cycling) may be associated with increased risks of atrial fibrillation, coronary artery calcification, and sudden cardiac death.

A recent analysis from the Copenhagen City Heart Study showed a U-shaped association between long-term all-cause mortality and 0 to 2.5 hours and more than 10 hours of weekly, leisure-time sports activities.

Most studies suggesting harm, however, have used only one measurement of physical activity capturing a mix of people who chronically exercise at high levels and those who do it sporadically, which possibly can be harmful, Dr. Giovannucci said. “We were better able to look at consistent long-term activity and saw there was no harm.”

The study included 116,221 participants in the Nurses’ Health Study and the Health Professionals Follow-up Study between 1988 and 2018, who completed up to 15 (median, 11) questionnaires on their health and leisure-time physical activity that were updated every 2 years.

Most were White (96%), 63% were female, and the average age and body mass index over follow-up was 66 years and 26 kg/m². During 30 years of follow-up, there were 47,596 deaths.
 

‘Any effort is worthwhile’

The analysis found that individuals who met the guideline for long-term vigorous physical activity (75-150 min/week) cut their adjusted risk of death from cardiovascular disease (CVD) by a whopping 31%, from non-CVD causes by 15%, and all-causes by 19%, compared with those with no long-term vigorous activity.

Those completing two to four times the recommended minimum (150-299 min/week) had a 27%-33% lower risk of CVD mortality, 19% lower risk of non-CVD mortality, and 21%-23% lower risk of all-cause mortality.

Higher levels did not appear to further lower mortality risk. For example, 300-374 min/week of vigorous physical activity was associated with a 32% lower risk of CVD death, 18% lower risk of non-CVD death, and 22% lower risk of dying from any cause.

The analysis also found that individuals who met the guidelines for moderate physical activity had lower CVD, non-CVD, and all-cause mortality risks whether they were active 150-244 min/week (22%, 19%, and 20%, respectively) or 225-299 min/week (21%, 25%, and 20%, respectively), compared with those with almost no long-term moderate activity.

Those fitting in two to four times the recommended minimum (300-599 min/week) had a 28%-38% lower risk of CVD mortality, 25%-27% lower risk of non-CVD mortality, and 26%-31% lower risk of all-cause mortality.

The mortality benefit appeared to plateau, with 600 min/week of moderate physical activity showing associations similar to 300-599 min/week.

“The sweet spot seems to be two to four times the recommended levels but for people who are sedentary, I think one of the key messages that I give my patients is that any effort is worthwhile; that any physical activity, even less than the recommended, has some mortality reduction,” Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview.

Indeed, individuals who reported doing just 20-74 minutes of moderate exercise per week had a 19% lower risk of dying from any cause and a 13% lower risk of dying from CVD compared with those doing less.

Current American Heart Association (AHA) recommendations are for at least 150 minutes per week of moderate-intensity aerobic exercise or 75 minutes per week of vigorous aerobic exercise, or a combination of both.

“This suggests that even more is probably better, in the range of two to four times that, so maybe we should move our targets a little bit higher, which is kind of what the Department of Health and Human Services has already done,” said Dr. Michos, who was not involved in the study.

Former AHA president Donna K. Arnett, PhD, who was not involved in the study, said in a statement that “we’ve known for a long time that moderate or intense levels of physical exercise can reduce a person’s risk of both atherosclerotic cardiovascular disease and mortality.

“We have also seen that getting more than 300 minutes of moderate-intensity aerobic physical activity or more than 150 minutes of vigorous-intensity aerobic physical exercise each week may reduce a person’s risk of atherosclerotic cardiovascular disease even further, so it makes sense that getting those extra minutes of exercise may also decrease mortality,” she added.
 

Mix and match

Dr. Giovannucci noted that the joint effects of the two types of exercise on mortality have not been studied and “there are some questions, for example, about whether doing a lot of moderate activity is sufficient or can you get more benefits by doing vigorous activity also.”

Joint analyses of both exercise intensities found that additional vigorous physical activity was associated with lower mortality among participants with insufficient (less than 300 min/week) levels of moderate exercise but not among those with at least 300 min/week of moderate exercise.

“The main message is that you can get essentially all of the benefit by just doing moderate exercise,” Dr. Giovannucci said. “There’s no magic benefit of doing vigorous [exercise]. But if someone wants to do vigorous, they can get the benefit in about half the time. So if you only have 2-3 hours a week to exercise and can do, say 2 or 3 hours of running, you can get pretty much the maximum benefit.”

Sensitivity analyses showed a consistent association between long-term leisure physical activity and mortality without adjustment for body mass index/calorie intake.

“Some people think the effect of exercise is to lower your body weight or keep it down, which could be one of the benefits, but even independent of that, you get benefits even if it has no effect on your weight,” he said. “So, definitely, that’s important.”

Dr. Michos pointed out that vigorous physical activity may seem daunting for many individuals but that moderate exercise can include activities such as brisk walking, ballroom dancing, active yoga, and recreational swimming.

“The nice thing is that you can really combine or substitute both and get just as similar mortality reductions with moderate physical activity, because a lot of patients may not want to do vigorous activity,” she said. “They don’t want to get on the treadmill; that’s too intimidating or stressful.”

The study was supported by the National Institutes of Health. The authors and Dr. Michos report no relevant financial relationships.

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


A new study suggests that going beyond current guidance on moderate and vigorous physical activity levels may add years to one’s life.

Americans are advised to do a minimum of 150-300 minutes a week of moderate exercise or 75-150 minutes a week of vigorous exercise, or an equivalent combination of both, according to U.S. Department of Health and Human Services Physical Activity Guidelines.

Results from more than 100,000 U.S. adults followed for 30 years showed that individuals who performed double the currently recommended range of either moderate or vigorous physical activity weekly had the lowest long-term risk of mortality.

Adults who reported completing four times the minimum recommended activity levels saw no clear incremental mortality benefit but also no harm, according to the study, published in the journal Circulation.

“I think we’re worried more about the lower end and people that are not even doing the minimum, but this should be reassuring to people who like to do a lot of exercise,” senior author Edward Giovannucci, MD, ScD, with the Harvard T.H. Chan School of Public Health, Boston, told this news organization.

Some studies have suggested that long-term, high-intensity exercise (e.g., marathons, triathlons, and long-distance cycling) may be associated with increased risks of atrial fibrillation, coronary artery calcification, and sudden cardiac death.

A recent analysis from the Copenhagen City Heart Study showed a U-shaped association between long-term all-cause mortality and 0 to 2.5 hours and more than 10 hours of weekly, leisure-time sports activities.

Most studies suggesting harm, however, have used only one measurement of physical activity capturing a mix of people who chronically exercise at high levels and those who do it sporadically, which possibly can be harmful, Dr. Giovannucci said. “We were better able to look at consistent long-term activity and saw there was no harm.”

The study included 116,221 participants in the Nurses’ Health Study and the Health Professionals Follow-up Study between 1988 and 2018, who completed up to 15 (median, 11) questionnaires on their health and leisure-time physical activity that were updated every 2 years.

Most were White (96%), 63% were female, and the average age and body mass index over follow-up was 66 years and 26 kg/m². During 30 years of follow-up, there were 47,596 deaths.
 

‘Any effort is worthwhile’

The analysis found that individuals who met the guideline for long-term vigorous physical activity (75-150 min/week) cut their adjusted risk of death from cardiovascular disease (CVD) by a whopping 31%, from non-CVD causes by 15%, and all-causes by 19%, compared with those with no long-term vigorous activity.

Those completing two to four times the recommended minimum (150-299 min/week) had a 27%-33% lower risk of CVD mortality, 19% lower risk of non-CVD mortality, and 21%-23% lower risk of all-cause mortality.

Higher levels did not appear to further lower mortality risk. For example, 300-374 min/week of vigorous physical activity was associated with a 32% lower risk of CVD death, 18% lower risk of non-CVD death, and 22% lower risk of dying from any cause.

The analysis also found that individuals who met the guidelines for moderate physical activity had lower CVD, non-CVD, and all-cause mortality risks whether they were active 150-244 min/week (22%, 19%, and 20%, respectively) or 225-299 min/week (21%, 25%, and 20%, respectively), compared with those with almost no long-term moderate activity.

Those fitting in two to four times the recommended minimum (300-599 min/week) had a 28%-38% lower risk of CVD mortality, 25%-27% lower risk of non-CVD mortality, and 26%-31% lower risk of all-cause mortality.

The mortality benefit appeared to plateau, with 600 min/week of moderate physical activity showing associations similar to 300-599 min/week.

“The sweet spot seems to be two to four times the recommended levels but for people who are sedentary, I think one of the key messages that I give my patients is that any effort is worthwhile; that any physical activity, even less than the recommended, has some mortality reduction,” Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview.

Indeed, individuals who reported doing just 20-74 minutes of moderate exercise per week had a 19% lower risk of dying from any cause and a 13% lower risk of dying from CVD compared with those doing less.

Current American Heart Association (AHA) recommendations are for at least 150 minutes per week of moderate-intensity aerobic exercise or 75 minutes per week of vigorous aerobic exercise, or a combination of both.

“This suggests that even more is probably better, in the range of two to four times that, so maybe we should move our targets a little bit higher, which is kind of what the Department of Health and Human Services has already done,” said Dr. Michos, who was not involved in the study.

Former AHA president Donna K. Arnett, PhD, who was not involved in the study, said in a statement that “we’ve known for a long time that moderate or intense levels of physical exercise can reduce a person’s risk of both atherosclerotic cardiovascular disease and mortality.

“We have also seen that getting more than 300 minutes of moderate-intensity aerobic physical activity or more than 150 minutes of vigorous-intensity aerobic physical exercise each week may reduce a person’s risk of atherosclerotic cardiovascular disease even further, so it makes sense that getting those extra minutes of exercise may also decrease mortality,” she added.
 

Mix and match

Dr. Giovannucci noted that the joint effects of the two types of exercise on mortality have not been studied and “there are some questions, for example, about whether doing a lot of moderate activity is sufficient or can you get more benefits by doing vigorous activity also.”

Joint analyses of both exercise intensities found that additional vigorous physical activity was associated with lower mortality among participants with insufficient (less than 300 min/week) levels of moderate exercise but not among those with at least 300 min/week of moderate exercise.

“The main message is that you can get essentially all of the benefit by just doing moderate exercise,” Dr. Giovannucci said. “There’s no magic benefit of doing vigorous [exercise]. But if someone wants to do vigorous, they can get the benefit in about half the time. So if you only have 2-3 hours a week to exercise and can do, say 2 or 3 hours of running, you can get pretty much the maximum benefit.”

Sensitivity analyses showed a consistent association between long-term leisure physical activity and mortality without adjustment for body mass index/calorie intake.

“Some people think the effect of exercise is to lower your body weight or keep it down, which could be one of the benefits, but even independent of that, you get benefits even if it has no effect on your weight,” he said. “So, definitely, that’s important.”

Dr. Michos pointed out that vigorous physical activity may seem daunting for many individuals but that moderate exercise can include activities such as brisk walking, ballroom dancing, active yoga, and recreational swimming.

“The nice thing is that you can really combine or substitute both and get just as similar mortality reductions with moderate physical activity, because a lot of patients may not want to do vigorous activity,” she said. “They don’t want to get on the treadmill; that’s too intimidating or stressful.”

The study was supported by the National Institutes of Health. The authors and Dr. Michos report no relevant financial relationships.

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


A new study suggests that going beyond current guidance on moderate and vigorous physical activity levels may add years to one’s life.

Americans are advised to do a minimum of 150-300 minutes a week of moderate exercise or 75-150 minutes a week of vigorous exercise, or an equivalent combination of both, according to U.S. Department of Health and Human Services Physical Activity Guidelines.

Results from more than 100,000 U.S. adults followed for 30 years showed that individuals who performed double the currently recommended range of either moderate or vigorous physical activity weekly had the lowest long-term risk of mortality.

Adults who reported completing four times the minimum recommended activity levels saw no clear incremental mortality benefit but also no harm, according to the study, published in the journal Circulation.

“I think we’re worried more about the lower end and people that are not even doing the minimum, but this should be reassuring to people who like to do a lot of exercise,” senior author Edward Giovannucci, MD, ScD, with the Harvard T.H. Chan School of Public Health, Boston, told this news organization.

Some studies have suggested that long-term, high-intensity exercise (e.g., marathons, triathlons, and long-distance cycling) may be associated with increased risks of atrial fibrillation, coronary artery calcification, and sudden cardiac death.

A recent analysis from the Copenhagen City Heart Study showed a U-shaped association between long-term all-cause mortality and 0 to 2.5 hours and more than 10 hours of weekly, leisure-time sports activities.

Most studies suggesting harm, however, have used only one measurement of physical activity capturing a mix of people who chronically exercise at high levels and those who do it sporadically, which possibly can be harmful, Dr. Giovannucci said. “We were better able to look at consistent long-term activity and saw there was no harm.”

The study included 116,221 participants in the Nurses’ Health Study and the Health Professionals Follow-up Study between 1988 and 2018, who completed up to 15 (median, 11) questionnaires on their health and leisure-time physical activity that were updated every 2 years.

Most were White (96%), 63% were female, and the average age and body mass index over follow-up was 66 years and 26 kg/m². During 30 years of follow-up, there were 47,596 deaths.
 

‘Any effort is worthwhile’

The analysis found that individuals who met the guideline for long-term vigorous physical activity (75-150 min/week) cut their adjusted risk of death from cardiovascular disease (CVD) by a whopping 31%, from non-CVD causes by 15%, and all-causes by 19%, compared with those with no long-term vigorous activity.

Those completing two to four times the recommended minimum (150-299 min/week) had a 27%-33% lower risk of CVD mortality, 19% lower risk of non-CVD mortality, and 21%-23% lower risk of all-cause mortality.

Higher levels did not appear to further lower mortality risk. For example, 300-374 min/week of vigorous physical activity was associated with a 32% lower risk of CVD death, 18% lower risk of non-CVD death, and 22% lower risk of dying from any cause.

The analysis also found that individuals who met the guidelines for moderate physical activity had lower CVD, non-CVD, and all-cause mortality risks whether they were active 150-244 min/week (22%, 19%, and 20%, respectively) or 225-299 min/week (21%, 25%, and 20%, respectively), compared with those with almost no long-term moderate activity.

Those fitting in two to four times the recommended minimum (300-599 min/week) had a 28%-38% lower risk of CVD mortality, 25%-27% lower risk of non-CVD mortality, and 26%-31% lower risk of all-cause mortality.

The mortality benefit appeared to plateau, with 600 min/week of moderate physical activity showing associations similar to 300-599 min/week.

“The sweet spot seems to be two to four times the recommended levels but for people who are sedentary, I think one of the key messages that I give my patients is that any effort is worthwhile; that any physical activity, even less than the recommended, has some mortality reduction,” Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview.

Indeed, individuals who reported doing just 20-74 minutes of moderate exercise per week had a 19% lower risk of dying from any cause and a 13% lower risk of dying from CVD compared with those doing less.

Current American Heart Association (AHA) recommendations are for at least 150 minutes per week of moderate-intensity aerobic exercise or 75 minutes per week of vigorous aerobic exercise, or a combination of both.

“This suggests that even more is probably better, in the range of two to four times that, so maybe we should move our targets a little bit higher, which is kind of what the Department of Health and Human Services has already done,” said Dr. Michos, who was not involved in the study.

Former AHA president Donna K. Arnett, PhD, who was not involved in the study, said in a statement that “we’ve known for a long time that moderate or intense levels of physical exercise can reduce a person’s risk of both atherosclerotic cardiovascular disease and mortality.

“We have also seen that getting more than 300 minutes of moderate-intensity aerobic physical activity or more than 150 minutes of vigorous-intensity aerobic physical exercise each week may reduce a person’s risk of atherosclerotic cardiovascular disease even further, so it makes sense that getting those extra minutes of exercise may also decrease mortality,” she added.
 

Mix and match

Dr. Giovannucci noted that the joint effects of the two types of exercise on mortality have not been studied and “there are some questions, for example, about whether doing a lot of moderate activity is sufficient or can you get more benefits by doing vigorous activity also.”

Joint analyses of both exercise intensities found that additional vigorous physical activity was associated with lower mortality among participants with insufficient (less than 300 min/week) levels of moderate exercise but not among those with at least 300 min/week of moderate exercise.

“The main message is that you can get essentially all of the benefit by just doing moderate exercise,” Dr. Giovannucci said. “There’s no magic benefit of doing vigorous [exercise]. But if someone wants to do vigorous, they can get the benefit in about half the time. So if you only have 2-3 hours a week to exercise and can do, say 2 or 3 hours of running, you can get pretty much the maximum benefit.”

Sensitivity analyses showed a consistent association between long-term leisure physical activity and mortality without adjustment for body mass index/calorie intake.

“Some people think the effect of exercise is to lower your body weight or keep it down, which could be one of the benefits, but even independent of that, you get benefits even if it has no effect on your weight,” he said. “So, definitely, that’s important.”

Dr. Michos pointed out that vigorous physical activity may seem daunting for many individuals but that moderate exercise can include activities such as brisk walking, ballroom dancing, active yoga, and recreational swimming.

“The nice thing is that you can really combine or substitute both and get just as similar mortality reductions with moderate physical activity, because a lot of patients may not want to do vigorous activity,” she said. “They don’t want to get on the treadmill; that’s too intimidating or stressful.”

The study was supported by the National Institutes of Health. The authors and Dr. Michos report no relevant financial relationships.

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


There’s little doubt that long COVID is real. Even as doctors and federal agencies struggle to define the syndrome, hospitals and health care systems are opening long COVID specialty treatment programs. As of July 25, there’s at least one long COVID center in almost every state – 48 out of 50, according to the patient advocacy group Survivor Corps.

Among the biggest challenges will be treating the mental health effects of long COVID. Well after people recover from acute COVID infections, they can still have a wide range of lingering symptoms, including depression, anxiety, brain fog, and PTSD.

courtesy Oregon Health & Science University

Specialized centers will be tackling these problems even as the United States struggles to deal with mental health needs.

One study of COVID patients found more than one-third of them had symptoms of depression, anxiety, or PTSD 3-6 months after their initial infection. Another analysis of 30 previous studies of long COVID patients found roughly one in eight of them had severe depression – and that the risk was similar regardless of whether people were hospitalized for COVID-19.

“Many of these symptoms can emerge months into the course of long COVID illness,” said Jordan Anderson, DO, a neuropsychiatrist who sees patients at the Long COVID-19 Program at Oregon Health & Science University, Portland. Psychological symptoms are often made worse by physical setbacks like extreme fatigue and by challenges of working, caring for children, and keeping up with daily routines, he said.

“This impact is not only severe, but also chronic for many,” he said.

Like dozens of hospitals around the country, Oregon Health & Science opened its center for long COVID as it became clear that more patients would need help for ongoing physical and mental health symptoms. Today, there’s at least one long COVID center – sometimes called post-COVID care centers or clinics – in every state but Kansas and South Dakota, Survivor Corps said.

Many long COVID care centers aim to tackle both physical and mental health symptoms, said Tracy Vannorsdall, PhD, a neuropsychologist with the Johns Hopkins Post-Acute COVID-19 Team program. One goal at Hopkins is to identify patients with psychological issues that might otherwise get overlooked.

A sizable minority of patients at the Johns Hopkins center – up to about 35% – report mental health problems that they didn’t have until after they got COVID-19, Dr. Vannorsdall says. The most common mental health issues providers see are depression, anxiety, and trauma-related distress.

“Routine assessment is key,” Dr. Vannorsdall said. “If patients are not asked about their mental health symptoms, they may not spontaneously report them to their provider due to fear of stigma or simply not appreciating that there are effective treatments available for these issues.”

Fear that doctors won’t take symptoms seriously is common, says Heather Murray MD, a senior instructor in psychiatry at the University of Colorado at Denver, Aurora.

“Many patients worry their physicians, loved ones, and society will not believe them or will minimize their symptoms and suffering,” said Dr. Murray, who treats patients at the UCHealth Post-COVID Clinic.

Diagnostic tests in long COVID patients often don’t have conclusive results, which can lead doctors and patients themselves to question whether symptoms are truly “physical versus psychosomatic,” she said. “It is important that providers believe their patients and treat their symptoms, even when diagnostic tests are unrevealing.”
 

Growing mental health crisis

Patients often find their way to academic treatment centers after surviving severe COVID-19 infections. But a growing number of long COVID patients show up at these centers after milder cases. These patients were never hospitalized for COVID-19 but still have persistent symptoms like fatigue, thinking problems, and mood disorders.

Among the major challenges is a shortage of mental health care providers to meet the surging need for care since the start of the pandemic. Around the world, anxiety and depression surged 25% during the first year of the pandemic, according to the World Health Organization.

In the United States, 40% of adults report feelings of anxiety and depression, and one in three high school students have feelings of sadness and hopelessness, according to a March 2022 statement from the White House.

Despite this surging need for care, almost half of Americans live in areas with a severe shortage of mental health care providers, according to the Health Resources and Services Administration. As of 2019, the United States had a shortage of about 6,790 mental health providers. Since then, the shortage has worsened; it’s now about 7,500 providers.

“One of the biggest challenges for hospitals and clinics in treating mental health disorders in long COVID is the limited resources and long wait times to get in for evaluations and treatment,” said Nyaz Didehbani, PhD, a neuropsychologist who treats long COVID patients at the COVID Recover program at the University of Texas Southwestern Medical Center, Dallas.

These delays can lead to worse outcomes, Dr. Didehbani said. “Additionally, patients do not feel that they are being heard, as many providers are not aware of the mental health impact and relationship with physical and cognitive symptoms.” .

Even when doctors recognize that psychological challenges are common with long COVID, they still have to think creatively to come up with treatments that meet the unique needs of these patients, said Thida Thant, MD, an assistant professor of psychiatry at the University of Colorado who treats patients at the UCHealth Post-COVID Clinic.

“There are at least two major factors that make treating psychological issues in long COVID more complex: The fact that the pandemic is still ongoing and still so divisive throughout society, and the fact that we don’t know a single best way to treat all symptoms of long COVID,” she said.

Some common treatments for anxiety and depression, like psychotherapy and medication, can be used for long COVID patients with these conditions. But another intervention that can work wonders for many people with mood disorders – exercise – doesn’t always work for long COVID patients. That’s because many of them struggle with physical challenges like chronic fatigue and what’s known as postexertional malaise, or a worsening of symptoms after even limited physical effort.

“While we normally encourage patients to be active, have a daily routine, and to engage in physical activity as part of their mental health treatment, some long COVID patients find that their symptoms worsen after increased activity,” Dr. Vannorsdall said.

Patients who are able to reach long COVID care centers are much more apt to get mental health problems diagnosed and treated, doctors at many programs around the country agree. But many patients hardest hit by the pandemic – the poor and racial and ethnic minorities – are also less likely to have ready access to hospitals that offer these programs, said Dr. Anderson.

“Affluent, predominantly White populations are showing up in these clinics, while we know that non-White populations have disproportionally high rates of acute infection, hospitalization, and death related to the virus,” he said.

Clinics are also concentrated in academic medical centers and in urban areas, limiting options for people in rural communities who may have to drive for hours to access care, Dr. Anderson said.

“Even before long COVID, we already knew that many people live in areas where there simply aren’t enough mental health services available,” said John Zulueta, MD, an assistant professor of clinical psychiatry at the University of Illinois at Chicago who provides mental health evaluations at the UI Health Post-COVID Clinic.

“As more patients develop mental health issues associated with long COVID, it’s going to put more stress on an already stressed system,” he said.

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

There’s little doubt that long COVID is real. Even as doctors and federal agencies struggle to define the syndrome, hospitals and health care systems are opening long COVID specialty treatment programs. As of July 25, there’s at least one long COVID center in almost every state – 48 out of 50, according to the patient advocacy group Survivor Corps.

Among the biggest challenges will be treating the mental health effects of long COVID. Well after people recover from acute COVID infections, they can still have a wide range of lingering symptoms, including depression, anxiety, brain fog, and PTSD.

courtesy Oregon Health & Science University

Specialized centers will be tackling these problems even as the United States struggles to deal with mental health needs.

One study of COVID patients found more than one-third of them had symptoms of depression, anxiety, or PTSD 3-6 months after their initial infection. Another analysis of 30 previous studies of long COVID patients found roughly one in eight of them had severe depression – and that the risk was similar regardless of whether people were hospitalized for COVID-19.

“Many of these symptoms can emerge months into the course of long COVID illness,” said Jordan Anderson, DO, a neuropsychiatrist who sees patients at the Long COVID-19 Program at Oregon Health & Science University, Portland. Psychological symptoms are often made worse by physical setbacks like extreme fatigue and by challenges of working, caring for children, and keeping up with daily routines, he said.

“This impact is not only severe, but also chronic for many,” he said.

Like dozens of hospitals around the country, Oregon Health & Science opened its center for long COVID as it became clear that more patients would need help for ongoing physical and mental health symptoms. Today, there’s at least one long COVID center – sometimes called post-COVID care centers or clinics – in every state but Kansas and South Dakota, Survivor Corps said.

Many long COVID care centers aim to tackle both physical and mental health symptoms, said Tracy Vannorsdall, PhD, a neuropsychologist with the Johns Hopkins Post-Acute COVID-19 Team program. One goal at Hopkins is to identify patients with psychological issues that might otherwise get overlooked.

A sizable minority of patients at the Johns Hopkins center – up to about 35% – report mental health problems that they didn’t have until after they got COVID-19, Dr. Vannorsdall says. The most common mental health issues providers see are depression, anxiety, and trauma-related distress.

“Routine assessment is key,” Dr. Vannorsdall said. “If patients are not asked about their mental health symptoms, they may not spontaneously report them to their provider due to fear of stigma or simply not appreciating that there are effective treatments available for these issues.”

Fear that doctors won’t take symptoms seriously is common, says Heather Murray MD, a senior instructor in psychiatry at the University of Colorado at Denver, Aurora.

“Many patients worry their physicians, loved ones, and society will not believe them or will minimize their symptoms and suffering,” said Dr. Murray, who treats patients at the UCHealth Post-COVID Clinic.

Diagnostic tests in long COVID patients often don’t have conclusive results, which can lead doctors and patients themselves to question whether symptoms are truly “physical versus psychosomatic,” she said. “It is important that providers believe their patients and treat their symptoms, even when diagnostic tests are unrevealing.”
 

Growing mental health crisis

Patients often find their way to academic treatment centers after surviving severe COVID-19 infections. But a growing number of long COVID patients show up at these centers after milder cases. These patients were never hospitalized for COVID-19 but still have persistent symptoms like fatigue, thinking problems, and mood disorders.

Among the major challenges is a shortage of mental health care providers to meet the surging need for care since the start of the pandemic. Around the world, anxiety and depression surged 25% during the first year of the pandemic, according to the World Health Organization.

In the United States, 40% of adults report feelings of anxiety and depression, and one in three high school students have feelings of sadness and hopelessness, according to a March 2022 statement from the White House.

Despite this surging need for care, almost half of Americans live in areas with a severe shortage of mental health care providers, according to the Health Resources and Services Administration. As of 2019, the United States had a shortage of about 6,790 mental health providers. Since then, the shortage has worsened; it’s now about 7,500 providers.

“One of the biggest challenges for hospitals and clinics in treating mental health disorders in long COVID is the limited resources and long wait times to get in for evaluations and treatment,” said Nyaz Didehbani, PhD, a neuropsychologist who treats long COVID patients at the COVID Recover program at the University of Texas Southwestern Medical Center, Dallas.

These delays can lead to worse outcomes, Dr. Didehbani said. “Additionally, patients do not feel that they are being heard, as many providers are not aware of the mental health impact and relationship with physical and cognitive symptoms.” .

Even when doctors recognize that psychological challenges are common with long COVID, they still have to think creatively to come up with treatments that meet the unique needs of these patients, said Thida Thant, MD, an assistant professor of psychiatry at the University of Colorado who treats patients at the UCHealth Post-COVID Clinic.

“There are at least two major factors that make treating psychological issues in long COVID more complex: The fact that the pandemic is still ongoing and still so divisive throughout society, and the fact that we don’t know a single best way to treat all symptoms of long COVID,” she said.

Some common treatments for anxiety and depression, like psychotherapy and medication, can be used for long COVID patients with these conditions. But another intervention that can work wonders for many people with mood disorders – exercise – doesn’t always work for long COVID patients. That’s because many of them struggle with physical challenges like chronic fatigue and what’s known as postexertional malaise, or a worsening of symptoms after even limited physical effort.

“While we normally encourage patients to be active, have a daily routine, and to engage in physical activity as part of their mental health treatment, some long COVID patients find that their symptoms worsen after increased activity,” Dr. Vannorsdall said.

Patients who are able to reach long COVID care centers are much more apt to get mental health problems diagnosed and treated, doctors at many programs around the country agree. But many patients hardest hit by the pandemic – the poor and racial and ethnic minorities – are also less likely to have ready access to hospitals that offer these programs, said Dr. Anderson.

“Affluent, predominantly White populations are showing up in these clinics, while we know that non-White populations have disproportionally high rates of acute infection, hospitalization, and death related to the virus,” he said.

Clinics are also concentrated in academic medical centers and in urban areas, limiting options for people in rural communities who may have to drive for hours to access care, Dr. Anderson said.

“Even before long COVID, we already knew that many people live in areas where there simply aren’t enough mental health services available,” said John Zulueta, MD, an assistant professor of clinical psychiatry at the University of Illinois at Chicago who provides mental health evaluations at the UI Health Post-COVID Clinic.

“As more patients develop mental health issues associated with long COVID, it’s going to put more stress on an already stressed system,” he said.

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

There’s little doubt that long COVID is real. Even as doctors and federal agencies struggle to define the syndrome, hospitals and health care systems are opening long COVID specialty treatment programs. As of July 25, there’s at least one long COVID center in almost every state – 48 out of 50, according to the patient advocacy group Survivor Corps.

Among the biggest challenges will be treating the mental health effects of long COVID. Well after people recover from acute COVID infections, they can still have a wide range of lingering symptoms, including depression, anxiety, brain fog, and PTSD.

courtesy Oregon Health & Science University

Specialized centers will be tackling these problems even as the United States struggles to deal with mental health needs.

One study of COVID patients found more than one-third of them had symptoms of depression, anxiety, or PTSD 3-6 months after their initial infection. Another analysis of 30 previous studies of long COVID patients found roughly one in eight of them had severe depression – and that the risk was similar regardless of whether people were hospitalized for COVID-19.

“Many of these symptoms can emerge months into the course of long COVID illness,” said Jordan Anderson, DO, a neuropsychiatrist who sees patients at the Long COVID-19 Program at Oregon Health & Science University, Portland. Psychological symptoms are often made worse by physical setbacks like extreme fatigue and by challenges of working, caring for children, and keeping up with daily routines, he said.

“This impact is not only severe, but also chronic for many,” he said.

Like dozens of hospitals around the country, Oregon Health & Science opened its center for long COVID as it became clear that more patients would need help for ongoing physical and mental health symptoms. Today, there’s at least one long COVID center – sometimes called post-COVID care centers or clinics – in every state but Kansas and South Dakota, Survivor Corps said.

Many long COVID care centers aim to tackle both physical and mental health symptoms, said Tracy Vannorsdall, PhD, a neuropsychologist with the Johns Hopkins Post-Acute COVID-19 Team program. One goal at Hopkins is to identify patients with psychological issues that might otherwise get overlooked.

A sizable minority of patients at the Johns Hopkins center – up to about 35% – report mental health problems that they didn’t have until after they got COVID-19, Dr. Vannorsdall says. The most common mental health issues providers see are depression, anxiety, and trauma-related distress.

“Routine assessment is key,” Dr. Vannorsdall said. “If patients are not asked about their mental health symptoms, they may not spontaneously report them to their provider due to fear of stigma or simply not appreciating that there are effective treatments available for these issues.”

Fear that doctors won’t take symptoms seriously is common, says Heather Murray MD, a senior instructor in psychiatry at the University of Colorado at Denver, Aurora.

“Many patients worry their physicians, loved ones, and society will not believe them or will minimize their symptoms and suffering,” said Dr. Murray, who treats patients at the UCHealth Post-COVID Clinic.

Diagnostic tests in long COVID patients often don’t have conclusive results, which can lead doctors and patients themselves to question whether symptoms are truly “physical versus psychosomatic,” she said. “It is important that providers believe their patients and treat their symptoms, even when diagnostic tests are unrevealing.”
 

Growing mental health crisis

Patients often find their way to academic treatment centers after surviving severe COVID-19 infections. But a growing number of long COVID patients show up at these centers after milder cases. These patients were never hospitalized for COVID-19 but still have persistent symptoms like fatigue, thinking problems, and mood disorders.

Among the major challenges is a shortage of mental health care providers to meet the surging need for care since the start of the pandemic. Around the world, anxiety and depression surged 25% during the first year of the pandemic, according to the World Health Organization.

In the United States, 40% of adults report feelings of anxiety and depression, and one in three high school students have feelings of sadness and hopelessness, according to a March 2022 statement from the White House.

Despite this surging need for care, almost half of Americans live in areas with a severe shortage of mental health care providers, according to the Health Resources and Services Administration. As of 2019, the United States had a shortage of about 6,790 mental health providers. Since then, the shortage has worsened; it’s now about 7,500 providers.

“One of the biggest challenges for hospitals and clinics in treating mental health disorders in long COVID is the limited resources and long wait times to get in for evaluations and treatment,” said Nyaz Didehbani, PhD, a neuropsychologist who treats long COVID patients at the COVID Recover program at the University of Texas Southwestern Medical Center, Dallas.

These delays can lead to worse outcomes, Dr. Didehbani said. “Additionally, patients do not feel that they are being heard, as many providers are not aware of the mental health impact and relationship with physical and cognitive symptoms.” .

Even when doctors recognize that psychological challenges are common with long COVID, they still have to think creatively to come up with treatments that meet the unique needs of these patients, said Thida Thant, MD, an assistant professor of psychiatry at the University of Colorado who treats patients at the UCHealth Post-COVID Clinic.

“There are at least two major factors that make treating psychological issues in long COVID more complex: The fact that the pandemic is still ongoing and still so divisive throughout society, and the fact that we don’t know a single best way to treat all symptoms of long COVID,” she said.

Some common treatments for anxiety and depression, like psychotherapy and medication, can be used for long COVID patients with these conditions. But another intervention that can work wonders for many people with mood disorders – exercise – doesn’t always work for long COVID patients. That’s because many of them struggle with physical challenges like chronic fatigue and what’s known as postexertional malaise, or a worsening of symptoms after even limited physical effort.

“While we normally encourage patients to be active, have a daily routine, and to engage in physical activity as part of their mental health treatment, some long COVID patients find that their symptoms worsen after increased activity,” Dr. Vannorsdall said.

Patients who are able to reach long COVID care centers are much more apt to get mental health problems diagnosed and treated, doctors at many programs around the country agree. But many patients hardest hit by the pandemic – the poor and racial and ethnic minorities – are also less likely to have ready access to hospitals that offer these programs, said Dr. Anderson.

“Affluent, predominantly White populations are showing up in these clinics, while we know that non-White populations have disproportionally high rates of acute infection, hospitalization, and death related to the virus,” he said.

Clinics are also concentrated in academic medical centers and in urban areas, limiting options for people in rural communities who may have to drive for hours to access care, Dr. Anderson said.

“Even before long COVID, we already knew that many people live in areas where there simply aren’t enough mental health services available,” said John Zulueta, MD, an assistant professor of clinical psychiatry at the University of Illinois at Chicago who provides mental health evaluations at the UI Health Post-COVID Clinic.

“As more patients develop mental health issues associated with long COVID, it’s going to put more stress on an already stressed system,” he said.

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

Biologic agents may not be as safe or effective in Hispanic patients with inflammatory bowel disease (IBD) as they are in non-Hispanic patients, suggest new data published online in Clinical Gastroenterology and Hepatology.

To compare risk for hospitalization, surgery, and serious infections, Nghia H. Nguyen, MD, and his team at the Inflammatory Bowel Disease Center at the University of California, San Diego, included a multicenter, electronic health record–based cohort of biologic-treated Hispanic and non-Hispanic patients with IBD and used 1:4 propensity score matching.

They compared 240 Hispanic patients (53% male; 45% with ulcerative colitis; 73% treated with tumor necrosis factor alpha [TNF-alpha] antagonist; 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male; 44% with ulcerative colitis; 67% treated with TNF-alpha antagonist; 27% with prior biologic exposure). Patients were new users of biologics (TNF-alpha antagonist, ustekinumab, or vedolizumab).

Compared with non-Hispanic patients, Hispanic patients had a higher risk for all-cause hospitalization (31% vs. 23%) within 1 year of starting a biologic agent.

Hispanic patients also had almost twice the risk for IBD-related surgeries (7% vs. 4.6%, respectively) and trended toward a higher risk for serious infection (8.8% vs. 4.9%, respectively).

The findings are particularly important because incidence and prevalence of IBD in Hispanic adults are increasing rapidly, according to the authors.

“Currently, 1.2% of Hispanic adults in the United States report having IBD, and this number is expected to increase progressively over the next few years with global immigration patterns and changing demographics of the United States,” the authors write.
 

Potential drivers of disparities

Hispanic patients have been underrepresented in clinical trials of biologic agents in IBD, making up fewer than 5% of participants, the authors note. This has resulted in limited data and created challenges in discerning reasons for the disparity.

The authors note the potential role of genetics in the effectiveness of some biologic agents, although that has not been well studied in Hispanic patients.

Additionally, according to this study, Hispanic patients with IBD lived with more negative social determinants of health, particularly related to food insecurity (27%) and lack of adequate social support (83%), compared with non-Hispanic patients (unpublished data).

“In other studies on health care utilization, Hispanic patients were found to have limited access to appropriate specialist care and lack of insurance coverage,” the authors point out.

The authors acknowledge that limitations of their study include the inability to pinpoint the primary reason for hospitalization because data on primary versus secondary discharge diagnoses were not available. Also, they relied on prescription information in electronic health records and could not confirm that medications were dispensed or that patients took them.

They also acknowledged selection bias as a limitation, because the focus was only on patients treated with biologics and not on outcomes for those who may have warranted a biologic treatment but were unable to receive it.

“Future studies are needed to investigate the biological, social, and environmental drivers of these differences,” the authors write.

The authors’ complete financial disclosures are available with the full text of the paper.

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

Biologic agents may not be as safe or effective in Hispanic patients with inflammatory bowel disease (IBD) as they are in non-Hispanic patients, suggest new data published online in Clinical Gastroenterology and Hepatology.

To compare risk for hospitalization, surgery, and serious infections, Nghia H. Nguyen, MD, and his team at the Inflammatory Bowel Disease Center at the University of California, San Diego, included a multicenter, electronic health record–based cohort of biologic-treated Hispanic and non-Hispanic patients with IBD and used 1:4 propensity score matching.

They compared 240 Hispanic patients (53% male; 45% with ulcerative colitis; 73% treated with tumor necrosis factor alpha [TNF-alpha] antagonist; 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male; 44% with ulcerative colitis; 67% treated with TNF-alpha antagonist; 27% with prior biologic exposure). Patients were new users of biologics (TNF-alpha antagonist, ustekinumab, or vedolizumab).

Compared with non-Hispanic patients, Hispanic patients had a higher risk for all-cause hospitalization (31% vs. 23%) within 1 year of starting a biologic agent.

Hispanic patients also had almost twice the risk for IBD-related surgeries (7% vs. 4.6%, respectively) and trended toward a higher risk for serious infection (8.8% vs. 4.9%, respectively).

The findings are particularly important because incidence and prevalence of IBD in Hispanic adults are increasing rapidly, according to the authors.

“Currently, 1.2% of Hispanic adults in the United States report having IBD, and this number is expected to increase progressively over the next few years with global immigration patterns and changing demographics of the United States,” the authors write.
 

Potential drivers of disparities

Hispanic patients have been underrepresented in clinical trials of biologic agents in IBD, making up fewer than 5% of participants, the authors note. This has resulted in limited data and created challenges in discerning reasons for the disparity.

The authors note the potential role of genetics in the effectiveness of some biologic agents, although that has not been well studied in Hispanic patients.

Additionally, according to this study, Hispanic patients with IBD lived with more negative social determinants of health, particularly related to food insecurity (27%) and lack of adequate social support (83%), compared with non-Hispanic patients (unpublished data).

“In other studies on health care utilization, Hispanic patients were found to have limited access to appropriate specialist care and lack of insurance coverage,” the authors point out.

The authors acknowledge that limitations of their study include the inability to pinpoint the primary reason for hospitalization because data on primary versus secondary discharge diagnoses were not available. Also, they relied on prescription information in electronic health records and could not confirm that medications were dispensed or that patients took them.

They also acknowledged selection bias as a limitation, because the focus was only on patients treated with biologics and not on outcomes for those who may have warranted a biologic treatment but were unable to receive it.

“Future studies are needed to investigate the biological, social, and environmental drivers of these differences,” the authors write.

The authors’ complete financial disclosures are available with the full text of the paper.

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

Biologic agents may not be as safe or effective in Hispanic patients with inflammatory bowel disease (IBD) as they are in non-Hispanic patients, suggest new data published online in Clinical Gastroenterology and Hepatology.

To compare risk for hospitalization, surgery, and serious infections, Nghia H. Nguyen, MD, and his team at the Inflammatory Bowel Disease Center at the University of California, San Diego, included a multicenter, electronic health record–based cohort of biologic-treated Hispanic and non-Hispanic patients with IBD and used 1:4 propensity score matching.

They compared 240 Hispanic patients (53% male; 45% with ulcerative colitis; 73% treated with tumor necrosis factor alpha [TNF-alpha] antagonist; 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male; 44% with ulcerative colitis; 67% treated with TNF-alpha antagonist; 27% with prior biologic exposure). Patients were new users of biologics (TNF-alpha antagonist, ustekinumab, or vedolizumab).

Compared with non-Hispanic patients, Hispanic patients had a higher risk for all-cause hospitalization (31% vs. 23%) within 1 year of starting a biologic agent.

Hispanic patients also had almost twice the risk for IBD-related surgeries (7% vs. 4.6%, respectively) and trended toward a higher risk for serious infection (8.8% vs. 4.9%, respectively).

The findings are particularly important because incidence and prevalence of IBD in Hispanic adults are increasing rapidly, according to the authors.

“Currently, 1.2% of Hispanic adults in the United States report having IBD, and this number is expected to increase progressively over the next few years with global immigration patterns and changing demographics of the United States,” the authors write.