Integrating geriatric assessments into oncology consultations for older patients with cancer could help address aging-related concerns about their disease and treatment, a study has found.

In a study published in JAMA Oncology, researchers reported the outcomes of a cluster-randomized clinical trial involving 541 cancer patients aged 70 years and older, from 31 community oncology practices.

The trial examined the effects of an intervention in which the patient’s oncologist was provided with a geriatric assessment summary of that patient’s age-related impairments, and guided recommendations on how to manage these.

“As an example, the summary would include information that a patient recently fell, that falls increase the risk of chemotherapy toxic effects, and a recommendation for physical therapy to prevent falls,” wrote Supriya G. Mohile, MD, of the University of Rochester (N.Y.), and coauthors. The usual care control arm provided oncologists with alerts only if their patients had scored abnormally on depression and cognitive tests.

The study found that over 6 months, patients in the intervention group reported significantly greater satisfaction with communication about aging-related concerns and greater satisfaction with their overall care.

The intervention group had an adjusted mean of 8.02 conversations about aging-related concerns compared with 4.43 conversations in the usual care group, and an adjusted mean of 4.6 high-quality conversations compared with 2.59 in the usual care group. There were also significantly more conversations about the assessment recommendations in the intervention group compared with the usual care group.

There were no significant differences between the two groups in health-related quality of life for patients or their caregivers. However, caregivers in the intervention group did report significantly greater satisfaction with communication about aging-related concerns and the patient’s condition. They also reported significantly greater satisfaction with their own communications with oncologists about overall care.

“Evidence increasingly supports the use of GA for evaluation and management of older patients with cancer to guide shared decision-making between older patients, caregivers, and oncologists,” the authors wrote. “Despite patient and caregiver concerns and preferences for maintaining function and cognition, oncologists often do not discuss implications of aging-related conditions or inform older patients and caregivers of heightened risk of adverse events from treatment.”

Overall, 90% of patients had at least three geriatric assessment domain impairments; 93.7% had impairments in physical performance, 25.1% reported impairments in psychological status, and 33.3% had possible cognitive impairments.

“These patients represent less-fit individuals for whom there is limited evidence for the risks and benefits of cancer treatment, yet these patients are commonly seen in real-world community practices,” the authors wrote.

The study was supported by funding and individual research grants from the Patient-Centered Outcomes Research Institute, the University of Rochester, the National Institute of Aging, and the National Cancer Institute. Two authors also declared funding from the pharmaceutical sector outside the study.

SOURCE: Mohile S et al. JAMA Oncol. 2019 Nov 7. doi: 10.1001/jamaoncol.2019.4728.

Integrating geriatric assessments into oncology consultations for older patients with cancer could help address aging-related concerns about their disease and treatment, a study has found.

In a study published in JAMA Oncology, researchers reported the outcomes of a cluster-randomized clinical trial involving 541 cancer patients aged 70 years and older, from 31 community oncology practices.

The trial examined the effects of an intervention in which the patient’s oncologist was provided with a geriatric assessment summary of that patient’s age-related impairments, and guided recommendations on how to manage these.

“As an example, the summary would include information that a patient recently fell, that falls increase the risk of chemotherapy toxic effects, and a recommendation for physical therapy to prevent falls,” wrote Supriya G. Mohile, MD, of the University of Rochester (N.Y.), and coauthors. The usual care control arm provided oncologists with alerts only if their patients had scored abnormally on depression and cognitive tests.

The study found that over 6 months, patients in the intervention group reported significantly greater satisfaction with communication about aging-related concerns and greater satisfaction with their overall care.

The intervention group had an adjusted mean of 8.02 conversations about aging-related concerns compared with 4.43 conversations in the usual care group, and an adjusted mean of 4.6 high-quality conversations compared with 2.59 in the usual care group. There were also significantly more conversations about the assessment recommendations in the intervention group compared with the usual care group.

There were no significant differences between the two groups in health-related quality of life for patients or their caregivers. However, caregivers in the intervention group did report significantly greater satisfaction with communication about aging-related concerns and the patient’s condition. They also reported significantly greater satisfaction with their own communications with oncologists about overall care.

“Evidence increasingly supports the use of GA for evaluation and management of older patients with cancer to guide shared decision-making between older patients, caregivers, and oncologists,” the authors wrote. “Despite patient and caregiver concerns and preferences for maintaining function and cognition, oncologists often do not discuss implications of aging-related conditions or inform older patients and caregivers of heightened risk of adverse events from treatment.”

Overall, 90% of patients had at least three geriatric assessment domain impairments; 93.7% had impairments in physical performance, 25.1% reported impairments in psychological status, and 33.3% had possible cognitive impairments.

“These patients represent less-fit individuals for whom there is limited evidence for the risks and benefits of cancer treatment, yet these patients are commonly seen in real-world community practices,” the authors wrote.

The study was supported by funding and individual research grants from the Patient-Centered Outcomes Research Institute, the University of Rochester, the National Institute of Aging, and the National Cancer Institute. Two authors also declared funding from the pharmaceutical sector outside the study.

SOURCE: Mohile S et al. JAMA Oncol. 2019 Nov 7. doi: 10.1001/jamaoncol.2019.4728.

Integrating geriatric assessments into oncology consultations for older patients with cancer could help address aging-related concerns about their disease and treatment, a study has found.

In a study published in JAMA Oncology, researchers reported the outcomes of a cluster-randomized clinical trial involving 541 cancer patients aged 70 years and older, from 31 community oncology practices.

The trial examined the effects of an intervention in which the patient’s oncologist was provided with a geriatric assessment summary of that patient’s age-related impairments, and guided recommendations on how to manage these.

“As an example, the summary would include information that a patient recently fell, that falls increase the risk of chemotherapy toxic effects, and a recommendation for physical therapy to prevent falls,” wrote Supriya G. Mohile, MD, of the University of Rochester (N.Y.), and coauthors. The usual care control arm provided oncologists with alerts only if their patients had scored abnormally on depression and cognitive tests.

The study found that over 6 months, patients in the intervention group reported significantly greater satisfaction with communication about aging-related concerns and greater satisfaction with their overall care.

The intervention group had an adjusted mean of 8.02 conversations about aging-related concerns compared with 4.43 conversations in the usual care group, and an adjusted mean of 4.6 high-quality conversations compared with 2.59 in the usual care group. There were also significantly more conversations about the assessment recommendations in the intervention group compared with the usual care group.

There were no significant differences between the two groups in health-related quality of life for patients or their caregivers. However, caregivers in the intervention group did report significantly greater satisfaction with communication about aging-related concerns and the patient’s condition. They also reported significantly greater satisfaction with their own communications with oncologists about overall care.

“Evidence increasingly supports the use of GA for evaluation and management of older patients with cancer to guide shared decision-making between older patients, caregivers, and oncologists,” the authors wrote. “Despite patient and caregiver concerns and preferences for maintaining function and cognition, oncologists often do not discuss implications of aging-related conditions or inform older patients and caregivers of heightened risk of adverse events from treatment.”

Overall, 90% of patients had at least three geriatric assessment domain impairments; 93.7% had impairments in physical performance, 25.1% reported impairments in psychological status, and 33.3% had possible cognitive impairments.

“These patients represent less-fit individuals for whom there is limited evidence for the risks and benefits of cancer treatment, yet these patients are commonly seen in real-world community practices,” the authors wrote.

The study was supported by funding and individual research grants from the Patient-Centered Outcomes Research Institute, the University of Rochester, the National Institute of Aging, and the National Cancer Institute. Two authors also declared funding from the pharmaceutical sector outside the study.

SOURCE: Mohile S et al. JAMA Oncol. 2019 Nov 7. doi: 10.1001/jamaoncol.2019.4728.

The most rural counties in the United States had higher percentages of potentially preventable deaths from the five leading causes of mortality, compared with the most urban counties during 2010-2017, according to study published in CDC’s Morbidity and Mortality Weekly Report.

These leading causes of death comprised heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke and accounted for approximately 1.7 million deaths or 61% of all deaths in 2017.

The study presents estimates, percentages, and annual percent changes for potentially excess deaths by urban-rural classification from heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke. Urban-rural categories were identified using the National Center for Health Statistics 2013 urban-rural classification scheme for counties.

The report’s main findings include the following statistics:

• In 2010, 28.7% of deaths from cancer in the most rural counties were potentially preventable, compared with 17.9% in the most urban counties. By 2017, 21.7% of cancer deaths in the most rural counties were potentially preventable, compared with 3.2% in the most urban counties.
• In 2010, 45.1% of deaths from heart disease in the most rural counties were potentially preventable, compared with 33.5% in the most urban counties. By 2017, 44.9% of deaths from heart disease in the most rural counties were potentially preventable, compared with 28.0% in the most urban counties.
• In 2010, 60.9% of deaths from unintentional injury in the most rural counties were potentially preventable, compared with 25.4% in the most urban counties. By 2017, 64.1% of deaths from unintentional injury in the most rural counties were potentially preventable, compared with 47.8% in the most urban counties.
• In 2010, 54.3% of deaths from chronic lower respiratory disease (such as COPD) in the most rural counties were potentially preventable, compared with 23.4% in the most urban counties. By 2017, 57.1% of deaths from chronic lower respiratory disease in the most rural counties were potentially preventable, compared with 13% in the most urban counties.
• In 2010, 41.6% of deaths from stroke in the most rural counties were potentially preventable, compared with 31.7% in most urban areas. By 2017, 37.8% of deaths from stroke in the most rural counties were potentially preventable, compared with 27.4% most urban counties.

“This report demonstrates the value of analyzing potentially excess deaths according to the six 2013 [National Center for Health Statistics] urban-rural county classifications. Reporting trends in potentially excess deaths over an 8-year period highlights differences over time, independent of traditional underlying structural, environmental, and genetic factors,” wrote Macarena C. Garcia, DrPH, and coauthors.

“Because of increasing percentages of potentially excess deaths in recent years for certain causes of death and certain demographic groups, these data can be used, with traditional rate comparisons, by public health practitioners who are involved in planning interventions. Comparing the findings in this report with data from tools such as the CDC Interactive Atlas of Heart Disease and Stroke might help identify the social determinants, health care infrastructures, and public policies that could increase or decrease numbers of deaths in specific nonmetropolitan areas,” they added.

The study authors did not disclose any potential conflicts of interest.
 

klennon@mdedge.com

SOURCE: Garcia MC et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 8: 68(10);1-11.

The most rural counties in the United States had higher percentages of potentially preventable deaths from the five leading causes of mortality, compared with the most urban counties during 2010-2017, according to study published in CDC’s Morbidity and Mortality Weekly Report.

These leading causes of death comprised heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke and accounted for approximately 1.7 million deaths or 61% of all deaths in 2017.

The study presents estimates, percentages, and annual percent changes for potentially excess deaths by urban-rural classification from heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke. Urban-rural categories were identified using the National Center for Health Statistics 2013 urban-rural classification scheme for counties.

The report’s main findings include the following statistics:

• In 2010, 28.7% of deaths from cancer in the most rural counties were potentially preventable, compared with 17.9% in the most urban counties. By 2017, 21.7% of cancer deaths in the most rural counties were potentially preventable, compared with 3.2% in the most urban counties.
• In 2010, 45.1% of deaths from heart disease in the most rural counties were potentially preventable, compared with 33.5% in the most urban counties. By 2017, 44.9% of deaths from heart disease in the most rural counties were potentially preventable, compared with 28.0% in the most urban counties.
• In 2010, 60.9% of deaths from unintentional injury in the most rural counties were potentially preventable, compared with 25.4% in the most urban counties. By 2017, 64.1% of deaths from unintentional injury in the most rural counties were potentially preventable, compared with 47.8% in the most urban counties.
• In 2010, 54.3% of deaths from chronic lower respiratory disease (such as COPD) in the most rural counties were potentially preventable, compared with 23.4% in the most urban counties. By 2017, 57.1% of deaths from chronic lower respiratory disease in the most rural counties were potentially preventable, compared with 13% in the most urban counties.
• In 2010, 41.6% of deaths from stroke in the most rural counties were potentially preventable, compared with 31.7% in most urban areas. By 2017, 37.8% of deaths from stroke in the most rural counties were potentially preventable, compared with 27.4% most urban counties.

“This report demonstrates the value of analyzing potentially excess deaths according to the six 2013 [National Center for Health Statistics] urban-rural county classifications. Reporting trends in potentially excess deaths over an 8-year period highlights differences over time, independent of traditional underlying structural, environmental, and genetic factors,” wrote Macarena C. Garcia, DrPH, and coauthors.

“Because of increasing percentages of potentially excess deaths in recent years for certain causes of death and certain demographic groups, these data can be used, with traditional rate comparisons, by public health practitioners who are involved in planning interventions. Comparing the findings in this report with data from tools such as the CDC Interactive Atlas of Heart Disease and Stroke might help identify the social determinants, health care infrastructures, and public policies that could increase or decrease numbers of deaths in specific nonmetropolitan areas,” they added.

The study authors did not disclose any potential conflicts of interest.
 

klennon@mdedge.com

SOURCE: Garcia MC et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 8: 68(10);1-11.

The most rural counties in the United States had higher percentages of potentially preventable deaths from the five leading causes of mortality, compared with the most urban counties during 2010-2017, according to study published in CDC’s Morbidity and Mortality Weekly Report.

These leading causes of death comprised heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke and accounted for approximately 1.7 million deaths or 61% of all deaths in 2017.

The study presents estimates, percentages, and annual percent changes for potentially excess deaths by urban-rural classification from heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke. Urban-rural categories were identified using the National Center for Health Statistics 2013 urban-rural classification scheme for counties.

The report’s main findings include the following statistics:

• In 2010, 28.7% of deaths from cancer in the most rural counties were potentially preventable, compared with 17.9% in the most urban counties. By 2017, 21.7% of cancer deaths in the most rural counties were potentially preventable, compared with 3.2% in the most urban counties.
• In 2010, 45.1% of deaths from heart disease in the most rural counties were potentially preventable, compared with 33.5% in the most urban counties. By 2017, 44.9% of deaths from heart disease in the most rural counties were potentially preventable, compared with 28.0% in the most urban counties.
• In 2010, 60.9% of deaths from unintentional injury in the most rural counties were potentially preventable, compared with 25.4% in the most urban counties. By 2017, 64.1% of deaths from unintentional injury in the most rural counties were potentially preventable, compared with 47.8% in the most urban counties.
• In 2010, 54.3% of deaths from chronic lower respiratory disease (such as COPD) in the most rural counties were potentially preventable, compared with 23.4% in the most urban counties. By 2017, 57.1% of deaths from chronic lower respiratory disease in the most rural counties were potentially preventable, compared with 13% in the most urban counties.
• In 2010, 41.6% of deaths from stroke in the most rural counties were potentially preventable, compared with 31.7% in most urban areas. By 2017, 37.8% of deaths from stroke in the most rural counties were potentially preventable, compared with 27.4% most urban counties.

“This report demonstrates the value of analyzing potentially excess deaths according to the six 2013 [National Center for Health Statistics] urban-rural county classifications. Reporting trends in potentially excess deaths over an 8-year period highlights differences over time, independent of traditional underlying structural, environmental, and genetic factors,” wrote Macarena C. Garcia, DrPH, and coauthors.

“Because of increasing percentages of potentially excess deaths in recent years for certain causes of death and certain demographic groups, these data can be used, with traditional rate comparisons, by public health practitioners who are involved in planning interventions. Comparing the findings in this report with data from tools such as the CDC Interactive Atlas of Heart Disease and Stroke might help identify the social determinants, health care infrastructures, and public policies that could increase or decrease numbers of deaths in specific nonmetropolitan areas,” they added.

The study authors did not disclose any potential conflicts of interest.
 

klennon@mdedge.com

SOURCE: Garcia MC et al. MMWR Morb Mortal Wkly Rep. 2019 Nov 8: 68(10);1-11.

LAS VEGAS – Dermatologists in Oregon have launched a project that targets melanoma by promoting education and early detection, with the goal of dramatically reducing melanoma deaths in the state of 4.2 million people.

Research shows that “early detection works in melanoma. And awareness seems to be important for the public in detecting melanoma early,” said Sancy Leachman, MD, PhD, professor and chair of the department of dermatology at Oregon Health & Science University, Portland, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Dr. Leachman, who is also the John D. Gray chair in melanoma research at OHSU, directs the “War on Melanoma” project, which was inspired by a project in the German state of Schleswig-Holstein that aimed to screen all residents aged over 21 years for melanoma. The project featured an education campaign and population-wide skin cancer screening, and mandated that certain patients – those at high risk and those who needed biopsies – would be referred to dermatologists (Br J Cancer. 2012 Feb 28;106[5]:970-4).

According to Dr. Leachman, the German project was initially a success, and was linked to a 50% decrease in melanoma mortality.

“In Oregon, we thought ‘that sounds very good, so we’re going to try that.’ ” But when it went national, the German project failed, she said, providing lessons for dermatologists in Oregon. “We’re going to try to improve upon the first [German] experiment by making ours controlled with a defined baseline. If it works, the plan is to extend it to select states nationwide.”

The War on Melanoma project was launched earlier this year. According to the university, the program is featuring or will feature the following elements:

• A media campaign called “Start Seeing Melanoma” that’s devoted to educating the public about the early detection of melanoma.
• The release of an iPhone app called MoleMapper that allows users to monitor moles over time.
• Education of medical professionals and partnerships with state-licensed skin care professionals such as massage therapists, cosmetologists, and tattoo artists.

In an interview at the meeting, Dr. Leachman said the project is expected to cost $1 million to $1.5 million over the first 18 months. At that time, she said, researchers will survey residents of Oregon and two control states – Washington and Utah– to see if their knowledge of melanoma has improved, compared with baseline survey results.

In 5 years, researchers plan to begin analyzing melanoma mortality in Oregon and the other states. “We hope to see a decline,” and to link it to increased awareness of melanoma, she said.

Dr. Leachman reported no relevant disclosures. She spoke during a forum on cutaneous malignancies at the meeting.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Dermatologists in Oregon have launched a project that targets melanoma by promoting education and early detection, with the goal of dramatically reducing melanoma deaths in the state of 4.2 million people.

Research shows that “early detection works in melanoma. And awareness seems to be important for the public in detecting melanoma early,” said Sancy Leachman, MD, PhD, professor and chair of the department of dermatology at Oregon Health & Science University, Portland, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Dr. Leachman, who is also the John D. Gray chair in melanoma research at OHSU, directs the “War on Melanoma” project, which was inspired by a project in the German state of Schleswig-Holstein that aimed to screen all residents aged over 21 years for melanoma. The project featured an education campaign and population-wide skin cancer screening, and mandated that certain patients – those at high risk and those who needed biopsies – would be referred to dermatologists (Br J Cancer. 2012 Feb 28;106[5]:970-4).

According to Dr. Leachman, the German project was initially a success, and was linked to a 50% decrease in melanoma mortality.

“In Oregon, we thought ‘that sounds very good, so we’re going to try that.’ ” But when it went national, the German project failed, she said, providing lessons for dermatologists in Oregon. “We’re going to try to improve upon the first [German] experiment by making ours controlled with a defined baseline. If it works, the plan is to extend it to select states nationwide.”

The War on Melanoma project was launched earlier this year. According to the university, the program is featuring or will feature the following elements:

• A media campaign called “Start Seeing Melanoma” that’s devoted to educating the public about the early detection of melanoma.
• The release of an iPhone app called MoleMapper that allows users to monitor moles over time.
• Education of medical professionals and partnerships with state-licensed skin care professionals such as massage therapists, cosmetologists, and tattoo artists.

In an interview at the meeting, Dr. Leachman said the project is expected to cost $1 million to $1.5 million over the first 18 months. At that time, she said, researchers will survey residents of Oregon and two control states – Washington and Utah– to see if their knowledge of melanoma has improved, compared with baseline survey results.

In 5 years, researchers plan to begin analyzing melanoma mortality in Oregon and the other states. “We hope to see a decline,” and to link it to increased awareness of melanoma, she said.

Dr. Leachman reported no relevant disclosures. She spoke during a forum on cutaneous malignancies at the meeting.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Dermatologists in Oregon have launched a project that targets melanoma by promoting education and early detection, with the goal of dramatically reducing melanoma deaths in the state of 4.2 million people.

Research shows that “early detection works in melanoma. And awareness seems to be important for the public in detecting melanoma early,” said Sancy Leachman, MD, PhD, professor and chair of the department of dermatology at Oregon Health & Science University, Portland, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Dr. Leachman, who is also the John D. Gray chair in melanoma research at OHSU, directs the “War on Melanoma” project, which was inspired by a project in the German state of Schleswig-Holstein that aimed to screen all residents aged over 21 years for melanoma. The project featured an education campaign and population-wide skin cancer screening, and mandated that certain patients – those at high risk and those who needed biopsies – would be referred to dermatologists (Br J Cancer. 2012 Feb 28;106[5]:970-4).

According to Dr. Leachman, the German project was initially a success, and was linked to a 50% decrease in melanoma mortality.

“In Oregon, we thought ‘that sounds very good, so we’re going to try that.’ ” But when it went national, the German project failed, she said, providing lessons for dermatologists in Oregon. “We’re going to try to improve upon the first [German] experiment by making ours controlled with a defined baseline. If it works, the plan is to extend it to select states nationwide.”

The War on Melanoma project was launched earlier this year. According to the university, the program is featuring or will feature the following elements:

• A media campaign called “Start Seeing Melanoma” that’s devoted to educating the public about the early detection of melanoma.
• The release of an iPhone app called MoleMapper that allows users to monitor moles over time.
• Education of medical professionals and partnerships with state-licensed skin care professionals such as massage therapists, cosmetologists, and tattoo artists.

In an interview at the meeting, Dr. Leachman said the project is expected to cost $1 million to $1.5 million over the first 18 months. At that time, she said, researchers will survey residents of Oregon and two control states – Washington and Utah– to see if their knowledge of melanoma has improved, compared with baseline survey results.

In 5 years, researchers plan to begin analyzing melanoma mortality in Oregon and the other states. “We hope to see a decline,” and to link it to increased awareness of melanoma, she said.

Dr. Leachman reported no relevant disclosures. She spoke during a forum on cutaneous malignancies at the meeting.

SDEF and this news organization are owned by the same parent company.

Diagnosis and treatment for obstructive sleep apnea resulted in medical cost savings in a group of U.S. truck drivers.

welcomia/Getty Images

“Among the 1.87 million U.S. commercial drivers estimated by the Bureau of Labor Statistics to be operating non–farm-based heavy trucks (gross weight at least 26,000 pounds), 17%-28%, or 318,00 to 524,000, are expected to have at least mild [obstructive sleep apnea] based on prevalence studies on commercial drivers,” wrote Stephen V. Burks, PhD, of the University of Minnesota, Morris, and colleagues.

“If the larger population of the 4.0 million drivers estimated by the Federal Motor Carrier Safety Administration to be using commercial driver’s licenses in interstate and intrastate transportation is considered, 0.68 to 1.1 million drivers may have OSA. The majority of these drivers are thought to be undiagnosed and untreated. There is thus considerable scope for healthcare cost savings through treatment of OSA among commercial drivers,” they noted.

The study was published in Sleep.

In 2017, after industry complaints about costs, the federal government withdrew its proposal to mandate testing truckers for OSA. Yet some commercial fleets do require testing, and a new study looking at retrospective data from a large fleet’s health insurance program shows that drivers diagnosed and treated for OSA saw medical cost savings, compared with those considered likely to have OSA who had neither diagnosis nor treatment.

Dr. Burks and his colleagues looked at records for 1,516 drivers tested for OSA, of whom 1,224 were positive, and compared these with an equal number of controls flagged through the same screening program as likely to have OSA, but who had never received a diagnosis in a sleep clinic or treatment with auto-adjusting positive airway pressure (APAP). All cases received auto-adjusting positive airway pressure (APAP) treatment. The investigators then looked at insurance costs for diagnosed drivers, compared with screen-positive controls before and after the polysomnogram date, over an 18-month period.

Most of the diagnosed cases in the cohort (n = 932) were deemed compliant with treatment. For every pair of subjects and controls, the researchers looked at per-member insurance costs over 18 months, though not all drivers were observed for a full period of 18 months, mostly because of turnover. Dr. Burks and colleagues found that non-OSA related medical claim costs savings after diagnosis and treatment of every 100 screen-positive controls was $153,042 (95% confidence interval, –$5,352, $330,525, P = .06.) Subjects adhering to treatment with APAP saw mean non-OSA related savings of $441 per member per month (95% CI, –$861, –$21, P = .035).

“Taken together, this is substantial evidence that OSA treatment is associated with savings in non-OSA–program medical insurance claim costs,” the authors wrote, adding that such savings could be expected to help offset expenses related to mandatory OSA programs. The authors acknowledged as a limitation of their study that it did not capture costs of pharmaceutical treatment or those of the OSA program itself. Nor did the findings capture “the value of injuries, lost work time, or disability days associated with untreated OSA, nor the savings from avoided preventable crashes.”

The study received funding from Harvard University and the National Surface Transportation Safety Center for Excellence. Two coauthors disclosed funding from pharmaceutical and device manufacturers and hold patents on sleep therapies. Another coauthor disclosed being an expert witness in trucking-related cases and one received funds from the study’s sponsor, a trucking safety research group.

SOURCE: Burks SV et al. Sleep 2019 Oct 24. doi: 10.1093/sleep/zsz262.

Diagnosis and treatment for obstructive sleep apnea resulted in medical cost savings in a group of U.S. truck drivers.

welcomia/Getty Images

“Among the 1.87 million U.S. commercial drivers estimated by the Bureau of Labor Statistics to be operating non–farm-based heavy trucks (gross weight at least 26,000 pounds), 17%-28%, or 318,00 to 524,000, are expected to have at least mild [obstructive sleep apnea] based on prevalence studies on commercial drivers,” wrote Stephen V. Burks, PhD, of the University of Minnesota, Morris, and colleagues.

“If the larger population of the 4.0 million drivers estimated by the Federal Motor Carrier Safety Administration to be using commercial driver’s licenses in interstate and intrastate transportation is considered, 0.68 to 1.1 million drivers may have OSA. The majority of these drivers are thought to be undiagnosed and untreated. There is thus considerable scope for healthcare cost savings through treatment of OSA among commercial drivers,” they noted.

The study was published in Sleep.

In 2017, after industry complaints about costs, the federal government withdrew its proposal to mandate testing truckers for OSA. Yet some commercial fleets do require testing, and a new study looking at retrospective data from a large fleet’s health insurance program shows that drivers diagnosed and treated for OSA saw medical cost savings, compared with those considered likely to have OSA who had neither diagnosis nor treatment.

Dr. Burks and his colleagues looked at records for 1,516 drivers tested for OSA, of whom 1,224 were positive, and compared these with an equal number of controls flagged through the same screening program as likely to have OSA, but who had never received a diagnosis in a sleep clinic or treatment with auto-adjusting positive airway pressure (APAP). All cases received auto-adjusting positive airway pressure (APAP) treatment. The investigators then looked at insurance costs for diagnosed drivers, compared with screen-positive controls before and after the polysomnogram date, over an 18-month period.

Most of the diagnosed cases in the cohort (n = 932) were deemed compliant with treatment. For every pair of subjects and controls, the researchers looked at per-member insurance costs over 18 months, though not all drivers were observed for a full period of 18 months, mostly because of turnover. Dr. Burks and colleagues found that non-OSA related medical claim costs savings after diagnosis and treatment of every 100 screen-positive controls was $153,042 (95% confidence interval, –$5,352, $330,525, P = .06.) Subjects adhering to treatment with APAP saw mean non-OSA related savings of $441 per member per month (95% CI, –$861, –$21, P = .035).

“Taken together, this is substantial evidence that OSA treatment is associated with savings in non-OSA–program medical insurance claim costs,” the authors wrote, adding that such savings could be expected to help offset expenses related to mandatory OSA programs. The authors acknowledged as a limitation of their study that it did not capture costs of pharmaceutical treatment or those of the OSA program itself. Nor did the findings capture “the value of injuries, lost work time, or disability days associated with untreated OSA, nor the savings from avoided preventable crashes.”

The study received funding from Harvard University and the National Surface Transportation Safety Center for Excellence. Two coauthors disclosed funding from pharmaceutical and device manufacturers and hold patents on sleep therapies. Another coauthor disclosed being an expert witness in trucking-related cases and one received funds from the study’s sponsor, a trucking safety research group.

SOURCE: Burks SV et al. Sleep 2019 Oct 24. doi: 10.1093/sleep/zsz262.

Diagnosis and treatment for obstructive sleep apnea resulted in medical cost savings in a group of U.S. truck drivers.

welcomia/Getty Images

“Among the 1.87 million U.S. commercial drivers estimated by the Bureau of Labor Statistics to be operating non–farm-based heavy trucks (gross weight at least 26,000 pounds), 17%-28%, or 318,00 to 524,000, are expected to have at least mild [obstructive sleep apnea] based on prevalence studies on commercial drivers,” wrote Stephen V. Burks, PhD, of the University of Minnesota, Morris, and colleagues.

“If the larger population of the 4.0 million drivers estimated by the Federal Motor Carrier Safety Administration to be using commercial driver’s licenses in interstate and intrastate transportation is considered, 0.68 to 1.1 million drivers may have OSA. The majority of these drivers are thought to be undiagnosed and untreated. There is thus considerable scope for healthcare cost savings through treatment of OSA among commercial drivers,” they noted.

The study was published in Sleep.

In 2017, after industry complaints about costs, the federal government withdrew its proposal to mandate testing truckers for OSA. Yet some commercial fleets do require testing, and a new study looking at retrospective data from a large fleet’s health insurance program shows that drivers diagnosed and treated for OSA saw medical cost savings, compared with those considered likely to have OSA who had neither diagnosis nor treatment.

Dr. Burks and his colleagues looked at records for 1,516 drivers tested for OSA, of whom 1,224 were positive, and compared these with an equal number of controls flagged through the same screening program as likely to have OSA, but who had never received a diagnosis in a sleep clinic or treatment with auto-adjusting positive airway pressure (APAP). All cases received auto-adjusting positive airway pressure (APAP) treatment. The investigators then looked at insurance costs for diagnosed drivers, compared with screen-positive controls before and after the polysomnogram date, over an 18-month period.

Most of the diagnosed cases in the cohort (n = 932) were deemed compliant with treatment. For every pair of subjects and controls, the researchers looked at per-member insurance costs over 18 months, though not all drivers were observed for a full period of 18 months, mostly because of turnover. Dr. Burks and colleagues found that non-OSA related medical claim costs savings after diagnosis and treatment of every 100 screen-positive controls was $153,042 (95% confidence interval, –$5,352, $330,525, P = .06.) Subjects adhering to treatment with APAP saw mean non-OSA related savings of $441 per member per month (95% CI, –$861, –$21, P = .035).

“Taken together, this is substantial evidence that OSA treatment is associated with savings in non-OSA–program medical insurance claim costs,” the authors wrote, adding that such savings could be expected to help offset expenses related to mandatory OSA programs. The authors acknowledged as a limitation of their study that it did not capture costs of pharmaceutical treatment or those of the OSA program itself. Nor did the findings capture “the value of injuries, lost work time, or disability days associated with untreated OSA, nor the savings from avoided preventable crashes.”

The study received funding from Harvard University and the National Surface Transportation Safety Center for Excellence. Two coauthors disclosed funding from pharmaceutical and device manufacturers and hold patents on sleep therapies. Another coauthor disclosed being an expert witness in trucking-related cases and one received funds from the study’s sponsor, a trucking safety research group.

SOURCE: Burks SV et al. Sleep 2019 Oct 24. doi: 10.1093/sleep/zsz262.

NEW ORLEANS – A new analysis suggests dupilumab is beneficial for patients with early- or late-onset asthma.

Dupilumab may be more effective in reducing severe asthma exacerbations in patients with late-onset asthma, but the drug’s effect on lung function appeared the same regardless of asthma onset. Nicola Hanania, MD, of Baylor College of Medicine in Houston presented these results at the annual meeting of the American College of Chest Physicians.

Dr. Hanania and colleagues conducted a subanalysis of the LIBERTY ASTHMA QUEST study (NCT02414854). Previous data from this study showed that patients with uncontrolled, moderate to severe asthma who received dupilumab had fewer exacerbations and better lung function than did patients who received placebo (N Engl J Med. 2018;378:2486-96).

In their subanalysis, Dr. Hanania and his colleagues evaluated the efficacy of dupilumab, given at 200 mg or 300 mg every 2 weeks, in patients with early-onset asthma (at 40 years of age or younger) and late-onset asthma (at 41 years or older). The analysis included 919 patients with early-onset asthma who received dupilumab and 450 early-onset patients who received placebo. There were 345 patients with late-onset asthma who received dupilumab and 188 late-onset patients who received placebo.

Exacerbations

Dupilumab significantly reduced the adjusted annualized severe exacerbation rates during the 52-week treatment period. Significant reductions occurred in both early- and late-onset patients, though reductions were greater in the late-onset group.

In early-onset patients, dupilumab reduced severe exacerbations by 38% when given at 200 mg and by 37% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients, dupilumab reduced exacerbations by 64% and 69%, respectively (P less than .001 vs. placebo).

Dr. Hanania said it isn’t clear why late-onset patients appear to derive more benefit with regard to exacerbations. It may be because these patients have more comorbidities or because they aren’t using their inhalers correctly. The researchers are investigating these possibilities.

Dr. Hanania went on to note that reductions in exacerbation rates were greatest in patients with elevated blood eosinophils (150 cells/mcL or greater) or fractional exhaled nitric oxide (FeNO; 25 ppb or greater).

In patients with early-onset asthma and elevated eosinophils, dupilumab reduced severe exacerbations by 50% when given at 200 mg and by 55% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients with elevated eosinophils, dupilumab reduced exacerbations by 65% and 73%, respectively (P less than .001 vs. placebo).

In patients with early-onset asthma and elevated FeNO, dupilumab reduced severe exacerbations by 56% when given at 200 mg and by 52% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients with elevated FeNO, dupilumab reduced exacerbations by 79% and 71%, respectively (P less than .001 vs. placebo).

Lung function

Dupilumab also improved prebronchodilator forced expiratory volume in 1 second (pre-BD FEV₁), compared with placebo, with similar results in early- and late-onset patients.

In early-onset patients, the P values were less than .001 for both doses of dupilumab at weeks 12 and 52. In late-onset patients, the P values were less than .001 for the 300-mg dose at week 12 and the 200-mg dose at week 52, less than .01 for the 200-mg dose at week 12, and less than .05 for the 300-mg dose at week 52.

The effects of dupilumab on pre-BD FEV₁ were greatest in patients with elevated eosinophils or FeNO. At week 12, the P value was less than .001 for both doses of dupilumab in early-onset patients with elevated eosinophils or FeNO. The P value was less than .01 for both doses in late-onset patients with elevated eosinophils. And the P value was less than .001 for both doses in late-onset patients with elevated FeNO.

This research was sponsored by Sanofi and Regeneron. Dr. Hanania disclosed relationships with Genentech, Novartis, AstraZeneca, Boehringer Ingelheim, GSK, Regeneron, and Sanofi.

jensmith@mdedge.com

SOURCE: Hanania N et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.870.

NEW ORLEANS – A new analysis suggests dupilumab is beneficial for patients with early- or late-onset asthma.

Dupilumab may be more effective in reducing severe asthma exacerbations in patients with late-onset asthma, but the drug’s effect on lung function appeared the same regardless of asthma onset. Nicola Hanania, MD, of Baylor College of Medicine in Houston presented these results at the annual meeting of the American College of Chest Physicians.

Dr. Hanania and colleagues conducted a subanalysis of the LIBERTY ASTHMA QUEST study (NCT02414854). Previous data from this study showed that patients with uncontrolled, moderate to severe asthma who received dupilumab had fewer exacerbations and better lung function than did patients who received placebo (N Engl J Med. 2018;378:2486-96).

In their subanalysis, Dr. Hanania and his colleagues evaluated the efficacy of dupilumab, given at 200 mg or 300 mg every 2 weeks, in patients with early-onset asthma (at 40 years of age or younger) and late-onset asthma (at 41 years or older). The analysis included 919 patients with early-onset asthma who received dupilumab and 450 early-onset patients who received placebo. There were 345 patients with late-onset asthma who received dupilumab and 188 late-onset patients who received placebo.

Exacerbations

Dupilumab significantly reduced the adjusted annualized severe exacerbation rates during the 52-week treatment period. Significant reductions occurred in both early- and late-onset patients, though reductions were greater in the late-onset group.

In early-onset patients, dupilumab reduced severe exacerbations by 38% when given at 200 mg and by 37% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients, dupilumab reduced exacerbations by 64% and 69%, respectively (P less than .001 vs. placebo).

Dr. Hanania said it isn’t clear why late-onset patients appear to derive more benefit with regard to exacerbations. It may be because these patients have more comorbidities or because they aren’t using their inhalers correctly. The researchers are investigating these possibilities.

Dr. Hanania went on to note that reductions in exacerbation rates were greatest in patients with elevated blood eosinophils (150 cells/mcL or greater) or fractional exhaled nitric oxide (FeNO; 25 ppb or greater).

In patients with early-onset asthma and elevated eosinophils, dupilumab reduced severe exacerbations by 50% when given at 200 mg and by 55% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients with elevated eosinophils, dupilumab reduced exacerbations by 65% and 73%, respectively (P less than .001 vs. placebo).

In patients with early-onset asthma and elevated FeNO, dupilumab reduced severe exacerbations by 56% when given at 200 mg and by 52% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients with elevated FeNO, dupilumab reduced exacerbations by 79% and 71%, respectively (P less than .001 vs. placebo).

Lung function

Dupilumab also improved prebronchodilator forced expiratory volume in 1 second (pre-BD FEV₁), compared with placebo, with similar results in early- and late-onset patients.

In early-onset patients, the P values were less than .001 for both doses of dupilumab at weeks 12 and 52. In late-onset patients, the P values were less than .001 for the 300-mg dose at week 12 and the 200-mg dose at week 52, less than .01 for the 200-mg dose at week 12, and less than .05 for the 300-mg dose at week 52.

The effects of dupilumab on pre-BD FEV₁ were greatest in patients with elevated eosinophils or FeNO. At week 12, the P value was less than .001 for both doses of dupilumab in early-onset patients with elevated eosinophils or FeNO. The P value was less than .01 for both doses in late-onset patients with elevated eosinophils. And the P value was less than .001 for both doses in late-onset patients with elevated FeNO.

This research was sponsored by Sanofi and Regeneron. Dr. Hanania disclosed relationships with Genentech, Novartis, AstraZeneca, Boehringer Ingelheim, GSK, Regeneron, and Sanofi.

jensmith@mdedge.com

SOURCE: Hanania N et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.870.

NEW ORLEANS – A new analysis suggests dupilumab is beneficial for patients with early- or late-onset asthma.

Dupilumab may be more effective in reducing severe asthma exacerbations in patients with late-onset asthma, but the drug’s effect on lung function appeared the same regardless of asthma onset. Nicola Hanania, MD, of Baylor College of Medicine in Houston presented these results at the annual meeting of the American College of Chest Physicians.

Dr. Hanania and colleagues conducted a subanalysis of the LIBERTY ASTHMA QUEST study (NCT02414854). Previous data from this study showed that patients with uncontrolled, moderate to severe asthma who received dupilumab had fewer exacerbations and better lung function than did patients who received placebo (N Engl J Med. 2018;378:2486-96).

In their subanalysis, Dr. Hanania and his colleagues evaluated the efficacy of dupilumab, given at 200 mg or 300 mg every 2 weeks, in patients with early-onset asthma (at 40 years of age or younger) and late-onset asthma (at 41 years or older). The analysis included 919 patients with early-onset asthma who received dupilumab and 450 early-onset patients who received placebo. There were 345 patients with late-onset asthma who received dupilumab and 188 late-onset patients who received placebo.

Exacerbations

Dupilumab significantly reduced the adjusted annualized severe exacerbation rates during the 52-week treatment period. Significant reductions occurred in both early- and late-onset patients, though reductions were greater in the late-onset group.

In early-onset patients, dupilumab reduced severe exacerbations by 38% when given at 200 mg and by 37% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients, dupilumab reduced exacerbations by 64% and 69%, respectively (P less than .001 vs. placebo).

Dr. Hanania said it isn’t clear why late-onset patients appear to derive more benefit with regard to exacerbations. It may be because these patients have more comorbidities or because they aren’t using their inhalers correctly. The researchers are investigating these possibilities.

Dr. Hanania went on to note that reductions in exacerbation rates were greatest in patients with elevated blood eosinophils (150 cells/mcL or greater) or fractional exhaled nitric oxide (FeNO; 25 ppb or greater).

In patients with early-onset asthma and elevated eosinophils, dupilumab reduced severe exacerbations by 50% when given at 200 mg and by 55% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients with elevated eosinophils, dupilumab reduced exacerbations by 65% and 73%, respectively (P less than .001 vs. placebo).

In patients with early-onset asthma and elevated FeNO, dupilumab reduced severe exacerbations by 56% when given at 200 mg and by 52% when given at 300 mg (P less than .001 vs. placebo). In late-onset patients with elevated FeNO, dupilumab reduced exacerbations by 79% and 71%, respectively (P less than .001 vs. placebo).

Lung function

Dupilumab also improved prebronchodilator forced expiratory volume in 1 second (pre-BD FEV₁), compared with placebo, with similar results in early- and late-onset patients.

In early-onset patients, the P values were less than .001 for both doses of dupilumab at weeks 12 and 52. In late-onset patients, the P values were less than .001 for the 300-mg dose at week 12 and the 200-mg dose at week 52, less than .01 for the 200-mg dose at week 12, and less than .05 for the 300-mg dose at week 52.

The effects of dupilumab on pre-BD FEV₁ were greatest in patients with elevated eosinophils or FeNO. At week 12, the P value was less than .001 for both doses of dupilumab in early-onset patients with elevated eosinophils or FeNO. The P value was less than .01 for both doses in late-onset patients with elevated eosinophils. And the P value was less than .001 for both doses in late-onset patients with elevated FeNO.

This research was sponsored by Sanofi and Regeneron. Dr. Hanania disclosed relationships with Genentech, Novartis, AstraZeneca, Boehringer Ingelheim, GSK, Regeneron, and Sanofi.

jensmith@mdedge.com

SOURCE: Hanania N et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.870.

Learn more about spinal muscular atrophy in this supplement to Pediatric News. 
 

Click here to read.

Supplement Faculty

Claudia A. Chiriboga, MD, MPH, FAAN
(Program Chair)
Professor of Neurology and Pediatrics at CUIMC
Division of Pediatric Neurology
Columbia University Irving Medical Center
New York, NY

Diana P. Castro, MD
Assistant Professor
Pediatrics and Neurology
Neurotherapeutics
UT Southwestern Medical Center
Neurologist
Children’s Health
Dallas, TX

Mary Schroth, MD
Chief Medical Officer
Cure SMA
Elk Grove Village, IL

Charlotte J. Sumner, MD
Professor of Neurology and Neuroscience
Johns Hopkins University School of Medicine
Baltimore, MD

Kathryn J. Swoboda, MD
Katherine B. Sims, MD, Endowed Chair in Neurogenetics
Director, Neurogenetics Program
Mass General Hospital for Children
Boston, MA

Learn more about spinal muscular atrophy in this supplement to Pediatric News. 
 

Click here to read.

Supplement Faculty

Claudia A. Chiriboga, MD, MPH, FAAN
(Program Chair)
Professor of Neurology and Pediatrics at CUIMC
Division of Pediatric Neurology
Columbia University Irving Medical Center
New York, NY

Diana P. Castro, MD
Assistant Professor
Pediatrics and Neurology
Neurotherapeutics
UT Southwestern Medical Center
Neurologist
Children’s Health
Dallas, TX

Mary Schroth, MD
Chief Medical Officer
Cure SMA
Elk Grove Village, IL

Charlotte J. Sumner, MD
Professor of Neurology and Neuroscience
Johns Hopkins University School of Medicine
Baltimore, MD

Kathryn J. Swoboda, MD
Katherine B. Sims, MD, Endowed Chair in Neurogenetics
Director, Neurogenetics Program
Mass General Hospital for Children
Boston, MA

Learn more about spinal muscular atrophy in this supplement to Pediatric News. 
 

Click here to read.

Supplement Faculty

Claudia A. Chiriboga, MD, MPH, FAAN
(Program Chair)
Professor of Neurology and Pediatrics at CUIMC
Division of Pediatric Neurology
Columbia University Irving Medical Center
New York, NY

Diana P. Castro, MD
Assistant Professor
Pediatrics and Neurology
Neurotherapeutics
UT Southwestern Medical Center
Neurologist
Children’s Health
Dallas, TX

Mary Schroth, MD
Chief Medical Officer
Cure SMA
Elk Grove Village, IL

Charlotte J. Sumner, MD
Professor of Neurology and Neuroscience
Johns Hopkins University School of Medicine
Baltimore, MD

Kathryn J. Swoboda, MD
Katherine B. Sims, MD, Endowed Chair in Neurogenetics
Director, Neurogenetics Program
Mass General Hospital for Children
Boston, MA

Background: The MEESSI-AHF (Multiple Estimation of Risk based on the Emergency Department Spanish Score In patients with Acute Heart Failure) score is a risk-stratification tool that includes systolic blood pressure, age, NT-proBNP, potassium, cardiac troponin T, New York Heart Association class 4 disease, respiratory rate, low-output symptoms, oxygen saturation, episode associated with acute coronary syndrome, signs of left ventricular hypertrophy on EKG, creatinine, and Barthel Index Score. Prior research has shown that it accurately risk-stratified ED patients with AHF in Spain. It has not been studied in other populations.

Dr. Radhakrishnan is a hospitalist at Beth Israel Deaconess Medical Center.

Background: The MEESSI-AHF (Multiple Estimation of Risk based on the Emergency Department Spanish Score In patients with Acute Heart Failure) score is a risk-stratification tool that includes systolic blood pressure, age, NT-proBNP, potassium, cardiac troponin T, New York Heart Association class 4 disease, respiratory rate, low-output symptoms, oxygen saturation, episode associated with acute coronary syndrome, signs of left ventricular hypertrophy on EKG, creatinine, and Barthel Index Score. Prior research has shown that it accurately risk-stratified ED patients with AHF in Spain. It has not been studied in other populations.

Dr. Radhakrishnan is a hospitalist at Beth Israel Deaconess Medical Center.

Background: The MEESSI-AHF (Multiple Estimation of Risk based on the Emergency Department Spanish Score In patients with Acute Heart Failure) score is a risk-stratification tool that includes systolic blood pressure, age, NT-proBNP, potassium, cardiac troponin T, New York Heart Association class 4 disease, respiratory rate, low-output symptoms, oxygen saturation, episode associated with acute coronary syndrome, signs of left ventricular hypertrophy on EKG, creatinine, and Barthel Index Score. Prior research has shown that it accurately risk-stratified ED patients with AHF in Spain. It has not been studied in other populations.

Dr. Radhakrishnan is a hospitalist at Beth Israel Deaconess Medical Center.

The majority of pediatricians support a new maintenance of certification (MOC) option as a favorable alternative to the traditional MOC examination, two recent surveys show.

sturti/Getty Images

Lead author Laurel K. Leslie, MD, of Tufts University, Boston, and colleagues analyzed the perceptions of 4,238 pediatricians who participated in a pilot MOC program in 2017 and completed a fourth-quarter survey, a voluntary end-of-year survey, or both surveys. The new MOC option was developed by the American Board of Pediatrics between 2015 and 2016 as an alternative to the current proctored, closed-book general pediatrics (GP) MOC examination. The Maintenance of Certification Assessment for Pediatrics (MOCA-Peds) includes timed, multiple-choice questions delivered quarterly through a Web-based interface, provides resources to help answer questions, and yields immediate feedback, rationale, and references pertaining to answers.

Of the pediatricians surveyed, 93% considered the MOCA-Peds to be a feasible and acceptable alternative to the traditional MOC GP examination, and 89% of pediatricians indicated they would chose the MOCA-Peds model over the proctored examination, according to the study, published in Pediatrics. Of doctors who completed the quarter 4 survey, 88% agreed or strongly agreed that assessment questions aligned with the stated learning objectives, 82% agreed the questions assessed clinical judgment, 82% agreed the questions were relevant to the practice of GP, and 59% agreed the questions were relevant to their specific practice setting, according to the study. For most pediatricians surveyed, the time to answer questions was sufficient (78%).

Regarding potential anxiety associated with MOC, 89% of doctors surveyed agreed that they felt less anxiety participating in the MOCA-Peds compared with the proctored examination, and that any anxiety they felt about the MOCA-Peds lessened during the pilot as their comfort with the assessment grew (81%). When asked whether they would partake in MOCA-Peds in the future, 97% of general pediatricians and 95% of subspecialists planned to participate in MOCA-Peds to maintain their GP certification; 95% of subspecialists said they would participate in MOCA-Peds to maintain their subspecialty certification.

In a second analysis of the same study population led by Adam L. Turner, MPH, of the American Board of Pediatrics, participants were asked whether the MOCA-Peds led to any practice or knowledge changes. Nearly all (98%) respondents reported they had “learned, refreshed, or enhanced their medical knowledge” because of the assessment and 62% of pediatricians reported a practice change associated with pilot participation, according to the study, published in Pediatrics. Of those who made a practice change, 70% were general pediatricians and 41% were subspecialists.

Of the 1,727 pediatricians who positively indicated a practice change, 84% reported details about the specific change made. The most common content domains associated with a practice change included ear, nose, and throat; preventive and well-child care; and mental and behavioral health.

Within the content domains, the three most frequently cited instances in which knowledge or a practice change took place included planning the management of a child with otitis media, managing a child with an acute asthma exacerbation, and planning the management of a child with influenza. Of 400 additional responses related to practice changes beyond answers associated with a specific content domain, the three most common subthemes were using evidence-based medicine, expanding review of materials or resource use, and improving differential diagnosis. Pediatricians reported that participation in MOCA-Peds exposed them to new material and encouraged them to review guidelines or standard care protocols and their application. Respondents also reported increased review of materials or resources in practice, updating the types of resources used, and/or an increased effort to stay more updated.

Dr. Turner and associates concluded that the results “support the notion that assessment and learning can be integrated into a single platform and need not be considered mutually exclusive activities, in turn adding value for practicing physicians.”

The studies were funded by the American Board of Pediatrics Foundation. Dr. Leslie, Dr. Linda Althouse, Mr. Andrew Bradford, and Mr. Adam L. Turner are employees of The American Board of Pediatrics. Dr. Victoria Dounoucos, Dr. Murrey G. Olmsted, and Ms. Amanda C. Smith are employees of RTI International, an international nonprofit research firm with whom the board contracted to conduct this evaluation.

SOURCE: Leslie LK et al. Pediatrics. Nov. 2019 Nov. doi: 10.1542/peds.2019-2303; Turner AL et al. Pediatrics. 2019 Nov. doi: 10.1542/peds.2019-2305.

The majority of pediatricians support a new maintenance of certification (MOC) option as a favorable alternative to the traditional MOC examination, two recent surveys show.

sturti/Getty Images

Lead author Laurel K. Leslie, MD, of Tufts University, Boston, and colleagues analyzed the perceptions of 4,238 pediatricians who participated in a pilot MOC program in 2017 and completed a fourth-quarter survey, a voluntary end-of-year survey, or both surveys. The new MOC option was developed by the American Board of Pediatrics between 2015 and 2016 as an alternative to the current proctored, closed-book general pediatrics (GP) MOC examination. The Maintenance of Certification Assessment for Pediatrics (MOCA-Peds) includes timed, multiple-choice questions delivered quarterly through a Web-based interface, provides resources to help answer questions, and yields immediate feedback, rationale, and references pertaining to answers.

Of the pediatricians surveyed, 93% considered the MOCA-Peds to be a feasible and acceptable alternative to the traditional MOC GP examination, and 89% of pediatricians indicated they would chose the MOCA-Peds model over the proctored examination, according to the study, published in Pediatrics. Of doctors who completed the quarter 4 survey, 88% agreed or strongly agreed that assessment questions aligned with the stated learning objectives, 82% agreed the questions assessed clinical judgment, 82% agreed the questions were relevant to the practice of GP, and 59% agreed the questions were relevant to their specific practice setting, according to the study. For most pediatricians surveyed, the time to answer questions was sufficient (78%).

Regarding potential anxiety associated with MOC, 89% of doctors surveyed agreed that they felt less anxiety participating in the MOCA-Peds compared with the proctored examination, and that any anxiety they felt about the MOCA-Peds lessened during the pilot as their comfort with the assessment grew (81%). When asked whether they would partake in MOCA-Peds in the future, 97% of general pediatricians and 95% of subspecialists planned to participate in MOCA-Peds to maintain their GP certification; 95% of subspecialists said they would participate in MOCA-Peds to maintain their subspecialty certification.

In a second analysis of the same study population led by Adam L. Turner, MPH, of the American Board of Pediatrics, participants were asked whether the MOCA-Peds led to any practice or knowledge changes. Nearly all (98%) respondents reported they had “learned, refreshed, or enhanced their medical knowledge” because of the assessment and 62% of pediatricians reported a practice change associated with pilot participation, according to the study, published in Pediatrics. Of those who made a practice change, 70% were general pediatricians and 41% were subspecialists.

Of the 1,727 pediatricians who positively indicated a practice change, 84% reported details about the specific change made. The most common content domains associated with a practice change included ear, nose, and throat; preventive and well-child care; and mental and behavioral health.

Within the content domains, the three most frequently cited instances in which knowledge or a practice change took place included planning the management of a child with otitis media, managing a child with an acute asthma exacerbation, and planning the management of a child with influenza. Of 400 additional responses related to practice changes beyond answers associated with a specific content domain, the three most common subthemes were using evidence-based medicine, expanding review of materials or resource use, and improving differential diagnosis. Pediatricians reported that participation in MOCA-Peds exposed them to new material and encouraged them to review guidelines or standard care protocols and their application. Respondents also reported increased review of materials or resources in practice, updating the types of resources used, and/or an increased effort to stay more updated.

Dr. Turner and associates concluded that the results “support the notion that assessment and learning can be integrated into a single platform and need not be considered mutually exclusive activities, in turn adding value for practicing physicians.”

The studies were funded by the American Board of Pediatrics Foundation. Dr. Leslie, Dr. Linda Althouse, Mr. Andrew Bradford, and Mr. Adam L. Turner are employees of The American Board of Pediatrics. Dr. Victoria Dounoucos, Dr. Murrey G. Olmsted, and Ms. Amanda C. Smith are employees of RTI International, an international nonprofit research firm with whom the board contracted to conduct this evaluation.

SOURCE: Leslie LK et al. Pediatrics. Nov. 2019 Nov. doi: 10.1542/peds.2019-2303; Turner AL et al. Pediatrics. 2019 Nov. doi: 10.1542/peds.2019-2305.

The majority of pediatricians support a new maintenance of certification (MOC) option as a favorable alternative to the traditional MOC examination, two recent surveys show.

sturti/Getty Images

Lead author Laurel K. Leslie, MD, of Tufts University, Boston, and colleagues analyzed the perceptions of 4,238 pediatricians who participated in a pilot MOC program in 2017 and completed a fourth-quarter survey, a voluntary end-of-year survey, or both surveys. The new MOC option was developed by the American Board of Pediatrics between 2015 and 2016 as an alternative to the current proctored, closed-book general pediatrics (GP) MOC examination. The Maintenance of Certification Assessment for Pediatrics (MOCA-Peds) includes timed, multiple-choice questions delivered quarterly through a Web-based interface, provides resources to help answer questions, and yields immediate feedback, rationale, and references pertaining to answers.

Of the pediatricians surveyed, 93% considered the MOCA-Peds to be a feasible and acceptable alternative to the traditional MOC GP examination, and 89% of pediatricians indicated they would chose the MOCA-Peds model over the proctored examination, according to the study, published in Pediatrics. Of doctors who completed the quarter 4 survey, 88% agreed or strongly agreed that assessment questions aligned with the stated learning objectives, 82% agreed the questions assessed clinical judgment, 82% agreed the questions were relevant to the practice of GP, and 59% agreed the questions were relevant to their specific practice setting, according to the study. For most pediatricians surveyed, the time to answer questions was sufficient (78%).

Regarding potential anxiety associated with MOC, 89% of doctors surveyed agreed that they felt less anxiety participating in the MOCA-Peds compared with the proctored examination, and that any anxiety they felt about the MOCA-Peds lessened during the pilot as their comfort with the assessment grew (81%). When asked whether they would partake in MOCA-Peds in the future, 97% of general pediatricians and 95% of subspecialists planned to participate in MOCA-Peds to maintain their GP certification; 95% of subspecialists said they would participate in MOCA-Peds to maintain their subspecialty certification.

In a second analysis of the same study population led by Adam L. Turner, MPH, of the American Board of Pediatrics, participants were asked whether the MOCA-Peds led to any practice or knowledge changes. Nearly all (98%) respondents reported they had “learned, refreshed, or enhanced their medical knowledge” because of the assessment and 62% of pediatricians reported a practice change associated with pilot participation, according to the study, published in Pediatrics. Of those who made a practice change, 70% were general pediatricians and 41% were subspecialists.

Of the 1,727 pediatricians who positively indicated a practice change, 84% reported details about the specific change made. The most common content domains associated with a practice change included ear, nose, and throat; preventive and well-child care; and mental and behavioral health.

Within the content domains, the three most frequently cited instances in which knowledge or a practice change took place included planning the management of a child with otitis media, managing a child with an acute asthma exacerbation, and planning the management of a child with influenza. Of 400 additional responses related to practice changes beyond answers associated with a specific content domain, the three most common subthemes were using evidence-based medicine, expanding review of materials or resource use, and improving differential diagnosis. Pediatricians reported that participation in MOCA-Peds exposed them to new material and encouraged them to review guidelines or standard care protocols and their application. Respondents also reported increased review of materials or resources in practice, updating the types of resources used, and/or an increased effort to stay more updated.

Dr. Turner and associates concluded that the results “support the notion that assessment and learning can be integrated into a single platform and need not be considered mutually exclusive activities, in turn adding value for practicing physicians.”

The studies were funded by the American Board of Pediatrics Foundation. Dr. Leslie, Dr. Linda Althouse, Mr. Andrew Bradford, and Mr. Adam L. Turner are employees of The American Board of Pediatrics. Dr. Victoria Dounoucos, Dr. Murrey G. Olmsted, and Ms. Amanda C. Smith are employees of RTI International, an international nonprofit research firm with whom the board contracted to conduct this evaluation.

SOURCE: Leslie LK et al. Pediatrics. Nov. 2019 Nov. doi: 10.1542/peds.2019-2303; Turner AL et al. Pediatrics. 2019 Nov. doi: 10.1542/peds.2019-2305.

LAS VEGAS – For patients with nonchallenging cases of basal cell carcinoma, surgery remains the gold standard of treatment, but imiquimod is another feasible option, according to Ervin H. Epstein, MD.

Doug Brunk/MDedge News

In a noninferiority trial, researchers in the Netherlands randomized 601 patients with superficial BCCs to one of three medical treatments: two treatments of photodynamic therapy (PDT) 1 week apart (group 1), imiquimod 5 days per week for 6 weeks with no occlusion (group 2), and 5-fluorouracil (5-FU) twice per day for 4 weeks with no occlusion (group 3). They followed the patients for 5 years to see which tumors came back (J Invest Dermatol. 2018 Mar;138[3]:527-33). At 5 years, tumor-free survival was 63% in group 1, 81% in group 2, and 70% in group 3. Based on this analysis the authors concluded that imiquimod is the first choice for noninvasive treatment of most primary BCCs.

“Yes, imiquimod is helpful, but it’s not as good as surgery,” Dr. Epstein said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Researchers like Dr. Epstein, a dermatologist at Brown & Toland Physicians in Oakland, Calif., have been exploring ways to reduce the recurrence of BCCs in those at high risk. One approach is to stay out of the sun, but that is not practical for most people, “and the data are not very supportive,” he said. “Very few people can actually avoid sunlight. What about topical 5-FU? Suppose you put on 5-FU and then study people for the next year, to see what the likelihood is of them getting a BCC? Why it has taken us so long to do this kind of study is in some ways shameful.” He mentioned one study in which patients at risk of superficial BCC recurrence applied topical 5-FU twice a day for 2-4 weeks. The regimen led to an 11% decrease in the development of BCCs, a trend that did not reach statistical significance.

Another approach to warding off BCC recurrence is to take oral hedgehog pathway inhibitors, which are highly effective. “The problem is, hedgehog pathway inhibitors have side effects that are not catastrophic, but they’re annoying,” Dr. Epstein said. “Patients can lose their hair, they get muscle cramps, and can lose their taste.”

To date, there have been at least three trials evaluating the feasibility of a topical hedgehog pathway inhibitor in adult subjects. In one of the trials, researchers evaluated the efficacy of LDE225, a selective antagonist of Smoothened, in eight patients with nevoid basal cell carcinoma syndrome. They were instructed to apply LDE225 twice per day for 4 weeks (J Invest Dermatol 2011 Aug;131[8]:1735-44). Of 13 BCCs treated in the patients, 12 had a partial to complete response. In fact, eight BCCs had an average of 56% volume reduction but none had complete histologic clearing.

At PellePharm, a biotechnology that Dr. Epstein cofounded, researchers are developing patidegib topical gel, 2%, for the reduction of disease burden of persistently developing BCCs in subjects with Gorlin syndrome. In a phase 3 trial, which just completed recruitment, adults are instructed to apply the gel twice daily to the face for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new surgically eligible BCCs that develop over the 12-month period. “We want to see if we can reduce the number of surgically eligible BCCs,” Dr. Epstein said. “We’re very hopeful.”

SDEF and this news organization are owned by the same parent company. Dr. Epstein spoke during a forum on cutaneous malignancies at the meeting.

Dr. Epstein disclosed that he has been a consultant for Genentech, Novartis, Amgen, and Infinity. He is also cofounder/director and stockholder in PellePharm.

dbrunk@mdedge.com

LAS VEGAS – For patients with nonchallenging cases of basal cell carcinoma, surgery remains the gold standard of treatment, but imiquimod is another feasible option, according to Ervin H. Epstein, MD.

Doug Brunk/MDedge News

In a noninferiority trial, researchers in the Netherlands randomized 601 patients with superficial BCCs to one of three medical treatments: two treatments of photodynamic therapy (PDT) 1 week apart (group 1), imiquimod 5 days per week for 6 weeks with no occlusion (group 2), and 5-fluorouracil (5-FU) twice per day for 4 weeks with no occlusion (group 3). They followed the patients for 5 years to see which tumors came back (J Invest Dermatol. 2018 Mar;138[3]:527-33). At 5 years, tumor-free survival was 63% in group 1, 81% in group 2, and 70% in group 3. Based on this analysis the authors concluded that imiquimod is the first choice for noninvasive treatment of most primary BCCs.

“Yes, imiquimod is helpful, but it’s not as good as surgery,” Dr. Epstein said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Researchers like Dr. Epstein, a dermatologist at Brown & Toland Physicians in Oakland, Calif., have been exploring ways to reduce the recurrence of BCCs in those at high risk. One approach is to stay out of the sun, but that is not practical for most people, “and the data are not very supportive,” he said. “Very few people can actually avoid sunlight. What about topical 5-FU? Suppose you put on 5-FU and then study people for the next year, to see what the likelihood is of them getting a BCC? Why it has taken us so long to do this kind of study is in some ways shameful.” He mentioned one study in which patients at risk of superficial BCC recurrence applied topical 5-FU twice a day for 2-4 weeks. The regimen led to an 11% decrease in the development of BCCs, a trend that did not reach statistical significance.

Another approach to warding off BCC recurrence is to take oral hedgehog pathway inhibitors, which are highly effective. “The problem is, hedgehog pathway inhibitors have side effects that are not catastrophic, but they’re annoying,” Dr. Epstein said. “Patients can lose their hair, they get muscle cramps, and can lose their taste.”

To date, there have been at least three trials evaluating the feasibility of a topical hedgehog pathway inhibitor in adult subjects. In one of the trials, researchers evaluated the efficacy of LDE225, a selective antagonist of Smoothened, in eight patients with nevoid basal cell carcinoma syndrome. They were instructed to apply LDE225 twice per day for 4 weeks (J Invest Dermatol 2011 Aug;131[8]:1735-44). Of 13 BCCs treated in the patients, 12 had a partial to complete response. In fact, eight BCCs had an average of 56% volume reduction but none had complete histologic clearing.

At PellePharm, a biotechnology that Dr. Epstein cofounded, researchers are developing patidegib topical gel, 2%, for the reduction of disease burden of persistently developing BCCs in subjects with Gorlin syndrome. In a phase 3 trial, which just completed recruitment, adults are instructed to apply the gel twice daily to the face for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new surgically eligible BCCs that develop over the 12-month period. “We want to see if we can reduce the number of surgically eligible BCCs,” Dr. Epstein said. “We’re very hopeful.”

SDEF and this news organization are owned by the same parent company. Dr. Epstein spoke during a forum on cutaneous malignancies at the meeting.

Dr. Epstein disclosed that he has been a consultant for Genentech, Novartis, Amgen, and Infinity. He is also cofounder/director and stockholder in PellePharm.

dbrunk@mdedge.com

LAS VEGAS – For patients with nonchallenging cases of basal cell carcinoma, surgery remains the gold standard of treatment, but imiquimod is another feasible option, according to Ervin H. Epstein, MD.

Doug Brunk/MDedge News

In a noninferiority trial, researchers in the Netherlands randomized 601 patients with superficial BCCs to one of three medical treatments: two treatments of photodynamic therapy (PDT) 1 week apart (group 1), imiquimod 5 days per week for 6 weeks with no occlusion (group 2), and 5-fluorouracil (5-FU) twice per day for 4 weeks with no occlusion (group 3). They followed the patients for 5 years to see which tumors came back (J Invest Dermatol. 2018 Mar;138[3]:527-33). At 5 years, tumor-free survival was 63% in group 1, 81% in group 2, and 70% in group 3. Based on this analysis the authors concluded that imiquimod is the first choice for noninvasive treatment of most primary BCCs.

“Yes, imiquimod is helpful, but it’s not as good as surgery,” Dr. Epstein said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Researchers like Dr. Epstein, a dermatologist at Brown & Toland Physicians in Oakland, Calif., have been exploring ways to reduce the recurrence of BCCs in those at high risk. One approach is to stay out of the sun, but that is not practical for most people, “and the data are not very supportive,” he said. “Very few people can actually avoid sunlight. What about topical 5-FU? Suppose you put on 5-FU and then study people for the next year, to see what the likelihood is of them getting a BCC? Why it has taken us so long to do this kind of study is in some ways shameful.” He mentioned one study in which patients at risk of superficial BCC recurrence applied topical 5-FU twice a day for 2-4 weeks. The regimen led to an 11% decrease in the development of BCCs, a trend that did not reach statistical significance.

Another approach to warding off BCC recurrence is to take oral hedgehog pathway inhibitors, which are highly effective. “The problem is, hedgehog pathway inhibitors have side effects that are not catastrophic, but they’re annoying,” Dr. Epstein said. “Patients can lose their hair, they get muscle cramps, and can lose their taste.”

To date, there have been at least three trials evaluating the feasibility of a topical hedgehog pathway inhibitor in adult subjects. In one of the trials, researchers evaluated the efficacy of LDE225, a selective antagonist of Smoothened, in eight patients with nevoid basal cell carcinoma syndrome. They were instructed to apply LDE225 twice per day for 4 weeks (J Invest Dermatol 2011 Aug;131[8]:1735-44). Of 13 BCCs treated in the patients, 12 had a partial to complete response. In fact, eight BCCs had an average of 56% volume reduction but none had complete histologic clearing.

At PellePharm, a biotechnology that Dr. Epstein cofounded, researchers are developing patidegib topical gel, 2%, for the reduction of disease burden of persistently developing BCCs in subjects with Gorlin syndrome. In a phase 3 trial, which just completed recruitment, adults are instructed to apply the gel twice daily to the face for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new surgically eligible BCCs that develop over the 12-month period. “We want to see if we can reduce the number of surgically eligible BCCs,” Dr. Epstein said. “We’re very hopeful.”

SDEF and this news organization are owned by the same parent company. Dr. Epstein spoke during a forum on cutaneous malignancies at the meeting.

Dr. Epstein disclosed that he has been a consultant for Genentech, Novartis, Amgen, and Infinity. He is also cofounder/director and stockholder in PellePharm.

dbrunk@mdedge.com

MADRID – In a phase 2, dose-ranging study, 78% of patients with long-standing moderate or severe alopecia areata rated their condition as “much improved” or “very much improved” after 24 weeks on the top dose of an investigational oral selective Janus kinase 1 and 2 (JAK1/2) inhibitor, compared with 21% of placebo-treated controls, James V. Cassella, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

The primary study endpoint – at least a 50% reduction in the Severity of Alopecia Tool (SALT) score between baseline and 24 weeks – was achieved in 58% of patients on the JAK1/2 inhibitor (known for now as CTP-543) at 12 mg twice a day, 47% of those on CTP-543 at 8 mg twice a day, 21% on 4 mg twice a day, and in 9% of controls on placebo in the double-blind randomized trial. The 4-mg twice-daily dosing will not move on to phase 3 studies because of its demonstrated lack of efficacy, according to Dr. Cassella, chief development officer at Concert Pharmaceuticals, the study sponsor.

The study included 149 adults whose current episode of alopecia areata was of 3-6 years’ duration, with an average lifetime 15-year history of active disease. Their average baseline score on the 0-100 SALT scale was in the upper 80s, indicative of 80% or greater hair loss.

A SALT 75 response, meaning at least a 75% reduction in SALT score from baseline, was achieved in a dose-dependent fashion: In 42% of patients at the top dose of CTP-543, 29% of those on 8 mg twice a day, 14% with 4 mg twice a day, and in 7% of controls. An even more rigorous SALT 90 response was attained in 36%, 16%, 2%, and no controls, respectively.

The 12-mg twice-daily dosing produced faster onset and greater magnitude of response than did the 8-mg twice-daily dosing, but this dose-ranging study is not the final word on that score, according to Dr. Cassella.

“Week 24 is not a magic number,” he said. “The slope of the efficacy line for 8 mg [twice a day] looked like it was still going up at week 24, and the 12-mg BID curve hadn’t completely plateaued. Those are things we will consider for the future in terms of long-term trials.”

Changes in the eyebrows and lashes weren’t formally assessed in this study, although they will be in future trials. Anecdotally, however, patients with alopecia areata at those sites typically experienced complete or nearly complete regrowth in response to the higher doses of CTP-543, he said.

Safety-wise, there was no trend for increased adverse events with increasing doses of CTP-543. The observed treatment side effects were those typical of JAK inhibitors as a class effect, mainly headache, nasopharyngitis, upper respiratory infections, and new-onset acne. In terms of hematologic findings of special interest, there was one case of reversible neutropenia in the control group and another in the 8-mg twice-daily group, which resolved upon temporary suspension of treatment.

“Nothing surprising to us, and nothing very serious,” Dr. Cassella said.

Most patients in the 12-mg twice daily group have enrolled in an ongoing long-term extension study. In addition, two phase 2 studies are ongoing, with a focus on once-daily versus twice-daily dosing at 8 mg or 12 mg. Phase 3 studies are in the planning stage, he added.

The phase 2 dose-ranging study was sponsored by Concert Pharmaceuticals.

CTP-543 is one of an array of oral JAK inhibitors now in the developmental pipeline for alopecia areata, a severe, psychosocially devastating disease for which at present there is no Food and Drug Administration–approved therapy.

bjancin@mdedge.com

MADRID – In a phase 2, dose-ranging study, 78% of patients with long-standing moderate or severe alopecia areata rated their condition as “much improved” or “very much improved” after 24 weeks on the top dose of an investigational oral selective Janus kinase 1 and 2 (JAK1/2) inhibitor, compared with 21% of placebo-treated controls, James V. Cassella, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

The primary study endpoint – at least a 50% reduction in the Severity of Alopecia Tool (SALT) score between baseline and 24 weeks – was achieved in 58% of patients on the JAK1/2 inhibitor (known for now as CTP-543) at 12 mg twice a day, 47% of those on CTP-543 at 8 mg twice a day, 21% on 4 mg twice a day, and in 9% of controls on placebo in the double-blind randomized trial. The 4-mg twice-daily dosing will not move on to phase 3 studies because of its demonstrated lack of efficacy, according to Dr. Cassella, chief development officer at Concert Pharmaceuticals, the study sponsor.

The study included 149 adults whose current episode of alopecia areata was of 3-6 years’ duration, with an average lifetime 15-year history of active disease. Their average baseline score on the 0-100 SALT scale was in the upper 80s, indicative of 80% or greater hair loss.

A SALT 75 response, meaning at least a 75% reduction in SALT score from baseline, was achieved in a dose-dependent fashion: In 42% of patients at the top dose of CTP-543, 29% of those on 8 mg twice a day, 14% with 4 mg twice a day, and in 7% of controls. An even more rigorous SALT 90 response was attained in 36%, 16%, 2%, and no controls, respectively.

The 12-mg twice-daily dosing produced faster onset and greater magnitude of response than did the 8-mg twice-daily dosing, but this dose-ranging study is not the final word on that score, according to Dr. Cassella.

“Week 24 is not a magic number,” he said. “The slope of the efficacy line for 8 mg [twice a day] looked like it was still going up at week 24, and the 12-mg BID curve hadn’t completely plateaued. Those are things we will consider for the future in terms of long-term trials.”

Changes in the eyebrows and lashes weren’t formally assessed in this study, although they will be in future trials. Anecdotally, however, patients with alopecia areata at those sites typically experienced complete or nearly complete regrowth in response to the higher doses of CTP-543, he said.

Safety-wise, there was no trend for increased adverse events with increasing doses of CTP-543. The observed treatment side effects were those typical of JAK inhibitors as a class effect, mainly headache, nasopharyngitis, upper respiratory infections, and new-onset acne. In terms of hematologic findings of special interest, there was one case of reversible neutropenia in the control group and another in the 8-mg twice-daily group, which resolved upon temporary suspension of treatment.

“Nothing surprising to us, and nothing very serious,” Dr. Cassella said.

Most patients in the 12-mg twice daily group have enrolled in an ongoing long-term extension study. In addition, two phase 2 studies are ongoing, with a focus on once-daily versus twice-daily dosing at 8 mg or 12 mg. Phase 3 studies are in the planning stage, he added.

The phase 2 dose-ranging study was sponsored by Concert Pharmaceuticals.

CTP-543 is one of an array of oral JAK inhibitors now in the developmental pipeline for alopecia areata, a severe, psychosocially devastating disease for which at present there is no Food and Drug Administration–approved therapy.

bjancin@mdedge.com

MADRID – In a phase 2, dose-ranging study, 78% of patients with long-standing moderate or severe alopecia areata rated their condition as “much improved” or “very much improved” after 24 weeks on the top dose of an investigational oral selective Janus kinase 1 and 2 (JAK1/2) inhibitor, compared with 21% of placebo-treated controls, James V. Cassella, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

The primary study endpoint – at least a 50% reduction in the Severity of Alopecia Tool (SALT) score between baseline and 24 weeks – was achieved in 58% of patients on the JAK1/2 inhibitor (known for now as CTP-543) at 12 mg twice a day, 47% of those on CTP-543 at 8 mg twice a day, 21% on 4 mg twice a day, and in 9% of controls on placebo in the double-blind randomized trial. The 4-mg twice-daily dosing will not move on to phase 3 studies because of its demonstrated lack of efficacy, according to Dr. Cassella, chief development officer at Concert Pharmaceuticals, the study sponsor.

The study included 149 adults whose current episode of alopecia areata was of 3-6 years’ duration, with an average lifetime 15-year history of active disease. Their average baseline score on the 0-100 SALT scale was in the upper 80s, indicative of 80% or greater hair loss.

A SALT 75 response, meaning at least a 75% reduction in SALT score from baseline, was achieved in a dose-dependent fashion: In 42% of patients at the top dose of CTP-543, 29% of those on 8 mg twice a day, 14% with 4 mg twice a day, and in 7% of controls. An even more rigorous SALT 90 response was attained in 36%, 16%, 2%, and no controls, respectively.

The 12-mg twice-daily dosing produced faster onset and greater magnitude of response than did the 8-mg twice-daily dosing, but this dose-ranging study is not the final word on that score, according to Dr. Cassella.

“Week 24 is not a magic number,” he said. “The slope of the efficacy line for 8 mg [twice a day] looked like it was still going up at week 24, and the 12-mg BID curve hadn’t completely plateaued. Those are things we will consider for the future in terms of long-term trials.”

Changes in the eyebrows and lashes weren’t formally assessed in this study, although they will be in future trials. Anecdotally, however, patients with alopecia areata at those sites typically experienced complete or nearly complete regrowth in response to the higher doses of CTP-543, he said.

Safety-wise, there was no trend for increased adverse events with increasing doses of CTP-543. The observed treatment side effects were those typical of JAK inhibitors as a class effect, mainly headache, nasopharyngitis, upper respiratory infections, and new-onset acne. In terms of hematologic findings of special interest, there was one case of reversible neutropenia in the control group and another in the 8-mg twice-daily group, which resolved upon temporary suspension of treatment.

“Nothing surprising to us, and nothing very serious,” Dr. Cassella said.

Most patients in the 12-mg twice daily group have enrolled in an ongoing long-term extension study. In addition, two phase 2 studies are ongoing, with a focus on once-daily versus twice-daily dosing at 8 mg or 12 mg. Phase 3 studies are in the planning stage, he added.

The phase 2 dose-ranging study was sponsored by Concert Pharmaceuticals.

CTP-543 is one of an array of oral JAK inhibitors now in the developmental pipeline for alopecia areata, a severe, psychosocially devastating disease for which at present there is no Food and Drug Administration–approved therapy.

bjancin@mdedge.com