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In Sweden, very few osteoporotic fractures prompt treatment within 12 months
MADRID – In Sweden, less than 7% of those who experience an osteoporotic fracture receive osteoporosis treatment within the first year, when the risk of a second fracture is the highest.
Women are more likely than are men to get a prescription, but people older than 80 years, and those with dementia or low socioeconomic status, are less likely to receive one, Anna Spångeus, MD, PhD, said at the European Congress of Rheumatology.
She expressed particular concern about the age differential observed in the study. “These drugs are equally as effective in the aged as in younger subjects. … It’s quite reasonable for a women aged 80-85 years to have treatment if she has a lower biological age and a good survival time that would allow her to benefit from the treatment.”
The investigators took advantage of Sweden’s multiple, inked national health registries to examine the rates of new osteoporosis prescriptions in treatment-naive patients who experienced a first osteoporotic bone fracture. Prescribing information came from the Prescribed Drug Register, which covers 100% of outpatient pharmacies. This database doesn’t include medications dispensed in hospitals, though, or intravenous osteoporotic treatments – a weakness of the study, Dr. Spångeus noted. The 6-year study period covered 2006-2012.
In all, almost 260,000 Swedish citizens naive to osteoporosis treatment had an osteoporotic bone fracture during that period. Most of these (68%) were women; the mean age was 73 years. Of these, 16,970 (6.6%) received therapy for osteoporosis within the first year after their fracture.
Vertebral fractures were the most likely to prompt treatment (21%). Only about 5% of all other fracture types prompted an osteoporosis treatment prescription, despite a clear clinical link to the disorder, Dr. Spångeus said. “Almost four times as many patients with clinical vertebral fractures initiated osteoporosis treatment in the year after the fracture. In contrast, treatment after hip fracture was significantly lower, despite the high subsequent risk.”
A good bit of news emerged when she parsed the group by comorbidities: 18% of patients with rheumatoid arthritis got an osteoporosis prescription, suggesting that clinicians were aware of the risk to bone posed by glucocorticoid therapy. Of all fracture patients on glucocorticoids, 17% got a prescription after their break. Only 6% of those not taking glucocorticoids got an osteoporosis medication.
Patients with chronic pulmonary diseases also tended to be treated more often, with about 10% getting a prescription. But those with dementia were much less likely to receive a prescription (1.5%), as were patients with any kind of social dependency – a marker of lower socioeconomic status (2%).
In an age analysis, patients aged 70-80 years were most often treated (19%). The youngest patients (50-60 years) and the oldest (90 and older) were the least likely to be treated (4% and 1.6%). About 6% of those aged 80-90 years were treated.
Women were almost four times more likely to get a prescription than were men (8.5% vs. 2.3%; odds ratio, 3.7). “This was concerning, because about a third of our cohort consisted of men,” Dr. Spångeus said. “Men do develop osteoporotic bone fractures, but this is not being recognized.”
The study was funded by an unrestricted grant from UCB Pharma. Dr. Spångeus disclosed that she has received research funding from Amgen and Eli Lilly.
[email protected]
On Twitter @alz_gal
MADRID – In Sweden, less than 7% of those who experience an osteoporotic fracture receive osteoporosis treatment within the first year, when the risk of a second fracture is the highest.
Women are more likely than are men to get a prescription, but people older than 80 years, and those with dementia or low socioeconomic status, are less likely to receive one, Anna Spångeus, MD, PhD, said at the European Congress of Rheumatology.
She expressed particular concern about the age differential observed in the study. “These drugs are equally as effective in the aged as in younger subjects. … It’s quite reasonable for a women aged 80-85 years to have treatment if she has a lower biological age and a good survival time that would allow her to benefit from the treatment.”
The investigators took advantage of Sweden’s multiple, inked national health registries to examine the rates of new osteoporosis prescriptions in treatment-naive patients who experienced a first osteoporotic bone fracture. Prescribing information came from the Prescribed Drug Register, which covers 100% of outpatient pharmacies. This database doesn’t include medications dispensed in hospitals, though, or intravenous osteoporotic treatments – a weakness of the study, Dr. Spångeus noted. The 6-year study period covered 2006-2012.
In all, almost 260,000 Swedish citizens naive to osteoporosis treatment had an osteoporotic bone fracture during that period. Most of these (68%) were women; the mean age was 73 years. Of these, 16,970 (6.6%) received therapy for osteoporosis within the first year after their fracture.
Vertebral fractures were the most likely to prompt treatment (21%). Only about 5% of all other fracture types prompted an osteoporosis treatment prescription, despite a clear clinical link to the disorder, Dr. Spångeus said. “Almost four times as many patients with clinical vertebral fractures initiated osteoporosis treatment in the year after the fracture. In contrast, treatment after hip fracture was significantly lower, despite the high subsequent risk.”
A good bit of news emerged when she parsed the group by comorbidities: 18% of patients with rheumatoid arthritis got an osteoporosis prescription, suggesting that clinicians were aware of the risk to bone posed by glucocorticoid therapy. Of all fracture patients on glucocorticoids, 17% got a prescription after their break. Only 6% of those not taking glucocorticoids got an osteoporosis medication.
Patients with chronic pulmonary diseases also tended to be treated more often, with about 10% getting a prescription. But those with dementia were much less likely to receive a prescription (1.5%), as were patients with any kind of social dependency – a marker of lower socioeconomic status (2%).
In an age analysis, patients aged 70-80 years were most often treated (19%). The youngest patients (50-60 years) and the oldest (90 and older) were the least likely to be treated (4% and 1.6%). About 6% of those aged 80-90 years were treated.
Women were almost four times more likely to get a prescription than were men (8.5% vs. 2.3%; odds ratio, 3.7). “This was concerning, because about a third of our cohort consisted of men,” Dr. Spångeus said. “Men do develop osteoporotic bone fractures, but this is not being recognized.”
The study was funded by an unrestricted grant from UCB Pharma. Dr. Spångeus disclosed that she has received research funding from Amgen and Eli Lilly.
[email protected]
On Twitter @alz_gal
MADRID – In Sweden, less than 7% of those who experience an osteoporotic fracture receive osteoporosis treatment within the first year, when the risk of a second fracture is the highest.
Women are more likely than are men to get a prescription, but people older than 80 years, and those with dementia or low socioeconomic status, are less likely to receive one, Anna Spångeus, MD, PhD, said at the European Congress of Rheumatology.
She expressed particular concern about the age differential observed in the study. “These drugs are equally as effective in the aged as in younger subjects. … It’s quite reasonable for a women aged 80-85 years to have treatment if she has a lower biological age and a good survival time that would allow her to benefit from the treatment.”
The investigators took advantage of Sweden’s multiple, inked national health registries to examine the rates of new osteoporosis prescriptions in treatment-naive patients who experienced a first osteoporotic bone fracture. Prescribing information came from the Prescribed Drug Register, which covers 100% of outpatient pharmacies. This database doesn’t include medications dispensed in hospitals, though, or intravenous osteoporotic treatments – a weakness of the study, Dr. Spångeus noted. The 6-year study period covered 2006-2012.
In all, almost 260,000 Swedish citizens naive to osteoporosis treatment had an osteoporotic bone fracture during that period. Most of these (68%) were women; the mean age was 73 years. Of these, 16,970 (6.6%) received therapy for osteoporosis within the first year after their fracture.
Vertebral fractures were the most likely to prompt treatment (21%). Only about 5% of all other fracture types prompted an osteoporosis treatment prescription, despite a clear clinical link to the disorder, Dr. Spångeus said. “Almost four times as many patients with clinical vertebral fractures initiated osteoporosis treatment in the year after the fracture. In contrast, treatment after hip fracture was significantly lower, despite the high subsequent risk.”
A good bit of news emerged when she parsed the group by comorbidities: 18% of patients with rheumatoid arthritis got an osteoporosis prescription, suggesting that clinicians were aware of the risk to bone posed by glucocorticoid therapy. Of all fracture patients on glucocorticoids, 17% got a prescription after their break. Only 6% of those not taking glucocorticoids got an osteoporosis medication.
Patients with chronic pulmonary diseases also tended to be treated more often, with about 10% getting a prescription. But those with dementia were much less likely to receive a prescription (1.5%), as were patients with any kind of social dependency – a marker of lower socioeconomic status (2%).
In an age analysis, patients aged 70-80 years were most often treated (19%). The youngest patients (50-60 years) and the oldest (90 and older) were the least likely to be treated (4% and 1.6%). About 6% of those aged 80-90 years were treated.
Women were almost four times more likely to get a prescription than were men (8.5% vs. 2.3%; odds ratio, 3.7). “This was concerning, because about a third of our cohort consisted of men,” Dr. Spångeus said. “Men do develop osteoporotic bone fractures, but this is not being recognized.”
The study was funded by an unrestricted grant from UCB Pharma. Dr. Spångeus disclosed that she has received research funding from Amgen and Eli Lilly.
[email protected]
On Twitter @alz_gal
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Only 6.6% of patients who were naive to osteoporotic therapy and experienced a break received a prescription.
Data source: The national registry study, comprising about 290,000 patients.
Disclosures: UCB Pharma sponsored the study with an unrestricted grant. Dr. Spångeus has received research funding from Amgen and Eli Lilly.
Knee OA structural defects predict pain trajectories
The presence of bone marrow lesions and cartilage defects on baseline MRI scans of knee osteoarthritis (OA) patients may help to predict moderate to severe pain trajectories, based on data from a population-based study presented here at the European Congress of Rheumatology.
Three pain trajectories were identified: 52% of the patients reported stable mild pain over time, 33% reported moderate pain over time, and 15% reported fluctuating or severe pain over time.
“Knee pain is the most prominent symptom of knee osteoarthritis,” Dr. Pan said in an interview. “It is also a main reason for people to seek joint replacement. Despite this, the causes of knee pain are poorly understood. Therapy will only improve if we understand this better.”
Dr. Pan and his colleagues studied 1,099 adults with knee OA who participated in a population-based study. The mean age was 63 years (ranging from 51 to 81 years). A total of 875 participants were assessed using the knee pain components of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 2.6 years’ follow-up, 768 at 5.1 years’ follow-up, and 563 at 10.7 years’ follow-up.
Knee OA was assessed at baseline by x-ray, and T1-weighted or T2-weighted MRI scans of the right knee were used to assess knee structural pathology. The researchers applied group-based trajectory modeling to identify pain trajectories.
“We identified three distinct trajectories over time,” Dr. Pan said. “Remarkably, structural, environmental, sociodemographic, and psychological factors are associated with a more ‘severe pain’ trajectory, suggesting that pain course is determined by an integrated mix of all these factors.”
Dr. Pan added: “We already know that structural damage is a major driver in the development and maintenance of pain severity, but less is known about the other factors.”
The researchers found a significant dose-response relationship between the number of knee structural abnormalities, including cartilage defects and bone marrow lesions, and the ‘moderate pain’ and ‘severe pain’ trajectories (P less than .001 comparing both categories to the ‘mild pain’ trajectory).
Other factors that were significantly associated with both moderate and severe pain, compared with mild pain, included higher body mass index (overweight but not obese), emotional problems, and musculoskeletal diseases.
The findings provide support to the concept that “pain experience is both complex and individual in nature, suggesting the clinician should target treatments according to which of these factors predominate in the individual,” Dr. Pan said.
Future research may aim to develop “a predictive model that could be utilized in clinical practice and target therapies based on these trajectories.”
Dr. Pan had no financial conflicts to disclose.
The presence of bone marrow lesions and cartilage defects on baseline MRI scans of knee osteoarthritis (OA) patients may help to predict moderate to severe pain trajectories, based on data from a population-based study presented here at the European Congress of Rheumatology.
Three pain trajectories were identified: 52% of the patients reported stable mild pain over time, 33% reported moderate pain over time, and 15% reported fluctuating or severe pain over time.
“Knee pain is the most prominent symptom of knee osteoarthritis,” Dr. Pan said in an interview. “It is also a main reason for people to seek joint replacement. Despite this, the causes of knee pain are poorly understood. Therapy will only improve if we understand this better.”
Dr. Pan and his colleagues studied 1,099 adults with knee OA who participated in a population-based study. The mean age was 63 years (ranging from 51 to 81 years). A total of 875 participants were assessed using the knee pain components of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 2.6 years’ follow-up, 768 at 5.1 years’ follow-up, and 563 at 10.7 years’ follow-up.
Knee OA was assessed at baseline by x-ray, and T1-weighted or T2-weighted MRI scans of the right knee were used to assess knee structural pathology. The researchers applied group-based trajectory modeling to identify pain trajectories.
“We identified three distinct trajectories over time,” Dr. Pan said. “Remarkably, structural, environmental, sociodemographic, and psychological factors are associated with a more ‘severe pain’ trajectory, suggesting that pain course is determined by an integrated mix of all these factors.”
Dr. Pan added: “We already know that structural damage is a major driver in the development and maintenance of pain severity, but less is known about the other factors.”
The researchers found a significant dose-response relationship between the number of knee structural abnormalities, including cartilage defects and bone marrow lesions, and the ‘moderate pain’ and ‘severe pain’ trajectories (P less than .001 comparing both categories to the ‘mild pain’ trajectory).
Other factors that were significantly associated with both moderate and severe pain, compared with mild pain, included higher body mass index (overweight but not obese), emotional problems, and musculoskeletal diseases.
The findings provide support to the concept that “pain experience is both complex and individual in nature, suggesting the clinician should target treatments according to which of these factors predominate in the individual,” Dr. Pan said.
Future research may aim to develop “a predictive model that could be utilized in clinical practice and target therapies based on these trajectories.”
Dr. Pan had no financial conflicts to disclose.
The presence of bone marrow lesions and cartilage defects on baseline MRI scans of knee osteoarthritis (OA) patients may help to predict moderate to severe pain trajectories, based on data from a population-based study presented here at the European Congress of Rheumatology.
Three pain trajectories were identified: 52% of the patients reported stable mild pain over time, 33% reported moderate pain over time, and 15% reported fluctuating or severe pain over time.
“Knee pain is the most prominent symptom of knee osteoarthritis,” Dr. Pan said in an interview. “It is also a main reason for people to seek joint replacement. Despite this, the causes of knee pain are poorly understood. Therapy will only improve if we understand this better.”
Dr. Pan and his colleagues studied 1,099 adults with knee OA who participated in a population-based study. The mean age was 63 years (ranging from 51 to 81 years). A total of 875 participants were assessed using the knee pain components of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 2.6 years’ follow-up, 768 at 5.1 years’ follow-up, and 563 at 10.7 years’ follow-up.
Knee OA was assessed at baseline by x-ray, and T1-weighted or T2-weighted MRI scans of the right knee were used to assess knee structural pathology. The researchers applied group-based trajectory modeling to identify pain trajectories.
“We identified three distinct trajectories over time,” Dr. Pan said. “Remarkably, structural, environmental, sociodemographic, and psychological factors are associated with a more ‘severe pain’ trajectory, suggesting that pain course is determined by an integrated mix of all these factors.”
Dr. Pan added: “We already know that structural damage is a major driver in the development and maintenance of pain severity, but less is known about the other factors.”
The researchers found a significant dose-response relationship between the number of knee structural abnormalities, including cartilage defects and bone marrow lesions, and the ‘moderate pain’ and ‘severe pain’ trajectories (P less than .001 comparing both categories to the ‘mild pain’ trajectory).
Other factors that were significantly associated with both moderate and severe pain, compared with mild pain, included higher body mass index (overweight but not obese), emotional problems, and musculoskeletal diseases.
The findings provide support to the concept that “pain experience is both complex and individual in nature, suggesting the clinician should target treatments according to which of these factors predominate in the individual,” Dr. Pan said.
Future research may aim to develop “a predictive model that could be utilized in clinical practice and target therapies based on these trajectories.”
Dr. Pan had no financial conflicts to disclose.
FROM THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Three pain trajectories were identified: stable mild pain (52% of patients), moderate pain (33%), and fluctuating or severe pain (15%).
Data source: Population-based cohort study of 1,099 patients with knee OA.
Disclosures: The presenter had no financial conflicts to disclose.
Physician-created APMs: Dermatology aims to learn from early recommendations
Dermatologists looking for a way to participate in an advanced alternative payment model under Medicare’s new Quality Payment Program will likely need to develop their own and get it approved.
Advanced alternative payment models (APMs) involve physicians taking on two-sided risk along with Medicare in exchange for the potential for higher bonus payments for delivering higher-value care to patients. Officials at the Centers for Medicare & Medicaid Services have created seven APMs (some primary care and some specialty focused), but they do not appeal to everyone.
“The likelihood that a private practice dermatologist is going to participate in a risk-bearing APM is, I think, possible but challenging,” said Kathryn Schwarzenberger, MD, chair of the American Academy of Dermatology’s Workgroup on Innovation in Payment and Delivery. “To have a fully qualified, double-sided risk APM for most private practitioners is going to be difficult. The advanced APMs, unless you are in a group, we have figured most dermatologists wouldn’t be interested.”
A physician-created APM might be a different story, however.
Getting approval for this type of APM – technically known as physician-focused payment models (PFPMs) – is tough. Of the first three PFPMs reviewed by Medicare’s Physician-Focused Payment Model Technical Advisory Committee (PTAC), two were recommended for limited trial periods only. A third proposal was not recommended. None of these early proposals were dermatology focused.
Not jumping into the process early was a prudent move, according to Dr. Schwarzenberger.
“We learned that it is probably good to sit back at this point and watch and see what is happening,” she said. “I think the rules have become much more clear. I think now that PTAC has provided us with some better guidelines for how to develop a successful APM, we have a much better chance of doing so.”
In this earliest review, each proposed APM was assigned to three commissioners, including at least one physician, for review against 10 criteria:
• Scope of proposed PFPM (high priority).
• Quality and cost (high priority).
• Payment methodology (high priority).
• Value over volume.
• Flexibility.
• Ability to be evaluated.
• Integration and care coordination.
• Patient choice.
• Patient safety.
• Health information technology.
While each proposal met a few of the criteria, none met all three high-priority criteria, and none was recommended for approval by its preliminary reviewers; however, after committee deliberation, two received provisional recommendation.
“We recommended the two models for small-scale testing,” PTAC Vice-Chairman Elizabeth Mitchell said in an interview. “Even though we think they are very good ideas, we know that more experience and evidence are required before they may be ready.”
The two models that got the limited recommendation were:
• Project Sonar, submitted by the Illinois Gastroenterology Group and SonarMD, a Web-based platform that queries patients with inflammatory bowel disease monthly to determine which are in need of more hands-on care.
• American College of Surgeons–Brandeis APM, submitted by the American College of Surgeons, an episode-based payment model that uses claims data but expands on existing CMS value-based models by not requiring hospitalizations. It creates an episodic payment using outpatient settings, including acute and chronic care.
The COPD [chronic obstructive pulmonary disease] and Asthma Monitoring Project (CAMP), a smartphone app to remotely monitor and guide treatment of patients with asthma and chronic obstructive pulmonary disease, was not recommended. It was submitted by Pulmonary Medicine, Infectious Disease and Critical Care Consultants Medical Group of Sacramento.
PTAC has received more than 20 letters of intent from physicians and aims to hold another round of public hearings in September to determine their usefulness.
“I think it is very safe to say that our whole committee has been really gratified with the level of interest and engagement,” said Ms. Mitchell, president and CEO of Network for Regional Healthcare Improvement in Portland, Maine. The volume of applications “underscores the level of interest from the field. The entire reason PTAC was established was to get those good ideas from practicing physicians and others who are identifying better ways to deliver care but are facing barriers in the current payment system.”
She offered advice to those who are contemplating submission of a payment model: “Really understand the criteria and review the request for proposals. I think the committee lays out what we are looking for in terms of information, and we are hoping that it is really straightforward.”
She also stressed that successful models need to work broadly. “We are not talking about something that works for a single practice,” she said. “We are talking about models that are ready for inclusion in the whole CMS portfolio. It is helpful if there is experience to draw from that informs our deliberations, but we recognize that, in some cases, there has not been the opportunity to test these models broadly.”
Most of all, the highest priority when it comes to the models is related to quality of care and cost.
“We are not soliciting models that are essentially tweaks to fee for service. We are looking for changes that cannot be made without a new method of payment,” she said, adding that the models “have to either reduce cost while maintaining quality or improve quality without raising cost.”
Meeting transcripts and video are posted online and can help potential applicants see how the committee came to its recommendations.
“The committee does not deliberate on the proposals except in public,” Ms. Mitchell said. “So, those public meetings were the first time we had deliberated on any of the proposals we have considered. The preliminary review teams have discussed it [in depth], but the full committee can only deliberate in public.”
Dr. Schwarzenberger said that while the AAD working group is looking at some dermatology-specific conditions that might be good for a PFPM a broader approach may be better. Perhaps the focus should be “where dermatology’s involvement with other physicians, where we might be able to help them practice medicine better or save money,” she said. “Maybe where we can make our biggest financial and potentially quality impacts.”
Dermatologists looking for a way to participate in an advanced alternative payment model under Medicare’s new Quality Payment Program will likely need to develop their own and get it approved.
Advanced alternative payment models (APMs) involve physicians taking on two-sided risk along with Medicare in exchange for the potential for higher bonus payments for delivering higher-value care to patients. Officials at the Centers for Medicare & Medicaid Services have created seven APMs (some primary care and some specialty focused), but they do not appeal to everyone.
“The likelihood that a private practice dermatologist is going to participate in a risk-bearing APM is, I think, possible but challenging,” said Kathryn Schwarzenberger, MD, chair of the American Academy of Dermatology’s Workgroup on Innovation in Payment and Delivery. “To have a fully qualified, double-sided risk APM for most private practitioners is going to be difficult. The advanced APMs, unless you are in a group, we have figured most dermatologists wouldn’t be interested.”
A physician-created APM might be a different story, however.
Getting approval for this type of APM – technically known as physician-focused payment models (PFPMs) – is tough. Of the first three PFPMs reviewed by Medicare’s Physician-Focused Payment Model Technical Advisory Committee (PTAC), two were recommended for limited trial periods only. A third proposal was not recommended. None of these early proposals were dermatology focused.
Not jumping into the process early was a prudent move, according to Dr. Schwarzenberger.
“We learned that it is probably good to sit back at this point and watch and see what is happening,” she said. “I think the rules have become much more clear. I think now that PTAC has provided us with some better guidelines for how to develop a successful APM, we have a much better chance of doing so.”
In this earliest review, each proposed APM was assigned to three commissioners, including at least one physician, for review against 10 criteria:
• Scope of proposed PFPM (high priority).
• Quality and cost (high priority).
• Payment methodology (high priority).
• Value over volume.
• Flexibility.
• Ability to be evaluated.
• Integration and care coordination.
• Patient choice.
• Patient safety.
• Health information technology.
While each proposal met a few of the criteria, none met all three high-priority criteria, and none was recommended for approval by its preliminary reviewers; however, after committee deliberation, two received provisional recommendation.
“We recommended the two models for small-scale testing,” PTAC Vice-Chairman Elizabeth Mitchell said in an interview. “Even though we think they are very good ideas, we know that more experience and evidence are required before they may be ready.”
The two models that got the limited recommendation were:
• Project Sonar, submitted by the Illinois Gastroenterology Group and SonarMD, a Web-based platform that queries patients with inflammatory bowel disease monthly to determine which are in need of more hands-on care.
• American College of Surgeons–Brandeis APM, submitted by the American College of Surgeons, an episode-based payment model that uses claims data but expands on existing CMS value-based models by not requiring hospitalizations. It creates an episodic payment using outpatient settings, including acute and chronic care.
The COPD [chronic obstructive pulmonary disease] and Asthma Monitoring Project (CAMP), a smartphone app to remotely monitor and guide treatment of patients with asthma and chronic obstructive pulmonary disease, was not recommended. It was submitted by Pulmonary Medicine, Infectious Disease and Critical Care Consultants Medical Group of Sacramento.
PTAC has received more than 20 letters of intent from physicians and aims to hold another round of public hearings in September to determine their usefulness.
“I think it is very safe to say that our whole committee has been really gratified with the level of interest and engagement,” said Ms. Mitchell, president and CEO of Network for Regional Healthcare Improvement in Portland, Maine. The volume of applications “underscores the level of interest from the field. The entire reason PTAC was established was to get those good ideas from practicing physicians and others who are identifying better ways to deliver care but are facing barriers in the current payment system.”
She offered advice to those who are contemplating submission of a payment model: “Really understand the criteria and review the request for proposals. I think the committee lays out what we are looking for in terms of information, and we are hoping that it is really straightforward.”
She also stressed that successful models need to work broadly. “We are not talking about something that works for a single practice,” she said. “We are talking about models that are ready for inclusion in the whole CMS portfolio. It is helpful if there is experience to draw from that informs our deliberations, but we recognize that, in some cases, there has not been the opportunity to test these models broadly.”
Most of all, the highest priority when it comes to the models is related to quality of care and cost.
“We are not soliciting models that are essentially tweaks to fee for service. We are looking for changes that cannot be made without a new method of payment,” she said, adding that the models “have to either reduce cost while maintaining quality or improve quality without raising cost.”
Meeting transcripts and video are posted online and can help potential applicants see how the committee came to its recommendations.
“The committee does not deliberate on the proposals except in public,” Ms. Mitchell said. “So, those public meetings were the first time we had deliberated on any of the proposals we have considered. The preliminary review teams have discussed it [in depth], but the full committee can only deliberate in public.”
Dr. Schwarzenberger said that while the AAD working group is looking at some dermatology-specific conditions that might be good for a PFPM a broader approach may be better. Perhaps the focus should be “where dermatology’s involvement with other physicians, where we might be able to help them practice medicine better or save money,” she said. “Maybe where we can make our biggest financial and potentially quality impacts.”
Dermatologists looking for a way to participate in an advanced alternative payment model under Medicare’s new Quality Payment Program will likely need to develop their own and get it approved.
Advanced alternative payment models (APMs) involve physicians taking on two-sided risk along with Medicare in exchange for the potential for higher bonus payments for delivering higher-value care to patients. Officials at the Centers for Medicare & Medicaid Services have created seven APMs (some primary care and some specialty focused), but they do not appeal to everyone.
“The likelihood that a private practice dermatologist is going to participate in a risk-bearing APM is, I think, possible but challenging,” said Kathryn Schwarzenberger, MD, chair of the American Academy of Dermatology’s Workgroup on Innovation in Payment and Delivery. “To have a fully qualified, double-sided risk APM for most private practitioners is going to be difficult. The advanced APMs, unless you are in a group, we have figured most dermatologists wouldn’t be interested.”
A physician-created APM might be a different story, however.
Getting approval for this type of APM – technically known as physician-focused payment models (PFPMs) – is tough. Of the first three PFPMs reviewed by Medicare’s Physician-Focused Payment Model Technical Advisory Committee (PTAC), two were recommended for limited trial periods only. A third proposal was not recommended. None of these early proposals were dermatology focused.
Not jumping into the process early was a prudent move, according to Dr. Schwarzenberger.
“We learned that it is probably good to sit back at this point and watch and see what is happening,” she said. “I think the rules have become much more clear. I think now that PTAC has provided us with some better guidelines for how to develop a successful APM, we have a much better chance of doing so.”
In this earliest review, each proposed APM was assigned to three commissioners, including at least one physician, for review against 10 criteria:
• Scope of proposed PFPM (high priority).
• Quality and cost (high priority).
• Payment methodology (high priority).
• Value over volume.
• Flexibility.
• Ability to be evaluated.
• Integration and care coordination.
• Patient choice.
• Patient safety.
• Health information technology.
While each proposal met a few of the criteria, none met all three high-priority criteria, and none was recommended for approval by its preliminary reviewers; however, after committee deliberation, two received provisional recommendation.
“We recommended the two models for small-scale testing,” PTAC Vice-Chairman Elizabeth Mitchell said in an interview. “Even though we think they are very good ideas, we know that more experience and evidence are required before they may be ready.”
The two models that got the limited recommendation were:
• Project Sonar, submitted by the Illinois Gastroenterology Group and SonarMD, a Web-based platform that queries patients with inflammatory bowel disease monthly to determine which are in need of more hands-on care.
• American College of Surgeons–Brandeis APM, submitted by the American College of Surgeons, an episode-based payment model that uses claims data but expands on existing CMS value-based models by not requiring hospitalizations. It creates an episodic payment using outpatient settings, including acute and chronic care.
The COPD [chronic obstructive pulmonary disease] and Asthma Monitoring Project (CAMP), a smartphone app to remotely monitor and guide treatment of patients with asthma and chronic obstructive pulmonary disease, was not recommended. It was submitted by Pulmonary Medicine, Infectious Disease and Critical Care Consultants Medical Group of Sacramento.
PTAC has received more than 20 letters of intent from physicians and aims to hold another round of public hearings in September to determine their usefulness.
“I think it is very safe to say that our whole committee has been really gratified with the level of interest and engagement,” said Ms. Mitchell, president and CEO of Network for Regional Healthcare Improvement in Portland, Maine. The volume of applications “underscores the level of interest from the field. The entire reason PTAC was established was to get those good ideas from practicing physicians and others who are identifying better ways to deliver care but are facing barriers in the current payment system.”
She offered advice to those who are contemplating submission of a payment model: “Really understand the criteria and review the request for proposals. I think the committee lays out what we are looking for in terms of information, and we are hoping that it is really straightforward.”
She also stressed that successful models need to work broadly. “We are not talking about something that works for a single practice,” she said. “We are talking about models that are ready for inclusion in the whole CMS portfolio. It is helpful if there is experience to draw from that informs our deliberations, but we recognize that, in some cases, there has not been the opportunity to test these models broadly.”
Most of all, the highest priority when it comes to the models is related to quality of care and cost.
“We are not soliciting models that are essentially tweaks to fee for service. We are looking for changes that cannot be made without a new method of payment,” she said, adding that the models “have to either reduce cost while maintaining quality or improve quality without raising cost.”
Meeting transcripts and video are posted online and can help potential applicants see how the committee came to its recommendations.
“The committee does not deliberate on the proposals except in public,” Ms. Mitchell said. “So, those public meetings were the first time we had deliberated on any of the proposals we have considered. The preliminary review teams have discussed it [in depth], but the full committee can only deliberate in public.”
Dr. Schwarzenberger said that while the AAD working group is looking at some dermatology-specific conditions that might be good for a PFPM a broader approach may be better. Perhaps the focus should be “where dermatology’s involvement with other physicians, where we might be able to help them practice medicine better or save money,” she said. “Maybe where we can make our biggest financial and potentially quality impacts.”
Telemedicine Boosts Number of Native Americans Who Can Obtain Retina Exams
American Indians and Alaska Natives (AI/ANs) have a high risk of diabetes-related vision loss, in part because only half get the annual eye exam needed for timely diagnosis and treatment. But using an innovative telemedicine program, IHS increased the number of AI/ANs who receive an annual retina exam by 20% from 2007 to 2015.
The IHS teleophthalmology program, established in 2000, provides high-quality retinal exams in primary care clinics. More than 70,000 retinal exams have been done for AI/AN patients, IHS says. The exam can be done during a regular office visit without dilation. The retinal photographs are sent electronically to a central reading center where they’re interpreted by trained and certified IHS eye doctors.
The program, available at about 100 sites in 25 states, has not only increased access, IHS says, but also reduced the overall cost of care by preventing complications resulting from delayed or missed care. Screening and treating eye disease in patients with diabetes mellitus costs $3,190 per quality-adjusted life-year saved, IHS says; $840,000 would be saved annually in detecting high-risk diabetic retinopathy (DR). Another $1,090,000 would be saved by reducing the need for additional surgery for complications resulting from delayed identification of patients with high-risk DR.
The program has been validated to American Telemedicine Association Category 3, meaning its clinical outcome is equal to or better than a conventional eye examination for DR. As one of the few and largest programs validated and operating at this level, IHS says the teleophthalmology program has brought high-quality point-of-care specialty service to more than 150,000 AI/AN patients.
American Indians and Alaska Natives (AI/ANs) have a high risk of diabetes-related vision loss, in part because only half get the annual eye exam needed for timely diagnosis and treatment. But using an innovative telemedicine program, IHS increased the number of AI/ANs who receive an annual retina exam by 20% from 2007 to 2015.
The IHS teleophthalmology program, established in 2000, provides high-quality retinal exams in primary care clinics. More than 70,000 retinal exams have been done for AI/AN patients, IHS says. The exam can be done during a regular office visit without dilation. The retinal photographs are sent electronically to a central reading center where they’re interpreted by trained and certified IHS eye doctors.
The program, available at about 100 sites in 25 states, has not only increased access, IHS says, but also reduced the overall cost of care by preventing complications resulting from delayed or missed care. Screening and treating eye disease in patients with diabetes mellitus costs $3,190 per quality-adjusted life-year saved, IHS says; $840,000 would be saved annually in detecting high-risk diabetic retinopathy (DR). Another $1,090,000 would be saved by reducing the need for additional surgery for complications resulting from delayed identification of patients with high-risk DR.
The program has been validated to American Telemedicine Association Category 3, meaning its clinical outcome is equal to or better than a conventional eye examination for DR. As one of the few and largest programs validated and operating at this level, IHS says the teleophthalmology program has brought high-quality point-of-care specialty service to more than 150,000 AI/AN patients.
American Indians and Alaska Natives (AI/ANs) have a high risk of diabetes-related vision loss, in part because only half get the annual eye exam needed for timely diagnosis and treatment. But using an innovative telemedicine program, IHS increased the number of AI/ANs who receive an annual retina exam by 20% from 2007 to 2015.
The IHS teleophthalmology program, established in 2000, provides high-quality retinal exams in primary care clinics. More than 70,000 retinal exams have been done for AI/AN patients, IHS says. The exam can be done during a regular office visit without dilation. The retinal photographs are sent electronically to a central reading center where they’re interpreted by trained and certified IHS eye doctors.
The program, available at about 100 sites in 25 states, has not only increased access, IHS says, but also reduced the overall cost of care by preventing complications resulting from delayed or missed care. Screening and treating eye disease in patients with diabetes mellitus costs $3,190 per quality-adjusted life-year saved, IHS says; $840,000 would be saved annually in detecting high-risk diabetic retinopathy (DR). Another $1,090,000 would be saved by reducing the need for additional surgery for complications resulting from delayed identification of patients with high-risk DR.
The program has been validated to American Telemedicine Association Category 3, meaning its clinical outcome is equal to or better than a conventional eye examination for DR. As one of the few and largest programs validated and operating at this level, IHS says the teleophthalmology program has brought high-quality point-of-care specialty service to more than 150,000 AI/AN patients.
Tipoffs that an infant hospitalized with pertussis may require ICU
MADRID – Infants hospitalized for pertussis are more likely to develop severe disease requiring pediatric ICU admission if they are experiencing apnea, are unvaccinated against pertussis, or are less than 2 months old, Maria Arranz, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“The presence of these parameters on admission should warn us of possible severe disease,” said Dr. Arranz of Gregorio Maranon Hospital in Madrid.
Dr. Arranz presented a retrospective observational study of 101 children under 1 year of age who were hospitalized for pertussis at the Madrid tertiary center prior to the hospital’s 2016 shift to a strategy of maternal immunization during pregnancy as a means of preventing pertussis in infancy. Thirteen percent of the children required admission to the pediatric ICU and thus by definition had severe disease.
Half of infants in the study were not vaccinated against pertussis. That proved to be a powerful risk factor for severe disease requiring an ICU stay. Only 8% of children with severe pertussis were vaccinated, compared with a 58% vaccination rate among those who avoided the ICU.
Apneic pauses were noted in 67% of the severe disease group, compared with 28% of the infants who didn’t need the ICU.
The pertussis patients admitted to the pediatric ICU averaged 1 month of age, compared with age 2 months in the nonsevere group.
The maximum leukocyte, lymphocyte, and neutrophil counts during the hospital stay of the severe disease group averaged 23,600 cells/mm3, 18,000/mm3, and 5,000/mm3, respectively, significantly greater than the 15,300, 10,700, and 3,900 cells/mm3 in infants who did not require the ICU. Levels of all three cells also were higher at admission in the severe pertussis group than in those who didn’t make it to the ICU, albeit not statistically significantly so.
Dr. Arranz reported having no financial conflicts of interest regarding her study.
MADRID – Infants hospitalized for pertussis are more likely to develop severe disease requiring pediatric ICU admission if they are experiencing apnea, are unvaccinated against pertussis, or are less than 2 months old, Maria Arranz, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“The presence of these parameters on admission should warn us of possible severe disease,” said Dr. Arranz of Gregorio Maranon Hospital in Madrid.
Dr. Arranz presented a retrospective observational study of 101 children under 1 year of age who were hospitalized for pertussis at the Madrid tertiary center prior to the hospital’s 2016 shift to a strategy of maternal immunization during pregnancy as a means of preventing pertussis in infancy. Thirteen percent of the children required admission to the pediatric ICU and thus by definition had severe disease.
Half of infants in the study were not vaccinated against pertussis. That proved to be a powerful risk factor for severe disease requiring an ICU stay. Only 8% of children with severe pertussis were vaccinated, compared with a 58% vaccination rate among those who avoided the ICU.
Apneic pauses were noted in 67% of the severe disease group, compared with 28% of the infants who didn’t need the ICU.
The pertussis patients admitted to the pediatric ICU averaged 1 month of age, compared with age 2 months in the nonsevere group.
The maximum leukocyte, lymphocyte, and neutrophil counts during the hospital stay of the severe disease group averaged 23,600 cells/mm3, 18,000/mm3, and 5,000/mm3, respectively, significantly greater than the 15,300, 10,700, and 3,900 cells/mm3 in infants who did not require the ICU. Levels of all three cells also were higher at admission in the severe pertussis group than in those who didn’t make it to the ICU, albeit not statistically significantly so.
Dr. Arranz reported having no financial conflicts of interest regarding her study.
MADRID – Infants hospitalized for pertussis are more likely to develop severe disease requiring pediatric ICU admission if they are experiencing apnea, are unvaccinated against pertussis, or are less than 2 months old, Maria Arranz, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
“The presence of these parameters on admission should warn us of possible severe disease,” said Dr. Arranz of Gregorio Maranon Hospital in Madrid.
Dr. Arranz presented a retrospective observational study of 101 children under 1 year of age who were hospitalized for pertussis at the Madrid tertiary center prior to the hospital’s 2016 shift to a strategy of maternal immunization during pregnancy as a means of preventing pertussis in infancy. Thirteen percent of the children required admission to the pediatric ICU and thus by definition had severe disease.
Half of infants in the study were not vaccinated against pertussis. That proved to be a powerful risk factor for severe disease requiring an ICU stay. Only 8% of children with severe pertussis were vaccinated, compared with a 58% vaccination rate among those who avoided the ICU.
Apneic pauses were noted in 67% of the severe disease group, compared with 28% of the infants who didn’t need the ICU.
The pertussis patients admitted to the pediatric ICU averaged 1 month of age, compared with age 2 months in the nonsevere group.
The maximum leukocyte, lymphocyte, and neutrophil counts during the hospital stay of the severe disease group averaged 23,600 cells/mm3, 18,000/mm3, and 5,000/mm3, respectively, significantly greater than the 15,300, 10,700, and 3,900 cells/mm3 in infants who did not require the ICU. Levels of all three cells also were higher at admission in the severe pertussis group than in those who didn’t make it to the ICU, albeit not statistically significantly so.
Dr. Arranz reported having no financial conflicts of interest regarding her study.
AT ESPID 2017
Key clinical point:
Major finding: Among infants hospitalized for pertussis, apneic pauses were present in two-thirds of those with severe disease, ultimately resulting in admission to the pediatric ICU, compared with 28% of those who didn’t require an ICU stay.
Data source: This retrospective observational study sought to identify factors associated with severe pertussis requiring an ICU stay in a group of 101 Spanish infants hospitalized with the disease.
Disclosures: The presenter reported having no financial conflicts of interest regarding her study.
Tafenoquine reduces relapse risk in patients with P vivax malaria
A single dose of tafenoquine, when given with chloroquine, can significantly reduce the risk of relapse in patients with Plasmodium vivax malaria compared to placebo, as demonstrated by the results of 2 phase 3 studies.
Patients who have had P vivax malaria, even a single infection, can relapse several weeks or even years after the initial occurrence.
Results of the studies were presented at the 6th International Conference on Plasmodium vivax Research (ICPVR) in Manaus, Brazil.
Tafenoquine, an 8-aminoquinoline derivative, is being developed by GlaxoSmithKline (GSK) in collaboration with Medicines for Malaria Venture (MMV).
“One of the greatest challenges for patients with P vivax malaria,” Patrick Vallance, of GSK, said, “is preventing relapses.”
“Being able to treat patients with a single dose of medicine would be an important step forward in ensuring efficacious treatment,” Vallance noted, “thereby reducing the risk of relapse, particularly in areas with very limited healthcare infrastructure.”
The DETECTIVE and GATHER studies were conducted in malaria-endemic countries in South America, Asia, and Africa.
DETECTIVE (TAF112582) study
This was a double-blind, double-dummy phase 3 study evaluating the efficacy, safety, and tolerability of tafenoquine in 522 patients aged 16 years or older with P vivax malaria.
Patients were randomized to receive placebo, a single dose of 300 mg tafenoquine, or primaquine at 15 mg daily for 14 days in a 1:2:1 ratio.
All patients received a 3-day course of chloroquine to treat the acute blood stage infection.
The study met its primary endpoint. A statistically significant greater proportion of patients treated with tafenoquine (60%) remained relapse-free over the 6-month follow-up period than patients on placebo (26%). The odds ratio for risk of relapse vs placebo given with chloroquine was 0.24, P<0.001.
Treatment with 14 days of primaquine also achieved a statistically significant improvement in relapse-free follow-up, with an odds ratio vs placebo when given with chloroquine of 0.20, P<0.001.
The frequency of adverse events was 63% for the tafenoquine group, 59% for the primaquine group, and 65% for the chloroquine group.
And the frequency of serious adverse events was 8% for the tafenoquine group, 3% for the primaquine group, and 5% for the chloroquine group.
GATHER (TAF116564) study
This study evaluated a single dose of 300 mg tafenoquine on hemoglobin levels compared to a 14-day course of 15 mg primaquine.
Agents in the 8-aminoquinoline drug class are associated with hemolytic anemia in individuals with inherited glucose-6-phosphate dehydrogenase (G6PD) deficiency.
All patients were screened for G6PD deficiency at baseline. Males with G6PD activity of at least 70% of the site median and females with 40% were eligible.
All 251 patients also received the standard 3-day course of chloroquine.
The incidence of decline in hemoglobin was low and similar between the 2 treatment arms, 2.4% for the tafenoquine group and 1.2% for the chloroquine group.
No patient required a blood transfusion.
The companies plan to develop a point-of-care diagnostic for G6PD as a mandatory test prior to treatment with tafenoquine.
“The positive results of the phase 3 trials for single-dose tafenoquine provide great hope that a new, effective drug to stop the relapse of P vivax malaria is in sight,” David Reddy, of MMV, affirmed.
Tafenoquine currently is not approved for use anywhere in the world. GSK plans to submit regulatory filings later in 2017. 
A single dose of tafenoquine, when given with chloroquine, can significantly reduce the risk of relapse in patients with Plasmodium vivax malaria compared to placebo, as demonstrated by the results of 2 phase 3 studies.
Patients who have had P vivax malaria, even a single infection, can relapse several weeks or even years after the initial occurrence.
Results of the studies were presented at the 6th International Conference on Plasmodium vivax Research (ICPVR) in Manaus, Brazil.
Tafenoquine, an 8-aminoquinoline derivative, is being developed by GlaxoSmithKline (GSK) in collaboration with Medicines for Malaria Venture (MMV).
“One of the greatest challenges for patients with P vivax malaria,” Patrick Vallance, of GSK, said, “is preventing relapses.”
“Being able to treat patients with a single dose of medicine would be an important step forward in ensuring efficacious treatment,” Vallance noted, “thereby reducing the risk of relapse, particularly in areas with very limited healthcare infrastructure.”
The DETECTIVE and GATHER studies were conducted in malaria-endemic countries in South America, Asia, and Africa.
DETECTIVE (TAF112582) study
This was a double-blind, double-dummy phase 3 study evaluating the efficacy, safety, and tolerability of tafenoquine in 522 patients aged 16 years or older with P vivax malaria.
Patients were randomized to receive placebo, a single dose of 300 mg tafenoquine, or primaquine at 15 mg daily for 14 days in a 1:2:1 ratio.
All patients received a 3-day course of chloroquine to treat the acute blood stage infection.
The study met its primary endpoint. A statistically significant greater proportion of patients treated with tafenoquine (60%) remained relapse-free over the 6-month follow-up period than patients on placebo (26%). The odds ratio for risk of relapse vs placebo given with chloroquine was 0.24, P<0.001.
Treatment with 14 days of primaquine also achieved a statistically significant improvement in relapse-free follow-up, with an odds ratio vs placebo when given with chloroquine of 0.20, P<0.001.
The frequency of adverse events was 63% for the tafenoquine group, 59% for the primaquine group, and 65% for the chloroquine group.
And the frequency of serious adverse events was 8% for the tafenoquine group, 3% for the primaquine group, and 5% for the chloroquine group.
GATHER (TAF116564) study
This study evaluated a single dose of 300 mg tafenoquine on hemoglobin levels compared to a 14-day course of 15 mg primaquine.
Agents in the 8-aminoquinoline drug class are associated with hemolytic anemia in individuals with inherited glucose-6-phosphate dehydrogenase (G6PD) deficiency.
All patients were screened for G6PD deficiency at baseline. Males with G6PD activity of at least 70% of the site median and females with 40% were eligible.
All 251 patients also received the standard 3-day course of chloroquine.
The incidence of decline in hemoglobin was low and similar between the 2 treatment arms, 2.4% for the tafenoquine group and 1.2% for the chloroquine group.
No patient required a blood transfusion.
The companies plan to develop a point-of-care diagnostic for G6PD as a mandatory test prior to treatment with tafenoquine.
“The positive results of the phase 3 trials for single-dose tafenoquine provide great hope that a new, effective drug to stop the relapse of P vivax malaria is in sight,” David Reddy, of MMV, affirmed.
Tafenoquine currently is not approved for use anywhere in the world. GSK plans to submit regulatory filings later in 2017.
A single dose of tafenoquine, when given with chloroquine, can significantly reduce the risk of relapse in patients with Plasmodium vivax malaria compared to placebo, as demonstrated by the results of 2 phase 3 studies.
Patients who have had P vivax malaria, even a single infection, can relapse several weeks or even years after the initial occurrence.
Results of the studies were presented at the 6th International Conference on Plasmodium vivax Research (ICPVR) in Manaus, Brazil.
Tafenoquine, an 8-aminoquinoline derivative, is being developed by GlaxoSmithKline (GSK) in collaboration with Medicines for Malaria Venture (MMV).
“One of the greatest challenges for patients with P vivax malaria,” Patrick Vallance, of GSK, said, “is preventing relapses.”
“Being able to treat patients with a single dose of medicine would be an important step forward in ensuring efficacious treatment,” Vallance noted, “thereby reducing the risk of relapse, particularly in areas with very limited healthcare infrastructure.”
The DETECTIVE and GATHER studies were conducted in malaria-endemic countries in South America, Asia, and Africa.
DETECTIVE (TAF112582) study
This was a double-blind, double-dummy phase 3 study evaluating the efficacy, safety, and tolerability of tafenoquine in 522 patients aged 16 years or older with P vivax malaria.
Patients were randomized to receive placebo, a single dose of 300 mg tafenoquine, or primaquine at 15 mg daily for 14 days in a 1:2:1 ratio.
All patients received a 3-day course of chloroquine to treat the acute blood stage infection.
The study met its primary endpoint. A statistically significant greater proportion of patients treated with tafenoquine (60%) remained relapse-free over the 6-month follow-up period than patients on placebo (26%). The odds ratio for risk of relapse vs placebo given with chloroquine was 0.24, P<0.001.
Treatment with 14 days of primaquine also achieved a statistically significant improvement in relapse-free follow-up, with an odds ratio vs placebo when given with chloroquine of 0.20, P<0.001.
The frequency of adverse events was 63% for the tafenoquine group, 59% for the primaquine group, and 65% for the chloroquine group.
And the frequency of serious adverse events was 8% for the tafenoquine group, 3% for the primaquine group, and 5% for the chloroquine group.
GATHER (TAF116564) study
This study evaluated a single dose of 300 mg tafenoquine on hemoglobin levels compared to a 14-day course of 15 mg primaquine.
Agents in the 8-aminoquinoline drug class are associated with hemolytic anemia in individuals with inherited glucose-6-phosphate dehydrogenase (G6PD) deficiency.
All patients were screened for G6PD deficiency at baseline. Males with G6PD activity of at least 70% of the site median and females with 40% were eligible.
All 251 patients also received the standard 3-day course of chloroquine.
The incidence of decline in hemoglobin was low and similar between the 2 treatment arms, 2.4% for the tafenoquine group and 1.2% for the chloroquine group.
No patient required a blood transfusion.
The companies plan to develop a point-of-care diagnostic for G6PD as a mandatory test prior to treatment with tafenoquine.
“The positive results of the phase 3 trials for single-dose tafenoquine provide great hope that a new, effective drug to stop the relapse of P vivax malaria is in sight,” David Reddy, of MMV, affirmed.
Tafenoquine currently is not approved for use anywhere in the world. GSK plans to submit regulatory filings later in 2017.
Fostamatinib under review by FDA for chronic ITP
The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for the use of fostamatinib disodium (Tavalisse™) in the treatment of patients with chronic/persistent immune thrombocytopenia (ITP).
Fostamatinib is an oral spleen tyrosine kinase (SYK) inhibitor that investigators believe may address an underlying autoimmune cause of ITP by impeding platelet destruction.
Rigel Pharmaceuticals, the drug’s developer, anticipates an action date by the FDA of April 17, 2018.
The FDA previously granted fostamatinib orphan drug designation.
Data from 3 clinical studies support the new drug application. Study 047 and 048 were randomized placebo-controlled trials, and study 049 was an open-label extension study.
Together with an initial proof of concept study, the application included data on 163 ITP patients. Fostamatinib has been evaluated in over 4,600 individuals across all indications.
The patients enrolled in studies 047 and 048 had been diagnosed with persistent or chronic ITP, had failed at least 1 prior therapy for ITP, and had platelet counts consistently below 30,000/uL.
In both studies, patients were randomized in a 2:1 ratio to receive either fostamatinib or placebo orally twice a day for up to 24 weeks.
Study 047
In this study, 51 patients were randomized to fostamatinib and 25 to placebo.
The median platelet counts at baseline were 15,000/uL and 16,000/uL in the fostamatinib and placebo arms, respectively.
The median age was 57 in both treatment arms. The duration of ITP was 7.5 years (range, 0.6-53) in the fostamatinib arm and 5.5 years (range, 0.4-45) in the placebo arm.
The primary efficacy endpoint in both study 047 and 048 was a stable platelet response, defined as achieving platelet counts greater than 50,000/uL for at least 4 of the 6 scheduled clinic visits between weeks 14 and 24 of treatment.
In study 047, the rate of stable platelet response was significantly higher in the fostamatinib arm than the placebo arm—18% (n=9) and 0%, respectively (P=0.026).
Study 048
Fifty patients were randomized to fostamatinib and 24 to placebo.
Patients’ median platelet counts at baseline were 16,000/uL and 21,000/uL in the fostamatinib and placebo arms, respectively.
The median age was 50 in both treatment arms. The duration of ITP was 8.8 years (range, 0.3-50) in the fostamatinib arm and 10.8 years (range, 0.9-29) in the placebo arm.
In this study, however, the difference in stable platelet response between the 2 arms was not significant—18% (n=9) and 4% (n=1), respectively (P=0.152).
However, when the data from study 047 and 048 were combined, the response rate was significantly higher in the fostamatinib arm than the placebo arm—18% (18/101) and 2% (1/49), respectively (P=0.007).
"The FDA acceptance for filing of our NDA is an exciting milestone for Rigel," Raul Rodriguez, Rigel's president and chief executive officer, said.
The approval of fostamatinib “will provide a new treatment option for patients with chronic or persistent ITP,” he affirmed. “We look forward to working closely with the FDA as they review our submission."
The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for the use of fostamatinib disodium (Tavalisse™) in the treatment of patients with chronic/persistent immune thrombocytopenia (ITP).
Fostamatinib is an oral spleen tyrosine kinase (SYK) inhibitor that investigators believe may address an underlying autoimmune cause of ITP by impeding platelet destruction.
Rigel Pharmaceuticals, the drug’s developer, anticipates an action date by the FDA of April 17, 2018.
The FDA previously granted fostamatinib orphan drug designation.
Data from 3 clinical studies support the new drug application. Study 047 and 048 were randomized placebo-controlled trials, and study 049 was an open-label extension study.
Together with an initial proof of concept study, the application included data on 163 ITP patients. Fostamatinib has been evaluated in over 4,600 individuals across all indications.
The patients enrolled in studies 047 and 048 had been diagnosed with persistent or chronic ITP, had failed at least 1 prior therapy for ITP, and had platelet counts consistently below 30,000/uL.
In both studies, patients were randomized in a 2:1 ratio to receive either fostamatinib or placebo orally twice a day for up to 24 weeks.
Study 047
In this study, 51 patients were randomized to fostamatinib and 25 to placebo.
The median platelet counts at baseline were 15,000/uL and 16,000/uL in the fostamatinib and placebo arms, respectively.
The median age was 57 in both treatment arms. The duration of ITP was 7.5 years (range, 0.6-53) in the fostamatinib arm and 5.5 years (range, 0.4-45) in the placebo arm.
The primary efficacy endpoint in both study 047 and 048 was a stable platelet response, defined as achieving platelet counts greater than 50,000/uL for at least 4 of the 6 scheduled clinic visits between weeks 14 and 24 of treatment.
In study 047, the rate of stable platelet response was significantly higher in the fostamatinib arm than the placebo arm—18% (n=9) and 0%, respectively (P=0.026).
Study 048
Fifty patients were randomized to fostamatinib and 24 to placebo.
Patients’ median platelet counts at baseline were 16,000/uL and 21,000/uL in the fostamatinib and placebo arms, respectively.
The median age was 50 in both treatment arms. The duration of ITP was 8.8 years (range, 0.3-50) in the fostamatinib arm and 10.8 years (range, 0.9-29) in the placebo arm.
In this study, however, the difference in stable platelet response between the 2 arms was not significant—18% (n=9) and 4% (n=1), respectively (P=0.152).
However, when the data from study 047 and 048 were combined, the response rate was significantly higher in the fostamatinib arm than the placebo arm—18% (18/101) and 2% (1/49), respectively (P=0.007).
"The FDA acceptance for filing of our NDA is an exciting milestone for Rigel," Raul Rodriguez, Rigel's president and chief executive officer, said.
The approval of fostamatinib “will provide a new treatment option for patients with chronic or persistent ITP,” he affirmed. “We look forward to working closely with the FDA as they review our submission."
The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for the use of fostamatinib disodium (Tavalisse™) in the treatment of patients with chronic/persistent immune thrombocytopenia (ITP).
Fostamatinib is an oral spleen tyrosine kinase (SYK) inhibitor that investigators believe may address an underlying autoimmune cause of ITP by impeding platelet destruction.
Rigel Pharmaceuticals, the drug’s developer, anticipates an action date by the FDA of April 17, 2018.
The FDA previously granted fostamatinib orphan drug designation.
Data from 3 clinical studies support the new drug application. Study 047 and 048 were randomized placebo-controlled trials, and study 049 was an open-label extension study.
Together with an initial proof of concept study, the application included data on 163 ITP patients. Fostamatinib has been evaluated in over 4,600 individuals across all indications.
The patients enrolled in studies 047 and 048 had been diagnosed with persistent or chronic ITP, had failed at least 1 prior therapy for ITP, and had platelet counts consistently below 30,000/uL.
In both studies, patients were randomized in a 2:1 ratio to receive either fostamatinib or placebo orally twice a day for up to 24 weeks.
Study 047
In this study, 51 patients were randomized to fostamatinib and 25 to placebo.
The median platelet counts at baseline were 15,000/uL and 16,000/uL in the fostamatinib and placebo arms, respectively.
The median age was 57 in both treatment arms. The duration of ITP was 7.5 years (range, 0.6-53) in the fostamatinib arm and 5.5 years (range, 0.4-45) in the placebo arm.
The primary efficacy endpoint in both study 047 and 048 was a stable platelet response, defined as achieving platelet counts greater than 50,000/uL for at least 4 of the 6 scheduled clinic visits between weeks 14 and 24 of treatment.
In study 047, the rate of stable platelet response was significantly higher in the fostamatinib arm than the placebo arm—18% (n=9) and 0%, respectively (P=0.026).
Study 048
Fifty patients were randomized to fostamatinib and 24 to placebo.
Patients’ median platelet counts at baseline were 16,000/uL and 21,000/uL in the fostamatinib and placebo arms, respectively.
The median age was 50 in both treatment arms. The duration of ITP was 8.8 years (range, 0.3-50) in the fostamatinib arm and 10.8 years (range, 0.9-29) in the placebo arm.
In this study, however, the difference in stable platelet response between the 2 arms was not significant—18% (n=9) and 4% (n=1), respectively (P=0.152).
However, when the data from study 047 and 048 were combined, the response rate was significantly higher in the fostamatinib arm than the placebo arm—18% (18/101) and 2% (1/49), respectively (P=0.007).
"The FDA acceptance for filing of our NDA is an exciting milestone for Rigel," Raul Rodriguez, Rigel's president and chief executive officer, said.
The approval of fostamatinib “will provide a new treatment option for patients with chronic or persistent ITP,” he affirmed. “We look forward to working closely with the FDA as they review our submission."
CMS proposes exempting more practices from MACRA
The Centers for Medicare & Medicaid Services seeks to exempt more practices participating in Medicare’s Quality Payment Program, the value-based payment program created by Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Currently, physicians who receive $30,000 or less in Medicare Part B payments or have 100 or fewer Medicare patients are exempt from QPP but may choose to participate. The proposed rule for the second year of QPP (calendar year 2018) would raise the threshold to $90,000 or less in Part B payments or 200 or fewer Medicare patients. The proposed rule was released June 20.
Under QPP, physicians and practices that are not exempt will choose one of two tracks – the Merit-Based Incentive Payment System (MIPS), which will pay bonuses based on meeting certain quality thresholds, or the advanced alternative payment models (APMs), under which physicians will assume more risk in exchange for greater potential rewards for quality improvement.
“We’ve heard the concerns that too many quality programs, technology requirements, and measures get between the doctor and the patient,” CMS Administrator Seema Verma said in a statement. “That’s why we’re taking a hard look at reducing burdens. By proposing this rule, we aim to improve Medicare by helping doctors and clinicians concentrate on caring for their patients rather than filling out paperwork.”
The proposed rule also introduces the framework for the development of “virtual groups,” a mechanism by which small and solo practices who meet the eligibility requirements for participating in MIPS can pool their reporting into the program to make it easier to share in the bonuses for meeting quality thresholds.
The Centers for Medicare & Medicaid Services seeks to exempt more practices participating in Medicare’s Quality Payment Program, the value-based payment program created by Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Currently, physicians who receive $30,000 or less in Medicare Part B payments or have 100 or fewer Medicare patients are exempt from QPP but may choose to participate. The proposed rule for the second year of QPP (calendar year 2018) would raise the threshold to $90,000 or less in Part B payments or 200 or fewer Medicare patients. The proposed rule was released June 20.
Under QPP, physicians and practices that are not exempt will choose one of two tracks – the Merit-Based Incentive Payment System (MIPS), which will pay bonuses based on meeting certain quality thresholds, or the advanced alternative payment models (APMs), under which physicians will assume more risk in exchange for greater potential rewards for quality improvement.
“We’ve heard the concerns that too many quality programs, technology requirements, and measures get between the doctor and the patient,” CMS Administrator Seema Verma said in a statement. “That’s why we’re taking a hard look at reducing burdens. By proposing this rule, we aim to improve Medicare by helping doctors and clinicians concentrate on caring for their patients rather than filling out paperwork.”
The proposed rule also introduces the framework for the development of “virtual groups,” a mechanism by which small and solo practices who meet the eligibility requirements for participating in MIPS can pool their reporting into the program to make it easier to share in the bonuses for meeting quality thresholds.
The Centers for Medicare & Medicaid Services seeks to exempt more practices participating in Medicare’s Quality Payment Program, the value-based payment program created by Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Currently, physicians who receive $30,000 or less in Medicare Part B payments or have 100 or fewer Medicare patients are exempt from QPP but may choose to participate. The proposed rule for the second year of QPP (calendar year 2018) would raise the threshold to $90,000 or less in Part B payments or 200 or fewer Medicare patients. The proposed rule was released June 20.
Under QPP, physicians and practices that are not exempt will choose one of two tracks – the Merit-Based Incentive Payment System (MIPS), which will pay bonuses based on meeting certain quality thresholds, or the advanced alternative payment models (APMs), under which physicians will assume more risk in exchange for greater potential rewards for quality improvement.
“We’ve heard the concerns that too many quality programs, technology requirements, and measures get between the doctor and the patient,” CMS Administrator Seema Verma said in a statement. “That’s why we’re taking a hard look at reducing burdens. By proposing this rule, we aim to improve Medicare by helping doctors and clinicians concentrate on caring for their patients rather than filling out paperwork.”
The proposed rule also introduces the framework for the development of “virtual groups,” a mechanism by which small and solo practices who meet the eligibility requirements for participating in MIPS can pool their reporting into the program to make it easier to share in the bonuses for meeting quality thresholds.
GALEN safe and effective in relapsed and refractory follicular lymphoma
LUGANO, SWITZERLAND – For patients with relapsed or refractory follicular lymphoma, a pairing of lenalidomide (Revlimid) and obinutuzumab (Gazyva) appeared to be especially useful among patients who had disease progression within 24 months, based on results from a Lymphoma Academic Research Organisation trial.
Among 86 patients who were enrolled in a phase II trial and were assessable for efficacy, overall response rates (ORR) with the combination therapy, nicknamed “GALEN,” were 80.2% by 1999 International Working Group criteria, and 74.4% according to the 2007 IWG criteria, reported Franck Morschhauser, MD, PhD, of the University of Lille, France.
The rationale for this combination is the known synergy between lenalidomide and rituximab in relapsed refractory non-Hodgkin lymphomas and in the frontline setting for patients with follicular lymphoma. Obinutuzumab, a follow-on to rituximab, is a unique type II glycoengineered monoclonal antibody directed against CD20, but with increased antibody-dependent cell-mediated cytotoxicity and increased direct cytotoxicity, compared with rituximab, he explained.
In the phase Ib part of the study, researchers settled on a dose of obinutuzumab 1000 mg and lenalidomide 20 mg. Obinutuzumab was administered on days 8, 15 and 22 and lenalidomide on days 1 to 21 of each 28 day cycle. Patients were evaluated for response after three cycles and at the end of induction (after completion of 4 to 6 cycles).
The maintenance phase consisted of obinutuzumab on day 1 of every other cycle beginning with cycle 1, and lenalidomide on days 1 through 22 for cycles 7 through 18. From cycles 19 through 24, obinutuzumab was given alone on the first day of every 56-day cycle.
The overall response rate (ORR) at the end of induction according to the IWG 1999 criteria, the primary endpoint, was 80.2%, including 39.5% complete or unconfirmed complete responses.
When the same patients were assessed according to 2007 IWG criteria, the ORR rate was slightly lower, at 74.4%, but the complete or unconfirmed complete response rate was slightly higher, at 44.2%.
An analysis of responses by time to relapse showed that the ORR among 24 patients with disease progression within 24 months was 70.8%, including 33.3% complete or unconfirmed complete responses by the 1999 criteria, and 66.7% with 54.2% complete or unconfirmed complete responses by the 2007 criteria.
ORR among the 64 patients with disease progression after more than 24 months was 83.9% with 41.9% complete or unconfirmed complete responses by 1999 criteria, and 77.4% with 40.3% complete or unconfirmed complete responses by 2007 criteria. The differences between the groups with disease progression within 24 months and later relapse groups were not significant.
A subanalysis by refractory status, however, showed that the 63 nonrefractory patients fared significantly better, with 87.3% ORR and 41.3% complete or unconfirmed complete responses by 1999 criteria, and 81.0% with 49.2% complete or unconfirmed complete response rate by 2007 determinations, compared with respective rates among 23 refractory patients of 60.9%/34.8% complete or unconfirmed complete response rate and 56.5% with 30.4% complete or unconfirmed complete responses (P = .0212 by 1999 criteria, and P = .022 by 2007 criteria).
After a median follow-up of 18 months, 1-year progression-free survival (PFS) among all patients was 75.5%, and 1-year overall survival (OS) was 88.8%.
There were no significant differences in either progression-free survival or overall survival by time to relapse. Although there appeared to be a nonsignificant trend toward worse outcomes among patients with refractory vs. nonrefractory disease, there was a significantly lower 1-year overall survival rate among refractory patients, at 71.5% compared with 95% for nonrefractory patients (censored logrank P = .0098).
Dr. Morschhauser said that the combination had no unexpected toxicities. Hematologic toxicities of grade 3 or greater included neutropenia in 28.4%, thrombocytopenia in 11.4%, and anemia and lymphopenia in 3.4% each.
The most common nonhematologic toxicities of all grades included infections in 62.5% of patients (grade 3 or greater in 6.8%), and asthenia in 52.3% of patients (grade 3 or greater in 2.3%). The only other grade 3 or greater toxicities were peripheral neuropathy in 1.1%, and infusion related rash in 3.4%.
Additional follow-up will be need for evaluation of the full impact of maintenance on outcomes, he added.
The study was funded by Celgene and Roche. Dr. Morschhauser disclosed receiving honoraria from and serving on advisory boards for both companies.
LUGANO, SWITZERLAND – For patients with relapsed or refractory follicular lymphoma, a pairing of lenalidomide (Revlimid) and obinutuzumab (Gazyva) appeared to be especially useful among patients who had disease progression within 24 months, based on results from a Lymphoma Academic Research Organisation trial.
Among 86 patients who were enrolled in a phase II trial and were assessable for efficacy, overall response rates (ORR) with the combination therapy, nicknamed “GALEN,” were 80.2% by 1999 International Working Group criteria, and 74.4% according to the 2007 IWG criteria, reported Franck Morschhauser, MD, PhD, of the University of Lille, France.
The rationale for this combination is the known synergy between lenalidomide and rituximab in relapsed refractory non-Hodgkin lymphomas and in the frontline setting for patients with follicular lymphoma. Obinutuzumab, a follow-on to rituximab, is a unique type II glycoengineered monoclonal antibody directed against CD20, but with increased antibody-dependent cell-mediated cytotoxicity and increased direct cytotoxicity, compared with rituximab, he explained.
In the phase Ib part of the study, researchers settled on a dose of obinutuzumab 1000 mg and lenalidomide 20 mg. Obinutuzumab was administered on days 8, 15 and 22 and lenalidomide on days 1 to 21 of each 28 day cycle. Patients were evaluated for response after three cycles and at the end of induction (after completion of 4 to 6 cycles).
The maintenance phase consisted of obinutuzumab on day 1 of every other cycle beginning with cycle 1, and lenalidomide on days 1 through 22 for cycles 7 through 18. From cycles 19 through 24, obinutuzumab was given alone on the first day of every 56-day cycle.
The overall response rate (ORR) at the end of induction according to the IWG 1999 criteria, the primary endpoint, was 80.2%, including 39.5% complete or unconfirmed complete responses.
When the same patients were assessed according to 2007 IWG criteria, the ORR rate was slightly lower, at 74.4%, but the complete or unconfirmed complete response rate was slightly higher, at 44.2%.
An analysis of responses by time to relapse showed that the ORR among 24 patients with disease progression within 24 months was 70.8%, including 33.3% complete or unconfirmed complete responses by the 1999 criteria, and 66.7% with 54.2% complete or unconfirmed complete responses by the 2007 criteria.
ORR among the 64 patients with disease progression after more than 24 months was 83.9% with 41.9% complete or unconfirmed complete responses by 1999 criteria, and 77.4% with 40.3% complete or unconfirmed complete responses by 2007 criteria. The differences between the groups with disease progression within 24 months and later relapse groups were not significant.
A subanalysis by refractory status, however, showed that the 63 nonrefractory patients fared significantly better, with 87.3% ORR and 41.3% complete or unconfirmed complete responses by 1999 criteria, and 81.0% with 49.2% complete or unconfirmed complete response rate by 2007 determinations, compared with respective rates among 23 refractory patients of 60.9%/34.8% complete or unconfirmed complete response rate and 56.5% with 30.4% complete or unconfirmed complete responses (P = .0212 by 1999 criteria, and P = .022 by 2007 criteria).
After a median follow-up of 18 months, 1-year progression-free survival (PFS) among all patients was 75.5%, and 1-year overall survival (OS) was 88.8%.
There were no significant differences in either progression-free survival or overall survival by time to relapse. Although there appeared to be a nonsignificant trend toward worse outcomes among patients with refractory vs. nonrefractory disease, there was a significantly lower 1-year overall survival rate among refractory patients, at 71.5% compared with 95% for nonrefractory patients (censored logrank P = .0098).
Dr. Morschhauser said that the combination had no unexpected toxicities. Hematologic toxicities of grade 3 or greater included neutropenia in 28.4%, thrombocytopenia in 11.4%, and anemia and lymphopenia in 3.4% each.
The most common nonhematologic toxicities of all grades included infections in 62.5% of patients (grade 3 or greater in 6.8%), and asthenia in 52.3% of patients (grade 3 or greater in 2.3%). The only other grade 3 or greater toxicities were peripheral neuropathy in 1.1%, and infusion related rash in 3.4%.
Additional follow-up will be need for evaluation of the full impact of maintenance on outcomes, he added.
The study was funded by Celgene and Roche. Dr. Morschhauser disclosed receiving honoraria from and serving on advisory boards for both companies.
LUGANO, SWITZERLAND – For patients with relapsed or refractory follicular lymphoma, a pairing of lenalidomide (Revlimid) and obinutuzumab (Gazyva) appeared to be especially useful among patients who had disease progression within 24 months, based on results from a Lymphoma Academic Research Organisation trial.
Among 86 patients who were enrolled in a phase II trial and were assessable for efficacy, overall response rates (ORR) with the combination therapy, nicknamed “GALEN,” were 80.2% by 1999 International Working Group criteria, and 74.4% according to the 2007 IWG criteria, reported Franck Morschhauser, MD, PhD, of the University of Lille, France.
The rationale for this combination is the known synergy between lenalidomide and rituximab in relapsed refractory non-Hodgkin lymphomas and in the frontline setting for patients with follicular lymphoma. Obinutuzumab, a follow-on to rituximab, is a unique type II glycoengineered monoclonal antibody directed against CD20, but with increased antibody-dependent cell-mediated cytotoxicity and increased direct cytotoxicity, compared with rituximab, he explained.
In the phase Ib part of the study, researchers settled on a dose of obinutuzumab 1000 mg and lenalidomide 20 mg. Obinutuzumab was administered on days 8, 15 and 22 and lenalidomide on days 1 to 21 of each 28 day cycle. Patients were evaluated for response after three cycles and at the end of induction (after completion of 4 to 6 cycles).
The maintenance phase consisted of obinutuzumab on day 1 of every other cycle beginning with cycle 1, and lenalidomide on days 1 through 22 for cycles 7 through 18. From cycles 19 through 24, obinutuzumab was given alone on the first day of every 56-day cycle.
The overall response rate (ORR) at the end of induction according to the IWG 1999 criteria, the primary endpoint, was 80.2%, including 39.5% complete or unconfirmed complete responses.
When the same patients were assessed according to 2007 IWG criteria, the ORR rate was slightly lower, at 74.4%, but the complete or unconfirmed complete response rate was slightly higher, at 44.2%.
An analysis of responses by time to relapse showed that the ORR among 24 patients with disease progression within 24 months was 70.8%, including 33.3% complete or unconfirmed complete responses by the 1999 criteria, and 66.7% with 54.2% complete or unconfirmed complete responses by the 2007 criteria.
ORR among the 64 patients with disease progression after more than 24 months was 83.9% with 41.9% complete or unconfirmed complete responses by 1999 criteria, and 77.4% with 40.3% complete or unconfirmed complete responses by 2007 criteria. The differences between the groups with disease progression within 24 months and later relapse groups were not significant.
A subanalysis by refractory status, however, showed that the 63 nonrefractory patients fared significantly better, with 87.3% ORR and 41.3% complete or unconfirmed complete responses by 1999 criteria, and 81.0% with 49.2% complete or unconfirmed complete response rate by 2007 determinations, compared with respective rates among 23 refractory patients of 60.9%/34.8% complete or unconfirmed complete response rate and 56.5% with 30.4% complete or unconfirmed complete responses (P = .0212 by 1999 criteria, and P = .022 by 2007 criteria).
After a median follow-up of 18 months, 1-year progression-free survival (PFS) among all patients was 75.5%, and 1-year overall survival (OS) was 88.8%.
There were no significant differences in either progression-free survival or overall survival by time to relapse. Although there appeared to be a nonsignificant trend toward worse outcomes among patients with refractory vs. nonrefractory disease, there was a significantly lower 1-year overall survival rate among refractory patients, at 71.5% compared with 95% for nonrefractory patients (censored logrank P = .0098).
Dr. Morschhauser said that the combination had no unexpected toxicities. Hematologic toxicities of grade 3 or greater included neutropenia in 28.4%, thrombocytopenia in 11.4%, and anemia and lymphopenia in 3.4% each.
The most common nonhematologic toxicities of all grades included infections in 62.5% of patients (grade 3 or greater in 6.8%), and asthenia in 52.3% of patients (grade 3 or greater in 2.3%). The only other grade 3 or greater toxicities were peripheral neuropathy in 1.1%, and infusion related rash in 3.4%.
Additional follow-up will be need for evaluation of the full impact of maintenance on outcomes, he added.
The study was funded by Celgene and Roche. Dr. Morschhauser disclosed receiving honoraria from and serving on advisory boards for both companies.
AT 14-ICML
Key clinical point: A combination of lenalidomide and obinutuzumab was safe and effective in patients with relapsed/refractory follicular lymphoma.
Major finding: The overall response rate according to 1999 International Working Group criteria was 80.2%, including 39.5% CR/CRu.
Data source: Single-arm phase II study with 86 patients evaluable for efficacy and 88 evaluable for safety.
Disclosures: The study was funded by Celgene and Roche. Dr. Morschhauser disclosed receiving honoraria from and serving on advisory boards for both companies.
Coconut oil and dairy fats pose similar CVD risk
Are saturated fats good for you or not? A new American Heart Association presidential advisory says no.
In a mixed-effects meta-analysis of four core trials and six noncore trials, the AHA found that replacing saturated fats – particularly coconut oil and dairy fats – with vegetable oils rich in polyunsaturated fats, such as soybean oil, significantly lowered the risk of cardiovascular disease (CVD) by 29%. Because many foods that are high in saturated fats are also high in cholesterol, these dietary changes have the added benefit of improving cholesterol levels.
On the other hand, replacing saturated fats with carbohydrates did not improve patients’ risk of CVD, according to the investigators, although further research into the effects of different types of carbohydrates is needed.
“Because coconut oil increases LDL cholesterol, a cause of CVD, and has no known offsetting favorable effects, we advise against the use of coconut oil” and other oils high in saturated fats, the researchers wrote.
Read more in Circulation (2017 Jun 15. doi: 10.1161/CIR.0000000000000510).
Dr. Sacks reported no relevant financial disclosures. Several researchers disclosed research grants from or consultant/advisory roles with a number of pharmaceutical and nutrition companies.
Are saturated fats good for you or not? A new American Heart Association presidential advisory says no.
In a mixed-effects meta-analysis of four core trials and six noncore trials, the AHA found that replacing saturated fats – particularly coconut oil and dairy fats – with vegetable oils rich in polyunsaturated fats, such as soybean oil, significantly lowered the risk of cardiovascular disease (CVD) by 29%. Because many foods that are high in saturated fats are also high in cholesterol, these dietary changes have the added benefit of improving cholesterol levels.
On the other hand, replacing saturated fats with carbohydrates did not improve patients’ risk of CVD, according to the investigators, although further research into the effects of different types of carbohydrates is needed.
“Because coconut oil increases LDL cholesterol, a cause of CVD, and has no known offsetting favorable effects, we advise against the use of coconut oil” and other oils high in saturated fats, the researchers wrote.
Read more in Circulation (2017 Jun 15. doi: 10.1161/CIR.0000000000000510).
Dr. Sacks reported no relevant financial disclosures. Several researchers disclosed research grants from or consultant/advisory roles with a number of pharmaceutical and nutrition companies.
Are saturated fats good for you or not? A new American Heart Association presidential advisory says no.
In a mixed-effects meta-analysis of four core trials and six noncore trials, the AHA found that replacing saturated fats – particularly coconut oil and dairy fats – with vegetable oils rich in polyunsaturated fats, such as soybean oil, significantly lowered the risk of cardiovascular disease (CVD) by 29%. Because many foods that are high in saturated fats are also high in cholesterol, these dietary changes have the added benefit of improving cholesterol levels.
On the other hand, replacing saturated fats with carbohydrates did not improve patients’ risk of CVD, according to the investigators, although further research into the effects of different types of carbohydrates is needed.
“Because coconut oil increases LDL cholesterol, a cause of CVD, and has no known offsetting favorable effects, we advise against the use of coconut oil” and other oils high in saturated fats, the researchers wrote.
Read more in Circulation (2017 Jun 15. doi: 10.1161/CIR.0000000000000510).
Dr. Sacks reported no relevant financial disclosures. Several researchers disclosed research grants from or consultant/advisory roles with a number of pharmaceutical and nutrition companies.
FROM CIRCULATION