U.S. physicians are not expecting to see improvements in health care costs and access in 2019, but most predict that the Affordable Care Act will make it through the year despite government efforts to defund it, according to a survey by health care market research company InCrowd.

Over 80% of the 200 physicians surveyed Dec. 20-22, 2018, said that it was somewhat or very unlikely that health care costs would improve over the course of this year, and almost 70% expressed those opinions regarding improved access to care. More than 70% said that the federal government will find ways to defund the ACA, but 60% believe that it will remain in place and almost 70% said that coverage for preexisting conditions will continue, InCrowd reported. A minority of respondents (45%) predicted that the quality of health care was very likely or somewhat likely to improve in 2019.

A number of other issues were covered in the survey: 71% of physicians predicted that children up to age 26 years will be able to stay on their parents’ coverage, 69% expect the insurance mandate to be eliminated, 58% believe that mental health coverage will be allowed, and 56% said that it is unlikely for more states to expand Medicaid, according to data from the 100 primary care physicians and 100 specialists who responded to the InCrowd MicroSurvey.

rfranki@mdedge.com

U.S. physicians are not expecting to see improvements in health care costs and access in 2019, but most predict that the Affordable Care Act will make it through the year despite government efforts to defund it, according to a survey by health care market research company InCrowd.

Over 80% of the 200 physicians surveyed Dec. 20-22, 2018, said that it was somewhat or very unlikely that health care costs would improve over the course of this year, and almost 70% expressed those opinions regarding improved access to care. More than 70% said that the federal government will find ways to defund the ACA, but 60% believe that it will remain in place and almost 70% said that coverage for preexisting conditions will continue, InCrowd reported. A minority of respondents (45%) predicted that the quality of health care was very likely or somewhat likely to improve in 2019.

A number of other issues were covered in the survey: 71% of physicians predicted that children up to age 26 years will be able to stay on their parents’ coverage, 69% expect the insurance mandate to be eliminated, 58% believe that mental health coverage will be allowed, and 56% said that it is unlikely for more states to expand Medicaid, according to data from the 100 primary care physicians and 100 specialists who responded to the InCrowd MicroSurvey.

rfranki@mdedge.com

U.S. physicians are not expecting to see improvements in health care costs and access in 2019, but most predict that the Affordable Care Act will make it through the year despite government efforts to defund it, according to a survey by health care market research company InCrowd.

Over 80% of the 200 physicians surveyed Dec. 20-22, 2018, said that it was somewhat or very unlikely that health care costs would improve over the course of this year, and almost 70% expressed those opinions regarding improved access to care. More than 70% said that the federal government will find ways to defund the ACA, but 60% believe that it will remain in place and almost 70% said that coverage for preexisting conditions will continue, InCrowd reported. A minority of respondents (45%) predicted that the quality of health care was very likely or somewhat likely to improve in 2019.

A number of other issues were covered in the survey: 71% of physicians predicted that children up to age 26 years will be able to stay on their parents’ coverage, 69% expect the insurance mandate to be eliminated, 58% believe that mental health coverage will be allowed, and 56% said that it is unlikely for more states to expand Medicaid, according to data from the 100 primary care physicians and 100 specialists who responded to the InCrowd MicroSurvey.

rfranki@mdedge.com

LAS VEGAS – Inflammatory bowel disease (IBD) can disrupt both fertility and pregnancy, especially if it’s not fully controlled, and there’s a risk that the condition can be passed onto an unborn child. Still a new study suggests many patients with IBD don’t receive appropriate reproductive counseling.

Nearly two-thirds of 100 patients surveyed at a single center reported that no physician had talked to them about reproductive topics, and some said they’d considered not having children because of the condition. “Really fundamental subjects have not made their way into the interactions between patients and their care teams,” coauthor and gastroenterologist Sarah Streett, MD, AGAF, of Stanford (Calif.) University, said in an interview before the study was presented at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

IBD can lower fertility in both sexes and boost complications in pregnancy. “The good news is that almost all the medications used for IBD appear safe,” Dr. Streett said. “In fact, the safety risks for the baby and the pregnancy revolve around not having IBD under good control.”

Unfortunately, she said, misinformation is common. “Patients who become pregnant or are trying to become pregnant, and are worried about potential harm to the baby, will stop the medications due to incorrect information. Or they’ll be told by their health care team to stop their medications.”

Dr. Streett and study lead author Aarti Rao, MD, a gastroenterology fellow at Stanford, launched their study of IBD clinic patients to gain more understanding about patient knowledge. “We know from research already published that those with IBD have a lot of concerns about starting families and don’t have a lot of information to base their decision making on,” Dr. Streett said. “We wanted to evaluate that in our population and see how much people knew and what the need was.”

In 2018 and 2019, Dr. Streett and Dr. Rao gave an anonymous, validated 17-question survey to patients aged 18-45 with IBD. One hundred patients responded (median age = 30, 54% female, 59% white, 66% with incomes over $100,000, 52% with ulcerative colitis, 21% with prior IBD surgery, 71% with prior IBD hospitalization).

©Stuart Jenner/Thinkstock

With proper planning, care and coordination among treating health care providers via a multidisciplinary approach, women with IBD can have healthy pregnancies and healthy babies. Learn more at www.IBDParenthoodProject.org. 

SOURCE: Rao A et al. Crohn’s & Colitis Congress, Abstract P009.

LAS VEGAS – Inflammatory bowel disease (IBD) can disrupt both fertility and pregnancy, especially if it’s not fully controlled, and there’s a risk that the condition can be passed onto an unborn child. Still a new study suggests many patients with IBD don’t receive appropriate reproductive counseling.

Nearly two-thirds of 100 patients surveyed at a single center reported that no physician had talked to them about reproductive topics, and some said they’d considered not having children because of the condition. “Really fundamental subjects have not made their way into the interactions between patients and their care teams,” coauthor and gastroenterologist Sarah Streett, MD, AGAF, of Stanford (Calif.) University, said in an interview before the study was presented at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

IBD can lower fertility in both sexes and boost complications in pregnancy. “The good news is that almost all the medications used for IBD appear safe,” Dr. Streett said. “In fact, the safety risks for the baby and the pregnancy revolve around not having IBD under good control.”

Unfortunately, she said, misinformation is common. “Patients who become pregnant or are trying to become pregnant, and are worried about potential harm to the baby, will stop the medications due to incorrect information. Or they’ll be told by their health care team to stop their medications.”

Dr. Streett and study lead author Aarti Rao, MD, a gastroenterology fellow at Stanford, launched their study of IBD clinic patients to gain more understanding about patient knowledge. “We know from research already published that those with IBD have a lot of concerns about starting families and don’t have a lot of information to base their decision making on,” Dr. Streett said. “We wanted to evaluate that in our population and see how much people knew and what the need was.”

In 2018 and 2019, Dr. Streett and Dr. Rao gave an anonymous, validated 17-question survey to patients aged 18-45 with IBD. One hundred patients responded (median age = 30, 54% female, 59% white, 66% with incomes over $100,000, 52% with ulcerative colitis, 21% with prior IBD surgery, 71% with prior IBD hospitalization).

©Stuart Jenner/Thinkstock

With proper planning, care and coordination among treating health care providers via a multidisciplinary approach, women with IBD can have healthy pregnancies and healthy babies. Learn more at www.IBDParenthoodProject.org. 

SOURCE: Rao A et al. Crohn’s & Colitis Congress, Abstract P009.

LAS VEGAS – Inflammatory bowel disease (IBD) can disrupt both fertility and pregnancy, especially if it’s not fully controlled, and there’s a risk that the condition can be passed onto an unborn child. Still a new study suggests many patients with IBD don’t receive appropriate reproductive counseling.

Nearly two-thirds of 100 patients surveyed at a single center reported that no physician had talked to them about reproductive topics, and some said they’d considered not having children because of the condition. “Really fundamental subjects have not made their way into the interactions between patients and their care teams,” coauthor and gastroenterologist Sarah Streett, MD, AGAF, of Stanford (Calif.) University, said in an interview before the study was presented at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

IBD can lower fertility in both sexes and boost complications in pregnancy. “The good news is that almost all the medications used for IBD appear safe,” Dr. Streett said. “In fact, the safety risks for the baby and the pregnancy revolve around not having IBD under good control.”

Unfortunately, she said, misinformation is common. “Patients who become pregnant or are trying to become pregnant, and are worried about potential harm to the baby, will stop the medications due to incorrect information. Or they’ll be told by their health care team to stop their medications.”

Dr. Streett and study lead author Aarti Rao, MD, a gastroenterology fellow at Stanford, launched their study of IBD clinic patients to gain more understanding about patient knowledge. “We know from research already published that those with IBD have a lot of concerns about starting families and don’t have a lot of information to base their decision making on,” Dr. Streett said. “We wanted to evaluate that in our population and see how much people knew and what the need was.”

In 2018 and 2019, Dr. Streett and Dr. Rao gave an anonymous, validated 17-question survey to patients aged 18-45 with IBD. One hundred patients responded (median age = 30, 54% female, 59% white, 66% with incomes over $100,000, 52% with ulcerative colitis, 21% with prior IBD surgery, 71% with prior IBD hospitalization).

©Stuart Jenner/Thinkstock

With proper planning, care and coordination among treating health care providers via a multidisciplinary approach, women with IBD can have healthy pregnancies and healthy babies. Learn more at www.IBDParenthoodProject.org. 

SOURCE: Rao A et al. Crohn’s & Colitis Congress, Abstract P009.

Our “Vascular Spectacular” VAM Gala will be held Friday, June 14, at the Gaylord National Resort & Convention Center in National Harbor, Md., site of our Vascular Annual Meeting. The event will be highlighted by both live and silent auctions. Anyone can participate in the Silent Auction, with bidding all done online. Tickets are $250 each, $150 of which is a tax-deductible donation. All proceeds will directly benefit the SVS Foundation and enable us to make greater progress in the fight against vascular diseases and improving patient care. For more information, contact SVS Development Manager Linda Maraba at 312-334-2352 or lmaraba@vascularsociety.org. 

Our “Vascular Spectacular” VAM Gala will be held Friday, June 14, at the Gaylord National Resort & Convention Center in National Harbor, Md., site of our Vascular Annual Meeting. The event will be highlighted by both live and silent auctions. Anyone can participate in the Silent Auction, with bidding all done online. Tickets are $250 each, $150 of which is a tax-deductible donation. All proceeds will directly benefit the SVS Foundation and enable us to make greater progress in the fight against vascular diseases and improving patient care. For more information, contact SVS Development Manager Linda Maraba at 312-334-2352 or lmaraba@vascularsociety.org. 

Our “Vascular Spectacular” VAM Gala will be held Friday, June 14, at the Gaylord National Resort & Convention Center in National Harbor, Md., site of our Vascular Annual Meeting. The event will be highlighted by both live and silent auctions. Anyone can participate in the Silent Auction, with bidding all done online. Tickets are $250 each, $150 of which is a tax-deductible donation. All proceeds will directly benefit the SVS Foundation and enable us to make greater progress in the fight against vascular diseases and improving patient care. For more information, contact SVS Development Manager Linda Maraba at 312-334-2352 or lmaraba@vascularsociety.org. 

The SVS Foundation has announced that its patient fliers project is completed, and fliers are now available free to members. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.

The SVS Foundation has announced that its patient fliers project is completed, and fliers are now available free to members. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.

The SVS Foundation has announced that its patient fliers project is completed, and fliers are now available free to members. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.

The antifibrinolytic drug tranexamic acid appears to significantly improve quality of life for young women who experience heavy menstrual bleeding, new research suggests.

Writing in the Journal of Pediatric & Adolescent Gynecology, Sarah H. O’Brien, MD, from Nationwide Children’s Hospital and the Ohio State University, both in Columbus, and her coauthors presented the results of an open-label efficacy study of the competitive plasminogen inhibitor in 25 adolescent girls aged 10-19 years who attended pediatric hematology clinics for evaluation or management of heavy menstrual bleeding. The study participants were instructed to take 1,300 mg of tranexamic acid (two tablets) three times a day for up to 5 days during their monthly menstruation for three cycles.

The study found a significant improvement in mean menstrual impact questionnaire (MIQ) scores, which improved from a mean of 3 at baseline to 1.91 (P less than .001). Two-thirds of patients reported at least a one-point improvement from baseline, and all reported that this was clinically meaningful. At baseline, 84% of patients reported heavy to very heavy blood loss, but this decreased to 23% after treatment with tranexamic acid (P less than .001).

The study population included ten individuals (40%) with bleeding disorders. However, the researchers did not see a significant difference in response between those with bleeding disorders and those without.

While the treatment did not significantly affect school attendance (only 24% reported that their heavy bleeding limited school attendance), researchers did see a significant improvement in limitations on physical activities and on social and leisure activities. Patients who reported at baseline that their menstrual bleeding significantly affected their social and leisure activities had an average score improvement of 1.74, a greater than or equal to one point improvement. Participants also reported significant improvements in their Pictorial Blood Assessment Chart scores, which dropped from an average of 255 to 155 (P less than .001).

The treatment did not show any significant effects on hemoglobin or ferritin. The most common adverse events were sinonasal symptoms, such as nasal congestion, headache, and sinus pain, but no thrombotic or ocular adverse events were seen.

Dr. O’Brien and her coauthors wrote that one limitation of their study was using the MIQ score as their primary endpoint as opposed to a more objective measure, such as change in measured blood loss.

“However, a major factor that motivates patients with heavy menstrual bleeding to seek medical care is the negative impact of heavy menstrual bleeding on daily life,” they wrote.

The study drug was supplied by Ferring pharmaceuticals, and the study was supported by the Hemostasis and Thrombosis Research Society. One author disclosed receiving the Joan Fellowship in Pediatric Hemostasis and Thrombosis at Nationwide Children’s Hospital; no other authors said they had relevant financial disclosures.

SOURCE: O’Brien SH et al. J Pediatr Adol Gynec. 2019 Feb 4. doi: 10.1016/j.jpag.2019.01.009.

The antifibrinolytic drug tranexamic acid appears to significantly improve quality of life for young women who experience heavy menstrual bleeding, new research suggests.

Writing in the Journal of Pediatric & Adolescent Gynecology, Sarah H. O’Brien, MD, from Nationwide Children’s Hospital and the Ohio State University, both in Columbus, and her coauthors presented the results of an open-label efficacy study of the competitive plasminogen inhibitor in 25 adolescent girls aged 10-19 years who attended pediatric hematology clinics for evaluation or management of heavy menstrual bleeding. The study participants were instructed to take 1,300 mg of tranexamic acid (two tablets) three times a day for up to 5 days during their monthly menstruation for three cycles.

The study found a significant improvement in mean menstrual impact questionnaire (MIQ) scores, which improved from a mean of 3 at baseline to 1.91 (P less than .001). Two-thirds of patients reported at least a one-point improvement from baseline, and all reported that this was clinically meaningful. At baseline, 84% of patients reported heavy to very heavy blood loss, but this decreased to 23% after treatment with tranexamic acid (P less than .001).

The study population included ten individuals (40%) with bleeding disorders. However, the researchers did not see a significant difference in response between those with bleeding disorders and those without.

While the treatment did not significantly affect school attendance (only 24% reported that their heavy bleeding limited school attendance), researchers did see a significant improvement in limitations on physical activities and on social and leisure activities. Patients who reported at baseline that their menstrual bleeding significantly affected their social and leisure activities had an average score improvement of 1.74, a greater than or equal to one point improvement. Participants also reported significant improvements in their Pictorial Blood Assessment Chart scores, which dropped from an average of 255 to 155 (P less than .001).

The treatment did not show any significant effects on hemoglobin or ferritin. The most common adverse events were sinonasal symptoms, such as nasal congestion, headache, and sinus pain, but no thrombotic or ocular adverse events were seen.

Dr. O’Brien and her coauthors wrote that one limitation of their study was using the MIQ score as their primary endpoint as opposed to a more objective measure, such as change in measured blood loss.

“However, a major factor that motivates patients with heavy menstrual bleeding to seek medical care is the negative impact of heavy menstrual bleeding on daily life,” they wrote.

The study drug was supplied by Ferring pharmaceuticals, and the study was supported by the Hemostasis and Thrombosis Research Society. One author disclosed receiving the Joan Fellowship in Pediatric Hemostasis and Thrombosis at Nationwide Children’s Hospital; no other authors said they had relevant financial disclosures.

SOURCE: O’Brien SH et al. J Pediatr Adol Gynec. 2019 Feb 4. doi: 10.1016/j.jpag.2019.01.009.

The antifibrinolytic drug tranexamic acid appears to significantly improve quality of life for young women who experience heavy menstrual bleeding, new research suggests.

Writing in the Journal of Pediatric & Adolescent Gynecology, Sarah H. O’Brien, MD, from Nationwide Children’s Hospital and the Ohio State University, both in Columbus, and her coauthors presented the results of an open-label efficacy study of the competitive plasminogen inhibitor in 25 adolescent girls aged 10-19 years who attended pediatric hematology clinics for evaluation or management of heavy menstrual bleeding. The study participants were instructed to take 1,300 mg of tranexamic acid (two tablets) three times a day for up to 5 days during their monthly menstruation for three cycles.

The study found a significant improvement in mean menstrual impact questionnaire (MIQ) scores, which improved from a mean of 3 at baseline to 1.91 (P less than .001). Two-thirds of patients reported at least a one-point improvement from baseline, and all reported that this was clinically meaningful. At baseline, 84% of patients reported heavy to very heavy blood loss, but this decreased to 23% after treatment with tranexamic acid (P less than .001).

The study population included ten individuals (40%) with bleeding disorders. However, the researchers did not see a significant difference in response between those with bleeding disorders and those without.

While the treatment did not significantly affect school attendance (only 24% reported that their heavy bleeding limited school attendance), researchers did see a significant improvement in limitations on physical activities and on social and leisure activities. Patients who reported at baseline that their menstrual bleeding significantly affected their social and leisure activities had an average score improvement of 1.74, a greater than or equal to one point improvement. Participants also reported significant improvements in their Pictorial Blood Assessment Chart scores, which dropped from an average of 255 to 155 (P less than .001).

The treatment did not show any significant effects on hemoglobin or ferritin. The most common adverse events were sinonasal symptoms, such as nasal congestion, headache, and sinus pain, but no thrombotic or ocular adverse events were seen.

Dr. O’Brien and her coauthors wrote that one limitation of their study was using the MIQ score as their primary endpoint as opposed to a more objective measure, such as change in measured blood loss.

“However, a major factor that motivates patients with heavy menstrual bleeding to seek medical care is the negative impact of heavy menstrual bleeding on daily life,” they wrote.

The study drug was supplied by Ferring pharmaceuticals, and the study was supported by the Hemostasis and Thrombosis Research Society. One author disclosed receiving the Joan Fellowship in Pediatric Hemostasis and Thrombosis at Nationwide Children’s Hospital; no other authors said they had relevant financial disclosures.

SOURCE: O’Brien SH et al. J Pediatr Adol Gynec. 2019 Feb 4. doi: 10.1016/j.jpag.2019.01.009.

WASHINGTON – Addressing issues related to step therapy and adapting the Stark Law for a value-based care environment are on the Department of Health & Human Service’s agenda this year, according to agency Secretary Alex M. Azar II.

Gregory Twachtman/MDedge News

Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.

“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.

“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”

The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.

“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”

He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.

Secretary Azar did not offer any timelines or other more specific details about how the agency plans to tackle these issues.

He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.

“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”

He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”

However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.

Secretary Azar did not acknowledge any mandatory participation in his pitch for support, noting that CMMI models “are carefully assessed. We will closely monitor how the model will affect clinical outcomes, including patients’ adherence to their drugs. We believe that the lower costs will, of course, mean better patient access to drugs, better adherence, and better outcomes for the care you provide. That is the goal.”

gtwachtman@mdedge.com

WASHINGTON – Addressing issues related to step therapy and adapting the Stark Law for a value-based care environment are on the Department of Health & Human Service’s agenda this year, according to agency Secretary Alex M. Azar II.

Gregory Twachtman/MDedge News

Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.

“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.

“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”

The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.

“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”

He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.

Secretary Azar did not offer any timelines or other more specific details about how the agency plans to tackle these issues.

He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.

“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”

He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”

However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.

Secretary Azar did not acknowledge any mandatory participation in his pitch for support, noting that CMMI models “are carefully assessed. We will closely monitor how the model will affect clinical outcomes, including patients’ adherence to their drugs. We believe that the lower costs will, of course, mean better patient access to drugs, better adherence, and better outcomes for the care you provide. That is the goal.”

gtwachtman@mdedge.com

WASHINGTON – Addressing issues related to step therapy and adapting the Stark Law for a value-based care environment are on the Department of Health & Human Service’s agenda this year, according to agency Secretary Alex M. Azar II.

Gregory Twachtman/MDedge News

Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.

“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.

“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”

The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.

“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”

He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.

Secretary Azar did not offer any timelines or other more specific details about how the agency plans to tackle these issues.

He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.

“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”

He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”

However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.

Secretary Azar did not acknowledge any mandatory participation in his pitch for support, noting that CMMI models “are carefully assessed. We will closely monitor how the model will affect clinical outcomes, including patients’ adherence to their drugs. We believe that the lower costs will, of course, mean better patient access to drugs, better adherence, and better outcomes for the care you provide. That is the goal.”

gtwachtman@mdedge.com

A decade ago, I gave my senior expert talk at the University of California, San Francisco, department of dermatology on skin care and brought up the controversial topic that sterile or clean skin is bad. At the time, I initiated the conversation on the microbiome and the importance of good bacteria in preserving the epidermal barrier of the skin, particularly with conditions such as atopic dermatitis. Today, I not only preach this message to my patients, but I also practice the “less-is-more” philosophy every day. It is my hope that this brief summary of the skin microbiome and the importance of skin bacteria will affect the development of the next generation of skin care products.

The normal human skin is a microbiome colonized by 10,000-1,000,000 bacteria units/cm² that prevent the growth of pathogenic organisms and maintain the immunity of the skin. The diversity and type of skin bacteria (that is, Staphylococcus or Propionibacterium acnes), as well as their concentration, varies by person, body location, and environment. Symbiotic with bacteria on the skin are yeasts, such as Malassezia, and parasites, such as Demodex. When the composition and diversity of microorganisms are disrupted, the skin can no longer protect its barrier functions, leading to pathogenic bacterial infections, altered skin pH, decreased production of antimicrobial peptides, and increased inflammation. The microbiome also serves to shield the skin from environmental stressors, such as free radicals, UV radiation, and pollution.

What can lead to disruption of our skin is hygiene. Over-washing; stripping of the skin with lathering cleaner; overexfoliation; long, hot showers; and the use of products with antibacterial properties have increased over the last 50 years, and so has skin disease. The removal of these microorganisms, either by overcleansing or with antibiotic use, disrupts the microflora and leads to pH-imbalanced and inflamed skin. Our microflora contains prebiotics, probiotics, and postbiotics. Prebiotics are the “fertilizer” or “food,” so to speak, that encourages these essential microorganisms to grow; probiotics are the microorganisms themselves; and postbiotics are the chemical byproducts of bacteria, such as antimicrobial peptides and fragments of dead bacterial cells that remain on the skin.

Skin care tailored to our unique microbiome is in its infancy. On the frontier of microflora-rich skin care are organisms like Bifidobacterium longum, which increases the skin’s resistance to temperature and product-related irritation. Streptococcus thermophilus has been shown to increase the production of ceramides in the skin, which could help atopic dermatitis. Lactobacillus paracasei has been shown to inhibit the neuropeptide substance P, which increases inflammation and oil production. Enterococcus faecalis, Streptococcus salivarius, and Lactobacillus plantarum have all been shown to decrease Propionibacterium acnes. Bacillus coagulans and Bifidobacterium breve have been shown to decrease free radicals and protect against UV rays.


Probiotic, prebiotic, and postbiotic skin care, however, does have its challenges. Probiotics are live bacteria, and thus need refrigeration. These products are also not intended for use in anyone who is immunosuppressed or neutropenic. Another complexity in the development of probiotic, prebiotic, and postbiotic skin care is that each person may have a different need in terms of their skin microflora and that microflora is inherently different in different body parts. Furthermore, people with skin inflammation may require a different concentration or population of that flora.

Darryl Leja, NHGRI

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

References

Al-Ghazzewi F et al. Benef Microbes. 2014 Jun 1;5(2):99-107.

Baquerizo Nole K et al. J Am Acad Dermatol. 2014 Oct;71(4):814-21.

Chen Y et al. J Am Acad Dermatol. 2013 Jul;69(1):143-55.e3.

Grice E et al. Nat Rev Microbiol. 2011 Apr;9(4):244-53.

Kong H et al. J Invest Dermatol. 2012 Mar;132(3, part 2):933-9.

Hutkins R et al. Curr Opin Biotechnol. 2016 Feb;37:1-7.

Kober MM et al. Int J Womens Dermatol. 2015 Apr 6;1(2):85-9.

Maquire M. et al. Arch Dermatol Res. 2017 Aug;309(6):411-421.

Sugimoto S. et al. Photodermatol. Photoimmunol. Photomed. 2012 Dec;28(6): 312-9.
 

A decade ago, I gave my senior expert talk at the University of California, San Francisco, department of dermatology on skin care and brought up the controversial topic that sterile or clean skin is bad. At the time, I initiated the conversation on the microbiome and the importance of good bacteria in preserving the epidermal barrier of the skin, particularly with conditions such as atopic dermatitis. Today, I not only preach this message to my patients, but I also practice the “less-is-more” philosophy every day. It is my hope that this brief summary of the skin microbiome and the importance of skin bacteria will affect the development of the next generation of skin care products.

The normal human skin is a microbiome colonized by 10,000-1,000,000 bacteria units/cm² that prevent the growth of pathogenic organisms and maintain the immunity of the skin. The diversity and type of skin bacteria (that is, Staphylococcus or Propionibacterium acnes), as well as their concentration, varies by person, body location, and environment. Symbiotic with bacteria on the skin are yeasts, such as Malassezia, and parasites, such as Demodex. When the composition and diversity of microorganisms are disrupted, the skin can no longer protect its barrier functions, leading to pathogenic bacterial infections, altered skin pH, decreased production of antimicrobial peptides, and increased inflammation. The microbiome also serves to shield the skin from environmental stressors, such as free radicals, UV radiation, and pollution.

What can lead to disruption of our skin is hygiene. Over-washing; stripping of the skin with lathering cleaner; overexfoliation; long, hot showers; and the use of products with antibacterial properties have increased over the last 50 years, and so has skin disease. The removal of these microorganisms, either by overcleansing or with antibiotic use, disrupts the microflora and leads to pH-imbalanced and inflamed skin. Our microflora contains prebiotics, probiotics, and postbiotics. Prebiotics are the “fertilizer” or “food,” so to speak, that encourages these essential microorganisms to grow; probiotics are the microorganisms themselves; and postbiotics are the chemical byproducts of bacteria, such as antimicrobial peptides and fragments of dead bacterial cells that remain on the skin.

Skin care tailored to our unique microbiome is in its infancy. On the frontier of microflora-rich skin care are organisms like Bifidobacterium longum, which increases the skin’s resistance to temperature and product-related irritation. Streptococcus thermophilus has been shown to increase the production of ceramides in the skin, which could help atopic dermatitis. Lactobacillus paracasei has been shown to inhibit the neuropeptide substance P, which increases inflammation and oil production. Enterococcus faecalis, Streptococcus salivarius, and Lactobacillus plantarum have all been shown to decrease Propionibacterium acnes. Bacillus coagulans and Bifidobacterium breve have been shown to decrease free radicals and protect against UV rays.


Probiotic, prebiotic, and postbiotic skin care, however, does have its challenges. Probiotics are live bacteria, and thus need refrigeration. These products are also not intended for use in anyone who is immunosuppressed or neutropenic. Another complexity in the development of probiotic, prebiotic, and postbiotic skin care is that each person may have a different need in terms of their skin microflora and that microflora is inherently different in different body parts. Furthermore, people with skin inflammation may require a different concentration or population of that flora.

Darryl Leja, NHGRI

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

References

Al-Ghazzewi F et al. Benef Microbes. 2014 Jun 1;5(2):99-107.

Baquerizo Nole K et al. J Am Acad Dermatol. 2014 Oct;71(4):814-21.

Chen Y et al. J Am Acad Dermatol. 2013 Jul;69(1):143-55.e3.

Grice E et al. Nat Rev Microbiol. 2011 Apr;9(4):244-53.

Kong H et al. J Invest Dermatol. 2012 Mar;132(3, part 2):933-9.

Hutkins R et al. Curr Opin Biotechnol. 2016 Feb;37:1-7.

Kober MM et al. Int J Womens Dermatol. 2015 Apr 6;1(2):85-9.

Maquire M. et al. Arch Dermatol Res. 2017 Aug;309(6):411-421.

Sugimoto S. et al. Photodermatol. Photoimmunol. Photomed. 2012 Dec;28(6): 312-9.
 

A decade ago, I gave my senior expert talk at the University of California, San Francisco, department of dermatology on skin care and brought up the controversial topic that sterile or clean skin is bad. At the time, I initiated the conversation on the microbiome and the importance of good bacteria in preserving the epidermal barrier of the skin, particularly with conditions such as atopic dermatitis. Today, I not only preach this message to my patients, but I also practice the “less-is-more” philosophy every day. It is my hope that this brief summary of the skin microbiome and the importance of skin bacteria will affect the development of the next generation of skin care products.

The normal human skin is a microbiome colonized by 10,000-1,000,000 bacteria units/cm² that prevent the growth of pathogenic organisms and maintain the immunity of the skin. The diversity and type of skin bacteria (that is, Staphylococcus or Propionibacterium acnes), as well as their concentration, varies by person, body location, and environment. Symbiotic with bacteria on the skin are yeasts, such as Malassezia, and parasites, such as Demodex. When the composition and diversity of microorganisms are disrupted, the skin can no longer protect its barrier functions, leading to pathogenic bacterial infections, altered skin pH, decreased production of antimicrobial peptides, and increased inflammation. The microbiome also serves to shield the skin from environmental stressors, such as free radicals, UV radiation, and pollution.

What can lead to disruption of our skin is hygiene. Over-washing; stripping of the skin with lathering cleaner; overexfoliation; long, hot showers; and the use of products with antibacterial properties have increased over the last 50 years, and so has skin disease. The removal of these microorganisms, either by overcleansing or with antibiotic use, disrupts the microflora and leads to pH-imbalanced and inflamed skin. Our microflora contains prebiotics, probiotics, and postbiotics. Prebiotics are the “fertilizer” or “food,” so to speak, that encourages these essential microorganisms to grow; probiotics are the microorganisms themselves; and postbiotics are the chemical byproducts of bacteria, such as antimicrobial peptides and fragments of dead bacterial cells that remain on the skin.

Skin care tailored to our unique microbiome is in its infancy. On the frontier of microflora-rich skin care are organisms like Bifidobacterium longum, which increases the skin’s resistance to temperature and product-related irritation. Streptococcus thermophilus has been shown to increase the production of ceramides in the skin, which could help atopic dermatitis. Lactobacillus paracasei has been shown to inhibit the neuropeptide substance P, which increases inflammation and oil production. Enterococcus faecalis, Streptococcus salivarius, and Lactobacillus plantarum have all been shown to decrease Propionibacterium acnes. Bacillus coagulans and Bifidobacterium breve have been shown to decrease free radicals and protect against UV rays.


Probiotic, prebiotic, and postbiotic skin care, however, does have its challenges. Probiotics are live bacteria, and thus need refrigeration. These products are also not intended for use in anyone who is immunosuppressed or neutropenic. Another complexity in the development of probiotic, prebiotic, and postbiotic skin care is that each person may have a different need in terms of their skin microflora and that microflora is inherently different in different body parts. Furthermore, people with skin inflammation may require a different concentration or population of that flora.

Darryl Leja, NHGRI

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

References

Al-Ghazzewi F et al. Benef Microbes. 2014 Jun 1;5(2):99-107.

Baquerizo Nole K et al. J Am Acad Dermatol. 2014 Oct;71(4):814-21.

Chen Y et al. J Am Acad Dermatol. 2013 Jul;69(1):143-55.e3.

Grice E et al. Nat Rev Microbiol. 2011 Apr;9(4):244-53.

Kong H et al. J Invest Dermatol. 2012 Mar;132(3, part 2):933-9.

Hutkins R et al. Curr Opin Biotechnol. 2016 Feb;37:1-7.

Kober MM et al. Int J Womens Dermatol. 2015 Apr 6;1(2):85-9.

Maquire M. et al. Arch Dermatol Res. 2017 Aug;309(6):411-421.

Sugimoto S. et al. Photodermatol. Photoimmunol. Photomed. 2012 Dec;28(6): 312-9.
 

Patients with the aggressive skin cancer Merkel cell carcinoma who were treated with the immune checkpoint inhibitor pembrolizumab (Keytruda) in the first line had higher complete response rates, better progression-free survival, and longer overall survival than historical controls treated with cytotoxic chemotherapy.

Among 50 adults with advanced Merkel cell carcinoma (MCC) with no prior systemic therapy who received pembrolizumab 2 mg/kg every 3 weeks for up to 2 years in a phase 2 clinical trial (NCT02267603), 24% had a complete response and 32% a partial response, for an overall response rate of 56%.

The 24-month overall survival rate was 68.7%, with median overall survival not reached after a median follow-up time of 14.9 months. In contrast, a retrospective study of 67 patients with MCC treated with first-line chemotherapy showed an ORR of 29.4%, a median OS of 10.5 months, and a 24-month OS of 24.5% (Future Oncol. 2017 Aug;13(19):1699-1710).

Similarly, a second retrospective study showed that, among 62 patients treated with first-line chemotherapy, the ORR was 55%, median OS was 9.5 months, and 24-month OS was 20% (Cancer Med. 2016 Sep;5(9):2294-2301), reported Paul Nghiem, MD, PhD, from the University of Washington and Fred Hutchinson Cancer Research Center in Seattle, and his colleagues.

The rationale for using a checkpoint inhibitor for advanced MCC is that “[m]ultiple lines of evidence support the notion that MCC is an immunogenic cancer, including the fact that MCC incidence is greater than 10-fold higher in chronically immunosuppressed persons,” they wrote in the Journal of Clinical Oncology.

The current National Comprehensive Cancer Network guideline on Merkel cell carcinoma recommends the use of the programmed death–1/programmed death–ligand 1 (PD-1/PD-L1) inhibitors pembrolizumab, avelumab (Bavencio), or nivolumab (Opdivo) as preferred first-line systemic therapy for patients with disseminated disease, Dr. Nghiem and his colleagues noted.

In the current report, they presented data on the longest follow-up to date of patients with advance MCC who received a PD-1 inhibitor in the first line.

In the multicenter, phase 2 trial, 50 patients with a median age of 70.5 years were treated. Of this group, 64% had tumors positive for the Merkel cell polyomavirus and 49% had PD-L1 expression on tumor cells.

Of the 50 total patients, 28 had an objective response according to Response Evaluation Criteria in Solid Tumors version 1.1, including 12 with a complete response and 16 with a partial response. A total of 5 patients had stable disease, 16 had progressive disease, and 1 patient died before the first on-treatment scan for assessment.

After a median follow-up of 4.9 months, the 24-month progression-free survival rate (PFS) was 48.3% months, with a median PFS of 16.8 months.

As noted before, the 24-month OS rate was 68.7% and the median OS had not been reached at the time of the analysis.

There were no significant differences in PFS or OS between patients with tumors positive or negative for the Merkel polyomavirus, and there was a nonsignificant trend toward better PFS and OS for patients whose tumors had PD-L1 expression greater than 1%.

In all, 48 of the 50 patients had a treatment-related adverse event of any kind, and 14 had grade 3 or greater events. Treatment-related events led to discontinuation of pembrolizumab for seven patients, and one patient, a 73-year-old man with metastatic MCC and atrial fibrillation, developed pericardial and pleural effusions 1 day after receiving a single pembrolizumab infusion. The patient died 10 days after receiving pembrolizumab, and his death was deemed to be related to the drug.

The investigators noted that the drug’s efficacy in patients with both polyomavirus- and UV-induced subtypes of MCC “provides compelling evidence that both the quality and quantity of tumor antigens are important factors driving antitumor immunity and tumor rejection.”

The study was supported by grants from the National Cancer Institute, the Merkel cell carcinoma (MCC) patient gift fund at University of Washington, the Kelsey Dickson MCC Challenge Grant from the Prostate Cancer Foundation, and Merck, which provided pembrolizumab and partial funding. Dr. Nghiem reported receiving honoraria, travel expenses, and a consulting or advisory role from/for Merck and others. Multiple coauthors reported similar relations with Merck and/or other companies.

SOURCE: Nghiem P et al. J Clin Oncol. 2019 Feb 6. doi: 10.1200/JCO.18.01896.

Patients with the aggressive skin cancer Merkel cell carcinoma who were treated with the immune checkpoint inhibitor pembrolizumab (Keytruda) in the first line had higher complete response rates, better progression-free survival, and longer overall survival than historical controls treated with cytotoxic chemotherapy.

Among 50 adults with advanced Merkel cell carcinoma (MCC) with no prior systemic therapy who received pembrolizumab 2 mg/kg every 3 weeks for up to 2 years in a phase 2 clinical trial (NCT02267603), 24% had a complete response and 32% a partial response, for an overall response rate of 56%.

The 24-month overall survival rate was 68.7%, with median overall survival not reached after a median follow-up time of 14.9 months. In contrast, a retrospective study of 67 patients with MCC treated with first-line chemotherapy showed an ORR of 29.4%, a median OS of 10.5 months, and a 24-month OS of 24.5% (Future Oncol. 2017 Aug;13(19):1699-1710).

Similarly, a second retrospective study showed that, among 62 patients treated with first-line chemotherapy, the ORR was 55%, median OS was 9.5 months, and 24-month OS was 20% (Cancer Med. 2016 Sep;5(9):2294-2301), reported Paul Nghiem, MD, PhD, from the University of Washington and Fred Hutchinson Cancer Research Center in Seattle, and his colleagues.

The rationale for using a checkpoint inhibitor for advanced MCC is that “[m]ultiple lines of evidence support the notion that MCC is an immunogenic cancer, including the fact that MCC incidence is greater than 10-fold higher in chronically immunosuppressed persons,” they wrote in the Journal of Clinical Oncology.

The current National Comprehensive Cancer Network guideline on Merkel cell carcinoma recommends the use of the programmed death–1/programmed death–ligand 1 (PD-1/PD-L1) inhibitors pembrolizumab, avelumab (Bavencio), or nivolumab (Opdivo) as preferred first-line systemic therapy for patients with disseminated disease, Dr. Nghiem and his colleagues noted.

In the current report, they presented data on the longest follow-up to date of patients with advance MCC who received a PD-1 inhibitor in the first line.

In the multicenter, phase 2 trial, 50 patients with a median age of 70.5 years were treated. Of this group, 64% had tumors positive for the Merkel cell polyomavirus and 49% had PD-L1 expression on tumor cells.

Of the 50 total patients, 28 had an objective response according to Response Evaluation Criteria in Solid Tumors version 1.1, including 12 with a complete response and 16 with a partial response. A total of 5 patients had stable disease, 16 had progressive disease, and 1 patient died before the first on-treatment scan for assessment.

After a median follow-up of 4.9 months, the 24-month progression-free survival rate (PFS) was 48.3% months, with a median PFS of 16.8 months.

As noted before, the 24-month OS rate was 68.7% and the median OS had not been reached at the time of the analysis.

There were no significant differences in PFS or OS between patients with tumors positive or negative for the Merkel polyomavirus, and there was a nonsignificant trend toward better PFS and OS for patients whose tumors had PD-L1 expression greater than 1%.

In all, 48 of the 50 patients had a treatment-related adverse event of any kind, and 14 had grade 3 or greater events. Treatment-related events led to discontinuation of pembrolizumab for seven patients, and one patient, a 73-year-old man with metastatic MCC and atrial fibrillation, developed pericardial and pleural effusions 1 day after receiving a single pembrolizumab infusion. The patient died 10 days after receiving pembrolizumab, and his death was deemed to be related to the drug.

The investigators noted that the drug’s efficacy in patients with both polyomavirus- and UV-induced subtypes of MCC “provides compelling evidence that both the quality and quantity of tumor antigens are important factors driving antitumor immunity and tumor rejection.”

The study was supported by grants from the National Cancer Institute, the Merkel cell carcinoma (MCC) patient gift fund at University of Washington, the Kelsey Dickson MCC Challenge Grant from the Prostate Cancer Foundation, and Merck, which provided pembrolizumab and partial funding. Dr. Nghiem reported receiving honoraria, travel expenses, and a consulting or advisory role from/for Merck and others. Multiple coauthors reported similar relations with Merck and/or other companies.

SOURCE: Nghiem P et al. J Clin Oncol. 2019 Feb 6. doi: 10.1200/JCO.18.01896.

Patients with the aggressive skin cancer Merkel cell carcinoma who were treated with the immune checkpoint inhibitor pembrolizumab (Keytruda) in the first line had higher complete response rates, better progression-free survival, and longer overall survival than historical controls treated with cytotoxic chemotherapy.

Among 50 adults with advanced Merkel cell carcinoma (MCC) with no prior systemic therapy who received pembrolizumab 2 mg/kg every 3 weeks for up to 2 years in a phase 2 clinical trial (NCT02267603), 24% had a complete response and 32% a partial response, for an overall response rate of 56%.

The 24-month overall survival rate was 68.7%, with median overall survival not reached after a median follow-up time of 14.9 months. In contrast, a retrospective study of 67 patients with MCC treated with first-line chemotherapy showed an ORR of 29.4%, a median OS of 10.5 months, and a 24-month OS of 24.5% (Future Oncol. 2017 Aug;13(19):1699-1710).

Similarly, a second retrospective study showed that, among 62 patients treated with first-line chemotherapy, the ORR was 55%, median OS was 9.5 months, and 24-month OS was 20% (Cancer Med. 2016 Sep;5(9):2294-2301), reported Paul Nghiem, MD, PhD, from the University of Washington and Fred Hutchinson Cancer Research Center in Seattle, and his colleagues.

The rationale for using a checkpoint inhibitor for advanced MCC is that “[m]ultiple lines of evidence support the notion that MCC is an immunogenic cancer, including the fact that MCC incidence is greater than 10-fold higher in chronically immunosuppressed persons,” they wrote in the Journal of Clinical Oncology.

The current National Comprehensive Cancer Network guideline on Merkel cell carcinoma recommends the use of the programmed death–1/programmed death–ligand 1 (PD-1/PD-L1) inhibitors pembrolizumab, avelumab (Bavencio), or nivolumab (Opdivo) as preferred first-line systemic therapy for patients with disseminated disease, Dr. Nghiem and his colleagues noted.

In the current report, they presented data on the longest follow-up to date of patients with advance MCC who received a PD-1 inhibitor in the first line.

In the multicenter, phase 2 trial, 50 patients with a median age of 70.5 years were treated. Of this group, 64% had tumors positive for the Merkel cell polyomavirus and 49% had PD-L1 expression on tumor cells.

Of the 50 total patients, 28 had an objective response according to Response Evaluation Criteria in Solid Tumors version 1.1, including 12 with a complete response and 16 with a partial response. A total of 5 patients had stable disease, 16 had progressive disease, and 1 patient died before the first on-treatment scan for assessment.

After a median follow-up of 4.9 months, the 24-month progression-free survival rate (PFS) was 48.3% months, with a median PFS of 16.8 months.

As noted before, the 24-month OS rate was 68.7% and the median OS had not been reached at the time of the analysis.

There were no significant differences in PFS or OS between patients with tumors positive or negative for the Merkel polyomavirus, and there was a nonsignificant trend toward better PFS and OS for patients whose tumors had PD-L1 expression greater than 1%.

In all, 48 of the 50 patients had a treatment-related adverse event of any kind, and 14 had grade 3 or greater events. Treatment-related events led to discontinuation of pembrolizumab for seven patients, and one patient, a 73-year-old man with metastatic MCC and atrial fibrillation, developed pericardial and pleural effusions 1 day after receiving a single pembrolizumab infusion. The patient died 10 days after receiving pembrolizumab, and his death was deemed to be related to the drug.

The investigators noted that the drug’s efficacy in patients with both polyomavirus- and UV-induced subtypes of MCC “provides compelling evidence that both the quality and quantity of tumor antigens are important factors driving antitumor immunity and tumor rejection.”

The study was supported by grants from the National Cancer Institute, the Merkel cell carcinoma (MCC) patient gift fund at University of Washington, the Kelsey Dickson MCC Challenge Grant from the Prostate Cancer Foundation, and Merck, which provided pembrolizumab and partial funding. Dr. Nghiem reported receiving honoraria, travel expenses, and a consulting or advisory role from/for Merck and others. Multiple coauthors reported similar relations with Merck and/or other companies.

SOURCE: Nghiem P et al. J Clin Oncol. 2019 Feb 6. doi: 10.1200/JCO.18.01896.

The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.

FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.

The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.

The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.

lfranki@mdedge.com

The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.

FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.

The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.

The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.

lfranki@mdedge.com

The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.

FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.

The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.

The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.

lfranki@mdedge.com

GRAND CAYMAN, CAYMAN ISLANDS – Atopic dermatitis (AD) researchers are serving up a lot more than oatmeal and steroids these days.

Moisturizers that confer skin barrier protection, lipid-replenishing topicals, and some biologics are available now or will soon be available for patients with AD, Joseph Fowler Jr., MD, said at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

With the approval of dupilumab for moderate to severe disease in 2017, a biologic finally became available for treating AD, said Dr. Fowler of the University of Louisville (Ky.). While it’s not a cure and may take as long as 6 months to really kick in, “I think almost everyone gets some benefit from it. And although it’s not approved yet for anyone under 18, I’m sure it will be.”

He provided a brief rundown of dupilumab; crisaborole, another relatively new agent for AD; and some agents that are being investigated.

• Dupilumab. For AD, dupilumab, which inhibits interleukin-4 and interleukin-13 signaling, is usually started at 600 mg, then tapered to 300 mg subcutaneously every 2 weeks. Its pivotal data showed a mean 70% decrease in Eczema Area and Severity Index (EASI) scores over 16 weeks at that dose.*

“Again, I would say most patients do get benefit from this, but they might not see it for more than 3 months, and even up to 6 months. I’m not sure why, but some develop eye symptoms – I think these are more severe cases who also have respiratory atopy. I would also be interested to see if dupilumab might work on patients with chronic hand eczema,” he said.

• Crisaborole ointment 2%. A nonsteroidal topical phosphodiesterase 4 (PDE4) inhibitor approved in 2016 for mild to moderate AD in people aged 2 and older, crisaborole (Eucrisa) blocks the release of cyclic adenosine monophosphate (cAMP), which is elevated in AD. Lower cAMP levels lead to lower levels of inflammatory cytokines. In its pivotal phase 3 study, about 35% of patients achieved clinical success – an Investigator’s Static Global Assessment (ISGA) score of 0 or 1, or at least a two-grade improvement over baseline.

“In my opinion, it’s similar or slightly better than topical corticosteroids, and safer as well, especially in our younger patients, or when the face or intertriginous areas are involved,” Dr. Fowler said. “There is often some application site stinging and burning. If you put it in the fridge and get it good and cold when it goes on, that seems to moderate the sensation. It’s a good steroid-sparing option.”

Crisaborole is now being investigated for use in infants aged 3-24 months with mild to moderate AD.

• Tofacitinib ointment. This topical form of tofacitinib, an inhibitor of Janus kinase 1 and 3, is being evaluated in a placebo-controlled trial in adults with mild to moderate AD. There are also a few reports of oral tofacitinib improving AD, including a case report (Clin Exp Dermatol. 2017 Dec;42[8]:942-4). Dr. Fowler noted a small series of six adults with moderate to severe AD uncontrolled with methotrexate or azathioprine. The patients received oral tofacitinib 5 mg twice a day for 8-29 weeks; there was a mean 67% improvement in the Scoring Atopic Dermatitis (SCORAD) index.
• Ustekinumab. The interleukin-12 and -23 antagonist indicated for moderate to severe psoriasis has also made an appearance in the AD literature, including an Austrian report of three patients with severe AD who received 45 mg of ustekinumab (Stelara) subcutaneously at 0, 4 and 12 weeks. By week 16, all of them experienced a 50% reduction in their EASI score, with a marked reduction in interleukin-22 markers (J Am Acad Dermatol. 2017 Jan;76[1]:91-7.e3).

But no matter which therapy is chosen, regular moisturizing is critically important, Dr. Fowler remarked. Expensive prescription moisturizers are available, but he questioned whether they offer any cost-worthy extra benefit over a good nonprescription moisturizer.

“Do these super-moisturizers protect the skin barrier any more than petrolatum? I can’t answer that. They promise better results, but each patient and doc have to make the decision. If your patient can afford it, maybe some will be better for their skin, but really, it’s not as important as some of the other medications. So, I tell them, if cost is an issue, don’t worry about the fancy moisturizers.”

Dr. Fowler disclosed relationships with multiple pharmaceutical companies.

Global Academy and this news organization are owned by the same parent company.

Correction, 2/15/19: An earlier version of this article mischaracterized the chemical action of dupilumab.

msullivan@mdedge.com

GRAND CAYMAN, CAYMAN ISLANDS – Atopic dermatitis (AD) researchers are serving up a lot more than oatmeal and steroids these days.

Moisturizers that confer skin barrier protection, lipid-replenishing topicals, and some biologics are available now or will soon be available for patients with AD, Joseph Fowler Jr., MD, said at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

With the approval of dupilumab for moderate to severe disease in 2017, a biologic finally became available for treating AD, said Dr. Fowler of the University of Louisville (Ky.). While it’s not a cure and may take as long as 6 months to really kick in, “I think almost everyone gets some benefit from it. And although it’s not approved yet for anyone under 18, I’m sure it will be.”

He provided a brief rundown of dupilumab; crisaborole, another relatively new agent for AD; and some agents that are being investigated.

• Dupilumab. For AD, dupilumab, which inhibits interleukin-4 and interleukin-13 signaling, is usually started at 600 mg, then tapered to 300 mg subcutaneously every 2 weeks. Its pivotal data showed a mean 70% decrease in Eczema Area and Severity Index (EASI) scores over 16 weeks at that dose.*

“Again, I would say most patients do get benefit from this, but they might not see it for more than 3 months, and even up to 6 months. I’m not sure why, but some develop eye symptoms – I think these are more severe cases who also have respiratory atopy. I would also be interested to see if dupilumab might work on patients with chronic hand eczema,” he said.

• Crisaborole ointment 2%. A nonsteroidal topical phosphodiesterase 4 (PDE4) inhibitor approved in 2016 for mild to moderate AD in people aged 2 and older, crisaborole (Eucrisa) blocks the release of cyclic adenosine monophosphate (cAMP), which is elevated in AD. Lower cAMP levels lead to lower levels of inflammatory cytokines. In its pivotal phase 3 study, about 35% of patients achieved clinical success – an Investigator’s Static Global Assessment (ISGA) score of 0 or 1, or at least a two-grade improvement over baseline.

“In my opinion, it’s similar or slightly better than topical corticosteroids, and safer as well, especially in our younger patients, or when the face or intertriginous areas are involved,” Dr. Fowler said. “There is often some application site stinging and burning. If you put it in the fridge and get it good and cold when it goes on, that seems to moderate the sensation. It’s a good steroid-sparing option.”

Crisaborole is now being investigated for use in infants aged 3-24 months with mild to moderate AD.

• Tofacitinib ointment. This topical form of tofacitinib, an inhibitor of Janus kinase 1 and 3, is being evaluated in a placebo-controlled trial in adults with mild to moderate AD. There are also a few reports of oral tofacitinib improving AD, including a case report (Clin Exp Dermatol. 2017 Dec;42[8]:942-4). Dr. Fowler noted a small series of six adults with moderate to severe AD uncontrolled with methotrexate or azathioprine. The patients received oral tofacitinib 5 mg twice a day for 8-29 weeks; there was a mean 67% improvement in the Scoring Atopic Dermatitis (SCORAD) index.
• Ustekinumab. The interleukin-12 and -23 antagonist indicated for moderate to severe psoriasis has also made an appearance in the AD literature, including an Austrian report of three patients with severe AD who received 45 mg of ustekinumab (Stelara) subcutaneously at 0, 4 and 12 weeks. By week 16, all of them experienced a 50% reduction in their EASI score, with a marked reduction in interleukin-22 markers (J Am Acad Dermatol. 2017 Jan;76[1]:91-7.e3).

But no matter which therapy is chosen, regular moisturizing is critically important, Dr. Fowler remarked. Expensive prescription moisturizers are available, but he questioned whether they offer any cost-worthy extra benefit over a good nonprescription moisturizer.

“Do these super-moisturizers protect the skin barrier any more than petrolatum? I can’t answer that. They promise better results, but each patient and doc have to make the decision. If your patient can afford it, maybe some will be better for their skin, but really, it’s not as important as some of the other medications. So, I tell them, if cost is an issue, don’t worry about the fancy moisturizers.”

Dr. Fowler disclosed relationships with multiple pharmaceutical companies.

Global Academy and this news organization are owned by the same parent company.

Correction, 2/15/19: An earlier version of this article mischaracterized the chemical action of dupilumab.

msullivan@mdedge.com

GRAND CAYMAN, CAYMAN ISLANDS – Atopic dermatitis (AD) researchers are serving up a lot more than oatmeal and steroids these days.

Moisturizers that confer skin barrier protection, lipid-replenishing topicals, and some biologics are available now or will soon be available for patients with AD, Joseph Fowler Jr., MD, said at the Caribbean Dermatology Symposium provided by Global Academy for Medical Education.

With the approval of dupilumab for moderate to severe disease in 2017, a biologic finally became available for treating AD, said Dr. Fowler of the University of Louisville (Ky.). While it’s not a cure and may take as long as 6 months to really kick in, “I think almost everyone gets some benefit from it. And although it’s not approved yet for anyone under 18, I’m sure it will be.”

He provided a brief rundown of dupilumab; crisaborole, another relatively new agent for AD; and some agents that are being investigated.

• Dupilumab. For AD, dupilumab, which inhibits interleukin-4 and interleukin-13 signaling, is usually started at 600 mg, then tapered to 300 mg subcutaneously every 2 weeks. Its pivotal data showed a mean 70% decrease in Eczema Area and Severity Index (EASI) scores over 16 weeks at that dose.*

“Again, I would say most patients do get benefit from this, but they might not see it for more than 3 months, and even up to 6 months. I’m not sure why, but some develop eye symptoms – I think these are more severe cases who also have respiratory atopy. I would also be interested to see if dupilumab might work on patients with chronic hand eczema,” he said.

• Crisaborole ointment 2%. A nonsteroidal topical phosphodiesterase 4 (PDE4) inhibitor approved in 2016 for mild to moderate AD in people aged 2 and older, crisaborole (Eucrisa) blocks the release of cyclic adenosine monophosphate (cAMP), which is elevated in AD. Lower cAMP levels lead to lower levels of inflammatory cytokines. In its pivotal phase 3 study, about 35% of patients achieved clinical success – an Investigator’s Static Global Assessment (ISGA) score of 0 or 1, or at least a two-grade improvement over baseline.

“In my opinion, it’s similar or slightly better than topical corticosteroids, and safer as well, especially in our younger patients, or when the face or intertriginous areas are involved,” Dr. Fowler said. “There is often some application site stinging and burning. If you put it in the fridge and get it good and cold when it goes on, that seems to moderate the sensation. It’s a good steroid-sparing option.”

Crisaborole is now being investigated for use in infants aged 3-24 months with mild to moderate AD.

• Tofacitinib ointment. This topical form of tofacitinib, an inhibitor of Janus kinase 1 and 3, is being evaluated in a placebo-controlled trial in adults with mild to moderate AD. There are also a few reports of oral tofacitinib improving AD, including a case report (Clin Exp Dermatol. 2017 Dec;42[8]:942-4). Dr. Fowler noted a small series of six adults with moderate to severe AD uncontrolled with methotrexate or azathioprine. The patients received oral tofacitinib 5 mg twice a day for 8-29 weeks; there was a mean 67% improvement in the Scoring Atopic Dermatitis (SCORAD) index.
• Ustekinumab. The interleukin-12 and -23 antagonist indicated for moderate to severe psoriasis has also made an appearance in the AD literature, including an Austrian report of three patients with severe AD who received 45 mg of ustekinumab (Stelara) subcutaneously at 0, 4 and 12 weeks. By week 16, all of them experienced a 50% reduction in their EASI score, with a marked reduction in interleukin-22 markers (J Am Acad Dermatol. 2017 Jan;76[1]:91-7.e3).

But no matter which therapy is chosen, regular moisturizing is critically important, Dr. Fowler remarked. Expensive prescription moisturizers are available, but he questioned whether they offer any cost-worthy extra benefit over a good nonprescription moisturizer.

“Do these super-moisturizers protect the skin barrier any more than petrolatum? I can’t answer that. They promise better results, but each patient and doc have to make the decision. If your patient can afford it, maybe some will be better for their skin, but really, it’s not as important as some of the other medications. So, I tell them, if cost is an issue, don’t worry about the fancy moisturizers.”

Dr. Fowler disclosed relationships with multiple pharmaceutical companies.

Global Academy and this news organization are owned by the same parent company.

Correction, 2/15/19: An earlier version of this article mischaracterized the chemical action of dupilumab.

msullivan@mdedge.com