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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
VIDEO: PsA Fast Facts: Psoriatic arthritis types
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
Dr. Alexis Ogdie discusses the latest research in psoriatic arthritis
What's new with potential treatment options such as tildrakizumab? Given the roles obesity and metabolic disease play in psoriatic arthritis, how does weight loss affect treatment response? Alexis Ogdie, MD, director of the psoriatic arthritis clinic at the University of Pennsylvania in Philadelphia, talks about the latest developments in psoriatic arthritis research.
What's new with potential treatment options such as tildrakizumab? Given the roles obesity and metabolic disease play in psoriatic arthritis, how does weight loss affect treatment response? Alexis Ogdie, MD, director of the psoriatic arthritis clinic at the University of Pennsylvania in Philadelphia, talks about the latest developments in psoriatic arthritis research.
What's new with potential treatment options such as tildrakizumab? Given the roles obesity and metabolic disease play in psoriatic arthritis, how does weight loss affect treatment response? Alexis Ogdie, MD, director of the psoriatic arthritis clinic at the University of Pennsylvania in Philadelphia, talks about the latest developments in psoriatic arthritis research.
RNase drug shows promise for Sjögren’s fatigue
MADRID – RSLV-132, a novel drug that eliminates circulating nucleic acids, improved the symptoms of mental fatigue in patients with primary Sjögren’s syndrome (pSS) in a phase 2, double-blind, randomized, placebo-controlled “proof-of-concept” study.
The mental component of fatigue on the Profile of Fatigue (PRO-F) scale improved by 1.53 points among the patients given RSLV-132, while there was a worsening of 0.06 points in the placebo group (P = .046). Scores range from 0 to 7 on the PRO-F.
There were also improvements in some patient-reported outcomes, namely the EULAR pSS Patient Reported Index (ESSPRI) and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (FACIT-F), and improvement of neuropsychological measures of cognitive function, but none were statistically significant. All of these outcomes, including fatigue, were secondary outcomes of the study.
“Fatigue is a major issue for patients with Sjögren’s syndrome,” Wan-Fai Ng, MBChB, PhD, said in an interview at the European Congress of Rheumatology. Indeed, fatigue can be disabling in the majority of individuals, he added.
Currently, the best way to manage fatigue is to first ask about it, said Dr. Ng, who is professor of rheumatology at the Institute of Cellular Medicine at Newcastle University, Newcastle-upon-Tyne, England. He then checks for any underlying problem that could be better managed – sleep problems or anemia, for example – and optimizes treatment for any underlying disease. “I think many people would at least feel satisfied that people take the symptoms seriously.”
Dr. Ng and his coauthors investigated the effects of RSLV-132, a first-in-class human RNase fused to the human Fc domain of human immunoglobulin (Ig) G1, in the RESOLVE 132-04 study. This novel drug been designed to increase serum RNase activity to digest RNA-associated immune complexes, Dr. Ng and associates observed in their abstract. As a consequence of this, they say, activation of toll-like receptors and the production of interferon (IFN) is affected, as is B-cell proliferation and the production of autoantibodies – all mechanisms that are “key to pSS pathogenesis.”
The IFN pathway has been implicated in fatigue, Dr. Ng observed when he presented the RESOLVE 132-04 study’s findings, which involved 30 patients with pSS who had been treated for 3 months. Inclusion criteria were pSS as defined by the American-European Consensus Group 2002 criteria, anti-Ro antibody positivity, and increased expression of three IFN-regulated genes: HERC5, EPSTI1, and CMPK2. Exclusion criteria were the use of hydroxychloroquine, prednisolone at daily doses above 10 mg, and the use of biologic disease-modifying antirheumatic drugs.
Patients were randomized in a 3:1 ratio to receive either 10 mg/kg of RSLV-132 (n = 20) or placebo (n = 8) at weeks 0, 1, 2, and then every fortnight until week 12. Dr. Ng noted that although 30 patients were randomized, two patients had dropped out in the placebo group before they could be “treated.”
The primary endpoint was the change in the blood cell gene expression or serum protein levels indicative of reduced inflammation. The results indicated reductions in noncoding RNA molecules in patients who received RSLV-132 versus placebo, “consistent with the mode of action of the molecule.” In addition, “the majority of inflammatory markers were reduced,” Dr. Ng said.
Another finding showed a nonsignificant trend for improvement of 0.8 units in the physical component in the RSLV-132 group, compared against 0.06 units with placebo (P = .142).
Patients who received RSLV-132 reduced the time needed to complete the Digital Symbol Substitution Test by 16.4 s, compared with an increase of 2.8 s for placebo (P = .024).
Similar trends were observed for ESSPRI and FACIT-F scores.
These are very early data and clearly a bigger study would be needed before any conclusions could be drawn, Dr. Ng said in an interview. What these data suggest is that “maybe there is some way that we could manage fatigue, and we just need to go and explore that.”
RSLV-132 has also been studied in patients with systemic lupus erythematosus (Lupus. 2017;26:825-34).
The trial was sponsored by Resolve Therapeutics. Dr. Ng was an investigator in the trial and disclosed other research collaborations with electroCore, GlaxoSmithKline, and AbbVie. He also disclosed acting as a consultant for Novartis, GlaxoSmithKline, AbbVie, MedImmune, Pfizer, and Bristol-Myers Squibb.
Source: Fisher B et al. Ann Rheum Dis. 2019 Jun;78(suppl 2):177, Abstract OP0202. doi: 10.1136/annrheumdis-2019-eular.3098.
MADRID – RSLV-132, a novel drug that eliminates circulating nucleic acids, improved the symptoms of mental fatigue in patients with primary Sjögren’s syndrome (pSS) in a phase 2, double-blind, randomized, placebo-controlled “proof-of-concept” study.
The mental component of fatigue on the Profile of Fatigue (PRO-F) scale improved by 1.53 points among the patients given RSLV-132, while there was a worsening of 0.06 points in the placebo group (P = .046). Scores range from 0 to 7 on the PRO-F.
There were also improvements in some patient-reported outcomes, namely the EULAR pSS Patient Reported Index (ESSPRI) and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (FACIT-F), and improvement of neuropsychological measures of cognitive function, but none were statistically significant. All of these outcomes, including fatigue, were secondary outcomes of the study.
“Fatigue is a major issue for patients with Sjögren’s syndrome,” Wan-Fai Ng, MBChB, PhD, said in an interview at the European Congress of Rheumatology. Indeed, fatigue can be disabling in the majority of individuals, he added.
Currently, the best way to manage fatigue is to first ask about it, said Dr. Ng, who is professor of rheumatology at the Institute of Cellular Medicine at Newcastle University, Newcastle-upon-Tyne, England. He then checks for any underlying problem that could be better managed – sleep problems or anemia, for example – and optimizes treatment for any underlying disease. “I think many people would at least feel satisfied that people take the symptoms seriously.”
Dr. Ng and his coauthors investigated the effects of RSLV-132, a first-in-class human RNase fused to the human Fc domain of human immunoglobulin (Ig) G1, in the RESOLVE 132-04 study. This novel drug been designed to increase serum RNase activity to digest RNA-associated immune complexes, Dr. Ng and associates observed in their abstract. As a consequence of this, they say, activation of toll-like receptors and the production of interferon (IFN) is affected, as is B-cell proliferation and the production of autoantibodies – all mechanisms that are “key to pSS pathogenesis.”
The IFN pathway has been implicated in fatigue, Dr. Ng observed when he presented the RESOLVE 132-04 study’s findings, which involved 30 patients with pSS who had been treated for 3 months. Inclusion criteria were pSS as defined by the American-European Consensus Group 2002 criteria, anti-Ro antibody positivity, and increased expression of three IFN-regulated genes: HERC5, EPSTI1, and CMPK2. Exclusion criteria were the use of hydroxychloroquine, prednisolone at daily doses above 10 mg, and the use of biologic disease-modifying antirheumatic drugs.
Patients were randomized in a 3:1 ratio to receive either 10 mg/kg of RSLV-132 (n = 20) or placebo (n = 8) at weeks 0, 1, 2, and then every fortnight until week 12. Dr. Ng noted that although 30 patients were randomized, two patients had dropped out in the placebo group before they could be “treated.”
The primary endpoint was the change in the blood cell gene expression or serum protein levels indicative of reduced inflammation. The results indicated reductions in noncoding RNA molecules in patients who received RSLV-132 versus placebo, “consistent with the mode of action of the molecule.” In addition, “the majority of inflammatory markers were reduced,” Dr. Ng said.
Another finding showed a nonsignificant trend for improvement of 0.8 units in the physical component in the RSLV-132 group, compared against 0.06 units with placebo (P = .142).
Patients who received RSLV-132 reduced the time needed to complete the Digital Symbol Substitution Test by 16.4 s, compared with an increase of 2.8 s for placebo (P = .024).
Similar trends were observed for ESSPRI and FACIT-F scores.
These are very early data and clearly a bigger study would be needed before any conclusions could be drawn, Dr. Ng said in an interview. What these data suggest is that “maybe there is some way that we could manage fatigue, and we just need to go and explore that.”
RSLV-132 has also been studied in patients with systemic lupus erythematosus (Lupus. 2017;26:825-34).
The trial was sponsored by Resolve Therapeutics. Dr. Ng was an investigator in the trial and disclosed other research collaborations with electroCore, GlaxoSmithKline, and AbbVie. He also disclosed acting as a consultant for Novartis, GlaxoSmithKline, AbbVie, MedImmune, Pfizer, and Bristol-Myers Squibb.
Source: Fisher B et al. Ann Rheum Dis. 2019 Jun;78(suppl 2):177, Abstract OP0202. doi: 10.1136/annrheumdis-2019-eular.3098.
MADRID – RSLV-132, a novel drug that eliminates circulating nucleic acids, improved the symptoms of mental fatigue in patients with primary Sjögren’s syndrome (pSS) in a phase 2, double-blind, randomized, placebo-controlled “proof-of-concept” study.
The mental component of fatigue on the Profile of Fatigue (PRO-F) scale improved by 1.53 points among the patients given RSLV-132, while there was a worsening of 0.06 points in the placebo group (P = .046). Scores range from 0 to 7 on the PRO-F.
There were also improvements in some patient-reported outcomes, namely the EULAR pSS Patient Reported Index (ESSPRI) and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (FACIT-F), and improvement of neuropsychological measures of cognitive function, but none were statistically significant. All of these outcomes, including fatigue, were secondary outcomes of the study.
“Fatigue is a major issue for patients with Sjögren’s syndrome,” Wan-Fai Ng, MBChB, PhD, said in an interview at the European Congress of Rheumatology. Indeed, fatigue can be disabling in the majority of individuals, he added.
Currently, the best way to manage fatigue is to first ask about it, said Dr. Ng, who is professor of rheumatology at the Institute of Cellular Medicine at Newcastle University, Newcastle-upon-Tyne, England. He then checks for any underlying problem that could be better managed – sleep problems or anemia, for example – and optimizes treatment for any underlying disease. “I think many people would at least feel satisfied that people take the symptoms seriously.”
Dr. Ng and his coauthors investigated the effects of RSLV-132, a first-in-class human RNase fused to the human Fc domain of human immunoglobulin (Ig) G1, in the RESOLVE 132-04 study. This novel drug been designed to increase serum RNase activity to digest RNA-associated immune complexes, Dr. Ng and associates observed in their abstract. As a consequence of this, they say, activation of toll-like receptors and the production of interferon (IFN) is affected, as is B-cell proliferation and the production of autoantibodies – all mechanisms that are “key to pSS pathogenesis.”
The IFN pathway has been implicated in fatigue, Dr. Ng observed when he presented the RESOLVE 132-04 study’s findings, which involved 30 patients with pSS who had been treated for 3 months. Inclusion criteria were pSS as defined by the American-European Consensus Group 2002 criteria, anti-Ro antibody positivity, and increased expression of three IFN-regulated genes: HERC5, EPSTI1, and CMPK2. Exclusion criteria were the use of hydroxychloroquine, prednisolone at daily doses above 10 mg, and the use of biologic disease-modifying antirheumatic drugs.
Patients were randomized in a 3:1 ratio to receive either 10 mg/kg of RSLV-132 (n = 20) or placebo (n = 8) at weeks 0, 1, 2, and then every fortnight until week 12. Dr. Ng noted that although 30 patients were randomized, two patients had dropped out in the placebo group before they could be “treated.”
The primary endpoint was the change in the blood cell gene expression or serum protein levels indicative of reduced inflammation. The results indicated reductions in noncoding RNA molecules in patients who received RSLV-132 versus placebo, “consistent with the mode of action of the molecule.” In addition, “the majority of inflammatory markers were reduced,” Dr. Ng said.
Another finding showed a nonsignificant trend for improvement of 0.8 units in the physical component in the RSLV-132 group, compared against 0.06 units with placebo (P = .142).
Patients who received RSLV-132 reduced the time needed to complete the Digital Symbol Substitution Test by 16.4 s, compared with an increase of 2.8 s for placebo (P = .024).
Similar trends were observed for ESSPRI and FACIT-F scores.
These are very early data and clearly a bigger study would be needed before any conclusions could be drawn, Dr. Ng said in an interview. What these data suggest is that “maybe there is some way that we could manage fatigue, and we just need to go and explore that.”
RSLV-132 has also been studied in patients with systemic lupus erythematosus (Lupus. 2017;26:825-34).
The trial was sponsored by Resolve Therapeutics. Dr. Ng was an investigator in the trial and disclosed other research collaborations with electroCore, GlaxoSmithKline, and AbbVie. He also disclosed acting as a consultant for Novartis, GlaxoSmithKline, AbbVie, MedImmune, Pfizer, and Bristol-Myers Squibb.
Source: Fisher B et al. Ann Rheum Dis. 2019 Jun;78(suppl 2):177, Abstract OP0202. doi: 10.1136/annrheumdis-2019-eular.3098.
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