Damian McNamara is a journalist for Medscape Medical News and MDedge. He worked full-time for MDedge as the Miami Bureau covering a dozen medical specialties during 2001-2012, then as a freelancer for Medscape and MDedge, before being hired on staff by Medscape in 2018. Now the two companies are one. He uses what he learned in school – Damian has a BS in chemistry and an MS in science, health and environmental reporting/journalism. He works out of a home office in Miami, with a 100-pound chocolate lab known to snore under his desk during work hours.

Pitchers Should Not 'Play Through the Pain'

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MIAMI BEACH — Throwing a baseball too many times and throwing the wrong kinds of pitches can predispose a child athlete to shoulder and elbow injuries, Dr. Jordan D. Metzl said.

If pain limits the child's ability to participate or worsens over time, further evaluation of the injury is warranted. “We know sports are great for kids, but they can experience sports-related injuries,” he said at a pediatric update sponsored by Miami Children's Hospital.

It is important to be extra careful with children, especially about getting them back into activity, Dr. Metzl said. Advise child athletes not to throw a ball until they are pain free.

“'Play through the pain' is terrible advice. Their bones are developing and some of the injuries can have negative, long-lasting consequences,” said Dr. Metzl, cofounder of the Sports Medicine Institute for Young Athletes and a pediatrician at the Hospital for Special Surgery in New York City.

The epiphysis in children is made of cartilage. If children who are baseball pitchers complain of shoulder pain, they might be pulling on their growth plate. Clinical consequences include a growth problem with that bone, or more seriously, the potential for the shoulder growth plate to split apart.

“The same thing can happen in the elbow,” he said. Children have an open growth plate near the ulnar collateral ligament “and can pull it off.”

An x-ray is recommended for initial evaluation. If available, a biomechanical assessment aids diagnosis of these sports injuries. It can illustrate how the pitch of one child athlete varies from another, and in some cases identify the etiology of the injury. “We know how you throw makes a difference, and the number of pitches makes a difference,” Dr. Metzl said.

He uses multiple cameras to observe the biomechanics of an individual patient's throwing. Every position in the pitching motion is assessed, including the stride and balance point (the position at which a baseball player raises one foot and rests on the other during a windup). Biomechanics also can reveal any flaws in the child's form that might cause an injury in the future.

Other injury prevention strategies include warming up for 5–10 minutes and performing strengthening exercises, Dr. Metzl said. Also, because a high frequency of pitching increases the risk of injury substantially, consider using pitch counts to set a maximum number of throws during practice, warm-up, and/or a game.

Disclosures: Dr. Metzl said he had no relevant financial conflicts to disclose.

The pitching motion and the number of pitches can affect the chance of injury.

Source © Sonya Etchison/Fotolia.com

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MIAMI BEACH — Throwing a baseball too many times and throwing the wrong kinds of pitches can predispose a child athlete to shoulder and elbow injuries, Dr. Jordan D. Metzl said.

If pain limits the child's ability to participate or worsens over time, further evaluation of the injury is warranted. “We know sports are great for kids, but they can experience sports-related injuries,” he said at a pediatric update sponsored by Miami Children's Hospital.

It is important to be extra careful with children, especially about getting them back into activity, Dr. Metzl said. Advise child athletes not to throw a ball until they are pain free.

“'Play through the pain' is terrible advice. Their bones are developing and some of the injuries can have negative, long-lasting consequences,” said Dr. Metzl, cofounder of the Sports Medicine Institute for Young Athletes and a pediatrician at the Hospital for Special Surgery in New York City.

The epiphysis in children is made of cartilage. If children who are baseball pitchers complain of shoulder pain, they might be pulling on their growth plate. Clinical consequences include a growth problem with that bone, or more seriously, the potential for the shoulder growth plate to split apart.

“The same thing can happen in the elbow,” he said. Children have an open growth plate near the ulnar collateral ligament “and can pull it off.”

An x-ray is recommended for initial evaluation. If available, a biomechanical assessment aids diagnosis of these sports injuries. It can illustrate how the pitch of one child athlete varies from another, and in some cases identify the etiology of the injury. “We know how you throw makes a difference, and the number of pitches makes a difference,” Dr. Metzl said.

He uses multiple cameras to observe the biomechanics of an individual patient's throwing. Every position in the pitching motion is assessed, including the stride and balance point (the position at which a baseball player raises one foot and rests on the other during a windup). Biomechanics also can reveal any flaws in the child's form that might cause an injury in the future.

Other injury prevention strategies include warming up for 5–10 minutes and performing strengthening exercises, Dr. Metzl said. Also, because a high frequency of pitching increases the risk of injury substantially, consider using pitch counts to set a maximum number of throws during practice, warm-up, and/or a game.

Disclosures: Dr. Metzl said he had no relevant financial conflicts to disclose.

The pitching motion and the number of pitches can affect the chance of injury.

Source © Sonya Etchison/Fotolia.com

MIAMI BEACH — Throwing a baseball too many times and throwing the wrong kinds of pitches can predispose a child athlete to shoulder and elbow injuries, Dr. Jordan D. Metzl said.

If pain limits the child's ability to participate or worsens over time, further evaluation of the injury is warranted. “We know sports are great for kids, but they can experience sports-related injuries,” he said at a pediatric update sponsored by Miami Children's Hospital.

It is important to be extra careful with children, especially about getting them back into activity, Dr. Metzl said. Advise child athletes not to throw a ball until they are pain free.

“'Play through the pain' is terrible advice. Their bones are developing and some of the injuries can have negative, long-lasting consequences,” said Dr. Metzl, cofounder of the Sports Medicine Institute for Young Athletes and a pediatrician at the Hospital for Special Surgery in New York City.

The epiphysis in children is made of cartilage. If children who are baseball pitchers complain of shoulder pain, they might be pulling on their growth plate. Clinical consequences include a growth problem with that bone, or more seriously, the potential for the shoulder growth plate to split apart.

“The same thing can happen in the elbow,” he said. Children have an open growth plate near the ulnar collateral ligament “and can pull it off.”

An x-ray is recommended for initial evaluation. If available, a biomechanical assessment aids diagnosis of these sports injuries. It can illustrate how the pitch of one child athlete varies from another, and in some cases identify the etiology of the injury. “We know how you throw makes a difference, and the number of pitches makes a difference,” Dr. Metzl said.

He uses multiple cameras to observe the biomechanics of an individual patient's throwing. Every position in the pitching motion is assessed, including the stride and balance point (the position at which a baseball player raises one foot and rests on the other during a windup). Biomechanics also can reveal any flaws in the child's form that might cause an injury in the future.

Other injury prevention strategies include warming up for 5–10 minutes and performing strengthening exercises, Dr. Metzl said. Also, because a high frequency of pitching increases the risk of injury substantially, consider using pitch counts to set a maximum number of throws during practice, warm-up, and/or a game.

Disclosures: Dr. Metzl said he had no relevant financial conflicts to disclose.

The pitching motion and the number of pitches can affect the chance of injury.

Source © Sonya Etchison/Fotolia.com

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Interferon-Gamma TB Tests Not Yet Ready for Prime Time

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MIAMI — Cost and other challenges need to be overcome before interferon-gamma release assays are adopted for widespread tuberculosis testing in children, according to Dr. John Bradley.

Although interferon-gamma release assays (IGRAs) are more accurate than standard tuberculin skin tests, they require 2–5 cc of blood, which can be a challenge in some children, Dr. Bradley said.

In addition, the accuracy of IGRAs is not well studied for children with latent TB infection, miliary TB or other disseminated infections, or active infections such as meningitis.

“There are insufficient data at present to recommend switching from tuberculin skin testing to an IGRA blood test for all kids,” Dr. Bradley said at a pediatric update sponsored by Miami Children's Hospital.

Also, “there are insufficient data to recommend a specific IGRA test,” said Dr. Bradley, an editor of the 2010 Red Book who is also with the division of infectious diseases, Rady Children's Hospital, San Diego.

There is a role for IGRA tests in specific clinical situations, however, Dr. Bradley said. For example, if a physician believes a parent is unlikely to return for the reading of a tuberculin skin test result, the IGRA may be indicated. In addition, the blood test is preferred for Bacillus Calmette-Gurin–immunized children with a positive tuberculin skin test result, as well as for a child with a positive skin test with no known exposures (these are presumed to be false-positive tuberculin skin tests, he said).

“Although the [IGRA] test is clearly an advance, it's not a perfect solution,” Dr. Bradley pointed out.

The two Food and Drug Administration–cleared IGRAs (QuantiFERON-TB Gold, Cellestis; T-SPOT.TB, Oxford Immunotec Ltd.) measure an in vitro lymphocyte response to Mycobacterium tuberculosis proteins.

“We believe the IGRA is a more sensitive test,” Dr. Bradley said. However, “they cost a lot more, so we're not ready to recommend them for widespread use.”

The tuberculin skin test remains the recommended TB assay in the 2010 Red Book, Dr. Bradley said, despite its having some limitations.

The immune competence of the child can impact the sensitivity, for example.

In addition, tuberculin skin tests are difficult to place intradermally, and if they are not intradermal, physicians cannot interpret them, he said. “Uncooperative, screaming children are challenges [also]. Two- and three-year-olds can be contortionists.”

Disclosures: Dr. Bradley said that he had no relevant financial conflicts

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MIAMI — Cost and other challenges need to be overcome before interferon-gamma release assays are adopted for widespread tuberculosis testing in children, according to Dr. John Bradley.

Although interferon-gamma release assays (IGRAs) are more accurate than standard tuberculin skin tests, they require 2–5 cc of blood, which can be a challenge in some children, Dr. Bradley said.

In addition, the accuracy of IGRAs is not well studied for children with latent TB infection, miliary TB or other disseminated infections, or active infections such as meningitis.

“There are insufficient data at present to recommend switching from tuberculin skin testing to an IGRA blood test for all kids,” Dr. Bradley said at a pediatric update sponsored by Miami Children's Hospital.

Also, “there are insufficient data to recommend a specific IGRA test,” said Dr. Bradley, an editor of the 2010 Red Book who is also with the division of infectious diseases, Rady Children's Hospital, San Diego.

There is a role for IGRA tests in specific clinical situations, however, Dr. Bradley said. For example, if a physician believes a parent is unlikely to return for the reading of a tuberculin skin test result, the IGRA may be indicated. In addition, the blood test is preferred for Bacillus Calmette-Gurin–immunized children with a positive tuberculin skin test result, as well as for a child with a positive skin test with no known exposures (these are presumed to be false-positive tuberculin skin tests, he said).

“Although the [IGRA] test is clearly an advance, it's not a perfect solution,” Dr. Bradley pointed out.

The two Food and Drug Administration–cleared IGRAs (QuantiFERON-TB Gold, Cellestis; T-SPOT.TB, Oxford Immunotec Ltd.) measure an in vitro lymphocyte response to Mycobacterium tuberculosis proteins.

“We believe the IGRA is a more sensitive test,” Dr. Bradley said. However, “they cost a lot more, so we're not ready to recommend them for widespread use.”

The tuberculin skin test remains the recommended TB assay in the 2010 Red Book, Dr. Bradley said, despite its having some limitations.

The immune competence of the child can impact the sensitivity, for example.

In addition, tuberculin skin tests are difficult to place intradermally, and if they are not intradermal, physicians cannot interpret them, he said. “Uncooperative, screaming children are challenges [also]. Two- and three-year-olds can be contortionists.”

Disclosures: Dr. Bradley said that he had no relevant financial conflicts

MIAMI — Cost and other challenges need to be overcome before interferon-gamma release assays are adopted for widespread tuberculosis testing in children, according to Dr. John Bradley.

Although interferon-gamma release assays (IGRAs) are more accurate than standard tuberculin skin tests, they require 2–5 cc of blood, which can be a challenge in some children, Dr. Bradley said.

In addition, the accuracy of IGRAs is not well studied for children with latent TB infection, miliary TB or other disseminated infections, or active infections such as meningitis.

“There are insufficient data at present to recommend switching from tuberculin skin testing to an IGRA blood test for all kids,” Dr. Bradley said at a pediatric update sponsored by Miami Children's Hospital.

Also, “there are insufficient data to recommend a specific IGRA test,” said Dr. Bradley, an editor of the 2010 Red Book who is also with the division of infectious diseases, Rady Children's Hospital, San Diego.

There is a role for IGRA tests in specific clinical situations, however, Dr. Bradley said. For example, if a physician believes a parent is unlikely to return for the reading of a tuberculin skin test result, the IGRA may be indicated. In addition, the blood test is preferred for Bacillus Calmette-Gurin–immunized children with a positive tuberculin skin test result, as well as for a child with a positive skin test with no known exposures (these are presumed to be false-positive tuberculin skin tests, he said).

“Although the [IGRA] test is clearly an advance, it's not a perfect solution,” Dr. Bradley pointed out.

The two Food and Drug Administration–cleared IGRAs (QuantiFERON-TB Gold, Cellestis; T-SPOT.TB, Oxford Immunotec Ltd.) measure an in vitro lymphocyte response to Mycobacterium tuberculosis proteins.

“We believe the IGRA is a more sensitive test,” Dr. Bradley said. However, “they cost a lot more, so we're not ready to recommend them for widespread use.”

The tuberculin skin test remains the recommended TB assay in the 2010 Red Book, Dr. Bradley said, despite its having some limitations.

The immune competence of the child can impact the sensitivity, for example.

In addition, tuberculin skin tests are difficult to place intradermally, and if they are not intradermal, physicians cannot interpret them, he said. “Uncooperative, screaming children are challenges [also]. Two- and three-year-olds can be contortionists.”

Disclosures: Dr. Bradley said that he had no relevant financial conflicts

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Methotrexate Linked to Serious Infections in RA

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Major Finding: The rate of infectious events among rheumatoid arthritis patients that required hospitalization and/or parenteral antibiotic treatment associated with methotrexate was 2.3 per 100 patient-years of exposure.

Data Source: Meta-analysis of 17 randomized, placebo-controlled clinical trials.

Disclosures: The study authors had no relevant disclosures.

MIAMI — The rate of serious infectious events is significantly higher for rheumatoid arthritis patients who are treated with methotrexate, compared with those taking placebo, according to a meta-analysis of 17 randomized, controlled trials.

The overall rate of infectious events that required hospitalization and/or parenteral antibiotic treatment was 2.3 per 100 patient-years of exposure.

This finding offers clinicians a specific number to consider when they compare serious infectious risks between methotrexate and other treatments, including biologic agents, Dr. Jennifer Powers said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Dr. Daniel E. Furst noted in an interview that the issue of infection in patients on methotrexate is one physicians often forget about, but it is significant because methotrexate's infection risk should be a factor when physicians consider whether to initiate biologic therapy.

Unfortunately, the research does not address whether the infection risk is even higher in patients who receive both methotrexate and a biologic agent than in patients on one or the other as monotherapy. But the findings still are of interest, said Dr. Furst, who is Carl M. Pearson professor of rheumatology at the University of California, Los Angeles.

In contrast, there was no statistically significant higher risk for a serious infectious event associated with methotrexate in a meta-analysis of five psoriasis trials (2.2 serious infectious events per 100 patient-years) or a meta-analysis of five psoriatic arthritis studies (0.9 events per 100 patient-years).

The small number of eligible studies in psoriasis and psoriatic arthritis might explain the lack of statistical significance, Dr. Powers said.

It could also be that patients with rheumatoid arthritis generally are sicker, said Dr. Powers, a first-year resident at Grand Rapids (Michigan) Medical Education and Research Center.

The Food and Drug Administration first approved methotrexate in 1953 and granted a new indication to treat rheumatoid arthritis in 1988. These approvals predate the era when the agency required more stringent reporting of infectious adverse events, Dr. Powers said.

She and her colleague, Dr. Richard W. Martin, conducted a literature search for randomized, placebo-controlled studies published from January 2005 through May 2009 in Embase Biomedical Answers, the National Library of Medicine's Medline database, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library. Patients in each study received oral methotrexate (7.5-30 mg/week) for at least 12 weeks.

Previous observational studies reported conflicting results. “It was interesting to me when going over the literature [to find] how controversial infection with methotrexate is and how little consensus there is,” Dr. Powers said. “These are rare cases, but they are out there.

“There are not great data about serious infectious events in methotrexate,” Dr. Powers continued. “So there was a hole in the literature we wanted to fill.”

Randomized, controlled studies were included in the meta-analyses only if they met objective quality criteria. For example, the participants had to be adults with clearly defined disease, and they could not be taking more than 10 mg of prednisone. Also, studies were excluded if 20% or more of the patients were lost to follow-up.

Biologic agents have transformed psoriasis treatment, but they are associated with increased serious infectious events and significant expense. Because of this, there is revived interest in the comparative efficacy of standard versus the newer therapies, the authors wrote.

“This is really an important counterpoint when we are discussing [serious infectious event] risks for methotrexate. … It is generally accepted that methotrexate has lower risk of [serious infectious events] than biologics,” Dr. Powers said.

For example, the product labeling for ustekinumab (Stelara) notes that serious infections have occurred with the use of that agent. In addition, the risk of serious infections that can lead to hospitalization and death are included on black box warnings for etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira).

A meeting attendee said the findings would be more robust if the methotrexate trials in the meta-analyses went beyond 12 weeks.

Dr. Powers agreed with that observation, adding that these results “are definitely limited by the fact that there are trials out there that do not follow patients for a longer time.”

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Major Finding: The rate of infectious events among rheumatoid arthritis patients that required hospitalization and/or parenteral antibiotic treatment associated with methotrexate was 2.3 per 100 patient-years of exposure.

Data Source: Meta-analysis of 17 randomized, placebo-controlled clinical trials.

Disclosures: The study authors had no relevant disclosures.

MIAMI — The rate of serious infectious events is significantly higher for rheumatoid arthritis patients who are treated with methotrexate, compared with those taking placebo, according to a meta-analysis of 17 randomized, controlled trials.

The overall rate of infectious events that required hospitalization and/or parenteral antibiotic treatment was 2.3 per 100 patient-years of exposure.

This finding offers clinicians a specific number to consider when they compare serious infectious risks between methotrexate and other treatments, including biologic agents, Dr. Jennifer Powers said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Dr. Daniel E. Furst noted in an interview that the issue of infection in patients on methotrexate is one physicians often forget about, but it is significant because methotrexate's infection risk should be a factor when physicians consider whether to initiate biologic therapy.

Unfortunately, the research does not address whether the infection risk is even higher in patients who receive both methotrexate and a biologic agent than in patients on one or the other as monotherapy. But the findings still are of interest, said Dr. Furst, who is Carl M. Pearson professor of rheumatology at the University of California, Los Angeles.

In contrast, there was no statistically significant higher risk for a serious infectious event associated with methotrexate in a meta-analysis of five psoriasis trials (2.2 serious infectious events per 100 patient-years) or a meta-analysis of five psoriatic arthritis studies (0.9 events per 100 patient-years).

The small number of eligible studies in psoriasis and psoriatic arthritis might explain the lack of statistical significance, Dr. Powers said.

It could also be that patients with rheumatoid arthritis generally are sicker, said Dr. Powers, a first-year resident at Grand Rapids (Michigan) Medical Education and Research Center.

The Food and Drug Administration first approved methotrexate in 1953 and granted a new indication to treat rheumatoid arthritis in 1988. These approvals predate the era when the agency required more stringent reporting of infectious adverse events, Dr. Powers said.

She and her colleague, Dr. Richard W. Martin, conducted a literature search for randomized, placebo-controlled studies published from January 2005 through May 2009 in Embase Biomedical Answers, the National Library of Medicine's Medline database, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library. Patients in each study received oral methotrexate (7.5-30 mg/week) for at least 12 weeks.

Previous observational studies reported conflicting results. “It was interesting to me when going over the literature [to find] how controversial infection with methotrexate is and how little consensus there is,” Dr. Powers said. “These are rare cases, but they are out there.

“There are not great data about serious infectious events in methotrexate,” Dr. Powers continued. “So there was a hole in the literature we wanted to fill.”

Randomized, controlled studies were included in the meta-analyses only if they met objective quality criteria. For example, the participants had to be adults with clearly defined disease, and they could not be taking more than 10 mg of prednisone. Also, studies were excluded if 20% or more of the patients were lost to follow-up.

Biologic agents have transformed psoriasis treatment, but they are associated with increased serious infectious events and significant expense. Because of this, there is revived interest in the comparative efficacy of standard versus the newer therapies, the authors wrote.

“This is really an important counterpoint when we are discussing [serious infectious event] risks for methotrexate. … It is generally accepted that methotrexate has lower risk of [serious infectious events] than biologics,” Dr. Powers said.

For example, the product labeling for ustekinumab (Stelara) notes that serious infections have occurred with the use of that agent. In addition, the risk of serious infections that can lead to hospitalization and death are included on black box warnings for etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira).

A meeting attendee said the findings would be more robust if the methotrexate trials in the meta-analyses went beyond 12 weeks.

Dr. Powers agreed with that observation, adding that these results “are definitely limited by the fact that there are trials out there that do not follow patients for a longer time.”

Major Finding: The rate of infectious events among rheumatoid arthritis patients that required hospitalization and/or parenteral antibiotic treatment associated with methotrexate was 2.3 per 100 patient-years of exposure.

Data Source: Meta-analysis of 17 randomized, placebo-controlled clinical trials.

Disclosures: The study authors had no relevant disclosures.

MIAMI — The rate of serious infectious events is significantly higher for rheumatoid arthritis patients who are treated with methotrexate, compared with those taking placebo, according to a meta-analysis of 17 randomized, controlled trials.

The overall rate of infectious events that required hospitalization and/or parenteral antibiotic treatment was 2.3 per 100 patient-years of exposure.

This finding offers clinicians a specific number to consider when they compare serious infectious risks between methotrexate and other treatments, including biologic agents, Dr. Jennifer Powers said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Dr. Daniel E. Furst noted in an interview that the issue of infection in patients on methotrexate is one physicians often forget about, but it is significant because methotrexate's infection risk should be a factor when physicians consider whether to initiate biologic therapy.

Unfortunately, the research does not address whether the infection risk is even higher in patients who receive both methotrexate and a biologic agent than in patients on one or the other as monotherapy. But the findings still are of interest, said Dr. Furst, who is Carl M. Pearson professor of rheumatology at the University of California, Los Angeles.

In contrast, there was no statistically significant higher risk for a serious infectious event associated with methotrexate in a meta-analysis of five psoriasis trials (2.2 serious infectious events per 100 patient-years) or a meta-analysis of five psoriatic arthritis studies (0.9 events per 100 patient-years).

The small number of eligible studies in psoriasis and psoriatic arthritis might explain the lack of statistical significance, Dr. Powers said.

It could also be that patients with rheumatoid arthritis generally are sicker, said Dr. Powers, a first-year resident at Grand Rapids (Michigan) Medical Education and Research Center.

The Food and Drug Administration first approved methotrexate in 1953 and granted a new indication to treat rheumatoid arthritis in 1988. These approvals predate the era when the agency required more stringent reporting of infectious adverse events, Dr. Powers said.

She and her colleague, Dr. Richard W. Martin, conducted a literature search for randomized, placebo-controlled studies published from January 2005 through May 2009 in Embase Biomedical Answers, the National Library of Medicine's Medline database, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library. Patients in each study received oral methotrexate (7.5-30 mg/week) for at least 12 weeks.

Previous observational studies reported conflicting results. “It was interesting to me when going over the literature [to find] how controversial infection with methotrexate is and how little consensus there is,” Dr. Powers said. “These are rare cases, but they are out there.

“There are not great data about serious infectious events in methotrexate,” Dr. Powers continued. “So there was a hole in the literature we wanted to fill.”

Randomized, controlled studies were included in the meta-analyses only if they met objective quality criteria. For example, the participants had to be adults with clearly defined disease, and they could not be taking more than 10 mg of prednisone. Also, studies were excluded if 20% or more of the patients were lost to follow-up.

Biologic agents have transformed psoriasis treatment, but they are associated with increased serious infectious events and significant expense. Because of this, there is revived interest in the comparative efficacy of standard versus the newer therapies, the authors wrote.

“This is really an important counterpoint when we are discussing [serious infectious event] risks for methotrexate. … It is generally accepted that methotrexate has lower risk of [serious infectious events] than biologics,” Dr. Powers said.

For example, the product labeling for ustekinumab (Stelara) notes that serious infections have occurred with the use of that agent. In addition, the risk of serious infections that can lead to hospitalization and death are included on black box warnings for etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira).

A meeting attendee said the findings would be more robust if the methotrexate trials in the meta-analyses went beyond 12 weeks.

Dr. Powers agreed with that observation, adding that these results “are definitely limited by the fact that there are trials out there that do not follow patients for a longer time.”

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PPN Stimulation Controls Parkinsonian Sleepiness

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MIAMI BEACH — Stimulation of the pedunculopontine nucleus could be a new target to treat excessive daytime sleepiness and other sleep disorders in people with Parkinson's disease, according to recent reports in the literature.

“Daytime sleepiness is a frequent and disabling problem in Parkinson's disease,” Dr. Isabelle Arnulf said at the World Federation of Neurology World Congress on Parkinson's Disease and Related Disorders.

Although excessive daytime sleepiness can interfere with the activities of daily life for Parkinson's disease patients, a main concern is their increased risk for a driving accident.

Dr. Arnulf, a sleep disorders specialist at H pital Piti-Salp tri re in Paris, advised telling patients to be cautious when driving. “The most dangerous for driving are those who do not feel their own sleepiness.”

In the first report of its kind, researchers at the University of Toronto demonstrated last year that deep brain stimulation of the pedunculopontine nucleus (PPN) alters human sleep patterns (Ann. Neurol. 2009;66:110-4).

They studied REM and non-REM phases for five parkinsonian patients undergoing unilateral deep brain stimulation of their PPN.

Nocturnal REM sleep time nearly doubled during stimulation, compared with periods when stimulation was turned off. The implication is that helping people with Parkinson's disease sleep better at night will decrease daytime sleepiness.

High frequency (80 Hz) PPN stimulation produces a sedative effect that “even occurs when the patient actively tries to maintain wakefulness,” Dr. Arnulf said.

In her experience, patients trying to stay awake during this stimulation demonstrate periods of microsleep. She showed meeting attendees a video of a man undergoing stimulation who, despite trying to fight off sleep, went on to establish sleep stage I and then non-REM sleep stage II within 2 minutes. The patient fell asleep 10 out of 10 times, she said.

The results that were obtained in the pilot study suggest that the PPN “could be a new target for sleep disorders,” she said.

Sleep attacks, or the sudden onset of sleep without prodroma, are primarily described in narcolepsy. Risk factors include an Epworth Sleepiness Scale score greater than 10 (range, 0-24), use of dopamine agonists, or high levodopa equivalent doses, Dr. Arnulf said.

Patients can be screened for excessive daytime sleepiness using objective measures such as the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test.

Among the possible causes of excessive daytime sleepiness in people with Parkinson's disease are the side effects of dopaminergic agents, insufficient sleep at nighttime, and lesions in arousal systems.

To treat excessive daytime sleepiness, one could decrease or switch dopamine agonists, or consider replacement of a dopamine agonist with levodopa. Combining dopamine agonist therapy with a stimulant drug is another option, Dr. Arnulf said .

Reports in the literature support sleepiness as a medication side effect. For example, in one study, researchers observed a “huge increase” in sedation effects—a decrease in sleep latency—about 3-5 hours after 12 healthy volunteers took a dopamine agonist (Br. J. Clin. Pharmacol. 2009;67:333-40).

In another study, researchers found that 22% of 929 patients with Parkinson's disease who were prescribed a dopamine agonist reported an episode of “uncontrollable somnolence” (Arch. Neurol. 2005;62:1242-8)

The risk for uncontrollable somnolence was nearly tripled in participants taking a dopamine agonist compared with other medication types.

Dr. Arnulf said that a common question is whether sustained-release dopamine agonists are less sedative. Dopamine-related sleepiness usually occurs at the peak of the dopamine agonist effect, she said, but a blunted peak does not prevent sleepiness from occurring,

Dr. Arnulf had no relevant financial disclosures.

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MIAMI BEACH — Stimulation of the pedunculopontine nucleus could be a new target to treat excessive daytime sleepiness and other sleep disorders in people with Parkinson's disease, according to recent reports in the literature.

“Daytime sleepiness is a frequent and disabling problem in Parkinson's disease,” Dr. Isabelle Arnulf said at the World Federation of Neurology World Congress on Parkinson's Disease and Related Disorders.

Although excessive daytime sleepiness can interfere with the activities of daily life for Parkinson's disease patients, a main concern is their increased risk for a driving accident.

Dr. Arnulf, a sleep disorders specialist at H pital Piti-Salp tri re in Paris, advised telling patients to be cautious when driving. “The most dangerous for driving are those who do not feel their own sleepiness.”

In the first report of its kind, researchers at the University of Toronto demonstrated last year that deep brain stimulation of the pedunculopontine nucleus (PPN) alters human sleep patterns (Ann. Neurol. 2009;66:110-4).

They studied REM and non-REM phases for five parkinsonian patients undergoing unilateral deep brain stimulation of their PPN.

Nocturnal REM sleep time nearly doubled during stimulation, compared with periods when stimulation was turned off. The implication is that helping people with Parkinson's disease sleep better at night will decrease daytime sleepiness.

High frequency (80 Hz) PPN stimulation produces a sedative effect that “even occurs when the patient actively tries to maintain wakefulness,” Dr. Arnulf said.

In her experience, patients trying to stay awake during this stimulation demonstrate periods of microsleep. She showed meeting attendees a video of a man undergoing stimulation who, despite trying to fight off sleep, went on to establish sleep stage I and then non-REM sleep stage II within 2 minutes. The patient fell asleep 10 out of 10 times, she said.

The results that were obtained in the pilot study suggest that the PPN “could be a new target for sleep disorders,” she said.

Sleep attacks, or the sudden onset of sleep without prodroma, are primarily described in narcolepsy. Risk factors include an Epworth Sleepiness Scale score greater than 10 (range, 0-24), use of dopamine agonists, or high levodopa equivalent doses, Dr. Arnulf said.

Patients can be screened for excessive daytime sleepiness using objective measures such as the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test.

Among the possible causes of excessive daytime sleepiness in people with Parkinson's disease are the side effects of dopaminergic agents, insufficient sleep at nighttime, and lesions in arousal systems.

To treat excessive daytime sleepiness, one could decrease or switch dopamine agonists, or consider replacement of a dopamine agonist with levodopa. Combining dopamine agonist therapy with a stimulant drug is another option, Dr. Arnulf said .

Reports in the literature support sleepiness as a medication side effect. For example, in one study, researchers observed a “huge increase” in sedation effects—a decrease in sleep latency—about 3-5 hours after 12 healthy volunteers took a dopamine agonist (Br. J. Clin. Pharmacol. 2009;67:333-40).

In another study, researchers found that 22% of 929 patients with Parkinson's disease who were prescribed a dopamine agonist reported an episode of “uncontrollable somnolence” (Arch. Neurol. 2005;62:1242-8)

The risk for uncontrollable somnolence was nearly tripled in participants taking a dopamine agonist compared with other medication types.

Dr. Arnulf said that a common question is whether sustained-release dopamine agonists are less sedative. Dopamine-related sleepiness usually occurs at the peak of the dopamine agonist effect, she said, but a blunted peak does not prevent sleepiness from occurring,

Dr. Arnulf had no relevant financial disclosures.

MIAMI BEACH — Stimulation of the pedunculopontine nucleus could be a new target to treat excessive daytime sleepiness and other sleep disorders in people with Parkinson's disease, according to recent reports in the literature.

“Daytime sleepiness is a frequent and disabling problem in Parkinson's disease,” Dr. Isabelle Arnulf said at the World Federation of Neurology World Congress on Parkinson's Disease and Related Disorders.

Although excessive daytime sleepiness can interfere with the activities of daily life for Parkinson's disease patients, a main concern is their increased risk for a driving accident.

Dr. Arnulf, a sleep disorders specialist at H pital Piti-Salp tri re in Paris, advised telling patients to be cautious when driving. “The most dangerous for driving are those who do not feel their own sleepiness.”

In the first report of its kind, researchers at the University of Toronto demonstrated last year that deep brain stimulation of the pedunculopontine nucleus (PPN) alters human sleep patterns (Ann. Neurol. 2009;66:110-4).

They studied REM and non-REM phases for five parkinsonian patients undergoing unilateral deep brain stimulation of their PPN.

Nocturnal REM sleep time nearly doubled during stimulation, compared with periods when stimulation was turned off. The implication is that helping people with Parkinson's disease sleep better at night will decrease daytime sleepiness.

High frequency (80 Hz) PPN stimulation produces a sedative effect that “even occurs when the patient actively tries to maintain wakefulness,” Dr. Arnulf said.

In her experience, patients trying to stay awake during this stimulation demonstrate periods of microsleep. She showed meeting attendees a video of a man undergoing stimulation who, despite trying to fight off sleep, went on to establish sleep stage I and then non-REM sleep stage II within 2 minutes. The patient fell asleep 10 out of 10 times, she said.

The results that were obtained in the pilot study suggest that the PPN “could be a new target for sleep disorders,” she said.

Sleep attacks, or the sudden onset of sleep without prodroma, are primarily described in narcolepsy. Risk factors include an Epworth Sleepiness Scale score greater than 10 (range, 0-24), use of dopamine agonists, or high levodopa equivalent doses, Dr. Arnulf said.

Patients can be screened for excessive daytime sleepiness using objective measures such as the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test.

Among the possible causes of excessive daytime sleepiness in people with Parkinson's disease are the side effects of dopaminergic agents, insufficient sleep at nighttime, and lesions in arousal systems.

To treat excessive daytime sleepiness, one could decrease or switch dopamine agonists, or consider replacement of a dopamine agonist with levodopa. Combining dopamine agonist therapy with a stimulant drug is another option, Dr. Arnulf said .

Reports in the literature support sleepiness as a medication side effect. For example, in one study, researchers observed a “huge increase” in sedation effects—a decrease in sleep latency—about 3-5 hours after 12 healthy volunteers took a dopamine agonist (Br. J. Clin. Pharmacol. 2009;67:333-40).

In another study, researchers found that 22% of 929 patients with Parkinson's disease who were prescribed a dopamine agonist reported an episode of “uncontrollable somnolence” (Arch. Neurol. 2005;62:1242-8)

The risk for uncontrollable somnolence was nearly tripled in participants taking a dopamine agonist compared with other medication types.

Dr. Arnulf said that a common question is whether sustained-release dopamine agonists are less sedative. Dopamine-related sleepiness usually occurs at the peak of the dopamine agonist effect, she said, but a blunted peak does not prevent sleepiness from occurring,

Dr. Arnulf had no relevant financial disclosures.

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Interferon-Gamma TB Tests Not Ready for Widespread Use

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MIAMI — Cost and other challenges need to be overcome before interferon-gamma release assays are adopted for widespread tuberculosis testing in children, according to Dr. John Bradley.

Although interferon-gamma release assays (IGRAs) are more accurate than standard tuberculin skin tests, they require 2–5 cc of blood, which can be a challenge in some children, Dr. Bradley said.

In addition, the accuracy of IGRAs is not well studied for children with latent TB infection, miliary TB or other disseminated infections, or active infections such as meningitis.

“There are insufficient data at present to recommend switching from tuberculin skin testing to an IGRA blood test for all kids,” Dr. Bradley said at a pediatric update sponsored by Miami Children's Hospital. Also, “there are insufficient data to recommend a specific IGRA test,” said Dr. Bradley, an editor of the 2010 Red Book who is also with the division of infectious diseases, Rady Children's Hospital, San Diego.

There is a role for IGRA tests in specific clinical situations, however, Dr. Bradley said. For example, if a pediatrician believes a parent is unlikely to return for the reading of a tuberculin skin test result, the IGRA may be indicated. In addition, the blood test is preferred for Bacillus Calmette-Guérin–immunized children with a positive tuberculin skin test result, as well as for a child with a positive skin test with no known exposures (these are presumed to be false-positive tuberculin skin tests, he said).

“Although the [IGRA] test is clearly an advance, it's not a perfect solution,” Dr. Bradley said.

The two Food and Drug Administration–cleared IGRAs (QuantiFERON-TB Gold, Cellestis; T-SPOT.TB, Oxford Immunotec Ltd.) measure an in vitro lymphocyte response to Mycobacterium tuberculosis proteins.

“We believe the IGRA is a more sensitive test,” Dr. Bradley said. However, “they cost a lot more, so we're not ready to recommend them for widespread use.”

The tuberculin skin test remains the recommended TB assay in the 2010 Red Book, Dr. Bradley said, despite its having some limitations.

The immune competence of the child can impact the sensitivity, for example. In addition, tuberculin skin tests are difficult to place intradermally, and if they are not intradermal, you cannot interpret them, he said.

“Uncooperative, screaming children are challenges [also]. Two- and three-year-olds can be contortionists.”

Disclosures: None was reported.

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MIAMI — Cost and other challenges need to be overcome before interferon-gamma release assays are adopted for widespread tuberculosis testing in children, according to Dr. John Bradley.

Although interferon-gamma release assays (IGRAs) are more accurate than standard tuberculin skin tests, they require 2–5 cc of blood, which can be a challenge in some children, Dr. Bradley said.

In addition, the accuracy of IGRAs is not well studied for children with latent TB infection, miliary TB or other disseminated infections, or active infections such as meningitis.

“There are insufficient data at present to recommend switching from tuberculin skin testing to an IGRA blood test for all kids,” Dr. Bradley said at a pediatric update sponsored by Miami Children's Hospital. Also, “there are insufficient data to recommend a specific IGRA test,” said Dr. Bradley, an editor of the 2010 Red Book who is also with the division of infectious diseases, Rady Children's Hospital, San Diego.

There is a role for IGRA tests in specific clinical situations, however, Dr. Bradley said. For example, if a pediatrician believes a parent is unlikely to return for the reading of a tuberculin skin test result, the IGRA may be indicated. In addition, the blood test is preferred for Bacillus Calmette-Guérin–immunized children with a positive tuberculin skin test result, as well as for a child with a positive skin test with no known exposures (these are presumed to be false-positive tuberculin skin tests, he said).

“Although the [IGRA] test is clearly an advance, it's not a perfect solution,” Dr. Bradley said.

The two Food and Drug Administration–cleared IGRAs (QuantiFERON-TB Gold, Cellestis; T-SPOT.TB, Oxford Immunotec Ltd.) measure an in vitro lymphocyte response to Mycobacterium tuberculosis proteins.

“We believe the IGRA is a more sensitive test,” Dr. Bradley said. However, “they cost a lot more, so we're not ready to recommend them for widespread use.”

The tuberculin skin test remains the recommended TB assay in the 2010 Red Book, Dr. Bradley said, despite its having some limitations.

The immune competence of the child can impact the sensitivity, for example. In addition, tuberculin skin tests are difficult to place intradermally, and if they are not intradermal, you cannot interpret them, he said.

“Uncooperative, screaming children are challenges [also]. Two- and three-year-olds can be contortionists.”

Disclosures: None was reported.

MIAMI — Cost and other challenges need to be overcome before interferon-gamma release assays are adopted for widespread tuberculosis testing in children, according to Dr. John Bradley.

Although interferon-gamma release assays (IGRAs) are more accurate than standard tuberculin skin tests, they require 2–5 cc of blood, which can be a challenge in some children, Dr. Bradley said.

In addition, the accuracy of IGRAs is not well studied for children with latent TB infection, miliary TB or other disseminated infections, or active infections such as meningitis.

“There are insufficient data at present to recommend switching from tuberculin skin testing to an IGRA blood test for all kids,” Dr. Bradley said at a pediatric update sponsored by Miami Children's Hospital. Also, “there are insufficient data to recommend a specific IGRA test,” said Dr. Bradley, an editor of the 2010 Red Book who is also with the division of infectious diseases, Rady Children's Hospital, San Diego.

There is a role for IGRA tests in specific clinical situations, however, Dr. Bradley said. For example, if a pediatrician believes a parent is unlikely to return for the reading of a tuberculin skin test result, the IGRA may be indicated. In addition, the blood test is preferred for Bacillus Calmette-Guérin–immunized children with a positive tuberculin skin test result, as well as for a child with a positive skin test with no known exposures (these are presumed to be false-positive tuberculin skin tests, he said).

“Although the [IGRA] test is clearly an advance, it's not a perfect solution,” Dr. Bradley said.

The two Food and Drug Administration–cleared IGRAs (QuantiFERON-TB Gold, Cellestis; T-SPOT.TB, Oxford Immunotec Ltd.) measure an in vitro lymphocyte response to Mycobacterium tuberculosis proteins.

“We believe the IGRA is a more sensitive test,” Dr. Bradley said. However, “they cost a lot more, so we're not ready to recommend them for widespread use.”

The tuberculin skin test remains the recommended TB assay in the 2010 Red Book, Dr. Bradley said, despite its having some limitations.

The immune competence of the child can impact the sensitivity, for example. In addition, tuberculin skin tests are difficult to place intradermally, and if they are not intradermal, you cannot interpret them, he said.

“Uncooperative, screaming children are challenges [also]. Two- and three-year-olds can be contortionists.”

Disclosures: None was reported.

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Impact of Childhood Trauma on Startle Response Persists

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ATLANTA – A single traumatic event when children are 8–12 years old might trigger neurophysiologic changes that predispose them to long-lasting vulnerability for a heightened startle response.

Dr. Robert S. Pynoos, director of outpatient trauma psychiatry at the University of California, Los Angeles, said he and his colleagues assessed 17 children who met the full criteria for posttraumatic stress disorder (PTSD), 8 with partial PTSD, and 16 age- and gender-matched controls without PTSD. They measured the startle magnitude to a binaural acoustic startle.

The groups with PTSD had experienced a single, circumscribed traumatic event in the past 14 months, Dr. Pynoos reported at the annual meeting of the International Society for Trauma Stress Studies. The traumatic events were serious–one child had been kidnapped and witnessed the rape of his or her mother.

Elapsed time since the event, IQ, ethnicity, and socioeconomic status had no significant effect on the findings. “Children with trauma but partial PTSD still [showed a] significant difference” he said, noting they could reduce their startle response by only 40%, compared with 50%-60% in controls. Children with full criteria PTSD were more severely impaired in their response, able to modulate it by only 30%, which is similar to a 3-year-old.

Humans and animals use the same four-neuron connection in startle; in humans, however, the amygdala can alter the response or the cortical system can inhibit it through many different mechanisms, said Dr. Pynoos. “All this is involved in modifying the startle reaction at the same point–before motor action. It is important to educate parents they cannot teach their children out of their responses. And we need to know [patients] may carry vulnerability into the future based on neurobiologic changes during this critical period.”

Dr. Pynoos said that he had no relevant disclosures.

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ATLANTA – A single traumatic event when children are 8–12 years old might trigger neurophysiologic changes that predispose them to long-lasting vulnerability for a heightened startle response.

Dr. Robert S. Pynoos, director of outpatient trauma psychiatry at the University of California, Los Angeles, said he and his colleagues assessed 17 children who met the full criteria for posttraumatic stress disorder (PTSD), 8 with partial PTSD, and 16 age- and gender-matched controls without PTSD. They measured the startle magnitude to a binaural acoustic startle.

The groups with PTSD had experienced a single, circumscribed traumatic event in the past 14 months, Dr. Pynoos reported at the annual meeting of the International Society for Trauma Stress Studies. The traumatic events were serious–one child had been kidnapped and witnessed the rape of his or her mother.

Elapsed time since the event, IQ, ethnicity, and socioeconomic status had no significant effect on the findings. “Children with trauma but partial PTSD still [showed a] significant difference” he said, noting they could reduce their startle response by only 40%, compared with 50%-60% in controls. Children with full criteria PTSD were more severely impaired in their response, able to modulate it by only 30%, which is similar to a 3-year-old.

Humans and animals use the same four-neuron connection in startle; in humans, however, the amygdala can alter the response or the cortical system can inhibit it through many different mechanisms, said Dr. Pynoos. “All this is involved in modifying the startle reaction at the same point–before motor action. It is important to educate parents they cannot teach their children out of their responses. And we need to know [patients] may carry vulnerability into the future based on neurobiologic changes during this critical period.”

Dr. Pynoos said that he had no relevant disclosures.

ATLANTA – A single traumatic event when children are 8–12 years old might trigger neurophysiologic changes that predispose them to long-lasting vulnerability for a heightened startle response.

Dr. Robert S. Pynoos, director of outpatient trauma psychiatry at the University of California, Los Angeles, said he and his colleagues assessed 17 children who met the full criteria for posttraumatic stress disorder (PTSD), 8 with partial PTSD, and 16 age- and gender-matched controls without PTSD. They measured the startle magnitude to a binaural acoustic startle.

The groups with PTSD had experienced a single, circumscribed traumatic event in the past 14 months, Dr. Pynoos reported at the annual meeting of the International Society for Trauma Stress Studies. The traumatic events were serious–one child had been kidnapped and witnessed the rape of his or her mother.

Elapsed time since the event, IQ, ethnicity, and socioeconomic status had no significant effect on the findings. “Children with trauma but partial PTSD still [showed a] significant difference” he said, noting they could reduce their startle response by only 40%, compared with 50%-60% in controls. Children with full criteria PTSD were more severely impaired in their response, able to modulate it by only 30%, which is similar to a 3-year-old.

Humans and animals use the same four-neuron connection in startle; in humans, however, the amygdala can alter the response or the cortical system can inhibit it through many different mechanisms, said Dr. Pynoos. “All this is involved in modifying the startle reaction at the same point–before motor action. It is important to educate parents they cannot teach their children out of their responses. And we need to know [patients] may carry vulnerability into the future based on neurobiologic changes during this critical period.”

Dr. Pynoos said that he had no relevant disclosures.

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AAD: Methotrexate May Drive Infection Risk in RA

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MIAMI – The rate of serious infectious events is significantly higher for rheumatoid arthritis patients who are treated with methotrexate vs. placebo, according to a meta-analysis of 17 randomized controlled trials.

The rate of infectious events that required hospitalization and/or parenteral antibiotic treatment was 2.3 per 100 patient-years of exposure.

This finding offers clinicians a number to consider when they compare serious infectious risks between methotrexate and other treatments, including biologic agents, Dr. Jennifer Powers said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Dr. Daniel E. Furst noted in an interview that the issue of infection in patients on methotrexate is one physicians often forget about, but it is significant because methotrexate’s infection risk should be a factor when physicians consider whether to initiate biologic therapy.

Unfortunately, the research does not address whether the infection risk is even higher in patients who receive both methotrexate and a biologic agent than in patients on one or the other as monotherapy. But the findings still are of interest, said Dr. Furst, who is the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

In contrast, there was no statistically significant higher risk for a serious infectious event (SIE) associated with methotrexate in a meta-analysis of five psoriasis trials (2.2 serious infectious events per 100 patient-years) or a meta-analysis of five psoriatic arthritis studies (0.9 events per 100 patient-years).

The small number of eligible studies in psoriasis and psoriatic arthritis might explain the lack of statistical significance, said Dr. Powers, a first-year resident at Grand Rapids (Michigan) Medical Education and Research Center. It could also be that patients with rheumatoid arthritis generally are sicker. The Food and Drug Administration first approved methotrexate in 1953 and granted a new indication to treat rheumatoid arthritis in 1988. These approvals predate the era when the agency required more stringent reporting of infectious adverse events, Dr. Powers said.

She and her colleague, Dr. Richard W. Martin, conducted a literature search for randomized, placebo-controlled studies published from January 2005 through May 2009 in Embase Biomedical Answers, the National Library of Medicine’s Medline database, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library. Patients in each study received oral methotrexate (7.5-30 mg/wk) for at least 12 weeks.

Previous observational studies reported conflicting results. “It was interesting to me when going over the literature [to find] how controversial infection with methotrexate is and how little consensus there is,” Dr. Powers said. “These are rare cases, but they are out there.”

“There are not great data about [SIEs] in methotrexate,” Dr. Powers said. “So there was a hole in the literature we wanted to fill.”

Randomized, controlled studies were included in the meta-analyses only if they met objective quality criteria. For example, participants had to be adults with clearly defined disease, and they could not be taking more than 10-mg prednisone. Also, studies were excluded if 20% or more of patients were lost to follow-up.

Biologic agents have transformed psoriasis treatment, but they are associated with increased serious infectious events and significant expense, which revives interest in the comparative efficacy of standard vs. new therapies, the authors wrote.

“This is really an important counterpoint when we are discussing SIE risks for methotrexate. ... It is generally accepted that methotrexate has lower risk of SIE than biologics,” Dr. Powers said. For example, the product labeling for ustekinumab (Stelara) notes that serious infections have occurred. In addition, the risk of serious infections that can lead to hospitalization and death are included on black box warnings for etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira).

A meeting attendee said the findings would be more robust if the methotrexate trials in the meta-analyses went beyond 12 weeks. Dr. Powers agreed, adding that these results, “are definitely limited by the fact that there are trials out there that do not follow patients for a longer time.”

None of the investigators had any relevant financial disclosures.

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MIAMI – The rate of serious infectious events is significantly higher for rheumatoid arthritis patients who are treated with methotrexate vs. placebo, according to a meta-analysis of 17 randomized controlled trials.

The rate of infectious events that required hospitalization and/or parenteral antibiotic treatment was 2.3 per 100 patient-years of exposure.

This finding offers clinicians a number to consider when they compare serious infectious risks between methotrexate and other treatments, including biologic agents, Dr. Jennifer Powers said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Dr. Daniel E. Furst noted in an interview that the issue of infection in patients on methotrexate is one physicians often forget about, but it is significant because methotrexate’s infection risk should be a factor when physicians consider whether to initiate biologic therapy.

Unfortunately, the research does not address whether the infection risk is even higher in patients who receive both methotrexate and a biologic agent than in patients on one or the other as monotherapy. But the findings still are of interest, said Dr. Furst, who is the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

In contrast, there was no statistically significant higher risk for a serious infectious event (SIE) associated with methotrexate in a meta-analysis of five psoriasis trials (2.2 serious infectious events per 100 patient-years) or a meta-analysis of five psoriatic arthritis studies (0.9 events per 100 patient-years).

The small number of eligible studies in psoriasis and psoriatic arthritis might explain the lack of statistical significance, said Dr. Powers, a first-year resident at Grand Rapids (Michigan) Medical Education and Research Center. It could also be that patients with rheumatoid arthritis generally are sicker. The Food and Drug Administration first approved methotrexate in 1953 and granted a new indication to treat rheumatoid arthritis in 1988. These approvals predate the era when the agency required more stringent reporting of infectious adverse events, Dr. Powers said.

She and her colleague, Dr. Richard W. Martin, conducted a literature search for randomized, placebo-controlled studies published from January 2005 through May 2009 in Embase Biomedical Answers, the National Library of Medicine’s Medline database, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library. Patients in each study received oral methotrexate (7.5-30 mg/wk) for at least 12 weeks.

Previous observational studies reported conflicting results. “It was interesting to me when going over the literature [to find] how controversial infection with methotrexate is and how little consensus there is,” Dr. Powers said. “These are rare cases, but they are out there.”

“There are not great data about [SIEs] in methotrexate,” Dr. Powers said. “So there was a hole in the literature we wanted to fill.”

Randomized, controlled studies were included in the meta-analyses only if they met objective quality criteria. For example, participants had to be adults with clearly defined disease, and they could not be taking more than 10-mg prednisone. Also, studies were excluded if 20% or more of patients were lost to follow-up.

Biologic agents have transformed psoriasis treatment, but they are associated with increased serious infectious events and significant expense, which revives interest in the comparative efficacy of standard vs. new therapies, the authors wrote.

“This is really an important counterpoint when we are discussing SIE risks for methotrexate. ... It is generally accepted that methotrexate has lower risk of SIE than biologics,” Dr. Powers said. For example, the product labeling for ustekinumab (Stelara) notes that serious infections have occurred. In addition, the risk of serious infections that can lead to hospitalization and death are included on black box warnings for etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira).

A meeting attendee said the findings would be more robust if the methotrexate trials in the meta-analyses went beyond 12 weeks. Dr. Powers agreed, adding that these results, “are definitely limited by the fact that there are trials out there that do not follow patients for a longer time.”

None of the investigators had any relevant financial disclosures.

MIAMI – The rate of serious infectious events is significantly higher for rheumatoid arthritis patients who are treated with methotrexate vs. placebo, according to a meta-analysis of 17 randomized controlled trials.

The rate of infectious events that required hospitalization and/or parenteral antibiotic treatment was 2.3 per 100 patient-years of exposure.

This finding offers clinicians a number to consider when they compare serious infectious risks between methotrexate and other treatments, including biologic agents, Dr. Jennifer Powers said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Dr. Daniel E. Furst noted in an interview that the issue of infection in patients on methotrexate is one physicians often forget about, but it is significant because methotrexate’s infection risk should be a factor when physicians consider whether to initiate biologic therapy.

Unfortunately, the research does not address whether the infection risk is even higher in patients who receive both methotrexate and a biologic agent than in patients on one or the other as monotherapy. But the findings still are of interest, said Dr. Furst, who is the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

In contrast, there was no statistically significant higher risk for a serious infectious event (SIE) associated with methotrexate in a meta-analysis of five psoriasis trials (2.2 serious infectious events per 100 patient-years) or a meta-analysis of five psoriatic arthritis studies (0.9 events per 100 patient-years).

The small number of eligible studies in psoriasis and psoriatic arthritis might explain the lack of statistical significance, said Dr. Powers, a first-year resident at Grand Rapids (Michigan) Medical Education and Research Center. It could also be that patients with rheumatoid arthritis generally are sicker. The Food and Drug Administration first approved methotrexate in 1953 and granted a new indication to treat rheumatoid arthritis in 1988. These approvals predate the era when the agency required more stringent reporting of infectious adverse events, Dr. Powers said.

She and her colleague, Dr. Richard W. Martin, conducted a literature search for randomized, placebo-controlled studies published from January 2005 through May 2009 in Embase Biomedical Answers, the National Library of Medicine’s Medline database, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library. Patients in each study received oral methotrexate (7.5-30 mg/wk) for at least 12 weeks.

Previous observational studies reported conflicting results. “It was interesting to me when going over the literature [to find] how controversial infection with methotrexate is and how little consensus there is,” Dr. Powers said. “These are rare cases, but they are out there.”

“There are not great data about [SIEs] in methotrexate,” Dr. Powers said. “So there was a hole in the literature we wanted to fill.”

Randomized, controlled studies were included in the meta-analyses only if they met objective quality criteria. For example, participants had to be adults with clearly defined disease, and they could not be taking more than 10-mg prednisone. Also, studies were excluded if 20% or more of patients were lost to follow-up.

Biologic agents have transformed psoriasis treatment, but they are associated with increased serious infectious events and significant expense, which revives interest in the comparative efficacy of standard vs. new therapies, the authors wrote.

“This is really an important counterpoint when we are discussing SIE risks for methotrexate. ... It is generally accepted that methotrexate has lower risk of SIE than biologics,” Dr. Powers said. For example, the product labeling for ustekinumab (Stelara) notes that serious infections have occurred. In addition, the risk of serious infections that can lead to hospitalization and death are included on black box warnings for etanercept (Enbrel), infliximab (Remicade), and adalimumab (Humira).

A meeting attendee said the findings would be more robust if the methotrexate trials in the meta-analyses went beyond 12 weeks. Dr. Powers agreed, adding that these results, “are definitely limited by the fact that there are trials out there that do not follow patients for a longer time.”

None of the investigators had any relevant financial disclosures.

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AAD: Ustekinumab Enhances Sexual Function for Psoriasis Patients

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MIAMI – Treatment with ustekinumab significantly improved sexual function in patients with moderate to severe psoriasis, according to a secondary analysis of phase III study data.

"It has become really clear that psoriasis has an influence on sexual function in our patients," Dr. Lyn Guenther said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

There is, however, a paucity of published data--with only a few researchers quantifying sexual function and none examining possible benefits of medical treatment in this patient population.

To find out if ustekinumab could improve sexual function, Dr. Guenther and her colleagues assessed quality-of-life data from the phase III PHOENIX I (Lancet 2008;371:1665-74) and PHOENIX II (Lancet 2008;371:1675-84) trials.

At baseline, 23% of the combined 1,996 study patients reported that psoriasis affected their sexual function. Impaired function was defined by a patient response of "very much" or "a lot" of sexual difficulties related to their skin disease on the Dermatology Life Quality Index (DLQI). All participants had moderate to severe psoriasis and 69% were men. By gender, 28% of women and 21% of men reported impaired sexual function.

DLQI scores range from 0 to 30. Mean DLQI patient score at baseline was 12, "indicating a very large negative effect on patients' lives," said Dr. Guenther, professor of dermatology at the University of Western Ontario, London.

The mean Psoriasis Area and Severity Index (PASI) score was a "fairly significant" 20, she said, and mean percentage of body surface area affected by psoriasis was 26%.

Worse sexual dysfunction was significantly associated with increased psoriasis disease severity. As an example, 54% of the women with a PASI score greater than 30 reported a significant impact of their condition on sexuality. "At each of the PASI severity cut-off points, it's almost a linear increase," Dr. Guenther said.

"Can we make a difference?" she asked. After 12 weeks, the percentage of patients who reported sexual function impairment dropped from 23% to 3% in both ustekinumab dosage groups, with no change observed in the control group. "It was surprising to me to see how quickly we could improve the impairment," she said.

Similarly, at week 12, DLQI scores in the treatment groups decreased by a mean of 9.1 points, versus a 0.5-point decrease in controls, a statistically significant difference.

A meeting attendee asked if there was a difference between men and women in terms of improvement. Dr. Guenther replied no, that "they each improved dramatically."

The PHOENIX I and II trial investigators randomized 1,334 patients to ustekinumab (45 mg or 90 mg) at weeks 0, 4, and every 12 weeks thereafter. They also randomized another 662 patients to placebo at weeks 0 and 4, with crossover to ustekinumab (45 mg or 90 mg) at week 12. Placebo patients who crossed over to ustekinumab experienced similar benefits. "The lessening of the sexual dysfunction continued to week 24," Dr. Guenther said.

The mechanism of action for improved sexual function is unknown, but patients treated with ustekinumab might experience less fatigue and more hope about their condition improving, she suggested.

"Why these people have [sexual function] problems is not clear. Future trials will be done to identify the reasons," Dr. Guenther said. She added that further research using validated sexual dysfunction instruments is warranted.

Dr. Guenther was a consultant for Johnson & Johnson, sponsor of the study. Ustekinumab (Stelara) is manufactured by Centocor Ortho Biotech, a wholly-owned subsidiary of Johnson & Johnson.

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MIAMI – Treatment with ustekinumab significantly improved sexual function in patients with moderate to severe psoriasis, according to a secondary analysis of phase III study data.

"It has become really clear that psoriasis has an influence on sexual function in our patients," Dr. Lyn Guenther said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

There is, however, a paucity of published data--with only a few researchers quantifying sexual function and none examining possible benefits of medical treatment in this patient population.

To find out if ustekinumab could improve sexual function, Dr. Guenther and her colleagues assessed quality-of-life data from the phase III PHOENIX I (Lancet 2008;371:1665-74) and PHOENIX II (Lancet 2008;371:1675-84) trials.

At baseline, 23% of the combined 1,996 study patients reported that psoriasis affected their sexual function. Impaired function was defined by a patient response of "very much" or "a lot" of sexual difficulties related to their skin disease on the Dermatology Life Quality Index (DLQI). All participants had moderate to severe psoriasis and 69% were men. By gender, 28% of women and 21% of men reported impaired sexual function.

DLQI scores range from 0 to 30. Mean DLQI patient score at baseline was 12, "indicating a very large negative effect on patients' lives," said Dr. Guenther, professor of dermatology at the University of Western Ontario, London.

The mean Psoriasis Area and Severity Index (PASI) score was a "fairly significant" 20, she said, and mean percentage of body surface area affected by psoriasis was 26%.

Worse sexual dysfunction was significantly associated with increased psoriasis disease severity. As an example, 54% of the women with a PASI score greater than 30 reported a significant impact of their condition on sexuality. "At each of the PASI severity cut-off points, it's almost a linear increase," Dr. Guenther said.

"Can we make a difference?" she asked. After 12 weeks, the percentage of patients who reported sexual function impairment dropped from 23% to 3% in both ustekinumab dosage groups, with no change observed in the control group. "It was surprising to me to see how quickly we could improve the impairment," she said.

Similarly, at week 12, DLQI scores in the treatment groups decreased by a mean of 9.1 points, versus a 0.5-point decrease in controls, a statistically significant difference.

A meeting attendee asked if there was a difference between men and women in terms of improvement. Dr. Guenther replied no, that "they each improved dramatically."

The PHOENIX I and II trial investigators randomized 1,334 patients to ustekinumab (45 mg or 90 mg) at weeks 0, 4, and every 12 weeks thereafter. They also randomized another 662 patients to placebo at weeks 0 and 4, with crossover to ustekinumab (45 mg or 90 mg) at week 12. Placebo patients who crossed over to ustekinumab experienced similar benefits. "The lessening of the sexual dysfunction continued to week 24," Dr. Guenther said.

The mechanism of action for improved sexual function is unknown, but patients treated with ustekinumab might experience less fatigue and more hope about their condition improving, she suggested.

"Why these people have [sexual function] problems is not clear. Future trials will be done to identify the reasons," Dr. Guenther said. She added that further research using validated sexual dysfunction instruments is warranted.

Dr. Guenther was a consultant for Johnson & Johnson, sponsor of the study. Ustekinumab (Stelara) is manufactured by Centocor Ortho Biotech, a wholly-owned subsidiary of Johnson & Johnson.

MIAMI – Treatment with ustekinumab significantly improved sexual function in patients with moderate to severe psoriasis, according to a secondary analysis of phase III study data.

"It has become really clear that psoriasis has an influence on sexual function in our patients," Dr. Lyn Guenther said during a poster discussion session at the annual meeting of the American Academy of Dermatology.

There is, however, a paucity of published data--with only a few researchers quantifying sexual function and none examining possible benefits of medical treatment in this patient population.

To find out if ustekinumab could improve sexual function, Dr. Guenther and her colleagues assessed quality-of-life data from the phase III PHOENIX I (Lancet 2008;371:1665-74) and PHOENIX II (Lancet 2008;371:1675-84) trials.

At baseline, 23% of the combined 1,996 study patients reported that psoriasis affected their sexual function. Impaired function was defined by a patient response of "very much" or "a lot" of sexual difficulties related to their skin disease on the Dermatology Life Quality Index (DLQI). All participants had moderate to severe psoriasis and 69% were men. By gender, 28% of women and 21% of men reported impaired sexual function.

DLQI scores range from 0 to 30. Mean DLQI patient score at baseline was 12, "indicating a very large negative effect on patients' lives," said Dr. Guenther, professor of dermatology at the University of Western Ontario, London.

The mean Psoriasis Area and Severity Index (PASI) score was a "fairly significant" 20, she said, and mean percentage of body surface area affected by psoriasis was 26%.

Worse sexual dysfunction was significantly associated with increased psoriasis disease severity. As an example, 54% of the women with a PASI score greater than 30 reported a significant impact of their condition on sexuality. "At each of the PASI severity cut-off points, it's almost a linear increase," Dr. Guenther said.

"Can we make a difference?" she asked. After 12 weeks, the percentage of patients who reported sexual function impairment dropped from 23% to 3% in both ustekinumab dosage groups, with no change observed in the control group. "It was surprising to me to see how quickly we could improve the impairment," she said.

Similarly, at week 12, DLQI scores in the treatment groups decreased by a mean of 9.1 points, versus a 0.5-point decrease in controls, a statistically significant difference.

A meeting attendee asked if there was a difference between men and women in terms of improvement. Dr. Guenther replied no, that "they each improved dramatically."

The PHOENIX I and II trial investigators randomized 1,334 patients to ustekinumab (45 mg or 90 mg) at weeks 0, 4, and every 12 weeks thereafter. They also randomized another 662 patients to placebo at weeks 0 and 4, with crossover to ustekinumab (45 mg or 90 mg) at week 12. Placebo patients who crossed over to ustekinumab experienced similar benefits. "The lessening of the sexual dysfunction continued to week 24," Dr. Guenther said.

The mechanism of action for improved sexual function is unknown, but patients treated with ustekinumab might experience less fatigue and more hope about their condition improving, she suggested.

"Why these people have [sexual function] problems is not clear. Future trials will be done to identify the reasons," Dr. Guenther said. She added that further research using validated sexual dysfunction instruments is warranted.

Dr. Guenther was a consultant for Johnson & Johnson, sponsor of the study. Ustekinumab (Stelara) is manufactured by Centocor Ortho Biotech, a wholly-owned subsidiary of Johnson & Johnson.

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Program Urges Weight Management in Children

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MIAMI — A regimented, no excuses approach to tackling childhood obesity at Miami Children's Hospital in South Florida could be a model of success for other programs, according to Dr. William I. Muiños.

However, he cautioned, “we cannot make a difference unless all the primary care providers get involved. There aren't enough soldiers in this battle. We need reinforcements.”

Childhood obesity is a worldwide problem, not just a major concern in the United States. “Children are more obese now than ever. We are seeing obesity in children as young as 2 years old,” Dr. Muiños said at a pediatric update sponsored by Miami Children's Hospital.

His message for primary care providers is to intervene: “Don't be afraid to jump in because they need your help. They cannot do it on their own.” Parents also need guidance and education.

Miami Children's Hospital employs a multidisciplinary approach that includes physicians, nurses, social service representatives, and psychologists, but “you don't need a lot of multidisciplinary help. You can do it on your own if you take the time,” said Dr. Muiños, a pediatric gastroenterologist and director of the hospital's weight management program.

The key is to involve the family in a consistent way. Participating family members, however, must be strong and not negotiate with the child. They must be “like a sergeant,” he said.

Treatment plans are individualized for each patient. Children and families are educated about the benefits of fruit, vegetables, and fiber. They are instructed to eat smaller portions, turn off the television, and walk instead of drive. Exercise is emphasized. Patients sign a contract that calls for at least 1 hour of exercise five times per week. They get graded on how well they follow the regimen. Weekly meetings are helpful for keeping participants on track, he said.

Unlike some programs for overweight and obese adults, the goal is weight management, not extensive weight reduction, Dr. Muiños said. “If you start a weight loss program in a child who is growing up … the issue of losing weight actually changes the metabolism of the child during the growing years. It actually starts them on stress modalities [that] are not good for the child because the child's physiology is trying to protect the body weight.

“We need to overcome that by stabilizing weight and allowing height and growth and development to take hold and be the driving force of diminution of body fat,” he said. “We can use this physiologic event to our benefit to diminish [body mass indices] over time.”

Dr. Muiños said that it can actually be helpful to show parents and patients photos of the potential comorbidities if obesity is left unchecked. “I started doing this years ago. I do a lot of hepatology in my practice. And I would see the liver engorged with fat. It is an ugly thing. The macronodular specimen of the liver gets totally distorted.”

He added that “it will impact you when you see that. It impacted me as a physician. So I try to use that impact on the parent so they can see we are not playing around here. This is very, very real.”

Dr. Muiños reported having no relevant conflicts.

To see an interview with Dr. Muiños, go to www.youtube.com/FamilyPracticeNews

Stabilizing weight can allow growth to reduce body fat over time, said Dr. William I. Muiños (right).

Source Damian McNamara/Elsevier Global Medical News

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MIAMI — A regimented, no excuses approach to tackling childhood obesity at Miami Children's Hospital in South Florida could be a model of success for other programs, according to Dr. William I. Muiños.

However, he cautioned, “we cannot make a difference unless all the primary care providers get involved. There aren't enough soldiers in this battle. We need reinforcements.”

Childhood obesity is a worldwide problem, not just a major concern in the United States. “Children are more obese now than ever. We are seeing obesity in children as young as 2 years old,” Dr. Muiños said at a pediatric update sponsored by Miami Children's Hospital.

His message for primary care providers is to intervene: “Don't be afraid to jump in because they need your help. They cannot do it on their own.” Parents also need guidance and education.

Miami Children's Hospital employs a multidisciplinary approach that includes physicians, nurses, social service representatives, and psychologists, but “you don't need a lot of multidisciplinary help. You can do it on your own if you take the time,” said Dr. Muiños, a pediatric gastroenterologist and director of the hospital's weight management program.

The key is to involve the family in a consistent way. Participating family members, however, must be strong and not negotiate with the child. They must be “like a sergeant,” he said.

Treatment plans are individualized for each patient. Children and families are educated about the benefits of fruit, vegetables, and fiber. They are instructed to eat smaller portions, turn off the television, and walk instead of drive. Exercise is emphasized. Patients sign a contract that calls for at least 1 hour of exercise five times per week. They get graded on how well they follow the regimen. Weekly meetings are helpful for keeping participants on track, he said.

Unlike some programs for overweight and obese adults, the goal is weight management, not extensive weight reduction, Dr. Muiños said. “If you start a weight loss program in a child who is growing up … the issue of losing weight actually changes the metabolism of the child during the growing years. It actually starts them on stress modalities [that] are not good for the child because the child's physiology is trying to protect the body weight.

“We need to overcome that by stabilizing weight and allowing height and growth and development to take hold and be the driving force of diminution of body fat,” he said. “We can use this physiologic event to our benefit to diminish [body mass indices] over time.”

Dr. Muiños said that it can actually be helpful to show parents and patients photos of the potential comorbidities if obesity is left unchecked. “I started doing this years ago. I do a lot of hepatology in my practice. And I would see the liver engorged with fat. It is an ugly thing. The macronodular specimen of the liver gets totally distorted.”

He added that “it will impact you when you see that. It impacted me as a physician. So I try to use that impact on the parent so they can see we are not playing around here. This is very, very real.”

Dr. Muiños reported having no relevant conflicts.

To see an interview with Dr. Muiños, go to www.youtube.com/FamilyPracticeNews

Stabilizing weight can allow growth to reduce body fat over time, said Dr. William I. Muiños (right).

Source Damian McNamara/Elsevier Global Medical News

MIAMI — A regimented, no excuses approach to tackling childhood obesity at Miami Children's Hospital in South Florida could be a model of success for other programs, according to Dr. William I. Muiños.

However, he cautioned, “we cannot make a difference unless all the primary care providers get involved. There aren't enough soldiers in this battle. We need reinforcements.”

Childhood obesity is a worldwide problem, not just a major concern in the United States. “Children are more obese now than ever. We are seeing obesity in children as young as 2 years old,” Dr. Muiños said at a pediatric update sponsored by Miami Children's Hospital.

His message for primary care providers is to intervene: “Don't be afraid to jump in because they need your help. They cannot do it on their own.” Parents also need guidance and education.

Miami Children's Hospital employs a multidisciplinary approach that includes physicians, nurses, social service representatives, and psychologists, but “you don't need a lot of multidisciplinary help. You can do it on your own if you take the time,” said Dr. Muiños, a pediatric gastroenterologist and director of the hospital's weight management program.

The key is to involve the family in a consistent way. Participating family members, however, must be strong and not negotiate with the child. They must be “like a sergeant,” he said.

Treatment plans are individualized for each patient. Children and families are educated about the benefits of fruit, vegetables, and fiber. They are instructed to eat smaller portions, turn off the television, and walk instead of drive. Exercise is emphasized. Patients sign a contract that calls for at least 1 hour of exercise five times per week. They get graded on how well they follow the regimen. Weekly meetings are helpful for keeping participants on track, he said.

Unlike some programs for overweight and obese adults, the goal is weight management, not extensive weight reduction, Dr. Muiños said. “If you start a weight loss program in a child who is growing up … the issue of losing weight actually changes the metabolism of the child during the growing years. It actually starts them on stress modalities [that] are not good for the child because the child's physiology is trying to protect the body weight.

“We need to overcome that by stabilizing weight and allowing height and growth and development to take hold and be the driving force of diminution of body fat,” he said. “We can use this physiologic event to our benefit to diminish [body mass indices] over time.”

Dr. Muiños said that it can actually be helpful to show parents and patients photos of the potential comorbidities if obesity is left unchecked. “I started doing this years ago. I do a lot of hepatology in my practice. And I would see the liver engorged with fat. It is an ugly thing. The macronodular specimen of the liver gets totally distorted.”

He added that “it will impact you when you see that. It impacted me as a physician. So I try to use that impact on the parent so they can see we are not playing around here. This is very, very real.”

Dr. Muiños reported having no relevant conflicts.

To see an interview with Dr. Muiños, go to www.youtube.com/FamilyPracticeNews

Stabilizing weight can allow growth to reduce body fat over time, said Dr. William I. Muiños (right).

Source Damian McNamara/Elsevier Global Medical News

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PTSD Predicts Increased Risk Of Suicidality in Veterans

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Major Findings: Suicidality and PTSD numbing symptoms were independently associated.

Data Source: Psychiatric diagnoses and suicidality were assessed in 393 military veterans formerly deployed to a region of conflict.

Disclosures: None reported.

ATLANTA — Assessment of suicidality might be warranted when treating recent combat veterans with posttraumatic stress disorder, according to a study.

PTSD, major depressive disorder (MDD), and a history of one or more suicide attempts each independently predicted increased risk of suicidality among 393 veterans of Operation Enduring Freedom or Operation Iraqi Freedom after their return to the United States.

Of note, PTSD predicted increased risk for suicidality even in the absence of well-known psychiatric comorbidity risk factors, Vito S. Guerra, Ph.D., said at the annual meeting of the International Society for Trauma Stress Studies.

“For someone with PTSD, even without alcohol use disorder or major depressive disorder, [there are] data that they are at risk for self-harm,” Dr. Guerra said in an interview at his poster.

Previous research showed a significantly increased risk for suicidality among veterans of the Vietnam War with PTSD (Mil. Med. 2007;172:1144-7). To assess the risks in more recent combat veterans, Dr. Guerra and his colleagues studied 322 men and 71 women deployed to Afghanistan or Iraq. Mean age of participants was 38 years.

Psychiatric diagnoses and suicidality were assessed using the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I); the Beck Depression Inventory–Second Edition; the Davidson Trauma Scale; the Combat Exposure Scale; and the Beck Scale for Suicide Ideation (BSS)/Scale for Suicide Ideation–Adapted (SSI-A).

A total of 143 (36%) veterans met SCID-I criteria for PTSD. The emotional numbing cluster of PTSD symptoms, measured on the Davidson Trauma Scale, was independently associated with suicidality within this subgroup (adjusted odds ratio 3.8).

Suicidality was defined as a combined score of three or more on the BSS and SSI-A measures, said Dr. Guerra, a postdoctoral psychology fellow at the VA Mid-Atlantic Mental Illness Research, Education and Clinical Center in Durham, N.C.

Major depression and alcohol use disorder (AUD) were less common than PTSD: 88 (22%) of veterans met MDD criteria and 17 (4%) met AUD criteria.

The researchers also looked at comorbidity: 66 (17%) participants met criteria for both PTSD and MDD and 11 (3%) veterans were comorbid with PTSD and AUD. However, presence of either comorbidity did not significantly elevate the risk for suicidality, compared with PTSD alone, Dr. Guerra said.

In contrast, there are data suggesting that people dually diagnosed with PTSD and MDD might be at greater risk of engaging in suicidal acts than persons diagnosed with MDD only, Dr. Guerra said (Am. J. Psychiatry 2005;162:560-6; Am. J. Psychiatry 2001;158:1467-73).

The cognitive-affective cluster of depressive symptoms, such as persistent depressed mood or excessive/inappropriate guilt, was positively associated with increased suicidality among PTSD-diagnosed participants.

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Major Findings: Suicidality and PTSD numbing symptoms were independently associated.

Data Source: Psychiatric diagnoses and suicidality were assessed in 393 military veterans formerly deployed to a region of conflict.

Disclosures: None reported.

ATLANTA — Assessment of suicidality might be warranted when treating recent combat veterans with posttraumatic stress disorder, according to a study.

PTSD, major depressive disorder (MDD), and a history of one or more suicide attempts each independently predicted increased risk of suicidality among 393 veterans of Operation Enduring Freedom or Operation Iraqi Freedom after their return to the United States.

Of note, PTSD predicted increased risk for suicidality even in the absence of well-known psychiatric comorbidity risk factors, Vito S. Guerra, Ph.D., said at the annual meeting of the International Society for Trauma Stress Studies.

“For someone with PTSD, even without alcohol use disorder or major depressive disorder, [there are] data that they are at risk for self-harm,” Dr. Guerra said in an interview at his poster.

Previous research showed a significantly increased risk for suicidality among veterans of the Vietnam War with PTSD (Mil. Med. 2007;172:1144-7). To assess the risks in more recent combat veterans, Dr. Guerra and his colleagues studied 322 men and 71 women deployed to Afghanistan or Iraq. Mean age of participants was 38 years.

Psychiatric diagnoses and suicidality were assessed using the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I); the Beck Depression Inventory–Second Edition; the Davidson Trauma Scale; the Combat Exposure Scale; and the Beck Scale for Suicide Ideation (BSS)/Scale for Suicide Ideation–Adapted (SSI-A).

A total of 143 (36%) veterans met SCID-I criteria for PTSD. The emotional numbing cluster of PTSD symptoms, measured on the Davidson Trauma Scale, was independently associated with suicidality within this subgroup (adjusted odds ratio 3.8).

Suicidality was defined as a combined score of three or more on the BSS and SSI-A measures, said Dr. Guerra, a postdoctoral psychology fellow at the VA Mid-Atlantic Mental Illness Research, Education and Clinical Center in Durham, N.C.

Major depression and alcohol use disorder (AUD) were less common than PTSD: 88 (22%) of veterans met MDD criteria and 17 (4%) met AUD criteria.

The researchers also looked at comorbidity: 66 (17%) participants met criteria for both PTSD and MDD and 11 (3%) veterans were comorbid with PTSD and AUD. However, presence of either comorbidity did not significantly elevate the risk for suicidality, compared with PTSD alone, Dr. Guerra said.

In contrast, there are data suggesting that people dually diagnosed with PTSD and MDD might be at greater risk of engaging in suicidal acts than persons diagnosed with MDD only, Dr. Guerra said (Am. J. Psychiatry 2005;162:560-6; Am. J. Psychiatry 2001;158:1467-73).

The cognitive-affective cluster of depressive symptoms, such as persistent depressed mood or excessive/inappropriate guilt, was positively associated with increased suicidality among PTSD-diagnosed participants.

Major Findings: Suicidality and PTSD numbing symptoms were independently associated.

Data Source: Psychiatric diagnoses and suicidality were assessed in 393 military veterans formerly deployed to a region of conflict.

Disclosures: None reported.

ATLANTA — Assessment of suicidality might be warranted when treating recent combat veterans with posttraumatic stress disorder, according to a study.

PTSD, major depressive disorder (MDD), and a history of one or more suicide attempts each independently predicted increased risk of suicidality among 393 veterans of Operation Enduring Freedom or Operation Iraqi Freedom after their return to the United States.

Of note, PTSD predicted increased risk for suicidality even in the absence of well-known psychiatric comorbidity risk factors, Vito S. Guerra, Ph.D., said at the annual meeting of the International Society for Trauma Stress Studies.

“For someone with PTSD, even without alcohol use disorder or major depressive disorder, [there are] data that they are at risk for self-harm,” Dr. Guerra said in an interview at his poster.

Previous research showed a significantly increased risk for suicidality among veterans of the Vietnam War with PTSD (Mil. Med. 2007;172:1144-7). To assess the risks in more recent combat veterans, Dr. Guerra and his colleagues studied 322 men and 71 women deployed to Afghanistan or Iraq. Mean age of participants was 38 years.

Psychiatric diagnoses and suicidality were assessed using the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I); the Beck Depression Inventory–Second Edition; the Davidson Trauma Scale; the Combat Exposure Scale; and the Beck Scale for Suicide Ideation (BSS)/Scale for Suicide Ideation–Adapted (SSI-A).

A total of 143 (36%) veterans met SCID-I criteria for PTSD. The emotional numbing cluster of PTSD symptoms, measured on the Davidson Trauma Scale, was independently associated with suicidality within this subgroup (adjusted odds ratio 3.8).

Suicidality was defined as a combined score of three or more on the BSS and SSI-A measures, said Dr. Guerra, a postdoctoral psychology fellow at the VA Mid-Atlantic Mental Illness Research, Education and Clinical Center in Durham, N.C.

Major depression and alcohol use disorder (AUD) were less common than PTSD: 88 (22%) of veterans met MDD criteria and 17 (4%) met AUD criteria.

The researchers also looked at comorbidity: 66 (17%) participants met criteria for both PTSD and MDD and 11 (3%) veterans were comorbid with PTSD and AUD. However, presence of either comorbidity did not significantly elevate the risk for suicidality, compared with PTSD alone, Dr. Guerra said.

In contrast, there are data suggesting that people dually diagnosed with PTSD and MDD might be at greater risk of engaging in suicidal acts than persons diagnosed with MDD only, Dr. Guerra said (Am. J. Psychiatry 2005;162:560-6; Am. J. Psychiatry 2001;158:1467-73).

The cognitive-affective cluster of depressive symptoms, such as persistent depressed mood or excessive/inappropriate guilt, was positively associated with increased suicidality among PTSD-diagnosed participants.

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