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More Evidence PTSD Tied to Obstructive Sleep Apnea Risk
Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.
“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”
The study was published online in JAMA Network Open.
A More Rigorous Evaluation
“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.
The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.
PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.
The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO2 less than 90% was 8.9%.
In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO2 less than 90%.
A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).
The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.
“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
Questions Remain
In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”
However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.
Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.
“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.
“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.
In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.
“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.
The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.
“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”
The study was published online in JAMA Network Open.
A More Rigorous Evaluation
“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.
The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.
PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.
The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO2 less than 90% was 8.9%.
In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO2 less than 90%.
A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).
The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.
“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
Questions Remain
In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”
However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.
Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.
“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.
“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.
In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.
“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.
The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said.
“The strength of the association was a bit surprising,” said study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, Georgia. “Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings.”
The study was published online in JAMA Network Open.
A More Rigorous Evaluation
“Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong,” Dr. Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis.
The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study.
PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%.
The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO2 less than 90% was 8.9%.
In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO2 less than 90%.
A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4).
The investigators called for more research into the underlying mechanisms but speculated that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role.
“Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity,” Dr. Shah said. “We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans.”
Questions Remain
In an accompanying editorial, Steven H. Woodward, PhD, and Ruth M. Benca, MD, PhD, VA Palo Alto Health Care Systems, Palo Alto, California, noted the study affirmatively answers the decades-old question of whether rates of OSA are elevated in PTSD and “eliminates many potential confounders that might cast doubt on the PTSD-OSA association.”
However, they noted, it’s difficult to ascertain the directionality of this association and point out that, in terms of potential mechanisms, the oft-cited 1994 study linking sleep fragmentation with upper airway collapsibility has never been replicated and that a recent study found no difference in airway collapsibility or evidence of differential loop gain in combat veterans with and without PTSD.
Dr. Woodward and Dr. Benca also highlighted the large body of evidence that psychiatric disorders such as bipolar disorder, schizophrenia, and, in particular, major depressive disorder, are strongly associated with higher rates of OSA.
“In sum, we do not believe that a fair reading of the current literature supports a conclusion that PTSD bears an association with OSA that does not overlap with those manifested by other psychiatric disorders,” they wrote.
“This commentary is not intended to discourage any specific line of inquiry. Rather, we seek to keep the door open as wide as possible to hypotheses and research designs aimed at elucidating the relationships between OSA and psychiatric disorders,” Dr. Woodward and Dr. Benca concluded.
In response, Dr. Shah said the editorialists’ “point about psychiatric conditions other than PTSD also being important in OSA is well taken. In our own cohort, we did not see such an association, but that does not mean that this does not exist.
“Autonomic physiology, which we plan to study next, may underlie not only the PTSD-OSA relationship but also the relationship between other psychiatric factors and OSA,” he added.
The study was funded by grants from the National Institutes of Health (NIH). One study author reported receiving personal fees from Idorsia, and another reported receiving personal fees from Clinilabs, Eisai, Ferring Pharmaceuticals, Huxley, Idorsia, and Merck Sharp & Dohme. Dr. Benca reported receiving grants from the NIH and Eisai and personal fees from Eisai, Idorsia, Haleon, and Sage Therapeutics. Dr. Woodward reported having no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
New Insight Into CVD, Stroke Risk in Migraine
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
SAN DIEGO – Researchers are unraveling the complex relationship between cardiovascular (CV)- and stroke-related outcomes in migraine with, and without, aura.
“We confirmed that aura increases the risk for these cerebrovascular and cardiovascular outcomes in people with migraine and that there’s an increased risk of these MACE events in men with migraine,” said study investigator Gina Dumkrieger, PhD, principal data science analyst and assistant professor of neurology, Mayo Clinic, Phoenix, Arizona.
The findings were presented at the annual meeting of the American Headache Society.
Few Data on Migraine and Stroke Risk
The extent to which migraine increases the risk for stroke CV outcomes has not been extensively studied.
“We’re trying to find out whether migraine-related factors make it more likely that you’re going to have one of these events,” said Dr. Dumkrieger. “Knowing a particular factor increases the risk is something patients and medical providers would want to know.”
Using Mayo Clinic electronic health records, which cover all three sites (Florida, Minnesota, and Arizona), researchers identified individuals with migraine using diagnostic codes. They also looked at data on sex, race, and the presence of aura.
They investigated whether a history of MACE risk factors — including atrial fibrillation, diabetes, hyperlipidemia, hypertension, and tobacco use — affected risk and the potential interaction of aura with these risk factors.
MACE events included cerebral infarction, intracerebral hemorrhage, and acute myocardial infarction.
The analysis included 130,126 participants (80% women, 95% White individuals). Of these, 6% experienced a MACE event, and 94% did not.
“We confirmed that aura does increase the risk for a MACE event, and all of the known risk factors that we included were also significant,” said Dr. Dumkrieger.
Odds ratios (ORs) were 3.82 for atrial fibrillation, 3.11 for hypertension, and 3.06 for hyperlipidemia.
It was surprising, said Dr. Dumkrieger, that male sex was tied to an increased risk for a MACE event (OR, 1.40). “This is not something that was known before,” she said.
The link between migraine and ischemic stroke, particularly with aura, was stronger in women — particularly young women.
Investigators also found an interaction between male sex and aura, when it comes to MACE outcomes, said Dr. Dumkrieger. “Males in general are at higher risk, and people with aura are at higher risk. Males with aura are also at higher risk, but maybe not as much as you would think they would be. It’s not a purely additive thing. This is something we need to look into more,” she said.
The study also revealed an interaction between aura and hypertension as well as aura and tobacco use, but here too, it was not an additive risk, said Dr. Dumkrieger. However, she added, the presence of aura does not moderate the risk for hyperlipidemia, diabetes, or atrial fibrillation.
The research also showed a significant interaction between male sex and Black race which was additive. “There’s apparently increased risk if you are male and Black or African American that’s greater than what you would expect. We should be especially concerned about these individuals,” she said.
Unanswered Questions
The current analysis is part of a larger study that will more closely examine these relationships. “We want to learn, for example, why aura moderates some of the risk factors but not others,” said Dr. Dumkrieger.
The researchers also plan to investigate other migraine features, including headache frequency, and headache sensations such as pulsating or throbbing.
Dr. Dumkrieger was an investigator of another study, also presented at the AHS meeting, that’s investigating the role of migraine-specific features and imaging results in the complex interrelationship between migraine and MACE risk.
That study, which also used the Mayo Clinic electronic health record data, included 60,454 migraine patients diagnosed with migraine after 2010.
Researchers divided participants into those with a MACE outcome (1107) and those without such an outcome (59,347) after at least 2 years of follow-up. They created a propensity cohort of individuals matched for age and risk factors for MACE outcome.
The final cohort consisted of 575 patients with and 652 patients without MACE outcome.
One of the most interesting early results from this study was that those with a MACE outcome had significantly more white matter hyperintensities than those with no MACE outcome, at 64% versus 51%, respectively.
This and other findings need to be validated in a different cohort with an electronic health records database from another institution. In future, the team plans to focus on identifying specific migraine features and medications and their relative contributions to MACE risk in migraine patients.
Yet another study featured at the AHS meeting confirmed the increased risk for stroke among migraine patients using a large database with over 410,000 subjects.
Results showed stroke was more than three times more common in those with a migraine diagnosis than in those without (risk ratio, [RR] 3.23; P < .001). The RR for hemorrhagic stroke (3.15) was comparable with that of ischemic stroke (3.20).
The overall stroke RR for chronic migraine versus controls without migraine was 3.68 (P < .001). The RR for migraine with aura versus migraine without aura was 1.37 (P < .001).
Useful Data
Commenting on the research, Juliana VanderPluym, MD, a headache specialist at the Mayo Clinic, Phoenix, Arizona, described this new information as “very useful.”
The fact that there are more white matter lesions on MRI scans in migraine patients with MACE needs further exploration, said Dr. VanderPluym.
“Understanding how much of that relates to migraine, how much relates to other comorbid conditions, and what this all means together, is very important, particularly because MACE can be life-threatening and life-altering,” she added.
Learning how migraine medications may impact MACE risk is also something that needs to be examined in greater depth, she said. “I would think that migraines that are controlled might have a different risk for MACE than uncontrolled migraine,” she said.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM AHS 2024
Frequent or Severe Flares Linked to Increased Atopic Dermatitis Severity
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source
Frequent or Severe Flares Linked to Increased Atopic Dermatitis Severity
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source
Key clinical point: Patients with atopic dermatitis (AD) who had many or severe flares were more likely to report higher disease severity and impairment in quality of life than those who had no or few flares.
Major finding: Patients with 1-5, 6-10, or >10 flares had higher median Patient-Oriented SCORing for Atopic Dermatitis (29.7, 36.3, and 42.9, respectively) and Dermatology Life Quality Index (3, 4, and 7, respectively) scores than those without flares.
Study details: This Danish population-based study included 1557 patients with AD who had 0 (n = 57), 1-5 (n = 698), 6-10 (n = 324), or >10 (n = 478) flares during the past 12 months.
Disclosures: The study was funded by Almirall S.A., Barcelona, Spain. Three authors declared being employees of Almirall, whereas the remaining authors reported having various ties with Almirall and other sources.
Source: Nielsen M-L, Nymand LK, Domenech Pena A, et al. Characterization of patients with atopic dermatitis based on flare patterns and severity of disease: A Danish population-based study. J Eur Acad Dermatol Venereol. 2024 (May 30). doi: 10.1111/jdv.20160 Source
Study Shows Bidirectional Association Between Polycystic Ovary Syndrome and Atopic Dermatitis
Key clinical point: Patients with polycystic ovary syndrome (PCOS) had a significantly increased risk for atopic dermatitis (AD), and patients with AD had a significantly increased risk for PCOS.
Major finding: The risk of developing AD was significantly higher in patients with PCOS (adjusted odds ratio [aOR] 1.99; P < .001) than in control participants. Similarly, the risk of developing PCOS was significantly higher in patients with AD (aOR 1.86; P < .001) than in control participants.
Study details: This nested case-control study included 3234 participants with PCOS who were matched with 12,936 control participants without PCOS using nearest-neighbor propensity-score matching, of whom 293 (4.55%) with PCOS and 588 (9.06%) without PCOS had AD.
Disclosures: This study did not disclose any source of funding. The authors declared no conflicts of interest.
Source: Kim IH, Andrade LF, Haq Z, et al. Association of polycystic ovary syndrome with atopic dermatitis: A case control study. Arch Dermatol Res. 2024;316:258. doi: 10.1007/s00403-024-03102-0 Source
Key clinical point: Patients with polycystic ovary syndrome (PCOS) had a significantly increased risk for atopic dermatitis (AD), and patients with AD had a significantly increased risk for PCOS.
Major finding: The risk of developing AD was significantly higher in patients with PCOS (adjusted odds ratio [aOR] 1.99; P < .001) than in control participants. Similarly, the risk of developing PCOS was significantly higher in patients with AD (aOR 1.86; P < .001) than in control participants.
Study details: This nested case-control study included 3234 participants with PCOS who were matched with 12,936 control participants without PCOS using nearest-neighbor propensity-score matching, of whom 293 (4.55%) with PCOS and 588 (9.06%) without PCOS had AD.
Disclosures: This study did not disclose any source of funding. The authors declared no conflicts of interest.
Source: Kim IH, Andrade LF, Haq Z, et al. Association of polycystic ovary syndrome with atopic dermatitis: A case control study. Arch Dermatol Res. 2024;316:258. doi: 10.1007/s00403-024-03102-0 Source
Key clinical point: Patients with polycystic ovary syndrome (PCOS) had a significantly increased risk for atopic dermatitis (AD), and patients with AD had a significantly increased risk for PCOS.
Major finding: The risk of developing AD was significantly higher in patients with PCOS (adjusted odds ratio [aOR] 1.99; P < .001) than in control participants. Similarly, the risk of developing PCOS was significantly higher in patients with AD (aOR 1.86; P < .001) than in control participants.
Study details: This nested case-control study included 3234 participants with PCOS who were matched with 12,936 control participants without PCOS using nearest-neighbor propensity-score matching, of whom 293 (4.55%) with PCOS and 588 (9.06%) without PCOS had AD.
Disclosures: This study did not disclose any source of funding. The authors declared no conflicts of interest.
Source: Kim IH, Andrade LF, Haq Z, et al. Association of polycystic ovary syndrome with atopic dermatitis: A case control study. Arch Dermatol Res. 2024;316:258. doi: 10.1007/s00403-024-03102-0 Source
Maintenance Optimization in Abrocitinib Induction Responders With Atopic Dermatitis
Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.
Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.
Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.
Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.
Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 Source
Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.
Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.
Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.
Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.
Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 Source
Key clinical point: Patients with moderate to severe atopic dermatitis (AD) who initially responded to a 12-week induction with 200 mg abrocitinib had a low risk for flares during the 40-week maintenance period, irrespective of whether the dose was continued or stepped down to 100 mg.
Major finding: The range of probabilities of not flaring were 6%-82%, 31%-92%, and 14%-34% in patients who received 100 mg abrocitinib, 200 mg abrocitinib, and placebo, respectively. An increased percentage change in the Eczema Area and Severity Index score from baseline to randomization and an Investigator's Global Assessment score of 0 at randomization (both P < .001) were predictors of not flaring.
Study details: This post hoc analysis of the JADE REGIMEN trial included 798 patients with moderate to severe AD who responded to 200 mg abrocitinib induction therapy and were randomly assigned to receive abrocitinib (200 or 100 mg) or placebo during the maintenance period.
Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and shareholders of Pfizer Inc. Other authors declared having other ties with various sources, including Pfizer Inc.
Source: Thyssen JP, Silverberg JI, Ruano J, et al. Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. J Eur Acad Dermatol Venereol. 2024 (May 16). doi: 10.1111/jdv.20095 Source
High Prevalence of Overweight or Obesity in Children With Atopic Dermatitis
Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.
Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD (OR 20.4; P < .001) vs those with mild AD.
Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).
Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.
Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source
Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.
Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD (OR 20.4; P < .001) vs those with mild AD.
Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).
Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.
Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source
Key clinical point: Children with atopic dermatitis (AD) have a significantly higher likelihood of increased body mass index (BMI) corresponding to overweight or obesity, with a positive correlation observed between increased BMI and AD severity.
Major finding: Patients with AD had a three times higher risk for overweight (odds ratio [OR] 3.61; P < .01) and a six times higher risk for obesity (OR 6.61; P < .05) than control participants. Furthermore, the risk for overweight or obesity was almost 20 times higher in patients with moderate to severe AD (OR 20.4; P < .001) vs those with mild AD.
Study details: This retrospective case-control study included 130 children with AD and 130 age- and sex-matched control participants who were categorized according to their BMI and nutritional status as underweight (percentile < 5), normal weight (percentile 5-84), overweight (percentile 85-94), or obese (percentile ≥ 95).
Disclosures: The authors did not disclose any source of funding. The authors declared no conflicts of interest.
Source: Sendrea AM, Cristea S, Salavastru CM. Association between increased body mass index (BMI) and atopic dermatitis in children attending a tertiary referral center: A case-control study. Cureus. 2024;16:e60770. doi: 10.7759/cureus.60770 Source
Tapinarof Effective and Well-Tolerated in Adults and Children With Atopic Dermatitis
Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).
Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.
Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.
Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.
Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi: 10.1016/j.jaad.2024.05.023 Source
Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).
Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.
Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.
Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.
Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi: 10.1016/j.jaad.2024.05.023 Source
Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).
Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.
Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.
Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.
Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi: 10.1016/j.jaad.2024.05.023 Source
Tapinarof Effective and Well-Tolerated in Adults and Children With Atopic Dermatitis
Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).
Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.
Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.
Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.
Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi: 10.1016/j.jaad.2024.05.023 Source
Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).
Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.
Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.
Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.
Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi: 10.1016/j.jaad.2024.05.023 Source
Key clinical point: Topical 1% tapinarof showed significant clinical efficacy and favorable safety and tolerability in adults and children age 2 years or older with moderate to severe atopic dermatitis (AD).
Major finding: At 8 weeks, a significantly higher proportion of patients treated with tapinarof vs vehicle achieved a Validated Investigator Global Assessment for Atopic Dermatitis™ score of 0 or 1 and ≥2-grade improvement from baseline in ADORING 1 (45.4% vs 13.9%) and ADORING 2 (46.4% vs 18.0%) trials (both P < .0001). Few serious treatment-emergent adverse events were reported; rates of discontinuation due to adverse events were lower with tapinarof compared to vehicle.
Study details: The phase 3 ADORING 1 (n = 407) and 2 (n = 406) trials included adults and children age 2 years or older with moderate to severe AD who were randomly assigned to receive 1% tapinarof cream or vehicle once daily for 8 weeks.
Disclosures: This study was supported by Dermavant Sciences, Inc. Five authors declared being employees of or holding stock options in Dermavant Sciences. Several authors declared having other ties with various sources, including Dermavant Sciences.
Source: Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 (May 20). doi: 10.1016/j.jaad.2024.05.023 Source
BMI May Influence Short-Term Therapeutic Response to Dupilumab in Adults With Atopic Dermatitis
Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.
Major finding: At week 16, patients with BMI ≥ 25 kg/m2 vs those with BMI < 25 kg/m2 showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.
Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m2 or ≥ 25 kg/m2 who received dupilumab.
Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.
Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source
Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.
Major finding: At week 16, patients with BMI ≥ 25 kg/m2 vs those with BMI < 25 kg/m2 showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.
Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m2 or ≥ 25 kg/m2 who received dupilumab.
Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.
Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source
Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.
Major finding: At week 16, patients with BMI ≥ 25 kg/m2 vs those with BMI < 25 kg/m2 showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.
Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m2 or ≥ 25 kg/m2 who received dupilumab.
Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.
Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source