MS clinic thrives by making regular care a ‘loss leader’

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– Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.

“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics. “The model of the fee-based reimbursement just doesn’t work with MS because comprehensive care has to be supported by a variety of resources.”

Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”

The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”

To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”

Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.

Mr. Smith discloses a consulting fee from Novartis.

Watch the interview to learn more about the center’s efforts.

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The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.

“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics. “The model of the fee-based reimbursement just doesn’t work with MS because comprehensive care has to be supported by a variety of resources.”

Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”

The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”

To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”

Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.

Mr. Smith discloses a consulting fee from Novartis.

Watch the interview to learn more about the center’s efforts.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Care for MS patients is expensive, and even non-profit treatment centers can’t survive on reimbursements alone. The solution, according to Terry Smith, CEO of the Multiple Sclerosis Center of Atlanta, is to transform regular care into a “loss leader” and embrace other revenue sources.

“The reimbursements for that 20- minute or 30-minute follow-up just really don’t cover all the resources necessary for comprehensive care,” Mr. Smith said in a video interview at the 2018 annual meeting of the Consortium of Multiple Sclerosis Clinics. “The model of the fee-based reimbursement just doesn’t work with MS because comprehensive care has to be supported by a variety of resources.”

Mr. Smith said his involvement in the MS community was sparked about 2 decades ago when his wife developed the condition. “I have seen what the center gets reimbursed for her office visit, and then what her neurologist gets reimbursed.”

The reimbursement for an MS patient’s follow-up, 25-minute appointment with a physician is $104.25, according to Mr. Smith. Yet these MS visits are “the cornerstone of treatment ... set the tone for how successful the care is.”

To make make up for losses, the Atlanta center has begun offering its own ancillary services. “Our doctors are at the forefront of telling patients we have a group of neurologists that handle both emergent as well as non-emergent neurology,” he said. “That offers a revenue stream beyond the patient encounter.”

Other sources include imaging and an infusion clinic managed for a local hospital through a professional service agreement. The Atlanta center also has created its own specialty pharmacy focused on MS. “We buy disease-modifying drugs, develop personal contact with patients on a regular basis, then develop an ongoing compliance-monitoring program,” he said.

Mr. Smith discloses a consulting fee from Novartis.

Watch the interview to learn more about the center’s efforts.

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Metastatic colorectal cancer chemo costs double in Washington vs. British Columbia

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First-line systemic therapy for metastatic colorectal cancer costs twice as much in western Washington state as it does just across the border in British Columbia, Canada, but the more costly therapy does not net better survival, finds a cohort study reported at the annual meeting of the American Society of Clinical Oncology.

Differences between the United States and Canada in health care systems are well established, with a multipayer mix of private and public insurers in the former, and a single-payer, universal, public system in the latter, lead study author Todd Yezefski, MD, a senior fellow at the Fred Hutchinson Cancer Research Center in Seattle and the University of Washington School of Medicine, noted in a press briefing.

“Several studies have shown that overall health care utilization and costs in the U.S. are higher than in Canada. However, outcomes are generally similar, if not worse, in the U.S.,” he commented. “There have really been few studies, though, that have looked at treatment patterns, costs, and outcomes associated with a specific disease such as colorectal cancer.”

Results of the study of 2,197 patients with newly diagnosed metastatic colorectal cancer showed that the monthly cost for first-line systemic therapy exceeded $12,000 in western Washington state (excluding Medicare beneficiaries), compared with about $6,000 in British Columbia, even though the leading regimen in the latter region contained a targeted therapy. At the same time, median overall survival for patients given systemic therapy was essentially the same, approaching 2 years.

“Despite significantly higher costs, patients in western Washington didn’t do any better than those in British Columbia. Another way of saying this is they got the same bang for more buck,” Dr. Yezefski summarized. “Drug prices in Canada are generally set by the government. In the United States, we believe that if Medicare is allowed to negotiate drug prices with pharmaceutical companies, drug prices can be lower, and private insurers will oftentimes follow suit.”

In future work, the investigators plan to repeat analyses after including Medicare patients in the western Washington cohort (likely rendering the two groups more comparable) and to assess other aspects of health care utilization, such as total duration of chemotherapy, hospital use, radiation therapy, and surgery.

Dr. Robert Schilsky

“The United States is probably the only country in the world where we actually have no real way of constraining the cost of health care. Certainly, that pertains to the cost of drugs,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and moderator of the press briefing. The U.S. Food and Drug Administration considers only the safety and efficacy of drugs when deciding whether they should be allowed on the market, he noted. “Once they are on the market, Medicare is generally required by law to pay for the cost of drugs, and the private insurers typically follow suit. So there really is no way to put any brakes on the system, which is not the case in most other health care systems in the world.” Other countries generally have a second agency or appointed body that performs some type of value assessment to determine whether the health care system can actually afford to offer the drug to the population. “That, of course, is a hypothesized reason for why, in Canada, you can get what would generally be considered a very expensive treatment regimen in the U.S. at half the cost of what it takes to deliver a similar regimen in the U.S. and still get equivalent outcomes,” Dr. Schilsky said.

 

 

For the study, Dr. Yezefski and colleagues identified patients with metastatic colorectal cancer newly diagnosed in 2010 or later in the regional database linking western Washington Surveillance, Epidemiology and End Results (SEER) data to claims from two large commercial insurers, and in the BC Cancer Agency database. Analyses were based on data from 575 patients in western Washington and 1,622 similar patients in British Columbia. Median age was 60 years in the former group and 66 years in the latter.

The rate of receipt of first-line systemic therapy was higher among the western Washington group than among the British Columbia group (79% vs. 68%, P less than.01), possibly because they were younger, Dr. Yezefski speculated. The most common regimen given to the former was FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) chemotherapy (39%), whereas the most common given to the latter was FOLFIRI (irinotecan, 5-fluorouracil, and folinic acid) chemotherapy with bevacizumab (Avastin) (32%).

The mean monthly per-patient cost of first-line systemic therapy was $12,345 in western Washington, roughly double the $6,195 in British Columbia (P less than .01). Mean lifetime monthly systemic therapy costs were also higher in the former region ($7,883 vs. $4,830, P less than .01). However, median overall survival between the two regions was essentially the same, both among patients who received systemic therapy (21.4 vs. 22.1 months) and among all patients (17.4 vs. 16.9 months). Dr. Yezefski disclosed that he had no relevant conflicts of interest.

The study received funding from the Fred Hutchinson Cancer Research Center and BC Cancer Agency.

SOURCE: Yezefski et al., abstract LBA3579, https://am.asco.org/abstracts.

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First-line systemic therapy for metastatic colorectal cancer costs twice as much in western Washington state as it does just across the border in British Columbia, Canada, but the more costly therapy does not net better survival, finds a cohort study reported at the annual meeting of the American Society of Clinical Oncology.

Differences between the United States and Canada in health care systems are well established, with a multipayer mix of private and public insurers in the former, and a single-payer, universal, public system in the latter, lead study author Todd Yezefski, MD, a senior fellow at the Fred Hutchinson Cancer Research Center in Seattle and the University of Washington School of Medicine, noted in a press briefing.

“Several studies have shown that overall health care utilization and costs in the U.S. are higher than in Canada. However, outcomes are generally similar, if not worse, in the U.S.,” he commented. “There have really been few studies, though, that have looked at treatment patterns, costs, and outcomes associated with a specific disease such as colorectal cancer.”

Results of the study of 2,197 patients with newly diagnosed metastatic colorectal cancer showed that the monthly cost for first-line systemic therapy exceeded $12,000 in western Washington state (excluding Medicare beneficiaries), compared with about $6,000 in British Columbia, even though the leading regimen in the latter region contained a targeted therapy. At the same time, median overall survival for patients given systemic therapy was essentially the same, approaching 2 years.

“Despite significantly higher costs, patients in western Washington didn’t do any better than those in British Columbia. Another way of saying this is they got the same bang for more buck,” Dr. Yezefski summarized. “Drug prices in Canada are generally set by the government. In the United States, we believe that if Medicare is allowed to negotiate drug prices with pharmaceutical companies, drug prices can be lower, and private insurers will oftentimes follow suit.”

In future work, the investigators plan to repeat analyses after including Medicare patients in the western Washington cohort (likely rendering the two groups more comparable) and to assess other aspects of health care utilization, such as total duration of chemotherapy, hospital use, radiation therapy, and surgery.

Dr. Robert Schilsky

“The United States is probably the only country in the world where we actually have no real way of constraining the cost of health care. Certainly, that pertains to the cost of drugs,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and moderator of the press briefing. The U.S. Food and Drug Administration considers only the safety and efficacy of drugs when deciding whether they should be allowed on the market, he noted. “Once they are on the market, Medicare is generally required by law to pay for the cost of drugs, and the private insurers typically follow suit. So there really is no way to put any brakes on the system, which is not the case in most other health care systems in the world.” Other countries generally have a second agency or appointed body that performs some type of value assessment to determine whether the health care system can actually afford to offer the drug to the population. “That, of course, is a hypothesized reason for why, in Canada, you can get what would generally be considered a very expensive treatment regimen in the U.S. at half the cost of what it takes to deliver a similar regimen in the U.S. and still get equivalent outcomes,” Dr. Schilsky said.

 

 

For the study, Dr. Yezefski and colleagues identified patients with metastatic colorectal cancer newly diagnosed in 2010 or later in the regional database linking western Washington Surveillance, Epidemiology and End Results (SEER) data to claims from two large commercial insurers, and in the BC Cancer Agency database. Analyses were based on data from 575 patients in western Washington and 1,622 similar patients in British Columbia. Median age was 60 years in the former group and 66 years in the latter.

The rate of receipt of first-line systemic therapy was higher among the western Washington group than among the British Columbia group (79% vs. 68%, P less than.01), possibly because they were younger, Dr. Yezefski speculated. The most common regimen given to the former was FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) chemotherapy (39%), whereas the most common given to the latter was FOLFIRI (irinotecan, 5-fluorouracil, and folinic acid) chemotherapy with bevacizumab (Avastin) (32%).

The mean monthly per-patient cost of first-line systemic therapy was $12,345 in western Washington, roughly double the $6,195 in British Columbia (P less than .01). Mean lifetime monthly systemic therapy costs were also higher in the former region ($7,883 vs. $4,830, P less than .01). However, median overall survival between the two regions was essentially the same, both among patients who received systemic therapy (21.4 vs. 22.1 months) and among all patients (17.4 vs. 16.9 months). Dr. Yezefski disclosed that he had no relevant conflicts of interest.

The study received funding from the Fred Hutchinson Cancer Research Center and BC Cancer Agency.

SOURCE: Yezefski et al., abstract LBA3579, https://am.asco.org/abstracts.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

First-line systemic therapy for metastatic colorectal cancer costs twice as much in western Washington state as it does just across the border in British Columbia, Canada, but the more costly therapy does not net better survival, finds a cohort study reported at the annual meeting of the American Society of Clinical Oncology.

Differences between the United States and Canada in health care systems are well established, with a multipayer mix of private and public insurers in the former, and a single-payer, universal, public system in the latter, lead study author Todd Yezefski, MD, a senior fellow at the Fred Hutchinson Cancer Research Center in Seattle and the University of Washington School of Medicine, noted in a press briefing.

“Several studies have shown that overall health care utilization and costs in the U.S. are higher than in Canada. However, outcomes are generally similar, if not worse, in the U.S.,” he commented. “There have really been few studies, though, that have looked at treatment patterns, costs, and outcomes associated with a specific disease such as colorectal cancer.”

Results of the study of 2,197 patients with newly diagnosed metastatic colorectal cancer showed that the monthly cost for first-line systemic therapy exceeded $12,000 in western Washington state (excluding Medicare beneficiaries), compared with about $6,000 in British Columbia, even though the leading regimen in the latter region contained a targeted therapy. At the same time, median overall survival for patients given systemic therapy was essentially the same, approaching 2 years.

“Despite significantly higher costs, patients in western Washington didn’t do any better than those in British Columbia. Another way of saying this is they got the same bang for more buck,” Dr. Yezefski summarized. “Drug prices in Canada are generally set by the government. In the United States, we believe that if Medicare is allowed to negotiate drug prices with pharmaceutical companies, drug prices can be lower, and private insurers will oftentimes follow suit.”

In future work, the investigators plan to repeat analyses after including Medicare patients in the western Washington cohort (likely rendering the two groups more comparable) and to assess other aspects of health care utilization, such as total duration of chemotherapy, hospital use, radiation therapy, and surgery.

Dr. Robert Schilsky

“The United States is probably the only country in the world where we actually have no real way of constraining the cost of health care. Certainly, that pertains to the cost of drugs,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and moderator of the press briefing. The U.S. Food and Drug Administration considers only the safety and efficacy of drugs when deciding whether they should be allowed on the market, he noted. “Once they are on the market, Medicare is generally required by law to pay for the cost of drugs, and the private insurers typically follow suit. So there really is no way to put any brakes on the system, which is not the case in most other health care systems in the world.” Other countries generally have a second agency or appointed body that performs some type of value assessment to determine whether the health care system can actually afford to offer the drug to the population. “That, of course, is a hypothesized reason for why, in Canada, you can get what would generally be considered a very expensive treatment regimen in the U.S. at half the cost of what it takes to deliver a similar regimen in the U.S. and still get equivalent outcomes,” Dr. Schilsky said.

 

 

For the study, Dr. Yezefski and colleagues identified patients with metastatic colorectal cancer newly diagnosed in 2010 or later in the regional database linking western Washington Surveillance, Epidemiology and End Results (SEER) data to claims from two large commercial insurers, and in the BC Cancer Agency database. Analyses were based on data from 575 patients in western Washington and 1,622 similar patients in British Columbia. Median age was 60 years in the former group and 66 years in the latter.

The rate of receipt of first-line systemic therapy was higher among the western Washington group than among the British Columbia group (79% vs. 68%, P less than.01), possibly because they were younger, Dr. Yezefski speculated. The most common regimen given to the former was FOLFOX (oxaliplatin, 5-fluorouracil, and folinic acid) chemotherapy (39%), whereas the most common given to the latter was FOLFIRI (irinotecan, 5-fluorouracil, and folinic acid) chemotherapy with bevacizumab (Avastin) (32%).

The mean monthly per-patient cost of first-line systemic therapy was $12,345 in western Washington, roughly double the $6,195 in British Columbia (P less than .01). Mean lifetime monthly systemic therapy costs were also higher in the former region ($7,883 vs. $4,830, P less than .01). However, median overall survival between the two regions was essentially the same, both among patients who received systemic therapy (21.4 vs. 22.1 months) and among all patients (17.4 vs. 16.9 months). Dr. Yezefski disclosed that he had no relevant conflicts of interest.

The study received funding from the Fred Hutchinson Cancer Research Center and BC Cancer Agency.

SOURCE: Yezefski et al., abstract LBA3579, https://am.asco.org/abstracts.

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Key clinical point: The higher cost for metastatic CRC systemic therapy in the United States versus Canada does not translate to better survival. 

Major finding: Monthly cost of first-line systemic therapy was $12,345 in western Washington vs. $6,195 in British Columbia (P less than .01), but median overall survival was statistically indistinguishable (21.4 vs. 22.1 months).

Study details: A cohort study of 2,197 patients with newly diagnosed metastatic CRC from a regional database linking western Washington SEER to claims from two large commercial insurers and from the BC (British Columbia) Cancer Agency database. 

Disclosures: Dr. Yezefski disclosed that he had no relevant conflicts of interest. The study received funding from the Fred Hutchinson Cancer Research Center and the BC Cancer Agency.

Source: Yezefski et al. Abstract LBA3579. 

 

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Geriatric assessments enhance patient care in advanced cancer

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CHICAGO – Adding routine geriatric assessment to cancer care in older patients with advanced malignancies resulted in significant improvements in doctor-patient communication about issues related to aging, and boosted patient satisfaction, results of a randomized trial show.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.

Dr. Mohile had no relevant financial disclosures.






 

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CHICAGO – Adding routine geriatric assessment to cancer care in older patients with advanced malignancies resulted in significant improvements in doctor-patient communication about issues related to aging, and boosted patient satisfaction, results of a randomized trial show.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.

Dr. Mohile had no relevant financial disclosures.






 

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

CHICAGO – Adding routine geriatric assessment to cancer care in older patients with advanced malignancies resulted in significant improvements in doctor-patient communication about issues related to aging, and boosted patient satisfaction, results of a randomized trial show.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.

Dr. Mohile had no relevant financial disclosures.






 

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Stronger abiraterone response in mCRPC seen in black men

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CHICAGO – Results of a prospective clinical trial in 100 men with metastatic castration-resistant prostate cancer (mCRPC) showed that black men were more likely to have a decline in prostate-specific antigen (PSA) and a longer median time to PSA rise in response to treatment with abiraterone (Zytiga) than white men receiving the same treatment (16.8 vs. 11.5 months).

The findings support earlier evidence indicating a stronger response to abiraterone among African Americans compared with Caucasians and suggest that at least some of the observed racial disparities in prostate cancer outcomes could be explained by genetic differences, according to lead study author Daniel George, MD, from Duke University in Durham, N.C.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Dr. George discusses the study findings, as well as issues surrounding the problems of recruiting African Americans for clinical trials and ensuring access to the standard of advanced prostate cancer care for all patients.

Dr. George disclosed consulting or advisory roles and research funding from numerous pharmaceutical companies.

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CHICAGO – Results of a prospective clinical trial in 100 men with metastatic castration-resistant prostate cancer (mCRPC) showed that black men were more likely to have a decline in prostate-specific antigen (PSA) and a longer median time to PSA rise in response to treatment with abiraterone (Zytiga) than white men receiving the same treatment (16.8 vs. 11.5 months).

The findings support earlier evidence indicating a stronger response to abiraterone among African Americans compared with Caucasians and suggest that at least some of the observed racial disparities in prostate cancer outcomes could be explained by genetic differences, according to lead study author Daniel George, MD, from Duke University in Durham, N.C.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Dr. George discusses the study findings, as well as issues surrounding the problems of recruiting African Americans for clinical trials and ensuring access to the standard of advanced prostate cancer care for all patients.

Dr. George disclosed consulting or advisory roles and research funding from numerous pharmaceutical companies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

CHICAGO – Results of a prospective clinical trial in 100 men with metastatic castration-resistant prostate cancer (mCRPC) showed that black men were more likely to have a decline in prostate-specific antigen (PSA) and a longer median time to PSA rise in response to treatment with abiraterone (Zytiga) than white men receiving the same treatment (16.8 vs. 11.5 months).

The findings support earlier evidence indicating a stronger response to abiraterone among African Americans compared with Caucasians and suggest that at least some of the observed racial disparities in prostate cancer outcomes could be explained by genetic differences, according to lead study author Daniel George, MD, from Duke University in Durham, N.C.

In this video interview from the annual meeting of the American Society of Clinical Oncology, Dr. George discusses the study findings, as well as issues surrounding the problems of recruiting African Americans for clinical trials and ensuring access to the standard of advanced prostate cancer care for all patients.

Dr. George disclosed consulting or advisory roles and research funding from numerous pharmaceutical companies.

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Head and neck cancers: Women less commonly receive intensive chemo

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– Women with head and neck cancer less commonly receive intensive chemotherapy (35% vs. 46%) and radiation therapy (60% vs. 70%) than do their male counterparts, finds an analysis of 223 female patients and 661 male patients with stage II-IVB disease treated at Kaiser Permanente Northern California. And this apparent undertreatment may be compromising survival for women, as their ratio of cancer deaths to other deaths is nearly twice that of men (adjusted relative hazard ratio, 1.92; 95% CI, 1.07-3.43).

In this video interview from the annual meeting of the American Society of Clinical Oncology, senior study author Jed A. Katzel, MD, of Kaiser Permanente in Santa Clara, Calif., described the new statistical approach used to assess outcomes and discussed ongoing research to pin down the reasons for the apparent treatment disparities, including patient preferences and the influences of tumor site and HPV status.

Dr. Katzel reported no financial disclosures.

 

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– Women with head and neck cancer less commonly receive intensive chemotherapy (35% vs. 46%) and radiation therapy (60% vs. 70%) than do their male counterparts, finds an analysis of 223 female patients and 661 male patients with stage II-IVB disease treated at Kaiser Permanente Northern California. And this apparent undertreatment may be compromising survival for women, as their ratio of cancer deaths to other deaths is nearly twice that of men (adjusted relative hazard ratio, 1.92; 95% CI, 1.07-3.43).

In this video interview from the annual meeting of the American Society of Clinical Oncology, senior study author Jed A. Katzel, MD, of Kaiser Permanente in Santa Clara, Calif., described the new statistical approach used to assess outcomes and discussed ongoing research to pin down the reasons for the apparent treatment disparities, including patient preferences and the influences of tumor site and HPV status.

Dr. Katzel reported no financial disclosures.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Women with head and neck cancer less commonly receive intensive chemotherapy (35% vs. 46%) and radiation therapy (60% vs. 70%) than do their male counterparts, finds an analysis of 223 female patients and 661 male patients with stage II-IVB disease treated at Kaiser Permanente Northern California. And this apparent undertreatment may be compromising survival for women, as their ratio of cancer deaths to other deaths is nearly twice that of men (adjusted relative hazard ratio, 1.92; 95% CI, 1.07-3.43).

In this video interview from the annual meeting of the American Society of Clinical Oncology, senior study author Jed A. Katzel, MD, of Kaiser Permanente in Santa Clara, Calif., described the new statistical approach used to assess outcomes and discussed ongoing research to pin down the reasons for the apparent treatment disparities, including patient preferences and the influences of tumor site and HPV status.

Dr. Katzel reported no financial disclosures.

 

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New guidelines for gadolinium-based contrast agents take conservative stance

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– Gadolinium-based contrast agents (GBCAs) are necessary for the accurate initial diagnosis of patients experiencing a first clinical attack of symptoms consistent with multiple sclerosis and for following patients with highly active disease or sudden, unexpected declines.

But according to new guidelines issued by the Consortium of Multiple Sclerosis Centers, GBCAs are optional – although helpful – in many other clinical scenarios, especially when noncontrast MRI can provide answers.

“The key is that there is an optional role for gadolinium,” David Li, MD, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. Although a GBCA is still “essential” for some clinical scenarios in clinically isolated syndrome and MS, the new guidelines suggest that standard, high-quality MRI without contrast can adequately identify the majority of new MS lesions over time.

“But I would like to remind you that if you need to know about ongoing, current activity,” in settings of acute change, then gadolinium is still necessary, Dr. Li of the University of British Columbia, Vancouver, said in a video interview.

The guideline is an update of CMSC’s 2015 document, which endorsed a more liberal use of GBCAs. This more conservative stance reflects new research on the agents and an update in 2017 from the Food and Drug Administration that required a class-wide warning about gadolinium retention.

The agency began investigating gadolinium in 2015. In May 2017, it issued a statement confirming that gadolinium accumulates in neural tissue and can be retained for an extended period. However, in reviewing the evidence, FDA found no concerning safety signals. Despite the presumed lack of toxicity, the agency issued the warning and recommended limiting the contrast agent’s use – a move reflected in CMSC’s new MRI protocol guidelines.

“While there is no known CNS toxicity, these agents should be used judiciously, recognizing that gadolinium continues to play an invaluable role in specific circumstances related to the diagnosis and follow-up of individuals with MS,” the document notes.

 

 


Dr. Li concurred.

“It remains indispensable in patients presenting with their first clinical attack (CIS) as [its] use allows for an earlier diagnosis by demonstrating lesion dissemination in time in addition to lesion dissemination in space, the hallmarks for the diagnosis of MS. Early diagnosis leads to early treatment, which may help in preventing disease progression and improve long-term prognosis.”

Dr. Li has received multiple drug company grants and acted as a consultant to multiple pharmaceutical companies, but had no disclosures relevant to gadolinium.
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– Gadolinium-based contrast agents (GBCAs) are necessary for the accurate initial diagnosis of patients experiencing a first clinical attack of symptoms consistent with multiple sclerosis and for following patients with highly active disease or sudden, unexpected declines.

But according to new guidelines issued by the Consortium of Multiple Sclerosis Centers, GBCAs are optional – although helpful – in many other clinical scenarios, especially when noncontrast MRI can provide answers.

“The key is that there is an optional role for gadolinium,” David Li, MD, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. Although a GBCA is still “essential” for some clinical scenarios in clinically isolated syndrome and MS, the new guidelines suggest that standard, high-quality MRI without contrast can adequately identify the majority of new MS lesions over time.

“But I would like to remind you that if you need to know about ongoing, current activity,” in settings of acute change, then gadolinium is still necessary, Dr. Li of the University of British Columbia, Vancouver, said in a video interview.

The guideline is an update of CMSC’s 2015 document, which endorsed a more liberal use of GBCAs. This more conservative stance reflects new research on the agents and an update in 2017 from the Food and Drug Administration that required a class-wide warning about gadolinium retention.

The agency began investigating gadolinium in 2015. In May 2017, it issued a statement confirming that gadolinium accumulates in neural tissue and can be retained for an extended period. However, in reviewing the evidence, FDA found no concerning safety signals. Despite the presumed lack of toxicity, the agency issued the warning and recommended limiting the contrast agent’s use – a move reflected in CMSC’s new MRI protocol guidelines.

“While there is no known CNS toxicity, these agents should be used judiciously, recognizing that gadolinium continues to play an invaluable role in specific circumstances related to the diagnosis and follow-up of individuals with MS,” the document notes.

 

 


Dr. Li concurred.

“It remains indispensable in patients presenting with their first clinical attack (CIS) as [its] use allows for an earlier diagnosis by demonstrating lesion dissemination in time in addition to lesion dissemination in space, the hallmarks for the diagnosis of MS. Early diagnosis leads to early treatment, which may help in preventing disease progression and improve long-term prognosis.”

Dr. Li has received multiple drug company grants and acted as a consultant to multiple pharmaceutical companies, but had no disclosures relevant to gadolinium.

– Gadolinium-based contrast agents (GBCAs) are necessary for the accurate initial diagnosis of patients experiencing a first clinical attack of symptoms consistent with multiple sclerosis and for following patients with highly active disease or sudden, unexpected declines.

But according to new guidelines issued by the Consortium of Multiple Sclerosis Centers, GBCAs are optional – although helpful – in many other clinical scenarios, especially when noncontrast MRI can provide answers.

“The key is that there is an optional role for gadolinium,” David Li, MD, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. Although a GBCA is still “essential” for some clinical scenarios in clinically isolated syndrome and MS, the new guidelines suggest that standard, high-quality MRI without contrast can adequately identify the majority of new MS lesions over time.

“But I would like to remind you that if you need to know about ongoing, current activity,” in settings of acute change, then gadolinium is still necessary, Dr. Li of the University of British Columbia, Vancouver, said in a video interview.

The guideline is an update of CMSC’s 2015 document, which endorsed a more liberal use of GBCAs. This more conservative stance reflects new research on the agents and an update in 2017 from the Food and Drug Administration that required a class-wide warning about gadolinium retention.

The agency began investigating gadolinium in 2015. In May 2017, it issued a statement confirming that gadolinium accumulates in neural tissue and can be retained for an extended period. However, in reviewing the evidence, FDA found no concerning safety signals. Despite the presumed lack of toxicity, the agency issued the warning and recommended limiting the contrast agent’s use – a move reflected in CMSC’s new MRI protocol guidelines.

“While there is no known CNS toxicity, these agents should be used judiciously, recognizing that gadolinium continues to play an invaluable role in specific circumstances related to the diagnosis and follow-up of individuals with MS,” the document notes.

 

 


Dr. Li concurred.

“It remains indispensable in patients presenting with their first clinical attack (CIS) as [its] use allows for an earlier diagnosis by demonstrating lesion dissemination in time in addition to lesion dissemination in space, the hallmarks for the diagnosis of MS. Early diagnosis leads to early treatment, which may help in preventing disease progression and improve long-term prognosis.”

Dr. Li has received multiple drug company grants and acted as a consultant to multiple pharmaceutical companies, but had no disclosures relevant to gadolinium.
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VIDEO: PML prevention is possible, even when treating patients with aggressive MS

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– Armed with new statistics, neurologist Joseph R. Berger, MD, has a message for colleagues about the widely feared risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis: It’s not as inevitable as you might think.

“You can actually prevent this disease from occurring because we have risk-limiting strategies in many circumstances,” said Dr. Berger of the University of Pennsylvania, Philadelphia, in a presentation on PML at the annual meeting of the Consortium of Multiple Sclerosis Centers.


Unlike other conditions such as HIV, MS itself is not linked to a higher risk of PML, said Dr. Berger, a leading PML researcher. Instead, it’s the medications that spark the condition, he said, with at least three and possibly four drugs posing a risk to patients.

Natalizumab (Tysabri) is especially risky. “We know that the risk with natalizumab is incredibly high in the context of JC [John Cunningham] virus antibody positivity and prolonged therapy,” Dr. Berger said in an interview after his presentation.

Still, “you can safely give natalizumab for a short period of time when treating patients with aggressive MS,” he said. “I will frequently employ that strategy even in the context of JC virus antibody positivity.”

According to Dr. Berger, there’s no risk of PML when natalizumab is used for under 8 months (Mult Scler Relat Disord. 2017 Feb;12:59-63).

However, “if you leave people on the drug indefinitely, there is a substantial risk of developing PML,” he said. “Individuals who have been left on the drug for 2 years, who’ve seen prior immunosuppressant therapy, who are JC virus antibody positive – that group of individuals develops PML at rates of 1 in 50 to 1 in 100.”

 

 


These levels are “enormous,” he said, higher even than those in the HIV population before the rise of antiretroviral medications.

Overall, as of Nov. 30, 2017, 177,800 patients have received natalizumab in the postmarketing setting, and 756 cases of PML have been reported as of Dec. 7, 2017. All but three of those cases were in patients with MS, and the overall incidence was 4.19/1,000.

Dr. Berger recommends regular screening MRIs for PML in patients taking natalizumab, and he advised physicians to be on alert for signs of trouble like the appearance of new neurologic symptoms or a new or increasing JC virus antibody index.

Two other MS drugs, fingolimod (Gilenya) and dimethyl fumarate (Tecfidera), fall into the category of low risk, with just 19 and 5 reported cases, respectively, as of February 2018, Dr. Berger said. He added that two of the fingolimod patients had earlier exposure to natalizumab.
 

 


With dimethyl fumarate, the risk appears to disappear – although this isn’t confirmed – when JC antibody–positive patients are taken off the drug, and their lymphocyte counts fall below 500 per mcL, Dr. Berger said.

“Unfortunately for fingolimod, we don’t have a defined risk-mitigation strategy,” he said. However, researchers have noticed that the fingolimod cases have occurred more often in older people, possibly because of the aging of the immune system, he said.

Another three MS drugs – alemtuzumab (Lemtrada), ocrelizumab (Ocrevus; with rituximab as proxy), and teriflunomide (Aubagio; with leflunomide as proxy) have unknown risk, according to Dr. Berger. There have been three cases in ocrelizumab (rituximab as proxy) and one in teriflunomide (leflunomide as proxy), but all were carry-overs from natalizumab or fingolimod exposure or occurred after natalizumab exposure.

What can physicians do if a patient develops PML? Stopping the drug and restoring the immune system is crucial, he said.
 

 


While there’s evidence that plasma exchange clears natalizumab (Neurology. 2009 Feb 3;72[5]:402-9), “there’s no study that demonstrates it’s in the patient’s best interest,” Dr. Berger said during his presentation. He noted that a retrospective study found no improvement in morbidity or mortality (Neurology. 2017 Mar 21;88[12];1144-52).

Multiple strategies to treat PML – including immunizations and inhibitors of DNA replication – have failed to make an impact so far, Dr. Berger said. According to him, the reasons for the failure of PML treatment are a lack of hard evidence, apart from anecdotal, to support them, based on a history of failed clinical trials.

Dr. Berger disclosed serving as a consultant for numerous pharmaceutical companies.
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– Armed with new statistics, neurologist Joseph R. Berger, MD, has a message for colleagues about the widely feared risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis: It’s not as inevitable as you might think.

“You can actually prevent this disease from occurring because we have risk-limiting strategies in many circumstances,” said Dr. Berger of the University of Pennsylvania, Philadelphia, in a presentation on PML at the annual meeting of the Consortium of Multiple Sclerosis Centers.


Unlike other conditions such as HIV, MS itself is not linked to a higher risk of PML, said Dr. Berger, a leading PML researcher. Instead, it’s the medications that spark the condition, he said, with at least three and possibly four drugs posing a risk to patients.

Natalizumab (Tysabri) is especially risky. “We know that the risk with natalizumab is incredibly high in the context of JC [John Cunningham] virus antibody positivity and prolonged therapy,” Dr. Berger said in an interview after his presentation.

Still, “you can safely give natalizumab for a short period of time when treating patients with aggressive MS,” he said. “I will frequently employ that strategy even in the context of JC virus antibody positivity.”

According to Dr. Berger, there’s no risk of PML when natalizumab is used for under 8 months (Mult Scler Relat Disord. 2017 Feb;12:59-63).

However, “if you leave people on the drug indefinitely, there is a substantial risk of developing PML,” he said. “Individuals who have been left on the drug for 2 years, who’ve seen prior immunosuppressant therapy, who are JC virus antibody positive – that group of individuals develops PML at rates of 1 in 50 to 1 in 100.”

 

 


These levels are “enormous,” he said, higher even than those in the HIV population before the rise of antiretroviral medications.

Overall, as of Nov. 30, 2017, 177,800 patients have received natalizumab in the postmarketing setting, and 756 cases of PML have been reported as of Dec. 7, 2017. All but three of those cases were in patients with MS, and the overall incidence was 4.19/1,000.

Dr. Berger recommends regular screening MRIs for PML in patients taking natalizumab, and he advised physicians to be on alert for signs of trouble like the appearance of new neurologic symptoms or a new or increasing JC virus antibody index.

Two other MS drugs, fingolimod (Gilenya) and dimethyl fumarate (Tecfidera), fall into the category of low risk, with just 19 and 5 reported cases, respectively, as of February 2018, Dr. Berger said. He added that two of the fingolimod patients had earlier exposure to natalizumab.
 

 


With dimethyl fumarate, the risk appears to disappear – although this isn’t confirmed – when JC antibody–positive patients are taken off the drug, and their lymphocyte counts fall below 500 per mcL, Dr. Berger said.

“Unfortunately for fingolimod, we don’t have a defined risk-mitigation strategy,” he said. However, researchers have noticed that the fingolimod cases have occurred more often in older people, possibly because of the aging of the immune system, he said.

Another three MS drugs – alemtuzumab (Lemtrada), ocrelizumab (Ocrevus; with rituximab as proxy), and teriflunomide (Aubagio; with leflunomide as proxy) have unknown risk, according to Dr. Berger. There have been three cases in ocrelizumab (rituximab as proxy) and one in teriflunomide (leflunomide as proxy), but all were carry-overs from natalizumab or fingolimod exposure or occurred after natalizumab exposure.

What can physicians do if a patient develops PML? Stopping the drug and restoring the immune system is crucial, he said.
 

 


While there’s evidence that plasma exchange clears natalizumab (Neurology. 2009 Feb 3;72[5]:402-9), “there’s no study that demonstrates it’s in the patient’s best interest,” Dr. Berger said during his presentation. He noted that a retrospective study found no improvement in morbidity or mortality (Neurology. 2017 Mar 21;88[12];1144-52).

Multiple strategies to treat PML – including immunizations and inhibitors of DNA replication – have failed to make an impact so far, Dr. Berger said. According to him, the reasons for the failure of PML treatment are a lack of hard evidence, apart from anecdotal, to support them, based on a history of failed clinical trials.

Dr. Berger disclosed serving as a consultant for numerous pharmaceutical companies.

– Armed with new statistics, neurologist Joseph R. Berger, MD, has a message for colleagues about the widely feared risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis: It’s not as inevitable as you might think.

“You can actually prevent this disease from occurring because we have risk-limiting strategies in many circumstances,” said Dr. Berger of the University of Pennsylvania, Philadelphia, in a presentation on PML at the annual meeting of the Consortium of Multiple Sclerosis Centers.


Unlike other conditions such as HIV, MS itself is not linked to a higher risk of PML, said Dr. Berger, a leading PML researcher. Instead, it’s the medications that spark the condition, he said, with at least three and possibly four drugs posing a risk to patients.

Natalizumab (Tysabri) is especially risky. “We know that the risk with natalizumab is incredibly high in the context of JC [John Cunningham] virus antibody positivity and prolonged therapy,” Dr. Berger said in an interview after his presentation.

Still, “you can safely give natalizumab for a short period of time when treating patients with aggressive MS,” he said. “I will frequently employ that strategy even in the context of JC virus antibody positivity.”

According to Dr. Berger, there’s no risk of PML when natalizumab is used for under 8 months (Mult Scler Relat Disord. 2017 Feb;12:59-63).

However, “if you leave people on the drug indefinitely, there is a substantial risk of developing PML,” he said. “Individuals who have been left on the drug for 2 years, who’ve seen prior immunosuppressant therapy, who are JC virus antibody positive – that group of individuals develops PML at rates of 1 in 50 to 1 in 100.”

 

 


These levels are “enormous,” he said, higher even than those in the HIV population before the rise of antiretroviral medications.

Overall, as of Nov. 30, 2017, 177,800 patients have received natalizumab in the postmarketing setting, and 756 cases of PML have been reported as of Dec. 7, 2017. All but three of those cases were in patients with MS, and the overall incidence was 4.19/1,000.

Dr. Berger recommends regular screening MRIs for PML in patients taking natalizumab, and he advised physicians to be on alert for signs of trouble like the appearance of new neurologic symptoms or a new or increasing JC virus antibody index.

Two other MS drugs, fingolimod (Gilenya) and dimethyl fumarate (Tecfidera), fall into the category of low risk, with just 19 and 5 reported cases, respectively, as of February 2018, Dr. Berger said. He added that two of the fingolimod patients had earlier exposure to natalizumab.
 

 


With dimethyl fumarate, the risk appears to disappear – although this isn’t confirmed – when JC antibody–positive patients are taken off the drug, and their lymphocyte counts fall below 500 per mcL, Dr. Berger said.

“Unfortunately for fingolimod, we don’t have a defined risk-mitigation strategy,” he said. However, researchers have noticed that the fingolimod cases have occurred more often in older people, possibly because of the aging of the immune system, he said.

Another three MS drugs – alemtuzumab (Lemtrada), ocrelizumab (Ocrevus; with rituximab as proxy), and teriflunomide (Aubagio; with leflunomide as proxy) have unknown risk, according to Dr. Berger. There have been three cases in ocrelizumab (rituximab as proxy) and one in teriflunomide (leflunomide as proxy), but all were carry-overs from natalizumab or fingolimod exposure or occurred after natalizumab exposure.

What can physicians do if a patient develops PML? Stopping the drug and restoring the immune system is crucial, he said.
 

 


While there’s evidence that plasma exchange clears natalizumab (Neurology. 2009 Feb 3;72[5]:402-9), “there’s no study that demonstrates it’s in the patient’s best interest,” Dr. Berger said during his presentation. He noted that a retrospective study found no improvement in morbidity or mortality (Neurology. 2017 Mar 21;88[12];1144-52).

Multiple strategies to treat PML – including immunizations and inhibitors of DNA replication – have failed to make an impact so far, Dr. Berger said. According to him, the reasons for the failure of PML treatment are a lack of hard evidence, apart from anecdotal, to support them, based on a history of failed clinical trials.

Dr. Berger disclosed serving as a consultant for numerous pharmaceutical companies.
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Research on exercise in MS needs to build up some muscle

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– Physical activity appears to have profound rehabilitative effects – both physical and cognitive – upon patients with multiple sclerosis, but the body of evidence remains largely based on small, sometimes problematic studies, Alan Thompson, MD, said at the annual meeting of the Consortium of Multiple Sclerosis Centers.

There are compelling animal data that exercise promotes a number of beneficial neuronal changes that improve patient-reported outcomes, said Dr. Thompson, the Garfield Weston Professor of Clinical Neurology and Neurorehabilitation at University College London (England).


“A lot of animal work suggests that exercise can have a major impact on repair and recovery in neurons, synaptic signaling, dendritic branching, long-term potentiation,” and can beneficially affect inflammation and demyelination, he said. Besides the direct effect on nerves, exercise builds up muscle mass, strengthens connective tissue, improves movement, and reduces cardiovascular risk. “Exercise improves inactivity, but also may improve the underlying disease process,” he said. “The effect can be quite profound, and we are building a very good evidence base to support the use of exercise in MS.”

Unfortunately, the existing body of literature remains unimpressive, Dr. Thompson admitted. He compared research in physical activity to that of medicinal therapeutics. Disease-modifying therapeutics research is highly regulated, very well funded, adequately powered and replicated, and – once it shows positive results – receives substantial marketing and sales effort. “As a result, there can be a substantial impact on care.”

Research on rehabilitation and symptom management, with physical activity and other similar interventions, is not well funded, relies on diverse outcome measures, has small cohort numbers, and often is unreplicated. Even positive results “are just left to lie there,” he said. “Thus, it has a modest impact on care. I would like to see equal resources for both research areas.”

The recent surge in stroke rehabilitation is an excellent example of how academic focus can change practice for neurologic illness, he said. A 2017 research letter in Lancet Neurology described the current state of research on exercise in MS (Lancet Neurol. 2017;16[10];848-56). An accompanying editorial compared the MS literature to that in stroke (Lancet Neurol. 2017;16[10]:768-9).

During 1990-2005, there were almost no clinical studies in rehabilitation for stroke, Parkinson’s disease, spinal cord injury, and MS. Around 2005, things began to change in stroke, with close to 60 publications in just 1 year. During 2010-2015, the pace of research accelerated dramatically. Researchers, clinicians, and patients began to see the immediate and long-term benefits of early poststroke rehabilitation. These interventions have now been encoded in practice guidelines and are a core part of clinical care, Dr. Thompson said.

 

 


The picture in MS, Parkinson’s, and spinal cord injury remained almost unchanged, although there has been a very slight increase in these studies since 2010.

“We are way behind the stroke research,” Dr. Thompson said. “We need global collaboration to correct this.”

That may be coming. Dr. Thompson described a newly minted, multinational study sponsored by the Canadian Multiple Sclerosis Society. The four-armed “Improving Cognition in People with Progressive MS” study will determine whether cognitive rehabilitation and exercise are effective treatments for cognitive dysfunction in people with progressive MS. It seeks to enroll 360 patients in six countries. They will be randomized to a wait list, exercise plus cognitive rehabilitation, exercise only, or cognitive rehabilitation only.

The primary investigator is Anthony Feinstein, MBBCh, PhD, a psychiatrist at the University of Toronto.

Dr. Thompson had no disclosures relevant to his discussion.
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– Physical activity appears to have profound rehabilitative effects – both physical and cognitive – upon patients with multiple sclerosis, but the body of evidence remains largely based on small, sometimes problematic studies, Alan Thompson, MD, said at the annual meeting of the Consortium of Multiple Sclerosis Centers.

There are compelling animal data that exercise promotes a number of beneficial neuronal changes that improve patient-reported outcomes, said Dr. Thompson, the Garfield Weston Professor of Clinical Neurology and Neurorehabilitation at University College London (England).


“A lot of animal work suggests that exercise can have a major impact on repair and recovery in neurons, synaptic signaling, dendritic branching, long-term potentiation,” and can beneficially affect inflammation and demyelination, he said. Besides the direct effect on nerves, exercise builds up muscle mass, strengthens connective tissue, improves movement, and reduces cardiovascular risk. “Exercise improves inactivity, but also may improve the underlying disease process,” he said. “The effect can be quite profound, and we are building a very good evidence base to support the use of exercise in MS.”

Unfortunately, the existing body of literature remains unimpressive, Dr. Thompson admitted. He compared research in physical activity to that of medicinal therapeutics. Disease-modifying therapeutics research is highly regulated, very well funded, adequately powered and replicated, and – once it shows positive results – receives substantial marketing and sales effort. “As a result, there can be a substantial impact on care.”

Research on rehabilitation and symptom management, with physical activity and other similar interventions, is not well funded, relies on diverse outcome measures, has small cohort numbers, and often is unreplicated. Even positive results “are just left to lie there,” he said. “Thus, it has a modest impact on care. I would like to see equal resources for both research areas.”

The recent surge in stroke rehabilitation is an excellent example of how academic focus can change practice for neurologic illness, he said. A 2017 research letter in Lancet Neurology described the current state of research on exercise in MS (Lancet Neurol. 2017;16[10];848-56). An accompanying editorial compared the MS literature to that in stroke (Lancet Neurol. 2017;16[10]:768-9).

During 1990-2005, there were almost no clinical studies in rehabilitation for stroke, Parkinson’s disease, spinal cord injury, and MS. Around 2005, things began to change in stroke, with close to 60 publications in just 1 year. During 2010-2015, the pace of research accelerated dramatically. Researchers, clinicians, and patients began to see the immediate and long-term benefits of early poststroke rehabilitation. These interventions have now been encoded in practice guidelines and are a core part of clinical care, Dr. Thompson said.

 

 


The picture in MS, Parkinson’s, and spinal cord injury remained almost unchanged, although there has been a very slight increase in these studies since 2010.

“We are way behind the stroke research,” Dr. Thompson said. “We need global collaboration to correct this.”

That may be coming. Dr. Thompson described a newly minted, multinational study sponsored by the Canadian Multiple Sclerosis Society. The four-armed “Improving Cognition in People with Progressive MS” study will determine whether cognitive rehabilitation and exercise are effective treatments for cognitive dysfunction in people with progressive MS. It seeks to enroll 360 patients in six countries. They will be randomized to a wait list, exercise plus cognitive rehabilitation, exercise only, or cognitive rehabilitation only.

The primary investigator is Anthony Feinstein, MBBCh, PhD, a psychiatrist at the University of Toronto.

Dr. Thompson had no disclosures relevant to his discussion.

– Physical activity appears to have profound rehabilitative effects – both physical and cognitive – upon patients with multiple sclerosis, but the body of evidence remains largely based on small, sometimes problematic studies, Alan Thompson, MD, said at the annual meeting of the Consortium of Multiple Sclerosis Centers.

There are compelling animal data that exercise promotes a number of beneficial neuronal changes that improve patient-reported outcomes, said Dr. Thompson, the Garfield Weston Professor of Clinical Neurology and Neurorehabilitation at University College London (England).


“A lot of animal work suggests that exercise can have a major impact on repair and recovery in neurons, synaptic signaling, dendritic branching, long-term potentiation,” and can beneficially affect inflammation and demyelination, he said. Besides the direct effect on nerves, exercise builds up muscle mass, strengthens connective tissue, improves movement, and reduces cardiovascular risk. “Exercise improves inactivity, but also may improve the underlying disease process,” he said. “The effect can be quite profound, and we are building a very good evidence base to support the use of exercise in MS.”

Unfortunately, the existing body of literature remains unimpressive, Dr. Thompson admitted. He compared research in physical activity to that of medicinal therapeutics. Disease-modifying therapeutics research is highly regulated, very well funded, adequately powered and replicated, and – once it shows positive results – receives substantial marketing and sales effort. “As a result, there can be a substantial impact on care.”

Research on rehabilitation and symptom management, with physical activity and other similar interventions, is not well funded, relies on diverse outcome measures, has small cohort numbers, and often is unreplicated. Even positive results “are just left to lie there,” he said. “Thus, it has a modest impact on care. I would like to see equal resources for both research areas.”

The recent surge in stroke rehabilitation is an excellent example of how academic focus can change practice for neurologic illness, he said. A 2017 research letter in Lancet Neurology described the current state of research on exercise in MS (Lancet Neurol. 2017;16[10];848-56). An accompanying editorial compared the MS literature to that in stroke (Lancet Neurol. 2017;16[10]:768-9).

During 1990-2005, there were almost no clinical studies in rehabilitation for stroke, Parkinson’s disease, spinal cord injury, and MS. Around 2005, things began to change in stroke, with close to 60 publications in just 1 year. During 2010-2015, the pace of research accelerated dramatically. Researchers, clinicians, and patients began to see the immediate and long-term benefits of early poststroke rehabilitation. These interventions have now been encoded in practice guidelines and are a core part of clinical care, Dr. Thompson said.

 

 


The picture in MS, Parkinson’s, and spinal cord injury remained almost unchanged, although there has been a very slight increase in these studies since 2010.

“We are way behind the stroke research,” Dr. Thompson said. “We need global collaboration to correct this.”

That may be coming. Dr. Thompson described a newly minted, multinational study sponsored by the Canadian Multiple Sclerosis Society. The four-armed “Improving Cognition in People with Progressive MS” study will determine whether cognitive rehabilitation and exercise are effective treatments for cognitive dysfunction in people with progressive MS. It seeks to enroll 360 patients in six countries. They will be randomized to a wait list, exercise plus cognitive rehabilitation, exercise only, or cognitive rehabilitation only.

The primary investigator is Anthony Feinstein, MBBCh, PhD, a psychiatrist at the University of Toronto.

Dr. Thompson had no disclosures relevant to his discussion.
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Pediatric MS gets a win with fingolimod

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– Pediatric multiple sclerosis is a confirmed clinical entity, which virtually always presents as relapsing-remitting disease, Brenda Banwell, MD, said at the at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS in children is the same disease as MS in adults,” said Dr. Banwell, chief of neurology at Children’s Hospital of Philadelphia and the Grace R. Loeb Endowed Chair in Neurosciences there. And although she is unaware of a single case of childhood MS presenting as primary progressive disease, the impact of relapsing-remitting childhood MS may ultimately be progressive damage.


Pediatric MS is also quite rare, a characteristic that makes therapeutic progress challenging. Recruiting sufficient patients for a definitive phase 3 trial is incredibly difficult, especially when multiple trials are commencing simultaneously, not only in the United States but around the world.

Nevertheless, there has been excellent news, Dr. Banwell said in a video interview. Fingolimod (Gilenya), the immunomodulator approved for adult relapsing-remitting MS, gained a pediatric approval under the breakthrough therapy designation on May 11, 2018, on the basis of the successful phase 3 PARADIGMS study.

Compared with intramuscular interferon beta-1a, fingolimod cut the annualized relapse rate by 82%. It also was associated with a 53% annualized reduction in new or newly enlarged T2 lesions and 66% decrease in gadolinium-enhancing T1 lesions.

This big win is prompting researchers and clinicians to rethink the pediatric MS treatment paradigm, Dr. Banwell said. Traditional thinking falls along a dose-escalation pattern that follows relapses. However, “we may take a cue from our rheumatology colleagues, who have seen the benefit of starting with more aggressive treatment and higher doses, getting disease control, and then slowly tapering off.”

Whether this option could actually modify disease progression, as it seems to do in some other inflammatory disorders, is an intriguing – but unproven – possibility, she said.

Dr. Banwell disclosed that she received financial remuneration as a central MRI reviewer for the Novartis-sponsored PARADIGMS study.

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– Pediatric multiple sclerosis is a confirmed clinical entity, which virtually always presents as relapsing-remitting disease, Brenda Banwell, MD, said at the at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS in children is the same disease as MS in adults,” said Dr. Banwell, chief of neurology at Children’s Hospital of Philadelphia and the Grace R. Loeb Endowed Chair in Neurosciences there. And although she is unaware of a single case of childhood MS presenting as primary progressive disease, the impact of relapsing-remitting childhood MS may ultimately be progressive damage.


Pediatric MS is also quite rare, a characteristic that makes therapeutic progress challenging. Recruiting sufficient patients for a definitive phase 3 trial is incredibly difficult, especially when multiple trials are commencing simultaneously, not only in the United States but around the world.

Nevertheless, there has been excellent news, Dr. Banwell said in a video interview. Fingolimod (Gilenya), the immunomodulator approved for adult relapsing-remitting MS, gained a pediatric approval under the breakthrough therapy designation on May 11, 2018, on the basis of the successful phase 3 PARADIGMS study.

Compared with intramuscular interferon beta-1a, fingolimod cut the annualized relapse rate by 82%. It also was associated with a 53% annualized reduction in new or newly enlarged T2 lesions and 66% decrease in gadolinium-enhancing T1 lesions.

This big win is prompting researchers and clinicians to rethink the pediatric MS treatment paradigm, Dr. Banwell said. Traditional thinking falls along a dose-escalation pattern that follows relapses. However, “we may take a cue from our rheumatology colleagues, who have seen the benefit of starting with more aggressive treatment and higher doses, getting disease control, and then slowly tapering off.”

Whether this option could actually modify disease progression, as it seems to do in some other inflammatory disorders, is an intriguing – but unproven – possibility, she said.

Dr. Banwell disclosed that she received financial remuneration as a central MRI reviewer for the Novartis-sponsored PARADIGMS study.

– Pediatric multiple sclerosis is a confirmed clinical entity, which virtually always presents as relapsing-remitting disease, Brenda Banwell, MD, said at the at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS in children is the same disease as MS in adults,” said Dr. Banwell, chief of neurology at Children’s Hospital of Philadelphia and the Grace R. Loeb Endowed Chair in Neurosciences there. And although she is unaware of a single case of childhood MS presenting as primary progressive disease, the impact of relapsing-remitting childhood MS may ultimately be progressive damage.


Pediatric MS is also quite rare, a characteristic that makes therapeutic progress challenging. Recruiting sufficient patients for a definitive phase 3 trial is incredibly difficult, especially when multiple trials are commencing simultaneously, not only in the United States but around the world.

Nevertheless, there has been excellent news, Dr. Banwell said in a video interview. Fingolimod (Gilenya), the immunomodulator approved for adult relapsing-remitting MS, gained a pediatric approval under the breakthrough therapy designation on May 11, 2018, on the basis of the successful phase 3 PARADIGMS study.

Compared with intramuscular interferon beta-1a, fingolimod cut the annualized relapse rate by 82%. It also was associated with a 53% annualized reduction in new or newly enlarged T2 lesions and 66% decrease in gadolinium-enhancing T1 lesions.

This big win is prompting researchers and clinicians to rethink the pediatric MS treatment paradigm, Dr. Banwell said. Traditional thinking falls along a dose-escalation pattern that follows relapses. However, “we may take a cue from our rheumatology colleagues, who have seen the benefit of starting with more aggressive treatment and higher doses, getting disease control, and then slowly tapering off.”

Whether this option could actually modify disease progression, as it seems to do in some other inflammatory disorders, is an intriguing – but unproven – possibility, she said.

Dr. Banwell disclosed that she received financial remuneration as a central MRI reviewer for the Novartis-sponsored PARADIGMS study.

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