Dermatology News

Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”

In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.

Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”

In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.

Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”

In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.

In the United States, the prevalence of patient-reported atopic dermatitis (AD) is higher in children and adult women, while Hispanic adults have a lower prevalence of AD than adults from other ethnic backgrounds.

Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.

“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.

Dr. Chovatiya

“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”

Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.

More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.

In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.

When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.

On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).

“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”

Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”

In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”

Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.

A version of this article appeared on Medscape.com .

In the United States, the prevalence of patient-reported atopic dermatitis (AD) is higher in children and adult women, while Hispanic adults have a lower prevalence of AD than adults from other ethnic backgrounds.

Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.

“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.

Dr. Chovatiya

“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”

Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.

More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.

In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.

When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.

On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).

“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”

Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”

In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”

Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.

A version of this article appeared on Medscape.com .

In the United States, the prevalence of patient-reported atopic dermatitis (AD) is higher in children and adult women, while Hispanic adults have a lower prevalence of AD than adults from other ethnic backgrounds.

Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.

“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.

Dr. Chovatiya

“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”

Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.

More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.

In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.

When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.

On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).

“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”

Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”

In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”

Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.

A version of this article appeared on Medscape.com .

Treatment with topical ruxolitinib cream 1.5% showed good tolerability and was effective over the course of 52 weeks in children aged 2-11 years with atopic dermatitis (AD) affecting ≥ 35% or more of their body surface area (BSA), results from a small open-label maximum-use trial showed.

When approved for this age group, ruxolitinib cream will provide a topical nonsteroidal option for patients aged 2-11, which will “simplify the treatment regimen,” one of the study investigators, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session.

Dr. Stein Gold

A topical formulation of the selective Janus kinase (JAK) 1/JAK2 inhibitor, ruxolitinib cream 1.5% is currently approved by the Food and Drug Administration for the short-term and noncontinuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients aged 12 years and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

In previous reports of this trial in children aged 2-11 years with ≥ 35% affected BSA, ruxolitinib cream 1.5% was generally well tolerated, with rapid anti-inflammatory and antipruritic effects and improvements in patient-reported outcomes observed with ≤ 4 weeks of continuous treatment and maintained with as-needed treatment from 4 to 8 weeks.

For the current trial, investigators evaluated data on tolerability, safety, systemic exposure, and clinical and patient-reported outcomes through 52 weeks to determine whether clinical benefits and tolerability observed through 8 weeks were sustained.

Dr. Stein Gold and colleagues reported results from 29 children who received ruxolitinib cream 1.5% from baseline through week 8. Of these, 22 continued into the long-term safety period from week 8 through 52. From baseline through week 8, patients applied a mean of 6.5 g per day of ruxolitinib cream; this dropped to a mean of 3.2 g per day from weeks 8 through 52. The mean steady-state plasma concentration of ruxolitinib throughout the study was 98.2 nM, which is “well below half-maximal concentration of JAK-mediated myelosuppression in adults (281 nM),” the researchers stated in their abstract.

No treatment-related interruptions, discontinuations, or serious adverse events were observed between baseline and week 52. One patient (3.4%) had two treatment-related application site reactions (paresthesia and folliculitis). At weeks 4 and 52, 53.8% of patients achieved treatment success, which was defined as an Investigator Global Assessment of 0/1 with a ≥ 2-grade improvement from baseline. The mean affected BSA decreased from 58.0% at baseline to 11.4% at week 4 and continued to decrease to 2.2% through week 52. “I was surprised that patients could maintain control over the long-term using the medication as needed,” Dr. Stein Gold told this news organization. “I was also pleased to see that there was low systemic exposure even when used on large body surface areas.”

In other findings, the mean total Patient Oriented Eczema Measure score dropped from a baseline of 19.4 to a mean of 4.5 at week 8 and 3.6 at week 52 and the mean total Children’s Dermatology Life Quality Index score fell from a baseline of 15.4 to a mean of 5.3 at week 8 and a mean of 2.1 at week 52. Meanwhile, the mean total Infants’ Dermatology Quality of Life Index score fell from a mean of 12.3 at baseline to a mean of 2.8 at week 8 and a mean of 0.7 at week 52.

Dr. Stein Gold noted certain limitations of the study, including the fact that it did not study children aged younger than 2 years.

The study was funded by Incyte, which markets ruxolitinib cream 1.5% as Opzelura. Dr. Stein Gold disclosed that she has served as an investigator, advisor, and/or speaker for several pharmaceutical companies, including Incyte.

A version of this article appeared on Medscape.com.

Treatment with topical ruxolitinib cream 1.5% showed good tolerability and was effective over the course of 52 weeks in children aged 2-11 years with atopic dermatitis (AD) affecting ≥ 35% or more of their body surface area (BSA), results from a small open-label maximum-use trial showed.

When approved for this age group, ruxolitinib cream will provide a topical nonsteroidal option for patients aged 2-11, which will “simplify the treatment regimen,” one of the study investigators, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session.

Dr. Stein Gold

A topical formulation of the selective Janus kinase (JAK) 1/JAK2 inhibitor, ruxolitinib cream 1.5% is currently approved by the Food and Drug Administration for the short-term and noncontinuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients aged 12 years and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

In previous reports of this trial in children aged 2-11 years with ≥ 35% affected BSA, ruxolitinib cream 1.5% was generally well tolerated, with rapid anti-inflammatory and antipruritic effects and improvements in patient-reported outcomes observed with ≤ 4 weeks of continuous treatment and maintained with as-needed treatment from 4 to 8 weeks.

For the current trial, investigators evaluated data on tolerability, safety, systemic exposure, and clinical and patient-reported outcomes through 52 weeks to determine whether clinical benefits and tolerability observed through 8 weeks were sustained.

Dr. Stein Gold and colleagues reported results from 29 children who received ruxolitinib cream 1.5% from baseline through week 8. Of these, 22 continued into the long-term safety period from week 8 through 52. From baseline through week 8, patients applied a mean of 6.5 g per day of ruxolitinib cream; this dropped to a mean of 3.2 g per day from weeks 8 through 52. The mean steady-state plasma concentration of ruxolitinib throughout the study was 98.2 nM, which is “well below half-maximal concentration of JAK-mediated myelosuppression in adults (281 nM),” the researchers stated in their abstract.

No treatment-related interruptions, discontinuations, or serious adverse events were observed between baseline and week 52. One patient (3.4%) had two treatment-related application site reactions (paresthesia and folliculitis). At weeks 4 and 52, 53.8% of patients achieved treatment success, which was defined as an Investigator Global Assessment of 0/1 with a ≥ 2-grade improvement from baseline. The mean affected BSA decreased from 58.0% at baseline to 11.4% at week 4 and continued to decrease to 2.2% through week 52. “I was surprised that patients could maintain control over the long-term using the medication as needed,” Dr. Stein Gold told this news organization. “I was also pleased to see that there was low systemic exposure even when used on large body surface areas.”

In other findings, the mean total Patient Oriented Eczema Measure score dropped from a baseline of 19.4 to a mean of 4.5 at week 8 and 3.6 at week 52 and the mean total Children’s Dermatology Life Quality Index score fell from a baseline of 15.4 to a mean of 5.3 at week 8 and a mean of 2.1 at week 52. Meanwhile, the mean total Infants’ Dermatology Quality of Life Index score fell from a mean of 12.3 at baseline to a mean of 2.8 at week 8 and a mean of 0.7 at week 52.

Dr. Stein Gold noted certain limitations of the study, including the fact that it did not study children aged younger than 2 years.

The study was funded by Incyte, which markets ruxolitinib cream 1.5% as Opzelura. Dr. Stein Gold disclosed that she has served as an investigator, advisor, and/or speaker for several pharmaceutical companies, including Incyte.

A version of this article appeared on Medscape.com.

Treatment with topical ruxolitinib cream 1.5% showed good tolerability and was effective over the course of 52 weeks in children aged 2-11 years with atopic dermatitis (AD) affecting ≥ 35% or more of their body surface area (BSA), results from a small open-label maximum-use trial showed.

When approved for this age group, ruxolitinib cream will provide a topical nonsteroidal option for patients aged 2-11, which will “simplify the treatment regimen,” one of the study investigators, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session.

Dr. Stein Gold

A topical formulation of the selective Janus kinase (JAK) 1/JAK2 inhibitor, ruxolitinib cream 1.5% is currently approved by the Food and Drug Administration for the short-term and noncontinuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients aged 12 years and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

In previous reports of this trial in children aged 2-11 years with ≥ 35% affected BSA, ruxolitinib cream 1.5% was generally well tolerated, with rapid anti-inflammatory and antipruritic effects and improvements in patient-reported outcomes observed with ≤ 4 weeks of continuous treatment and maintained with as-needed treatment from 4 to 8 weeks.

For the current trial, investigators evaluated data on tolerability, safety, systemic exposure, and clinical and patient-reported outcomes through 52 weeks to determine whether clinical benefits and tolerability observed through 8 weeks were sustained.

Dr. Stein Gold and colleagues reported results from 29 children who received ruxolitinib cream 1.5% from baseline through week 8. Of these, 22 continued into the long-term safety period from week 8 through 52. From baseline through week 8, patients applied a mean of 6.5 g per day of ruxolitinib cream; this dropped to a mean of 3.2 g per day from weeks 8 through 52. The mean steady-state plasma concentration of ruxolitinib throughout the study was 98.2 nM, which is “well below half-maximal concentration of JAK-mediated myelosuppression in adults (281 nM),” the researchers stated in their abstract.

No treatment-related interruptions, discontinuations, or serious adverse events were observed between baseline and week 52. One patient (3.4%) had two treatment-related application site reactions (paresthesia and folliculitis). At weeks 4 and 52, 53.8% of patients achieved treatment success, which was defined as an Investigator Global Assessment of 0/1 with a ≥ 2-grade improvement from baseline. The mean affected BSA decreased from 58.0% at baseline to 11.4% at week 4 and continued to decrease to 2.2% through week 52. “I was surprised that patients could maintain control over the long-term using the medication as needed,” Dr. Stein Gold told this news organization. “I was also pleased to see that there was low systemic exposure even when used on large body surface areas.”

In other findings, the mean total Patient Oriented Eczema Measure score dropped from a baseline of 19.4 to a mean of 4.5 at week 8 and 3.6 at week 52 and the mean total Children’s Dermatology Life Quality Index score fell from a baseline of 15.4 to a mean of 5.3 at week 8 and a mean of 2.1 at week 52. Meanwhile, the mean total Infants’ Dermatology Quality of Life Index score fell from a mean of 12.3 at baseline to a mean of 2.8 at week 8 and a mean of 0.7 at week 52.

Dr. Stein Gold noted certain limitations of the study, including the fact that it did not study children aged younger than 2 years.

The study was funded by Incyte, which markets ruxolitinib cream 1.5% as Opzelura. Dr. Stein Gold disclosed that she has served as an investigator, advisor, and/or speaker for several pharmaceutical companies, including Incyte.

A version of this article appeared on Medscape.com.

TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
• Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
• Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

• Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; P = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
• The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
• Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
• However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
• Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
• Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

• Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; P = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
• The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
• Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
• However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
• Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
• Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

• Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; P = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
• The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
• Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
• However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com .

TOPLINE:

A meta-analysis showed that the use of oral tranexamic acid along with the standard triple combination cream (TCC) reduces melasma severity and recurrence in patients with melasma, without increasing toxicity.

METHODOLOGY:

• Current treatments for melasma focus on inducing remission and preventing relapse. Tranexamic acid, an antifibrinolytic drug, has shown promise in recent studies, but its optimal use, either alone or as an adjunct to TCC, remains unclear.
• Researchers conducted a meta-analysis of four randomized controlled trials patients that compared oral tranexamic acid plus TCC (hydroquinone, retinoic acid, and hydrocortisone) and TCC alone in 480 patients with melasma, divided almost evenly into the two treatment groups.
• The main outcome was the change in the Melasma Severity Area Index (MASI) score and recurrence rate from baseline.

TAKEAWAY:

• Patients treated with oral tranexamic acid plus TCC showed a greater reduction in MASI scores compared with those who received TCC alone (mean difference, −3.10; P = .03).
• The recurrence rate of melasma was significantly lower in the tranexamic acid plus TCC group (risk ratio [RR], 0.28; P < .001).
• There was no significant difference in the incidences of erythema (RR, 0.63; P = .147) and burning (RR, 0.59; P = .131).

IN PRACTICE:

“Evidence indicates that oral tranexamic acid confers clinical benefits, contributing to the enhancement of treatment outcomes in melasma when used in conjunction with TCC therapy,” and results are promising with regards to minimizing recurrence, the authors concluded.

SOURCE:

The study was led by Ocílio Ribeiro Gonçalves, MS, of the Federal University of Piauí, Teresina, Brazil, and was published online on June 8, 2024, in Clinical and Experimental Dermatology.

LIMITATIONS:

There was heterogeneity across studies, including different methods of administration, treatment protocols (including dosage), and timing of treatment.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A meta-analysis showed that the use of oral tranexamic acid along with the standard triple combination cream (TCC) reduces melasma severity and recurrence in patients with melasma, without increasing toxicity.

METHODOLOGY:

• Current treatments for melasma focus on inducing remission and preventing relapse. Tranexamic acid, an antifibrinolytic drug, has shown promise in recent studies, but its optimal use, either alone or as an adjunct to TCC, remains unclear.
• Researchers conducted a meta-analysis of four randomized controlled trials patients that compared oral tranexamic acid plus TCC (hydroquinone, retinoic acid, and hydrocortisone) and TCC alone in 480 patients with melasma, divided almost evenly into the two treatment groups.
• The main outcome was the change in the Melasma Severity Area Index (MASI) score and recurrence rate from baseline.

TAKEAWAY:

• Patients treated with oral tranexamic acid plus TCC showed a greater reduction in MASI scores compared with those who received TCC alone (mean difference, −3.10; P = .03).
• The recurrence rate of melasma was significantly lower in the tranexamic acid plus TCC group (risk ratio [RR], 0.28; P < .001).
• There was no significant difference in the incidences of erythema (RR, 0.63; P = .147) and burning (RR, 0.59; P = .131).

IN PRACTICE:

“Evidence indicates that oral tranexamic acid confers clinical benefits, contributing to the enhancement of treatment outcomes in melasma when used in conjunction with TCC therapy,” and results are promising with regards to minimizing recurrence, the authors concluded.

SOURCE:

The study was led by Ocílio Ribeiro Gonçalves, MS, of the Federal University of Piauí, Teresina, Brazil, and was published online on June 8, 2024, in Clinical and Experimental Dermatology.

LIMITATIONS:

There was heterogeneity across studies, including different methods of administration, treatment protocols (including dosage), and timing of treatment.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A meta-analysis showed that the use of oral tranexamic acid along with the standard triple combination cream (TCC) reduces melasma severity and recurrence in patients with melasma, without increasing toxicity.

METHODOLOGY:

• Current treatments for melasma focus on inducing remission and preventing relapse. Tranexamic acid, an antifibrinolytic drug, has shown promise in recent studies, but its optimal use, either alone or as an adjunct to TCC, remains unclear.
• Researchers conducted a meta-analysis of four randomized controlled trials patients that compared oral tranexamic acid plus TCC (hydroquinone, retinoic acid, and hydrocortisone) and TCC alone in 480 patients with melasma, divided almost evenly into the two treatment groups.
• The main outcome was the change in the Melasma Severity Area Index (MASI) score and recurrence rate from baseline.

TAKEAWAY:

• Patients treated with oral tranexamic acid plus TCC showed a greater reduction in MASI scores compared with those who received TCC alone (mean difference, −3.10; P = .03).
• The recurrence rate of melasma was significantly lower in the tranexamic acid plus TCC group (risk ratio [RR], 0.28; P < .001).
• There was no significant difference in the incidences of erythema (RR, 0.63; P = .147) and burning (RR, 0.59; P = .131).

IN PRACTICE:

“Evidence indicates that oral tranexamic acid confers clinical benefits, contributing to the enhancement of treatment outcomes in melasma when used in conjunction with TCC therapy,” and results are promising with regards to minimizing recurrence, the authors concluded.

SOURCE:

The study was led by Ocílio Ribeiro Gonçalves, MS, of the Federal University of Piauí, Teresina, Brazil, and was published online on June 8, 2024, in Clinical and Experimental Dermatology.

LIMITATIONS:

There was heterogeneity across studies, including different methods of administration, treatment protocols (including dosage), and timing of treatment.

DISCLOSURES:

The study reported receiving no funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

CHICAGO —The use of kratom, an opioid-like supplement widely available over the counter at convenience stores, smoke shops, and online, is resulting in emerging cases of hyperpigmentation, most often on the face and hands.

“This is something we will see more and more,” Heather Woolery-Lloyd, MD, director of the Skin of Color Division at the University of Miami Department of Dermatology, said at the Pigmentary Disorders Exchange Symposium. The key marker of this hyperpigmentation, she said, is that “it’s strongly photoaccentuated,” affecting areas exposed to the sun — but it also tends to spare the knuckles on patients’ hands.
 

Used Like an Opioid, But It’s Not Regulated

Kratom is a plant common in southeast Asia and is used as an analgesic. It’s marketed as a “legal opioid” or “legal high” and is sold in 2- or 3-ounce containers of extract or sold as a powder, Dr. Woolery-Lloyd said. The leaves may be boiled into a tea, smoked, chewed, or put into capsules, according to a case report published in February in the Journal of Integrative Dermatology. It is used worldwide and is not regulated in the United States.

“Many of our patients think kratom is a safe, herbal supplement” but often don’t know it can have several side effects and can be addictive, Dr. Woolery-Lloyd said. Its popularity is increasing as reflected by the number of posts related to kratom on social media platforms.

In the February case report, Shaina Patel, BA, and Nathaniel Phelan, MD, from Kansas City University, Kansas City, Missouri, wrote that side effects of kratom include drowsiness, tachycardia, vomiting, respiratory depression, and cardiac arrest, in addition to confusion and hallucinations.

Kratom also has many different effects on the psyche, Dr. Woolery-Lloyd said at the meeting. At low doses, it blocks the reuptake of norepinephrine, serotonin, and dopamine, producing a motivational effect, and at high doses, it creates an analgesic, calming effect. And people who chronically consume high doses of kratom may be susceptible to hyperpigmentation.

Kratom-associated hyperpigmentation should be considered as a diagnosis when evaluating patients for other drug-associated pigmentary disorders, “especially if pigment is photodistributed,” she said. “If you see new-onset hyperpigmentation or onset over several months and it’s very photoaccentuated, definitely ask about use of kratom.”
 

Case Reports Show Patterns of Presentation

A 2022 report from Landon R. Powell, BS, with the department of biology, Whitworth University in Spokane, Washington, and coauthors, published in JAAD Case Reports, noted that kratom use in the United States has increased dramatically. “As measured by call reports to the United States National Poison Data System, in 2011, there were 11 reported kratom exposures, and in the first 7 months of 2018, there were 357 reported exposures,” they wrote.

An estimated 1.7 million Americans aged ≥ 12 years said they had used kratom in the previous year, according to the Substance Abuse and Mental Health Services Administration 2021 National Survey on Drug Use and Health.

In the case report, Mr. Powell and coauthors described a 54-year-old White male patient who had been using kratom for the previous four to five years to reduce opioid use. During this period, he consumed kratom powder mixed with orange juice three to four times a day. He presented with “diffuse hyperpigmented patches on his arms and face in a photodistributed manner, with notable sparing of the knuckles on both hands.”
 

Dark Gray-Blue Skin

In the more recent case report, Ms. Patel and Dr. Phelan described a 30-year-old White male patient who presented with dark gray-blue skin coloring on his cheeks, back of his neck, and the backs of his hands and forearms. He had no other medical conditions and did not take any medications or supplements that cause hyperpigmentation while using kratom.

The patient had been taking kratom for years in the wake of an opioid addiction following medications for a high school injury. He developed an opioid use disorder and tried to replace his pain medications with kratom.

“The patient stopped using kratom in May 2022, but the discoloration remains. It has not regressed in the following 16 months after discontinuing kratom use,” the authors wrote, noting that “whether or not the hyperpigmentation is able to regress is unknown.”

Dr. Woolery-Lloyd is a consultant for AbbVie, Incyte, Johnson & Johnson Consumer, LivDerm, and L’Oreal; a speaker for Eli Lilly, Incyte, L’Oreal, and Ortho Dermatologics; and a researcher/investigator for AbbVie, Allergan, Eirion Therapeutics, Galderma, Pfizer, Sanofi, and Vyne Therapeutics.
 

According to an information page on kratom on the Food and Drug Administration website, health care professionals and consumers can report adverse reactions associated with kratom to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

In the wake of a debilitating cyberattack against one of the nation’s largest health care systems, Marvin Ruckle, a nurse at an Ascension hospital in Wichita, Kansas, said he had a frightening experience: He nearly gave a baby “the wrong dose of narcotic” because of confusing paperwork.

Ruckle, who has worked in the neonatal intensive care unit at Ascension Via Christi St. Joseph for two decades, said it was “hard to decipher which was the correct dose” on the medication record. He’d “never seen that happen,” he said, “when we were on the computer system” before the cyberattack.

A May 8 ransomware attack against Ascension, a Catholic health system with 140 hospitals in at least 10 states, locked providers out of systems that track and coordinate nearly every aspect of patient care. They include its systems for electronic health records, some phones, and ones “utilized to order certain tests, procedures and medications,” the company said in a May 9 statement.

More than a dozen doctors and nurses who work for the sprawling health system told Michigan Public and KFF Health News that patient care at its hospitals across the nation was compromised in the fallout of the cyberattack over the past several weeks. Clinicians working for hospitals in three states described harrowing lapses, including delayed or lost lab results, medication errors, and an absence of routine safety checks via technology to prevent potentially fatal mistakes.

Despite a precipitous rise in cyberattacks against the health sector in recent years, a weeks-long disruption of this magnitude is beyond what most health systems are prepared for, said John S. Clark, an associate chief pharmacy officer at the University of Michigan health system.

“I don’t believe that anyone is fully prepared,” he said. Most emergency management plans “are designed around long-term downtimes that are into one, two, or three days.”

Ascension in a public statement May 9 said its care teams were “trained for these kinds of disruptions,” but did not respond to questions in early June about whether it had prepared for longer periods of downtime. Ascension said June 14 it had restored access to electronic health records across its network, but that patient “medical records and other information collected between May 8” and when the service was restored “may be temporarily inaccessible as we work to update the portal with information collected during the system downtime.”

Ruckle said he “had no training” for the cyberattack.
 

Back to Paper

Lisa Watson, an intensive care unit nurse at Ascension Via Christi St. Francis hospital in Wichita, described her own close call. She said she nearly administered the wrong medication to a critically ill patient because she couldn’t scan it as she normally would. “My patient probably would have passed away had I not caught it,” she said.

Watson is no stranger to using paper for patients’ medical charts, saying she did so “for probably half of my career,” before electronic health records became ubiquitous in hospitals. What happened after the cyberattack was “by no means the same.”

“When we paper-charted, we had systems in place to get those orders to other departments in a timely manner,” she said, “and those have all gone away.”

Melissa LaRue, an ICU nurse at Ascension Saint Agnes Hospital in Baltimore, described a close call with “administering the wrong dosage” of a patient’s blood pressure medication. “Luckily,” she said, it was “triple-checked and remedied before that could happen. But I think the potential for harm is there when you have so much information and paperwork that you have to go through.”

Clinicians say their hospitals have relied on slapdash workarounds, using handwritten notes, faxes, sticky notes, and basic computer spreadsheets — many devised on the fly by doctors and nurses — to care for patients.

More than a dozen other nurses and doctors, some of them without union protections, at Ascension hospitals in Michigan recounted situations in which they say patient care was compromised. Those clinicians spoke on the condition that they not be named for fear of retaliation by their employer.

An Ascension hospital emergency room doctor in Detroit said a man on the city’s east side was given a dangerous narcotic intended for another patient because of a paperwork mix-up. As a result, the patient’s breathing slowed to the point that he had to be put on a ventilator. “We intubated him and we sent him to the ICU because he got the wrong medication.”

A nurse in a Michigan Ascension hospital ER said a woman with low blood sugar and “altered mental status” went into cardiac arrest and died after staff said they waited four hours for lab results they needed to determine how to treat her, but never received. “If I started having crushing chest pain in the middle of work and thought I was having a big one, I would grab someone to drive me down the street to another hospital,” the same ER nurse said.

Similar concerns reportedly led a travel nurse at an Ascension hospital in Indiana to quit. “I just want to warn those patients that are coming to any of the Ascension facilities that there will be delays in care. There is potential for error and for harm,” Justin Neisser told CBS4 in Indianapolis in May.

Several nurses and doctors at Ascension hospitals said they feared the errors they’ve witnessed since the cyberattack began could threaten their professional licenses. “This is how a RaDonda Vaught happens,” one nurse said, referring to the Tennessee nurse who was convicted of criminally negligent homicide in 2022 for a fatal drug error.

Reporters were not able to review records to verify clinicians’ claims because of privacy laws surrounding patients’ medical information that apply to health care professionals.

Ascension declined to answer questions about claims that care has been affected by the ransomware attack. “As we have made clear throughout this cyber attack which has impacted our system and our dedicated clinical providers, caring for our patients is our highest priority,” Sean Fitzpatrick, Ascension’s vice president of external communications, said via email on June 3. “We are confident that our care providers in our hospitals and facilities continue to provide quality medical care.”

The federal government requires hospitals to protect patients’ sensitive health data, according to cybersecurity experts. However, there are no federal requirements for hospitals to prevent or prepare for cyberattacks that could compromise their electronic systems.
 

Hospitals: ‘The No.1 Target of Ransomware’

“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” said Jeff Tully, a co-director of the Center for Healthcare Cybersecurity at the University of California-San Diego. “These types of cybersecurity incidents should be thought of as a matter of when, and not if.”

Josh Corman, a cybersecurity expert and advocate, said ransom crews regard hospitals as the perfect prey: “They have terrible security and they’ll pay. So almost immediately, hospitals went to the No. 1 target of ransomware.”

In 2023, the health sector experienced the largest share of ransomware attacks of 16 infrastructure sectors considered vital to national security or safety, according to an FBI report on internet crimes. In March, the federal Department of Health and Human Services said reported large breaches involving ransomware had jumped by 264% over the past five years.

A cyberattack this year on Change Healthcare, a unit of UnitedHealth Group’s Optum division that processes billions of health care transactions every year, crippled the business of providers, pharmacies, and hospitals.

In May, UnitedHealth Group CEO Andrew Witty told lawmakers the company paid a $22 million ransom as a result of the Change Healthcare attack — which occurred after hackers accessed a company portal that didn’t have multifactor authentication, a basic cybersecurity tool.

The Biden administration in recent months has pushed to bolster health care cybersecurity standards, but it’s not clear which new measures will be required.

In January, HHS nudged companies to improve email security, add multifactor authentication, and institute cybersecurity training and testing, among other voluntary measures. The Centers for Medicare & Medicaid Services is expected to release new requirements for hospitals, but the scope and timing are unclear. The same is true of an update HHS is expected to make to patient privacy regulations.

HHS said the voluntary measures “will inform the creation of new enforceable cybersecurity standards,” department spokesperson Jeff Nesbit said in a statement.

“The recent cyberattack at Ascension only underscores the need for everyone in the health care ecosystem to do their part to secure their systems and protect patients,” Nesbit said.

Meanwhile, lobbyists for the hospital industry contend cybersecurity mandates or penalties are misplaced and would curtail hospitals’ resources to fend off attacks.

“Hospitals and health systems are not the primary source of cyber risk exposure facing the health care sector,” the American Hospital Association, the largest lobbying group for U.S. hospitals, said in an April statement prepared for U.S. House lawmakers. Most large data breaches that hit hospitals in 2023 originated with third-party “business associates” or other health entities, including CMS itself, the AHA statement said.

Hospitals consolidating into large multistate health systems face increased risk of data breaches and ransomware attacks, according to one study. Ascension in 2022 was the third-largest hospital chain in the U.S. by number of beds, according to the most recent data from the federal Agency for Healthcare Research and Quality.

And while cybersecurity regulations can quickly become outdated, they can at least make it clear that if health systems fail to implement basic protections there “should be consequences for that,” Jim Bagian, a former director of the National Center for Patient Safety at the Veterans Health Administration, told Michigan Public’s Stateside.

Patients can pay the price when lapses occur. Those in hospital care face a greater likelihood of death during a cyberattack, according to researchers at the University of Minnesota School of Public Health.

Workers concerned about patient safety at Ascension hospitals in Michigan have called for the company to make changes.

“We implore Ascension to recognize the internal problems that continue to plague its hospitals, both publicly and transparently,” said Dina Carlisle, a nurse and the president of the OPEIU Local 40 union, which represents nurses at Ascension Providence Rochester. At least 125 staff members at that Ascension hospital have signed a petition asking administrators to temporarily reduce elective surgeries and nonemergency patient admissions, like under the protocols many hospitals adopted early in the covid-19 pandemic.

Watson, the Kansas ICU nurse, said in late May that nurses had urged management to bring in more nurses to help manage the workflow. “Everything that we say has fallen on deaf ears,” she said.

“It is very hard to be a nurse at Ascension right now,” Watson said in late May. “It is very hard to be a patient at Ascension right now.”

If you’re a patient or worker at an Ascension hospital and would like to tell KFF Health News about your experiences, click here to share your story with us.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

In the wake of a debilitating cyberattack against one of the nation’s largest health care systems, Marvin Ruckle, a nurse at an Ascension hospital in Wichita, Kansas, said he had a frightening experience: He nearly gave a baby “the wrong dose of narcotic” because of confusing paperwork.

Ruckle, who has worked in the neonatal intensive care unit at Ascension Via Christi St. Joseph for two decades, said it was “hard to decipher which was the correct dose” on the medication record. He’d “never seen that happen,” he said, “when we were on the computer system” before the cyberattack.

A May 8 ransomware attack against Ascension, a Catholic health system with 140 hospitals in at least 10 states, locked providers out of systems that track and coordinate nearly every aspect of patient care. They include its systems for electronic health records, some phones, and ones “utilized to order certain tests, procedures and medications,” the company said in a May 9 statement.

More than a dozen doctors and nurses who work for the sprawling health system told Michigan Public and KFF Health News that patient care at its hospitals across the nation was compromised in the fallout of the cyberattack over the past several weeks. Clinicians working for hospitals in three states described harrowing lapses, including delayed or lost lab results, medication errors, and an absence of routine safety checks via technology to prevent potentially fatal mistakes.

Despite a precipitous rise in cyberattacks against the health sector in recent years, a weeks-long disruption of this magnitude is beyond what most health systems are prepared for, said John S. Clark, an associate chief pharmacy officer at the University of Michigan health system.

“I don’t believe that anyone is fully prepared,” he said. Most emergency management plans “are designed around long-term downtimes that are into one, two, or three days.”

Ascension in a public statement May 9 said its care teams were “trained for these kinds of disruptions,” but did not respond to questions in early June about whether it had prepared for longer periods of downtime. Ascension said June 14 it had restored access to electronic health records across its network, but that patient “medical records and other information collected between May 8” and when the service was restored “may be temporarily inaccessible as we work to update the portal with information collected during the system downtime.”

Ruckle said he “had no training” for the cyberattack.
 

Back to Paper

Lisa Watson, an intensive care unit nurse at Ascension Via Christi St. Francis hospital in Wichita, described her own close call. She said she nearly administered the wrong medication to a critically ill patient because she couldn’t scan it as she normally would. “My patient probably would have passed away had I not caught it,” she said.

Watson is no stranger to using paper for patients’ medical charts, saying she did so “for probably half of my career,” before electronic health records became ubiquitous in hospitals. What happened after the cyberattack was “by no means the same.”

“When we paper-charted, we had systems in place to get those orders to other departments in a timely manner,” she said, “and those have all gone away.”

Melissa LaRue, an ICU nurse at Ascension Saint Agnes Hospital in Baltimore, described a close call with “administering the wrong dosage” of a patient’s blood pressure medication. “Luckily,” she said, it was “triple-checked and remedied before that could happen. But I think the potential for harm is there when you have so much information and paperwork that you have to go through.”

Clinicians say their hospitals have relied on slapdash workarounds, using handwritten notes, faxes, sticky notes, and basic computer spreadsheets — many devised on the fly by doctors and nurses — to care for patients.

More than a dozen other nurses and doctors, some of them without union protections, at Ascension hospitals in Michigan recounted situations in which they say patient care was compromised. Those clinicians spoke on the condition that they not be named for fear of retaliation by their employer.

An Ascension hospital emergency room doctor in Detroit said a man on the city’s east side was given a dangerous narcotic intended for another patient because of a paperwork mix-up. As a result, the patient’s breathing slowed to the point that he had to be put on a ventilator. “We intubated him and we sent him to the ICU because he got the wrong medication.”

A nurse in a Michigan Ascension hospital ER said a woman with low blood sugar and “altered mental status” went into cardiac arrest and died after staff said they waited four hours for lab results they needed to determine how to treat her, but never received. “If I started having crushing chest pain in the middle of work and thought I was having a big one, I would grab someone to drive me down the street to another hospital,” the same ER nurse said.

Similar concerns reportedly led a travel nurse at an Ascension hospital in Indiana to quit. “I just want to warn those patients that are coming to any of the Ascension facilities that there will be delays in care. There is potential for error and for harm,” Justin Neisser told CBS4 in Indianapolis in May.

Several nurses and doctors at Ascension hospitals said they feared the errors they’ve witnessed since the cyberattack began could threaten their professional licenses. “This is how a RaDonda Vaught happens,” one nurse said, referring to the Tennessee nurse who was convicted of criminally negligent homicide in 2022 for a fatal drug error.

Reporters were not able to review records to verify clinicians’ claims because of privacy laws surrounding patients’ medical information that apply to health care professionals.

Ascension declined to answer questions about claims that care has been affected by the ransomware attack. “As we have made clear throughout this cyber attack which has impacted our system and our dedicated clinical providers, caring for our patients is our highest priority,” Sean Fitzpatrick, Ascension’s vice president of external communications, said via email on June 3. “We are confident that our care providers in our hospitals and facilities continue to provide quality medical care.”

The federal government requires hospitals to protect patients’ sensitive health data, according to cybersecurity experts. However, there are no federal requirements for hospitals to prevent or prepare for cyberattacks that could compromise their electronic systems.
 

Hospitals: ‘The No.1 Target of Ransomware’

“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” said Jeff Tully, a co-director of the Center for Healthcare Cybersecurity at the University of California-San Diego. “These types of cybersecurity incidents should be thought of as a matter of when, and not if.”

Josh Corman, a cybersecurity expert and advocate, said ransom crews regard hospitals as the perfect prey: “They have terrible security and they’ll pay. So almost immediately, hospitals went to the No. 1 target of ransomware.”

In 2023, the health sector experienced the largest share of ransomware attacks of 16 infrastructure sectors considered vital to national security or safety, according to an FBI report on internet crimes. In March, the federal Department of Health and Human Services said reported large breaches involving ransomware had jumped by 264% over the past five years.

A cyberattack this year on Change Healthcare, a unit of UnitedHealth Group’s Optum division that processes billions of health care transactions every year, crippled the business of providers, pharmacies, and hospitals.

In May, UnitedHealth Group CEO Andrew Witty told lawmakers the company paid a $22 million ransom as a result of the Change Healthcare attack — which occurred after hackers accessed a company portal that didn’t have multifactor authentication, a basic cybersecurity tool.

The Biden administration in recent months has pushed to bolster health care cybersecurity standards, but it’s not clear which new measures will be required.

In January, HHS nudged companies to improve email security, add multifactor authentication, and institute cybersecurity training and testing, among other voluntary measures. The Centers for Medicare & Medicaid Services is expected to release new requirements for hospitals, but the scope and timing are unclear. The same is true of an update HHS is expected to make to patient privacy regulations.

HHS said the voluntary measures “will inform the creation of new enforceable cybersecurity standards,” department spokesperson Jeff Nesbit said in a statement.

“The recent cyberattack at Ascension only underscores the need for everyone in the health care ecosystem to do their part to secure their systems and protect patients,” Nesbit said.

Meanwhile, lobbyists for the hospital industry contend cybersecurity mandates or penalties are misplaced and would curtail hospitals’ resources to fend off attacks.

“Hospitals and health systems are not the primary source of cyber risk exposure facing the health care sector,” the American Hospital Association, the largest lobbying group for U.S. hospitals, said in an April statement prepared for U.S. House lawmakers. Most large data breaches that hit hospitals in 2023 originated with third-party “business associates” or other health entities, including CMS itself, the AHA statement said.

Hospitals consolidating into large multistate health systems face increased risk of data breaches and ransomware attacks, according to one study. Ascension in 2022 was the third-largest hospital chain in the U.S. by number of beds, according to the most recent data from the federal Agency for Healthcare Research and Quality.

And while cybersecurity regulations can quickly become outdated, they can at least make it clear that if health systems fail to implement basic protections there “should be consequences for that,” Jim Bagian, a former director of the National Center for Patient Safety at the Veterans Health Administration, told Michigan Public’s Stateside.

Patients can pay the price when lapses occur. Those in hospital care face a greater likelihood of death during a cyberattack, according to researchers at the University of Minnesota School of Public Health.

Workers concerned about patient safety at Ascension hospitals in Michigan have called for the company to make changes.

“We implore Ascension to recognize the internal problems that continue to plague its hospitals, both publicly and transparently,” said Dina Carlisle, a nurse and the president of the OPEIU Local 40 union, which represents nurses at Ascension Providence Rochester. At least 125 staff members at that Ascension hospital have signed a petition asking administrators to temporarily reduce elective surgeries and nonemergency patient admissions, like under the protocols many hospitals adopted early in the covid-19 pandemic.

Watson, the Kansas ICU nurse, said in late May that nurses had urged management to bring in more nurses to help manage the workflow. “Everything that we say has fallen on deaf ears,” she said.

“It is very hard to be a nurse at Ascension right now,” Watson said in late May. “It is very hard to be a patient at Ascension right now.”

If you’re a patient or worker at an Ascension hospital and would like to tell KFF Health News about your experiences, click here to share your story with us.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

In the wake of a debilitating cyberattack against one of the nation’s largest health care systems, Marvin Ruckle, a nurse at an Ascension hospital in Wichita, Kansas, said he had a frightening experience: He nearly gave a baby “the wrong dose of narcotic” because of confusing paperwork.

Ruckle, who has worked in the neonatal intensive care unit at Ascension Via Christi St. Joseph for two decades, said it was “hard to decipher which was the correct dose” on the medication record. He’d “never seen that happen,” he said, “when we were on the computer system” before the cyberattack.

A May 8 ransomware attack against Ascension, a Catholic health system with 140 hospitals in at least 10 states, locked providers out of systems that track and coordinate nearly every aspect of patient care. They include its systems for electronic health records, some phones, and ones “utilized to order certain tests, procedures and medications,” the company said in a May 9 statement.

More than a dozen doctors and nurses who work for the sprawling health system told Michigan Public and KFF Health News that patient care at its hospitals across the nation was compromised in the fallout of the cyberattack over the past several weeks. Clinicians working for hospitals in three states described harrowing lapses, including delayed or lost lab results, medication errors, and an absence of routine safety checks via technology to prevent potentially fatal mistakes.

Despite a precipitous rise in cyberattacks against the health sector in recent years, a weeks-long disruption of this magnitude is beyond what most health systems are prepared for, said John S. Clark, an associate chief pharmacy officer at the University of Michigan health system.

“I don’t believe that anyone is fully prepared,” he said. Most emergency management plans “are designed around long-term downtimes that are into one, two, or three days.”

Ascension in a public statement May 9 said its care teams were “trained for these kinds of disruptions,” but did not respond to questions in early June about whether it had prepared for longer periods of downtime. Ascension said June 14 it had restored access to electronic health records across its network, but that patient “medical records and other information collected between May 8” and when the service was restored “may be temporarily inaccessible as we work to update the portal with information collected during the system downtime.”

Ruckle said he “had no training” for the cyberattack.
 

Back to Paper

Lisa Watson, an intensive care unit nurse at Ascension Via Christi St. Francis hospital in Wichita, described her own close call. She said she nearly administered the wrong medication to a critically ill patient because she couldn’t scan it as she normally would. “My patient probably would have passed away had I not caught it,” she said.

Watson is no stranger to using paper for patients’ medical charts, saying she did so “for probably half of my career,” before electronic health records became ubiquitous in hospitals. What happened after the cyberattack was “by no means the same.”

“When we paper-charted, we had systems in place to get those orders to other departments in a timely manner,” she said, “and those have all gone away.”

Melissa LaRue, an ICU nurse at Ascension Saint Agnes Hospital in Baltimore, described a close call with “administering the wrong dosage” of a patient’s blood pressure medication. “Luckily,” she said, it was “triple-checked and remedied before that could happen. But I think the potential for harm is there when you have so much information and paperwork that you have to go through.”

Clinicians say their hospitals have relied on slapdash workarounds, using handwritten notes, faxes, sticky notes, and basic computer spreadsheets — many devised on the fly by doctors and nurses — to care for patients.

More than a dozen other nurses and doctors, some of them without union protections, at Ascension hospitals in Michigan recounted situations in which they say patient care was compromised. Those clinicians spoke on the condition that they not be named for fear of retaliation by their employer.

An Ascension hospital emergency room doctor in Detroit said a man on the city’s east side was given a dangerous narcotic intended for another patient because of a paperwork mix-up. As a result, the patient’s breathing slowed to the point that he had to be put on a ventilator. “We intubated him and we sent him to the ICU because he got the wrong medication.”

A nurse in a Michigan Ascension hospital ER said a woman with low blood sugar and “altered mental status” went into cardiac arrest and died after staff said they waited four hours for lab results they needed to determine how to treat her, but never received. “If I started having crushing chest pain in the middle of work and thought I was having a big one, I would grab someone to drive me down the street to another hospital,” the same ER nurse said.

Similar concerns reportedly led a travel nurse at an Ascension hospital in Indiana to quit. “I just want to warn those patients that are coming to any of the Ascension facilities that there will be delays in care. There is potential for error and for harm,” Justin Neisser told CBS4 in Indianapolis in May.

Several nurses and doctors at Ascension hospitals said they feared the errors they’ve witnessed since the cyberattack began could threaten their professional licenses. “This is how a RaDonda Vaught happens,” one nurse said, referring to the Tennessee nurse who was convicted of criminally negligent homicide in 2022 for a fatal drug error.

Reporters were not able to review records to verify clinicians’ claims because of privacy laws surrounding patients’ medical information that apply to health care professionals.

Ascension declined to answer questions about claims that care has been affected by the ransomware attack. “As we have made clear throughout this cyber attack which has impacted our system and our dedicated clinical providers, caring for our patients is our highest priority,” Sean Fitzpatrick, Ascension’s vice president of external communications, said via email on June 3. “We are confident that our care providers in our hospitals and facilities continue to provide quality medical care.”

The federal government requires hospitals to protect patients’ sensitive health data, according to cybersecurity experts. However, there are no federal requirements for hospitals to prevent or prepare for cyberattacks that could compromise their electronic systems.
 

Hospitals: ‘The No.1 Target of Ransomware’

“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” said Jeff Tully, a co-director of the Center for Healthcare Cybersecurity at the University of California-San Diego. “These types of cybersecurity incidents should be thought of as a matter of when, and not if.”

Josh Corman, a cybersecurity expert and advocate, said ransom crews regard hospitals as the perfect prey: “They have terrible security and they’ll pay. So almost immediately, hospitals went to the No. 1 target of ransomware.”

In 2023, the health sector experienced the largest share of ransomware attacks of 16 infrastructure sectors considered vital to national security or safety, according to an FBI report on internet crimes. In March, the federal Department of Health and Human Services said reported large breaches involving ransomware had jumped by 264% over the past five years.

A cyberattack this year on Change Healthcare, a unit of UnitedHealth Group’s Optum division that processes billions of health care transactions every year, crippled the business of providers, pharmacies, and hospitals.

In May, UnitedHealth Group CEO Andrew Witty told lawmakers the company paid a $22 million ransom as a result of the Change Healthcare attack — which occurred after hackers accessed a company portal that didn’t have multifactor authentication, a basic cybersecurity tool.

The Biden administration in recent months has pushed to bolster health care cybersecurity standards, but it’s not clear which new measures will be required.

In January, HHS nudged companies to improve email security, add multifactor authentication, and institute cybersecurity training and testing, among other voluntary measures. The Centers for Medicare & Medicaid Services is expected to release new requirements for hospitals, but the scope and timing are unclear. The same is true of an update HHS is expected to make to patient privacy regulations.

HHS said the voluntary measures “will inform the creation of new enforceable cybersecurity standards,” department spokesperson Jeff Nesbit said in a statement.

“The recent cyberattack at Ascension only underscores the need for everyone in the health care ecosystem to do their part to secure their systems and protect patients,” Nesbit said.

Meanwhile, lobbyists for the hospital industry contend cybersecurity mandates or penalties are misplaced and would curtail hospitals’ resources to fend off attacks.

“Hospitals and health systems are not the primary source of cyber risk exposure facing the health care sector,” the American Hospital Association, the largest lobbying group for U.S. hospitals, said in an April statement prepared for U.S. House lawmakers. Most large data breaches that hit hospitals in 2023 originated with third-party “business associates” or other health entities, including CMS itself, the AHA statement said.

Hospitals consolidating into large multistate health systems face increased risk of data breaches and ransomware attacks, according to one study. Ascension in 2022 was the third-largest hospital chain in the U.S. by number of beds, according to the most recent data from the federal Agency for Healthcare Research and Quality.

And while cybersecurity regulations can quickly become outdated, they can at least make it clear that if health systems fail to implement basic protections there “should be consequences for that,” Jim Bagian, a former director of the National Center for Patient Safety at the Veterans Health Administration, told Michigan Public’s Stateside.

Patients can pay the price when lapses occur. Those in hospital care face a greater likelihood of death during a cyberattack, according to researchers at the University of Minnesota School of Public Health.

Workers concerned about patient safety at Ascension hospitals in Michigan have called for the company to make changes.

“We implore Ascension to recognize the internal problems that continue to plague its hospitals, both publicly and transparently,” said Dina Carlisle, a nurse and the president of the OPEIU Local 40 union, which represents nurses at Ascension Providence Rochester. At least 125 staff members at that Ascension hospital have signed a petition asking administrators to temporarily reduce elective surgeries and nonemergency patient admissions, like under the protocols many hospitals adopted early in the covid-19 pandemic.

Watson, the Kansas ICU nurse, said in late May that nurses had urged management to bring in more nurses to help manage the workflow. “Everything that we say has fallen on deaf ears,” she said.

“It is very hard to be a nurse at Ascension right now,” Watson said in late May. “It is very hard to be a patient at Ascension right now.”

If you’re a patient or worker at an Ascension hospital and would like to tell KFF Health News about your experiences, click here to share your story with us.
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Editor’s note: This is Dr. Eastern’s last “Managing Your Practice” column for Dermatology News. After his first column was published in 1986, Dr. Eastern continued writing his column monthly until the mid-1990s, resuming in 2005. In total, he has written over 300 columns on topics relevant to medical practice, ranging from hiring employees, selling and merging practices, complying with OSHA, and avoiding embezzlement, to electronic health records, burnout, medical assistants, negative online reviews, artificial intelligence in the office, and more. In the future, he will continue to provide commentary on practice issues with an occasional guest editorial.

Medicare reimbursement cuts, increasing overhead and staff salaries, and inflation have made running a profitable private practice increasingly challenging, particularly for rural and smaller offices. Medical credit cards are an increasingly popular choice to fill this gap.

Unlike a conventional credit card, a medical credit card is used only to pay for medical services.

alexialex/Getty Images

Traditionally, these cards were used to help cover procedures insurance didn’t cover — such as cosmetic procedures — but over the years, they have been expanded to cover other healthcare charges, mostly for patients who are paying out of pocket due to inadequate insurance or other reasons.

Advantages for physicians include immediate payment from the credit card company and reduced billing and collection costs. Patients are also less likely to delay or defer treatment if they can charge the payment and pay it back in installments.

The first step in offering medical credit cards is signing up with one or more third-party card companies. CareCredit is the most common provider in the medical credit card market. Other vendors include Wells Fargo, AccessOne, Alphaeon Credit, and iCare Financial. (As always, I have no financial interest in any product or service mentioned in this column.) A member of your staff signs patients up, and the credit card company checks their credit. If approved, the card company pays you your fee and assumes responsibility for collecting from the patient.

The interest charge on medical credit cards is often deferred for a period of time, typically between 6 and 24 months. If patients pay off the debt within this time, they can avoid paying interest. But, like other credit cards, if they make late payments or have an unpaid balance once the promotional period ends, they may end up with interest and fees totaling 25%-30% or more. It is important to make it very clear to your patients that payments are interest-free only if they are all made on time and within the promotional period.

According to a Consumer Financial Protection Bureau report released earlier this year, deferred interest medical credit cards or loans were used to pay nearly $23 billion in healthcare expenses from 2018 to 2020. Individuals unable to complete payment during the promotional period paid $1 billion in deferred interest payments during that period.

Despite the growing popularity of medical credit cards among physicians, it is worth noting that some consumer groups view them as predatory financial products, marketed toward people in tough financial situations. A coalition of 60 health advocacy groups has urged the Biden Administration to ban deferred interest medical credit cards. So there is that much more reason to choose candidates for medical credit cards carefully, and to make them fully aware of what obligations they are assuming.

Patients who do not think they can pay off the balance within the interest-free time frame should probably be advised to pursue an alternative payment method, such as using a conventional credit card, taking out a personal or home-equity loan, or borrowing from a retirement savings account. Some physicians are willing to negotiate a reduced fee for patients who agree to pay cash at the time of service.

Those who do choose to apply for a medical credit card should be informed of their options, which can vary considerably depending on the product and the third-party vendor. Some medical credit products can be used only for elective procedures, but some can be used more broadly for various medical expenses. Check to make sure that each patient’s financing option can be used for his or her desired medical service.

Some payment products can only be used at specific practices or groups, while others can be used at a variety of medical offices and hospitals. If a patient arrives with a medical credit card already in hand, confirm that it is one that your office accepts.

Interest rates generally vary with each card and vendor. Make patients aware of when interest rates start accruing and if the plan offers a fixed or variable APR, or if it charges compounding interest. Confirm if there is a deferred interest option, and if so, for how long.

Different medical credit products also have varying fees and payment schedules. See that each patient reads the terms of the agreement to understand when interest may start to accrue or change, as well as when certain fees may apply. Understanding when the payments are due will help them avoid additional fees, including late fees. Some medical payment plans may also have administrative or processing fees. If so, patients should be made aware of them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, New Jersey. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Editor’s note: This is Dr. Eastern’s last “Managing Your Practice” column for Dermatology News. After his first column was published in 1986, Dr. Eastern continued writing his column monthly until the mid-1990s, resuming in 2005. In total, he has written over 300 columns on topics relevant to medical practice, ranging from hiring employees, selling and merging practices, complying with OSHA, and avoiding embezzlement, to electronic health records, burnout, medical assistants, negative online reviews, artificial intelligence in the office, and more. In the future, he will continue to provide commentary on practice issues with an occasional guest editorial.

Medicare reimbursement cuts, increasing overhead and staff salaries, and inflation have made running a profitable private practice increasingly challenging, particularly for rural and smaller offices. Medical credit cards are an increasingly popular choice to fill this gap.

Unlike a conventional credit card, a medical credit card is used only to pay for medical services.

alexialex/Getty Images

Traditionally, these cards were used to help cover procedures insurance didn’t cover — such as cosmetic procedures — but over the years, they have been expanded to cover other healthcare charges, mostly for patients who are paying out of pocket due to inadequate insurance or other reasons.

Advantages for physicians include immediate payment from the credit card company and reduced billing and collection costs. Patients are also less likely to delay or defer treatment if they can charge the payment and pay it back in installments.

The first step in offering medical credit cards is signing up with one or more third-party card companies. CareCredit is the most common provider in the medical credit card market. Other vendors include Wells Fargo, AccessOne, Alphaeon Credit, and iCare Financial. (As always, I have no financial interest in any product or service mentioned in this column.) A member of your staff signs patients up, and the credit card company checks their credit. If approved, the card company pays you your fee and assumes responsibility for collecting from the patient.

The interest charge on medical credit cards is often deferred for a period of time, typically between 6 and 24 months. If patients pay off the debt within this time, they can avoid paying interest. But, like other credit cards, if they make late payments or have an unpaid balance once the promotional period ends, they may end up with interest and fees totaling 25%-30% or more. It is important to make it very clear to your patients that payments are interest-free only if they are all made on time and within the promotional period.

According to a Consumer Financial Protection Bureau report released earlier this year, deferred interest medical credit cards or loans were used to pay nearly $23 billion in healthcare expenses from 2018 to 2020. Individuals unable to complete payment during the promotional period paid $1 billion in deferred interest payments during that period.

Despite the growing popularity of medical credit cards among physicians, it is worth noting that some consumer groups view them as predatory financial products, marketed toward people in tough financial situations. A coalition of 60 health advocacy groups has urged the Biden Administration to ban deferred interest medical credit cards. So there is that much more reason to choose candidates for medical credit cards carefully, and to make them fully aware of what obligations they are assuming.

Patients who do not think they can pay off the balance within the interest-free time frame should probably be advised to pursue an alternative payment method, such as using a conventional credit card, taking out a personal or home-equity loan, or borrowing from a retirement savings account. Some physicians are willing to negotiate a reduced fee for patients who agree to pay cash at the time of service.

Those who do choose to apply for a medical credit card should be informed of their options, which can vary considerably depending on the product and the third-party vendor. Some medical credit products can be used only for elective procedures, but some can be used more broadly for various medical expenses. Check to make sure that each patient’s financing option can be used for his or her desired medical service.

Some payment products can only be used at specific practices or groups, while others can be used at a variety of medical offices and hospitals. If a patient arrives with a medical credit card already in hand, confirm that it is one that your office accepts.

Interest rates generally vary with each card and vendor. Make patients aware of when interest rates start accruing and if the plan offers a fixed or variable APR, or if it charges compounding interest. Confirm if there is a deferred interest option, and if so, for how long.

Different medical credit products also have varying fees and payment schedules. See that each patient reads the terms of the agreement to understand when interest may start to accrue or change, as well as when certain fees may apply. Understanding when the payments are due will help them avoid additional fees, including late fees. Some medical payment plans may also have administrative or processing fees. If so, patients should be made aware of them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, New Jersey. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Editor’s note: This is Dr. Eastern’s last “Managing Your Practice” column for Dermatology News. After his first column was published in 1986, Dr. Eastern continued writing his column monthly until the mid-1990s, resuming in 2005. In total, he has written over 300 columns on topics relevant to medical practice, ranging from hiring employees, selling and merging practices, complying with OSHA, and avoiding embezzlement, to electronic health records, burnout, medical assistants, negative online reviews, artificial intelligence in the office, and more. In the future, he will continue to provide commentary on practice issues with an occasional guest editorial.

Medicare reimbursement cuts, increasing overhead and staff salaries, and inflation have made running a profitable private practice increasingly challenging, particularly for rural and smaller offices. Medical credit cards are an increasingly popular choice to fill this gap.

Unlike a conventional credit card, a medical credit card is used only to pay for medical services.

alexialex/Getty Images

Traditionally, these cards were used to help cover procedures insurance didn’t cover — such as cosmetic procedures — but over the years, they have been expanded to cover other healthcare charges, mostly for patients who are paying out of pocket due to inadequate insurance or other reasons.

Advantages for physicians include immediate payment from the credit card company and reduced billing and collection costs. Patients are also less likely to delay or defer treatment if they can charge the payment and pay it back in installments.

The first step in offering medical credit cards is signing up with one or more third-party card companies. CareCredit is the most common provider in the medical credit card market. Other vendors include Wells Fargo, AccessOne, Alphaeon Credit, and iCare Financial. (As always, I have no financial interest in any product or service mentioned in this column.) A member of your staff signs patients up, and the credit card company checks their credit. If approved, the card company pays you your fee and assumes responsibility for collecting from the patient.

The interest charge on medical credit cards is often deferred for a period of time, typically between 6 and 24 months. If patients pay off the debt within this time, they can avoid paying interest. But, like other credit cards, if they make late payments or have an unpaid balance once the promotional period ends, they may end up with interest and fees totaling 25%-30% or more. It is important to make it very clear to your patients that payments are interest-free only if they are all made on time and within the promotional period.

According to a Consumer Financial Protection Bureau report released earlier this year, deferred interest medical credit cards or loans were used to pay nearly $23 billion in healthcare expenses from 2018 to 2020. Individuals unable to complete payment during the promotional period paid $1 billion in deferred interest payments during that period.

Despite the growing popularity of medical credit cards among physicians, it is worth noting that some consumer groups view them as predatory financial products, marketed toward people in tough financial situations. A coalition of 60 health advocacy groups has urged the Biden Administration to ban deferred interest medical credit cards. So there is that much more reason to choose candidates for medical credit cards carefully, and to make them fully aware of what obligations they are assuming.

Patients who do not think they can pay off the balance within the interest-free time frame should probably be advised to pursue an alternative payment method, such as using a conventional credit card, taking out a personal or home-equity loan, or borrowing from a retirement savings account. Some physicians are willing to negotiate a reduced fee for patients who agree to pay cash at the time of service.

Those who do choose to apply for a medical credit card should be informed of their options, which can vary considerably depending on the product and the third-party vendor. Some medical credit products can be used only for elective procedures, but some can be used more broadly for various medical expenses. Check to make sure that each patient’s financing option can be used for his or her desired medical service.

Some payment products can only be used at specific practices or groups, while others can be used at a variety of medical offices and hospitals. If a patient arrives with a medical credit card already in hand, confirm that it is one that your office accepts.

Interest rates generally vary with each card and vendor. Make patients aware of when interest rates start accruing and if the plan offers a fixed or variable APR, or if it charges compounding interest. Confirm if there is a deferred interest option, and if so, for how long.

Different medical credit products also have varying fees and payment schedules. See that each patient reads the terms of the agreement to understand when interest may start to accrue or change, as well as when certain fees may apply. Understanding when the payments are due will help them avoid additional fees, including late fees. Some medical payment plans may also have administrative or processing fees. If so, patients should be made aware of them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, New Jersey. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

VIENNA — The investigational interleukin (IL)-17 inhibitor izokibep hit its mark when it came to improving overall disease activity in people with active psoriatic arthritis (PsA) in a phase 2b/3 trial, but it was no better than placebo at reducing inflammation of the entheses. 

This apparent and unexpected lack of effect in the entheses was a key talking point after Philip J. Mease, MD, presented the late-breaking trial findings at the annual European Congress of Rheumatology.

Sara Freeman/Medscape Medical News

At just 18.6 kilodaltons in size, izokibep is just “one tenth the size of a standard monoclonal antibody” and is classed as a small protein therapeutic, Dr. Mease said. It has a “very tight” binding affinity for IL-17A, and because it also binds to albumin, it has a prolonged half-life compared with other IL-17 inhibitors. Potentially, it should be able to “penetrate into difficult areas,” such as the entheses, he said.
 

Prespecified Enthesitis Analysis

However, results of a prespecified secondary analysis conducted in 209 of the 343 trial participants who had received treatment showed no significant difference in the proportions with enthesis resolution at 16 weeks, defined as a Leeds Enthesitis Index (LEI) of 0.

Comparing two dosing regimens of izokibep 160 mg once weekly (QW) vs every other week (Q2W) with placebo, enthesitis resolution was seen in 45%, 56%, and 47%, respectively, of patients.

The LEI is “sometimes subject to problems with evaluation because of placebo response, which is what we see here,” noted Dr. Mease, director of rheumatology research at the Providence Swedish Medical Center and a rheumatology professor at the University of Washington School of Medicine in Seattle.

An exploratory analysis showed that there was a better response for izokibep vs placebo if the analysis included only patients with higher LEI scores at baseline, at 8.0% (n = 12) for placebo, 22.0% (n = 9) for izokibep 160 mg QW, and 50.0% (n = 12) for izokibep 160 mg Q2W.
 

Main Efficacy Data

The primary endpoint for the trial was the proportion of patients who had 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks. This showed a clear advantage for treatment with izokibep 160 QW and Q2W compared with placebo, with a respective 40%, 43%, and 15% of patients meeting this endpoint.

Corresponding ACR20 response rates were 59%, 64%, and 35%, respectively; ACR70 response rates were a respective 25%, 23%, and 5%.

In addition to ACR70, izokibep 160 QW and Q2W met a number of other “high hurdle” efficacy endpoints better than did placebo, Dr. Mease reported. A 90% reduction from baseline in the Psoriasis Area and Severity Index (PASI90) was achieved by a respective 64%, 58%, and 12% of patients, and a 100% reduction in this index (PASI100) was achieved by a respective 51%, 47%, and 12%. And 41%, 42%, and 14% of patients, respectively, met the criteria for minimal disease activity.
 

Patient Population

Mease pointed out during his presentation that the trial included patients with adult-onset PsA that had been ongoing for ≥ 6 months. Patients had to have at least three tender or swollen joints and an inadequate response, intolerance, or contraindication to commonly used front-line therapies such as nonsteroidal anti-inflammatory drugs, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), and tumor necrosis factor inhibitors (TNFi).

In fact, around half of the participants across the three treatment arms had received prior csDMARDs, and almost a quarter had received a TNFi.

The mean duration of disease was around 7 years, the average age was about 50 years, and the majority of the participants were White individuals. There were more women than men in the placebo vs the izokibep arms (43.4% vs about 60.0%).
 

Adverse Events

Injection site reactions were the most common adverse events, most of which were mild to moderate. Very few (< 1% to 4%) led to any need to discontinue the drug.

Serious adverse events occurred at low rates in all study arms: 0.8% for placebo, 2.7% for izokibep QW, and 1.8% for izokibep Q2W.

One patient each (0.9%) in the izokibep arms developed ulcerative colitis, whereas none in the placebo group did. Only two patients developed candidiasis. One was in the placebo group and had a skin infection, and the other was an oral infection in the QW izokibep arm.

There were no cases of uveitis, suicidal ideation, or deaths reported.
 

Comments on the Study

During the discussion that followed the presentation, Walter P. Maksymowych, MBChB, of the University of Alberta in Edmonton, Alberta, Canada, addressed the dosing regimens used.

“Looking at the side effect profile and then looking at the response rate, comparing the weekly dosing and every 2 weeks, do you think, in hindsight, you might be remiss that there wasn’t an additional dosing on a monthly basis, especially since this is a construct that is meant to prolong the half-life of the molecule?” he asked, adding that perhaps this should be something to consider in future studies.

Mease responded that there had been a fourth dosing arm in the trial — izokibep 80 mg once a month — but because there were only eight patients, the data were not sufficiently robust to analyze. 

Commenting on the study, Laura C. Coates, MBChB, PhD, said: “It’s a pretty standard phase 2b/3 study,” and the outcomes were not wildly different from what has been seen with other IL-17A inhibitors.

“In phase 2, the enthesitis data looked really good; in phase 3, the enthesitis data looks the same as for any other IL-17 inhibitor,” Dr. Coates said.

A version of this article appeared on Medscape.com.

VIENNA — The investigational interleukin (IL)-17 inhibitor izokibep hit its mark when it came to improving overall disease activity in people with active psoriatic arthritis (PsA) in a phase 2b/3 trial, but it was no better than placebo at reducing inflammation of the entheses. 

This apparent and unexpected lack of effect in the entheses was a key talking point after Philip J. Mease, MD, presented the late-breaking trial findings at the annual European Congress of Rheumatology.

Sara Freeman/Medscape Medical News

At just 18.6 kilodaltons in size, izokibep is just “one tenth the size of a standard monoclonal antibody” and is classed as a small protein therapeutic, Dr. Mease said. It has a “very tight” binding affinity for IL-17A, and because it also binds to albumin, it has a prolonged half-life compared with other IL-17 inhibitors. Potentially, it should be able to “penetrate into difficult areas,” such as the entheses, he said.
 

Prespecified Enthesitis Analysis

However, results of a prespecified secondary analysis conducted in 209 of the 343 trial participants who had received treatment showed no significant difference in the proportions with enthesis resolution at 16 weeks, defined as a Leeds Enthesitis Index (LEI) of 0.

Comparing two dosing regimens of izokibep 160 mg once weekly (QW) vs every other week (Q2W) with placebo, enthesitis resolution was seen in 45%, 56%, and 47%, respectively, of patients.

The LEI is “sometimes subject to problems with evaluation because of placebo response, which is what we see here,” noted Dr. Mease, director of rheumatology research at the Providence Swedish Medical Center and a rheumatology professor at the University of Washington School of Medicine in Seattle.

An exploratory analysis showed that there was a better response for izokibep vs placebo if the analysis included only patients with higher LEI scores at baseline, at 8.0% (n = 12) for placebo, 22.0% (n = 9) for izokibep 160 mg QW, and 50.0% (n = 12) for izokibep 160 mg Q2W.
 

Main Efficacy Data

The primary endpoint for the trial was the proportion of patients who had 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks. This showed a clear advantage for treatment with izokibep 160 QW and Q2W compared with placebo, with a respective 40%, 43%, and 15% of patients meeting this endpoint.

Corresponding ACR20 response rates were 59%, 64%, and 35%, respectively; ACR70 response rates were a respective 25%, 23%, and 5%.

In addition to ACR70, izokibep 160 QW and Q2W met a number of other “high hurdle” efficacy endpoints better than did placebo, Dr. Mease reported. A 90% reduction from baseline in the Psoriasis Area and Severity Index (PASI90) was achieved by a respective 64%, 58%, and 12% of patients, and a 100% reduction in this index (PASI100) was achieved by a respective 51%, 47%, and 12%. And 41%, 42%, and 14% of patients, respectively, met the criteria for minimal disease activity.
 

Patient Population

Mease pointed out during his presentation that the trial included patients with adult-onset PsA that had been ongoing for ≥ 6 months. Patients had to have at least three tender or swollen joints and an inadequate response, intolerance, or contraindication to commonly used front-line therapies such as nonsteroidal anti-inflammatory drugs, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), and tumor necrosis factor inhibitors (TNFi).

In fact, around half of the participants across the three treatment arms had received prior csDMARDs, and almost a quarter had received a TNFi.

The mean duration of disease was around 7 years, the average age was about 50 years, and the majority of the participants were White individuals. There were more women than men in the placebo vs the izokibep arms (43.4% vs about 60.0%).
 

Adverse Events

Injection site reactions were the most common adverse events, most of which were mild to moderate. Very few (< 1% to 4%) led to any need to discontinue the drug.

Serious adverse events occurred at low rates in all study arms: 0.8% for placebo, 2.7% for izokibep QW, and 1.8% for izokibep Q2W.

One patient each (0.9%) in the izokibep arms developed ulcerative colitis, whereas none in the placebo group did. Only two patients developed candidiasis. One was in the placebo group and had a skin infection, and the other was an oral infection in the QW izokibep arm.

There were no cases of uveitis, suicidal ideation, or deaths reported.
 

Comments on the Study

During the discussion that followed the presentation, Walter P. Maksymowych, MBChB, of the University of Alberta in Edmonton, Alberta, Canada, addressed the dosing regimens used.

“Looking at the side effect profile and then looking at the response rate, comparing the weekly dosing and every 2 weeks, do you think, in hindsight, you might be remiss that there wasn’t an additional dosing on a monthly basis, especially since this is a construct that is meant to prolong the half-life of the molecule?” he asked, adding that perhaps this should be something to consider in future studies.

Mease responded that there had been a fourth dosing arm in the trial — izokibep 80 mg once a month — but because there were only eight patients, the data were not sufficiently robust to analyze. 

Commenting on the study, Laura C. Coates, MBChB, PhD, said: “It’s a pretty standard phase 2b/3 study,” and the outcomes were not wildly different from what has been seen with other IL-17A inhibitors.

“In phase 2, the enthesitis data looked really good; in phase 3, the enthesitis data looks the same as for any other IL-17 inhibitor,” Dr. Coates said.

A version of this article appeared on Medscape.com.

VIENNA — The investigational interleukin (IL)-17 inhibitor izokibep hit its mark when it came to improving overall disease activity in people with active psoriatic arthritis (PsA) in a phase 2b/3 trial, but it was no better than placebo at reducing inflammation of the entheses. 

This apparent and unexpected lack of effect in the entheses was a key talking point after Philip J. Mease, MD, presented the late-breaking trial findings at the annual European Congress of Rheumatology.

Sara Freeman/Medscape Medical News

At just 18.6 kilodaltons in size, izokibep is just “one tenth the size of a standard monoclonal antibody” and is classed as a small protein therapeutic, Dr. Mease said. It has a “very tight” binding affinity for IL-17A, and because it also binds to albumin, it has a prolonged half-life compared with other IL-17 inhibitors. Potentially, it should be able to “penetrate into difficult areas,” such as the entheses, he said.
 

Prespecified Enthesitis Analysis

However, results of a prespecified secondary analysis conducted in 209 of the 343 trial participants who had received treatment showed no significant difference in the proportions with enthesis resolution at 16 weeks, defined as a Leeds Enthesitis Index (LEI) of 0.

Comparing two dosing regimens of izokibep 160 mg once weekly (QW) vs every other week (Q2W) with placebo, enthesitis resolution was seen in 45%, 56%, and 47%, respectively, of patients.

The LEI is “sometimes subject to problems with evaluation because of placebo response, which is what we see here,” noted Dr. Mease, director of rheumatology research at the Providence Swedish Medical Center and a rheumatology professor at the University of Washington School of Medicine in Seattle.

An exploratory analysis showed that there was a better response for izokibep vs placebo if the analysis included only patients with higher LEI scores at baseline, at 8.0% (n = 12) for placebo, 22.0% (n = 9) for izokibep 160 mg QW, and 50.0% (n = 12) for izokibep 160 mg Q2W.
 

Main Efficacy Data

The primary endpoint for the trial was the proportion of patients who had 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks. This showed a clear advantage for treatment with izokibep 160 QW and Q2W compared with placebo, with a respective 40%, 43%, and 15% of patients meeting this endpoint.

Corresponding ACR20 response rates were 59%, 64%, and 35%, respectively; ACR70 response rates were a respective 25%, 23%, and 5%.

In addition to ACR70, izokibep 160 QW and Q2W met a number of other “high hurdle” efficacy endpoints better than did placebo, Dr. Mease reported. A 90% reduction from baseline in the Psoriasis Area and Severity Index (PASI90) was achieved by a respective 64%, 58%, and 12% of patients, and a 100% reduction in this index (PASI100) was achieved by a respective 51%, 47%, and 12%. And 41%, 42%, and 14% of patients, respectively, met the criteria for minimal disease activity.
 

Patient Population

Mease pointed out during his presentation that the trial included patients with adult-onset PsA that had been ongoing for ≥ 6 months. Patients had to have at least three tender or swollen joints and an inadequate response, intolerance, or contraindication to commonly used front-line therapies such as nonsteroidal anti-inflammatory drugs, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), and tumor necrosis factor inhibitors (TNFi).

In fact, around half of the participants across the three treatment arms had received prior csDMARDs, and almost a quarter had received a TNFi.

The mean duration of disease was around 7 years, the average age was about 50 years, and the majority of the participants were White individuals. There were more women than men in the placebo vs the izokibep arms (43.4% vs about 60.0%).
 

Adverse Events

Injection site reactions were the most common adverse events, most of which were mild to moderate. Very few (< 1% to 4%) led to any need to discontinue the drug.

Serious adverse events occurred at low rates in all study arms: 0.8% for placebo, 2.7% for izokibep QW, and 1.8% for izokibep Q2W.

One patient each (0.9%) in the izokibep arms developed ulcerative colitis, whereas none in the placebo group did. Only two patients developed candidiasis. One was in the placebo group and had a skin infection, and the other was an oral infection in the QW izokibep arm.

There were no cases of uveitis, suicidal ideation, or deaths reported.
 

Comments on the Study

During the discussion that followed the presentation, Walter P. Maksymowych, MBChB, of the University of Alberta in Edmonton, Alberta, Canada, addressed the dosing regimens used.

“Looking at the side effect profile and then looking at the response rate, comparing the weekly dosing and every 2 weeks, do you think, in hindsight, you might be remiss that there wasn’t an additional dosing on a monthly basis, especially since this is a construct that is meant to prolong the half-life of the molecule?” he asked, adding that perhaps this should be something to consider in future studies.

Mease responded that there had been a fourth dosing arm in the trial — izokibep 80 mg once a month — but because there were only eight patients, the data were not sufficiently robust to analyze. 

Commenting on the study, Laura C. Coates, MBChB, PhD, said: “It’s a pretty standard phase 2b/3 study,” and the outcomes were not wildly different from what has been seen with other IL-17A inhibitors.

“In phase 2, the enthesitis data looked really good; in phase 3, the enthesitis data looks the same as for any other IL-17 inhibitor,” Dr. Coates said.

A version of this article appeared on Medscape.com.

Skin manifestations are common in the vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic (VEXAS) syndrome and present early in the disease course. Additionally, the most common histologic findings include leukocytoclastic vasculitis, neutrophilic dermatosis, and perivascular dermatitis; different variants in the UBA1 gene are associated with specific skin manifestations.

Those are key findings from a cohort study of 112 patients with VEXAS published online in JAMA Dermatology. The study, conducted by researchers at the National Institutes of Health (NIH) and several other institutions, aimed to define the spectrum of cutaneous manifestations in VEXAS in association with genetic, histologic, and other clinical findings.

Edward W. Cowen, MD, MHSc

First described in 2020, VEXAS syndrome is an adult-onset multisystem disease that can pose a diagnostic challenge to clinicians, the study’s corresponding author, Edward W. Cowen, MD, MHSc, of the dermatology branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), said in an interview. The disease is caused by pathogenic variants in the UBA1 gene, located on the X chromosome. Affected individuals exhibit a wide range of manifestations, including cytopenia/myelodysplasia, multiorgan systemic inflammation, and cutaneous involvement.

“Patients may present to a variety of disease specialists depending on their symptoms and providers may not immediately consider a genetic etiology in an older individual,” Dr. Cowen said in an interview. “Although skin involvement occurs in more than 80% of patients, it is pleomorphic and may resemble a variety of other conditions such as vasculitis and Sweet syndrome.”

To better understand the cutaneous manifestations of VEXAS syndrome, the researchers evaluated data from 112 patients with VEXAS-defining genetic variants in the UBA1 gene between 2019 and 2023. Of the 112 patients, 73 underwent medical record review only, and 39 were prospectively evaluated at NIH. All but one of the patients were men, 94% were White individuals, and their mean age was 64 years. Skin involvement occurred in 83% of cases and was the most common presenting feature of VEXAS in 61% of cases.

Of the 64 histopathologic reports available from 60 patients, the main skin histopathologic findings were leukocytoclastic vasculitis in 23 patients (36%), neutrophilic dermatosis in 22 patients (34%), and perivascular dermatitis in 19 patients (30%). According to Dr. Cowen, one key histologic finding was a distinct pattern of “histiocytoid” dermal neutrophilic inflammation, which was present in 13 of 15 specimens (86%) that underwent central re-review. “This pattern can occasionally also be seen in patients with Sweet syndrome, unrelated to VEXAS, but was a hallmark feature found in the majority of skin biopsies of patients with VEXAS,” he said.

Image courtesy of JAMA Network

“Together with another pathologic finding, leukocytoclasia, these features can be useful clues to alert the pathologist to a potential diagnosis of VEXAS. This myeloid predominant pattern of skin inflammation was also most strongly associated with the leucine pathogenic variant of the UBA1 gene.” In contrast, cutaneous vasculitis was most strongly associated with the valine pathogenic variant of UBA1. “This is important because the valine variant has been previously independently linked to decreased survival,” he said.

In findings related to pathogenic genetic variants, the researchers observed that the p.Met41Leu variant was most frequently associated with neutrophilic dermal infiltrates in 14 of 17 patients (82%) with this variant and often resembled histiocytoid Sweet syndrome. In addition, the p.Met41Val variant was associated with vasculitic lesions in 11 of 20 patients (55%) with this variant and with a mixed leukocytic infiltrate in 17 of these 20 patients (85%).
 

Treatment Outcomes

In the realm of therapies, skin manifestations improved in 67 of 73 patients (92%) treated with oral prednisone, while treatment with the interleukin-1 receptor antagonist anakinra improved cutaneous disease in 9 of the 16 (56%) who received it. However, 12 (75%) of those who received anakinra developed severe injection-site reactions, including ulceration in two patients and abscess formation in one patient.

Dr. Cowen noted that VEXAS is associated with high mortality (22% in this cohort), and a high degree of suspicion is required to diagnose patients with VEXAS before significant end organ damage has occurred. “This diagnosis should be considered in all older male patients who present with neutrophilic dermatosis — particularly histiocytoid Sweet syndrome, vasculitis, or leukocytoclasia without vasculitis. Patients who appear to have isolated skin involvement may have cytopenias and acute phase reactants. Therefore, complete blood count with differential and ESR and CRP should be considered to investigate for macrocytosis, cytopenias, and systemic inflammation.”

He acknowledged certain limitations of the study, including the fact that many patients were first evaluated at the NIH after having disease symptoms for many months or years. “It is possible that patients with VEXAS referred to the NIH, either for genetic testing or in person evaluation, represent a population with more aggressive disease.”

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was asked to comment on the study, emphasized the importance of the UBA1 mutation in the diagnosis of this complex syndrome. “Dermatologists should be aware of VEXAS syndrome as the majority of patients present with skin lesions, which can range from urticarial to Sweet syndrome–like to palpable purpura,” Dr. Ko said.

“Chondritis and periorbital edema, sometimes unilateral, are also associated. Histopathologic clues include a predominantly histiocytoid infiltrate,” she noted. In addition, “the prominent myxoid stroma around blood vessels and adnexal structures as a clue to VEXAS syndrome surprised me; I had not read that before.”

The study was supported by the Intramural Research Program of NIAMS. One of the study authors reported personal fees from Alexion, Novartis, and Sobi outside of the submitted work. No other disclosures were reported. Dr. Ko reported having no disclosures.

A version of this article appeared on Medscape.com .

Skin manifestations are common in the vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic (VEXAS) syndrome and present early in the disease course. Additionally, the most common histologic findings include leukocytoclastic vasculitis, neutrophilic dermatosis, and perivascular dermatitis; different variants in the UBA1 gene are associated with specific skin manifestations.

Those are key findings from a cohort study of 112 patients with VEXAS published online in JAMA Dermatology. The study, conducted by researchers at the National Institutes of Health (NIH) and several other institutions, aimed to define the spectrum of cutaneous manifestations in VEXAS in association with genetic, histologic, and other clinical findings.

Edward W. Cowen, MD, MHSc

First described in 2020, VEXAS syndrome is an adult-onset multisystem disease that can pose a diagnostic challenge to clinicians, the study’s corresponding author, Edward W. Cowen, MD, MHSc, of the dermatology branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), said in an interview. The disease is caused by pathogenic variants in the UBA1 gene, located on the X chromosome. Affected individuals exhibit a wide range of manifestations, including cytopenia/myelodysplasia, multiorgan systemic inflammation, and cutaneous involvement.

“Patients may present to a variety of disease specialists depending on their symptoms and providers may not immediately consider a genetic etiology in an older individual,” Dr. Cowen said in an interview. “Although skin involvement occurs in more than 80% of patients, it is pleomorphic and may resemble a variety of other conditions such as vasculitis and Sweet syndrome.”

To better understand the cutaneous manifestations of VEXAS syndrome, the researchers evaluated data from 112 patients with VEXAS-defining genetic variants in the UBA1 gene between 2019 and 2023. Of the 112 patients, 73 underwent medical record review only, and 39 were prospectively evaluated at NIH. All but one of the patients were men, 94% were White individuals, and their mean age was 64 years. Skin involvement occurred in 83% of cases and was the most common presenting feature of VEXAS in 61% of cases.

Of the 64 histopathologic reports available from 60 patients, the main skin histopathologic findings were leukocytoclastic vasculitis in 23 patients (36%), neutrophilic dermatosis in 22 patients (34%), and perivascular dermatitis in 19 patients (30%). According to Dr. Cowen, one key histologic finding was a distinct pattern of “histiocytoid” dermal neutrophilic inflammation, which was present in 13 of 15 specimens (86%) that underwent central re-review. “This pattern can occasionally also be seen in patients with Sweet syndrome, unrelated to VEXAS, but was a hallmark feature found in the majority of skin biopsies of patients with VEXAS,” he said.

Image courtesy of JAMA Network

“Together with another pathologic finding, leukocytoclasia, these features can be useful clues to alert the pathologist to a potential diagnosis of VEXAS. This myeloid predominant pattern of skin inflammation was also most strongly associated with the leucine pathogenic variant of the UBA1 gene.” In contrast, cutaneous vasculitis was most strongly associated with the valine pathogenic variant of UBA1. “This is important because the valine variant has been previously independently linked to decreased survival,” he said.

In findings related to pathogenic genetic variants, the researchers observed that the p.Met41Leu variant was most frequently associated with neutrophilic dermal infiltrates in 14 of 17 patients (82%) with this variant and often resembled histiocytoid Sweet syndrome. In addition, the p.Met41Val variant was associated with vasculitic lesions in 11 of 20 patients (55%) with this variant and with a mixed leukocytic infiltrate in 17 of these 20 patients (85%).
 

Treatment Outcomes

In the realm of therapies, skin manifestations improved in 67 of 73 patients (92%) treated with oral prednisone, while treatment with the interleukin-1 receptor antagonist anakinra improved cutaneous disease in 9 of the 16 (56%) who received it. However, 12 (75%) of those who received anakinra developed severe injection-site reactions, including ulceration in two patients and abscess formation in one patient.

Dr. Cowen noted that VEXAS is associated with high mortality (22% in this cohort), and a high degree of suspicion is required to diagnose patients with VEXAS before significant end organ damage has occurred. “This diagnosis should be considered in all older male patients who present with neutrophilic dermatosis — particularly histiocytoid Sweet syndrome, vasculitis, or leukocytoclasia without vasculitis. Patients who appear to have isolated skin involvement may have cytopenias and acute phase reactants. Therefore, complete blood count with differential and ESR and CRP should be considered to investigate for macrocytosis, cytopenias, and systemic inflammation.”

He acknowledged certain limitations of the study, including the fact that many patients were first evaluated at the NIH after having disease symptoms for many months or years. “It is possible that patients with VEXAS referred to the NIH, either for genetic testing or in person evaluation, represent a population with more aggressive disease.”

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was asked to comment on the study, emphasized the importance of the UBA1 mutation in the diagnosis of this complex syndrome. “Dermatologists should be aware of VEXAS syndrome as the majority of patients present with skin lesions, which can range from urticarial to Sweet syndrome–like to palpable purpura,” Dr. Ko said.

“Chondritis and periorbital edema, sometimes unilateral, are also associated. Histopathologic clues include a predominantly histiocytoid infiltrate,” she noted. In addition, “the prominent myxoid stroma around blood vessels and adnexal structures as a clue to VEXAS syndrome surprised me; I had not read that before.”

The study was supported by the Intramural Research Program of NIAMS. One of the study authors reported personal fees from Alexion, Novartis, and Sobi outside of the submitted work. No other disclosures were reported. Dr. Ko reported having no disclosures.

A version of this article appeared on Medscape.com .

Skin manifestations are common in the vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic (VEXAS) syndrome and present early in the disease course. Additionally, the most common histologic findings include leukocytoclastic vasculitis, neutrophilic dermatosis, and perivascular dermatitis; different variants in the UBA1 gene are associated with specific skin manifestations.

Those are key findings from a cohort study of 112 patients with VEXAS published online in JAMA Dermatology. The study, conducted by researchers at the National Institutes of Health (NIH) and several other institutions, aimed to define the spectrum of cutaneous manifestations in VEXAS in association with genetic, histologic, and other clinical findings.

Edward W. Cowen, MD, MHSc

First described in 2020, VEXAS syndrome is an adult-onset multisystem disease that can pose a diagnostic challenge to clinicians, the study’s corresponding author, Edward W. Cowen, MD, MHSc, of the dermatology branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), said in an interview. The disease is caused by pathogenic variants in the UBA1 gene, located on the X chromosome. Affected individuals exhibit a wide range of manifestations, including cytopenia/myelodysplasia, multiorgan systemic inflammation, and cutaneous involvement.

“Patients may present to a variety of disease specialists depending on their symptoms and providers may not immediately consider a genetic etiology in an older individual,” Dr. Cowen said in an interview. “Although skin involvement occurs in more than 80% of patients, it is pleomorphic and may resemble a variety of other conditions such as vasculitis and Sweet syndrome.”

To better understand the cutaneous manifestations of VEXAS syndrome, the researchers evaluated data from 112 patients with VEXAS-defining genetic variants in the UBA1 gene between 2019 and 2023. Of the 112 patients, 73 underwent medical record review only, and 39 were prospectively evaluated at NIH. All but one of the patients were men, 94% were White individuals, and their mean age was 64 years. Skin involvement occurred in 83% of cases and was the most common presenting feature of VEXAS in 61% of cases.

Of the 64 histopathologic reports available from 60 patients, the main skin histopathologic findings were leukocytoclastic vasculitis in 23 patients (36%), neutrophilic dermatosis in 22 patients (34%), and perivascular dermatitis in 19 patients (30%). According to Dr. Cowen, one key histologic finding was a distinct pattern of “histiocytoid” dermal neutrophilic inflammation, which was present in 13 of 15 specimens (86%) that underwent central re-review. “This pattern can occasionally also be seen in patients with Sweet syndrome, unrelated to VEXAS, but was a hallmark feature found in the majority of skin biopsies of patients with VEXAS,” he said.

Image courtesy of JAMA Network

“Together with another pathologic finding, leukocytoclasia, these features can be useful clues to alert the pathologist to a potential diagnosis of VEXAS. This myeloid predominant pattern of skin inflammation was also most strongly associated with the leucine pathogenic variant of the UBA1 gene.” In contrast, cutaneous vasculitis was most strongly associated with the valine pathogenic variant of UBA1. “This is important because the valine variant has been previously independently linked to decreased survival,” he said.

In findings related to pathogenic genetic variants, the researchers observed that the p.Met41Leu variant was most frequently associated with neutrophilic dermal infiltrates in 14 of 17 patients (82%) with this variant and often resembled histiocytoid Sweet syndrome. In addition, the p.Met41Val variant was associated with vasculitic lesions in 11 of 20 patients (55%) with this variant and with a mixed leukocytic infiltrate in 17 of these 20 patients (85%).
 

Treatment Outcomes

In the realm of therapies, skin manifestations improved in 67 of 73 patients (92%) treated with oral prednisone, while treatment with the interleukin-1 receptor antagonist anakinra improved cutaneous disease in 9 of the 16 (56%) who received it. However, 12 (75%) of those who received anakinra developed severe injection-site reactions, including ulceration in two patients and abscess formation in one patient.

Dr. Cowen noted that VEXAS is associated with high mortality (22% in this cohort), and a high degree of suspicion is required to diagnose patients with VEXAS before significant end organ damage has occurred. “This diagnosis should be considered in all older male patients who present with neutrophilic dermatosis — particularly histiocytoid Sweet syndrome, vasculitis, or leukocytoclasia without vasculitis. Patients who appear to have isolated skin involvement may have cytopenias and acute phase reactants. Therefore, complete blood count with differential and ESR and CRP should be considered to investigate for macrocytosis, cytopenias, and systemic inflammation.”

He acknowledged certain limitations of the study, including the fact that many patients were first evaluated at the NIH after having disease symptoms for many months or years. “It is possible that patients with VEXAS referred to the NIH, either for genetic testing or in person evaluation, represent a population with more aggressive disease.”

Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Connecticut, who was asked to comment on the study, emphasized the importance of the UBA1 mutation in the diagnosis of this complex syndrome. “Dermatologists should be aware of VEXAS syndrome as the majority of patients present with skin lesions, which can range from urticarial to Sweet syndrome–like to palpable purpura,” Dr. Ko said.

“Chondritis and periorbital edema, sometimes unilateral, are also associated. Histopathologic clues include a predominantly histiocytoid infiltrate,” she noted. In addition, “the prominent myxoid stroma around blood vessels and adnexal structures as a clue to VEXAS syndrome surprised me; I had not read that before.”

The study was supported by the Intramural Research Program of NIAMS. One of the study authors reported personal fees from Alexion, Novartis, and Sobi outside of the submitted work. No other disclosures were reported. Dr. Ko reported having no disclosures.

A version of this article appeared on Medscape.com .