PHILADELPHIA – The proof of concept shown by the CANTOS study in 2017 that an anti-inflammatory drug could cut the incidence of cardiovascular events has now been replicated in a study with more than 4,700 post-MI patients who received the much more affordable oral anti-inflammatory drug colchicine.

Mitchel L. Zoler/MDedge News

Daily treatment with a single, 0.5-mg/day colchicine tablet cut cardiovascular disease events by a statistically significant 23%, compared with placebo patients during nearly 20 months on treatment when colchicine was added on top of a regimen that included aspirin, a second antiplatelet drug, a statin, and in many patients a beta-blocking drug, Jean-Claude Tardif, MD, said at the American Heart Association scientific sessions.

Adding colchicine to the treatment of patients within 30 days of having a MI led to an absolute reduction in the study’s primary endpoint of 1.6% during a median 19.6 months on treatment. In a secondary analysis that looked at total cardiovascular events and not just first events, adding colchicine to background therapy was associated with a relative 34% decline, said Dr. Tardif, professor of medicine at the University of Montreal and director of the Research Centre at the Montreal Heart Institute. In addition to his report at the meeting, the results also appeared concurrently in an article published online (N Engl J Med. 2019 Nov 16. doi: 10.1056/NEJMoa1912388).

The dramatic efficacy and overall safety shown by colchicine in COLCOT (Colchicine Cardiovascular Outcomes Trial) appeared to replicate the benefit seen with the relatively expensive monoclonal antibody canakinumab (Ilaris) in CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcome Study), where a canakinumab injection every 3 months led to a 15% reduction in the incidence of cardiovascular events, compared with placebo, during a median 3.7 years of follow-up in a study with just over 10,000 post-MI patients (N Engl J Med. 2017 Sep 21;377[12]:1119-31).

“One of the limitations of CANTOS was that canakinumab is a very expensive, injectable drug. We followed in the footsteps of CANTOS with a less expensive, oral drug,” Dr. Tardif explained during a press briefing. “Colchicine is a known, potent anti-inflammatory drug,” and as of November 2019, the average U.S. cost of a 30-day supply of 0.6-mg capsules was $147. The colchicine formulation used in COLCOT delivered a 0.5-mg daily dose to patients, a formulation that’s not currently on the U.S. market.

Mitchel L. Zoler/MDedge News

“Having a safe drug that’s easily available; it will be hard to hold this one back,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago. “What the guidelines will need to wrestle with is there are five drugs” already recommended to use after an MI; “is colchicine number six?” The existing guideline-directed drugs for post-MI patients include aspirin, a second antiplatelet agent, a statin, a beta-blocker, and an angiotensin-converting enzyme inhibitor, Dr. Lloyd-Jones noted. The incremental benefit from adding colchicine to background regimen was “modest, but statistically significant,” he said, and “importantly, this was not an industry-sponsored trial.” Dr. Lloyd-Jones said that he has recently heard from a patient of his in the Chicago area who takes colchicine for gout that the monthly cost for the drug has risen to as high as $270. By comparison, the price in Montreal is less than $9/month, Dr. Tardif said.

COLCOT enrolled 4,745 patients at a median of about 13.5 days following an acute MI at 167 centers in 12 countries. The study’s primary endpoint was the combination of death from cardiovascular causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization in a time-to-event analysis. The combined endpoint occurred in 5.5% of the patients on colchicine and 7.1% of those on placebo during a median of nearly 20 months on treatment. The adverse effects data showed generally similarly rates among patients on colchicine and in the control group, including their rates of gastrointestinal effects. The one exception was the rate of serious pneumonias, which were more than double in the colchicine recipients, a statistically significant difference.

COLCOT received no commercial support. Dr. Tardif has received honoraria from Amarin, DalCor, Sanofi, and Servier; he has an ownership interest in DalCor; and he has received research funding from Amarin, AstraZeneca, DalCor, Esperion, Ionis, RegenxBio, Sanofi, and Servier. Dr. Lloyd-Jones had no disclosures.

mzoler@mdedge.com

SOURCE: Tardif J-C et al. AHA 2019, Abstract.

PHILADELPHIA – The proof of concept shown by the CANTOS study in 2017 that an anti-inflammatory drug could cut the incidence of cardiovascular events has now been replicated in a study with more than 4,700 post-MI patients who received the much more affordable oral anti-inflammatory drug colchicine.

Mitchel L. Zoler/MDedge News

Daily treatment with a single, 0.5-mg/day colchicine tablet cut cardiovascular disease events by a statistically significant 23%, compared with placebo patients during nearly 20 months on treatment when colchicine was added on top of a regimen that included aspirin, a second antiplatelet drug, a statin, and in many patients a beta-blocking drug, Jean-Claude Tardif, MD, said at the American Heart Association scientific sessions.

Adding colchicine to the treatment of patients within 30 days of having a MI led to an absolute reduction in the study’s primary endpoint of 1.6% during a median 19.6 months on treatment. In a secondary analysis that looked at total cardiovascular events and not just first events, adding colchicine to background therapy was associated with a relative 34% decline, said Dr. Tardif, professor of medicine at the University of Montreal and director of the Research Centre at the Montreal Heart Institute. In addition to his report at the meeting, the results also appeared concurrently in an article published online (N Engl J Med. 2019 Nov 16. doi: 10.1056/NEJMoa1912388).

The dramatic efficacy and overall safety shown by colchicine in COLCOT (Colchicine Cardiovascular Outcomes Trial) appeared to replicate the benefit seen with the relatively expensive monoclonal antibody canakinumab (Ilaris) in CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcome Study), where a canakinumab injection every 3 months led to a 15% reduction in the incidence of cardiovascular events, compared with placebo, during a median 3.7 years of follow-up in a study with just over 10,000 post-MI patients (N Engl J Med. 2017 Sep 21;377[12]:1119-31).

“One of the limitations of CANTOS was that canakinumab is a very expensive, injectable drug. We followed in the footsteps of CANTOS with a less expensive, oral drug,” Dr. Tardif explained during a press briefing. “Colchicine is a known, potent anti-inflammatory drug,” and as of November 2019, the average U.S. cost of a 30-day supply of 0.6-mg capsules was $147. The colchicine formulation used in COLCOT delivered a 0.5-mg daily dose to patients, a formulation that’s not currently on the U.S. market.

Mitchel L. Zoler/MDedge News

“Having a safe drug that’s easily available; it will be hard to hold this one back,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago. “What the guidelines will need to wrestle with is there are five drugs” already recommended to use after an MI; “is colchicine number six?” The existing guideline-directed drugs for post-MI patients include aspirin, a second antiplatelet agent, a statin, a beta-blocker, and an angiotensin-converting enzyme inhibitor, Dr. Lloyd-Jones noted. The incremental benefit from adding colchicine to background regimen was “modest, but statistically significant,” he said, and “importantly, this was not an industry-sponsored trial.” Dr. Lloyd-Jones said that he has recently heard from a patient of his in the Chicago area who takes colchicine for gout that the monthly cost for the drug has risen to as high as $270. By comparison, the price in Montreal is less than $9/month, Dr. Tardif said.

COLCOT enrolled 4,745 patients at a median of about 13.5 days following an acute MI at 167 centers in 12 countries. The study’s primary endpoint was the combination of death from cardiovascular causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization in a time-to-event analysis. The combined endpoint occurred in 5.5% of the patients on colchicine and 7.1% of those on placebo during a median of nearly 20 months on treatment. The adverse effects data showed generally similarly rates among patients on colchicine and in the control group, including their rates of gastrointestinal effects. The one exception was the rate of serious pneumonias, which were more than double in the colchicine recipients, a statistically significant difference.

COLCOT received no commercial support. Dr. Tardif has received honoraria from Amarin, DalCor, Sanofi, and Servier; he has an ownership interest in DalCor; and he has received research funding from Amarin, AstraZeneca, DalCor, Esperion, Ionis, RegenxBio, Sanofi, and Servier. Dr. Lloyd-Jones had no disclosures.

mzoler@mdedge.com

SOURCE: Tardif J-C et al. AHA 2019, Abstract.

PHILADELPHIA – The proof of concept shown by the CANTOS study in 2017 that an anti-inflammatory drug could cut the incidence of cardiovascular events has now been replicated in a study with more than 4,700 post-MI patients who received the much more affordable oral anti-inflammatory drug colchicine.

Mitchel L. Zoler/MDedge News

Daily treatment with a single, 0.5-mg/day colchicine tablet cut cardiovascular disease events by a statistically significant 23%, compared with placebo patients during nearly 20 months on treatment when colchicine was added on top of a regimen that included aspirin, a second antiplatelet drug, a statin, and in many patients a beta-blocking drug, Jean-Claude Tardif, MD, said at the American Heart Association scientific sessions.

Adding colchicine to the treatment of patients within 30 days of having a MI led to an absolute reduction in the study’s primary endpoint of 1.6% during a median 19.6 months on treatment. In a secondary analysis that looked at total cardiovascular events and not just first events, adding colchicine to background therapy was associated with a relative 34% decline, said Dr. Tardif, professor of medicine at the University of Montreal and director of the Research Centre at the Montreal Heart Institute. In addition to his report at the meeting, the results also appeared concurrently in an article published online (N Engl J Med. 2019 Nov 16. doi: 10.1056/NEJMoa1912388).

The dramatic efficacy and overall safety shown by colchicine in COLCOT (Colchicine Cardiovascular Outcomes Trial) appeared to replicate the benefit seen with the relatively expensive monoclonal antibody canakinumab (Ilaris) in CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcome Study), where a canakinumab injection every 3 months led to a 15% reduction in the incidence of cardiovascular events, compared with placebo, during a median 3.7 years of follow-up in a study with just over 10,000 post-MI patients (N Engl J Med. 2017 Sep 21;377[12]:1119-31).

“One of the limitations of CANTOS was that canakinumab is a very expensive, injectable drug. We followed in the footsteps of CANTOS with a less expensive, oral drug,” Dr. Tardif explained during a press briefing. “Colchicine is a known, potent anti-inflammatory drug,” and as of November 2019, the average U.S. cost of a 30-day supply of 0.6-mg capsules was $147. The colchicine formulation used in COLCOT delivered a 0.5-mg daily dose to patients, a formulation that’s not currently on the U.S. market.

Mitchel L. Zoler/MDedge News

“Having a safe drug that’s easily available; it will be hard to hold this one back,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago. “What the guidelines will need to wrestle with is there are five drugs” already recommended to use after an MI; “is colchicine number six?” The existing guideline-directed drugs for post-MI patients include aspirin, a second antiplatelet agent, a statin, a beta-blocker, and an angiotensin-converting enzyme inhibitor, Dr. Lloyd-Jones noted. The incremental benefit from adding colchicine to background regimen was “modest, but statistically significant,” he said, and “importantly, this was not an industry-sponsored trial.” Dr. Lloyd-Jones said that he has recently heard from a patient of his in the Chicago area who takes colchicine for gout that the monthly cost for the drug has risen to as high as $270. By comparison, the price in Montreal is less than $9/month, Dr. Tardif said.

COLCOT enrolled 4,745 patients at a median of about 13.5 days following an acute MI at 167 centers in 12 countries. The study’s primary endpoint was the combination of death from cardiovascular causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization in a time-to-event analysis. The combined endpoint occurred in 5.5% of the patients on colchicine and 7.1% of those on placebo during a median of nearly 20 months on treatment. The adverse effects data showed generally similarly rates among patients on colchicine and in the control group, including their rates of gastrointestinal effects. The one exception was the rate of serious pneumonias, which were more than double in the colchicine recipients, a statistically significant difference.

COLCOT received no commercial support. Dr. Tardif has received honoraria from Amarin, DalCor, Sanofi, and Servier; he has an ownership interest in DalCor; and he has received research funding from Amarin, AstraZeneca, DalCor, Esperion, Ionis, RegenxBio, Sanofi, and Servier. Dr. Lloyd-Jones had no disclosures.

mzoler@mdedge.com

SOURCE: Tardif J-C et al. AHA 2019, Abstract.

Allopathic and naturopathic providers use similar strategies to diagnose atopic dermatitis (AD) in children, including distribution, morphology, and pruritus, but they diverge when it comes to treatment, based on data from a small survey of the two.

Data from previous studies show that more than half of patients with AD have used complementary and alternative medicine in addition to allopathic care, but providers may be unaware of each other’s treatment approaches and confuse patients, wrote Julie Dhossche, MD, of Oregon Health & Science University, Portland, and her colleagues.

In a study published in Pediatric Dermatology, the researchers assessed results of an 11-question, free-text survey of 30 allopathic providers and 21 naturopathic providers about AD. The survey included questions on patient education and evaluation, skin care, and treatment.

Overall, both allopathic and naturopathic providers recommended skin care protocols involving moisturization and “soak and seal” bathing. However, allopathic providers were more likely to prescribe topical corticosteroids for mild to moderate disease (100% vs. 19%), followed by phototherapy and systemic treatments in more severe cases. Naturopathic providers were more likely than allopathic providers to choose topical botanicals, oils, or probiotics (52% vs. 0%) for mild to moderate disease, as well stress relief and acupuncture. Naturopathic providers favored topical corticosteroids and referrals to dermatologists for second- or third-line treatment.

Of note, 85% of naturopathic providers said they thought diet had a probable or definite role in AD, compared with 3% of allopathic providers.

In addition, naturopathic providers differed in their response to an optional question on the use of additional education about food and diet. A total of 11 of 19 naturopathic providers (58%) recommended dietary changes, including “remove potential food allergens/reduce sugar” and “emphasize anti-inflammatory diet,” the researchers said.

“Confusion regarding the role of food in AD management is a common source of frustration for patients, and perhaps a consensus statement from both fields regarding the role of food allergy in AD management could be aspired toward in the name of reducing patient confusion,” they wrote.

The study findings were limited by several factors, including the small sample size and self-selection bias, as well as the subjective nature of an open-ended survey, the researchers noted. However, the results provide evidence of differences in treatment approaches between allopathic and naturopathic providers and suggest that “respectful collaboration between allopathic and naturopathic providers will help practitioners find common ground, decrease patient confusion, and improve patient outcomes,” they concluded.

The researchers had no financial conflicts to disclose.

SOURCE: Dhossche J et al. Ped Dermatol. 2019 Nov 19. doi: 10.1111/pde.14036.

Allopathic and naturopathic providers use similar strategies to diagnose atopic dermatitis (AD) in children, including distribution, morphology, and pruritus, but they diverge when it comes to treatment, based on data from a small survey of the two.

Data from previous studies show that more than half of patients with AD have used complementary and alternative medicine in addition to allopathic care, but providers may be unaware of each other’s treatment approaches and confuse patients, wrote Julie Dhossche, MD, of Oregon Health & Science University, Portland, and her colleagues.

In a study published in Pediatric Dermatology, the researchers assessed results of an 11-question, free-text survey of 30 allopathic providers and 21 naturopathic providers about AD. The survey included questions on patient education and evaluation, skin care, and treatment.

Overall, both allopathic and naturopathic providers recommended skin care protocols involving moisturization and “soak and seal” bathing. However, allopathic providers were more likely to prescribe topical corticosteroids for mild to moderate disease (100% vs. 19%), followed by phototherapy and systemic treatments in more severe cases. Naturopathic providers were more likely than allopathic providers to choose topical botanicals, oils, or probiotics (52% vs. 0%) for mild to moderate disease, as well stress relief and acupuncture. Naturopathic providers favored topical corticosteroids and referrals to dermatologists for second- or third-line treatment.

Of note, 85% of naturopathic providers said they thought diet had a probable or definite role in AD, compared with 3% of allopathic providers.

In addition, naturopathic providers differed in their response to an optional question on the use of additional education about food and diet. A total of 11 of 19 naturopathic providers (58%) recommended dietary changes, including “remove potential food allergens/reduce sugar” and “emphasize anti-inflammatory diet,” the researchers said.

“Confusion regarding the role of food in AD management is a common source of frustration for patients, and perhaps a consensus statement from both fields regarding the role of food allergy in AD management could be aspired toward in the name of reducing patient confusion,” they wrote.

The study findings were limited by several factors, including the small sample size and self-selection bias, as well as the subjective nature of an open-ended survey, the researchers noted. However, the results provide evidence of differences in treatment approaches between allopathic and naturopathic providers and suggest that “respectful collaboration between allopathic and naturopathic providers will help practitioners find common ground, decrease patient confusion, and improve patient outcomes,” they concluded.

The researchers had no financial conflicts to disclose.

SOURCE: Dhossche J et al. Ped Dermatol. 2019 Nov 19. doi: 10.1111/pde.14036.

Allopathic and naturopathic providers use similar strategies to diagnose atopic dermatitis (AD) in children, including distribution, morphology, and pruritus, but they diverge when it comes to treatment, based on data from a small survey of the two.

Data from previous studies show that more than half of patients with AD have used complementary and alternative medicine in addition to allopathic care, but providers may be unaware of each other’s treatment approaches and confuse patients, wrote Julie Dhossche, MD, of Oregon Health & Science University, Portland, and her colleagues.

In a study published in Pediatric Dermatology, the researchers assessed results of an 11-question, free-text survey of 30 allopathic providers and 21 naturopathic providers about AD. The survey included questions on patient education and evaluation, skin care, and treatment.

Overall, both allopathic and naturopathic providers recommended skin care protocols involving moisturization and “soak and seal” bathing. However, allopathic providers were more likely to prescribe topical corticosteroids for mild to moderate disease (100% vs. 19%), followed by phototherapy and systemic treatments in more severe cases. Naturopathic providers were more likely than allopathic providers to choose topical botanicals, oils, or probiotics (52% vs. 0%) for mild to moderate disease, as well stress relief and acupuncture. Naturopathic providers favored topical corticosteroids and referrals to dermatologists for second- or third-line treatment.

Of note, 85% of naturopathic providers said they thought diet had a probable or definite role in AD, compared with 3% of allopathic providers.

In addition, naturopathic providers differed in their response to an optional question on the use of additional education about food and diet. A total of 11 of 19 naturopathic providers (58%) recommended dietary changes, including “remove potential food allergens/reduce sugar” and “emphasize anti-inflammatory diet,” the researchers said.

“Confusion regarding the role of food in AD management is a common source of frustration for patients, and perhaps a consensus statement from both fields regarding the role of food allergy in AD management could be aspired toward in the name of reducing patient confusion,” they wrote.

The study findings were limited by several factors, including the small sample size and self-selection bias, as well as the subjective nature of an open-ended survey, the researchers noted. However, the results provide evidence of differences in treatment approaches between allopathic and naturopathic providers and suggest that “respectful collaboration between allopathic and naturopathic providers will help practitioners find common ground, decrease patient confusion, and improve patient outcomes,” they concluded.

The researchers had no financial conflicts to disclose.

SOURCE: Dhossche J et al. Ped Dermatol. 2019 Nov 19. doi: 10.1111/pde.14036.

LAS VEGAS – Recent research is offering new insights into psoriasis and alopecia in the pediatric population, a dermatologist told colleagues, and it’s time to be on the lookout for psoriasis linked to treatment with tumor necrosis factor (TNF) inhibitors.

Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics, at the University of California, San Diego, offered these tips and comments in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar:

Psoriasis

It’s a brand new day for adult psoriasis sufferers, but it seems to be only a brand new morning for their pediatric counterparts. “Kids and teenagers were left behind in the biologic revolution,” Dr. Eichenfield said. “Only two systemic biologics have been approved for psoriasis in children.” They are ustekinumab (Stelara), approved by the Food and Drug Administration for treating psoriasis in children aged 12 years and older, and etanercept, approved for aged 4 years and older.

The good news, he said, is that “our new biologic agents are now being studied in children.”

Research is also providing new insight into pediatric psoriasis, said Dr. Eichenfield, who is also chief of pediatric and adolescent dermatology at Rady Children’s Hospital in San Diego. It’s now clear that “there’s a lot more facial involvement, and a high involvement of scalp and nail,” he noted.

It’s also clear, he said, that inflammation begins early in pediatric psoriasis. That raises the question of whether it’s a good idea to launch aggressive treatment to stop the “psoriatic march” toward cardiovascular and other medical problems down the line, he commented.

“Keep an open mind to getting aggressive in therapy,” he advised, although he acknowledged that “it’s hard to get beyond the two biologics, and only one is approved for children under 12.”

Dr. Eichenfield advised colleagues to keep an eye out for TNF inhibitor–induced psoriasis. “We’re seeing it pretty regularly,” he said, commonly in children who are treated with TNF inhibitors for rheumatoid arthritis or Crohn’s disease.

The lesions “look like dermatitis but are very psoriasiform,” he said, and research suggests this can appear after a single dose or after as many as 63 months of treatment. Topical and light therapy can be helpful. But if those treatments do not help, he said, it’s time to consider changing the biologic that the patient is taking. “Is the biologic adequately controlling their underlying disease? If not, you can help find one that would be great for their underlying disease and clear up their psoriasis.”

Alopecia

Pediatric alopecia “is a problem I see pretty regularly in practice,” Dr. Eichenfield said. When he sees patients with alopecia, he says that, “‘if your child doesn’t have 50% hair loss, you’re in the good group. It will generally heal up and never come back again.’ ”

He referred to a recent study, where investigators at the Children’s Hospital of Philadelphia retrospectively studied 125 children under age 4 years who were diagnosed with alopecia areata and followed for 2 years. Over time, those children with over 50% of hair loss initially were more likely to have worsening Severity of Alopecia Tool (SALT) scores over the follow-up period. But a high proportion of those with mild alopecia initially continued to have mild alopecia at follow-up (Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990).

Dr. Eichenfield noted that the study found that 41% of the patients also had atopic dermatitis.

He also highlighted two other recent studies on pediatric alopecia: One found that while vitamin D levels were low in a majority of children with alopecia in the study, the proportion who had a deficiency was similar to the proportion in a larger pediatric population, at about 22% in both groups (J Am Acad Dermatol. 2018 Sep;79(3):e43-e44). Supplementation doesn’t seem to help. “It’s not important to test levels,” he said.

Another study examined whether it’s a good idea to test patients for celiac disease in children with alopecia (Pediatr Dermatol. 2018 Jul;35[4]:535-8). Some parents may ask this question, but the answer, he said, is generally no.

What’s next? “We were hoping oral and topical JAK inhibitors would work well” in this population, Dr. Eichenfield said, but study findings haven’t been promising.

Still, oral tofacitinib (Xeljanz) showed some “pretty impressive” success in a recent study in four children, he noted. Based on the results, the authors wrote that “we suggest that, after proper counseling regarding the risks, including severe infection and malignancy, the use of tofacitinib may be considered for preadolescent children with AA [alopecia areata] who are experiencing psychosocial impairment” (J Am Acad Dermatol. 2019 Feb;80[2]:568-70).

In general, Dr. Eichenfield said, research on pediatric alopecia “will be secondary, especially with JAK inhibitors because of the risk of side effects. But [children will] probably tolerate them better than adults do because they have fewer medical problems.”

Meanwhile, he added, controversy continues to swirl around how to treat children over age 10 years who have lost 50% or more of their hair. “I’ve seen hundreds of kids with alopecia areata,” he said, “and I can’t predict what the course may be.”

Dr. Eichenfield reports multiple relationships (consultant or investigator) with various pharmaceutical companies, including Abbvie, Allergan, Lilly, Novartis, and others. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Recent research is offering new insights into psoriasis and alopecia in the pediatric population, a dermatologist told colleagues, and it’s time to be on the lookout for psoriasis linked to treatment with tumor necrosis factor (TNF) inhibitors.

Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics, at the University of California, San Diego, offered these tips and comments in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar:

Psoriasis

It’s a brand new day for adult psoriasis sufferers, but it seems to be only a brand new morning for their pediatric counterparts. “Kids and teenagers were left behind in the biologic revolution,” Dr. Eichenfield said. “Only two systemic biologics have been approved for psoriasis in children.” They are ustekinumab (Stelara), approved by the Food and Drug Administration for treating psoriasis in children aged 12 years and older, and etanercept, approved for aged 4 years and older.

The good news, he said, is that “our new biologic agents are now being studied in children.”

Research is also providing new insight into pediatric psoriasis, said Dr. Eichenfield, who is also chief of pediatric and adolescent dermatology at Rady Children’s Hospital in San Diego. It’s now clear that “there’s a lot more facial involvement, and a high involvement of scalp and nail,” he noted.

It’s also clear, he said, that inflammation begins early in pediatric psoriasis. That raises the question of whether it’s a good idea to launch aggressive treatment to stop the “psoriatic march” toward cardiovascular and other medical problems down the line, he commented.

“Keep an open mind to getting aggressive in therapy,” he advised, although he acknowledged that “it’s hard to get beyond the two biologics, and only one is approved for children under 12.”

Dr. Eichenfield advised colleagues to keep an eye out for TNF inhibitor–induced psoriasis. “We’re seeing it pretty regularly,” he said, commonly in children who are treated with TNF inhibitors for rheumatoid arthritis or Crohn’s disease.

The lesions “look like dermatitis but are very psoriasiform,” he said, and research suggests this can appear after a single dose or after as many as 63 months of treatment. Topical and light therapy can be helpful. But if those treatments do not help, he said, it’s time to consider changing the biologic that the patient is taking. “Is the biologic adequately controlling their underlying disease? If not, you can help find one that would be great for their underlying disease and clear up their psoriasis.”

Alopecia

Pediatric alopecia “is a problem I see pretty regularly in practice,” Dr. Eichenfield said. When he sees patients with alopecia, he says that, “‘if your child doesn’t have 50% hair loss, you’re in the good group. It will generally heal up and never come back again.’ ”

He referred to a recent study, where investigators at the Children’s Hospital of Philadelphia retrospectively studied 125 children under age 4 years who were diagnosed with alopecia areata and followed for 2 years. Over time, those children with over 50% of hair loss initially were more likely to have worsening Severity of Alopecia Tool (SALT) scores over the follow-up period. But a high proportion of those with mild alopecia initially continued to have mild alopecia at follow-up (Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990).

Dr. Eichenfield noted that the study found that 41% of the patients also had atopic dermatitis.

He also highlighted two other recent studies on pediatric alopecia: One found that while vitamin D levels were low in a majority of children with alopecia in the study, the proportion who had a deficiency was similar to the proportion in a larger pediatric population, at about 22% in both groups (J Am Acad Dermatol. 2018 Sep;79(3):e43-e44). Supplementation doesn’t seem to help. “It’s not important to test levels,” he said.

Another study examined whether it’s a good idea to test patients for celiac disease in children with alopecia (Pediatr Dermatol. 2018 Jul;35[4]:535-8). Some parents may ask this question, but the answer, he said, is generally no.

What’s next? “We were hoping oral and topical JAK inhibitors would work well” in this population, Dr. Eichenfield said, but study findings haven’t been promising.

Still, oral tofacitinib (Xeljanz) showed some “pretty impressive” success in a recent study in four children, he noted. Based on the results, the authors wrote that “we suggest that, after proper counseling regarding the risks, including severe infection and malignancy, the use of tofacitinib may be considered for preadolescent children with AA [alopecia areata] who are experiencing psychosocial impairment” (J Am Acad Dermatol. 2019 Feb;80[2]:568-70).

In general, Dr. Eichenfield said, research on pediatric alopecia “will be secondary, especially with JAK inhibitors because of the risk of side effects. But [children will] probably tolerate them better than adults do because they have fewer medical problems.”

Meanwhile, he added, controversy continues to swirl around how to treat children over age 10 years who have lost 50% or more of their hair. “I’ve seen hundreds of kids with alopecia areata,” he said, “and I can’t predict what the course may be.”

Dr. Eichenfield reports multiple relationships (consultant or investigator) with various pharmaceutical companies, including Abbvie, Allergan, Lilly, Novartis, and others. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Recent research is offering new insights into psoriasis and alopecia in the pediatric population, a dermatologist told colleagues, and it’s time to be on the lookout for psoriasis linked to treatment with tumor necrosis factor (TNF) inhibitors.

Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics, at the University of California, San Diego, offered these tips and comments in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar:

Psoriasis

It’s a brand new day for adult psoriasis sufferers, but it seems to be only a brand new morning for their pediatric counterparts. “Kids and teenagers were left behind in the biologic revolution,” Dr. Eichenfield said. “Only two systemic biologics have been approved for psoriasis in children.” They are ustekinumab (Stelara), approved by the Food and Drug Administration for treating psoriasis in children aged 12 years and older, and etanercept, approved for aged 4 years and older.

The good news, he said, is that “our new biologic agents are now being studied in children.”

Research is also providing new insight into pediatric psoriasis, said Dr. Eichenfield, who is also chief of pediatric and adolescent dermatology at Rady Children’s Hospital in San Diego. It’s now clear that “there’s a lot more facial involvement, and a high involvement of scalp and nail,” he noted.

It’s also clear, he said, that inflammation begins early in pediatric psoriasis. That raises the question of whether it’s a good idea to launch aggressive treatment to stop the “psoriatic march” toward cardiovascular and other medical problems down the line, he commented.

“Keep an open mind to getting aggressive in therapy,” he advised, although he acknowledged that “it’s hard to get beyond the two biologics, and only one is approved for children under 12.”

Dr. Eichenfield advised colleagues to keep an eye out for TNF inhibitor–induced psoriasis. “We’re seeing it pretty regularly,” he said, commonly in children who are treated with TNF inhibitors for rheumatoid arthritis or Crohn’s disease.

The lesions “look like dermatitis but are very psoriasiform,” he said, and research suggests this can appear after a single dose or after as many as 63 months of treatment. Topical and light therapy can be helpful. But if those treatments do not help, he said, it’s time to consider changing the biologic that the patient is taking. “Is the biologic adequately controlling their underlying disease? If not, you can help find one that would be great for their underlying disease and clear up their psoriasis.”

Alopecia

Pediatric alopecia “is a problem I see pretty regularly in practice,” Dr. Eichenfield said. When he sees patients with alopecia, he says that, “‘if your child doesn’t have 50% hair loss, you’re in the good group. It will generally heal up and never come back again.’ ”

He referred to a recent study, where investigators at the Children’s Hospital of Philadelphia retrospectively studied 125 children under age 4 years who were diagnosed with alopecia areata and followed for 2 years. Over time, those children with over 50% of hair loss initially were more likely to have worsening Severity of Alopecia Tool (SALT) scores over the follow-up period. But a high proportion of those with mild alopecia initially continued to have mild alopecia at follow-up (Pediatr Dermatol. 2019 Aug 29. doi: 10.1111/pde.13990).

Dr. Eichenfield noted that the study found that 41% of the patients also had atopic dermatitis.

He also highlighted two other recent studies on pediatric alopecia: One found that while vitamin D levels were low in a majority of children with alopecia in the study, the proportion who had a deficiency was similar to the proportion in a larger pediatric population, at about 22% in both groups (J Am Acad Dermatol. 2018 Sep;79(3):e43-e44). Supplementation doesn’t seem to help. “It’s not important to test levels,” he said.

Another study examined whether it’s a good idea to test patients for celiac disease in children with alopecia (Pediatr Dermatol. 2018 Jul;35[4]:535-8). Some parents may ask this question, but the answer, he said, is generally no.

What’s next? “We were hoping oral and topical JAK inhibitors would work well” in this population, Dr. Eichenfield said, but study findings haven’t been promising.

Still, oral tofacitinib (Xeljanz) showed some “pretty impressive” success in a recent study in four children, he noted. Based on the results, the authors wrote that “we suggest that, after proper counseling regarding the risks, including severe infection and malignancy, the use of tofacitinib may be considered for preadolescent children with AA [alopecia areata] who are experiencing psychosocial impairment” (J Am Acad Dermatol. 2019 Feb;80[2]:568-70).

In general, Dr. Eichenfield said, research on pediatric alopecia “will be secondary, especially with JAK inhibitors because of the risk of side effects. But [children will] probably tolerate them better than adults do because they have fewer medical problems.”

Meanwhile, he added, controversy continues to swirl around how to treat children over age 10 years who have lost 50% or more of their hair. “I’ve seen hundreds of kids with alopecia areata,” he said, “and I can’t predict what the course may be.”

Dr. Eichenfield reports multiple relationships (consultant or investigator) with various pharmaceutical companies, including Abbvie, Allergan, Lilly, Novartis, and others. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – While biologics have dramatically changed the picture, drugs like methotrexate, acitretin, cyclosporine, and apremilast still have roles to play in the treatment of psoriasis, a dermatologist told colleagues.

However, caution is necessary, especially when the drugs are used in combination with biologics, Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn., said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Dr. Strober offered these tips about the proper use of these four drugs in psoriasis patients:

Acitretin (Soriatane). “This was used as monotherapy initially, but at this point in history, fewer and fewer patients are getting it as monotherapy,” he said. A dose of 25 mg/day appears to provide the best mix of efficacy and side-effect control, “although it’s not a high-efficacy drug, especially at 25 mg a day. It’s a slow-acting drug, and you may need 4 if not 6 months to see the maximum effect before you give up on it.”

What about using acitretin in combination with other therapies? Studies examining its use with phototherapy haven’t been promising, Dr. Strober said. The drug can be used with methotrexate, he said, even though the combination will worry pharmacists. “Follow the liver, and you’ll be fine” he noted. “That combination can be successful. Laboratory monitoring is not onerous: Discontinue after a few months if you’ve not seen any movement.” The drug can also be used with biologics, he said.

Apremilast (Otezla). This drug will bring about a third of patients to a Psoriasis Area and Severity Index (PASI) 75. “That’s not the most impressive efficacy. Rarely do we clear patients with this drug, and it has tolerability issues in some patients,” Dr. Strober said. Side effects can include diarrhea, nausea, headache, and depression. “Warn patients of these possibilities,” he added.

Methotrexate. “It’s very helpful and not a drug to be feared if it’s monitored correctly,” Dr. Strober said. “It’s certainly not a biologic, but it’s not a bad drug from an efficacy standpoint, and it does have efficacy in psoriatic arthritis.”

The drug’s low cost can make it a good alternative to biologics in patients with limited insurance options – such as those on Medicare – or those who don’t have insurance, he said.

“Psoriasis is often controlled at a mean dose of 15 mg/week [orally], with no test dose; start at 15-mg weekly,” he said. “It’s an interesting drug that allows you to dose weekly and still get efficacy,” especially when dosed subcutaneously.

Beware the many contraindications such as pregnancy, possible pregnancy, and high alcohol intake, he added. Dr. Strober doesn’t recommend liver biopsies to monitor hepatic effects. “It’s a poor test with risk and sampling error,” he said.

Cyclosporine. This drug is best “in severe patients in need of a quick response,” said Dr. Strober, who added that biologics are often a better option even in patients who are sensitive to price since samples and free-drug programs are available. “It’s in and out of the body quickly, and most people skip doses and get recurrence of their disease quickly,” he said.

Blood tests are a hassle for patients, he said, and “people often don’t feel great on the drug,” said Dr. Strober, who added, however, that he still does occasionally use it.

Dr. Strober reported multiple disclosures including consultant/advisory board (AbbVie, Amgen, Lilly, Pfizer, among others) and investigator relationships. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – While biologics have dramatically changed the picture, drugs like methotrexate, acitretin, cyclosporine, and apremilast still have roles to play in the treatment of psoriasis, a dermatologist told colleagues.

However, caution is necessary, especially when the drugs are used in combination with biologics, Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn., said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Dr. Strober offered these tips about the proper use of these four drugs in psoriasis patients:

Acitretin (Soriatane). “This was used as monotherapy initially, but at this point in history, fewer and fewer patients are getting it as monotherapy,” he said. A dose of 25 mg/day appears to provide the best mix of efficacy and side-effect control, “although it’s not a high-efficacy drug, especially at 25 mg a day. It’s a slow-acting drug, and you may need 4 if not 6 months to see the maximum effect before you give up on it.”

What about using acitretin in combination with other therapies? Studies examining its use with phototherapy haven’t been promising, Dr. Strober said. The drug can be used with methotrexate, he said, even though the combination will worry pharmacists. “Follow the liver, and you’ll be fine” he noted. “That combination can be successful. Laboratory monitoring is not onerous: Discontinue after a few months if you’ve not seen any movement.” The drug can also be used with biologics, he said.

Apremilast (Otezla). This drug will bring about a third of patients to a Psoriasis Area and Severity Index (PASI) 75. “That’s not the most impressive efficacy. Rarely do we clear patients with this drug, and it has tolerability issues in some patients,” Dr. Strober said. Side effects can include diarrhea, nausea, headache, and depression. “Warn patients of these possibilities,” he added.

Methotrexate. “It’s very helpful and not a drug to be feared if it’s monitored correctly,” Dr. Strober said. “It’s certainly not a biologic, but it’s not a bad drug from an efficacy standpoint, and it does have efficacy in psoriatic arthritis.”

The drug’s low cost can make it a good alternative to biologics in patients with limited insurance options – such as those on Medicare – or those who don’t have insurance, he said.

“Psoriasis is often controlled at a mean dose of 15 mg/week [orally], with no test dose; start at 15-mg weekly,” he said. “It’s an interesting drug that allows you to dose weekly and still get efficacy,” especially when dosed subcutaneously.

Beware the many contraindications such as pregnancy, possible pregnancy, and high alcohol intake, he added. Dr. Strober doesn’t recommend liver biopsies to monitor hepatic effects. “It’s a poor test with risk and sampling error,” he said.

Cyclosporine. This drug is best “in severe patients in need of a quick response,” said Dr. Strober, who added that biologics are often a better option even in patients who are sensitive to price since samples and free-drug programs are available. “It’s in and out of the body quickly, and most people skip doses and get recurrence of their disease quickly,” he said.

Blood tests are a hassle for patients, he said, and “people often don’t feel great on the drug,” said Dr. Strober, who added, however, that he still does occasionally use it.

Dr. Strober reported multiple disclosures including consultant/advisory board (AbbVie, Amgen, Lilly, Pfizer, among others) and investigator relationships. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – While biologics have dramatically changed the picture, drugs like methotrexate, acitretin, cyclosporine, and apremilast still have roles to play in the treatment of psoriasis, a dermatologist told colleagues.

However, caution is necessary, especially when the drugs are used in combination with biologics, Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn., said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Dr. Strober offered these tips about the proper use of these four drugs in psoriasis patients:

Acitretin (Soriatane). “This was used as monotherapy initially, but at this point in history, fewer and fewer patients are getting it as monotherapy,” he said. A dose of 25 mg/day appears to provide the best mix of efficacy and side-effect control, “although it’s not a high-efficacy drug, especially at 25 mg a day. It’s a slow-acting drug, and you may need 4 if not 6 months to see the maximum effect before you give up on it.”

What about using acitretin in combination with other therapies? Studies examining its use with phototherapy haven’t been promising, Dr. Strober said. The drug can be used with methotrexate, he said, even though the combination will worry pharmacists. “Follow the liver, and you’ll be fine” he noted. “That combination can be successful. Laboratory monitoring is not onerous: Discontinue after a few months if you’ve not seen any movement.” The drug can also be used with biologics, he said.

Apremilast (Otezla). This drug will bring about a third of patients to a Psoriasis Area and Severity Index (PASI) 75. “That’s not the most impressive efficacy. Rarely do we clear patients with this drug, and it has tolerability issues in some patients,” Dr. Strober said. Side effects can include diarrhea, nausea, headache, and depression. “Warn patients of these possibilities,” he added.

Methotrexate. “It’s very helpful and not a drug to be feared if it’s monitored correctly,” Dr. Strober said. “It’s certainly not a biologic, but it’s not a bad drug from an efficacy standpoint, and it does have efficacy in psoriatic arthritis.”

The drug’s low cost can make it a good alternative to biologics in patients with limited insurance options – such as those on Medicare – or those who don’t have insurance, he said.

“Psoriasis is often controlled at a mean dose of 15 mg/week [orally], with no test dose; start at 15-mg weekly,” he said. “It’s an interesting drug that allows you to dose weekly and still get efficacy,” especially when dosed subcutaneously.

Beware the many contraindications such as pregnancy, possible pregnancy, and high alcohol intake, he added. Dr. Strober doesn’t recommend liver biopsies to monitor hepatic effects. “It’s a poor test with risk and sampling error,” he said.

Cyclosporine. This drug is best “in severe patients in need of a quick response,” said Dr. Strober, who added that biologics are often a better option even in patients who are sensitive to price since samples and free-drug programs are available. “It’s in and out of the body quickly, and most people skip doses and get recurrence of their disease quickly,” he said.

Blood tests are a hassle for patients, he said, and “people often don’t feel great on the drug,” said Dr. Strober, who added, however, that he still does occasionally use it.

Dr. Strober reported multiple disclosures including consultant/advisory board (AbbVie, Amgen, Lilly, Pfizer, among others) and investigator relationships. SDEF and this news organization are owned by the same parent company.

ATLANTA – Gout is associated with an increased risk of both fatal and nonfatal cardiovascular disease events, according to a large population-based health data linkage study in New Zealand.

Sharon Worcester/MDedge News

“Overall, the survival was quite good within both cohorts, but ... there is a clear and statistically significant difference in the survival between the people with gout and those without gout,” Ken Cai, MBBS, reported at the annual meeting of the American College of Rheumatology, noting that a similarly “significant and clear” difference was seen in nonfatal CVD events between the groups.

Of 968,387 individuals included in the analysis, 34,056 had gout, said Dr. Cai, a rheumatology clinical fellow at the University of Auckland (New Zealand). After adjusting for population-level estimated 5-year CVD risk for cardiovascular death, nonfatal myocardial infarction, stroke, or other vascular event, the adjusted hazard ratios were 1.20 for fatal and 1.32 for nonfatal first CVD events in patients with gout. The CVD risk score used in the analysis accounted for age, gender, ethnicity, level of social deprivation, diabetes status, previous hospitalization for atrial fibrillation, and baseline dispensing of blood pressure–lowering, lipid-lowering, and antiplatelet/anticoagulant medications.

“To allow for any other differences between the gout and nongout cohorts with respect to gender, age, ethnicity, and social deprivation, we further adjusted for these factors again, even though they had been accounted for within our CVD risk score,” he said, noting that “gout continued to demonstrate an increased adjusted hazard ratio” for fatal and nonfatal events after that adjustment (HRs, 1.40 and 1.35, respectively)

Additional analysis in the gout patients showed that CVD risk was similarly increased both in those who had been dispensed allopurinol at least once in the prior 5 years and those who had not (adjusted HRs for fatal events, 1.41 and 1.33; and for nonfatal, first CVD events, 1.34 and 1.38, respectively), and “there was no significant difference between these two groups, compared to people without gout,” he said.

Adjustment for serum urate levels in gout patients also showed similarly increased risk for fatal and nonfatal events for those with levels less than 6 mg/dL and those with levels of 6 mg/dL or greater (adjusted HRs of 1.32 and 1.42 for fatal events, and 1.27 and 1.43 for nonfatal first CVD events, respectively).

Again, no significant difference was seen in the risk of events between these two groups and those without gout, Dr. Cai said, noting that patients with no serum urate monitoring also had an increased risk of events (adjusted HR of 1.41 for fatal events and 1.29 for nonfatal, first CVD events).

Gout and hyperuricemia have previously been reported to be independent risk factors for CVD and CVD events, and urate-lowering therapy such as allopurinol have been thought to potentially be associated with reduced risk of CVD, he said, noting that the relationships are of particular concern in New Zealand, where gout affects more than 4% of the adult population.

“Maori, who are the indigenous people of New Zealand, and Pasifika people are disproportionately affected by gout; 8.5% of Maori, and 13.9% of Pasifika adults have gout,” he said, adding that an estimated one-third of Maori and Pasifika adults over age 65 years have gout.

To further assess the relationships between gout and CVD risk, he and his colleagues used validated population-level risk-prediction equations and linked National Health Identifier (NHI) data, he said.

National registries of medicines dispensing data, hospitalization, and death were linked to the Auckland/Northland regional repository of laboratory results from Jan. 1, 2012 to Dec. 31, 2016.

“We included all New Zealand residents aged 20 years or older who were in contact with publicly funded services in 2011 and were alive at the end of December, 2011,” he said, adding that those with a previous hospitalization for CVD or heart failure prior to the end of December 2011 were excluded, as were those with primary residence outside of the region for the prior 3 years and those missing predictor variable data.

Although the findings are limited by an inability to adjust for smoking status, body mass index, and blood pressure – as such data are not collected at the national level, and by the population-based nature of the study, which does not allow determination about causation, they nevertheless reinforce the association between gout and an increased estimated risk of CVD events, Dr. Cai said.

“Even after adjustment for estimated 5-year CVD risk and the additional weighting of risk factors within it, gout independently increased the hazard ratio for fatal and nonfatal events,” he said. “In our study, this effect was not ameliorated by allopurinol use or serum urate lowering to treatment target.”

Similar studies are needed in other populations, he said.

Dr. Cai reported grant support from Arthritis Australia.

sworcester@mdedge.com

SOURCE: Cai K et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 2732.

ATLANTA – Gout is associated with an increased risk of both fatal and nonfatal cardiovascular disease events, according to a large population-based health data linkage study in New Zealand.

Sharon Worcester/MDedge News

“Overall, the survival was quite good within both cohorts, but ... there is a clear and statistically significant difference in the survival between the people with gout and those without gout,” Ken Cai, MBBS, reported at the annual meeting of the American College of Rheumatology, noting that a similarly “significant and clear” difference was seen in nonfatal CVD events between the groups.

Of 968,387 individuals included in the analysis, 34,056 had gout, said Dr. Cai, a rheumatology clinical fellow at the University of Auckland (New Zealand). After adjusting for population-level estimated 5-year CVD risk for cardiovascular death, nonfatal myocardial infarction, stroke, or other vascular event, the adjusted hazard ratios were 1.20 for fatal and 1.32 for nonfatal first CVD events in patients with gout. The CVD risk score used in the analysis accounted for age, gender, ethnicity, level of social deprivation, diabetes status, previous hospitalization for atrial fibrillation, and baseline dispensing of blood pressure–lowering, lipid-lowering, and antiplatelet/anticoagulant medications.

“To allow for any other differences between the gout and nongout cohorts with respect to gender, age, ethnicity, and social deprivation, we further adjusted for these factors again, even though they had been accounted for within our CVD risk score,” he said, noting that “gout continued to demonstrate an increased adjusted hazard ratio” for fatal and nonfatal events after that adjustment (HRs, 1.40 and 1.35, respectively)

Additional analysis in the gout patients showed that CVD risk was similarly increased both in those who had been dispensed allopurinol at least once in the prior 5 years and those who had not (adjusted HRs for fatal events, 1.41 and 1.33; and for nonfatal, first CVD events, 1.34 and 1.38, respectively), and “there was no significant difference between these two groups, compared to people without gout,” he said.

Adjustment for serum urate levels in gout patients also showed similarly increased risk for fatal and nonfatal events for those with levels less than 6 mg/dL and those with levels of 6 mg/dL or greater (adjusted HRs of 1.32 and 1.42 for fatal events, and 1.27 and 1.43 for nonfatal first CVD events, respectively).

Again, no significant difference was seen in the risk of events between these two groups and those without gout, Dr. Cai said, noting that patients with no serum urate monitoring also had an increased risk of events (adjusted HR of 1.41 for fatal events and 1.29 for nonfatal, first CVD events).

Gout and hyperuricemia have previously been reported to be independent risk factors for CVD and CVD events, and urate-lowering therapy such as allopurinol have been thought to potentially be associated with reduced risk of CVD, he said, noting that the relationships are of particular concern in New Zealand, where gout affects more than 4% of the adult population.

“Maori, who are the indigenous people of New Zealand, and Pasifika people are disproportionately affected by gout; 8.5% of Maori, and 13.9% of Pasifika adults have gout,” he said, adding that an estimated one-third of Maori and Pasifika adults over age 65 years have gout.

To further assess the relationships between gout and CVD risk, he and his colleagues used validated population-level risk-prediction equations and linked National Health Identifier (NHI) data, he said.

National registries of medicines dispensing data, hospitalization, and death were linked to the Auckland/Northland regional repository of laboratory results from Jan. 1, 2012 to Dec. 31, 2016.

“We included all New Zealand residents aged 20 years or older who were in contact with publicly funded services in 2011 and were alive at the end of December, 2011,” he said, adding that those with a previous hospitalization for CVD or heart failure prior to the end of December 2011 were excluded, as were those with primary residence outside of the region for the prior 3 years and those missing predictor variable data.

Although the findings are limited by an inability to adjust for smoking status, body mass index, and blood pressure – as such data are not collected at the national level, and by the population-based nature of the study, which does not allow determination about causation, they nevertheless reinforce the association between gout and an increased estimated risk of CVD events, Dr. Cai said.

“Even after adjustment for estimated 5-year CVD risk and the additional weighting of risk factors within it, gout independently increased the hazard ratio for fatal and nonfatal events,” he said. “In our study, this effect was not ameliorated by allopurinol use or serum urate lowering to treatment target.”

Similar studies are needed in other populations, he said.

Dr. Cai reported grant support from Arthritis Australia.

sworcester@mdedge.com

SOURCE: Cai K et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 2732.

ATLANTA – Gout is associated with an increased risk of both fatal and nonfatal cardiovascular disease events, according to a large population-based health data linkage study in New Zealand.

Sharon Worcester/MDedge News

“Overall, the survival was quite good within both cohorts, but ... there is a clear and statistically significant difference in the survival between the people with gout and those without gout,” Ken Cai, MBBS, reported at the annual meeting of the American College of Rheumatology, noting that a similarly “significant and clear” difference was seen in nonfatal CVD events between the groups.

Of 968,387 individuals included in the analysis, 34,056 had gout, said Dr. Cai, a rheumatology clinical fellow at the University of Auckland (New Zealand). After adjusting for population-level estimated 5-year CVD risk for cardiovascular death, nonfatal myocardial infarction, stroke, or other vascular event, the adjusted hazard ratios were 1.20 for fatal and 1.32 for nonfatal first CVD events in patients with gout. The CVD risk score used in the analysis accounted for age, gender, ethnicity, level of social deprivation, diabetes status, previous hospitalization for atrial fibrillation, and baseline dispensing of blood pressure–lowering, lipid-lowering, and antiplatelet/anticoagulant medications.

“To allow for any other differences between the gout and nongout cohorts with respect to gender, age, ethnicity, and social deprivation, we further adjusted for these factors again, even though they had been accounted for within our CVD risk score,” he said, noting that “gout continued to demonstrate an increased adjusted hazard ratio” for fatal and nonfatal events after that adjustment (HRs, 1.40 and 1.35, respectively)

Additional analysis in the gout patients showed that CVD risk was similarly increased both in those who had been dispensed allopurinol at least once in the prior 5 years and those who had not (adjusted HRs for fatal events, 1.41 and 1.33; and for nonfatal, first CVD events, 1.34 and 1.38, respectively), and “there was no significant difference between these two groups, compared to people without gout,” he said.

Adjustment for serum urate levels in gout patients also showed similarly increased risk for fatal and nonfatal events for those with levels less than 6 mg/dL and those with levels of 6 mg/dL or greater (adjusted HRs of 1.32 and 1.42 for fatal events, and 1.27 and 1.43 for nonfatal first CVD events, respectively).

Again, no significant difference was seen in the risk of events between these two groups and those without gout, Dr. Cai said, noting that patients with no serum urate monitoring also had an increased risk of events (adjusted HR of 1.41 for fatal events and 1.29 for nonfatal, first CVD events).

Gout and hyperuricemia have previously been reported to be independent risk factors for CVD and CVD events, and urate-lowering therapy such as allopurinol have been thought to potentially be associated with reduced risk of CVD, he said, noting that the relationships are of particular concern in New Zealand, where gout affects more than 4% of the adult population.

“Maori, who are the indigenous people of New Zealand, and Pasifika people are disproportionately affected by gout; 8.5% of Maori, and 13.9% of Pasifika adults have gout,” he said, adding that an estimated one-third of Maori and Pasifika adults over age 65 years have gout.

To further assess the relationships between gout and CVD risk, he and his colleagues used validated population-level risk-prediction equations and linked National Health Identifier (NHI) data, he said.

National registries of medicines dispensing data, hospitalization, and death were linked to the Auckland/Northland regional repository of laboratory results from Jan. 1, 2012 to Dec. 31, 2016.

“We included all New Zealand residents aged 20 years or older who were in contact with publicly funded services in 2011 and were alive at the end of December, 2011,” he said, adding that those with a previous hospitalization for CVD or heart failure prior to the end of December 2011 were excluded, as were those with primary residence outside of the region for the prior 3 years and those missing predictor variable data.

Although the findings are limited by an inability to adjust for smoking status, body mass index, and blood pressure – as such data are not collected at the national level, and by the population-based nature of the study, which does not allow determination about causation, they nevertheless reinforce the association between gout and an increased estimated risk of CVD events, Dr. Cai said.

“Even after adjustment for estimated 5-year CVD risk and the additional weighting of risk factors within it, gout independently increased the hazard ratio for fatal and nonfatal events,” he said. “In our study, this effect was not ameliorated by allopurinol use or serum urate lowering to treatment target.”

Similar studies are needed in other populations, he said.

Dr. Cai reported grant support from Arthritis Australia.

sworcester@mdedge.com

SOURCE: Cai K et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 2732.

ST. LOUIS – Dementia and death were about four times more likely after 11 years in patients with Parkinson’s disease and cognitive or psychiatric symptoms at baseline, versus those with motor symptoms alone, according to the results of a longitudinal study of 162 patients at Washington University, St. Louis.

Parkinson’s disease is often only staged as mild, moderate, or severe, and sometimes cognitive and psychiatric symptoms are not assessed. The St. Louis team wanted to see if there are actual subtypes, and if they have clinical relevance, said lead investigator Peter Myers, PhD, a postdoctoral research associate at Washington University.

The magnitude of the findings was “surprising. ... We don’t think we are seeing stages” because the different symptom patterns were apparent at baseline. Instead, “we are seeing really distinct clinical subtypes that could inform patient prognosis and help prepare families and caregivers. It is important that you assess more than just motor symptoms,” he said at the annual meeting of the American Neurological Association.

Some of the subjects were newly diagnosed and others diagnosed years earlier. At baseline, they had symptoms for an average of 6 years, and none had dementia.

After a battery of cognitive, psychiatric, and movement tests, Dr. Myers and his colleagues found that their subjects fell into three patterns: motor symptoms only, with normal cognitive and psychiatric performance (63 subjects); motor symptoms plus prominent anxiety or depression (17); and motor symptoms plus cognitive deficits (82).

A total of 42 patients developed dementia – a score of at least 1 on the Clinical Dementia Rating evaluation – including three in the motor-only group (5%), two in the psychiatric/motor group (12%), and 37 in the cognitive/motor group (45%).

After controlling for age, sex, and symptom duration, the risk of dementia conversion was far higher in the cognitive/motor group (relative risk, 4.16, 95% confidence interval, 1.18-14.65) and psychiatric/motor group (RR, 3.08; 95% CI, 0.72-13.28), compared with motor-only subjects.

Thirty-eight patients died, the majority because of Parkinson’s disease-related causes, including five in the motor-only group (8%), two in the psychiatric/motor group (12%), and 31 in the cognitive/motor group (38%).

The risk of death, relative to motor-only patients, was higher with both the cognitive/motor (RR, 4.06; 95% CI, 1.37-12.03) and psychiatric/motor subtypes (RR, 4.17; 95% CI, 0.70-24.91).

It is unclear what leads to the progression differences, but the researchers’ hypothesis is that the broader scope of symptoms indicates a greater extent of brain pathology. The St. Louis team is looking at brain-imaging data to see if that is true, and if the subtypes can be distinguished on imaging. They are also interested in seeing if genetics plays a role in susceptibility to the different subtypes, and if the baseline subtypes are stable over time or if patients convert between them.

Subjects were, on average, 66 years old, and 62% were men. The mean levodopa-equivalent daily dose was 613 mg in the motor-only group, 1,004 mg in the psychiatric/motor group, and 783 mg in the cognitive/motor group (P = .03). Mean symptom duration was shorter in motor-only patients (5.1 years) versus the psychiatric/motor group (7.2 years) and cognitive/motor group (6.9 years, P less than .01).

Although relative risks crossed 1 in the psychiatric/motor group, it was probably because there were only 17 patients. “We do think there is a very strong likelihood that” the psychiatric/motor findings, like the cognitive/motor findings, “are valid,” Dr. Myer said.

“I think [the findings] could be real,” said Clair Henchcliffe, MD, DPhil, vice chair for clinical research in the department of neurology at Weill Cornell Medical College in New York.

“Other publications have shown that people who have cognitive symptoms at onset are more likely to go on to develop dementia down the line. This is much in line with that,” she said when asked for comment.

The field has “always been interested in finding data that help us personalize treatment, and a lot of people are looking to subtype Parkinson’s disease to help us plan with our patients.” It could also help with frequency of follow-up, trial participation, and maybe someday treatment selection. “We are always thinking a few years ahead” with Parkinson’s disease, she said.

There was no industry funding, and the investigators did not have any relevant disclosures.

aotto@mdedge.com

ST. LOUIS – Dementia and death were about four times more likely after 11 years in patients with Parkinson’s disease and cognitive or psychiatric symptoms at baseline, versus those with motor symptoms alone, according to the results of a longitudinal study of 162 patients at Washington University, St. Louis.

Parkinson’s disease is often only staged as mild, moderate, or severe, and sometimes cognitive and psychiatric symptoms are not assessed. The St. Louis team wanted to see if there are actual subtypes, and if they have clinical relevance, said lead investigator Peter Myers, PhD, a postdoctoral research associate at Washington University.

The magnitude of the findings was “surprising. ... We don’t think we are seeing stages” because the different symptom patterns were apparent at baseline. Instead, “we are seeing really distinct clinical subtypes that could inform patient prognosis and help prepare families and caregivers. It is important that you assess more than just motor symptoms,” he said at the annual meeting of the American Neurological Association.

Some of the subjects were newly diagnosed and others diagnosed years earlier. At baseline, they had symptoms for an average of 6 years, and none had dementia.

After a battery of cognitive, psychiatric, and movement tests, Dr. Myers and his colleagues found that their subjects fell into three patterns: motor symptoms only, with normal cognitive and psychiatric performance (63 subjects); motor symptoms plus prominent anxiety or depression (17); and motor symptoms plus cognitive deficits (82).

A total of 42 patients developed dementia – a score of at least 1 on the Clinical Dementia Rating evaluation – including three in the motor-only group (5%), two in the psychiatric/motor group (12%), and 37 in the cognitive/motor group (45%).

After controlling for age, sex, and symptom duration, the risk of dementia conversion was far higher in the cognitive/motor group (relative risk, 4.16, 95% confidence interval, 1.18-14.65) and psychiatric/motor group (RR, 3.08; 95% CI, 0.72-13.28), compared with motor-only subjects.

Thirty-eight patients died, the majority because of Parkinson’s disease-related causes, including five in the motor-only group (8%), two in the psychiatric/motor group (12%), and 31 in the cognitive/motor group (38%).

The risk of death, relative to motor-only patients, was higher with both the cognitive/motor (RR, 4.06; 95% CI, 1.37-12.03) and psychiatric/motor subtypes (RR, 4.17; 95% CI, 0.70-24.91).

It is unclear what leads to the progression differences, but the researchers’ hypothesis is that the broader scope of symptoms indicates a greater extent of brain pathology. The St. Louis team is looking at brain-imaging data to see if that is true, and if the subtypes can be distinguished on imaging. They are also interested in seeing if genetics plays a role in susceptibility to the different subtypes, and if the baseline subtypes are stable over time or if patients convert between them.

Subjects were, on average, 66 years old, and 62% were men. The mean levodopa-equivalent daily dose was 613 mg in the motor-only group, 1,004 mg in the psychiatric/motor group, and 783 mg in the cognitive/motor group (P = .03). Mean symptom duration was shorter in motor-only patients (5.1 years) versus the psychiatric/motor group (7.2 years) and cognitive/motor group (6.9 years, P less than .01).

Although relative risks crossed 1 in the psychiatric/motor group, it was probably because there were only 17 patients. “We do think there is a very strong likelihood that” the psychiatric/motor findings, like the cognitive/motor findings, “are valid,” Dr. Myer said.

“I think [the findings] could be real,” said Clair Henchcliffe, MD, DPhil, vice chair for clinical research in the department of neurology at Weill Cornell Medical College in New York.

“Other publications have shown that people who have cognitive symptoms at onset are more likely to go on to develop dementia down the line. This is much in line with that,” she said when asked for comment.

The field has “always been interested in finding data that help us personalize treatment, and a lot of people are looking to subtype Parkinson’s disease to help us plan with our patients.” It could also help with frequency of follow-up, trial participation, and maybe someday treatment selection. “We are always thinking a few years ahead” with Parkinson’s disease, she said.

There was no industry funding, and the investigators did not have any relevant disclosures.

aotto@mdedge.com

ST. LOUIS – Dementia and death were about four times more likely after 11 years in patients with Parkinson’s disease and cognitive or psychiatric symptoms at baseline, versus those with motor symptoms alone, according to the results of a longitudinal study of 162 patients at Washington University, St. Louis.

Parkinson’s disease is often only staged as mild, moderate, or severe, and sometimes cognitive and psychiatric symptoms are not assessed. The St. Louis team wanted to see if there are actual subtypes, and if they have clinical relevance, said lead investigator Peter Myers, PhD, a postdoctoral research associate at Washington University.

The magnitude of the findings was “surprising. ... We don’t think we are seeing stages” because the different symptom patterns were apparent at baseline. Instead, “we are seeing really distinct clinical subtypes that could inform patient prognosis and help prepare families and caregivers. It is important that you assess more than just motor symptoms,” he said at the annual meeting of the American Neurological Association.

Some of the subjects were newly diagnosed and others diagnosed years earlier. At baseline, they had symptoms for an average of 6 years, and none had dementia.

After a battery of cognitive, psychiatric, and movement tests, Dr. Myers and his colleagues found that their subjects fell into three patterns: motor symptoms only, with normal cognitive and psychiatric performance (63 subjects); motor symptoms plus prominent anxiety or depression (17); and motor symptoms plus cognitive deficits (82).

A total of 42 patients developed dementia – a score of at least 1 on the Clinical Dementia Rating evaluation – including three in the motor-only group (5%), two in the psychiatric/motor group (12%), and 37 in the cognitive/motor group (45%).

After controlling for age, sex, and symptom duration, the risk of dementia conversion was far higher in the cognitive/motor group (relative risk, 4.16, 95% confidence interval, 1.18-14.65) and psychiatric/motor group (RR, 3.08; 95% CI, 0.72-13.28), compared with motor-only subjects.

Thirty-eight patients died, the majority because of Parkinson’s disease-related causes, including five in the motor-only group (8%), two in the psychiatric/motor group (12%), and 31 in the cognitive/motor group (38%).

The risk of death, relative to motor-only patients, was higher with both the cognitive/motor (RR, 4.06; 95% CI, 1.37-12.03) and psychiatric/motor subtypes (RR, 4.17; 95% CI, 0.70-24.91).

It is unclear what leads to the progression differences, but the researchers’ hypothesis is that the broader scope of symptoms indicates a greater extent of brain pathology. The St. Louis team is looking at brain-imaging data to see if that is true, and if the subtypes can be distinguished on imaging. They are also interested in seeing if genetics plays a role in susceptibility to the different subtypes, and if the baseline subtypes are stable over time or if patients convert between them.

Subjects were, on average, 66 years old, and 62% were men. The mean levodopa-equivalent daily dose was 613 mg in the motor-only group, 1,004 mg in the psychiatric/motor group, and 783 mg in the cognitive/motor group (P = .03). Mean symptom duration was shorter in motor-only patients (5.1 years) versus the psychiatric/motor group (7.2 years) and cognitive/motor group (6.9 years, P less than .01).

Although relative risks crossed 1 in the psychiatric/motor group, it was probably because there were only 17 patients. “We do think there is a very strong likelihood that” the psychiatric/motor findings, like the cognitive/motor findings, “are valid,” Dr. Myer said.

“I think [the findings] could be real,” said Clair Henchcliffe, MD, DPhil, vice chair for clinical research in the department of neurology at Weill Cornell Medical College in New York.

“Other publications have shown that people who have cognitive symptoms at onset are more likely to go on to develop dementia down the line. This is much in line with that,” she said when asked for comment.

The field has “always been interested in finding data that help us personalize treatment, and a lot of people are looking to subtype Parkinson’s disease to help us plan with our patients.” It could also help with frequency of follow-up, trial participation, and maybe someday treatment selection. “We are always thinking a few years ahead” with Parkinson’s disease, she said.

There was no industry funding, and the investigators did not have any relevant disclosures.

aotto@mdedge.com

LAS VEGAS – Eczema is eczema is eczema, right? Maybe not. “Atopic dermatitis might not be one disease,” a dermatologist told colleagues, and treatments may need to be adjusted to reflect the age and ethnicity of patients.

More research is needed, Kenneth B. Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, said during a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “We’re probably just on the tip of the iceberg of understanding the physiology of atopic dermatitis. Hopefully, it will lead to the therapeutic advances we’ve seen in psoriasis.”

As Dr. Gordon explained, there’s a wide gap between our understanding of psoriasis and atopic dermatitis (AD). Currently, there’s only one biologic treatment for AD, he said, “and our medicines aren’t well understood.”

As for the disease itself, he said, “you might hear a renowned [expert] say, ‘This is how it works,’ and another say, ‘This is absolutely not how it works.’ ” One camp focused on the skin barrier, he said, while another camp highlighted inflammation in AD.

“Both the barrier and inflammation are important,” he said. “There are multiple cell types and cytokines that are important, but we don’t know yet the relative importance of them all. You have this cytokine soup, and we’re still trying to figure out the driving forces.”

What is clear, Dr. Gordon said, is that AD acts differently in certain patient populations. It’s not the same in pediatric versus adult patients, he said, and it’s not the same in white versus black versus Asian patients. Research, for example, suggests that Th2, Th22, and Th17 pathways appear to be important in pediatric AD, but not Th1, he said. In contrast, the Th1 pathway plays a role in white adults – but not in black adults

Different cytokines appear to play different roles in these populations, he said. “One of the key things moving forward is going to be figuring out which patients you apply these medications to,” he noted.

Dr. Gordon has multiple disclosures including honoraria or research support from Abbvie, Lilly, Novartis, Pfizer, UCB, and others. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Eczema is eczema is eczema, right? Maybe not. “Atopic dermatitis might not be one disease,” a dermatologist told colleagues, and treatments may need to be adjusted to reflect the age and ethnicity of patients.

More research is needed, Kenneth B. Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, said during a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “We’re probably just on the tip of the iceberg of understanding the physiology of atopic dermatitis. Hopefully, it will lead to the therapeutic advances we’ve seen in psoriasis.”

As Dr. Gordon explained, there’s a wide gap between our understanding of psoriasis and atopic dermatitis (AD). Currently, there’s only one biologic treatment for AD, he said, “and our medicines aren’t well understood.”

As for the disease itself, he said, “you might hear a renowned [expert] say, ‘This is how it works,’ and another say, ‘This is absolutely not how it works.’ ” One camp focused on the skin barrier, he said, while another camp highlighted inflammation in AD.

“Both the barrier and inflammation are important,” he said. “There are multiple cell types and cytokines that are important, but we don’t know yet the relative importance of them all. You have this cytokine soup, and we’re still trying to figure out the driving forces.”

What is clear, Dr. Gordon said, is that AD acts differently in certain patient populations. It’s not the same in pediatric versus adult patients, he said, and it’s not the same in white versus black versus Asian patients. Research, for example, suggests that Th2, Th22, and Th17 pathways appear to be important in pediatric AD, but not Th1, he said. In contrast, the Th1 pathway plays a role in white adults – but not in black adults

Different cytokines appear to play different roles in these populations, he said. “One of the key things moving forward is going to be figuring out which patients you apply these medications to,” he noted.

Dr. Gordon has multiple disclosures including honoraria or research support from Abbvie, Lilly, Novartis, Pfizer, UCB, and others. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Eczema is eczema is eczema, right? Maybe not. “Atopic dermatitis might not be one disease,” a dermatologist told colleagues, and treatments may need to be adjusted to reflect the age and ethnicity of patients.

More research is needed, Kenneth B. Gordon, MD, chair and professor of dermatology at the Medical College of Wisconsin, Milwaukee, said during a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “We’re probably just on the tip of the iceberg of understanding the physiology of atopic dermatitis. Hopefully, it will lead to the therapeutic advances we’ve seen in psoriasis.”

As Dr. Gordon explained, there’s a wide gap between our understanding of psoriasis and atopic dermatitis (AD). Currently, there’s only one biologic treatment for AD, he said, “and our medicines aren’t well understood.”

As for the disease itself, he said, “you might hear a renowned [expert] say, ‘This is how it works,’ and another say, ‘This is absolutely not how it works.’ ” One camp focused on the skin barrier, he said, while another camp highlighted inflammation in AD.

“Both the barrier and inflammation are important,” he said. “There are multiple cell types and cytokines that are important, but we don’t know yet the relative importance of them all. You have this cytokine soup, and we’re still trying to figure out the driving forces.”

What is clear, Dr. Gordon said, is that AD acts differently in certain patient populations. It’s not the same in pediatric versus adult patients, he said, and it’s not the same in white versus black versus Asian patients. Research, for example, suggests that Th2, Th22, and Th17 pathways appear to be important in pediatric AD, but not Th1, he said. In contrast, the Th1 pathway plays a role in white adults – but not in black adults

Different cytokines appear to play different roles in these populations, he said. “One of the key things moving forward is going to be figuring out which patients you apply these medications to,” he noted.

Dr. Gordon has multiple disclosures including honoraria or research support from Abbvie, Lilly, Novartis, Pfizer, UCB, and others. SDEF and this news organization are owned by the same parent company.

MADRID – Adding the oral Janus kinase (JAK) inhibitor baricitinib to standard atopic dermatitis therapy with low- and midpotency topical corticosteroids markedly improved disease severity and key patient-reported outcomes, compared with topical corticosteroids alone, in the phase 3, randomized, double-blind BREEZE-AD7 trial, Kristian Reich, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Baricitinib, a JAK 1/2 inhibitor, had already proved superior to placebo as monotherapy for adults with moderate to severe atopic dermatitis in the phase 3 BREEZE-AD1 and -AD2 trials. But BREEZE-AD7 further advances the field because it’s the first phase 3 study testing the efficacy of a JAK inhibitor in combination with low- and midpotency topical steroids.

“I think this study is important because it looks into the situation that’s more like what happens in the real world, which is, as with dupilumab and other drugs, we use the systemic agent in combination with topical therapies and, in particular, with topical corticosteroids,” commented Dr. Reich, professor of dermatology at University Medical Center, Hamburg, and medical director at SCIderm, a scientific research company.

“This is what I think we can expect from existing and upcoming systemic therapies in atopic dermatitis: We will use them in combination with topical corticosteroids, and hopefully this will allow patients to dramatically reduce the concomitant use of topical corticosteroids, as shown here in BREEZE-AD7,” he added.

BREEZE-AD7 was a 16-week study that included 329 adults with moderate or severe atopic dermatitis who were randomized to low- and midpotency topical corticosteroids plus either baricitinib at 2 mg once daily, baricitinib at 4 mg once daily, or placebo. The group’s mean baseline Eczema Area and Severity Index (EASI) score was 29. Overall, 45% of participants had a baseline Investigator’s Global Assessment (IGA) of disease severity of 4 on a 0-4 scale.

The primary endpoint was achievement of an IGA of 0 or 1, meaning clear or almost clear, along with at least a 2-point IGA improvement from baseline at week 16. This was accomplished in 30.6% of those on 4 mg/day of baricitinib, 23.9% of patients in the 2-mg group, and 14.7% of controls.

The 4-mg dose of baricitinib was statistically superior to placebo; the 2-mg dose was not. However, Dr. Reich indicated he was untroubled by this because the primary endpoint was set at a high bar, and both doses of baricitinib proved to be significantly better than topical steroids plus placebo in terms of EASI 75 response rates, as well as reductions in itch, skin pain, and sleep problems, which aren’t captured in EASI scores (see graphic).

“One of my big learnings from this year’s EADV is that we have to rethink the dimensions of atopic dermatitis. I think we have underestimated the relevance of important symptoms such as itch, the impact atopic dermatitis has on pain, and the effect it has on sleeping problems,” the dermatologist said. “My feeling is that baricitinib is strongest in reducing itch, improving sleep, and reducing pain, but it also has good effects on the clinical signs of atopic dermatitis.”

The baricitinib-treated patients’ rapidity of improvement in the various endpoints was particularly impressive. Both doses of the JAK 1/2 inhibitor showed significant separation from the control group in the first week, and the majority of improvement occurred by week 4.

A key finding was that patients on baricitinib at 2 mg/day and 4 mg/day used a mean total of 162 g and 137 g of midpotency topical steroids, respectively, during the 16 weeks, compared with 225 g in the control group. The higher-dose baricitinib group was topical corticosteroid-free on 33% of study days, compared with 25% of days for the baricitinib 2 mg patients and 17% of days for controls.

In terms of safety, there was a case of pulmonary embolism in the higher-dose baricitinib group and an opportunistic toxoplasmosis eye infection in the control population. The frequency of oral herpes and herpes simplex virus infections was 2.8% in controls, 4.6% in the baricitinib 2-mg group, and 6.3% in the 4-mg group. There was also a signal of a dose-dependent increased risk of new-onset acne, with rates of 0.9% in controls and patients on baricitinib 2 mg, climbing to 3.6% with baricitinib 4 mg.

“In phase 2 results with upadacitinib [another oral JAK inhibitor], we saw that more than 10% of patients in the highest-dose group developed what was classified as acne. I cannot explain this, but it’s something we will monitor in the future,” Dr. Reich promised.

A fuller picture of baricitinib’s safety profile in the setting of atopic dermatitis clearly requires larger and longer-term studies, he added.

Baricitinib at the 2 mg daily dose is already marketed as Olumiant for the treatment of rheumatoid arthritis, with labeling that includes a boxed warning about serious infections, malignancy, and thrombosis. The Food and Drug Administration did not approve the 4-mg dose after determining that its higher safety hazard outweighed the efficacy advantage over the lower dose.

The BREEZE-AD7 study was sponsored by Eli Lilly. Dr. Reich reported serving as an adviser to, paid speaker for, and recipient of research grants from that pharmaceutical company and more than two dozen others.
 

bjancin@mdedge.com

MADRID – Adding the oral Janus kinase (JAK) inhibitor baricitinib to standard atopic dermatitis therapy with low- and midpotency topical corticosteroids markedly improved disease severity and key patient-reported outcomes, compared with topical corticosteroids alone, in the phase 3, randomized, double-blind BREEZE-AD7 trial, Kristian Reich, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Baricitinib, a JAK 1/2 inhibitor, had already proved superior to placebo as monotherapy for adults with moderate to severe atopic dermatitis in the phase 3 BREEZE-AD1 and -AD2 trials. But BREEZE-AD7 further advances the field because it’s the first phase 3 study testing the efficacy of a JAK inhibitor in combination with low- and midpotency topical steroids.

“I think this study is important because it looks into the situation that’s more like what happens in the real world, which is, as with dupilumab and other drugs, we use the systemic agent in combination with topical therapies and, in particular, with topical corticosteroids,” commented Dr. Reich, professor of dermatology at University Medical Center, Hamburg, and medical director at SCIderm, a scientific research company.

“This is what I think we can expect from existing and upcoming systemic therapies in atopic dermatitis: We will use them in combination with topical corticosteroids, and hopefully this will allow patients to dramatically reduce the concomitant use of topical corticosteroids, as shown here in BREEZE-AD7,” he added.

BREEZE-AD7 was a 16-week study that included 329 adults with moderate or severe atopic dermatitis who were randomized to low- and midpotency topical corticosteroids plus either baricitinib at 2 mg once daily, baricitinib at 4 mg once daily, or placebo. The group’s mean baseline Eczema Area and Severity Index (EASI) score was 29. Overall, 45% of participants had a baseline Investigator’s Global Assessment (IGA) of disease severity of 4 on a 0-4 scale.

The primary endpoint was achievement of an IGA of 0 or 1, meaning clear or almost clear, along with at least a 2-point IGA improvement from baseline at week 16. This was accomplished in 30.6% of those on 4 mg/day of baricitinib, 23.9% of patients in the 2-mg group, and 14.7% of controls.

The 4-mg dose of baricitinib was statistically superior to placebo; the 2-mg dose was not. However, Dr. Reich indicated he was untroubled by this because the primary endpoint was set at a high bar, and both doses of baricitinib proved to be significantly better than topical steroids plus placebo in terms of EASI 75 response rates, as well as reductions in itch, skin pain, and sleep problems, which aren’t captured in EASI scores (see graphic).

“One of my big learnings from this year’s EADV is that we have to rethink the dimensions of atopic dermatitis. I think we have underestimated the relevance of important symptoms such as itch, the impact atopic dermatitis has on pain, and the effect it has on sleeping problems,” the dermatologist said. “My feeling is that baricitinib is strongest in reducing itch, improving sleep, and reducing pain, but it also has good effects on the clinical signs of atopic dermatitis.”

The baricitinib-treated patients’ rapidity of improvement in the various endpoints was particularly impressive. Both doses of the JAK 1/2 inhibitor showed significant separation from the control group in the first week, and the majority of improvement occurred by week 4.

A key finding was that patients on baricitinib at 2 mg/day and 4 mg/day used a mean total of 162 g and 137 g of midpotency topical steroids, respectively, during the 16 weeks, compared with 225 g in the control group. The higher-dose baricitinib group was topical corticosteroid-free on 33% of study days, compared with 25% of days for the baricitinib 2 mg patients and 17% of days for controls.

In terms of safety, there was a case of pulmonary embolism in the higher-dose baricitinib group and an opportunistic toxoplasmosis eye infection in the control population. The frequency of oral herpes and herpes simplex virus infections was 2.8% in controls, 4.6% in the baricitinib 2-mg group, and 6.3% in the 4-mg group. There was also a signal of a dose-dependent increased risk of new-onset acne, with rates of 0.9% in controls and patients on baricitinib 2 mg, climbing to 3.6% with baricitinib 4 mg.

“In phase 2 results with upadacitinib [another oral JAK inhibitor], we saw that more than 10% of patients in the highest-dose group developed what was classified as acne. I cannot explain this, but it’s something we will monitor in the future,” Dr. Reich promised.

A fuller picture of baricitinib’s safety profile in the setting of atopic dermatitis clearly requires larger and longer-term studies, he added.

Baricitinib at the 2 mg daily dose is already marketed as Olumiant for the treatment of rheumatoid arthritis, with labeling that includes a boxed warning about serious infections, malignancy, and thrombosis. The Food and Drug Administration did not approve the 4-mg dose after determining that its higher safety hazard outweighed the efficacy advantage over the lower dose.

The BREEZE-AD7 study was sponsored by Eli Lilly. Dr. Reich reported serving as an adviser to, paid speaker for, and recipient of research grants from that pharmaceutical company and more than two dozen others.
 

bjancin@mdedge.com

MADRID – Adding the oral Janus kinase (JAK) inhibitor baricitinib to standard atopic dermatitis therapy with low- and midpotency topical corticosteroids markedly improved disease severity and key patient-reported outcomes, compared with topical corticosteroids alone, in the phase 3, randomized, double-blind BREEZE-AD7 trial, Kristian Reich, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Baricitinib, a JAK 1/2 inhibitor, had already proved superior to placebo as monotherapy for adults with moderate to severe atopic dermatitis in the phase 3 BREEZE-AD1 and -AD2 trials. But BREEZE-AD7 further advances the field because it’s the first phase 3 study testing the efficacy of a JAK inhibitor in combination with low- and midpotency topical steroids.

“I think this study is important because it looks into the situation that’s more like what happens in the real world, which is, as with dupilumab and other drugs, we use the systemic agent in combination with topical therapies and, in particular, with topical corticosteroids,” commented Dr. Reich, professor of dermatology at University Medical Center, Hamburg, and medical director at SCIderm, a scientific research company.

“This is what I think we can expect from existing and upcoming systemic therapies in atopic dermatitis: We will use them in combination with topical corticosteroids, and hopefully this will allow patients to dramatically reduce the concomitant use of topical corticosteroids, as shown here in BREEZE-AD7,” he added.

BREEZE-AD7 was a 16-week study that included 329 adults with moderate or severe atopic dermatitis who were randomized to low- and midpotency topical corticosteroids plus either baricitinib at 2 mg once daily, baricitinib at 4 mg once daily, or placebo. The group’s mean baseline Eczema Area and Severity Index (EASI) score was 29. Overall, 45% of participants had a baseline Investigator’s Global Assessment (IGA) of disease severity of 4 on a 0-4 scale.

The primary endpoint was achievement of an IGA of 0 or 1, meaning clear or almost clear, along with at least a 2-point IGA improvement from baseline at week 16. This was accomplished in 30.6% of those on 4 mg/day of baricitinib, 23.9% of patients in the 2-mg group, and 14.7% of controls.

The 4-mg dose of baricitinib was statistically superior to placebo; the 2-mg dose was not. However, Dr. Reich indicated he was untroubled by this because the primary endpoint was set at a high bar, and both doses of baricitinib proved to be significantly better than topical steroids plus placebo in terms of EASI 75 response rates, as well as reductions in itch, skin pain, and sleep problems, which aren’t captured in EASI scores (see graphic).

“One of my big learnings from this year’s EADV is that we have to rethink the dimensions of atopic dermatitis. I think we have underestimated the relevance of important symptoms such as itch, the impact atopic dermatitis has on pain, and the effect it has on sleeping problems,” the dermatologist said. “My feeling is that baricitinib is strongest in reducing itch, improving sleep, and reducing pain, but it also has good effects on the clinical signs of atopic dermatitis.”

The baricitinib-treated patients’ rapidity of improvement in the various endpoints was particularly impressive. Both doses of the JAK 1/2 inhibitor showed significant separation from the control group in the first week, and the majority of improvement occurred by week 4.

A key finding was that patients on baricitinib at 2 mg/day and 4 mg/day used a mean total of 162 g and 137 g of midpotency topical steroids, respectively, during the 16 weeks, compared with 225 g in the control group. The higher-dose baricitinib group was topical corticosteroid-free on 33% of study days, compared with 25% of days for the baricitinib 2 mg patients and 17% of days for controls.

In terms of safety, there was a case of pulmonary embolism in the higher-dose baricitinib group and an opportunistic toxoplasmosis eye infection in the control population. The frequency of oral herpes and herpes simplex virus infections was 2.8% in controls, 4.6% in the baricitinib 2-mg group, and 6.3% in the 4-mg group. There was also a signal of a dose-dependent increased risk of new-onset acne, with rates of 0.9% in controls and patients on baricitinib 2 mg, climbing to 3.6% with baricitinib 4 mg.

“In phase 2 results with upadacitinib [another oral JAK inhibitor], we saw that more than 10% of patients in the highest-dose group developed what was classified as acne. I cannot explain this, but it’s something we will monitor in the future,” Dr. Reich promised.

A fuller picture of baricitinib’s safety profile in the setting of atopic dermatitis clearly requires larger and longer-term studies, he added.

Baricitinib at the 2 mg daily dose is already marketed as Olumiant for the treatment of rheumatoid arthritis, with labeling that includes a boxed warning about serious infections, malignancy, and thrombosis. The Food and Drug Administration did not approve the 4-mg dose after determining that its higher safety hazard outweighed the efficacy advantage over the lower dose.

The BREEZE-AD7 study was sponsored by Eli Lilly. Dr. Reich reported serving as an adviser to, paid speaker for, and recipient of research grants from that pharmaceutical company and more than two dozen others.
 

bjancin@mdedge.com

In November 2019, more than 1,500 pediatric hospitalists will be first to take the subspecialty exam approved by the American Board of Pediatrics (ABP) for certification in pediatric hospital medicine (PHM). This landmark signifies the recognition of hospital medicine as an essential component of the health care landscape and further acknowledges the importance of our expanding field.

But recent controversy over the requirements set by the ABP to sit for the exam has highlighted the new considerations for practice management that will be associated with this change. The need to analyze and understand how PHM programs function has never been more important for hospital medicine groups that care for children. This information is essential if they are to remain nimble in their approach to the changes that will occur in the years ahead.

To understand the impact that the new subspecialty board exam will have on groups that care for children, we need to first understand the criteria for eligibility. As for all ABP subspecialty boards, applicants must be Pediatric Board certified. The ABP has established three pathways by which practitioners can attain eligibility to sit for the PHM exam.¹ Most currently practicing hospitalists have applied to take the exam under the “practice pathway,” which will be available temporarily to allow candidates to apply for the certifying exam based on experience rather than fellowship training. This temporary period will span the first three examination cycles (2019, 2021, 2023). The requirements for inclusion via this pathway, recently modified by the ABP in response to concerns voiced by the PHM community at large,² consist of the following:

1. Practice period of 4 years (with a start date of July 2015 to be eligible for the November 2019 exam.

2. Work hours for all PHM professional activities of more than 900-1000 hours/year.

3. Patient care hours in PHM of more than 450-500 hours per year, every year for the preceding 4 years.

4. Scope of practice covering the full range of hospitalized children.

5. Practice experience and hours acquired in the United States or Canada.

This set of criteria raises several questions about the eligibility of the physicians currently caring for children in the hospital setting. The State of Hospital Medicine Report is an excellent source of information about hospital medicine trends in staffing and much more. While the response to the survey is more robust from practices that care for adults only, important information can be gleaned from the participant groups that care for children.

Question 1: How many clinicians that care for children in the hospital are trained in pediatrics, thereby meeting the first criteria to sit for the boards?

Based on the 2018 State of Hospital Medicine Report, 100% of groups that treat only children had physicians trained in pediatrics, 41.7% employed physicians trained in med/peds, and 5.6% had clinicians trained in internal medicine.

In groups that treat both children and adults the variation in practitioner type was much broader. While 85.7% of groups reported employing physicians trained in internal medicine and 64.3% employed family medicine practitioners, only 35.7% reported employing physicians trained in pediatrics and 46.4% with training in med/peds. A smattering of other clinician types was also noted, most of which were not likely to be pediatrics trained.

If information based on this relatively small number of respondents is generalizable, it means that a large number of the practitioners currently caring for hospitalized children are not pediatrics board-certified and therefore will not be eligible to sit for the subspecialty exam.

Question 2: What portion of the current PHM new hires are fellowship trained?

The 2018 State of Hospital Medicine Report notes that over 50% of new physicians joining a group treating only children come directly from residency, while only 5.1% come from a hospital medicine fellowship. For groups that treat adults and children, this percentage is even more significant, with 63% coming directly from residency and only 2.2% coming from a fellowship program.

The residents who recently graduated in 2019 are the last to be eligible to meet the practice duration criteria (4 years) during the “practice pathway” temporary period, thereby allowing them to sit for the subspecialty board exam without completing a fellowship. Recent surveys have shown that over 10% of graduating residents in pediatrics plan to pursue a career in PHM (over 280 respondents), however only under 75 fellows graduate from PHM fellowships each year.³ As the current number of fellowship positions in PHM are not adequate to meet the demand of the rapidly expanding workforce, groups treating children will need to continue to fill staff vacancies with variably trained clinicians.

In the years to come, information from the State of Hospital Medicine Report will be increasingly important, as programs that care for children meet the challenge of blending their workforce to include members with variable board certification and eligibility.

Question 3: How do the “patient care hours” and “work hours for all PHM activities” requirements affect currently practicing hospitalists in terms of their board eligibility?

Because of rigorous ABP criteria to sit for the PHM subspecialty exam, especially those regarding the minimum clinical and overall work hours in the care of children, many part time and med-peds practitioners may find that they are not board eligible. Variations in clinical coverage needs at individual sites, as well as competing nonclinical tasks in the adult setting, may limit pediatric-specific work hours for med/peds trained hospitalists.

As noted above, in groups that treat only children and groups that treat both adults and children, the 2018 State of Hospital Medicine Report shows that over 40% had physicians trained in med-peds. These highly trained and capable physicians will continue to be assets to their group; however, they may wish to find other ways to achieve merit-based distinction. For these physicians, the Fellow designation through SHM may provide an alternate means of recognition.

With the increasing complexity of staffing a workforce for the treatment of children that the PHM board subspecialty exam brings, the SHM Practice Analysis Committee developed a task force of pediatric leaders from across the country to aid in the development of additional pediatric-specific questions for the 2020 version of the State of Hospital Medicine Report. The questions to be included in the 2020 version will request information about the number of clinical hours (rather than shifts) per year required for full-time faculty, the percentage of the workforce that is part time, and the percentage of personnel in each group that is board certified in pediatric hospital medicine.

It is our hope that all groups treating children will respond to the 2020 State of Hospital Medicine survey, as a robust response will provide meaningful information to direct the leaders of these groups in the changing days ahead.

Dr. Gage is associate division chief, department of hospital medicine, at Phoenix Children’s Hospital and clinical associate professor, University of Arizona, Phoenix. She is a member of the SHM Practice Analysis Committee.

References

1. American Board of Pediatrics. Pediatric Hospital Medicine Certification. 2019 Edition.

2. American Board of Pediatrics. ABP responds to pediatric hospital medicine petition. 2019 Aug 29.

3. Pediatric Hospital Medicine Fellows. 2019 Edition.

In November 2019, more than 1,500 pediatric hospitalists will be first to take the subspecialty exam approved by the American Board of Pediatrics (ABP) for certification in pediatric hospital medicine (PHM). This landmark signifies the recognition of hospital medicine as an essential component of the health care landscape and further acknowledges the importance of our expanding field.

But recent controversy over the requirements set by the ABP to sit for the exam has highlighted the new considerations for practice management that will be associated with this change. The need to analyze and understand how PHM programs function has never been more important for hospital medicine groups that care for children. This information is essential if they are to remain nimble in their approach to the changes that will occur in the years ahead.

To understand the impact that the new subspecialty board exam will have on groups that care for children, we need to first understand the criteria for eligibility. As for all ABP subspecialty boards, applicants must be Pediatric Board certified. The ABP has established three pathways by which practitioners can attain eligibility to sit for the PHM exam.¹ Most currently practicing hospitalists have applied to take the exam under the “practice pathway,” which will be available temporarily to allow candidates to apply for the certifying exam based on experience rather than fellowship training. This temporary period will span the first three examination cycles (2019, 2021, 2023). The requirements for inclusion via this pathway, recently modified by the ABP in response to concerns voiced by the PHM community at large,² consist of the following:

1. Practice period of 4 years (with a start date of July 2015 to be eligible for the November 2019 exam.

2. Work hours for all PHM professional activities of more than 900-1000 hours/year.

3. Patient care hours in PHM of more than 450-500 hours per year, every year for the preceding 4 years.

4. Scope of practice covering the full range of hospitalized children.

5. Practice experience and hours acquired in the United States or Canada.

This set of criteria raises several questions about the eligibility of the physicians currently caring for children in the hospital setting. The State of Hospital Medicine Report is an excellent source of information about hospital medicine trends in staffing and much more. While the response to the survey is more robust from practices that care for adults only, important information can be gleaned from the participant groups that care for children.

Question 1: How many clinicians that care for children in the hospital are trained in pediatrics, thereby meeting the first criteria to sit for the boards?

Based on the 2018 State of Hospital Medicine Report, 100% of groups that treat only children had physicians trained in pediatrics, 41.7% employed physicians trained in med/peds, and 5.6% had clinicians trained in internal medicine.

In groups that treat both children and adults the variation in practitioner type was much broader. While 85.7% of groups reported employing physicians trained in internal medicine and 64.3% employed family medicine practitioners, only 35.7% reported employing physicians trained in pediatrics and 46.4% with training in med/peds. A smattering of other clinician types was also noted, most of which were not likely to be pediatrics trained.

If information based on this relatively small number of respondents is generalizable, it means that a large number of the practitioners currently caring for hospitalized children are not pediatrics board-certified and therefore will not be eligible to sit for the subspecialty exam.

Question 2: What portion of the current PHM new hires are fellowship trained?

The 2018 State of Hospital Medicine Report notes that over 50% of new physicians joining a group treating only children come directly from residency, while only 5.1% come from a hospital medicine fellowship. For groups that treat adults and children, this percentage is even more significant, with 63% coming directly from residency and only 2.2% coming from a fellowship program.

The residents who recently graduated in 2019 are the last to be eligible to meet the practice duration criteria (4 years) during the “practice pathway” temporary period, thereby allowing them to sit for the subspecialty board exam without completing a fellowship. Recent surveys have shown that over 10% of graduating residents in pediatrics plan to pursue a career in PHM (over 280 respondents), however only under 75 fellows graduate from PHM fellowships each year.³ As the current number of fellowship positions in PHM are not adequate to meet the demand of the rapidly expanding workforce, groups treating children will need to continue to fill staff vacancies with variably trained clinicians.

In the years to come, information from the State of Hospital Medicine Report will be increasingly important, as programs that care for children meet the challenge of blending their workforce to include members with variable board certification and eligibility.

Question 3: How do the “patient care hours” and “work hours for all PHM activities” requirements affect currently practicing hospitalists in terms of their board eligibility?

Because of rigorous ABP criteria to sit for the PHM subspecialty exam, especially those regarding the minimum clinical and overall work hours in the care of children, many part time and med-peds practitioners may find that they are not board eligible. Variations in clinical coverage needs at individual sites, as well as competing nonclinical tasks in the adult setting, may limit pediatric-specific work hours for med/peds trained hospitalists.

As noted above, in groups that treat only children and groups that treat both adults and children, the 2018 State of Hospital Medicine Report shows that over 40% had physicians trained in med-peds. These highly trained and capable physicians will continue to be assets to their group; however, they may wish to find other ways to achieve merit-based distinction. For these physicians, the Fellow designation through SHM may provide an alternate means of recognition.

With the increasing complexity of staffing a workforce for the treatment of children that the PHM board subspecialty exam brings, the SHM Practice Analysis Committee developed a task force of pediatric leaders from across the country to aid in the development of additional pediatric-specific questions for the 2020 version of the State of Hospital Medicine Report. The questions to be included in the 2020 version will request information about the number of clinical hours (rather than shifts) per year required for full-time faculty, the percentage of the workforce that is part time, and the percentage of personnel in each group that is board certified in pediatric hospital medicine.

It is our hope that all groups treating children will respond to the 2020 State of Hospital Medicine survey, as a robust response will provide meaningful information to direct the leaders of these groups in the changing days ahead.

Dr. Gage is associate division chief, department of hospital medicine, at Phoenix Children’s Hospital and clinical associate professor, University of Arizona, Phoenix. She is a member of the SHM Practice Analysis Committee.

References

1. American Board of Pediatrics. Pediatric Hospital Medicine Certification. 2019 Edition.

2. American Board of Pediatrics. ABP responds to pediatric hospital medicine petition. 2019 Aug 29.

3. Pediatric Hospital Medicine Fellows. 2019 Edition.

In November 2019, more than 1,500 pediatric hospitalists will be first to take the subspecialty exam approved by the American Board of Pediatrics (ABP) for certification in pediatric hospital medicine (PHM). This landmark signifies the recognition of hospital medicine as an essential component of the health care landscape and further acknowledges the importance of our expanding field.

But recent controversy over the requirements set by the ABP to sit for the exam has highlighted the new considerations for practice management that will be associated with this change. The need to analyze and understand how PHM programs function has never been more important for hospital medicine groups that care for children. This information is essential if they are to remain nimble in their approach to the changes that will occur in the years ahead.

To understand the impact that the new subspecialty board exam will have on groups that care for children, we need to first understand the criteria for eligibility. As for all ABP subspecialty boards, applicants must be Pediatric Board certified. The ABP has established three pathways by which practitioners can attain eligibility to sit for the PHM exam.¹ Most currently practicing hospitalists have applied to take the exam under the “practice pathway,” which will be available temporarily to allow candidates to apply for the certifying exam based on experience rather than fellowship training. This temporary period will span the first three examination cycles (2019, 2021, 2023). The requirements for inclusion via this pathway, recently modified by the ABP in response to concerns voiced by the PHM community at large,² consist of the following:

1. Practice period of 4 years (with a start date of July 2015 to be eligible for the November 2019 exam.

2. Work hours for all PHM professional activities of more than 900-1000 hours/year.

3. Patient care hours in PHM of more than 450-500 hours per year, every year for the preceding 4 years.

4. Scope of practice covering the full range of hospitalized children.

5. Practice experience and hours acquired in the United States or Canada.

This set of criteria raises several questions about the eligibility of the physicians currently caring for children in the hospital setting. The State of Hospital Medicine Report is an excellent source of information about hospital medicine trends in staffing and much more. While the response to the survey is more robust from practices that care for adults only, important information can be gleaned from the participant groups that care for children.

Question 1: How many clinicians that care for children in the hospital are trained in pediatrics, thereby meeting the first criteria to sit for the boards?

Based on the 2018 State of Hospital Medicine Report, 100% of groups that treat only children had physicians trained in pediatrics, 41.7% employed physicians trained in med/peds, and 5.6% had clinicians trained in internal medicine.

In groups that treat both children and adults the variation in practitioner type was much broader. While 85.7% of groups reported employing physicians trained in internal medicine and 64.3% employed family medicine practitioners, only 35.7% reported employing physicians trained in pediatrics and 46.4% with training in med/peds. A smattering of other clinician types was also noted, most of which were not likely to be pediatrics trained.

If information based on this relatively small number of respondents is generalizable, it means that a large number of the practitioners currently caring for hospitalized children are not pediatrics board-certified and therefore will not be eligible to sit for the subspecialty exam.

Question 2: What portion of the current PHM new hires are fellowship trained?

The 2018 State of Hospital Medicine Report notes that over 50% of new physicians joining a group treating only children come directly from residency, while only 5.1% come from a hospital medicine fellowship. For groups that treat adults and children, this percentage is even more significant, with 63% coming directly from residency and only 2.2% coming from a fellowship program.

The residents who recently graduated in 2019 are the last to be eligible to meet the practice duration criteria (4 years) during the “practice pathway” temporary period, thereby allowing them to sit for the subspecialty board exam without completing a fellowship. Recent surveys have shown that over 10% of graduating residents in pediatrics plan to pursue a career in PHM (over 280 respondents), however only under 75 fellows graduate from PHM fellowships each year.³ As the current number of fellowship positions in PHM are not adequate to meet the demand of the rapidly expanding workforce, groups treating children will need to continue to fill staff vacancies with variably trained clinicians.

In the years to come, information from the State of Hospital Medicine Report will be increasingly important, as programs that care for children meet the challenge of blending their workforce to include members with variable board certification and eligibility.

Question 3: How do the “patient care hours” and “work hours for all PHM activities” requirements affect currently practicing hospitalists in terms of their board eligibility?

Because of rigorous ABP criteria to sit for the PHM subspecialty exam, especially those regarding the minimum clinical and overall work hours in the care of children, many part time and med-peds practitioners may find that they are not board eligible. Variations in clinical coverage needs at individual sites, as well as competing nonclinical tasks in the adult setting, may limit pediatric-specific work hours for med/peds trained hospitalists.

As noted above, in groups that treat only children and groups that treat both adults and children, the 2018 State of Hospital Medicine Report shows that over 40% had physicians trained in med-peds. These highly trained and capable physicians will continue to be assets to their group; however, they may wish to find other ways to achieve merit-based distinction. For these physicians, the Fellow designation through SHM may provide an alternate means of recognition.

With the increasing complexity of staffing a workforce for the treatment of children that the PHM board subspecialty exam brings, the SHM Practice Analysis Committee developed a task force of pediatric leaders from across the country to aid in the development of additional pediatric-specific questions for the 2020 version of the State of Hospital Medicine Report. The questions to be included in the 2020 version will request information about the number of clinical hours (rather than shifts) per year required for full-time faculty, the percentage of the workforce that is part time, and the percentage of personnel in each group that is board certified in pediatric hospital medicine.

It is our hope that all groups treating children will respond to the 2020 State of Hospital Medicine survey, as a robust response will provide meaningful information to direct the leaders of these groups in the changing days ahead.

Dr. Gage is associate division chief, department of hospital medicine, at Phoenix Children’s Hospital and clinical associate professor, University of Arizona, Phoenix. She is a member of the SHM Practice Analysis Committee.

References

1. American Board of Pediatrics. Pediatric Hospital Medicine Certification. 2019 Edition.

2. American Board of Pediatrics. ABP responds to pediatric hospital medicine petition. 2019 Aug 29.

3. Pediatric Hospital Medicine Fellows. 2019 Edition.

NEW YORK – Career burnout is common is common among physicians and surgeons, but vascular surgeons might be able to lower their risk simply by taking steps to improve their posture in the operating room, according to data presented at a symposium on vascular and endovascular issues on an evolution that is already underway.

“We looked at physical pain and we were able to demonstrate a correlation with burnout. More pain, more burnout,” said Samuel R. Money, MD, division of vascular surgery, Mayo Clinic, Phoenix, Arizona.

Pain was a reasonable focus for efforts to identify causes of burnout because it is so common among vascular surgeons. In data recently published by Dr. Money and his coinvestigators, 78.3% reported moderate to severe physical pain at the end of a day of surgery (J Vasc Surg 2018;70:913-920).

“Forty percent of vascular surgeons have chronic pain,” Dr. Money said at the symposium sponsored by the Cleveland Clinic Foundation.

Physical pain is not the only cause of burnout, which affects 30% of vascular surgeons, according to data recently presented at the annual meeting of the Society of Vascular Surgery (J Vasc Surg 2019;69[6]:e97.). In that survey, physical pain was joined by work hours, documentation tasks, on-call frequency, and conflicts between work and personal life as significant factors.

“The average vascular surgeon in North America works 63 hours per week,” noted Dr. Money, adding that his survey found nearly 90% of surgeons operate on 3 or more days of every week. This amount of time in the operating room is relevant because almost all surgeons report some degree of pain after a procedure. In the survey, the proportion was greater than 95%.

Yet, risk of pain is modifiable.

“Body position matters,” said Dr. Money, citing studies showing that open procedures are most closely associated with neck pain whereas endovascular procedures are more likely to produce back pain. Although there is a high risk of either type of pain with these procedures, the types of predominant pain are consistent with the demands on body positioning.

“The more you lean forward, the more stress is placed on your neck and back. When standing straight, your head weighs 10-12 pounds, but leaning forward, it can put 60 pounds of pressure on your neck,” he said.

The relative stress can be measured objectively. Dr. Money cited work with a device that measures the body force in inertial measurement units (IMU). According to Dr. Money, the neck is in a high stress position about 75% of the time spent performing typical vascular surgery.

“The trunk is placed in a high stress position approximately 40% of the time, while the other parts of the body that were measured were not generally that bad,” Dr. Money said.

To avoid postural pain, which is not often stressed in surgical training, Dr. Money had specific recommendations. Some are obvious, such as positioning the operating table to minimize the amount of time the head is inclined. He also recommended positioning display monitors no more than 10-20 degrees below and no higher than eye level.

“If you sit down to perform tasks during the procedure, use an adjustable chair so that you can optimize the height,” he said.

He identified loupes as a risk factor for bad posture, and he stressed the importance of wearing lead garments only when necessary and adjusted properly.

“Padded floor mats? They really help,” Dr. Money said. He also recommended appropriate footwear and support stocking.

“Microbreaks are being used in a lot of professions. This means stopping for a moment to stretch every 15-30 minutes,” Dr. Money said.

As a first step, Dr. Money recommended simply developing posture awareness. Many surgeons are simply ignoring the risk and failing to optimize the ways they can increase their comfort during surgery.

Even before entering the surgical suite, regular exercise, yoga, and stretching are all strategies that have the potential to make a difference, according to Dr. Money.

The immediate goal is to reduce the physical pain that is an important occupational hazard for vascular surgeons, but the ultimate goal is to improve job satisfaction, an important defense against professional burnout.

NEW YORK – Career burnout is common is common among physicians and surgeons, but vascular surgeons might be able to lower their risk simply by taking steps to improve their posture in the operating room, according to data presented at a symposium on vascular and endovascular issues on an evolution that is already underway.

“We looked at physical pain and we were able to demonstrate a correlation with burnout. More pain, more burnout,” said Samuel R. Money, MD, division of vascular surgery, Mayo Clinic, Phoenix, Arizona.

Pain was a reasonable focus for efforts to identify causes of burnout because it is so common among vascular surgeons. In data recently published by Dr. Money and his coinvestigators, 78.3% reported moderate to severe physical pain at the end of a day of surgery (J Vasc Surg 2018;70:913-920).

“Forty percent of vascular surgeons have chronic pain,” Dr. Money said at the symposium sponsored by the Cleveland Clinic Foundation.

Physical pain is not the only cause of burnout, which affects 30% of vascular surgeons, according to data recently presented at the annual meeting of the Society of Vascular Surgery (J Vasc Surg 2019;69[6]:e97.). In that survey, physical pain was joined by work hours, documentation tasks, on-call frequency, and conflicts between work and personal life as significant factors.

“The average vascular surgeon in North America works 63 hours per week,” noted Dr. Money, adding that his survey found nearly 90% of surgeons operate on 3 or more days of every week. This amount of time in the operating room is relevant because almost all surgeons report some degree of pain after a procedure. In the survey, the proportion was greater than 95%.

Yet, risk of pain is modifiable.

“Body position matters,” said Dr. Money, citing studies showing that open procedures are most closely associated with neck pain whereas endovascular procedures are more likely to produce back pain. Although there is a high risk of either type of pain with these procedures, the types of predominant pain are consistent with the demands on body positioning.

“The more you lean forward, the more stress is placed on your neck and back. When standing straight, your head weighs 10-12 pounds, but leaning forward, it can put 60 pounds of pressure on your neck,” he said.

The relative stress can be measured objectively. Dr. Money cited work with a device that measures the body force in inertial measurement units (IMU). According to Dr. Money, the neck is in a high stress position about 75% of the time spent performing typical vascular surgery.

“The trunk is placed in a high stress position approximately 40% of the time, while the other parts of the body that were measured were not generally that bad,” Dr. Money said.

To avoid postural pain, which is not often stressed in surgical training, Dr. Money had specific recommendations. Some are obvious, such as positioning the operating table to minimize the amount of time the head is inclined. He also recommended positioning display monitors no more than 10-20 degrees below and no higher than eye level.

“If you sit down to perform tasks during the procedure, use an adjustable chair so that you can optimize the height,” he said.

He identified loupes as a risk factor for bad posture, and he stressed the importance of wearing lead garments only when necessary and adjusted properly.

“Padded floor mats? They really help,” Dr. Money said. He also recommended appropriate footwear and support stocking.

“Microbreaks are being used in a lot of professions. This means stopping for a moment to stretch every 15-30 minutes,” Dr. Money said.

As a first step, Dr. Money recommended simply developing posture awareness. Many surgeons are simply ignoring the risk and failing to optimize the ways they can increase their comfort during surgery.

Even before entering the surgical suite, regular exercise, yoga, and stretching are all strategies that have the potential to make a difference, according to Dr. Money.

The immediate goal is to reduce the physical pain that is an important occupational hazard for vascular surgeons, but the ultimate goal is to improve job satisfaction, an important defense against professional burnout.

NEW YORK – Career burnout is common is common among physicians and surgeons, but vascular surgeons might be able to lower their risk simply by taking steps to improve their posture in the operating room, according to data presented at a symposium on vascular and endovascular issues on an evolution that is already underway.

“We looked at physical pain and we were able to demonstrate a correlation with burnout. More pain, more burnout,” said Samuel R. Money, MD, division of vascular surgery, Mayo Clinic, Phoenix, Arizona.

Pain was a reasonable focus for efforts to identify causes of burnout because it is so common among vascular surgeons. In data recently published by Dr. Money and his coinvestigators, 78.3% reported moderate to severe physical pain at the end of a day of surgery (J Vasc Surg 2018;70:913-920).

“Forty percent of vascular surgeons have chronic pain,” Dr. Money said at the symposium sponsored by the Cleveland Clinic Foundation.

Physical pain is not the only cause of burnout, which affects 30% of vascular surgeons, according to data recently presented at the annual meeting of the Society of Vascular Surgery (J Vasc Surg 2019;69[6]:e97.). In that survey, physical pain was joined by work hours, documentation tasks, on-call frequency, and conflicts between work and personal life as significant factors.

“The average vascular surgeon in North America works 63 hours per week,” noted Dr. Money, adding that his survey found nearly 90% of surgeons operate on 3 or more days of every week. This amount of time in the operating room is relevant because almost all surgeons report some degree of pain after a procedure. In the survey, the proportion was greater than 95%.

Yet, risk of pain is modifiable.

“Body position matters,” said Dr. Money, citing studies showing that open procedures are most closely associated with neck pain whereas endovascular procedures are more likely to produce back pain. Although there is a high risk of either type of pain with these procedures, the types of predominant pain are consistent with the demands on body positioning.

“The more you lean forward, the more stress is placed on your neck and back. When standing straight, your head weighs 10-12 pounds, but leaning forward, it can put 60 pounds of pressure on your neck,” he said.

The relative stress can be measured objectively. Dr. Money cited work with a device that measures the body force in inertial measurement units (IMU). According to Dr. Money, the neck is in a high stress position about 75% of the time spent performing typical vascular surgery.

“The trunk is placed in a high stress position approximately 40% of the time, while the other parts of the body that were measured were not generally that bad,” Dr. Money said.

To avoid postural pain, which is not often stressed in surgical training, Dr. Money had specific recommendations. Some are obvious, such as positioning the operating table to minimize the amount of time the head is inclined. He also recommended positioning display monitors no more than 10-20 degrees below and no higher than eye level.

“If you sit down to perform tasks during the procedure, use an adjustable chair so that you can optimize the height,” he said.

He identified loupes as a risk factor for bad posture, and he stressed the importance of wearing lead garments only when necessary and adjusted properly.

“Padded floor mats? They really help,” Dr. Money said. He also recommended appropriate footwear and support stocking.

“Microbreaks are being used in a lot of professions. This means stopping for a moment to stretch every 15-30 minutes,” Dr. Money said.

As a first step, Dr. Money recommended simply developing posture awareness. Many surgeons are simply ignoring the risk and failing to optimize the ways they can increase their comfort during surgery.

Even before entering the surgical suite, regular exercise, yoga, and stretching are all strategies that have the potential to make a difference, according to Dr. Money.

The immediate goal is to reduce the physical pain that is an important occupational hazard for vascular surgeons, but the ultimate goal is to improve job satisfaction, an important defense against professional burnout.