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Dr. Lene Dreyer discusses psoriatic arthritis and cancer risk

Do patients with psoriatic arthritis face greater cancer risks? Lene Dreyer, MD, clinical professor at Aalborg (Denmark) University Hospital, talks about the mostly reassuring findings from a cancer registry analysis in four Nordic countries.

Do patients with psoriatic arthritis face greater cancer risks? Lene Dreyer, MD, clinical professor at Aalborg (Denmark) University Hospital, talks about the mostly reassuring findings from a cancer registry analysis in four Nordic countries.

Do patients with psoriatic arthritis face greater cancer risks? Lene Dreyer, MD, clinical professor at Aalborg (Denmark) University Hospital, talks about the mostly reassuring findings from a cancer registry analysis in four Nordic countries.
Nearly 20% of migraineurs use opioids for migraine
PHILADELPHIA – People with 4 or more migraine headache days per month are more likely to use opioids, compared with people with fewer migraine headache days per month, researchers said. Opioid use for migraine “remains alarmingly high,” the investigators said at the annual meeting of the American Headache Society.
Although opioid use for the treatment of migraine typically is discouraged, studies indicate that it is common. Evidence suggests that opioids may increase the risk of progression from episodic to chronic migraine.
To evaluate opioid use in people with migraine, Sait Ashina, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, and the research colleagues analyzed data from 21,143 people with migraine who participated in the OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine), a Web-based study of a representative U.S. sample. OVERCOME enrolled participants in the fall of 2018.
The researchers classified self-reported opioid use for migraine as current use in the past 12 months, former use, or never. Participants had a mean age of 42 years, and 74% were female. The researchers used a multivariable logistic regression model adjusted for age and sex in their analyses.
“Strikingly, we were able to find 19% of people with migraine were reporting current use of opioids,” Dr. Ashina said.
Among 12,299 patients with 0-3 migraine headache days per month, 59% were never, 26% former, and 15% current users of opioids for migraine. Among 8,844 patients with 4 or more migraine headache days per month, 44.9% were never, 31.2% former, and 23.9% current users of opioids for migraine.
There was an increased likelihood of opioid use for migraine in people with pain comorbidities such as back pain, neck pain, and fibromyalgia and in people with anxiety and depression.
Approximately 30%-40% of those who used opioids for migraine were using strong opioids, as defined by the World Health Organization, Dr. Ashina noted. Preliminary analyses indicate that patients tended to receive opioids in a primary care setting, he said.
Eli Lilly funded the OVERCOME study. Dr. Ashina has consulted for Novartis, Amgen, Promius, Supernus, Satsuma, and Allergan. He is on the Editorial Advisory Board for Neurology Reviews.
PHILADELPHIA – People with 4 or more migraine headache days per month are more likely to use opioids, compared with people with fewer migraine headache days per month, researchers said. Opioid use for migraine “remains alarmingly high,” the investigators said at the annual meeting of the American Headache Society.
Although opioid use for the treatment of migraine typically is discouraged, studies indicate that it is common. Evidence suggests that opioids may increase the risk of progression from episodic to chronic migraine.
To evaluate opioid use in people with migraine, Sait Ashina, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, and the research colleagues analyzed data from 21,143 people with migraine who participated in the OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine), a Web-based study of a representative U.S. sample. OVERCOME enrolled participants in the fall of 2018.
The researchers classified self-reported opioid use for migraine as current use in the past 12 months, former use, or never. Participants had a mean age of 42 years, and 74% were female. The researchers used a multivariable logistic regression model adjusted for age and sex in their analyses.
“Strikingly, we were able to find 19% of people with migraine were reporting current use of opioids,” Dr. Ashina said.
Among 12,299 patients with 0-3 migraine headache days per month, 59% were never, 26% former, and 15% current users of opioids for migraine. Among 8,844 patients with 4 or more migraine headache days per month, 44.9% were never, 31.2% former, and 23.9% current users of opioids for migraine.
There was an increased likelihood of opioid use for migraine in people with pain comorbidities such as back pain, neck pain, and fibromyalgia and in people with anxiety and depression.
Approximately 30%-40% of those who used opioids for migraine were using strong opioids, as defined by the World Health Organization, Dr. Ashina noted. Preliminary analyses indicate that patients tended to receive opioids in a primary care setting, he said.
Eli Lilly funded the OVERCOME study. Dr. Ashina has consulted for Novartis, Amgen, Promius, Supernus, Satsuma, and Allergan. He is on the Editorial Advisory Board for Neurology Reviews.
PHILADELPHIA – People with 4 or more migraine headache days per month are more likely to use opioids, compared with people with fewer migraine headache days per month, researchers said. Opioid use for migraine “remains alarmingly high,” the investigators said at the annual meeting of the American Headache Society.
Although opioid use for the treatment of migraine typically is discouraged, studies indicate that it is common. Evidence suggests that opioids may increase the risk of progression from episodic to chronic migraine.
To evaluate opioid use in people with migraine, Sait Ashina, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, and the research colleagues analyzed data from 21,143 people with migraine who participated in the OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine), a Web-based study of a representative U.S. sample. OVERCOME enrolled participants in the fall of 2018.
The researchers classified self-reported opioid use for migraine as current use in the past 12 months, former use, or never. Participants had a mean age of 42 years, and 74% were female. The researchers used a multivariable logistic regression model adjusted for age and sex in their analyses.
“Strikingly, we were able to find 19% of people with migraine were reporting current use of opioids,” Dr. Ashina said.
Among 12,299 patients with 0-3 migraine headache days per month, 59% were never, 26% former, and 15% current users of opioids for migraine. Among 8,844 patients with 4 or more migraine headache days per month, 44.9% were never, 31.2% former, and 23.9% current users of opioids for migraine.
There was an increased likelihood of opioid use for migraine in people with pain comorbidities such as back pain, neck pain, and fibromyalgia and in people with anxiety and depression.
Approximately 30%-40% of those who used opioids for migraine were using strong opioids, as defined by the World Health Organization, Dr. Ashina noted. Preliminary analyses indicate that patients tended to receive opioids in a primary care setting, he said.
Eli Lilly funded the OVERCOME study. Dr. Ashina has consulted for Novartis, Amgen, Promius, Supernus, Satsuma, and Allergan. He is on the Editorial Advisory Board for Neurology Reviews.
EXPERT ANALYSIS FROM AHS 2019
Overreliance on DAS scores undermines rheumatoid arthritis management
MADRID – Two major changes that improved RA management in recent years – the introduction of potent biologic and targeted synthetic drugs to control inflammatory disease, and the treat-to-target strategy – have also produced an unanticipated snag in the care patients receive. Their persistent comorbidities and their more atypical rheumatoid manifestations often go overlooked and untreated.
The situation has been dubbed “DAS blindness,” when clinicians caring for patients with RA are so focused on a patient’s disease activity score (DAS), measured by counting their swollen and tender joints (usually 28 joints to tally the DAS28 score), that they lose sight of other important features of a RA patient’s disease such as pain and fatigue, Ruth Williams, MBChB, said in an invited talk at the European Congress of Rheumatology.
“There is so much focus on the DAS28 that people are blinded by it. Clinicians concentrate too much on the primary physical condition” of RA, “and they miss important functional, psychological, and social impacts of the disease,” said Dr. Williams, a general-practice physician who is also a long-time RA patient who works as a patient representative and RA researcher at King’s College London.
In Dr. William’s extended personal experience as an RA patient (she was first diagnosed in 1966 as a child), management of the disease changed dramatically with the relatively recent, widespread adoption of the DAS28 score in routine clinical practice in Europe and the United States, migrating from its initial use in research studies. Once her clinicians began to use the DAS28 “I felt that perhaps I wasn’t being seen anymore. It was just the biology of my disease being noted rather than me as an individual,” Dr. Williams said in an interview. Clinicians “need to discuss with patients what remission means to them, and their objectives” from treatment, because a patient’s treatment goals may go beyond just reducing the number of swollen or tender joints they total in the DAS28 assessment.
Rheumatologists also have begun to recognize this common disconnect between both the assessment and the antirheumatoid treatment that RA patients routinely receive, and the symptoms that cause problems for RA patients that are not directly tied to their inflammatory disease. Patients can present with remission-level responses in their tender and swollen joint counts and in their serum level of C-reactive protein or erythrocyte sedimentation rate but still score high on the patient global assessment (PGA) scale, a residual consequence of RA that places them out of remission range based on the 2011 “Boolean” criteria for RA remission in trials endorsed by the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) (Arthritis Rheum. 2011 Mar;63[3]:373-86).
In a review of 411 RA patients who met three of the four ACR/EULAR criteria that collectively define remission, 61% missed on the PGA measure (Ann Rheum Dis. 2012 Oct;71[10]:1702-5), noted Joan M. Bathon, MD, professor of medicine and director of rheumatology at Columbia University, New York, in a talk during the Congress. Another review of 273 RA patients who missed on one of the four criteria showed 80% missing because of their PGA score (Arthritis Res Ther. 2013;15:R221). The specific clinical features that triggered high PGAs in these patients were things like fibromyalgia, back pain, anxiety, depression, and rheumatoid activity in joints not included in the DAS28 score, Dr. Bathon noted. The PGA can have poor correlation with the other three measures, but that is a strength because it reflects different dimensions of RA that are important to patients. When the PGA is discordant with the other three measures of remission, it may not make sense to try to improve it by simply using more immunosuppressive treatment.
The solution to the dilemma of what remission target to aim for when treating to target is to apply common sense to existing guidelines and recommendations and tailor management to each patient, she concluded. “The worst thing we can do is to take criteria meant for clinical rials and for patients with average scores and apply them to every individual patient,” she said. Remission guidelines are good for large populations, “but we shouldn’t apply them to every single patient without thinking.”
A similar plea for thoughtful use of the treat-to-target model and immunomodulatory treatment came in a separate talk from Laure Gossec, MD, a professor of rheumatology at Pitie-Salpétriere Hospital and Sorbonne University in Paris.
The challenge of DAS28 is that it was a remission criteria developed by the ACR and EULAR to use in clinical trials that was coopted for use in routine practice. Despite that, Dr. Gossec believes that DAS28 largely succeeded in this transition. “The DAS28 performs well, it has good prognostic capacity and is widely used.” In her practice, Dr. Gossec relies on the DAS28 score as her primary tool to track disease status in RA patients. “It’s not perfect, but I’m familiar with it, and I work with it,” she said.
It’s undeniable, she acknowledged, that a high PGA often stands between a patient and remission. PGA “is hard to use to guide anti-inflammatory treatment. Many patients have high PGA scores even though they have no inflammation.” Discrepancies like this create a case for dual-treatment targets, both a low swollen and tender joint count and low PGA, as separate and equal treatment goals, Dr. Gossec said, an approach she and her associates proposed in a recent article (Arthritis Care Res. 2018 Mar;709[3]:369-78).
Dr. Williams had no disclosures. Dr. Bathon has been a consultant to AbbVie and has received research funding from Bristol-Myers Squibb and Pfizer. Dr. Gossec has been a consultant to and has received research funding from several companies.
MADRID – Two major changes that improved RA management in recent years – the introduction of potent biologic and targeted synthetic drugs to control inflammatory disease, and the treat-to-target strategy – have also produced an unanticipated snag in the care patients receive. Their persistent comorbidities and their more atypical rheumatoid manifestations often go overlooked and untreated.
The situation has been dubbed “DAS blindness,” when clinicians caring for patients with RA are so focused on a patient’s disease activity score (DAS), measured by counting their swollen and tender joints (usually 28 joints to tally the DAS28 score), that they lose sight of other important features of a RA patient’s disease such as pain and fatigue, Ruth Williams, MBChB, said in an invited talk at the European Congress of Rheumatology.
“There is so much focus on the DAS28 that people are blinded by it. Clinicians concentrate too much on the primary physical condition” of RA, “and they miss important functional, psychological, and social impacts of the disease,” said Dr. Williams, a general-practice physician who is also a long-time RA patient who works as a patient representative and RA researcher at King’s College London.
In Dr. William’s extended personal experience as an RA patient (she was first diagnosed in 1966 as a child), management of the disease changed dramatically with the relatively recent, widespread adoption of the DAS28 score in routine clinical practice in Europe and the United States, migrating from its initial use in research studies. Once her clinicians began to use the DAS28 “I felt that perhaps I wasn’t being seen anymore. It was just the biology of my disease being noted rather than me as an individual,” Dr. Williams said in an interview. Clinicians “need to discuss with patients what remission means to them, and their objectives” from treatment, because a patient’s treatment goals may go beyond just reducing the number of swollen or tender joints they total in the DAS28 assessment.
Rheumatologists also have begun to recognize this common disconnect between both the assessment and the antirheumatoid treatment that RA patients routinely receive, and the symptoms that cause problems for RA patients that are not directly tied to their inflammatory disease. Patients can present with remission-level responses in their tender and swollen joint counts and in their serum level of C-reactive protein or erythrocyte sedimentation rate but still score high on the patient global assessment (PGA) scale, a residual consequence of RA that places them out of remission range based on the 2011 “Boolean” criteria for RA remission in trials endorsed by the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) (Arthritis Rheum. 2011 Mar;63[3]:373-86).
In a review of 411 RA patients who met three of the four ACR/EULAR criteria that collectively define remission, 61% missed on the PGA measure (Ann Rheum Dis. 2012 Oct;71[10]:1702-5), noted Joan M. Bathon, MD, professor of medicine and director of rheumatology at Columbia University, New York, in a talk during the Congress. Another review of 273 RA patients who missed on one of the four criteria showed 80% missing because of their PGA score (Arthritis Res Ther. 2013;15:R221). The specific clinical features that triggered high PGAs in these patients were things like fibromyalgia, back pain, anxiety, depression, and rheumatoid activity in joints not included in the DAS28 score, Dr. Bathon noted. The PGA can have poor correlation with the other three measures, but that is a strength because it reflects different dimensions of RA that are important to patients. When the PGA is discordant with the other three measures of remission, it may not make sense to try to improve it by simply using more immunosuppressive treatment.
The solution to the dilemma of what remission target to aim for when treating to target is to apply common sense to existing guidelines and recommendations and tailor management to each patient, she concluded. “The worst thing we can do is to take criteria meant for clinical rials and for patients with average scores and apply them to every individual patient,” she said. Remission guidelines are good for large populations, “but we shouldn’t apply them to every single patient without thinking.”
A similar plea for thoughtful use of the treat-to-target model and immunomodulatory treatment came in a separate talk from Laure Gossec, MD, a professor of rheumatology at Pitie-Salpétriere Hospital and Sorbonne University in Paris.
The challenge of DAS28 is that it was a remission criteria developed by the ACR and EULAR to use in clinical trials that was coopted for use in routine practice. Despite that, Dr. Gossec believes that DAS28 largely succeeded in this transition. “The DAS28 performs well, it has good prognostic capacity and is widely used.” In her practice, Dr. Gossec relies on the DAS28 score as her primary tool to track disease status in RA patients. “It’s not perfect, but I’m familiar with it, and I work with it,” she said.
It’s undeniable, she acknowledged, that a high PGA often stands between a patient and remission. PGA “is hard to use to guide anti-inflammatory treatment. Many patients have high PGA scores even though they have no inflammation.” Discrepancies like this create a case for dual-treatment targets, both a low swollen and tender joint count and low PGA, as separate and equal treatment goals, Dr. Gossec said, an approach she and her associates proposed in a recent article (Arthritis Care Res. 2018 Mar;709[3]:369-78).
Dr. Williams had no disclosures. Dr. Bathon has been a consultant to AbbVie and has received research funding from Bristol-Myers Squibb and Pfizer. Dr. Gossec has been a consultant to and has received research funding from several companies.
MADRID – Two major changes that improved RA management in recent years – the introduction of potent biologic and targeted synthetic drugs to control inflammatory disease, and the treat-to-target strategy – have also produced an unanticipated snag in the care patients receive. Their persistent comorbidities and their more atypical rheumatoid manifestations often go overlooked and untreated.
The situation has been dubbed “DAS blindness,” when clinicians caring for patients with RA are so focused on a patient’s disease activity score (DAS), measured by counting their swollen and tender joints (usually 28 joints to tally the DAS28 score), that they lose sight of other important features of a RA patient’s disease such as pain and fatigue, Ruth Williams, MBChB, said in an invited talk at the European Congress of Rheumatology.
“There is so much focus on the DAS28 that people are blinded by it. Clinicians concentrate too much on the primary physical condition” of RA, “and they miss important functional, psychological, and social impacts of the disease,” said Dr. Williams, a general-practice physician who is also a long-time RA patient who works as a patient representative and RA researcher at King’s College London.
In Dr. William’s extended personal experience as an RA patient (she was first diagnosed in 1966 as a child), management of the disease changed dramatically with the relatively recent, widespread adoption of the DAS28 score in routine clinical practice in Europe and the United States, migrating from its initial use in research studies. Once her clinicians began to use the DAS28 “I felt that perhaps I wasn’t being seen anymore. It was just the biology of my disease being noted rather than me as an individual,” Dr. Williams said in an interview. Clinicians “need to discuss with patients what remission means to them, and their objectives” from treatment, because a patient’s treatment goals may go beyond just reducing the number of swollen or tender joints they total in the DAS28 assessment.
Rheumatologists also have begun to recognize this common disconnect between both the assessment and the antirheumatoid treatment that RA patients routinely receive, and the symptoms that cause problems for RA patients that are not directly tied to their inflammatory disease. Patients can present with remission-level responses in their tender and swollen joint counts and in their serum level of C-reactive protein or erythrocyte sedimentation rate but still score high on the patient global assessment (PGA) scale, a residual consequence of RA that places them out of remission range based on the 2011 “Boolean” criteria for RA remission in trials endorsed by the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) (Arthritis Rheum. 2011 Mar;63[3]:373-86).
In a review of 411 RA patients who met three of the four ACR/EULAR criteria that collectively define remission, 61% missed on the PGA measure (Ann Rheum Dis. 2012 Oct;71[10]:1702-5), noted Joan M. Bathon, MD, professor of medicine and director of rheumatology at Columbia University, New York, in a talk during the Congress. Another review of 273 RA patients who missed on one of the four criteria showed 80% missing because of their PGA score (Arthritis Res Ther. 2013;15:R221). The specific clinical features that triggered high PGAs in these patients were things like fibromyalgia, back pain, anxiety, depression, and rheumatoid activity in joints not included in the DAS28 score, Dr. Bathon noted. The PGA can have poor correlation with the other three measures, but that is a strength because it reflects different dimensions of RA that are important to patients. When the PGA is discordant with the other three measures of remission, it may not make sense to try to improve it by simply using more immunosuppressive treatment.
The solution to the dilemma of what remission target to aim for when treating to target is to apply common sense to existing guidelines and recommendations and tailor management to each patient, she concluded. “The worst thing we can do is to take criteria meant for clinical rials and for patients with average scores and apply them to every individual patient,” she said. Remission guidelines are good for large populations, “but we shouldn’t apply them to every single patient without thinking.”
A similar plea for thoughtful use of the treat-to-target model and immunomodulatory treatment came in a separate talk from Laure Gossec, MD, a professor of rheumatology at Pitie-Salpétriere Hospital and Sorbonne University in Paris.
The challenge of DAS28 is that it was a remission criteria developed by the ACR and EULAR to use in clinical trials that was coopted for use in routine practice. Despite that, Dr. Gossec believes that DAS28 largely succeeded in this transition. “The DAS28 performs well, it has good prognostic capacity and is widely used.” In her practice, Dr. Gossec relies on the DAS28 score as her primary tool to track disease status in RA patients. “It’s not perfect, but I’m familiar with it, and I work with it,” she said.
It’s undeniable, she acknowledged, that a high PGA often stands between a patient and remission. PGA “is hard to use to guide anti-inflammatory treatment. Many patients have high PGA scores even though they have no inflammation.” Discrepancies like this create a case for dual-treatment targets, both a low swollen and tender joint count and low PGA, as separate and equal treatment goals, Dr. Gossec said, an approach she and her associates proposed in a recent article (Arthritis Care Res. 2018 Mar;709[3]:369-78).
Dr. Williams had no disclosures. Dr. Bathon has been a consultant to AbbVie and has received research funding from Bristol-Myers Squibb and Pfizer. Dr. Gossec has been a consultant to and has received research funding from several companies.
REPORTING FROM EULAR 2019 CONGRESS
White light exposure is associated with acute risk of headache in migraine
PHILADELPHIA – , according to research presented at the annual meeting of the American Headache Society. The data raise the question of whether modifying light exposure could reduce headache frequency in this population, said Suzanne M. Bertisch, MD, MPH, a physician and clinical investigator in the division of sleep and circadian disorders at Brigham and Women’s Hospital in Boston.
About 40% of patients with migraine identify light as a trigger. Most studies that have examined the association between light and migraine onset have been retrospective and have relied on subjective measures of light exposure.
From March 2016 to August 2017, Dr. Bertisch and colleagues enrolled 101 adults with episodic migraine into a prospective cohort study. For 79 of these participants, light exposure was measured continuously for 6 weeks by actigraph. In the morning and evening, participants recorded data such as headache onset, duration, and intensity in electronic headache diaries. They also recorded data about covariates such as caffeine intake, alcohol intake, sleep, and stress.
Dr. Bertisch and colleagues divided the day into four 6-hour periods and calculated mean light exposure within each period. After researchers adjusted for covariates, they found that higher mean photopic illuminance was associated with a 12% higher risk of headache during the same period. Mean photopic illuminance was not associated with headache onset in the next period, however.
Dr. Bertisch had no disclosures relevant to this study.
PHILADELPHIA – , according to research presented at the annual meeting of the American Headache Society. The data raise the question of whether modifying light exposure could reduce headache frequency in this population, said Suzanne M. Bertisch, MD, MPH, a physician and clinical investigator in the division of sleep and circadian disorders at Brigham and Women’s Hospital in Boston.
About 40% of patients with migraine identify light as a trigger. Most studies that have examined the association between light and migraine onset have been retrospective and have relied on subjective measures of light exposure.
From March 2016 to August 2017, Dr. Bertisch and colleagues enrolled 101 adults with episodic migraine into a prospective cohort study. For 79 of these participants, light exposure was measured continuously for 6 weeks by actigraph. In the morning and evening, participants recorded data such as headache onset, duration, and intensity in electronic headache diaries. They also recorded data about covariates such as caffeine intake, alcohol intake, sleep, and stress.
Dr. Bertisch and colleagues divided the day into four 6-hour periods and calculated mean light exposure within each period. After researchers adjusted for covariates, they found that higher mean photopic illuminance was associated with a 12% higher risk of headache during the same period. Mean photopic illuminance was not associated with headache onset in the next period, however.
Dr. Bertisch had no disclosures relevant to this study.
PHILADELPHIA – , according to research presented at the annual meeting of the American Headache Society. The data raise the question of whether modifying light exposure could reduce headache frequency in this population, said Suzanne M. Bertisch, MD, MPH, a physician and clinical investigator in the division of sleep and circadian disorders at Brigham and Women’s Hospital in Boston.
About 40% of patients with migraine identify light as a trigger. Most studies that have examined the association between light and migraine onset have been retrospective and have relied on subjective measures of light exposure.
From March 2016 to August 2017, Dr. Bertisch and colleagues enrolled 101 adults with episodic migraine into a prospective cohort study. For 79 of these participants, light exposure was measured continuously for 6 weeks by actigraph. In the morning and evening, participants recorded data such as headache onset, duration, and intensity in electronic headache diaries. They also recorded data about covariates such as caffeine intake, alcohol intake, sleep, and stress.
Dr. Bertisch and colleagues divided the day into four 6-hour periods and calculated mean light exposure within each period. After researchers adjusted for covariates, they found that higher mean photopic illuminance was associated with a 12% higher risk of headache during the same period. Mean photopic illuminance was not associated with headache onset in the next period, however.
Dr. Bertisch had no disclosures relevant to this study.
EXPERT ANALYSIS FROM AHS 2019
Which migraineurs seek care from a neurologist?
PHILADELPHIA – , said Alice R. Pressman, PhD at the annual meeting of the American Headache Society.
Dr. Pressman, executive director of research, development, and dissemination for Sutter Health, and her research colleagues analyzed data from primary care patients who sought care for migraine in the Sutter Health healthcare network in Northern California. They found that women were 10% more likely than men to consult a neurologist and that Asian patients had a longer time to a first neurology encounter for migraine, compared with Caucasian patients.
“Those who sought care from neurology had more severe migraine symptomology, disability, and comorbidities,” the researchers reported. Furthermore, patients with migraine seen by neurologists were more likely to receive prescriptions for acute and preventive migraine medications, compared with patients only seen by primary care physicians.
The study, known as the Migraine Signature Study, used electronic health records (EHR) and patient-reported questionnaire data to examine the clinical experiences and care of patients with migraine.
The primary care population consisted of 1.4 million adults with at least one office visit to primary care in 2013-2017. Using the validated Migraine Probability Algorithm, the researchers identified approximately 94,000 patients who sought care for migraine.
The investigators also invited 38,536 patients to complete an online survey about migraine criteria, symptomology, health resource utilization, and patient-reported outcomes such as disability, acute treatment optimization, cutaneous allodynia, depression, anxiety, and posttraumatic stress disorder (PTSD).
Of the patients who sought care for migraine, 72,624 patients did not receive migraine care from neurology, and 21,525 did.
Patients with migraine care from a neurologist were more likely to have at least one acute migraine medication order (89.4% vs. 80.6%), at least one preventive migraine medication order (78.6% vs. 49.1%), and any migraine medication order (95.3% vs. 85.9%). In addition, those with at least one medication order in the primary care setting had fewer orders per person per year, compared with those with at least one medication order in the neurology setting (1.1 vs. 1.6).
About one-third of the patients who sought care for migraine had no migraine encounters in the first 12 months of the study. Of the more than 33,000 patients with first migraine consults, approximately two-thirds did not receive a neurology consultation during the study and received their migraine diagnosis in the primary care setting.
Of the 31% of patients with first migraine consults in primary care who later had a neurology consult, two-thirds received a migraine diagnosis from neurology. “The high rate of initial migraine diagnosis within neurology was surprising among this sample with primary care encounters first,” the researchers said.
The investigators also examined patient-reported outcomes from 391 respondents who received migraine care from neurology and 399 respondents who received migraine care from primary care. “Patients who consulted a neurologist were likely to report moderate-to-severe disability, poor acute treatment optimization, and major depression,” they said. “Allodynia, anxiety, and PTSD did not differ by type of provider.”
Confounding may have influenced the results, and the researchers plan to assess factors such as headache frequency and severity using patient-reported survey data in future analyses.
The Migraine Signature Study was supported by Amgen, Inc.
PHILADELPHIA – , said Alice R. Pressman, PhD at the annual meeting of the American Headache Society.
Dr. Pressman, executive director of research, development, and dissemination for Sutter Health, and her research colleagues analyzed data from primary care patients who sought care for migraine in the Sutter Health healthcare network in Northern California. They found that women were 10% more likely than men to consult a neurologist and that Asian patients had a longer time to a first neurology encounter for migraine, compared with Caucasian patients.
“Those who sought care from neurology had more severe migraine symptomology, disability, and comorbidities,” the researchers reported. Furthermore, patients with migraine seen by neurologists were more likely to receive prescriptions for acute and preventive migraine medications, compared with patients only seen by primary care physicians.
The study, known as the Migraine Signature Study, used electronic health records (EHR) and patient-reported questionnaire data to examine the clinical experiences and care of patients with migraine.
The primary care population consisted of 1.4 million adults with at least one office visit to primary care in 2013-2017. Using the validated Migraine Probability Algorithm, the researchers identified approximately 94,000 patients who sought care for migraine.
The investigators also invited 38,536 patients to complete an online survey about migraine criteria, symptomology, health resource utilization, and patient-reported outcomes such as disability, acute treatment optimization, cutaneous allodynia, depression, anxiety, and posttraumatic stress disorder (PTSD).
Of the patients who sought care for migraine, 72,624 patients did not receive migraine care from neurology, and 21,525 did.
Patients with migraine care from a neurologist were more likely to have at least one acute migraine medication order (89.4% vs. 80.6%), at least one preventive migraine medication order (78.6% vs. 49.1%), and any migraine medication order (95.3% vs. 85.9%). In addition, those with at least one medication order in the primary care setting had fewer orders per person per year, compared with those with at least one medication order in the neurology setting (1.1 vs. 1.6).
About one-third of the patients who sought care for migraine had no migraine encounters in the first 12 months of the study. Of the more than 33,000 patients with first migraine consults, approximately two-thirds did not receive a neurology consultation during the study and received their migraine diagnosis in the primary care setting.
Of the 31% of patients with first migraine consults in primary care who later had a neurology consult, two-thirds received a migraine diagnosis from neurology. “The high rate of initial migraine diagnosis within neurology was surprising among this sample with primary care encounters first,” the researchers said.
The investigators also examined patient-reported outcomes from 391 respondents who received migraine care from neurology and 399 respondents who received migraine care from primary care. “Patients who consulted a neurologist were likely to report moderate-to-severe disability, poor acute treatment optimization, and major depression,” they said. “Allodynia, anxiety, and PTSD did not differ by type of provider.”
Confounding may have influenced the results, and the researchers plan to assess factors such as headache frequency and severity using patient-reported survey data in future analyses.
The Migraine Signature Study was supported by Amgen, Inc.
PHILADELPHIA – , said Alice R. Pressman, PhD at the annual meeting of the American Headache Society.
Dr. Pressman, executive director of research, development, and dissemination for Sutter Health, and her research colleagues analyzed data from primary care patients who sought care for migraine in the Sutter Health healthcare network in Northern California. They found that women were 10% more likely than men to consult a neurologist and that Asian patients had a longer time to a first neurology encounter for migraine, compared with Caucasian patients.
“Those who sought care from neurology had more severe migraine symptomology, disability, and comorbidities,” the researchers reported. Furthermore, patients with migraine seen by neurologists were more likely to receive prescriptions for acute and preventive migraine medications, compared with patients only seen by primary care physicians.
The study, known as the Migraine Signature Study, used electronic health records (EHR) and patient-reported questionnaire data to examine the clinical experiences and care of patients with migraine.
The primary care population consisted of 1.4 million adults with at least one office visit to primary care in 2013-2017. Using the validated Migraine Probability Algorithm, the researchers identified approximately 94,000 patients who sought care for migraine.
The investigators also invited 38,536 patients to complete an online survey about migraine criteria, symptomology, health resource utilization, and patient-reported outcomes such as disability, acute treatment optimization, cutaneous allodynia, depression, anxiety, and posttraumatic stress disorder (PTSD).
Of the patients who sought care for migraine, 72,624 patients did not receive migraine care from neurology, and 21,525 did.
Patients with migraine care from a neurologist were more likely to have at least one acute migraine medication order (89.4% vs. 80.6%), at least one preventive migraine medication order (78.6% vs. 49.1%), and any migraine medication order (95.3% vs. 85.9%). In addition, those with at least one medication order in the primary care setting had fewer orders per person per year, compared with those with at least one medication order in the neurology setting (1.1 vs. 1.6).
About one-third of the patients who sought care for migraine had no migraine encounters in the first 12 months of the study. Of the more than 33,000 patients with first migraine consults, approximately two-thirds did not receive a neurology consultation during the study and received their migraine diagnosis in the primary care setting.
Of the 31% of patients with first migraine consults in primary care who later had a neurology consult, two-thirds received a migraine diagnosis from neurology. “The high rate of initial migraine diagnosis within neurology was surprising among this sample with primary care encounters first,” the researchers said.
The investigators also examined patient-reported outcomes from 391 respondents who received migraine care from neurology and 399 respondents who received migraine care from primary care. “Patients who consulted a neurologist were likely to report moderate-to-severe disability, poor acute treatment optimization, and major depression,” they said. “Allodynia, anxiety, and PTSD did not differ by type of provider.”
Confounding may have influenced the results, and the researchers plan to assess factors such as headache frequency and severity using patient-reported survey data in future analyses.
The Migraine Signature Study was supported by Amgen, Inc.
EXPERT ANALYSIS FROM AHS 2019
Can mindfulness-based cognitive therapy treat migraine?
PHILADELPHIA – , according to randomized clinical trial results.
“The fact that people can improve how they live their daily life even with the same amount of headache days and the same pain intensity is remarkable,” said study investigator Elizabeth K. Seng, PhD, associate professor of psychology at Yeshiva University and research associate professor of neurology at Albert Einstein College of Medicine, both in New York. “I think this gives us a little bit of a clue about when to use these kinds of treatments.”
Dr. Seng presented findings from the phase 2b pilot trial at the annual meeting of the American Headache Society.
To study the efficacy of mindfulness-based cognitive therapy for migraine, Dr. Seng and her research colleagues recruited participants with migraine in the New York City area between 2015 and 2018. In all, 60 patients were randomized to receive 8 weekly individual 75-minute mindfulness-based cognitive therapy for migraine sessions or 8 weeks on a wait list with treatment as usual.
Primary outcomes were Month 0 to Month 4 changes in perceived disability, measured using the Henry Ford Disability Inventory (HDI) and functional disability measured using the Migraine Disability Assessment Scale (MIDAS). Secondary outcomes included changes in headache days per 30 days and headache pain intensity.
Participants had a mean age of about 40 years, about 92% were women, and approximately half of the patients had chronic migraine. Participants had an average baseline HDI of 51.4, and 83.3% had MIDAS scores indicating severe disability. Patients averaged 10.4 headache attack days per month, and mean headache attack severity on a 0-10 scale was 6.2. Attrition did not significantly differ between the mindfulness-based cognitive therapy and control groups.
Patients who received mindfulness-based cognitive therapy for migraine experienced an approximately 15-point reduction on the HDI scale at 4 months, whereas wait-listed patients did not experience much of a change, Dr. Seng said. The difference between groups was statistically significant.
At 4 months, a smaller proportion of patients in the mindfulness-based cognitive therapy group had a MIDAS score of 21 or greater, but the difference between groups was not statistically significant. The data indicate a large effect that the study was underpowered to detect, Dr. Seng said.
A planned subgroup analysis found that mindfulness-based cognitive therapy produced changes in disability that were greater in patients with episodic migraine, compared with patients with chronic migraine. A reduction in MIDAS scores was statistically significant among patients with episodic migraine.
During the trial, one patient experienced increased headache frequency and intensity and changed their preventive treatment regimen, which investigators considered unrelated to mindfulness-based cognitive therapy. In addition, one patient experienced flooding – a vivid recollection of a traumatic event – which is an expected effect of meditation and relaxation therapy, Dr. Seng said. The patient completed the study and was satisfied with the mindfulness-based cognitive therapy training, she said.
“Preliminary evidence suggests that mindfulness-based cognitive therapy could be recommended to reduce headache-related disability in people with episodic migraine or people who have some kind of effective prevention on board, but they are still experiencing high levels of disability,” Dr. Seng said.
Although flooding may occur in patients with a trauma history who use meditation and relaxation, the techniques still may be useful, Dr. Seng said. “In the VA setting, we use meditation and relaxation all the time. But it helps to forewarn patients that they might experience distressful flooding and [to provide] techniques that they can use to reduce the impact of that.”
PHILADELPHIA – , according to randomized clinical trial results.
“The fact that people can improve how they live their daily life even with the same amount of headache days and the same pain intensity is remarkable,” said study investigator Elizabeth K. Seng, PhD, associate professor of psychology at Yeshiva University and research associate professor of neurology at Albert Einstein College of Medicine, both in New York. “I think this gives us a little bit of a clue about when to use these kinds of treatments.”
Dr. Seng presented findings from the phase 2b pilot trial at the annual meeting of the American Headache Society.
To study the efficacy of mindfulness-based cognitive therapy for migraine, Dr. Seng and her research colleagues recruited participants with migraine in the New York City area between 2015 and 2018. In all, 60 patients were randomized to receive 8 weekly individual 75-minute mindfulness-based cognitive therapy for migraine sessions or 8 weeks on a wait list with treatment as usual.
Primary outcomes were Month 0 to Month 4 changes in perceived disability, measured using the Henry Ford Disability Inventory (HDI) and functional disability measured using the Migraine Disability Assessment Scale (MIDAS). Secondary outcomes included changes in headache days per 30 days and headache pain intensity.
Participants had a mean age of about 40 years, about 92% were women, and approximately half of the patients had chronic migraine. Participants had an average baseline HDI of 51.4, and 83.3% had MIDAS scores indicating severe disability. Patients averaged 10.4 headache attack days per month, and mean headache attack severity on a 0-10 scale was 6.2. Attrition did not significantly differ between the mindfulness-based cognitive therapy and control groups.
Patients who received mindfulness-based cognitive therapy for migraine experienced an approximately 15-point reduction on the HDI scale at 4 months, whereas wait-listed patients did not experience much of a change, Dr. Seng said. The difference between groups was statistically significant.
At 4 months, a smaller proportion of patients in the mindfulness-based cognitive therapy group had a MIDAS score of 21 or greater, but the difference between groups was not statistically significant. The data indicate a large effect that the study was underpowered to detect, Dr. Seng said.
A planned subgroup analysis found that mindfulness-based cognitive therapy produced changes in disability that were greater in patients with episodic migraine, compared with patients with chronic migraine. A reduction in MIDAS scores was statistically significant among patients with episodic migraine.
During the trial, one patient experienced increased headache frequency and intensity and changed their preventive treatment regimen, which investigators considered unrelated to mindfulness-based cognitive therapy. In addition, one patient experienced flooding – a vivid recollection of a traumatic event – which is an expected effect of meditation and relaxation therapy, Dr. Seng said. The patient completed the study and was satisfied with the mindfulness-based cognitive therapy training, she said.
“Preliminary evidence suggests that mindfulness-based cognitive therapy could be recommended to reduce headache-related disability in people with episodic migraine or people who have some kind of effective prevention on board, but they are still experiencing high levels of disability,” Dr. Seng said.
Although flooding may occur in patients with a trauma history who use meditation and relaxation, the techniques still may be useful, Dr. Seng said. “In the VA setting, we use meditation and relaxation all the time. But it helps to forewarn patients that they might experience distressful flooding and [to provide] techniques that they can use to reduce the impact of that.”
PHILADELPHIA – , according to randomized clinical trial results.
“The fact that people can improve how they live their daily life even with the same amount of headache days and the same pain intensity is remarkable,” said study investigator Elizabeth K. Seng, PhD, associate professor of psychology at Yeshiva University and research associate professor of neurology at Albert Einstein College of Medicine, both in New York. “I think this gives us a little bit of a clue about when to use these kinds of treatments.”
Dr. Seng presented findings from the phase 2b pilot trial at the annual meeting of the American Headache Society.
To study the efficacy of mindfulness-based cognitive therapy for migraine, Dr. Seng and her research colleagues recruited participants with migraine in the New York City area between 2015 and 2018. In all, 60 patients were randomized to receive 8 weekly individual 75-minute mindfulness-based cognitive therapy for migraine sessions or 8 weeks on a wait list with treatment as usual.
Primary outcomes were Month 0 to Month 4 changes in perceived disability, measured using the Henry Ford Disability Inventory (HDI) and functional disability measured using the Migraine Disability Assessment Scale (MIDAS). Secondary outcomes included changes in headache days per 30 days and headache pain intensity.
Participants had a mean age of about 40 years, about 92% were women, and approximately half of the patients had chronic migraine. Participants had an average baseline HDI of 51.4, and 83.3% had MIDAS scores indicating severe disability. Patients averaged 10.4 headache attack days per month, and mean headache attack severity on a 0-10 scale was 6.2. Attrition did not significantly differ between the mindfulness-based cognitive therapy and control groups.
Patients who received mindfulness-based cognitive therapy for migraine experienced an approximately 15-point reduction on the HDI scale at 4 months, whereas wait-listed patients did not experience much of a change, Dr. Seng said. The difference between groups was statistically significant.
At 4 months, a smaller proportion of patients in the mindfulness-based cognitive therapy group had a MIDAS score of 21 or greater, but the difference between groups was not statistically significant. The data indicate a large effect that the study was underpowered to detect, Dr. Seng said.
A planned subgroup analysis found that mindfulness-based cognitive therapy produced changes in disability that were greater in patients with episodic migraine, compared with patients with chronic migraine. A reduction in MIDAS scores was statistically significant among patients with episodic migraine.
During the trial, one patient experienced increased headache frequency and intensity and changed their preventive treatment regimen, which investigators considered unrelated to mindfulness-based cognitive therapy. In addition, one patient experienced flooding – a vivid recollection of a traumatic event – which is an expected effect of meditation and relaxation therapy, Dr. Seng said. The patient completed the study and was satisfied with the mindfulness-based cognitive therapy training, she said.
“Preliminary evidence suggests that mindfulness-based cognitive therapy could be recommended to reduce headache-related disability in people with episodic migraine or people who have some kind of effective prevention on board, but they are still experiencing high levels of disability,” Dr. Seng said.
Although flooding may occur in patients with a trauma history who use meditation and relaxation, the techniques still may be useful, Dr. Seng said. “In the VA setting, we use meditation and relaxation all the time. But it helps to forewarn patients that they might experience distressful flooding and [to provide] techniques that they can use to reduce the impact of that.”
EXPERT ANALYSIS FROM AHS 2019
Telemedicine migraine consults are as effective as in-office visits
PHILADELPHIA – in a single-center, randomized trial with 40 patients, the first reported randomized study of the impact of true telemedicine on mid-term migraine management.
“Telemedicine was viable and produced similar outcomes at 1 year in a highly disabled cohort,” Deborah I. Friedman, MD, said at the annual meeting of the American Headache Society. Many patients expressed high satisfaction with the approach. In addition to resulting in predictably shorter travel times for patients, it also linked with a cut in the consultation length by about a quarter, reported Dr. Friedman, a professor of neurology and chief of the division of headache medicine at UT Southwestern Medical Center in Dallas.
“There is a lot of opportunity for telemedicine, particularly in headache medicine because usually after the first visit we mostly just talk with patients with no further examinations, so it lends itself to telemedicine. It extends your reach.” Dr. Friedman said in a video interview. It is particularly attractive to patients who live a substantial distance from the clinic or find it hard to fit an office visit into their schedule, but some participants said they preferred the direct interaction of an office visit, she noted.
In addition to showing the efficacy of telemedicine in this setting, Dr. Friedman said that she hoped the findings may help pave the way for easier insurance payment for telemedicine consultations with migraineurs.
“One of the main reasons I did this study was to provide evidence to use for compensation for telemedicine visits. It will be good to have evidence in the medical literature that the outcomes are similar and that nothing is lost in patient care with telemedicine,” she said.
The study randomized 40 patients scheduled to see Dr. Friedman for the first time for a migraine consultation and to start treatment. After all patients had their initial office visit and examination, 22 of the patients entered the telemedicine arm and had follow-up consultations after 4-6 weeks, and after 3, 6, 9, and 12 months. The remaining 18 patients were randomized to receive these consultations in the office. Eighteen of the telemedicine patients and 12 of the in-office patients returned for a 12-month assessment. Patients averaged about 40 years old, they had actual or potential travel distances for in-office visits that in some cases exceeded 300 miles one way, and their Migraine Disability Assessment score averaged just above 40.
The telmedicine patients completed 93% of their visits compared with 88% of the in-office patients, a difference that was not statistically different. Migraine Disability Assessment scores improved by an average of 24 points in the telemedicine patients and by an average 19 points among the in-office controls, a difference that was not significant. The two groups also showed similar levels of treatment response for reductions in number of headache days and headache severity improvement. Average session length was 25 minutes with telemedicine and 34 minutes in office, a statistically significant difference that Dr. Friedman attributed to the interest by patients who have traveled long distances to see her to “get their money’s worth” from their visit.
Dr. Friedman highlighted the importance of having the visual aspect of a telemedicine consultation in addition to the conversation. For the trial the audio-visual link was via a standard laptop connection. Some patients assigned to telemedicine voiced regret over not being able to be examined, immediately start a new treatment, or receive drug samples. Dr. Friedman said that she couldn’t think of any migraine patients to whom she wouldn’t offer the option of telemedicine visits following an initial, in-person visit. But her use of telemedicine in routine practice is on hold right now as her institution, UT Southwestern, is still working out its consent and billing system, she said.
The study received partial funding from Merck. Dr. Friedman had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
SOURCE: Friedman DI. Headache. 2019 June;59[S1]:1-208, LBOR01.
PHILADELPHIA – in a single-center, randomized trial with 40 patients, the first reported randomized study of the impact of true telemedicine on mid-term migraine management.
“Telemedicine was viable and produced similar outcomes at 1 year in a highly disabled cohort,” Deborah I. Friedman, MD, said at the annual meeting of the American Headache Society. Many patients expressed high satisfaction with the approach. In addition to resulting in predictably shorter travel times for patients, it also linked with a cut in the consultation length by about a quarter, reported Dr. Friedman, a professor of neurology and chief of the division of headache medicine at UT Southwestern Medical Center in Dallas.
“There is a lot of opportunity for telemedicine, particularly in headache medicine because usually after the first visit we mostly just talk with patients with no further examinations, so it lends itself to telemedicine. It extends your reach.” Dr. Friedman said in a video interview. It is particularly attractive to patients who live a substantial distance from the clinic or find it hard to fit an office visit into their schedule, but some participants said they preferred the direct interaction of an office visit, she noted.
In addition to showing the efficacy of telemedicine in this setting, Dr. Friedman said that she hoped the findings may help pave the way for easier insurance payment for telemedicine consultations with migraineurs.
“One of the main reasons I did this study was to provide evidence to use for compensation for telemedicine visits. It will be good to have evidence in the medical literature that the outcomes are similar and that nothing is lost in patient care with telemedicine,” she said.
The study randomized 40 patients scheduled to see Dr. Friedman for the first time for a migraine consultation and to start treatment. After all patients had their initial office visit and examination, 22 of the patients entered the telemedicine arm and had follow-up consultations after 4-6 weeks, and after 3, 6, 9, and 12 months. The remaining 18 patients were randomized to receive these consultations in the office. Eighteen of the telemedicine patients and 12 of the in-office patients returned for a 12-month assessment. Patients averaged about 40 years old, they had actual or potential travel distances for in-office visits that in some cases exceeded 300 miles one way, and their Migraine Disability Assessment score averaged just above 40.
The telmedicine patients completed 93% of their visits compared with 88% of the in-office patients, a difference that was not statistically different. Migraine Disability Assessment scores improved by an average of 24 points in the telemedicine patients and by an average 19 points among the in-office controls, a difference that was not significant. The two groups also showed similar levels of treatment response for reductions in number of headache days and headache severity improvement. Average session length was 25 minutes with telemedicine and 34 minutes in office, a statistically significant difference that Dr. Friedman attributed to the interest by patients who have traveled long distances to see her to “get their money’s worth” from their visit.
Dr. Friedman highlighted the importance of having the visual aspect of a telemedicine consultation in addition to the conversation. For the trial the audio-visual link was via a standard laptop connection. Some patients assigned to telemedicine voiced regret over not being able to be examined, immediately start a new treatment, or receive drug samples. Dr. Friedman said that she couldn’t think of any migraine patients to whom she wouldn’t offer the option of telemedicine visits following an initial, in-person visit. But her use of telemedicine in routine practice is on hold right now as her institution, UT Southwestern, is still working out its consent and billing system, she said.
The study received partial funding from Merck. Dr. Friedman had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
SOURCE: Friedman DI. Headache. 2019 June;59[S1]:1-208, LBOR01.
PHILADELPHIA – in a single-center, randomized trial with 40 patients, the first reported randomized study of the impact of true telemedicine on mid-term migraine management.
“Telemedicine was viable and produced similar outcomes at 1 year in a highly disabled cohort,” Deborah I. Friedman, MD, said at the annual meeting of the American Headache Society. Many patients expressed high satisfaction with the approach. In addition to resulting in predictably shorter travel times for patients, it also linked with a cut in the consultation length by about a quarter, reported Dr. Friedman, a professor of neurology and chief of the division of headache medicine at UT Southwestern Medical Center in Dallas.
“There is a lot of opportunity for telemedicine, particularly in headache medicine because usually after the first visit we mostly just talk with patients with no further examinations, so it lends itself to telemedicine. It extends your reach.” Dr. Friedman said in a video interview. It is particularly attractive to patients who live a substantial distance from the clinic or find it hard to fit an office visit into their schedule, but some participants said they preferred the direct interaction of an office visit, she noted.
In addition to showing the efficacy of telemedicine in this setting, Dr. Friedman said that she hoped the findings may help pave the way for easier insurance payment for telemedicine consultations with migraineurs.
“One of the main reasons I did this study was to provide evidence to use for compensation for telemedicine visits. It will be good to have evidence in the medical literature that the outcomes are similar and that nothing is lost in patient care with telemedicine,” she said.
The study randomized 40 patients scheduled to see Dr. Friedman for the first time for a migraine consultation and to start treatment. After all patients had their initial office visit and examination, 22 of the patients entered the telemedicine arm and had follow-up consultations after 4-6 weeks, and after 3, 6, 9, and 12 months. The remaining 18 patients were randomized to receive these consultations in the office. Eighteen of the telemedicine patients and 12 of the in-office patients returned for a 12-month assessment. Patients averaged about 40 years old, they had actual or potential travel distances for in-office visits that in some cases exceeded 300 miles one way, and their Migraine Disability Assessment score averaged just above 40.
The telmedicine patients completed 93% of their visits compared with 88% of the in-office patients, a difference that was not statistically different. Migraine Disability Assessment scores improved by an average of 24 points in the telemedicine patients and by an average 19 points among the in-office controls, a difference that was not significant. The two groups also showed similar levels of treatment response for reductions in number of headache days and headache severity improvement. Average session length was 25 minutes with telemedicine and 34 minutes in office, a statistically significant difference that Dr. Friedman attributed to the interest by patients who have traveled long distances to see her to “get their money’s worth” from their visit.
Dr. Friedman highlighted the importance of having the visual aspect of a telemedicine consultation in addition to the conversation. For the trial the audio-visual link was via a standard laptop connection. Some patients assigned to telemedicine voiced regret over not being able to be examined, immediately start a new treatment, or receive drug samples. Dr. Friedman said that she couldn’t think of any migraine patients to whom she wouldn’t offer the option of telemedicine visits following an initial, in-person visit. But her use of telemedicine in routine practice is on hold right now as her institution, UT Southwestern, is still working out its consent and billing system, she said.
The study received partial funding from Merck. Dr. Friedman had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
SOURCE: Friedman DI. Headache. 2019 June;59[S1]:1-208, LBOR01.
REPORTING FROM AHS 2019
How does gender bias affect the headache field?
PHILADELPHIA – , said Elizabeth W. Loder, MD, chief of the Division of Headache and Pain at Brigham and Women’s Hospital in Boston, at the annual meeting of the American Headache Society. Women accrue credentials and are accorded respect as headache experts more slowly than men, she said. They are underrepresented among the speakers at headache conferences and are less likely than men to be invited to write editorials for peer-reviewed publications. Furthermore, a significant proportion of female headache specialists experiences sexual harassment in their professional environments.
Bias also affects interactions between patients and headache specialists, said Dr. Loder. Regardless of their gender, patients expect female care providers to be sympathetic and understanding. If they perceive that a female physician does not sufficiently display these attributes, they often write critical reviews of them on the Internet. In contrast, male physicians are not expected to be particularly caring, and patients praise them highly when they are.
Recognition of these biases is increasing, however. Representation of women in professional societies and on conference programs will improve, and emerging codes of conduct will reduce sexual harassment, said Dr. Loder. Headache specialists can take various steps, such as offering recognition and encouragement, to make the field more welcoming to women and to other disadvantaged groups.
PHILADELPHIA – , said Elizabeth W. Loder, MD, chief of the Division of Headache and Pain at Brigham and Women’s Hospital in Boston, at the annual meeting of the American Headache Society. Women accrue credentials and are accorded respect as headache experts more slowly than men, she said. They are underrepresented among the speakers at headache conferences and are less likely than men to be invited to write editorials for peer-reviewed publications. Furthermore, a significant proportion of female headache specialists experiences sexual harassment in their professional environments.
Bias also affects interactions between patients and headache specialists, said Dr. Loder. Regardless of their gender, patients expect female care providers to be sympathetic and understanding. If they perceive that a female physician does not sufficiently display these attributes, they often write critical reviews of them on the Internet. In contrast, male physicians are not expected to be particularly caring, and patients praise them highly when they are.
Recognition of these biases is increasing, however. Representation of women in professional societies and on conference programs will improve, and emerging codes of conduct will reduce sexual harassment, said Dr. Loder. Headache specialists can take various steps, such as offering recognition and encouragement, to make the field more welcoming to women and to other disadvantaged groups.
PHILADELPHIA – , said Elizabeth W. Loder, MD, chief of the Division of Headache and Pain at Brigham and Women’s Hospital in Boston, at the annual meeting of the American Headache Society. Women accrue credentials and are accorded respect as headache experts more slowly than men, she said. They are underrepresented among the speakers at headache conferences and are less likely than men to be invited to write editorials for peer-reviewed publications. Furthermore, a significant proportion of female headache specialists experiences sexual harassment in their professional environments.
Bias also affects interactions between patients and headache specialists, said Dr. Loder. Regardless of their gender, patients expect female care providers to be sympathetic and understanding. If they perceive that a female physician does not sufficiently display these attributes, they often write critical reviews of them on the Internet. In contrast, male physicians are not expected to be particularly caring, and patients praise them highly when they are.
Recognition of these biases is increasing, however. Representation of women in professional societies and on conference programs will improve, and emerging codes of conduct will reduce sexual harassment, said Dr. Loder. Headache specialists can take various steps, such as offering recognition and encouragement, to make the field more welcoming to women and to other disadvantaged groups.
EXPERT ANALYSIS FROM AHS 2019
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SC daratumumab deemed feasible for every multiple myeloma patient
CHICAGO – Subcutaneous (SC) daratumumab is noninferior to intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma (MM), according findings from a phase 3 trial.
In the COLUMBA trial, SC daratumumab proved noninferior to IV daratumumab with regard to overall response rate and maximum trough concentration (Ctrough).
The safety profiles of the two formulations were similar, although patients who received SC daratumumab had a lower rate of infusion-related reactions. SC daratumumab also had a lower treatment burden.
“The COLUMBA study shows that [SC daratumumab] can be used in every myeloma patient [as a] single agent or, maybe in the future, in combination with the different backbones,” said Maria-Victoria Mateos, MD, PhD, of University Hospital of Salamanca (Spain).
Dr. Mateos presented results from the COLUMBA trial at the annual meeting of the American Society of Clinical Oncology.
Dr. Mateos cited a previous phase 1b study that had suggested that SC daratumumab might produce similar results as IV daratumumab (Blood. 2017;130:838) while providing a more convenient delivery method. She pointed out that infusions of IV daratumumab can last hours, while the SC formulation can be delivered in minutes.
The aim of the phase 3 COLUMBA study was to compare the IV and SC formulations head-to-head. The trial enrolled 522 patients with relapsed/refractory multiple myeloma. They were randomized to receive daratumumab SC (n = 263) or IV (n = 259).
The median patient age was 68 years (range, 33-92 years) in the IV arm and 65 years (range, 42-84 years) in the SC arm. Patients had received a median of four prior lines of therapy (range, 1-15 in the IV arm and 2-12 in the SC arm). Most patients were refractory to their last line of therapy – 85% in the IV arm and 80% in the SC arm – and most patients had standard-risk cytogenetics – 83% and 74%, respectively.
Treatment
Patients received SC daratumumab at 1,800 mg and IV daratumumab at 16 mg/kg. Both were given weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter until disease progression.
The median duration of the first infusion was 421 minutes in the IV arm and 5 minutes in the SC arm. The median duration of the second infusion was 255 minutes and 5 minutes, respectively, and the median duration of subsequent infusions was 205 minutes and 5 minutes, respectively.
At a median follow-up of 7.46 months, 57% of patients in each arm had discontinued the study treatment. The most common reasons for discontinuation were progression – 44% of the IV arm and 43% of the SC arm – and adverse events (AEs) – 8% and 7%, respectively.
Safety
Dr. Mateos said the safety profiles of IV and SC daratumumab were comparable. However, infusion-related reactions were significantly less likely in the SC arm, occurring in 12.7% of those patients and 34.5% of patients in the IV arm (P less than .0001).
Grade 3 or higher treatment-emergent AEs occurred in 49% of patients in the IV arm and 46% of those in the SC arm. Rates of grade 5 AEs were 7% and 5%, respectively. The most common grade 3/4 AEs (in the IV and SC arms, respectively) were anemia (14% and 13%), thrombocytopenia (14% for both), neutropenia (8% and 13%), lymphopenia (6% and 5%), and hypertension (6% and 3%).
Efficacy
One of the study’s primary endpoints was overall response rate, which was 37.1% in the IV arm and 41.1% in the SC arm (relative risk, 1.11; 95% CI, 0.89-1.37; P less than .0001). This met the criteria for noninferiority, and overall response rates were comparable across all patient subgroups, Dr. Mateos noted.
The rates of complete response or stringent complete response were also comparable at 2.7% in the IV arm and 1.9% in the SC arm. Rates of very good partial response were 17.0% and 19.0%, respectively.
The study’s other primary endpoint was maximum Ctrough predose on day 1 of cycle 3. The ratio of maximum Ctrough for daratumumab SC over IV was 107.93% (90% CI, 95.74%-121.67%), which met the noninferiority criterion.
Survival outcomes were also similar between the IV and SC arms. The median progression-free survival was 6.1 months and 5.6 months, respectively (P = .9258). The rate of overall survival at 6 months was 83.0% and 87.5%, respectively (P = .6032).
Considering these results together, Dr. Mateos and colleagues concluded that SC daratumumab is noninferior to IV daratumumab.
“[SC daratumumab] has a reduced treatment burden due to a considerably shorter administration duration, and patients treated with [SC daratumumab] reported higher satisfaction with therapy,” Dr. Mateos said.
The results support the use of flat-dose 1,800-mg SC daratumumab, which is comparable with the IV formulation, she said.
The COLUMBA trial was sponsored by Janssen Research & Development. Dr. Mateos reported relationships with Amgen, Celgene, Janssen-Cilag, and Takeda.
SOURCE: Mateos MV et al. ASCO 2019, Abstract 8005.
CHICAGO – Subcutaneous (SC) daratumumab is noninferior to intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma (MM), according findings from a phase 3 trial.
In the COLUMBA trial, SC daratumumab proved noninferior to IV daratumumab with regard to overall response rate and maximum trough concentration (Ctrough).
The safety profiles of the two formulations were similar, although patients who received SC daratumumab had a lower rate of infusion-related reactions. SC daratumumab also had a lower treatment burden.
“The COLUMBA study shows that [SC daratumumab] can be used in every myeloma patient [as a] single agent or, maybe in the future, in combination with the different backbones,” said Maria-Victoria Mateos, MD, PhD, of University Hospital of Salamanca (Spain).
Dr. Mateos presented results from the COLUMBA trial at the annual meeting of the American Society of Clinical Oncology.
Dr. Mateos cited a previous phase 1b study that had suggested that SC daratumumab might produce similar results as IV daratumumab (Blood. 2017;130:838) while providing a more convenient delivery method. She pointed out that infusions of IV daratumumab can last hours, while the SC formulation can be delivered in minutes.
The aim of the phase 3 COLUMBA study was to compare the IV and SC formulations head-to-head. The trial enrolled 522 patients with relapsed/refractory multiple myeloma. They were randomized to receive daratumumab SC (n = 263) or IV (n = 259).
The median patient age was 68 years (range, 33-92 years) in the IV arm and 65 years (range, 42-84 years) in the SC arm. Patients had received a median of four prior lines of therapy (range, 1-15 in the IV arm and 2-12 in the SC arm). Most patients were refractory to their last line of therapy – 85% in the IV arm and 80% in the SC arm – and most patients had standard-risk cytogenetics – 83% and 74%, respectively.
Treatment
Patients received SC daratumumab at 1,800 mg and IV daratumumab at 16 mg/kg. Both were given weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter until disease progression.
The median duration of the first infusion was 421 minutes in the IV arm and 5 minutes in the SC arm. The median duration of the second infusion was 255 minutes and 5 minutes, respectively, and the median duration of subsequent infusions was 205 minutes and 5 minutes, respectively.
At a median follow-up of 7.46 months, 57% of patients in each arm had discontinued the study treatment. The most common reasons for discontinuation were progression – 44% of the IV arm and 43% of the SC arm – and adverse events (AEs) – 8% and 7%, respectively.
Safety
Dr. Mateos said the safety profiles of IV and SC daratumumab were comparable. However, infusion-related reactions were significantly less likely in the SC arm, occurring in 12.7% of those patients and 34.5% of patients in the IV arm (P less than .0001).
Grade 3 or higher treatment-emergent AEs occurred in 49% of patients in the IV arm and 46% of those in the SC arm. Rates of grade 5 AEs were 7% and 5%, respectively. The most common grade 3/4 AEs (in the IV and SC arms, respectively) were anemia (14% and 13%), thrombocytopenia (14% for both), neutropenia (8% and 13%), lymphopenia (6% and 5%), and hypertension (6% and 3%).
Efficacy
One of the study’s primary endpoints was overall response rate, which was 37.1% in the IV arm and 41.1% in the SC arm (relative risk, 1.11; 95% CI, 0.89-1.37; P less than .0001). This met the criteria for noninferiority, and overall response rates were comparable across all patient subgroups, Dr. Mateos noted.
The rates of complete response or stringent complete response were also comparable at 2.7% in the IV arm and 1.9% in the SC arm. Rates of very good partial response were 17.0% and 19.0%, respectively.
The study’s other primary endpoint was maximum Ctrough predose on day 1 of cycle 3. The ratio of maximum Ctrough for daratumumab SC over IV was 107.93% (90% CI, 95.74%-121.67%), which met the noninferiority criterion.
Survival outcomes were also similar between the IV and SC arms. The median progression-free survival was 6.1 months and 5.6 months, respectively (P = .9258). The rate of overall survival at 6 months was 83.0% and 87.5%, respectively (P = .6032).
Considering these results together, Dr. Mateos and colleagues concluded that SC daratumumab is noninferior to IV daratumumab.
“[SC daratumumab] has a reduced treatment burden due to a considerably shorter administration duration, and patients treated with [SC daratumumab] reported higher satisfaction with therapy,” Dr. Mateos said.
The results support the use of flat-dose 1,800-mg SC daratumumab, which is comparable with the IV formulation, she said.
The COLUMBA trial was sponsored by Janssen Research & Development. Dr. Mateos reported relationships with Amgen, Celgene, Janssen-Cilag, and Takeda.
SOURCE: Mateos MV et al. ASCO 2019, Abstract 8005.
CHICAGO – Subcutaneous (SC) daratumumab is noninferior to intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma (MM), according findings from a phase 3 trial.
In the COLUMBA trial, SC daratumumab proved noninferior to IV daratumumab with regard to overall response rate and maximum trough concentration (Ctrough).
The safety profiles of the two formulations were similar, although patients who received SC daratumumab had a lower rate of infusion-related reactions. SC daratumumab also had a lower treatment burden.
“The COLUMBA study shows that [SC daratumumab] can be used in every myeloma patient [as a] single agent or, maybe in the future, in combination with the different backbones,” said Maria-Victoria Mateos, MD, PhD, of University Hospital of Salamanca (Spain).
Dr. Mateos presented results from the COLUMBA trial at the annual meeting of the American Society of Clinical Oncology.
Dr. Mateos cited a previous phase 1b study that had suggested that SC daratumumab might produce similar results as IV daratumumab (Blood. 2017;130:838) while providing a more convenient delivery method. She pointed out that infusions of IV daratumumab can last hours, while the SC formulation can be delivered in minutes.
The aim of the phase 3 COLUMBA study was to compare the IV and SC formulations head-to-head. The trial enrolled 522 patients with relapsed/refractory multiple myeloma. They were randomized to receive daratumumab SC (n = 263) or IV (n = 259).
The median patient age was 68 years (range, 33-92 years) in the IV arm and 65 years (range, 42-84 years) in the SC arm. Patients had received a median of four prior lines of therapy (range, 1-15 in the IV arm and 2-12 in the SC arm). Most patients were refractory to their last line of therapy – 85% in the IV arm and 80% in the SC arm – and most patients had standard-risk cytogenetics – 83% and 74%, respectively.
Treatment
Patients received SC daratumumab at 1,800 mg and IV daratumumab at 16 mg/kg. Both were given weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter until disease progression.
The median duration of the first infusion was 421 minutes in the IV arm and 5 minutes in the SC arm. The median duration of the second infusion was 255 minutes and 5 minutes, respectively, and the median duration of subsequent infusions was 205 minutes and 5 minutes, respectively.
At a median follow-up of 7.46 months, 57% of patients in each arm had discontinued the study treatment. The most common reasons for discontinuation were progression – 44% of the IV arm and 43% of the SC arm – and adverse events (AEs) – 8% and 7%, respectively.
Safety
Dr. Mateos said the safety profiles of IV and SC daratumumab were comparable. However, infusion-related reactions were significantly less likely in the SC arm, occurring in 12.7% of those patients and 34.5% of patients in the IV arm (P less than .0001).
Grade 3 or higher treatment-emergent AEs occurred in 49% of patients in the IV arm and 46% of those in the SC arm. Rates of grade 5 AEs were 7% and 5%, respectively. The most common grade 3/4 AEs (in the IV and SC arms, respectively) were anemia (14% and 13%), thrombocytopenia (14% for both), neutropenia (8% and 13%), lymphopenia (6% and 5%), and hypertension (6% and 3%).
Efficacy
One of the study’s primary endpoints was overall response rate, which was 37.1% in the IV arm and 41.1% in the SC arm (relative risk, 1.11; 95% CI, 0.89-1.37; P less than .0001). This met the criteria for noninferiority, and overall response rates were comparable across all patient subgroups, Dr. Mateos noted.
The rates of complete response or stringent complete response were also comparable at 2.7% in the IV arm and 1.9% in the SC arm. Rates of very good partial response were 17.0% and 19.0%, respectively.
The study’s other primary endpoint was maximum Ctrough predose on day 1 of cycle 3. The ratio of maximum Ctrough for daratumumab SC over IV was 107.93% (90% CI, 95.74%-121.67%), which met the noninferiority criterion.
Survival outcomes were also similar between the IV and SC arms. The median progression-free survival was 6.1 months and 5.6 months, respectively (P = .9258). The rate of overall survival at 6 months was 83.0% and 87.5%, respectively (P = .6032).
Considering these results together, Dr. Mateos and colleagues concluded that SC daratumumab is noninferior to IV daratumumab.
“[SC daratumumab] has a reduced treatment burden due to a considerably shorter administration duration, and patients treated with [SC daratumumab] reported higher satisfaction with therapy,” Dr. Mateos said.
The results support the use of flat-dose 1,800-mg SC daratumumab, which is comparable with the IV formulation, she said.
The COLUMBA trial was sponsored by Janssen Research & Development. Dr. Mateos reported relationships with Amgen, Celgene, Janssen-Cilag, and Takeda.
SOURCE: Mateos MV et al. ASCO 2019, Abstract 8005.
REPORTING FROM ASCO 2019