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Emotional problems in young girls predict anxiety
Elementary school girls with particular emotional and behavioral symptoms, including irritability, were significantly more likely to experience anxiety disorders in adolescence and young adulthood, based on data from a network analysis of 932 girls.
Data from previous studies suggest that targeting emotional problems in early childhood might prevent mental health disorders in young adults, wrote Alexandra Rouquette, MD, PhD, of Paris-Saclay University, Paris, and her colleagues. “However, these interventions are challenging to implement because we lack knowledge on which specific childhood symptoms have predictive associations with adult psychopathologic disorders,” they said.
In the study, published in JAMA Psychiatry, the researchers used data from an ongoing longitudinal prospective analysis of kindergarten children in the Canadian province of Quebec to assess potential “bridge symptoms,” defined as those that might affect the development of anxiety later in life. The study population included 932 girls whose parents completed the Social Behavior Questionnaire (SBQ) at baseline when the girls were 6 years old, and again at ages 8 and 10 years. Of these, 780 participants underwent screening for mental health disorders at age 15 and/or 22 years.
Of the 780 participants assessed at follow-up, 270 (35%) had developed at least one anxiety disorder, and 128 (16%) had developed at least one diagnosis of major depression or another depressive disorder.
The researchers used a network analysis technique to review 33 items in the SBQ and how they related to future anxiety disorders. – as having “a distinctive position in the network because most of the direct relationships between the disruptive and internalized communities transited through them.”
In addition, children who were disobedient, irritable, and not liked by others had the strongest and earliest association with anxiety disorders over time, the researchers said. By contrast, the kicks disruptive symptom in early childhood was a negative predictor of anxiety disorders at follow-up.
The study findings were limited by several factors, including the relatively small study population, the number of statistical tests performed, and the challenges of identifying anxiety disorders at follow-up. However, the results support the potential role of childhood bridge symptoms in later life anxiety, the researchers said. “Clinicians may wish to focus on these bridge symptoms when assessing patients,” they noted, because those symptoms could be “early targets in disease-prevention and health-promotion interventions.”
The researchers had no financial conflicts to disclose. The study was funded by a grant to Dr. Rouquette from the OpenHealth Institute.
SOURCE: Rouquette A et al. JAMA Psychiatry. 2018 Aug 15. doi: 10.1001/jamapsychiatry.2018.2119.
Elementary school girls with particular emotional and behavioral symptoms, including irritability, were significantly more likely to experience anxiety disorders in adolescence and young adulthood, based on data from a network analysis of 932 girls.
Data from previous studies suggest that targeting emotional problems in early childhood might prevent mental health disorders in young adults, wrote Alexandra Rouquette, MD, PhD, of Paris-Saclay University, Paris, and her colleagues. “However, these interventions are challenging to implement because we lack knowledge on which specific childhood symptoms have predictive associations with adult psychopathologic disorders,” they said.
In the study, published in JAMA Psychiatry, the researchers used data from an ongoing longitudinal prospective analysis of kindergarten children in the Canadian province of Quebec to assess potential “bridge symptoms,” defined as those that might affect the development of anxiety later in life. The study population included 932 girls whose parents completed the Social Behavior Questionnaire (SBQ) at baseline when the girls were 6 years old, and again at ages 8 and 10 years. Of these, 780 participants underwent screening for mental health disorders at age 15 and/or 22 years.
Of the 780 participants assessed at follow-up, 270 (35%) had developed at least one anxiety disorder, and 128 (16%) had developed at least one diagnosis of major depression or another depressive disorder.
The researchers used a network analysis technique to review 33 items in the SBQ and how they related to future anxiety disorders. – as having “a distinctive position in the network because most of the direct relationships between the disruptive and internalized communities transited through them.”
In addition, children who were disobedient, irritable, and not liked by others had the strongest and earliest association with anxiety disorders over time, the researchers said. By contrast, the kicks disruptive symptom in early childhood was a negative predictor of anxiety disorders at follow-up.
The study findings were limited by several factors, including the relatively small study population, the number of statistical tests performed, and the challenges of identifying anxiety disorders at follow-up. However, the results support the potential role of childhood bridge symptoms in later life anxiety, the researchers said. “Clinicians may wish to focus on these bridge symptoms when assessing patients,” they noted, because those symptoms could be “early targets in disease-prevention and health-promotion interventions.”
The researchers had no financial conflicts to disclose. The study was funded by a grant to Dr. Rouquette from the OpenHealth Institute.
SOURCE: Rouquette A et al. JAMA Psychiatry. 2018 Aug 15. doi: 10.1001/jamapsychiatry.2018.2119.
Elementary school girls with particular emotional and behavioral symptoms, including irritability, were significantly more likely to experience anxiety disorders in adolescence and young adulthood, based on data from a network analysis of 932 girls.
Data from previous studies suggest that targeting emotional problems in early childhood might prevent mental health disorders in young adults, wrote Alexandra Rouquette, MD, PhD, of Paris-Saclay University, Paris, and her colleagues. “However, these interventions are challenging to implement because we lack knowledge on which specific childhood symptoms have predictive associations with adult psychopathologic disorders,” they said.
In the study, published in JAMA Psychiatry, the researchers used data from an ongoing longitudinal prospective analysis of kindergarten children in the Canadian province of Quebec to assess potential “bridge symptoms,” defined as those that might affect the development of anxiety later in life. The study population included 932 girls whose parents completed the Social Behavior Questionnaire (SBQ) at baseline when the girls were 6 years old, and again at ages 8 and 10 years. Of these, 780 participants underwent screening for mental health disorders at age 15 and/or 22 years.
Of the 780 participants assessed at follow-up, 270 (35%) had developed at least one anxiety disorder, and 128 (16%) had developed at least one diagnosis of major depression or another depressive disorder.
The researchers used a network analysis technique to review 33 items in the SBQ and how they related to future anxiety disorders. – as having “a distinctive position in the network because most of the direct relationships between the disruptive and internalized communities transited through them.”
In addition, children who were disobedient, irritable, and not liked by others had the strongest and earliest association with anxiety disorders over time, the researchers said. By contrast, the kicks disruptive symptom in early childhood was a negative predictor of anxiety disorders at follow-up.
The study findings were limited by several factors, including the relatively small study population, the number of statistical tests performed, and the challenges of identifying anxiety disorders at follow-up. However, the results support the potential role of childhood bridge symptoms in later life anxiety, the researchers said. “Clinicians may wish to focus on these bridge symptoms when assessing patients,” they noted, because those symptoms could be “early targets in disease-prevention and health-promotion interventions.”
The researchers had no financial conflicts to disclose. The study was funded by a grant to Dr. Rouquette from the OpenHealth Institute.
SOURCE: Rouquette A et al. JAMA Psychiatry. 2018 Aug 15. doi: 10.1001/jamapsychiatry.2018.2119.
FROM JAMA PSYCHIATRY
Key clinical point: “Clinicians may wish to focus on these bridge symptoms when assessing patients.”
Major finding: Of 780 participants assessed at follow-up, 270 (35%) had developed at least one anxiety disorder, and 128 (16%) had developed at least one diagnosis of major depression or another depressive disorder.
Study details: The data come from a network analysis of 932 girls who entered the study at about 6 years of age.
Disclosures: The researchers had no financial conflicts to disclose. The study was funded by a grant to Dr. Rouquette from the OpenHealth Institute.
Source: Rouquette A et al. JAMA Psychiatry. 2018 Aug 15. doi: 10.1001/jamapsychiatry.2018.2119.
Low-dose CT fails to improve small cell lung cancer survival
Early had no significant impact on patient survival, based on data from a randomized trial.
Although early detection of small-cell lung cancer might improve outcomes for patients given the metastatic nature of the disease, previous studies on the value and impact of low-dose CT have been divergent, wrote Anish Thomas, MD, of the National Cancer Institute and his colleagues.
In a study published in Chest, the researchers reviewed characteristics of low-dose CT–detected small cell lung cancer (SCLC) in the randomized National Lung Screening Trial (NLST). The trial compared low-dose CT (LDCT) with chest radiography to assess patients at high risk for developing lung cancer. The study population included adults aged 55-74 years with a history of smoking of at least 30 pack-years, and former smokers who had quit within the past 15 years.
A total of 26,722 participants were randomized to the LDCT treatment arm with a median follow-up of 6.5 years; 143 SCLC cases and 926 non–small cell lung cancer (NSCLC) cases were identified in this group.
Of the 143 SCLC cases, 49 (34.2%) were screen detected, 15 (10.5%) were interval detected and 79 (55.2%) were not screened or were identified post screening.
A cancer was defined as screen detected if it was diagnosed within 1 year of a positive screening or diagnosed after a longer period but with no time gap between diagnostic procedures of more than 1 year; an interval cancer was diagnosed within a year of a negative screen, and non-screened cancers were those found in patients who received no NLST screening or other post screening.
Significantly more of the SCLC cases were at stage III or IV than the NSCLC cases (86% vs. 36%). Unfavorable stage III or IV lung cancers were identified in 80% of screen detected, 86% of interval detected, and 90% of nonscreened or postscreened cases.
In addition, 31 (63%) of the 49 screen-detected SCLC cases had at least one noncalcified nodule in the cancer lobe and 24 (49%) had a single NCN in the cancer lobe.
The 3-year cancer-specific survival rates were not significantly different for screen-detected, interval-detected, and nonscreened or postscreened cases (15.3%, 20.0%, and 13.8%, respectively).
“As expected, the majority of SCLC were late-stage cancers, but surprisingly the unfavorable stage distribution was present regardless of whether the cancer was screen-, interval- or post-screen detected,” the researchers noted.
The findings differed from the results of previous smaller studies showing more favorable stage distribution for SCLC cases detected by LDCT, but this difference may be accounted for by various factors including study populations that were smaller, younger, and lacking well-defined risk factors, the researchers said.
“Our findings underscore and provide further granularity to the premise that SCLC is a very aggressive neoplasm, and contrary to smaller prior studies, indicate that LDCT is an ineffective tool to screen for SCLC,” they said. “If early detection of SCLC were to be realistic, it would need to be detected before [lesions] are visible on LDCT,” they emphasized.
The study was supported in part by the National Cancer Institute. The researchers had no financial conflicts to disclose.
SOURCE: Thomas A et al. Chest. 2018 Aug 3. doi: 10.1016/j.chest.2018.07.029.
Early had no significant impact on patient survival, based on data from a randomized trial.
Although early detection of small-cell lung cancer might improve outcomes for patients given the metastatic nature of the disease, previous studies on the value and impact of low-dose CT have been divergent, wrote Anish Thomas, MD, of the National Cancer Institute and his colleagues.
In a study published in Chest, the researchers reviewed characteristics of low-dose CT–detected small cell lung cancer (SCLC) in the randomized National Lung Screening Trial (NLST). The trial compared low-dose CT (LDCT) with chest radiography to assess patients at high risk for developing lung cancer. The study population included adults aged 55-74 years with a history of smoking of at least 30 pack-years, and former smokers who had quit within the past 15 years.
A total of 26,722 participants were randomized to the LDCT treatment arm with a median follow-up of 6.5 years; 143 SCLC cases and 926 non–small cell lung cancer (NSCLC) cases were identified in this group.
Of the 143 SCLC cases, 49 (34.2%) were screen detected, 15 (10.5%) were interval detected and 79 (55.2%) were not screened or were identified post screening.
A cancer was defined as screen detected if it was diagnosed within 1 year of a positive screening or diagnosed after a longer period but with no time gap between diagnostic procedures of more than 1 year; an interval cancer was diagnosed within a year of a negative screen, and non-screened cancers were those found in patients who received no NLST screening or other post screening.
Significantly more of the SCLC cases were at stage III or IV than the NSCLC cases (86% vs. 36%). Unfavorable stage III or IV lung cancers were identified in 80% of screen detected, 86% of interval detected, and 90% of nonscreened or postscreened cases.
In addition, 31 (63%) of the 49 screen-detected SCLC cases had at least one noncalcified nodule in the cancer lobe and 24 (49%) had a single NCN in the cancer lobe.
The 3-year cancer-specific survival rates were not significantly different for screen-detected, interval-detected, and nonscreened or postscreened cases (15.3%, 20.0%, and 13.8%, respectively).
“As expected, the majority of SCLC were late-stage cancers, but surprisingly the unfavorable stage distribution was present regardless of whether the cancer was screen-, interval- or post-screen detected,” the researchers noted.
The findings differed from the results of previous smaller studies showing more favorable stage distribution for SCLC cases detected by LDCT, but this difference may be accounted for by various factors including study populations that were smaller, younger, and lacking well-defined risk factors, the researchers said.
“Our findings underscore and provide further granularity to the premise that SCLC is a very aggressive neoplasm, and contrary to smaller prior studies, indicate that LDCT is an ineffective tool to screen for SCLC,” they said. “If early detection of SCLC were to be realistic, it would need to be detected before [lesions] are visible on LDCT,” they emphasized.
The study was supported in part by the National Cancer Institute. The researchers had no financial conflicts to disclose.
SOURCE: Thomas A et al. Chest. 2018 Aug 3. doi: 10.1016/j.chest.2018.07.029.
Early had no significant impact on patient survival, based on data from a randomized trial.
Although early detection of small-cell lung cancer might improve outcomes for patients given the metastatic nature of the disease, previous studies on the value and impact of low-dose CT have been divergent, wrote Anish Thomas, MD, of the National Cancer Institute and his colleagues.
In a study published in Chest, the researchers reviewed characteristics of low-dose CT–detected small cell lung cancer (SCLC) in the randomized National Lung Screening Trial (NLST). The trial compared low-dose CT (LDCT) with chest radiography to assess patients at high risk for developing lung cancer. The study population included adults aged 55-74 years with a history of smoking of at least 30 pack-years, and former smokers who had quit within the past 15 years.
A total of 26,722 participants were randomized to the LDCT treatment arm with a median follow-up of 6.5 years; 143 SCLC cases and 926 non–small cell lung cancer (NSCLC) cases were identified in this group.
Of the 143 SCLC cases, 49 (34.2%) were screen detected, 15 (10.5%) were interval detected and 79 (55.2%) were not screened or were identified post screening.
A cancer was defined as screen detected if it was diagnosed within 1 year of a positive screening or diagnosed after a longer period but with no time gap between diagnostic procedures of more than 1 year; an interval cancer was diagnosed within a year of a negative screen, and non-screened cancers were those found in patients who received no NLST screening or other post screening.
Significantly more of the SCLC cases were at stage III or IV than the NSCLC cases (86% vs. 36%). Unfavorable stage III or IV lung cancers were identified in 80% of screen detected, 86% of interval detected, and 90% of nonscreened or postscreened cases.
In addition, 31 (63%) of the 49 screen-detected SCLC cases had at least one noncalcified nodule in the cancer lobe and 24 (49%) had a single NCN in the cancer lobe.
The 3-year cancer-specific survival rates were not significantly different for screen-detected, interval-detected, and nonscreened or postscreened cases (15.3%, 20.0%, and 13.8%, respectively).
“As expected, the majority of SCLC were late-stage cancers, but surprisingly the unfavorable stage distribution was present regardless of whether the cancer was screen-, interval- or post-screen detected,” the researchers noted.
The findings differed from the results of previous smaller studies showing more favorable stage distribution for SCLC cases detected by LDCT, but this difference may be accounted for by various factors including study populations that were smaller, younger, and lacking well-defined risk factors, the researchers said.
“Our findings underscore and provide further granularity to the premise that SCLC is a very aggressive neoplasm, and contrary to smaller prior studies, indicate that LDCT is an ineffective tool to screen for SCLC,” they said. “If early detection of SCLC were to be realistic, it would need to be detected before [lesions] are visible on LDCT,” they emphasized.
The study was supported in part by the National Cancer Institute. The researchers had no financial conflicts to disclose.
SOURCE: Thomas A et al. Chest. 2018 Aug 3. doi: 10.1016/j.chest.2018.07.029.
FROM CHEST
Key clinical point: No significant difference in survival occurred in SCLC cancer patients identified early by low-dose CT vs. those identified at interval or post screening.
Major finding: Unfavorable stage III or IV lung cancers were identified in 80% of screen-detected, 86% of interval-detected, and 90% of nonscreened or postscreened cases.
Study details: The data come from 143 small cell lung cancer cases identified in the randomized National Lung Screening Trial.
Disclosures: The study was supported in part by the National Cancer Institute. The researchers had no financial conflicts to disclose.
Source: Thomas A et al. Chest. 2018 Aug 3. doi: 10.1016/j.chest.2018.07.029.
Secondhand smoke drives ED visits for teens
Teens who were exposed to any type of and to have more such visits, compared with unexposed controls, based on data from more than 7,000 adolescents.
Approximately 35% of U.S. teens spent more than an hour exposed to secondhand smoke in a given week, wrote Ashley L. Merianos, PhD, of the University of Cincinnati and her colleagues.
In a study published in Pediatrics, the researchers conducted a secondary analysis of nonsmoking adolescents aged 12-17 years who had not been diagnosed with asthma and who were part of the PATH (Population Assessment of Tobacco and Health) study, a longitudinal cohort trial of tobacco use behavior and related health outcomes in adolescents and adults in the United States. The data were collected between Oct. 3, 2014, and Oct. 30, 2015. The researchers reviewed three main measures of tobacco smoke exposure (TSE): living with a smoker, being exposed to secondhand smoke at home, and being exposed to secondhand smoke for an hour or more in the past 7 days.
Overall, teens who lived with a smoker, had secondary exposure at home, or had at least 1 hour of TSE had significantly more emergency department and/or urgent care visits (mean ranged from 1.62 to 1.65), compared with unexposed peers (mean visits ranged from 1.42 to 1.48). Those who both lived with a smoker and had at least 1 hour of TSE exposure were significantly more likely to visit an ED or urgent care center.
In addition, teens who lived with a smoker, had secondary exposure at home, and had at least 1 hour of TSE were significantly more likely than were unexposed peers to report shortness of breath, difficulty exercising, wheezing during and after exercise, and a dry cough at night (P less than .001).
The researchers also assessed other health indicators, and found that teens with TSE exposure were significantly less likely than were unexposed peers to report very good or excellent health and were approximately 1.50 times more likely than unexposed peers to report missing school because of poor health.
The results were limited by several factors including the use of self-reports of TSE and parent reports of emergency or urgent care visits, and by the inclusion only of other public use variables in the PATH database, the researchers noted. But they adjusted for potentially confounding factors such as household income level, parent education, and health insurance status. However, “Because adolescents are high users of EDs and/or [urgent care] for primary care reasons, these venues are high-volume settings that should be used to offer interventions to adolescents with TSE and their families,” they said.
The researchers had no financial conflicts to disclose. The study was funded by the National Institutes of Health via the National Institute on Drug Abuse and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Merianos AL et al. Pediatrics 2018 Aug 6. doi: org/10.1542/peds.2018-0266.
Teens who were exposed to any type of and to have more such visits, compared with unexposed controls, based on data from more than 7,000 adolescents.
Approximately 35% of U.S. teens spent more than an hour exposed to secondhand smoke in a given week, wrote Ashley L. Merianos, PhD, of the University of Cincinnati and her colleagues.
In a study published in Pediatrics, the researchers conducted a secondary analysis of nonsmoking adolescents aged 12-17 years who had not been diagnosed with asthma and who were part of the PATH (Population Assessment of Tobacco and Health) study, a longitudinal cohort trial of tobacco use behavior and related health outcomes in adolescents and adults in the United States. The data were collected between Oct. 3, 2014, and Oct. 30, 2015. The researchers reviewed three main measures of tobacco smoke exposure (TSE): living with a smoker, being exposed to secondhand smoke at home, and being exposed to secondhand smoke for an hour or more in the past 7 days.
Overall, teens who lived with a smoker, had secondary exposure at home, or had at least 1 hour of TSE had significantly more emergency department and/or urgent care visits (mean ranged from 1.62 to 1.65), compared with unexposed peers (mean visits ranged from 1.42 to 1.48). Those who both lived with a smoker and had at least 1 hour of TSE exposure were significantly more likely to visit an ED or urgent care center.
In addition, teens who lived with a smoker, had secondary exposure at home, and had at least 1 hour of TSE were significantly more likely than were unexposed peers to report shortness of breath, difficulty exercising, wheezing during and after exercise, and a dry cough at night (P less than .001).
The researchers also assessed other health indicators, and found that teens with TSE exposure were significantly less likely than were unexposed peers to report very good or excellent health and were approximately 1.50 times more likely than unexposed peers to report missing school because of poor health.
The results were limited by several factors including the use of self-reports of TSE and parent reports of emergency or urgent care visits, and by the inclusion only of other public use variables in the PATH database, the researchers noted. But they adjusted for potentially confounding factors such as household income level, parent education, and health insurance status. However, “Because adolescents are high users of EDs and/or [urgent care] for primary care reasons, these venues are high-volume settings that should be used to offer interventions to adolescents with TSE and their families,” they said.
The researchers had no financial conflicts to disclose. The study was funded by the National Institutes of Health via the National Institute on Drug Abuse and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Merianos AL et al. Pediatrics 2018 Aug 6. doi: org/10.1542/peds.2018-0266.
Teens who were exposed to any type of and to have more such visits, compared with unexposed controls, based on data from more than 7,000 adolescents.
Approximately 35% of U.S. teens spent more than an hour exposed to secondhand smoke in a given week, wrote Ashley L. Merianos, PhD, of the University of Cincinnati and her colleagues.
In a study published in Pediatrics, the researchers conducted a secondary analysis of nonsmoking adolescents aged 12-17 years who had not been diagnosed with asthma and who were part of the PATH (Population Assessment of Tobacco and Health) study, a longitudinal cohort trial of tobacco use behavior and related health outcomes in adolescents and adults in the United States. The data were collected between Oct. 3, 2014, and Oct. 30, 2015. The researchers reviewed three main measures of tobacco smoke exposure (TSE): living with a smoker, being exposed to secondhand smoke at home, and being exposed to secondhand smoke for an hour or more in the past 7 days.
Overall, teens who lived with a smoker, had secondary exposure at home, or had at least 1 hour of TSE had significantly more emergency department and/or urgent care visits (mean ranged from 1.62 to 1.65), compared with unexposed peers (mean visits ranged from 1.42 to 1.48). Those who both lived with a smoker and had at least 1 hour of TSE exposure were significantly more likely to visit an ED or urgent care center.
In addition, teens who lived with a smoker, had secondary exposure at home, and had at least 1 hour of TSE were significantly more likely than were unexposed peers to report shortness of breath, difficulty exercising, wheezing during and after exercise, and a dry cough at night (P less than .001).
The researchers also assessed other health indicators, and found that teens with TSE exposure were significantly less likely than were unexposed peers to report very good or excellent health and were approximately 1.50 times more likely than unexposed peers to report missing school because of poor health.
The results were limited by several factors including the use of self-reports of TSE and parent reports of emergency or urgent care visits, and by the inclusion only of other public use variables in the PATH database, the researchers noted. But they adjusted for potentially confounding factors such as household income level, parent education, and health insurance status. However, “Because adolescents are high users of EDs and/or [urgent care] for primary care reasons, these venues are high-volume settings that should be used to offer interventions to adolescents with TSE and their families,” they said.
The researchers had no financial conflicts to disclose. The study was funded by the National Institutes of Health via the National Institute on Drug Abuse and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Merianos AL et al. Pediatrics 2018 Aug 6. doi: org/10.1542/peds.2018-0266.
FROM PEDIATRICS
Tease out genetic and structural causes of children’s hair loss
according to Maria Hordinsky, MD, of the University of Minnesota, Minneapolis.
The ectodermal dysplasias are a heterogeneous group of disorders in which a main feature is the absent, incomplete, or delayed development of one or more of the appendages derived from ectoderm, such as the hair follicle, Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
Patients with pure hair and nail ectodermal dysplasia generally present with absent or sparse eyebrows and eyelashes, as well as follicular papules on the scalp and fragile, irregular hair, Dr. Hordinsky said. The condition is caused by a mutation in a gene associated with the production of keratin. In another rare form of hereditary hair loss – hypotrichosis simplex – patients are born with normal hair but lose it gradually from the scalp during the middle of the first decade of life.
The inability to grow long hair characterizes short anagen syndrome, a congenital disorder not to be confused with loose anagen syndrome, Dr. Hordinsky said. Patients with short anagen syndrome experience an idiopathic short anagen phase and as a result, an increased number of hairs in the telogen phase. Children with short anagen syndrome have unusually short hair in early childhood. “Parents typically complain that their children exhibit short hair even though they have never had a haircut,” she explained.
Trichothiodystrophy, a rare autosomal recessive disease, is distinguished by hair that is brittle and sulfur deficient, Dr. Hordinsky said. She cited a review of 112 patients with trichothiodystrophy in which additional distinguishing features included developmental delay/intellectual impairment (86%), short stature (73%), and ichthyosis (65%).
Some cases of hair loss in children have a structural basis, Dr. Hordinsky noted. Structural hair abnormalities include fractures of the hair shaft, extraneous matter on the hair shaft, and hair shaft irregularities such as coiling or twisting, she said.
In trichoptilosis, extensive cuticle loss results in fraying and splitting of the hair shaft, while in patients with trichoclasis, a fractured hair is splinted by a partially intact cuticle.
In trichorrhexis nodosa, the most common type of structural hair abnormality, “intact nodes [of hair] resemble two paintbrushes thrust together,” Dr. Hordinsky explained. Trichorrhexis nodosa may be congenital or acquired, and occurs in children with mental retardation and argininosuccinic aciduria, she said.
A hair shaft abnormality is the culprit behind uncombable hair syndrome, which can be inherited or can occur sporadically, Dr. Hordinsky said. The key feature of the condition is unruly hair caused by a distinctive hair shaft defect, “possibly related to an abnormality in the inner root sheath.” Abnormal hairs usually become apparent at about 3-4 years of age, but eyebrows and eyelashes appear normal. Many patients have a silvery blonde tint to their hair because of how the abnormal hairs reflect light, she said.
Dr. Hordinsky is a consultant for P&G, Concert, Cassiopea, and BioAZ; and receives grant/research support from Aclaris, Allergan, and the National Alopecia Areata Foundation. SDEF and this news organization are owned by Frontline Medical Communications.
according to Maria Hordinsky, MD, of the University of Minnesota, Minneapolis.
The ectodermal dysplasias are a heterogeneous group of disorders in which a main feature is the absent, incomplete, or delayed development of one or more of the appendages derived from ectoderm, such as the hair follicle, Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
Patients with pure hair and nail ectodermal dysplasia generally present with absent or sparse eyebrows and eyelashes, as well as follicular papules on the scalp and fragile, irregular hair, Dr. Hordinsky said. The condition is caused by a mutation in a gene associated with the production of keratin. In another rare form of hereditary hair loss – hypotrichosis simplex – patients are born with normal hair but lose it gradually from the scalp during the middle of the first decade of life.
The inability to grow long hair characterizes short anagen syndrome, a congenital disorder not to be confused with loose anagen syndrome, Dr. Hordinsky said. Patients with short anagen syndrome experience an idiopathic short anagen phase and as a result, an increased number of hairs in the telogen phase. Children with short anagen syndrome have unusually short hair in early childhood. “Parents typically complain that their children exhibit short hair even though they have never had a haircut,” she explained.
Trichothiodystrophy, a rare autosomal recessive disease, is distinguished by hair that is brittle and sulfur deficient, Dr. Hordinsky said. She cited a review of 112 patients with trichothiodystrophy in which additional distinguishing features included developmental delay/intellectual impairment (86%), short stature (73%), and ichthyosis (65%).
Some cases of hair loss in children have a structural basis, Dr. Hordinsky noted. Structural hair abnormalities include fractures of the hair shaft, extraneous matter on the hair shaft, and hair shaft irregularities such as coiling or twisting, she said.
In trichoptilosis, extensive cuticle loss results in fraying and splitting of the hair shaft, while in patients with trichoclasis, a fractured hair is splinted by a partially intact cuticle.
In trichorrhexis nodosa, the most common type of structural hair abnormality, “intact nodes [of hair] resemble two paintbrushes thrust together,” Dr. Hordinsky explained. Trichorrhexis nodosa may be congenital or acquired, and occurs in children with mental retardation and argininosuccinic aciduria, she said.
A hair shaft abnormality is the culprit behind uncombable hair syndrome, which can be inherited or can occur sporadically, Dr. Hordinsky said. The key feature of the condition is unruly hair caused by a distinctive hair shaft defect, “possibly related to an abnormality in the inner root sheath.” Abnormal hairs usually become apparent at about 3-4 years of age, but eyebrows and eyelashes appear normal. Many patients have a silvery blonde tint to their hair because of how the abnormal hairs reflect light, she said.
Dr. Hordinsky is a consultant for P&G, Concert, Cassiopea, and BioAZ; and receives grant/research support from Aclaris, Allergan, and the National Alopecia Areata Foundation. SDEF and this news organization are owned by Frontline Medical Communications.
according to Maria Hordinsky, MD, of the University of Minnesota, Minneapolis.
The ectodermal dysplasias are a heterogeneous group of disorders in which a main feature is the absent, incomplete, or delayed development of one or more of the appendages derived from ectoderm, such as the hair follicle, Dr. Hordinsky said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
Patients with pure hair and nail ectodermal dysplasia generally present with absent or sparse eyebrows and eyelashes, as well as follicular papules on the scalp and fragile, irregular hair, Dr. Hordinsky said. The condition is caused by a mutation in a gene associated with the production of keratin. In another rare form of hereditary hair loss – hypotrichosis simplex – patients are born with normal hair but lose it gradually from the scalp during the middle of the first decade of life.
The inability to grow long hair characterizes short anagen syndrome, a congenital disorder not to be confused with loose anagen syndrome, Dr. Hordinsky said. Patients with short anagen syndrome experience an idiopathic short anagen phase and as a result, an increased number of hairs in the telogen phase. Children with short anagen syndrome have unusually short hair in early childhood. “Parents typically complain that their children exhibit short hair even though they have never had a haircut,” she explained.
Trichothiodystrophy, a rare autosomal recessive disease, is distinguished by hair that is brittle and sulfur deficient, Dr. Hordinsky said. She cited a review of 112 patients with trichothiodystrophy in which additional distinguishing features included developmental delay/intellectual impairment (86%), short stature (73%), and ichthyosis (65%).
Some cases of hair loss in children have a structural basis, Dr. Hordinsky noted. Structural hair abnormalities include fractures of the hair shaft, extraneous matter on the hair shaft, and hair shaft irregularities such as coiling or twisting, she said.
In trichoptilosis, extensive cuticle loss results in fraying and splitting of the hair shaft, while in patients with trichoclasis, a fractured hair is splinted by a partially intact cuticle.
In trichorrhexis nodosa, the most common type of structural hair abnormality, “intact nodes [of hair] resemble two paintbrushes thrust together,” Dr. Hordinsky explained. Trichorrhexis nodosa may be congenital or acquired, and occurs in children with mental retardation and argininosuccinic aciduria, she said.
A hair shaft abnormality is the culprit behind uncombable hair syndrome, which can be inherited or can occur sporadically, Dr. Hordinsky said. The key feature of the condition is unruly hair caused by a distinctive hair shaft defect, “possibly related to an abnormality in the inner root sheath.” Abnormal hairs usually become apparent at about 3-4 years of age, but eyebrows and eyelashes appear normal. Many patients have a silvery blonde tint to their hair because of how the abnormal hairs reflect light, she said.
Dr. Hordinsky is a consultant for P&G, Concert, Cassiopea, and BioAZ; and receives grant/research support from Aclaris, Allergan, and the National Alopecia Areata Foundation. SDEF and this news organization are owned by Frontline Medical Communications.
FROM SDEF WOMEN’S & PEDIATRIC DERMATOLOGY SEMINAR
Advise parents on validity of AD-associated conditions
including allergic rhinitis and asthma, according to Douglas W. Kress, MD, of the department of dermatology at the University of Pittsburgh.
Recent studies suggest that atopic dermatitis (AD) affects 10%-17% of the U.S. population, and 80%-90% of patients are diagnosed by the age of 5 years, Dr. Kress said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
“There seem to be multiple pathways, which initiate and perpetuate the cutaneous inflammation of AD including exposure to allergens, irritants, and physical trauma, infection, stress, extremes in temperature and humidity,” Dr. Kress said. In addition, foods and airborne allergens may trigger AD.
Many parents may believe that certain factors are associated with AD, but most of these perceptions are not supported by evidence, said Dr. Kress, who is also chief of the division of pediatric dermatology at the Children’s Hospital of Pittsburgh. AD appears to be a disorder of T cell dysregulation dominated by Th2 lesions in acute cases and Th1 inflammation in patients with chronic lesions.
No associations have been proven between the development of AD in the first 18 months of life and any maternal dietary restrictions, according to a recent Cochrane review, nor is there evidence for an association between AD and the introduction of solid foods, exposure to fish oil, or exposure to animals at a young age, he said. In addition, a study published in 2016 showed a lack of evidence to support the use of specific allergen immunotherapy for AD.
However, evidence does support an association between the presence of AD in children and certain other conditions, Dr. Kress said. “Other associations include an increased incidence of alopecia areata, a threefold increase in autism spectrum disorders, and a twofold increase in ADHD in children with atopic dermatitis.”
The only known food allergy linked to AD severity is egg whites; reducing egg white exposure has been shown to improve AD in children with both conditions, he noted.
Although many patients with AD experience annoying but relatively mild symptoms, health care providers should be alert to the potential for infections, particularly with Staphylococcus aureus, and remember that an active egg white allergy has been associated with staphylococcal superantigen sensitization, said Dr. Kress. The increased risk for S. aureus in children with AD may stem from a tendency to underuse antibiotics in AD children, which results in a delayed treatment until the infection becomes overt. In addition, the increased pH in patients with AD might promote the development of pathogenic strains of staph. However, ceramide-based moisturizers could help inhibit these strains by increasing skin acidity.
For patients who have poor AD control with standard therapy, antibiotics may be used as adjunctive therapy. “Consider bleach baths and/or staph decolonization with mupirocin, both of which led to significant improvement in eczema severity compared to placebo,” Dr. Kress said. “Bleach may also have an anti-inflammatory effect.”
Dr. Kress disclosed relationships with Pfizer, Amgen, and Sanofi/Regeneron. SDEF and this news organization are owned by Frontline Medical Communications.
including allergic rhinitis and asthma, according to Douglas W. Kress, MD, of the department of dermatology at the University of Pittsburgh.
Recent studies suggest that atopic dermatitis (AD) affects 10%-17% of the U.S. population, and 80%-90% of patients are diagnosed by the age of 5 years, Dr. Kress said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
“There seem to be multiple pathways, which initiate and perpetuate the cutaneous inflammation of AD including exposure to allergens, irritants, and physical trauma, infection, stress, extremes in temperature and humidity,” Dr. Kress said. In addition, foods and airborne allergens may trigger AD.
Many parents may believe that certain factors are associated with AD, but most of these perceptions are not supported by evidence, said Dr. Kress, who is also chief of the division of pediatric dermatology at the Children’s Hospital of Pittsburgh. AD appears to be a disorder of T cell dysregulation dominated by Th2 lesions in acute cases and Th1 inflammation in patients with chronic lesions.
No associations have been proven between the development of AD in the first 18 months of life and any maternal dietary restrictions, according to a recent Cochrane review, nor is there evidence for an association between AD and the introduction of solid foods, exposure to fish oil, or exposure to animals at a young age, he said. In addition, a study published in 2016 showed a lack of evidence to support the use of specific allergen immunotherapy for AD.
However, evidence does support an association between the presence of AD in children and certain other conditions, Dr. Kress said. “Other associations include an increased incidence of alopecia areata, a threefold increase in autism spectrum disorders, and a twofold increase in ADHD in children with atopic dermatitis.”
The only known food allergy linked to AD severity is egg whites; reducing egg white exposure has been shown to improve AD in children with both conditions, he noted.
Although many patients with AD experience annoying but relatively mild symptoms, health care providers should be alert to the potential for infections, particularly with Staphylococcus aureus, and remember that an active egg white allergy has been associated with staphylococcal superantigen sensitization, said Dr. Kress. The increased risk for S. aureus in children with AD may stem from a tendency to underuse antibiotics in AD children, which results in a delayed treatment until the infection becomes overt. In addition, the increased pH in patients with AD might promote the development of pathogenic strains of staph. However, ceramide-based moisturizers could help inhibit these strains by increasing skin acidity.
For patients who have poor AD control with standard therapy, antibiotics may be used as adjunctive therapy. “Consider bleach baths and/or staph decolonization with mupirocin, both of which led to significant improvement in eczema severity compared to placebo,” Dr. Kress said. “Bleach may also have an anti-inflammatory effect.”
Dr. Kress disclosed relationships with Pfizer, Amgen, and Sanofi/Regeneron. SDEF and this news organization are owned by Frontline Medical Communications.
including allergic rhinitis and asthma, according to Douglas W. Kress, MD, of the department of dermatology at the University of Pittsburgh.
Recent studies suggest that atopic dermatitis (AD) affects 10%-17% of the U.S. population, and 80%-90% of patients are diagnosed by the age of 5 years, Dr. Kress said in a presentation at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
“There seem to be multiple pathways, which initiate and perpetuate the cutaneous inflammation of AD including exposure to allergens, irritants, and physical trauma, infection, stress, extremes in temperature and humidity,” Dr. Kress said. In addition, foods and airborne allergens may trigger AD.
Many parents may believe that certain factors are associated with AD, but most of these perceptions are not supported by evidence, said Dr. Kress, who is also chief of the division of pediatric dermatology at the Children’s Hospital of Pittsburgh. AD appears to be a disorder of T cell dysregulation dominated by Th2 lesions in acute cases and Th1 inflammation in patients with chronic lesions.
No associations have been proven between the development of AD in the first 18 months of life and any maternal dietary restrictions, according to a recent Cochrane review, nor is there evidence for an association between AD and the introduction of solid foods, exposure to fish oil, or exposure to animals at a young age, he said. In addition, a study published in 2016 showed a lack of evidence to support the use of specific allergen immunotherapy for AD.
However, evidence does support an association between the presence of AD in children and certain other conditions, Dr. Kress said. “Other associations include an increased incidence of alopecia areata, a threefold increase in autism spectrum disorders, and a twofold increase in ADHD in children with atopic dermatitis.”
The only known food allergy linked to AD severity is egg whites; reducing egg white exposure has been shown to improve AD in children with both conditions, he noted.
Although many patients with AD experience annoying but relatively mild symptoms, health care providers should be alert to the potential for infections, particularly with Staphylococcus aureus, and remember that an active egg white allergy has been associated with staphylococcal superantigen sensitization, said Dr. Kress. The increased risk for S. aureus in children with AD may stem from a tendency to underuse antibiotics in AD children, which results in a delayed treatment until the infection becomes overt. In addition, the increased pH in patients with AD might promote the development of pathogenic strains of staph. However, ceramide-based moisturizers could help inhibit these strains by increasing skin acidity.
For patients who have poor AD control with standard therapy, antibiotics may be used as adjunctive therapy. “Consider bleach baths and/or staph decolonization with mupirocin, both of which led to significant improvement in eczema severity compared to placebo,” Dr. Kress said. “Bleach may also have an anti-inflammatory effect.”
Dr. Kress disclosed relationships with Pfizer, Amgen, and Sanofi/Regeneron. SDEF and this news organization are owned by Frontline Medical Communications.
EXPERT ANALYSIS FROM SDEF WOMEN’S & PEDIATRIC DERMATOLOGY SEMINAR
Treatment of relapsing progressive MS may reduce disability progression
Superimposed relapses were associated with a significantly reduced risk of disability progression in a longitudinal, prospective cohort study of 1,419 multiple sclerosis patients (MS) of the progressive-onset type.
To determine the role of inflammatory relapses on disability in the progressive-relapsing phenotype of progressive-onset MS, the researchers collected data from MSBase, an international, observational cohort of MS patients, from January 1995 to February 2017. The study population included 1,419 adults with MS (553 in the relapse subgroup, 866 in a nonrelapse subgroup) from 83 centers in 28 countries; the median prospective follow-up period was 5 years. The patients included in the analysis had adult-onset disease, at least three clinic visits with Expanded Disability Status Scale (EDSS) score recorded, and a time frame of more than 3 months between the second and last visit.
Overall, patients with relapses had significantly less risk of disability progression after adjusting for confounding variables (adjusted hazard ratio, 0.83; 95% confidence interval, 0.74-0.94; P = .003). Disease progression was defined as worsening of the EDSS score.
In addition, the researchers examined the data in a stratified model and found a 4% relative decrease in the hazard of confirmed disability progression events for each 10% increment of follow-up time for receiving disease-modifying therapy (DMT). However, DMT did not reduce disease progression risk in progressive-onset MS patients without relapse.
“This suggests that relapses in progressive-onset MS, as a clinical correlate of episodic inflammatory activity, represent a positive prognostic marker and provide an opportunity to improve disease outcomes through prevention of relapse-related disability accrual,” the researchers wrote.
Interferon-beta was the most common DMT, given to 73% of the relapse patients and 56% of the nonrelapse patients, followed by glatiramer acetate (20% and 13%, respectively), and fingolimod (12% and 16%, respectively).
The study’s main limitation was the use of the EDSS as a measure of disability, as well as the absence of quantifiable disability change to confirm relapse, the researchers noted. However, “these findings provide further evidence for a progressive-onset MS phenotype with acute episodic inflammatory changes, thereby identifying patients who may respond to existing immunotherapies.”
The study was supported by grants from the National Health and Medical Research Council of Australia and the MSBase Foundation, a nonprofit organization that itself receives support from multiple companies, including Merck, Novartis, and Sanofi. Dr. Hughes had no financial conflicts to disclose, but most coauthors disclosed relationships with multiple companies including Merck, Novartis, Sanofi. Genzyme, and Biogen.
SOURCE: Hughes J et al. JAMA Neurol. 2018 Aug 6. doi: 10.1001/jamaneurol.2018.2109.
This study is important because it addresses an area of controversy in management of patients with a progressive multiple sclerosis (MS) phenotype. The role of superimposed relapses in patients with progressive MS has long been debated, with some studies reporting no impact on long-term disability accrual and other reporting a negative impact of relapses. Treatment of progressive MS remains controversial as well, with only one therapy approved by the Food and Drug Administration for any form of progressive MS. There is considerable ongoing debate about whether MS disease-modifying therapies (MSDMT) are effective in progressive forms of MS, and whether clinical or MRI evidence of active inflammation predicts a better chance of response.
This study has several important strengths and limitations. The large sample size allowed statistical power to detect relatively small differences in disability progression risk between progressive MS subtypes. The better prognosis in progressive patients with superimposed relapses contradicts some earlier studies that suggested a worse prognosis or no difference in prognosis between progressive patients with and without relapses. This study also supports a role for MSDMT in progressive MS patients, at least those with clinical evidence of relapses, and possibly MRI evidence of inflammatory disease activity (although this was not specifically addressed in the current study). Limitations of the study include the observational nature of the database, variable periods of follow-up, lack of objective verification of recorded relapses either with EDSS scores or MRI confirmation, and lack of an untreated control group. Therefore, no conclusions can be drawn as to whether MSDMT exposure had a favorable impact on the whole cohort of progressive patients versus no treatment.
Jonathan L. Carter, MD , is an MS specialist at the Mayo Clinic in Scottsdale, Ariz. He had no relevant disclosures to report.
This study is important because it addresses an area of controversy in management of patients with a progressive multiple sclerosis (MS) phenotype. The role of superimposed relapses in patients with progressive MS has long been debated, with some studies reporting no impact on long-term disability accrual and other reporting a negative impact of relapses. Treatment of progressive MS remains controversial as well, with only one therapy approved by the Food and Drug Administration for any form of progressive MS. There is considerable ongoing debate about whether MS disease-modifying therapies (MSDMT) are effective in progressive forms of MS, and whether clinical or MRI evidence of active inflammation predicts a better chance of response.
This study has several important strengths and limitations. The large sample size allowed statistical power to detect relatively small differences in disability progression risk between progressive MS subtypes. The better prognosis in progressive patients with superimposed relapses contradicts some earlier studies that suggested a worse prognosis or no difference in prognosis between progressive patients with and without relapses. This study also supports a role for MSDMT in progressive MS patients, at least those with clinical evidence of relapses, and possibly MRI evidence of inflammatory disease activity (although this was not specifically addressed in the current study). Limitations of the study include the observational nature of the database, variable periods of follow-up, lack of objective verification of recorded relapses either with EDSS scores or MRI confirmation, and lack of an untreated control group. Therefore, no conclusions can be drawn as to whether MSDMT exposure had a favorable impact on the whole cohort of progressive patients versus no treatment.
Jonathan L. Carter, MD , is an MS specialist at the Mayo Clinic in Scottsdale, Ariz. He had no relevant disclosures to report.
This study is important because it addresses an area of controversy in management of patients with a progressive multiple sclerosis (MS) phenotype. The role of superimposed relapses in patients with progressive MS has long been debated, with some studies reporting no impact on long-term disability accrual and other reporting a negative impact of relapses. Treatment of progressive MS remains controversial as well, with only one therapy approved by the Food and Drug Administration for any form of progressive MS. There is considerable ongoing debate about whether MS disease-modifying therapies (MSDMT) are effective in progressive forms of MS, and whether clinical or MRI evidence of active inflammation predicts a better chance of response.
This study has several important strengths and limitations. The large sample size allowed statistical power to detect relatively small differences in disability progression risk between progressive MS subtypes. The better prognosis in progressive patients with superimposed relapses contradicts some earlier studies that suggested a worse prognosis or no difference in prognosis between progressive patients with and without relapses. This study also supports a role for MSDMT in progressive MS patients, at least those with clinical evidence of relapses, and possibly MRI evidence of inflammatory disease activity (although this was not specifically addressed in the current study). Limitations of the study include the observational nature of the database, variable periods of follow-up, lack of objective verification of recorded relapses either with EDSS scores or MRI confirmation, and lack of an untreated control group. Therefore, no conclusions can be drawn as to whether MSDMT exposure had a favorable impact on the whole cohort of progressive patients versus no treatment.
Jonathan L. Carter, MD , is an MS specialist at the Mayo Clinic in Scottsdale, Ariz. He had no relevant disclosures to report.
Superimposed relapses were associated with a significantly reduced risk of disability progression in a longitudinal, prospective cohort study of 1,419 multiple sclerosis patients (MS) of the progressive-onset type.
To determine the role of inflammatory relapses on disability in the progressive-relapsing phenotype of progressive-onset MS, the researchers collected data from MSBase, an international, observational cohort of MS patients, from January 1995 to February 2017. The study population included 1,419 adults with MS (553 in the relapse subgroup, 866 in a nonrelapse subgroup) from 83 centers in 28 countries; the median prospective follow-up period was 5 years. The patients included in the analysis had adult-onset disease, at least three clinic visits with Expanded Disability Status Scale (EDSS) score recorded, and a time frame of more than 3 months between the second and last visit.
Overall, patients with relapses had significantly less risk of disability progression after adjusting for confounding variables (adjusted hazard ratio, 0.83; 95% confidence interval, 0.74-0.94; P = .003). Disease progression was defined as worsening of the EDSS score.
In addition, the researchers examined the data in a stratified model and found a 4% relative decrease in the hazard of confirmed disability progression events for each 10% increment of follow-up time for receiving disease-modifying therapy (DMT). However, DMT did not reduce disease progression risk in progressive-onset MS patients without relapse.
“This suggests that relapses in progressive-onset MS, as a clinical correlate of episodic inflammatory activity, represent a positive prognostic marker and provide an opportunity to improve disease outcomes through prevention of relapse-related disability accrual,” the researchers wrote.
Interferon-beta was the most common DMT, given to 73% of the relapse patients and 56% of the nonrelapse patients, followed by glatiramer acetate (20% and 13%, respectively), and fingolimod (12% and 16%, respectively).
The study’s main limitation was the use of the EDSS as a measure of disability, as well as the absence of quantifiable disability change to confirm relapse, the researchers noted. However, “these findings provide further evidence for a progressive-onset MS phenotype with acute episodic inflammatory changes, thereby identifying patients who may respond to existing immunotherapies.”
The study was supported by grants from the National Health and Medical Research Council of Australia and the MSBase Foundation, a nonprofit organization that itself receives support from multiple companies, including Merck, Novartis, and Sanofi. Dr. Hughes had no financial conflicts to disclose, but most coauthors disclosed relationships with multiple companies including Merck, Novartis, Sanofi. Genzyme, and Biogen.
SOURCE: Hughes J et al. JAMA Neurol. 2018 Aug 6. doi: 10.1001/jamaneurol.2018.2109.
Superimposed relapses were associated with a significantly reduced risk of disability progression in a longitudinal, prospective cohort study of 1,419 multiple sclerosis patients (MS) of the progressive-onset type.
To determine the role of inflammatory relapses on disability in the progressive-relapsing phenotype of progressive-onset MS, the researchers collected data from MSBase, an international, observational cohort of MS patients, from January 1995 to February 2017. The study population included 1,419 adults with MS (553 in the relapse subgroup, 866 in a nonrelapse subgroup) from 83 centers in 28 countries; the median prospective follow-up period was 5 years. The patients included in the analysis had adult-onset disease, at least three clinic visits with Expanded Disability Status Scale (EDSS) score recorded, and a time frame of more than 3 months between the second and last visit.
Overall, patients with relapses had significantly less risk of disability progression after adjusting for confounding variables (adjusted hazard ratio, 0.83; 95% confidence interval, 0.74-0.94; P = .003). Disease progression was defined as worsening of the EDSS score.
In addition, the researchers examined the data in a stratified model and found a 4% relative decrease in the hazard of confirmed disability progression events for each 10% increment of follow-up time for receiving disease-modifying therapy (DMT). However, DMT did not reduce disease progression risk in progressive-onset MS patients without relapse.
“This suggests that relapses in progressive-onset MS, as a clinical correlate of episodic inflammatory activity, represent a positive prognostic marker and provide an opportunity to improve disease outcomes through prevention of relapse-related disability accrual,” the researchers wrote.
Interferon-beta was the most common DMT, given to 73% of the relapse patients and 56% of the nonrelapse patients, followed by glatiramer acetate (20% and 13%, respectively), and fingolimod (12% and 16%, respectively).
The study’s main limitation was the use of the EDSS as a measure of disability, as well as the absence of quantifiable disability change to confirm relapse, the researchers noted. However, “these findings provide further evidence for a progressive-onset MS phenotype with acute episodic inflammatory changes, thereby identifying patients who may respond to existing immunotherapies.”
The study was supported by grants from the National Health and Medical Research Council of Australia and the MSBase Foundation, a nonprofit organization that itself receives support from multiple companies, including Merck, Novartis, and Sanofi. Dr. Hughes had no financial conflicts to disclose, but most coauthors disclosed relationships with multiple companies including Merck, Novartis, Sanofi. Genzyme, and Biogen.
SOURCE: Hughes J et al. JAMA Neurol. 2018 Aug 6. doi: 10.1001/jamaneurol.2018.2109.
FROM JAMA NEUROLOGY
Key clinical point: Disease-modifying therapy was significantly associated with less disability progression in multiple sclerosis patients with superimposed relapses, compared with those without relapses.
Major finding: Progressive-onset multiple sclerosis patients with superimposed relapses were significantly less likely to have confirmed disability progression (adjusted hazard ratio, 0.83).
Study details: The data came from a longitudinal, prospective cohort study of 1,419 adults with progressive-onset multiple sclerosis.
Disclosures: The study was supported by grants from the National Health and Medical Research Council of Australia and the MSBase Foundation, a nonprofit organization that itself receives support from multiple companies, including Merck, Novartis, and Sanofi. Dr. Hughes had no financial conflicts to disclose, but most coauthors disclosed relationships with multiple companies, including Merck, Novartis, Sanofi, Genzyme, and Biogen.
Source: Hughes J et al. JAMA Neurol. 2018 Aug 6. doi: 10.1001/jamaneurol.2018.2109.
FDA rejects mepolizumab on efficacy, but supports safety for COPD
Asthma drug mepolizumab could be added safely to inhaled corticosteroids for maintenance therapy to help reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients who meet criteria for eosinophil counts, but the current data do not support its efficacy strongly enough for approval, according to a majority of members of the Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee.
The committee voted 16-3 that there was insufficient evidence of efficacy to support guided by eosinophil levels; they also voted 16-3 that the risk-benefit profile was not adequate to support approval.
However, on a voting question of safety, the committee voted 17-2 that the safety data on mepolizumab were sufficient to support approval.
Mepolizumab, a humanized monoclonal antibody, is currently approved for the treatment of asthma with eosinophilic phenotype for patients aged 12 years and older and for adults with eosinophilic granulomatosis with polyangiitis. Manufacturer GlaxoSmithKline is seeking approval for its use as an add-on therapy in COPD patients at a subcutaneous dose of 100 mg every 4 weeks. Mepolizumab works by binding to interleukin-5 (IL-5) and reducing eosinophil maturation and survival, which prompted GlaxoSmithKline to pursue an indication for COPD patients in a high-eosinophil stratum.
The application was supported in part by two concurrent randomized trials of 52 weeks’ duration.
Banu A. Karimi-Shah, MD, clinical team leader of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, presented data from the two studies, referred to as Study 106 and Study 113.
In Study 106, researchers found statistically significant reductions in exacerbations for patients in the highest eosinophil group. However, challenges of the studies included a lack of consensus over the definition and possible relevance of an eosinophilic COPD phenotype, Dr. Karimi-Shah said in a presentation at the meeting.
In Study 113, mepolizumab had no significant impact on reducing moderate to severe exacerbations at either a 100-mg or 300-mg dose, Dr. Karimi-Shah said. In addition, most secondary endpoints, with the exception of reducing time to the first exacerbation among patients in the highest eosinophil group, did not consistently support the primary endpoint of exacerbation reduction in either study, she said.
Robert Busch, MD, also of the FDA’s Division of Pulmonary, Allergy, and Rheumatology products, served as a clinical reviewer and presented data on safety, efficacy, and risk-benefit profile of mepolizumab.
Dr. Busch noted that the variability in blood eosinophils make it challenging to use as a potential marker to identify patients who would benefit from mepolizumab as an add-on therapy.
Overall, most of the committee agreed on the existence of an eosinophilic COPD phenotype, but expressed concern about the threshold being used.
“The studies were not particularly well controlled regarding the characterization of patients,” said William J. Calhoun, MD, of the University of Texas Medical Branch, Galveston, who cast one of the ‘no’ votes on the question of efficacy.
By contrast, Jeffrey S. Wagener, MD, of the University of Colorado at Denver, Aurora, referenced his background in cystic fibrosis, and voted “yes” on the question of efficacy. “For patients that have no other option, this is a step forward,” he said.
Committee members on both sides of the vote emphasized the need for more research with larger numbers, better patient characterization, and more female patients. The committee members reported no relevant conflicts of interest.
Asthma drug mepolizumab could be added safely to inhaled corticosteroids for maintenance therapy to help reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients who meet criteria for eosinophil counts, but the current data do not support its efficacy strongly enough for approval, according to a majority of members of the Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee.
The committee voted 16-3 that there was insufficient evidence of efficacy to support guided by eosinophil levels; they also voted 16-3 that the risk-benefit profile was not adequate to support approval.
However, on a voting question of safety, the committee voted 17-2 that the safety data on mepolizumab were sufficient to support approval.
Mepolizumab, a humanized monoclonal antibody, is currently approved for the treatment of asthma with eosinophilic phenotype for patients aged 12 years and older and for adults with eosinophilic granulomatosis with polyangiitis. Manufacturer GlaxoSmithKline is seeking approval for its use as an add-on therapy in COPD patients at a subcutaneous dose of 100 mg every 4 weeks. Mepolizumab works by binding to interleukin-5 (IL-5) and reducing eosinophil maturation and survival, which prompted GlaxoSmithKline to pursue an indication for COPD patients in a high-eosinophil stratum.
The application was supported in part by two concurrent randomized trials of 52 weeks’ duration.
Banu A. Karimi-Shah, MD, clinical team leader of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, presented data from the two studies, referred to as Study 106 and Study 113.
In Study 106, researchers found statistically significant reductions in exacerbations for patients in the highest eosinophil group. However, challenges of the studies included a lack of consensus over the definition and possible relevance of an eosinophilic COPD phenotype, Dr. Karimi-Shah said in a presentation at the meeting.
In Study 113, mepolizumab had no significant impact on reducing moderate to severe exacerbations at either a 100-mg or 300-mg dose, Dr. Karimi-Shah said. In addition, most secondary endpoints, with the exception of reducing time to the first exacerbation among patients in the highest eosinophil group, did not consistently support the primary endpoint of exacerbation reduction in either study, she said.
Robert Busch, MD, also of the FDA’s Division of Pulmonary, Allergy, and Rheumatology products, served as a clinical reviewer and presented data on safety, efficacy, and risk-benefit profile of mepolizumab.
Dr. Busch noted that the variability in blood eosinophils make it challenging to use as a potential marker to identify patients who would benefit from mepolizumab as an add-on therapy.
Overall, most of the committee agreed on the existence of an eosinophilic COPD phenotype, but expressed concern about the threshold being used.
“The studies were not particularly well controlled regarding the characterization of patients,” said William J. Calhoun, MD, of the University of Texas Medical Branch, Galveston, who cast one of the ‘no’ votes on the question of efficacy.
By contrast, Jeffrey S. Wagener, MD, of the University of Colorado at Denver, Aurora, referenced his background in cystic fibrosis, and voted “yes” on the question of efficacy. “For patients that have no other option, this is a step forward,” he said.
Committee members on both sides of the vote emphasized the need for more research with larger numbers, better patient characterization, and more female patients. The committee members reported no relevant conflicts of interest.
Asthma drug mepolizumab could be added safely to inhaled corticosteroids for maintenance therapy to help reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients who meet criteria for eosinophil counts, but the current data do not support its efficacy strongly enough for approval, according to a majority of members of the Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee.
The committee voted 16-3 that there was insufficient evidence of efficacy to support guided by eosinophil levels; they also voted 16-3 that the risk-benefit profile was not adequate to support approval.
However, on a voting question of safety, the committee voted 17-2 that the safety data on mepolizumab were sufficient to support approval.
Mepolizumab, a humanized monoclonal antibody, is currently approved for the treatment of asthma with eosinophilic phenotype for patients aged 12 years and older and for adults with eosinophilic granulomatosis with polyangiitis. Manufacturer GlaxoSmithKline is seeking approval for its use as an add-on therapy in COPD patients at a subcutaneous dose of 100 mg every 4 weeks. Mepolizumab works by binding to interleukin-5 (IL-5) and reducing eosinophil maturation and survival, which prompted GlaxoSmithKline to pursue an indication for COPD patients in a high-eosinophil stratum.
The application was supported in part by two concurrent randomized trials of 52 weeks’ duration.
Banu A. Karimi-Shah, MD, clinical team leader of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, presented data from the two studies, referred to as Study 106 and Study 113.
In Study 106, researchers found statistically significant reductions in exacerbations for patients in the highest eosinophil group. However, challenges of the studies included a lack of consensus over the definition and possible relevance of an eosinophilic COPD phenotype, Dr. Karimi-Shah said in a presentation at the meeting.
In Study 113, mepolizumab had no significant impact on reducing moderate to severe exacerbations at either a 100-mg or 300-mg dose, Dr. Karimi-Shah said. In addition, most secondary endpoints, with the exception of reducing time to the first exacerbation among patients in the highest eosinophil group, did not consistently support the primary endpoint of exacerbation reduction in either study, she said.
Robert Busch, MD, also of the FDA’s Division of Pulmonary, Allergy, and Rheumatology products, served as a clinical reviewer and presented data on safety, efficacy, and risk-benefit profile of mepolizumab.
Dr. Busch noted that the variability in blood eosinophils make it challenging to use as a potential marker to identify patients who would benefit from mepolizumab as an add-on therapy.
Overall, most of the committee agreed on the existence of an eosinophilic COPD phenotype, but expressed concern about the threshold being used.
“The studies were not particularly well controlled regarding the characterization of patients,” said William J. Calhoun, MD, of the University of Texas Medical Branch, Galveston, who cast one of the ‘no’ votes on the question of efficacy.
By contrast, Jeffrey S. Wagener, MD, of the University of Colorado at Denver, Aurora, referenced his background in cystic fibrosis, and voted “yes” on the question of efficacy. “For patients that have no other option, this is a step forward,” he said.
Committee members on both sides of the vote emphasized the need for more research with larger numbers, better patient characterization, and more female patients. The committee members reported no relevant conflicts of interest.
FROM AN FDA ADVISORY COMMITTEE MEETING
Less is more: Nanotechnology enhances antifungal’s efficacy
The use of nanotechnology significantly reduced the amount of efinaconazole needed to effectively treat nail fungus in a study that pitted nitric oxide–releasing nanoparticles combined with the antifungal against reference strains of Trichophyton rubrum.
Efinaconazole has demonstrated effectiveness as a topical treatment for T. rubrum, but treatment can be expensive, with a single 4-mL bottle costing $691 at a major chain pharmacy, wrote Caroline B. Costa-Orlandi, PhD, of Universidade Estadual Paulista, Sao Paulo, Brazil, and her colleagues.
In a study published in the Journal of Drugs in Dermatology, an international research team evaluated topical efinaconazole and topical terbinafine, each combined with previously characterized, nitric oxide–releasing nanoparticles (NO-np) in a checkerboard design, to attack two reference strains of T. rubrum, ATCC MYA-4438 and ATCC 28189. NO-np was combined with 10% efinaconazole or with terbinafine.
The combination of NO-np and efinaconazole reduced the minimum inhibitory concentration (MIC) of efinaconazole by 16 times compared with treatment alone against ATCC MYA-4438; by 4 times when combined against ATCC 28189. With NO-np plus terbinafine, MICs against ATCC 28189 and ATCC MYA-4438 were reduced by four- and twofold, respectively, when compared with terbinafine alone. These data follow recently published findings in a study cited by the authors that demonstrated that NO-np is superior to topical terbinafine 1% cream in clearing infection in a mouse model of deep dermal dermatophytosis, suggesting that the combination may be even more effective (Nanomedicine. 2017 Oct;13[7]:2267-70).
“What we found was that we could impart the same antifungal activity at the highest concentrations tested of either alone by combining them at a fraction of these concentrations,” corresponding author Adam Friedman, MD, professor of dermatology, George Washington University, Washington, said in a press release issued by the university. The impact of this combination, “which we visualized using electron microscopy as compared to either product alone, highlighted their synergistic damaging effects at concentrations that would be completely safe to human cells,” he added.
Other benefits of NO-np include low cost, safety, ease of use, reduced likelihood for the development of antimicrobial resistance, and proven efficacy against other dermatophyte infections, the researchers noted.
The findings support the potential value of further research to evaluate nanoparticles combined with topical antifungals in a clinical setting, they said.
Dr. Costa-Orlandi had no financial conflicts to disclose. Authors Adam Friedman, MD, and Joel Friedman, MD, are coinventors of the nitric oxide–releasing nanoparticles used in the study. Dr. Adam Friedman is on the advisory board of Dermatology News.
SOURCE: Costa-Orlandi C et al. J Drugs Dermatol. 2018;17(7):717-20.
The use of nanotechnology significantly reduced the amount of efinaconazole needed to effectively treat nail fungus in a study that pitted nitric oxide–releasing nanoparticles combined with the antifungal against reference strains of Trichophyton rubrum.
Efinaconazole has demonstrated effectiveness as a topical treatment for T. rubrum, but treatment can be expensive, with a single 4-mL bottle costing $691 at a major chain pharmacy, wrote Caroline B. Costa-Orlandi, PhD, of Universidade Estadual Paulista, Sao Paulo, Brazil, and her colleagues.
In a study published in the Journal of Drugs in Dermatology, an international research team evaluated topical efinaconazole and topical terbinafine, each combined with previously characterized, nitric oxide–releasing nanoparticles (NO-np) in a checkerboard design, to attack two reference strains of T. rubrum, ATCC MYA-4438 and ATCC 28189. NO-np was combined with 10% efinaconazole or with terbinafine.
The combination of NO-np and efinaconazole reduced the minimum inhibitory concentration (MIC) of efinaconazole by 16 times compared with treatment alone against ATCC MYA-4438; by 4 times when combined against ATCC 28189. With NO-np plus terbinafine, MICs against ATCC 28189 and ATCC MYA-4438 were reduced by four- and twofold, respectively, when compared with terbinafine alone. These data follow recently published findings in a study cited by the authors that demonstrated that NO-np is superior to topical terbinafine 1% cream in clearing infection in a mouse model of deep dermal dermatophytosis, suggesting that the combination may be even more effective (Nanomedicine. 2017 Oct;13[7]:2267-70).
“What we found was that we could impart the same antifungal activity at the highest concentrations tested of either alone by combining them at a fraction of these concentrations,” corresponding author Adam Friedman, MD, professor of dermatology, George Washington University, Washington, said in a press release issued by the university. The impact of this combination, “which we visualized using electron microscopy as compared to either product alone, highlighted their synergistic damaging effects at concentrations that would be completely safe to human cells,” he added.
Other benefits of NO-np include low cost, safety, ease of use, reduced likelihood for the development of antimicrobial resistance, and proven efficacy against other dermatophyte infections, the researchers noted.
The findings support the potential value of further research to evaluate nanoparticles combined with topical antifungals in a clinical setting, they said.
Dr. Costa-Orlandi had no financial conflicts to disclose. Authors Adam Friedman, MD, and Joel Friedman, MD, are coinventors of the nitric oxide–releasing nanoparticles used in the study. Dr. Adam Friedman is on the advisory board of Dermatology News.
SOURCE: Costa-Orlandi C et al. J Drugs Dermatol. 2018;17(7):717-20.
The use of nanotechnology significantly reduced the amount of efinaconazole needed to effectively treat nail fungus in a study that pitted nitric oxide–releasing nanoparticles combined with the antifungal against reference strains of Trichophyton rubrum.
Efinaconazole has demonstrated effectiveness as a topical treatment for T. rubrum, but treatment can be expensive, with a single 4-mL bottle costing $691 at a major chain pharmacy, wrote Caroline B. Costa-Orlandi, PhD, of Universidade Estadual Paulista, Sao Paulo, Brazil, and her colleagues.
In a study published in the Journal of Drugs in Dermatology, an international research team evaluated topical efinaconazole and topical terbinafine, each combined with previously characterized, nitric oxide–releasing nanoparticles (NO-np) in a checkerboard design, to attack two reference strains of T. rubrum, ATCC MYA-4438 and ATCC 28189. NO-np was combined with 10% efinaconazole or with terbinafine.
The combination of NO-np and efinaconazole reduced the minimum inhibitory concentration (MIC) of efinaconazole by 16 times compared with treatment alone against ATCC MYA-4438; by 4 times when combined against ATCC 28189. With NO-np plus terbinafine, MICs against ATCC 28189 and ATCC MYA-4438 were reduced by four- and twofold, respectively, when compared with terbinafine alone. These data follow recently published findings in a study cited by the authors that demonstrated that NO-np is superior to topical terbinafine 1% cream in clearing infection in a mouse model of deep dermal dermatophytosis, suggesting that the combination may be even more effective (Nanomedicine. 2017 Oct;13[7]:2267-70).
“What we found was that we could impart the same antifungal activity at the highest concentrations tested of either alone by combining them at a fraction of these concentrations,” corresponding author Adam Friedman, MD, professor of dermatology, George Washington University, Washington, said in a press release issued by the university. The impact of this combination, “which we visualized using electron microscopy as compared to either product alone, highlighted their synergistic damaging effects at concentrations that would be completely safe to human cells,” he added.
Other benefits of NO-np include low cost, safety, ease of use, reduced likelihood for the development of antimicrobial resistance, and proven efficacy against other dermatophyte infections, the researchers noted.
The findings support the potential value of further research to evaluate nanoparticles combined with topical antifungals in a clinical setting, they said.
Dr. Costa-Orlandi had no financial conflicts to disclose. Authors Adam Friedman, MD, and Joel Friedman, MD, are coinventors of the nitric oxide–releasing nanoparticles used in the study. Dr. Adam Friedman is on the advisory board of Dermatology News.
SOURCE: Costa-Orlandi C et al. J Drugs Dermatol. 2018;17(7):717-20.
FROM JOURNAL OF DRUGS IN DERMATOLOGY
Key clinical point: Adding nanoparticles to antifungal medication improved the drug’s effectiveness and reduced the amount needed.
Major finding: Efinaconazole combined with nitric oxide–releasing nanoparticles reduced the antifungal’s minimum inhibitory concentration 16-fold, compared with the antifungal alone against T. rubrum reference strains.
Study details: The data come from an in vitro analysis of nanoparticle-enhanced efinaconazole or terbinafine against T. rubrum.
Disclosures: Dr. Costa-Orlandi had no financial conflicts to disclose. Coauthors Dr. Adam Friedman and Dr. Joel Friedman are coinventors of the nitric oxide–releasing nanoparticles used in the study.
Source: Costa-Orlandi C et al. J Drugs Dermatol. 2018;17(7):717-20.
MIS underused for hernia repair
Surgeons in the United States have been slow to adopt according to data from more than 6,000 patients.
“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.
In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.
Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.
Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).
Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.
The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.
The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.
“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.
“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.
The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.
Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.
SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.
Surgeons in the United States have been slow to adopt according to data from more than 6,000 patients.
“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.
In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.
Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.
Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).
Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.
The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.
The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.
“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.
“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.
The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.
Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.
SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.
Surgeons in the United States have been slow to adopt according to data from more than 6,000 patients.
“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.
In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.
Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.
Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).
Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.
The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.
The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.
“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.
“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.
The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.
Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.
SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.
FROM SURGICAL ENDOSCOPY
Key clinical point: Minimally invasive surgery remains underused as a method for managing inguinal hernias.
Major finding: Overall, 75% of MIS hernia repairs were performed by 14% of the surgeons.
Study details: The data come from a retrospective cohort study of 6,723 hernia surgery patients treated between 2012 and 2016.
Disclosures: Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.
Source: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.
Extended data support ixekizumab for plaque psoriasis
followed over a 4-year extension of a randomized trial.
Patients from a previous study of ixekizumab were treated with 120 mg at the start of the extension, and then 80 mg subcutaneously every 4 weeks, Claus Zachariae, MD, of the University Hospital of Copenhagen Gentofte, and his coauthors reported in the Journal of the American Academy of Dermatology.
At week 208, 82% of the patients achieved Psoriasis Area and Severity Index (PASI) 75, 65% achieved PASI 90, and 45% achieved PASI 100; 65% scored a 0 or 1 on the Physician’s Global Assessment Scale. In addition, 45% of patients reported a score of 0 on the Physician Global Assessment. Patients also reported a decrease in itching from baseline.
A total of 17% of patients experienced a serious adverse event and 87% of the patients experienced at least one treatment-related adverse event by the end of the 4-year extension period. Most of the reported events were mild to moderate; the most common were nasopharyngitis (23%), sinusitis (13%), upper respiratory tract infection (13%), and headache (10%).
The study findings were limited by several factors including the lack of blinding and lack of a placebo, the researchers noted.
However, the results demonstrate “that efficacy can be maintained at high levels for up to 4 years of ixekizumab therapy without apparent increases in health risks or safety issues,” for psoriasis patients, Dr. Zachariae and his associates said. “Longer treatment periods in larger numbers of patients will be reported for patients enrolled in the 5-year phase 3 ixekizumab studies.”
The study was supported by Eli Lilly. Dr. Zachariae disclosed relationships with Eli Lilly and other companies including Janssen, Novartis, AbbVie, and Amgen. His coauthors had financial relationships with multiple companies.
SOURCE: Zachariae C et al. J Am Acad Dermatol. 2018 Aug;79(2):294-301.e6.
followed over a 4-year extension of a randomized trial.
Patients from a previous study of ixekizumab were treated with 120 mg at the start of the extension, and then 80 mg subcutaneously every 4 weeks, Claus Zachariae, MD, of the University Hospital of Copenhagen Gentofte, and his coauthors reported in the Journal of the American Academy of Dermatology.
At week 208, 82% of the patients achieved Psoriasis Area and Severity Index (PASI) 75, 65% achieved PASI 90, and 45% achieved PASI 100; 65% scored a 0 or 1 on the Physician’s Global Assessment Scale. In addition, 45% of patients reported a score of 0 on the Physician Global Assessment. Patients also reported a decrease in itching from baseline.
A total of 17% of patients experienced a serious adverse event and 87% of the patients experienced at least one treatment-related adverse event by the end of the 4-year extension period. Most of the reported events were mild to moderate; the most common were nasopharyngitis (23%), sinusitis (13%), upper respiratory tract infection (13%), and headache (10%).
The study findings were limited by several factors including the lack of blinding and lack of a placebo, the researchers noted.
However, the results demonstrate “that efficacy can be maintained at high levels for up to 4 years of ixekizumab therapy without apparent increases in health risks or safety issues,” for psoriasis patients, Dr. Zachariae and his associates said. “Longer treatment periods in larger numbers of patients will be reported for patients enrolled in the 5-year phase 3 ixekizumab studies.”
The study was supported by Eli Lilly. Dr. Zachariae disclosed relationships with Eli Lilly and other companies including Janssen, Novartis, AbbVie, and Amgen. His coauthors had financial relationships with multiple companies.
SOURCE: Zachariae C et al. J Am Acad Dermatol. 2018 Aug;79(2):294-301.e6.
followed over a 4-year extension of a randomized trial.
Patients from a previous study of ixekizumab were treated with 120 mg at the start of the extension, and then 80 mg subcutaneously every 4 weeks, Claus Zachariae, MD, of the University Hospital of Copenhagen Gentofte, and his coauthors reported in the Journal of the American Academy of Dermatology.
At week 208, 82% of the patients achieved Psoriasis Area and Severity Index (PASI) 75, 65% achieved PASI 90, and 45% achieved PASI 100; 65% scored a 0 or 1 on the Physician’s Global Assessment Scale. In addition, 45% of patients reported a score of 0 on the Physician Global Assessment. Patients also reported a decrease in itching from baseline.
A total of 17% of patients experienced a serious adverse event and 87% of the patients experienced at least one treatment-related adverse event by the end of the 4-year extension period. Most of the reported events were mild to moderate; the most common were nasopharyngitis (23%), sinusitis (13%), upper respiratory tract infection (13%), and headache (10%).
The study findings were limited by several factors including the lack of blinding and lack of a placebo, the researchers noted.
However, the results demonstrate “that efficacy can be maintained at high levels for up to 4 years of ixekizumab therapy without apparent increases in health risks or safety issues,” for psoriasis patients, Dr. Zachariae and his associates said. “Longer treatment periods in larger numbers of patients will be reported for patients enrolled in the 5-year phase 3 ixekizumab studies.”
The study was supported by Eli Lilly. Dr. Zachariae disclosed relationships with Eli Lilly and other companies including Janssen, Novartis, AbbVie, and Amgen. His coauthors had financial relationships with multiple companies.
SOURCE: Zachariae C et al. J Am Acad Dermatol. 2018 Aug;79(2):294-301.e6.
FROM JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Key clinical point: Ixekizumab appears to be an effective option for long-term treatment of patients with moderate to severe psoriasis.
Major finding: A total of 82% of patients achieved PASI 75 at week 208 of the open-label extension study.
Study details: The data come from a 4-year open-label extension of a phase 2 randomized, placebo-controlled trial including 120 adults with psoriasis.
Disclosures: The study was supported by Eli Lilly. Dr. Zachariae disclosed relationships with Eli Lilly and other companies including Janssen, Novartis, AbbVie, and Amgen. His coauthors had financial relationships with multiple companies.
Source: Zachariae C et al. J Am Acad Dermatol. 2018 Aug;79(2):294-301.e6.
