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Asthma hospitalization in kids linked with doubled migraine incidence
when compared with a similar pediatric population without asthma. The finding is based on an analysis of more than 11 million U.S. pediatric hospitalizations over the course of a decade.
Among children and adolescents aged 3-21 years who were hospitalized for asthma, migraine rates were significantly higher among girls, adolescents, and whites, compared with boys, children aged 12 years or younger, and nonwhites, respectively, in a trio of adjusted analyses, Riddhiben S. Patel, MD, and associates reported in a poster at the annual meeting of the American Headache Society.
“Our hope is that, by establishing an association between childhood asthma and migraine, [these children] may be more easily screened for, diagnosed, and treated early by providers,” wrote Dr. Patel, a pediatric neurologist and headache specialist at the University of Mississippi, Jackson, and associates.
Their analysis used administrative billing data collected by the Kids’ Inpatient Database, maintained by the U.S. Healthcare Cost and Utilization Project. The project includes a representative national sample of about 3 million pediatric hospital discharges every 3 years. The study used data from 11,483,103 hospitalizations of children and adolescents aged 3-21 years during 2003, 2006, 2009, and 2012, and found an overall hospitalization rate of 0.8% billed for migraine. For patients also hospitalized with a billing code for asthma, the rate jumped to 1.36%, a 120% statistically significant relative increase in migraine hospitalizations after adjustment for baseline demographic differences, the researchers said.
Among the children and adolescents hospitalized with an asthma billing code, the relative rate of also having a billing code for migraine after adjustment was a statistically significant 80% higher in girls, compared with boys, a statistically significant 7% higher in adolescents, compared with children 12 years or younger, and was significantly reduced by a relative 45% rate in nonwhites, compared with whites.
The mechanisms behind these associations are not known, but could involve mast-cell degranulation, autonomic dysfunction, or shared genetic or environmental etiologic factors, the authors said.
Dr. Patel reported no relevant disclosures.
SOURCE: Patel RS et al. Headache. 2019 June;59[S1]:1-208, Abstract P78.
when compared with a similar pediatric population without asthma. The finding is based on an analysis of more than 11 million U.S. pediatric hospitalizations over the course of a decade.
Among children and adolescents aged 3-21 years who were hospitalized for asthma, migraine rates were significantly higher among girls, adolescents, and whites, compared with boys, children aged 12 years or younger, and nonwhites, respectively, in a trio of adjusted analyses, Riddhiben S. Patel, MD, and associates reported in a poster at the annual meeting of the American Headache Society.
“Our hope is that, by establishing an association between childhood asthma and migraine, [these children] may be more easily screened for, diagnosed, and treated early by providers,” wrote Dr. Patel, a pediatric neurologist and headache specialist at the University of Mississippi, Jackson, and associates.
Their analysis used administrative billing data collected by the Kids’ Inpatient Database, maintained by the U.S. Healthcare Cost and Utilization Project. The project includes a representative national sample of about 3 million pediatric hospital discharges every 3 years. The study used data from 11,483,103 hospitalizations of children and adolescents aged 3-21 years during 2003, 2006, 2009, and 2012, and found an overall hospitalization rate of 0.8% billed for migraine. For patients also hospitalized with a billing code for asthma, the rate jumped to 1.36%, a 120% statistically significant relative increase in migraine hospitalizations after adjustment for baseline demographic differences, the researchers said.
Among the children and adolescents hospitalized with an asthma billing code, the relative rate of also having a billing code for migraine after adjustment was a statistically significant 80% higher in girls, compared with boys, a statistically significant 7% higher in adolescents, compared with children 12 years or younger, and was significantly reduced by a relative 45% rate in nonwhites, compared with whites.
The mechanisms behind these associations are not known, but could involve mast-cell degranulation, autonomic dysfunction, or shared genetic or environmental etiologic factors, the authors said.
Dr. Patel reported no relevant disclosures.
SOURCE: Patel RS et al. Headache. 2019 June;59[S1]:1-208, Abstract P78.
when compared with a similar pediatric population without asthma. The finding is based on an analysis of more than 11 million U.S. pediatric hospitalizations over the course of a decade.
Among children and adolescents aged 3-21 years who were hospitalized for asthma, migraine rates were significantly higher among girls, adolescents, and whites, compared with boys, children aged 12 years or younger, and nonwhites, respectively, in a trio of adjusted analyses, Riddhiben S. Patel, MD, and associates reported in a poster at the annual meeting of the American Headache Society.
“Our hope is that, by establishing an association between childhood asthma and migraine, [these children] may be more easily screened for, diagnosed, and treated early by providers,” wrote Dr. Patel, a pediatric neurologist and headache specialist at the University of Mississippi, Jackson, and associates.
Their analysis used administrative billing data collected by the Kids’ Inpatient Database, maintained by the U.S. Healthcare Cost and Utilization Project. The project includes a representative national sample of about 3 million pediatric hospital discharges every 3 years. The study used data from 11,483,103 hospitalizations of children and adolescents aged 3-21 years during 2003, 2006, 2009, and 2012, and found an overall hospitalization rate of 0.8% billed for migraine. For patients also hospitalized with a billing code for asthma, the rate jumped to 1.36%, a 120% statistically significant relative increase in migraine hospitalizations after adjustment for baseline demographic differences, the researchers said.
Among the children and adolescents hospitalized with an asthma billing code, the relative rate of also having a billing code for migraine after adjustment was a statistically significant 80% higher in girls, compared with boys, a statistically significant 7% higher in adolescents, compared with children 12 years or younger, and was significantly reduced by a relative 45% rate in nonwhites, compared with whites.
The mechanisms behind these associations are not known, but could involve mast-cell degranulation, autonomic dysfunction, or shared genetic or environmental etiologic factors, the authors said.
Dr. Patel reported no relevant disclosures.
SOURCE: Patel RS et al. Headache. 2019 June;59[S1]:1-208, Abstract P78.
REPORTING FROM AHS 2019
Lasmiditan is associated with driving impairment
Philadelphia – according to research presented at the annual meeting of the American Headache Society. This impairment coincides with the time of peak drug concentration and is resolved by 8 hours after dosing.
Lasmiditan, a 5-HT1F receptor agonist, is under regulatory review as an acute treatment of migraine in adults. In two phase 3 trials, a significant proportion of participants who received the treatment were pain-free at 2 hours and free of their most bothersome symptom at 2 hours, compared with controls. The most common treatment-emergent adverse events (dizziness, paresthesia, somnolence, fatigue, and hypoaesthesia) reflected the drug’s penetration of the CNS. Because CNS-related adverse events could affect a patient’s ability to drive, the effects of lasmiditan on simulated driving were studied, consistent with regulatory guidance.
Two studies in healthy participants
Eric Pearlman, MD, PhD, senior medical director for neuroscience, U.S. Medical Affairs, at Eli Lilly, and colleagues conducted two simulated driving studies with crossover designs. In the first study, the researchers randomized 90 healthy subjects (mean age, 34.9 years) to 50 mg, 100 mg, or 200 mg of lasmiditan; 1 mg of alprazolam (an active control); or placebo. After appropriate washout periods, participants received each treatment in random order. At 1.5 hours after each treatment, participants underwent a driving assessment using a driving simulator.
In the second study, Dr. Pearlman and colleagues randomized 68 healthy subjects (mean age, 32.8 years) to 100 mg or 200 mg of lasmiditan, 50 mg of diphenhydramine (an active control), or placebo. Participants underwent driving assessments at 8, 12, and 24 hours after baseline. Participants randomized to lasmiditan received treatment at baseline, but participants randomized to diphenhydramine received treatment 2 hours before each driving assessment. The diphenhydramine arm was intended to test the sensitivity of the driving assessment to impairment, as was the alprazolam arm in the first study.
During the driving assessments, participants were asked to maintain a speed of 100 km/h and to stay in the middle of the lane. The simulated road included gentle curves and hills, and oncoming traffic appeared occasionally. Participants also completed a secondary attention task, mimicking real-world conditions. Each assessment took about 1 hour. The primary endpoint was the standard deviation of lateral position (SDLP), which is known colloquially as weaving. The investigators defined noninferiority to placebo as an SDLP of 4.4 cm or less.
Participants reported that they could drive safely
In the first study, Dr. Pearlman and colleagues reported a dose-related increase in SDLP at 1.5 hours post treatment. All three doses of lasmiditan were inferior to placebo, in terms of their effect on SDLP. In the second study, both doses of lasmiditan were noninferior to placebo at 8 hours, 12 hours, and 24 hours. In both studies, the positive control confirmed the assay’s sensitivity to driving impairment. Secondary endpoints in the second study did not indicate an association between lasmiditan and clinically meaningful driving impairment at 8, 12, and 24 hours after dosing.
Single oral doses of lasmiditan were absorbed rapidly. The median time to peak concentration was approximately 2 hours, and the mean elimination half-life was about 4.25 hours. Exposure to lasmiditan was approximately dose proportional.
Before each driving assessment, investigators asked participants, “Do you feel safe to drive?” Depending on the dose, 55%-80% of participants responded affirmatively, but the majority of participants had clinically meaningful changes in SDLP. “This [result] is consistent with the FDA guidance in the literature that subject perception of safety to drive is faulty and supports the need for formal driving assessments,” said Dr. Pearlman.
Dizziness, somnolence, and headache were the most common adverse events in the study, and this result was similar to those of the phase 3 trials. Most of the adverse events were of mild to moderate severity.
Questions for further study
Among the questions that future research could address is whether the lasmiditan-related effects seen in these studies in healthy subjects are similar to those in patients with migraine when lasmiditan is taken to treat a migraine attack, said Dr. Pearlman. Another open question is whether migraine has ictal and interictal effects on driving performance.
Eli Lilly, which has developed lasmiditan, sponsored the studies. Dr. Pearlman and several of coinvestigators are employees of the company.
SOURCE: Pearlman E et al. AHS 2019, Abstract IOR06.
Philadelphia – according to research presented at the annual meeting of the American Headache Society. This impairment coincides with the time of peak drug concentration and is resolved by 8 hours after dosing.
Lasmiditan, a 5-HT1F receptor agonist, is under regulatory review as an acute treatment of migraine in adults. In two phase 3 trials, a significant proportion of participants who received the treatment were pain-free at 2 hours and free of their most bothersome symptom at 2 hours, compared with controls. The most common treatment-emergent adverse events (dizziness, paresthesia, somnolence, fatigue, and hypoaesthesia) reflected the drug’s penetration of the CNS. Because CNS-related adverse events could affect a patient’s ability to drive, the effects of lasmiditan on simulated driving were studied, consistent with regulatory guidance.
Two studies in healthy participants
Eric Pearlman, MD, PhD, senior medical director for neuroscience, U.S. Medical Affairs, at Eli Lilly, and colleagues conducted two simulated driving studies with crossover designs. In the first study, the researchers randomized 90 healthy subjects (mean age, 34.9 years) to 50 mg, 100 mg, or 200 mg of lasmiditan; 1 mg of alprazolam (an active control); or placebo. After appropriate washout periods, participants received each treatment in random order. At 1.5 hours after each treatment, participants underwent a driving assessment using a driving simulator.
In the second study, Dr. Pearlman and colleagues randomized 68 healthy subjects (mean age, 32.8 years) to 100 mg or 200 mg of lasmiditan, 50 mg of diphenhydramine (an active control), or placebo. Participants underwent driving assessments at 8, 12, and 24 hours after baseline. Participants randomized to lasmiditan received treatment at baseline, but participants randomized to diphenhydramine received treatment 2 hours before each driving assessment. The diphenhydramine arm was intended to test the sensitivity of the driving assessment to impairment, as was the alprazolam arm in the first study.
During the driving assessments, participants were asked to maintain a speed of 100 km/h and to stay in the middle of the lane. The simulated road included gentle curves and hills, and oncoming traffic appeared occasionally. Participants also completed a secondary attention task, mimicking real-world conditions. Each assessment took about 1 hour. The primary endpoint was the standard deviation of lateral position (SDLP), which is known colloquially as weaving. The investigators defined noninferiority to placebo as an SDLP of 4.4 cm or less.
Participants reported that they could drive safely
In the first study, Dr. Pearlman and colleagues reported a dose-related increase in SDLP at 1.5 hours post treatment. All three doses of lasmiditan were inferior to placebo, in terms of their effect on SDLP. In the second study, both doses of lasmiditan were noninferior to placebo at 8 hours, 12 hours, and 24 hours. In both studies, the positive control confirmed the assay’s sensitivity to driving impairment. Secondary endpoints in the second study did not indicate an association between lasmiditan and clinically meaningful driving impairment at 8, 12, and 24 hours after dosing.
Single oral doses of lasmiditan were absorbed rapidly. The median time to peak concentration was approximately 2 hours, and the mean elimination half-life was about 4.25 hours. Exposure to lasmiditan was approximately dose proportional.
Before each driving assessment, investigators asked participants, “Do you feel safe to drive?” Depending on the dose, 55%-80% of participants responded affirmatively, but the majority of participants had clinically meaningful changes in SDLP. “This [result] is consistent with the FDA guidance in the literature that subject perception of safety to drive is faulty and supports the need for formal driving assessments,” said Dr. Pearlman.
Dizziness, somnolence, and headache were the most common adverse events in the study, and this result was similar to those of the phase 3 trials. Most of the adverse events were of mild to moderate severity.
Questions for further study
Among the questions that future research could address is whether the lasmiditan-related effects seen in these studies in healthy subjects are similar to those in patients with migraine when lasmiditan is taken to treat a migraine attack, said Dr. Pearlman. Another open question is whether migraine has ictal and interictal effects on driving performance.
Eli Lilly, which has developed lasmiditan, sponsored the studies. Dr. Pearlman and several of coinvestigators are employees of the company.
SOURCE: Pearlman E et al. AHS 2019, Abstract IOR06.
Philadelphia – according to research presented at the annual meeting of the American Headache Society. This impairment coincides with the time of peak drug concentration and is resolved by 8 hours after dosing.
Lasmiditan, a 5-HT1F receptor agonist, is under regulatory review as an acute treatment of migraine in adults. In two phase 3 trials, a significant proportion of participants who received the treatment were pain-free at 2 hours and free of their most bothersome symptom at 2 hours, compared with controls. The most common treatment-emergent adverse events (dizziness, paresthesia, somnolence, fatigue, and hypoaesthesia) reflected the drug’s penetration of the CNS. Because CNS-related adverse events could affect a patient’s ability to drive, the effects of lasmiditan on simulated driving were studied, consistent with regulatory guidance.
Two studies in healthy participants
Eric Pearlman, MD, PhD, senior medical director for neuroscience, U.S. Medical Affairs, at Eli Lilly, and colleagues conducted two simulated driving studies with crossover designs. In the first study, the researchers randomized 90 healthy subjects (mean age, 34.9 years) to 50 mg, 100 mg, or 200 mg of lasmiditan; 1 mg of alprazolam (an active control); or placebo. After appropriate washout periods, participants received each treatment in random order. At 1.5 hours after each treatment, participants underwent a driving assessment using a driving simulator.
In the second study, Dr. Pearlman and colleagues randomized 68 healthy subjects (mean age, 32.8 years) to 100 mg or 200 mg of lasmiditan, 50 mg of diphenhydramine (an active control), or placebo. Participants underwent driving assessments at 8, 12, and 24 hours after baseline. Participants randomized to lasmiditan received treatment at baseline, but participants randomized to diphenhydramine received treatment 2 hours before each driving assessment. The diphenhydramine arm was intended to test the sensitivity of the driving assessment to impairment, as was the alprazolam arm in the first study.
During the driving assessments, participants were asked to maintain a speed of 100 km/h and to stay in the middle of the lane. The simulated road included gentle curves and hills, and oncoming traffic appeared occasionally. Participants also completed a secondary attention task, mimicking real-world conditions. Each assessment took about 1 hour. The primary endpoint was the standard deviation of lateral position (SDLP), which is known colloquially as weaving. The investigators defined noninferiority to placebo as an SDLP of 4.4 cm or less.
Participants reported that they could drive safely
In the first study, Dr. Pearlman and colleagues reported a dose-related increase in SDLP at 1.5 hours post treatment. All three doses of lasmiditan were inferior to placebo, in terms of their effect on SDLP. In the second study, both doses of lasmiditan were noninferior to placebo at 8 hours, 12 hours, and 24 hours. In both studies, the positive control confirmed the assay’s sensitivity to driving impairment. Secondary endpoints in the second study did not indicate an association between lasmiditan and clinically meaningful driving impairment at 8, 12, and 24 hours after dosing.
Single oral doses of lasmiditan were absorbed rapidly. The median time to peak concentration was approximately 2 hours, and the mean elimination half-life was about 4.25 hours. Exposure to lasmiditan was approximately dose proportional.
Before each driving assessment, investigators asked participants, “Do you feel safe to drive?” Depending on the dose, 55%-80% of participants responded affirmatively, but the majority of participants had clinically meaningful changes in SDLP. “This [result] is consistent with the FDA guidance in the literature that subject perception of safety to drive is faulty and supports the need for formal driving assessments,” said Dr. Pearlman.
Dizziness, somnolence, and headache were the most common adverse events in the study, and this result was similar to those of the phase 3 trials. Most of the adverse events were of mild to moderate severity.
Questions for further study
Among the questions that future research could address is whether the lasmiditan-related effects seen in these studies in healthy subjects are similar to those in patients with migraine when lasmiditan is taken to treat a migraine attack, said Dr. Pearlman. Another open question is whether migraine has ictal and interictal effects on driving performance.
Eli Lilly, which has developed lasmiditan, sponsored the studies. Dr. Pearlman and several of coinvestigators are employees of the company.
SOURCE: Pearlman E et al. AHS 2019, Abstract IOR06.
REPORTING FROM AHS 2019
Treatment of episodic cluster headache deviates from recommendations
PHILADELPHIA – , according to an analysis presented at the annual meeting of the American Headache Society.
Although consensus treatment guidelines do not exist for episodic cluster headache, treatment of this disorder did not follow many established recommendations that call for the use of preventive medications (e.g., MacGregor et al., 2010; Sarchielli et al., 2012; and May et al., 2006). Additional preventive medication options may be needed.
Patients with episodic cluster headache have several unilateral headache attacks per day. Little information is available to guide the selection of treatments for this population, and little is known about how available treatments are used in routine practice.
Analyzing cross-sectional survey data
To address this paucity of evidence, Jeffrey Scott Andrews, PharmD, a senior research scientist at Eli Lilly in Indianapolis, and colleagues examined data from the Adelphi 2017 Cluster Headache Disease Specific Programme, a large, international, cross-sectional survey. Physicians and patients in Germany, the United Kingdom, and the United States responded to the survey. Eligible physicians consulted with at least four patients with cluster headache per month, and eligible patients had a diagnosis of episodic cluster headache that was consistent with ICHD-3 beta criteria. Additional data were collected from all participants through questionnaires.
The analysis included 309 patients in Germany, 328 in the United Kingdom, and 375 in the United States. The average age of the patients was 40 years, and most of the patients were male. Less than 70% of patients reported working full time, which may indicate “the impact of this condition on work status,” said Dr. Andrews. Patients’ average number of attacks per day within an active period was 2.4. The two most commonly reported comorbidities were anxiety and depression. About 40% of cases of depression were reported to have occurred after the receipt of a diagnosis of cluster headache.
Use of inhaled oxygen was low
Most patients received acute treatments. The proportion of patients who received acute therapy only was 53% in Germany, 48% in the United Kingdom, and 43% in the United States. Approximately 34% of patients in Germany received a combination of acute and preventive therapy, compared with 37% in the United Kingdom and 42% in the United States. The proportion of patients who received preventive therapy only was 10% in Germany, 8% in the United Kingdom, and 12% in the United States.
The most commonly prescribed acute treatment, regardless of formulation, was sumatriptan. About 60% of patients received this medication. Less than one-third of patients used inhaled oxygen. Oxygen was prescribed more often in Germany (45%) and the United Kingdom (33%), compared with the United States (19%). U.S. patients face well-known obstacles in getting access to, and reimbursement for, oxygen, said Dr. Andrews. “That’s an area that deserves increased attention.” Zolmitriptan was the third most commonly prescribed acute medication.
Among prescriptions for sumatriptan, oral and injectable formulations were approximately equally common. Recommendations, however, indicate formulations with potentially fast onset of action. “The average duration of one of these attacks is between 15 and 180 minutes, so that certainly suggests that a formulation that gives you a faster onset of action might improve outcomes,” said Dr. Andrews. The use of injectable sumatriptan was lowest in the United States and highest in the United Kingdom.
“The most common decision regarding preventive treatment was [to give] no preventive treatment,” said Dr. Andrews. Verapamil was the most commonly prescribed preventive therapy (34% in Germany, 29% in the United States, and 25% in the United Kingdom), followed by topiramate, lithium, and valproate.
Nonadherence and noncompliance was common
Fewer U.K. patients (32%) reported taking their preventive therapy as advised, compared with German patients (60%) and U.S. patients (80%). Common reasons for noncompliance, regardless of location, were forgetfulness, the belief that a dose was not needed, and side effects. Most patients in the United Kingdom (60%) and the United States (54%) reported the need to take an extra dose of their acute medication to relieve pain symptoms, compared with 30% in Germany. Furthermore, 13% of U.S. patients indicated that they took extra doses all the time or nearly all the time, compared with 2% in Germany and 7% in the United Kingdom. Among patients who had discontinued a preventive treatment in the past, the most common reasons for discontinuation were lack of efficacy and problems with tolerability.
One limitation of the study was that the survey was not designed to represent the general cluster headache or treating physician populations fully. The data may reflect selection bias in favor of physicians who treat high volumes of patients and in favor of patients who frequently seek health care. In addition, the data were based on self-reports.
“Increased awareness and educational efforts that aim at promoting the need and benefit of the preventive treatment for these patients is warranted,” Dr. Andrews concluded.
Dr. Andrews is an employee of Eli Lilly, which funded the study.
SOURCE: Nichols R et al. AHS 2019. Abstract OR04.
PHILADELPHIA – , according to an analysis presented at the annual meeting of the American Headache Society.
Although consensus treatment guidelines do not exist for episodic cluster headache, treatment of this disorder did not follow many established recommendations that call for the use of preventive medications (e.g., MacGregor et al., 2010; Sarchielli et al., 2012; and May et al., 2006). Additional preventive medication options may be needed.
Patients with episodic cluster headache have several unilateral headache attacks per day. Little information is available to guide the selection of treatments for this population, and little is known about how available treatments are used in routine practice.
Analyzing cross-sectional survey data
To address this paucity of evidence, Jeffrey Scott Andrews, PharmD, a senior research scientist at Eli Lilly in Indianapolis, and colleagues examined data from the Adelphi 2017 Cluster Headache Disease Specific Programme, a large, international, cross-sectional survey. Physicians and patients in Germany, the United Kingdom, and the United States responded to the survey. Eligible physicians consulted with at least four patients with cluster headache per month, and eligible patients had a diagnosis of episodic cluster headache that was consistent with ICHD-3 beta criteria. Additional data were collected from all participants through questionnaires.
The analysis included 309 patients in Germany, 328 in the United Kingdom, and 375 in the United States. The average age of the patients was 40 years, and most of the patients were male. Less than 70% of patients reported working full time, which may indicate “the impact of this condition on work status,” said Dr. Andrews. Patients’ average number of attacks per day within an active period was 2.4. The two most commonly reported comorbidities were anxiety and depression. About 40% of cases of depression were reported to have occurred after the receipt of a diagnosis of cluster headache.
Use of inhaled oxygen was low
Most patients received acute treatments. The proportion of patients who received acute therapy only was 53% in Germany, 48% in the United Kingdom, and 43% in the United States. Approximately 34% of patients in Germany received a combination of acute and preventive therapy, compared with 37% in the United Kingdom and 42% in the United States. The proportion of patients who received preventive therapy only was 10% in Germany, 8% in the United Kingdom, and 12% in the United States.
The most commonly prescribed acute treatment, regardless of formulation, was sumatriptan. About 60% of patients received this medication. Less than one-third of patients used inhaled oxygen. Oxygen was prescribed more often in Germany (45%) and the United Kingdom (33%), compared with the United States (19%). U.S. patients face well-known obstacles in getting access to, and reimbursement for, oxygen, said Dr. Andrews. “That’s an area that deserves increased attention.” Zolmitriptan was the third most commonly prescribed acute medication.
Among prescriptions for sumatriptan, oral and injectable formulations were approximately equally common. Recommendations, however, indicate formulations with potentially fast onset of action. “The average duration of one of these attacks is between 15 and 180 minutes, so that certainly suggests that a formulation that gives you a faster onset of action might improve outcomes,” said Dr. Andrews. The use of injectable sumatriptan was lowest in the United States and highest in the United Kingdom.
“The most common decision regarding preventive treatment was [to give] no preventive treatment,” said Dr. Andrews. Verapamil was the most commonly prescribed preventive therapy (34% in Germany, 29% in the United States, and 25% in the United Kingdom), followed by topiramate, lithium, and valproate.
Nonadherence and noncompliance was common
Fewer U.K. patients (32%) reported taking their preventive therapy as advised, compared with German patients (60%) and U.S. patients (80%). Common reasons for noncompliance, regardless of location, were forgetfulness, the belief that a dose was not needed, and side effects. Most patients in the United Kingdom (60%) and the United States (54%) reported the need to take an extra dose of their acute medication to relieve pain symptoms, compared with 30% in Germany. Furthermore, 13% of U.S. patients indicated that they took extra doses all the time or nearly all the time, compared with 2% in Germany and 7% in the United Kingdom. Among patients who had discontinued a preventive treatment in the past, the most common reasons for discontinuation were lack of efficacy and problems with tolerability.
One limitation of the study was that the survey was not designed to represent the general cluster headache or treating physician populations fully. The data may reflect selection bias in favor of physicians who treat high volumes of patients and in favor of patients who frequently seek health care. In addition, the data were based on self-reports.
“Increased awareness and educational efforts that aim at promoting the need and benefit of the preventive treatment for these patients is warranted,” Dr. Andrews concluded.
Dr. Andrews is an employee of Eli Lilly, which funded the study.
SOURCE: Nichols R et al. AHS 2019. Abstract OR04.
PHILADELPHIA – , according to an analysis presented at the annual meeting of the American Headache Society.
Although consensus treatment guidelines do not exist for episodic cluster headache, treatment of this disorder did not follow many established recommendations that call for the use of preventive medications (e.g., MacGregor et al., 2010; Sarchielli et al., 2012; and May et al., 2006). Additional preventive medication options may be needed.
Patients with episodic cluster headache have several unilateral headache attacks per day. Little information is available to guide the selection of treatments for this population, and little is known about how available treatments are used in routine practice.
Analyzing cross-sectional survey data
To address this paucity of evidence, Jeffrey Scott Andrews, PharmD, a senior research scientist at Eli Lilly in Indianapolis, and colleagues examined data from the Adelphi 2017 Cluster Headache Disease Specific Programme, a large, international, cross-sectional survey. Physicians and patients in Germany, the United Kingdom, and the United States responded to the survey. Eligible physicians consulted with at least four patients with cluster headache per month, and eligible patients had a diagnosis of episodic cluster headache that was consistent with ICHD-3 beta criteria. Additional data were collected from all participants through questionnaires.
The analysis included 309 patients in Germany, 328 in the United Kingdom, and 375 in the United States. The average age of the patients was 40 years, and most of the patients were male. Less than 70% of patients reported working full time, which may indicate “the impact of this condition on work status,” said Dr. Andrews. Patients’ average number of attacks per day within an active period was 2.4. The two most commonly reported comorbidities were anxiety and depression. About 40% of cases of depression were reported to have occurred after the receipt of a diagnosis of cluster headache.
Use of inhaled oxygen was low
Most patients received acute treatments. The proportion of patients who received acute therapy only was 53% in Germany, 48% in the United Kingdom, and 43% in the United States. Approximately 34% of patients in Germany received a combination of acute and preventive therapy, compared with 37% in the United Kingdom and 42% in the United States. The proportion of patients who received preventive therapy only was 10% in Germany, 8% in the United Kingdom, and 12% in the United States.
The most commonly prescribed acute treatment, regardless of formulation, was sumatriptan. About 60% of patients received this medication. Less than one-third of patients used inhaled oxygen. Oxygen was prescribed more often in Germany (45%) and the United Kingdom (33%), compared with the United States (19%). U.S. patients face well-known obstacles in getting access to, and reimbursement for, oxygen, said Dr. Andrews. “That’s an area that deserves increased attention.” Zolmitriptan was the third most commonly prescribed acute medication.
Among prescriptions for sumatriptan, oral and injectable formulations were approximately equally common. Recommendations, however, indicate formulations with potentially fast onset of action. “The average duration of one of these attacks is between 15 and 180 minutes, so that certainly suggests that a formulation that gives you a faster onset of action might improve outcomes,” said Dr. Andrews. The use of injectable sumatriptan was lowest in the United States and highest in the United Kingdom.
“The most common decision regarding preventive treatment was [to give] no preventive treatment,” said Dr. Andrews. Verapamil was the most commonly prescribed preventive therapy (34% in Germany, 29% in the United States, and 25% in the United Kingdom), followed by topiramate, lithium, and valproate.
Nonadherence and noncompliance was common
Fewer U.K. patients (32%) reported taking their preventive therapy as advised, compared with German patients (60%) and U.S. patients (80%). Common reasons for noncompliance, regardless of location, were forgetfulness, the belief that a dose was not needed, and side effects. Most patients in the United Kingdom (60%) and the United States (54%) reported the need to take an extra dose of their acute medication to relieve pain symptoms, compared with 30% in Germany. Furthermore, 13% of U.S. patients indicated that they took extra doses all the time or nearly all the time, compared with 2% in Germany and 7% in the United Kingdom. Among patients who had discontinued a preventive treatment in the past, the most common reasons for discontinuation were lack of efficacy and problems with tolerability.
One limitation of the study was that the survey was not designed to represent the general cluster headache or treating physician populations fully. The data may reflect selection bias in favor of physicians who treat high volumes of patients and in favor of patients who frequently seek health care. In addition, the data were based on self-reports.
“Increased awareness and educational efforts that aim at promoting the need and benefit of the preventive treatment for these patients is warranted,” Dr. Andrews concluded.
Dr. Andrews is an employee of Eli Lilly, which funded the study.
SOURCE: Nichols R et al. AHS 2019. Abstract OR04.
REPORTING FROM AHS 2019
Can Remote Electrical Neuromodulation Help Acute Migraine?
Remote Electrical Neuromodulation (REN) may provide relief of migraine pain and most bothersome symptoms compared to placebo, a new study found. The efficacy and safety of a REN device for acute treatment of migraine was assessed. The randomized, double-blind, multicenter study was conducted at 7 sites in the United States and 5 sites in Israel. The study included 252 adults meeting the International Classification of Headache Disorders criteria for migraine with 2 to 8 migraine headaches per month, and the patients were randomized 1:1 to active or sham stimulation. Among the findings:
- Active stimulation was more effective than sham stimulation in achieving pain relief, pain-free, and MBS relief at 2 hours post-treatment.
- The pain relief of the active treatment was sustained 48 hours post-treatment.
- Incidence of device-related adverse events was low and similar between treatment groups.
Yarnitsky D, et al. Remote electrical neuromodulation (REN) relieves acute migraine: A randomized, double-blind, placebo-controlled, multicenter trial. [Published online ahead of print May 9, 2019]. Headache. doi: 10.1111/head.13551.
Remote Electrical Neuromodulation (REN) may provide relief of migraine pain and most bothersome symptoms compared to placebo, a new study found. The efficacy and safety of a REN device for acute treatment of migraine was assessed. The randomized, double-blind, multicenter study was conducted at 7 sites in the United States and 5 sites in Israel. The study included 252 adults meeting the International Classification of Headache Disorders criteria for migraine with 2 to 8 migraine headaches per month, and the patients were randomized 1:1 to active or sham stimulation. Among the findings:
- Active stimulation was more effective than sham stimulation in achieving pain relief, pain-free, and MBS relief at 2 hours post-treatment.
- The pain relief of the active treatment was sustained 48 hours post-treatment.
- Incidence of device-related adverse events was low and similar between treatment groups.
Yarnitsky D, et al. Remote electrical neuromodulation (REN) relieves acute migraine: A randomized, double-blind, placebo-controlled, multicenter trial. [Published online ahead of print May 9, 2019]. Headache. doi: 10.1111/head.13551.
Remote Electrical Neuromodulation (REN) may provide relief of migraine pain and most bothersome symptoms compared to placebo, a new study found. The efficacy and safety of a REN device for acute treatment of migraine was assessed. The randomized, double-blind, multicenter study was conducted at 7 sites in the United States and 5 sites in Israel. The study included 252 adults meeting the International Classification of Headache Disorders criteria for migraine with 2 to 8 migraine headaches per month, and the patients were randomized 1:1 to active or sham stimulation. Among the findings:
- Active stimulation was more effective than sham stimulation in achieving pain relief, pain-free, and MBS relief at 2 hours post-treatment.
- The pain relief of the active treatment was sustained 48 hours post-treatment.
- Incidence of device-related adverse events was low and similar between treatment groups.
Yarnitsky D, et al. Remote electrical neuromodulation (REN) relieves acute migraine: A randomized, double-blind, placebo-controlled, multicenter trial. [Published online ahead of print May 9, 2019]. Headache. doi: 10.1111/head.13551.
Multiple Cranial Nerve Blocks in Patients With Chronic Headache
Multiple cranial nerve blocks may provide an efficacious, well tolerated and reproducible transitional treatment for chronic headache disorders, a new study found. The uncontrolled, open-label study included 119 patients with chronic cluster headache, chronic migraine, short-lasting unilateral neuralgiform attack disorders, new daily persistent headaches, hemicrania continua and chronic paroxysmal hemicrania. All had failed to respond to greater occipital nerve blocks. Researchers found:
- Response rate for the entire cohort was 55.4%: Chronic cluster headache (69.2%), chronic migraine (49%), short-lasting unilateral neuralgiform attack disorders (56.3%), new daily persistent headache (10%), hemicrania continua (83.3%), and chronic paroxysmal hemicrania (25%).
- Time to benefit was between 0.5 and 33.58 hours.
- Benefit was maintained up to 4 weeks in over half of responders in all groups except chronic migraine and paroxysmal hemicrania.
Miller S, et al. Multiple cranial nerve blocks for the transitional treatment of chronic headaches. [Published online ahead of print May 13, 2019]. Cephalalgia. doi: 10.1177/0333102419848121.
Multiple cranial nerve blocks may provide an efficacious, well tolerated and reproducible transitional treatment for chronic headache disorders, a new study found. The uncontrolled, open-label study included 119 patients with chronic cluster headache, chronic migraine, short-lasting unilateral neuralgiform attack disorders, new daily persistent headaches, hemicrania continua and chronic paroxysmal hemicrania. All had failed to respond to greater occipital nerve blocks. Researchers found:
- Response rate for the entire cohort was 55.4%: Chronic cluster headache (69.2%), chronic migraine (49%), short-lasting unilateral neuralgiform attack disorders (56.3%), new daily persistent headache (10%), hemicrania continua (83.3%), and chronic paroxysmal hemicrania (25%).
- Time to benefit was between 0.5 and 33.58 hours.
- Benefit was maintained up to 4 weeks in over half of responders in all groups except chronic migraine and paroxysmal hemicrania.
Miller S, et al. Multiple cranial nerve blocks for the transitional treatment of chronic headaches. [Published online ahead of print May 13, 2019]. Cephalalgia. doi: 10.1177/0333102419848121.
Multiple cranial nerve blocks may provide an efficacious, well tolerated and reproducible transitional treatment for chronic headache disorders, a new study found. The uncontrolled, open-label study included 119 patients with chronic cluster headache, chronic migraine, short-lasting unilateral neuralgiform attack disorders, new daily persistent headaches, hemicrania continua and chronic paroxysmal hemicrania. All had failed to respond to greater occipital nerve blocks. Researchers found:
- Response rate for the entire cohort was 55.4%: Chronic cluster headache (69.2%), chronic migraine (49%), short-lasting unilateral neuralgiform attack disorders (56.3%), new daily persistent headache (10%), hemicrania continua (83.3%), and chronic paroxysmal hemicrania (25%).
- Time to benefit was between 0.5 and 33.58 hours.
- Benefit was maintained up to 4 weeks in over half of responders in all groups except chronic migraine and paroxysmal hemicrania.
Miller S, et al. Multiple cranial nerve blocks for the transitional treatment of chronic headaches. [Published online ahead of print May 13, 2019]. Cephalalgia. doi: 10.1177/0333102419848121.
Brainstem Raphe and Depression in Patients With Migraine
Transcranial sonography (TCS) signal alteration of brainstem raphe (BR) can be a biomarker for depression in migraine but is not associated with migraine headache itself, a new study found. Forty-two patients who had migraine without aura and 40 healthy controls were recruited for the study. Echogenicity of lentiform nuclei (LN), caudate nuclei (CN), substantia nigra (SN) and BR, width of the frontal horns of the lateral ventricles, and the third ventricle were assessed with TCS. Researchers found:
- There were no significant differences between migraineurs and controls in the width of front horn of the lateral ventricle, width of third ventricle, as well as in the echogenicity of SN, CN, LN and BR.
- More patients with migraine were detected with increased echogenicity of CN and LN compared with controls.
- Patients with hypoechogenic BR had significantly higher Hamilton Rating Scale for Depression (HAM-D) and Hospital Anxiety and Depression Scale depression subscale (HADS-D) scores than those with normal BR signal.
Tao WW, et al. Hypoechogenicity of brainstem raphe correlates with depression in migraine patients. [Published online ahead of print May 15, 2019]. J Headache Pain. doi: 10.1186/s10194-019-1011-2.
Transcranial sonography (TCS) signal alteration of brainstem raphe (BR) can be a biomarker for depression in migraine but is not associated with migraine headache itself, a new study found. Forty-two patients who had migraine without aura and 40 healthy controls were recruited for the study. Echogenicity of lentiform nuclei (LN), caudate nuclei (CN), substantia nigra (SN) and BR, width of the frontal horns of the lateral ventricles, and the third ventricle were assessed with TCS. Researchers found:
- There were no significant differences between migraineurs and controls in the width of front horn of the lateral ventricle, width of third ventricle, as well as in the echogenicity of SN, CN, LN and BR.
- More patients with migraine were detected with increased echogenicity of CN and LN compared with controls.
- Patients with hypoechogenic BR had significantly higher Hamilton Rating Scale for Depression (HAM-D) and Hospital Anxiety and Depression Scale depression subscale (HADS-D) scores than those with normal BR signal.
Tao WW, et al. Hypoechogenicity of brainstem raphe correlates with depression in migraine patients. [Published online ahead of print May 15, 2019]. J Headache Pain. doi: 10.1186/s10194-019-1011-2.
Transcranial sonography (TCS) signal alteration of brainstem raphe (BR) can be a biomarker for depression in migraine but is not associated with migraine headache itself, a new study found. Forty-two patients who had migraine without aura and 40 healthy controls were recruited for the study. Echogenicity of lentiform nuclei (LN), caudate nuclei (CN), substantia nigra (SN) and BR, width of the frontal horns of the lateral ventricles, and the third ventricle were assessed with TCS. Researchers found:
- There were no significant differences between migraineurs and controls in the width of front horn of the lateral ventricle, width of third ventricle, as well as in the echogenicity of SN, CN, LN and BR.
- More patients with migraine were detected with increased echogenicity of CN and LN compared with controls.
- Patients with hypoechogenic BR had significantly higher Hamilton Rating Scale for Depression (HAM-D) and Hospital Anxiety and Depression Scale depression subscale (HADS-D) scores than those with normal BR signal.
Tao WW, et al. Hypoechogenicity of brainstem raphe correlates with depression in migraine patients. [Published online ahead of print May 15, 2019]. J Headache Pain. doi: 10.1186/s10194-019-1011-2.
Quarterly intravenous eptinezumab prevents migraine
PHILADELPHIA – An intravenous formulation of a calcitonin gene–related peptide inhibitor monoclonal antibody showed efficacy for preventing chronic migraine headaches for 3 months in a dose-ranging, phase 3 trial with 1,072 patients.
In a separate study with 669 patients, a single IV dose of the antibody, eptinezumab, also significantly reduced the incidence of episodic migraine headaches during 3 months of follow-up, compared with placebo. And in both the chronic and episodic migraine studies a similar 3-month effect resulted from a second IV dose of the humanized antibody that binds the calcitonin gene–related peptide (CGRP) ligand, thereby blocking the pathway, Laszlo L. Mechtler, MD, and his associates reported in a poster at the annual meeting of the American Headache Society.
Eptinezumab follows the therapeutic approach already used by three Food and Drug Administration–approved monoclonal antibody drugs that cut migraine headache recurrences by blocking the CGRP pathway by binding either the peptide ligand or its receptor: erenumab-aooe (Aimovig), fremanezumab-vfrm (Ajovy), and galcanezumab-gnlm (Emgality). Eptinezumab differs from the three approved CGRP antibodies by using an IV route of administration – the other three are delivered by subcutaneous injection – and by a 3-month dosing interval. Both erenumab-aooe and galcanezumab-gnlm are labeled for monthly administration only, while fremanezumab-vfrm is labeled for both monthly and once every 3 months dosing schedules.
The PROMISE-1 (A Multicenter Assessment of ALD403 in Frequent Episodic Migraine) trial randomized 669 patients with episodic migraine (defined as 4-14 headache days/month with at least 4 classifiable as migraine headache days) at 87 centers mostly in the United States and with some in Georgia. The PROMISE-2 (Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine) trial randomized 1,072 patients with chronic migraine (defined as a history of 15-26 headache days/month and with at least 8 of the days involving a migraine headache) at any of 145 study sites, many in the United States, in several countries.
In PROMISE-1, patients could receive as many as four serial infusions every 3 months, and up to two serial infusions in PROMISE-2, but the primary endpoint in both studies was the change in monthly migraine count from baseline during the 3 months following the first dosage.
Among patients with chronic migraine in PROMISE-2, the average monthly migraine number fell by 8.2 migraine days/month, compared with an average 5.6 monthly migraine days drop from baseline among placebo patients, which was a statistically significant difference for the higher dosage of eptinezumab tested, 300 mg. A 100-mg dose linked with an average 7.7 migraine days/month reduction, also a statistically significant difference from the placebo patients, reported Dr. Mechtler, professor of neurology at the State University of New York at Buffalo and medical director of the Dent Neurologic Institute in Buffalo, and his associates.
Among patients with episodic migraine in PROMISE-1, the 300-mg dosage cut monthly migraines by an average 4.3 migraine headache days/month, compared with 3.2 in the placebo group, a statistically significant difference. Among patients who received the 100-mg dosage, the average cut was 3.9 migraine headache days/month, also a statistically significant difference from the placebo controls.
The researchers included no safety findings in their report, but in an interview Dr. Mechtler said that eptinezumab showed an excellent safety profile that was consistent with what’s been previously reported for the approved agents from this class. He cited the safety of the drugs in the class as a major feature of their clinical utility.
PROMISE-1 and PROMISE-2 were sponsored by Alder BioPharmaceuticals, the company developing eptinezumab. Dr. Mechtler has been a speaker on behalf of Allergan, Amgen/Novartis, Boston Biomedical, Promius, Avanir, and Teva, and he has received research funding from Allergan, Autonomic Technologies, Boston Biomedical, and Teva.
SOURCE: Mechtler LL et al. Headache. 2019 June;59[S1]:34, Abstract P12
PHILADELPHIA – An intravenous formulation of a calcitonin gene–related peptide inhibitor monoclonal antibody showed efficacy for preventing chronic migraine headaches for 3 months in a dose-ranging, phase 3 trial with 1,072 patients.
In a separate study with 669 patients, a single IV dose of the antibody, eptinezumab, also significantly reduced the incidence of episodic migraine headaches during 3 months of follow-up, compared with placebo. And in both the chronic and episodic migraine studies a similar 3-month effect resulted from a second IV dose of the humanized antibody that binds the calcitonin gene–related peptide (CGRP) ligand, thereby blocking the pathway, Laszlo L. Mechtler, MD, and his associates reported in a poster at the annual meeting of the American Headache Society.
Eptinezumab follows the therapeutic approach already used by three Food and Drug Administration–approved monoclonal antibody drugs that cut migraine headache recurrences by blocking the CGRP pathway by binding either the peptide ligand or its receptor: erenumab-aooe (Aimovig), fremanezumab-vfrm (Ajovy), and galcanezumab-gnlm (Emgality). Eptinezumab differs from the three approved CGRP antibodies by using an IV route of administration – the other three are delivered by subcutaneous injection – and by a 3-month dosing interval. Both erenumab-aooe and galcanezumab-gnlm are labeled for monthly administration only, while fremanezumab-vfrm is labeled for both monthly and once every 3 months dosing schedules.
The PROMISE-1 (A Multicenter Assessment of ALD403 in Frequent Episodic Migraine) trial randomized 669 patients with episodic migraine (defined as 4-14 headache days/month with at least 4 classifiable as migraine headache days) at 87 centers mostly in the United States and with some in Georgia. The PROMISE-2 (Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine) trial randomized 1,072 patients with chronic migraine (defined as a history of 15-26 headache days/month and with at least 8 of the days involving a migraine headache) at any of 145 study sites, many in the United States, in several countries.
In PROMISE-1, patients could receive as many as four serial infusions every 3 months, and up to two serial infusions in PROMISE-2, but the primary endpoint in both studies was the change in monthly migraine count from baseline during the 3 months following the first dosage.
Among patients with chronic migraine in PROMISE-2, the average monthly migraine number fell by 8.2 migraine days/month, compared with an average 5.6 monthly migraine days drop from baseline among placebo patients, which was a statistically significant difference for the higher dosage of eptinezumab tested, 300 mg. A 100-mg dose linked with an average 7.7 migraine days/month reduction, also a statistically significant difference from the placebo patients, reported Dr. Mechtler, professor of neurology at the State University of New York at Buffalo and medical director of the Dent Neurologic Institute in Buffalo, and his associates.
Among patients with episodic migraine in PROMISE-1, the 300-mg dosage cut monthly migraines by an average 4.3 migraine headache days/month, compared with 3.2 in the placebo group, a statistically significant difference. Among patients who received the 100-mg dosage, the average cut was 3.9 migraine headache days/month, also a statistically significant difference from the placebo controls.
The researchers included no safety findings in their report, but in an interview Dr. Mechtler said that eptinezumab showed an excellent safety profile that was consistent with what’s been previously reported for the approved agents from this class. He cited the safety of the drugs in the class as a major feature of their clinical utility.
PROMISE-1 and PROMISE-2 were sponsored by Alder BioPharmaceuticals, the company developing eptinezumab. Dr. Mechtler has been a speaker on behalf of Allergan, Amgen/Novartis, Boston Biomedical, Promius, Avanir, and Teva, and he has received research funding from Allergan, Autonomic Technologies, Boston Biomedical, and Teva.
SOURCE: Mechtler LL et al. Headache. 2019 June;59[S1]:34, Abstract P12
PHILADELPHIA – An intravenous formulation of a calcitonin gene–related peptide inhibitor monoclonal antibody showed efficacy for preventing chronic migraine headaches for 3 months in a dose-ranging, phase 3 trial with 1,072 patients.
In a separate study with 669 patients, a single IV dose of the antibody, eptinezumab, also significantly reduced the incidence of episodic migraine headaches during 3 months of follow-up, compared with placebo. And in both the chronic and episodic migraine studies a similar 3-month effect resulted from a second IV dose of the humanized antibody that binds the calcitonin gene–related peptide (CGRP) ligand, thereby blocking the pathway, Laszlo L. Mechtler, MD, and his associates reported in a poster at the annual meeting of the American Headache Society.
Eptinezumab follows the therapeutic approach already used by three Food and Drug Administration–approved monoclonal antibody drugs that cut migraine headache recurrences by blocking the CGRP pathway by binding either the peptide ligand or its receptor: erenumab-aooe (Aimovig), fremanezumab-vfrm (Ajovy), and galcanezumab-gnlm (Emgality). Eptinezumab differs from the three approved CGRP antibodies by using an IV route of administration – the other three are delivered by subcutaneous injection – and by a 3-month dosing interval. Both erenumab-aooe and galcanezumab-gnlm are labeled for monthly administration only, while fremanezumab-vfrm is labeled for both monthly and once every 3 months dosing schedules.
The PROMISE-1 (A Multicenter Assessment of ALD403 in Frequent Episodic Migraine) trial randomized 669 patients with episodic migraine (defined as 4-14 headache days/month with at least 4 classifiable as migraine headache days) at 87 centers mostly in the United States and with some in Georgia. The PROMISE-2 (Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine) trial randomized 1,072 patients with chronic migraine (defined as a history of 15-26 headache days/month and with at least 8 of the days involving a migraine headache) at any of 145 study sites, many in the United States, in several countries.
In PROMISE-1, patients could receive as many as four serial infusions every 3 months, and up to two serial infusions in PROMISE-2, but the primary endpoint in both studies was the change in monthly migraine count from baseline during the 3 months following the first dosage.
Among patients with chronic migraine in PROMISE-2, the average monthly migraine number fell by 8.2 migraine days/month, compared with an average 5.6 monthly migraine days drop from baseline among placebo patients, which was a statistically significant difference for the higher dosage of eptinezumab tested, 300 mg. A 100-mg dose linked with an average 7.7 migraine days/month reduction, also a statistically significant difference from the placebo patients, reported Dr. Mechtler, professor of neurology at the State University of New York at Buffalo and medical director of the Dent Neurologic Institute in Buffalo, and his associates.
Among patients with episodic migraine in PROMISE-1, the 300-mg dosage cut monthly migraines by an average 4.3 migraine headache days/month, compared with 3.2 in the placebo group, a statistically significant difference. Among patients who received the 100-mg dosage, the average cut was 3.9 migraine headache days/month, also a statistically significant difference from the placebo controls.
The researchers included no safety findings in their report, but in an interview Dr. Mechtler said that eptinezumab showed an excellent safety profile that was consistent with what’s been previously reported for the approved agents from this class. He cited the safety of the drugs in the class as a major feature of their clinical utility.
PROMISE-1 and PROMISE-2 were sponsored by Alder BioPharmaceuticals, the company developing eptinezumab. Dr. Mechtler has been a speaker on behalf of Allergan, Amgen/Novartis, Boston Biomedical, Promius, Avanir, and Teva, and he has received research funding from Allergan, Autonomic Technologies, Boston Biomedical, and Teva.
SOURCE: Mechtler LL et al. Headache. 2019 June;59[S1]:34, Abstract P12
REPORTING FROM AHS 2019
Efficacy of erenumab is sustained over more than 4 years of treatment
PHILADELPHIA – “Erenumab was well tolerated and safe, with no safety signals detected over this period,” said Messoud Ashina, MD, PhD, professor of neurology at the University of Copenhagen. Dr. Ashina presented the interim data from a 5-year, open-label extension study of erenumab at the annual meeting of the American Headache Society.
Erenumab is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide (CGRP) receptor. In May 2018, the Food and Drug Administration approved erenumab for the preventive treatment of migraine in adults. The treatment, marketed as Aimovig, is administered once monthly by self-injection.
During the open-label study, patients initially received 70 mg of erenumab monthly. After approximately 2 years, patients switched to 140 mg of erenumab monthly. The researchers’ interim efficacy analysis included all patients on 140 mg of erenumab with data about monthly migraine days after more than 4 years of treatment. The safety analysis included all patients who enrolled in the open-label treatment period and received at least one dose of erenumab.
Of 250 patients who increased the erenumab dose from 70 mg to 140 mg, a total of 221 (88%) completed the open-label treatment period or remained on 140 mg after more than 4 years. Patients’ average number of monthly migraine days at study baseline was 8.7, and the average change from baseline to the most recent month in the interim analysis was –5.8.
During the most recent month of assessment, 77% of patients had at least a 50% reduction in monthly migraine days from baseline, 56% had at least a 75% reduction, and 33% had a 100% reduction.
Mean change from baseline in acute migraine‐specific medication treatment days was –4.6, from a baseline of 6.1.
Among the 383 patients who entered the open-label treatment period and received at least one dose of erenumab (mean age, 41.3; 79% female), the median erenumab exposure was 58.5 months. The exposure‐adjusted incidence of adverse events per 100 patient‐years was 124.9, and the three most frequent adverse events (per 100 patient-years) were nasopharyngitis (10.9), upper respiratory tract infection (6.8), and influenza (4.7). The exposure‐adjusted incidence rate per 100 patient‐years for constipation was 1.3 (9/383) for 70-mg erenumab and 2.6 (15/250) for 140-mg erenumab.
“The exposure‐adjusted incidence rate per 100 patient‐years of serious adverse events was 3.8, similar to the rate observed for erenumab and placebo during the placebo‐controlled periods of studies,” the researchers said.
The study was sponsored by Amgen, and several study authors are employees of Amgen or Novartis, the companies that market erenumab. Dr. Ashina is a consultant for Amgen, Novartis, and other companies.
SOURCE: Ashina M et al. AHS 2019, Abstract IOR10.
PHILADELPHIA – “Erenumab was well tolerated and safe, with no safety signals detected over this period,” said Messoud Ashina, MD, PhD, professor of neurology at the University of Copenhagen. Dr. Ashina presented the interim data from a 5-year, open-label extension study of erenumab at the annual meeting of the American Headache Society.
Erenumab is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide (CGRP) receptor. In May 2018, the Food and Drug Administration approved erenumab for the preventive treatment of migraine in adults. The treatment, marketed as Aimovig, is administered once monthly by self-injection.
During the open-label study, patients initially received 70 mg of erenumab monthly. After approximately 2 years, patients switched to 140 mg of erenumab monthly. The researchers’ interim efficacy analysis included all patients on 140 mg of erenumab with data about monthly migraine days after more than 4 years of treatment. The safety analysis included all patients who enrolled in the open-label treatment period and received at least one dose of erenumab.
Of 250 patients who increased the erenumab dose from 70 mg to 140 mg, a total of 221 (88%) completed the open-label treatment period or remained on 140 mg after more than 4 years. Patients’ average number of monthly migraine days at study baseline was 8.7, and the average change from baseline to the most recent month in the interim analysis was –5.8.
During the most recent month of assessment, 77% of patients had at least a 50% reduction in monthly migraine days from baseline, 56% had at least a 75% reduction, and 33% had a 100% reduction.
Mean change from baseline in acute migraine‐specific medication treatment days was –4.6, from a baseline of 6.1.
Among the 383 patients who entered the open-label treatment period and received at least one dose of erenumab (mean age, 41.3; 79% female), the median erenumab exposure was 58.5 months. The exposure‐adjusted incidence of adverse events per 100 patient‐years was 124.9, and the three most frequent adverse events (per 100 patient-years) were nasopharyngitis (10.9), upper respiratory tract infection (6.8), and influenza (4.7). The exposure‐adjusted incidence rate per 100 patient‐years for constipation was 1.3 (9/383) for 70-mg erenumab and 2.6 (15/250) for 140-mg erenumab.
“The exposure‐adjusted incidence rate per 100 patient‐years of serious adverse events was 3.8, similar to the rate observed for erenumab and placebo during the placebo‐controlled periods of studies,” the researchers said.
The study was sponsored by Amgen, and several study authors are employees of Amgen or Novartis, the companies that market erenumab. Dr. Ashina is a consultant for Amgen, Novartis, and other companies.
SOURCE: Ashina M et al. AHS 2019, Abstract IOR10.
PHILADELPHIA – “Erenumab was well tolerated and safe, with no safety signals detected over this period,” said Messoud Ashina, MD, PhD, professor of neurology at the University of Copenhagen. Dr. Ashina presented the interim data from a 5-year, open-label extension study of erenumab at the annual meeting of the American Headache Society.
Erenumab is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide (CGRP) receptor. In May 2018, the Food and Drug Administration approved erenumab for the preventive treatment of migraine in adults. The treatment, marketed as Aimovig, is administered once monthly by self-injection.
During the open-label study, patients initially received 70 mg of erenumab monthly. After approximately 2 years, patients switched to 140 mg of erenumab monthly. The researchers’ interim efficacy analysis included all patients on 140 mg of erenumab with data about monthly migraine days after more than 4 years of treatment. The safety analysis included all patients who enrolled in the open-label treatment period and received at least one dose of erenumab.
Of 250 patients who increased the erenumab dose from 70 mg to 140 mg, a total of 221 (88%) completed the open-label treatment period or remained on 140 mg after more than 4 years. Patients’ average number of monthly migraine days at study baseline was 8.7, and the average change from baseline to the most recent month in the interim analysis was –5.8.
During the most recent month of assessment, 77% of patients had at least a 50% reduction in monthly migraine days from baseline, 56% had at least a 75% reduction, and 33% had a 100% reduction.
Mean change from baseline in acute migraine‐specific medication treatment days was –4.6, from a baseline of 6.1.
Among the 383 patients who entered the open-label treatment period and received at least one dose of erenumab (mean age, 41.3; 79% female), the median erenumab exposure was 58.5 months. The exposure‐adjusted incidence of adverse events per 100 patient‐years was 124.9, and the three most frequent adverse events (per 100 patient-years) were nasopharyngitis (10.9), upper respiratory tract infection (6.8), and influenza (4.7). The exposure‐adjusted incidence rate per 100 patient‐years for constipation was 1.3 (9/383) for 70-mg erenumab and 2.6 (15/250) for 140-mg erenumab.
“The exposure‐adjusted incidence rate per 100 patient‐years of serious adverse events was 3.8, similar to the rate observed for erenumab and placebo during the placebo‐controlled periods of studies,” the researchers said.
The study was sponsored by Amgen, and several study authors are employees of Amgen or Novartis, the companies that market erenumab. Dr. Ashina is a consultant for Amgen, Novartis, and other companies.
SOURCE: Ashina M et al. AHS 2019, Abstract IOR10.
REPORTING FROM AHS 2019
Posttraumatic headache may be associated with reduced pain thresholds
PHILADELPHIA – , according to results of a pilot study presented at the annual meeting of the American Headache Society. The findings suggest that patients with posttraumatic headache have abnormal, multimodal sensory processing, said Amaal J. Starling, MD, a neurologist at Mayo Clinic in Phoenix.
Mild traumatic brain injury (TBI) is a growing public health problem. Headache is the most common symptom after mild TBI, and often the most debilitating symptom for these patients. No Food and Drug Administration–approved treatments are available for patients with posttraumatic headache, and about three-quarters of these patients report that current treatments bring them no relief.
Identifying novel targets and developing new treatment options will require a deeper understanding of the pathophysiology of posttraumatic headache, said Dr. Starling. She and her colleagues conducted a pilot study to characterize allodynia, cutaneous heat pain thresholds, photophobia, and light-induced pain thresholds objectively in patients with posttraumatic headache, compared with healthy controls.
Participants were exposed to a bright-light stressor
The researchers enrolled 20 patients between ages 18 years and 65 years with posttraumatic headache attributed to mild TBI in their study. They matched these patients by age with 20 healthy controls. Dr. Starling and colleagues evaluated all participants prospectively using the Allodynia Symptom Checklist (ASC-12), Photosensitivity Assessment Questionnaire (PAQ), State-Trait Anxiety Inventory (STAI), and Beck Depression Inventory (BDI).
The investigators performed quantitative sensory testing to measure each participant’s cutaneous forearm heat pain threshold. Using a progressive light stimulation device, they quantified each participant’s light-induced pain threshold. Finally, Dr. Starling and colleagues obtained participants’ cutaneous heat pain thresholds immediately after, 10 minutes after, and 40 minutes after exposing them to a bright-light stressor.
The researchers found no significant differences between groups in age, gender, or race. The population’s average age was 41 years. Approximately 70% of the sample was female. Among participants with posttraumatic headache, the average time since the onset of posttraumatic headache was 46 months. The average number of headache days per month in that group was 17.2, which represented “a significantly high headache burden,” said Dr. Starling. Approximately 80% of patients with posttraumatic headache had headaches with a migraine phenotype.
Patients’ pain thresholds were lower
STAI and BDI scores were significantly higher among patients with posttraumatic headache, compared with controls. Mean PAQ score was 0.62 among patients and 0.24 among controls, representing significantly greater photophobia symptom severity among patients, said Dr. Starling.
Light-induced pain thresholds were significantly lower in patients with posttraumatic headache (median, 90.5 lux), compared with healthy controls (median, 863.5 lux), independent of depression and anxiety. Allodynia symptom severity was significantly higher in patients with posttraumatic headache (mean ASC-12 score, 5.7), compared with controls (mean ASC-12 score, 0.98).
In addition, the mean baseline cutaneous heat pain threshold was 40.8° C in patients with posttraumatic headache and 44.4° C in healthy controls. When participants were subjected to the bright-light stressor, the immediate change in heat pain threshold was significant in patients with posttraumatic headache (−1.9° C), compared with healthy controls. The difference between groups was not significant at 10 and 40 minutes after exposure to the stressor, however. The light intensity inducing moderate pain was 688 lux in patients with posttraumatic headache, compared with 6,000 lux in healthy controls.
“Our next steps are going to be replicating this [study] in a larger population, as well as determining whether any type of intervention would change these different types of sensory sensitivities and thresholds,” said Dr. Starling. She and her colleagues will use this human research model to examine whether posttraumatic headache differs from other headache disorders such as migraine and to examine potential differences between acute and persistent posttraumatic headache.
The study was funded through an intramural Mayo Clinic early career research award.
SOURCE: Starling AJ et al. AHS 2019. Abstract OR14.
PHILADELPHIA – , according to results of a pilot study presented at the annual meeting of the American Headache Society. The findings suggest that patients with posttraumatic headache have abnormal, multimodal sensory processing, said Amaal J. Starling, MD, a neurologist at Mayo Clinic in Phoenix.
Mild traumatic brain injury (TBI) is a growing public health problem. Headache is the most common symptom after mild TBI, and often the most debilitating symptom for these patients. No Food and Drug Administration–approved treatments are available for patients with posttraumatic headache, and about three-quarters of these patients report that current treatments bring them no relief.
Identifying novel targets and developing new treatment options will require a deeper understanding of the pathophysiology of posttraumatic headache, said Dr. Starling. She and her colleagues conducted a pilot study to characterize allodynia, cutaneous heat pain thresholds, photophobia, and light-induced pain thresholds objectively in patients with posttraumatic headache, compared with healthy controls.
Participants were exposed to a bright-light stressor
The researchers enrolled 20 patients between ages 18 years and 65 years with posttraumatic headache attributed to mild TBI in their study. They matched these patients by age with 20 healthy controls. Dr. Starling and colleagues evaluated all participants prospectively using the Allodynia Symptom Checklist (ASC-12), Photosensitivity Assessment Questionnaire (PAQ), State-Trait Anxiety Inventory (STAI), and Beck Depression Inventory (BDI).
The investigators performed quantitative sensory testing to measure each participant’s cutaneous forearm heat pain threshold. Using a progressive light stimulation device, they quantified each participant’s light-induced pain threshold. Finally, Dr. Starling and colleagues obtained participants’ cutaneous heat pain thresholds immediately after, 10 minutes after, and 40 minutes after exposing them to a bright-light stressor.
The researchers found no significant differences between groups in age, gender, or race. The population’s average age was 41 years. Approximately 70% of the sample was female. Among participants with posttraumatic headache, the average time since the onset of posttraumatic headache was 46 months. The average number of headache days per month in that group was 17.2, which represented “a significantly high headache burden,” said Dr. Starling. Approximately 80% of patients with posttraumatic headache had headaches with a migraine phenotype.
Patients’ pain thresholds were lower
STAI and BDI scores were significantly higher among patients with posttraumatic headache, compared with controls. Mean PAQ score was 0.62 among patients and 0.24 among controls, representing significantly greater photophobia symptom severity among patients, said Dr. Starling.
Light-induced pain thresholds were significantly lower in patients with posttraumatic headache (median, 90.5 lux), compared with healthy controls (median, 863.5 lux), independent of depression and anxiety. Allodynia symptom severity was significantly higher in patients with posttraumatic headache (mean ASC-12 score, 5.7), compared with controls (mean ASC-12 score, 0.98).
In addition, the mean baseline cutaneous heat pain threshold was 40.8° C in patients with posttraumatic headache and 44.4° C in healthy controls. When participants were subjected to the bright-light stressor, the immediate change in heat pain threshold was significant in patients with posttraumatic headache (−1.9° C), compared with healthy controls. The difference between groups was not significant at 10 and 40 minutes after exposure to the stressor, however. The light intensity inducing moderate pain was 688 lux in patients with posttraumatic headache, compared with 6,000 lux in healthy controls.
“Our next steps are going to be replicating this [study] in a larger population, as well as determining whether any type of intervention would change these different types of sensory sensitivities and thresholds,” said Dr. Starling. She and her colleagues will use this human research model to examine whether posttraumatic headache differs from other headache disorders such as migraine and to examine potential differences between acute and persistent posttraumatic headache.
The study was funded through an intramural Mayo Clinic early career research award.
SOURCE: Starling AJ et al. AHS 2019. Abstract OR14.
PHILADELPHIA – , according to results of a pilot study presented at the annual meeting of the American Headache Society. The findings suggest that patients with posttraumatic headache have abnormal, multimodal sensory processing, said Amaal J. Starling, MD, a neurologist at Mayo Clinic in Phoenix.
Mild traumatic brain injury (TBI) is a growing public health problem. Headache is the most common symptom after mild TBI, and often the most debilitating symptom for these patients. No Food and Drug Administration–approved treatments are available for patients with posttraumatic headache, and about three-quarters of these patients report that current treatments bring them no relief.
Identifying novel targets and developing new treatment options will require a deeper understanding of the pathophysiology of posttraumatic headache, said Dr. Starling. She and her colleagues conducted a pilot study to characterize allodynia, cutaneous heat pain thresholds, photophobia, and light-induced pain thresholds objectively in patients with posttraumatic headache, compared with healthy controls.
Participants were exposed to a bright-light stressor
The researchers enrolled 20 patients between ages 18 years and 65 years with posttraumatic headache attributed to mild TBI in their study. They matched these patients by age with 20 healthy controls. Dr. Starling and colleagues evaluated all participants prospectively using the Allodynia Symptom Checklist (ASC-12), Photosensitivity Assessment Questionnaire (PAQ), State-Trait Anxiety Inventory (STAI), and Beck Depression Inventory (BDI).
The investigators performed quantitative sensory testing to measure each participant’s cutaneous forearm heat pain threshold. Using a progressive light stimulation device, they quantified each participant’s light-induced pain threshold. Finally, Dr. Starling and colleagues obtained participants’ cutaneous heat pain thresholds immediately after, 10 minutes after, and 40 minutes after exposing them to a bright-light stressor.
The researchers found no significant differences between groups in age, gender, or race. The population’s average age was 41 years. Approximately 70% of the sample was female. Among participants with posttraumatic headache, the average time since the onset of posttraumatic headache was 46 months. The average number of headache days per month in that group was 17.2, which represented “a significantly high headache burden,” said Dr. Starling. Approximately 80% of patients with posttraumatic headache had headaches with a migraine phenotype.
Patients’ pain thresholds were lower
STAI and BDI scores were significantly higher among patients with posttraumatic headache, compared with controls. Mean PAQ score was 0.62 among patients and 0.24 among controls, representing significantly greater photophobia symptom severity among patients, said Dr. Starling.
Light-induced pain thresholds were significantly lower in patients with posttraumatic headache (median, 90.5 lux), compared with healthy controls (median, 863.5 lux), independent of depression and anxiety. Allodynia symptom severity was significantly higher in patients with posttraumatic headache (mean ASC-12 score, 5.7), compared with controls (mean ASC-12 score, 0.98).
In addition, the mean baseline cutaneous heat pain threshold was 40.8° C in patients with posttraumatic headache and 44.4° C in healthy controls. When participants were subjected to the bright-light stressor, the immediate change in heat pain threshold was significant in patients with posttraumatic headache (−1.9° C), compared with healthy controls. The difference between groups was not significant at 10 and 40 minutes after exposure to the stressor, however. The light intensity inducing moderate pain was 688 lux in patients with posttraumatic headache, compared with 6,000 lux in healthy controls.
“Our next steps are going to be replicating this [study] in a larger population, as well as determining whether any type of intervention would change these different types of sensory sensitivities and thresholds,” said Dr. Starling. She and her colleagues will use this human research model to examine whether posttraumatic headache differs from other headache disorders such as migraine and to examine potential differences between acute and persistent posttraumatic headache.
The study was funded through an intramural Mayo Clinic early career research award.
SOURCE: Starling AJ et al. AHS 2019. Abstract OR14.
REPORTING FROM AHS 2019
Exposure to patients with migraine increases likelihood of stigmatizing attitudes
Philadelphia – , according to an analysis presented at the annual meeting of the American Headache Society.
“We need to understand why this is true,” said Robert Shapiro, MD, PhD, professor of neurological sciences at the University of Vermont in Burlington. The finding also raises questions about which measures could successfully mitigate these stigmatizing attitudes.
An examination of data from OVERCOME
Stigma is a social process by which people are excluded from society because of particular traits that they have. The process encompasses stereotypes, prejudice, and discrimination. Data suggest that the level of stigma that people with migraine experience is similar to that experienced by people with epilepsy. Other data indicate that people without migraine are equally likely to hold stigmatizing attitudes toward people with migraine and people with epilepsy.
Dr. Shapiro and colleagues examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study to better understand the attitudes that people without migraine have toward those who have the disorder. The data were gathered in fall 2018 through a web-based survey of a representative U.S. sample population. The researchers focused on a random sample of 2,000 people without migraine who responded to 11 questions about their attitudes toward patients with migraine. Responses described the frequency of holding attitudes and were scored on a 5-point Likert scale. The researchers categorized the responses “don’t know,” “never,” and “rarely” as “no” answers, and “sometimes,” “often,” and “very often” as “yes” answers. In addition, Dr. Shapiro and colleagues characterized each responder’s proximity to migraine according to the number of people with migraine that he or she knew (0, 1, or 2 or more) and the type of relationship (none, coworker, friend, or family member).
Sample was demographically representative
The demographic and socioeconomic characteristics of the study sample were similar to those of the most recent U.S. census data. The population’s mean age was 48, and 51% were female. Approximately 65% of respondents were non-Hispanic white, 14% were Hispanic, 11% were non-Hispanic black, 5% were Asian, and 5% were “other.” Approximately 45% of respondents reported that they had never known anyone with migraine. “Given the prevalence of migraine, it’s extraordinary that only 13% acknowledged that they had known two or more people with migraine,” said Dr. Shapiro. The finding raises questions about whether people with migraine have received adequate diagnoses and are aware of their disorder, he added. About 5% of the sample reported knowing only a coworker with migraine, and 37% reported knowing only one person with migraine.
About 31% of respondents thought that people with migraine use the disorder to avoid school or work commitments, and 33% thought that patients used migraine to avoid family or social commitments. Approximately 27% of respondents thought that people with migraine used it to get attention. About 45% of respondents thought that migraine should be treated easily, and 36% thought that people have migraine because of their own unhealthy behavior.
Individuals who knew people with migraine consistently held more negative attitudes toward those people, compared with those who did not know anyone with migraine. “These data are a little alarming,” said Dr. Shapiro. “They point to the difficulties that people with disabling migraine often encounter in having their experiences with the disease receive validation and understanding.”
Among the study’s strengths is the fact that it examined a large, population-based sample. The survey was conducted before many of the newer medications for migraine were available, and respondents were not likely to have been influenced by commercials that raised awareness of migraine, said Dr. Shapiro. The sample was not random, however, and the survey questions were based on the investigators’ interests, rather than on objective data. The generalizability of the results is in question, he added.
Dr. Shapiro consults for Eli Lilly, which sponsored the OVERCOME study.
SOURCE: Shapiro R et al. AHS 2019. Abstract OR15.
Philadelphia – , according to an analysis presented at the annual meeting of the American Headache Society.
“We need to understand why this is true,” said Robert Shapiro, MD, PhD, professor of neurological sciences at the University of Vermont in Burlington. The finding also raises questions about which measures could successfully mitigate these stigmatizing attitudes.
An examination of data from OVERCOME
Stigma is a social process by which people are excluded from society because of particular traits that they have. The process encompasses stereotypes, prejudice, and discrimination. Data suggest that the level of stigma that people with migraine experience is similar to that experienced by people with epilepsy. Other data indicate that people without migraine are equally likely to hold stigmatizing attitudes toward people with migraine and people with epilepsy.
Dr. Shapiro and colleagues examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study to better understand the attitudes that people without migraine have toward those who have the disorder. The data were gathered in fall 2018 through a web-based survey of a representative U.S. sample population. The researchers focused on a random sample of 2,000 people without migraine who responded to 11 questions about their attitudes toward patients with migraine. Responses described the frequency of holding attitudes and were scored on a 5-point Likert scale. The researchers categorized the responses “don’t know,” “never,” and “rarely” as “no” answers, and “sometimes,” “often,” and “very often” as “yes” answers. In addition, Dr. Shapiro and colleagues characterized each responder’s proximity to migraine according to the number of people with migraine that he or she knew (0, 1, or 2 or more) and the type of relationship (none, coworker, friend, or family member).
Sample was demographically representative
The demographic and socioeconomic characteristics of the study sample were similar to those of the most recent U.S. census data. The population’s mean age was 48, and 51% were female. Approximately 65% of respondents were non-Hispanic white, 14% were Hispanic, 11% were non-Hispanic black, 5% were Asian, and 5% were “other.” Approximately 45% of respondents reported that they had never known anyone with migraine. “Given the prevalence of migraine, it’s extraordinary that only 13% acknowledged that they had known two or more people with migraine,” said Dr. Shapiro. The finding raises questions about whether people with migraine have received adequate diagnoses and are aware of their disorder, he added. About 5% of the sample reported knowing only a coworker with migraine, and 37% reported knowing only one person with migraine.
About 31% of respondents thought that people with migraine use the disorder to avoid school or work commitments, and 33% thought that patients used migraine to avoid family or social commitments. Approximately 27% of respondents thought that people with migraine used it to get attention. About 45% of respondents thought that migraine should be treated easily, and 36% thought that people have migraine because of their own unhealthy behavior.
Individuals who knew people with migraine consistently held more negative attitudes toward those people, compared with those who did not know anyone with migraine. “These data are a little alarming,” said Dr. Shapiro. “They point to the difficulties that people with disabling migraine often encounter in having their experiences with the disease receive validation and understanding.”
Among the study’s strengths is the fact that it examined a large, population-based sample. The survey was conducted before many of the newer medications for migraine were available, and respondents were not likely to have been influenced by commercials that raised awareness of migraine, said Dr. Shapiro. The sample was not random, however, and the survey questions were based on the investigators’ interests, rather than on objective data. The generalizability of the results is in question, he added.
Dr. Shapiro consults for Eli Lilly, which sponsored the OVERCOME study.
SOURCE: Shapiro R et al. AHS 2019. Abstract OR15.
Philadelphia – , according to an analysis presented at the annual meeting of the American Headache Society.
“We need to understand why this is true,” said Robert Shapiro, MD, PhD, professor of neurological sciences at the University of Vermont in Burlington. The finding also raises questions about which measures could successfully mitigate these stigmatizing attitudes.
An examination of data from OVERCOME
Stigma is a social process by which people are excluded from society because of particular traits that they have. The process encompasses stereotypes, prejudice, and discrimination. Data suggest that the level of stigma that people with migraine experience is similar to that experienced by people with epilepsy. Other data indicate that people without migraine are equally likely to hold stigmatizing attitudes toward people with migraine and people with epilepsy.
Dr. Shapiro and colleagues examined data from the Observational Survey of the Epidemiology, Treatment, and Care of Migraine (OVERCOME) study to better understand the attitudes that people without migraine have toward those who have the disorder. The data were gathered in fall 2018 through a web-based survey of a representative U.S. sample population. The researchers focused on a random sample of 2,000 people without migraine who responded to 11 questions about their attitudes toward patients with migraine. Responses described the frequency of holding attitudes and were scored on a 5-point Likert scale. The researchers categorized the responses “don’t know,” “never,” and “rarely” as “no” answers, and “sometimes,” “often,” and “very often” as “yes” answers. In addition, Dr. Shapiro and colleagues characterized each responder’s proximity to migraine according to the number of people with migraine that he or she knew (0, 1, or 2 or more) and the type of relationship (none, coworker, friend, or family member).
Sample was demographically representative
The demographic and socioeconomic characteristics of the study sample were similar to those of the most recent U.S. census data. The population’s mean age was 48, and 51% were female. Approximately 65% of respondents were non-Hispanic white, 14% were Hispanic, 11% were non-Hispanic black, 5% were Asian, and 5% were “other.” Approximately 45% of respondents reported that they had never known anyone with migraine. “Given the prevalence of migraine, it’s extraordinary that only 13% acknowledged that they had known two or more people with migraine,” said Dr. Shapiro. The finding raises questions about whether people with migraine have received adequate diagnoses and are aware of their disorder, he added. About 5% of the sample reported knowing only a coworker with migraine, and 37% reported knowing only one person with migraine.
About 31% of respondents thought that people with migraine use the disorder to avoid school or work commitments, and 33% thought that patients used migraine to avoid family or social commitments. Approximately 27% of respondents thought that people with migraine used it to get attention. About 45% of respondents thought that migraine should be treated easily, and 36% thought that people have migraine because of their own unhealthy behavior.
Individuals who knew people with migraine consistently held more negative attitudes toward those people, compared with those who did not know anyone with migraine. “These data are a little alarming,” said Dr. Shapiro. “They point to the difficulties that people with disabling migraine often encounter in having their experiences with the disease receive validation and understanding.”
Among the study’s strengths is the fact that it examined a large, population-based sample. The survey was conducted before many of the newer medications for migraine were available, and respondents were not likely to have been influenced by commercials that raised awareness of migraine, said Dr. Shapiro. The sample was not random, however, and the survey questions were based on the investigators’ interests, rather than on objective data. The generalizability of the results is in question, he added.
Dr. Shapiro consults for Eli Lilly, which sponsored the OVERCOME study.
SOURCE: Shapiro R et al. AHS 2019. Abstract OR15.
REPORTING FROM AHS 2019
