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Appeals court may strike down ACA
During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.
Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.
“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”
Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.
“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”
However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”
Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.
“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”
Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.
The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.
Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.
“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”
By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.
“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”
Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.
“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.
Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.
“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”
A decision by the Court of Appeals is expected in the next two months.
AGA calls on Congress to enact legislation that contains essential patient protections and other improvements to ensure affordability, accessibility, and quality health care for all Americans. Learn more at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/patient-protections-and-access-to-care.
[email protected]
During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.
Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.
“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”
Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.
“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”
However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”
Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.
“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”
Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.
The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.
Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.
“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”
By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.
“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”
Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.
“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.
Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.
“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”
A decision by the Court of Appeals is expected in the next two months.
AGA calls on Congress to enact legislation that contains essential patient protections and other improvements to ensure affordability, accessibility, and quality health care for all Americans. Learn more at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/patient-protections-and-access-to-care.
[email protected]
During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.
Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.
“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”
Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.
“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”
However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”
Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.
“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”
Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.
The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.
Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.
“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”
By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.
“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”
Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.
“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.
Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.
“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”
A decision by the Court of Appeals is expected in the next two months.
AGA calls on Congress to enact legislation that contains essential patient protections and other improvements to ensure affordability, accessibility, and quality health care for all Americans. Learn more at https://www.gastro.org/advocacy-and-policy/issues-and-news/top-issues/patient-protections-and-access-to-care.
[email protected]
Osteoporotic fracture risk appears higher in adults with hemophilia
Adults with newly diagnosed hemophilia may be at a higher risk of developing osteoporotic fractures, according to results from a retrospective study.
Sheng-Hui Tuan, MD, of Cishan Hospital in Kaohsiung, Taiwan, and colleagues conducted a population-based nationwide cohort study that included 75 patients with hemophilia and 300 control subjects without hemophilia matched for age and sex. Data was obtained from a national insurance database in Taiwan from January 2000 to December 2013. The findings were published in Haemophilia.
The primary outcome measured was newly diagnosed osteoporotic fractures, defined as wrist, vertebral, and hip fractures among individuals from both groups. Patients with osteoporotic fractures before hemophilia diagnosis were excluded.
In the analysis, the team calculated hazard ratios and incidence rates of new-onset osteoporotic fractures in both cohorts.
After analysis, the researchers found that the risk of developing new-onset osteoporotic fractures was greater in the hemophilia group versus the comparison group (HR, 5.41; 95% confidence interval, 2.42-12.1; P less than .001).
After adjusting for covariates, such as socioeconomic status, age, sex, and other comorbidities, patients with hemophilia had a 337% higher risk of developing osteoporotic fractures post diagnosis versus matched controls (95% CI, 1.88-10.17; P = .001).
“The risk of osteoporotic fractures following haemophilia increased with time and was significantly higher at 5 years after the diagnosis,” the researchers wrote.
The underlying mechanisms driving these associations remain unknown, according to the authors. Possible risk factors include reduced physical activity, HIV and hepatitis C virus infections, and arthropathy.
The researchers acknowledged that a key limitation of the study was the absence of some relevant clinical information within the database. As a result, information bias could have lowered the accuracy of the analysis.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: Tuan S-H et al. Haemophilia. 2019 Jul 7. doi: 10.1111/hae.13814.
Adults with newly diagnosed hemophilia may be at a higher risk of developing osteoporotic fractures, according to results from a retrospective study.
Sheng-Hui Tuan, MD, of Cishan Hospital in Kaohsiung, Taiwan, and colleagues conducted a population-based nationwide cohort study that included 75 patients with hemophilia and 300 control subjects without hemophilia matched for age and sex. Data was obtained from a national insurance database in Taiwan from January 2000 to December 2013. The findings were published in Haemophilia.
The primary outcome measured was newly diagnosed osteoporotic fractures, defined as wrist, vertebral, and hip fractures among individuals from both groups. Patients with osteoporotic fractures before hemophilia diagnosis were excluded.
In the analysis, the team calculated hazard ratios and incidence rates of new-onset osteoporotic fractures in both cohorts.
After analysis, the researchers found that the risk of developing new-onset osteoporotic fractures was greater in the hemophilia group versus the comparison group (HR, 5.41; 95% confidence interval, 2.42-12.1; P less than .001).
After adjusting for covariates, such as socioeconomic status, age, sex, and other comorbidities, patients with hemophilia had a 337% higher risk of developing osteoporotic fractures post diagnosis versus matched controls (95% CI, 1.88-10.17; P = .001).
“The risk of osteoporotic fractures following haemophilia increased with time and was significantly higher at 5 years after the diagnosis,” the researchers wrote.
The underlying mechanisms driving these associations remain unknown, according to the authors. Possible risk factors include reduced physical activity, HIV and hepatitis C virus infections, and arthropathy.
The researchers acknowledged that a key limitation of the study was the absence of some relevant clinical information within the database. As a result, information bias could have lowered the accuracy of the analysis.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: Tuan S-H et al. Haemophilia. 2019 Jul 7. doi: 10.1111/hae.13814.
Adults with newly diagnosed hemophilia may be at a higher risk of developing osteoporotic fractures, according to results from a retrospective study.
Sheng-Hui Tuan, MD, of Cishan Hospital in Kaohsiung, Taiwan, and colleagues conducted a population-based nationwide cohort study that included 75 patients with hemophilia and 300 control subjects without hemophilia matched for age and sex. Data was obtained from a national insurance database in Taiwan from January 2000 to December 2013. The findings were published in Haemophilia.
The primary outcome measured was newly diagnosed osteoporotic fractures, defined as wrist, vertebral, and hip fractures among individuals from both groups. Patients with osteoporotic fractures before hemophilia diagnosis were excluded.
In the analysis, the team calculated hazard ratios and incidence rates of new-onset osteoporotic fractures in both cohorts.
After analysis, the researchers found that the risk of developing new-onset osteoporotic fractures was greater in the hemophilia group versus the comparison group (HR, 5.41; 95% confidence interval, 2.42-12.1; P less than .001).
After adjusting for covariates, such as socioeconomic status, age, sex, and other comorbidities, patients with hemophilia had a 337% higher risk of developing osteoporotic fractures post diagnosis versus matched controls (95% CI, 1.88-10.17; P = .001).
“The risk of osteoporotic fractures following haemophilia increased with time and was significantly higher at 5 years after the diagnosis,” the researchers wrote.
The underlying mechanisms driving these associations remain unknown, according to the authors. Possible risk factors include reduced physical activity, HIV and hepatitis C virus infections, and arthropathy.
The researchers acknowledged that a key limitation of the study was the absence of some relevant clinical information within the database. As a result, information bias could have lowered the accuracy of the analysis.
No funding sources were reported. The authors reported having no conflicts of interest.
SOURCE: Tuan S-H et al. Haemophilia. 2019 Jul 7. doi: 10.1111/hae.13814.
FROM HAEMOPHILIA
Novel point-of-care assay appears accurate in monitoring hemophilia A
A novel point-of-care assay demonstrated sensitivity to monitor coagulation factor replacement therapy in patients with severe hemophilia A, with and without inhibitors, according to recent study findings.
The ClotChip assay is a novel factor-replacement therapy monitoring tool that uses a dielectric microsensor to assess whole-blood coagulation in patients with severe hemophilia A.
Debnath Maji of Case Western Reserve University, Cleveland, and colleagues evaluated the novel assay in attempt to address the unmet need of reliable monitoring of coagulation factor–replacement therapy. While global haemostasis assays are available to measure the missing function, these tools require expert interpretation, are technically challenging to operate, and may be unavailable at the bedside, they wrote in Haemophilia.
They evaluated the analytical capabilities of the assay in 6 patients with inhibitors and 12 patients without inhibitors. A total of 50 healthy controls were included in the study.
The team collected whole blood samples pre- and postcoagulation factor–replacement therapy. Measurements were also conducted on the thrombin generation assay (TGA), thromboelastography (TEG), and rotational thromboelastometry (ROTEM) global assays for comparison.
After analysis, the researchers found that ClotChip T-peak parameters showed a significant reduction for samples obtained post–factor replacement therapy versus pretherapy among patients with and without inhibitors (P = .028 and P = .0001, respectively).
Additionally, ClotChip T-peak values exhibited strong correlations with factor VIII clotting activity, clotting time parameters of ROTEM, and peak thrombin and endogenous thrombin potential of TGA.
“Taken together, these data suggest that the ClotChip T-peak parameter is sensitive to detection and correction of coagulopathy in children with haemophilia with and without inhibitors, as indicated by T-peak reaching reference‐range values after coagulation factor replacement therapy,” the researchers wrote.
One key limitation of the study was the small sample size, which may limit the generalizability of the findings.
The novel assay may be an appropriate tool for “real-world” decision making around the use of coagulation factor replacement therapy in patients with severe hemophilia A, they added.
The study was funded by the National Institutes of Health, the American Heart Association, and a Veterans Affairs Research Center of Excellence at Case Western Reserve University. The authors reported financial affiliations with Bayer, Bioverativ, Shire, and XaTek.
SOURCE: Maji D et al. Haemophilia. 2019 Jul 7. doi: 10.1111/hae.13799.
A novel point-of-care assay demonstrated sensitivity to monitor coagulation factor replacement therapy in patients with severe hemophilia A, with and without inhibitors, according to recent study findings.
The ClotChip assay is a novel factor-replacement therapy monitoring tool that uses a dielectric microsensor to assess whole-blood coagulation in patients with severe hemophilia A.
Debnath Maji of Case Western Reserve University, Cleveland, and colleagues evaluated the novel assay in attempt to address the unmet need of reliable monitoring of coagulation factor–replacement therapy. While global haemostasis assays are available to measure the missing function, these tools require expert interpretation, are technically challenging to operate, and may be unavailable at the bedside, they wrote in Haemophilia.
They evaluated the analytical capabilities of the assay in 6 patients with inhibitors and 12 patients without inhibitors. A total of 50 healthy controls were included in the study.
The team collected whole blood samples pre- and postcoagulation factor–replacement therapy. Measurements were also conducted on the thrombin generation assay (TGA), thromboelastography (TEG), and rotational thromboelastometry (ROTEM) global assays for comparison.
After analysis, the researchers found that ClotChip T-peak parameters showed a significant reduction for samples obtained post–factor replacement therapy versus pretherapy among patients with and without inhibitors (P = .028 and P = .0001, respectively).
Additionally, ClotChip T-peak values exhibited strong correlations with factor VIII clotting activity, clotting time parameters of ROTEM, and peak thrombin and endogenous thrombin potential of TGA.
“Taken together, these data suggest that the ClotChip T-peak parameter is sensitive to detection and correction of coagulopathy in children with haemophilia with and without inhibitors, as indicated by T-peak reaching reference‐range values after coagulation factor replacement therapy,” the researchers wrote.
One key limitation of the study was the small sample size, which may limit the generalizability of the findings.
The novel assay may be an appropriate tool for “real-world” decision making around the use of coagulation factor replacement therapy in patients with severe hemophilia A, they added.
The study was funded by the National Institutes of Health, the American Heart Association, and a Veterans Affairs Research Center of Excellence at Case Western Reserve University. The authors reported financial affiliations with Bayer, Bioverativ, Shire, and XaTek.
SOURCE: Maji D et al. Haemophilia. 2019 Jul 7. doi: 10.1111/hae.13799.
A novel point-of-care assay demonstrated sensitivity to monitor coagulation factor replacement therapy in patients with severe hemophilia A, with and without inhibitors, according to recent study findings.
The ClotChip assay is a novel factor-replacement therapy monitoring tool that uses a dielectric microsensor to assess whole-blood coagulation in patients with severe hemophilia A.
Debnath Maji of Case Western Reserve University, Cleveland, and colleagues evaluated the novel assay in attempt to address the unmet need of reliable monitoring of coagulation factor–replacement therapy. While global haemostasis assays are available to measure the missing function, these tools require expert interpretation, are technically challenging to operate, and may be unavailable at the bedside, they wrote in Haemophilia.
They evaluated the analytical capabilities of the assay in 6 patients with inhibitors and 12 patients without inhibitors. A total of 50 healthy controls were included in the study.
The team collected whole blood samples pre- and postcoagulation factor–replacement therapy. Measurements were also conducted on the thrombin generation assay (TGA), thromboelastography (TEG), and rotational thromboelastometry (ROTEM) global assays for comparison.
After analysis, the researchers found that ClotChip T-peak parameters showed a significant reduction for samples obtained post–factor replacement therapy versus pretherapy among patients with and without inhibitors (P = .028 and P = .0001, respectively).
Additionally, ClotChip T-peak values exhibited strong correlations with factor VIII clotting activity, clotting time parameters of ROTEM, and peak thrombin and endogenous thrombin potential of TGA.
“Taken together, these data suggest that the ClotChip T-peak parameter is sensitive to detection and correction of coagulopathy in children with haemophilia with and without inhibitors, as indicated by T-peak reaching reference‐range values after coagulation factor replacement therapy,” the researchers wrote.
One key limitation of the study was the small sample size, which may limit the generalizability of the findings.
The novel assay may be an appropriate tool for “real-world” decision making around the use of coagulation factor replacement therapy in patients with severe hemophilia A, they added.
The study was funded by the National Institutes of Health, the American Heart Association, and a Veterans Affairs Research Center of Excellence at Case Western Reserve University. The authors reported financial affiliations with Bayer, Bioverativ, Shire, and XaTek.
SOURCE: Maji D et al. Haemophilia. 2019 Jul 7. doi: 10.1111/hae.13799.
FROM HAEMOPHILIA
Risk of atrial fibrillation 900% higher with cancer
MELBOURNE – The overall prevalence of atrial fibrillation in people who have or have had cancer is 10 times that of individuals without cancer, according to a study presented at the International Society on Thrombosis and Haemostasis congress.
Cihan Ay, MD, of the division of hematology and hemostaseology at the Medical University of Vienna reported on a nationwide cohort study using health insurance data from more than 8.3 million people in Austria, including roughly 159,000 with a diagnosis of cancer and 113,000 with a diagnosis of atrial fibrillation.
The analysis found that, in individuals whose records showed a diagnosis of cancer, there was a 950% higher relative risk of also having a diagnosis of atrial fibrillation, compared with those with no cancer diagnosis.
The overall prevalence of atrial fibrillation among individuals with a cancer diagnosis was 9.8%, compared with 1.2% in those without cancer.
There was significant variation in relative risk according to age. Although the prevalence of atrial fibrillation increased with age, the highest relative risks were seen in the youngest age groups.
In those aged 12 years or under with a cancer diagnosis, the relative risk of atrial fibrillation was 150 times greater than in those without cancer, and in those aged 13-18 years, it was 200 times higher. At the other end of the age spectrum, individuals aged 70-79 years with a recorded cancer diagnosis, the relative risk of atrial fibrillation was still 130% higher than the noncancer population, and in those aged 80-90 years it was a significant 54% higher.
However, the analysis did not find any effect of gender on the risk of atrial fibrillation associated with cancer, regardless of the age group.
Researchers also examined the influence of different cancer types. They found the highest relative risk of atrial fibrillation was in persons with hematologic malignancies – at nine times the risk in the noncancer population – and the lowest was in the endocrine cancer patients, who had three times the risk.
Dr. Ay told the conference that the association between cancer and atrial fibrillation had been suggested in the literature, but it was still an unexplored field. “The exact magnitude of this association between cancer and atrial fibrillation is still unclear.”
There was also the question of what mechanisms might underlie the association. Dr. Ay pointed out that the health insurance database did not allow researchers to explore the temporal relationship between the two diagnoses, and therefore could not tell which came first.
One audience member queried whether the fact that cancer patients were likely to be visiting a clinician more frequently might mean that the atrial fibrillation would be more likely to be diagnosed.
To that, Dr. Ay suggested the significantly higher relative risk in children was supportive of the notion that cancer itself, or treatment effects, were influencing atrial fibrillation risk.
“There is evidence suggesting that cancer treatments are triggering atrial fibrillation,” he said in an interview. “Also, patients with cancer have situations of in which they are sick – they have neutropenia or sepsis and so on – which can also trigger atrial fibrillation.”
Given the limitations of the retrospective cohort study, Dr. Ay said he was hoping to do a prospective study that would enable baseline measurements of cancer patients to determine how much of the atrial fibrillation was preexisting.
“We have also more and more cancer survivors, and over the years they’re living longer and the likelihood of getting atrial fibrillation increases,” he added.
Commenting on the data, Gerald Soff, MD, chief of hematology at the Memorial Sloan Kettering Cancer Center in New York, said it was very important to quantify the association between cancer and atrial fibrillation.
“What’s striking to me is how many people with cancer come in with preexisting atrial fibrillation,” he said. “It could be that they have cancer and they’re already messed up, but we have, on a given day, several people coming in with newly diagnosed cancers, already on warfarin or apixaban or rivaroxaban because they have atrial fibrillation.”
Dr. Ay reported advisory board positions and speaking engagements for the pharmaceutical sector.
MELBOURNE – The overall prevalence of atrial fibrillation in people who have or have had cancer is 10 times that of individuals without cancer, according to a study presented at the International Society on Thrombosis and Haemostasis congress.
Cihan Ay, MD, of the division of hematology and hemostaseology at the Medical University of Vienna reported on a nationwide cohort study using health insurance data from more than 8.3 million people in Austria, including roughly 159,000 with a diagnosis of cancer and 113,000 with a diagnosis of atrial fibrillation.
The analysis found that, in individuals whose records showed a diagnosis of cancer, there was a 950% higher relative risk of also having a diagnosis of atrial fibrillation, compared with those with no cancer diagnosis.
The overall prevalence of atrial fibrillation among individuals with a cancer diagnosis was 9.8%, compared with 1.2% in those without cancer.
There was significant variation in relative risk according to age. Although the prevalence of atrial fibrillation increased with age, the highest relative risks were seen in the youngest age groups.
In those aged 12 years or under with a cancer diagnosis, the relative risk of atrial fibrillation was 150 times greater than in those without cancer, and in those aged 13-18 years, it was 200 times higher. At the other end of the age spectrum, individuals aged 70-79 years with a recorded cancer diagnosis, the relative risk of atrial fibrillation was still 130% higher than the noncancer population, and in those aged 80-90 years it was a significant 54% higher.
However, the analysis did not find any effect of gender on the risk of atrial fibrillation associated with cancer, regardless of the age group.
Researchers also examined the influence of different cancer types. They found the highest relative risk of atrial fibrillation was in persons with hematologic malignancies – at nine times the risk in the noncancer population – and the lowest was in the endocrine cancer patients, who had three times the risk.
Dr. Ay told the conference that the association between cancer and atrial fibrillation had been suggested in the literature, but it was still an unexplored field. “The exact magnitude of this association between cancer and atrial fibrillation is still unclear.”
There was also the question of what mechanisms might underlie the association. Dr. Ay pointed out that the health insurance database did not allow researchers to explore the temporal relationship between the two diagnoses, and therefore could not tell which came first.
One audience member queried whether the fact that cancer patients were likely to be visiting a clinician more frequently might mean that the atrial fibrillation would be more likely to be diagnosed.
To that, Dr. Ay suggested the significantly higher relative risk in children was supportive of the notion that cancer itself, or treatment effects, were influencing atrial fibrillation risk.
“There is evidence suggesting that cancer treatments are triggering atrial fibrillation,” he said in an interview. “Also, patients with cancer have situations of in which they are sick – they have neutropenia or sepsis and so on – which can also trigger atrial fibrillation.”
Given the limitations of the retrospective cohort study, Dr. Ay said he was hoping to do a prospective study that would enable baseline measurements of cancer patients to determine how much of the atrial fibrillation was preexisting.
“We have also more and more cancer survivors, and over the years they’re living longer and the likelihood of getting atrial fibrillation increases,” he added.
Commenting on the data, Gerald Soff, MD, chief of hematology at the Memorial Sloan Kettering Cancer Center in New York, said it was very important to quantify the association between cancer and atrial fibrillation.
“What’s striking to me is how many people with cancer come in with preexisting atrial fibrillation,” he said. “It could be that they have cancer and they’re already messed up, but we have, on a given day, several people coming in with newly diagnosed cancers, already on warfarin or apixaban or rivaroxaban because they have atrial fibrillation.”
Dr. Ay reported advisory board positions and speaking engagements for the pharmaceutical sector.
MELBOURNE – The overall prevalence of atrial fibrillation in people who have or have had cancer is 10 times that of individuals without cancer, according to a study presented at the International Society on Thrombosis and Haemostasis congress.
Cihan Ay, MD, of the division of hematology and hemostaseology at the Medical University of Vienna reported on a nationwide cohort study using health insurance data from more than 8.3 million people in Austria, including roughly 159,000 with a diagnosis of cancer and 113,000 with a diagnosis of atrial fibrillation.
The analysis found that, in individuals whose records showed a diagnosis of cancer, there was a 950% higher relative risk of also having a diagnosis of atrial fibrillation, compared with those with no cancer diagnosis.
The overall prevalence of atrial fibrillation among individuals with a cancer diagnosis was 9.8%, compared with 1.2% in those without cancer.
There was significant variation in relative risk according to age. Although the prevalence of atrial fibrillation increased with age, the highest relative risks were seen in the youngest age groups.
In those aged 12 years or under with a cancer diagnosis, the relative risk of atrial fibrillation was 150 times greater than in those without cancer, and in those aged 13-18 years, it was 200 times higher. At the other end of the age spectrum, individuals aged 70-79 years with a recorded cancer diagnosis, the relative risk of atrial fibrillation was still 130% higher than the noncancer population, and in those aged 80-90 years it was a significant 54% higher.
However, the analysis did not find any effect of gender on the risk of atrial fibrillation associated with cancer, regardless of the age group.
Researchers also examined the influence of different cancer types. They found the highest relative risk of atrial fibrillation was in persons with hematologic malignancies – at nine times the risk in the noncancer population – and the lowest was in the endocrine cancer patients, who had three times the risk.
Dr. Ay told the conference that the association between cancer and atrial fibrillation had been suggested in the literature, but it was still an unexplored field. “The exact magnitude of this association between cancer and atrial fibrillation is still unclear.”
There was also the question of what mechanisms might underlie the association. Dr. Ay pointed out that the health insurance database did not allow researchers to explore the temporal relationship between the two diagnoses, and therefore could not tell which came first.
One audience member queried whether the fact that cancer patients were likely to be visiting a clinician more frequently might mean that the atrial fibrillation would be more likely to be diagnosed.
To that, Dr. Ay suggested the significantly higher relative risk in children was supportive of the notion that cancer itself, or treatment effects, were influencing atrial fibrillation risk.
“There is evidence suggesting that cancer treatments are triggering atrial fibrillation,” he said in an interview. “Also, patients with cancer have situations of in which they are sick – they have neutropenia or sepsis and so on – which can also trigger atrial fibrillation.”
Given the limitations of the retrospective cohort study, Dr. Ay said he was hoping to do a prospective study that would enable baseline measurements of cancer patients to determine how much of the atrial fibrillation was preexisting.
“We have also more and more cancer survivors, and over the years they’re living longer and the likelihood of getting atrial fibrillation increases,” he added.
Commenting on the data, Gerald Soff, MD, chief of hematology at the Memorial Sloan Kettering Cancer Center in New York, said it was very important to quantify the association between cancer and atrial fibrillation.
“What’s striking to me is how many people with cancer come in with preexisting atrial fibrillation,” he said. “It could be that they have cancer and they’re already messed up, but we have, on a given day, several people coming in with newly diagnosed cancers, already on warfarin or apixaban or rivaroxaban because they have atrial fibrillation.”
Dr. Ay reported advisory board positions and speaking engagements for the pharmaceutical sector.
REPORTING FROM 2019 ISTH CONGRESS
Using Obamacare authority, Trump aims to shift dialysis care to patients’ homes
President Trump on July 10 announced a bold plan to improve care to patients with kidney disease, which he claimed would save thousands of lives each year and billions of dollars for taxpayers.
“It could be higher if it works the way we anticipate,” Mr. Trump boasted in a 25-minute speech to dozens of kidney patients, their families, and kidney care providers in Washington.
Ten Americans die each day because of the shortage of organs, Mr. Trump said.
Kidney disease is the ninth-leading cause of death in the United States and accounts for 20% of annual Medicare spending, or about $110 billion, administration officials said.
Mr. Trump’s strategy centers on changing how Medicare pays doctors and dialysis centers to boost their incentives to help patients get dialysis at home and keep them healthy enough to be eligible for transplantation. This would be a far cry from the current system, which focuses on in-patient dialysis center treatment.
Mark E. Rosenberg, MD, president of the American Society of Nephrology, said he was pleased that some of the new payment models offered by the Centers for Medicare & Medicaid Services have only “upside” potential for doctors. He said doctors now get paid more to see their patients at the dialysis center than at home. As a result, there is little incentive to promote home dialysis options.
“I have been a kidney doctor for 35 years, and this is the most game-changing thing ever to happen,” he said.
The authority to make such major changes without congressional approval comes from the Centers for Medicare and Medicaid Innovation (CMMI), which was created by the 2010 Affordable Care Act.
On Tuesday, the Trump administration was in a federal appeals court in New Orleans arguing the entire health law should be declared unconstitutional.
“If the law is invalidated, the Innovation Center, and all its authorities, would be eliminated,” said Nicholas Bagley, a University of Michigan law professor.
In touting the new effort, Health and Human Services Secretary Alex M. Azar II and CMMI Director Adam Boehler spoke about how kidney disease has affected their families. Mr. Azar noted his father was on dialysis for several years before receiving a kidney transplant. Mr. Boehler said an aunt died while on dialysis.
Since 1973, all Americans with end-stage kidney disease have been entitled to coverage through Medicare.
The administration said it would expand the number of kidneys available for transplant by increasing public awareness about the need for living donors and help those who donate a kidney. Currently, their medical costs are covered, but the president’s plan would provide financial assistance to cover day care and time missed from work. Mr. Trump said the initiative would also hold organ procurement organizations more accountable so that fewer usable organs are discarded.
Trump said his plan would help 17,000 additional Americans get a kidney transplant each year by 2030. The policy would also help 11,000 more Americans get hearts, lungs, and livers annually.
Kidney transplants cost less than having patients spend years on dialysis, according to government figures. Dialysis treatment runs on average about $89,000 a year, while a kidney transplant surgery averages about $32,000 and postsurgery care runs about $25,000 per year. Mr. Trump estimated his plan would save families and taxpayers $4.2 billion a year. “This is a dramatic and long overdue reform,” he said.
In the United States, only about 12% of patients get dialysis at home, far lower than in other countries, Mr. Trump said. The plan calls for increasing that share to 80% by 2025.
Nichole Jefferson, 47 years, of Dallas, who is awaiting a second transplant to replace a transplanted kidney that is failing, said getting the treatment at home is much less taxing. She had home dialysis for 4 years before her initial transplant in 2008.
“It’s great to be at home where I was more comfortable and more relaxed and the care was in my hands,” she said in an interview at the Trump event. By getting dialysis at night while she slept, she was able to work during the day and take part in family events.
She had to go to a center for the dialysis when the home dialysis stopped working. “I was depressed to be in the center tied to a chair for 4 hours next to people I did not know,” she said. Patients often have dialysis several days a week.
Other patient advocates applauded Mr. Trump’s plan.
“The administration’s commitment to charting a new course for kidney health will help revolutionize transplantation and dialysis and advance new innovations, therapies and treatments, which patients everywhere have been waiting on for far too long,” said Kevin Longino, CEO of the National Kidney Foundation and a kidney transplant patient.
DaVita, the Denver-based company that is the largest provider of home dialysis in the country, offered a more muted response, saying it looked forward to working with the administration. The company’s stock, which fell in recent days ahead of the announcement, rose about 5% Wednesday.
Administration officials said many aspects of their plan would begin next year. Health providers in half the country will be required to participate in one of the new payment models in which they will face some financial risk for caring for patients. Doctors and health systems will have options to take on more financial risk, which means they could make more money or lose more money based on the health of their kidney patients.
Patients, however, will continue to be able to choose their doctors and dialysis providers.
Joe Grogan, head of the White House Domestic Policy Council, said the kidney disease issue “fits in the wheelhouse of items the president likes to confront. ... The current quality of outcomes are pathetic in this area.”
About half of patients on dialysis die within 5 years, Mr. Azar said.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
President Trump on July 10 announced a bold plan to improve care to patients with kidney disease, which he claimed would save thousands of lives each year and billions of dollars for taxpayers.
“It could be higher if it works the way we anticipate,” Mr. Trump boasted in a 25-minute speech to dozens of kidney patients, their families, and kidney care providers in Washington.
Ten Americans die each day because of the shortage of organs, Mr. Trump said.
Kidney disease is the ninth-leading cause of death in the United States and accounts for 20% of annual Medicare spending, or about $110 billion, administration officials said.
Mr. Trump’s strategy centers on changing how Medicare pays doctors and dialysis centers to boost their incentives to help patients get dialysis at home and keep them healthy enough to be eligible for transplantation. This would be a far cry from the current system, which focuses on in-patient dialysis center treatment.
Mark E. Rosenberg, MD, president of the American Society of Nephrology, said he was pleased that some of the new payment models offered by the Centers for Medicare & Medicaid Services have only “upside” potential for doctors. He said doctors now get paid more to see their patients at the dialysis center than at home. As a result, there is little incentive to promote home dialysis options.
“I have been a kidney doctor for 35 years, and this is the most game-changing thing ever to happen,” he said.
The authority to make such major changes without congressional approval comes from the Centers for Medicare and Medicaid Innovation (CMMI), which was created by the 2010 Affordable Care Act.
On Tuesday, the Trump administration was in a federal appeals court in New Orleans arguing the entire health law should be declared unconstitutional.
“If the law is invalidated, the Innovation Center, and all its authorities, would be eliminated,” said Nicholas Bagley, a University of Michigan law professor.
In touting the new effort, Health and Human Services Secretary Alex M. Azar II and CMMI Director Adam Boehler spoke about how kidney disease has affected their families. Mr. Azar noted his father was on dialysis for several years before receiving a kidney transplant. Mr. Boehler said an aunt died while on dialysis.
Since 1973, all Americans with end-stage kidney disease have been entitled to coverage through Medicare.
The administration said it would expand the number of kidneys available for transplant by increasing public awareness about the need for living donors and help those who donate a kidney. Currently, their medical costs are covered, but the president’s plan would provide financial assistance to cover day care and time missed from work. Mr. Trump said the initiative would also hold organ procurement organizations more accountable so that fewer usable organs are discarded.
Trump said his plan would help 17,000 additional Americans get a kidney transplant each year by 2030. The policy would also help 11,000 more Americans get hearts, lungs, and livers annually.
Kidney transplants cost less than having patients spend years on dialysis, according to government figures. Dialysis treatment runs on average about $89,000 a year, while a kidney transplant surgery averages about $32,000 and postsurgery care runs about $25,000 per year. Mr. Trump estimated his plan would save families and taxpayers $4.2 billion a year. “This is a dramatic and long overdue reform,” he said.
In the United States, only about 12% of patients get dialysis at home, far lower than in other countries, Mr. Trump said. The plan calls for increasing that share to 80% by 2025.
Nichole Jefferson, 47 years, of Dallas, who is awaiting a second transplant to replace a transplanted kidney that is failing, said getting the treatment at home is much less taxing. She had home dialysis for 4 years before her initial transplant in 2008.
“It’s great to be at home where I was more comfortable and more relaxed and the care was in my hands,” she said in an interview at the Trump event. By getting dialysis at night while she slept, she was able to work during the day and take part in family events.
She had to go to a center for the dialysis when the home dialysis stopped working. “I was depressed to be in the center tied to a chair for 4 hours next to people I did not know,” she said. Patients often have dialysis several days a week.
Other patient advocates applauded Mr. Trump’s plan.
“The administration’s commitment to charting a new course for kidney health will help revolutionize transplantation and dialysis and advance new innovations, therapies and treatments, which patients everywhere have been waiting on for far too long,” said Kevin Longino, CEO of the National Kidney Foundation and a kidney transplant patient.
DaVita, the Denver-based company that is the largest provider of home dialysis in the country, offered a more muted response, saying it looked forward to working with the administration. The company’s stock, which fell in recent days ahead of the announcement, rose about 5% Wednesday.
Administration officials said many aspects of their plan would begin next year. Health providers in half the country will be required to participate in one of the new payment models in which they will face some financial risk for caring for patients. Doctors and health systems will have options to take on more financial risk, which means they could make more money or lose more money based on the health of their kidney patients.
Patients, however, will continue to be able to choose their doctors and dialysis providers.
Joe Grogan, head of the White House Domestic Policy Council, said the kidney disease issue “fits in the wheelhouse of items the president likes to confront. ... The current quality of outcomes are pathetic in this area.”
About half of patients on dialysis die within 5 years, Mr. Azar said.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
President Trump on July 10 announced a bold plan to improve care to patients with kidney disease, which he claimed would save thousands of lives each year and billions of dollars for taxpayers.
“It could be higher if it works the way we anticipate,” Mr. Trump boasted in a 25-minute speech to dozens of kidney patients, their families, and kidney care providers in Washington.
Ten Americans die each day because of the shortage of organs, Mr. Trump said.
Kidney disease is the ninth-leading cause of death in the United States and accounts for 20% of annual Medicare spending, or about $110 billion, administration officials said.
Mr. Trump’s strategy centers on changing how Medicare pays doctors and dialysis centers to boost their incentives to help patients get dialysis at home and keep them healthy enough to be eligible for transplantation. This would be a far cry from the current system, which focuses on in-patient dialysis center treatment.
Mark E. Rosenberg, MD, president of the American Society of Nephrology, said he was pleased that some of the new payment models offered by the Centers for Medicare & Medicaid Services have only “upside” potential for doctors. He said doctors now get paid more to see their patients at the dialysis center than at home. As a result, there is little incentive to promote home dialysis options.
“I have been a kidney doctor for 35 years, and this is the most game-changing thing ever to happen,” he said.
The authority to make such major changes without congressional approval comes from the Centers for Medicare and Medicaid Innovation (CMMI), which was created by the 2010 Affordable Care Act.
On Tuesday, the Trump administration was in a federal appeals court in New Orleans arguing the entire health law should be declared unconstitutional.
“If the law is invalidated, the Innovation Center, and all its authorities, would be eliminated,” said Nicholas Bagley, a University of Michigan law professor.
In touting the new effort, Health and Human Services Secretary Alex M. Azar II and CMMI Director Adam Boehler spoke about how kidney disease has affected their families. Mr. Azar noted his father was on dialysis for several years before receiving a kidney transplant. Mr. Boehler said an aunt died while on dialysis.
Since 1973, all Americans with end-stage kidney disease have been entitled to coverage through Medicare.
The administration said it would expand the number of kidneys available for transplant by increasing public awareness about the need for living donors and help those who donate a kidney. Currently, their medical costs are covered, but the president’s plan would provide financial assistance to cover day care and time missed from work. Mr. Trump said the initiative would also hold organ procurement organizations more accountable so that fewer usable organs are discarded.
Trump said his plan would help 17,000 additional Americans get a kidney transplant each year by 2030. The policy would also help 11,000 more Americans get hearts, lungs, and livers annually.
Kidney transplants cost less than having patients spend years on dialysis, according to government figures. Dialysis treatment runs on average about $89,000 a year, while a kidney transplant surgery averages about $32,000 and postsurgery care runs about $25,000 per year. Mr. Trump estimated his plan would save families and taxpayers $4.2 billion a year. “This is a dramatic and long overdue reform,” he said.
In the United States, only about 12% of patients get dialysis at home, far lower than in other countries, Mr. Trump said. The plan calls for increasing that share to 80% by 2025.
Nichole Jefferson, 47 years, of Dallas, who is awaiting a second transplant to replace a transplanted kidney that is failing, said getting the treatment at home is much less taxing. She had home dialysis for 4 years before her initial transplant in 2008.
“It’s great to be at home where I was more comfortable and more relaxed and the care was in my hands,” she said in an interview at the Trump event. By getting dialysis at night while she slept, she was able to work during the day and take part in family events.
She had to go to a center for the dialysis when the home dialysis stopped working. “I was depressed to be in the center tied to a chair for 4 hours next to people I did not know,” she said. Patients often have dialysis several days a week.
Other patient advocates applauded Mr. Trump’s plan.
“The administration’s commitment to charting a new course for kidney health will help revolutionize transplantation and dialysis and advance new innovations, therapies and treatments, which patients everywhere have been waiting on for far too long,” said Kevin Longino, CEO of the National Kidney Foundation and a kidney transplant patient.
DaVita, the Denver-based company that is the largest provider of home dialysis in the country, offered a more muted response, saying it looked forward to working with the administration. The company’s stock, which fell in recent days ahead of the announcement, rose about 5% Wednesday.
Administration officials said many aspects of their plan would begin next year. Health providers in half the country will be required to participate in one of the new payment models in which they will face some financial risk for caring for patients. Doctors and health systems will have options to take on more financial risk, which means they could make more money or lose more money based on the health of their kidney patients.
Patients, however, will continue to be able to choose their doctors and dialysis providers.
Joe Grogan, head of the White House Domestic Policy Council, said the kidney disease issue “fits in the wheelhouse of items the president likes to confront. ... The current quality of outcomes are pathetic in this area.”
About half of patients on dialysis die within 5 years, Mr. Azar said.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Medicare going in ‘right direction’ on opioid epidemic
About 174,000 Medicare beneficiaries received such a medication – either buprenorphine or naltrexone – to help them with recovery in 2018, according to the Office of Inspector General in the Department of Health & Human Services.
In addition, prescriptions for naloxone – the drug that can reverse an opioid overdose – spiked since 2016, rising 501% – and that is likely an underestimate because it doesn’t include doses of the nasal spray Medicare members might have received through local programs, the OIG said.
“For now, the numbers are going in the right direction,” said Miriam Anderson, lead investigator on the report. “But this is a national crisis and we must remain vigilant and continue to fight this epidemic and ensure that opioids are prescribed and used appropriately.”
During the 2 years studied, the threat of new addictions appeared to slow. Prescriptions for an opioid through Medicare Part D decreased by 11%. The numbers of the beneficiaries considered at serious risk for misuse or overdose ― either because they received extreme amounts of opioids or appeared to be “doctor shopping” – dropped 46%. And there were 51% fewer doctors or other providers flagged for prescribing opioids to patients at serious risk from 2016 to 2018.
The report says the OIG and other law enforcement agencies will investigate the highest-level prescribers for possible fraud and signs that some providers operate pill mills. The report mentions a physician in Florida who provided 104 high-risk Medicare patients with 2,619 opioid prescriptions.
It will be up to Medicare to follow up with patients whose opioid use suggests addiction, recreational use, or resale. In one case, a Pennsylvania woman received 10,728 oxycodone pills and 570 fentanyl patches from a single physician during 2018. A Medicare member in Alabama acquired 56 opioid prescriptions from 25 different prescribers within 1 year.
In a statement, the Centers for Medicare & Medicaid Services said: “Fighting the opioid epidemic has been a top priority for the Trump administration. We are encouraged by the OIG’s conclusion which finds significant progress has been made in our efforts to decrease opioid misuse while simultaneously increasing medication-assisted treatment in the Medicare Part D program.”
The agency points to recent efforts to curb opioid misuse including a 7-day limit on first-time opioid prescriptions, pharmacy alerts about Medicare beneficiaries who receive high doses of pain medication, and drug management programs that may restrict a patient’s supply. CMS says it does not use a “one-size-fits-all” approach. Medicare patients in long-term care facilities or hospice care and those in cancer treatment are exempt from the opioid-prescribing restrictions.
The opioid-prescribing limits are raising alarms among some Medicare recipients, especially those who qualify based on a long-term disability and deal with severe, chronic pain.
Jae Kennedy, PhD, a disability policy expert at Washington State University, Spokane, said cutting back on opioid prescriptions is generally a good development.
“But we hear from people in the disability community who feel like they’re being victimized by this new, very stringent set of dispensing limits,” said Dr. Kennedy. “People have been managing their pain, in some cases for many years without a problem, and now they’re being kind of criminalized by this new bureaucratic backlash.”
Ms. Anderson said the OIG agrees that “some patients need opioids and they should receive those needed for their condition. This report raises concerns that some patients may be receiving opioids above and beyond those needs.”
While most Medicare beneficiaries are 65 years or older, the 15% who are under 65 and disabled may be the key piece of this report. Dr. Kennedy’s research shows they are up to three times more likely to describe persistent pain than are other adults and 50% more likely to report opioid misuse. A 2017 OIG report found that 74% of Medicare beneficiaries at serious risk for addiction and overdose deaths were under age 65 years.
Dr. Kennedy said it’s good to see Medicare expanding access to medication-assisted treatment, known as MAT, for addiction, but the agency needs to make sure that more buprenorphine prescribers accept all patients, not just the ones who are easiest to manage. Patients with disabilities often need many different medications for multiple physical and mental health conditions.
“Saying, ‘Well, because you’ve got schizophrenia or manic depressive disorder, we can’t treat you,’ I think is discriminatory,” Dr. Kennedy said. “It’s happening with private buprenorphine prescribers in this country because there are so few.”
Americans 65 years or older have the lowest rates of opioid overdose deaths. Even so, the Centers for Disease Control and Prevention says the number of deaths among seniors increased by 279% from 1999 to 2017.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. WBUR, a public radio station owned by Boston University, is a member station of NPR.
About 174,000 Medicare beneficiaries received such a medication – either buprenorphine or naltrexone – to help them with recovery in 2018, according to the Office of Inspector General in the Department of Health & Human Services.
In addition, prescriptions for naloxone – the drug that can reverse an opioid overdose – spiked since 2016, rising 501% – and that is likely an underestimate because it doesn’t include doses of the nasal spray Medicare members might have received through local programs, the OIG said.
“For now, the numbers are going in the right direction,” said Miriam Anderson, lead investigator on the report. “But this is a national crisis and we must remain vigilant and continue to fight this epidemic and ensure that opioids are prescribed and used appropriately.”
During the 2 years studied, the threat of new addictions appeared to slow. Prescriptions for an opioid through Medicare Part D decreased by 11%. The numbers of the beneficiaries considered at serious risk for misuse or overdose ― either because they received extreme amounts of opioids or appeared to be “doctor shopping” – dropped 46%. And there were 51% fewer doctors or other providers flagged for prescribing opioids to patients at serious risk from 2016 to 2018.
The report says the OIG and other law enforcement agencies will investigate the highest-level prescribers for possible fraud and signs that some providers operate pill mills. The report mentions a physician in Florida who provided 104 high-risk Medicare patients with 2,619 opioid prescriptions.
It will be up to Medicare to follow up with patients whose opioid use suggests addiction, recreational use, or resale. In one case, a Pennsylvania woman received 10,728 oxycodone pills and 570 fentanyl patches from a single physician during 2018. A Medicare member in Alabama acquired 56 opioid prescriptions from 25 different prescribers within 1 year.
In a statement, the Centers for Medicare & Medicaid Services said: “Fighting the opioid epidemic has been a top priority for the Trump administration. We are encouraged by the OIG’s conclusion which finds significant progress has been made in our efforts to decrease opioid misuse while simultaneously increasing medication-assisted treatment in the Medicare Part D program.”
The agency points to recent efforts to curb opioid misuse including a 7-day limit on first-time opioid prescriptions, pharmacy alerts about Medicare beneficiaries who receive high doses of pain medication, and drug management programs that may restrict a patient’s supply. CMS says it does not use a “one-size-fits-all” approach. Medicare patients in long-term care facilities or hospice care and those in cancer treatment are exempt from the opioid-prescribing restrictions.
The opioid-prescribing limits are raising alarms among some Medicare recipients, especially those who qualify based on a long-term disability and deal with severe, chronic pain.
Jae Kennedy, PhD, a disability policy expert at Washington State University, Spokane, said cutting back on opioid prescriptions is generally a good development.
“But we hear from people in the disability community who feel like they’re being victimized by this new, very stringent set of dispensing limits,” said Dr. Kennedy. “People have been managing their pain, in some cases for many years without a problem, and now they’re being kind of criminalized by this new bureaucratic backlash.”
Ms. Anderson said the OIG agrees that “some patients need opioids and they should receive those needed for their condition. This report raises concerns that some patients may be receiving opioids above and beyond those needs.”
While most Medicare beneficiaries are 65 years or older, the 15% who are under 65 and disabled may be the key piece of this report. Dr. Kennedy’s research shows they are up to three times more likely to describe persistent pain than are other adults and 50% more likely to report opioid misuse. A 2017 OIG report found that 74% of Medicare beneficiaries at serious risk for addiction and overdose deaths were under age 65 years.
Dr. Kennedy said it’s good to see Medicare expanding access to medication-assisted treatment, known as MAT, for addiction, but the agency needs to make sure that more buprenorphine prescribers accept all patients, not just the ones who are easiest to manage. Patients with disabilities often need many different medications for multiple physical and mental health conditions.
“Saying, ‘Well, because you’ve got schizophrenia or manic depressive disorder, we can’t treat you,’ I think is discriminatory,” Dr. Kennedy said. “It’s happening with private buprenorphine prescribers in this country because there are so few.”
Americans 65 years or older have the lowest rates of opioid overdose deaths. Even so, the Centers for Disease Control and Prevention says the number of deaths among seniors increased by 279% from 1999 to 2017.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. WBUR, a public radio station owned by Boston University, is a member station of NPR.
About 174,000 Medicare beneficiaries received such a medication – either buprenorphine or naltrexone – to help them with recovery in 2018, according to the Office of Inspector General in the Department of Health & Human Services.
In addition, prescriptions for naloxone – the drug that can reverse an opioid overdose – spiked since 2016, rising 501% – and that is likely an underestimate because it doesn’t include doses of the nasal spray Medicare members might have received through local programs, the OIG said.
“For now, the numbers are going in the right direction,” said Miriam Anderson, lead investigator on the report. “But this is a national crisis and we must remain vigilant and continue to fight this epidemic and ensure that opioids are prescribed and used appropriately.”
During the 2 years studied, the threat of new addictions appeared to slow. Prescriptions for an opioid through Medicare Part D decreased by 11%. The numbers of the beneficiaries considered at serious risk for misuse or overdose ― either because they received extreme amounts of opioids or appeared to be “doctor shopping” – dropped 46%. And there were 51% fewer doctors or other providers flagged for prescribing opioids to patients at serious risk from 2016 to 2018.
The report says the OIG and other law enforcement agencies will investigate the highest-level prescribers for possible fraud and signs that some providers operate pill mills. The report mentions a physician in Florida who provided 104 high-risk Medicare patients with 2,619 opioid prescriptions.
It will be up to Medicare to follow up with patients whose opioid use suggests addiction, recreational use, or resale. In one case, a Pennsylvania woman received 10,728 oxycodone pills and 570 fentanyl patches from a single physician during 2018. A Medicare member in Alabama acquired 56 opioid prescriptions from 25 different prescribers within 1 year.
In a statement, the Centers for Medicare & Medicaid Services said: “Fighting the opioid epidemic has been a top priority for the Trump administration. We are encouraged by the OIG’s conclusion which finds significant progress has been made in our efforts to decrease opioid misuse while simultaneously increasing medication-assisted treatment in the Medicare Part D program.”
The agency points to recent efforts to curb opioid misuse including a 7-day limit on first-time opioid prescriptions, pharmacy alerts about Medicare beneficiaries who receive high doses of pain medication, and drug management programs that may restrict a patient’s supply. CMS says it does not use a “one-size-fits-all” approach. Medicare patients in long-term care facilities or hospice care and those in cancer treatment are exempt from the opioid-prescribing restrictions.
The opioid-prescribing limits are raising alarms among some Medicare recipients, especially those who qualify based on a long-term disability and deal with severe, chronic pain.
Jae Kennedy, PhD, a disability policy expert at Washington State University, Spokane, said cutting back on opioid prescriptions is generally a good development.
“But we hear from people in the disability community who feel like they’re being victimized by this new, very stringent set of dispensing limits,” said Dr. Kennedy. “People have been managing their pain, in some cases for many years without a problem, and now they’re being kind of criminalized by this new bureaucratic backlash.”
Ms. Anderson said the OIG agrees that “some patients need opioids and they should receive those needed for their condition. This report raises concerns that some patients may be receiving opioids above and beyond those needs.”
While most Medicare beneficiaries are 65 years or older, the 15% who are under 65 and disabled may be the key piece of this report. Dr. Kennedy’s research shows they are up to three times more likely to describe persistent pain than are other adults and 50% more likely to report opioid misuse. A 2017 OIG report found that 74% of Medicare beneficiaries at serious risk for addiction and overdose deaths were under age 65 years.
Dr. Kennedy said it’s good to see Medicare expanding access to medication-assisted treatment, known as MAT, for addiction, but the agency needs to make sure that more buprenorphine prescribers accept all patients, not just the ones who are easiest to manage. Patients with disabilities often need many different medications for multiple physical and mental health conditions.
“Saying, ‘Well, because you’ve got schizophrenia or manic depressive disorder, we can’t treat you,’ I think is discriminatory,” Dr. Kennedy said. “It’s happening with private buprenorphine prescribers in this country because there are so few.”
Americans 65 years or older have the lowest rates of opioid overdose deaths. Even so, the Centers for Disease Control and Prevention says the number of deaths among seniors increased by 279% from 1999 to 2017.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. WBUR, a public radio station owned by Boston University, is a member station of NPR.
Acalabrutinib extends PFS in advanced CLL
AMSTERDAM – For patients with relapsed or refractory chronic lymphocytic leukemia (CLL), monotherapy with the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence) was associated with better progression-free survival and a more tolerable safety profile than rituximab combined with either idelalisib (Zydelig) or bendamustine, an interim analysis from the phase 3 ASCEND trial showed.
Among 310 patients with previously treated CLL followed for a median of 16.1 months, the primary endpoint of median progression-free survival (PFS), as assessed by independent reviewers, had not been reached for patients treated with acalabrutinib, compared with 16.5 months for patients treated with idelalisib and rituximab (IdR) or bendamustine and rituximab (BR), reported Paolo Ghia, MD, PhD, from Università Vita-Salute San Raffaele in Milan.
“We show that acalabrutinib improved progression-free survival across all groups, including those with high-risk features,” he said at the annual congress of the European Hematology Association.
Acalabrutinib is approved in the United States for treatment of mantle cell lymphoma that has progressed on at least one prior therapy. It has been shown in preclinical studies to be more selective for BTK than the first-in-class agent ibrutinib (Imbruvica), with less off-target kinase inhibition, Dr. Ghia said.
ASCEND was designed to see whether acalabrutinib monotherapy could offer superior PFS to IdR or BR in patients with CLL who had progressed or were refractory to at least one prior line of therapy.
Patients were randomly assigned, with 155 patients in each arm, to either acalabrutinib 100 mg orally twice daily or the investigator’s choice of either idelalisib 150 mg orally twice daily plus IV rituximab at an initial dose of 375 mg/m2, followed by up to seven doses at 500 mg/m2 delivered every 2 weeks for four infusions, then every 4 weeks for the remaining three infusions or IV bendamustine 70 mg/m2 on days 1 and 2 of each cycle, plus rituximab at the 375 mg/m2 dose on day 1 for the first cycle, followed by 500 mg/m2 for up to six total cycles.
Dr. Ghia presented results of an interim analysis planned for when two-thirds of the predicted PFS events (approximately 79) had occurred.
The baseline patient characteristics were generally similar, with a median age of 68 years in the acalabrutinib arm and 67 years in the comparison arm. Almost half of all patients in each arm had bulky disease, defined as 5 cm or greater. The majority of patients had two or more prior lines of therapy.
The primary endpoint of PFS as assessed by independent review favored acalabrutinib, with a hazard ratio of 0.31 (P less than .0001). Results were similar when acalabrutinib was compared with each of the regimens in the comparison arm (HR, 0.29 vs. IdR, 0.36 vs. BR; P less than .001 for each comparison).
Acalabrutinib was also superior in patients with high-risk cytogenetic features, compared with the other two regimens combined (HR, 0.27; P less than .001).
The benefit of the BTK inhibitor was consistent across all subgroups, including age, sex, performance status, Rai stage at screening, bulky/nonbulky disease, number of prior therapies, presence or absence of deletion 17p or TP53 mutation, mutated or unmutated immunoglobulin heavy chain, and complex/noncomplex karyotype.
Reviewer-assessed objective response rates were similar, occurring in 81% of patients on acalabrutinib and 76% of patients on other regimens.
There were no complete responses in the acalabrutinib arm, compared with two complete responses in the comparison arm. The majority of responses in each arm were partial responses (81% and 74%, respectively).
The median duration of response was not reached with acalabrutinib, compared with 13.6 months with the other therapies (HR, 0.33; P less than .0001).
In all, 85% of patients on acalabrutinib had a response lasting at least 12 months, compared with 60% of patients on the other regimens. There was no difference in overall survival at the 16.1-month median follow-up.
Adverse events of any grade occurred in 94% of patients on acalabrutinib, 99% on IdR, and 80% on BR; the respective incidences of serious adverse events were 29%, 56%, and 26%. Grade 3-4 adverse events occurred in 45%, 86%, and 43% of patients, respectively.
There were 13 treatment-related deaths. Six deaths in the acalabrutinib arm were caused by brain neoplasm, cachexia, cerebral ischemia, malignant lung tumor, neuroendocrine carcinoma, and sepsis. Five deaths among IdR-treated patients included chronic heart failure, cardiopulmonary disease, interstitial lung disease, MI, and pseudomonal pneumonia. Two deaths in BR-treated patients were attributed to acute cardiac failure and a gastric neoplasm.
The results show that “acalabrutinib has demonstrated efficacy in previously untreated and relapsed/refractory CLL and may be considered as an option in the future treatment paradigm,” Dr. Ghia said.
Acalabrutinib monotherapy is currently being compared with ibrutinib monotherapy in patients with relapsed/refractory CLL; in addition, the phase 3 ELEVATE-TN study investigating acalabrutinib in combination with obinutuzumab (Gazyva) versus obinutuzumab plus chlorambucil has reached its primary PFS endpoint and will be reported soon, Dr. Ghia said.
The ASCEND trial is sponsored by Acerta Pharma; AstraZeneca holds majority shares in the company. Dr. Ghia reported consulting fees and honoraria from AstraZeneca and other companies, and research funding from several different companies.
SOURCE: Ghia P et al. EHA Congress, Abstract LB2606.
AMSTERDAM – For patients with relapsed or refractory chronic lymphocytic leukemia (CLL), monotherapy with the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence) was associated with better progression-free survival and a more tolerable safety profile than rituximab combined with either idelalisib (Zydelig) or bendamustine, an interim analysis from the phase 3 ASCEND trial showed.
Among 310 patients with previously treated CLL followed for a median of 16.1 months, the primary endpoint of median progression-free survival (PFS), as assessed by independent reviewers, had not been reached for patients treated with acalabrutinib, compared with 16.5 months for patients treated with idelalisib and rituximab (IdR) or bendamustine and rituximab (BR), reported Paolo Ghia, MD, PhD, from Università Vita-Salute San Raffaele in Milan.
“We show that acalabrutinib improved progression-free survival across all groups, including those with high-risk features,” he said at the annual congress of the European Hematology Association.
Acalabrutinib is approved in the United States for treatment of mantle cell lymphoma that has progressed on at least one prior therapy. It has been shown in preclinical studies to be more selective for BTK than the first-in-class agent ibrutinib (Imbruvica), with less off-target kinase inhibition, Dr. Ghia said.
ASCEND was designed to see whether acalabrutinib monotherapy could offer superior PFS to IdR or BR in patients with CLL who had progressed or were refractory to at least one prior line of therapy.
Patients were randomly assigned, with 155 patients in each arm, to either acalabrutinib 100 mg orally twice daily or the investigator’s choice of either idelalisib 150 mg orally twice daily plus IV rituximab at an initial dose of 375 mg/m2, followed by up to seven doses at 500 mg/m2 delivered every 2 weeks for four infusions, then every 4 weeks for the remaining three infusions or IV bendamustine 70 mg/m2 on days 1 and 2 of each cycle, plus rituximab at the 375 mg/m2 dose on day 1 for the first cycle, followed by 500 mg/m2 for up to six total cycles.
Dr. Ghia presented results of an interim analysis planned for when two-thirds of the predicted PFS events (approximately 79) had occurred.
The baseline patient characteristics were generally similar, with a median age of 68 years in the acalabrutinib arm and 67 years in the comparison arm. Almost half of all patients in each arm had bulky disease, defined as 5 cm or greater. The majority of patients had two or more prior lines of therapy.
The primary endpoint of PFS as assessed by independent review favored acalabrutinib, with a hazard ratio of 0.31 (P less than .0001). Results were similar when acalabrutinib was compared with each of the regimens in the comparison arm (HR, 0.29 vs. IdR, 0.36 vs. BR; P less than .001 for each comparison).
Acalabrutinib was also superior in patients with high-risk cytogenetic features, compared with the other two regimens combined (HR, 0.27; P less than .001).
The benefit of the BTK inhibitor was consistent across all subgroups, including age, sex, performance status, Rai stage at screening, bulky/nonbulky disease, number of prior therapies, presence or absence of deletion 17p or TP53 mutation, mutated or unmutated immunoglobulin heavy chain, and complex/noncomplex karyotype.
Reviewer-assessed objective response rates were similar, occurring in 81% of patients on acalabrutinib and 76% of patients on other regimens.
There were no complete responses in the acalabrutinib arm, compared with two complete responses in the comparison arm. The majority of responses in each arm were partial responses (81% and 74%, respectively).
The median duration of response was not reached with acalabrutinib, compared with 13.6 months with the other therapies (HR, 0.33; P less than .0001).
In all, 85% of patients on acalabrutinib had a response lasting at least 12 months, compared with 60% of patients on the other regimens. There was no difference in overall survival at the 16.1-month median follow-up.
Adverse events of any grade occurred in 94% of patients on acalabrutinib, 99% on IdR, and 80% on BR; the respective incidences of serious adverse events were 29%, 56%, and 26%. Grade 3-4 adverse events occurred in 45%, 86%, and 43% of patients, respectively.
There were 13 treatment-related deaths. Six deaths in the acalabrutinib arm were caused by brain neoplasm, cachexia, cerebral ischemia, malignant lung tumor, neuroendocrine carcinoma, and sepsis. Five deaths among IdR-treated patients included chronic heart failure, cardiopulmonary disease, interstitial lung disease, MI, and pseudomonal pneumonia. Two deaths in BR-treated patients were attributed to acute cardiac failure and a gastric neoplasm.
The results show that “acalabrutinib has demonstrated efficacy in previously untreated and relapsed/refractory CLL and may be considered as an option in the future treatment paradigm,” Dr. Ghia said.
Acalabrutinib monotherapy is currently being compared with ibrutinib monotherapy in patients with relapsed/refractory CLL; in addition, the phase 3 ELEVATE-TN study investigating acalabrutinib in combination with obinutuzumab (Gazyva) versus obinutuzumab plus chlorambucil has reached its primary PFS endpoint and will be reported soon, Dr. Ghia said.
The ASCEND trial is sponsored by Acerta Pharma; AstraZeneca holds majority shares in the company. Dr. Ghia reported consulting fees and honoraria from AstraZeneca and other companies, and research funding from several different companies.
SOURCE: Ghia P et al. EHA Congress, Abstract LB2606.
AMSTERDAM – For patients with relapsed or refractory chronic lymphocytic leukemia (CLL), monotherapy with the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence) was associated with better progression-free survival and a more tolerable safety profile than rituximab combined with either idelalisib (Zydelig) or bendamustine, an interim analysis from the phase 3 ASCEND trial showed.
Among 310 patients with previously treated CLL followed for a median of 16.1 months, the primary endpoint of median progression-free survival (PFS), as assessed by independent reviewers, had not been reached for patients treated with acalabrutinib, compared with 16.5 months for patients treated with idelalisib and rituximab (IdR) or bendamustine and rituximab (BR), reported Paolo Ghia, MD, PhD, from Università Vita-Salute San Raffaele in Milan.
“We show that acalabrutinib improved progression-free survival across all groups, including those with high-risk features,” he said at the annual congress of the European Hematology Association.
Acalabrutinib is approved in the United States for treatment of mantle cell lymphoma that has progressed on at least one prior therapy. It has been shown in preclinical studies to be more selective for BTK than the first-in-class agent ibrutinib (Imbruvica), with less off-target kinase inhibition, Dr. Ghia said.
ASCEND was designed to see whether acalabrutinib monotherapy could offer superior PFS to IdR or BR in patients with CLL who had progressed or were refractory to at least one prior line of therapy.
Patients were randomly assigned, with 155 patients in each arm, to either acalabrutinib 100 mg orally twice daily or the investigator’s choice of either idelalisib 150 mg orally twice daily plus IV rituximab at an initial dose of 375 mg/m2, followed by up to seven doses at 500 mg/m2 delivered every 2 weeks for four infusions, then every 4 weeks for the remaining three infusions or IV bendamustine 70 mg/m2 on days 1 and 2 of each cycle, plus rituximab at the 375 mg/m2 dose on day 1 for the first cycle, followed by 500 mg/m2 for up to six total cycles.
Dr. Ghia presented results of an interim analysis planned for when two-thirds of the predicted PFS events (approximately 79) had occurred.
The baseline patient characteristics were generally similar, with a median age of 68 years in the acalabrutinib arm and 67 years in the comparison arm. Almost half of all patients in each arm had bulky disease, defined as 5 cm or greater. The majority of patients had two or more prior lines of therapy.
The primary endpoint of PFS as assessed by independent review favored acalabrutinib, with a hazard ratio of 0.31 (P less than .0001). Results were similar when acalabrutinib was compared with each of the regimens in the comparison arm (HR, 0.29 vs. IdR, 0.36 vs. BR; P less than .001 for each comparison).
Acalabrutinib was also superior in patients with high-risk cytogenetic features, compared with the other two regimens combined (HR, 0.27; P less than .001).
The benefit of the BTK inhibitor was consistent across all subgroups, including age, sex, performance status, Rai stage at screening, bulky/nonbulky disease, number of prior therapies, presence or absence of deletion 17p or TP53 mutation, mutated or unmutated immunoglobulin heavy chain, and complex/noncomplex karyotype.
Reviewer-assessed objective response rates were similar, occurring in 81% of patients on acalabrutinib and 76% of patients on other regimens.
There were no complete responses in the acalabrutinib arm, compared with two complete responses in the comparison arm. The majority of responses in each arm were partial responses (81% and 74%, respectively).
The median duration of response was not reached with acalabrutinib, compared with 13.6 months with the other therapies (HR, 0.33; P less than .0001).
In all, 85% of patients on acalabrutinib had a response lasting at least 12 months, compared with 60% of patients on the other regimens. There was no difference in overall survival at the 16.1-month median follow-up.
Adverse events of any grade occurred in 94% of patients on acalabrutinib, 99% on IdR, and 80% on BR; the respective incidences of serious adverse events were 29%, 56%, and 26%. Grade 3-4 adverse events occurred in 45%, 86%, and 43% of patients, respectively.
There were 13 treatment-related deaths. Six deaths in the acalabrutinib arm were caused by brain neoplasm, cachexia, cerebral ischemia, malignant lung tumor, neuroendocrine carcinoma, and sepsis. Five deaths among IdR-treated patients included chronic heart failure, cardiopulmonary disease, interstitial lung disease, MI, and pseudomonal pneumonia. Two deaths in BR-treated patients were attributed to acute cardiac failure and a gastric neoplasm.
The results show that “acalabrutinib has demonstrated efficacy in previously untreated and relapsed/refractory CLL and may be considered as an option in the future treatment paradigm,” Dr. Ghia said.
Acalabrutinib monotherapy is currently being compared with ibrutinib monotherapy in patients with relapsed/refractory CLL; in addition, the phase 3 ELEVATE-TN study investigating acalabrutinib in combination with obinutuzumab (Gazyva) versus obinutuzumab plus chlorambucil has reached its primary PFS endpoint and will be reported soon, Dr. Ghia said.
The ASCEND trial is sponsored by Acerta Pharma; AstraZeneca holds majority shares in the company. Dr. Ghia reported consulting fees and honoraria from AstraZeneca and other companies, and research funding from several different companies.
SOURCE: Ghia P et al. EHA Congress, Abstract LB2606.
REPORTING FROM EHA CONGRESS
Establishing the Diagnosis of Rosacea in Skin of Color Patients
Rosacea is a chronic inflammatory cutaneous disorder that affects the vasculature and pilosebaceous units of the face. Delayed and misdiagnosed rosacea in the SOC population has led to increased morbidity in this patient population. 1-3 It is characterized by facial flushing and warmth, erythema, telangiectasia, papules, and pustules. The 4 major subtypes include erythematotelangiectatic, papulopustular, phymatous, and ocular rosacea. 4 Granulomatous rosacea is considered to be a unique variant of rosacea. Until recently, rosacea was thought to predominately affect lighter-skinned individuals of Celtic and northern European origin. 5,6 A paucity of studies and case reports in the literature have contributed to the commonly held belief that rosacea occurs infrequently in patients with skin of color (SOC). 1 A PubMed search of articles indexed for MEDLINE revealed 32 results using the terms skin of color and rosacea vs 3786 using the term rosacea alone. It is possible that the nuance involved in appreciating erythema or other clinical manifestations of rosacea in SOC patients has led to underdiagnosis. Alternatively, these patients may be unaware that their symptoms represent a disease process and do not seek treatment. Many patients with darker skin will have endured rosacea for months or even years because the disease has been unrecognized or misdiagnosed. 6-8 Another factor possibly accounting for the perception that rosacea occurs infrequently in patients with SOC is misdiagnosis of rosacea as other diseases that are known to occur more commonly in the SOC population. Dermatologists should be aware that rosacea can affect SOC patients and that there are several rosacea mimickers to be considered and excluded when making the rosacea diagnosis in this patient population. To promote accurate and timely diagnosis of rosacea, we review several possible rosacea mimickers in SOC patients and highlight the distinguishing features.
Epidemiology
In 2018, a meta-analysis of published studies on rosacea estimated the global prevalence in all adults to be 5.46%.9 A multicenter study across 6 cities in Colombia identified 291 outpatients with rosacea; of them, 12.4% had either Fitzpatrick skin types IV or V.10 A study of 2743 Angolan adults with Fitzpatrick skin types V and VI reported that only 0.4% of patients had a diagnosis of rosacea.11 A Saudi study of 50 dark-skinned female patients with rosacea revealed 40% (20/50), 18% (9/50), and 42% (21/50) were Fitzpatrick skin types IV, V, and VI, respectively.12 The prevalence of rosacea in SOC patients in the United States is less defined. Data from the US National Ambulatory Medical Care Survey (1993-2010) of 31.5 million rosacea visits showed that 2% of rosacea patients were black, 2.3% were Asian or Pacific Islander, and 3.9% were Hispanic or Latino.8
Clinical Features
Each of the 4 major rosacea subtypes can present in the SOC population. The granulomatous variant has been predominantly reported in black patients.13 This predilection has been attributed to either an increased susceptibility in black patients to develop this variant or a delay in diagnosis of earlier phases of inflammatory rosacea.7
In a Saudi study (N=50), severe erythematotelangiectatic rosacea was diagnosed in 42% (21/50) of patients, with the majority having Fitzpatrick skin type IV. The severe papulopustular subtype was seen in 14% (7/50) of patients, with 20% (10/50) and 14% (7/50) having Fitzpatrick skin types IV and VI, respectively.12 In a Tunisian study (N=244), erythematotelangiectatic rosacea was seen in 12% of patients, papulopustular rosacea in 69%, phymatous rosacea in 4%, and ocular rosacea in 16%. Less frequently, the granulomatous variant was seen in 3% of patients, and steroid rosacea was noted in 12% patients.14
Recognizing the signs of rosacea may be a challenge, particularly erythema and telangiectasia. Tips for making an accurate diagnosis include use of adequate lighting, blanching of the skin (Figure 1), photography of the affected area against a dark blue background, and dermatoscopic examination.3 Furthermore, a thorough medical history, especially when evaluating the presence of facial erythema and identifying triggers, may help reach the correct diagnosis. Careful examination of the distribution of papules and pustules as well as the morphology and color of the papules in SOC patients also may provide diagnostic clues.
Differential Diagnosis and Distinguishing Features
Several disorders are included in the differential diagnosis of rosacea and may confound a correct rosacea diagnosis, including systemic lupus erythematosus (SLE), seborrheic dermatitis, dermatomyositis, acne vulgaris, sarcoidosis, and steroid dermatitis. Many of these disorders also occur more commonly in patients with SOC; therefore, it is important to clearly distinguish these entities from rosacea in this population.
Systemic Lupus Erythematosus
Systemic lupus erythematosus is an autoimmune disease that commonly presents with erythema as well as erythematous inflammatory facial lesions similar to rosacea. The classic clinical appearance of SLE is the butterfly or malar rash, an erythematous macular eruption on the malar region of the face that also may involve the nose. This rash can appear similar to rosacea; however, the malar rash classically spares the nasolabial folds, while erythema of rosacea often involves this anatomic boundary. Although the facial erythema in both SLE and early stages of rosacea may be patchy and similar in presentation, the presence of papules and pustules rarely occurs in SLE and may help to differentiate SLE from certain variants of rosacea.15
Both SLE and rosacea may be exacerbated by sun exposure, and patients may report burning and stinging.16-18 Performing a complete physical examination, performing a skin biopsy with hematoxylin and eosin and direct immunofluorescence, and checking serologies including antinuclear antibody (ANA) can assist in making the diagnosis. It is important to note that elevated ANA, albeit lower than what is typically seen in SLE, has been reported in rosacea patients.19 If ANA is elevated, more specific SLE antibodies should be tested (eg, double-stranded DNA). Additionally, SLE can be differentiated on histology by a considerably lower CD4:CD8 ratio, fewer CD4+CD25+ regulatory T cells, and more CD123+ plasmacytoid dendritic cells compared to rosacea.20
Seborrheic Dermatitis
Seborrheic dermatitis is a frequent cause of facial erythema linked to the Malassezia yeast species in susceptible individuals. Seborrheic dermatitis has a notable prevalence in women of African descent and often is considered normal by these patients.21 Rosacea and seborrheic dermatitis are relatively common dermatoses and therefore can present concurrently. In both diseases, facial erythema may be difficult to discern upon cursory inspection. Seborrheic dermatitis may be distinguished from rosacea by the clinical appearance of erythematous patches and plaques involving the scalp, anterior and posterior hairlines, preauricular and postauricular areas, and medial eyebrows. Both seborrheic dermatitis and rosacea may involve the nasolabial folds, but the presence of scale in seborrheic dermatitis is a distinguishing feature. Scale may vary in appearance from thick, greasy, and yellowish to fine, thin, and whitish.22 In contrast to rosacea, the erythematous lesions of seborrheic dermatitis often are annular in configuration. Furthermore, postinflammatory hypopigmentation and, to a lesser extent, postinflammatory hyperpigmentation are key clinical components of seborrheic dermatitis in SOC patients but are not as commonly observed in rosacea.
Dermatomyositis
Dermatomyositis is a systemic autoimmune disease characterized by progressive and symmetric proximal musculoskeletal weakness and cutaneous findings. Facial erythema in the malar and nasolabial folds can be seen in patients with dermatomyositis18; however, the facial erythema seen in dermatomyositis, known as heliotrope rash, has a violaceous dusky quality and also involves the periorbital region. The violaceous hue and periorbital involvement are distinguishing features from rosacea. Okiyama et al23 described facial macular violaceous erythema with scale and edema in Japanese patients with dermatomyositis on the nasolabial folds, eyebrows, chin, cheeks, and ears; they also described mild atrophy with telangiectasia. Other clinical signs to help distinguish rosacea from dermatomyositis are the presence of edema of the face and extremities, Gottron papules, and poikiloderma. Dermatomyositis is a disease that affects all races; however, it is 4 times more common in black vs white patients,24 making it even more important to be able to distinguish between these conditions.
Acne Vulgaris
Acne vulgaris, the most commonly diagnosed dermatosis in patients with SOC, is characterized by papules, pustules, cysts, nodules, open and closed comedones, and hyperpigmented macules on the face, chest, and back.25,26 The absence of comedonal lesions and the presence of hyperpigmented macules distinguishes acne vulgaris from rosacea in this population.1 In addition, the absence of telangiectasia and flushing are important distinguishing factors when making the diagnosis of acne vulgaris.
Sarcoidosis
Sarcoidosis is a multisystem inflammatory disease characterized histologically by the presence of noncaseating granulomas in sites such as the lungs, lymph nodes, eyes, nervous system, liver, spleen, heart, and skin.27 Cutaneous sarcoidosis is known as a great mimicker of many other dermatoses, as it may present with multiple morphologic features. Cutaneous sarcoidosis most typically presents as papules, but nodules, plaques, lupus pernio, subcutaneous infiltrates, and infiltration of scars also have been identified.28 Sarcoid papules typically are 1 to 5 mm in size on the face, neck, and periorbital skin29; they are initially orange or yellow-brown in color, turn brownish red or violaceous, then involute to form faint macules.30 Papular lesions may either resolve or evolve into plaques, particularly on the extremities, face, scalp, back, and buttocks. Additionally, there are a few case reports of patients with cutaneous sarcoidosis presenting with large bulbous nasal masses initially thought to be rhinophyma.31-33 Finally, it may be difficult to distinguish sarcoidosis from granulomatous rosacea, which is characterized by firm yellow, brown, violaceous, red, or flesh-colored monomorphic papules or nodules affecting the perioral, periocular, medial, and/or lateral areas of the face (Figure 2).4,34 Patients also can have unilateral disease.35 Patients with granulomatous rosacea lack flushing and erythema as seen in more characteristic presentations of rosacea. They may report pain, pruritus, or burning, or they may be asymptomatic.36 Features that distinguish granulomatous rosacea from sarcoidosis include the absence of nodules, plaques, lupus pernio, subcutaneous infiltrates, and infiltration of scars. Clinical, histological, and radiographic evaluation are necessary to make the diagnosis of sarcoidosis over rosacea.
Steroid Dermatitis
Steroid dermatitis involving the face may mimic rosacea. It is caused by the application of a potent corticosteroid to the facial skin for a prolonged period of time. In a report from a teaching hospital in Baghdad, the duration of application was 0.25 to 10 years on average.37 Reported characteristics of steroid dermatitis included facial erythema, telangiectasia, papules, pustules, and warmth to the touch. Distinguishing features from rosacea may be the presence of steroid dermatitis on the entire face, whereas rosacea tends to occur on the center of the face. Diagnosis of steroid dermatitis is made based on a history of chronic topical steroid use with rebound flares upon discontinuation of steroid.
Final Thoughts
Rosacea has features common to many other facial dermatoses, making the diagnosis challenging, particularly in patients with SOC. This difficulty in diagnosis may contribute to an underestimation of the prevalence of this disease in SOC patients. An understanding of rosacea, its nuances in clinical appearance, and its mimickers in SOC patients is important in making an accurate diagnosis.
References
- Alexis AF. Rosacea in patients with skin of color: uncommon but not rare. Cutis. 2010;86:60-62.
- Kim NH, Yun SJ, Lee JB. Clinical features of Korean patients with rhinophyma. J Dermatol. 2017;44:710-712.
- Hua TC, Chung PI, Chen YJ, et al. Cardiovascular comorbidities in patients with rosacea: a nationwide case-control study from Taiwan. J Am Acad Dermatol. 2015;73:249-254.
- Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;46:584-587.
- Elewski BE, Draelos Z, Dreno B, et al. Global diversity and optimized outcome: proposed international consensus from the Rosacea International Expert Group. J Eur Acad Dermatol Venereol. 2011;25:188-200.
- Alexis AF, Callender VD, Baldwin HE, et al. Global epidemiology and clinical spectrum of rosacea, highlighting skin of color: review and clinical practice experience [published online September 19, 2018]. J Am Acad Dermatol. 2019;80:1722-1729.e7.
- Dlova NC, Mosam A. Rosacea in black South Africans with skin phototypes V and VI. Clin Exp Dermatol. 2017;42:670-673.
- Al-Dabagh A, Davis SA, McMichael AJ, et al. Rosacea in skin of color: not a rare diagnosis [published online October 15, 2014]. Dermatol Online J. 2014;20. pii:13030/qt1mv9r0ss.
- Gether L, Overgaard LK, Egeberg A, et al. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Br J Dermatol. 2018;179:282-289.
- Rueda LJ, Motta A, Pabon JG, et al. Epidemiology of rosacea in Colombia. Int J Dermatol. 2017;56:510-513.
- De Luca DA, Maianski Z, Averbukh M. A study of skin disease spectrum occurring in Angola phototype V-VI population in Luanda. Int J Dermatol. 2018;57:849-855.
- Al Balbeesi AO, Halawani MR. Unusual features of rosacea in Saudi females with dark skin. Ochsner J. 2014;14:321-327.
- Rosen T, Stone MS. Acne rosacea in blacks. J Am Acad Dermatol. 1987;17:70-73.
- Khaled A, Hammami H, Zeglaoui F, et al. Rosacea: 244 Tunisian cases. Tunis Med. 2010;88:597-601.
- Usatine RP, Smith MA, Chumley HS, et al. The Color Atlas of Family Medicine. 2nd ed. New York, NY: The McGraw-Hill Companies; 2013.
- O'Gorman SM, Murphy GM. Photoaggravated disorders. Dermatol Clin. 2014;32:385-398, ix.
- Foering K, Chang AY, Piette EW, et al. Characterization of clinical photosensitivity in cutaneous lupus erythematosus. J Am Acad Dermatol. 2013;69:205-213.
- Saleem MD, Wilkin JK. Evaluating and optimizing the diagnosis of erythematotelangiectatic rosacea. Dermatol Clin. 2018;36:127-134.
- Black AA, McCauliffe DP, Sontheimer RD. Prevalence of acne rosacea in a rheumatic skin disease subspecialty clinic. Lupus. 1992;1:229-237.
- Brown TT, Choi EY, Thomas DG, et al. Comparative analysis of rosacea and cutaneous lupus erythematosus: histopathologic features, T-cell subsets, and plasmacytoid dendritic cells. J Am Acad Dermatol. 2014;71:100-107.
- Taylor SC, Barbosa V, Burgess C, et al. Hair and scalp disorders in adult and pediatric patients with skin of color. Cutis. 2017;100:31-35.
- Gary G. Optimizing treatment approaches in seborrheic dermatitis. J Clin Aesthet Dermatol. 2013;6:44-49.
- Okiyama N, Kohsaka H, Ueda N, et al. Seborrheic area erythema as a common skin manifestation in Japanese patients with dermatomyositis. Dermatology. 2008;217:374-377.
- Taylor SC, Kyei A. Defining skin of color. In: Taylor SC, Kelly AP, Lim HW, et al, eds. Taylor and Kelly's Dermatology for Skin of Color. 2nd ed. New York, NY: McGraw-Hill; 2016:9-15.
- Davis SA, Narahari S, Feldman SR, et al. Top dermatologic conditions in patients of color: an analysis of nationally representative data. J Drugs Dermatol. 2012;11:466-473.
- Taylor SC, Cook-Bolden F, Rahman Z, et al. Acne vulgaris in skin of color. J Am Acad Dermatol. 2002;46(2 suppl understanding):S98-S106.
- Wick MR. Granulomatous & histiocytic dermatitides. Semin Diagn Pathol. 2017;34:301-311.
- Ball NJ, Kho GT, Martinka M. The histologic spectrum of cutaneous sarcoidosis: a study of twenty-eight cases. J Cutan Pathol. 2004;31:160-168.
- Marchell RM, Judson MA. Chronic cutaneous lesions of sarcoidosis. Clin Dermatol. 2007;25:295-302.
- Mahajan VK, Sharma NL, Sharma RC, et al. Cutaneous sarcoidosis: clinical profile of 23 Indian patients. Indian J Dermatol Venereol Leprol. 2007;73:16-21.
- Goldenberg JD, Kotler HS, Shamsai R, et al. Sarcoidosis of the external nose mimicking rhinophyma. case report and review of the literature. Ann Otol Rhinol Laryngol. 1998;107:514-518.
- Gupta-Elera G, Lam C, Chung C, et al. Violaceous plaque on the nose referred for rhinophyma surgery. Int J Dermatol. 2015;54:1011-1013.
- Leonard AL. A case of sarcoidosis mimicking rhinophyma. J Drugs Dermatol. 2003;2:333-334.
- Kelati A, Mernissi FZ. Granulomatous rosacea: a case report. J Med Case Rep. 2017;11:230.
- Crawford GH, Pelle MT, James WD. Rosacea: I. etiology, pathogenesis, and subtype classification. J Am Acad Dermatol. 2004;51:327-341; quiz 342-324.
- Reinholz M, Ruzicka T, Steinhoff M, et al. Pathogenesis and clinical presentation of rosacea as a key for a symptom-oriented therapy. J Dtsch Dermatol Ges. 2016;14(suppl 6):4-15.
- Hameed AF. Steroid dermatitis resembling rosacea: a clinical evaluation of 75 patients. ISRN Dermatol. 2013;2013:491376.
Rosacea is a chronic inflammatory cutaneous disorder that affects the vasculature and pilosebaceous units of the face. Delayed and misdiagnosed rosacea in the SOC population has led to increased morbidity in this patient population. 1-3 It is characterized by facial flushing and warmth, erythema, telangiectasia, papules, and pustules. The 4 major subtypes include erythematotelangiectatic, papulopustular, phymatous, and ocular rosacea. 4 Granulomatous rosacea is considered to be a unique variant of rosacea. Until recently, rosacea was thought to predominately affect lighter-skinned individuals of Celtic and northern European origin. 5,6 A paucity of studies and case reports in the literature have contributed to the commonly held belief that rosacea occurs infrequently in patients with skin of color (SOC). 1 A PubMed search of articles indexed for MEDLINE revealed 32 results using the terms skin of color and rosacea vs 3786 using the term rosacea alone. It is possible that the nuance involved in appreciating erythema or other clinical manifestations of rosacea in SOC patients has led to underdiagnosis. Alternatively, these patients may be unaware that their symptoms represent a disease process and do not seek treatment. Many patients with darker skin will have endured rosacea for months or even years because the disease has been unrecognized or misdiagnosed. 6-8 Another factor possibly accounting for the perception that rosacea occurs infrequently in patients with SOC is misdiagnosis of rosacea as other diseases that are known to occur more commonly in the SOC population. Dermatologists should be aware that rosacea can affect SOC patients and that there are several rosacea mimickers to be considered and excluded when making the rosacea diagnosis in this patient population. To promote accurate and timely diagnosis of rosacea, we review several possible rosacea mimickers in SOC patients and highlight the distinguishing features.
Epidemiology
In 2018, a meta-analysis of published studies on rosacea estimated the global prevalence in all adults to be 5.46%.9 A multicenter study across 6 cities in Colombia identified 291 outpatients with rosacea; of them, 12.4% had either Fitzpatrick skin types IV or V.10 A study of 2743 Angolan adults with Fitzpatrick skin types V and VI reported that only 0.4% of patients had a diagnosis of rosacea.11 A Saudi study of 50 dark-skinned female patients with rosacea revealed 40% (20/50), 18% (9/50), and 42% (21/50) were Fitzpatrick skin types IV, V, and VI, respectively.12 The prevalence of rosacea in SOC patients in the United States is less defined. Data from the US National Ambulatory Medical Care Survey (1993-2010) of 31.5 million rosacea visits showed that 2% of rosacea patients were black, 2.3% were Asian or Pacific Islander, and 3.9% were Hispanic or Latino.8
Clinical Features
Each of the 4 major rosacea subtypes can present in the SOC population. The granulomatous variant has been predominantly reported in black patients.13 This predilection has been attributed to either an increased susceptibility in black patients to develop this variant or a delay in diagnosis of earlier phases of inflammatory rosacea.7
In a Saudi study (N=50), severe erythematotelangiectatic rosacea was diagnosed in 42% (21/50) of patients, with the majority having Fitzpatrick skin type IV. The severe papulopustular subtype was seen in 14% (7/50) of patients, with 20% (10/50) and 14% (7/50) having Fitzpatrick skin types IV and VI, respectively.12 In a Tunisian study (N=244), erythematotelangiectatic rosacea was seen in 12% of patients, papulopustular rosacea in 69%, phymatous rosacea in 4%, and ocular rosacea in 16%. Less frequently, the granulomatous variant was seen in 3% of patients, and steroid rosacea was noted in 12% patients.14
Recognizing the signs of rosacea may be a challenge, particularly erythema and telangiectasia. Tips for making an accurate diagnosis include use of adequate lighting, blanching of the skin (Figure 1), photography of the affected area against a dark blue background, and dermatoscopic examination.3 Furthermore, a thorough medical history, especially when evaluating the presence of facial erythema and identifying triggers, may help reach the correct diagnosis. Careful examination of the distribution of papules and pustules as well as the morphology and color of the papules in SOC patients also may provide diagnostic clues.
Differential Diagnosis and Distinguishing Features
Several disorders are included in the differential diagnosis of rosacea and may confound a correct rosacea diagnosis, including systemic lupus erythematosus (SLE), seborrheic dermatitis, dermatomyositis, acne vulgaris, sarcoidosis, and steroid dermatitis. Many of these disorders also occur more commonly in patients with SOC; therefore, it is important to clearly distinguish these entities from rosacea in this population.
Systemic Lupus Erythematosus
Systemic lupus erythematosus is an autoimmune disease that commonly presents with erythema as well as erythematous inflammatory facial lesions similar to rosacea. The classic clinical appearance of SLE is the butterfly or malar rash, an erythematous macular eruption on the malar region of the face that also may involve the nose. This rash can appear similar to rosacea; however, the malar rash classically spares the nasolabial folds, while erythema of rosacea often involves this anatomic boundary. Although the facial erythema in both SLE and early stages of rosacea may be patchy and similar in presentation, the presence of papules and pustules rarely occurs in SLE and may help to differentiate SLE from certain variants of rosacea.15
Both SLE and rosacea may be exacerbated by sun exposure, and patients may report burning and stinging.16-18 Performing a complete physical examination, performing a skin biopsy with hematoxylin and eosin and direct immunofluorescence, and checking serologies including antinuclear antibody (ANA) can assist in making the diagnosis. It is important to note that elevated ANA, albeit lower than what is typically seen in SLE, has been reported in rosacea patients.19 If ANA is elevated, more specific SLE antibodies should be tested (eg, double-stranded DNA). Additionally, SLE can be differentiated on histology by a considerably lower CD4:CD8 ratio, fewer CD4+CD25+ regulatory T cells, and more CD123+ plasmacytoid dendritic cells compared to rosacea.20
Seborrheic Dermatitis
Seborrheic dermatitis is a frequent cause of facial erythema linked to the Malassezia yeast species in susceptible individuals. Seborrheic dermatitis has a notable prevalence in women of African descent and often is considered normal by these patients.21 Rosacea and seborrheic dermatitis are relatively common dermatoses and therefore can present concurrently. In both diseases, facial erythema may be difficult to discern upon cursory inspection. Seborrheic dermatitis may be distinguished from rosacea by the clinical appearance of erythematous patches and plaques involving the scalp, anterior and posterior hairlines, preauricular and postauricular areas, and medial eyebrows. Both seborrheic dermatitis and rosacea may involve the nasolabial folds, but the presence of scale in seborrheic dermatitis is a distinguishing feature. Scale may vary in appearance from thick, greasy, and yellowish to fine, thin, and whitish.22 In contrast to rosacea, the erythematous lesions of seborrheic dermatitis often are annular in configuration. Furthermore, postinflammatory hypopigmentation and, to a lesser extent, postinflammatory hyperpigmentation are key clinical components of seborrheic dermatitis in SOC patients but are not as commonly observed in rosacea.
Dermatomyositis
Dermatomyositis is a systemic autoimmune disease characterized by progressive and symmetric proximal musculoskeletal weakness and cutaneous findings. Facial erythema in the malar and nasolabial folds can be seen in patients with dermatomyositis18; however, the facial erythema seen in dermatomyositis, known as heliotrope rash, has a violaceous dusky quality and also involves the periorbital region. The violaceous hue and periorbital involvement are distinguishing features from rosacea. Okiyama et al23 described facial macular violaceous erythema with scale and edema in Japanese patients with dermatomyositis on the nasolabial folds, eyebrows, chin, cheeks, and ears; they also described mild atrophy with telangiectasia. Other clinical signs to help distinguish rosacea from dermatomyositis are the presence of edema of the face and extremities, Gottron papules, and poikiloderma. Dermatomyositis is a disease that affects all races; however, it is 4 times more common in black vs white patients,24 making it even more important to be able to distinguish between these conditions.
Acne Vulgaris
Acne vulgaris, the most commonly diagnosed dermatosis in patients with SOC, is characterized by papules, pustules, cysts, nodules, open and closed comedones, and hyperpigmented macules on the face, chest, and back.25,26 The absence of comedonal lesions and the presence of hyperpigmented macules distinguishes acne vulgaris from rosacea in this population.1 In addition, the absence of telangiectasia and flushing are important distinguishing factors when making the diagnosis of acne vulgaris.
Sarcoidosis
Sarcoidosis is a multisystem inflammatory disease characterized histologically by the presence of noncaseating granulomas in sites such as the lungs, lymph nodes, eyes, nervous system, liver, spleen, heart, and skin.27 Cutaneous sarcoidosis is known as a great mimicker of many other dermatoses, as it may present with multiple morphologic features. Cutaneous sarcoidosis most typically presents as papules, but nodules, plaques, lupus pernio, subcutaneous infiltrates, and infiltration of scars also have been identified.28 Sarcoid papules typically are 1 to 5 mm in size on the face, neck, and periorbital skin29; they are initially orange or yellow-brown in color, turn brownish red or violaceous, then involute to form faint macules.30 Papular lesions may either resolve or evolve into plaques, particularly on the extremities, face, scalp, back, and buttocks. Additionally, there are a few case reports of patients with cutaneous sarcoidosis presenting with large bulbous nasal masses initially thought to be rhinophyma.31-33 Finally, it may be difficult to distinguish sarcoidosis from granulomatous rosacea, which is characterized by firm yellow, brown, violaceous, red, or flesh-colored monomorphic papules or nodules affecting the perioral, periocular, medial, and/or lateral areas of the face (Figure 2).4,34 Patients also can have unilateral disease.35 Patients with granulomatous rosacea lack flushing and erythema as seen in more characteristic presentations of rosacea. They may report pain, pruritus, or burning, or they may be asymptomatic.36 Features that distinguish granulomatous rosacea from sarcoidosis include the absence of nodules, plaques, lupus pernio, subcutaneous infiltrates, and infiltration of scars. Clinical, histological, and radiographic evaluation are necessary to make the diagnosis of sarcoidosis over rosacea.
Steroid Dermatitis
Steroid dermatitis involving the face may mimic rosacea. It is caused by the application of a potent corticosteroid to the facial skin for a prolonged period of time. In a report from a teaching hospital in Baghdad, the duration of application was 0.25 to 10 years on average.37 Reported characteristics of steroid dermatitis included facial erythema, telangiectasia, papules, pustules, and warmth to the touch. Distinguishing features from rosacea may be the presence of steroid dermatitis on the entire face, whereas rosacea tends to occur on the center of the face. Diagnosis of steroid dermatitis is made based on a history of chronic topical steroid use with rebound flares upon discontinuation of steroid.
Final Thoughts
Rosacea has features common to many other facial dermatoses, making the diagnosis challenging, particularly in patients with SOC. This difficulty in diagnosis may contribute to an underestimation of the prevalence of this disease in SOC patients. An understanding of rosacea, its nuances in clinical appearance, and its mimickers in SOC patients is important in making an accurate diagnosis.
References
Rosacea is a chronic inflammatory cutaneous disorder that affects the vasculature and pilosebaceous units of the face. Delayed and misdiagnosed rosacea in the SOC population has led to increased morbidity in this patient population. 1-3 It is characterized by facial flushing and warmth, erythema, telangiectasia, papules, and pustules. The 4 major subtypes include erythematotelangiectatic, papulopustular, phymatous, and ocular rosacea. 4 Granulomatous rosacea is considered to be a unique variant of rosacea. Until recently, rosacea was thought to predominately affect lighter-skinned individuals of Celtic and northern European origin. 5,6 A paucity of studies and case reports in the literature have contributed to the commonly held belief that rosacea occurs infrequently in patients with skin of color (SOC). 1 A PubMed search of articles indexed for MEDLINE revealed 32 results using the terms skin of color and rosacea vs 3786 using the term rosacea alone. It is possible that the nuance involved in appreciating erythema or other clinical manifestations of rosacea in SOC patients has led to underdiagnosis. Alternatively, these patients may be unaware that their symptoms represent a disease process and do not seek treatment. Many patients with darker skin will have endured rosacea for months or even years because the disease has been unrecognized or misdiagnosed. 6-8 Another factor possibly accounting for the perception that rosacea occurs infrequently in patients with SOC is misdiagnosis of rosacea as other diseases that are known to occur more commonly in the SOC population. Dermatologists should be aware that rosacea can affect SOC patients and that there are several rosacea mimickers to be considered and excluded when making the rosacea diagnosis in this patient population. To promote accurate and timely diagnosis of rosacea, we review several possible rosacea mimickers in SOC patients and highlight the distinguishing features.
Epidemiology
In 2018, a meta-analysis of published studies on rosacea estimated the global prevalence in all adults to be 5.46%.9 A multicenter study across 6 cities in Colombia identified 291 outpatients with rosacea; of them, 12.4% had either Fitzpatrick skin types IV or V.10 A study of 2743 Angolan adults with Fitzpatrick skin types V and VI reported that only 0.4% of patients had a diagnosis of rosacea.11 A Saudi study of 50 dark-skinned female patients with rosacea revealed 40% (20/50), 18% (9/50), and 42% (21/50) were Fitzpatrick skin types IV, V, and VI, respectively.12 The prevalence of rosacea in SOC patients in the United States is less defined. Data from the US National Ambulatory Medical Care Survey (1993-2010) of 31.5 million rosacea visits showed that 2% of rosacea patients were black, 2.3% were Asian or Pacific Islander, and 3.9% were Hispanic or Latino.8
Clinical Features
Each of the 4 major rosacea subtypes can present in the SOC population. The granulomatous variant has been predominantly reported in black patients.13 This predilection has been attributed to either an increased susceptibility in black patients to develop this variant or a delay in diagnosis of earlier phases of inflammatory rosacea.7
In a Saudi study (N=50), severe erythematotelangiectatic rosacea was diagnosed in 42% (21/50) of patients, with the majority having Fitzpatrick skin type IV. The severe papulopustular subtype was seen in 14% (7/50) of patients, with 20% (10/50) and 14% (7/50) having Fitzpatrick skin types IV and VI, respectively.12 In a Tunisian study (N=244), erythematotelangiectatic rosacea was seen in 12% of patients, papulopustular rosacea in 69%, phymatous rosacea in 4%, and ocular rosacea in 16%. Less frequently, the granulomatous variant was seen in 3% of patients, and steroid rosacea was noted in 12% patients.14
Recognizing the signs of rosacea may be a challenge, particularly erythema and telangiectasia. Tips for making an accurate diagnosis include use of adequate lighting, blanching of the skin (Figure 1), photography of the affected area against a dark blue background, and dermatoscopic examination.3 Furthermore, a thorough medical history, especially when evaluating the presence of facial erythema and identifying triggers, may help reach the correct diagnosis. Careful examination of the distribution of papules and pustules as well as the morphology and color of the papules in SOC patients also may provide diagnostic clues.
Differential Diagnosis and Distinguishing Features
Several disorders are included in the differential diagnosis of rosacea and may confound a correct rosacea diagnosis, including systemic lupus erythematosus (SLE), seborrheic dermatitis, dermatomyositis, acne vulgaris, sarcoidosis, and steroid dermatitis. Many of these disorders also occur more commonly in patients with SOC; therefore, it is important to clearly distinguish these entities from rosacea in this population.
Systemic Lupus Erythematosus
Systemic lupus erythematosus is an autoimmune disease that commonly presents with erythema as well as erythematous inflammatory facial lesions similar to rosacea. The classic clinical appearance of SLE is the butterfly or malar rash, an erythematous macular eruption on the malar region of the face that also may involve the nose. This rash can appear similar to rosacea; however, the malar rash classically spares the nasolabial folds, while erythema of rosacea often involves this anatomic boundary. Although the facial erythema in both SLE and early stages of rosacea may be patchy and similar in presentation, the presence of papules and pustules rarely occurs in SLE and may help to differentiate SLE from certain variants of rosacea.15
Both SLE and rosacea may be exacerbated by sun exposure, and patients may report burning and stinging.16-18 Performing a complete physical examination, performing a skin biopsy with hematoxylin and eosin and direct immunofluorescence, and checking serologies including antinuclear antibody (ANA) can assist in making the diagnosis. It is important to note that elevated ANA, albeit lower than what is typically seen in SLE, has been reported in rosacea patients.19 If ANA is elevated, more specific SLE antibodies should be tested (eg, double-stranded DNA). Additionally, SLE can be differentiated on histology by a considerably lower CD4:CD8 ratio, fewer CD4+CD25+ regulatory T cells, and more CD123+ plasmacytoid dendritic cells compared to rosacea.20
Seborrheic Dermatitis
Seborrheic dermatitis is a frequent cause of facial erythema linked to the Malassezia yeast species in susceptible individuals. Seborrheic dermatitis has a notable prevalence in women of African descent and often is considered normal by these patients.21 Rosacea and seborrheic dermatitis are relatively common dermatoses and therefore can present concurrently. In both diseases, facial erythema may be difficult to discern upon cursory inspection. Seborrheic dermatitis may be distinguished from rosacea by the clinical appearance of erythematous patches and plaques involving the scalp, anterior and posterior hairlines, preauricular and postauricular areas, and medial eyebrows. Both seborrheic dermatitis and rosacea may involve the nasolabial folds, but the presence of scale in seborrheic dermatitis is a distinguishing feature. Scale may vary in appearance from thick, greasy, and yellowish to fine, thin, and whitish.22 In contrast to rosacea, the erythematous lesions of seborrheic dermatitis often are annular in configuration. Furthermore, postinflammatory hypopigmentation and, to a lesser extent, postinflammatory hyperpigmentation are key clinical components of seborrheic dermatitis in SOC patients but are not as commonly observed in rosacea.
Dermatomyositis
Dermatomyositis is a systemic autoimmune disease characterized by progressive and symmetric proximal musculoskeletal weakness and cutaneous findings. Facial erythema in the malar and nasolabial folds can be seen in patients with dermatomyositis18; however, the facial erythema seen in dermatomyositis, known as heliotrope rash, has a violaceous dusky quality and also involves the periorbital region. The violaceous hue and periorbital involvement are distinguishing features from rosacea. Okiyama et al23 described facial macular violaceous erythema with scale and edema in Japanese patients with dermatomyositis on the nasolabial folds, eyebrows, chin, cheeks, and ears; they also described mild atrophy with telangiectasia. Other clinical signs to help distinguish rosacea from dermatomyositis are the presence of edema of the face and extremities, Gottron papules, and poikiloderma. Dermatomyositis is a disease that affects all races; however, it is 4 times more common in black vs white patients,24 making it even more important to be able to distinguish between these conditions.
Acne Vulgaris
Acne vulgaris, the most commonly diagnosed dermatosis in patients with SOC, is characterized by papules, pustules, cysts, nodules, open and closed comedones, and hyperpigmented macules on the face, chest, and back.25,26 The absence of comedonal lesions and the presence of hyperpigmented macules distinguishes acne vulgaris from rosacea in this population.1 In addition, the absence of telangiectasia and flushing are important distinguishing factors when making the diagnosis of acne vulgaris.
Sarcoidosis
Sarcoidosis is a multisystem inflammatory disease characterized histologically by the presence of noncaseating granulomas in sites such as the lungs, lymph nodes, eyes, nervous system, liver, spleen, heart, and skin.27 Cutaneous sarcoidosis is known as a great mimicker of many other dermatoses, as it may present with multiple morphologic features. Cutaneous sarcoidosis most typically presents as papules, but nodules, plaques, lupus pernio, subcutaneous infiltrates, and infiltration of scars also have been identified.28 Sarcoid papules typically are 1 to 5 mm in size on the face, neck, and periorbital skin29; they are initially orange or yellow-brown in color, turn brownish red or violaceous, then involute to form faint macules.30 Papular lesions may either resolve or evolve into plaques, particularly on the extremities, face, scalp, back, and buttocks. Additionally, there are a few case reports of patients with cutaneous sarcoidosis presenting with large bulbous nasal masses initially thought to be rhinophyma.31-33 Finally, it may be difficult to distinguish sarcoidosis from granulomatous rosacea, which is characterized by firm yellow, brown, violaceous, red, or flesh-colored monomorphic papules or nodules affecting the perioral, periocular, medial, and/or lateral areas of the face (Figure 2).4,34 Patients also can have unilateral disease.35 Patients with granulomatous rosacea lack flushing and erythema as seen in more characteristic presentations of rosacea. They may report pain, pruritus, or burning, or they may be asymptomatic.36 Features that distinguish granulomatous rosacea from sarcoidosis include the absence of nodules, plaques, lupus pernio, subcutaneous infiltrates, and infiltration of scars. Clinical, histological, and radiographic evaluation are necessary to make the diagnosis of sarcoidosis over rosacea.
Steroid Dermatitis
Steroid dermatitis involving the face may mimic rosacea. It is caused by the application of a potent corticosteroid to the facial skin for a prolonged period of time. In a report from a teaching hospital in Baghdad, the duration of application was 0.25 to 10 years on average.37 Reported characteristics of steroid dermatitis included facial erythema, telangiectasia, papules, pustules, and warmth to the touch. Distinguishing features from rosacea may be the presence of steroid dermatitis on the entire face, whereas rosacea tends to occur on the center of the face. Diagnosis of steroid dermatitis is made based on a history of chronic topical steroid use with rebound flares upon discontinuation of steroid.
Final Thoughts
Rosacea has features common to many other facial dermatoses, making the diagnosis challenging, particularly in patients with SOC. This difficulty in diagnosis may contribute to an underestimation of the prevalence of this disease in SOC patients. An understanding of rosacea, its nuances in clinical appearance, and its mimickers in SOC patients is important in making an accurate diagnosis.
References
- Alexis AF. Rosacea in patients with skin of color: uncommon but not rare. Cutis. 2010;86:60-62.
- Kim NH, Yun SJ, Lee JB. Clinical features of Korean patients with rhinophyma. J Dermatol. 2017;44:710-712.
- Hua TC, Chung PI, Chen YJ, et al. Cardiovascular comorbidities in patients with rosacea: a nationwide case-control study from Taiwan. J Am Acad Dermatol. 2015;73:249-254.
- Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;46:584-587.
- Elewski BE, Draelos Z, Dreno B, et al. Global diversity and optimized outcome: proposed international consensus from the Rosacea International Expert Group. J Eur Acad Dermatol Venereol. 2011;25:188-200.
- Alexis AF, Callender VD, Baldwin HE, et al. Global epidemiology and clinical spectrum of rosacea, highlighting skin of color: review and clinical practice experience [published online September 19, 2018]. J Am Acad Dermatol. 2019;80:1722-1729.e7.
- Dlova NC, Mosam A. Rosacea in black South Africans with skin phototypes V and VI. Clin Exp Dermatol. 2017;42:670-673.
- Al-Dabagh A, Davis SA, McMichael AJ, et al. Rosacea in skin of color: not a rare diagnosis [published online October 15, 2014]. Dermatol Online J. 2014;20. pii:13030/qt1mv9r0ss.
- Gether L, Overgaard LK, Egeberg A, et al. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Br J Dermatol. 2018;179:282-289.
- Rueda LJ, Motta A, Pabon JG, et al. Epidemiology of rosacea in Colombia. Int J Dermatol. 2017;56:510-513.
- De Luca DA, Maianski Z, Averbukh M. A study of skin disease spectrum occurring in Angola phototype V-VI population in Luanda. Int J Dermatol. 2018;57:849-855.
- Al Balbeesi AO, Halawani MR. Unusual features of rosacea in Saudi females with dark skin. Ochsner J. 2014;14:321-327.
- Rosen T, Stone MS. Acne rosacea in blacks. J Am Acad Dermatol. 1987;17:70-73.
- Khaled A, Hammami H, Zeglaoui F, et al. Rosacea: 244 Tunisian cases. Tunis Med. 2010;88:597-601.
- Usatine RP, Smith MA, Chumley HS, et al. The Color Atlas of Family Medicine. 2nd ed. New York, NY: The McGraw-Hill Companies; 2013.
- O'Gorman SM, Murphy GM. Photoaggravated disorders. Dermatol Clin. 2014;32:385-398, ix.
- Foering K, Chang AY, Piette EW, et al. Characterization of clinical photosensitivity in cutaneous lupus erythematosus. J Am Acad Dermatol. 2013;69:205-213.
- Saleem MD, Wilkin JK. Evaluating and optimizing the diagnosis of erythematotelangiectatic rosacea. Dermatol Clin. 2018;36:127-134.
- Black AA, McCauliffe DP, Sontheimer RD. Prevalence of acne rosacea in a rheumatic skin disease subspecialty clinic. Lupus. 1992;1:229-237.
- Brown TT, Choi EY, Thomas DG, et al. Comparative analysis of rosacea and cutaneous lupus erythematosus: histopathologic features, T-cell subsets, and plasmacytoid dendritic cells. J Am Acad Dermatol. 2014;71:100-107.
- Taylor SC, Barbosa V, Burgess C, et al. Hair and scalp disorders in adult and pediatric patients with skin of color. Cutis. 2017;100:31-35.
- Gary G. Optimizing treatment approaches in seborrheic dermatitis. J Clin Aesthet Dermatol. 2013;6:44-49.
- Okiyama N, Kohsaka H, Ueda N, et al. Seborrheic area erythema as a common skin manifestation in Japanese patients with dermatomyositis. Dermatology. 2008;217:374-377.
- Taylor SC, Kyei A. Defining skin of color. In: Taylor SC, Kelly AP, Lim HW, et al, eds. Taylor and Kelly's Dermatology for Skin of Color. 2nd ed. New York, NY: McGraw-Hill; 2016:9-15.
- Davis SA, Narahari S, Feldman SR, et al. Top dermatologic conditions in patients of color: an analysis of nationally representative data. J Drugs Dermatol. 2012;11:466-473.
- Taylor SC, Cook-Bolden F, Rahman Z, et al. Acne vulgaris in skin of color. J Am Acad Dermatol. 2002;46(2 suppl understanding):S98-S106.
- Wick MR. Granulomatous & histiocytic dermatitides. Semin Diagn Pathol. 2017;34:301-311.
- Ball NJ, Kho GT, Martinka M. The histologic spectrum of cutaneous sarcoidosis: a study of twenty-eight cases. J Cutan Pathol. 2004;31:160-168.
- Marchell RM, Judson MA. Chronic cutaneous lesions of sarcoidosis. Clin Dermatol. 2007;25:295-302.
- Mahajan VK, Sharma NL, Sharma RC, et al. Cutaneous sarcoidosis: clinical profile of 23 Indian patients. Indian J Dermatol Venereol Leprol. 2007;73:16-21.
- Goldenberg JD, Kotler HS, Shamsai R, et al. Sarcoidosis of the external nose mimicking rhinophyma. case report and review of the literature. Ann Otol Rhinol Laryngol. 1998;107:514-518.
- Gupta-Elera G, Lam C, Chung C, et al. Violaceous plaque on the nose referred for rhinophyma surgery. Int J Dermatol. 2015;54:1011-1013.
- Leonard AL. A case of sarcoidosis mimicking rhinophyma. J Drugs Dermatol. 2003;2:333-334.
- Kelati A, Mernissi FZ. Granulomatous rosacea: a case report. J Med Case Rep. 2017;11:230.
- Crawford GH, Pelle MT, James WD. Rosacea: I. etiology, pathogenesis, and subtype classification. J Am Acad Dermatol. 2004;51:327-341; quiz 342-324.
- Reinholz M, Ruzicka T, Steinhoff M, et al. Pathogenesis and clinical presentation of rosacea as a key for a symptom-oriented therapy. J Dtsch Dermatol Ges. 2016;14(suppl 6):4-15.
- Hameed AF. Steroid dermatitis resembling rosacea: a clinical evaluation of 75 patients. ISRN Dermatol. 2013;2013:491376.
- Alexis AF. Rosacea in patients with skin of color: uncommon but not rare. Cutis. 2010;86:60-62.
- Kim NH, Yun SJ, Lee JB. Clinical features of Korean patients with rhinophyma. J Dermatol. 2017;44:710-712.
- Hua TC, Chung PI, Chen YJ, et al. Cardiovascular comorbidities in patients with rosacea: a nationwide case-control study from Taiwan. J Am Acad Dermatol. 2015;73:249-254.
- Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;46:584-587.
- Elewski BE, Draelos Z, Dreno B, et al. Global diversity and optimized outcome: proposed international consensus from the Rosacea International Expert Group. J Eur Acad Dermatol Venereol. 2011;25:188-200.
- Alexis AF, Callender VD, Baldwin HE, et al. Global epidemiology and clinical spectrum of rosacea, highlighting skin of color: review and clinical practice experience [published online September 19, 2018]. J Am Acad Dermatol. 2019;80:1722-1729.e7.
- Dlova NC, Mosam A. Rosacea in black South Africans with skin phototypes V and VI. Clin Exp Dermatol. 2017;42:670-673.
- Al-Dabagh A, Davis SA, McMichael AJ, et al. Rosacea in skin of color: not a rare diagnosis [published online October 15, 2014]. Dermatol Online J. 2014;20. pii:13030/qt1mv9r0ss.
- Gether L, Overgaard LK, Egeberg A, et al. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Br J Dermatol. 2018;179:282-289.
- Rueda LJ, Motta A, Pabon JG, et al. Epidemiology of rosacea in Colombia. Int J Dermatol. 2017;56:510-513.
- De Luca DA, Maianski Z, Averbukh M. A study of skin disease spectrum occurring in Angola phototype V-VI population in Luanda. Int J Dermatol. 2018;57:849-855.
- Al Balbeesi AO, Halawani MR. Unusual features of rosacea in Saudi females with dark skin. Ochsner J. 2014;14:321-327.
- Rosen T, Stone MS. Acne rosacea in blacks. J Am Acad Dermatol. 1987;17:70-73.
- Khaled A, Hammami H, Zeglaoui F, et al. Rosacea: 244 Tunisian cases. Tunis Med. 2010;88:597-601.
- Usatine RP, Smith MA, Chumley HS, et al. The Color Atlas of Family Medicine. 2nd ed. New York, NY: The McGraw-Hill Companies; 2013.
- O'Gorman SM, Murphy GM. Photoaggravated disorders. Dermatol Clin. 2014;32:385-398, ix.
- Foering K, Chang AY, Piette EW, et al. Characterization of clinical photosensitivity in cutaneous lupus erythematosus. J Am Acad Dermatol. 2013;69:205-213.
- Saleem MD, Wilkin JK. Evaluating and optimizing the diagnosis of erythematotelangiectatic rosacea. Dermatol Clin. 2018;36:127-134.
- Black AA, McCauliffe DP, Sontheimer RD. Prevalence of acne rosacea in a rheumatic skin disease subspecialty clinic. Lupus. 1992;1:229-237.
- Brown TT, Choi EY, Thomas DG, et al. Comparative analysis of rosacea and cutaneous lupus erythematosus: histopathologic features, T-cell subsets, and plasmacytoid dendritic cells. J Am Acad Dermatol. 2014;71:100-107.
- Taylor SC, Barbosa V, Burgess C, et al. Hair and scalp disorders in adult and pediatric patients with skin of color. Cutis. 2017;100:31-35.
- Gary G. Optimizing treatment approaches in seborrheic dermatitis. J Clin Aesthet Dermatol. 2013;6:44-49.
- Okiyama N, Kohsaka H, Ueda N, et al. Seborrheic area erythema as a common skin manifestation in Japanese patients with dermatomyositis. Dermatology. 2008;217:374-377.
- Taylor SC, Kyei A. Defining skin of color. In: Taylor SC, Kelly AP, Lim HW, et al, eds. Taylor and Kelly's Dermatology for Skin of Color. 2nd ed. New York, NY: McGraw-Hill; 2016:9-15.
- Davis SA, Narahari S, Feldman SR, et al. Top dermatologic conditions in patients of color: an analysis of nationally representative data. J Drugs Dermatol. 2012;11:466-473.
- Taylor SC, Cook-Bolden F, Rahman Z, et al. Acne vulgaris in skin of color. J Am Acad Dermatol. 2002;46(2 suppl understanding):S98-S106.
- Wick MR. Granulomatous & histiocytic dermatitides. Semin Diagn Pathol. 2017;34:301-311.
- Ball NJ, Kho GT, Martinka M. The histologic spectrum of cutaneous sarcoidosis: a study of twenty-eight cases. J Cutan Pathol. 2004;31:160-168.
- Marchell RM, Judson MA. Chronic cutaneous lesions of sarcoidosis. Clin Dermatol. 2007;25:295-302.
- Mahajan VK, Sharma NL, Sharma RC, et al. Cutaneous sarcoidosis: clinical profile of 23 Indian patients. Indian J Dermatol Venereol Leprol. 2007;73:16-21.
- Goldenberg JD, Kotler HS, Shamsai R, et al. Sarcoidosis of the external nose mimicking rhinophyma. case report and review of the literature. Ann Otol Rhinol Laryngol. 1998;107:514-518.
- Gupta-Elera G, Lam C, Chung C, et al. Violaceous plaque on the nose referred for rhinophyma surgery. Int J Dermatol. 2015;54:1011-1013.
- Leonard AL. A case of sarcoidosis mimicking rhinophyma. J Drugs Dermatol. 2003;2:333-334.
- Kelati A, Mernissi FZ. Granulomatous rosacea: a case report. J Med Case Rep. 2017;11:230.
- Crawford GH, Pelle MT, James WD. Rosacea: I. etiology, pathogenesis, and subtype classification. J Am Acad Dermatol. 2004;51:327-341; quiz 342-324.
- Reinholz M, Ruzicka T, Steinhoff M, et al. Pathogenesis and clinical presentation of rosacea as a key for a symptom-oriented therapy. J Dtsch Dermatol Ges. 2016;14(suppl 6):4-15.
- Hameed AF. Steroid dermatitis resembling rosacea: a clinical evaluation of 75 patients. ISRN Dermatol. 2013;2013:491376.
Practice Points
- The clinical signs of rosacea may be similar in all skin types; however, dermatologists must have a high clinical index of suspicion for rosacea in patients with skin of color (SOC).
- Dermatologists should consider a wide differential diagnosis when presented with an SOC patient with facial erythema and/or papules and pustules.
Rash over homemade tattoo
Although the FP had never seen anything like this before, he was aware that dyes in tattoos could cause an allergic reaction. His research also suggested that sarcoidosis could occur in a tattoo, so this was part of his differential diagnosis written on the pathology form. He suggested a 4 mm punch biopsy to determine what was going on.
(See the Watch & Learn video on “Punch biopsy.”)
The pathology came back consistent with sarcoidosis. On the follow-up visit, the FP explained the diagnosis and suggested that the patient have a chest x-ray. The chest x-ray showed bilateral hilar adenopathy consistent with stage I sarcoidosis. The FP prescribed a 15-g tube of 0.05% clobetasol to treat the lesion and referred the patient to Dermatology and Pulmonology.
When the patient visited Dermatology 2 months later, most of the sarcoid plaques were flat but some remained raised and pruritic. The dermatologist offered intralesional triamcinolone for the stubborn plaques, and the patient consented. This intralesional steroid in conjunction with the topical steroid provided a good result that treated the itching and flattened the lesions. The remaining tattoo and color of the skin were not normal, but the patient was happy with the result. She had no pulmonary symptoms, and her pulmonary function tests showed a mild decrease in her diffusing capacity. She continued to see the dermatologist and pulmonologist for ongoing care of her sarcoidosis.
Photo courtesy of Amor Khachemoune, MD, and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Bae E, Bae Y, Sarabi K, et al. Sarcoidosis. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1153-1160.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
Although the FP had never seen anything like this before, he was aware that dyes in tattoos could cause an allergic reaction. His research also suggested that sarcoidosis could occur in a tattoo, so this was part of his differential diagnosis written on the pathology form. He suggested a 4 mm punch biopsy to determine what was going on.
(See the Watch & Learn video on “Punch biopsy.”)
The pathology came back consistent with sarcoidosis. On the follow-up visit, the FP explained the diagnosis and suggested that the patient have a chest x-ray. The chest x-ray showed bilateral hilar adenopathy consistent with stage I sarcoidosis. The FP prescribed a 15-g tube of 0.05% clobetasol to treat the lesion and referred the patient to Dermatology and Pulmonology.
When the patient visited Dermatology 2 months later, most of the sarcoid plaques were flat but some remained raised and pruritic. The dermatologist offered intralesional triamcinolone for the stubborn plaques, and the patient consented. This intralesional steroid in conjunction with the topical steroid provided a good result that treated the itching and flattened the lesions. The remaining tattoo and color of the skin were not normal, but the patient was happy with the result. She had no pulmonary symptoms, and her pulmonary function tests showed a mild decrease in her diffusing capacity. She continued to see the dermatologist and pulmonologist for ongoing care of her sarcoidosis.
Photo courtesy of Amor Khachemoune, MD, and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Bae E, Bae Y, Sarabi K, et al. Sarcoidosis. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1153-1160.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
Although the FP had never seen anything like this before, he was aware that dyes in tattoos could cause an allergic reaction. His research also suggested that sarcoidosis could occur in a tattoo, so this was part of his differential diagnosis written on the pathology form. He suggested a 4 mm punch biopsy to determine what was going on.
(See the Watch & Learn video on “Punch biopsy.”)
The pathology came back consistent with sarcoidosis. On the follow-up visit, the FP explained the diagnosis and suggested that the patient have a chest x-ray. The chest x-ray showed bilateral hilar adenopathy consistent with stage I sarcoidosis. The FP prescribed a 15-g tube of 0.05% clobetasol to treat the lesion and referred the patient to Dermatology and Pulmonology.
When the patient visited Dermatology 2 months later, most of the sarcoid plaques were flat but some remained raised and pruritic. The dermatologist offered intralesional triamcinolone for the stubborn plaques, and the patient consented. This intralesional steroid in conjunction with the topical steroid provided a good result that treated the itching and flattened the lesions. The remaining tattoo and color of the skin were not normal, but the patient was happy with the result. She had no pulmonary symptoms, and her pulmonary function tests showed a mild decrease in her diffusing capacity. She continued to see the dermatologist and pulmonologist for ongoing care of her sarcoidosis.
Photo courtesy of Amor Khachemoune, MD, and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Bae E, Bae Y, Sarabi K, et al. Sarcoidosis. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1153-1160.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
This month in the journal CHEST®
Editor’s picks
EDITORIAL
The CHEST Editorial Team: Serving Our Contributors and Readers
By Dr. P. J. Mazzone
ORIGINAL RESEARCH
Pulmonary Arterial Histologic Lesions in Patients With COPD With Severe Pulmonary Hypertension
By Dr. V. Bunel, et al.
Pulmonary Edema Following Initiation of Parenteral Prostacyclin Therapy for Pulmonary Arterial Hypertension: A Retrospective Study
By Dr. N. A. Khan, et al.
Lung Allocation Score Thresholds Prioritize Survival After Lung Transplantation
By Dr. S. S. Li, et al.
EVIDENCE-BASED MEDICINE
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By Dr. A. B. Chang, et al.
Editor’s picks
Editor’s picks
EDITORIAL
The CHEST Editorial Team: Serving Our Contributors and Readers
By Dr. P. J. Mazzone
ORIGINAL RESEARCH
Pulmonary Arterial Histologic Lesions in Patients With COPD With Severe Pulmonary Hypertension
By Dr. V. Bunel, et al.
Pulmonary Edema Following Initiation of Parenteral Prostacyclin Therapy for Pulmonary Arterial Hypertension: A Retrospective Study
By Dr. N. A. Khan, et al.
Lung Allocation Score Thresholds Prioritize Survival After Lung Transplantation
By Dr. S. S. Li, et al.
EVIDENCE-BASED MEDICINE
Chronic Cough and Gastroesophageal Reflux in Children: CHEST Guideline and Expert Panel Report
By Dr. A. B. Chang, et al.
EDITORIAL
The CHEST Editorial Team: Serving Our Contributors and Readers
By Dr. P. J. Mazzone
ORIGINAL RESEARCH
Pulmonary Arterial Histologic Lesions in Patients With COPD With Severe Pulmonary Hypertension
By Dr. V. Bunel, et al.
Pulmonary Edema Following Initiation of Parenteral Prostacyclin Therapy for Pulmonary Arterial Hypertension: A Retrospective Study
By Dr. N. A. Khan, et al.
Lung Allocation Score Thresholds Prioritize Survival After Lung Transplantation
By Dr. S. S. Li, et al.
EVIDENCE-BASED MEDICINE
Chronic Cough and Gastroesophageal Reflux in Children: CHEST Guideline and Expert Panel Report
By Dr. A. B. Chang, et al.