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VIDEO: School program aims to cut diagnostic delay in endometriosis
VANCOUVER – Although symptoms can start young in endometriosis – sometimes in adolescence – women often suffer for years from bowel problems, pain, dyspareunia, and other complications before the condition is recognized and addressed.
Endometriosis can be “a monster of a disease,” especially if it’s not recognized early, said Deborah Bush, cofounder and CEO of the patient advocacy group Endometriosis New Zealand.
To help, she and her colleagues started an education program in New Zealand to teach secondary school students how to recognize – and seek help – when menstrual symptoms fall outside the norm.
In an interview at the World Congress on Endometriosis, Ms. Bush explained the importance of such efforts, and the impact they’ve had in New Zealand over the past 20 years (Aust N Z J Obstet Gynaecol. 2017 Mar 28. doi: 10.1111/ajo.12614).
She also gave an example from her own endometriosis consulting practice of what it took to turn around a patient who had been suffering with the disease for 15 years. Treatment had to move far beyond pelvic lesions.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER – Although symptoms can start young in endometriosis – sometimes in adolescence – women often suffer for years from bowel problems, pain, dyspareunia, and other complications before the condition is recognized and addressed.
Endometriosis can be “a monster of a disease,” especially if it’s not recognized early, said Deborah Bush, cofounder and CEO of the patient advocacy group Endometriosis New Zealand.
To help, she and her colleagues started an education program in New Zealand to teach secondary school students how to recognize – and seek help – when menstrual symptoms fall outside the norm.
In an interview at the World Congress on Endometriosis, Ms. Bush explained the importance of such efforts, and the impact they’ve had in New Zealand over the past 20 years (Aust N Z J Obstet Gynaecol. 2017 Mar 28. doi: 10.1111/ajo.12614).
She also gave an example from her own endometriosis consulting practice of what it took to turn around a patient who had been suffering with the disease for 15 years. Treatment had to move far beyond pelvic lesions.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER – Although symptoms can start young in endometriosis – sometimes in adolescence – women often suffer for years from bowel problems, pain, dyspareunia, and other complications before the condition is recognized and addressed.
Endometriosis can be “a monster of a disease,” especially if it’s not recognized early, said Deborah Bush, cofounder and CEO of the patient advocacy group Endometriosis New Zealand.
To help, she and her colleagues started an education program in New Zealand to teach secondary school students how to recognize – and seek help – when menstrual symptoms fall outside the norm.
In an interview at the World Congress on Endometriosis, Ms. Bush explained the importance of such efforts, and the impact they’ve had in New Zealand over the past 20 years (Aust N Z J Obstet Gynaecol. 2017 Mar 28. doi: 10.1111/ajo.12614).
She also gave an example from her own endometriosis consulting practice of what it took to turn around a patient who had been suffering with the disease for 15 years. Treatment had to move far beyond pelvic lesions.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT WCE 2017
VIDEO: Endometriosis research: What women want
VANCOUVER – To define the top 10 research priorities in endometriosis, researchers at the University of Edinburgh, Scotland, and their colleagues did something unusual in the world of medical science. They asked the women who have the disease.
More than 70% of the 1,225 people initially surveyed to define what most needs to be figured out in endometriosis were patients, and most of the rest were clinicians who take care of them. Patients were involved throughout an exhaustive process that whittled down nearly 5,000 initial suggestions to a list of 10 priorities.
The first priority is to determine if endometriosis can be cured, and the second task is to find its cause (Lancet. 2017 May 18. doi: 10.1016/S0140-6736(17)31344-2).
Women who have endometriosis said they want a noninvasive diagnostic test. They also want help managing the emotional and physical impacts of living with the disease, not simply treatments that focus on lesions, according to Andrew Horne, MBChB, PhD, a professor of gynecology and reproductive sciences at the University of Edinburgh, who led the efforts.
In an interview at the World Congress on Endometriosis, Dr. Horne explained why it’s critical to define the top research priorities and what doing so could mean for patients and doctors. He also explained the importance of a recent insight into the pathogenesis of endometriosis: It behaves like cancer.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER – To define the top 10 research priorities in endometriosis, researchers at the University of Edinburgh, Scotland, and their colleagues did something unusual in the world of medical science. They asked the women who have the disease.
More than 70% of the 1,225 people initially surveyed to define what most needs to be figured out in endometriosis were patients, and most of the rest were clinicians who take care of them. Patients were involved throughout an exhaustive process that whittled down nearly 5,000 initial suggestions to a list of 10 priorities.
The first priority is to determine if endometriosis can be cured, and the second task is to find its cause (Lancet. 2017 May 18. doi: 10.1016/S0140-6736(17)31344-2).
Women who have endometriosis said they want a noninvasive diagnostic test. They also want help managing the emotional and physical impacts of living with the disease, not simply treatments that focus on lesions, according to Andrew Horne, MBChB, PhD, a professor of gynecology and reproductive sciences at the University of Edinburgh, who led the efforts.
In an interview at the World Congress on Endometriosis, Dr. Horne explained why it’s critical to define the top research priorities and what doing so could mean for patients and doctors. He also explained the importance of a recent insight into the pathogenesis of endometriosis: It behaves like cancer.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER – To define the top 10 research priorities in endometriosis, researchers at the University of Edinburgh, Scotland, and their colleagues did something unusual in the world of medical science. They asked the women who have the disease.
More than 70% of the 1,225 people initially surveyed to define what most needs to be figured out in endometriosis were patients, and most of the rest were clinicians who take care of them. Patients were involved throughout an exhaustive process that whittled down nearly 5,000 initial suggestions to a list of 10 priorities.
The first priority is to determine if endometriosis can be cured, and the second task is to find its cause (Lancet. 2017 May 18. doi: 10.1016/S0140-6736(17)31344-2).
Women who have endometriosis said they want a noninvasive diagnostic test. They also want help managing the emotional and physical impacts of living with the disease, not simply treatments that focus on lesions, according to Andrew Horne, MBChB, PhD, a professor of gynecology and reproductive sciences at the University of Edinburgh, who led the efforts.
In an interview at the World Congress on Endometriosis, Dr. Horne explained why it’s critical to define the top research priorities and what doing so could mean for patients and doctors. He also explained the importance of a recent insight into the pathogenesis of endometriosis: It behaves like cancer.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT WCE 2017
Should Patients on B Cell–Depleting Therapies Be Immunized Against Influenza?
NEW ORLEANS—Immunizing patients on B cell–depleting therapies against influenza using the inactivated virus vaccine may be beneficial, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers. “Creating virus-specific T cell immunity and boosting highly cross-reactive memory T cells from prior exposures to influenza are valuable in reducing the severity of the infection,” said Elena Grebenciucova, MD, and Eric Williamson, MD, of the Multiple Sclerosis Division of the Perelman Center for Advanced Medicine at the University of Pennsylvania in Philadelphia.
The use of B cell–depleting therapies in patients with multiple sclerosis, neuromyelitis optica, and other inflammatory disorders raises a clinical dilemma. Given that the ability to generate an adequate protective antibody response is severely impaired due to B-cell depletion, is it still beneficial to immunize patients using the inactivated influenza vaccine? The practice of vaccinating patients on B cell–depleting therapies is not universal among neurologists. Many assume that the practice has no benefit and choose not to vaccinate their patients. However, antibody-mediated immune responses are not the only part of the immune system that helps control influenza infection. T cell–mediated immunity, although affected by the absence of B cells in many complex ways, is not abolished, and may offer protection, limit severity of the disease, and reduce influenza-associated morbidity.
Drs. Grebenciucova and Williamson conducted a literature review and analysis to provide a mechanistic rationale for immunizing against influenza in patients on B cell–depleting therapies.
In 2008, Stambas et al reported that virus-specific CD8+ T effector cells are important in clearing influenza infection. They also found that CD4+ T memory cells are critical in maintaining virus-specific CD8+ memory responses. Influenza vaccine helps prime naïve T cells and generates virus-specific T cells. Vaccinating also can boost pre-existent influenza-specific memory T cells, which, unlike the specific antibodies, are effective against various strains of the virus.
Dolphi et al. showed that memory T cell CD8+ and CD4+ epitopes cross-react with internal viral protein sequences (matrix [M] and nucleoprotein [NP]) that are highly conserved among various influenza strains, and thus may offer protection even when the antibody response is either inadequate or directed against the wrong strain of the virus.
A study by Sridhar et al conducted in the setting of the 2009 H1N1 pandemic highlighted the importance of cross-reactive cellular immunity by evaluating CD8+ T cell responses prior to, during, and after the influenza infection and showed that those with pre-existent CD8+ T cells specific for highly conserved internal viral proteins experienced a less severe illness, despite the absence of neutralizing antibodies.
Wilkinson et al and McElhaney et al also showed that even in the setting of inadequate antibody responses, virus-specific T cell–mediated immunity against influenza virus offers protection and may reduce morbidity.
Suggested Reading
McElhaney JE, Kuchel GA, Zhou X, et al. T-cell immunity to influenza in older adults: a pathophysiological framework for development of more effective vaccines. Front Immunol. 2016;7:41.
Sridhar S, Begom S, Bermingham A, et al. Cellular immune correlates of protection against symptomatic pandemic influenza. Nat Med. 2013;19(10):1305-1312.
Stambas J, Guillonneau C, Kedzierska K, et al. Killer T cells in influenza. Pharmacol Ther. 2008;120(2):186-196.
Wilkinson TM, Li CK, Chui CS, et al. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nat Med. 2012;18(2):274-280.
NEW ORLEANS—Immunizing patients on B cell–depleting therapies against influenza using the inactivated virus vaccine may be beneficial, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers. “Creating virus-specific T cell immunity and boosting highly cross-reactive memory T cells from prior exposures to influenza are valuable in reducing the severity of the infection,” said Elena Grebenciucova, MD, and Eric Williamson, MD, of the Multiple Sclerosis Division of the Perelman Center for Advanced Medicine at the University of Pennsylvania in Philadelphia.
The use of B cell–depleting therapies in patients with multiple sclerosis, neuromyelitis optica, and other inflammatory disorders raises a clinical dilemma. Given that the ability to generate an adequate protective antibody response is severely impaired due to B-cell depletion, is it still beneficial to immunize patients using the inactivated influenza vaccine? The practice of vaccinating patients on B cell–depleting therapies is not universal among neurologists. Many assume that the practice has no benefit and choose not to vaccinate their patients. However, antibody-mediated immune responses are not the only part of the immune system that helps control influenza infection. T cell–mediated immunity, although affected by the absence of B cells in many complex ways, is not abolished, and may offer protection, limit severity of the disease, and reduce influenza-associated morbidity.
Drs. Grebenciucova and Williamson conducted a literature review and analysis to provide a mechanistic rationale for immunizing against influenza in patients on B cell–depleting therapies.
In 2008, Stambas et al reported that virus-specific CD8+ T effector cells are important in clearing influenza infection. They also found that CD4+ T memory cells are critical in maintaining virus-specific CD8+ memory responses. Influenza vaccine helps prime naïve T cells and generates virus-specific T cells. Vaccinating also can boost pre-existent influenza-specific memory T cells, which, unlike the specific antibodies, are effective against various strains of the virus.
Dolphi et al. showed that memory T cell CD8+ and CD4+ epitopes cross-react with internal viral protein sequences (matrix [M] and nucleoprotein [NP]) that are highly conserved among various influenza strains, and thus may offer protection even when the antibody response is either inadequate or directed against the wrong strain of the virus.
A study by Sridhar et al conducted in the setting of the 2009 H1N1 pandemic highlighted the importance of cross-reactive cellular immunity by evaluating CD8+ T cell responses prior to, during, and after the influenza infection and showed that those with pre-existent CD8+ T cells specific for highly conserved internal viral proteins experienced a less severe illness, despite the absence of neutralizing antibodies.
Wilkinson et al and McElhaney et al also showed that even in the setting of inadequate antibody responses, virus-specific T cell–mediated immunity against influenza virus offers protection and may reduce morbidity.
Suggested Reading
McElhaney JE, Kuchel GA, Zhou X, et al. T-cell immunity to influenza in older adults: a pathophysiological framework for development of more effective vaccines. Front Immunol. 2016;7:41.
Sridhar S, Begom S, Bermingham A, et al. Cellular immune correlates of protection against symptomatic pandemic influenza. Nat Med. 2013;19(10):1305-1312.
Stambas J, Guillonneau C, Kedzierska K, et al. Killer T cells in influenza. Pharmacol Ther. 2008;120(2):186-196.
Wilkinson TM, Li CK, Chui CS, et al. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nat Med. 2012;18(2):274-280.
NEW ORLEANS—Immunizing patients on B cell–depleting therapies against influenza using the inactivated virus vaccine may be beneficial, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers. “Creating virus-specific T cell immunity and boosting highly cross-reactive memory T cells from prior exposures to influenza are valuable in reducing the severity of the infection,” said Elena Grebenciucova, MD, and Eric Williamson, MD, of the Multiple Sclerosis Division of the Perelman Center for Advanced Medicine at the University of Pennsylvania in Philadelphia.
The use of B cell–depleting therapies in patients with multiple sclerosis, neuromyelitis optica, and other inflammatory disorders raises a clinical dilemma. Given that the ability to generate an adequate protective antibody response is severely impaired due to B-cell depletion, is it still beneficial to immunize patients using the inactivated influenza vaccine? The practice of vaccinating patients on B cell–depleting therapies is not universal among neurologists. Many assume that the practice has no benefit and choose not to vaccinate their patients. However, antibody-mediated immune responses are not the only part of the immune system that helps control influenza infection. T cell–mediated immunity, although affected by the absence of B cells in many complex ways, is not abolished, and may offer protection, limit severity of the disease, and reduce influenza-associated morbidity.
Drs. Grebenciucova and Williamson conducted a literature review and analysis to provide a mechanistic rationale for immunizing against influenza in patients on B cell–depleting therapies.
In 2008, Stambas et al reported that virus-specific CD8+ T effector cells are important in clearing influenza infection. They also found that CD4+ T memory cells are critical in maintaining virus-specific CD8+ memory responses. Influenza vaccine helps prime naïve T cells and generates virus-specific T cells. Vaccinating also can boost pre-existent influenza-specific memory T cells, which, unlike the specific antibodies, are effective against various strains of the virus.
Dolphi et al. showed that memory T cell CD8+ and CD4+ epitopes cross-react with internal viral protein sequences (matrix [M] and nucleoprotein [NP]) that are highly conserved among various influenza strains, and thus may offer protection even when the antibody response is either inadequate or directed against the wrong strain of the virus.
A study by Sridhar et al conducted in the setting of the 2009 H1N1 pandemic highlighted the importance of cross-reactive cellular immunity by evaluating CD8+ T cell responses prior to, during, and after the influenza infection and showed that those with pre-existent CD8+ T cells specific for highly conserved internal viral proteins experienced a less severe illness, despite the absence of neutralizing antibodies.
Wilkinson et al and McElhaney et al also showed that even in the setting of inadequate antibody responses, virus-specific T cell–mediated immunity against influenza virus offers protection and may reduce morbidity.
Suggested Reading
McElhaney JE, Kuchel GA, Zhou X, et al. T-cell immunity to influenza in older adults: a pathophysiological framework for development of more effective vaccines. Front Immunol. 2016;7:41.
Sridhar S, Begom S, Bermingham A, et al. Cellular immune correlates of protection against symptomatic pandemic influenza. Nat Med. 2013;19(10):1305-1312.
Stambas J, Guillonneau C, Kedzierska K, et al. Killer T cells in influenza. Pharmacol Ther. 2008;120(2):186-196.
Wilkinson TM, Li CK, Chui CS, et al. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nat Med. 2012;18(2):274-280.
Health reform action shifts to Senate, exacerbated by poor AHCA CBO score
With a highly anticipated impact analysis from the nonpartisan Congressional Budget Office, the much maligned American Health Care Act seems relegated to a Capitol Hill recycling bin and repeal/replace focus has moved to the Senate.
Sen. Orrin Hatch (R-Utah), chairman of the Senate Finance Committee, has reached out to physicians’ organizations to learn their priorities.
The organization also called for the reduction of regulatory burdens and increased cost transparency.
Additional recommendations include
• Support for advanceable, refundable tax credits to help individuals purchase private health care coverage, with the current tax credit structure in the ACA maintained.
• Maintenance of the ACA cost-sharing reductions for 2017 and 2018.
• Enhanced tax credits for young adults aged 19-30 years and modest funding of health savings accounts to help counter high deductibles.
The AMA also supports maintenance of the current Medicaid expansion while offering states even more flexibility for innovation.
Similarly, the American Osteopathic Association noted that any policy changes “should be to expand or at least maintain access to comprehensive, affordable coverage and care. With that said, we are also concerned about the growing potential for market instability and the deleterious effect that a collapse would have on patients’ access to insurance coverage and health care services,” according to a May 23 letter from Boyd Buser, DO, president of AOA.
The organization called for continued coverage of preventive care services with no copayment and expressed concern that “the changes being considered for the Medicaid program as part of health reform discussions will significantly impact coverage for these Americans.”
The House-passed American Health Care Act (H.R. 1628) would repeal the ACA’s Medicaid expansion provisions and implement a per-capita funding scheme for state Medicaid programs. “The AOA is concerned that this will leave states with insufficient funds to provide care to the most vulnerable in our society,” Dr. Buser wrote.
AOA recommended a number of consumer protections, including adequate funding of an invisible risk-sharing program that is maintained by an organization outside of the government; efforts to improve health literacy, and other cost-containment recommendations, particularly the maintenance of the cost-sharing reduction payments.
Even if the Senate were able to incorporate these recommendations, its leaders face an uphill battle to get enough support for passage.
“If, on the Republican side, they can come to an agreement on the bill, I think they have a chance of passing it,” Julius Hobson, senior policy analyst at the Washington law firm Polsinelli, said in an interview. “The GOP is not taking up the House-passed AHCA but is proceeding with writing its own reform legislation.
However, he pointed out that there is very little margin for error because the party only holds a two-seat majority and moderates Republican senators have expressed concerns about cuts to Medicaid.
If Senate Republicans do pass a bill that appeals to its more moderate members, that legislation is likely to face stiff opposition in the House.
“Given what we just saw the House go through, I don’t know” if a more moderate bill could pass in that chamber, he said, adding that, if “they don’t do this by the end of the calendar year, you can forget it.”
The potential death blow to the AHCA came in the form of a financial impact “score” from the Congressional Budget Office (CBO).
The government budget watchdog estimated the AHCA would reduce the budget deficit by $119 billion from 2017 to 2026, with the largest savings coming from “reductions in outlays for Medicaid and from the replacement of the Affordable Care Act’s subsidies for nongroup health insurance with new tax credits for nongroup health insurance. Those savings would be partially offset by other changes in coverage provisions – spending for a new Patient and State Stability Fund, designed to reduce premiums, and a reduction in revenues from repealing penalties on employers who do not offer insurance and on people who do not purchase insurance.”
The CBO score also predicted that an additional 23 million patients would be uninsured by 2026 – for a total of 51 million – compared with a total of 28 million uninsured under the ACA.
CBO analysts predicted that nongroup health insurance markets would stabilize before 2020 under the AHCA, but instability could increased if states seek waivers to modify the essential health benefits and community rating requirements.
Although premiums overall would decrease under the AHCA, certain subpopulations could see substantial increases under state waivers.
Additionally, the waivers could also impact the provision of care.
Analysis of the impact of the waiving of essential health benefits is the part doctors should be paying most attention to, Laura Wooster, AOA senior vice president of public policy, said in an interview.
“They would start seeing patients who potentially would have insurance plans that only cover certain benefits,” she said. That would “prevent them from providing certain services or care for their patients under the patients’ coverage. Even a more immediate administrative aspect of it that things would become more complicated if there isn’t a uniform standard, then it is going to be even more complicated for patients to navigate what’s covered, what’s not, and, if the physician takes the insurance, which services are they able to provide.”
She added that, if states waive any or all of the essential health benefits, those benefits would no longer be subject to lifetime and annual caps on spending.
Mr. Hobson suggested that the biggest part of the CBO score that doctors should be worried about is the spike in uninsured that could result from any reform effort.
“The concern for physicians will be that they are more likely to see more patients who don’t have insurance depending on the specialty,” Mr. Hobson said. “Primary care will certainly see a lot of that. Physicians in emergency departments will see more of them because, as you well know, when people don’t have insurance, that’s where they show up when they are at their sickest.”
He added that a “patient can come in, a physician can diagnose the problem, but, if the patient doesn’t have the insurance, he or she may not have the ability to spend the money to do what they need to do, which means they will be back.”
With a highly anticipated impact analysis from the nonpartisan Congressional Budget Office, the much maligned American Health Care Act seems relegated to a Capitol Hill recycling bin and repeal/replace focus has moved to the Senate.
Sen. Orrin Hatch (R-Utah), chairman of the Senate Finance Committee, has reached out to physicians’ organizations to learn their priorities.
The organization also called for the reduction of regulatory burdens and increased cost transparency.
Additional recommendations include
• Support for advanceable, refundable tax credits to help individuals purchase private health care coverage, with the current tax credit structure in the ACA maintained.
• Maintenance of the ACA cost-sharing reductions for 2017 and 2018.
• Enhanced tax credits for young adults aged 19-30 years and modest funding of health savings accounts to help counter high deductibles.
The AMA also supports maintenance of the current Medicaid expansion while offering states even more flexibility for innovation.
Similarly, the American Osteopathic Association noted that any policy changes “should be to expand or at least maintain access to comprehensive, affordable coverage and care. With that said, we are also concerned about the growing potential for market instability and the deleterious effect that a collapse would have on patients’ access to insurance coverage and health care services,” according to a May 23 letter from Boyd Buser, DO, president of AOA.
The organization called for continued coverage of preventive care services with no copayment and expressed concern that “the changes being considered for the Medicaid program as part of health reform discussions will significantly impact coverage for these Americans.”
The House-passed American Health Care Act (H.R. 1628) would repeal the ACA’s Medicaid expansion provisions and implement a per-capita funding scheme for state Medicaid programs. “The AOA is concerned that this will leave states with insufficient funds to provide care to the most vulnerable in our society,” Dr. Buser wrote.
AOA recommended a number of consumer protections, including adequate funding of an invisible risk-sharing program that is maintained by an organization outside of the government; efforts to improve health literacy, and other cost-containment recommendations, particularly the maintenance of the cost-sharing reduction payments.
Even if the Senate were able to incorporate these recommendations, its leaders face an uphill battle to get enough support for passage.
“If, on the Republican side, they can come to an agreement on the bill, I think they have a chance of passing it,” Julius Hobson, senior policy analyst at the Washington law firm Polsinelli, said in an interview. “The GOP is not taking up the House-passed AHCA but is proceeding with writing its own reform legislation.
However, he pointed out that there is very little margin for error because the party only holds a two-seat majority and moderates Republican senators have expressed concerns about cuts to Medicaid.
If Senate Republicans do pass a bill that appeals to its more moderate members, that legislation is likely to face stiff opposition in the House.
“Given what we just saw the House go through, I don’t know” if a more moderate bill could pass in that chamber, he said, adding that, if “they don’t do this by the end of the calendar year, you can forget it.”
The potential death blow to the AHCA came in the form of a financial impact “score” from the Congressional Budget Office (CBO).
The government budget watchdog estimated the AHCA would reduce the budget deficit by $119 billion from 2017 to 2026, with the largest savings coming from “reductions in outlays for Medicaid and from the replacement of the Affordable Care Act’s subsidies for nongroup health insurance with new tax credits for nongroup health insurance. Those savings would be partially offset by other changes in coverage provisions – spending for a new Patient and State Stability Fund, designed to reduce premiums, and a reduction in revenues from repealing penalties on employers who do not offer insurance and on people who do not purchase insurance.”
The CBO score also predicted that an additional 23 million patients would be uninsured by 2026 – for a total of 51 million – compared with a total of 28 million uninsured under the ACA.
CBO analysts predicted that nongroup health insurance markets would stabilize before 2020 under the AHCA, but instability could increased if states seek waivers to modify the essential health benefits and community rating requirements.
Although premiums overall would decrease under the AHCA, certain subpopulations could see substantial increases under state waivers.
Additionally, the waivers could also impact the provision of care.
Analysis of the impact of the waiving of essential health benefits is the part doctors should be paying most attention to, Laura Wooster, AOA senior vice president of public policy, said in an interview.
“They would start seeing patients who potentially would have insurance plans that only cover certain benefits,” she said. That would “prevent them from providing certain services or care for their patients under the patients’ coverage. Even a more immediate administrative aspect of it that things would become more complicated if there isn’t a uniform standard, then it is going to be even more complicated for patients to navigate what’s covered, what’s not, and, if the physician takes the insurance, which services are they able to provide.”
She added that, if states waive any or all of the essential health benefits, those benefits would no longer be subject to lifetime and annual caps on spending.
Mr. Hobson suggested that the biggest part of the CBO score that doctors should be worried about is the spike in uninsured that could result from any reform effort.
“The concern for physicians will be that they are more likely to see more patients who don’t have insurance depending on the specialty,” Mr. Hobson said. “Primary care will certainly see a lot of that. Physicians in emergency departments will see more of them because, as you well know, when people don’t have insurance, that’s where they show up when they are at their sickest.”
He added that a “patient can come in, a physician can diagnose the problem, but, if the patient doesn’t have the insurance, he or she may not have the ability to spend the money to do what they need to do, which means they will be back.”
With a highly anticipated impact analysis from the nonpartisan Congressional Budget Office, the much maligned American Health Care Act seems relegated to a Capitol Hill recycling bin and repeal/replace focus has moved to the Senate.
Sen. Orrin Hatch (R-Utah), chairman of the Senate Finance Committee, has reached out to physicians’ organizations to learn their priorities.
The organization also called for the reduction of regulatory burdens and increased cost transparency.
Additional recommendations include
• Support for advanceable, refundable tax credits to help individuals purchase private health care coverage, with the current tax credit structure in the ACA maintained.
• Maintenance of the ACA cost-sharing reductions for 2017 and 2018.
• Enhanced tax credits for young adults aged 19-30 years and modest funding of health savings accounts to help counter high deductibles.
The AMA also supports maintenance of the current Medicaid expansion while offering states even more flexibility for innovation.
Similarly, the American Osteopathic Association noted that any policy changes “should be to expand or at least maintain access to comprehensive, affordable coverage and care. With that said, we are also concerned about the growing potential for market instability and the deleterious effect that a collapse would have on patients’ access to insurance coverage and health care services,” according to a May 23 letter from Boyd Buser, DO, president of AOA.
The organization called for continued coverage of preventive care services with no copayment and expressed concern that “the changes being considered for the Medicaid program as part of health reform discussions will significantly impact coverage for these Americans.”
The House-passed American Health Care Act (H.R. 1628) would repeal the ACA’s Medicaid expansion provisions and implement a per-capita funding scheme for state Medicaid programs. “The AOA is concerned that this will leave states with insufficient funds to provide care to the most vulnerable in our society,” Dr. Buser wrote.
AOA recommended a number of consumer protections, including adequate funding of an invisible risk-sharing program that is maintained by an organization outside of the government; efforts to improve health literacy, and other cost-containment recommendations, particularly the maintenance of the cost-sharing reduction payments.
Even if the Senate were able to incorporate these recommendations, its leaders face an uphill battle to get enough support for passage.
“If, on the Republican side, they can come to an agreement on the bill, I think they have a chance of passing it,” Julius Hobson, senior policy analyst at the Washington law firm Polsinelli, said in an interview. “The GOP is not taking up the House-passed AHCA but is proceeding with writing its own reform legislation.
However, he pointed out that there is very little margin for error because the party only holds a two-seat majority and moderates Republican senators have expressed concerns about cuts to Medicaid.
If Senate Republicans do pass a bill that appeals to its more moderate members, that legislation is likely to face stiff opposition in the House.
“Given what we just saw the House go through, I don’t know” if a more moderate bill could pass in that chamber, he said, adding that, if “they don’t do this by the end of the calendar year, you can forget it.”
The potential death blow to the AHCA came in the form of a financial impact “score” from the Congressional Budget Office (CBO).
The government budget watchdog estimated the AHCA would reduce the budget deficit by $119 billion from 2017 to 2026, with the largest savings coming from “reductions in outlays for Medicaid and from the replacement of the Affordable Care Act’s subsidies for nongroup health insurance with new tax credits for nongroup health insurance. Those savings would be partially offset by other changes in coverage provisions – spending for a new Patient and State Stability Fund, designed to reduce premiums, and a reduction in revenues from repealing penalties on employers who do not offer insurance and on people who do not purchase insurance.”
The CBO score also predicted that an additional 23 million patients would be uninsured by 2026 – for a total of 51 million – compared with a total of 28 million uninsured under the ACA.
CBO analysts predicted that nongroup health insurance markets would stabilize before 2020 under the AHCA, but instability could increased if states seek waivers to modify the essential health benefits and community rating requirements.
Although premiums overall would decrease under the AHCA, certain subpopulations could see substantial increases under state waivers.
Additionally, the waivers could also impact the provision of care.
Analysis of the impact of the waiving of essential health benefits is the part doctors should be paying most attention to, Laura Wooster, AOA senior vice president of public policy, said in an interview.
“They would start seeing patients who potentially would have insurance plans that only cover certain benefits,” she said. That would “prevent them from providing certain services or care for their patients under the patients’ coverage. Even a more immediate administrative aspect of it that things would become more complicated if there isn’t a uniform standard, then it is going to be even more complicated for patients to navigate what’s covered, what’s not, and, if the physician takes the insurance, which services are they able to provide.”
She added that, if states waive any or all of the essential health benefits, those benefits would no longer be subject to lifetime and annual caps on spending.
Mr. Hobson suggested that the biggest part of the CBO score that doctors should be worried about is the spike in uninsured that could result from any reform effort.
“The concern for physicians will be that they are more likely to see more patients who don’t have insurance depending on the specialty,” Mr. Hobson said. “Primary care will certainly see a lot of that. Physicians in emergency departments will see more of them because, as you well know, when people don’t have insurance, that’s where they show up when they are at their sickest.”
He added that a “patient can come in, a physician can diagnose the problem, but, if the patient doesn’t have the insurance, he or she may not have the ability to spend the money to do what they need to do, which means they will be back.”
ATS conference participants shout for science
WASHINGTON – A group of about 60 individuals in lab coats marched through the rain from buses to Upper Senate Park on the evening of May 23, gathering in front of a raised podium in the park shadowed by the Capitol Building.
The demonstrators were trying to bring attention to recent policies that threaten to undermine research funding, tobacco regulation, affordable health care, clean air, and other advocacy priorities of the American Thoracic Society. The ATS had organized this rally – “Lab Coats for Lungs” – in conjunction with its international conference, which took place in Washington May 19-24.
“We rally today because we share growing anxiety that science in general, and our field in particular, is being dismissed in the halls of power,” ATS Vice President Polly Parsons, MD, announced from the podium.
Other speakers condemned the Trump administration’s proposals to scale down on environmental, health, and safety regulations, as well as proposed cuts to federal funding for scientific research, including an 18% reduction to National Institutes of Health funding.
Some speakers, including Gary Ewart, ATS chief of advocacy and government relations, and the event’s organizer, encouraged the crowd to raise their voices.
“Tell me what democracy looks like,” he yelled several times.
“This is what democracy looked like,” his fellow marchers shouted.
“What brought us the ability to transplant a lung and save a patient’s life who is dying of respiratory failure? What will cause the next breakthrough discovery? When our elected officials are looking for answers to challenging questions, what should they use for their guiding light?”
“Science!” bellowed the demonstrators, following each of Dr. Moss’s inquiries.
Some of the marchers wore pink lab coats rather than white, as a demonstration of women’s rights and gender equality in the field of science and medicine.
“The idea to wear pink coats was a result of discussions that mentioned that women’s rights were an integral part of the campaign for science, health, and clean air,” said ATS member Naftali Kaminski, MD. “Access to health care is critical to women, as is clean air. This why we chose to wear pink instead of white coats.”
Other speakers included Sen. Tom Carper (D-DE), Sen. Ed Markey (D-MA), pulmonary fibrosis patient advocate Teresa Barnes, and past ATS President David Gozal, MD.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WASHINGTON – A group of about 60 individuals in lab coats marched through the rain from buses to Upper Senate Park on the evening of May 23, gathering in front of a raised podium in the park shadowed by the Capitol Building.
The demonstrators were trying to bring attention to recent policies that threaten to undermine research funding, tobacco regulation, affordable health care, clean air, and other advocacy priorities of the American Thoracic Society. The ATS had organized this rally – “Lab Coats for Lungs” – in conjunction with its international conference, which took place in Washington May 19-24.
“We rally today because we share growing anxiety that science in general, and our field in particular, is being dismissed in the halls of power,” ATS Vice President Polly Parsons, MD, announced from the podium.
Other speakers condemned the Trump administration’s proposals to scale down on environmental, health, and safety regulations, as well as proposed cuts to federal funding for scientific research, including an 18% reduction to National Institutes of Health funding.
Some speakers, including Gary Ewart, ATS chief of advocacy and government relations, and the event’s organizer, encouraged the crowd to raise their voices.
“Tell me what democracy looks like,” he yelled several times.
“This is what democracy looked like,” his fellow marchers shouted.
“What brought us the ability to transplant a lung and save a patient’s life who is dying of respiratory failure? What will cause the next breakthrough discovery? When our elected officials are looking for answers to challenging questions, what should they use for their guiding light?”
“Science!” bellowed the demonstrators, following each of Dr. Moss’s inquiries.
Some of the marchers wore pink lab coats rather than white, as a demonstration of women’s rights and gender equality in the field of science and medicine.
“The idea to wear pink coats was a result of discussions that mentioned that women’s rights were an integral part of the campaign for science, health, and clean air,” said ATS member Naftali Kaminski, MD. “Access to health care is critical to women, as is clean air. This why we chose to wear pink instead of white coats.”
Other speakers included Sen. Tom Carper (D-DE), Sen. Ed Markey (D-MA), pulmonary fibrosis patient advocate Teresa Barnes, and past ATS President David Gozal, MD.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WASHINGTON – A group of about 60 individuals in lab coats marched through the rain from buses to Upper Senate Park on the evening of May 23, gathering in front of a raised podium in the park shadowed by the Capitol Building.
The demonstrators were trying to bring attention to recent policies that threaten to undermine research funding, tobacco regulation, affordable health care, clean air, and other advocacy priorities of the American Thoracic Society. The ATS had organized this rally – “Lab Coats for Lungs” – in conjunction with its international conference, which took place in Washington May 19-24.
“We rally today because we share growing anxiety that science in general, and our field in particular, is being dismissed in the halls of power,” ATS Vice President Polly Parsons, MD, announced from the podium.
Other speakers condemned the Trump administration’s proposals to scale down on environmental, health, and safety regulations, as well as proposed cuts to federal funding for scientific research, including an 18% reduction to National Institutes of Health funding.
Some speakers, including Gary Ewart, ATS chief of advocacy and government relations, and the event’s organizer, encouraged the crowd to raise their voices.
“Tell me what democracy looks like,” he yelled several times.
“This is what democracy looked like,” his fellow marchers shouted.
“What brought us the ability to transplant a lung and save a patient’s life who is dying of respiratory failure? What will cause the next breakthrough discovery? When our elected officials are looking for answers to challenging questions, what should they use for their guiding light?”
“Science!” bellowed the demonstrators, following each of Dr. Moss’s inquiries.
Some of the marchers wore pink lab coats rather than white, as a demonstration of women’s rights and gender equality in the field of science and medicine.
“The idea to wear pink coats was a result of discussions that mentioned that women’s rights were an integral part of the campaign for science, health, and clean air,” said ATS member Naftali Kaminski, MD. “Access to health care is critical to women, as is clean air. This why we chose to wear pink instead of white coats.”
Other speakers included Sen. Tom Carper (D-DE), Sen. Ed Markey (D-MA), pulmonary fibrosis patient advocate Teresa Barnes, and past ATS President David Gozal, MD.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ATS 2017
Does a High-Quality Diet Affect Disability Status in Patients With MS?
NEW ORLEANS—A diet high in fruits, vegetables, legumes, and whole grains and low in sugar and red meat is associated with less disability and fewer depressive symptoms in patients with multiple sclerosis (MS), according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.
“Our findings suggest that people with MS who have a healthier diet have less disability, and that a generally healthy lifestyle is associated with a lower burden of severe depression, pain, fatigue, and cognitive problems. Therefore, modifying diet may offer a way of improving symptoms,” said Ruth Ann Marrie, MD, PhD, Associate Professor of Neurology and Director of the MS Clinic at the University of Manitoba in Winnipeg, Canada.
Many patients with MS ask whether their diet could influence their disease status. To address this question, Dr. Marrie and colleagues assessed the association between overall diet quality and disability and physical and mental functioning in a large cohort of people with MS. They conducted a cross-sectional study of North American Research Committee on MS (NARCOMS) registry participants who had completed a dietary screener questionnaire. The questionnaire, created by the National Health and Nutrition Examination Survey, provides an assessment of diet composition when full information on diet is unavailable. The survey estimates intake of fruits, vegetables and legumes, whole grains, added sugars, and red and processed meats.
The researchers constructed an overall diet-quality score based on responses to the questionnaire and assigned participants to sex-specific quintiles of each of the questionnaire’s five food groups. They then assigned scores for fruits, vegetables, legumes, and whole grains based on the patient’s quintile ranking. The investigators inverted scores for red and processed meats and added sugar. The researchers summed individual food-group scores to obtain an overall diet score, ranging from 4 (poor quality) to 20 (high quality).
Dr. Marrie and colleagues assessed the association between diet quality and disability status (using the Patient-Determined Disease Steps) and mental and physical functioning (ie, depression, fatigue, cognition, mobility, vision, pain, spasticity, tremor, and sensory function) using proportional odds models adjusting for age, gender, income, BMI, smoking status, and disease duration.
In all, 7,418 responders had an average quality-diet score of 11.9. Patients with higher scores tended to be older, leaner, and nonsmokers. People with diet-quality scores in the top quintile had lower levels of disability and lower depression scores. Diet-quality scores were not associated with other physical or mental functioning scores, however.
A lack of details about potentially important dietary factors, such as types of fat, is one limitation of the study, said Dr. Marrie.
“While our study does not prove that diet change will improve symptoms, a high-quality diet that emphasizes intake of fruits, vegetables, and whole grains, and lower intake of red meat, can be encouraged, given the known benefits for general health,” said Dr. Marrie. “Future studies should look at the relationship between diet and disability, as well as symptoms over time, so that we can establish whether changing diet will improve outcomes in MS. These studies should also look at diet in more detail.”
The National MS Society supported this study.
—Erica Tricarico
NEW ORLEANS—A diet high in fruits, vegetables, legumes, and whole grains and low in sugar and red meat is associated with less disability and fewer depressive symptoms in patients with multiple sclerosis (MS), according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.
“Our findings suggest that people with MS who have a healthier diet have less disability, and that a generally healthy lifestyle is associated with a lower burden of severe depression, pain, fatigue, and cognitive problems. Therefore, modifying diet may offer a way of improving symptoms,” said Ruth Ann Marrie, MD, PhD, Associate Professor of Neurology and Director of the MS Clinic at the University of Manitoba in Winnipeg, Canada.
Many patients with MS ask whether their diet could influence their disease status. To address this question, Dr. Marrie and colleagues assessed the association between overall diet quality and disability and physical and mental functioning in a large cohort of people with MS. They conducted a cross-sectional study of North American Research Committee on MS (NARCOMS) registry participants who had completed a dietary screener questionnaire. The questionnaire, created by the National Health and Nutrition Examination Survey, provides an assessment of diet composition when full information on diet is unavailable. The survey estimates intake of fruits, vegetables and legumes, whole grains, added sugars, and red and processed meats.
The researchers constructed an overall diet-quality score based on responses to the questionnaire and assigned participants to sex-specific quintiles of each of the questionnaire’s five food groups. They then assigned scores for fruits, vegetables, legumes, and whole grains based on the patient’s quintile ranking. The investigators inverted scores for red and processed meats and added sugar. The researchers summed individual food-group scores to obtain an overall diet score, ranging from 4 (poor quality) to 20 (high quality).
Dr. Marrie and colleagues assessed the association between diet quality and disability status (using the Patient-Determined Disease Steps) and mental and physical functioning (ie, depression, fatigue, cognition, mobility, vision, pain, spasticity, tremor, and sensory function) using proportional odds models adjusting for age, gender, income, BMI, smoking status, and disease duration.
In all, 7,418 responders had an average quality-diet score of 11.9. Patients with higher scores tended to be older, leaner, and nonsmokers. People with diet-quality scores in the top quintile had lower levels of disability and lower depression scores. Diet-quality scores were not associated with other physical or mental functioning scores, however.
A lack of details about potentially important dietary factors, such as types of fat, is one limitation of the study, said Dr. Marrie.
“While our study does not prove that diet change will improve symptoms, a high-quality diet that emphasizes intake of fruits, vegetables, and whole grains, and lower intake of red meat, can be encouraged, given the known benefits for general health,” said Dr. Marrie. “Future studies should look at the relationship between diet and disability, as well as symptoms over time, so that we can establish whether changing diet will improve outcomes in MS. These studies should also look at diet in more detail.”
The National MS Society supported this study.
—Erica Tricarico
NEW ORLEANS—A diet high in fruits, vegetables, legumes, and whole grains and low in sugar and red meat is associated with less disability and fewer depressive symptoms in patients with multiple sclerosis (MS), according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.
“Our findings suggest that people with MS who have a healthier diet have less disability, and that a generally healthy lifestyle is associated with a lower burden of severe depression, pain, fatigue, and cognitive problems. Therefore, modifying diet may offer a way of improving symptoms,” said Ruth Ann Marrie, MD, PhD, Associate Professor of Neurology and Director of the MS Clinic at the University of Manitoba in Winnipeg, Canada.
Many patients with MS ask whether their diet could influence their disease status. To address this question, Dr. Marrie and colleagues assessed the association between overall diet quality and disability and physical and mental functioning in a large cohort of people with MS. They conducted a cross-sectional study of North American Research Committee on MS (NARCOMS) registry participants who had completed a dietary screener questionnaire. The questionnaire, created by the National Health and Nutrition Examination Survey, provides an assessment of diet composition when full information on diet is unavailable. The survey estimates intake of fruits, vegetables and legumes, whole grains, added sugars, and red and processed meats.
The researchers constructed an overall diet-quality score based on responses to the questionnaire and assigned participants to sex-specific quintiles of each of the questionnaire’s five food groups. They then assigned scores for fruits, vegetables, legumes, and whole grains based on the patient’s quintile ranking. The investigators inverted scores for red and processed meats and added sugar. The researchers summed individual food-group scores to obtain an overall diet score, ranging from 4 (poor quality) to 20 (high quality).
Dr. Marrie and colleagues assessed the association between diet quality and disability status (using the Patient-Determined Disease Steps) and mental and physical functioning (ie, depression, fatigue, cognition, mobility, vision, pain, spasticity, tremor, and sensory function) using proportional odds models adjusting for age, gender, income, BMI, smoking status, and disease duration.
In all, 7,418 responders had an average quality-diet score of 11.9. Patients with higher scores tended to be older, leaner, and nonsmokers. People with diet-quality scores in the top quintile had lower levels of disability and lower depression scores. Diet-quality scores were not associated with other physical or mental functioning scores, however.
A lack of details about potentially important dietary factors, such as types of fat, is one limitation of the study, said Dr. Marrie.
“While our study does not prove that diet change will improve symptoms, a high-quality diet that emphasizes intake of fruits, vegetables, and whole grains, and lower intake of red meat, can be encouraged, given the known benefits for general health,” said Dr. Marrie. “Future studies should look at the relationship between diet and disability, as well as symptoms over time, so that we can establish whether changing diet will improve outcomes in MS. These studies should also look at diet in more detail.”
The National MS Society supported this study.
—Erica Tricarico
Light Physical Activity May Improve Physical Function in Older Patients With MS
NEW ORLEANS—Older adults with multiple sclerosis (MS) who engaged more in light physical activity demonstrated better physical function independent of sedentary behavior and moderate-to-vigorous activity, according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.
“Such results might underscore light physical activity as a suitable target of future rehabilitative interventions for improving physical function in older adults with MS,” said Katie L.J. Cederberg, a doctoral student at the University of Alabama at Birmingham.
Rate and pattern of participation in physical activity and sedentary behavior might be associated with a reduction of physical function among older adults with MS. Ms. Cederberg conducted a study that examined the associations among levels of light and moderate-to-vigorous physical activity, sedentary behavior, and physical function in older adults with MS.
Ms. Cederberg’s study sample included 40 older adults with MS with a median age of 60. Participants wore an accelerometer during the waking hours of a seven-day period. In addition, Ms. Cederberg used cut-points for MS to process data for time spent in moderate-to-vigorous physical activity, light physical activity, and sedentary behavior. Finally, patients completed the Short Physical Performance Battery (SPPB), the Six-Minute Walk Test, and the Timed 25-Foot Walk.
The median scores for time spent in moderate-to-vigorous physical activity and light physical activity were lower, and sedentary behavior was significantly greater, than those reported for older adults in the general population.
In addition, bivariate correlation analyses suggested that light physical activity and moderate to vigorous physical activity were associated with SPPB, Six-Minute Walk Test, and Timed 25-Foot Walk scores, but the association was stronger for light physical activity. Regression analyses yielded significant associations between light physical activity, but not moderate-to-vigorous physical activity or sedentary behavior, and SPPB, Six-Minute Walk Test, and Timed 25-Foot Walk scores.
NEW ORLEANS—Older adults with multiple sclerosis (MS) who engaged more in light physical activity demonstrated better physical function independent of sedentary behavior and moderate-to-vigorous activity, according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.
“Such results might underscore light physical activity as a suitable target of future rehabilitative interventions for improving physical function in older adults with MS,” said Katie L.J. Cederberg, a doctoral student at the University of Alabama at Birmingham.
Rate and pattern of participation in physical activity and sedentary behavior might be associated with a reduction of physical function among older adults with MS. Ms. Cederberg conducted a study that examined the associations among levels of light and moderate-to-vigorous physical activity, sedentary behavior, and physical function in older adults with MS.
Ms. Cederberg’s study sample included 40 older adults with MS with a median age of 60. Participants wore an accelerometer during the waking hours of a seven-day period. In addition, Ms. Cederberg used cut-points for MS to process data for time spent in moderate-to-vigorous physical activity, light physical activity, and sedentary behavior. Finally, patients completed the Short Physical Performance Battery (SPPB), the Six-Minute Walk Test, and the Timed 25-Foot Walk.
The median scores for time spent in moderate-to-vigorous physical activity and light physical activity were lower, and sedentary behavior was significantly greater, than those reported for older adults in the general population.
In addition, bivariate correlation analyses suggested that light physical activity and moderate to vigorous physical activity were associated with SPPB, Six-Minute Walk Test, and Timed 25-Foot Walk scores, but the association was stronger for light physical activity. Regression analyses yielded significant associations between light physical activity, but not moderate-to-vigorous physical activity or sedentary behavior, and SPPB, Six-Minute Walk Test, and Timed 25-Foot Walk scores.
NEW ORLEANS—Older adults with multiple sclerosis (MS) who engaged more in light physical activity demonstrated better physical function independent of sedentary behavior and moderate-to-vigorous activity, according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.
“Such results might underscore light physical activity as a suitable target of future rehabilitative interventions for improving physical function in older adults with MS,” said Katie L.J. Cederberg, a doctoral student at the University of Alabama at Birmingham.
Rate and pattern of participation in physical activity and sedentary behavior might be associated with a reduction of physical function among older adults with MS. Ms. Cederberg conducted a study that examined the associations among levels of light and moderate-to-vigorous physical activity, sedentary behavior, and physical function in older adults with MS.
Ms. Cederberg’s study sample included 40 older adults with MS with a median age of 60. Participants wore an accelerometer during the waking hours of a seven-day period. In addition, Ms. Cederberg used cut-points for MS to process data for time spent in moderate-to-vigorous physical activity, light physical activity, and sedentary behavior. Finally, patients completed the Short Physical Performance Battery (SPPB), the Six-Minute Walk Test, and the Timed 25-Foot Walk.
The median scores for time spent in moderate-to-vigorous physical activity and light physical activity were lower, and sedentary behavior was significantly greater, than those reported for older adults in the general population.
In addition, bivariate correlation analyses suggested that light physical activity and moderate to vigorous physical activity were associated with SPPB, Six-Minute Walk Test, and Timed 25-Foot Walk scores, but the association was stronger for light physical activity. Regression analyses yielded significant associations between light physical activity, but not moderate-to-vigorous physical activity or sedentary behavior, and SPPB, Six-Minute Walk Test, and Timed 25-Foot Walk scores.
FDA panel backs licensure for epoetin alfa biosimilar
A Food and Drug Administration advisory committee voted overwhelmingly in support of licensure for Epoetin Hospira as a biosimilar product to epoetin alfa (Epogen/Procrit) for all approved Epogen/Procrit indications.
Most committee members who voted “yes” said they were hesitant to do so, however, because of safety concerns, particularly in HIV and oncology patients.
“I voted yes. I came in with concerns about the HIV and oncology patients. However, I do believe ... after hearing the justification, that it meets the [FDA regulatory guideline],” said temporary voting member and patient representative Karen E. Arscott, DO, of the Commonwealth Medical College, Scranton, Penn. “I would like to see extensive follow-up in these two population groups,” she said.
The concerns about HIV and oncology patients are related to the potential for immunogenicity-related events. Some members noted that the study populations were likely too small to detect these rare events.
Scott A. Waldman, MD, of Thomas Jefferson University, Philadelphia, also a temporary member, said he voted “yes” because there was “no substantial difference analytically, biologically, or clinically in what was tested.”
“I think the residual uncertainty of immunogenicity and hypersensitivity and the extrapolation across different patient populations will emerge in postmarketing surveillance. I think that’s when we’ll get the clearest picture of whether there really is any uncertainty in how these drugs perform,” he said.
For one member, however, the concerns were enough for a “no” vote.
“The analytical, clinical, and preclinical data support biosimilarity, and I strongly support approval for indications 1 and 4 based on the clinical data ... but I have residual concerns about lack of data, immunogenicity, basic safety data in patients with HIV and cancer and, for that reason, voted no for the broader indication,” said Thomas S. Uldrick, MD, of the HIV & AIDS Malignancy Branch at the Center for Cancer Research, National Cancer Institute, Bethesda, Md.
Gregory J. Riely, MD, of Memorial Sloan-Kettering Cancer Center in New York expressed similar concerns but said he found the data compelling.
“I understand the concerns around immunogenicity for HIV and cancer patients. I was somewhat reassured by the nonclinical data showing an absence of increased immunogenicity for this biosimilar,” he said.
To support its BLA for Epoetin Hospira, Hospira submitted data from four studies comparing it with the U.S.-licensed Epogen/Procrit and presented an analytical biosimilarity assessment and a nonclinical, clinical pharmacology and clinical biosimilarity assessment. The FDA analysis of the data considered chemistry, manufacturing, and controls, as well as pharmacology/toxicology, immunogenicity, clinical pharmacology, and clinical efficacy and safety.
Sumant Ramachandra, MD, of Pfizer Essential Health noted that the company is not currently seeking an interchangeability designation and that, while this is the first application for a biosimilar product to Amgen’s Epogen/Procrit product, which was approved in 1989, a “highly related epoetin product” from Pfizer (Retacrit) has been available in Europe for 9 years, with more than 363,000 patient years of treatment administered.
The demonstration of biosimilarity in the Epoetin Hospira data presented to the FDA, coupled with well-characterized nature of the reference product, “together support extrapolation across all conditions of use for the reference product,” he said, noting that the data demonstrate that the mechanism of action for both the biosimilar and reference product is the same, and that the immunogenicity profiles are consistent.
The FDA assessment of the data led to a similar conclusion that no clinically significant differences were found between the biosimilar and reference product.
Among other concerns expressed by advisory committee members and/or the public were in regard to the extrapolation of data from patients with chronic kidney disease on hemodialysis to other indications (although this is considered acceptable, according to FDA regulations) and to populations that weren’t studied and about the possibility that Epoetin Hospira would be forced on patients inappropriately, despite the fact that Hospira is not seeking an interchangeability designation. Patients and others speaking on behalf of various patient groups and advocacy organizations called for safeguards against such inappropriate substitution.
Acting committee chair, Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Clinic, Ohio, said he voted “yes” because the product met all regulatory requirements but agreed that the “need for vigilance is exceedingly important not only for this drug but for all drugs in this circumstance.”
The FDA, which usually follows the recommendations of its advisory committees, will now consider the BLA for Epoetin Hospira.
In a statement released after the vote, Diem Nguyen, Pfizer Essential Health global president, Americas, said the committee’s recommendation for approval “reinforces the potential value of biosimilars in expanding access to additional high-quality treatment options for the patients in the U.S. who need them.”
The advisory committee members were screened and found to have no relevant conflicts of interest.
A Food and Drug Administration advisory committee voted overwhelmingly in support of licensure for Epoetin Hospira as a biosimilar product to epoetin alfa (Epogen/Procrit) for all approved Epogen/Procrit indications.
Most committee members who voted “yes” said they were hesitant to do so, however, because of safety concerns, particularly in HIV and oncology patients.
“I voted yes. I came in with concerns about the HIV and oncology patients. However, I do believe ... after hearing the justification, that it meets the [FDA regulatory guideline],” said temporary voting member and patient representative Karen E. Arscott, DO, of the Commonwealth Medical College, Scranton, Penn. “I would like to see extensive follow-up in these two population groups,” she said.
The concerns about HIV and oncology patients are related to the potential for immunogenicity-related events. Some members noted that the study populations were likely too small to detect these rare events.
Scott A. Waldman, MD, of Thomas Jefferson University, Philadelphia, also a temporary member, said he voted “yes” because there was “no substantial difference analytically, biologically, or clinically in what was tested.”
“I think the residual uncertainty of immunogenicity and hypersensitivity and the extrapolation across different patient populations will emerge in postmarketing surveillance. I think that’s when we’ll get the clearest picture of whether there really is any uncertainty in how these drugs perform,” he said.
For one member, however, the concerns were enough for a “no” vote.
“The analytical, clinical, and preclinical data support biosimilarity, and I strongly support approval for indications 1 and 4 based on the clinical data ... but I have residual concerns about lack of data, immunogenicity, basic safety data in patients with HIV and cancer and, for that reason, voted no for the broader indication,” said Thomas S. Uldrick, MD, of the HIV & AIDS Malignancy Branch at the Center for Cancer Research, National Cancer Institute, Bethesda, Md.
Gregory J. Riely, MD, of Memorial Sloan-Kettering Cancer Center in New York expressed similar concerns but said he found the data compelling.
“I understand the concerns around immunogenicity for HIV and cancer patients. I was somewhat reassured by the nonclinical data showing an absence of increased immunogenicity for this biosimilar,” he said.
To support its BLA for Epoetin Hospira, Hospira submitted data from four studies comparing it with the U.S.-licensed Epogen/Procrit and presented an analytical biosimilarity assessment and a nonclinical, clinical pharmacology and clinical biosimilarity assessment. The FDA analysis of the data considered chemistry, manufacturing, and controls, as well as pharmacology/toxicology, immunogenicity, clinical pharmacology, and clinical efficacy and safety.
Sumant Ramachandra, MD, of Pfizer Essential Health noted that the company is not currently seeking an interchangeability designation and that, while this is the first application for a biosimilar product to Amgen’s Epogen/Procrit product, which was approved in 1989, a “highly related epoetin product” from Pfizer (Retacrit) has been available in Europe for 9 years, with more than 363,000 patient years of treatment administered.
The demonstration of biosimilarity in the Epoetin Hospira data presented to the FDA, coupled with well-characterized nature of the reference product, “together support extrapolation across all conditions of use for the reference product,” he said, noting that the data demonstrate that the mechanism of action for both the biosimilar and reference product is the same, and that the immunogenicity profiles are consistent.
The FDA assessment of the data led to a similar conclusion that no clinically significant differences were found between the biosimilar and reference product.
Among other concerns expressed by advisory committee members and/or the public were in regard to the extrapolation of data from patients with chronic kidney disease on hemodialysis to other indications (although this is considered acceptable, according to FDA regulations) and to populations that weren’t studied and about the possibility that Epoetin Hospira would be forced on patients inappropriately, despite the fact that Hospira is not seeking an interchangeability designation. Patients and others speaking on behalf of various patient groups and advocacy organizations called for safeguards against such inappropriate substitution.
Acting committee chair, Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Clinic, Ohio, said he voted “yes” because the product met all regulatory requirements but agreed that the “need for vigilance is exceedingly important not only for this drug but for all drugs in this circumstance.”
The FDA, which usually follows the recommendations of its advisory committees, will now consider the BLA for Epoetin Hospira.
In a statement released after the vote, Diem Nguyen, Pfizer Essential Health global president, Americas, said the committee’s recommendation for approval “reinforces the potential value of biosimilars in expanding access to additional high-quality treatment options for the patients in the U.S. who need them.”
The advisory committee members were screened and found to have no relevant conflicts of interest.
A Food and Drug Administration advisory committee voted overwhelmingly in support of licensure for Epoetin Hospira as a biosimilar product to epoetin alfa (Epogen/Procrit) for all approved Epogen/Procrit indications.
Most committee members who voted “yes” said they were hesitant to do so, however, because of safety concerns, particularly in HIV and oncology patients.
“I voted yes. I came in with concerns about the HIV and oncology patients. However, I do believe ... after hearing the justification, that it meets the [FDA regulatory guideline],” said temporary voting member and patient representative Karen E. Arscott, DO, of the Commonwealth Medical College, Scranton, Penn. “I would like to see extensive follow-up in these two population groups,” she said.
The concerns about HIV and oncology patients are related to the potential for immunogenicity-related events. Some members noted that the study populations were likely too small to detect these rare events.
Scott A. Waldman, MD, of Thomas Jefferson University, Philadelphia, also a temporary member, said he voted “yes” because there was “no substantial difference analytically, biologically, or clinically in what was tested.”
“I think the residual uncertainty of immunogenicity and hypersensitivity and the extrapolation across different patient populations will emerge in postmarketing surveillance. I think that’s when we’ll get the clearest picture of whether there really is any uncertainty in how these drugs perform,” he said.
For one member, however, the concerns were enough for a “no” vote.
“The analytical, clinical, and preclinical data support biosimilarity, and I strongly support approval for indications 1 and 4 based on the clinical data ... but I have residual concerns about lack of data, immunogenicity, basic safety data in patients with HIV and cancer and, for that reason, voted no for the broader indication,” said Thomas S. Uldrick, MD, of the HIV & AIDS Malignancy Branch at the Center for Cancer Research, National Cancer Institute, Bethesda, Md.
Gregory J. Riely, MD, of Memorial Sloan-Kettering Cancer Center in New York expressed similar concerns but said he found the data compelling.
“I understand the concerns around immunogenicity for HIV and cancer patients. I was somewhat reassured by the nonclinical data showing an absence of increased immunogenicity for this biosimilar,” he said.
To support its BLA for Epoetin Hospira, Hospira submitted data from four studies comparing it with the U.S.-licensed Epogen/Procrit and presented an analytical biosimilarity assessment and a nonclinical, clinical pharmacology and clinical biosimilarity assessment. The FDA analysis of the data considered chemistry, manufacturing, and controls, as well as pharmacology/toxicology, immunogenicity, clinical pharmacology, and clinical efficacy and safety.
Sumant Ramachandra, MD, of Pfizer Essential Health noted that the company is not currently seeking an interchangeability designation and that, while this is the first application for a biosimilar product to Amgen’s Epogen/Procrit product, which was approved in 1989, a “highly related epoetin product” from Pfizer (Retacrit) has been available in Europe for 9 years, with more than 363,000 patient years of treatment administered.
The demonstration of biosimilarity in the Epoetin Hospira data presented to the FDA, coupled with well-characterized nature of the reference product, “together support extrapolation across all conditions of use for the reference product,” he said, noting that the data demonstrate that the mechanism of action for both the biosimilar and reference product is the same, and that the immunogenicity profiles are consistent.
The FDA assessment of the data led to a similar conclusion that no clinically significant differences were found between the biosimilar and reference product.
Among other concerns expressed by advisory committee members and/or the public were in regard to the extrapolation of data from patients with chronic kidney disease on hemodialysis to other indications (although this is considered acceptable, according to FDA regulations) and to populations that weren’t studied and about the possibility that Epoetin Hospira would be forced on patients inappropriately, despite the fact that Hospira is not seeking an interchangeability designation. Patients and others speaking on behalf of various patient groups and advocacy organizations called for safeguards against such inappropriate substitution.
Acting committee chair, Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Clinic, Ohio, said he voted “yes” because the product met all regulatory requirements but agreed that the “need for vigilance is exceedingly important not only for this drug but for all drugs in this circumstance.”
The FDA, which usually follows the recommendations of its advisory committees, will now consider the BLA for Epoetin Hospira.
In a statement released after the vote, Diem Nguyen, Pfizer Essential Health global president, Americas, said the committee’s recommendation for approval “reinforces the potential value of biosimilars in expanding access to additional high-quality treatment options for the patients in the U.S. who need them.”
The advisory committee members were screened and found to have no relevant conflicts of interest.
Key clinical point:
Major finding: The data demonstrate that the mechanism of action for both the biosimilar and reference product is the same, and that the immunogenicity profiles are consistent.
Data source: An FDA advisory committee review of epoetin alfa biosimilar Epoetin Hospira.
Disclosures: The advisory committee members were screened and found to have no relevant conflicts of interest.
Guideline May Enhance Conversations About SUDEP
A new guideline codeveloped by the American Academy of Neurology and the American Epilepsy Society is intended to aid clinicians as they counsel patients about SUDEP. The practice guideline, published in the April 25 issue of Neurology, provides information about SUDEP incidence in different epilepsy populations, data about risk factors, and recommendations for patient care.
“Our guideline brings clarity to the [SUDEP] discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk,” said Cynthia Harden, MD, Director of Epilepsy Services for the Mount Sinai Health System in New York City.
A panel of experts searched the MEDLINE and Embase databases from the earliest available article to November 2010. An identical search was performed in April 2015 for articles published since November 2010. The keywords for both searches were “SUDEP” and other traditional medical subheadings for epilepsy (eg, “epilepsy/abnormalities,” “epilepsy/drug effects,” or “epilepsy/therapy”).
After reviewing more than 1,000 abstracts, the panel selected 70 relevant articles. The team then conducted a systematic review and developed conclusions using the modified Grading Recommendations Assessment, Development, and Evaluation process. All recommendations were made by consensus.
Incidence rates were based on 12 Class I studies. The systematic review found that SUDEP affects one in 4,500 children with epilepsy per year. Based on these findings, the experts recommend that clinicians inform parents or guardians about this low risk of SUDEP in children (Level B). In addition, the panel recommends that clinicians inform adult patients about the small risk of SUDEP, which typically affects one in 1,000 adults with epilepsy annually (Level B).
The panel also found that generalized tonic-clonic seizures, which involve convulsions and loss of consciousness, are a major risk factor for SUDEP. In addition, they noted that patients who have three or more of these seizures per year have a 15-fold increased risk of SUDEP. To reduce this risk, clinicians are advised to manage epilepsy therapies actively in these patients to reduce seizures (Level B).
The guideline also recommends nocturnal supervision or other nocturnal precautions for patients who experience frequent generalized tonic-clonic seizures and nocturnal seizures (Level C). Furthermore, the presence of an additional person age 10 or older in the bedroom is associated with a decreased SUDEP risk. If individualized epilepsy and psychosocial circumstances permit, such a person should be present, said the panel. Providing nighttime observation might be overly burdensome or intrusive for some patients, the authors added.
Finally, clinicians are advised to inform patients that seizure freedom, especially freedom from generalized tonic-clonic seizures, is strongly associated with a decreased risk of SUDEP (Level B). The panel also analyzed other SUDEP risk factors (eg, lamotrigine use in women, heart rate variability, and male gender), but too little evidence was available to support recommendations.
“Research to identify preventable risk factors should be supported and encouraged so that future clinical trials will be conducted to reduce SUDEP occurrence,” said Dr. Harden.
—Erica Tricarico
Suggested Reading
Harden C, Tomson T, Gloss D, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88(17):1674-1680.
A new guideline codeveloped by the American Academy of Neurology and the American Epilepsy Society is intended to aid clinicians as they counsel patients about SUDEP. The practice guideline, published in the April 25 issue of Neurology, provides information about SUDEP incidence in different epilepsy populations, data about risk factors, and recommendations for patient care.
“Our guideline brings clarity to the [SUDEP] discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk,” said Cynthia Harden, MD, Director of Epilepsy Services for the Mount Sinai Health System in New York City.
A panel of experts searched the MEDLINE and Embase databases from the earliest available article to November 2010. An identical search was performed in April 2015 for articles published since November 2010. The keywords for both searches were “SUDEP” and other traditional medical subheadings for epilepsy (eg, “epilepsy/abnormalities,” “epilepsy/drug effects,” or “epilepsy/therapy”).
After reviewing more than 1,000 abstracts, the panel selected 70 relevant articles. The team then conducted a systematic review and developed conclusions using the modified Grading Recommendations Assessment, Development, and Evaluation process. All recommendations were made by consensus.
Incidence rates were based on 12 Class I studies. The systematic review found that SUDEP affects one in 4,500 children with epilepsy per year. Based on these findings, the experts recommend that clinicians inform parents or guardians about this low risk of SUDEP in children (Level B). In addition, the panel recommends that clinicians inform adult patients about the small risk of SUDEP, which typically affects one in 1,000 adults with epilepsy annually (Level B).
The panel also found that generalized tonic-clonic seizures, which involve convulsions and loss of consciousness, are a major risk factor for SUDEP. In addition, they noted that patients who have three or more of these seizures per year have a 15-fold increased risk of SUDEP. To reduce this risk, clinicians are advised to manage epilepsy therapies actively in these patients to reduce seizures (Level B).
The guideline also recommends nocturnal supervision or other nocturnal precautions for patients who experience frequent generalized tonic-clonic seizures and nocturnal seizures (Level C). Furthermore, the presence of an additional person age 10 or older in the bedroom is associated with a decreased SUDEP risk. If individualized epilepsy and psychosocial circumstances permit, such a person should be present, said the panel. Providing nighttime observation might be overly burdensome or intrusive for some patients, the authors added.
Finally, clinicians are advised to inform patients that seizure freedom, especially freedom from generalized tonic-clonic seizures, is strongly associated with a decreased risk of SUDEP (Level B). The panel also analyzed other SUDEP risk factors (eg, lamotrigine use in women, heart rate variability, and male gender), but too little evidence was available to support recommendations.
“Research to identify preventable risk factors should be supported and encouraged so that future clinical trials will be conducted to reduce SUDEP occurrence,” said Dr. Harden.
—Erica Tricarico
Suggested Reading
Harden C, Tomson T, Gloss D, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88(17):1674-1680.
A new guideline codeveloped by the American Academy of Neurology and the American Epilepsy Society is intended to aid clinicians as they counsel patients about SUDEP. The practice guideline, published in the April 25 issue of Neurology, provides information about SUDEP incidence in different epilepsy populations, data about risk factors, and recommendations for patient care.
“Our guideline brings clarity to the [SUDEP] discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk,” said Cynthia Harden, MD, Director of Epilepsy Services for the Mount Sinai Health System in New York City.
A panel of experts searched the MEDLINE and Embase databases from the earliest available article to November 2010. An identical search was performed in April 2015 for articles published since November 2010. The keywords for both searches were “SUDEP” and other traditional medical subheadings for epilepsy (eg, “epilepsy/abnormalities,” “epilepsy/drug effects,” or “epilepsy/therapy”).
After reviewing more than 1,000 abstracts, the panel selected 70 relevant articles. The team then conducted a systematic review and developed conclusions using the modified Grading Recommendations Assessment, Development, and Evaluation process. All recommendations were made by consensus.
Incidence rates were based on 12 Class I studies. The systematic review found that SUDEP affects one in 4,500 children with epilepsy per year. Based on these findings, the experts recommend that clinicians inform parents or guardians about this low risk of SUDEP in children (Level B). In addition, the panel recommends that clinicians inform adult patients about the small risk of SUDEP, which typically affects one in 1,000 adults with epilepsy annually (Level B).
The panel also found that generalized tonic-clonic seizures, which involve convulsions and loss of consciousness, are a major risk factor for SUDEP. In addition, they noted that patients who have three or more of these seizures per year have a 15-fold increased risk of SUDEP. To reduce this risk, clinicians are advised to manage epilepsy therapies actively in these patients to reduce seizures (Level B).
The guideline also recommends nocturnal supervision or other nocturnal precautions for patients who experience frequent generalized tonic-clonic seizures and nocturnal seizures (Level C). Furthermore, the presence of an additional person age 10 or older in the bedroom is associated with a decreased SUDEP risk. If individualized epilepsy and psychosocial circumstances permit, such a person should be present, said the panel. Providing nighttime observation might be overly burdensome or intrusive for some patients, the authors added.
Finally, clinicians are advised to inform patients that seizure freedom, especially freedom from generalized tonic-clonic seizures, is strongly associated with a decreased risk of SUDEP (Level B). The panel also analyzed other SUDEP risk factors (eg, lamotrigine use in women, heart rate variability, and male gender), but too little evidence was available to support recommendations.
“Research to identify preventable risk factors should be supported and encouraged so that future clinical trials will be conducted to reduce SUDEP occurrence,” said Dr. Harden.
—Erica Tricarico
Suggested Reading
Harden C, Tomson T, Gloss D, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88(17):1674-1680.
Number Needed to Treat Analyses Comparing Alemtuzumab With Ocrelizumab
NEW ORLEANS—Two-year analyses show that fewer patients required treatment with alemtuzumab than ocrelizumab to prevent one relapse, to prevent relapse in one patient, and to prevent six-month confirmed disability worsening in one patient versus subcutaneous interferon beta-1a, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers.
In the absence of head-to-head trials, researchers can use the number needed to treat to indirectly assess the comparative efficacy of disease-modifying therapies. Aaron L. Boster, MD, and colleagues analyzed the number needed to treat to prevent clinical disease events in studies of alemtuzumab and ocrelizumab in relapsing-remitting multiple sclerosis (MS). Dr. Boster is a clinical neuroimmunologist at the OhioHealth MS Clinic in Columbus.
Number needed to treat values were derived from post hoc analyses of two-year data from studies of alemtuzumab (12 mg) and ocrelizumab (600 mg). Alemtuzumab data were of pooled treatment-naive patients from the CAMMS223 and CARE-MS I studies (n = 786), and separately, patients with inadequate response to prior therapy from CARE-MS II (n = 628). Ocrelizumab data were derived from the OPERA I and II studies (n = 821 and n = 835, respectively). Alemtuzumab was administered as two annual courses; ocrelizumab was administered at baseline and weeks 24, 48, and 72. Number needed to treat was based on inverse of absolute risk differences versus subcutaneous interferon beta-1a 44 μg three times per week (common comparator) for annualized relapse rate and proportion of patients experiencing relapse, and the Altman method for six-month confirmed disability worsening. Lower number needed to treat values reflect greater efficacy.
Baseline mean Expanded Disability Status Scale (EDSS) scores were 2.0 for CAMMS223 and CARE-MS I, 2.7 for CARE-MS II, 2.9 for OPERA I, and 2.8 for OPERA II. Mean MS duration was 1.9 years in CAMMS223 and CARE-MS I, 4.5 years in CARE-MS II, and 6.7 years in OPERA I and II. Mean number of relapses in the previous two years was 2.5 for CAMMS223 and CARE-MS I, 2.8 for CARE-MS II, and 1.8 in OPERA I and II.
Alemtuzumab and ocrelizumab significantly reduced annualized relapse rates and confirmed disability worsening versus subcutaneous interferon beta-1a. Number needed to treat values to prevent one relapse versus subcutaneous interferon beta-1a were lower with alemtuzumab (CAMMS223/CARE-MS I: five; CARE-MS II: four) than with ocrelizumab (OPERA I/II: eight in each study), as were number needed to treat values to prevent one patient from experiencing relapse (CAMMS223/CARE-MS I and CARE-MS II: six in each study; OPERA I and II: eight in each study), and to prevent one patient from experiencing six-month confirmed disability worsening (CAMMS223/CARE-MS I: 15; CARE-MS II: 13; OPERA I: 23; OPERA II: 21).
Although the populations in the available datasets differ, these findings suggest a benefit of alemtuzumab over ocrelizumab.
This study was supported by Sanofi Genzyme.
NEW ORLEANS—Two-year analyses show that fewer patients required treatment with alemtuzumab than ocrelizumab to prevent one relapse, to prevent relapse in one patient, and to prevent six-month confirmed disability worsening in one patient versus subcutaneous interferon beta-1a, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers.
In the absence of head-to-head trials, researchers can use the number needed to treat to indirectly assess the comparative efficacy of disease-modifying therapies. Aaron L. Boster, MD, and colleagues analyzed the number needed to treat to prevent clinical disease events in studies of alemtuzumab and ocrelizumab in relapsing-remitting multiple sclerosis (MS). Dr. Boster is a clinical neuroimmunologist at the OhioHealth MS Clinic in Columbus.
Number needed to treat values were derived from post hoc analyses of two-year data from studies of alemtuzumab (12 mg) and ocrelizumab (600 mg). Alemtuzumab data were of pooled treatment-naive patients from the CAMMS223 and CARE-MS I studies (n = 786), and separately, patients with inadequate response to prior therapy from CARE-MS II (n = 628). Ocrelizumab data were derived from the OPERA I and II studies (n = 821 and n = 835, respectively). Alemtuzumab was administered as two annual courses; ocrelizumab was administered at baseline and weeks 24, 48, and 72. Number needed to treat was based on inverse of absolute risk differences versus subcutaneous interferon beta-1a 44 μg three times per week (common comparator) for annualized relapse rate and proportion of patients experiencing relapse, and the Altman method for six-month confirmed disability worsening. Lower number needed to treat values reflect greater efficacy.
Baseline mean Expanded Disability Status Scale (EDSS) scores were 2.0 for CAMMS223 and CARE-MS I, 2.7 for CARE-MS II, 2.9 for OPERA I, and 2.8 for OPERA II. Mean MS duration was 1.9 years in CAMMS223 and CARE-MS I, 4.5 years in CARE-MS II, and 6.7 years in OPERA I and II. Mean number of relapses in the previous two years was 2.5 for CAMMS223 and CARE-MS I, 2.8 for CARE-MS II, and 1.8 in OPERA I and II.
Alemtuzumab and ocrelizumab significantly reduced annualized relapse rates and confirmed disability worsening versus subcutaneous interferon beta-1a. Number needed to treat values to prevent one relapse versus subcutaneous interferon beta-1a were lower with alemtuzumab (CAMMS223/CARE-MS I: five; CARE-MS II: four) than with ocrelizumab (OPERA I/II: eight in each study), as were number needed to treat values to prevent one patient from experiencing relapse (CAMMS223/CARE-MS I and CARE-MS II: six in each study; OPERA I and II: eight in each study), and to prevent one patient from experiencing six-month confirmed disability worsening (CAMMS223/CARE-MS I: 15; CARE-MS II: 13; OPERA I: 23; OPERA II: 21).
Although the populations in the available datasets differ, these findings suggest a benefit of alemtuzumab over ocrelizumab.
This study was supported by Sanofi Genzyme.
NEW ORLEANS—Two-year analyses show that fewer patients required treatment with alemtuzumab than ocrelizumab to prevent one relapse, to prevent relapse in one patient, and to prevent six-month confirmed disability worsening in one patient versus subcutaneous interferon beta-1a, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers.
In the absence of head-to-head trials, researchers can use the number needed to treat to indirectly assess the comparative efficacy of disease-modifying therapies. Aaron L. Boster, MD, and colleagues analyzed the number needed to treat to prevent clinical disease events in studies of alemtuzumab and ocrelizumab in relapsing-remitting multiple sclerosis (MS). Dr. Boster is a clinical neuroimmunologist at the OhioHealth MS Clinic in Columbus.
Number needed to treat values were derived from post hoc analyses of two-year data from studies of alemtuzumab (12 mg) and ocrelizumab (600 mg). Alemtuzumab data were of pooled treatment-naive patients from the CAMMS223 and CARE-MS I studies (n = 786), and separately, patients with inadequate response to prior therapy from CARE-MS II (n = 628). Ocrelizumab data were derived from the OPERA I and II studies (n = 821 and n = 835, respectively). Alemtuzumab was administered as two annual courses; ocrelizumab was administered at baseline and weeks 24, 48, and 72. Number needed to treat was based on inverse of absolute risk differences versus subcutaneous interferon beta-1a 44 μg three times per week (common comparator) for annualized relapse rate and proportion of patients experiencing relapse, and the Altman method for six-month confirmed disability worsening. Lower number needed to treat values reflect greater efficacy.
Baseline mean Expanded Disability Status Scale (EDSS) scores were 2.0 for CAMMS223 and CARE-MS I, 2.7 for CARE-MS II, 2.9 for OPERA I, and 2.8 for OPERA II. Mean MS duration was 1.9 years in CAMMS223 and CARE-MS I, 4.5 years in CARE-MS II, and 6.7 years in OPERA I and II. Mean number of relapses in the previous two years was 2.5 for CAMMS223 and CARE-MS I, 2.8 for CARE-MS II, and 1.8 in OPERA I and II.
Alemtuzumab and ocrelizumab significantly reduced annualized relapse rates and confirmed disability worsening versus subcutaneous interferon beta-1a. Number needed to treat values to prevent one relapse versus subcutaneous interferon beta-1a were lower with alemtuzumab (CAMMS223/CARE-MS I: five; CARE-MS II: four) than with ocrelizumab (OPERA I/II: eight in each study), as were number needed to treat values to prevent one patient from experiencing relapse (CAMMS223/CARE-MS I and CARE-MS II: six in each study; OPERA I and II: eight in each study), and to prevent one patient from experiencing six-month confirmed disability worsening (CAMMS223/CARE-MS I: 15; CARE-MS II: 13; OPERA I: 23; OPERA II: 21).
Although the populations in the available datasets differ, these findings suggest a benefit of alemtuzumab over ocrelizumab.
This study was supported by Sanofi Genzyme.