Some of the Affordable Care Act’s insurance marketplaces are in turmoil as the fourth open enrollment season approaches this fall, but what’s ahead for consumers very much depends on where they live.

Competition on these exchanges will be diminished next year when three of the nation’s largest health insurers – Aetna, UnitedHealthcare and Humana – will sell individual plans in many fewer markets. So too will several Blue Cross and Blue Shield plans in various states. That’s on top of the 16 nonprofit co-ops that have closed since January 2015.

The announcements, however, apply generally only to the individual market. The much larger market of employer-sponsored insurance is not part of the health law exchanges.

Aetna’s exit announcement Aug. 15 that blamed financial losses on its marketplace plans gave Obamacare opponents who have from the start predicted the ACA’s failure a fresh chance to proclaim “I told you so.”

That story line got more complicated Aug. 17 after the Huffington Post reported that Aetna CEO Mark Bertolini sent a letter to the Department of Justice (DOJ) on July 5 threatening to withdraw from the Obamacare marketplaces if the DOJ sued to block his company’s planned merger with Humana. The DOJ did just that a couple weeks later.

But most marketplace consumers won’t see any ill effects from insurers’ withdrawals, according to ACA advocates and independent experts.

“The effect on consumers is going to be mixed around the country,” said Katherine Hempstead, PhD, a senior adviser at the nonpartisan Robert Wood Johnson Foundation. “Most of these marketplaces are not dependent on” the large national carriers.

Many major metropolitan areas, such as those in California, New York, and Texas, will still have several insurers for individual health insurance consumers to choose from. In Texas, all major metro areas – including Austin, Dallas, Houston, and San Antonio – will have at least three insurers after Aetna and UnitedHealthcare exit.

That’s true also for most urban exchange customers living in the Northwest, the Midwest, and New England.

Most hurt will be marketplace consumers in Arizona, North and South Carolina, Georgia, and parts of Florida, where only one or two insurers will be left when open enrollment season begins Nov. 15.

Remaining insurers might raise their monthly premiums as a result, but more than eight in 10 consumers on the marketplaces who get government subsidies would be insulated. Subsidies increase as premiums rise.

Still, health experts worry that with less competition, insurers may tighten their provider networks and give these consumers fewer choices of hospitals and doctors. That trend started several years ago, and some states have responded with regulations requiring insurers to provide customers with reasonable access to doctors and hospitals in each county where they sell plans.

Nearly 13 million people signed up for Obamacare marketplace policies for 2016. Aetna, UnitedHealthcare, and Humana have 2 million members in total, but their exit from certain states is predicted to affect between 1 million and 1.5 million people who will have to choose new carriers.

While changing plans can force people to find new doctors, it’s also the best way for consumers get the best deals on coverage.

Aetna will exit 11 of 15 states where it sells plans on the exchanges. UnitedHealthcare has said it will quit 22 of 34 states, and Humana will leave 4 of the 15 states where it operates.

In late May, the Kaiser Family Foundation estimated the number of rural counties at risk of having one insurer on the exchanges would triple in 2017. That was before Humana and Aetna detailed their plans. (KHN is an editorially independent project of the foundation.)

Now, “we could be looking at about one in four counties in the U.S. with just one exchange insurer next year, though this could change between now and open enrollment in November,” said Cynthia Cox, associate director for the Kaiser Family Foundation Program for the Study of Health Reform and Private Insurance.

Overshadowed by the big insurers’ withdrawals is the prospect that other carriers will enter markets the three giants are leaving. Smaller insurers Molina and Centene have said they’re doing fine on the exchanges. And Cigna, a larger insurer, has said it will move into some North Carolina counties for 2017.

North Carolina will be left with just one or two plans in most of the state after it loses UnitedHealthcare and Aetna plans. Health insurance experts say three insurers are needed for a healthy competitive market.

“We’ve had a very robust enrollment under the ACA and hope consumers will still see benefits of having coverage even if they have fewer options,” said Ciara Zachary, health policy analyst for the North Carolina Justice Center’s Health Access Coalition.

Rural Americans had few health insurers to choose from even before Obamacare, but some suburban and urban parts of the Southeast will be in the same fix next year. In southeast Florida, consumers in counties near Naples and Fort Myers will have only one marketplace insurer – Florida Blue – next year, unless other insurers step in.

“There are some headwinds, but it’s not a question of whether the market will stabilize but how quickly and how well,” said Dr. Hempstead.

Strong winds are already blowing toward Arizona’s Pinal County, southeast of Phoenix, health care advocates say. Nearly 10,000 people enrolled in Obamacare marketplace policies this year and about 85% received a federal subsidy.

In 2017, Pinal stands to lose its only two insurers – UnitedHealthcare and Blue Cross and Blue Shield of Arizona.

“Clearly this is a big concern for consumers,” said Allen Gjersvig, director of navigator and enrollment services for the Arizona Alliance for Community Health Centers. He said he is hopeful, but not confident, that another insurer will step in.

Neighboring Maricopa County, which includes Phoenix, is expected to have just two relatively small insurers left on its marketplace next year. Mr. Gjersvig said that he questions whether those two – Cigna and Phoenix Health Plan – will have enough doctors and hospitals under contract to handle their new members after larger rival Blue Cross and Blue Shield of Arizona gives up its 40,000 customers.

At least a dozen other counties in Arizona will be left with just one health insurer, he said.

Arizona had eight insurers operating in various parts of the state this year, but four are leaving entirely – Aetna, UnitedHealthcare, Humana, and Health Choice. Two more, Blue Cross Blue Shield and Health Net, are scaling back their participation.

Despite the problems with the marketplaces, Mr. Gjersvig said thousands of people have gained coverage through them and he is confident they will survive.

“We do not see this as a death knell for the marketplace,” he said.

Tammie King, an insurance agent in Columbia, S.C., is less sure how insurer departures will affect consumers in the Palmetto State. Pullouts by UnitedHealthcare and Aetna mean only one carrier in the state in 2017 – Blue Cross and Blue Shield of South Carolina.

That’s a concern in Columbia, S.C., because the Blue Cross plan does not include one of the biggest hospitals, Lexington Medical Center, and its affiliated physicians, she said.

“People will be left unable to see the doctors they are now using,” she added.

Ms. King said she worried the Blue Cross plan will use its monopoly power to further reduce the number of doctors and hospitals in its network and limit its choice of prescription drugs. “You can’t blame them because … they have to do something to control costs,” she said.

This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Some of the Affordable Care Act’s insurance marketplaces are in turmoil as the fourth open enrollment season approaches this fall, but what’s ahead for consumers very much depends on where they live.

Competition on these exchanges will be diminished next year when three of the nation’s largest health insurers – Aetna, UnitedHealthcare and Humana – will sell individual plans in many fewer markets. So too will several Blue Cross and Blue Shield plans in various states. That’s on top of the 16 nonprofit co-ops that have closed since January 2015.

The announcements, however, apply generally only to the individual market. The much larger market of employer-sponsored insurance is not part of the health law exchanges.

Aetna’s exit announcement Aug. 15 that blamed financial losses on its marketplace plans gave Obamacare opponents who have from the start predicted the ACA’s failure a fresh chance to proclaim “I told you so.”

That story line got more complicated Aug. 17 after the Huffington Post reported that Aetna CEO Mark Bertolini sent a letter to the Department of Justice (DOJ) on July 5 threatening to withdraw from the Obamacare marketplaces if the DOJ sued to block his company’s planned merger with Humana. The DOJ did just that a couple weeks later.

But most marketplace consumers won’t see any ill effects from insurers’ withdrawals, according to ACA advocates and independent experts.

“The effect on consumers is going to be mixed around the country,” said Katherine Hempstead, PhD, a senior adviser at the nonpartisan Robert Wood Johnson Foundation. “Most of these marketplaces are not dependent on” the large national carriers.

Many major metropolitan areas, such as those in California, New York, and Texas, will still have several insurers for individual health insurance consumers to choose from. In Texas, all major metro areas – including Austin, Dallas, Houston, and San Antonio – will have at least three insurers after Aetna and UnitedHealthcare exit.

That’s true also for most urban exchange customers living in the Northwest, the Midwest, and New England.

Most hurt will be marketplace consumers in Arizona, North and South Carolina, Georgia, and parts of Florida, where only one or two insurers will be left when open enrollment season begins Nov. 15.

Remaining insurers might raise their monthly premiums as a result, but more than eight in 10 consumers on the marketplaces who get government subsidies would be insulated. Subsidies increase as premiums rise.

Still, health experts worry that with less competition, insurers may tighten their provider networks and give these consumers fewer choices of hospitals and doctors. That trend started several years ago, and some states have responded with regulations requiring insurers to provide customers with reasonable access to doctors and hospitals in each county where they sell plans.

Nearly 13 million people signed up for Obamacare marketplace policies for 2016. Aetna, UnitedHealthcare, and Humana have 2 million members in total, but their exit from certain states is predicted to affect between 1 million and 1.5 million people who will have to choose new carriers.

While changing plans can force people to find new doctors, it’s also the best way for consumers get the best deals on coverage.

Aetna will exit 11 of 15 states where it sells plans on the exchanges. UnitedHealthcare has said it will quit 22 of 34 states, and Humana will leave 4 of the 15 states where it operates.

In late May, the Kaiser Family Foundation estimated the number of rural counties at risk of having one insurer on the exchanges would triple in 2017. That was before Humana and Aetna detailed their plans. (KHN is an editorially independent project of the foundation.)

Now, “we could be looking at about one in four counties in the U.S. with just one exchange insurer next year, though this could change between now and open enrollment in November,” said Cynthia Cox, associate director for the Kaiser Family Foundation Program for the Study of Health Reform and Private Insurance.

Overshadowed by the big insurers’ withdrawals is the prospect that other carriers will enter markets the three giants are leaving. Smaller insurers Molina and Centene have said they’re doing fine on the exchanges. And Cigna, a larger insurer, has said it will move into some North Carolina counties for 2017.

North Carolina will be left with just one or two plans in most of the state after it loses UnitedHealthcare and Aetna plans. Health insurance experts say three insurers are needed for a healthy competitive market.

“We’ve had a very robust enrollment under the ACA and hope consumers will still see benefits of having coverage even if they have fewer options,” said Ciara Zachary, health policy analyst for the North Carolina Justice Center’s Health Access Coalition.

Rural Americans had few health insurers to choose from even before Obamacare, but some suburban and urban parts of the Southeast will be in the same fix next year. In southeast Florida, consumers in counties near Naples and Fort Myers will have only one marketplace insurer – Florida Blue – next year, unless other insurers step in.

“There are some headwinds, but it’s not a question of whether the market will stabilize but how quickly and how well,” said Dr. Hempstead.

Strong winds are already blowing toward Arizona’s Pinal County, southeast of Phoenix, health care advocates say. Nearly 10,000 people enrolled in Obamacare marketplace policies this year and about 85% received a federal subsidy.

In 2017, Pinal stands to lose its only two insurers – UnitedHealthcare and Blue Cross and Blue Shield of Arizona.

“Clearly this is a big concern for consumers,” said Allen Gjersvig, director of navigator and enrollment services for the Arizona Alliance for Community Health Centers. He said he is hopeful, but not confident, that another insurer will step in.

Neighboring Maricopa County, which includes Phoenix, is expected to have just two relatively small insurers left on its marketplace next year. Mr. Gjersvig said that he questions whether those two – Cigna and Phoenix Health Plan – will have enough doctors and hospitals under contract to handle their new members after larger rival Blue Cross and Blue Shield of Arizona gives up its 40,000 customers.

At least a dozen other counties in Arizona will be left with just one health insurer, he said.

Arizona had eight insurers operating in various parts of the state this year, but four are leaving entirely – Aetna, UnitedHealthcare, Humana, and Health Choice. Two more, Blue Cross Blue Shield and Health Net, are scaling back their participation.

Despite the problems with the marketplaces, Mr. Gjersvig said thousands of people have gained coverage through them and he is confident they will survive.

“We do not see this as a death knell for the marketplace,” he said.

Tammie King, an insurance agent in Columbia, S.C., is less sure how insurer departures will affect consumers in the Palmetto State. Pullouts by UnitedHealthcare and Aetna mean only one carrier in the state in 2017 – Blue Cross and Blue Shield of South Carolina.

That’s a concern in Columbia, S.C., because the Blue Cross plan does not include one of the biggest hospitals, Lexington Medical Center, and its affiliated physicians, she said.

“People will be left unable to see the doctors they are now using,” she added.

Ms. King said she worried the Blue Cross plan will use its monopoly power to further reduce the number of doctors and hospitals in its network and limit its choice of prescription drugs. “You can’t blame them because … they have to do something to control costs,” she said.

This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Some of the Affordable Care Act’s insurance marketplaces are in turmoil as the fourth open enrollment season approaches this fall, but what’s ahead for consumers very much depends on where they live.

Competition on these exchanges will be diminished next year when three of the nation’s largest health insurers – Aetna, UnitedHealthcare and Humana – will sell individual plans in many fewer markets. So too will several Blue Cross and Blue Shield plans in various states. That’s on top of the 16 nonprofit co-ops that have closed since January 2015.

The announcements, however, apply generally only to the individual market. The much larger market of employer-sponsored insurance is not part of the health law exchanges.

Aetna’s exit announcement Aug. 15 that blamed financial losses on its marketplace plans gave Obamacare opponents who have from the start predicted the ACA’s failure a fresh chance to proclaim “I told you so.”

That story line got more complicated Aug. 17 after the Huffington Post reported that Aetna CEO Mark Bertolini sent a letter to the Department of Justice (DOJ) on July 5 threatening to withdraw from the Obamacare marketplaces if the DOJ sued to block his company’s planned merger with Humana. The DOJ did just that a couple weeks later.

But most marketplace consumers won’t see any ill effects from insurers’ withdrawals, according to ACA advocates and independent experts.

“The effect on consumers is going to be mixed around the country,” said Katherine Hempstead, PhD, a senior adviser at the nonpartisan Robert Wood Johnson Foundation. “Most of these marketplaces are not dependent on” the large national carriers.

Many major metropolitan areas, such as those in California, New York, and Texas, will still have several insurers for individual health insurance consumers to choose from. In Texas, all major metro areas – including Austin, Dallas, Houston, and San Antonio – will have at least three insurers after Aetna and UnitedHealthcare exit.

That’s true also for most urban exchange customers living in the Northwest, the Midwest, and New England.

Most hurt will be marketplace consumers in Arizona, North and South Carolina, Georgia, and parts of Florida, where only one or two insurers will be left when open enrollment season begins Nov. 15.

Remaining insurers might raise their monthly premiums as a result, but more than eight in 10 consumers on the marketplaces who get government subsidies would be insulated. Subsidies increase as premiums rise.

Still, health experts worry that with less competition, insurers may tighten their provider networks and give these consumers fewer choices of hospitals and doctors. That trend started several years ago, and some states have responded with regulations requiring insurers to provide customers with reasonable access to doctors and hospitals in each county where they sell plans.

Nearly 13 million people signed up for Obamacare marketplace policies for 2016. Aetna, UnitedHealthcare, and Humana have 2 million members in total, but their exit from certain states is predicted to affect between 1 million and 1.5 million people who will have to choose new carriers.

While changing plans can force people to find new doctors, it’s also the best way for consumers get the best deals on coverage.

Aetna will exit 11 of 15 states where it sells plans on the exchanges. UnitedHealthcare has said it will quit 22 of 34 states, and Humana will leave 4 of the 15 states where it operates.

In late May, the Kaiser Family Foundation estimated the number of rural counties at risk of having one insurer on the exchanges would triple in 2017. That was before Humana and Aetna detailed their plans. (KHN is an editorially independent project of the foundation.)

Now, “we could be looking at about one in four counties in the U.S. with just one exchange insurer next year, though this could change between now and open enrollment in November,” said Cynthia Cox, associate director for the Kaiser Family Foundation Program for the Study of Health Reform and Private Insurance.

Overshadowed by the big insurers’ withdrawals is the prospect that other carriers will enter markets the three giants are leaving. Smaller insurers Molina and Centene have said they’re doing fine on the exchanges. And Cigna, a larger insurer, has said it will move into some North Carolina counties for 2017.

North Carolina will be left with just one or two plans in most of the state after it loses UnitedHealthcare and Aetna plans. Health insurance experts say three insurers are needed for a healthy competitive market.

“We’ve had a very robust enrollment under the ACA and hope consumers will still see benefits of having coverage even if they have fewer options,” said Ciara Zachary, health policy analyst for the North Carolina Justice Center’s Health Access Coalition.

Rural Americans had few health insurers to choose from even before Obamacare, but some suburban and urban parts of the Southeast will be in the same fix next year. In southeast Florida, consumers in counties near Naples and Fort Myers will have only one marketplace insurer – Florida Blue – next year, unless other insurers step in.

“There are some headwinds, but it’s not a question of whether the market will stabilize but how quickly and how well,” said Dr. Hempstead.

Strong winds are already blowing toward Arizona’s Pinal County, southeast of Phoenix, health care advocates say. Nearly 10,000 people enrolled in Obamacare marketplace policies this year and about 85% received a federal subsidy.

In 2017, Pinal stands to lose its only two insurers – UnitedHealthcare and Blue Cross and Blue Shield of Arizona.

“Clearly this is a big concern for consumers,” said Allen Gjersvig, director of navigator and enrollment services for the Arizona Alliance for Community Health Centers. He said he is hopeful, but not confident, that another insurer will step in.

Neighboring Maricopa County, which includes Phoenix, is expected to have just two relatively small insurers left on its marketplace next year. Mr. Gjersvig said that he questions whether those two – Cigna and Phoenix Health Plan – will have enough doctors and hospitals under contract to handle their new members after larger rival Blue Cross and Blue Shield of Arizona gives up its 40,000 customers.

At least a dozen other counties in Arizona will be left with just one health insurer, he said.

Arizona had eight insurers operating in various parts of the state this year, but four are leaving entirely – Aetna, UnitedHealthcare, Humana, and Health Choice. Two more, Blue Cross Blue Shield and Health Net, are scaling back their participation.

Despite the problems with the marketplaces, Mr. Gjersvig said thousands of people have gained coverage through them and he is confident they will survive.

“We do not see this as a death knell for the marketplace,” he said.

Tammie King, an insurance agent in Columbia, S.C., is less sure how insurer departures will affect consumers in the Palmetto State. Pullouts by UnitedHealthcare and Aetna mean only one carrier in the state in 2017 – Blue Cross and Blue Shield of South Carolina.

That’s a concern in Columbia, S.C., because the Blue Cross plan does not include one of the biggest hospitals, Lexington Medical Center, and its affiliated physicians, she said.

“People will be left unable to see the doctors they are now using,” she added.

Ms. King said she worried the Blue Cross plan will use its monopoly power to further reduce the number of doctors and hospitals in its network and limit its choice of prescription drugs. “You can’t blame them because … they have to do something to control costs,” she said.

This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Compared to other healthcare-associated infections, catheter-associated urinary tract infections (CAUTIs) cause relatively low rates of mortality and morbidity, but their prevalence nevertheless leads to a considerable cumulative burden.

Hospitalists can impact CAUTI rates by using a simple bundle of interventions. This idea was recently demonstrated by a quality improvement project addressing high CAUTI rates in the hospital setting. The project was summarized in a paper published in The Joint Commission Journal on Quality and Patient Safety.

The project identified a bundle of primary interventions to reduce CAUTI, which consisted of six elements: the “6 Cs” of CAUTI reduction. These include “consider alternatives,” “culture urine only when indication is clear,” and “connect with a securement device.” The interventions were implemented on one ICU with excellent results and subsequently diffused throughout the healthcare facility using multimedia tools. CAUTI rates decreased by 70%.

“The first steps in CAUTI prevention are to ensure that catheters are placed only when necessary, aseptic technique used for placement, and that they are removed when no longer essential,” says lead author Priya Sampathkumar, MD, Mayo Clinic associate professor of medicine. “Once this has been achieved, if CAUTI rates are still high, a secondary bundle of CAUTI prevention can help to reduce CAUTI further.”

About one in four hospitalized patients have a urinary catheter in place.2 “Hospitalists, therefore, can have a significant impact on CAUTI by being mindful about catheter use and catheter management.” Dr. Sampathkumar says.

References

1. Sampathkumar P, Barth JW, Johnson M, et al. Mayo Clinic reduces catheter-associated urinary tract infections. Jt Comm J Qual Patient Saf. 2016;42(6):254-265.
2. Catheter-associated urinary tract infections (CAUTI). Centers for Disease Control and Prevention website. Accessed August 8, 2016.

Compared to other healthcare-associated infections, catheter-associated urinary tract infections (CAUTIs) cause relatively low rates of mortality and morbidity, but their prevalence nevertheless leads to a considerable cumulative burden.

Hospitalists can impact CAUTI rates by using a simple bundle of interventions. This idea was recently demonstrated by a quality improvement project addressing high CAUTI rates in the hospital setting. The project was summarized in a paper published in The Joint Commission Journal on Quality and Patient Safety.

The project identified a bundle of primary interventions to reduce CAUTI, which consisted of six elements: the “6 Cs” of CAUTI reduction. These include “consider alternatives,” “culture urine only when indication is clear,” and “connect with a securement device.” The interventions were implemented on one ICU with excellent results and subsequently diffused throughout the healthcare facility using multimedia tools. CAUTI rates decreased by 70%.

“The first steps in CAUTI prevention are to ensure that catheters are placed only when necessary, aseptic technique used for placement, and that they are removed when no longer essential,” says lead author Priya Sampathkumar, MD, Mayo Clinic associate professor of medicine. “Once this has been achieved, if CAUTI rates are still high, a secondary bundle of CAUTI prevention can help to reduce CAUTI further.”

About one in four hospitalized patients have a urinary catheter in place.2 “Hospitalists, therefore, can have a significant impact on CAUTI by being mindful about catheter use and catheter management.” Dr. Sampathkumar says.

References

1. Sampathkumar P, Barth JW, Johnson M, et al. Mayo Clinic reduces catheter-associated urinary tract infections. Jt Comm J Qual Patient Saf. 2016;42(6):254-265.
2. Catheter-associated urinary tract infections (CAUTI). Centers for Disease Control and Prevention website. Accessed August 8, 2016.

Compared to other healthcare-associated infections, catheter-associated urinary tract infections (CAUTIs) cause relatively low rates of mortality and morbidity, but their prevalence nevertheless leads to a considerable cumulative burden.

Hospitalists can impact CAUTI rates by using a simple bundle of interventions. This idea was recently demonstrated by a quality improvement project addressing high CAUTI rates in the hospital setting. The project was summarized in a paper published in The Joint Commission Journal on Quality and Patient Safety.

The project identified a bundle of primary interventions to reduce CAUTI, which consisted of six elements: the “6 Cs” of CAUTI reduction. These include “consider alternatives,” “culture urine only when indication is clear,” and “connect with a securement device.” The interventions were implemented on one ICU with excellent results and subsequently diffused throughout the healthcare facility using multimedia tools. CAUTI rates decreased by 70%.

“The first steps in CAUTI prevention are to ensure that catheters are placed only when necessary, aseptic technique used for placement, and that they are removed when no longer essential,” says lead author Priya Sampathkumar, MD, Mayo Clinic associate professor of medicine. “Once this has been achieved, if CAUTI rates are still high, a secondary bundle of CAUTI prevention can help to reduce CAUTI further.”

About one in four hospitalized patients have a urinary catheter in place.2 “Hospitalists, therefore, can have a significant impact on CAUTI by being mindful about catheter use and catheter management.” Dr. Sampathkumar says.

References

1. Sampathkumar P, Barth JW, Johnson M, et al. Mayo Clinic reduces catheter-associated urinary tract infections. Jt Comm J Qual Patient Saf. 2016;42(6):254-265.
2. Catheter-associated urinary tract infections (CAUTI). Centers for Disease Control and Prevention website. Accessed August 8, 2016.

Plasmodium sporozoite

Image courtesy of Ute

Frevert and Margaret Shear

A synthetic version of the protein PD-L2 can treat malaria in mice and protect them from re-infection, according to researchers.

The team’s experiments indicated that PD-L2 determines the severity of malaria infection and is essential for CD4+ T-cell immunity against malaria.

When the researchers administered soluble multimeric PD-L2 to mice, the animals were cured of severe malaria and protected from re-infection months later.

Michelle Wykes, DPhil, of QIMR Berghofer Medical Research Institute in Herston, Queensland, Australia, and her colleagues reported these results in Immunity.

The researchers noted that Plasmodium parasites exploit the interaction between PD-1 and PD-L1 to prevent T cells from fighting malaria, but the role of PD-L2 has not been clear.

With this study, the team found that PD-L2 regulates the PD-1—PD-L1 interaction and might therefore be used to treat malaria.

“We found that, when humans and mice are infected with severe malaria, levels of PD-L2 decrease, and so the T cells aren’t being told to keep fighting the parasites,” Dr Wykes explained.

“We don’t know how malaria manages to block the production of PD-L2. But once we knew how important this protein was for fighting the disease, we developed a synthetic version of it in the laboratory.”

The researchers gave 3 doses of this synthetic PD-L2 to mice that had been infected with a lethal dose of malaria.

“All of these mice were cured of the malaria,” Dr Wykes said. “About 5 months later, we re-infected the same mice with malaria parasites, but, this time, we didn’t give them any more of the synthetic protein. All of the mice were completely protected and didn’t become infected.”

Dr Wykes said these findings could form the basis for new ways to treat malaria in the future.

“[I]f this approach is successful, it should treat all species of malaria parasite,” she noted. “This would be a completely new way of treating malaria—by stimulating a person’s own immune system to destroy the parasites.”

Plasmodium sporozoite

Image courtesy of Ute

Frevert and Margaret Shear

A synthetic version of the protein PD-L2 can treat malaria in mice and protect them from re-infection, according to researchers.

The team’s experiments indicated that PD-L2 determines the severity of malaria infection and is essential for CD4+ T-cell immunity against malaria.

When the researchers administered soluble multimeric PD-L2 to mice, the animals were cured of severe malaria and protected from re-infection months later.

Michelle Wykes, DPhil, of QIMR Berghofer Medical Research Institute in Herston, Queensland, Australia, and her colleagues reported these results in Immunity.

The researchers noted that Plasmodium parasites exploit the interaction between PD-1 and PD-L1 to prevent T cells from fighting malaria, but the role of PD-L2 has not been clear.

With this study, the team found that PD-L2 regulates the PD-1—PD-L1 interaction and might therefore be used to treat malaria.

“We found that, when humans and mice are infected with severe malaria, levels of PD-L2 decrease, and so the T cells aren’t being told to keep fighting the parasites,” Dr Wykes explained.

“We don’t know how malaria manages to block the production of PD-L2. But once we knew how important this protein was for fighting the disease, we developed a synthetic version of it in the laboratory.”

The researchers gave 3 doses of this synthetic PD-L2 to mice that had been infected with a lethal dose of malaria.

“All of these mice were cured of the malaria,” Dr Wykes said. “About 5 months later, we re-infected the same mice with malaria parasites, but, this time, we didn’t give them any more of the synthetic protein. All of the mice were completely protected and didn’t become infected.”

Dr Wykes said these findings could form the basis for new ways to treat malaria in the future.

“[I]f this approach is successful, it should treat all species of malaria parasite,” she noted. “This would be a completely new way of treating malaria—by stimulating a person’s own immune system to destroy the parasites.”

Plasmodium sporozoite

Image courtesy of Ute

Frevert and Margaret Shear

A synthetic version of the protein PD-L2 can treat malaria in mice and protect them from re-infection, according to researchers.

The team’s experiments indicated that PD-L2 determines the severity of malaria infection and is essential for CD4+ T-cell immunity against malaria.

When the researchers administered soluble multimeric PD-L2 to mice, the animals were cured of severe malaria and protected from re-infection months later.

Michelle Wykes, DPhil, of QIMR Berghofer Medical Research Institute in Herston, Queensland, Australia, and her colleagues reported these results in Immunity.

The researchers noted that Plasmodium parasites exploit the interaction between PD-1 and PD-L1 to prevent T cells from fighting malaria, but the role of PD-L2 has not been clear.

With this study, the team found that PD-L2 regulates the PD-1—PD-L1 interaction and might therefore be used to treat malaria.

“We found that, when humans and mice are infected with severe malaria, levels of PD-L2 decrease, and so the T cells aren’t being told to keep fighting the parasites,” Dr Wykes explained.

“We don’t know how malaria manages to block the production of PD-L2. But once we knew how important this protein was for fighting the disease, we developed a synthetic version of it in the laboratory.”

The researchers gave 3 doses of this synthetic PD-L2 to mice that had been infected with a lethal dose of malaria.

“All of these mice were cured of the malaria,” Dr Wykes said. “About 5 months later, we re-infected the same mice with malaria parasites, but, this time, we didn’t give them any more of the synthetic protein. All of the mice were completely protected and didn’t become infected.”

Dr Wykes said these findings could form the basis for new ways to treat malaria in the future.

“[I]f this approach is successful, it should treat all species of malaria parasite,” she noted. “This would be a completely new way of treating malaria—by stimulating a person’s own immune system to destroy the parasites.”

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new study suggests cancer survivors and the general population have comparable sex lives, although cancer survivors don’t realize it.

According to a survey of more than 6500 people, cancer survivors over the age of 49 have just as much sex and similar levels of sexual function as individuals of the same age who never had cancer.

However, the cancer survivors were more likely to report being dissatisfied with their sex lives.

“We hope our findings will put cancer survivors’ concerns to rest—showing that they are just as sexually active and function just as well as others their age,” said Sarah Jackson, PhD, of University College London in the UK.

“The next stage of our research will look at why cancer patients feel less satisfied with their sex lives.”

Dr Jackson and her colleagues reported their current findings in Cancer.

The researchers set out to explore differences in sexual activity and function, as well as concerns about sex, between cancer survivors and cancer-free controls in a population-based study.

The team surveyed 3708 women (341 cancer survivors and 3367 controls) and 2982 men (220 cancer survivors and 2762 controls) aged 50 and older. Male and female cancer survivors were significantly older than controls (P<0.001 for both) and reported more comorbidities (P=0.003 for both).

Frequency

There were no significant differences in levels of sexual activity between cancer survivors and controls of either sex.

Among women, 58.2% of cancer survivors and 55.5% of controls reported having any sexual activity in the last year. Among men, the rates were 76.0% and 78.5%, respectively.

Overall, about half of the people surveyed reported having “frequent” sexual intercourse, which was defined as 2 to 3 times a month or more.

This included 49.1% of female cancer survivors, 50.1% of female controls, 49% of male cancer survivors, and 48% of male controls.

Function

The incidence of sexual problems was similar in cancer survivors and controls—both male and female.

For example, around a third of the women said they had problems becoming aroused (31.4% of cancer survivors and 31.8% of controls), and about 40% of the men had erectile dysfunction (40.3% of cancer survivors and 39.3% of controls).

Satisfaction

Despite similar levels of sexual activity and function, cancer survivors were more likely than controls to report feeling dissatisfied with their sex lives.

Among the women, 18.2% of cancer survivors and 11.8% of controls reported dissatisfaction (P=0.034). Among the men, the rates were 30.9% and 19.8%, respectively (P=0.023).

In addition, female cancer survivors were more likely to be concerned about their libido than female controls—10.2% and 7.1%, respectively (P=0.006). But there was no significant difference for the men.

Time from cancer diagnosis

The researchers also found the amount of time from cancer diagnosis was a factor affecting sexual function and concern among women but not men.

Females diagnosed with cancer less than 5 years from the time they were surveyed were more likely than female controls to report difficulty becoming aroused (55.4% and 31.8%, respectively, P=0.016) and achieving orgasm (60.6% and 28.3%, respectively, P<0.001).

The recently diagnosed females were also more likely than controls to be concerned about sexual desire (14.8% and 7.1%, respectively, P=0.007) and orgasmic experience (17.6% and 7.1%, respectively, P=0.042).

“Although some cancer treatments are known to impact on sexual function, this study suggests that the majority of cancer patients have similar sexual function and activity as the general population,” said Martin Ledwick, of Cancer Research UK, which sponsored this study.

“However, cancer patients in the study were more likely to be dissatisfied with their sex lives . . . . This highlights the need for health professionals to make sure they talk about sex with all patients—not just the ones whose sexual function is likely to be affected by their cancer or its treatment.”

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new study suggests cancer survivors and the general population have comparable sex lives, although cancer survivors don’t realize it.

According to a survey of more than 6500 people, cancer survivors over the age of 49 have just as much sex and similar levels of sexual function as individuals of the same age who never had cancer.

However, the cancer survivors were more likely to report being dissatisfied with their sex lives.

“We hope our findings will put cancer survivors’ concerns to rest—showing that they are just as sexually active and function just as well as others their age,” said Sarah Jackson, PhD, of University College London in the UK.

“The next stage of our research will look at why cancer patients feel less satisfied with their sex lives.”

Dr Jackson and her colleagues reported their current findings in Cancer.

The researchers set out to explore differences in sexual activity and function, as well as concerns about sex, between cancer survivors and cancer-free controls in a population-based study.

The team surveyed 3708 women (341 cancer survivors and 3367 controls) and 2982 men (220 cancer survivors and 2762 controls) aged 50 and older. Male and female cancer survivors were significantly older than controls (P<0.001 for both) and reported more comorbidities (P=0.003 for both).

Frequency

There were no significant differences in levels of sexual activity between cancer survivors and controls of either sex.

Among women, 58.2% of cancer survivors and 55.5% of controls reported having any sexual activity in the last year. Among men, the rates were 76.0% and 78.5%, respectively.

Overall, about half of the people surveyed reported having “frequent” sexual intercourse, which was defined as 2 to 3 times a month or more.

This included 49.1% of female cancer survivors, 50.1% of female controls, 49% of male cancer survivors, and 48% of male controls.

Function

The incidence of sexual problems was similar in cancer survivors and controls—both male and female.

For example, around a third of the women said they had problems becoming aroused (31.4% of cancer survivors and 31.8% of controls), and about 40% of the men had erectile dysfunction (40.3% of cancer survivors and 39.3% of controls).

Satisfaction

Despite similar levels of sexual activity and function, cancer survivors were more likely than controls to report feeling dissatisfied with their sex lives.

Among the women, 18.2% of cancer survivors and 11.8% of controls reported dissatisfaction (P=0.034). Among the men, the rates were 30.9% and 19.8%, respectively (P=0.023).

In addition, female cancer survivors were more likely to be concerned about their libido than female controls—10.2% and 7.1%, respectively (P=0.006). But there was no significant difference for the men.

Time from cancer diagnosis

The researchers also found the amount of time from cancer diagnosis was a factor affecting sexual function and concern among women but not men.

Females diagnosed with cancer less than 5 years from the time they were surveyed were more likely than female controls to report difficulty becoming aroused (55.4% and 31.8%, respectively, P=0.016) and achieving orgasm (60.6% and 28.3%, respectively, P<0.001).

The recently diagnosed females were also more likely than controls to be concerned about sexual desire (14.8% and 7.1%, respectively, P=0.007) and orgasmic experience (17.6% and 7.1%, respectively, P=0.042).

“Although some cancer treatments are known to impact on sexual function, this study suggests that the majority of cancer patients have similar sexual function and activity as the general population,” said Martin Ledwick, of Cancer Research UK, which sponsored this study.

“However, cancer patients in the study were more likely to be dissatisfied with their sex lives . . . . This highlights the need for health professionals to make sure they talk about sex with all patients—not just the ones whose sexual function is likely to be affected by their cancer or its treatment.”

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new study suggests cancer survivors and the general population have comparable sex lives, although cancer survivors don’t realize it.

According to a survey of more than 6500 people, cancer survivors over the age of 49 have just as much sex and similar levels of sexual function as individuals of the same age who never had cancer.

However, the cancer survivors were more likely to report being dissatisfied with their sex lives.

“We hope our findings will put cancer survivors’ concerns to rest—showing that they are just as sexually active and function just as well as others their age,” said Sarah Jackson, PhD, of University College London in the UK.

“The next stage of our research will look at why cancer patients feel less satisfied with their sex lives.”

Dr Jackson and her colleagues reported their current findings in Cancer.

The researchers set out to explore differences in sexual activity and function, as well as concerns about sex, between cancer survivors and cancer-free controls in a population-based study.

The team surveyed 3708 women (341 cancer survivors and 3367 controls) and 2982 men (220 cancer survivors and 2762 controls) aged 50 and older. Male and female cancer survivors were significantly older than controls (P<0.001 for both) and reported more comorbidities (P=0.003 for both).

Frequency

There were no significant differences in levels of sexual activity between cancer survivors and controls of either sex.

Among women, 58.2% of cancer survivors and 55.5% of controls reported having any sexual activity in the last year. Among men, the rates were 76.0% and 78.5%, respectively.

Overall, about half of the people surveyed reported having “frequent” sexual intercourse, which was defined as 2 to 3 times a month or more.

This included 49.1% of female cancer survivors, 50.1% of female controls, 49% of male cancer survivors, and 48% of male controls.

Function

The incidence of sexual problems was similar in cancer survivors and controls—both male and female.

For example, around a third of the women said they had problems becoming aroused (31.4% of cancer survivors and 31.8% of controls), and about 40% of the men had erectile dysfunction (40.3% of cancer survivors and 39.3% of controls).

Satisfaction

Despite similar levels of sexual activity and function, cancer survivors were more likely than controls to report feeling dissatisfied with their sex lives.

Among the women, 18.2% of cancer survivors and 11.8% of controls reported dissatisfaction (P=0.034). Among the men, the rates were 30.9% and 19.8%, respectively (P=0.023).

In addition, female cancer survivors were more likely to be concerned about their libido than female controls—10.2% and 7.1%, respectively (P=0.006). But there was no significant difference for the men.

Time from cancer diagnosis

The researchers also found the amount of time from cancer diagnosis was a factor affecting sexual function and concern among women but not men.

Females diagnosed with cancer less than 5 years from the time they were surveyed were more likely than female controls to report difficulty becoming aroused (55.4% and 31.8%, respectively, P=0.016) and achieving orgasm (60.6% and 28.3%, respectively, P<0.001).

The recently diagnosed females were also more likely than controls to be concerned about sexual desire (14.8% and 7.1%, respectively, P=0.007) and orgasmic experience (17.6% and 7.1%, respectively, P=0.042).

“Although some cancer treatments are known to impact on sexual function, this study suggests that the majority of cancer patients have similar sexual function and activity as the general population,” said Martin Ledwick, of Cancer Research UK, which sponsored this study.

“However, cancer patients in the study were more likely to be dissatisfied with their sex lives . . . . This highlights the need for health professionals to make sure they talk about sex with all patients—not just the ones whose sexual function is likely to be affected by their cancer or its treatment.”

Red blood cells

Anemia may increase the risk of death in older adults who have had a stroke, according to research published in the Journal of the American Heart Association.

An initial analysis of more than 8000 patients showed that anemia was associated with a higher risk of death for up to 1 year following ischemic or hemorrhagic stroke.

A second analysis of nearly 30,000 patients suggested the risk of dying from ischemic stroke is about 2 times higher in patients with anemia than those without it, and the risk of death from hemorrhagic stroke is about 1.5 times higher in anemic patients.

“So there’s the potential for a much poorer outcome if somebody comes in with stroke and they’re also anemic,” said study author Phyo Myint, MD, of the University of Aberdeen in Scotland.

Dr Myint and his colleagues first examined data from the UK Regional Stroke Register. This included 8013 patients with an average age of 78 who were admitted to the hospital with acute stroke between 2003 and 2015.

The team assessed the impact of anemia and hemoglobin levels at admission on death at different time points—inpatient, 7 days, 14 days, 1 month, 3 months, 6 months, and 1 year after stroke.

Anemia was associated with higher odds of death at most of the time points examined. And elevated hemoglobin was associated with a higher risk of death, mainly within the first month.

In addition to analyzing data from the UK Regional Stroke Registry, the researchers systematically reviewed relevant literature published to date. They compiled data from 20 previous studies, increasing the study population to 29,943 stroke patients.

In analyzing these patients, the researchers found that anemia on admission was associated with an increased risk of mortality in both ischemic stroke and hemorrhagic stroke. The odds ratios were 1.97 and 1.46, respectively.

The researchers believe this study emphasizes the impact of anemia on stroke outcomes and the need for increased awareness and interventions for stroke patients with anemia.

“One example of an intervention might be treating the underlying causes of anemia, such as iron deficiency, which is common in this age group,” said study author Raphae Barlas, a medical student at the University of Aberdeen.

“As the study has convincingly demonstrated, anemia does worsen the outcome of stroke, so it is very important that we identify at-risk patients and optimize the management.”

Red blood cells

Anemia may increase the risk of death in older adults who have had a stroke, according to research published in the Journal of the American Heart Association.

An initial analysis of more than 8000 patients showed that anemia was associated with a higher risk of death for up to 1 year following ischemic or hemorrhagic stroke.

A second analysis of nearly 30,000 patients suggested the risk of dying from ischemic stroke is about 2 times higher in patients with anemia than those without it, and the risk of death from hemorrhagic stroke is about 1.5 times higher in anemic patients.

“So there’s the potential for a much poorer outcome if somebody comes in with stroke and they’re also anemic,” said study author Phyo Myint, MD, of the University of Aberdeen in Scotland.

Dr Myint and his colleagues first examined data from the UK Regional Stroke Register. This included 8013 patients with an average age of 78 who were admitted to the hospital with acute stroke between 2003 and 2015.

The team assessed the impact of anemia and hemoglobin levels at admission on death at different time points—inpatient, 7 days, 14 days, 1 month, 3 months, 6 months, and 1 year after stroke.

Anemia was associated with higher odds of death at most of the time points examined. And elevated hemoglobin was associated with a higher risk of death, mainly within the first month.

In addition to analyzing data from the UK Regional Stroke Registry, the researchers systematically reviewed relevant literature published to date. They compiled data from 20 previous studies, increasing the study population to 29,943 stroke patients.

In analyzing these patients, the researchers found that anemia on admission was associated with an increased risk of mortality in both ischemic stroke and hemorrhagic stroke. The odds ratios were 1.97 and 1.46, respectively.

The researchers believe this study emphasizes the impact of anemia on stroke outcomes and the need for increased awareness and interventions for stroke patients with anemia.

“One example of an intervention might be treating the underlying causes of anemia, such as iron deficiency, which is common in this age group,” said study author Raphae Barlas, a medical student at the University of Aberdeen.

“As the study has convincingly demonstrated, anemia does worsen the outcome of stroke, so it is very important that we identify at-risk patients and optimize the management.”

Red blood cells

Anemia may increase the risk of death in older adults who have had a stroke, according to research published in the Journal of the American Heart Association.

An initial analysis of more than 8000 patients showed that anemia was associated with a higher risk of death for up to 1 year following ischemic or hemorrhagic stroke.

A second analysis of nearly 30,000 patients suggested the risk of dying from ischemic stroke is about 2 times higher in patients with anemia than those without it, and the risk of death from hemorrhagic stroke is about 1.5 times higher in anemic patients.

“So there’s the potential for a much poorer outcome if somebody comes in with stroke and they’re also anemic,” said study author Phyo Myint, MD, of the University of Aberdeen in Scotland.

Dr Myint and his colleagues first examined data from the UK Regional Stroke Register. This included 8013 patients with an average age of 78 who were admitted to the hospital with acute stroke between 2003 and 2015.

The team assessed the impact of anemia and hemoglobin levels at admission on death at different time points—inpatient, 7 days, 14 days, 1 month, 3 months, 6 months, and 1 year after stroke.

Anemia was associated with higher odds of death at most of the time points examined. And elevated hemoglobin was associated with a higher risk of death, mainly within the first month.

In addition to analyzing data from the UK Regional Stroke Registry, the researchers systematically reviewed relevant literature published to date. They compiled data from 20 previous studies, increasing the study population to 29,943 stroke patients.

In analyzing these patients, the researchers found that anemia on admission was associated with an increased risk of mortality in both ischemic stroke and hemorrhagic stroke. The odds ratios were 1.97 and 1.46, respectively.

The researchers believe this study emphasizes the impact of anemia on stroke outcomes and the need for increased awareness and interventions for stroke patients with anemia.

“One example of an intervention might be treating the underlying causes of anemia, such as iron deficiency, which is common in this age group,” said study author Raphae Barlas, a medical student at the University of Aberdeen.

“As the study has convincingly demonstrated, anemia does worsen the outcome of stroke, so it is very important that we identify at-risk patients and optimize the management.”

Woman listening to music

Photo by Lars Frantzen

Results of a systematic review suggest music can help alleviate symptoms of anxiety, pain, and fatigue in cancer patients.

The review included more than 50 studies investigating the impact of music therapy—a personalized music experience offered by trained music therapists—and music medicine—listening to pre-recorded music provided by a doctor or nurse—on psychological and physical outcomes in people with cancer.

“We found that music therapy interventions specifically help improve patients’ quality of life,” said study author Joke Bradt, PhD, of Drexel University in Philadelphia, Pennsylvania.

“These are important findings, as these outcomes play an important role in patients’ overall well-being.”

Dr Bradt and her colleagues reported their findings in Cochrane Database of Systematic Reviews.

The researchers examined 52 trials including 3731 cancer patients. The music interventions were classified as music therapy in 23 of the trials and as music medicine in 29 trials.

Analyses suggested that both types of music interventions positively impacted patients. The interventions had a moderate-to-strong effect on anxiety, a strong effect on pain reduction, and a small-to-moderate effect on fatigue.

Small reductions in heart and respiratory rates, as well as lowered blood pressure, were linked to the interventions as well.

In addition, the researchers observed a moderate increase in patients’ quality of life with music therapy but not music medicine.

The team could not determine the effect of music interventions on depression due to the low quality of evidence. And there was no evidence that the interventions improve mood, distress, or physical functioning, but there were few trials investigating these outcomes.

Similarly, the researchers said they could not draw any conclusions about the effect of music interventions on immunologic functioning, coping, resilience, or communication because there were not enough trials evaluating these outcomes.

Still, the researchers hope music interventions will become more widely used, in light of the potential benefits to cancer patients.

“We hope that the findings of this review will encourage healthcare providers in medical settings to seriously consider the use of music therapy in the psychosocial care of people with cancer,” Dr Bradt said.

Woman listening to music

Photo by Lars Frantzen

Results of a systematic review suggest music can help alleviate symptoms of anxiety, pain, and fatigue in cancer patients.

The review included more than 50 studies investigating the impact of music therapy—a personalized music experience offered by trained music therapists—and music medicine—listening to pre-recorded music provided by a doctor or nurse—on psychological and physical outcomes in people with cancer.

“We found that music therapy interventions specifically help improve patients’ quality of life,” said study author Joke Bradt, PhD, of Drexel University in Philadelphia, Pennsylvania.

“These are important findings, as these outcomes play an important role in patients’ overall well-being.”

Dr Bradt and her colleagues reported their findings in Cochrane Database of Systematic Reviews.

The researchers examined 52 trials including 3731 cancer patients. The music interventions were classified as music therapy in 23 of the trials and as music medicine in 29 trials.

Analyses suggested that both types of music interventions positively impacted patients. The interventions had a moderate-to-strong effect on anxiety, a strong effect on pain reduction, and a small-to-moderate effect on fatigue.

Small reductions in heart and respiratory rates, as well as lowered blood pressure, were linked to the interventions as well.

In addition, the researchers observed a moderate increase in patients’ quality of life with music therapy but not music medicine.

The team could not determine the effect of music interventions on depression due to the low quality of evidence. And there was no evidence that the interventions improve mood, distress, or physical functioning, but there were few trials investigating these outcomes.

Similarly, the researchers said they could not draw any conclusions about the effect of music interventions on immunologic functioning, coping, resilience, or communication because there were not enough trials evaluating these outcomes.

Still, the researchers hope music interventions will become more widely used, in light of the potential benefits to cancer patients.

“We hope that the findings of this review will encourage healthcare providers in medical settings to seriously consider the use of music therapy in the psychosocial care of people with cancer,” Dr Bradt said.

Woman listening to music

Photo by Lars Frantzen

Results of a systematic review suggest music can help alleviate symptoms of anxiety, pain, and fatigue in cancer patients.

The review included more than 50 studies investigating the impact of music therapy—a personalized music experience offered by trained music therapists—and music medicine—listening to pre-recorded music provided by a doctor or nurse—on psychological and physical outcomes in people with cancer.

“We found that music therapy interventions specifically help improve patients’ quality of life,” said study author Joke Bradt, PhD, of Drexel University in Philadelphia, Pennsylvania.

“These are important findings, as these outcomes play an important role in patients’ overall well-being.”

Dr Bradt and her colleagues reported their findings in Cochrane Database of Systematic Reviews.

The researchers examined 52 trials including 3731 cancer patients. The music interventions were classified as music therapy in 23 of the trials and as music medicine in 29 trials.

Analyses suggested that both types of music interventions positively impacted patients. The interventions had a moderate-to-strong effect on anxiety, a strong effect on pain reduction, and a small-to-moderate effect on fatigue.

Small reductions in heart and respiratory rates, as well as lowered blood pressure, were linked to the interventions as well.

In addition, the researchers observed a moderate increase in patients’ quality of life with music therapy but not music medicine.

The team could not determine the effect of music interventions on depression due to the low quality of evidence. And there was no evidence that the interventions improve mood, distress, or physical functioning, but there were few trials investigating these outcomes.

Similarly, the researchers said they could not draw any conclusions about the effect of music interventions on immunologic functioning, coping, resilience, or communication because there were not enough trials evaluating these outcomes.

Still, the researchers hope music interventions will become more widely used, in light of the potential benefits to cancer patients.

“We hope that the findings of this review will encourage healthcare providers in medical settings to seriously consider the use of music therapy in the psychosocial care of people with cancer,” Dr Bradt said.

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.

A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.

©Ricardo Gaudêncio/News Farma

They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.

The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.

In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.

In the open-label extension phase of the study, treatment efficacy was similar.

The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.

The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.

Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.

A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.

©Ricardo Gaudêncio/News Farma

They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.

The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.

In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.

In the open-label extension phase of the study, treatment efficacy was similar.

The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.

The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.

Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.

A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.

©Ricardo Gaudêncio/News Farma

They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.

The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.

In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.

In the open-label extension phase of the study, treatment efficacy was similar.

The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.

The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.