SEATTLE – In patients with multiple sclerosis (MS), black holes are associated with worse cognitive function, including processing speed and visuospatial memory, according to an investigation presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Black holes are not associated with physical function, however. Evaluating black holes as part of routine clinical practice could be a quick method for screening people with MS for referral to a comprehensive cognitive assessment, said the authors.

Black holes (also known as T1-hypointense lesions) can be used as a marker of axonal loss and neuronal tissue destruction in patients with MS. Loss of axons and destruction of neuronal tissue contribute to cognitive and physical disability, but the literature contains few data about whether black holes correlate with cognitive and physical outcomes in MS.

Serkan Özakbas, MD, professor of neurology at Dokuz Eylül University in Izmir, Turkey, and colleagues examined 226 patients with MS to investigate this potential correlation. The population’s median Expanded Disability Status Scale score was 1.5. The researchers categorized participants into two groups according whether they had at least one black hole or not. They assessed patients’ cognitive function by administering the Brief International Cognitive Assessment for MS (BICAMS), which comprises the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test–Revised (BVMTR). They evaluated participants’ physical function using the Timed 25-Foot Walk (T25FW), Nine-Hole Peg Test (9HPT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), and 12-Item MS Walking Scale (MSWS-12).

In all, 116 (43.6%) participants had at least one black hole, and 150 (56.4%) had no black hole. Dr. Özakbas and colleagues found no significant difference between patients with and without black holes on the T25FW, 9HPT, 6MWT, TUG, MSWS-12, and CVLT-II. Patients without a black hole, however, had significantly higher SDMT (49.0 vs 42.9) and BVMTR (26.3 vs 23.3) scores, compared with those with at least one black hole.

“This study suggests that presence of black holes is related to cognitive function, but not to physical function,” the researchers concluded.

The investigators had no disclosures and conducted their study without financial support.
 

[email protected]

SOURCE: Özakbas S et al. CMSC 2019, Abstract IMG02.

SEATTLE – In patients with multiple sclerosis (MS), black holes are associated with worse cognitive function, including processing speed and visuospatial memory, according to an investigation presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Black holes are not associated with physical function, however. Evaluating black holes as part of routine clinical practice could be a quick method for screening people with MS for referral to a comprehensive cognitive assessment, said the authors.

Black holes (also known as T1-hypointense lesions) can be used as a marker of axonal loss and neuronal tissue destruction in patients with MS. Loss of axons and destruction of neuronal tissue contribute to cognitive and physical disability, but the literature contains few data about whether black holes correlate with cognitive and physical outcomes in MS.

Serkan Özakbas, MD, professor of neurology at Dokuz Eylül University in Izmir, Turkey, and colleagues examined 226 patients with MS to investigate this potential correlation. The population’s median Expanded Disability Status Scale score was 1.5. The researchers categorized participants into two groups according whether they had at least one black hole or not. They assessed patients’ cognitive function by administering the Brief International Cognitive Assessment for MS (BICAMS), which comprises the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test–Revised (BVMTR). They evaluated participants’ physical function using the Timed 25-Foot Walk (T25FW), Nine-Hole Peg Test (9HPT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), and 12-Item MS Walking Scale (MSWS-12).

In all, 116 (43.6%) participants had at least one black hole, and 150 (56.4%) had no black hole. Dr. Özakbas and colleagues found no significant difference between patients with and without black holes on the T25FW, 9HPT, 6MWT, TUG, MSWS-12, and CVLT-II. Patients without a black hole, however, had significantly higher SDMT (49.0 vs 42.9) and BVMTR (26.3 vs 23.3) scores, compared with those with at least one black hole.

“This study suggests that presence of black holes is related to cognitive function, but not to physical function,” the researchers concluded.

The investigators had no disclosures and conducted their study without financial support.
 

[email protected]

SOURCE: Özakbas S et al. CMSC 2019, Abstract IMG02.

SEATTLE – In patients with multiple sclerosis (MS), black holes are associated with worse cognitive function, including processing speed and visuospatial memory, according to an investigation presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Black holes are not associated with physical function, however. Evaluating black holes as part of routine clinical practice could be a quick method for screening people with MS for referral to a comprehensive cognitive assessment, said the authors.

Black holes (also known as T1-hypointense lesions) can be used as a marker of axonal loss and neuronal tissue destruction in patients with MS. Loss of axons and destruction of neuronal tissue contribute to cognitive and physical disability, but the literature contains few data about whether black holes correlate with cognitive and physical outcomes in MS.

Serkan Özakbas, MD, professor of neurology at Dokuz Eylül University in Izmir, Turkey, and colleagues examined 226 patients with MS to investigate this potential correlation. The population’s median Expanded Disability Status Scale score was 1.5. The researchers categorized participants into two groups according whether they had at least one black hole or not. They assessed patients’ cognitive function by administering the Brief International Cognitive Assessment for MS (BICAMS), which comprises the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test–Revised (BVMTR). They evaluated participants’ physical function using the Timed 25-Foot Walk (T25FW), Nine-Hole Peg Test (9HPT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), and 12-Item MS Walking Scale (MSWS-12).

In all, 116 (43.6%) participants had at least one black hole, and 150 (56.4%) had no black hole. Dr. Özakbas and colleagues found no significant difference between patients with and without black holes on the T25FW, 9HPT, 6MWT, TUG, MSWS-12, and CVLT-II. Patients without a black hole, however, had significantly higher SDMT (49.0 vs 42.9) and BVMTR (26.3 vs 23.3) scores, compared with those with at least one black hole.

“This study suggests that presence of black holes is related to cognitive function, but not to physical function,” the researchers concluded.

The investigators had no disclosures and conducted their study without financial support.
 

[email protected]

SOURCE: Özakbas S et al. CMSC 2019, Abstract IMG02.

Postpartum teenage mothers who use long-acting reversible contraceptives (LARC) reported using condoms half as often as their peers using non-LARC methods such as the birth control pill, vaginal ring, contraceptive patch, or injection, according to research in JAMA Pediatrics.

This highlights a need for education to lower the risk of sexually transmitted infections in this population.

©Florea Marius Catalin/iStockphoto.com

SOURCE: Kortsmit K et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1136; Hoopes AJ et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1133.

Postpartum teenage mothers who use long-acting reversible contraceptives (LARC) reported using condoms half as often as their peers using non-LARC methods such as the birth control pill, vaginal ring, contraceptive patch, or injection, according to research in JAMA Pediatrics.

This highlights a need for education to lower the risk of sexually transmitted infections in this population.

©Florea Marius Catalin/iStockphoto.com

SOURCE: Kortsmit K et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1136; Hoopes AJ et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1133.

Postpartum teenage mothers who use long-acting reversible contraceptives (LARC) reported using condoms half as often as their peers using non-LARC methods such as the birth control pill, vaginal ring, contraceptive patch, or injection, according to research in JAMA Pediatrics.

This highlights a need for education to lower the risk of sexually transmitted infections in this population.

©Florea Marius Catalin/iStockphoto.com

SOURCE: Kortsmit K et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1136; Hoopes AJ et al. JAMA Pediatr. 2019. doi: 10.1001/jamapediatrics.2019.1133.

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

[email protected]

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

[email protected]

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

[email protected]

Watch for the symptoms of acute flaccid myelitis early and report any suspected cases to your health department, the CDC said in a telebriefing.

Acute flaccid myelitis (AFM) is defined as acute, flaccid muscle weakness that occurs less than 1 week after a fever or respiratory illness. Viruses, including enterovirus, are believed to play a role in AFM, but the cause still is unknown. The disease appears mostly in children, and the average age of a patient diagnosed with AFM is 5 years.

“Doctors and other clinicians in the United States play a critical role,” Anne Schuchat, MD, principal deputy director of the Centers for Disease Control and Prevention, said in the telebriefing. “We ask for your help with early recognition of patients with AFM symptoms, prompt specimen collection for testing, and immediate reporting of suspected AFM cases to health departments.”

While there is no proven treatment for AFM, early diagnosis is critical to getting patients the best care possible, according to a Vital Signs report released today. This means that clinicians should not wait for the CDC’s case definition before diagnosis, the CDC said.

“When specimens are collected as soon as possible after symptom onset, we have a better chance of understanding the causes of AFM, these recurrent outbreaks, and developing a diagnostic test,” Dr. Schuchat said. “Rapid reporting also helps us to identify and respond to outbreaks early and alert other clinicians and the public.”

AFM appears to follow a seasonal and biennial pattern, with the number of cases increasing mainly in the late summer and early fall. As the season approaches where AFM cases increase, CDC is asking clinicians to look out for patients with suspected AFM so cases can be reported as early as possible.

Since the CDC began tracking AFM, the number of cases has risen every 2 years. In 2018, there were 233 cases in 41 states, the highest number of reported cases since the CDC began tracking AFM following an outbreak in 2014, according to a Vital Signs report. Overall, there have been 570 cases of AFM reported in 48 states and the District of Columbia since 2014.

There is yet to be a confirmatory test for AFM, but clinicians should obtain cerebrospinal fluid, serum, stool and nasopharyngeal swab from patients with suspected AFM as soon as possible, followed by an MRI. AFM has unique MRI features , such as gray matter involvement, that can help distinguish it from other diseases characterized by acute weakness.

In the Vital Signs report, which examined AFM in 2018, 92% of confirmed cases had respiratory symptoms or fever, and 42% of confirmed cases had upper limb involvement. The median time from limb weakness to hospitalization was 1 day, and time from weakness to MRI was 2 days. Cases were reported to the CDC a median of 18 days from onset of limb weakness, but time to reporting ranged between 18 days and 36 days, said Tom Clark, MD, MPH, deputy director of the division of viral diseases at CDC.

“This delay hampers our ability to understand the causes AFM,” he said. “We believe that recognizing AFM early is critical and can lead to better patient management.”

In lieu of a diagnostic test for AFM, clinicians should make management decisions through review of patient symptoms, exam findings, MRI, other test results, and in consulting with neurology experts. The Transverse Myelitis Association also has created a support portal for 24/7 physician consultation in AFM cases.

SOURCE: Lopez A et al. MMWR Morb Mortal Wkly Rep. 2019;68:1-7 .

Watch for the symptoms of acute flaccid myelitis early and report any suspected cases to your health department, the CDC said in a telebriefing.

Acute flaccid myelitis (AFM) is defined as acute, flaccid muscle weakness that occurs less than 1 week after a fever or respiratory illness. Viruses, including enterovirus, are believed to play a role in AFM, but the cause still is unknown. The disease appears mostly in children, and the average age of a patient diagnosed with AFM is 5 years.

“Doctors and other clinicians in the United States play a critical role,” Anne Schuchat, MD, principal deputy director of the Centers for Disease Control and Prevention, said in the telebriefing. “We ask for your help with early recognition of patients with AFM symptoms, prompt specimen collection for testing, and immediate reporting of suspected AFM cases to health departments.”

While there is no proven treatment for AFM, early diagnosis is critical to getting patients the best care possible, according to a Vital Signs report released today. This means that clinicians should not wait for the CDC’s case definition before diagnosis, the CDC said.

“When specimens are collected as soon as possible after symptom onset, we have a better chance of understanding the causes of AFM, these recurrent outbreaks, and developing a diagnostic test,” Dr. Schuchat said. “Rapid reporting also helps us to identify and respond to outbreaks early and alert other clinicians and the public.”

AFM appears to follow a seasonal and biennial pattern, with the number of cases increasing mainly in the late summer and early fall. As the season approaches where AFM cases increase, CDC is asking clinicians to look out for patients with suspected AFM so cases can be reported as early as possible.

Since the CDC began tracking AFM, the number of cases has risen every 2 years. In 2018, there were 233 cases in 41 states, the highest number of reported cases since the CDC began tracking AFM following an outbreak in 2014, according to a Vital Signs report. Overall, there have been 570 cases of AFM reported in 48 states and the District of Columbia since 2014.

There is yet to be a confirmatory test for AFM, but clinicians should obtain cerebrospinal fluid, serum, stool and nasopharyngeal swab from patients with suspected AFM as soon as possible, followed by an MRI. AFM has unique MRI features , such as gray matter involvement, that can help distinguish it from other diseases characterized by acute weakness.

In the Vital Signs report, which examined AFM in 2018, 92% of confirmed cases had respiratory symptoms or fever, and 42% of confirmed cases had upper limb involvement. The median time from limb weakness to hospitalization was 1 day, and time from weakness to MRI was 2 days. Cases were reported to the CDC a median of 18 days from onset of limb weakness, but time to reporting ranged between 18 days and 36 days, said Tom Clark, MD, MPH, deputy director of the division of viral diseases at CDC.

“This delay hampers our ability to understand the causes AFM,” he said. “We believe that recognizing AFM early is critical and can lead to better patient management.”

In lieu of a diagnostic test for AFM, clinicians should make management decisions through review of patient symptoms, exam findings, MRI, other test results, and in consulting with neurology experts. The Transverse Myelitis Association also has created a support portal for 24/7 physician consultation in AFM cases.

SOURCE: Lopez A et al. MMWR Morb Mortal Wkly Rep. 2019;68:1-7 .

Watch for the symptoms of acute flaccid myelitis early and report any suspected cases to your health department, the CDC said in a telebriefing.

Acute flaccid myelitis (AFM) is defined as acute, flaccid muscle weakness that occurs less than 1 week after a fever or respiratory illness. Viruses, including enterovirus, are believed to play a role in AFM, but the cause still is unknown. The disease appears mostly in children, and the average age of a patient diagnosed with AFM is 5 years.

“Doctors and other clinicians in the United States play a critical role,” Anne Schuchat, MD, principal deputy director of the Centers for Disease Control and Prevention, said in the telebriefing. “We ask for your help with early recognition of patients with AFM symptoms, prompt specimen collection for testing, and immediate reporting of suspected AFM cases to health departments.”

While there is no proven treatment for AFM, early diagnosis is critical to getting patients the best care possible, according to a Vital Signs report released today. This means that clinicians should not wait for the CDC’s case definition before diagnosis, the CDC said.

“When specimens are collected as soon as possible after symptom onset, we have a better chance of understanding the causes of AFM, these recurrent outbreaks, and developing a diagnostic test,” Dr. Schuchat said. “Rapid reporting also helps us to identify and respond to outbreaks early and alert other clinicians and the public.”

AFM appears to follow a seasonal and biennial pattern, with the number of cases increasing mainly in the late summer and early fall. As the season approaches where AFM cases increase, CDC is asking clinicians to look out for patients with suspected AFM so cases can be reported as early as possible.

Since the CDC began tracking AFM, the number of cases has risen every 2 years. In 2018, there were 233 cases in 41 states, the highest number of reported cases since the CDC began tracking AFM following an outbreak in 2014, according to a Vital Signs report. Overall, there have been 570 cases of AFM reported in 48 states and the District of Columbia since 2014.

There is yet to be a confirmatory test for AFM, but clinicians should obtain cerebrospinal fluid, serum, stool and nasopharyngeal swab from patients with suspected AFM as soon as possible, followed by an MRI. AFM has unique MRI features , such as gray matter involvement, that can help distinguish it from other diseases characterized by acute weakness.

In the Vital Signs report, which examined AFM in 2018, 92% of confirmed cases had respiratory symptoms or fever, and 42% of confirmed cases had upper limb involvement. The median time from limb weakness to hospitalization was 1 day, and time from weakness to MRI was 2 days. Cases were reported to the CDC a median of 18 days from onset of limb weakness, but time to reporting ranged between 18 days and 36 days, said Tom Clark, MD, MPH, deputy director of the division of viral diseases at CDC.

“This delay hampers our ability to understand the causes AFM,” he said. “We believe that recognizing AFM early is critical and can lead to better patient management.”

In lieu of a diagnostic test for AFM, clinicians should make management decisions through review of patient symptoms, exam findings, MRI, other test results, and in consulting with neurology experts. The Transverse Myelitis Association also has created a support portal for 24/7 physician consultation in AFM cases.

SOURCE: Lopez A et al. MMWR Morb Mortal Wkly Rep. 2019;68:1-7 .

Among Medicare patients with chronic obstructive pulmonary disease (COPD), those who had at least one exacerbation and had a COPD-related hospitalization were most likely to receive nebulized arformoterol, according to study to identify predictors of its use. In addition to being sicker, being treated by a pulmonologist rather than a primary care physician and being white were factors that increased a patient’s likelihood of receiving nebulized arformoterol.

designer491/Thinkstock

Patients less likely to receive the nebulized version of this long-acting beta2 adrenoreceptor agonist (LABA) were African Americans, patients with psychiatric comorbidities, and patients eligible for both Medicare and Medicaid.

“Studies have shown that 40% to 71% of Medicare beneficiaries receive no maintenance treatment for COPD. Although a recent longitudinal study on Medicare populations reported that use of maintenance medications has been improving, in general, it is recognized that Medicare beneficiaries with COPD remain undertreated,” Todd P. Gilmer, PhD, from the department of family medicine and public health at the University of California, San Diego, and colleagues wrote.

The investigators identified patients with COPD using Medicare administrative data; of these patients, 11,887 were arformoterol users, and 450,178 were control patients who did not use arformoterol. Patients were included in the study if they had at least one claim for COPD medication and were continuously enrolled in Medicare Parts A, B, and D. The cohort consisted of mostly white women aged 70 years or older, and 47% were dual-eligible to receive both Medicare and Medicaid benefits. A subgroup of 1,778 arformoterol users were also identified for analysis who were hospitalized and discharged within 30 days of using arformoterol, as well as a subgroup of 21,910 control patients with hospitalizations.

The researchers found COPD-related hospitalization (odds ratio, 1.31; 95% confidence interval, 1.24-1.39; P less than .001), exacerbation (OR, 1.33; 95% CI, 1.26-1.41; P less than .001), use of a systemic corticosteroid (OR, 1.50; 95% CI, 1.43-1.57; P less than .001) or methylxanthine (OR, 1.37; 95% CI, 1.28-1.47; P less than .001), use of oxygen therapy (OR, 2.01; 95% CI, 1.93-2.09; P less than .001), pulmonologist care (OR, 1.40; 95% CI, 1.34-1.46; P less than .001), and respiratory therapist care (OR, 1.23; 95% CI, 1.11-1.36; P less than .001) strongly predicted arformoterol use, while racial/ethnic minority status, psychiatric comorbidity (OR, 0.65; 95% CI, 0.56-0.76; P less than .001), acquired immune deficiency syndrome (OR, 0.69; 95% CI, 0.52-0.94; P less than .01), and dual-eligibility for Medicare and Medicaid (OR, 0.73; 95% CI, 0.70-0.77; P less than .001) lowered the odds of arformoterol use (P less than .001). In the subgroup of patients with hospitalizations, COPD-related admission (OR, 1.83; 95% CI, 1.55-2.14; P less than .001), exacerbation (OR, 2.62; 95% CI, 1.88-3.63; P less than .001)m and inpatient care from a pulmonologist (OR, 1.78; 95% CI, 1.58-2.01; P less than .001) predicted arformoterol use.

“Given the results of this study, increasing access to nebulized maintenance therapy is warranted for select populations with COPD including racial/ethnic minorities, the dual-eligible, and those with certain comorbidities, such as psychiatric disorders,” Dr. Gilmer and colleagues wrote in their study. “Future studies are needed to explore the optimal time to initiate nebulized maintenance therapy, and the potential differential impact of early versus late initiation on patient outcomes.”

Researchers noted that, although their results may seem initially counterintuitive given that COPD has a higher prevalence in men, 56% of the beneficiaries in their Medicare data were women who were 65 years or older, and the results are consistent with other studies that show similar gender distribution findings for maintenance treatment patterns among COPD patients receiving Medicare.

“Since most Medicare beneficiaries with COPD are older than 70 years of age, the higher percentage of women than men in our two cohorts can be explained by the age distributions that ensued as a result of applying our various inclusion and exclusion criteria,” they said.

This study was funded by Sunovian. Dr. Gilmer and one coauthor are paid employees of University of California San Diego, which receives research funding from Advance Health Solutions. Another coauthor is an advisory board member for Advance Health Solutions and a consultant for GlaxoSmithKline, Boehringer-Ingelheim, Astra Zeneca, Novartis, and Pulmonix. Two other coauthors are paid employees of Advance Health Solutions, and another is a paid employee of Sunovion.

SOURCE: Gilmer TP et al. COPD. 2019 Jun 19. doi: 10.1080/15412555.2019.1618256.

Among Medicare patients with chronic obstructive pulmonary disease (COPD), those who had at least one exacerbation and had a COPD-related hospitalization were most likely to receive nebulized arformoterol, according to study to identify predictors of its use. In addition to being sicker, being treated by a pulmonologist rather than a primary care physician and being white were factors that increased a patient’s likelihood of receiving nebulized arformoterol.

designer491/Thinkstock

Patients less likely to receive the nebulized version of this long-acting beta2 adrenoreceptor agonist (LABA) were African Americans, patients with psychiatric comorbidities, and patients eligible for both Medicare and Medicaid.

“Studies have shown that 40% to 71% of Medicare beneficiaries receive no maintenance treatment for COPD. Although a recent longitudinal study on Medicare populations reported that use of maintenance medications has been improving, in general, it is recognized that Medicare beneficiaries with COPD remain undertreated,” Todd P. Gilmer, PhD, from the department of family medicine and public health at the University of California, San Diego, and colleagues wrote.

The investigators identified patients with COPD using Medicare administrative data; of these patients, 11,887 were arformoterol users, and 450,178 were control patients who did not use arformoterol. Patients were included in the study if they had at least one claim for COPD medication and were continuously enrolled in Medicare Parts A, B, and D. The cohort consisted of mostly white women aged 70 years or older, and 47% were dual-eligible to receive both Medicare and Medicaid benefits. A subgroup of 1,778 arformoterol users were also identified for analysis who were hospitalized and discharged within 30 days of using arformoterol, as well as a subgroup of 21,910 control patients with hospitalizations.

The researchers found COPD-related hospitalization (odds ratio, 1.31; 95% confidence interval, 1.24-1.39; P less than .001), exacerbation (OR, 1.33; 95% CI, 1.26-1.41; P less than .001), use of a systemic corticosteroid (OR, 1.50; 95% CI, 1.43-1.57; P less than .001) or methylxanthine (OR, 1.37; 95% CI, 1.28-1.47; P less than .001), use of oxygen therapy (OR, 2.01; 95% CI, 1.93-2.09; P less than .001), pulmonologist care (OR, 1.40; 95% CI, 1.34-1.46; P less than .001), and respiratory therapist care (OR, 1.23; 95% CI, 1.11-1.36; P less than .001) strongly predicted arformoterol use, while racial/ethnic minority status, psychiatric comorbidity (OR, 0.65; 95% CI, 0.56-0.76; P less than .001), acquired immune deficiency syndrome (OR, 0.69; 95% CI, 0.52-0.94; P less than .01), and dual-eligibility for Medicare and Medicaid (OR, 0.73; 95% CI, 0.70-0.77; P less than .001) lowered the odds of arformoterol use (P less than .001). In the subgroup of patients with hospitalizations, COPD-related admission (OR, 1.83; 95% CI, 1.55-2.14; P less than .001), exacerbation (OR, 2.62; 95% CI, 1.88-3.63; P less than .001)m and inpatient care from a pulmonologist (OR, 1.78; 95% CI, 1.58-2.01; P less than .001) predicted arformoterol use.

“Given the results of this study, increasing access to nebulized maintenance therapy is warranted for select populations with COPD including racial/ethnic minorities, the dual-eligible, and those with certain comorbidities, such as psychiatric disorders,” Dr. Gilmer and colleagues wrote in their study. “Future studies are needed to explore the optimal time to initiate nebulized maintenance therapy, and the potential differential impact of early versus late initiation on patient outcomes.”

Researchers noted that, although their results may seem initially counterintuitive given that COPD has a higher prevalence in men, 56% of the beneficiaries in their Medicare data were women who were 65 years or older, and the results are consistent with other studies that show similar gender distribution findings for maintenance treatment patterns among COPD patients receiving Medicare.

“Since most Medicare beneficiaries with COPD are older than 70 years of age, the higher percentage of women than men in our two cohorts can be explained by the age distributions that ensued as a result of applying our various inclusion and exclusion criteria,” they said.

This study was funded by Sunovian. Dr. Gilmer and one coauthor are paid employees of University of California San Diego, which receives research funding from Advance Health Solutions. Another coauthor is an advisory board member for Advance Health Solutions and a consultant for GlaxoSmithKline, Boehringer-Ingelheim, Astra Zeneca, Novartis, and Pulmonix. Two other coauthors are paid employees of Advance Health Solutions, and another is a paid employee of Sunovion.

SOURCE: Gilmer TP et al. COPD. 2019 Jun 19. doi: 10.1080/15412555.2019.1618256.

Among Medicare patients with chronic obstructive pulmonary disease (COPD), those who had at least one exacerbation and had a COPD-related hospitalization were most likely to receive nebulized arformoterol, according to study to identify predictors of its use. In addition to being sicker, being treated by a pulmonologist rather than a primary care physician and being white were factors that increased a patient’s likelihood of receiving nebulized arformoterol.

designer491/Thinkstock

Patients less likely to receive the nebulized version of this long-acting beta2 adrenoreceptor agonist (LABA) were African Americans, patients with psychiatric comorbidities, and patients eligible for both Medicare and Medicaid.

“Studies have shown that 40% to 71% of Medicare beneficiaries receive no maintenance treatment for COPD. Although a recent longitudinal study on Medicare populations reported that use of maintenance medications has been improving, in general, it is recognized that Medicare beneficiaries with COPD remain undertreated,” Todd P. Gilmer, PhD, from the department of family medicine and public health at the University of California, San Diego, and colleagues wrote.

The investigators identified patients with COPD using Medicare administrative data; of these patients, 11,887 were arformoterol users, and 450,178 were control patients who did not use arformoterol. Patients were included in the study if they had at least one claim for COPD medication and were continuously enrolled in Medicare Parts A, B, and D. The cohort consisted of mostly white women aged 70 years or older, and 47% were dual-eligible to receive both Medicare and Medicaid benefits. A subgroup of 1,778 arformoterol users were also identified for analysis who were hospitalized and discharged within 30 days of using arformoterol, as well as a subgroup of 21,910 control patients with hospitalizations.

The researchers found COPD-related hospitalization (odds ratio, 1.31; 95% confidence interval, 1.24-1.39; P less than .001), exacerbation (OR, 1.33; 95% CI, 1.26-1.41; P less than .001), use of a systemic corticosteroid (OR, 1.50; 95% CI, 1.43-1.57; P less than .001) or methylxanthine (OR, 1.37; 95% CI, 1.28-1.47; P less than .001), use of oxygen therapy (OR, 2.01; 95% CI, 1.93-2.09; P less than .001), pulmonologist care (OR, 1.40; 95% CI, 1.34-1.46; P less than .001), and respiratory therapist care (OR, 1.23; 95% CI, 1.11-1.36; P less than .001) strongly predicted arformoterol use, while racial/ethnic minority status, psychiatric comorbidity (OR, 0.65; 95% CI, 0.56-0.76; P less than .001), acquired immune deficiency syndrome (OR, 0.69; 95% CI, 0.52-0.94; P less than .01), and dual-eligibility for Medicare and Medicaid (OR, 0.73; 95% CI, 0.70-0.77; P less than .001) lowered the odds of arformoterol use (P less than .001). In the subgroup of patients with hospitalizations, COPD-related admission (OR, 1.83; 95% CI, 1.55-2.14; P less than .001), exacerbation (OR, 2.62; 95% CI, 1.88-3.63; P less than .001)m and inpatient care from a pulmonologist (OR, 1.78; 95% CI, 1.58-2.01; P less than .001) predicted arformoterol use.

“Given the results of this study, increasing access to nebulized maintenance therapy is warranted for select populations with COPD including racial/ethnic minorities, the dual-eligible, and those with certain comorbidities, such as psychiatric disorders,” Dr. Gilmer and colleagues wrote in their study. “Future studies are needed to explore the optimal time to initiate nebulized maintenance therapy, and the potential differential impact of early versus late initiation on patient outcomes.”

Researchers noted that, although their results may seem initially counterintuitive given that COPD has a higher prevalence in men, 56% of the beneficiaries in their Medicare data were women who were 65 years or older, and the results are consistent with other studies that show similar gender distribution findings for maintenance treatment patterns among COPD patients receiving Medicare.

“Since most Medicare beneficiaries with COPD are older than 70 years of age, the higher percentage of women than men in our two cohorts can be explained by the age distributions that ensued as a result of applying our various inclusion and exclusion criteria,” they said.

This study was funded by Sunovian. Dr. Gilmer and one coauthor are paid employees of University of California San Diego, which receives research funding from Advance Health Solutions. Another coauthor is an advisory board member for Advance Health Solutions and a consultant for GlaxoSmithKline, Boehringer-Ingelheim, Astra Zeneca, Novartis, and Pulmonix. Two other coauthors are paid employees of Advance Health Solutions, and another is a paid employee of Sunovion.

SOURCE: Gilmer TP et al. COPD. 2019 Jun 19. doi: 10.1080/15412555.2019.1618256.

Controlling CNS disease is “paramount” in treating diffuse large B-cell lymphoma with synchronous CNS and systemic disease (synDLBCL), according to researchers.

Nephron/Wikimedia Commons/CC BY-SA 3.0

In a retrospective study, the CNS was the most common site of relapse in patients with synDLBCL, and patients had better outcomes when they received CNS-directed therapy.

The 2-year progression-free survival rate was 50% in patients who received CNS-intensive therapy and 31% in those who received CNS-conservative therapy. The 2-year overall survival rate was 54% and 44%, respectively.

Dr. Joel C. Wight, of Austin Health in Heidelberg, Australia, and colleagues conducted this study and recounted their findings in the British Journal of Haematology.

The researchers retrospectively analyzed 80 patients with synDLBCL treated at 10 centers in Australia and the United Kingdom. Patients had DLBCL not otherwise specified (n = 67); high-grade B-cell lymphoma, including double-hit lymphoma (n = 12); or T-cell histiocyte-rich DLBCL (n = 1).

At baseline, all patients were treatment-naive, they had a median age of 64 years (range, 18-87 years), and 68% were male. Seventy percent of patients had high-risk disease according to the CNS International Prognostic Index (IPI), and 96% had non-CNS extranodal disease. The median number of extranodal sites outside the CNS was 2 (range, 0 to more than 10).

Patients were divided into those who received CNS-intensive therapy (n = 38) and those given CNS-conservative therapy (n = 42). The CNS-conservative group was significantly older (P less than .001), significantly more likely to have high-risk disease according to the National Comprehensive Cancer Network IPI (P = .009) or CNS IPI (P = .01) and significantly more likely to have leptomeningeal disease only (P less than .001).
 

Treatment

CNS-intensive therapy was defined as any established multiagent IV chemotherapy regimen with two or more CNS-penetrating drugs and cytarabine, with or without intrathecal chemotherapy and/or radiotherapy.

CNS-conservative therapy was defined as one or fewer IV CNS-penetrating chemotherapy agents in induction, with or without intrathecal chemotherapy and/or radiotherapy.

Systemic induction in the CNS-intensive group consisted of R-HyperCVAD (rituximab, hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with IV methotrexate and cytarabine) in 66% of patients and R-CODOX-M/IVAC (rituximab, hyperfractionated cyclophosphamide, vincristine, doxorubicin, methotrexate/ifosfamide, etoposide, cytarabine) in 24% of patients.

The most common systemic induction regimens in the CNS-conservative group were R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone) or CHOP-like regimens, given to 83% of patients.

CNS-directed IV therapy was given to 100% of the CNS-intensive group and 60% of the CNS-conservative group. This consisted of IV methotrexate plus cytarabine (97%) or MATRix (methotrexate, cytarabine, and thiotepa; 3%) in the CNS-intensive group and high-dose methotrexate in the conservative group.

Intrathecal chemotherapy was given to 97% of the CNS-intensive group and 60% of the CNS-conservative group. CNS-directed radiation was given to 32% and 19%, respectively.

Thirteen patients in the CNS-intensive group and one in the CNS-conservative group underwent autologous transplant as consolidation.

Outcomes

Dose reductions were more frequent in the CNS-conservative group than in the CNS-intensive group, at 48% and 18% (P = .009), as was early cessation of chemotherapy, at 52% and 18% (P = .002). Rates of treatment-related mortality were similar, at 13% in the CNS-intensive group and 12% in the CNS-conservative group.

At the end of induction, the complete response rate was 69% in the CNS-intensive group and 51% in the CNS-conservative group (P = .16). Primary refractory disease was observed in 19% and 38% of patients, respectively (P = .07).

The CNS was the most common site of relapse or progression (n = 28). CNS progression or relapse occurred in 25% of the CNS-intensive group and 49% of the CNS-conservative group (P = .03).

The 2-year progression-free survival rate was 50% for the CNS-intensive group and 31% for the CNS-conservative group (P = .006). The 2-year overall survival rate was 54% and 44%, respectively (P = .037).

When patients were matched for induction outcomes, consolidative transplant did not improve survival.

“The most significant factor affecting survival was the ability to control the CNS disease, which was improved by the addition of IV cytarabine to [high-dose methotrexate],” the researchers wrote.

“Whilst the younger age and more intensive systemic treatment of the CNS-intensive group may have contributed to the improved survival, it is clear that CNS disease control was substantially improved by the addition of cytarabine with lower rates of CNS relapse/progression observed.”

The researchers noted that “adequate control of the CNS disease is paramount and is best achieved by intensive CNS-directed induction.”

There was no formal funding for this study, and the researchers did not provide financial disclosures.

[email protected]

SOURCE: Wight JC et al. Br J Haematol. 2019 Jun 24. doi: 10.1111/bjh.16064.

Controlling CNS disease is “paramount” in treating diffuse large B-cell lymphoma with synchronous CNS and systemic disease (synDLBCL), according to researchers.

Nephron/Wikimedia Commons/CC BY-SA 3.0

In a retrospective study, the CNS was the most common site of relapse in patients with synDLBCL, and patients had better outcomes when they received CNS-directed therapy.

The 2-year progression-free survival rate was 50% in patients who received CNS-intensive therapy and 31% in those who received CNS-conservative therapy. The 2-year overall survival rate was 54% and 44%, respectively.

Dr. Joel C. Wight, of Austin Health in Heidelberg, Australia, and colleagues conducted this study and recounted their findings in the British Journal of Haematology.

The researchers retrospectively analyzed 80 patients with synDLBCL treated at 10 centers in Australia and the United Kingdom. Patients had DLBCL not otherwise specified (n = 67); high-grade B-cell lymphoma, including double-hit lymphoma (n = 12); or T-cell histiocyte-rich DLBCL (n = 1).

At baseline, all patients were treatment-naive, they had a median age of 64 years (range, 18-87 years), and 68% were male. Seventy percent of patients had high-risk disease according to the CNS International Prognostic Index (IPI), and 96% had non-CNS extranodal disease. The median number of extranodal sites outside the CNS was 2 (range, 0 to more than 10).

Patients were divided into those who received CNS-intensive therapy (n = 38) and those given CNS-conservative therapy (n = 42). The CNS-conservative group was significantly older (P less than .001), significantly more likely to have high-risk disease according to the National Comprehensive Cancer Network IPI (P = .009) or CNS IPI (P = .01) and significantly more likely to have leptomeningeal disease only (P less than .001).
 

Treatment

CNS-intensive therapy was defined as any established multiagent IV chemotherapy regimen with two or more CNS-penetrating drugs and cytarabine, with or without intrathecal chemotherapy and/or radiotherapy.

CNS-conservative therapy was defined as one or fewer IV CNS-penetrating chemotherapy agents in induction, with or without intrathecal chemotherapy and/or radiotherapy.

Systemic induction in the CNS-intensive group consisted of R-HyperCVAD (rituximab, hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with IV methotrexate and cytarabine) in 66% of patients and R-CODOX-M/IVAC (rituximab, hyperfractionated cyclophosphamide, vincristine, doxorubicin, methotrexate/ifosfamide, etoposide, cytarabine) in 24% of patients.

The most common systemic induction regimens in the CNS-conservative group were R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone) or CHOP-like regimens, given to 83% of patients.

CNS-directed IV therapy was given to 100% of the CNS-intensive group and 60% of the CNS-conservative group. This consisted of IV methotrexate plus cytarabine (97%) or MATRix (methotrexate, cytarabine, and thiotepa; 3%) in the CNS-intensive group and high-dose methotrexate in the conservative group.

Intrathecal chemotherapy was given to 97% of the CNS-intensive group and 60% of the CNS-conservative group. CNS-directed radiation was given to 32% and 19%, respectively.

Thirteen patients in the CNS-intensive group and one in the CNS-conservative group underwent autologous transplant as consolidation.

Outcomes

Dose reductions were more frequent in the CNS-conservative group than in the CNS-intensive group, at 48% and 18% (P = .009), as was early cessation of chemotherapy, at 52% and 18% (P = .002). Rates of treatment-related mortality were similar, at 13% in the CNS-intensive group and 12% in the CNS-conservative group.

At the end of induction, the complete response rate was 69% in the CNS-intensive group and 51% in the CNS-conservative group (P = .16). Primary refractory disease was observed in 19% and 38% of patients, respectively (P = .07).

The CNS was the most common site of relapse or progression (n = 28). CNS progression or relapse occurred in 25% of the CNS-intensive group and 49% of the CNS-conservative group (P = .03).

The 2-year progression-free survival rate was 50% for the CNS-intensive group and 31% for the CNS-conservative group (P = .006). The 2-year overall survival rate was 54% and 44%, respectively (P = .037).

When patients were matched for induction outcomes, consolidative transplant did not improve survival.

“The most significant factor affecting survival was the ability to control the CNS disease, which was improved by the addition of IV cytarabine to [high-dose methotrexate],” the researchers wrote.

“Whilst the younger age and more intensive systemic treatment of the CNS-intensive group may have contributed to the improved survival, it is clear that CNS disease control was substantially improved by the addition of cytarabine with lower rates of CNS relapse/progression observed.”

The researchers noted that “adequate control of the CNS disease is paramount and is best achieved by intensive CNS-directed induction.”

There was no formal funding for this study, and the researchers did not provide financial disclosures.

[email protected]

SOURCE: Wight JC et al. Br J Haematol. 2019 Jun 24. doi: 10.1111/bjh.16064.

Controlling CNS disease is “paramount” in treating diffuse large B-cell lymphoma with synchronous CNS and systemic disease (synDLBCL), according to researchers.

Nephron/Wikimedia Commons/CC BY-SA 3.0

In a retrospective study, the CNS was the most common site of relapse in patients with synDLBCL, and patients had better outcomes when they received CNS-directed therapy.

The 2-year progression-free survival rate was 50% in patients who received CNS-intensive therapy and 31% in those who received CNS-conservative therapy. The 2-year overall survival rate was 54% and 44%, respectively.

Dr. Joel C. Wight, of Austin Health in Heidelberg, Australia, and colleagues conducted this study and recounted their findings in the British Journal of Haematology.

The researchers retrospectively analyzed 80 patients with synDLBCL treated at 10 centers in Australia and the United Kingdom. Patients had DLBCL not otherwise specified (n = 67); high-grade B-cell lymphoma, including double-hit lymphoma (n = 12); or T-cell histiocyte-rich DLBCL (n = 1).

At baseline, all patients were treatment-naive, they had a median age of 64 years (range, 18-87 years), and 68% were male. Seventy percent of patients had high-risk disease according to the CNS International Prognostic Index (IPI), and 96% had non-CNS extranodal disease. The median number of extranodal sites outside the CNS was 2 (range, 0 to more than 10).

Patients were divided into those who received CNS-intensive therapy (n = 38) and those given CNS-conservative therapy (n = 42). The CNS-conservative group was significantly older (P less than .001), significantly more likely to have high-risk disease according to the National Comprehensive Cancer Network IPI (P = .009) or CNS IPI (P = .01) and significantly more likely to have leptomeningeal disease only (P less than .001).
 

Treatment

CNS-intensive therapy was defined as any established multiagent IV chemotherapy regimen with two or more CNS-penetrating drugs and cytarabine, with or without intrathecal chemotherapy and/or radiotherapy.

CNS-conservative therapy was defined as one or fewer IV CNS-penetrating chemotherapy agents in induction, with or without intrathecal chemotherapy and/or radiotherapy.

Systemic induction in the CNS-intensive group consisted of R-HyperCVAD (rituximab, hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with IV methotrexate and cytarabine) in 66% of patients and R-CODOX-M/IVAC (rituximab, hyperfractionated cyclophosphamide, vincristine, doxorubicin, methotrexate/ifosfamide, etoposide, cytarabine) in 24% of patients.

The most common systemic induction regimens in the CNS-conservative group were R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone) or CHOP-like regimens, given to 83% of patients.

CNS-directed IV therapy was given to 100% of the CNS-intensive group and 60% of the CNS-conservative group. This consisted of IV methotrexate plus cytarabine (97%) or MATRix (methotrexate, cytarabine, and thiotepa; 3%) in the CNS-intensive group and high-dose methotrexate in the conservative group.

Intrathecal chemotherapy was given to 97% of the CNS-intensive group and 60% of the CNS-conservative group. CNS-directed radiation was given to 32% and 19%, respectively.

Thirteen patients in the CNS-intensive group and one in the CNS-conservative group underwent autologous transplant as consolidation.

Outcomes

Dose reductions were more frequent in the CNS-conservative group than in the CNS-intensive group, at 48% and 18% (P = .009), as was early cessation of chemotherapy, at 52% and 18% (P = .002). Rates of treatment-related mortality were similar, at 13% in the CNS-intensive group and 12% in the CNS-conservative group.

At the end of induction, the complete response rate was 69% in the CNS-intensive group and 51% in the CNS-conservative group (P = .16). Primary refractory disease was observed in 19% and 38% of patients, respectively (P = .07).

The CNS was the most common site of relapse or progression (n = 28). CNS progression or relapse occurred in 25% of the CNS-intensive group and 49% of the CNS-conservative group (P = .03).

The 2-year progression-free survival rate was 50% for the CNS-intensive group and 31% for the CNS-conservative group (P = .006). The 2-year overall survival rate was 54% and 44%, respectively (P = .037).

When patients were matched for induction outcomes, consolidative transplant did not improve survival.

“The most significant factor affecting survival was the ability to control the CNS disease, which was improved by the addition of IV cytarabine to [high-dose methotrexate],” the researchers wrote.

“Whilst the younger age and more intensive systemic treatment of the CNS-intensive group may have contributed to the improved survival, it is clear that CNS disease control was substantially improved by the addition of cytarabine with lower rates of CNS relapse/progression observed.”

The researchers noted that “adequate control of the CNS disease is paramount and is best achieved by intensive CNS-directed induction.”

There was no formal funding for this study, and the researchers did not provide financial disclosures.

[email protected]

SOURCE: Wight JC et al. Br J Haematol. 2019 Jun 24. doi: 10.1111/bjh.16064.

MADRID – Initial results of an ongoing small pilot study of the anti-interferon gamma (IFN-gamma) monoclonal antibody emapalumab has demonstrated efficacy in the treatment of glucocorticoid-refractory macrophage activation syndrome (MAS) in patients with systemic juvenile idiopathic arthritis (SJIA).

Ted Bosworth/MDedge News

“By week 4 there was a complete response in all six patients treated. All of them had failed conventional therapy,” Fabrizio De Benedetti, MD, PhD, head of the division of rheumatology at IRCCS Ospedale Pediatrico Bambino Gesù, Rome, reported at the European Congress of Rheumatology.

The results are the first of a multicenter, pilot study with twin protocols in Europe and North America. Emapalumab (Gamifant) is already approved by the Food and Drug Administration for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) unresponsive to conventional therapy.

The study is enrolling children with MAS complicating SJIA that is unresponsive to high-dose intravenous glucocorticoids. Emapalumab, which has been shown to neutralize IFN-gamma in animal models, is being administered in an initial dose of 6 mg/kg followed by doses of 3 mg/kg every 3 days for 4 weeks.

MAS is a common complication of rheumatic diseases, particularly SJIA, according to Dr. De Benedetti. It has been characterized as a secondary form of HLH involving an excessive activation and expansion of macrophages as well as T cells. It can produce a wide variety of complications, including hepatosplenomegaly, liver dysfunction, and coagulation abnormalities. If uncontrolled, it can lead to organ failure and death.


Among the first six patients, four had confirmed SJIA and two had presumptive SJIA. The average age was 11 years with a range of 2 to 25 years. Four of the patients were female.

Many of the patients had failed therapies in addition to glucocorticoids, such as cyclosporine and anakinra. A diagnosis of HLH and prior treatment with a biologic therapy were exclusion criteria.

By 8 weeks, six had a complete response, which included the resolution of symptoms by normalization of ferritin, liver enzymes, and D-dimers. In three of the six patients, a complete response was achieved by week 4.

“Steroid tapering by investigator discretion was permitted, and four of the six patients had a meaningful tapering of steroids within 8 weeks,” Dr. De Benedetti reported.

Of the three serious adverse events recorded so far, only reactivation of cytomegalovirus (CMV) infection was attributed to emapalumab. This infection resolved with treatment. Several other infections observed over the course of the study were not thought to be related to treatment.

The initial results have encouraged an expansion of the study protocol in Europe where several treatment centers are expected to begin enrolling patients shortly. A second parallel study protocol will begin soon in North America, but no patient had been treated at the time that Dr. De Benedetti presented these initial findings.

Based on evidence that IFN-gamma drives hyperinflammation and hypercytokinemia in MAS, the initial results with emapalumab are encouraging, according to Dr. De Benedetti. He said the results not only provide evidence that emapalumab is active in MAS but support the pathogenic role of IFN-gamma in this disease.

Dr. De Benedetti reported financial relationships with multiple pharmaceutical companies, including SOBI, the sponsor of this study.

SOURCE: De Benedetti F et al. Ann Rheum Dis. Jun 2019;78(Suppl2):178. Abstract OPO204, doi: 10.1136/annrheumdis-2019-eular.3341.

MADRID – Initial results of an ongoing small pilot study of the anti-interferon gamma (IFN-gamma) monoclonal antibody emapalumab has demonstrated efficacy in the treatment of glucocorticoid-refractory macrophage activation syndrome (MAS) in patients with systemic juvenile idiopathic arthritis (SJIA).

Ted Bosworth/MDedge News

“By week 4 there was a complete response in all six patients treated. All of them had failed conventional therapy,” Fabrizio De Benedetti, MD, PhD, head of the division of rheumatology at IRCCS Ospedale Pediatrico Bambino Gesù, Rome, reported at the European Congress of Rheumatology.

The results are the first of a multicenter, pilot study with twin protocols in Europe and North America. Emapalumab (Gamifant) is already approved by the Food and Drug Administration for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) unresponsive to conventional therapy.

The study is enrolling children with MAS complicating SJIA that is unresponsive to high-dose intravenous glucocorticoids. Emapalumab, which has been shown to neutralize IFN-gamma in animal models, is being administered in an initial dose of 6 mg/kg followed by doses of 3 mg/kg every 3 days for 4 weeks.

MAS is a common complication of rheumatic diseases, particularly SJIA, according to Dr. De Benedetti. It has been characterized as a secondary form of HLH involving an excessive activation and expansion of macrophages as well as T cells. It can produce a wide variety of complications, including hepatosplenomegaly, liver dysfunction, and coagulation abnormalities. If uncontrolled, it can lead to organ failure and death.


Among the first six patients, four had confirmed SJIA and two had presumptive SJIA. The average age was 11 years with a range of 2 to 25 years. Four of the patients were female.

Many of the patients had failed therapies in addition to glucocorticoids, such as cyclosporine and anakinra. A diagnosis of HLH and prior treatment with a biologic therapy were exclusion criteria.

By 8 weeks, six had a complete response, which included the resolution of symptoms by normalization of ferritin, liver enzymes, and D-dimers. In three of the six patients, a complete response was achieved by week 4.

“Steroid tapering by investigator discretion was permitted, and four of the six patients had a meaningful tapering of steroids within 8 weeks,” Dr. De Benedetti reported.

Of the three serious adverse events recorded so far, only reactivation of cytomegalovirus (CMV) infection was attributed to emapalumab. This infection resolved with treatment. Several other infections observed over the course of the study were not thought to be related to treatment.

The initial results have encouraged an expansion of the study protocol in Europe where several treatment centers are expected to begin enrolling patients shortly. A second parallel study protocol will begin soon in North America, but no patient had been treated at the time that Dr. De Benedetti presented these initial findings.

Based on evidence that IFN-gamma drives hyperinflammation and hypercytokinemia in MAS, the initial results with emapalumab are encouraging, according to Dr. De Benedetti. He said the results not only provide evidence that emapalumab is active in MAS but support the pathogenic role of IFN-gamma in this disease.

Dr. De Benedetti reported financial relationships with multiple pharmaceutical companies, including SOBI, the sponsor of this study.

SOURCE: De Benedetti F et al. Ann Rheum Dis. Jun 2019;78(Suppl2):178. Abstract OPO204, doi: 10.1136/annrheumdis-2019-eular.3341.

MADRID – Initial results of an ongoing small pilot study of the anti-interferon gamma (IFN-gamma) monoclonal antibody emapalumab has demonstrated efficacy in the treatment of glucocorticoid-refractory macrophage activation syndrome (MAS) in patients with systemic juvenile idiopathic arthritis (SJIA).

Ted Bosworth/MDedge News

“By week 4 there was a complete response in all six patients treated. All of them had failed conventional therapy,” Fabrizio De Benedetti, MD, PhD, head of the division of rheumatology at IRCCS Ospedale Pediatrico Bambino Gesù, Rome, reported at the European Congress of Rheumatology.

The results are the first of a multicenter, pilot study with twin protocols in Europe and North America. Emapalumab (Gamifant) is already approved by the Food and Drug Administration for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) unresponsive to conventional therapy.

The study is enrolling children with MAS complicating SJIA that is unresponsive to high-dose intravenous glucocorticoids. Emapalumab, which has been shown to neutralize IFN-gamma in animal models, is being administered in an initial dose of 6 mg/kg followed by doses of 3 mg/kg every 3 days for 4 weeks.

MAS is a common complication of rheumatic diseases, particularly SJIA, according to Dr. De Benedetti. It has been characterized as a secondary form of HLH involving an excessive activation and expansion of macrophages as well as T cells. It can produce a wide variety of complications, including hepatosplenomegaly, liver dysfunction, and coagulation abnormalities. If uncontrolled, it can lead to organ failure and death.


Among the first six patients, four had confirmed SJIA and two had presumptive SJIA. The average age was 11 years with a range of 2 to 25 years. Four of the patients were female.

Many of the patients had failed therapies in addition to glucocorticoids, such as cyclosporine and anakinra. A diagnosis of HLH and prior treatment with a biologic therapy were exclusion criteria.

By 8 weeks, six had a complete response, which included the resolution of symptoms by normalization of ferritin, liver enzymes, and D-dimers. In three of the six patients, a complete response was achieved by week 4.

“Steroid tapering by investigator discretion was permitted, and four of the six patients had a meaningful tapering of steroids within 8 weeks,” Dr. De Benedetti reported.

Of the three serious adverse events recorded so far, only reactivation of cytomegalovirus (CMV) infection was attributed to emapalumab. This infection resolved with treatment. Several other infections observed over the course of the study were not thought to be related to treatment.

The initial results have encouraged an expansion of the study protocol in Europe where several treatment centers are expected to begin enrolling patients shortly. A second parallel study protocol will begin soon in North America, but no patient had been treated at the time that Dr. De Benedetti presented these initial findings.

Based on evidence that IFN-gamma drives hyperinflammation and hypercytokinemia in MAS, the initial results with emapalumab are encouraging, according to Dr. De Benedetti. He said the results not only provide evidence that emapalumab is active in MAS but support the pathogenic role of IFN-gamma in this disease.

Dr. De Benedetti reported financial relationships with multiple pharmaceutical companies, including SOBI, the sponsor of this study.

SOURCE: De Benedetti F et al. Ann Rheum Dis. Jun 2019;78(Suppl2):178. Abstract OPO204, doi: 10.1136/annrheumdis-2019-eular.3341.

MADRID – The efficacy results from new rheumatoid arthritis drugs tested in many phase 2 trials run over the past couple of decades have routinely overestimated the efficacy of many of the drugs tested when compared with how the same agents performed in subsequent phase 3 testing, according to an analysis of published results from 44 pairs of phase 2 and 3 trials.

MItchel L. Zoler/MDedge News

Based on the percentage of rheumatoid arthritis (RA) patients who showed an American College of Rheumatology 20% improvement (ACR20) in their joint symptoms, the 44 phase 2 trials overestimated efficacy by an average of 39% when compared with the ACR20 responses seen in paired phase 3 trials, Andreas Kerschbaumer, MD, said at the European Congress of Rheumatology. The ACR50 results overstated efficacy by an average of 34% when compared with phase 3 results for the same drugs, and the ACR70 endpoint showed drug efficacy that averaged 39% better during phase 2 studies than it did in the phase 3 trials. All three between-group differences were statistically significant, said Dr. Kerschbaumer, a rheumatologist at the Medical University of Vienna.

“Active treatment arms of phase 2 studies systematically overestimated efficacy when compared with subsequent phase 3 studies,” he said.

“Many researchers had already seen this, and realized that phase 2 trials often overestimated [efficacy], but no one has ever shown this systematically,” Dr. Kerschbaumer said in an interview. The same problem also appears to affect trials of oncology drugs, he noted, but a unique feature of RA studies allowed him and his colleagues to examine the ubiquity and persistence of this phase 2 bias in rheumatology trials over time: ongoing reliance during more than 2 decades of experience on the ACR20 response as the primary endpoint of RA drug trials. Even with this advantage, which allowed inclusion of 44 pairs of studies, “it was very surprising to find a statistically significant effect in the meta-analysis,” he said.

He and his associates also ran a further analysis that looked for measured parameters that showed significant correlation with mismatch of the phase 2 and 3 results, and this identified two apparently causal factors: having a low number of swollen and tender joints as an inclusion criterion for patients and using a 28-joint count rather than a 66-joint count for assessing disease activity during the study. The analysis lacked enough information to provide clear evidence on why these two aspects of patient assessment could lead to misleading phase 2 results, but Dr. Kerschbaumer believed the findings were clear enough to influence future trial design.

Going forward, trialists “should be very careful of how you include patients [in studies]. This is what our study shows. And they should not use 28 joints but 66. The higher the number of swollen and tender joints detected for study inclusion, the less the possibility to overestimate [efficacy]. It’s easier to achieve ACR20 when you look at fewer joints.”

Until now, companies that sponsor drug trials had an incentive to use a lower minimum number of swollen and tender joints for enrolled patients because it made enrollment easier, he noted. The downside, in addition to overstating efficacy at the phase 2 stage, is subjecting patients to treatments in phase 3 trials with a reduced likelihood for success.

Dr. Kerschbaumer offered two examples of drugs that showed promising RA efficacy based on ACR20 responses in phase 2 trial results that were followed by neutral phase 3 trial outcomes. One episode involved tabalumab (Ann Rheum Dis. 2015 Aug;74[8]:1567-70), and a second was a trial of fostamatinib (Arthritis Rheumatol. 2014 Dec;66[12]:3255-64).

The systematic review he led identified 44 study pairs run since the late 1990s that met all the study criteria, which covered 19 different drugs tested in more than 17,000 RA patients.

What the results showed was “just an association, so we must be careful not to overstate the results, but we saw something that may explain what people have seen [anecdotally] over the past 20 years,” he said. “Some people get very excited by phase 2 results, but we need to be careful about interpreting these outcomes.” Validation of the finding would require analysis of patient-level data, something that would be hard to obtain for a large number of phase 2 and 3 trials, Dr. Kerschbaumer noted.

Dr. Kerschbaumer has been a speaker on behalf of Bristol-Myers Squibb, Celgene, Merck Sharp & Dohme, and Pfizer.

[email protected]

SOURCE: Kerschbaumer A et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):191-2. Abstract OP0229, doi: 10.1136/annrheumdis-2019-eular.5161.

MADRID – The efficacy results from new rheumatoid arthritis drugs tested in many phase 2 trials run over the past couple of decades have routinely overestimated the efficacy of many of the drugs tested when compared with how the same agents performed in subsequent phase 3 testing, according to an analysis of published results from 44 pairs of phase 2 and 3 trials.

MItchel L. Zoler/MDedge News

Based on the percentage of rheumatoid arthritis (RA) patients who showed an American College of Rheumatology 20% improvement (ACR20) in their joint symptoms, the 44 phase 2 trials overestimated efficacy by an average of 39% when compared with the ACR20 responses seen in paired phase 3 trials, Andreas Kerschbaumer, MD, said at the European Congress of Rheumatology. The ACR50 results overstated efficacy by an average of 34% when compared with phase 3 results for the same drugs, and the ACR70 endpoint showed drug efficacy that averaged 39% better during phase 2 studies than it did in the phase 3 trials. All three between-group differences were statistically significant, said Dr. Kerschbaumer, a rheumatologist at the Medical University of Vienna.

“Active treatment arms of phase 2 studies systematically overestimated efficacy when compared with subsequent phase 3 studies,” he said.

“Many researchers had already seen this, and realized that phase 2 trials often overestimated [efficacy], but no one has ever shown this systematically,” Dr. Kerschbaumer said in an interview. The same problem also appears to affect trials of oncology drugs, he noted, but a unique feature of RA studies allowed him and his colleagues to examine the ubiquity and persistence of this phase 2 bias in rheumatology trials over time: ongoing reliance during more than 2 decades of experience on the ACR20 response as the primary endpoint of RA drug trials. Even with this advantage, which allowed inclusion of 44 pairs of studies, “it was very surprising to find a statistically significant effect in the meta-analysis,” he said.

He and his associates also ran a further analysis that looked for measured parameters that showed significant correlation with mismatch of the phase 2 and 3 results, and this identified two apparently causal factors: having a low number of swollen and tender joints as an inclusion criterion for patients and using a 28-joint count rather than a 66-joint count for assessing disease activity during the study. The analysis lacked enough information to provide clear evidence on why these two aspects of patient assessment could lead to misleading phase 2 results, but Dr. Kerschbaumer believed the findings were clear enough to influence future trial design.

Going forward, trialists “should be very careful of how you include patients [in studies]. This is what our study shows. And they should not use 28 joints but 66. The higher the number of swollen and tender joints detected for study inclusion, the less the possibility to overestimate [efficacy]. It’s easier to achieve ACR20 when you look at fewer joints.”

Until now, companies that sponsor drug trials had an incentive to use a lower minimum number of swollen and tender joints for enrolled patients because it made enrollment easier, he noted. The downside, in addition to overstating efficacy at the phase 2 stage, is subjecting patients to treatments in phase 3 trials with a reduced likelihood for success.

Dr. Kerschbaumer offered two examples of drugs that showed promising RA efficacy based on ACR20 responses in phase 2 trial results that were followed by neutral phase 3 trial outcomes. One episode involved tabalumab (Ann Rheum Dis. 2015 Aug;74[8]:1567-70), and a second was a trial of fostamatinib (Arthritis Rheumatol. 2014 Dec;66[12]:3255-64).

The systematic review he led identified 44 study pairs run since the late 1990s that met all the study criteria, which covered 19 different drugs tested in more than 17,000 RA patients.

What the results showed was “just an association, so we must be careful not to overstate the results, but we saw something that may explain what people have seen [anecdotally] over the past 20 years,” he said. “Some people get very excited by phase 2 results, but we need to be careful about interpreting these outcomes.” Validation of the finding would require analysis of patient-level data, something that would be hard to obtain for a large number of phase 2 and 3 trials, Dr. Kerschbaumer noted.

Dr. Kerschbaumer has been a speaker on behalf of Bristol-Myers Squibb, Celgene, Merck Sharp & Dohme, and Pfizer.

[email protected]

SOURCE: Kerschbaumer A et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):191-2. Abstract OP0229, doi: 10.1136/annrheumdis-2019-eular.5161.

MADRID – The efficacy results from new rheumatoid arthritis drugs tested in many phase 2 trials run over the past couple of decades have routinely overestimated the efficacy of many of the drugs tested when compared with how the same agents performed in subsequent phase 3 testing, according to an analysis of published results from 44 pairs of phase 2 and 3 trials.

MItchel L. Zoler/MDedge News

Based on the percentage of rheumatoid arthritis (RA) patients who showed an American College of Rheumatology 20% improvement (ACR20) in their joint symptoms, the 44 phase 2 trials overestimated efficacy by an average of 39% when compared with the ACR20 responses seen in paired phase 3 trials, Andreas Kerschbaumer, MD, said at the European Congress of Rheumatology. The ACR50 results overstated efficacy by an average of 34% when compared with phase 3 results for the same drugs, and the ACR70 endpoint showed drug efficacy that averaged 39% better during phase 2 studies than it did in the phase 3 trials. All three between-group differences were statistically significant, said Dr. Kerschbaumer, a rheumatologist at the Medical University of Vienna.

“Active treatment arms of phase 2 studies systematically overestimated efficacy when compared with subsequent phase 3 studies,” he said.

“Many researchers had already seen this, and realized that phase 2 trials often overestimated [efficacy], but no one has ever shown this systematically,” Dr. Kerschbaumer said in an interview. The same problem also appears to affect trials of oncology drugs, he noted, but a unique feature of RA studies allowed him and his colleagues to examine the ubiquity and persistence of this phase 2 bias in rheumatology trials over time: ongoing reliance during more than 2 decades of experience on the ACR20 response as the primary endpoint of RA drug trials. Even with this advantage, which allowed inclusion of 44 pairs of studies, “it was very surprising to find a statistically significant effect in the meta-analysis,” he said.

He and his associates also ran a further analysis that looked for measured parameters that showed significant correlation with mismatch of the phase 2 and 3 results, and this identified two apparently causal factors: having a low number of swollen and tender joints as an inclusion criterion for patients and using a 28-joint count rather than a 66-joint count for assessing disease activity during the study. The analysis lacked enough information to provide clear evidence on why these two aspects of patient assessment could lead to misleading phase 2 results, but Dr. Kerschbaumer believed the findings were clear enough to influence future trial design.

Going forward, trialists “should be very careful of how you include patients [in studies]. This is what our study shows. And they should not use 28 joints but 66. The higher the number of swollen and tender joints detected for study inclusion, the less the possibility to overestimate [efficacy]. It’s easier to achieve ACR20 when you look at fewer joints.”

Until now, companies that sponsor drug trials had an incentive to use a lower minimum number of swollen and tender joints for enrolled patients because it made enrollment easier, he noted. The downside, in addition to overstating efficacy at the phase 2 stage, is subjecting patients to treatments in phase 3 trials with a reduced likelihood for success.

Dr. Kerschbaumer offered two examples of drugs that showed promising RA efficacy based on ACR20 responses in phase 2 trial results that were followed by neutral phase 3 trial outcomes. One episode involved tabalumab (Ann Rheum Dis. 2015 Aug;74[8]:1567-70), and a second was a trial of fostamatinib (Arthritis Rheumatol. 2014 Dec;66[12]:3255-64).

The systematic review he led identified 44 study pairs run since the late 1990s that met all the study criteria, which covered 19 different drugs tested in more than 17,000 RA patients.

What the results showed was “just an association, so we must be careful not to overstate the results, but we saw something that may explain what people have seen [anecdotally] over the past 20 years,” he said. “Some people get very excited by phase 2 results, but we need to be careful about interpreting these outcomes.” Validation of the finding would require analysis of patient-level data, something that would be hard to obtain for a large number of phase 2 and 3 trials, Dr. Kerschbaumer noted.

Dr. Kerschbaumer has been a speaker on behalf of Bristol-Myers Squibb, Celgene, Merck Sharp & Dohme, and Pfizer.

[email protected]

SOURCE: Kerschbaumer A et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):191-2. Abstract OP0229, doi: 10.1136/annrheumdis-2019-eular.5161.

Christopher Moriates, MD, has been named executive director of the nonprofit health care organization Costs of Care (Boston). He replaces Neel Shah, MD, who was tabbed chairperson of the board.

Dr. Moriates serves a number of roles at the University of Texas at Austin. He is the assistant dean for health care value; associate chair for quality, safety and value; and associate professor of internal medicine.

In his role at Costs of Care, Dr. Moriates will direct an organization that uses feedback and stories from frontline physicians to help health systems provide high-quality care at lower costs.

Kai Mebust, MD, was recently named the new associate chief of medicine at Bassett Hospital (Cooperstown, N.Y.), where he has worked the past 15 years as a hospitalist and internist, serving as chief of hospitalists for the last decade. Dr. Mebust also completed his internship and residency at Bassett, and he is a fellow with the Society of Hospital Medicine.

Dr. Mebust will work closely with Dr. Charles Hyman, the center’s physician in chief, who is leaving the role at the end of the calendar year. Dr. Mebust will oversee inpatient services and be part of the transition process when Dr. Hyman departs.

Ronak Bhimani, MD, has been appointed chief medical officer at Lower Bucks Hospital (Bristol, Pa.). Dr. Bhimani moves over from Suburban Community Hospital (Norristown, Pa.), where he served as an academic hospitalist the past 2 years.

Previously, Dr. Bhimani was medical director of Kindred/Avalon Hospice and a core faculty member in the internal medicine program for residents at Suburban Community.

Danielle Prince, MD, was recently named associate medical director at St. Luke’s Siouxland PACE (Sioux City, Iowa), an affiliate of UnityPoint Health. Dr. Prince is a practicing hospitalist at UnityPoint Health St. Luke’s and served previously in as a family physician while working as chief medical informatics officer at Mercy Medical Center (Sioux City).

At Siouxland PACE, Dr. Prince will assist in managing the full-service care of elderly patients, including home health, specialty care, medications, transportation, and other therapies.

Alex Rankin, MD, has been named the new associate chief medical officer for the University of New Mexico Health Transfer Center and Patient Throughput in Albuquerque. A hospitalist with UNMH’s Family and Community Medicine department, Dr. Rankin was previously the medical director at the system’s 3 North facility since 2014.

Dr. Rankin came to UNMH after working for hospitals in Colorado and Nebraska and is a founding member of the UNMH patient flow committee, striving to improve patient care processes throughout the institution.

Tom Guirkin, MD, has been appointed vice president of medical affairs for Virginia Commonwealth University Community Memorial Hospital (South Hill, Va.). Dr. Guirkin, a Virginia native, returns to his home state after most recently overseeing the hospitalist group at Saint Francis Health System (Tulsa, Okla.).

Dr. Guirkin will have the opportunity to continue practicing medicine at CMH while helping to manage the quality management side of the business. He received his MBA from Virginia Commonwealth, working for James River Hospitalist Group in Richmond at the same time.

Alteon Health (Germantown, Md.) has become the manager of hospitalist services for three facilities in Maryland and Ohio, including Carroll Hospital (Westminster, Md.), Washington Adventist Hospital (Takoma Park, Md.), and University Hospitals Cleveland Medical Center.

At Carroll, Alteon physicians will provide critical care services in addition to hospitalist duties. Alteon has been Carroll’s emergency medicine provider for more than two decades.

At Washington Adventist, Alteon will take over the hospitalist program, adding to the emergency medicine services it has provided since 1991 and critical care services it has managed since 1996.

At UH Cleveland, Alteon will assume hospitalist management at its third University Hospitals facility. Alteon controls emergency medicine at 14 UH locations as well. UH Cleveland is an affiliate of Case Western Reserve University.

Christopher Moriates, MD, has been named executive director of the nonprofit health care organization Costs of Care (Boston). He replaces Neel Shah, MD, who was tabbed chairperson of the board.

Dr. Moriates serves a number of roles at the University of Texas at Austin. He is the assistant dean for health care value; associate chair for quality, safety and value; and associate professor of internal medicine.

In his role at Costs of Care, Dr. Moriates will direct an organization that uses feedback and stories from frontline physicians to help health systems provide high-quality care at lower costs.

Kai Mebust, MD, was recently named the new associate chief of medicine at Bassett Hospital (Cooperstown, N.Y.), where he has worked the past 15 years as a hospitalist and internist, serving as chief of hospitalists for the last decade. Dr. Mebust also completed his internship and residency at Bassett, and he is a fellow with the Society of Hospital Medicine.

Dr. Mebust will work closely with Dr. Charles Hyman, the center’s physician in chief, who is leaving the role at the end of the calendar year. Dr. Mebust will oversee inpatient services and be part of the transition process when Dr. Hyman departs.

Ronak Bhimani, MD, has been appointed chief medical officer at Lower Bucks Hospital (Bristol, Pa.). Dr. Bhimani moves over from Suburban Community Hospital (Norristown, Pa.), where he served as an academic hospitalist the past 2 years.

Previously, Dr. Bhimani was medical director of Kindred/Avalon Hospice and a core faculty member in the internal medicine program for residents at Suburban Community.

Danielle Prince, MD, was recently named associate medical director at St. Luke’s Siouxland PACE (Sioux City, Iowa), an affiliate of UnityPoint Health. Dr. Prince is a practicing hospitalist at UnityPoint Health St. Luke’s and served previously in as a family physician while working as chief medical informatics officer at Mercy Medical Center (Sioux City).

At Siouxland PACE, Dr. Prince will assist in managing the full-service care of elderly patients, including home health, specialty care, medications, transportation, and other therapies.

Alex Rankin, MD, has been named the new associate chief medical officer for the University of New Mexico Health Transfer Center and Patient Throughput in Albuquerque. A hospitalist with UNMH’s Family and Community Medicine department, Dr. Rankin was previously the medical director at the system’s 3 North facility since 2014.

Dr. Rankin came to UNMH after working for hospitals in Colorado and Nebraska and is a founding member of the UNMH patient flow committee, striving to improve patient care processes throughout the institution.

Tom Guirkin, MD, has been appointed vice president of medical affairs for Virginia Commonwealth University Community Memorial Hospital (South Hill, Va.). Dr. Guirkin, a Virginia native, returns to his home state after most recently overseeing the hospitalist group at Saint Francis Health System (Tulsa, Okla.).

Dr. Guirkin will have the opportunity to continue practicing medicine at CMH while helping to manage the quality management side of the business. He received his MBA from Virginia Commonwealth, working for James River Hospitalist Group in Richmond at the same time.

Alteon Health (Germantown, Md.) has become the manager of hospitalist services for three facilities in Maryland and Ohio, including Carroll Hospital (Westminster, Md.), Washington Adventist Hospital (Takoma Park, Md.), and University Hospitals Cleveland Medical Center.

At Carroll, Alteon physicians will provide critical care services in addition to hospitalist duties. Alteon has been Carroll’s emergency medicine provider for more than two decades.

At Washington Adventist, Alteon will take over the hospitalist program, adding to the emergency medicine services it has provided since 1991 and critical care services it has managed since 1996.

At UH Cleveland, Alteon will assume hospitalist management at its third University Hospitals facility. Alteon controls emergency medicine at 14 UH locations as well. UH Cleveland is an affiliate of Case Western Reserve University.

Christopher Moriates, MD, has been named executive director of the nonprofit health care organization Costs of Care (Boston). He replaces Neel Shah, MD, who was tabbed chairperson of the board.

Dr. Moriates serves a number of roles at the University of Texas at Austin. He is the assistant dean for health care value; associate chair for quality, safety and value; and associate professor of internal medicine.

In his role at Costs of Care, Dr. Moriates will direct an organization that uses feedback and stories from frontline physicians to help health systems provide high-quality care at lower costs.

Kai Mebust, MD, was recently named the new associate chief of medicine at Bassett Hospital (Cooperstown, N.Y.), where he has worked the past 15 years as a hospitalist and internist, serving as chief of hospitalists for the last decade. Dr. Mebust also completed his internship and residency at Bassett, and he is a fellow with the Society of Hospital Medicine.

Dr. Mebust will work closely with Dr. Charles Hyman, the center’s physician in chief, who is leaving the role at the end of the calendar year. Dr. Mebust will oversee inpatient services and be part of the transition process when Dr. Hyman departs.

Ronak Bhimani, MD, has been appointed chief medical officer at Lower Bucks Hospital (Bristol, Pa.). Dr. Bhimani moves over from Suburban Community Hospital (Norristown, Pa.), where he served as an academic hospitalist the past 2 years.

Previously, Dr. Bhimani was medical director of Kindred/Avalon Hospice and a core faculty member in the internal medicine program for residents at Suburban Community.

Danielle Prince, MD, was recently named associate medical director at St. Luke’s Siouxland PACE (Sioux City, Iowa), an affiliate of UnityPoint Health. Dr. Prince is a practicing hospitalist at UnityPoint Health St. Luke’s and served previously in as a family physician while working as chief medical informatics officer at Mercy Medical Center (Sioux City).

At Siouxland PACE, Dr. Prince will assist in managing the full-service care of elderly patients, including home health, specialty care, medications, transportation, and other therapies.

Alex Rankin, MD, has been named the new associate chief medical officer for the University of New Mexico Health Transfer Center and Patient Throughput in Albuquerque. A hospitalist with UNMH’s Family and Community Medicine department, Dr. Rankin was previously the medical director at the system’s 3 North facility since 2014.

Dr. Rankin came to UNMH after working for hospitals in Colorado and Nebraska and is a founding member of the UNMH patient flow committee, striving to improve patient care processes throughout the institution.

Tom Guirkin, MD, has been appointed vice president of medical affairs for Virginia Commonwealth University Community Memorial Hospital (South Hill, Va.). Dr. Guirkin, a Virginia native, returns to his home state after most recently overseeing the hospitalist group at Saint Francis Health System (Tulsa, Okla.).

Dr. Guirkin will have the opportunity to continue practicing medicine at CMH while helping to manage the quality management side of the business. He received his MBA from Virginia Commonwealth, working for James River Hospitalist Group in Richmond at the same time.

Alteon Health (Germantown, Md.) has become the manager of hospitalist services for three facilities in Maryland and Ohio, including Carroll Hospital (Westminster, Md.), Washington Adventist Hospital (Takoma Park, Md.), and University Hospitals Cleveland Medical Center.

At Carroll, Alteon physicians will provide critical care services in addition to hospitalist duties. Alteon has been Carroll’s emergency medicine provider for more than two decades.

At Washington Adventist, Alteon will take over the hospitalist program, adding to the emergency medicine services it has provided since 1991 and critical care services it has managed since 1996.

At UH Cleveland, Alteon will assume hospitalist management at its third University Hospitals facility. Alteon controls emergency medicine at 14 UH locations as well. UH Cleveland is an affiliate of Case Western Reserve University.

SAN FRANCISCO – Used appropriately, the benefits of benzodiazepines far outweigh the risks in elderly people, according to Carl Salzman, MD, a psychiatry professor at Harvard Medical School, Boston.

M. Alexander Otto/MDedge News

Appropriate use means very low doses – 0.5 mg or less every day or b.i.d. – of short-acting benzodiazepines, either lorazepam, oxazepam, or temazepam. There’s no worry of dose escalation or addiction in the elderly, and since the drugs are not metabolized by the cytochrome P450 system, the risk of drug interactions is very small, except for a compounding effect with alcohol and other sedative hypnotics, such as zolpidem (Ambien). The fall risk is lower than it is with antidepressants and antipsychotics (Psychiatr Serv. 2003 Jul;54[7]:1006-1); (Arch Intern Med. 2009 Nov 23;169[21]:1952-60).

In short, the drugs are “wonderful” for geriatric anxiety and anxiety-related insomnia, Dr. Salzman said at the American Psychiatric Association annual meeting.

Even so, it’s “very hard to get doctors and residents to prescribe them.” It’s like the benzodiazepine scare in the 1980s, about valium. “Newspapers were filled with stories about addicts. I’m having a little bit of déjà vu all over again,” he said.

This time around, the problem is a concern that benzodiazepines cause Alzheimer’s disease, plus collateral damage from the opioid crisis. People with addiction to opioids like benzodiazepines, because they boost the high, so they have significant street value, and drug seekers demand them in the clinic. Some clinicians would rather not deal with the drugs at all.

The Alzheimer’s worry stems largely from a widely reported review that found an association between Alzheimer’s disease and previous benzodiazepine use. The finding was based on public health insurance data from Quebec; no patients were seen (BMJ. 2014 Sep 9;349:g5205).

Among many “very large questions” about the study’s validity, people “may have been on benzos because they already had memory impairment and were anxious about it,” a common occurrence. In that case, “it’s not that benzos caused dementia; it was the other way around.” Also, there was no control for substance and alcohol use, Dr. Salzman said (J Clin Psychopharmacol. 2015 Feb;35[1]:1-3).

A more robust study followed patients 65 years and older for a mean of 7.3 years, comparing benzodiazepine users to nonusers. The team found a slightly higher risk of dementia in people with minimal exposure to benzodiazepines but not with the highest level of exposure, and concluded that the finding did “not support a causal association between benzodiazepine use and dementia” (BMJ. 2016 Feb 2;352:i90).

Meanwhile, a recent review of more than a million patients found either no or a minor increased risk of mortality, another concern with benzodiazepines in the elderly. “If a detrimental effect exists, it is likely to be much smaller than previously stated and to have uncertain clinical relevance. Residual confounding likely explains at least part of” it, the investigators concluded (BMJ. 2017 Jul 6;358:j294).

To be sure, short-term memory loss can occur with benzodiazepines, but patients did not seem to mind in a study Dr. Salzman conducted years ago in an upscale nursing home in Boston. A “dramatic” rebound was reported in short-term recall 2 weeks after volunteers tapered off benzodiazepines, mostly lorazepam, compared with those who stayed on them.

“I sat down to have lunch with the discontinuers, and I said to them, ‘Aren’t you glad that you are not taking these horrible drugs anymore, and your memory is so much better? They said, ‘No, what’s to remember? It was true that when we were taking those drugs, we might not have remembered what we watched on television the night before, but if you give a choice between feeling calm in the days, sleeping at night, and remembering what we watch on television, we’ll take the calm and the sleep every time,’ ” Dr. Salzman said.

He had no disclosures.

[email protected]

SAN FRANCISCO – Used appropriately, the benefits of benzodiazepines far outweigh the risks in elderly people, according to Carl Salzman, MD, a psychiatry professor at Harvard Medical School, Boston.

M. Alexander Otto/MDedge News

Appropriate use means very low doses – 0.5 mg or less every day or b.i.d. – of short-acting benzodiazepines, either lorazepam, oxazepam, or temazepam. There’s no worry of dose escalation or addiction in the elderly, and since the drugs are not metabolized by the cytochrome P450 system, the risk of drug interactions is very small, except for a compounding effect with alcohol and other sedative hypnotics, such as zolpidem (Ambien). The fall risk is lower than it is with antidepressants and antipsychotics (Psychiatr Serv. 2003 Jul;54[7]:1006-1); (Arch Intern Med. 2009 Nov 23;169[21]:1952-60).

In short, the drugs are “wonderful” for geriatric anxiety and anxiety-related insomnia, Dr. Salzman said at the American Psychiatric Association annual meeting.

Even so, it’s “very hard to get doctors and residents to prescribe them.” It’s like the benzodiazepine scare in the 1980s, about valium. “Newspapers were filled with stories about addicts. I’m having a little bit of déjà vu all over again,” he said.

This time around, the problem is a concern that benzodiazepines cause Alzheimer’s disease, plus collateral damage from the opioid crisis. People with addiction to opioids like benzodiazepines, because they boost the high, so they have significant street value, and drug seekers demand them in the clinic. Some clinicians would rather not deal with the drugs at all.

The Alzheimer’s worry stems largely from a widely reported review that found an association between Alzheimer’s disease and previous benzodiazepine use. The finding was based on public health insurance data from Quebec; no patients were seen (BMJ. 2014 Sep 9;349:g5205).

Among many “very large questions” about the study’s validity, people “may have been on benzos because they already had memory impairment and were anxious about it,” a common occurrence. In that case, “it’s not that benzos caused dementia; it was the other way around.” Also, there was no control for substance and alcohol use, Dr. Salzman said (J Clin Psychopharmacol. 2015 Feb;35[1]:1-3).

A more robust study followed patients 65 years and older for a mean of 7.3 years, comparing benzodiazepine users to nonusers. The team found a slightly higher risk of dementia in people with minimal exposure to benzodiazepines but not with the highest level of exposure, and concluded that the finding did “not support a causal association between benzodiazepine use and dementia” (BMJ. 2016 Feb 2;352:i90).

Meanwhile, a recent review of more than a million patients found either no or a minor increased risk of mortality, another concern with benzodiazepines in the elderly. “If a detrimental effect exists, it is likely to be much smaller than previously stated and to have uncertain clinical relevance. Residual confounding likely explains at least part of” it, the investigators concluded (BMJ. 2017 Jul 6;358:j294).

To be sure, short-term memory loss can occur with benzodiazepines, but patients did not seem to mind in a study Dr. Salzman conducted years ago in an upscale nursing home in Boston. A “dramatic” rebound was reported in short-term recall 2 weeks after volunteers tapered off benzodiazepines, mostly lorazepam, compared with those who stayed on them.

“I sat down to have lunch with the discontinuers, and I said to them, ‘Aren’t you glad that you are not taking these horrible drugs anymore, and your memory is so much better? They said, ‘No, what’s to remember? It was true that when we were taking those drugs, we might not have remembered what we watched on television the night before, but if you give a choice between feeling calm in the days, sleeping at night, and remembering what we watch on television, we’ll take the calm and the sleep every time,’ ” Dr. Salzman said.

He had no disclosures.

[email protected]

SAN FRANCISCO – Used appropriately, the benefits of benzodiazepines far outweigh the risks in elderly people, according to Carl Salzman, MD, a psychiatry professor at Harvard Medical School, Boston.

M. Alexander Otto/MDedge News

Appropriate use means very low doses – 0.5 mg or less every day or b.i.d. – of short-acting benzodiazepines, either lorazepam, oxazepam, or temazepam. There’s no worry of dose escalation or addiction in the elderly, and since the drugs are not metabolized by the cytochrome P450 system, the risk of drug interactions is very small, except for a compounding effect with alcohol and other sedative hypnotics, such as zolpidem (Ambien). The fall risk is lower than it is with antidepressants and antipsychotics (Psychiatr Serv. 2003 Jul;54[7]:1006-1); (Arch Intern Med. 2009 Nov 23;169[21]:1952-60).

In short, the drugs are “wonderful” for geriatric anxiety and anxiety-related insomnia, Dr. Salzman said at the American Psychiatric Association annual meeting.

Even so, it’s “very hard to get doctors and residents to prescribe them.” It’s like the benzodiazepine scare in the 1980s, about valium. “Newspapers were filled with stories about addicts. I’m having a little bit of déjà vu all over again,” he said.

This time around, the problem is a concern that benzodiazepines cause Alzheimer’s disease, plus collateral damage from the opioid crisis. People with addiction to opioids like benzodiazepines, because they boost the high, so they have significant street value, and drug seekers demand them in the clinic. Some clinicians would rather not deal with the drugs at all.

The Alzheimer’s worry stems largely from a widely reported review that found an association between Alzheimer’s disease and previous benzodiazepine use. The finding was based on public health insurance data from Quebec; no patients were seen (BMJ. 2014 Sep 9;349:g5205).

Among many “very large questions” about the study’s validity, people “may have been on benzos because they already had memory impairment and were anxious about it,” a common occurrence. In that case, “it’s not that benzos caused dementia; it was the other way around.” Also, there was no control for substance and alcohol use, Dr. Salzman said (J Clin Psychopharmacol. 2015 Feb;35[1]:1-3).

A more robust study followed patients 65 years and older for a mean of 7.3 years, comparing benzodiazepine users to nonusers. The team found a slightly higher risk of dementia in people with minimal exposure to benzodiazepines but not with the highest level of exposure, and concluded that the finding did “not support a causal association between benzodiazepine use and dementia” (BMJ. 2016 Feb 2;352:i90).

Meanwhile, a recent review of more than a million patients found either no or a minor increased risk of mortality, another concern with benzodiazepines in the elderly. “If a detrimental effect exists, it is likely to be much smaller than previously stated and to have uncertain clinical relevance. Residual confounding likely explains at least part of” it, the investigators concluded (BMJ. 2017 Jul 6;358:j294).

To be sure, short-term memory loss can occur with benzodiazepines, but patients did not seem to mind in a study Dr. Salzman conducted years ago in an upscale nursing home in Boston. A “dramatic” rebound was reported in short-term recall 2 weeks after volunteers tapered off benzodiazepines, mostly lorazepam, compared with those who stayed on them.

“I sat down to have lunch with the discontinuers, and I said to them, ‘Aren’t you glad that you are not taking these horrible drugs anymore, and your memory is so much better? They said, ‘No, what’s to remember? It was true that when we were taking those drugs, we might not have remembered what we watched on television the night before, but if you give a choice between feeling calm in the days, sleeping at night, and remembering what we watch on television, we’ll take the calm and the sleep every time,’ ” Dr. Salzman said.

He had no disclosures.

[email protected]