TOPLINE:

Registry data show a lower incidence of postcolonoscopy colorectal cancer (PCCRC) among endoscopists with higher sessile serrated lesion detection rates, validating the SSLDR as a clinically relevant quality measure.

METHODOLOGY:

• An analysis of the association between PCCRC and SSLDR was conducted using data from the New Hampshire Colonoscopy Registry.
• The cohort included patients who had either a colonoscopy or a diagnosis of CRC.
• The outcome was PCCRC (that is, CRC diagnosed at least 6 months after index colonoscopy).
• The exposure of interest was endoscopist-specific SSLDR.

TAKEAWAY:

• Of 26,901 patients, 162 were diagnosed with PCCRC.
• Endoscopists with a higher SSLDR had lower unadjusted risks for PCCRC (0.3% among those with an SSLDR of at least 6.0% (hazard ratio, 0.29).
• There was a significant 14% reduction in PCCRC for each 1% increase in SSLDR (HR, 0.86).
• Roughly one-third of endoscopists had an adequate adenoma detection rate yet had an SSLDR that was less than the most protective SSLDR of 6%.

IN PRACTICE:

“Endoscopists should strive to achieve the highest SSLDR rate, perhaps with the use of artificial intelligence,” the authors wrote. “Our data linking low SSLDR to increased PCCRC support development of recommendations to measure SDR [serrated detection rates] in clinical practice, and development of educational platforms, techniques and devices to improve low SDR.”

SOURCE:

The study was led by Joseph C. Anderson, MD, with the Geisel School of Medicine at Dartmouth, Hanover, N.H. It was published online in the American Journal of Gastroenterology. The study had no commercial funding.

LIMITATIONS:

The study population came from New Hampshire, which lacks racial diversity. There may be differences in serrated polyp detection in other populations with more high-risk groups, such as smokers. There may be significant variation in SSLDR because of variation in pathological interpretation.

DISCLOSURES:

The authors reported no relevant financial conflicts of interest.

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

TOPLINE:

Registry data show a lower incidence of postcolonoscopy colorectal cancer (PCCRC) among endoscopists with higher sessile serrated lesion detection rates, validating the SSLDR as a clinically relevant quality measure.

METHODOLOGY:

• An analysis of the association between PCCRC and SSLDR was conducted using data from the New Hampshire Colonoscopy Registry.
• The cohort included patients who had either a colonoscopy or a diagnosis of CRC.
• The outcome was PCCRC (that is, CRC diagnosed at least 6 months after index colonoscopy).
• The exposure of interest was endoscopist-specific SSLDR.

TAKEAWAY:

• Of 26,901 patients, 162 were diagnosed with PCCRC.
• Endoscopists with a higher SSLDR had lower unadjusted risks for PCCRC (0.3% among those with an SSLDR of at least 6.0% (hazard ratio, 0.29).
• There was a significant 14% reduction in PCCRC for each 1% increase in SSLDR (HR, 0.86).
• Roughly one-third of endoscopists had an adequate adenoma detection rate yet had an SSLDR that was less than the most protective SSLDR of 6%.

IN PRACTICE:

“Endoscopists should strive to achieve the highest SSLDR rate, perhaps with the use of artificial intelligence,” the authors wrote. “Our data linking low SSLDR to increased PCCRC support development of recommendations to measure SDR [serrated detection rates] in clinical practice, and development of educational platforms, techniques and devices to improve low SDR.”

SOURCE:

The study was led by Joseph C. Anderson, MD, with the Geisel School of Medicine at Dartmouth, Hanover, N.H. It was published online in the American Journal of Gastroenterology. The study had no commercial funding.

LIMITATIONS:

The study population came from New Hampshire, which lacks racial diversity. There may be differences in serrated polyp detection in other populations with more high-risk groups, such as smokers. There may be significant variation in SSLDR because of variation in pathological interpretation.

DISCLOSURES:

The authors reported no relevant financial conflicts of interest.

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

TOPLINE:

Registry data show a lower incidence of postcolonoscopy colorectal cancer (PCCRC) among endoscopists with higher sessile serrated lesion detection rates, validating the SSLDR as a clinically relevant quality measure.

METHODOLOGY:

• An analysis of the association between PCCRC and SSLDR was conducted using data from the New Hampshire Colonoscopy Registry.
• The cohort included patients who had either a colonoscopy or a diagnosis of CRC.
• The outcome was PCCRC (that is, CRC diagnosed at least 6 months after index colonoscopy).
• The exposure of interest was endoscopist-specific SSLDR.

TAKEAWAY:

• Of 26,901 patients, 162 were diagnosed with PCCRC.
• Endoscopists with a higher SSLDR had lower unadjusted risks for PCCRC (0.3% among those with an SSLDR of at least 6.0% (hazard ratio, 0.29).
• There was a significant 14% reduction in PCCRC for each 1% increase in SSLDR (HR, 0.86).
• Roughly one-third of endoscopists had an adequate adenoma detection rate yet had an SSLDR that was less than the most protective SSLDR of 6%.

IN PRACTICE:

“Endoscopists should strive to achieve the highest SSLDR rate, perhaps with the use of artificial intelligence,” the authors wrote. “Our data linking low SSLDR to increased PCCRC support development of recommendations to measure SDR [serrated detection rates] in clinical practice, and development of educational platforms, techniques and devices to improve low SDR.”

SOURCE:

The study was led by Joseph C. Anderson, MD, with the Geisel School of Medicine at Dartmouth, Hanover, N.H. It was published online in the American Journal of Gastroenterology. The study had no commercial funding.

LIMITATIONS:

The study population came from New Hampshire, which lacks racial diversity. There may be differences in serrated polyp detection in other populations with more high-risk groups, such as smokers. There may be significant variation in SSLDR because of variation in pathological interpretation.

DISCLOSURES:

The authors reported no relevant financial conflicts of interest.

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

Treatment with an experimental oral tau aggregation inhibitor, hydromethylthionine mesylate (HMTM), led to a statistically significant reduction in an established biomarker of neurodegeneration in Alzheimer’s disease (AD) in the LUCIDITY phase 3 trial.
 

Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.

“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.

“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.

Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.

The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
 

Support for tau inhibitor

Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.

However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.

As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.

That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.

For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.

Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.

In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.

NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
 

‘Exciting’ biomarker data

Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”

“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.

He said the biomarker data from the LUCIDITY study are “exciting.”

“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.

Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”

The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.

“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.

Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.

In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.

The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.

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

Treatment with an experimental oral tau aggregation inhibitor, hydromethylthionine mesylate (HMTM), led to a statistically significant reduction in an established biomarker of neurodegeneration in Alzheimer’s disease (AD) in the LUCIDITY phase 3 trial.
 

Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.

“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.

“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.

Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.

The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
 

Support for tau inhibitor

Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.

However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.

As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.

That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.

For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.

Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.

In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.

NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
 

‘Exciting’ biomarker data

Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”

“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.

He said the biomarker data from the LUCIDITY study are “exciting.”

“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.

Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”

The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.

“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.

Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.

In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.

The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.

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

Treatment with an experimental oral tau aggregation inhibitor, hydromethylthionine mesylate (HMTM), led to a statistically significant reduction in an established biomarker of neurodegeneration in Alzheimer’s disease (AD) in the LUCIDITY phase 3 trial.
 

Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.

“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.

“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.

Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.

The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
 

Support for tau inhibitor

Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.

However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.

As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.

That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.

For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.

Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.

In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.

NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
 

‘Exciting’ biomarker data

Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”

“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.

He said the biomarker data from the LUCIDITY study are “exciting.”

“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.

Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”

The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.

“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.

Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.

In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.

The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.

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

Children and adults with attention-deficit/hyperactivity disorder (ADHD) show greater improvement in symptoms with viloxazine extended release (ER) compared with treatment with atomoxetine, new research suggests.

Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.

Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.

In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.

“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
 

Nonstimulant treatment options

Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”

Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.

Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.

Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.

However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.

There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.

“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.

The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.

The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.

Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.

At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
 

‘Paradigm shift’

At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).

Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).

By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.

Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.

Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.

“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”

The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
 

Real-world study

Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”

This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.

“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.

“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.

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

Children and adults with attention-deficit/hyperactivity disorder (ADHD) show greater improvement in symptoms with viloxazine extended release (ER) compared with treatment with atomoxetine, new research suggests.

Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.

Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.

In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.

“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
 

Nonstimulant treatment options

Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”

Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.

Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.

Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.

However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.

There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.

“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.

The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.

The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.

Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.

At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
 

‘Paradigm shift’

At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).

Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).

By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.

Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.

Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.

“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”

The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
 

Real-world study

Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”

This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.

“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.

“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.

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

Children and adults with attention-deficit/hyperactivity disorder (ADHD) show greater improvement in symptoms with viloxazine extended release (ER) compared with treatment with atomoxetine, new research suggests.

Investigators studied patients who started out taking atomoxetine and, after a washout period, initiated treatment with viloxazine. Participants’ ADHD symptoms were assessed prior to initiation of each treatment and after 4 weeks.

Children and adults showed significantly larger improvement in inattentiveness and hyperactivity/impulsivity when taking viloxazine vs. atomoxetine, with almost all patients preferring the former to the latter, according to results of the study.

In addition, close to one half of the study participants were taking a prior stimulant, and 85% were able to taper off stimulant treatment. Viloxazine’s effects were more rapid than were those of atomoxetine.

“It is timely to have a rapidly acting, and highly effective nonstimulant option across the full spectrum of ADHD symptoms, for both children and adults, in light of recent stimulant shortages and the new [Food and Drug Administration] boxed warnings regarding increased mortality associated with overuse of stimulants” study investigator Maxwell Z. Price, a medical student at Hackensack Meridian School of Medicine, Nutley, N.J., said in an interview.
 

Nonstimulant treatment options

Study coauthor Richard L. Price, MD, noted that the study was conducted to find a more acceptable alternative to psychostimulant treatments for ADHD, which are currently considered the “gold standard.”

Although they are effective, said Dr. Price, they are fraught with adverse effects, including appetite suppression, insomnia, exacerbation of mood disorders, anxiety, tics, or misuse.

Atomoxetine, a nonstimulant option, has been around for a few decades and is often used in combination with a stimulant medication. However, he said, the drug has a mild effect, requires frequent dosage adjustment, takes a long time to work, and people have “soured” on its utility, Dr. Price added.

Like atomoxetine, viloxazine is a selective norepinephrine inhibitor that has been used an antidepressant in Europe for 30 years. It was recently reformulated as an extended-release medication and approved by the FDA for pediatric and adult ADHD.

However, unlike atomoxetine, viloxazine is associated with increased prefrontal cortex 5-hydroxytrytamine, norepinephrine, and dopamine levels in vivo.

There have been no head-to-head trials comparing the two agents. However, even in head-to-head ADHD medication trials, the agents that are under investigation are typically compared in matched patients. The current investigators wanted to compare the two agents in the same patients whose insurers mandate a trial of generic atomoxetine prior to covering branded viloxazine.

“We wanted to find out whether patients taking atomoxetine for ADHD combined type would experience improvement in ADHD symptoms following voluntary, open-label switch to viloxazine,” said Dr. Price.

The researchers studied 50 patients who presented with ADHD combined type and had no other psychiatric, medical, or substance-related comorbidities or prior exposure to atomoxetine or viloxazine.

The study included 35 children (mean age, 11.9 ± 2.9 years; 94.3% male) and 15 adults (mean age, 29.3 ± 9.0 years; 73.3% male). Of these, 42.9% and 73.3%, respectively, were taking concurrent stimulants.

Patients received mean doses of atomoxetine once daily followed by viloxazine once daily after a 5-day washout period between the two drugs. Participants were seen weekly for titration and monitoring.

At baseline, the pediatric ADHD–Rating Scale 5 (ADHD-RS-5) and the Adult Investigator Symptoms Rating Scale (AISRS) were completed, then again after 4 weeks of treatment with atomoxetine (or upon earlier response or discontinuation due to side effects, whichever came first), and 5 days after discontinuing atomoxetine, which “reestablished the baseline score.” The same protocol was then repeated with viloxazine.
 

‘Paradigm shift’

At baseline, the total ADHD-RS-5 mean score was 40.3 ± 10.3. Improvements at 4 weeks were greater in viloxazine vs atomoxetine, with scores of 13.9 ± 10.2 vs 33.1 ± 12.1, respectively (t = -10.12, P < .00001). In inattention and hyperactivity/impulsivity, the t values were –8.57 and –9.87, respectively (both P values < .0001).

Similarly, from the baseline total, AISRS mean score of 37.3 ± 11.8, improvements were greater on viloxazine vs. atomoxetine, with scores of 11.9 ± 9.4 vs. 28.8 ± 14.9, respectively (t = −4.18, P = .0009 overall; for inattention, t = −3.50, P > .004 and for hyperactivity/impulsivity, t = 3.90, P > .002).

By 2 weeks, 86% of patients taking viloxazine reported a positive response vs. 14% when taking atomoxetine.

Side effects were lower in viloxazine vs. atomoxetine, with 36% of patients discontinuing treatment with atomoxetine because of side effects that included gastrointestinal upset, irritability, fatigue, and insomnia vs. 4% who discontinued viloxazine because of fatigue.

Almost all participants (96%) preferred viloxazine over atomoxetine and 85% were able to taper off stimulant treatment following stabilization on viloxazine.

“These were not small differences,” said Dr. Richard L. Price. “These were clinically and statistically meaningful differences.”

The findings could represent “a paradigm shift for the field” because “we always think of starting ADHD treatment with stimulants, but perhaps treatment with viloxazine could help patients to avoid stimulants entirely,” he suggested.
 

Real-world study

Commenting for this article, Greg Mattingly, MD, associate clinical professor, Washington University, St. Louis, called it “a timely addition to the clinical literature where for the first time ever we have two nonstimulant options approved for adults with ADHD.”

This real-world clinic study “yields many answers,” said Dr. Mattingly, president-elect of the American Professional Society of ADHD and Related Disorders (APSARD), who was not involved with the study.

“Simply put, this real-world study of 50 clinic patients found that viloxazine ER had faster onset, was significantly more effective, and was preferred by 96% of patients as compared to atomoxetine,” he said.

“Another intriguing part of the study that will be of high interest to both patients and providers was that, of those initially treated concurrently with stimulant and viloxazine ER, 85% were able to discontinue their stimulant medication,” Dr. Mattingly added.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The open access fee was funded by the investigators. Dr. Maxwell Z. Price certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Dr. Richard L. Price has received honoraria from AbbVie, Alkermes, Idorsia, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Dr. Mattingly reports financial disclosures with various pharmaceutical companies, which are listed in full in the paper.

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

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

Key clinical point: Serum neutrophil gelatinase-associated lipocalin (NGAL) showed no value as a biomarker either for disease activity or for monitoring in relation to anti-inflammatory treatment in patients with peripheral psoriatic arthritis (PsA).

Major finding: Overall, the mean serum NGAL reduced by 11% after 12 months of treatment with any disease-modifying antirheumatic drug (DMARD), with no clear trend of a clinically significant increase or decrease after 12 months of treatment with conventional-synthetic DMARDs, tumor necrosis factor-alpha inhibitors, or interleukin-17 inhibitors. The changes in NGAL levels showed no correlation with changes in PsA outcomes (Spearman correlation coefficients close to 0.0).

Study details: This exploratory prospective cohort study included 117 patients with peripheral PsA who initiated conventional synthetic or biologic DMARDs, 20 patients with psoriasis without arthritis who did not receive systemic treatment, and 20 control individuals.

Disclosures: This study was supported by the Danish Rheumatism Association and others. Five authors reported ties with various sources. The other authors declared no conflict of interests.

Source: Stisen ZR et al. Treatment-related changes in serum neutrophil gelatinase-associated lipocalin (NGAL) in psoriatic arthritis: Results from the PIPA cohort study. Scand J Rheumatol. 2023;1-8 (Jun 20). Doi: 10.1080/03009742.2023.2216046.

Key clinical point: Serum neutrophil gelatinase-associated lipocalin (NGAL) showed no value as a biomarker either for disease activity or for monitoring in relation to anti-inflammatory treatment in patients with peripheral psoriatic arthritis (PsA).

Major finding: Overall, the mean serum NGAL reduced by 11% after 12 months of treatment with any disease-modifying antirheumatic drug (DMARD), with no clear trend of a clinically significant increase or decrease after 12 months of treatment with conventional-synthetic DMARDs, tumor necrosis factor-alpha inhibitors, or interleukin-17 inhibitors. The changes in NGAL levels showed no correlation with changes in PsA outcomes (Spearman correlation coefficients close to 0.0).

Study details: This exploratory prospective cohort study included 117 patients with peripheral PsA who initiated conventional synthetic or biologic DMARDs, 20 patients with psoriasis without arthritis who did not receive systemic treatment, and 20 control individuals.

Disclosures: This study was supported by the Danish Rheumatism Association and others. Five authors reported ties with various sources. The other authors declared no conflict of interests.

Source: Stisen ZR et al. Treatment-related changes in serum neutrophil gelatinase-associated lipocalin (NGAL) in psoriatic arthritis: Results from the PIPA cohort study. Scand J Rheumatol. 2023;1-8 (Jun 20). Doi: 10.1080/03009742.2023.2216046.

Key clinical point: Serum neutrophil gelatinase-associated lipocalin (NGAL) showed no value as a biomarker either for disease activity or for monitoring in relation to anti-inflammatory treatment in patients with peripheral psoriatic arthritis (PsA).

Major finding: Overall, the mean serum NGAL reduced by 11% after 12 months of treatment with any disease-modifying antirheumatic drug (DMARD), with no clear trend of a clinically significant increase or decrease after 12 months of treatment with conventional-synthetic DMARDs, tumor necrosis factor-alpha inhibitors, or interleukin-17 inhibitors. The changes in NGAL levels showed no correlation with changes in PsA outcomes (Spearman correlation coefficients close to 0.0).

Study details: This exploratory prospective cohort study included 117 patients with peripheral PsA who initiated conventional synthetic or biologic DMARDs, 20 patients with psoriasis without arthritis who did not receive systemic treatment, and 20 control individuals.

Disclosures: This study was supported by the Danish Rheumatism Association and others. Five authors reported ties with various sources. The other authors declared no conflict of interests.

Source: Stisen ZR et al. Treatment-related changes in serum neutrophil gelatinase-associated lipocalin (NGAL) in psoriatic arthritis: Results from the PIPA cohort study. Scand J Rheumatol. 2023;1-8 (Jun 20). Doi: 10.1080/03009742.2023.2216046.

Key clinical point: The combination of serum interleukin-6 (IL-6), platelet to lymphocyte ratio (PLR), and nail psoriasis can help screen and predict early stage of psoriatic arthritis (PsA).

Major finding: The proportion of patients with elevated serum IL-6 levels was significantly higher in the PsA vs. plaque psoriasis group (P < .0167), with the elevations in PLR levels and systemic immune-inflammation index being significantly higher among patients with PsA and early PsA vs. plaque psoriasis (P < .05 for all). The combination of nail psoriasis (P = .002), IL-6 (P < .001), and PLR (P < .001) as a predictor for early PsA diagnosis showed an area under curve of 0.84 (95% CI, 0.77-0.90).

Study details: Findings are from a case-control study including 109 patients with plaque psoriasis without joint involvement, 47 patients with PsA, and 41 patients with rheumatoid arthritis.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Liu X et al. The combination of IL-6, PLR and nail psoriasis: Screen for the early diagnosis of psoriatic arthritis. Clin Cosmet Investig Dermatol. 2023;16:1703-1713 (Jun 28). Doi: 10.2147/CCID.S413853.

Key clinical point: The combination of serum interleukin-6 (IL-6), platelet to lymphocyte ratio (PLR), and nail psoriasis can help screen and predict early stage of psoriatic arthritis (PsA).

Major finding: The proportion of patients with elevated serum IL-6 levels was significantly higher in the PsA vs. plaque psoriasis group (P < .0167), with the elevations in PLR levels and systemic immune-inflammation index being significantly higher among patients with PsA and early PsA vs. plaque psoriasis (P < .05 for all). The combination of nail psoriasis (P = .002), IL-6 (P < .001), and PLR (P < .001) as a predictor for early PsA diagnosis showed an area under curve of 0.84 (95% CI, 0.77-0.90).

Study details: Findings are from a case-control study including 109 patients with plaque psoriasis without joint involvement, 47 patients with PsA, and 41 patients with rheumatoid arthritis.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Liu X et al. The combination of IL-6, PLR and nail psoriasis: Screen for the early diagnosis of psoriatic arthritis. Clin Cosmet Investig Dermatol. 2023;16:1703-1713 (Jun 28). Doi: 10.2147/CCID.S413853.

Key clinical point: The combination of serum interleukin-6 (IL-6), platelet to lymphocyte ratio (PLR), and nail psoriasis can help screen and predict early stage of psoriatic arthritis (PsA).

Major finding: The proportion of patients with elevated serum IL-6 levels was significantly higher in the PsA vs. plaque psoriasis group (P < .0167), with the elevations in PLR levels and systemic immune-inflammation index being significantly higher among patients with PsA and early PsA vs. plaque psoriasis (P < .05 for all). The combination of nail psoriasis (P = .002), IL-6 (P < .001), and PLR (P < .001) as a predictor for early PsA diagnosis showed an area under curve of 0.84 (95% CI, 0.77-0.90).

Study details: Findings are from a case-control study including 109 patients with plaque psoriasis without joint involvement, 47 patients with PsA, and 41 patients with rheumatoid arthritis.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Liu X et al. The combination of IL-6, PLR and nail psoriasis: Screen for the early diagnosis of psoriatic arthritis. Clin Cosmet Investig Dermatol. 2023;16:1703-1713 (Jun 28). Doi: 10.2147/CCID.S413853.

Key clinical point: The presentation of disease domains is heterogenous in psoriatic arthritis (PsA) making assessment of all domains important for optimal disease management.

Major finding: Peripheral arthritis (86%) and skin disease (82%) were the most common, whereas dactylitis (23%) and axial disease (20%) were the least common disease domains identified in the overall PsA population and across treatment groups. The triad of peripheral arthritis, nail psoriasis, and skin disease was the most common domain combination (13.7%) not only in the overall PsA population but also when stratified by those who initiated tumor necrosis factor inhibitors (TNFis; 14.4%) or interleukin-17 inhibitors (IL-17is; 12.6%). At 6 months, the minimal disease activity improved across PsA domains.

Study details: This real-world analysis included 1,005 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated either TNFis or IL-17is at baseline.

Disclosures: This study was sponsored by Amgen Inc. Three authors declared being employees of and owning stocks or options in Amgen. Two authors declared being employees of CorEvitas, LLC. PJ Mease and A Ogdie declared ties with various sources, including Amgen.

Source: Mease PJ et al. Real-world evidence assessing psoriatic arthritis by disease domain: An evaluation of the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. ACR Open Rheumatol. 2023 (Jun 25). Doi: 10.1002/acr2.11556.

Key clinical point: The presentation of disease domains is heterogenous in psoriatic arthritis (PsA) making assessment of all domains important for optimal disease management.

Major finding: Peripheral arthritis (86%) and skin disease (82%) were the most common, whereas dactylitis (23%) and axial disease (20%) were the least common disease domains identified in the overall PsA population and across treatment groups. The triad of peripheral arthritis, nail psoriasis, and skin disease was the most common domain combination (13.7%) not only in the overall PsA population but also when stratified by those who initiated tumor necrosis factor inhibitors (TNFis; 14.4%) or interleukin-17 inhibitors (IL-17is; 12.6%). At 6 months, the minimal disease activity improved across PsA domains.

Study details: This real-world analysis included 1,005 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated either TNFis or IL-17is at baseline.

Disclosures: This study was sponsored by Amgen Inc. Three authors declared being employees of and owning stocks or options in Amgen. Two authors declared being employees of CorEvitas, LLC. PJ Mease and A Ogdie declared ties with various sources, including Amgen.

Source: Mease PJ et al. Real-world evidence assessing psoriatic arthritis by disease domain: An evaluation of the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. ACR Open Rheumatol. 2023 (Jun 25). Doi: 10.1002/acr2.11556.

Key clinical point: The presentation of disease domains is heterogenous in psoriatic arthritis (PsA) making assessment of all domains important for optimal disease management.

Major finding: Peripheral arthritis (86%) and skin disease (82%) were the most common, whereas dactylitis (23%) and axial disease (20%) were the least common disease domains identified in the overall PsA population and across treatment groups. The triad of peripheral arthritis, nail psoriasis, and skin disease was the most common domain combination (13.7%) not only in the overall PsA population but also when stratified by those who initiated tumor necrosis factor inhibitors (TNFis; 14.4%) or interleukin-17 inhibitors (IL-17is; 12.6%). At 6 months, the minimal disease activity improved across PsA domains.

Study details: This real-world analysis included 1,005 patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry who initiated either TNFis or IL-17is at baseline.

Disclosures: This study was sponsored by Amgen Inc. Three authors declared being employees of and owning stocks or options in Amgen. Two authors declared being employees of CorEvitas, LLC. PJ Mease and A Ogdie declared ties with various sources, including Amgen.

Source: Mease PJ et al. Real-world evidence assessing psoriatic arthritis by disease domain: An evaluation of the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. ACR Open Rheumatol. 2023 (Jun 25). Doi: 10.1002/acr2.11556.

Key clinical point: Patients with moderate-high psoriatic arthritis (PsA) disease activity without traditional cardiovascular risk factors had an increased prevalence of subclinical myocardial dysfunction, lower adiponectin levels, and higher serum interleukin-17A (IL-17A) levels.

Major finding: Patients with moderate and high PsA disease activity had lower global longitudinal strain (GLS), tricuspid annular plane systolic excursion, left ventricular ejection fraction, and adiponectin levels and higher IL-17A levels compared with patients with low PsA disease activity and control individuals (all P < .05). GLS was significantly associated with serum IL-17A (P = .001) and adiponectin (P = .032) levels.

Study details: This study included 55 patients with PsA and 25 control individuals without cardiovascular disease.

Disclosures: This study did not disclose the funding source. The authors declared no conflict of interests.

Source: Pletikosic I et al. Association of inflammatory biomarkers and disease activity with subclinical myocardial dysfunction in psoriatic arthritis. Sci Rep. 2023;13(1):10371 (Jun 26). Doi: 10.1038/s41598-023-37412-6.

Key clinical point: Patients with moderate-high psoriatic arthritis (PsA) disease activity without traditional cardiovascular risk factors had an increased prevalence of subclinical myocardial dysfunction, lower adiponectin levels, and higher serum interleukin-17A (IL-17A) levels.

Major finding: Patients with moderate and high PsA disease activity had lower global longitudinal strain (GLS), tricuspid annular plane systolic excursion, left ventricular ejection fraction, and adiponectin levels and higher IL-17A levels compared with patients with low PsA disease activity and control individuals (all P < .05). GLS was significantly associated with serum IL-17A (P = .001) and adiponectin (P = .032) levels.

Study details: This study included 55 patients with PsA and 25 control individuals without cardiovascular disease.

Disclosures: This study did not disclose the funding source. The authors declared no conflict of interests.

Source: Pletikosic I et al. Association of inflammatory biomarkers and disease activity with subclinical myocardial dysfunction in psoriatic arthritis. Sci Rep. 2023;13(1):10371 (Jun 26). Doi: 10.1038/s41598-023-37412-6.

Key clinical point: Patients with moderate-high psoriatic arthritis (PsA) disease activity without traditional cardiovascular risk factors had an increased prevalence of subclinical myocardial dysfunction, lower adiponectin levels, and higher serum interleukin-17A (IL-17A) levels.

Major finding: Patients with moderate and high PsA disease activity had lower global longitudinal strain (GLS), tricuspid annular plane systolic excursion, left ventricular ejection fraction, and adiponectin levels and higher IL-17A levels compared with patients with low PsA disease activity and control individuals (all P < .05). GLS was significantly associated with serum IL-17A (P = .001) and adiponectin (P = .032) levels.

Study details: This study included 55 patients with PsA and 25 control individuals without cardiovascular disease.

Disclosures: This study did not disclose the funding source. The authors declared no conflict of interests.

Source: Pletikosic I et al. Association of inflammatory biomarkers and disease activity with subclinical myocardial dysfunction in psoriatic arthritis. Sci Rep. 2023;13(1):10371 (Jun 26). Doi: 10.1038/s41598-023-37412-6.

Key clinical point: A 12-month anti-tumor necrosis factor-alpha (anti-TNF-α) regimen improved nailfold capillaroscopic abnormalities in patients with psoriatic arthritis (PsA), highlighting the usefulness of nailfold videocapillaroscopy in the evaluation of disease severity and in monitoring the efficacy of biologic treatment.

Major finding: After 12 months of initiating anti-TNF-α therapy, the proportion of patients with PsA showing structural integrity increased from 29.4% to 67.6% and those of patients with low capillaroscopic density and avascular areas decreased from 30.3% to 15.2% and 39.4% to 24.2%, respectively. The use of anti-TNF-α therapy was positively associated with a decrease in angiogenesis (P = .0003) and in the number of giant capillaries (P = .007) and elongated capillaries (P = .0003).

Study details: Findings are from a retrospective observational study including patients with PsA (n=34) and those with rheumatoid arthritis (n=34) who received anti-TNF-α therapy and control individuals (n=24).

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Anghel D et al. Nailfold videocapillaroscopy in patients with rheumatoid arthritis and psoriatic arthropathy on ANTI-TNF-ALPHA therapy. Diagnostics (Basel). 2023;13(12):2079 (Jun 15). Doi: 10.3390/diagnostics13122079.

Key clinical point: A 12-month anti-tumor necrosis factor-alpha (anti-TNF-α) regimen improved nailfold capillaroscopic abnormalities in patients with psoriatic arthritis (PsA), highlighting the usefulness of nailfold videocapillaroscopy in the evaluation of disease severity and in monitoring the efficacy of biologic treatment.

Major finding: After 12 months of initiating anti-TNF-α therapy, the proportion of patients with PsA showing structural integrity increased from 29.4% to 67.6% and those of patients with low capillaroscopic density and avascular areas decreased from 30.3% to 15.2% and 39.4% to 24.2%, respectively. The use of anti-TNF-α therapy was positively associated with a decrease in angiogenesis (P = .0003) and in the number of giant capillaries (P = .007) and elongated capillaries (P = .0003).

Study details: Findings are from a retrospective observational study including patients with PsA (n=34) and those with rheumatoid arthritis (n=34) who received anti-TNF-α therapy and control individuals (n=24).

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Anghel D et al. Nailfold videocapillaroscopy in patients with rheumatoid arthritis and psoriatic arthropathy on ANTI-TNF-ALPHA therapy. Diagnostics (Basel). 2023;13(12):2079 (Jun 15). Doi: 10.3390/diagnostics13122079.

Key clinical point: A 12-month anti-tumor necrosis factor-alpha (anti-TNF-α) regimen improved nailfold capillaroscopic abnormalities in patients with psoriatic arthritis (PsA), highlighting the usefulness of nailfold videocapillaroscopy in the evaluation of disease severity and in monitoring the efficacy of biologic treatment.

Major finding: After 12 months of initiating anti-TNF-α therapy, the proportion of patients with PsA showing structural integrity increased from 29.4% to 67.6% and those of patients with low capillaroscopic density and avascular areas decreased from 30.3% to 15.2% and 39.4% to 24.2%, respectively. The use of anti-TNF-α therapy was positively associated with a decrease in angiogenesis (P = .0003) and in the number of giant capillaries (P = .007) and elongated capillaries (P = .0003).

Study details: Findings are from a retrospective observational study including patients with PsA (n=34) and those with rheumatoid arthritis (n=34) who received anti-TNF-α therapy and control individuals (n=24).

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Anghel D et al. Nailfold videocapillaroscopy in patients with rheumatoid arthritis and psoriatic arthropathy on ANTI-TNF-ALPHA therapy. Diagnostics (Basel). 2023;13(12):2079 (Jun 15). Doi: 10.3390/diagnostics13122079.

Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).

Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).

Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.

Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.

Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.

Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).

Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).

Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.

Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.

Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.

Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).

Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).

Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.

Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.

Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.