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Free testosterone linked to frailty in older men
A new study provides more evidence of a link between lower free testosterone levels and higher levels of frailty in older men, but a researcher says proof of a causal connection remains elusive.
“Our study demonstrates clear associations between testosterone and frailty progression, and, although causality and directionality of the hormone/frailty relationships require clarification, the results presented here make a strong case for large interventional trials of testosterone therapy in frail men to determine whether such treatment would be beneficial,” lead author Agnieszka Swiecicka, MD, of the andrology research unit in the division of diabetes, endocrinology, and gastroenterology at the University of Manchester (England), said in an interview.
As Dr. Swiecicka noted, “in men, testosterone levels decline with age, and it has been suggested that this phenomenon might play a role in the development of frailty.”
However, evidence is limited, and studies have offered conflicting results Dr. Swiecicka said.
For the new study, the researchers prospectively tracked 3,369 community-dwelling men aged 40-79 years from eight European centers. Hundreds were excluded for various reasons or lost to follow-up, and 2,278 men were ultimately included.
The average age was 58 years, and the average body mass index was 28 kg/m2.
Hormone measurements were performed, and frailty was tracked via frailty status (FS, n = 2,278) and frailty phenotype (FP, n = 1,980).
After adjusting their statistics to account for various factors, the researchers were able to link only free testosterone – and not testosterone or dihydrotestosterone – to changes in frailty index (FI). They linked each standard deviation improvement in free testosterone level at baseline to a –2.8% change in FI over 4 years (95% confidence interval, –4.9 to –0.3, P = .030).
“Higher free testosterone levels were associated with a lower risk of worsening frailty status. The direction of this association was consistent regardless of the frailty construct used (FI and FP),” Dr. Swiecicka said. “Higher androgen remained significantly associated with improving frailty status, as assessed by FI, despite age adjustment, suggesting that these relationships cannot be explained by age-related differences in androgen levels.”
Overall, “sex hormones are associated with the development/worsening of frailty in middle-aged and older men, but these relationships vary between different constructs of frailty assessment,” Dr. Swiecicka said. “In light of the findings, a therapeutic role for testosterone in the context of physical frailty prevention or alleviation remains an attractive possibility that should be further explored.”
The study was published in the Journal of Clinical Endocrinology and Metabolism.
In an interview, Steve Borst, PhD, of the University of Florida, questioned the study’s approach because it looks only at baseline hormone levels. “What would be much more interesting to study would be changes in hormone levels vs. changes in frailty,” he said.
Dr. Borst added that researchers already know that “the relationship between testosterone and frailty is both large in magnitude and causal in nature.”
He pointed to his group’s research that linked testosterone injections to an increase in muscle strength, and he said others have linked testosterone administration to an increase in bone density. “While these measures are not exactly the same as frailty index,” he said, “it is well established that lower body muscle strength keeps older people in an independent living state and that the changes in bone mineral density are enough to account for protection against fracture.”
John Morley, MBBCh, of Saint Louis University, said in an interview that testosterone has a role in combating frailty. “But it’s not like it’s going to turn people into super people,” he said.
He added that “we shouldn’t say ‘Let’s do testosterone before we do exercise.’ It’s better to do resistance exercise than it is to take testosterone. But most older males are loath to do any physical work to make themselves better. That’s just human nature.”
The study was funded by various European research-based organizations. The study authors reported multiple disclosures. Dr. Morley reports no disclosures.
SOURCE: Swiecicka A et al. J Clin Endocrinol Metab. 2018 Feb;103(2):701-9.
A new study provides more evidence of a link between lower free testosterone levels and higher levels of frailty in older men, but a researcher says proof of a causal connection remains elusive.
“Our study demonstrates clear associations between testosterone and frailty progression, and, although causality and directionality of the hormone/frailty relationships require clarification, the results presented here make a strong case for large interventional trials of testosterone therapy in frail men to determine whether such treatment would be beneficial,” lead author Agnieszka Swiecicka, MD, of the andrology research unit in the division of diabetes, endocrinology, and gastroenterology at the University of Manchester (England), said in an interview.
As Dr. Swiecicka noted, “in men, testosterone levels decline with age, and it has been suggested that this phenomenon might play a role in the development of frailty.”
However, evidence is limited, and studies have offered conflicting results Dr. Swiecicka said.
For the new study, the researchers prospectively tracked 3,369 community-dwelling men aged 40-79 years from eight European centers. Hundreds were excluded for various reasons or lost to follow-up, and 2,278 men were ultimately included.
The average age was 58 years, and the average body mass index was 28 kg/m2.
Hormone measurements were performed, and frailty was tracked via frailty status (FS, n = 2,278) and frailty phenotype (FP, n = 1,980).
After adjusting their statistics to account for various factors, the researchers were able to link only free testosterone – and not testosterone or dihydrotestosterone – to changes in frailty index (FI). They linked each standard deviation improvement in free testosterone level at baseline to a –2.8% change in FI over 4 years (95% confidence interval, –4.9 to –0.3, P = .030).
“Higher free testosterone levels were associated with a lower risk of worsening frailty status. The direction of this association was consistent regardless of the frailty construct used (FI and FP),” Dr. Swiecicka said. “Higher androgen remained significantly associated with improving frailty status, as assessed by FI, despite age adjustment, suggesting that these relationships cannot be explained by age-related differences in androgen levels.”
Overall, “sex hormones are associated with the development/worsening of frailty in middle-aged and older men, but these relationships vary between different constructs of frailty assessment,” Dr. Swiecicka said. “In light of the findings, a therapeutic role for testosterone in the context of physical frailty prevention or alleviation remains an attractive possibility that should be further explored.”
The study was published in the Journal of Clinical Endocrinology and Metabolism.
In an interview, Steve Borst, PhD, of the University of Florida, questioned the study’s approach because it looks only at baseline hormone levels. “What would be much more interesting to study would be changes in hormone levels vs. changes in frailty,” he said.
Dr. Borst added that researchers already know that “the relationship between testosterone and frailty is both large in magnitude and causal in nature.”
He pointed to his group’s research that linked testosterone injections to an increase in muscle strength, and he said others have linked testosterone administration to an increase in bone density. “While these measures are not exactly the same as frailty index,” he said, “it is well established that lower body muscle strength keeps older people in an independent living state and that the changes in bone mineral density are enough to account for protection against fracture.”
John Morley, MBBCh, of Saint Louis University, said in an interview that testosterone has a role in combating frailty. “But it’s not like it’s going to turn people into super people,” he said.
He added that “we shouldn’t say ‘Let’s do testosterone before we do exercise.’ It’s better to do resistance exercise than it is to take testosterone. But most older males are loath to do any physical work to make themselves better. That’s just human nature.”
The study was funded by various European research-based organizations. The study authors reported multiple disclosures. Dr. Morley reports no disclosures.
SOURCE: Swiecicka A et al. J Clin Endocrinol Metab. 2018 Feb;103(2):701-9.
A new study provides more evidence of a link between lower free testosterone levels and higher levels of frailty in older men, but a researcher says proof of a causal connection remains elusive.
“Our study demonstrates clear associations between testosterone and frailty progression, and, although causality and directionality of the hormone/frailty relationships require clarification, the results presented here make a strong case for large interventional trials of testosterone therapy in frail men to determine whether such treatment would be beneficial,” lead author Agnieszka Swiecicka, MD, of the andrology research unit in the division of diabetes, endocrinology, and gastroenterology at the University of Manchester (England), said in an interview.
As Dr. Swiecicka noted, “in men, testosterone levels decline with age, and it has been suggested that this phenomenon might play a role in the development of frailty.”
However, evidence is limited, and studies have offered conflicting results Dr. Swiecicka said.
For the new study, the researchers prospectively tracked 3,369 community-dwelling men aged 40-79 years from eight European centers. Hundreds were excluded for various reasons or lost to follow-up, and 2,278 men were ultimately included.
The average age was 58 years, and the average body mass index was 28 kg/m2.
Hormone measurements were performed, and frailty was tracked via frailty status (FS, n = 2,278) and frailty phenotype (FP, n = 1,980).
After adjusting their statistics to account for various factors, the researchers were able to link only free testosterone – and not testosterone or dihydrotestosterone – to changes in frailty index (FI). They linked each standard deviation improvement in free testosterone level at baseline to a –2.8% change in FI over 4 years (95% confidence interval, –4.9 to –0.3, P = .030).
“Higher free testosterone levels were associated with a lower risk of worsening frailty status. The direction of this association was consistent regardless of the frailty construct used (FI and FP),” Dr. Swiecicka said. “Higher androgen remained significantly associated with improving frailty status, as assessed by FI, despite age adjustment, suggesting that these relationships cannot be explained by age-related differences in androgen levels.”
Overall, “sex hormones are associated with the development/worsening of frailty in middle-aged and older men, but these relationships vary between different constructs of frailty assessment,” Dr. Swiecicka said. “In light of the findings, a therapeutic role for testosterone in the context of physical frailty prevention or alleviation remains an attractive possibility that should be further explored.”
The study was published in the Journal of Clinical Endocrinology and Metabolism.
In an interview, Steve Borst, PhD, of the University of Florida, questioned the study’s approach because it looks only at baseline hormone levels. “What would be much more interesting to study would be changes in hormone levels vs. changes in frailty,” he said.
Dr. Borst added that researchers already know that “the relationship between testosterone and frailty is both large in magnitude and causal in nature.”
He pointed to his group’s research that linked testosterone injections to an increase in muscle strength, and he said others have linked testosterone administration to an increase in bone density. “While these measures are not exactly the same as frailty index,” he said, “it is well established that lower body muscle strength keeps older people in an independent living state and that the changes in bone mineral density are enough to account for protection against fracture.”
John Morley, MBBCh, of Saint Louis University, said in an interview that testosterone has a role in combating frailty. “But it’s not like it’s going to turn people into super people,” he said.
He added that “we shouldn’t say ‘Let’s do testosterone before we do exercise.’ It’s better to do resistance exercise than it is to take testosterone. But most older males are loath to do any physical work to make themselves better. That’s just human nature.”
The study was funded by various European research-based organizations. The study authors reported multiple disclosures. Dr. Morley reports no disclosures.
SOURCE: Swiecicka A et al. J Clin Endocrinol Metab. 2018 Feb;103(2):701-9.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM
Key clinical point: Free testosterone levels are linked to frailty in older men.
Major finding: For each standard deviation improvement in free testosterone level at baseline, frailty index was 2.8% lower at 4 years. (95% CI, –4.9% to –0.3%, P = .030)
Study details: Prospective cohort study of 3,369 men aged 40-79 years at eight European centers.
Disclosures: The study was funded by various European research-based organizations. The investigators reported multiple disclosures.
Source: Swiecicka A et al. J Clin Endocrinol Metab. 2018 Feb;103(2):701-9.
Study: Natpara slightly boosts health-related QoL in hypoparathyroidism
A new industry-funded analysis suggests that recombinant human parathyroid hormone, an extraordinarily expensive treatment for hypoparathyroidism, produces slight improvement in some health-related quality of life (HRQoL) domains.
While researchers didn’t find any statistically significant between-group differences vs. a placebo, the study lead author said the positive findings about within-group differences reflect her experiences with some patients. “They’re telling me they feel much better, and they don’t have emergency room visits,” endocrinologist Tamara J. Vokes, MD, of the University of Chicago, said in an interview.
And, she said, as reflected in the findings, she’s seen that those with the lowest HRQoL levels at baseline especially show signs of improvement.
The treatment, known as rhPTH(1-84) or Natpara, was approved by the Food and Drug Administration as a treatment for hypoparathyroidism in 2015. The FDA stated that the drug “is only for people who do not respond well to treatment with calcium and active forms of vitamin D alone, because it may increase the possible risk of bone cancer, known as osteosarcoma.”
Pharmacies list the drug as costing $9,500-$9,900 per month with a coupon or discount. According to the new study, research has shown that quality of life is often impaired in patients who have tried the traditional hypoparathyroidism treatments of calcium supplements and vitamin D. Dr. Vokes and her colleagues aimed to expand upon previous studies of HRQoL that did not reach conclusions or failed to include controls.
They examined findings of a previous multinational, randomized, placebo-controlled study of 122 adults with hypoparathyroidism. Average age was 48 years, and roughly 80% of the patients were women.
After their serum calcium levels were adjusted through medication, the patients were randomly assigned to placebo (n = 39) or rhPTH(1-84) (n = 83, starting dose of 50 mg/d that could be raised to 100 mg/d).
The study, which appears in the Journal of Clinical Endocrinology and Metabolism, analyzes the changes in HRQoL from baseline to 24 weeks per the 36-Item Short-Form Health Survey (SF-36).
The researchers found no significant between-group differences. However, those who took the drug did see statistically significant improvements in 4 of 10 domains: physical component summary score (P = .004), body pain (P = .05), general health (P = .05), and vitality (P less than .001). The changes were small, with the vitality score improving the most, from a mean SF-36 score of 49.5 to 53.
In some cases, she said, she’s seen QoL improve in patients whom she normally wouldn’t consider candidates for the medication. “I would have not have recommended PTH for them, but they insisted on taking it, and they report feeling better.”
This may be a placebo effect, she said. Even so, “if someone doesn’t feel well, it’s worth it at least to try to use PTH and see whether they improve.”
She added that lack of well-being is a preexisting condition for some hypoparathyroidism patients. “I’ve seen quite a number of them who have what we call premorbid personality disorder. They didn’t feel well and weren’t happy, and when you get hypoparathyroidism, you’re more unwell and unhappy.”
With medication, however, “you’re a bit less unhappy but you’re still miserable,” she said.
Carol Greenlee, MD, an endocrinologist in Grand Junction, Colo., said in an interview that she saw a patient in a clinical study who had experienced a marked improvement in QoL. However, she said, “it will be the cost of the PTH that is the burden.”
For her part, Dr. Vokes cautioned that it’s important to take special care with patients taking Natpara. “You can’t just give this injection and say, ‘Goodbye, you will be better.’ It requires following certain protocol, frequent monitoring of the blood levels. Be sure the patient has access to the lab, and insurance that covers the test.”
Dr. Greenlee reported no relevant disclosures. The study was funded by Shire Human Genetic Therapies, and the initial clinical trial was funded by NPS Pharmaceuticals, a wholly owned indirect subsidiary. Dr. Vokes reported consulting for Shire and serving as an investigator for the initial clinical trial. Other study authors reported serving as clinical investigators and/or consulting for Shire, and three authors are employees of Shire.
SOURCE: Vokes, TJ et al. J Clin Endocrinol Metab. 2018 Feb 1;103(2):722-31
A new industry-funded analysis suggests that recombinant human parathyroid hormone, an extraordinarily expensive treatment for hypoparathyroidism, produces slight improvement in some health-related quality of life (HRQoL) domains.
While researchers didn’t find any statistically significant between-group differences vs. a placebo, the study lead author said the positive findings about within-group differences reflect her experiences with some patients. “They’re telling me they feel much better, and they don’t have emergency room visits,” endocrinologist Tamara J. Vokes, MD, of the University of Chicago, said in an interview.
And, she said, as reflected in the findings, she’s seen that those with the lowest HRQoL levels at baseline especially show signs of improvement.
The treatment, known as rhPTH(1-84) or Natpara, was approved by the Food and Drug Administration as a treatment for hypoparathyroidism in 2015. The FDA stated that the drug “is only for people who do not respond well to treatment with calcium and active forms of vitamin D alone, because it may increase the possible risk of bone cancer, known as osteosarcoma.”
Pharmacies list the drug as costing $9,500-$9,900 per month with a coupon or discount. According to the new study, research has shown that quality of life is often impaired in patients who have tried the traditional hypoparathyroidism treatments of calcium supplements and vitamin D. Dr. Vokes and her colleagues aimed to expand upon previous studies of HRQoL that did not reach conclusions or failed to include controls.
They examined findings of a previous multinational, randomized, placebo-controlled study of 122 adults with hypoparathyroidism. Average age was 48 years, and roughly 80% of the patients were women.
After their serum calcium levels were adjusted through medication, the patients were randomly assigned to placebo (n = 39) or rhPTH(1-84) (n = 83, starting dose of 50 mg/d that could be raised to 100 mg/d).
The study, which appears in the Journal of Clinical Endocrinology and Metabolism, analyzes the changes in HRQoL from baseline to 24 weeks per the 36-Item Short-Form Health Survey (SF-36).
The researchers found no significant between-group differences. However, those who took the drug did see statistically significant improvements in 4 of 10 domains: physical component summary score (P = .004), body pain (P = .05), general health (P = .05), and vitality (P less than .001). The changes were small, with the vitality score improving the most, from a mean SF-36 score of 49.5 to 53.
In some cases, she said, she’s seen QoL improve in patients whom she normally wouldn’t consider candidates for the medication. “I would have not have recommended PTH for them, but they insisted on taking it, and they report feeling better.”
This may be a placebo effect, she said. Even so, “if someone doesn’t feel well, it’s worth it at least to try to use PTH and see whether they improve.”
She added that lack of well-being is a preexisting condition for some hypoparathyroidism patients. “I’ve seen quite a number of them who have what we call premorbid personality disorder. They didn’t feel well and weren’t happy, and when you get hypoparathyroidism, you’re more unwell and unhappy.”
With medication, however, “you’re a bit less unhappy but you’re still miserable,” she said.
Carol Greenlee, MD, an endocrinologist in Grand Junction, Colo., said in an interview that she saw a patient in a clinical study who had experienced a marked improvement in QoL. However, she said, “it will be the cost of the PTH that is the burden.”
For her part, Dr. Vokes cautioned that it’s important to take special care with patients taking Natpara. “You can’t just give this injection and say, ‘Goodbye, you will be better.’ It requires following certain protocol, frequent monitoring of the blood levels. Be sure the patient has access to the lab, and insurance that covers the test.”
Dr. Greenlee reported no relevant disclosures. The study was funded by Shire Human Genetic Therapies, and the initial clinical trial was funded by NPS Pharmaceuticals, a wholly owned indirect subsidiary. Dr. Vokes reported consulting for Shire and serving as an investigator for the initial clinical trial. Other study authors reported serving as clinical investigators and/or consulting for Shire, and three authors are employees of Shire.
SOURCE: Vokes, TJ et al. J Clin Endocrinol Metab. 2018 Feb 1;103(2):722-31
A new industry-funded analysis suggests that recombinant human parathyroid hormone, an extraordinarily expensive treatment for hypoparathyroidism, produces slight improvement in some health-related quality of life (HRQoL) domains.
While researchers didn’t find any statistically significant between-group differences vs. a placebo, the study lead author said the positive findings about within-group differences reflect her experiences with some patients. “They’re telling me they feel much better, and they don’t have emergency room visits,” endocrinologist Tamara J. Vokes, MD, of the University of Chicago, said in an interview.
And, she said, as reflected in the findings, she’s seen that those with the lowest HRQoL levels at baseline especially show signs of improvement.
The treatment, known as rhPTH(1-84) or Natpara, was approved by the Food and Drug Administration as a treatment for hypoparathyroidism in 2015. The FDA stated that the drug “is only for people who do not respond well to treatment with calcium and active forms of vitamin D alone, because it may increase the possible risk of bone cancer, known as osteosarcoma.”
Pharmacies list the drug as costing $9,500-$9,900 per month with a coupon or discount. According to the new study, research has shown that quality of life is often impaired in patients who have tried the traditional hypoparathyroidism treatments of calcium supplements and vitamin D. Dr. Vokes and her colleagues aimed to expand upon previous studies of HRQoL that did not reach conclusions or failed to include controls.
They examined findings of a previous multinational, randomized, placebo-controlled study of 122 adults with hypoparathyroidism. Average age was 48 years, and roughly 80% of the patients were women.
After their serum calcium levels were adjusted through medication, the patients were randomly assigned to placebo (n = 39) or rhPTH(1-84) (n = 83, starting dose of 50 mg/d that could be raised to 100 mg/d).
The study, which appears in the Journal of Clinical Endocrinology and Metabolism, analyzes the changes in HRQoL from baseline to 24 weeks per the 36-Item Short-Form Health Survey (SF-36).
The researchers found no significant between-group differences. However, those who took the drug did see statistically significant improvements in 4 of 10 domains: physical component summary score (P = .004), body pain (P = .05), general health (P = .05), and vitality (P less than .001). The changes were small, with the vitality score improving the most, from a mean SF-36 score of 49.5 to 53.
In some cases, she said, she’s seen QoL improve in patients whom she normally wouldn’t consider candidates for the medication. “I would have not have recommended PTH for them, but they insisted on taking it, and they report feeling better.”
This may be a placebo effect, she said. Even so, “if someone doesn’t feel well, it’s worth it at least to try to use PTH and see whether they improve.”
She added that lack of well-being is a preexisting condition for some hypoparathyroidism patients. “I’ve seen quite a number of them who have what we call premorbid personality disorder. They didn’t feel well and weren’t happy, and when you get hypoparathyroidism, you’re more unwell and unhappy.”
With medication, however, “you’re a bit less unhappy but you’re still miserable,” she said.
Carol Greenlee, MD, an endocrinologist in Grand Junction, Colo., said in an interview that she saw a patient in a clinical study who had experienced a marked improvement in QoL. However, she said, “it will be the cost of the PTH that is the burden.”
For her part, Dr. Vokes cautioned that it’s important to take special care with patients taking Natpara. “You can’t just give this injection and say, ‘Goodbye, you will be better.’ It requires following certain protocol, frequent monitoring of the blood levels. Be sure the patient has access to the lab, and insurance that covers the test.”
Dr. Greenlee reported no relevant disclosures. The study was funded by Shire Human Genetic Therapies, and the initial clinical trial was funded by NPS Pharmaceuticals, a wholly owned indirect subsidiary. Dr. Vokes reported consulting for Shire and serving as an investigator for the initial clinical trial. Other study authors reported serving as clinical investigators and/or consulting for Shire, and three authors are employees of Shire.
SOURCE: Vokes, TJ et al. J Clin Endocrinol Metab. 2018 Feb 1;103(2):722-31
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Key clinical point: Health-related quality of life (HRQoL) may improve slightly in patients on recombinant human parathyroid hormone for hypoparathyroidism.
Major finding: In 4 of 10 SF-36 domains, HRQoL improved in within-group analysis. There was no statistically significant improvement vs. placebo.
Study details: A 24-week analysis of previous drug vs. placebo clinical trial of 122 adults with hypoparathyroidism.
Disclosures: Shire Human Genetic Therapies funded the study, and the initial clinical trial was funded by NPS Pharmaceuticals, a wholly owned indirect subsidiary. The researchers reported various relationships to Shire, including employment.
Source: Vokes TJ et al. J Clin Endocrinol Metab. 2018 Feb 1;103(2):722-31.
VIDEO: With new therapies available, it’s the ‘decade of eczema,’ researcher says
SAN DIEGO – A long dry spell in the development of new atopic dermatitis (AD) medications came to an end in 2016 with the approval of a topical treatment, and last year brought the first biologic for AD to the market. With more targets and potential treatments being studied, “it’s the decade of eczema,” according to a leading researcher.
And I think we’ll have many more approvals in the next few years,” said Emma Guttman, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she was presenting a talk on the translational revolution in atopic dermatitis.
In the interview, she also discussed research showing that children with AD don’t have the same distribution of lesions as adults, and a study of young children, which found that during an early stage of the disease, when compared with adults, they showed much higher increases in Th17 similar to that seen in psoriasis. It will be interesting to see if “some drugs that work for psoriasis may work in children,” said Dr. Guttman, professor of dermatology and director of the laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York.
Dr. Guttman disclosed research support, consulting, or lecture fees from Regeneron, Sanofi, Pfizer, and other companies developing AD treatments.
SAN DIEGO – A long dry spell in the development of new atopic dermatitis (AD) medications came to an end in 2016 with the approval of a topical treatment, and last year brought the first biologic for AD to the market. With more targets and potential treatments being studied, “it’s the decade of eczema,” according to a leading researcher.
And I think we’ll have many more approvals in the next few years,” said Emma Guttman, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she was presenting a talk on the translational revolution in atopic dermatitis.
In the interview, she also discussed research showing that children with AD don’t have the same distribution of lesions as adults, and a study of young children, which found that during an early stage of the disease, when compared with adults, they showed much higher increases in Th17 similar to that seen in psoriasis. It will be interesting to see if “some drugs that work for psoriasis may work in children,” said Dr. Guttman, professor of dermatology and director of the laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York.
Dr. Guttman disclosed research support, consulting, or lecture fees from Regeneron, Sanofi, Pfizer, and other companies developing AD treatments.
SAN DIEGO – A long dry spell in the development of new atopic dermatitis (AD) medications came to an end in 2016 with the approval of a topical treatment, and last year brought the first biologic for AD to the market. With more targets and potential treatments being studied, “it’s the decade of eczema,” according to a leading researcher.
And I think we’ll have many more approvals in the next few years,” said Emma Guttman, MD, PhD, said in a video interview at the annual meeting of the American Academy of Dermatology, where she was presenting a talk on the translational revolution in atopic dermatitis.
In the interview, she also discussed research showing that children with AD don’t have the same distribution of lesions as adults, and a study of young children, which found that during an early stage of the disease, when compared with adults, they showed much higher increases in Th17 similar to that seen in psoriasis. It will be interesting to see if “some drugs that work for psoriasis may work in children,” said Dr. Guttman, professor of dermatology and director of the laboratory of inflammatory skin diseases at the Icahn School of Medicine at Mount Sinai, New York.
Dr. Guttman disclosed research support, consulting, or lecture fees from Regeneron, Sanofi, Pfizer, and other companies developing AD treatments.
REPORTING FROM AAD 18
Extended-interval dosing of natalizumab linked to lower risk of PML
SAN DIEGO – A large industry-funded study of the multiple sclerosis drug natalizumab suggests that physicians can dramatically lower the likelihood of progressive multifocal leukoencephalopathy in patients at higher risk of the condition by increasing the interval between doses.
Previous research has suggested that natalizumab (Tysabri) doesn’t lose efficacy when given less frequently.
Dr. Zhovtis Ryerson presented the study findings at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
As a 2014 report explains, natalizumab is a “highly effective disease-modifying therapy for the treatment of relapsing forms of multiple sclerosis,” but the risk of progressive multifocal leukoencephalopathy (PML) “has largely contributed to it being relegated to a second-line position” (Ther Adv Chronic Dis. 2014 Mar;5[2]:62-8).
Patients previously exposed to John Cunningham (JC) virus are at higher risk of PML, a rare viral brain disease that can be severely disabling or deadly. A 2017 report estimated the combined cumulative PML probability at 2.7% (with previous immunosuppressant use) and 1.7% (no previous immunosuppressant use) over 6 years in patients with signs of exposure to the JC virus (Lancet Neurol. 2017 Nov;16[11]:925-33). According to Dr. Zhovtis Ryerson, natalizumab manufacturer Biogen reported in December 2017 that it has confirmed 756 cases of PML in natalizumab-treated patients, all except for 3 in MS patients.
Doctors are wary in the at-risk patient population. “In general,” she said, “clinicians treating patients who are JC virus positive, and therefore have a risk for PML, may not utilize the drug or may take the patient off it after 2 years, which is when the risk goes up.”
Some physicians have experimented with longer intervals between treatments of 300 mg given intravenously, administering it every 5-8 weeks instead of every 4 weeks, with an eye on not extending the interval for too long “because MS disease activity returns after 12 weeks of withholding therapy,” Dr. Zhovtis Ryerson said.
In 2016, Dr. Zhovtis Ryerson and colleagues reported in a retrospective analysis that natalizumab dosing intervals of up to 8 weeks, 5 days didn’t affect the drug’s efficacy (J Neurol Neurosurg Psychiatry. 2016 Aug;87[8]:885-9).
For the primary analyses in the new study – whether dosing history in the last 18 months of natalizumab treatment affects PML – researchers tracked 1,988 patients who took the drug via an extended interval schedule and 13,132 who took it via a standard interval. The patients were tracked in the mandated TOUCH Prescribing Program; all participants showed signs of exposure to the JC virus.
The two groups were similar at about 68% female, an average age at first infusion of about 43, and a median number of about 48 natalizumab infusions.
For patients without previous immunosuppressant use who had received 49-60 doses, the researchers estimated the incidence of PML per 1,000 patients as 1.23 in the extended-interval group and 3.96 in the standard-interval group. The numbers were slightly higher for those who received 61-72 doses. At 48 or fewer doses, there were no PML cases in patients on extended-interval dosing.
“The data showed highly significant risk reductions of up to 94%,” Dr. Zhovtis Ryerson said.
Moving forward, “in collaboration with Biogen, we have more sensitivity analysis to be done to assure that our conclusions on this are correct,” she said. “Furthermore, more evidence of efficacy of extended-interval dosing natalizumab is needed, and we hope to move forward with a prospective, randomized, controlled trial to give clinicians the highest level of evidence we can.”
The study was funded by Biogen. Dr. Zhovtis Ryerson reported personal compensation from Teva, speaker/advisory board activities for Biogen, and research support from Biogen. Seven other authors reported being Biogen employees. Other authors reported no disclosures or various disclosures, including connections to Biogen.
SOURCE: Zhovtis R et al. ACTRIMS Forum 2018 Abstract LB250.
SAN DIEGO – A large industry-funded study of the multiple sclerosis drug natalizumab suggests that physicians can dramatically lower the likelihood of progressive multifocal leukoencephalopathy in patients at higher risk of the condition by increasing the interval between doses.
Previous research has suggested that natalizumab (Tysabri) doesn’t lose efficacy when given less frequently.
Dr. Zhovtis Ryerson presented the study findings at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
As a 2014 report explains, natalizumab is a “highly effective disease-modifying therapy for the treatment of relapsing forms of multiple sclerosis,” but the risk of progressive multifocal leukoencephalopathy (PML) “has largely contributed to it being relegated to a second-line position” (Ther Adv Chronic Dis. 2014 Mar;5[2]:62-8).
Patients previously exposed to John Cunningham (JC) virus are at higher risk of PML, a rare viral brain disease that can be severely disabling or deadly. A 2017 report estimated the combined cumulative PML probability at 2.7% (with previous immunosuppressant use) and 1.7% (no previous immunosuppressant use) over 6 years in patients with signs of exposure to the JC virus (Lancet Neurol. 2017 Nov;16[11]:925-33). According to Dr. Zhovtis Ryerson, natalizumab manufacturer Biogen reported in December 2017 that it has confirmed 756 cases of PML in natalizumab-treated patients, all except for 3 in MS patients.
Doctors are wary in the at-risk patient population. “In general,” she said, “clinicians treating patients who are JC virus positive, and therefore have a risk for PML, may not utilize the drug or may take the patient off it after 2 years, which is when the risk goes up.”
Some physicians have experimented with longer intervals between treatments of 300 mg given intravenously, administering it every 5-8 weeks instead of every 4 weeks, with an eye on not extending the interval for too long “because MS disease activity returns after 12 weeks of withholding therapy,” Dr. Zhovtis Ryerson said.
In 2016, Dr. Zhovtis Ryerson and colleagues reported in a retrospective analysis that natalizumab dosing intervals of up to 8 weeks, 5 days didn’t affect the drug’s efficacy (J Neurol Neurosurg Psychiatry. 2016 Aug;87[8]:885-9).
For the primary analyses in the new study – whether dosing history in the last 18 months of natalizumab treatment affects PML – researchers tracked 1,988 patients who took the drug via an extended interval schedule and 13,132 who took it via a standard interval. The patients were tracked in the mandated TOUCH Prescribing Program; all participants showed signs of exposure to the JC virus.
The two groups were similar at about 68% female, an average age at first infusion of about 43, and a median number of about 48 natalizumab infusions.
For patients without previous immunosuppressant use who had received 49-60 doses, the researchers estimated the incidence of PML per 1,000 patients as 1.23 in the extended-interval group and 3.96 in the standard-interval group. The numbers were slightly higher for those who received 61-72 doses. At 48 or fewer doses, there were no PML cases in patients on extended-interval dosing.
“The data showed highly significant risk reductions of up to 94%,” Dr. Zhovtis Ryerson said.
Moving forward, “in collaboration with Biogen, we have more sensitivity analysis to be done to assure that our conclusions on this are correct,” she said. “Furthermore, more evidence of efficacy of extended-interval dosing natalizumab is needed, and we hope to move forward with a prospective, randomized, controlled trial to give clinicians the highest level of evidence we can.”
The study was funded by Biogen. Dr. Zhovtis Ryerson reported personal compensation from Teva, speaker/advisory board activities for Biogen, and research support from Biogen. Seven other authors reported being Biogen employees. Other authors reported no disclosures or various disclosures, including connections to Biogen.
SOURCE: Zhovtis R et al. ACTRIMS Forum 2018 Abstract LB250.
SAN DIEGO – A large industry-funded study of the multiple sclerosis drug natalizumab suggests that physicians can dramatically lower the likelihood of progressive multifocal leukoencephalopathy in patients at higher risk of the condition by increasing the interval between doses.
Previous research has suggested that natalizumab (Tysabri) doesn’t lose efficacy when given less frequently.
Dr. Zhovtis Ryerson presented the study findings at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
As a 2014 report explains, natalizumab is a “highly effective disease-modifying therapy for the treatment of relapsing forms of multiple sclerosis,” but the risk of progressive multifocal leukoencephalopathy (PML) “has largely contributed to it being relegated to a second-line position” (Ther Adv Chronic Dis. 2014 Mar;5[2]:62-8).
Patients previously exposed to John Cunningham (JC) virus are at higher risk of PML, a rare viral brain disease that can be severely disabling or deadly. A 2017 report estimated the combined cumulative PML probability at 2.7% (with previous immunosuppressant use) and 1.7% (no previous immunosuppressant use) over 6 years in patients with signs of exposure to the JC virus (Lancet Neurol. 2017 Nov;16[11]:925-33). According to Dr. Zhovtis Ryerson, natalizumab manufacturer Biogen reported in December 2017 that it has confirmed 756 cases of PML in natalizumab-treated patients, all except for 3 in MS patients.
Doctors are wary in the at-risk patient population. “In general,” she said, “clinicians treating patients who are JC virus positive, and therefore have a risk for PML, may not utilize the drug or may take the patient off it after 2 years, which is when the risk goes up.”
Some physicians have experimented with longer intervals between treatments of 300 mg given intravenously, administering it every 5-8 weeks instead of every 4 weeks, with an eye on not extending the interval for too long “because MS disease activity returns after 12 weeks of withholding therapy,” Dr. Zhovtis Ryerson said.
In 2016, Dr. Zhovtis Ryerson and colleagues reported in a retrospective analysis that natalizumab dosing intervals of up to 8 weeks, 5 days didn’t affect the drug’s efficacy (J Neurol Neurosurg Psychiatry. 2016 Aug;87[8]:885-9).
For the primary analyses in the new study – whether dosing history in the last 18 months of natalizumab treatment affects PML – researchers tracked 1,988 patients who took the drug via an extended interval schedule and 13,132 who took it via a standard interval. The patients were tracked in the mandated TOUCH Prescribing Program; all participants showed signs of exposure to the JC virus.
The two groups were similar at about 68% female, an average age at first infusion of about 43, and a median number of about 48 natalizumab infusions.
For patients without previous immunosuppressant use who had received 49-60 doses, the researchers estimated the incidence of PML per 1,000 patients as 1.23 in the extended-interval group and 3.96 in the standard-interval group. The numbers were slightly higher for those who received 61-72 doses. At 48 or fewer doses, there were no PML cases in patients on extended-interval dosing.
“The data showed highly significant risk reductions of up to 94%,” Dr. Zhovtis Ryerson said.
Moving forward, “in collaboration with Biogen, we have more sensitivity analysis to be done to assure that our conclusions on this are correct,” she said. “Furthermore, more evidence of efficacy of extended-interval dosing natalizumab is needed, and we hope to move forward with a prospective, randomized, controlled trial to give clinicians the highest level of evidence we can.”
The study was funded by Biogen. Dr. Zhovtis Ryerson reported personal compensation from Teva, speaker/advisory board activities for Biogen, and research support from Biogen. Seven other authors reported being Biogen employees. Other authors reported no disclosures or various disclosures, including connections to Biogen.
SOURCE: Zhovtis R et al. ACTRIMS Forum 2018 Abstract LB250.
REPORTING FROM ACTRIMS FORUM 2018
Key clinical point: , compared with standard-interval dosing in patients who showed signs of exposure to the JC virus.
Major finding: Estimated incidence of PML per 1,000 patients was 1.23 in an extended-interval group and 3.96 in a standard-interval group among those who had received 49-60 natalizumab doses.
Study details: 18-month analysis of multiple sclerosis patients on natalizumab who showed signs of exposure to the JC virus: 1,988 on extended-interval dosing and 13,132 on standard-interval dosing.
Disclosures: The study was funded by Biogen, and multiple study authors report being employees of Biogen or having other relationships to the company.
Source: Zhovtis R et al. ACTRIMS Forum 2018, Abstract LB250.
Is MS caused by one-two punch of pinworm and Epstein-Barr virus?
SAN DIEGO – What causes multiple sclerosis (MS)? A team of Scottish researchers offers a new theory that it’s triggered in part by a one-two punch of infection with pinworm – a common condition in the United States, especially among children – and the Epstein-Barr virus (EBV).
The theory identifies pinworm as the prime suspect to be the “missing link” that explains why EBV and MS are so tightly connected, said Patrick Kearns, MBChB, a graduate student at Harvard T.H. Chan School of Public Health in Boston.
Dr. Kearns is the lead author of two reports about the possible role of pinworm that were presented at ACTRIMS Forum 2018, which is held by the Americas Committee for Treatment and Research in Multiple Sclerosis. He spoke in an interview.
Dr. Kearns and his colleagues focused on a well-known cluster of MS cases that began to appear in the Faroe Islands – a Danish possession in the North Atlantic – during World War II. The cases began to appear after British troops occupied the islands.
“Many of the occupation soldiers were from the Scottish Highlands, where the MS prevalence is quite high: 90 cases per 100,000, comparable to the northern U.S.,” according to a National MS Society summary about MS clusters.
In a theory that spawned controversy, the late neurologist John Kurtzke, MD, speculated that the British soldiers brought a transmissible agent to the islands, which triggered MS cases.
Could the agent be EBV alone? The authors of the new studies don’t think so, although they note that EBV is “robustly linked” to MS. Indeed, a 2012 meta-analysis reported that the virus “appears to be present in 100% of MS patients,” based on studies considered to be the strongest (Mult Scler. 2013 Feb;19[2]:162-6).
The authors of the new reports note that, while EBV infection “appears necessary,” it is “clearly not sufficient” to cause the disease on its own.
“Certainly almost everyone gets EBV eventually,” Dr. Kearns said. “So mere presence of the virus is certainly not sufficient for causing the disease. But it seems still to be necessary, and timing of infection might be everything.”
So what’s the missing piece of the puzzle?
Dr. Kearns began to think it might be the lowly pinworm after helping a colleague by analyzing data from appendicitis samples in children. He noted that uninflamed samples often had pinworms in them, but the inflamed samples often didn’t, which suggested that “the rate of pinworms in normal appendices must be very high in the healthy pediatric population at any given time.”
More data confirmed this to be true, and medical literature told Dr. Kearns that pinworms were common in high latitudes – places where people often are especially prone to MS.
“Most remarkably, they are known to have very little migration and stay spatially stable in populations over long periods of time,” Dr. Kearns said, “and typically everyone in an affected population will encounter them because their eggs are transmitted in household dust.”
And, he said, “they are known to be common in soldiers who live in military accommodation.”
According to the Centers for Disease Control and Prevention, pinworm prevalence can be as high as 50% in at-risk groups – children, caregivers of infected children, and people who live in institutions. Pinworms, which are spread through ingestion, are often asymptomatic but may cause anal itching and trigger bacterial infections.
The researchers suggest that pinworm infection comes first, followed by EBV infection. This makes sense because “late EBV infection in the form of infectious mononucleosis is known to be a risk factor for MS,” Dr. Kearns said.
The one-two punch of pinworm and then EBV is a plausible theory “because EBV lives in memory B cells, which are known to be important in MS and could be specific for the previous exposure to pinworm,” Dr. Kearns said. “However, this is very speculative and some researchers will argue this is very unlikely to be the case. But I think there is a chance it could explain some of the epidemiology, so I’m keen to try and test the theory if I can.”
What’s next? Dr. Kearns wants to explore data from Scotland in search of areas of high and low MS incidence that could offer insight into environmental triggers.
He added that the development of a serological blood test to prove a history of pinworm infection would be “the most effective way to prove or disprove this theory.”
“I have approached an investigator who has a track record of doing this for other infections and have been encouraged that he thinks that it would be achievable,” he said. “But this will definitely take time and funding.”
No specific funding was reported. The study authors reported no relevant disclosures.
SOURCE: Kearns P et al. ACTRIMS Forum 2018, Abstracts LB257 and LB264.
SAN DIEGO – What causes multiple sclerosis (MS)? A team of Scottish researchers offers a new theory that it’s triggered in part by a one-two punch of infection with pinworm – a common condition in the United States, especially among children – and the Epstein-Barr virus (EBV).
The theory identifies pinworm as the prime suspect to be the “missing link” that explains why EBV and MS are so tightly connected, said Patrick Kearns, MBChB, a graduate student at Harvard T.H. Chan School of Public Health in Boston.
Dr. Kearns is the lead author of two reports about the possible role of pinworm that were presented at ACTRIMS Forum 2018, which is held by the Americas Committee for Treatment and Research in Multiple Sclerosis. He spoke in an interview.
Dr. Kearns and his colleagues focused on a well-known cluster of MS cases that began to appear in the Faroe Islands – a Danish possession in the North Atlantic – during World War II. The cases began to appear after British troops occupied the islands.
“Many of the occupation soldiers were from the Scottish Highlands, where the MS prevalence is quite high: 90 cases per 100,000, comparable to the northern U.S.,” according to a National MS Society summary about MS clusters.
In a theory that spawned controversy, the late neurologist John Kurtzke, MD, speculated that the British soldiers brought a transmissible agent to the islands, which triggered MS cases.
Could the agent be EBV alone? The authors of the new studies don’t think so, although they note that EBV is “robustly linked” to MS. Indeed, a 2012 meta-analysis reported that the virus “appears to be present in 100% of MS patients,” based on studies considered to be the strongest (Mult Scler. 2013 Feb;19[2]:162-6).
The authors of the new reports note that, while EBV infection “appears necessary,” it is “clearly not sufficient” to cause the disease on its own.
“Certainly almost everyone gets EBV eventually,” Dr. Kearns said. “So mere presence of the virus is certainly not sufficient for causing the disease. But it seems still to be necessary, and timing of infection might be everything.”
So what’s the missing piece of the puzzle?
Dr. Kearns began to think it might be the lowly pinworm after helping a colleague by analyzing data from appendicitis samples in children. He noted that uninflamed samples often had pinworms in them, but the inflamed samples often didn’t, which suggested that “the rate of pinworms in normal appendices must be very high in the healthy pediatric population at any given time.”
More data confirmed this to be true, and medical literature told Dr. Kearns that pinworms were common in high latitudes – places where people often are especially prone to MS.
“Most remarkably, they are known to have very little migration and stay spatially stable in populations over long periods of time,” Dr. Kearns said, “and typically everyone in an affected population will encounter them because their eggs are transmitted in household dust.”
And, he said, “they are known to be common in soldiers who live in military accommodation.”
According to the Centers for Disease Control and Prevention, pinworm prevalence can be as high as 50% in at-risk groups – children, caregivers of infected children, and people who live in institutions. Pinworms, which are spread through ingestion, are often asymptomatic but may cause anal itching and trigger bacterial infections.
The researchers suggest that pinworm infection comes first, followed by EBV infection. This makes sense because “late EBV infection in the form of infectious mononucleosis is known to be a risk factor for MS,” Dr. Kearns said.
The one-two punch of pinworm and then EBV is a plausible theory “because EBV lives in memory B cells, which are known to be important in MS and could be specific for the previous exposure to pinworm,” Dr. Kearns said. “However, this is very speculative and some researchers will argue this is very unlikely to be the case. But I think there is a chance it could explain some of the epidemiology, so I’m keen to try and test the theory if I can.”
What’s next? Dr. Kearns wants to explore data from Scotland in search of areas of high and low MS incidence that could offer insight into environmental triggers.
He added that the development of a serological blood test to prove a history of pinworm infection would be “the most effective way to prove or disprove this theory.”
“I have approached an investigator who has a track record of doing this for other infections and have been encouraged that he thinks that it would be achievable,” he said. “But this will definitely take time and funding.”
No specific funding was reported. The study authors reported no relevant disclosures.
SOURCE: Kearns P et al. ACTRIMS Forum 2018, Abstracts LB257 and LB264.
SAN DIEGO – What causes multiple sclerosis (MS)? A team of Scottish researchers offers a new theory that it’s triggered in part by a one-two punch of infection with pinworm – a common condition in the United States, especially among children – and the Epstein-Barr virus (EBV).
The theory identifies pinworm as the prime suspect to be the “missing link” that explains why EBV and MS are so tightly connected, said Patrick Kearns, MBChB, a graduate student at Harvard T.H. Chan School of Public Health in Boston.
Dr. Kearns is the lead author of two reports about the possible role of pinworm that were presented at ACTRIMS Forum 2018, which is held by the Americas Committee for Treatment and Research in Multiple Sclerosis. He spoke in an interview.
Dr. Kearns and his colleagues focused on a well-known cluster of MS cases that began to appear in the Faroe Islands – a Danish possession in the North Atlantic – during World War II. The cases began to appear after British troops occupied the islands.
“Many of the occupation soldiers were from the Scottish Highlands, where the MS prevalence is quite high: 90 cases per 100,000, comparable to the northern U.S.,” according to a National MS Society summary about MS clusters.
In a theory that spawned controversy, the late neurologist John Kurtzke, MD, speculated that the British soldiers brought a transmissible agent to the islands, which triggered MS cases.
Could the agent be EBV alone? The authors of the new studies don’t think so, although they note that EBV is “robustly linked” to MS. Indeed, a 2012 meta-analysis reported that the virus “appears to be present in 100% of MS patients,” based on studies considered to be the strongest (Mult Scler. 2013 Feb;19[2]:162-6).
The authors of the new reports note that, while EBV infection “appears necessary,” it is “clearly not sufficient” to cause the disease on its own.
“Certainly almost everyone gets EBV eventually,” Dr. Kearns said. “So mere presence of the virus is certainly not sufficient for causing the disease. But it seems still to be necessary, and timing of infection might be everything.”
So what’s the missing piece of the puzzle?
Dr. Kearns began to think it might be the lowly pinworm after helping a colleague by analyzing data from appendicitis samples in children. He noted that uninflamed samples often had pinworms in them, but the inflamed samples often didn’t, which suggested that “the rate of pinworms in normal appendices must be very high in the healthy pediatric population at any given time.”
More data confirmed this to be true, and medical literature told Dr. Kearns that pinworms were common in high latitudes – places where people often are especially prone to MS.
“Most remarkably, they are known to have very little migration and stay spatially stable in populations over long periods of time,” Dr. Kearns said, “and typically everyone in an affected population will encounter them because their eggs are transmitted in household dust.”
And, he said, “they are known to be common in soldiers who live in military accommodation.”
According to the Centers for Disease Control and Prevention, pinworm prevalence can be as high as 50% in at-risk groups – children, caregivers of infected children, and people who live in institutions. Pinworms, which are spread through ingestion, are often asymptomatic but may cause anal itching and trigger bacterial infections.
The researchers suggest that pinworm infection comes first, followed by EBV infection. This makes sense because “late EBV infection in the form of infectious mononucleosis is known to be a risk factor for MS,” Dr. Kearns said.
The one-two punch of pinworm and then EBV is a plausible theory “because EBV lives in memory B cells, which are known to be important in MS and could be specific for the previous exposure to pinworm,” Dr. Kearns said. “However, this is very speculative and some researchers will argue this is very unlikely to be the case. But I think there is a chance it could explain some of the epidemiology, so I’m keen to try and test the theory if I can.”
What’s next? Dr. Kearns wants to explore data from Scotland in search of areas of high and low MS incidence that could offer insight into environmental triggers.
He added that the development of a serological blood test to prove a history of pinworm infection would be “the most effective way to prove or disprove this theory.”
“I have approached an investigator who has a track record of doing this for other infections and have been encouraged that he thinks that it would be achievable,” he said. “But this will definitely take time and funding.”
No specific funding was reported. The study authors reported no relevant disclosures.
SOURCE: Kearns P et al. ACTRIMS Forum 2018, Abstracts LB257 and LB264.
REPORTING FROM ACTRIMS FORUM 2018
VIDEO: Painful skin conditions need pain management by dermatologists
Patients with painful skin conditions need pain management that is provided by their dermatologists, Robert G. Micheletti, MD, contended in a presentation at the annual meeting of the American Academy of Dermatology.
Dermatologists are the experts when it comes to treating painful skin conditions like pyoderma gangrenosum, hidradenitis suppurativa, calciphylaxis, and vasculopathies. “We should be willing to treat the pain that goes with (these conditions), at least within our scope of practice,” said Dr. Micheletti, co-director of the Inpatient Dermatology Consult Service at the University of Pennsylvania, Philadelphia. “At the same time, we know opioids should be prescribed only when necessary, at the lowest effective dose, and for the shortest possible duration.”
In our exclusive video interview, Dr. Micheletti outlined the keys to successful care of patients with painful skin disease. He described patient characteristics that influence prescribing choices and tips for accurately assessing pain needs with a preference for a conservative regimen that utilizes non-opioids and avoids over-reliance on narcotics.
Source: Micheletti, R., Session F013
Patients with painful skin conditions need pain management that is provided by their dermatologists, Robert G. Micheletti, MD, contended in a presentation at the annual meeting of the American Academy of Dermatology.
Dermatologists are the experts when it comes to treating painful skin conditions like pyoderma gangrenosum, hidradenitis suppurativa, calciphylaxis, and vasculopathies. “We should be willing to treat the pain that goes with (these conditions), at least within our scope of practice,” said Dr. Micheletti, co-director of the Inpatient Dermatology Consult Service at the University of Pennsylvania, Philadelphia. “At the same time, we know opioids should be prescribed only when necessary, at the lowest effective dose, and for the shortest possible duration.”
In our exclusive video interview, Dr. Micheletti outlined the keys to successful care of patients with painful skin disease. He described patient characteristics that influence prescribing choices and tips for accurately assessing pain needs with a preference for a conservative regimen that utilizes non-opioids and avoids over-reliance on narcotics.
Source: Micheletti, R., Session F013
Patients with painful skin conditions need pain management that is provided by their dermatologists, Robert G. Micheletti, MD, contended in a presentation at the annual meeting of the American Academy of Dermatology.
Dermatologists are the experts when it comes to treating painful skin conditions like pyoderma gangrenosum, hidradenitis suppurativa, calciphylaxis, and vasculopathies. “We should be willing to treat the pain that goes with (these conditions), at least within our scope of practice,” said Dr. Micheletti, co-director of the Inpatient Dermatology Consult Service at the University of Pennsylvania, Philadelphia. “At the same time, we know opioids should be prescribed only when necessary, at the lowest effective dose, and for the shortest possible duration.”
In our exclusive video interview, Dr. Micheletti outlined the keys to successful care of patients with painful skin disease. He described patient characteristics that influence prescribing choices and tips for accurately assessing pain needs with a preference for a conservative regimen that utilizes non-opioids and avoids over-reliance on narcotics.
Source: Micheletti, R., Session F013
VIDEO: Delusional parasitosis? Try these real solutions
SAN DIEGO – The path to successful treatment of patients with imagined skin disorders is paved with compassion, according to John Koo, MD, a dermatologist and psychiatrist with the University of California at San Francisco.
When a patient presents with delusional parasitosis -- horror stories about imagined infestations of parasites or bugs – the key to successful treatment is a positive attitude and validation, not denial, Dr. Koo said in a presentation at the annual meeting of the American Academy of Dermatology.
"I cannot afford to go in (the exam room) with a long face," he said. "If I go in and I’m not looking happy, things can deteriorate quickly. So I make sure I go in with the biggest smile on my face like I'm meeting my favorite Hollywood star."
"When I say something like 'It's like a living hell, isn't it,' patients are really touched, he said. The patient’s response is typically 'You're the first dermatologist to understand what I'm going through.' You cannot endorse their delusion, but you can endorse their suffering."
In our video interview, Dr. Koo delved into techniques for the successful work-up and evaluation of patients with delusional parasitosis, the varying degrees of the condition, medications used for treatment, and the prospects for eventual drug-free relief.
Dr. Koo reports no relevant financial disclosures.
SAN DIEGO – The path to successful treatment of patients with imagined skin disorders is paved with compassion, according to John Koo, MD, a dermatologist and psychiatrist with the University of California at San Francisco.
When a patient presents with delusional parasitosis -- horror stories about imagined infestations of parasites or bugs – the key to successful treatment is a positive attitude and validation, not denial, Dr. Koo said in a presentation at the annual meeting of the American Academy of Dermatology.
"I cannot afford to go in (the exam room) with a long face," he said. "If I go in and I’m not looking happy, things can deteriorate quickly. So I make sure I go in with the biggest smile on my face like I'm meeting my favorite Hollywood star."
"When I say something like 'It's like a living hell, isn't it,' patients are really touched, he said. The patient’s response is typically 'You're the first dermatologist to understand what I'm going through.' You cannot endorse their delusion, but you can endorse their suffering."
In our video interview, Dr. Koo delved into techniques for the successful work-up and evaluation of patients with delusional parasitosis, the varying degrees of the condition, medications used for treatment, and the prospects for eventual drug-free relief.
Dr. Koo reports no relevant financial disclosures.
SAN DIEGO – The path to successful treatment of patients with imagined skin disorders is paved with compassion, according to John Koo, MD, a dermatologist and psychiatrist with the University of California at San Francisco.
When a patient presents with delusional parasitosis -- horror stories about imagined infestations of parasites or bugs – the key to successful treatment is a positive attitude and validation, not denial, Dr. Koo said in a presentation at the annual meeting of the American Academy of Dermatology.
"I cannot afford to go in (the exam room) with a long face," he said. "If I go in and I’m not looking happy, things can deteriorate quickly. So I make sure I go in with the biggest smile on my face like I'm meeting my favorite Hollywood star."
"When I say something like 'It's like a living hell, isn't it,' patients are really touched, he said. The patient’s response is typically 'You're the first dermatologist to understand what I'm going through.' You cannot endorse their delusion, but you can endorse their suffering."
In our video interview, Dr. Koo delved into techniques for the successful work-up and evaluation of patients with delusional parasitosis, the varying degrees of the condition, medications used for treatment, and the prospects for eventual drug-free relief.
Dr. Koo reports no relevant financial disclosures.
REPORTING FROM AAD 18
Biologics gaining traction in children with moderate to severe psoriasis
SAN DIEGO – Systemic therapies are increasingly being used for children with moderate to severe psoriasis; methotrexate is still the mainstay of systemic treatment, but biologics appear to achieve superior results with fewer side effects, Amy S. Paller, MD, said at the annual meeting of the American Academy of Dermatology.
Etanercept was approved in 2016 for children ages 6 and up, and ustekinumab was approved for use in patients aged 12 years or older in October 2017. Ongoing trials are examining adalimumab, apremilast, ustekinumab, and ixekizumab for use in adolescents and younger children. Trials are also being planned for other therapies that inhibit the Th17/IL-23 pathway, said Dr. Paller, the Walter J. Hamlin Professor and chair of dermatology at Northwestern University Feinberg School of Medicine, Chicago.
Further, the study found that biologic agents, primarily etanercept, were used by 27%, acitretin by nearly 15%, cyclosporine by about 8%, and fumaric acid esters by 5%. More than 1 medication was used by 19%, according to the study results.
Adverse events affected the ability to tolerate therapy, and methotrexate and biologic agents were taken for a mean duration that was 2-fold greater than the mean duration for cyclosporine or fumaric acid esters. “A prospective registry is needed to track the long-term risks of systemic agents for pediatric psoriasis,” the authors concluded.
Dr. Paller reported that, in her practice, "we're still primarily using methotrexate. It takes time to see an effect with methotrexate, and you have to let people know this up front.” She pointed to a 2015 single-site prospective study of 25 children that found just 40% achieved Psoriasis Area and Severity Index 50 at 12 weeks, with that number rising to 80% by 36 weeks. (J Derm Treat 2015; 26: 406-12)
Dr. Paller recommends baseline and annual TB testing, updated vaccinations and pregnancy counseling for all patients taking immunosuppressant therapies.
"I don't use a lot of retinoids for plaque psoriasis in kids," Dr. Paller said, "but for pustular psoriasis, I use (them) quite a bit. The beauty of retinoids is that they are not immunosuppressants, and you can start and stop them without loss of efficacy. There are many potential side effects, primarily skin and mucosal dryness."
Cyclosporine "has the greatest potential toxicity, which leaves it lower on the therapeutic ladder," Dr. Paller said. "But it has a pretty good safety record. The nice thing we can say is that (cyclosporine has) been around a long time. We have decades of experience in children, and we're using a low dose."
Benefits of biologics include convenience, infrequent dosing, and, potentially, fewer lab tests, Dr. Paller said. She added that there's no consensus about whether lab tests beyond annual TB tests are a good idea for patients on biologics.
Long-term risks are unclear, however, and drug holidays could spell trouble for efficacy when kids return to the medications.
Dr. Paller noted that biologics can cost tens of thousands of dollars for several weeks of treatment, and insurers may not cover them.
A 2014 meta-analysis of 48 randomized, controlled trials of 16,696 adult patients with psoriasis put biologics as the most effective therapies, with infliximab at the top (risk difference 76%), followed by adalimumab (RD 61%) and ustekinumab (RD 63%).
“These biologics are more effective than etanercept and all conventional treatments. Head-to-head trials indicate the superiority of adalimumab and infliximab over methotrexate (MTX), the superiority of ustekinumab over etanercept …” the meta-analysis concluded. (Br J Dermatol. 2014 Feb;170(2):274-303)
Dr. Paller disclosed that she is an investigator for Abbvie; Celgene; Eli Lilly, Janssen, Leo Foundation; Novartis. She is a consultant with honorarium for Amgen; Celgene; Eli Lilly; and Novartis.
SOURCE: Paller, A. et al, Session F025 Update on systemic therapies and emerging treatments
SAN DIEGO – Systemic therapies are increasingly being used for children with moderate to severe psoriasis; methotrexate is still the mainstay of systemic treatment, but biologics appear to achieve superior results with fewer side effects, Amy S. Paller, MD, said at the annual meeting of the American Academy of Dermatology.
Etanercept was approved in 2016 for children ages 6 and up, and ustekinumab was approved for use in patients aged 12 years or older in October 2017. Ongoing trials are examining adalimumab, apremilast, ustekinumab, and ixekizumab for use in adolescents and younger children. Trials are also being planned for other therapies that inhibit the Th17/IL-23 pathway, said Dr. Paller, the Walter J. Hamlin Professor and chair of dermatology at Northwestern University Feinberg School of Medicine, Chicago.
Further, the study found that biologic agents, primarily etanercept, were used by 27%, acitretin by nearly 15%, cyclosporine by about 8%, and fumaric acid esters by 5%. More than 1 medication was used by 19%, according to the study results.
Adverse events affected the ability to tolerate therapy, and methotrexate and biologic agents were taken for a mean duration that was 2-fold greater than the mean duration for cyclosporine or fumaric acid esters. “A prospective registry is needed to track the long-term risks of systemic agents for pediatric psoriasis,” the authors concluded.
Dr. Paller reported that, in her practice, "we're still primarily using methotrexate. It takes time to see an effect with methotrexate, and you have to let people know this up front.” She pointed to a 2015 single-site prospective study of 25 children that found just 40% achieved Psoriasis Area and Severity Index 50 at 12 weeks, with that number rising to 80% by 36 weeks. (J Derm Treat 2015; 26: 406-12)
Dr. Paller recommends baseline and annual TB testing, updated vaccinations and pregnancy counseling for all patients taking immunosuppressant therapies.
"I don't use a lot of retinoids for plaque psoriasis in kids," Dr. Paller said, "but for pustular psoriasis, I use (them) quite a bit. The beauty of retinoids is that they are not immunosuppressants, and you can start and stop them without loss of efficacy. There are many potential side effects, primarily skin and mucosal dryness."
Cyclosporine "has the greatest potential toxicity, which leaves it lower on the therapeutic ladder," Dr. Paller said. "But it has a pretty good safety record. The nice thing we can say is that (cyclosporine has) been around a long time. We have decades of experience in children, and we're using a low dose."
Benefits of biologics include convenience, infrequent dosing, and, potentially, fewer lab tests, Dr. Paller said. She added that there's no consensus about whether lab tests beyond annual TB tests are a good idea for patients on biologics.
Long-term risks are unclear, however, and drug holidays could spell trouble for efficacy when kids return to the medications.
Dr. Paller noted that biologics can cost tens of thousands of dollars for several weeks of treatment, and insurers may not cover them.
A 2014 meta-analysis of 48 randomized, controlled trials of 16,696 adult patients with psoriasis put biologics as the most effective therapies, with infliximab at the top (risk difference 76%), followed by adalimumab (RD 61%) and ustekinumab (RD 63%).
“These biologics are more effective than etanercept and all conventional treatments. Head-to-head trials indicate the superiority of adalimumab and infliximab over methotrexate (MTX), the superiority of ustekinumab over etanercept …” the meta-analysis concluded. (Br J Dermatol. 2014 Feb;170(2):274-303)
Dr. Paller disclosed that she is an investigator for Abbvie; Celgene; Eli Lilly, Janssen, Leo Foundation; Novartis. She is a consultant with honorarium for Amgen; Celgene; Eli Lilly; and Novartis.
SOURCE: Paller, A. et al, Session F025 Update on systemic therapies and emerging treatments
SAN DIEGO – Systemic therapies are increasingly being used for children with moderate to severe psoriasis; methotrexate is still the mainstay of systemic treatment, but biologics appear to achieve superior results with fewer side effects, Amy S. Paller, MD, said at the annual meeting of the American Academy of Dermatology.
Etanercept was approved in 2016 for children ages 6 and up, and ustekinumab was approved for use in patients aged 12 years or older in October 2017. Ongoing trials are examining adalimumab, apremilast, ustekinumab, and ixekizumab for use in adolescents and younger children. Trials are also being planned for other therapies that inhibit the Th17/IL-23 pathway, said Dr. Paller, the Walter J. Hamlin Professor and chair of dermatology at Northwestern University Feinberg School of Medicine, Chicago.
Further, the study found that biologic agents, primarily etanercept, were used by 27%, acitretin by nearly 15%, cyclosporine by about 8%, and fumaric acid esters by 5%. More than 1 medication was used by 19%, according to the study results.
Adverse events affected the ability to tolerate therapy, and methotrexate and biologic agents were taken for a mean duration that was 2-fold greater than the mean duration for cyclosporine or fumaric acid esters. “A prospective registry is needed to track the long-term risks of systemic agents for pediatric psoriasis,” the authors concluded.
Dr. Paller reported that, in her practice, "we're still primarily using methotrexate. It takes time to see an effect with methotrexate, and you have to let people know this up front.” She pointed to a 2015 single-site prospective study of 25 children that found just 40% achieved Psoriasis Area and Severity Index 50 at 12 weeks, with that number rising to 80% by 36 weeks. (J Derm Treat 2015; 26: 406-12)
Dr. Paller recommends baseline and annual TB testing, updated vaccinations and pregnancy counseling for all patients taking immunosuppressant therapies.
"I don't use a lot of retinoids for plaque psoriasis in kids," Dr. Paller said, "but for pustular psoriasis, I use (them) quite a bit. The beauty of retinoids is that they are not immunosuppressants, and you can start and stop them without loss of efficacy. There are many potential side effects, primarily skin and mucosal dryness."
Cyclosporine "has the greatest potential toxicity, which leaves it lower on the therapeutic ladder," Dr. Paller said. "But it has a pretty good safety record. The nice thing we can say is that (cyclosporine has) been around a long time. We have decades of experience in children, and we're using a low dose."
Benefits of biologics include convenience, infrequent dosing, and, potentially, fewer lab tests, Dr. Paller said. She added that there's no consensus about whether lab tests beyond annual TB tests are a good idea for patients on biologics.
Long-term risks are unclear, however, and drug holidays could spell trouble for efficacy when kids return to the medications.
Dr. Paller noted that biologics can cost tens of thousands of dollars for several weeks of treatment, and insurers may not cover them.
A 2014 meta-analysis of 48 randomized, controlled trials of 16,696 adult patients with psoriasis put biologics as the most effective therapies, with infliximab at the top (risk difference 76%), followed by adalimumab (RD 61%) and ustekinumab (RD 63%).
“These biologics are more effective than etanercept and all conventional treatments. Head-to-head trials indicate the superiority of adalimumab and infliximab over methotrexate (MTX), the superiority of ustekinumab over etanercept …” the meta-analysis concluded. (Br J Dermatol. 2014 Feb;170(2):274-303)
Dr. Paller disclosed that she is an investigator for Abbvie; Celgene; Eli Lilly, Janssen, Leo Foundation; Novartis. She is a consultant with honorarium for Amgen; Celgene; Eli Lilly; and Novartis.
SOURCE: Paller, A. et al, Session F025 Update on systemic therapies and emerging treatments
EXPERT ANALYSIS AT AAD 18
Physicians often bypass cognition, depression screening in MS
SAN DIEGO – A new study finds that physicians at two . Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.
In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.
The study findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Three of the study authors spoke in interviews.
The researchers sought to understand how frequently MS patients are screened for cognitive problems and depression.
“Cognitive impairment is experienced by approximately half of patients with multiple sclerosis, yet many are never screened or treated, which can impact their daily activities, their ability to work, and overall quality of life,” Dr. Sapir said.
Depression, meanwhile, is believed to be much more common in patients with MS than in the general population, with one recent meta-analysis of 58 studies finding that the average prevalence was 31%. Other research suggests depression is underdiagnosed and undertreated in this population (J Neurol Sci. 2017 Jan 15;372:331-41; ISRN Neurology. 2012, Article ID 427102. doi: 10.5402/2012/427102).
For the current study, researchers tracked 300 patients at two unidentified MS clinics via their charts over a 2-year period from 2014 to 2016. Their median age was 52 years, 76% were women, and 15 had experienced at least one relapse within the previous 24 months.
“Screening for cognitive impairment and depression was documented for only 52% and 63% of MS patients, respectively, and only about a quarter of patients diagnosed with these conditions were referred to a higher level of care,” said lead author Guy J. Buckle, MD, MPH, of the Andrew C. Carlos MS Institute at Shepherd Center in Atlanta.
Among all 300 patients, just 2% and 4% were screened using a validated tool for cognitive impairment and depression, respectively.
The screening often turned up evidence of the conditions: Physicians saw signs of cognitive impairment in 69% and 78% of those screened aged under 65 years and aged 65 and older, respectively, and they detected depression in 71% and 54% of those screened in those two age groups, respectively.
Researchers also noted several disparities. “Cognitive screening was conducted more frequently in older, employed, or white patients, while the presence of cognitive impairment was documented more often in black, nonworking, and those on Medicare or Medicaid,” Dr. Buckle said. “Depression screening was performed most frequently in older or white patients, yet depression was more common in younger, nonworking patients and those on Medicare/Medicaid.”
In another part of their study, researchers surveyed 13 unidentified “national leaders” in MS research and treatment. Just seven said they used validated tools to screen for cognitive impairment and six said they used them to screen for depression.
“We hear from MS specialists that they want to be measuring for cognition but don’t know how to efficiently work it into their routine, how to approach the patient, and what tools to use,” said study coauthor Derrick S. Robertson, MD, of the University of South Florida, Tampa. “In addition, there is no one tool that is accepted in the MS treatment community.”
MS specialists who didn’t use the screening tests also pointed to factors like lack of reimbursement and lack of integration into electronic medical records. “Doubt very much that neurologists have time to use any of these tests,” one respondent said, referring to cognitive impairment screening.
What’s next? “There are several new exciting developments in clinical trials demonstrating efficacy of disease-modifying therapies in maintaining or improving cognition in patients with relapsing MS,” Dr. Robertson said. “This highlights the urgent need to overcome barriers to use of formal cognitive screening tools in clinical practice to identify patients who need a higher level of care, and perhaps even a change in treatment with the ultimate goal to improve quality of life and overall outcomes.”
Genentech funded the study through an educational grant. Dr. Sapir and three other study authors reported no relevant disclosures. Dr. Buckle and Dr. Robertson reported multiple disclosures, including principle investigator and advisory board/panel member work.
SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.
SAN DIEGO – A new study finds that physicians at two . Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.
In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.
The study findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Three of the study authors spoke in interviews.
The researchers sought to understand how frequently MS patients are screened for cognitive problems and depression.
“Cognitive impairment is experienced by approximately half of patients with multiple sclerosis, yet many are never screened or treated, which can impact their daily activities, their ability to work, and overall quality of life,” Dr. Sapir said.
Depression, meanwhile, is believed to be much more common in patients with MS than in the general population, with one recent meta-analysis of 58 studies finding that the average prevalence was 31%. Other research suggests depression is underdiagnosed and undertreated in this population (J Neurol Sci. 2017 Jan 15;372:331-41; ISRN Neurology. 2012, Article ID 427102. doi: 10.5402/2012/427102).
For the current study, researchers tracked 300 patients at two unidentified MS clinics via their charts over a 2-year period from 2014 to 2016. Their median age was 52 years, 76% were women, and 15 had experienced at least one relapse within the previous 24 months.
“Screening for cognitive impairment and depression was documented for only 52% and 63% of MS patients, respectively, and only about a quarter of patients diagnosed with these conditions were referred to a higher level of care,” said lead author Guy J. Buckle, MD, MPH, of the Andrew C. Carlos MS Institute at Shepherd Center in Atlanta.
Among all 300 patients, just 2% and 4% were screened using a validated tool for cognitive impairment and depression, respectively.
The screening often turned up evidence of the conditions: Physicians saw signs of cognitive impairment in 69% and 78% of those screened aged under 65 years and aged 65 and older, respectively, and they detected depression in 71% and 54% of those screened in those two age groups, respectively.
Researchers also noted several disparities. “Cognitive screening was conducted more frequently in older, employed, or white patients, while the presence of cognitive impairment was documented more often in black, nonworking, and those on Medicare or Medicaid,” Dr. Buckle said. “Depression screening was performed most frequently in older or white patients, yet depression was more common in younger, nonworking patients and those on Medicare/Medicaid.”
In another part of their study, researchers surveyed 13 unidentified “national leaders” in MS research and treatment. Just seven said they used validated tools to screen for cognitive impairment and six said they used them to screen for depression.
“We hear from MS specialists that they want to be measuring for cognition but don’t know how to efficiently work it into their routine, how to approach the patient, and what tools to use,” said study coauthor Derrick S. Robertson, MD, of the University of South Florida, Tampa. “In addition, there is no one tool that is accepted in the MS treatment community.”
MS specialists who didn’t use the screening tests also pointed to factors like lack of reimbursement and lack of integration into electronic medical records. “Doubt very much that neurologists have time to use any of these tests,” one respondent said, referring to cognitive impairment screening.
What’s next? “There are several new exciting developments in clinical trials demonstrating efficacy of disease-modifying therapies in maintaining or improving cognition in patients with relapsing MS,” Dr. Robertson said. “This highlights the urgent need to overcome barriers to use of formal cognitive screening tools in clinical practice to identify patients who need a higher level of care, and perhaps even a change in treatment with the ultimate goal to improve quality of life and overall outcomes.”
Genentech funded the study through an educational grant. Dr. Sapir and three other study authors reported no relevant disclosures. Dr. Buckle and Dr. Robertson reported multiple disclosures, including principle investigator and advisory board/panel member work.
SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.
SAN DIEGO – A new study finds that physicians at two . Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.
In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.
The study findings were presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. Three of the study authors spoke in interviews.
The researchers sought to understand how frequently MS patients are screened for cognitive problems and depression.
“Cognitive impairment is experienced by approximately half of patients with multiple sclerosis, yet many are never screened or treated, which can impact their daily activities, their ability to work, and overall quality of life,” Dr. Sapir said.
Depression, meanwhile, is believed to be much more common in patients with MS than in the general population, with one recent meta-analysis of 58 studies finding that the average prevalence was 31%. Other research suggests depression is underdiagnosed and undertreated in this population (J Neurol Sci. 2017 Jan 15;372:331-41; ISRN Neurology. 2012, Article ID 427102. doi: 10.5402/2012/427102).
For the current study, researchers tracked 300 patients at two unidentified MS clinics via their charts over a 2-year period from 2014 to 2016. Their median age was 52 years, 76% were women, and 15 had experienced at least one relapse within the previous 24 months.
“Screening for cognitive impairment and depression was documented for only 52% and 63% of MS patients, respectively, and only about a quarter of patients diagnosed with these conditions were referred to a higher level of care,” said lead author Guy J. Buckle, MD, MPH, of the Andrew C. Carlos MS Institute at Shepherd Center in Atlanta.
Among all 300 patients, just 2% and 4% were screened using a validated tool for cognitive impairment and depression, respectively.
The screening often turned up evidence of the conditions: Physicians saw signs of cognitive impairment in 69% and 78% of those screened aged under 65 years and aged 65 and older, respectively, and they detected depression in 71% and 54% of those screened in those two age groups, respectively.
Researchers also noted several disparities. “Cognitive screening was conducted more frequently in older, employed, or white patients, while the presence of cognitive impairment was documented more often in black, nonworking, and those on Medicare or Medicaid,” Dr. Buckle said. “Depression screening was performed most frequently in older or white patients, yet depression was more common in younger, nonworking patients and those on Medicare/Medicaid.”
In another part of their study, researchers surveyed 13 unidentified “national leaders” in MS research and treatment. Just seven said they used validated tools to screen for cognitive impairment and six said they used them to screen for depression.
“We hear from MS specialists that they want to be measuring for cognition but don’t know how to efficiently work it into their routine, how to approach the patient, and what tools to use,” said study coauthor Derrick S. Robertson, MD, of the University of South Florida, Tampa. “In addition, there is no one tool that is accepted in the MS treatment community.”
MS specialists who didn’t use the screening tests also pointed to factors like lack of reimbursement and lack of integration into electronic medical records. “Doubt very much that neurologists have time to use any of these tests,” one respondent said, referring to cognitive impairment screening.
What’s next? “There are several new exciting developments in clinical trials demonstrating efficacy of disease-modifying therapies in maintaining or improving cognition in patients with relapsing MS,” Dr. Robertson said. “This highlights the urgent need to overcome barriers to use of formal cognitive screening tools in clinical practice to identify patients who need a higher level of care, and perhaps even a change in treatment with the ultimate goal to improve quality of life and overall outcomes.”
Genentech funded the study through an educational grant. Dr. Sapir and three other study authors reported no relevant disclosures. Dr. Buckle and Dr. Robertson reported multiple disclosures, including principle investigator and advisory board/panel member work.
SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.
REPORTING FROM ACTRIMS FORUM 2018
Key clinical point: Screening often turns up signs of trouble, but many MS patients are not screened annually for depression and cognitive impairment.
Major finding: 52% and 63% of patients with MS were screened for cognitive impairment and depression, respectively, over a 1-year period. Study details: 2-year analysis of medical records from two MS clinics in the Southeast.
Disclosures: Genentech funded the study through an educational grant. Some of the study authors reported various disclosures.
Source: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.
Nearly half of MS patients treated by primary docs miss out on meds
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
REPORTING FROM ACTRIMS FORUM 2018