Excessive drooling by patients with advanced Parkinson’s disease is an indicator of greater motor and nonmotor dysfunction, new research shows. “Sialorrhea is not just a cosmetic problem,” study investigator Francesca Morgante, MD, associate professor of neurology, St. George’s University, London, told this news organization.

“We need to understand the relationship between sialorrhea and these speech and swallowing disturbances and whether treatment for sialorrhea improves that,” Dr. Morgante added.

The findings were presented at the 2021 Congress of the European Academy of Neurology.
 

Underrecognized symptom

Sialorrhea is an underrecognized nonmotor symptom that can affect up to 70% of patients with Parkinson’s disease, said co-investigator Ioana Cociasu, PhD, postdoctoral research fellow, Neurosciences Research Center, St. George’s University. The impact on quality of life increases with disease severity, she said.

The current study included 101 consecutive patients attending an advanced Parkinson’s disease disorders clinic. Researchers collected demographic data that included information on gender, age, age at Parkinson’s disease onset, and disease duration. They also gathered data on motor symptoms by assessing total levodopa equivalent daily dose (LEDD) and LEDD dopamine agonists. They also assessed results on the Unified Parkinson’s Disease Rating Scale (UPDRS) part III and the Hoehn and Yahr scale for on- and off-medication states.

Nonmotor functioning was assessed using the Non-Motor Symptoms Scale (NMSS) and Scales for Outcomes in Parkinson’s disease–autonomic dysfunction (SCOPA-AUT) questionnaire. Among patients with Parkinson’s disease, autonomic dysfunction can precede motor impairment and can involve orthostatic and postprandial hypotension, among other symptoms, the investigators noted.

Health status and quality of life were assessed using the Parkinson’s disease questionnaire–39 items (PDQ-39). The Radboud Oral Motor Inventory for PD (ROMP) was used to measure orofacial symptoms. ROMP is a self-administered questionnaire that evaluates speech, swallowing disturbances, and drooling of saliva. The Montreal Cognitive Assessment test was also used.

Investigators compared participants with sialorrhea to those without sialorrhea, described as droolers and nondroolers. Droolers were defined as those scoring higher than 1 on the UPDRS-II item 6. This signified slight but definite presence of saliva in the mouth and/or the possibility of nighttime drooling.
 

Greater impairment

Among the participants, 65 (64.4%) were classified as droolers, and 36 (35.6%) as nondroolers.

Patients with both Parkinson’s disease and sialorrhea were significantly more impaired in terms of motor functioning than those without sialorrhea. In these patients, the UPDRS-III was more severe in both the off- (P = .03) and on-states (P = .002), and they had less improvement with the levodopa challenge test (P = .007).

Droolers were also more severely affected by nonmotor problems. They had more severe speech dysfunction (P < .0001) and swallowing dysfunction (P < .05), and they had higher scores on the NMSS (P = .0008) and SCOPA-AUT (P = .003) and poorer quality-of-life scores on the PDQ-39 (P = .049).

To evaluate respiratory tract infections, the researchers used electronic health records. About 15.4% of the study population had had a documented respiratory infection since they were diagnosed with Parkinson’s disease.

Upper and lower respiratory tract infections were more frequent among droolers than nondroolers (P = .05).

“Infections might arise from swallowing disturbances leading to aspiration and drooling,” Dr. Morgante noted.

The drooling did not appear to affect cognition or sleep in these patients.
 

Treatment options?

Following the study presentation, session co-chair Philippe G. Damier, MD, PhD, professor of neurology, University Hospital, Nantes, France, asked about the best treatment for sialorrhea for these patients.

In general, those with milder disease might try chewing gum to improve swallowing; patients with more severe cases may benefit from botulinum toxin injections, said Dr. Cociasu. The treatment choice, she added, “very much depends on the severity of the sialorrhea.”

Botulinum toxin therapy involves injections into the salivary gland to reduce saliva production. It is typically administered about every 4 months.

The second session co-chair, Elena Moro, MD, PhD, director of the Movement Disorders Unit at Grenoble Alpes University, France, pointed out that chewing gum may be a swallowing hazard for patients with PD and severe dementia.

Asked by Dr. Moro whether patients with higher scores on balance and posture were more likely to have sialorrhea, Dr. Cociasu said she and her colleagues are currently looking into this.

Dr. Morgante said that the current study did not examine the effect of treatment on speech disorders associated with sialorrhea. “We are running another study now to understand the effect of treatment of sialorrhea on these features,” she said.

Dr. Morgante and Dr. Cociasu have reported no relevant financial relationships.

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

Excessive drooling by patients with advanced Parkinson’s disease is an indicator of greater motor and nonmotor dysfunction, new research shows. “Sialorrhea is not just a cosmetic problem,” study investigator Francesca Morgante, MD, associate professor of neurology, St. George’s University, London, told this news organization.

“We need to understand the relationship between sialorrhea and these speech and swallowing disturbances and whether treatment for sialorrhea improves that,” Dr. Morgante added.

The findings were presented at the 2021 Congress of the European Academy of Neurology.
 

Underrecognized symptom

Sialorrhea is an underrecognized nonmotor symptom that can affect up to 70% of patients with Parkinson’s disease, said co-investigator Ioana Cociasu, PhD, postdoctoral research fellow, Neurosciences Research Center, St. George’s University. The impact on quality of life increases with disease severity, she said.

The current study included 101 consecutive patients attending an advanced Parkinson’s disease disorders clinic. Researchers collected demographic data that included information on gender, age, age at Parkinson’s disease onset, and disease duration. They also gathered data on motor symptoms by assessing total levodopa equivalent daily dose (LEDD) and LEDD dopamine agonists. They also assessed results on the Unified Parkinson’s Disease Rating Scale (UPDRS) part III and the Hoehn and Yahr scale for on- and off-medication states.

Nonmotor functioning was assessed using the Non-Motor Symptoms Scale (NMSS) and Scales for Outcomes in Parkinson’s disease–autonomic dysfunction (SCOPA-AUT) questionnaire. Among patients with Parkinson’s disease, autonomic dysfunction can precede motor impairment and can involve orthostatic and postprandial hypotension, among other symptoms, the investigators noted.

Health status and quality of life were assessed using the Parkinson’s disease questionnaire–39 items (PDQ-39). The Radboud Oral Motor Inventory for PD (ROMP) was used to measure orofacial symptoms. ROMP is a self-administered questionnaire that evaluates speech, swallowing disturbances, and drooling of saliva. The Montreal Cognitive Assessment test was also used.

Investigators compared participants with sialorrhea to those without sialorrhea, described as droolers and nondroolers. Droolers were defined as those scoring higher than 1 on the UPDRS-II item 6. This signified slight but definite presence of saliva in the mouth and/or the possibility of nighttime drooling.
 

Greater impairment

Among the participants, 65 (64.4%) were classified as droolers, and 36 (35.6%) as nondroolers.

Patients with both Parkinson’s disease and sialorrhea were significantly more impaired in terms of motor functioning than those without sialorrhea. In these patients, the UPDRS-III was more severe in both the off- (P = .03) and on-states (P = .002), and they had less improvement with the levodopa challenge test (P = .007).

Droolers were also more severely affected by nonmotor problems. They had more severe speech dysfunction (P < .0001) and swallowing dysfunction (P < .05), and they had higher scores on the NMSS (P = .0008) and SCOPA-AUT (P = .003) and poorer quality-of-life scores on the PDQ-39 (P = .049).

To evaluate respiratory tract infections, the researchers used electronic health records. About 15.4% of the study population had had a documented respiratory infection since they were diagnosed with Parkinson’s disease.

Upper and lower respiratory tract infections were more frequent among droolers than nondroolers (P = .05).

“Infections might arise from swallowing disturbances leading to aspiration and drooling,” Dr. Morgante noted.

The drooling did not appear to affect cognition or sleep in these patients.
 

Treatment options?

Following the study presentation, session co-chair Philippe G. Damier, MD, PhD, professor of neurology, University Hospital, Nantes, France, asked about the best treatment for sialorrhea for these patients.

In general, those with milder disease might try chewing gum to improve swallowing; patients with more severe cases may benefit from botulinum toxin injections, said Dr. Cociasu. The treatment choice, she added, “very much depends on the severity of the sialorrhea.”

Botulinum toxin therapy involves injections into the salivary gland to reduce saliva production. It is typically administered about every 4 months.

The second session co-chair, Elena Moro, MD, PhD, director of the Movement Disorders Unit at Grenoble Alpes University, France, pointed out that chewing gum may be a swallowing hazard for patients with PD and severe dementia.

Asked by Dr. Moro whether patients with higher scores on balance and posture were more likely to have sialorrhea, Dr. Cociasu said she and her colleagues are currently looking into this.

Dr. Morgante said that the current study did not examine the effect of treatment on speech disorders associated with sialorrhea. “We are running another study now to understand the effect of treatment of sialorrhea on these features,” she said.

Dr. Morgante and Dr. Cociasu have reported no relevant financial relationships.

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

Excessive drooling by patients with advanced Parkinson’s disease is an indicator of greater motor and nonmotor dysfunction, new research shows. “Sialorrhea is not just a cosmetic problem,” study investigator Francesca Morgante, MD, associate professor of neurology, St. George’s University, London, told this news organization.

“We need to understand the relationship between sialorrhea and these speech and swallowing disturbances and whether treatment for sialorrhea improves that,” Dr. Morgante added.

The findings were presented at the 2021 Congress of the European Academy of Neurology.
 

Underrecognized symptom

Sialorrhea is an underrecognized nonmotor symptom that can affect up to 70% of patients with Parkinson’s disease, said co-investigator Ioana Cociasu, PhD, postdoctoral research fellow, Neurosciences Research Center, St. George’s University. The impact on quality of life increases with disease severity, she said.

The current study included 101 consecutive patients attending an advanced Parkinson’s disease disorders clinic. Researchers collected demographic data that included information on gender, age, age at Parkinson’s disease onset, and disease duration. They also gathered data on motor symptoms by assessing total levodopa equivalent daily dose (LEDD) and LEDD dopamine agonists. They also assessed results on the Unified Parkinson’s Disease Rating Scale (UPDRS) part III and the Hoehn and Yahr scale for on- and off-medication states.

Nonmotor functioning was assessed using the Non-Motor Symptoms Scale (NMSS) and Scales for Outcomes in Parkinson’s disease–autonomic dysfunction (SCOPA-AUT) questionnaire. Among patients with Parkinson’s disease, autonomic dysfunction can precede motor impairment and can involve orthostatic and postprandial hypotension, among other symptoms, the investigators noted.

Health status and quality of life were assessed using the Parkinson’s disease questionnaire–39 items (PDQ-39). The Radboud Oral Motor Inventory for PD (ROMP) was used to measure orofacial symptoms. ROMP is a self-administered questionnaire that evaluates speech, swallowing disturbances, and drooling of saliva. The Montreal Cognitive Assessment test was also used.

Investigators compared participants with sialorrhea to those without sialorrhea, described as droolers and nondroolers. Droolers were defined as those scoring higher than 1 on the UPDRS-II item 6. This signified slight but definite presence of saliva in the mouth and/or the possibility of nighttime drooling.
 

Greater impairment

Among the participants, 65 (64.4%) were classified as droolers, and 36 (35.6%) as nondroolers.

Patients with both Parkinson’s disease and sialorrhea were significantly more impaired in terms of motor functioning than those without sialorrhea. In these patients, the UPDRS-III was more severe in both the off- (P = .03) and on-states (P = .002), and they had less improvement with the levodopa challenge test (P = .007).

Droolers were also more severely affected by nonmotor problems. They had more severe speech dysfunction (P < .0001) and swallowing dysfunction (P < .05), and they had higher scores on the NMSS (P = .0008) and SCOPA-AUT (P = .003) and poorer quality-of-life scores on the PDQ-39 (P = .049).

To evaluate respiratory tract infections, the researchers used electronic health records. About 15.4% of the study population had had a documented respiratory infection since they were diagnosed with Parkinson’s disease.

Upper and lower respiratory tract infections were more frequent among droolers than nondroolers (P = .05).

“Infections might arise from swallowing disturbances leading to aspiration and drooling,” Dr. Morgante noted.

The drooling did not appear to affect cognition or sleep in these patients.
 

Treatment options?

Following the study presentation, session co-chair Philippe G. Damier, MD, PhD, professor of neurology, University Hospital, Nantes, France, asked about the best treatment for sialorrhea for these patients.

In general, those with milder disease might try chewing gum to improve swallowing; patients with more severe cases may benefit from botulinum toxin injections, said Dr. Cociasu. The treatment choice, she added, “very much depends on the severity of the sialorrhea.”

Botulinum toxin therapy involves injections into the salivary gland to reduce saliva production. It is typically administered about every 4 months.

The second session co-chair, Elena Moro, MD, PhD, director of the Movement Disorders Unit at Grenoble Alpes University, France, pointed out that chewing gum may be a swallowing hazard for patients with PD and severe dementia.

Asked by Dr. Moro whether patients with higher scores on balance and posture were more likely to have sialorrhea, Dr. Cociasu said she and her colleagues are currently looking into this.

Dr. Morgante said that the current study did not examine the effect of treatment on speech disorders associated with sialorrhea. “We are running another study now to understand the effect of treatment of sialorrhea on these features,” she said.

Dr. Morgante and Dr. Cociasu have reported no relevant financial relationships.

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

A key molecular mechanism underpinning the anti-inflammatory, antidepressant, and neuroprotective effects of omega-3 fatty acids has been identified. In findings that could lead to the development of new treatments for depression, the research provides the “first evidence” that hippocampal neurons are able to produce two key lipid metabolites of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – lipoxygenase and cytochrome P450, lead investigator Alessandra Borsini, PhD, told this news organization.

This is how EPA and DHA exert their anti-inflammatory and neurogenic properties in vitro, as well as antidepressant properties in patients with depression, said Dr. Borsini, from King’s College London.

“Indeed, we found evidence for a correlation between increased levels of these metabolites and a decrease in severity of depressive symptoms in patients with major depressive disorder,” Dr. Borsini said.

The study was published online June 16 in Molecular Psychiatry.
 

‘Depression in a dish’

Despite the known role of inflammation in depression, there remains a lack of data showing anti-inflammatory strategies that are effective, safe for everyday use, and with a clear mechanism of action, the researchers note.  

Dr. Borsini and colleagues tested the theory that when EPA and DHA are metabolized, some of their metabolites, or lipid mediators, can protect the brain from the harmful effects of inflammation. They used a validated “depression in a dish” in vitro human hippocampal cell model to test their theory.

They found that treating human hippocampal cells with EPA or DHA before exposing them to cytokines prevented increased cell death and decreased neurogenesis. Both these impacts had been previously observed in cells exposed to cytokines alone.

They confirmed that these effects were mediated by the formation of several key lipid mediators produced by EPA and DHA – namely hydroxyeicosapentaenoic acid, hydroxydocosahexaenoic acid, epoxyeicosatetraenoic acid (EpETE), and epoxydocosapentaenoic acid (EpDPA).

It’s the first time these lipid mediators were detected in human hippocampal neurons, the researchers say.

They also found that treating the neurons with an enzyme inhibitor increased the availability of two of these metabolites (EpETE and EpDPA), suggesting a possible way by which future treatments could be optimized.

The findings were replicated in 22 patients with major depression given either EPA (3 g/day) or DHA (1.4 g/day) for 12 weeks. In both groups, EPA or DHA treatment was associated with an increase in their respective metabolites and significant improvement in depressive symptoms.

The average reduction in symptom scores was 64% and 71% in the EPA and DHA groups, respectively, and there was some evidence that higher levels of the same metabolites correlated with less severe depressive symptoms.

“For some time we have known that omega-3 [polyunsaturated fatty acid (PUFA)] can induce antidepressant and anti-inflammatory effects, but, without further understanding of how this happens in the human brain, it has been difficult to develop treatments,” Dr. Borsini said in a news release.

“Our study has helped shine a light on the molecular mechanisms involved in this relationship which can inform the development of potential new treatments for depression using omega-3 PUFA,” Dr. Borsini added.

“We need to be cautious when interpreting data generated from the correlation between levels of metabolites and depressive symptoms as findings require further validation in a bigger sample of patients,” Dr. Borsini said.

“It is important to highlight that our research has not shown that by simply increasing omega-3 fatty acids in our diets or through taking nutritional supplements we can reduce inflammation or depression,” study author Carmine Pariante, MD, PhD, from King’s College London, said in the news release.

“The mechanisms behind the associations between depression and omega-3 PUFA are complicated and require further research and clinical trials to fully understand how they work and inform future therapeutic approaches,” Dr. Pariante said.
 

No clinical implications

Weighing in on this research in a Science Media Centre statement, Kevin McConway, emeritus professor of applied statistics, The Open University, Milton Keynes, United Kingdom, said, “The point of the study was to throw some light on the mechanisms in the body by which omega-3 fatty acids might work to reduce inflammation or depression.”

“The research mostly involved cells in laboratory dishes, but it also involved treating a small sample of patients with major depression by giving them supplements of one or other of the two omega-3 acids under investigation for 12 weeks,” he noted.

“The researchers found that the patients’ average scores on a standard set of questions, used to diagnose and measure depression, improved over that 12-week period, for each of the two fatty acids.

While depression symptoms improved over 12 weeks with omega-3 fatty acid treatment, “depression symptoms change over time anyway, for many reasons,” and depressive symptoms might have improved over 12 weeks even if the patients had not been given the omega-3 acids, Dr. McConway said.

“We just can’t tell since every patient got omega-3 fatty acids. So these results can hint that omega-3 fatty acids might help in depression, but it comes nowhere near showing that this is the case with a reasonable degree of certainty,” he cautioned.

“Indeed the researchers did not carry out this part of their study to see whether the omega-3 supplements help with depression – they did it to see whether the biochemical changes that they had seen in cell cultures in the lab might also occur in human bodies,” he noted.

This research was funded in part by grants to the investigators from the U.K. Medical Research Council, the European Commission Horizon 2020, and the National Institute for Health Research (NIHR), Maudsley Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London. Dr. Borsini has received research funding from Johnson & Johnson for research on depression and inflammation. Dr. McConway is a trustee of the Science Media Centre and a member of its advisory committee.

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

A key molecular mechanism underpinning the anti-inflammatory, antidepressant, and neuroprotective effects of omega-3 fatty acids has been identified. In findings that could lead to the development of new treatments for depression, the research provides the “first evidence” that hippocampal neurons are able to produce two key lipid metabolites of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – lipoxygenase and cytochrome P450, lead investigator Alessandra Borsini, PhD, told this news organization.

This is how EPA and DHA exert their anti-inflammatory and neurogenic properties in vitro, as well as antidepressant properties in patients with depression, said Dr. Borsini, from King’s College London.

“Indeed, we found evidence for a correlation between increased levels of these metabolites and a decrease in severity of depressive symptoms in patients with major depressive disorder,” Dr. Borsini said.

The study was published online June 16 in Molecular Psychiatry.
 

‘Depression in a dish’

Despite the known role of inflammation in depression, there remains a lack of data showing anti-inflammatory strategies that are effective, safe for everyday use, and with a clear mechanism of action, the researchers note.  

Dr. Borsini and colleagues tested the theory that when EPA and DHA are metabolized, some of their metabolites, or lipid mediators, can protect the brain from the harmful effects of inflammation. They used a validated “depression in a dish” in vitro human hippocampal cell model to test their theory.

They found that treating human hippocampal cells with EPA or DHA before exposing them to cytokines prevented increased cell death and decreased neurogenesis. Both these impacts had been previously observed in cells exposed to cytokines alone.

They confirmed that these effects were mediated by the formation of several key lipid mediators produced by EPA and DHA – namely hydroxyeicosapentaenoic acid, hydroxydocosahexaenoic acid, epoxyeicosatetraenoic acid (EpETE), and epoxydocosapentaenoic acid (EpDPA).

It’s the first time these lipid mediators were detected in human hippocampal neurons, the researchers say.

They also found that treating the neurons with an enzyme inhibitor increased the availability of two of these metabolites (EpETE and EpDPA), suggesting a possible way by which future treatments could be optimized.

The findings were replicated in 22 patients with major depression given either EPA (3 g/day) or DHA (1.4 g/day) for 12 weeks. In both groups, EPA or DHA treatment was associated with an increase in their respective metabolites and significant improvement in depressive symptoms.

The average reduction in symptom scores was 64% and 71% in the EPA and DHA groups, respectively, and there was some evidence that higher levels of the same metabolites correlated with less severe depressive symptoms.

“For some time we have known that omega-3 [polyunsaturated fatty acid (PUFA)] can induce antidepressant and anti-inflammatory effects, but, without further understanding of how this happens in the human brain, it has been difficult to develop treatments,” Dr. Borsini said in a news release.

“Our study has helped shine a light on the molecular mechanisms involved in this relationship which can inform the development of potential new treatments for depression using omega-3 PUFA,” Dr. Borsini added.

“We need to be cautious when interpreting data generated from the correlation between levels of metabolites and depressive symptoms as findings require further validation in a bigger sample of patients,” Dr. Borsini said.

“It is important to highlight that our research has not shown that by simply increasing omega-3 fatty acids in our diets or through taking nutritional supplements we can reduce inflammation or depression,” study author Carmine Pariante, MD, PhD, from King’s College London, said in the news release.

“The mechanisms behind the associations between depression and omega-3 PUFA are complicated and require further research and clinical trials to fully understand how they work and inform future therapeutic approaches,” Dr. Pariante said.
 

No clinical implications

Weighing in on this research in a Science Media Centre statement, Kevin McConway, emeritus professor of applied statistics, The Open University, Milton Keynes, United Kingdom, said, “The point of the study was to throw some light on the mechanisms in the body by which omega-3 fatty acids might work to reduce inflammation or depression.”

“The research mostly involved cells in laboratory dishes, but it also involved treating a small sample of patients with major depression by giving them supplements of one or other of the two omega-3 acids under investigation for 12 weeks,” he noted.

“The researchers found that the patients’ average scores on a standard set of questions, used to diagnose and measure depression, improved over that 12-week period, for each of the two fatty acids.

While depression symptoms improved over 12 weeks with omega-3 fatty acid treatment, “depression symptoms change over time anyway, for many reasons,” and depressive symptoms might have improved over 12 weeks even if the patients had not been given the omega-3 acids, Dr. McConway said.

“We just can’t tell since every patient got omega-3 fatty acids. So these results can hint that omega-3 fatty acids might help in depression, but it comes nowhere near showing that this is the case with a reasonable degree of certainty,” he cautioned.

“Indeed the researchers did not carry out this part of their study to see whether the omega-3 supplements help with depression – they did it to see whether the biochemical changes that they had seen in cell cultures in the lab might also occur in human bodies,” he noted.

This research was funded in part by grants to the investigators from the U.K. Medical Research Council, the European Commission Horizon 2020, and the National Institute for Health Research (NIHR), Maudsley Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London. Dr. Borsini has received research funding from Johnson & Johnson for research on depression and inflammation. Dr. McConway is a trustee of the Science Media Centre and a member of its advisory committee.

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

A key molecular mechanism underpinning the anti-inflammatory, antidepressant, and neuroprotective effects of omega-3 fatty acids has been identified. In findings that could lead to the development of new treatments for depression, the research provides the “first evidence” that hippocampal neurons are able to produce two key lipid metabolites of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – lipoxygenase and cytochrome P450, lead investigator Alessandra Borsini, PhD, told this news organization.

This is how EPA and DHA exert their anti-inflammatory and neurogenic properties in vitro, as well as antidepressant properties in patients with depression, said Dr. Borsini, from King’s College London.

“Indeed, we found evidence for a correlation between increased levels of these metabolites and a decrease in severity of depressive symptoms in patients with major depressive disorder,” Dr. Borsini said.

The study was published online June 16 in Molecular Psychiatry.
 

‘Depression in a dish’

Despite the known role of inflammation in depression, there remains a lack of data showing anti-inflammatory strategies that are effective, safe for everyday use, and with a clear mechanism of action, the researchers note.  

Dr. Borsini and colleagues tested the theory that when EPA and DHA are metabolized, some of their metabolites, or lipid mediators, can protect the brain from the harmful effects of inflammation. They used a validated “depression in a dish” in vitro human hippocampal cell model to test their theory.

They found that treating human hippocampal cells with EPA or DHA before exposing them to cytokines prevented increased cell death and decreased neurogenesis. Both these impacts had been previously observed in cells exposed to cytokines alone.

They confirmed that these effects were mediated by the formation of several key lipid mediators produced by EPA and DHA – namely hydroxyeicosapentaenoic acid, hydroxydocosahexaenoic acid, epoxyeicosatetraenoic acid (EpETE), and epoxydocosapentaenoic acid (EpDPA).

It’s the first time these lipid mediators were detected in human hippocampal neurons, the researchers say.

They also found that treating the neurons with an enzyme inhibitor increased the availability of two of these metabolites (EpETE and EpDPA), suggesting a possible way by which future treatments could be optimized.

The findings were replicated in 22 patients with major depression given either EPA (3 g/day) or DHA (1.4 g/day) for 12 weeks. In both groups, EPA or DHA treatment was associated with an increase in their respective metabolites and significant improvement in depressive symptoms.

The average reduction in symptom scores was 64% and 71% in the EPA and DHA groups, respectively, and there was some evidence that higher levels of the same metabolites correlated with less severe depressive symptoms.

“For some time we have known that omega-3 [polyunsaturated fatty acid (PUFA)] can induce antidepressant and anti-inflammatory effects, but, without further understanding of how this happens in the human brain, it has been difficult to develop treatments,” Dr. Borsini said in a news release.

“Our study has helped shine a light on the molecular mechanisms involved in this relationship which can inform the development of potential new treatments for depression using omega-3 PUFA,” Dr. Borsini added.

“We need to be cautious when interpreting data generated from the correlation between levels of metabolites and depressive symptoms as findings require further validation in a bigger sample of patients,” Dr. Borsini said.

“It is important to highlight that our research has not shown that by simply increasing omega-3 fatty acids in our diets or through taking nutritional supplements we can reduce inflammation or depression,” study author Carmine Pariante, MD, PhD, from King’s College London, said in the news release.

“The mechanisms behind the associations between depression and omega-3 PUFA are complicated and require further research and clinical trials to fully understand how they work and inform future therapeutic approaches,” Dr. Pariante said.
 

No clinical implications

Weighing in on this research in a Science Media Centre statement, Kevin McConway, emeritus professor of applied statistics, The Open University, Milton Keynes, United Kingdom, said, “The point of the study was to throw some light on the mechanisms in the body by which omega-3 fatty acids might work to reduce inflammation or depression.”

“The research mostly involved cells in laboratory dishes, but it also involved treating a small sample of patients with major depression by giving them supplements of one or other of the two omega-3 acids under investigation for 12 weeks,” he noted.

“The researchers found that the patients’ average scores on a standard set of questions, used to diagnose and measure depression, improved over that 12-week period, for each of the two fatty acids.

While depression symptoms improved over 12 weeks with omega-3 fatty acid treatment, “depression symptoms change over time anyway, for many reasons,” and depressive symptoms might have improved over 12 weeks even if the patients had not been given the omega-3 acids, Dr. McConway said.

“We just can’t tell since every patient got omega-3 fatty acids. So these results can hint that omega-3 fatty acids might help in depression, but it comes nowhere near showing that this is the case with a reasonable degree of certainty,” he cautioned.

“Indeed the researchers did not carry out this part of their study to see whether the omega-3 supplements help with depression – they did it to see whether the biochemical changes that they had seen in cell cultures in the lab might also occur in human bodies,” he noted.

This research was funded in part by grants to the investigators from the U.K. Medical Research Council, the European Commission Horizon 2020, and the National Institute for Health Research (NIHR), Maudsley Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London. Dr. Borsini has received research funding from Johnson & Johnson for research on depression and inflammation. Dr. McConway is a trustee of the Science Media Centre and a member of its advisory committee.

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

Deprescribing may help in reducing inappropriate medication use and adverse events, but for cardiovascular care in the elderly, eliminating statins among patients taking other medications may have negative effects that far outweigh the benefits, a new study suggests.

In a large cohort study, researchers found that the withdrawal of statins from an elderly population receiving polypharmacy was associated with an increase in the risk for hospital admission for heart failure and any cardiovascular outcome, as well as death from any cause.

Statins are “lifesaving” drugs, and “according to the findings of our study, the discontinuation of this therapy has significant effects,” lead study author Federico Rea, PhD, research fellow, Laboratory of Healthcare Research and Pharmacoepidemiology, the department of statistics and quantitative methods, the University of Milano-Bicocca, said in an interview.

The article was published online June 14, 2021, in JAMA Network Open.

Negative clinical consequences, including adverse drug reactions leading to hospitalizations, are causing more physicians to consider deprescribing as a way to reduce problems associated with polypharmacy, the researchers noted.

Statins are “the most widely prescribed medication in the Western world, being a pivotal component in the primary and secondary prevention of cardiovascular (CV) diseases,” they wrote, but because randomized trials usually exclude patients with serious clinical conditions, the precise role statins play for frail patients, such as those with polypharmacy, “is still unclear.”

The population-based cohort study examined 29,047 Italian residents aged 65 years and older who were receiving uninterrupted treatment with statins as well as blood pressure–lowering, antidiabetic, and antiplatelet agents over 16 months. The follow-up period was more than 3 years.

The cohort members were followed to identify those for whom statins were discontinued. Those who continued taking other therapies during the first 6 months after stopping statins were propensity score matched in a 1:1 ratio with patients who did not discontinue taking statins or other drugs. The patient pairs were then followed for fatal and nonfatal outcomes to estimate the risk associated with statin discontinuation.

Of the overall cohort exposed to polypharmacy, 5819 (20.0%) discontinued statins while continuing to take their other medications. Of those, 4,010 were matched with a comparator.

Compared with the maintaining group, those who discontinued statins had the following outcomes: an increased risk for hospital admissions for heart failure (hazard ratio, 1.24; 95% confidence interval, 1.07-1.43), any cardiovascular outcomes (HR, 1.14; 95% CI, 1.03-1.26), death from any cause (HR, 1.15; 95% CI, 1.02-1.30), and emergency admissions for any cause (HR, 1.12; 95% CI, 1.01-1.19)

The increased risk occurred in patients with mild or severe profiles, regardless of gender and whether statins were prescribed as primary or secondary CV prevention.

“We expected that the discontinuation of statins could reduce the risk of access to the emergency department for neurological causes, considered a proxy for the onset of episodes of delirium, [but] this was not observed, suggesting that statin therapy has essential benefits on the reduction of fatal/nonfatal cardiovascular events with no harm effect,” said Dr. Rea, “at least considering major adverse events like hospital and emergency department admissions.”
 

Findings no surprise

Neil Stone, MD, Bonow Professor of Medicine (Cardiology) and Preventive Medicine at Northwestern University, Chicago, said the study results aren’t surprising.

“Older patients have a higher absolute risk of dying, and withdrawing proven therapy shown to reduce risk of coronary/stroke events in randomized, controlled trials would be expected to result in more cardiovascular events,” Dr. Stone said.

Although polypharmacy is a concern for the elderly and is a factor in decreased adherence, he said better solutions are needed than withdrawing proven, effective therapy. “In that sense, this study indirectly supports more research in the use of polypills to address cardiovascular risk factors,” he said. Giving a single pill that combines medications of proven value in reducing blood pressure and cholesterol might be preferable to reducing the total number of medications.

Given the complexity of polypharmacy, the study investigators say more attention is needed from all health care professionals who care for elderly patients.

“We hope that future studies can shed light on the best way to balance the undeniable benefit of [statins] and the harms, especially among the elderly exposed to polypharmacy,” said Rea.

Further research is also needed into why statins are discontinued in the first place, added Dr. Stone. “We know that statins often are stopped due to symptoms that on further scrutiny may not be related to statin use.”

The study was funded by grants from Fondo d’Ateneo per la Ricerca and Modelling Effectiveness, Cost-effectiveness, and Promoting Health Care Value in the Real World: the Motive Project from the Italian Ministry of the Education, University, and Research. One coauthor served on the advisory board of Roche and has received grants from Bristol Myers Squibb, GlaxoSmithKline, and Novartis outside the submitted work. The other authors disclosed no relevant financial relationships.

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

Deprescribing may help in reducing inappropriate medication use and adverse events, but for cardiovascular care in the elderly, eliminating statins among patients taking other medications may have negative effects that far outweigh the benefits, a new study suggests.

In a large cohort study, researchers found that the withdrawal of statins from an elderly population receiving polypharmacy was associated with an increase in the risk for hospital admission for heart failure and any cardiovascular outcome, as well as death from any cause.

Statins are “lifesaving” drugs, and “according to the findings of our study, the discontinuation of this therapy has significant effects,” lead study author Federico Rea, PhD, research fellow, Laboratory of Healthcare Research and Pharmacoepidemiology, the department of statistics and quantitative methods, the University of Milano-Bicocca, said in an interview.

The article was published online June 14, 2021, in JAMA Network Open.

Negative clinical consequences, including adverse drug reactions leading to hospitalizations, are causing more physicians to consider deprescribing as a way to reduce problems associated with polypharmacy, the researchers noted.

Statins are “the most widely prescribed medication in the Western world, being a pivotal component in the primary and secondary prevention of cardiovascular (CV) diseases,” they wrote, but because randomized trials usually exclude patients with serious clinical conditions, the precise role statins play for frail patients, such as those with polypharmacy, “is still unclear.”

The population-based cohort study examined 29,047 Italian residents aged 65 years and older who were receiving uninterrupted treatment with statins as well as blood pressure–lowering, antidiabetic, and antiplatelet agents over 16 months. The follow-up period was more than 3 years.

The cohort members were followed to identify those for whom statins were discontinued. Those who continued taking other therapies during the first 6 months after stopping statins were propensity score matched in a 1:1 ratio with patients who did not discontinue taking statins or other drugs. The patient pairs were then followed for fatal and nonfatal outcomes to estimate the risk associated with statin discontinuation.

Of the overall cohort exposed to polypharmacy, 5819 (20.0%) discontinued statins while continuing to take their other medications. Of those, 4,010 were matched with a comparator.

Compared with the maintaining group, those who discontinued statins had the following outcomes: an increased risk for hospital admissions for heart failure (hazard ratio, 1.24; 95% confidence interval, 1.07-1.43), any cardiovascular outcomes (HR, 1.14; 95% CI, 1.03-1.26), death from any cause (HR, 1.15; 95% CI, 1.02-1.30), and emergency admissions for any cause (HR, 1.12; 95% CI, 1.01-1.19)

The increased risk occurred in patients with mild or severe profiles, regardless of gender and whether statins were prescribed as primary or secondary CV prevention.

“We expected that the discontinuation of statins could reduce the risk of access to the emergency department for neurological causes, considered a proxy for the onset of episodes of delirium, [but] this was not observed, suggesting that statin therapy has essential benefits on the reduction of fatal/nonfatal cardiovascular events with no harm effect,” said Dr. Rea, “at least considering major adverse events like hospital and emergency department admissions.”
 

Findings no surprise

Neil Stone, MD, Bonow Professor of Medicine (Cardiology) and Preventive Medicine at Northwestern University, Chicago, said the study results aren’t surprising.

“Older patients have a higher absolute risk of dying, and withdrawing proven therapy shown to reduce risk of coronary/stroke events in randomized, controlled trials would be expected to result in more cardiovascular events,” Dr. Stone said.

Although polypharmacy is a concern for the elderly and is a factor in decreased adherence, he said better solutions are needed than withdrawing proven, effective therapy. “In that sense, this study indirectly supports more research in the use of polypills to address cardiovascular risk factors,” he said. Giving a single pill that combines medications of proven value in reducing blood pressure and cholesterol might be preferable to reducing the total number of medications.

Given the complexity of polypharmacy, the study investigators say more attention is needed from all health care professionals who care for elderly patients.

“We hope that future studies can shed light on the best way to balance the undeniable benefit of [statins] and the harms, especially among the elderly exposed to polypharmacy,” said Rea.

Further research is also needed into why statins are discontinued in the first place, added Dr. Stone. “We know that statins often are stopped due to symptoms that on further scrutiny may not be related to statin use.”

The study was funded by grants from Fondo d’Ateneo per la Ricerca and Modelling Effectiveness, Cost-effectiveness, and Promoting Health Care Value in the Real World: the Motive Project from the Italian Ministry of the Education, University, and Research. One coauthor served on the advisory board of Roche and has received grants from Bristol Myers Squibb, GlaxoSmithKline, and Novartis outside the submitted work. The other authors disclosed no relevant financial relationships.

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

Deprescribing may help in reducing inappropriate medication use and adverse events, but for cardiovascular care in the elderly, eliminating statins among patients taking other medications may have negative effects that far outweigh the benefits, a new study suggests.

In a large cohort study, researchers found that the withdrawal of statins from an elderly population receiving polypharmacy was associated with an increase in the risk for hospital admission for heart failure and any cardiovascular outcome, as well as death from any cause.

Statins are “lifesaving” drugs, and “according to the findings of our study, the discontinuation of this therapy has significant effects,” lead study author Federico Rea, PhD, research fellow, Laboratory of Healthcare Research and Pharmacoepidemiology, the department of statistics and quantitative methods, the University of Milano-Bicocca, said in an interview.

The article was published online June 14, 2021, in JAMA Network Open.

Negative clinical consequences, including adverse drug reactions leading to hospitalizations, are causing more physicians to consider deprescribing as a way to reduce problems associated with polypharmacy, the researchers noted.

Statins are “the most widely prescribed medication in the Western world, being a pivotal component in the primary and secondary prevention of cardiovascular (CV) diseases,” they wrote, but because randomized trials usually exclude patients with serious clinical conditions, the precise role statins play for frail patients, such as those with polypharmacy, “is still unclear.”

The population-based cohort study examined 29,047 Italian residents aged 65 years and older who were receiving uninterrupted treatment with statins as well as blood pressure–lowering, antidiabetic, and antiplatelet agents over 16 months. The follow-up period was more than 3 years.

The cohort members were followed to identify those for whom statins were discontinued. Those who continued taking other therapies during the first 6 months after stopping statins were propensity score matched in a 1:1 ratio with patients who did not discontinue taking statins or other drugs. The patient pairs were then followed for fatal and nonfatal outcomes to estimate the risk associated with statin discontinuation.

Of the overall cohort exposed to polypharmacy, 5819 (20.0%) discontinued statins while continuing to take their other medications. Of those, 4,010 were matched with a comparator.

Compared with the maintaining group, those who discontinued statins had the following outcomes: an increased risk for hospital admissions for heart failure (hazard ratio, 1.24; 95% confidence interval, 1.07-1.43), any cardiovascular outcomes (HR, 1.14; 95% CI, 1.03-1.26), death from any cause (HR, 1.15; 95% CI, 1.02-1.30), and emergency admissions for any cause (HR, 1.12; 95% CI, 1.01-1.19)

The increased risk occurred in patients with mild or severe profiles, regardless of gender and whether statins were prescribed as primary or secondary CV prevention.

“We expected that the discontinuation of statins could reduce the risk of access to the emergency department for neurological causes, considered a proxy for the onset of episodes of delirium, [but] this was not observed, suggesting that statin therapy has essential benefits on the reduction of fatal/nonfatal cardiovascular events with no harm effect,” said Dr. Rea, “at least considering major adverse events like hospital and emergency department admissions.”
 

Findings no surprise

Neil Stone, MD, Bonow Professor of Medicine (Cardiology) and Preventive Medicine at Northwestern University, Chicago, said the study results aren’t surprising.

“Older patients have a higher absolute risk of dying, and withdrawing proven therapy shown to reduce risk of coronary/stroke events in randomized, controlled trials would be expected to result in more cardiovascular events,” Dr. Stone said.

Although polypharmacy is a concern for the elderly and is a factor in decreased adherence, he said better solutions are needed than withdrawing proven, effective therapy. “In that sense, this study indirectly supports more research in the use of polypills to address cardiovascular risk factors,” he said. Giving a single pill that combines medications of proven value in reducing blood pressure and cholesterol might be preferable to reducing the total number of medications.

Given the complexity of polypharmacy, the study investigators say more attention is needed from all health care professionals who care for elderly patients.

“We hope that future studies can shed light on the best way to balance the undeniable benefit of [statins] and the harms, especially among the elderly exposed to polypharmacy,” said Rea.

Further research is also needed into why statins are discontinued in the first place, added Dr. Stone. “We know that statins often are stopped due to symptoms that on further scrutiny may not be related to statin use.”

The study was funded by grants from Fondo d’Ateneo per la Ricerca and Modelling Effectiveness, Cost-effectiveness, and Promoting Health Care Value in the Real World: the Motive Project from the Italian Ministry of the Education, University, and Research. One coauthor served on the advisory board of Roche and has received grants from Bristol Myers Squibb, GlaxoSmithKline, and Novartis outside the submitted work. The other authors disclosed no relevant financial relationships.

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

A software program based on artificial intelligence (AI) is effective for distinguishing young children with autism spectrum disorder (ASD) from those with other conditions, according to results of a pivotal trial presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

The AI-based software, which will be submitted to regulatory approval as a device, employs an algorithm that assembles inputs from a caregiver questionnaire, a video, and a clinician questionnaire, according to Sharief Taraman, MD, a pediatric neurologist at CHOC, a pediatric health care system in Orange County, Calif.

Although the device could be employed in a variety of settings, it is envisioned for use by primary care physicians. This will circumvent the need for specialist evaluation except in challenging cases. Currently, nearly all children with ASD are diagnosed in specialty care, according to data cited by Dr. Taraman.

“The lack of diagnostic tools for ASD in primary care settings contributes to an average delay of 3 years between first parental concern and diagnosis and to long wait lists for specialty evaluation,” he reported at the virtual meeting, presented by MedscapeLive.

When used with clinical judgment and criteria from the American Psychiatric Association’s 5th edition of the Diagnostic and Statistical Manual (DSM-5), the data from the trial suggest the diagnostic tool in the hands of primary care physicians “could efficiently and accurately assess ASD in children 18 to 72 months old,” said Dr. Taraman, also an associate clinical professor of pediatrics at the University of California, Irvine.*

The AI-assisted software was evaluated in 425 children at 14 sites in 6 states. The study population was reflective of U.S. demographics. Although only 36% of the children were female, this is consistent with ASD prevalence. Only 60% of the subjects were White. Nearly 30% were Black or Latinx and other populations, such as those of Asian heritage, were represented.

Children between the ages of 18 and 72 months were eligible if both a caregiver and a health care professional were concerned that the child had ASD. About the same time that a caregiver completed a 20-item questionnaire and the primary care physician completed a 15-item questionnaire on a mobile device, the caregiver uploaded two videos of 1-2 minutes in length.

This information, along with a 33-item questionnaire completed by an analyst of the submitted videos, was then processed by the software algorithm. It provided a patient status of positive or negative for ASD, or it concluded that the status was indeterminate.

“To reduce the risk of false classifications, the indeterminate status was included as a safety feature,” Dr. Taraman explained. However, Dr. Taraman considers an indeterminate designation potentially actionable. Rather than a negative result, this status suggests a complex neurodevelopmental disorder and indicates the need for further evaluation.

The reference standard diagnosis, completed in all participants in this study, was a specialist evaluation completed independently by two experts. The presence or absence of ASD was confirmed if the experts agreed. If they did not, a third specialist made the final determination.

On the basis of the software, there was a determinate result in 52% of the children. In comparison to the specialist determinations, all were correctly classified except for one child, in which the software was determined to have made a false-negative diagnosis. A diagnosis of ASD was reached in 29% of the study participants.

For those with a determinate designation, the sensitivity was 98.4% and the specificity was 78.9%. This translated into positive predictive and negative predictive values of 80.8% and 98.3%, respectively.

Of those identified as indeterminate by the AI-assisted algorithm, 91% were ultimately considered by specialist evaluation to have complex issues. In this group, ASD was part of the complex clinical picture in 20%. The others had non-ASD neurodevelopmental conditions, according to Dr. Taraman.

When the accuracy was evaluated across ages, ethnicity, and factors such as parent education or family income, the tool performed consistently, Dr. Taraman reported. This is important, he said, because the presence or absence of ASD is misdiagnosed in many underserved populations.

The focus on developing a methodology specific for use in primary care was based on evidence that the delay in the diagnosis of ASD is attributable to long wait times for specialty evaluations.

“There will never be enough specialists. There is a need for a way to streamline the diagnosis of ASD,” Dr. Taraman maintained. This is helpful not only to parents concerned about their children, he said, but also there are data to suggest that early intervention improves outcomes.

A specialist in ASD, Paul Carbone, MD, medical director of the child development program at the University of Utah, Salt Lake City, agreed. He said early diagnosis and intervention should be a goal.

“Reducing the age of ASD diagnosis is a priority because early entry into autism-specific interventions is a strong predictor of optimal developmental outcomes for children,” Dr. Carbone said.

Although he is not familiar with this experimental AI-assisted diagnostic program, he has published on the feasibility of ASD diagnosis at the primary care level. In his study, Dr. Carbone examined the Modified Checklist for Autism in Toddlers (M-CHAT) as one of several methodologies that might be considered.

Diagnosis of ASD “can be achieved through systematic processes within primary care that facilitate universal development surveillance and autism screening followed by prompt and timely diagnostic evaluations of at-risk children,” Dr. Carbone said.

MedscapeLive and this news organization are owned by the same parent company. Dr. Taraman reported a financial relationship with Cognoa, the company that is developing the ASD software for clinical use. Dr. Carbone reported that he has no conflicts of interest.

*Updated, 7/7/21

A software program based on artificial intelligence (AI) is effective for distinguishing young children with autism spectrum disorder (ASD) from those with other conditions, according to results of a pivotal trial presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

The AI-based software, which will be submitted to regulatory approval as a device, employs an algorithm that assembles inputs from a caregiver questionnaire, a video, and a clinician questionnaire, according to Sharief Taraman, MD, a pediatric neurologist at CHOC, a pediatric health care system in Orange County, Calif.

Although the device could be employed in a variety of settings, it is envisioned for use by primary care physicians. This will circumvent the need for specialist evaluation except in challenging cases. Currently, nearly all children with ASD are diagnosed in specialty care, according to data cited by Dr. Taraman.

“The lack of diagnostic tools for ASD in primary care settings contributes to an average delay of 3 years between first parental concern and diagnosis and to long wait lists for specialty evaluation,” he reported at the virtual meeting, presented by MedscapeLive.

When used with clinical judgment and criteria from the American Psychiatric Association’s 5th edition of the Diagnostic and Statistical Manual (DSM-5), the data from the trial suggest the diagnostic tool in the hands of primary care physicians “could efficiently and accurately assess ASD in children 18 to 72 months old,” said Dr. Taraman, also an associate clinical professor of pediatrics at the University of California, Irvine.*

The AI-assisted software was evaluated in 425 children at 14 sites in 6 states. The study population was reflective of U.S. demographics. Although only 36% of the children were female, this is consistent with ASD prevalence. Only 60% of the subjects were White. Nearly 30% were Black or Latinx and other populations, such as those of Asian heritage, were represented.

Children between the ages of 18 and 72 months were eligible if both a caregiver and a health care professional were concerned that the child had ASD. About the same time that a caregiver completed a 20-item questionnaire and the primary care physician completed a 15-item questionnaire on a mobile device, the caregiver uploaded two videos of 1-2 minutes in length.

This information, along with a 33-item questionnaire completed by an analyst of the submitted videos, was then processed by the software algorithm. It provided a patient status of positive or negative for ASD, or it concluded that the status was indeterminate.

“To reduce the risk of false classifications, the indeterminate status was included as a safety feature,” Dr. Taraman explained. However, Dr. Taraman considers an indeterminate designation potentially actionable. Rather than a negative result, this status suggests a complex neurodevelopmental disorder and indicates the need for further evaluation.

The reference standard diagnosis, completed in all participants in this study, was a specialist evaluation completed independently by two experts. The presence or absence of ASD was confirmed if the experts agreed. If they did not, a third specialist made the final determination.

On the basis of the software, there was a determinate result in 52% of the children. In comparison to the specialist determinations, all were correctly classified except for one child, in which the software was determined to have made a false-negative diagnosis. A diagnosis of ASD was reached in 29% of the study participants.

For those with a determinate designation, the sensitivity was 98.4% and the specificity was 78.9%. This translated into positive predictive and negative predictive values of 80.8% and 98.3%, respectively.

Of those identified as indeterminate by the AI-assisted algorithm, 91% were ultimately considered by specialist evaluation to have complex issues. In this group, ASD was part of the complex clinical picture in 20%. The others had non-ASD neurodevelopmental conditions, according to Dr. Taraman.

When the accuracy was evaluated across ages, ethnicity, and factors such as parent education or family income, the tool performed consistently, Dr. Taraman reported. This is important, he said, because the presence or absence of ASD is misdiagnosed in many underserved populations.

The focus on developing a methodology specific for use in primary care was based on evidence that the delay in the diagnosis of ASD is attributable to long wait times for specialty evaluations.

“There will never be enough specialists. There is a need for a way to streamline the diagnosis of ASD,” Dr. Taraman maintained. This is helpful not only to parents concerned about their children, he said, but also there are data to suggest that early intervention improves outcomes.

A specialist in ASD, Paul Carbone, MD, medical director of the child development program at the University of Utah, Salt Lake City, agreed. He said early diagnosis and intervention should be a goal.

“Reducing the age of ASD diagnosis is a priority because early entry into autism-specific interventions is a strong predictor of optimal developmental outcomes for children,” Dr. Carbone said.

Although he is not familiar with this experimental AI-assisted diagnostic program, he has published on the feasibility of ASD diagnosis at the primary care level. In his study, Dr. Carbone examined the Modified Checklist for Autism in Toddlers (M-CHAT) as one of several methodologies that might be considered.

Diagnosis of ASD “can be achieved through systematic processes within primary care that facilitate universal development surveillance and autism screening followed by prompt and timely diagnostic evaluations of at-risk children,” Dr. Carbone said.

MedscapeLive and this news organization are owned by the same parent company. Dr. Taraman reported a financial relationship with Cognoa, the company that is developing the ASD software for clinical use. Dr. Carbone reported that he has no conflicts of interest.

*Updated, 7/7/21

A software program based on artificial intelligence (AI) is effective for distinguishing young children with autism spectrum disorder (ASD) from those with other conditions, according to results of a pivotal trial presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

The AI-based software, which will be submitted to regulatory approval as a device, employs an algorithm that assembles inputs from a caregiver questionnaire, a video, and a clinician questionnaire, according to Sharief Taraman, MD, a pediatric neurologist at CHOC, a pediatric health care system in Orange County, Calif.

Although the device could be employed in a variety of settings, it is envisioned for use by primary care physicians. This will circumvent the need for specialist evaluation except in challenging cases. Currently, nearly all children with ASD are diagnosed in specialty care, according to data cited by Dr. Taraman.

“The lack of diagnostic tools for ASD in primary care settings contributes to an average delay of 3 years between first parental concern and diagnosis and to long wait lists for specialty evaluation,” he reported at the virtual meeting, presented by MedscapeLive.

When used with clinical judgment and criteria from the American Psychiatric Association’s 5th edition of the Diagnostic and Statistical Manual (DSM-5), the data from the trial suggest the diagnostic tool in the hands of primary care physicians “could efficiently and accurately assess ASD in children 18 to 72 months old,” said Dr. Taraman, also an associate clinical professor of pediatrics at the University of California, Irvine.*

The AI-assisted software was evaluated in 425 children at 14 sites in 6 states. The study population was reflective of U.S. demographics. Although only 36% of the children were female, this is consistent with ASD prevalence. Only 60% of the subjects were White. Nearly 30% were Black or Latinx and other populations, such as those of Asian heritage, were represented.

Children between the ages of 18 and 72 months were eligible if both a caregiver and a health care professional were concerned that the child had ASD. About the same time that a caregiver completed a 20-item questionnaire and the primary care physician completed a 15-item questionnaire on a mobile device, the caregiver uploaded two videos of 1-2 minutes in length.

This information, along with a 33-item questionnaire completed by an analyst of the submitted videos, was then processed by the software algorithm. It provided a patient status of positive or negative for ASD, or it concluded that the status was indeterminate.

“To reduce the risk of false classifications, the indeterminate status was included as a safety feature,” Dr. Taraman explained. However, Dr. Taraman considers an indeterminate designation potentially actionable. Rather than a negative result, this status suggests a complex neurodevelopmental disorder and indicates the need for further evaluation.

The reference standard diagnosis, completed in all participants in this study, was a specialist evaluation completed independently by two experts. The presence or absence of ASD was confirmed if the experts agreed. If they did not, a third specialist made the final determination.

On the basis of the software, there was a determinate result in 52% of the children. In comparison to the specialist determinations, all were correctly classified except for one child, in which the software was determined to have made a false-negative diagnosis. A diagnosis of ASD was reached in 29% of the study participants.

For those with a determinate designation, the sensitivity was 98.4% and the specificity was 78.9%. This translated into positive predictive and negative predictive values of 80.8% and 98.3%, respectively.

Of those identified as indeterminate by the AI-assisted algorithm, 91% were ultimately considered by specialist evaluation to have complex issues. In this group, ASD was part of the complex clinical picture in 20%. The others had non-ASD neurodevelopmental conditions, according to Dr. Taraman.

When the accuracy was evaluated across ages, ethnicity, and factors such as parent education or family income, the tool performed consistently, Dr. Taraman reported. This is important, he said, because the presence or absence of ASD is misdiagnosed in many underserved populations.

The focus on developing a methodology specific for use in primary care was based on evidence that the delay in the diagnosis of ASD is attributable to long wait times for specialty evaluations.

“There will never be enough specialists. There is a need for a way to streamline the diagnosis of ASD,” Dr. Taraman maintained. This is helpful not only to parents concerned about their children, he said, but also there are data to suggest that early intervention improves outcomes.

A specialist in ASD, Paul Carbone, MD, medical director of the child development program at the University of Utah, Salt Lake City, agreed. He said early diagnosis and intervention should be a goal.

“Reducing the age of ASD diagnosis is a priority because early entry into autism-specific interventions is a strong predictor of optimal developmental outcomes for children,” Dr. Carbone said.

Although he is not familiar with this experimental AI-assisted diagnostic program, he has published on the feasibility of ASD diagnosis at the primary care level. In his study, Dr. Carbone examined the Modified Checklist for Autism in Toddlers (M-CHAT) as one of several methodologies that might be considered.

Diagnosis of ASD “can be achieved through systematic processes within primary care that facilitate universal development surveillance and autism screening followed by prompt and timely diagnostic evaluations of at-risk children,” Dr. Carbone said.

MedscapeLive and this news organization are owned by the same parent company. Dr. Taraman reported a financial relationship with Cognoa, the company that is developing the ASD software for clinical use. Dr. Carbone reported that he has no conflicts of interest.

*Updated, 7/7/21

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

--

Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

--

Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

--

Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

--

Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

--

Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

--

Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Key clinical point: The use of antitumor necrosis factor (anti-TNF) therapy was associated with an increased risk for herpes zoster (HZ) in patients with inflammatory bowel disease (IBD).

Major finding: Compared with nonuse, current use of anti-TNF therapy was associated with an increased risk for HZ (adjusted odds ratio [aOR], 1.5; 95% confidence interval [CI], 1.1-2.1), particularly in patients below 50 years of age (aOR, 2.0; 95% CI, 1.2-3.5) and those additionally using steroids and immunosuppressants (aOR, 4.1; 95% CI, 2.3-7.2).

Study details: This was a nested case-control study of 15,454 patients with incident IBD. Patients diagnosed with HZ (n=824) were matched with 8,240 HZ-free controls.

Disclosures: The study was supported by the Division of Gastroenterology and Hepatology McGill University health center. Some of the authors reported serving as a speaker, advisory board member, and/or receiving unrestricted research grants from various sources.

Source: Santella C et al. Inflamm Bowel Dis. 2021 May 17. doi: 10.1093/ibd/izab092.

Key clinical point: The use of antitumor necrosis factor (anti-TNF) therapy was associated with an increased risk for herpes zoster (HZ) in patients with inflammatory bowel disease (IBD).

Major finding: Compared with nonuse, current use of anti-TNF therapy was associated with an increased risk for HZ (adjusted odds ratio [aOR], 1.5; 95% confidence interval [CI], 1.1-2.1), particularly in patients below 50 years of age (aOR, 2.0; 95% CI, 1.2-3.5) and those additionally using steroids and immunosuppressants (aOR, 4.1; 95% CI, 2.3-7.2).

Study details: This was a nested case-control study of 15,454 patients with incident IBD. Patients diagnosed with HZ (n=824) were matched with 8,240 HZ-free controls.

Disclosures: The study was supported by the Division of Gastroenterology and Hepatology McGill University health center. Some of the authors reported serving as a speaker, advisory board member, and/or receiving unrestricted research grants from various sources.

Source: Santella C et al. Inflamm Bowel Dis. 2021 May 17. doi: 10.1093/ibd/izab092.

Key clinical point: The use of antitumor necrosis factor (anti-TNF) therapy was associated with an increased risk for herpes zoster (HZ) in patients with inflammatory bowel disease (IBD).

Major finding: Compared with nonuse, current use of anti-TNF therapy was associated with an increased risk for HZ (adjusted odds ratio [aOR], 1.5; 95% confidence interval [CI], 1.1-2.1), particularly in patients below 50 years of age (aOR, 2.0; 95% CI, 1.2-3.5) and those additionally using steroids and immunosuppressants (aOR, 4.1; 95% CI, 2.3-7.2).

Study details: This was a nested case-control study of 15,454 patients with incident IBD. Patients diagnosed with HZ (n=824) were matched with 8,240 HZ-free controls.

Disclosures: The study was supported by the Division of Gastroenterology and Hepatology McGill University health center. Some of the authors reported serving as a speaker, advisory board member, and/or receiving unrestricted research grants from various sources.

Source: Santella C et al. Inflamm Bowel Dis. 2021 May 17. doi: 10.1093/ibd/izab092.

Key clinical point: Obesity among patients with inflammatory bowel disease (IBD) was associated with significantly higher all-cause early readmission than nonobese patients with IBD.

Major finding: Independent association was observed between obesity and higher all-cause readmission rates at 30 days (adjusted odds ratio [aOR], 1.16; P = .005) and 90 days (aOR, 1.27; P less than .0001) compared with those without obesity.

Study details: Findings are from a retrospective cohort study of 143,190 patients hospitalized with IBD, of which 9.1% of patients were obese (body mass index [BMI], 30 kg/m² or higher) and the remaining 90.9% were nonobese (BMI less than 30 kg/m²).

Disclosures: No funding information was reported. The authors had no financial disclosures and conflicts of interest relevant to this article.

Source: Weissman S et al. J Crohns Colitis. 2021 May 17. doi: 10.1093/ecco-jcc/jjab088.

Key clinical point: Obesity among patients with inflammatory bowel disease (IBD) was associated with significantly higher all-cause early readmission than nonobese patients with IBD.

Major finding: Independent association was observed between obesity and higher all-cause readmission rates at 30 days (adjusted odds ratio [aOR], 1.16; P = .005) and 90 days (aOR, 1.27; P less than .0001) compared with those without obesity.

Study details: Findings are from a retrospective cohort study of 143,190 patients hospitalized with IBD, of which 9.1% of patients were obese (body mass index [BMI], 30 kg/m² or higher) and the remaining 90.9% were nonobese (BMI less than 30 kg/m²).

Disclosures: No funding information was reported. The authors had no financial disclosures and conflicts of interest relevant to this article.

Source: Weissman S et al. J Crohns Colitis. 2021 May 17. doi: 10.1093/ecco-jcc/jjab088.

Key clinical point: Obesity among patients with inflammatory bowel disease (IBD) was associated with significantly higher all-cause early readmission than nonobese patients with IBD.

Major finding: Independent association was observed between obesity and higher all-cause readmission rates at 30 days (adjusted odds ratio [aOR], 1.16; P = .005) and 90 days (aOR, 1.27; P less than .0001) compared with those without obesity.

Study details: Findings are from a retrospective cohort study of 143,190 patients hospitalized with IBD, of which 9.1% of patients were obese (body mass index [BMI], 30 kg/m² or higher) and the remaining 90.9% were nonobese (BMI less than 30 kg/m²).

Disclosures: No funding information was reported. The authors had no financial disclosures and conflicts of interest relevant to this article.

Source: Weissman S et al. J Crohns Colitis. 2021 May 17. doi: 10.1093/ecco-jcc/jjab088.

Key clinical point: Hyperbaric oxygen therapy (HBOT) was safe and associated with substantial rates of clinical remission in patients with various inflammatory bowel disease (IBD) phenotypes refractory to conventional therapies.

Major finding: HBOT resulted in substantial rates of clinical remission across multiple IBD phenotypes including ulcerative colitis (67%; 95% confidence interval [CI], 39%-86%), luminal Crohn’s disease (CD; 87.5%; 95% CI, 46.3%-98.3%), perianal CD (55%; 95% CI, 44%-65%), inflammatory disorders of the pouch (31%; 95% CI, 16%-50%), pyoderma gangrenosum (91.7%; 95% CI, 37.8%-99.5%), and perianal sinus/metastatic CD (65.2%; 95% CI, 10%-96.9%). Overall, 15% of patients reported minor adverse events.

Study details: Data come from a systematic review and proportional meta-analysis of 19 studies.

Disclosures: No information on funding was available. Some of the authors disclosed receiving consultancy fees and/or honoraria from multiple sources. All other authors had no conflicts of interest to disclose.

Source: McCurdy J et al. Inflamm Bowel Dis. 2021 May 18. doi: 10.1093/ibd/izab098.

Key clinical point: Hyperbaric oxygen therapy (HBOT) was safe and associated with substantial rates of clinical remission in patients with various inflammatory bowel disease (IBD) phenotypes refractory to conventional therapies.

Major finding: HBOT resulted in substantial rates of clinical remission across multiple IBD phenotypes including ulcerative colitis (67%; 95% confidence interval [CI], 39%-86%), luminal Crohn’s disease (CD; 87.5%; 95% CI, 46.3%-98.3%), perianal CD (55%; 95% CI, 44%-65%), inflammatory disorders of the pouch (31%; 95% CI, 16%-50%), pyoderma gangrenosum (91.7%; 95% CI, 37.8%-99.5%), and perianal sinus/metastatic CD (65.2%; 95% CI, 10%-96.9%). Overall, 15% of patients reported minor adverse events.

Study details: Data come from a systematic review and proportional meta-analysis of 19 studies.

Disclosures: No information on funding was available. Some of the authors disclosed receiving consultancy fees and/or honoraria from multiple sources. All other authors had no conflicts of interest to disclose.

Source: McCurdy J et al. Inflamm Bowel Dis. 2021 May 18. doi: 10.1093/ibd/izab098.

Key clinical point: Hyperbaric oxygen therapy (HBOT) was safe and associated with substantial rates of clinical remission in patients with various inflammatory bowel disease (IBD) phenotypes refractory to conventional therapies.

Major finding: HBOT resulted in substantial rates of clinical remission across multiple IBD phenotypes including ulcerative colitis (67%; 95% confidence interval [CI], 39%-86%), luminal Crohn’s disease (CD; 87.5%; 95% CI, 46.3%-98.3%), perianal CD (55%; 95% CI, 44%-65%), inflammatory disorders of the pouch (31%; 95% CI, 16%-50%), pyoderma gangrenosum (91.7%; 95% CI, 37.8%-99.5%), and perianal sinus/metastatic CD (65.2%; 95% CI, 10%-96.9%). Overall, 15% of patients reported minor adverse events.

Study details: Data come from a systematic review and proportional meta-analysis of 19 studies.

Disclosures: No information on funding was available. Some of the authors disclosed receiving consultancy fees and/or honoraria from multiple sources. All other authors had no conflicts of interest to disclose.

Source: McCurdy J et al. Inflamm Bowel Dis. 2021 May 18. doi: 10.1093/ibd/izab098.

Key clinical point: In patients with inflammatory bowel disease (IBD), multiple successive switching from originator infliximab (IFX) to biosimilars (CT-P13 and SB2) was effective and safe, particularly if patients were in remission during the switch.

Major finding: At 12 months after the most recent switch, 76.9%, 65.7%, and 76.9% of patients successively switching from IFX to CT-P13 and then to SB2, from CT-P13 to SB2, and from IFX to CT-P13, respectively, were in clinical remission. Rate of clinical remission (P = .375), C-reactive protein (P = .582), and fecal calprotectin remission (P = .641) was not significantly different between the 3 groups. Overall, infusion reactions occurred in 1.7% of patients.

Study details: Data come from a multicenter prospective cohort study of 176 patients with IBD who switched from originator IFX to CT-P13 and then to SB2 (n=69), from CT-P13 to SB2 (n=80), or from IFX to CT-P13 (n=27).

Disclosures: No information on funding was available. Some of the authors reported serving on advisory boards or as a speaker or consultant for and receiving speaker’s fees, consultancy fees, and/or honoraria from multiple sources.

Source: Hanzel J et al. Inflamm Bowel Dis. 2021 May 20. doi: 10.1093/ibd/izab099.

Key clinical point: In patients with inflammatory bowel disease (IBD), multiple successive switching from originator infliximab (IFX) to biosimilars (CT-P13 and SB2) was effective and safe, particularly if patients were in remission during the switch.

Major finding: At 12 months after the most recent switch, 76.9%, 65.7%, and 76.9% of patients successively switching from IFX to CT-P13 and then to SB2, from CT-P13 to SB2, and from IFX to CT-P13, respectively, were in clinical remission. Rate of clinical remission (P = .375), C-reactive protein (P = .582), and fecal calprotectin remission (P = .641) was not significantly different between the 3 groups. Overall, infusion reactions occurred in 1.7% of patients.

Study details: Data come from a multicenter prospective cohort study of 176 patients with IBD who switched from originator IFX to CT-P13 and then to SB2 (n=69), from CT-P13 to SB2 (n=80), or from IFX to CT-P13 (n=27).

Disclosures: No information on funding was available. Some of the authors reported serving on advisory boards or as a speaker or consultant for and receiving speaker’s fees, consultancy fees, and/or honoraria from multiple sources.

Source: Hanzel J et al. Inflamm Bowel Dis. 2021 May 20. doi: 10.1093/ibd/izab099.

Key clinical point: In patients with inflammatory bowel disease (IBD), multiple successive switching from originator infliximab (IFX) to biosimilars (CT-P13 and SB2) was effective and safe, particularly if patients were in remission during the switch.

Major finding: At 12 months after the most recent switch, 76.9%, 65.7%, and 76.9% of patients successively switching from IFX to CT-P13 and then to SB2, from CT-P13 to SB2, and from IFX to CT-P13, respectively, were in clinical remission. Rate of clinical remission (P = .375), C-reactive protein (P = .582), and fecal calprotectin remission (P = .641) was not significantly different between the 3 groups. Overall, infusion reactions occurred in 1.7% of patients.

Study details: Data come from a multicenter prospective cohort study of 176 patients with IBD who switched from originator IFX to CT-P13 and then to SB2 (n=69), from CT-P13 to SB2 (n=80), or from IFX to CT-P13 (n=27).

Disclosures: No information on funding was available. Some of the authors reported serving on advisory boards or as a speaker or consultant for and receiving speaker’s fees, consultancy fees, and/or honoraria from multiple sources.

Source: Hanzel J et al. Inflamm Bowel Dis. 2021 May 20. doi: 10.1093/ibd/izab099.