Heidi Splete

Adults with less-severe psychological distress contributed to most of the recent increase in outpatient mental health services, based on survey data from nearly 140,000 adults.

“Rising national rates of suicide, opioid misuse, and opioid-related deaths further suggest increasing psychological distress,” wrote Mark Olfson, MD, MPH, of Columbia University, New York, and his colleagues. “However, it is not known whether or to what extent an increase in mental health treatment has occurred in response to rising rates of psychological distress.”

Dr. Olfson and his colleagues reviewed data from the Medical Expenditure Panel Surveys for the years 2004-2005, 2009-2010, and 2014-2015. Overall, 19% of adults received outpatient mental health services in 2004-2005; the percentage increased to 23% in 2014-2015. About half of the study subjects were women, 67% were white, and the average age was 46 years.

The total percentage of adults with serious psychological distress decreased from 5% in 2004-2005 to 4% in 2014-2015, the researchers noted, although those with serious psychological distress had a greater proportionate increase in the use of outpatient services during the study period, from 54% to 68%.

Serious psychological distress was more likely in women, compared with men, and in older and middle-aged adults, compared with younger adults. The number of adults with less-serious distress or no distress who were treated with outpatient mental health services increased from 35 million in 2004-2005 to 48 million in 2014-2015, the researchers wrote in JAMA Psychiatry.

The study results were limited by several factors, including the partial reliance on self-reports of mental health care use and on the limitations of the Kessler 6 scale as an assessment of psychological distress. Other limitations included an absence of data on the specific services used and on the effectiveness of treatments. However, the results suggest that, despite increases in outpatient mental health treatment, many adults with serious psychological distress received no mental health care, they wrote. Individuals with more-severe distress might view mental health care less favorably. In addition, the investigators emphasized the need for continued improvement in general medical settings for detecting and treating or referring adults for mental health service.

Dr. Olfson reported no disclosures. One of the coauthors, Steven C. Marcus, PhD, reported receiving consulting fees from several pharmaceutical companies. The study was supported in part by the National Institutes of Health and the New York State Psychiatric Institute. The Medical Expenditure Panel Surveys are sponsored by the Agency for Healthcare Research and Quality.

SOURCE: Olfson M et al. JAMA Psychiatry. 2018 Nov 28. doi: 10.1001/jamapsychiatry.2018.3550.

Adults with less-severe psychological distress contributed to most of the recent increase in outpatient mental health services, based on survey data from nearly 140,000 adults.

“Rising national rates of suicide, opioid misuse, and opioid-related deaths further suggest increasing psychological distress,” wrote Mark Olfson, MD, MPH, of Columbia University, New York, and his colleagues. “However, it is not known whether or to what extent an increase in mental health treatment has occurred in response to rising rates of psychological distress.”

Dr. Olfson and his colleagues reviewed data from the Medical Expenditure Panel Surveys for the years 2004-2005, 2009-2010, and 2014-2015. Overall, 19% of adults received outpatient mental health services in 2004-2005; the percentage increased to 23% in 2014-2015. About half of the study subjects were women, 67% were white, and the average age was 46 years.

The total percentage of adults with serious psychological distress decreased from 5% in 2004-2005 to 4% in 2014-2015, the researchers noted, although those with serious psychological distress had a greater proportionate increase in the use of outpatient services during the study period, from 54% to 68%.

Serious psychological distress was more likely in women, compared with men, and in older and middle-aged adults, compared with younger adults. The number of adults with less-serious distress or no distress who were treated with outpatient mental health services increased from 35 million in 2004-2005 to 48 million in 2014-2015, the researchers wrote in JAMA Psychiatry.

The study results were limited by several factors, including the partial reliance on self-reports of mental health care use and on the limitations of the Kessler 6 scale as an assessment of psychological distress. Other limitations included an absence of data on the specific services used and on the effectiveness of treatments. However, the results suggest that, despite increases in outpatient mental health treatment, many adults with serious psychological distress received no mental health care, they wrote. Individuals with more-severe distress might view mental health care less favorably. In addition, the investigators emphasized the need for continued improvement in general medical settings for detecting and treating or referring adults for mental health service.

Dr. Olfson reported no disclosures. One of the coauthors, Steven C. Marcus, PhD, reported receiving consulting fees from several pharmaceutical companies. The study was supported in part by the National Institutes of Health and the New York State Psychiatric Institute. The Medical Expenditure Panel Surveys are sponsored by the Agency for Healthcare Research and Quality.

SOURCE: Olfson M et al. JAMA Psychiatry. 2018 Nov 28. doi: 10.1001/jamapsychiatry.2018.3550.

Adults with less-severe psychological distress contributed to most of the recent increase in outpatient mental health services, based on survey data from nearly 140,000 adults.

“Rising national rates of suicide, opioid misuse, and opioid-related deaths further suggest increasing psychological distress,” wrote Mark Olfson, MD, MPH, of Columbia University, New York, and his colleagues. “However, it is not known whether or to what extent an increase in mental health treatment has occurred in response to rising rates of psychological distress.”

Dr. Olfson and his colleagues reviewed data from the Medical Expenditure Panel Surveys for the years 2004-2005, 2009-2010, and 2014-2015. Overall, 19% of adults received outpatient mental health services in 2004-2005; the percentage increased to 23% in 2014-2015. About half of the study subjects were women, 67% were white, and the average age was 46 years.

The total percentage of adults with serious psychological distress decreased from 5% in 2004-2005 to 4% in 2014-2015, the researchers noted, although those with serious psychological distress had a greater proportionate increase in the use of outpatient services during the study period, from 54% to 68%.

Serious psychological distress was more likely in women, compared with men, and in older and middle-aged adults, compared with younger adults. The number of adults with less-serious distress or no distress who were treated with outpatient mental health services increased from 35 million in 2004-2005 to 48 million in 2014-2015, the researchers wrote in JAMA Psychiatry.

The study results were limited by several factors, including the partial reliance on self-reports of mental health care use and on the limitations of the Kessler 6 scale as an assessment of psychological distress. Other limitations included an absence of data on the specific services used and on the effectiveness of treatments. However, the results suggest that, despite increases in outpatient mental health treatment, many adults with serious psychological distress received no mental health care, they wrote. Individuals with more-severe distress might view mental health care less favorably. In addition, the investigators emphasized the need for continued improvement in general medical settings for detecting and treating or referring adults for mental health service.

Dr. Olfson reported no disclosures. One of the coauthors, Steven C. Marcus, PhD, reported receiving consulting fees from several pharmaceutical companies. The study was supported in part by the National Institutes of Health and the New York State Psychiatric Institute. The Medical Expenditure Panel Surveys are sponsored by the Agency for Healthcare Research and Quality.

SOURCE: Olfson M et al. JAMA Psychiatry. 2018 Nov 28. doi: 10.1001/jamapsychiatry.2018.3550.

Individuals aged 15-65 years, including pregnant women, should be screened for HIV infection, and those at risk should be given prophylaxis, according to draft recommendations issued by the U.S. Preventive Services Task Force. The screening recommendation extends to younger adolescents and older adults at increased risk for HIV infection. The recommendations are level A.

varnent/Wikimedia Commons/CC BY-SA 3.0

HIV remains a significant public health issue in the United States, with rates rising among individuals aged 25-29 years, although the overall number of cases has dropped slightly, according to the USPSTF report.

HIV prevention is a multistep process that includes not only screening but also wearing condoms during sex and using clean needles and syringes if injecting drugs, the researchers noted.

However, those at high risk for HIV, such as intravenous drug users, can help reduce their risk by taking a daily pill, the researchers wrote.

In an evidence report submitted to the Agency for Healthcare Research and Quality, researchers reviewed the Cochrane databases, MEDLINE, and Embase for studies up to June 2018. Based on data from 11 trials, pre-exposure prophylaxis (PrEP) consisting of antiretroviral therapy was associated with decreased risk of HIV infection, compared with placebo or no PrEP, with consistent effects across risk categories, the investigators noted.

The most common HIV risk factors include man-to-man sexual contact, injection drug use, having sex without a condom, exchanging sex for drugs or money, and having sex with an HIV-infected partner, according to the USPSTF report.

Although PrEP was associated with renal and gastrointestinal adverse effects, most were mild and resolved when the therapy either ended or continued long term. The use of PrEP does not absolve high-risk individuals from observing safety in sex activity and intravenous drug use, the researchers noted.

The Task Force’s draft recommendation statements and draft evidence reviews are available for public comment and are posted on the Task Force website at www.uspreventiveservicestaskforce.org. Comments can be submitted from Nov. 20, 2018, to Dec. 26, 2018, at www.uspreventiveservicestaskforce.org/tfcomment.htm.

Individuals aged 15-65 years, including pregnant women, should be screened for HIV infection, and those at risk should be given prophylaxis, according to draft recommendations issued by the U.S. Preventive Services Task Force. The screening recommendation extends to younger adolescents and older adults at increased risk for HIV infection. The recommendations are level A.

varnent/Wikimedia Commons/CC BY-SA 3.0

HIV remains a significant public health issue in the United States, with rates rising among individuals aged 25-29 years, although the overall number of cases has dropped slightly, according to the USPSTF report.

HIV prevention is a multistep process that includes not only screening but also wearing condoms during sex and using clean needles and syringes if injecting drugs, the researchers noted.

However, those at high risk for HIV, such as intravenous drug users, can help reduce their risk by taking a daily pill, the researchers wrote.

In an evidence report submitted to the Agency for Healthcare Research and Quality, researchers reviewed the Cochrane databases, MEDLINE, and Embase for studies up to June 2018. Based on data from 11 trials, pre-exposure prophylaxis (PrEP) consisting of antiretroviral therapy was associated with decreased risk of HIV infection, compared with placebo or no PrEP, with consistent effects across risk categories, the investigators noted.

The most common HIV risk factors include man-to-man sexual contact, injection drug use, having sex without a condom, exchanging sex for drugs or money, and having sex with an HIV-infected partner, according to the USPSTF report.

Although PrEP was associated with renal and gastrointestinal adverse effects, most were mild and resolved when the therapy either ended or continued long term. The use of PrEP does not absolve high-risk individuals from observing safety in sex activity and intravenous drug use, the researchers noted.

The Task Force’s draft recommendation statements and draft evidence reviews are available for public comment and are posted on the Task Force website at www.uspreventiveservicestaskforce.org. Comments can be submitted from Nov. 20, 2018, to Dec. 26, 2018, at www.uspreventiveservicestaskforce.org/tfcomment.htm.

Individuals aged 15-65 years, including pregnant women, should be screened for HIV infection, and those at risk should be given prophylaxis, according to draft recommendations issued by the U.S. Preventive Services Task Force. The screening recommendation extends to younger adolescents and older adults at increased risk for HIV infection. The recommendations are level A.

varnent/Wikimedia Commons/CC BY-SA 3.0

HIV remains a significant public health issue in the United States, with rates rising among individuals aged 25-29 years, although the overall number of cases has dropped slightly, according to the USPSTF report.

HIV prevention is a multistep process that includes not only screening but also wearing condoms during sex and using clean needles and syringes if injecting drugs, the researchers noted.

However, those at high risk for HIV, such as intravenous drug users, can help reduce their risk by taking a daily pill, the researchers wrote.

In an evidence report submitted to the Agency for Healthcare Research and Quality, researchers reviewed the Cochrane databases, MEDLINE, and Embase for studies up to June 2018. Based on data from 11 trials, pre-exposure prophylaxis (PrEP) consisting of antiretroviral therapy was associated with decreased risk of HIV infection, compared with placebo or no PrEP, with consistent effects across risk categories, the investigators noted.

The most common HIV risk factors include man-to-man sexual contact, injection drug use, having sex without a condom, exchanging sex for drugs or money, and having sex with an HIV-infected partner, according to the USPSTF report.

Although PrEP was associated with renal and gastrointestinal adverse effects, most were mild and resolved when the therapy either ended or continued long term. The use of PrEP does not absolve high-risk individuals from observing safety in sex activity and intravenous drug use, the researchers noted.

The Task Force’s draft recommendation statements and draft evidence reviews are available for public comment and are posted on the Task Force website at www.uspreventiveservicestaskforce.org. Comments can be submitted from Nov. 20, 2018, to Dec. 26, 2018, at www.uspreventiveservicestaskforce.org/tfcomment.htm.

Early-onset sepsis requires different management strategies in preterm and term neonates, according to a pair of clinical reports published in Pediatrics.

herjua/Thinkstock

Early-onset sepsis usually begins during labor in term infants, but in preterm infants, “the pathogenesis of preterm EOS likely begins before the onset of labor in many cases of preterm labor and/or PROM [premature rupture of membranes],” wrote Karen M. Puopolo, MD, of the University of Pennsylvania, Philadelphia, and her colleagues.

In the report on preterm infants, the researchers noted that EOS risk assessment using gestational age can be useful for term infants, but not for preterm infants. Instead, they advised categorizing preterm infants as low risk based on birth circumstances. Low-risk preterm infants were defined as those born by cesarean delivery because of maternal noninfectious illness or placental insufficiency in the absence of labor, attempts to induce labor, or rupture of membranes before delivery. Consider the risk/benefit balance of performing an EOS laboratory evaluation and empirical antibiotics, depending on the neonate’s clinical condition, the researchers said.

Preterm infants at high risk for EOS are those born preterm because of maternal cervical incompetence, preterm labor, premature rupture of membranes, clinical concerns for intra-amniotic infection, or acute onset of “unexplained nonreassuring fetal status,” Dr. Puopolo and her associates said. These infants should be managed with a blood culture and empirical antibiotics.

“The combination of ampicillin and gentamicin is the most appropriate empirical antibiotic regimen for infants at risk for EOS,” they noted. “Empirical administration of additional broad-spectrum antibiotics may be indicated in preterm infants who are severely ill and at a high risk for EOS, particularly after prolonged antepartum maternal antibiotic treatment,” they said. Antibiotics should be discontinued by 36-48 hours of incubation unless the infant shows signs of site-specific infection.

In the second report, again with Dr. Puopolo as the primary author, management of EOS was addressed for full-term infants, defined as those born at 35 weeks’ gestation or later.

Infants born at 35 weeks’ gestation or later can be stratified for EOS risk based on algorithms for intrapartum risk factors as well as risk assessments based on these risk factors and infant examinations, the researchers said.

There are a variety of acceptable approaches to risk stratification: categorical algorithms with threshold values for intrapartum risk factors; multivariate risk assessment based on both intrapartum risk factors (such as maternal chorioamnionitis, group B streptococcus colonization, adequacy of intrapartum antibiotic prophylaxis, and duration of ROM); and serial infant examination to detect clinical signs of illness after birth, Dr. Puopolo and her associates wrote.

They recommended that birth centers choose which type of EOS risk assessment to use and tailor it to their own situation. Once local guidelines are developed, ongoing surveillance is suggested.

The same recommendations apply to term infants as preterm infants regarding first-choice use of ampicillin and gentamicin when necessary, to be discontinued when blood cultures are sterile at 36-48 hours of incubation in the absence of site-specific infection, they said.

The reports do “not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate,” Dr. Puopolo and her associates noted.

The researchers had no financial conflicts to disclose, and there was no external funding.

SOURCE: Puopolo KM et al. Pediatrics. 2018 Nov. doi: 10.1542/peds.2018-2896; Puopolo KM et al. Pediatrics. 2018 Nov. doi: 10.1542/peds.2018-2894.

Early-onset sepsis requires different management strategies in preterm and term neonates, according to a pair of clinical reports published in Pediatrics.

herjua/Thinkstock

Early-onset sepsis usually begins during labor in term infants, but in preterm infants, “the pathogenesis of preterm EOS likely begins before the onset of labor in many cases of preterm labor and/or PROM [premature rupture of membranes],” wrote Karen M. Puopolo, MD, of the University of Pennsylvania, Philadelphia, and her colleagues.

In the report on preterm infants, the researchers noted that EOS risk assessment using gestational age can be useful for term infants, but not for preterm infants. Instead, they advised categorizing preterm infants as low risk based on birth circumstances. Low-risk preterm infants were defined as those born by cesarean delivery because of maternal noninfectious illness or placental insufficiency in the absence of labor, attempts to induce labor, or rupture of membranes before delivery. Consider the risk/benefit balance of performing an EOS laboratory evaluation and empirical antibiotics, depending on the neonate’s clinical condition, the researchers said.

Preterm infants at high risk for EOS are those born preterm because of maternal cervical incompetence, preterm labor, premature rupture of membranes, clinical concerns for intra-amniotic infection, or acute onset of “unexplained nonreassuring fetal status,” Dr. Puopolo and her associates said. These infants should be managed with a blood culture and empirical antibiotics.

“The combination of ampicillin and gentamicin is the most appropriate empirical antibiotic regimen for infants at risk for EOS,” they noted. “Empirical administration of additional broad-spectrum antibiotics may be indicated in preterm infants who are severely ill and at a high risk for EOS, particularly after prolonged antepartum maternal antibiotic treatment,” they said. Antibiotics should be discontinued by 36-48 hours of incubation unless the infant shows signs of site-specific infection.

In the second report, again with Dr. Puopolo as the primary author, management of EOS was addressed for full-term infants, defined as those born at 35 weeks’ gestation or later.

Infants born at 35 weeks’ gestation or later can be stratified for EOS risk based on algorithms for intrapartum risk factors as well as risk assessments based on these risk factors and infant examinations, the researchers said.

There are a variety of acceptable approaches to risk stratification: categorical algorithms with threshold values for intrapartum risk factors; multivariate risk assessment based on both intrapartum risk factors (such as maternal chorioamnionitis, group B streptococcus colonization, adequacy of intrapartum antibiotic prophylaxis, and duration of ROM); and serial infant examination to detect clinical signs of illness after birth, Dr. Puopolo and her associates wrote.

They recommended that birth centers choose which type of EOS risk assessment to use and tailor it to their own situation. Once local guidelines are developed, ongoing surveillance is suggested.

The same recommendations apply to term infants as preterm infants regarding first-choice use of ampicillin and gentamicin when necessary, to be discontinued when blood cultures are sterile at 36-48 hours of incubation in the absence of site-specific infection, they said.

The reports do “not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate,” Dr. Puopolo and her associates noted.

The researchers had no financial conflicts to disclose, and there was no external funding.

SOURCE: Puopolo KM et al. Pediatrics. 2018 Nov. doi: 10.1542/peds.2018-2896; Puopolo KM et al. Pediatrics. 2018 Nov. doi: 10.1542/peds.2018-2894.

Early-onset sepsis requires different management strategies in preterm and term neonates, according to a pair of clinical reports published in Pediatrics.

herjua/Thinkstock

Early-onset sepsis usually begins during labor in term infants, but in preterm infants, “the pathogenesis of preterm EOS likely begins before the onset of labor in many cases of preterm labor and/or PROM [premature rupture of membranes],” wrote Karen M. Puopolo, MD, of the University of Pennsylvania, Philadelphia, and her colleagues.

In the report on preterm infants, the researchers noted that EOS risk assessment using gestational age can be useful for term infants, but not for preterm infants. Instead, they advised categorizing preterm infants as low risk based on birth circumstances. Low-risk preterm infants were defined as those born by cesarean delivery because of maternal noninfectious illness or placental insufficiency in the absence of labor, attempts to induce labor, or rupture of membranes before delivery. Consider the risk/benefit balance of performing an EOS laboratory evaluation and empirical antibiotics, depending on the neonate’s clinical condition, the researchers said.

Preterm infants at high risk for EOS are those born preterm because of maternal cervical incompetence, preterm labor, premature rupture of membranes, clinical concerns for intra-amniotic infection, or acute onset of “unexplained nonreassuring fetal status,” Dr. Puopolo and her associates said. These infants should be managed with a blood culture and empirical antibiotics.

“The combination of ampicillin and gentamicin is the most appropriate empirical antibiotic regimen for infants at risk for EOS,” they noted. “Empirical administration of additional broad-spectrum antibiotics may be indicated in preterm infants who are severely ill and at a high risk for EOS, particularly after prolonged antepartum maternal antibiotic treatment,” they said. Antibiotics should be discontinued by 36-48 hours of incubation unless the infant shows signs of site-specific infection.

In the second report, again with Dr. Puopolo as the primary author, management of EOS was addressed for full-term infants, defined as those born at 35 weeks’ gestation or later.

Infants born at 35 weeks’ gestation or later can be stratified for EOS risk based on algorithms for intrapartum risk factors as well as risk assessments based on these risk factors and infant examinations, the researchers said.

There are a variety of acceptable approaches to risk stratification: categorical algorithms with threshold values for intrapartum risk factors; multivariate risk assessment based on both intrapartum risk factors (such as maternal chorioamnionitis, group B streptococcus colonization, adequacy of intrapartum antibiotic prophylaxis, and duration of ROM); and serial infant examination to detect clinical signs of illness after birth, Dr. Puopolo and her associates wrote.

They recommended that birth centers choose which type of EOS risk assessment to use and tailor it to their own situation. Once local guidelines are developed, ongoing surveillance is suggested.

The same recommendations apply to term infants as preterm infants regarding first-choice use of ampicillin and gentamicin when necessary, to be discontinued when blood cultures are sterile at 36-48 hours of incubation in the absence of site-specific infection, they said.

The reports do “not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate,” Dr. Puopolo and her associates noted.

The researchers had no financial conflicts to disclose, and there was no external funding.

SOURCE: Puopolo KM et al. Pediatrics. 2018 Nov. doi: 10.1542/peds.2018-2896; Puopolo KM et al. Pediatrics. 2018 Nov. doi: 10.1542/peds.2018-2894.

Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

Children and adolescents who suffer sports-related concussion should engage in light activities for their minds and bodies, while being monitored and evaluated, according to a new clinical report from the American Academy of Pediatrics.

The update to the 2010 guidelines was needed to reflect the latest research “and it was necessary to provide this new information to guide pediatricians in evaluating and treating concussions they may see in their practice,” Mark Halstead, MD, of Washington University, St. Louis, said in an interview.

The biggest changes to the guidelines involve management of concussion, noted Dr. Halstead, who was a coauthor of the AAP clinical report. “The previous recommendation called for cognitive and physical rest, which unfortunately was interpreted as complete removal from all physical activity and limiting many other things including electronic use.

“Because of research that has been conducted since the original report, it has been shown that starting some light physical activity to increase heart rate, provided it does not worsen symptoms, can be beneficial in recovery. Also, the recommendation for complete removal of electronics and computer use has unfortunately created some issues with kids getting socially isolated,” he added.

James Boulette/iStockphoto

“For better or for worse, kids are connected through their electronic devices. Removing them, with no evidence that it worsens the concussion, essentially punishes kids for their injury. We also are trying to discourage prolonged removal of kids from school,” Dr. Halstead emphasized.

The new recommendations emphasize the unique nature of sports-related concussion (SRC) from one individual to another, and the need for individualized management.

Symptoms of SRC fall into five categories, according to the guidelines: somatic, vestibular, oculomotor, cognitive, and emotional/sleep. Pediatric health care providers should rule out more severe head injuries and recognize that concussion symptoms are nonspecific and may reflect preexisting conditions, such as migraine or headache disorders, learning disorders, ADHD, mental health conditions, or sleep disorders.

Use of assessments such as the Sport Concussion Management Tool (SCAT5 for 13 years and older or Child SCAT5 for 5-12 years) can help guide clinicians, but should not be used in isolation to diagnose a concussion, the guideline authors wrote.

Strategies for injury prevention are included in the guidelines as well, such as the use of appropriate headgear. As for management, computerized neurocognitive testing can play a role in decisions regarding return to play, but should not be used in isolation.

“The biggest thing we are lacking is an objective diagnostic test to determine the presence of a concussion or its resolution,” coauthor Kody A. Moffatt, MD, of Creighton University, Omaha, Nebraska, said in an interview.

“Mandatory baseline and postinjury computerized neurocognitive testing is not recommended,” he added.

Clinicians can best manage SRC with prompt recognition and diagnosis using the available tools, followed by relative rest and return to school, then noncontact physical activities, and eventually a return to sport if appropriate.

“Most concussions in children and adolescents will resolve within 4 weeks as long as there is not additional injury to the brain during that time,” Dr. Moffat said.

More research is needed in particular about concussions in elementary and middle school children, Dr. Halstead added.

In the meantime, the take-home message to pediatricians for managing SRC is one of common sense. “Extremes of removing all stimulus from a child is not likely to get them better sooner and research suggests may take them longer to get better,” Dr. Halstead noted. “That doesn’t mean they don’t have to reduce anything, as it is important to reduce physical activity and modify school workload while recovering but we should be avoiding the blanket recommendation to ‘stay home and do nothing until you are better’ approach to concussion management.”

Dr. Halstead and Dr. Moffatt reported no relevant financial conflicts to disclose; the same was true for the other report coauthors. There was no external funding for the report.

SOURCE: Halstead M et al. Pediatrics. 2018 Nov 12. doi: 10.1542/peds.2018-3074.

Children and adolescents who suffer sports-related concussion should engage in light activities for their minds and bodies, while being monitored and evaluated, according to a new clinical report from the American Academy of Pediatrics.

The update to the 2010 guidelines was needed to reflect the latest research “and it was necessary to provide this new information to guide pediatricians in evaluating and treating concussions they may see in their practice,” Mark Halstead, MD, of Washington University, St. Louis, said in an interview.

The biggest changes to the guidelines involve management of concussion, noted Dr. Halstead, who was a coauthor of the AAP clinical report. “The previous recommendation called for cognitive and physical rest, which unfortunately was interpreted as complete removal from all physical activity and limiting many other things including electronic use.

“Because of research that has been conducted since the original report, it has been shown that starting some light physical activity to increase heart rate, provided it does not worsen symptoms, can be beneficial in recovery. Also, the recommendation for complete removal of electronics and computer use has unfortunately created some issues with kids getting socially isolated,” he added.

James Boulette/iStockphoto

“For better or for worse, kids are connected through their electronic devices. Removing them, with no evidence that it worsens the concussion, essentially punishes kids for their injury. We also are trying to discourage prolonged removal of kids from school,” Dr. Halstead emphasized.

The new recommendations emphasize the unique nature of sports-related concussion (SRC) from one individual to another, and the need for individualized management.

Symptoms of SRC fall into five categories, according to the guidelines: somatic, vestibular, oculomotor, cognitive, and emotional/sleep. Pediatric health care providers should rule out more severe head injuries and recognize that concussion symptoms are nonspecific and may reflect preexisting conditions, such as migraine or headache disorders, learning disorders, ADHD, mental health conditions, or sleep disorders.

Use of assessments such as the Sport Concussion Management Tool (SCAT5 for 13 years and older or Child SCAT5 for 5-12 years) can help guide clinicians, but should not be used in isolation to diagnose a concussion, the guideline authors wrote.

Strategies for injury prevention are included in the guidelines as well, such as the use of appropriate headgear. As for management, computerized neurocognitive testing can play a role in decisions regarding return to play, but should not be used in isolation.

“The biggest thing we are lacking is an objective diagnostic test to determine the presence of a concussion or its resolution,” coauthor Kody A. Moffatt, MD, of Creighton University, Omaha, Nebraska, said in an interview.

“Mandatory baseline and postinjury computerized neurocognitive testing is not recommended,” he added.

Clinicians can best manage SRC with prompt recognition and diagnosis using the available tools, followed by relative rest and return to school, then noncontact physical activities, and eventually a return to sport if appropriate.

“Most concussions in children and adolescents will resolve within 4 weeks as long as there is not additional injury to the brain during that time,” Dr. Moffat said.

More research is needed in particular about concussions in elementary and middle school children, Dr. Halstead added.

In the meantime, the take-home message to pediatricians for managing SRC is one of common sense. “Extremes of removing all stimulus from a child is not likely to get them better sooner and research suggests may take them longer to get better,” Dr. Halstead noted. “That doesn’t mean they don’t have to reduce anything, as it is important to reduce physical activity and modify school workload while recovering but we should be avoiding the blanket recommendation to ‘stay home and do nothing until you are better’ approach to concussion management.”

Dr. Halstead and Dr. Moffatt reported no relevant financial conflicts to disclose; the same was true for the other report coauthors. There was no external funding for the report.

SOURCE: Halstead M et al. Pediatrics. 2018 Nov 12. doi: 10.1542/peds.2018-3074.

Children and adolescents who suffer sports-related concussion should engage in light activities for their minds and bodies, while being monitored and evaluated, according to a new clinical report from the American Academy of Pediatrics.

The update to the 2010 guidelines was needed to reflect the latest research “and it was necessary to provide this new information to guide pediatricians in evaluating and treating concussions they may see in their practice,” Mark Halstead, MD, of Washington University, St. Louis, said in an interview.

The biggest changes to the guidelines involve management of concussion, noted Dr. Halstead, who was a coauthor of the AAP clinical report. “The previous recommendation called for cognitive and physical rest, which unfortunately was interpreted as complete removal from all physical activity and limiting many other things including electronic use.

“Because of research that has been conducted since the original report, it has been shown that starting some light physical activity to increase heart rate, provided it does not worsen symptoms, can be beneficial in recovery. Also, the recommendation for complete removal of electronics and computer use has unfortunately created some issues with kids getting socially isolated,” he added.

James Boulette/iStockphoto

“For better or for worse, kids are connected through their electronic devices. Removing them, with no evidence that it worsens the concussion, essentially punishes kids for their injury. We also are trying to discourage prolonged removal of kids from school,” Dr. Halstead emphasized.

The new recommendations emphasize the unique nature of sports-related concussion (SRC) from one individual to another, and the need for individualized management.

Symptoms of SRC fall into five categories, according to the guidelines: somatic, vestibular, oculomotor, cognitive, and emotional/sleep. Pediatric health care providers should rule out more severe head injuries and recognize that concussion symptoms are nonspecific and may reflect preexisting conditions, such as migraine or headache disorders, learning disorders, ADHD, mental health conditions, or sleep disorders.

Use of assessments such as the Sport Concussion Management Tool (SCAT5 for 13 years and older or Child SCAT5 for 5-12 years) can help guide clinicians, but should not be used in isolation to diagnose a concussion, the guideline authors wrote.

Strategies for injury prevention are included in the guidelines as well, such as the use of appropriate headgear. As for management, computerized neurocognitive testing can play a role in decisions regarding return to play, but should not be used in isolation.

“The biggest thing we are lacking is an objective diagnostic test to determine the presence of a concussion or its resolution,” coauthor Kody A. Moffatt, MD, of Creighton University, Omaha, Nebraska, said in an interview.

“Mandatory baseline and postinjury computerized neurocognitive testing is not recommended,” he added.

Clinicians can best manage SRC with prompt recognition and diagnosis using the available tools, followed by relative rest and return to school, then noncontact physical activities, and eventually a return to sport if appropriate.

“Most concussions in children and adolescents will resolve within 4 weeks as long as there is not additional injury to the brain during that time,” Dr. Moffat said.

More research is needed in particular about concussions in elementary and middle school children, Dr. Halstead added.

In the meantime, the take-home message to pediatricians for managing SRC is one of common sense. “Extremes of removing all stimulus from a child is not likely to get them better sooner and research suggests may take them longer to get better,” Dr. Halstead noted. “That doesn’t mean they don’t have to reduce anything, as it is important to reduce physical activity and modify school workload while recovering but we should be avoiding the blanket recommendation to ‘stay home and do nothing until you are better’ approach to concussion management.”

Dr. Halstead and Dr. Moffatt reported no relevant financial conflicts to disclose; the same was true for the other report coauthors. There was no external funding for the report.

SOURCE: Halstead M et al. Pediatrics. 2018 Nov 12. doi: 10.1542/peds.2018-3074.

All adults aged 18 years and older, including pregnant women, should be screened in primary care settings for unhealthy alcohol use and offered behavioral counseling if needed, according to recommendations from the U.S. Preventive Services Task Force.

Vonschonertagen/Thinkstock

Adults who meet the criteria for unhealthy alcohol use should be offered brief behavioral counseling interventions, the task force concluded with a B recommendation.

However, the task force also concluded that evidence is insufficient to recommend screening for alcohol use in adolescents aged 12-17 years in primary care settings (an I statement), wrote Susan J. Curry, PhD, of the University of Iowa, Iowa City, and colleagues. The recommendations were published in JAMA as an update of the USPSTF 2013 recommendation on screening for unhealthy alcohol use in primary care settings.

Approximately 88,000 deaths occurred each year in the United States between 2006 and 2010, the task force noted. Those deaths include death by acute causes, such as alcohol-related injuries, and chronic causes, such as alcoholic liver disease. In addition, alcohol use during pregnancy is a major preventable cause of birth defects and developmental disabilities, the task force wrote.

After reviewing the evidence, the USPSTF concluded that brief behavioral counseling offered moderate net benefits for adults 18 years and older, including pregnant women, who met criteria for unhealthy alcohol use.

Unhealthy alcohol used was defined as exceeding the National Institute on Alcohol Abuse and Alcoholism (NIAAA) recommended limits of 4 drinks per day, or 14 drinks per week, for men aged 21-64 years, and 3 drinks per day, or 7 drinks per week, for women aged 21-64 years.

In the evidence review accompanying the recommendations, Elizabeth A. O’Connor, PhD, of Kaiser Permanente in Portland, Ore., and colleagues analyzed data from 113 studies, including 314,466 individuals; 10 studies included adolescents.

In 68 studies including 36,528 individuals, brief counseling was associated with fewer drinks per week, fewer individuals exceeding recommended limits for alcohol consumption, fewer drinkers reporting a heavy drinking episode, and a greater proportion of pregnant women reporting alcohol abstinence after 6-12 months.

None of the studies assessed benefits or harms, but no evidence suggested that the interventions could be harmful.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.

SOURCES: Curry S et al. JAMA. 2018;320(18):1899-1909; O’Connor E et al. JAMA. 2018;320(18):1910-28.

All adults aged 18 years and older, including pregnant women, should be screened in primary care settings for unhealthy alcohol use and offered behavioral counseling if needed, according to recommendations from the U.S. Preventive Services Task Force.

Vonschonertagen/Thinkstock

Adults who meet the criteria for unhealthy alcohol use should be offered brief behavioral counseling interventions, the task force concluded with a B recommendation.

However, the task force also concluded that evidence is insufficient to recommend screening for alcohol use in adolescents aged 12-17 years in primary care settings (an I statement), wrote Susan J. Curry, PhD, of the University of Iowa, Iowa City, and colleagues. The recommendations were published in JAMA as an update of the USPSTF 2013 recommendation on screening for unhealthy alcohol use in primary care settings.

Approximately 88,000 deaths occurred each year in the United States between 2006 and 2010, the task force noted. Those deaths include death by acute causes, such as alcohol-related injuries, and chronic causes, such as alcoholic liver disease. In addition, alcohol use during pregnancy is a major preventable cause of birth defects and developmental disabilities, the task force wrote.

After reviewing the evidence, the USPSTF concluded that brief behavioral counseling offered moderate net benefits for adults 18 years and older, including pregnant women, who met criteria for unhealthy alcohol use.

Unhealthy alcohol used was defined as exceeding the National Institute on Alcohol Abuse and Alcoholism (NIAAA) recommended limits of 4 drinks per day, or 14 drinks per week, for men aged 21-64 years, and 3 drinks per day, or 7 drinks per week, for women aged 21-64 years.

In the evidence review accompanying the recommendations, Elizabeth A. O’Connor, PhD, of Kaiser Permanente in Portland, Ore., and colleagues analyzed data from 113 studies, including 314,466 individuals; 10 studies included adolescents.

In 68 studies including 36,528 individuals, brief counseling was associated with fewer drinks per week, fewer individuals exceeding recommended limits for alcohol consumption, fewer drinkers reporting a heavy drinking episode, and a greater proportion of pregnant women reporting alcohol abstinence after 6-12 months.

None of the studies assessed benefits or harms, but no evidence suggested that the interventions could be harmful.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.

SOURCES: Curry S et al. JAMA. 2018;320(18):1899-1909; O’Connor E et al. JAMA. 2018;320(18):1910-28.

All adults aged 18 years and older, including pregnant women, should be screened in primary care settings for unhealthy alcohol use and offered behavioral counseling if needed, according to recommendations from the U.S. Preventive Services Task Force.

Vonschonertagen/Thinkstock

Adults who meet the criteria for unhealthy alcohol use should be offered brief behavioral counseling interventions, the task force concluded with a B recommendation.

However, the task force also concluded that evidence is insufficient to recommend screening for alcohol use in adolescents aged 12-17 years in primary care settings (an I statement), wrote Susan J. Curry, PhD, of the University of Iowa, Iowa City, and colleagues. The recommendations were published in JAMA as an update of the USPSTF 2013 recommendation on screening for unhealthy alcohol use in primary care settings.

Approximately 88,000 deaths occurred each year in the United States between 2006 and 2010, the task force noted. Those deaths include death by acute causes, such as alcohol-related injuries, and chronic causes, such as alcoholic liver disease. In addition, alcohol use during pregnancy is a major preventable cause of birth defects and developmental disabilities, the task force wrote.

After reviewing the evidence, the USPSTF concluded that brief behavioral counseling offered moderate net benefits for adults 18 years and older, including pregnant women, who met criteria for unhealthy alcohol use.

Unhealthy alcohol used was defined as exceeding the National Institute on Alcohol Abuse and Alcoholism (NIAAA) recommended limits of 4 drinks per day, or 14 drinks per week, for men aged 21-64 years, and 3 drinks per day, or 7 drinks per week, for women aged 21-64 years.

In the evidence review accompanying the recommendations, Elizabeth A. O’Connor, PhD, of Kaiser Permanente in Portland, Ore., and colleagues analyzed data from 113 studies, including 314,466 individuals; 10 studies included adolescents.

In 68 studies including 36,528 individuals, brief counseling was associated with fewer drinks per week, fewer individuals exceeding recommended limits for alcohol consumption, fewer drinkers reporting a heavy drinking episode, and a greater proportion of pregnant women reporting alcohol abstinence after 6-12 months.

None of the studies assessed benefits or harms, but no evidence suggested that the interventions could be harmful.

The USPSTF is supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.

SOURCES: Curry S et al. JAMA. 2018;320(18):1899-1909; O’Connor E et al. JAMA. 2018;320(18):1910-28.

The Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) for dupilumab in patients aged 12-17 years with moderate to severe atopic dermatitis (AD) who have not been well controlled with topical therapies or who are unable to use topical therapies.

In a statement, dupilumab manufacturers Regeneron and Sanofi announced that the target action data for an FDA decision on dupilumab for adolescents is March 11, 2019. “Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate to severe atopic dermatitis,” the companies said in the statement.

The sBLA for dupilumab use in teens is based on data from a phase 3 study presented at the annual congress of European Academy of Dermatology and Venereology in September 2018. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo.

According to the companies, the most common adverse events included injection site reactions, oropharyngeal pain, and cold sores. Conjunctivitis has also been reported in some patients.

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, is currently approved for treating uncontrolled moderate to severe AD in adults and, more recently, as an add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid–dependent asthma.

The FDA granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications.

The Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) for dupilumab in patients aged 12-17 years with moderate to severe atopic dermatitis (AD) who have not been well controlled with topical therapies or who are unable to use topical therapies.

In a statement, dupilumab manufacturers Regeneron and Sanofi announced that the target action data for an FDA decision on dupilumab for adolescents is March 11, 2019. “Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate to severe atopic dermatitis,” the companies said in the statement.

The sBLA for dupilumab use in teens is based on data from a phase 3 study presented at the annual congress of European Academy of Dermatology and Venereology in September 2018. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo.

According to the companies, the most common adverse events included injection site reactions, oropharyngeal pain, and cold sores. Conjunctivitis has also been reported in some patients.

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, is currently approved for treating uncontrolled moderate to severe AD in adults and, more recently, as an add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid–dependent asthma.

The FDA granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications.

The Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) for dupilumab in patients aged 12-17 years with moderate to severe atopic dermatitis (AD) who have not been well controlled with topical therapies or who are unable to use topical therapies.

In a statement, dupilumab manufacturers Regeneron and Sanofi announced that the target action data for an FDA decision on dupilumab for adolescents is March 11, 2019. “Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate to severe atopic dermatitis,” the companies said in the statement.

The sBLA for dupilumab use in teens is based on data from a phase 3 study presented at the annual congress of European Academy of Dermatology and Venereology in September 2018. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo.

According to the companies, the most common adverse events included injection site reactions, oropharyngeal pain, and cold sores. Conjunctivitis has also been reported in some patients.

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, is currently approved for treating uncontrolled moderate to severe AD in adults and, more recently, as an add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid–dependent asthma.

The FDA granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

A joint panel of the Food and Drug Administration voted Nov. 2 in support of brexanolone infusion as a treatment for postpartum depression.

The 17-1 vote by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based primarily on data from three studies, including 247 women aged 18-44 years with postpartum depression; 140 received brexanolone and 107 received placebo. Effectiveness was assessed based on the Hamilton Depression Scale (HAM-D) at the end of the infusion (hour 60).

In all three studies, patients given brexanolone showed significantly improved HAM-D scores, compared with placebo. The patients experienced significant differences at hour 24, which illustrated the rapid response. “The individual item scores of the HAM-D consistently favored brexanolone IV over placebo, confirming an overall antidepressant effect of the drug,” according to the briefing document of Sage Therapeutics, developer of the drug. In addition, more than 80% of the patients in the treatment and placebo groups sustained their improvement in symptoms at 30 days after the end of the infusion.

“[Postpartum depression] is symptomatically indistinguishable from an episode of major depression,” the FDA briefing document said. “However, the timing of its onset has led to its recognition as a potentially unique illness. There are no drugs specifically approved to treat [postpartum depression].”

Some clinicians use drugs approved for major depression to treat postpartum depression, but the effectiveness of these drugs is limited, the agency said. Other interventions, such as electroconvulsive therapy, repetitive transcranial magnetic stimulation, and psychotherapy also are used, but they can take several weeks to show results.

Recent estimates of postpartum depression in the United States range from about 8% to 20%, according to the FDA document. and both the FDA and Sage Therapeutics agreed on the need for additional treatment options for women with postpartum depression. Potential advantages of brexanolone include a rapid onset of action and significant improvement of depressive symptoms, according to Sage.

The treatment protocol for brexanolone involves a single 60-hour continuous infusion with a recommended maximum dose of 90 µg/kg/h, referred to as a “90 dose regimen.” The patient receives a single infusion per episode of postpartum depression. The infusion includes three dosing phases: titration at 30 μg/kg/h for 4 hours followed by 60 μg/kg/h for 20 hours (hour 0-24), maintenance at 90 μg/kg/h for 28 hours (hour 24-52), and taper at 60 μg/kg/h for 4 hours – followed by 30 μg/kg/h for 4 hours (hour 52-60).

Brexanolone is an allosteric modulator of GABAA receptors and “a new molecular entity not currently marketed anywhere in the world for any indication,” according to the FDA document. The drug originally was studied as a treatment for seizure patients before its antidepressant properties were discovered.

Adverse reactions observed in 3% or more of the brexanolone patients during the 60-hour treatment and 4-week follow-up included dry mouth, infusion site pain, fatigue, headache, sedation/somnolence, dizziness/vertigo, and loss of consciousness.

Of those reactions, loss of consciousness was the issue of greatest concern to the committee members and informed their discussion of the strict Risk Evaluation and Mitigation Strategy protocol that would be needed to accompany approval of the drug. The details of the REMS will be determined, but the basics of the FDA’s proposed REMS to mitigate the risk of loss of consciousness include administration of the drug only in medically supervised settings by an authorized representative.

In addition, the proposed REMS states that the authorized representative must “establish policies and procedures to ensure that 1) all staff are trained on the risks and 2) the product is not dispensed for use outside the health care setting.”

The proposed REMS also stated that, “Patients must be continuously monitored for the duration of the infusion and 12 hours after, by health care provider who can intervene if the patient experiences excessive sedation or loss of consciousness.”

Despite those concerns, which most committee members thought could be addressed by the REMS, the overall impression of the committees’ members was that brexanolone could have a significant impact on postpartum depression. According to one member, brexanolone is mechanistically “groundbreaking” and “could be a tremendous help in changing the trajectory of postpartum depression.”

The FDA usually follows its panels’ recommendations, which are not binding.

A joint panel of the Food and Drug Administration voted Nov. 2 in support of brexanolone infusion as a treatment for postpartum depression.

The 17-1 vote by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based primarily on data from three studies, including 247 women aged 18-44 years with postpartum depression; 140 received brexanolone and 107 received placebo. Effectiveness was assessed based on the Hamilton Depression Scale (HAM-D) at the end of the infusion (hour 60).

In all three studies, patients given brexanolone showed significantly improved HAM-D scores, compared with placebo. The patients experienced significant differences at hour 24, which illustrated the rapid response. “The individual item scores of the HAM-D consistently favored brexanolone IV over placebo, confirming an overall antidepressant effect of the drug,” according to the briefing document of Sage Therapeutics, developer of the drug. In addition, more than 80% of the patients in the treatment and placebo groups sustained their improvement in symptoms at 30 days after the end of the infusion.

“[Postpartum depression] is symptomatically indistinguishable from an episode of major depression,” the FDA briefing document said. “However, the timing of its onset has led to its recognition as a potentially unique illness. There are no drugs specifically approved to treat [postpartum depression].”

Some clinicians use drugs approved for major depression to treat postpartum depression, but the effectiveness of these drugs is limited, the agency said. Other interventions, such as electroconvulsive therapy, repetitive transcranial magnetic stimulation, and psychotherapy also are used, but they can take several weeks to show results.

Recent estimates of postpartum depression in the United States range from about 8% to 20%, according to the FDA document. and both the FDA and Sage Therapeutics agreed on the need for additional treatment options for women with postpartum depression. Potential advantages of brexanolone include a rapid onset of action and significant improvement of depressive symptoms, according to Sage.

The treatment protocol for brexanolone involves a single 60-hour continuous infusion with a recommended maximum dose of 90 µg/kg/h, referred to as a “90 dose regimen.” The patient receives a single infusion per episode of postpartum depression. The infusion includes three dosing phases: titration at 30 μg/kg/h for 4 hours followed by 60 μg/kg/h for 20 hours (hour 0-24), maintenance at 90 μg/kg/h for 28 hours (hour 24-52), and taper at 60 μg/kg/h for 4 hours – followed by 30 μg/kg/h for 4 hours (hour 52-60).

Brexanolone is an allosteric modulator of GABAA receptors and “a new molecular entity not currently marketed anywhere in the world for any indication,” according to the FDA document. The drug originally was studied as a treatment for seizure patients before its antidepressant properties were discovered.

Adverse reactions observed in 3% or more of the brexanolone patients during the 60-hour treatment and 4-week follow-up included dry mouth, infusion site pain, fatigue, headache, sedation/somnolence, dizziness/vertigo, and loss of consciousness.

Of those reactions, loss of consciousness was the issue of greatest concern to the committee members and informed their discussion of the strict Risk Evaluation and Mitigation Strategy protocol that would be needed to accompany approval of the drug. The details of the REMS will be determined, but the basics of the FDA’s proposed REMS to mitigate the risk of loss of consciousness include administration of the drug only in medically supervised settings by an authorized representative.

In addition, the proposed REMS states that the authorized representative must “establish policies and procedures to ensure that 1) all staff are trained on the risks and 2) the product is not dispensed for use outside the health care setting.”

The proposed REMS also stated that, “Patients must be continuously monitored for the duration of the infusion and 12 hours after, by health care provider who can intervene if the patient experiences excessive sedation or loss of consciousness.”

Despite those concerns, which most committee members thought could be addressed by the REMS, the overall impression of the committees’ members was that brexanolone could have a significant impact on postpartum depression. According to one member, brexanolone is mechanistically “groundbreaking” and “could be a tremendous help in changing the trajectory of postpartum depression.”

The FDA usually follows its panels’ recommendations, which are not binding.

A joint panel of the Food and Drug Administration voted Nov. 2 in support of brexanolone infusion as a treatment for postpartum depression.

The 17-1 vote by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based primarily on data from three studies, including 247 women aged 18-44 years with postpartum depression; 140 received brexanolone and 107 received placebo. Effectiveness was assessed based on the Hamilton Depression Scale (HAM-D) at the end of the infusion (hour 60).

In all three studies, patients given brexanolone showed significantly improved HAM-D scores, compared with placebo. The patients experienced significant differences at hour 24, which illustrated the rapid response. “The individual item scores of the HAM-D consistently favored brexanolone IV over placebo, confirming an overall antidepressant effect of the drug,” according to the briefing document of Sage Therapeutics, developer of the drug. In addition, more than 80% of the patients in the treatment and placebo groups sustained their improvement in symptoms at 30 days after the end of the infusion.

“[Postpartum depression] is symptomatically indistinguishable from an episode of major depression,” the FDA briefing document said. “However, the timing of its onset has led to its recognition as a potentially unique illness. There are no drugs specifically approved to treat [postpartum depression].”

Some clinicians use drugs approved for major depression to treat postpartum depression, but the effectiveness of these drugs is limited, the agency said. Other interventions, such as electroconvulsive therapy, repetitive transcranial magnetic stimulation, and psychotherapy also are used, but they can take several weeks to show results.

Recent estimates of postpartum depression in the United States range from about 8% to 20%, according to the FDA document. and both the FDA and Sage Therapeutics agreed on the need for additional treatment options for women with postpartum depression. Potential advantages of brexanolone include a rapid onset of action and significant improvement of depressive symptoms, according to Sage.

The treatment protocol for brexanolone involves a single 60-hour continuous infusion with a recommended maximum dose of 90 µg/kg/h, referred to as a “90 dose regimen.” The patient receives a single infusion per episode of postpartum depression. The infusion includes three dosing phases: titration at 30 μg/kg/h for 4 hours followed by 60 μg/kg/h for 20 hours (hour 0-24), maintenance at 90 μg/kg/h for 28 hours (hour 24-52), and taper at 60 μg/kg/h for 4 hours – followed by 30 μg/kg/h for 4 hours (hour 52-60).

Brexanolone is an allosteric modulator of GABAA receptors and “a new molecular entity not currently marketed anywhere in the world for any indication,” according to the FDA document. The drug originally was studied as a treatment for seizure patients before its antidepressant properties were discovered.

Adverse reactions observed in 3% or more of the brexanolone patients during the 60-hour treatment and 4-week follow-up included dry mouth, infusion site pain, fatigue, headache, sedation/somnolence, dizziness/vertigo, and loss of consciousness.

Of those reactions, loss of consciousness was the issue of greatest concern to the committee members and informed their discussion of the strict Risk Evaluation and Mitigation Strategy protocol that would be needed to accompany approval of the drug. The details of the REMS will be determined, but the basics of the FDA’s proposed REMS to mitigate the risk of loss of consciousness include administration of the drug only in medically supervised settings by an authorized representative.

In addition, the proposed REMS states that the authorized representative must “establish policies and procedures to ensure that 1) all staff are trained on the risks and 2) the product is not dispensed for use outside the health care setting.”

The proposed REMS also stated that, “Patients must be continuously monitored for the duration of the infusion and 12 hours after, by health care provider who can intervene if the patient experiences excessive sedation or loss of consciousness.”

Despite those concerns, which most committee members thought could be addressed by the REMS, the overall impression of the committees’ members was that brexanolone could have a significant impact on postpartum depression. According to one member, brexanolone is mechanistically “groundbreaking” and “could be a tremendous help in changing the trajectory of postpartum depression.”

The FDA usually follows its panels’ recommendations, which are not binding.

WASHINGTON – Pediatric indications appeared in approximately 36% of orphan drug approvals between 2000 and 2017, according to data from the Food and Drug Administration.

“Given the impact of rare disease on children, it is of particular interest to better understand where new drug approvals and advances are occurring, through the lens of pediatrics,” said Kathleen L. Miller, Ph.D., and Michael Lanthier of the Food and Drug Administration in Silver Spring, Md. They presented their findings in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.

Overall, 31% of 314 orphan drug approvals by the FDA between 2000 and 2017 had a pediatric and adult indication, 5% had pediatric-only indications, and 64% had adult-only indications.

For the 112 pediatric indication approvals, 14% were for inherited blood disorders, 14% for inherited metabolic disorders, 13% for rare cancers, 10% for antidotes and medical countermeasures, 9% for infectious diseases, 8% for auto-inflammatory diseases, 7% for neurologic disorders, and 25% for other conditions.

Approximately 63% of the total orphan drug approvals during the study period were for rare cancers or genetic disorders (138 approvals and 59 approvals, respectively). Although 90% of the rare cancer approvals were for adults only, 84% of genetic disorder drug approvals had pediatric indications, Dr. Miller and Mr. Lanthier noted.

When analyzed by submission type, pediatric indications were included in 52% of new orphan formulations, 35% of orphan secondary indication approvals, and 32% of new molecular entity approvals.

Although more research is needed, the results suggest that “pediatric indications represent a sizable proportion of orphan drug approvals in both a range of therapeutic areas and in a range of approval types,” the investigators concluded.

The researchers are employed by the FDA, which sponsored the study. They had no financial conflicts to disclose.

WASHINGTON – Pediatric indications appeared in approximately 36% of orphan drug approvals between 2000 and 2017, according to data from the Food and Drug Administration.

“Given the impact of rare disease on children, it is of particular interest to better understand where new drug approvals and advances are occurring, through the lens of pediatrics,” said Kathleen L. Miller, Ph.D., and Michael Lanthier of the Food and Drug Administration in Silver Spring, Md. They presented their findings in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.

Overall, 31% of 314 orphan drug approvals by the FDA between 2000 and 2017 had a pediatric and adult indication, 5% had pediatric-only indications, and 64% had adult-only indications.

For the 112 pediatric indication approvals, 14% were for inherited blood disorders, 14% for inherited metabolic disorders, 13% for rare cancers, 10% for antidotes and medical countermeasures, 9% for infectious diseases, 8% for auto-inflammatory diseases, 7% for neurologic disorders, and 25% for other conditions.

Approximately 63% of the total orphan drug approvals during the study period were for rare cancers or genetic disorders (138 approvals and 59 approvals, respectively). Although 90% of the rare cancer approvals were for adults only, 84% of genetic disorder drug approvals had pediatric indications, Dr. Miller and Mr. Lanthier noted.

When analyzed by submission type, pediatric indications were included in 52% of new orphan formulations, 35% of orphan secondary indication approvals, and 32% of new molecular entity approvals.

Although more research is needed, the results suggest that “pediatric indications represent a sizable proportion of orphan drug approvals in both a range of therapeutic areas and in a range of approval types,” the investigators concluded.

The researchers are employed by the FDA, which sponsored the study. They had no financial conflicts to disclose.

WASHINGTON – Pediatric indications appeared in approximately 36% of orphan drug approvals between 2000 and 2017, according to data from the Food and Drug Administration.

“Given the impact of rare disease on children, it is of particular interest to better understand where new drug approvals and advances are occurring, through the lens of pediatrics,” said Kathleen L. Miller, Ph.D., and Michael Lanthier of the Food and Drug Administration in Silver Spring, Md. They presented their findings in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.

Overall, 31% of 314 orphan drug approvals by the FDA between 2000 and 2017 had a pediatric and adult indication, 5% had pediatric-only indications, and 64% had adult-only indications.

For the 112 pediatric indication approvals, 14% were for inherited blood disorders, 14% for inherited metabolic disorders, 13% for rare cancers, 10% for antidotes and medical countermeasures, 9% for infectious diseases, 8% for auto-inflammatory diseases, 7% for neurologic disorders, and 25% for other conditions.

Approximately 63% of the total orphan drug approvals during the study period were for rare cancers or genetic disorders (138 approvals and 59 approvals, respectively). Although 90% of the rare cancer approvals were for adults only, 84% of genetic disorder drug approvals had pediatric indications, Dr. Miller and Mr. Lanthier noted.

When analyzed by submission type, pediatric indications were included in 52% of new orphan formulations, 35% of orphan secondary indication approvals, and 32% of new molecular entity approvals.

Although more research is needed, the results suggest that “pediatric indications represent a sizable proportion of orphan drug approvals in both a range of therapeutic areas and in a range of approval types,” the investigators concluded.

The researchers are employed by the FDA, which sponsored the study. They had no financial conflicts to disclose.