Clarity on torsemide vs. furosemide in HF: TRANSFORM-HF published

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Survival and readmission risk were similar whether patients hospitalized with heart failure (HF) were discharged on furosemide or torsemide in a randomized trial.

The study, TRANSFORM-HF, helps fill a major gap in the sparse evidence base guiding diuretic therapy in patients with a history of HF hospitalization. In that setting, for example, results suggest that discharge on any appropriate loop diuretic is more important than which loop diuretic is chosen.

TRANSFORM-HF is no ordinary randomized trial. Designed as a pragmatic comparative effectiveness study, it featured a streamlined protocol and other adaptations that made it easier and cheaper to conduct but that have also complicated its interpretation, the trialists and some observers acknowledge.
 

Perceived torsemide advantages

Furosemide may be the most-prescribed loop diuretic in HF, but in practice – based on some limited evidence – clinicians often prefer torsemide for its perceived advantages that include greater bioavailability, potassium sparing, and potentially helpful pleiotropic effects.

TRANSFORM-HF, however, provides no evidence to support such a preference. The primary endpoint of all-cause mortality was about 26% over a median 17 months whether patients were assigned to an initial furosemide or torsemide-first strategy, regardless of ejection fraction. Composite rates of death or hospitalization at 12 months also weren’t significantly different, at about 49% and 47%, respectively.

The findings suggest that clinicians may safely continue to prescribe either loop diuretic at their discretion, now with the support of data from a randomized trial.

TRANSFORM-HF was published in the Journal of the American Medical Association, with lead author Robert J. Mentz, MD, Duke University School of Medicine, Durham, N.C.

Dr. Robert J. Mentz


Dr. Mentz had also presented the trial’s preliminary results at the November American Heart Association Scientific Sessions in Chicago. The findings unveiled at the meeting and those published in the journal are essentially the same.
 

Reflections of standard practice

With its pragmatic design, TRANSFORM-HF entered a diverse HF population broadly representative of actual clinical practice. Patients were managed with few restrictions in a protocol that allowed, for example, loop-diuretic crossovers and other discretionary diuretic changes.

Diuretic dosing also varied significantly between the groups, and there was an unexpectedly high prevalence of diuretic withdrawal, the published report notes. Those factors, it states, may have “diminished” the trial’s ability “to distinguish the hypothesized between-group differences.”

Still, the trial “should be celebrated for dispelling a long-standing myth, based on surrogate markers and small trials, of the superiority of torsemide over furosemide,” writes Michelle M. Kittleson, MD, PhD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, in an accompanying editorial .

Now, she continues, “when faced with a patient with heart failure and congestive symptoms, clinicians can focus their energy on what really matters: Not the relative merits of different loop diuretics, but rather the initiation and optimization of evidence and guideline-based therapies to help their patients feel better and live longer.”
 

Trial design caveats

But that pragmatic design raises cautions, the editorial notes. “Pragmatic trials are more flexible and nimbler in design and execution, but this agility comes at a cost. An overly heterogeneous patient population can impact the trial’s ability to assess efficacy of therapies while minimally intensive follow-up precludes comprehensive outcome assessment.”

The study’s 2,859 patients hospitalized with HF were assigned to open-label treatment with furosemide or torsemide at more than 60 U.S. centers. Of the 1,428 and 1,431 patients, respectively, about 37% were women and 34% were African American.

The hazard ratio for all cause mortality across the 17.4-month follow-up, torsemide versus furosemide, was 1.02 (95% confidence interval, 0.89-1.18). The HR for death or hospitalization for any cause at 12 months was 0.92 (95% CI, 0.83-1.02). And the rate ratio for 12-month all-cause hospitalization was 0.94 (95% CI, 0.84-1.07).

“TRANSFORM-HF joins a catalog of cautionary tales in cardiology, whereby carefully executed negative trials have refuted the misleading promise of plausible surrogate end points and preliminary data,” Dr. Kittleson writes.

“The lesson: Clinicians should have a healthy suspicion for plausible pathophysiology, surrogate end points, and nonrandomized data as the sole basis of defining superiority of an intervention.”

TRANSFORM-HF was funded by the National Institutes of Health. Dr. Mentz reports receiving grants from American Regent and Novartis; personal fees from AstraZeneca, Boehringer Ingelheim/Eli Lilly, Cytokinetics, Bayer, Merck, and Pharmacosmos; and research support from Abbott, Amgen, Bayer, Boston Scientific, Fast BioMedical, Gilead, Innolife, Medtronic, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. Disclosures for the other authors can be found with the original article. Dr. Kittleson reports no relevant financial relationships.

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

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Survival and readmission risk were similar whether patients hospitalized with heart failure (HF) were discharged on furosemide or torsemide in a randomized trial.

The study, TRANSFORM-HF, helps fill a major gap in the sparse evidence base guiding diuretic therapy in patients with a history of HF hospitalization. In that setting, for example, results suggest that discharge on any appropriate loop diuretic is more important than which loop diuretic is chosen.

TRANSFORM-HF is no ordinary randomized trial. Designed as a pragmatic comparative effectiveness study, it featured a streamlined protocol and other adaptations that made it easier and cheaper to conduct but that have also complicated its interpretation, the trialists and some observers acknowledge.
 

Perceived torsemide advantages

Furosemide may be the most-prescribed loop diuretic in HF, but in practice – based on some limited evidence – clinicians often prefer torsemide for its perceived advantages that include greater bioavailability, potassium sparing, and potentially helpful pleiotropic effects.

TRANSFORM-HF, however, provides no evidence to support such a preference. The primary endpoint of all-cause mortality was about 26% over a median 17 months whether patients were assigned to an initial furosemide or torsemide-first strategy, regardless of ejection fraction. Composite rates of death or hospitalization at 12 months also weren’t significantly different, at about 49% and 47%, respectively.

The findings suggest that clinicians may safely continue to prescribe either loop diuretic at their discretion, now with the support of data from a randomized trial.

TRANSFORM-HF was published in the Journal of the American Medical Association, with lead author Robert J. Mentz, MD, Duke University School of Medicine, Durham, N.C.

Dr. Robert J. Mentz


Dr. Mentz had also presented the trial’s preliminary results at the November American Heart Association Scientific Sessions in Chicago. The findings unveiled at the meeting and those published in the journal are essentially the same.
 

Reflections of standard practice

With its pragmatic design, TRANSFORM-HF entered a diverse HF population broadly representative of actual clinical practice. Patients were managed with few restrictions in a protocol that allowed, for example, loop-diuretic crossovers and other discretionary diuretic changes.

Diuretic dosing also varied significantly between the groups, and there was an unexpectedly high prevalence of diuretic withdrawal, the published report notes. Those factors, it states, may have “diminished” the trial’s ability “to distinguish the hypothesized between-group differences.”

Still, the trial “should be celebrated for dispelling a long-standing myth, based on surrogate markers and small trials, of the superiority of torsemide over furosemide,” writes Michelle M. Kittleson, MD, PhD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, in an accompanying editorial .

Now, she continues, “when faced with a patient with heart failure and congestive symptoms, clinicians can focus their energy on what really matters: Not the relative merits of different loop diuretics, but rather the initiation and optimization of evidence and guideline-based therapies to help their patients feel better and live longer.”
 

Trial design caveats

But that pragmatic design raises cautions, the editorial notes. “Pragmatic trials are more flexible and nimbler in design and execution, but this agility comes at a cost. An overly heterogeneous patient population can impact the trial’s ability to assess efficacy of therapies while minimally intensive follow-up precludes comprehensive outcome assessment.”

The study’s 2,859 patients hospitalized with HF were assigned to open-label treatment with furosemide or torsemide at more than 60 U.S. centers. Of the 1,428 and 1,431 patients, respectively, about 37% were women and 34% were African American.

The hazard ratio for all cause mortality across the 17.4-month follow-up, torsemide versus furosemide, was 1.02 (95% confidence interval, 0.89-1.18). The HR for death or hospitalization for any cause at 12 months was 0.92 (95% CI, 0.83-1.02). And the rate ratio for 12-month all-cause hospitalization was 0.94 (95% CI, 0.84-1.07).

“TRANSFORM-HF joins a catalog of cautionary tales in cardiology, whereby carefully executed negative trials have refuted the misleading promise of plausible surrogate end points and preliminary data,” Dr. Kittleson writes.

“The lesson: Clinicians should have a healthy suspicion for plausible pathophysiology, surrogate end points, and nonrandomized data as the sole basis of defining superiority of an intervention.”

TRANSFORM-HF was funded by the National Institutes of Health. Dr. Mentz reports receiving grants from American Regent and Novartis; personal fees from AstraZeneca, Boehringer Ingelheim/Eli Lilly, Cytokinetics, Bayer, Merck, and Pharmacosmos; and research support from Abbott, Amgen, Bayer, Boston Scientific, Fast BioMedical, Gilead, Innolife, Medtronic, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. Disclosures for the other authors can be found with the original article. Dr. Kittleson reports no relevant financial relationships.

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

Survival and readmission risk were similar whether patients hospitalized with heart failure (HF) were discharged on furosemide or torsemide in a randomized trial.

The study, TRANSFORM-HF, helps fill a major gap in the sparse evidence base guiding diuretic therapy in patients with a history of HF hospitalization. In that setting, for example, results suggest that discharge on any appropriate loop diuretic is more important than which loop diuretic is chosen.

TRANSFORM-HF is no ordinary randomized trial. Designed as a pragmatic comparative effectiveness study, it featured a streamlined protocol and other adaptations that made it easier and cheaper to conduct but that have also complicated its interpretation, the trialists and some observers acknowledge.
 

Perceived torsemide advantages

Furosemide may be the most-prescribed loop diuretic in HF, but in practice – based on some limited evidence – clinicians often prefer torsemide for its perceived advantages that include greater bioavailability, potassium sparing, and potentially helpful pleiotropic effects.

TRANSFORM-HF, however, provides no evidence to support such a preference. The primary endpoint of all-cause mortality was about 26% over a median 17 months whether patients were assigned to an initial furosemide or torsemide-first strategy, regardless of ejection fraction. Composite rates of death or hospitalization at 12 months also weren’t significantly different, at about 49% and 47%, respectively.

The findings suggest that clinicians may safely continue to prescribe either loop diuretic at their discretion, now with the support of data from a randomized trial.

TRANSFORM-HF was published in the Journal of the American Medical Association, with lead author Robert J. Mentz, MD, Duke University School of Medicine, Durham, N.C.

Dr. Robert J. Mentz


Dr. Mentz had also presented the trial’s preliminary results at the November American Heart Association Scientific Sessions in Chicago. The findings unveiled at the meeting and those published in the journal are essentially the same.
 

Reflections of standard practice

With its pragmatic design, TRANSFORM-HF entered a diverse HF population broadly representative of actual clinical practice. Patients were managed with few restrictions in a protocol that allowed, for example, loop-diuretic crossovers and other discretionary diuretic changes.

Diuretic dosing also varied significantly between the groups, and there was an unexpectedly high prevalence of diuretic withdrawal, the published report notes. Those factors, it states, may have “diminished” the trial’s ability “to distinguish the hypothesized between-group differences.”

Still, the trial “should be celebrated for dispelling a long-standing myth, based on surrogate markers and small trials, of the superiority of torsemide over furosemide,” writes Michelle M. Kittleson, MD, PhD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, in an accompanying editorial .

Now, she continues, “when faced with a patient with heart failure and congestive symptoms, clinicians can focus their energy on what really matters: Not the relative merits of different loop diuretics, but rather the initiation and optimization of evidence and guideline-based therapies to help their patients feel better and live longer.”
 

Trial design caveats

But that pragmatic design raises cautions, the editorial notes. “Pragmatic trials are more flexible and nimbler in design and execution, but this agility comes at a cost. An overly heterogeneous patient population can impact the trial’s ability to assess efficacy of therapies while minimally intensive follow-up precludes comprehensive outcome assessment.”

The study’s 2,859 patients hospitalized with HF were assigned to open-label treatment with furosemide or torsemide at more than 60 U.S. centers. Of the 1,428 and 1,431 patients, respectively, about 37% were women and 34% were African American.

The hazard ratio for all cause mortality across the 17.4-month follow-up, torsemide versus furosemide, was 1.02 (95% confidence interval, 0.89-1.18). The HR for death or hospitalization for any cause at 12 months was 0.92 (95% CI, 0.83-1.02). And the rate ratio for 12-month all-cause hospitalization was 0.94 (95% CI, 0.84-1.07).

“TRANSFORM-HF joins a catalog of cautionary tales in cardiology, whereby carefully executed negative trials have refuted the misleading promise of plausible surrogate end points and preliminary data,” Dr. Kittleson writes.

“The lesson: Clinicians should have a healthy suspicion for plausible pathophysiology, surrogate end points, and nonrandomized data as the sole basis of defining superiority of an intervention.”

TRANSFORM-HF was funded by the National Institutes of Health. Dr. Mentz reports receiving grants from American Regent and Novartis; personal fees from AstraZeneca, Boehringer Ingelheim/Eli Lilly, Cytokinetics, Bayer, Merck, and Pharmacosmos; and research support from Abbott, Amgen, Bayer, Boston Scientific, Fast BioMedical, Gilead, Innolife, Medtronic, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. Disclosures for the other authors can be found with the original article. Dr. Kittleson reports no relevant financial relationships.

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

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Children with autism but no intellectual disability may be falling through the cracks

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Approximately two out of three children with autism spectrum disorder (ASD) do not have concurrent intellectual disability, according to a population study of ASD trends.

Dr. Josephine Shenouda

Intellectual functioning remains the best predictor of functional outcomes in kids with ASD, and missing those with no cognitive impairment (ASD-N) can prevent intervention and affect future achievement.

Furthermore, while the study found that ASD-N increased among all demographic subgroups from 2000 to 2016, it also observed widespread health disparities in identifying ASD-N, especially in Black, Hispanic, and underprivileged children.

“ASD is a major public health concern and prevalence estimates are likely to continue to rise as disparities are reduced and ASD identification is improved,” wrote researchers led by Josephine Shenouda, DrPH, MS, of Rutgers School of Public Health in Piscataway, N.J., in Pediatrics .

The study period saw a surprising 500% increase in the prevalence of ASD-N and a 200% increase in the prevalence of cognitive impairment–associated ASD-I , with higher rates across all sex, race, ethnicity, and socioeconomic subgroups. The five- and twofold respective increases are consistent with previous research.

“To a large degree, the rise in autism estimates has been driven by individuals without intellectual disability,” Dr. Shenouda said in an interview. “The best way to address increasing autism and to affect disparities in autism identification is through universal autism screening during the toddler period. And different metrics of functional outcomes need to be developed to understand the expression of autism better.”

Her group had previously seen autism estimates of approximately 1% in 2000 rise to 3% by 2016 but had noted variations, with some communities exceeding 5% for autism estimates. “That led to the question of why, and we saw that in areas with high estimates, we are identifying more children with autism without intellectual disability,” she said. “We wanted to know if the increase over time was equally distributed among children with autism with and without intellectual disability.”
 

A study in disparities

The cross-sectional study examined data from active ASD surveillance by the CDC’s Autism and Developmental Disabilities Monitoring Network in 8-year-olds residing in the New York/New Jersey Metropolitan Area. Overall, 4,661 children were identified with ASD, with ASD-I affecting 1,505 (32.3%), and ASD-N affecting 2,764 (59.3%). Non-Hispanic Black children who were affected numbered 946 (20.3%), while 1,230 (26.4%) were Hispanic, and 2,114 (45.4%) were non-Hispanic White.

Notably, Black children were 30% less likely to be identified with ASD-N compared with White children, and children residing in affluent areas were 80% more likely to be identified with ASD-N versus those in underserved areas. Furthermore, a greater proportion of children with ASD-I resided in vulnerable areas compared with their counterparts with ASD-N.

While males had a higher prevalence compared with females regardless of intellectual disability status, male-to-female ratios were slightly lower among ASD-I compared with ASD-N cases.

Dr. Barbara J. Howard

Commenting on the study but not involved in it, Barbara J. Howard, MD, an assistant professor of medicine at Johns Hopkins University, Baltimore, said the increasing gap in identifying ASD-N according to race, ethnicity, and socioeconomic status measures probably reflects greater parental awareness of ASD and access to diagnostic services in White families and those of higher socioeconomic status. “There were no racial, ethnicity, or socioeconomic status differences in the prevalence of the more obvious and impairing ASD-I in the sample, but its prevalence was also increasing over this period,” she said.

Although the greater recognition of the less impairing ASD-N is important for optimal outcomes through intervention, the increasing discrepancies mean that more children generally and more marginalized children specifically are not being diagnosed or served. “There should be no differences in prevalence by these characteristics,” Dr. Howard said. “The striking inequity for non-White children and those of lower socioeconomic status in being diagnosed with ASD-N and thus qualifying for intervention that could improve their long-term functioning is likely also compounded by service, educational, and social disadvantages they may experience.”

Dr. Emily Hotez

In light of these disparities, an accompanying editorial by Emily Hotez, PhD, of the University of California, Los Angeles, and Lindsay Shea, DrPH, of the A.J. Drexel Autism Institute at Drexel University, Philadelphia, argues that social determinants of health (SDOH) should be prioritized in the public health surveillance of autism since these factors potentially contribute to the general underdiagnosis of autism in minority groups and merit more attention from pediatricians. While SDOH affects many nonautistic conditions, it may be even more important for families dealing with the stressors and isolation associated with autism, the commentators said. “Our commentary speaks to the utility of increasing SDOH surveillance in improving our understanding of autistic individuals’ needs, experiences, and priorities on a population level,” Dr. Hotez said in an interview. She added that integrating SDOH surveillance into pediatricians’ workflows will lead to improvements in clinical practice and patient care in the long term.

“Specifically, increased uptake of universal SDOH screening and referral practices will allow pediatricians to more proactively link autistic children and families, particularly those from marginalized groups, with much-needed health-promoting services and supports.” She cautioned, however, that while most providers believe universal SDOH screening is important, fewer report that screening is feasible or feel prepared to address families’ social needs when they are identified.

This study was supported by the Centers for Disease Control and Prevention and the National Institutes of Health/National Institute of Environmental Health Sciences. The authors had no conflicts of interest to disclose. The commentators had no potential conflicts of interest to disclose. Dr. Howard disclosed no competing interests relevant to her comments.
 

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Approximately two out of three children with autism spectrum disorder (ASD) do not have concurrent intellectual disability, according to a population study of ASD trends.

Dr. Josephine Shenouda

Intellectual functioning remains the best predictor of functional outcomes in kids with ASD, and missing those with no cognitive impairment (ASD-N) can prevent intervention and affect future achievement.

Furthermore, while the study found that ASD-N increased among all demographic subgroups from 2000 to 2016, it also observed widespread health disparities in identifying ASD-N, especially in Black, Hispanic, and underprivileged children.

“ASD is a major public health concern and prevalence estimates are likely to continue to rise as disparities are reduced and ASD identification is improved,” wrote researchers led by Josephine Shenouda, DrPH, MS, of Rutgers School of Public Health in Piscataway, N.J., in Pediatrics .

The study period saw a surprising 500% increase in the prevalence of ASD-N and a 200% increase in the prevalence of cognitive impairment–associated ASD-I , with higher rates across all sex, race, ethnicity, and socioeconomic subgroups. The five- and twofold respective increases are consistent with previous research.

“To a large degree, the rise in autism estimates has been driven by individuals without intellectual disability,” Dr. Shenouda said in an interview. “The best way to address increasing autism and to affect disparities in autism identification is through universal autism screening during the toddler period. And different metrics of functional outcomes need to be developed to understand the expression of autism better.”

Her group had previously seen autism estimates of approximately 1% in 2000 rise to 3% by 2016 but had noted variations, with some communities exceeding 5% for autism estimates. “That led to the question of why, and we saw that in areas with high estimates, we are identifying more children with autism without intellectual disability,” she said. “We wanted to know if the increase over time was equally distributed among children with autism with and without intellectual disability.”
 

A study in disparities

The cross-sectional study examined data from active ASD surveillance by the CDC’s Autism and Developmental Disabilities Monitoring Network in 8-year-olds residing in the New York/New Jersey Metropolitan Area. Overall, 4,661 children were identified with ASD, with ASD-I affecting 1,505 (32.3%), and ASD-N affecting 2,764 (59.3%). Non-Hispanic Black children who were affected numbered 946 (20.3%), while 1,230 (26.4%) were Hispanic, and 2,114 (45.4%) were non-Hispanic White.

Notably, Black children were 30% less likely to be identified with ASD-N compared with White children, and children residing in affluent areas were 80% more likely to be identified with ASD-N versus those in underserved areas. Furthermore, a greater proportion of children with ASD-I resided in vulnerable areas compared with their counterparts with ASD-N.

While males had a higher prevalence compared with females regardless of intellectual disability status, male-to-female ratios were slightly lower among ASD-I compared with ASD-N cases.

Dr. Barbara J. Howard

Commenting on the study but not involved in it, Barbara J. Howard, MD, an assistant professor of medicine at Johns Hopkins University, Baltimore, said the increasing gap in identifying ASD-N according to race, ethnicity, and socioeconomic status measures probably reflects greater parental awareness of ASD and access to diagnostic services in White families and those of higher socioeconomic status. “There were no racial, ethnicity, or socioeconomic status differences in the prevalence of the more obvious and impairing ASD-I in the sample, but its prevalence was also increasing over this period,” she said.

Although the greater recognition of the less impairing ASD-N is important for optimal outcomes through intervention, the increasing discrepancies mean that more children generally and more marginalized children specifically are not being diagnosed or served. “There should be no differences in prevalence by these characteristics,” Dr. Howard said. “The striking inequity for non-White children and those of lower socioeconomic status in being diagnosed with ASD-N and thus qualifying for intervention that could improve their long-term functioning is likely also compounded by service, educational, and social disadvantages they may experience.”

Dr. Emily Hotez

In light of these disparities, an accompanying editorial by Emily Hotez, PhD, of the University of California, Los Angeles, and Lindsay Shea, DrPH, of the A.J. Drexel Autism Institute at Drexel University, Philadelphia, argues that social determinants of health (SDOH) should be prioritized in the public health surveillance of autism since these factors potentially contribute to the general underdiagnosis of autism in minority groups and merit more attention from pediatricians. While SDOH affects many nonautistic conditions, it may be even more important for families dealing with the stressors and isolation associated with autism, the commentators said. “Our commentary speaks to the utility of increasing SDOH surveillance in improving our understanding of autistic individuals’ needs, experiences, and priorities on a population level,” Dr. Hotez said in an interview. She added that integrating SDOH surveillance into pediatricians’ workflows will lead to improvements in clinical practice and patient care in the long term.

“Specifically, increased uptake of universal SDOH screening and referral practices will allow pediatricians to more proactively link autistic children and families, particularly those from marginalized groups, with much-needed health-promoting services and supports.” She cautioned, however, that while most providers believe universal SDOH screening is important, fewer report that screening is feasible or feel prepared to address families’ social needs when they are identified.

This study was supported by the Centers for Disease Control and Prevention and the National Institutes of Health/National Institute of Environmental Health Sciences. The authors had no conflicts of interest to disclose. The commentators had no potential conflicts of interest to disclose. Dr. Howard disclosed no competing interests relevant to her comments.
 

Approximately two out of three children with autism spectrum disorder (ASD) do not have concurrent intellectual disability, according to a population study of ASD trends.

Dr. Josephine Shenouda

Intellectual functioning remains the best predictor of functional outcomes in kids with ASD, and missing those with no cognitive impairment (ASD-N) can prevent intervention and affect future achievement.

Furthermore, while the study found that ASD-N increased among all demographic subgroups from 2000 to 2016, it also observed widespread health disparities in identifying ASD-N, especially in Black, Hispanic, and underprivileged children.

“ASD is a major public health concern and prevalence estimates are likely to continue to rise as disparities are reduced and ASD identification is improved,” wrote researchers led by Josephine Shenouda, DrPH, MS, of Rutgers School of Public Health in Piscataway, N.J., in Pediatrics .

The study period saw a surprising 500% increase in the prevalence of ASD-N and a 200% increase in the prevalence of cognitive impairment–associated ASD-I , with higher rates across all sex, race, ethnicity, and socioeconomic subgroups. The five- and twofold respective increases are consistent with previous research.

“To a large degree, the rise in autism estimates has been driven by individuals without intellectual disability,” Dr. Shenouda said in an interview. “The best way to address increasing autism and to affect disparities in autism identification is through universal autism screening during the toddler period. And different metrics of functional outcomes need to be developed to understand the expression of autism better.”

Her group had previously seen autism estimates of approximately 1% in 2000 rise to 3% by 2016 but had noted variations, with some communities exceeding 5% for autism estimates. “That led to the question of why, and we saw that in areas with high estimates, we are identifying more children with autism without intellectual disability,” she said. “We wanted to know if the increase over time was equally distributed among children with autism with and without intellectual disability.”
 

A study in disparities

The cross-sectional study examined data from active ASD surveillance by the CDC’s Autism and Developmental Disabilities Monitoring Network in 8-year-olds residing in the New York/New Jersey Metropolitan Area. Overall, 4,661 children were identified with ASD, with ASD-I affecting 1,505 (32.3%), and ASD-N affecting 2,764 (59.3%). Non-Hispanic Black children who were affected numbered 946 (20.3%), while 1,230 (26.4%) were Hispanic, and 2,114 (45.4%) were non-Hispanic White.

Notably, Black children were 30% less likely to be identified with ASD-N compared with White children, and children residing in affluent areas were 80% more likely to be identified with ASD-N versus those in underserved areas. Furthermore, a greater proportion of children with ASD-I resided in vulnerable areas compared with their counterparts with ASD-N.

While males had a higher prevalence compared with females regardless of intellectual disability status, male-to-female ratios were slightly lower among ASD-I compared with ASD-N cases.

Dr. Barbara J. Howard

Commenting on the study but not involved in it, Barbara J. Howard, MD, an assistant professor of medicine at Johns Hopkins University, Baltimore, said the increasing gap in identifying ASD-N according to race, ethnicity, and socioeconomic status measures probably reflects greater parental awareness of ASD and access to diagnostic services in White families and those of higher socioeconomic status. “There were no racial, ethnicity, or socioeconomic status differences in the prevalence of the more obvious and impairing ASD-I in the sample, but its prevalence was also increasing over this period,” she said.

Although the greater recognition of the less impairing ASD-N is important for optimal outcomes through intervention, the increasing discrepancies mean that more children generally and more marginalized children specifically are not being diagnosed or served. “There should be no differences in prevalence by these characteristics,” Dr. Howard said. “The striking inequity for non-White children and those of lower socioeconomic status in being diagnosed with ASD-N and thus qualifying for intervention that could improve their long-term functioning is likely also compounded by service, educational, and social disadvantages they may experience.”

Dr. Emily Hotez

In light of these disparities, an accompanying editorial by Emily Hotez, PhD, of the University of California, Los Angeles, and Lindsay Shea, DrPH, of the A.J. Drexel Autism Institute at Drexel University, Philadelphia, argues that social determinants of health (SDOH) should be prioritized in the public health surveillance of autism since these factors potentially contribute to the general underdiagnosis of autism in minority groups and merit more attention from pediatricians. While SDOH affects many nonautistic conditions, it may be even more important for families dealing with the stressors and isolation associated with autism, the commentators said. “Our commentary speaks to the utility of increasing SDOH surveillance in improving our understanding of autistic individuals’ needs, experiences, and priorities on a population level,” Dr. Hotez said in an interview. She added that integrating SDOH surveillance into pediatricians’ workflows will lead to improvements in clinical practice and patient care in the long term.

“Specifically, increased uptake of universal SDOH screening and referral practices will allow pediatricians to more proactively link autistic children and families, particularly those from marginalized groups, with much-needed health-promoting services and supports.” She cautioned, however, that while most providers believe universal SDOH screening is important, fewer report that screening is feasible or feel prepared to address families’ social needs when they are identified.

This study was supported by the Centers for Disease Control and Prevention and the National Institutes of Health/National Institute of Environmental Health Sciences. The authors had no conflicts of interest to disclose. The commentators had no potential conflicts of interest to disclose. Dr. Howard disclosed no competing interests relevant to her comments.
 

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Pre-existing radiographic damage influence response to secukinumab in PsA

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Key clinical point: Pre-existing radiographic damage was substantially prevalent in patients with psoriatic arthritis (PsA), with secukinumab therapy being associated with the inhibition of joint tenderness and swelling; however, high baseline radiographic damage reduced the likelihood of achieving minimal disease activity (MDA).

 

Major finding: Overall, 86% and 60% of patients had erosion and joint space narrowing (JSN) scores of >0, respectively. At week 16 and 52, 150 and 300 mg secukinumab reduced tender and swollen joint counts across all values of baseline erosion and JSN scores; however, patients with higher baseline erosion and JSN scores were less likely to achieve MDA.

 

Study details: This was a post hoc analysis of two phase 3 trials, FUTURE 1 and FUTURE 5, including 1554 patients with PsA who received 300 or 150 mg secukinumab with or without a loading dose.

 

Disclosures: This study received funding from Novartis Pharma AG. Four authors declared being employees of or owning stocks in Novartis. Seven authors declared ties with various sources, including Novartis.

 

Source: Mease P et al. Quantification of pre-existing radiographic damage and its relationship with joint activity and long-term clinical outcomes with secukinumab therapy in patients with psoriatic arthritis. Arthritis Res Ther. 2022;24(1):283 (Dec 28). Doi: 10.1186/s13075-022-02944-1

 

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Key clinical point: Pre-existing radiographic damage was substantially prevalent in patients with psoriatic arthritis (PsA), with secukinumab therapy being associated with the inhibition of joint tenderness and swelling; however, high baseline radiographic damage reduced the likelihood of achieving minimal disease activity (MDA).

 

Major finding: Overall, 86% and 60% of patients had erosion and joint space narrowing (JSN) scores of >0, respectively. At week 16 and 52, 150 and 300 mg secukinumab reduced tender and swollen joint counts across all values of baseline erosion and JSN scores; however, patients with higher baseline erosion and JSN scores were less likely to achieve MDA.

 

Study details: This was a post hoc analysis of two phase 3 trials, FUTURE 1 and FUTURE 5, including 1554 patients with PsA who received 300 or 150 mg secukinumab with or without a loading dose.

 

Disclosures: This study received funding from Novartis Pharma AG. Four authors declared being employees of or owning stocks in Novartis. Seven authors declared ties with various sources, including Novartis.

 

Source: Mease P et al. Quantification of pre-existing radiographic damage and its relationship with joint activity and long-term clinical outcomes with secukinumab therapy in patients with psoriatic arthritis. Arthritis Res Ther. 2022;24(1):283 (Dec 28). Doi: 10.1186/s13075-022-02944-1

 

Key clinical point: Pre-existing radiographic damage was substantially prevalent in patients with psoriatic arthritis (PsA), with secukinumab therapy being associated with the inhibition of joint tenderness and swelling; however, high baseline radiographic damage reduced the likelihood of achieving minimal disease activity (MDA).

 

Major finding: Overall, 86% and 60% of patients had erosion and joint space narrowing (JSN) scores of >0, respectively. At week 16 and 52, 150 and 300 mg secukinumab reduced tender and swollen joint counts across all values of baseline erosion and JSN scores; however, patients with higher baseline erosion and JSN scores were less likely to achieve MDA.

 

Study details: This was a post hoc analysis of two phase 3 trials, FUTURE 1 and FUTURE 5, including 1554 patients with PsA who received 300 or 150 mg secukinumab with or without a loading dose.

 

Disclosures: This study received funding from Novartis Pharma AG. Four authors declared being employees of or owning stocks in Novartis. Seven authors declared ties with various sources, including Novartis.

 

Source: Mease P et al. Quantification of pre-existing radiographic damage and its relationship with joint activity and long-term clinical outcomes with secukinumab therapy in patients with psoriatic arthritis. Arthritis Res Ther. 2022;24(1):283 (Dec 28). Doi: 10.1186/s13075-022-02944-1

 

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PsA-related uveitis: Real-world data on epidemiology and clinical features

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Key clinical point: Uveitis related to psoriatic arthritis (PsA) had a prevalence of approximately 5%, presented as an acute and recurrent disease with anterior and unilateral involvement, and was associated with impaired quality of life and increased functional disability.

 

Major finding: Uveitis onset was acute in all cases, with 50% being recurrent and 80% being anterior and unilateral. Patients with vs without uveitis had a higher PsA impact of Disease Score (P  =  .001) and Bath Ankylosing Spondylitis Functional Index (P  =  .01) and a higher prevalence of HLA-B27 (P < .0001), sacroiliitis on magnetic resonance imaging (P  =  .027), and ocular surface pathology (P  =  .021).

 

Study details: This retrospective longitudinal study included 406 patients with PsA, of which 4.9% of patients experienced 1 episode of uveitis.

 

Disclosures: This study did not receive any specific funding. Several authors declared receiving grants, research support, consulting fees, or honoraria for participation in company-sponsored speaker's bureaus from various sources.

 

Source: De Vicente Delmás A et al. Uveitis in psoriatic arthritis: Study of 406 patients in a single university center and literature review. RMD Open. 2023;9(1):e002781 (Jan 12). Doi: 10.1136/rmdopen-2022-002781

 

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Key clinical point: Uveitis related to psoriatic arthritis (PsA) had a prevalence of approximately 5%, presented as an acute and recurrent disease with anterior and unilateral involvement, and was associated with impaired quality of life and increased functional disability.

 

Major finding: Uveitis onset was acute in all cases, with 50% being recurrent and 80% being anterior and unilateral. Patients with vs without uveitis had a higher PsA impact of Disease Score (P  =  .001) and Bath Ankylosing Spondylitis Functional Index (P  =  .01) and a higher prevalence of HLA-B27 (P < .0001), sacroiliitis on magnetic resonance imaging (P  =  .027), and ocular surface pathology (P  =  .021).

 

Study details: This retrospective longitudinal study included 406 patients with PsA, of which 4.9% of patients experienced 1 episode of uveitis.

 

Disclosures: This study did not receive any specific funding. Several authors declared receiving grants, research support, consulting fees, or honoraria for participation in company-sponsored speaker's bureaus from various sources.

 

Source: De Vicente Delmás A et al. Uveitis in psoriatic arthritis: Study of 406 patients in a single university center and literature review. RMD Open. 2023;9(1):e002781 (Jan 12). Doi: 10.1136/rmdopen-2022-002781

 

Key clinical point: Uveitis related to psoriatic arthritis (PsA) had a prevalence of approximately 5%, presented as an acute and recurrent disease with anterior and unilateral involvement, and was associated with impaired quality of life and increased functional disability.

 

Major finding: Uveitis onset was acute in all cases, with 50% being recurrent and 80% being anterior and unilateral. Patients with vs without uveitis had a higher PsA impact of Disease Score (P  =  .001) and Bath Ankylosing Spondylitis Functional Index (P  =  .01) and a higher prevalence of HLA-B27 (P < .0001), sacroiliitis on magnetic resonance imaging (P  =  .027), and ocular surface pathology (P  =  .021).

 

Study details: This retrospective longitudinal study included 406 patients with PsA, of which 4.9% of patients experienced 1 episode of uveitis.

 

Disclosures: This study did not receive any specific funding. Several authors declared receiving grants, research support, consulting fees, or honoraria for participation in company-sponsored speaker's bureaus from various sources.

 

Source: De Vicente Delmás A et al. Uveitis in psoriatic arthritis: Study of 406 patients in a single university center and literature review. RMD Open. 2023;9(1):e002781 (Jan 12). Doi: 10.1136/rmdopen-2022-002781

 

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Musculoskeletal ultrasound improves accuracy of early PsA diagnosis

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Key clinical point: Targeted musculoskeletal ultrasound performed by trained dermatologists improved the accuracy of early psoriatic arthritis (PsA) diagnosis and may eventually decrease referral to rheumatologists.

 

Major finding: Use of musculoskeletal ultrasound changed the sensitivity and specificity of early PsA screening strategy from 88.2% (95% CI 58.1%-94.6%) and 54.4% (95% CI 44.8%-64.1%) to 70.6% (95% CI 38.4%-81.9%) and 90.4% (95% CI 83.9%-95.6%), respectively. Overall, 45 of the 46 patients were cleared of preliminary diagnosis-based PsA suspicion after musculoskeletal ultrasound.

 

Study details: This was a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia, of which 19 patients were diagnosed with PsA by a rheumatologist.

 

Disclosures: This study was supported by Novartis Pharma. The authors declared no conflicts of interest.

 

Source: Grobelski J et al. Prospective double-blind study on the value of musculoskeletal ultrasound by dermatologists as a screening instrument for psoriatic arthritis. Rheumatology (Oxford). 2022 (Dec 22). Doi: 10.1093/rheumatology/keac702

 

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Key clinical point: Targeted musculoskeletal ultrasound performed by trained dermatologists improved the accuracy of early psoriatic arthritis (PsA) diagnosis and may eventually decrease referral to rheumatologists.

 

Major finding: Use of musculoskeletal ultrasound changed the sensitivity and specificity of early PsA screening strategy from 88.2% (95% CI 58.1%-94.6%) and 54.4% (95% CI 44.8%-64.1%) to 70.6% (95% CI 38.4%-81.9%) and 90.4% (95% CI 83.9%-95.6%), respectively. Overall, 45 of the 46 patients were cleared of preliminary diagnosis-based PsA suspicion after musculoskeletal ultrasound.

 

Study details: This was a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia, of which 19 patients were diagnosed with PsA by a rheumatologist.

 

Disclosures: This study was supported by Novartis Pharma. The authors declared no conflicts of interest.

 

Source: Grobelski J et al. Prospective double-blind study on the value of musculoskeletal ultrasound by dermatologists as a screening instrument for psoriatic arthritis. Rheumatology (Oxford). 2022 (Dec 22). Doi: 10.1093/rheumatology/keac702

 

Key clinical point: Targeted musculoskeletal ultrasound performed by trained dermatologists improved the accuracy of early psoriatic arthritis (PsA) diagnosis and may eventually decrease referral to rheumatologists.

 

Major finding: Use of musculoskeletal ultrasound changed the sensitivity and specificity of early PsA screening strategy from 88.2% (95% CI 58.1%-94.6%) and 54.4% (95% CI 44.8%-64.1%) to 70.6% (95% CI 38.4%-81.9%) and 90.4% (95% CI 83.9%-95.6%), respectively. Overall, 45 of the 46 patients were cleared of preliminary diagnosis-based PsA suspicion after musculoskeletal ultrasound.

 

Study details: This was a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia, of which 19 patients were diagnosed with PsA by a rheumatologist.

 

Disclosures: This study was supported by Novartis Pharma. The authors declared no conflicts of interest.

 

Source: Grobelski J et al. Prospective double-blind study on the value of musculoskeletal ultrasound by dermatologists as a screening instrument for psoriatic arthritis. Rheumatology (Oxford). 2022 (Dec 22). Doi: 10.1093/rheumatology/keac702

 

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Minorities with epilepsy blocked from receiving ‘highest quality of care’

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People of color with epilepsy, including Black, Hispanic, and Native Hawaiian and other Pacific Islander patients, are significantly less likely to be prescribed the latest antiseizure medications (ASMs), compared with their White counterparts, new research shows.

Even after controlling for epilepsy severity, comorbid conditions, and other factors that might affect medication choice, researchers found that newer medication use was 29% less likely in Black patients, 23% less likely in Native Hawaiian and other Pacific Islander patients, and 7% less likely in Hispanic patients, compared with White individuals.

“I hope that clinicians will see from our findings that minoritized patients with epilepsy face a myriad of barriers in receiving the highest quality of care, including ASM use,” said lead investigator Wyatt P. Bensken, PhD, adjunct assistant professor of Population and Quantitative Health Sciences at Case Western Reserve University, Cleveland. “Considering your patients’ barriers, and how that influences their care – including ASM selection – will be critical to helping reduce these population-level inequities.”

Dr. Wyatt Bensken


The study was published online in Neurology Clinical Practice.
 

A prompt for practice change

For the study, researchers used Medicaid claims for more than 78,000 people who had filled at least two prescriptions for an ASM between 2010 and 2014.

Most patients were White (53.4%); 22.6% were Black; 11.9% were Hispanic; 1.6% were Asian; 1.5% were Native Hawaiian or other Pacific Islander; 0.6% American Indian or Alaskan Native; and 8.3% were classified as “other.”

One-quarter of participants were taking an older ASM, such as carbamazepine, phenytoin, and valproate. About 65% were taking second-generation ASMs, including gabapentin, levetiracetam, and zonisamide. A little less than 10% were taking lacosamide, perampenel, or another third-generation ASM.

Compared with White patients, newer medication prescriptions were significantly less likely in Black individuals (adjusted odds ratio, 0.71; 95% confidence interval, 0.68-0.75), Native Hawaiian or other Pacific Islanders (aOR, 0.77; 95% CI, 0.67-0.88), and Hispanic patients (aOR, 0.93; 95% CI, 0.88-0.99).

Third-generation ASMs were used by 10.7% of White patients versus 6% of Black individuals and 5.1% of American Indian or Alaskan Native patients.

Researchers also found that taking a second-generation ASM was associated with better treatment adherence (aOR, 1.17; 95% CI, 1.11-1.23) and that patients on newer ASMs were more than three times as likely to be under the care of a neurologist (aOR, 3.26; 95% CI, 3.13-3.41).

The findings draw attention to racial inequities surrounding access to medication and specialists and subspecialists, Dr. Bensken said. Identifying specific barriers and developing solutions is the long-range goal, he added.

“In the interim, increasing the attention to these inequities will, we hope, prompt changes across practices,” Dr. Bensken said.
 

A ‘wake-up call’

Commenting on the findings, Joseph Sirven, MD, professor of neurology at the Mayo Clinic Florida, Jacksonville, said the results were “striking” because newer ASMs are generally the go-to for most physicians who treat epilepsy. 

“Use of first-generation ASMs is typically reserved [for] if one runs out of options,” Dr. Sirven said.

This study and others like it should serve as a “wake-up call” for clinicians, Dr. Sirven added.

“This study is important because it shows that whether we realize it or not, race and ethnicities are playing a role in ASM, and this is related to financial access to newer-generation drugs,” he said. “Similar findings are seen in impoverished countries where first-generation ASM drugs are routinely used because of drug pricing.”
 

 

 

More to explore

Also commenting on the study, Scott Mintzer, MD, a professor and director of the Epilepsy Monitoring Unit at Thomas Jefferson University, Philadelphia, said using first-generation ASMs as a proxy for quality of care is “a very innovative concept.”

“From that perspective, the finding that racial minority patients are more likely to be on a first-generation drug is not surprising. But after that it gets far more complicated to interpret,” he added.  

Neither adherence nor care by a neurologist was different in a consistent direction within the various minority populations, Dr. Mintzer noted. In addition, Black patients were as likely to see a neurologist as White patients but still more likely to be on a first-generation drug.

There are also a few caveats to the findings that should be considered, Dr. Mintzer added. First, the sample included only Medicaid recipients, nearly 35% of whom had a comorbid psychosis. Those and other characteristics of the study pool suggest participants aren’t representative of the United States population as a whole. Second, significant shifts in ASM use have occurred since the study data cutoff in 2014, none of which are reflected in these findings.

“So, I don’t think we can really say how to address this yet,” Dr. Mintzer said. “There’s a lot to explore about whether this is still occurring, how generalizable these findings are, and what they might be due to, as there are a host of potential explanations, which the authors themselves acknowledge.”

The study was funded by the U.S. Centers for Disease Control and Prevention and the National Institute on Minority Health and Health Disparities. Dr. Bensken has received support for this work from NIMHD and serves on the Editorial Board of the journal Neurology. Dr. Sirven and Mintzer report no relevant financial relationships.

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

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People of color with epilepsy, including Black, Hispanic, and Native Hawaiian and other Pacific Islander patients, are significantly less likely to be prescribed the latest antiseizure medications (ASMs), compared with their White counterparts, new research shows.

Even after controlling for epilepsy severity, comorbid conditions, and other factors that might affect medication choice, researchers found that newer medication use was 29% less likely in Black patients, 23% less likely in Native Hawaiian and other Pacific Islander patients, and 7% less likely in Hispanic patients, compared with White individuals.

“I hope that clinicians will see from our findings that minoritized patients with epilepsy face a myriad of barriers in receiving the highest quality of care, including ASM use,” said lead investigator Wyatt P. Bensken, PhD, adjunct assistant professor of Population and Quantitative Health Sciences at Case Western Reserve University, Cleveland. “Considering your patients’ barriers, and how that influences their care – including ASM selection – will be critical to helping reduce these population-level inequities.”

Dr. Wyatt Bensken


The study was published online in Neurology Clinical Practice.
 

A prompt for practice change

For the study, researchers used Medicaid claims for more than 78,000 people who had filled at least two prescriptions for an ASM between 2010 and 2014.

Most patients were White (53.4%); 22.6% were Black; 11.9% were Hispanic; 1.6% were Asian; 1.5% were Native Hawaiian or other Pacific Islander; 0.6% American Indian or Alaskan Native; and 8.3% were classified as “other.”

One-quarter of participants were taking an older ASM, such as carbamazepine, phenytoin, and valproate. About 65% were taking second-generation ASMs, including gabapentin, levetiracetam, and zonisamide. A little less than 10% were taking lacosamide, perampenel, or another third-generation ASM.

Compared with White patients, newer medication prescriptions were significantly less likely in Black individuals (adjusted odds ratio, 0.71; 95% confidence interval, 0.68-0.75), Native Hawaiian or other Pacific Islanders (aOR, 0.77; 95% CI, 0.67-0.88), and Hispanic patients (aOR, 0.93; 95% CI, 0.88-0.99).

Third-generation ASMs were used by 10.7% of White patients versus 6% of Black individuals and 5.1% of American Indian or Alaskan Native patients.

Researchers also found that taking a second-generation ASM was associated with better treatment adherence (aOR, 1.17; 95% CI, 1.11-1.23) and that patients on newer ASMs were more than three times as likely to be under the care of a neurologist (aOR, 3.26; 95% CI, 3.13-3.41).

The findings draw attention to racial inequities surrounding access to medication and specialists and subspecialists, Dr. Bensken said. Identifying specific barriers and developing solutions is the long-range goal, he added.

“In the interim, increasing the attention to these inequities will, we hope, prompt changes across practices,” Dr. Bensken said.
 

A ‘wake-up call’

Commenting on the findings, Joseph Sirven, MD, professor of neurology at the Mayo Clinic Florida, Jacksonville, said the results were “striking” because newer ASMs are generally the go-to for most physicians who treat epilepsy. 

“Use of first-generation ASMs is typically reserved [for] if one runs out of options,” Dr. Sirven said.

This study and others like it should serve as a “wake-up call” for clinicians, Dr. Sirven added.

“This study is important because it shows that whether we realize it or not, race and ethnicities are playing a role in ASM, and this is related to financial access to newer-generation drugs,” he said. “Similar findings are seen in impoverished countries where first-generation ASM drugs are routinely used because of drug pricing.”
 

 

 

More to explore

Also commenting on the study, Scott Mintzer, MD, a professor and director of the Epilepsy Monitoring Unit at Thomas Jefferson University, Philadelphia, said using first-generation ASMs as a proxy for quality of care is “a very innovative concept.”

“From that perspective, the finding that racial minority patients are more likely to be on a first-generation drug is not surprising. But after that it gets far more complicated to interpret,” he added.  

Neither adherence nor care by a neurologist was different in a consistent direction within the various minority populations, Dr. Mintzer noted. In addition, Black patients were as likely to see a neurologist as White patients but still more likely to be on a first-generation drug.

There are also a few caveats to the findings that should be considered, Dr. Mintzer added. First, the sample included only Medicaid recipients, nearly 35% of whom had a comorbid psychosis. Those and other characteristics of the study pool suggest participants aren’t representative of the United States population as a whole. Second, significant shifts in ASM use have occurred since the study data cutoff in 2014, none of which are reflected in these findings.

“So, I don’t think we can really say how to address this yet,” Dr. Mintzer said. “There’s a lot to explore about whether this is still occurring, how generalizable these findings are, and what they might be due to, as there are a host of potential explanations, which the authors themselves acknowledge.”

The study was funded by the U.S. Centers for Disease Control and Prevention and the National Institute on Minority Health and Health Disparities. Dr. Bensken has received support for this work from NIMHD and serves on the Editorial Board of the journal Neurology. Dr. Sirven and Mintzer report no relevant financial relationships.

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

People of color with epilepsy, including Black, Hispanic, and Native Hawaiian and other Pacific Islander patients, are significantly less likely to be prescribed the latest antiseizure medications (ASMs), compared with their White counterparts, new research shows.

Even after controlling for epilepsy severity, comorbid conditions, and other factors that might affect medication choice, researchers found that newer medication use was 29% less likely in Black patients, 23% less likely in Native Hawaiian and other Pacific Islander patients, and 7% less likely in Hispanic patients, compared with White individuals.

“I hope that clinicians will see from our findings that minoritized patients with epilepsy face a myriad of barriers in receiving the highest quality of care, including ASM use,” said lead investigator Wyatt P. Bensken, PhD, adjunct assistant professor of Population and Quantitative Health Sciences at Case Western Reserve University, Cleveland. “Considering your patients’ barriers, and how that influences their care – including ASM selection – will be critical to helping reduce these population-level inequities.”

Dr. Wyatt Bensken


The study was published online in Neurology Clinical Practice.
 

A prompt for practice change

For the study, researchers used Medicaid claims for more than 78,000 people who had filled at least two prescriptions for an ASM between 2010 and 2014.

Most patients were White (53.4%); 22.6% were Black; 11.9% were Hispanic; 1.6% were Asian; 1.5% were Native Hawaiian or other Pacific Islander; 0.6% American Indian or Alaskan Native; and 8.3% were classified as “other.”

One-quarter of participants were taking an older ASM, such as carbamazepine, phenytoin, and valproate. About 65% were taking second-generation ASMs, including gabapentin, levetiracetam, and zonisamide. A little less than 10% were taking lacosamide, perampenel, or another third-generation ASM.

Compared with White patients, newer medication prescriptions were significantly less likely in Black individuals (adjusted odds ratio, 0.71; 95% confidence interval, 0.68-0.75), Native Hawaiian or other Pacific Islanders (aOR, 0.77; 95% CI, 0.67-0.88), and Hispanic patients (aOR, 0.93; 95% CI, 0.88-0.99).

Third-generation ASMs were used by 10.7% of White patients versus 6% of Black individuals and 5.1% of American Indian or Alaskan Native patients.

Researchers also found that taking a second-generation ASM was associated with better treatment adherence (aOR, 1.17; 95% CI, 1.11-1.23) and that patients on newer ASMs were more than three times as likely to be under the care of a neurologist (aOR, 3.26; 95% CI, 3.13-3.41).

The findings draw attention to racial inequities surrounding access to medication and specialists and subspecialists, Dr. Bensken said. Identifying specific barriers and developing solutions is the long-range goal, he added.

“In the interim, increasing the attention to these inequities will, we hope, prompt changes across practices,” Dr. Bensken said.
 

A ‘wake-up call’

Commenting on the findings, Joseph Sirven, MD, professor of neurology at the Mayo Clinic Florida, Jacksonville, said the results were “striking” because newer ASMs are generally the go-to for most physicians who treat epilepsy. 

“Use of first-generation ASMs is typically reserved [for] if one runs out of options,” Dr. Sirven said.

This study and others like it should serve as a “wake-up call” for clinicians, Dr. Sirven added.

“This study is important because it shows that whether we realize it or not, race and ethnicities are playing a role in ASM, and this is related to financial access to newer-generation drugs,” he said. “Similar findings are seen in impoverished countries where first-generation ASM drugs are routinely used because of drug pricing.”
 

 

 

More to explore

Also commenting on the study, Scott Mintzer, MD, a professor and director of the Epilepsy Monitoring Unit at Thomas Jefferson University, Philadelphia, said using first-generation ASMs as a proxy for quality of care is “a very innovative concept.”

“From that perspective, the finding that racial minority patients are more likely to be on a first-generation drug is not surprising. But after that it gets far more complicated to interpret,” he added.  

Neither adherence nor care by a neurologist was different in a consistent direction within the various minority populations, Dr. Mintzer noted. In addition, Black patients were as likely to see a neurologist as White patients but still more likely to be on a first-generation drug.

There are also a few caveats to the findings that should be considered, Dr. Mintzer added. First, the sample included only Medicaid recipients, nearly 35% of whom had a comorbid psychosis. Those and other characteristics of the study pool suggest participants aren’t representative of the United States population as a whole. Second, significant shifts in ASM use have occurred since the study data cutoff in 2014, none of which are reflected in these findings.

“So, I don’t think we can really say how to address this yet,” Dr. Mintzer said. “There’s a lot to explore about whether this is still occurring, how generalizable these findings are, and what they might be due to, as there are a host of potential explanations, which the authors themselves acknowledge.”

The study was funded by the U.S. Centers for Disease Control and Prevention and the National Institute on Minority Health and Health Disparities. Dr. Bensken has received support for this work from NIMHD and serves on the Editorial Board of the journal Neurology. Dr. Sirven and Mintzer report no relevant financial relationships.

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

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PsA: Long-term efficacy, persistence, and safety of ustekinumab and TNFi in real world

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Key clinical point: Ustekinumab and tumor necrosis factor inhibitors (TNFi) demonstrated similar efficacy and persistence and were well tolerated as first-line to third-line biologic treatment for psoriatic arthritis (PsA).

 

Major finding: Over 3 years, treatment with ustekinumab vs TNFi resulted in comparable odds of attaining clinical Disease Activity Index for PsA low disease activity (adjusted odds ratio [aOR] 0.89; 95% CI 0.63-1.26) and remission (aOR 0.72; 95% CI 0.50-1.05), similar risk for stopping/switching treatment (adjusted hazard ratio 0.87; 95% CI 0.68-1.11), and no clinically relevant difference in serious adverse event rates (6.3% vs 7.2%).

 

Study details: The data come from an analysis of 895 patients with PsA from PsABio, a prospective observational study, who were prescribed first-line to third-line ustekinumab or a TNFi.

 

Disclosures: This study was sponsored by Janssen. Two authors declared being current or former employees of or owning stocks in Johnson & Johnson or Janssen. Several authors reported receiving personal fees, consulting fees, grants, payments, or honoraria from Janssen and various other sources.

 

Source: Gossec L et al. Long-term effectiveness and persistence of ustekinumab and TNF inhibitors in patients with psoriatic arthritis: Final 3-year results from the PsABio real-world study. Ann Rheum Dis. 2022 (Dec 13). Doi: 10.1136/ard-2022-222879

 

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Key clinical point: Ustekinumab and tumor necrosis factor inhibitors (TNFi) demonstrated similar efficacy and persistence and were well tolerated as first-line to third-line biologic treatment for psoriatic arthritis (PsA).

 

Major finding: Over 3 years, treatment with ustekinumab vs TNFi resulted in comparable odds of attaining clinical Disease Activity Index for PsA low disease activity (adjusted odds ratio [aOR] 0.89; 95% CI 0.63-1.26) and remission (aOR 0.72; 95% CI 0.50-1.05), similar risk for stopping/switching treatment (adjusted hazard ratio 0.87; 95% CI 0.68-1.11), and no clinically relevant difference in serious adverse event rates (6.3% vs 7.2%).

 

Study details: The data come from an analysis of 895 patients with PsA from PsABio, a prospective observational study, who were prescribed first-line to third-line ustekinumab or a TNFi.

 

Disclosures: This study was sponsored by Janssen. Two authors declared being current or former employees of or owning stocks in Johnson & Johnson or Janssen. Several authors reported receiving personal fees, consulting fees, grants, payments, or honoraria from Janssen and various other sources.

 

Source: Gossec L et al. Long-term effectiveness and persistence of ustekinumab and TNF inhibitors in patients with psoriatic arthritis: Final 3-year results from the PsABio real-world study. Ann Rheum Dis. 2022 (Dec 13). Doi: 10.1136/ard-2022-222879

 

Key clinical point: Ustekinumab and tumor necrosis factor inhibitors (TNFi) demonstrated similar efficacy and persistence and were well tolerated as first-line to third-line biologic treatment for psoriatic arthritis (PsA).

 

Major finding: Over 3 years, treatment with ustekinumab vs TNFi resulted in comparable odds of attaining clinical Disease Activity Index for PsA low disease activity (adjusted odds ratio [aOR] 0.89; 95% CI 0.63-1.26) and remission (aOR 0.72; 95% CI 0.50-1.05), similar risk for stopping/switching treatment (adjusted hazard ratio 0.87; 95% CI 0.68-1.11), and no clinically relevant difference in serious adverse event rates (6.3% vs 7.2%).

 

Study details: The data come from an analysis of 895 patients with PsA from PsABio, a prospective observational study, who were prescribed first-line to third-line ustekinumab or a TNFi.

 

Disclosures: This study was sponsored by Janssen. Two authors declared being current or former employees of or owning stocks in Johnson & Johnson or Janssen. Several authors reported receiving personal fees, consulting fees, grants, payments, or honoraria from Janssen and various other sources.

 

Source: Gossec L et al. Long-term effectiveness and persistence of ustekinumab and TNF inhibitors in patients with psoriatic arthritis: Final 3-year results from the PsABio real-world study. Ann Rheum Dis. 2022 (Dec 13). Doi: 10.1136/ard-2022-222879

 

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Fluorescence-optical imaging detects early transition from psoriasis to PsA

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Key clinical point: Fluorescence-optical imaging (FOI) successfully detected the early signs of musculoskeletal inflammation in hands and predicted transition from psoriasis to psoriatic arthritis (PsA) at initial stages in patients with psoriasis at risk for PsA.

 

Major finding: PsA diagnosis was confirmed by clinical evaluations (CE) in 50% of patients with psoriasis at risk for PsA and an additional 30% of patients who were positive on FOI. Compared with previously published annual incidence rates, the incidence rate of PsA was higher among patients positive on FOI but negative on CE (11.8%).

 

Study details: This was an investigator-initiated prospective two-part observational cohort study including 389 patients with plaque psoriasis who were at risk for PsA.

 

Disclosures: This study was sponsored by Fraunhofer ITMP and supported by a research grant from Pfizer Germany. Five authors declared being supported by Fraunhofer ITMP. Several authors reported ties with various sources, including Pfizer. GR Burmester reported being on the editorial board of RMD Open.

 

Source: Koehm M et al. Fluorescence-optical imaging as a promising easy-to-use imaging biomarker to increase early psoriatic arthritis detection in patients with psoriasis: A cross-sectional cohort study with follow-up. RMD Open. 2022;8(2):e002682 (Dec 6). Doi: 10.1136/rmdopen-2022-002682

 

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Key clinical point: Fluorescence-optical imaging (FOI) successfully detected the early signs of musculoskeletal inflammation in hands and predicted transition from psoriasis to psoriatic arthritis (PsA) at initial stages in patients with psoriasis at risk for PsA.

 

Major finding: PsA diagnosis was confirmed by clinical evaluations (CE) in 50% of patients with psoriasis at risk for PsA and an additional 30% of patients who were positive on FOI. Compared with previously published annual incidence rates, the incidence rate of PsA was higher among patients positive on FOI but negative on CE (11.8%).

 

Study details: This was an investigator-initiated prospective two-part observational cohort study including 389 patients with plaque psoriasis who were at risk for PsA.

 

Disclosures: This study was sponsored by Fraunhofer ITMP and supported by a research grant from Pfizer Germany. Five authors declared being supported by Fraunhofer ITMP. Several authors reported ties with various sources, including Pfizer. GR Burmester reported being on the editorial board of RMD Open.

 

Source: Koehm M et al. Fluorescence-optical imaging as a promising easy-to-use imaging biomarker to increase early psoriatic arthritis detection in patients with psoriasis: A cross-sectional cohort study with follow-up. RMD Open. 2022;8(2):e002682 (Dec 6). Doi: 10.1136/rmdopen-2022-002682

 

Key clinical point: Fluorescence-optical imaging (FOI) successfully detected the early signs of musculoskeletal inflammation in hands and predicted transition from psoriasis to psoriatic arthritis (PsA) at initial stages in patients with psoriasis at risk for PsA.

 

Major finding: PsA diagnosis was confirmed by clinical evaluations (CE) in 50% of patients with psoriasis at risk for PsA and an additional 30% of patients who were positive on FOI. Compared with previously published annual incidence rates, the incidence rate of PsA was higher among patients positive on FOI but negative on CE (11.8%).

 

Study details: This was an investigator-initiated prospective two-part observational cohort study including 389 patients with plaque psoriasis who were at risk for PsA.

 

Disclosures: This study was sponsored by Fraunhofer ITMP and supported by a research grant from Pfizer Germany. Five authors declared being supported by Fraunhofer ITMP. Several authors reported ties with various sources, including Pfizer. GR Burmester reported being on the editorial board of RMD Open.

 

Source: Koehm M et al. Fluorescence-optical imaging as a promising easy-to-use imaging biomarker to increase early psoriatic arthritis detection in patients with psoriasis: A cross-sectional cohort study with follow-up. RMD Open. 2022;8(2):e002682 (Dec 6). Doi: 10.1136/rmdopen-2022-002682

 

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Patient-reported flares correlate well with increased disease activity in PsA

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Key clinical point: Patient-reported flares occurred more frequently than physician-reported flares and demonstrated moderate agreement with worsening of disease activity in psoriatic arthritis (DAPSA), with patients with psoriatic arthritis (PsA) who reported flares having a significantly more active disease.

 

Major finding: Overall, 27.0% and 17.6% of patients had patient-reported and physician-reported flares, respectively, with patient-reported flare demonstrating 69.8% crude agreement with DAPSA (prevalence adjusted bias adjusted kappa  =  0.40) and patients reporting vs not reporting disease flare indicating a significantly more active disease for all outcomes (P < .001) except skin lesions (P  =  .01).

 

Study details: This was a longitudinal observational study including 222 patients with PsA.

 

Disclosures: This study was supported by unrestricted investigator-initiated research grant from Pfizer. Three authors declared receiving funds, research grants, or support from the US National Institutes of Health and other sources.

 

Source: Sousa M et al. Patient-defined flares and disease activity worsening in 222 patients with psoriatic arthritis from 14 countries. Joint Bone Spine. 2022;90(3):105511 (Dec 15). Doi: 10.1016/j.jbspin.2022.105511

 

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Key clinical point: Patient-reported flares occurred more frequently than physician-reported flares and demonstrated moderate agreement with worsening of disease activity in psoriatic arthritis (DAPSA), with patients with psoriatic arthritis (PsA) who reported flares having a significantly more active disease.

 

Major finding: Overall, 27.0% and 17.6% of patients had patient-reported and physician-reported flares, respectively, with patient-reported flare demonstrating 69.8% crude agreement with DAPSA (prevalence adjusted bias adjusted kappa  =  0.40) and patients reporting vs not reporting disease flare indicating a significantly more active disease for all outcomes (P < .001) except skin lesions (P  =  .01).

 

Study details: This was a longitudinal observational study including 222 patients with PsA.

 

Disclosures: This study was supported by unrestricted investigator-initiated research grant from Pfizer. Three authors declared receiving funds, research grants, or support from the US National Institutes of Health and other sources.

 

Source: Sousa M et al. Patient-defined flares and disease activity worsening in 222 patients with psoriatic arthritis from 14 countries. Joint Bone Spine. 2022;90(3):105511 (Dec 15). Doi: 10.1016/j.jbspin.2022.105511

 

Key clinical point: Patient-reported flares occurred more frequently than physician-reported flares and demonstrated moderate agreement with worsening of disease activity in psoriatic arthritis (DAPSA), with patients with psoriatic arthritis (PsA) who reported flares having a significantly more active disease.

 

Major finding: Overall, 27.0% and 17.6% of patients had patient-reported and physician-reported flares, respectively, with patient-reported flare demonstrating 69.8% crude agreement with DAPSA (prevalence adjusted bias adjusted kappa  =  0.40) and patients reporting vs not reporting disease flare indicating a significantly more active disease for all outcomes (P < .001) except skin lesions (P  =  .01).

 

Study details: This was a longitudinal observational study including 222 patients with PsA.

 

Disclosures: This study was supported by unrestricted investigator-initiated research grant from Pfizer. Three authors declared receiving funds, research grants, or support from the US National Institutes of Health and other sources.

 

Source: Sousa M et al. Patient-defined flares and disease activity worsening in 222 patients with psoriatic arthritis from 14 countries. Joint Bone Spine. 2022;90(3):105511 (Dec 15). Doi: 10.1016/j.jbspin.2022.105511

 

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Residual inflammation may persist despite stable minimal disease activity in PsA

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Key clinical point: Ultrasound-detected residual inflammation in peripheral articular structures may be present even in patients with psoriatic arthritis (PsA) who have achieved stable minimal disease activity (MDA), with residual inflammation being more prevalent in patients with shorter duration of MDA.

 

Major finding: Despite stable MDA, 54.2% of patients had 1 positive Power Doppler (PD) signal in examined tissues, with 19.4% and 23.6% of patients showing 1 joint and enthesis with a positive PD signal, respectively. A higher proportion of patients with 12 vs >12 months of sustained MDA had 1 ultrasound detected PD lesion (55% vs 41%; P  =  .024).

 

Study details: This cross-sectional study included 72 patients with PsA who were on biologic or conventional synthetic disease-modifying antirheumatic drugs for 12 months and in continuous MDA for ≥6 months.

 

Disclosures: This study did not declare the source of funding. The authors declared no conflicts of interest.

 

Source: Macchioni P et al. Residual inflammation in psoriatic arthritis patients in stable minimal disease activity. Front Med. 2022;9:1096547 (Dec 20). Doi: 10.3389/fmed.2022.1096547

 

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Key clinical point: Ultrasound-detected residual inflammation in peripheral articular structures may be present even in patients with psoriatic arthritis (PsA) who have achieved stable minimal disease activity (MDA), with residual inflammation being more prevalent in patients with shorter duration of MDA.

 

Major finding: Despite stable MDA, 54.2% of patients had 1 positive Power Doppler (PD) signal in examined tissues, with 19.4% and 23.6% of patients showing 1 joint and enthesis with a positive PD signal, respectively. A higher proportion of patients with 12 vs >12 months of sustained MDA had 1 ultrasound detected PD lesion (55% vs 41%; P  =  .024).

 

Study details: This cross-sectional study included 72 patients with PsA who were on biologic or conventional synthetic disease-modifying antirheumatic drugs for 12 months and in continuous MDA for ≥6 months.

 

Disclosures: This study did not declare the source of funding. The authors declared no conflicts of interest.

 

Source: Macchioni P et al. Residual inflammation in psoriatic arthritis patients in stable minimal disease activity. Front Med. 2022;9:1096547 (Dec 20). Doi: 10.3389/fmed.2022.1096547

 

Key clinical point: Ultrasound-detected residual inflammation in peripheral articular structures may be present even in patients with psoriatic arthritis (PsA) who have achieved stable minimal disease activity (MDA), with residual inflammation being more prevalent in patients with shorter duration of MDA.

 

Major finding: Despite stable MDA, 54.2% of patients had 1 positive Power Doppler (PD) signal in examined tissues, with 19.4% and 23.6% of patients showing 1 joint and enthesis with a positive PD signal, respectively. A higher proportion of patients with 12 vs >12 months of sustained MDA had 1 ultrasound detected PD lesion (55% vs 41%; P  =  .024).

 

Study details: This cross-sectional study included 72 patients with PsA who were on biologic or conventional synthetic disease-modifying antirheumatic drugs for 12 months and in continuous MDA for ≥6 months.

 

Disclosures: This study did not declare the source of funding. The authors declared no conflicts of interest.

 

Source: Macchioni P et al. Residual inflammation in psoriatic arthritis patients in stable minimal disease activity. Front Med. 2022;9:1096547 (Dec 20). Doi: 10.3389/fmed.2022.1096547

 

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