Heidi Splete

Catch-up human papillomavirus (HPV) vaccination should be harmonized to include all individuals through 26 years of age, according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.

copyright DesignPics/Thinkstock

The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.

In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.

Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.

The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.

The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.

However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.

Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.

Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.

The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”

The ACIP members had no financial conflicts to disclose.

Catch-up human papillomavirus (HPV) vaccination should be harmonized to include all individuals through 26 years of age, according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.

copyright DesignPics/Thinkstock

The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.

In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.

Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.

The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.

The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.

However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.

Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.

Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.

The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”

The ACIP members had no financial conflicts to disclose.

Catch-up human papillomavirus (HPV) vaccination should be harmonized to include all individuals through 26 years of age, according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.

copyright DesignPics/Thinkstock

The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.

In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.

Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.

The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.

The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.

However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.

Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.

Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.

The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”

The ACIP members had no financial conflicts to disclose.

Patients given lower prescription quantities of opioid tablets with and without opioid education used significantly less of the medication compared with those given more tablets and no education, according to data from 264 adults and adolescents who underwent anterior cruciate ligament (ACL) surgery.

KatarzynaBialasiewicz/Thinkstock

Although lower default prescription programs have been shown to reduce the number of tablets prescribed, “the effect of reduced prescription quantities on actual patient opioid consumption remains undetermined,” wrote Kevin X. Farley, BS, of Emory University, Atlanta, and colleagues.

In a study published in JAMA, the researchers examined whether patients took fewer tablets if given fewer, and whether patient education about opioids further reduced the number of tablets taken.

The study population included adults and adolescents who underwent ACL surgery at a single center. The patients were divided into three groups: 109 patients received 50 opioid tablets after surgery, 78 received 30 tablets plus education prior to surgery about appropriate opioid use and alternative pain management, and 77 received 30 tablets but no education on opioid use.

Patients given 50 tablets consumed an average of 25 tablets for an average of 5.8 days. By contrast, patients given 30 tablets but no opioid education consumed an average of 16 tablets for an average of 4.5 days, and those given 30 tablets and preoperative education consumed an average of 12 tablets for an average of 3.5 days.

In addition, patients given 30 tablets reported lower levels of constipation and fatigue compared with patients given 50 tablets. No differences were seen in medication refills among the groups.

The findings were limited by several factors including the use of data from a single center, the lack of randomization, and the potential for recall bias, the researchers noted. However, the results suggest that prescribing fewer tablets may further reduce use, as each group consumed approximately half of the tablets given, the researchers added.

“Further investigation should evaluate whether similar opioid stewardship and education protocols would be successful in other patient populations,” they said.

Corresponding author John Xerogeanes, MD, disclosed personal fees from Arthrex and stock options from Trice. The other researchers had no financial conflicts to disclose.

SOURCE: Farley KX et al. JAMA. 2019 June 25.321(24):2465-7.

Patients given lower prescription quantities of opioid tablets with and without opioid education used significantly less of the medication compared with those given more tablets and no education, according to data from 264 adults and adolescents who underwent anterior cruciate ligament (ACL) surgery.

KatarzynaBialasiewicz/Thinkstock

Although lower default prescription programs have been shown to reduce the number of tablets prescribed, “the effect of reduced prescription quantities on actual patient opioid consumption remains undetermined,” wrote Kevin X. Farley, BS, of Emory University, Atlanta, and colleagues.

In a study published in JAMA, the researchers examined whether patients took fewer tablets if given fewer, and whether patient education about opioids further reduced the number of tablets taken.

The study population included adults and adolescents who underwent ACL surgery at a single center. The patients were divided into three groups: 109 patients received 50 opioid tablets after surgery, 78 received 30 tablets plus education prior to surgery about appropriate opioid use and alternative pain management, and 77 received 30 tablets but no education on opioid use.

Patients given 50 tablets consumed an average of 25 tablets for an average of 5.8 days. By contrast, patients given 30 tablets but no opioid education consumed an average of 16 tablets for an average of 4.5 days, and those given 30 tablets and preoperative education consumed an average of 12 tablets for an average of 3.5 days.

In addition, patients given 30 tablets reported lower levels of constipation and fatigue compared with patients given 50 tablets. No differences were seen in medication refills among the groups.

The findings were limited by several factors including the use of data from a single center, the lack of randomization, and the potential for recall bias, the researchers noted. However, the results suggest that prescribing fewer tablets may further reduce use, as each group consumed approximately half of the tablets given, the researchers added.

“Further investigation should evaluate whether similar opioid stewardship and education protocols would be successful in other patient populations,” they said.

Corresponding author John Xerogeanes, MD, disclosed personal fees from Arthrex and stock options from Trice. The other researchers had no financial conflicts to disclose.

SOURCE: Farley KX et al. JAMA. 2019 June 25.321(24):2465-7.

Patients given lower prescription quantities of opioid tablets with and without opioid education used significantly less of the medication compared with those given more tablets and no education, according to data from 264 adults and adolescents who underwent anterior cruciate ligament (ACL) surgery.

KatarzynaBialasiewicz/Thinkstock

Although lower default prescription programs have been shown to reduce the number of tablets prescribed, “the effect of reduced prescription quantities on actual patient opioid consumption remains undetermined,” wrote Kevin X. Farley, BS, of Emory University, Atlanta, and colleagues.

In a study published in JAMA, the researchers examined whether patients took fewer tablets if given fewer, and whether patient education about opioids further reduced the number of tablets taken.

The study population included adults and adolescents who underwent ACL surgery at a single center. The patients were divided into three groups: 109 patients received 50 opioid tablets after surgery, 78 received 30 tablets plus education prior to surgery about appropriate opioid use and alternative pain management, and 77 received 30 tablets but no education on opioid use.

Patients given 50 tablets consumed an average of 25 tablets for an average of 5.8 days. By contrast, patients given 30 tablets but no opioid education consumed an average of 16 tablets for an average of 4.5 days, and those given 30 tablets and preoperative education consumed an average of 12 tablets for an average of 3.5 days.

In addition, patients given 30 tablets reported lower levels of constipation and fatigue compared with patients given 50 tablets. No differences were seen in medication refills among the groups.

The findings were limited by several factors including the use of data from a single center, the lack of randomization, and the potential for recall bias, the researchers noted. However, the results suggest that prescribing fewer tablets may further reduce use, as each group consumed approximately half of the tablets given, the researchers added.

“Further investigation should evaluate whether similar opioid stewardship and education protocols would be successful in other patient populations,” they said.

Corresponding author John Xerogeanes, MD, disclosed personal fees from Arthrex and stock options from Trice. The other researchers had no financial conflicts to disclose.

SOURCE: Farley KX et al. JAMA. 2019 June 25.321(24):2465-7.

Postmenopausal breast cancer survivors are at greater risk for cardiovascular disease than are their peers without breast cancer, according to a new study of nearly 300 women.

Previous studies have shown that cardiovascular risk is greater among postmenopausal women treated for breast cancer compared with those without cancer, but specific risk factors have not been well studied, wrote Daniel de Araujo Brito Buttros, MD, of Paulista State University, Sao Paulo, Brazil, and colleagues.

In a study published in Menopause, the researchers evaluated several CVD risk factors in 96 postmenopausal women with breast cancer and 192 women without breast cancer, including metabolic syndrome, subclinical atherosclerosis, and heat shock proteins (HSP) 60 and 70.

Overall, breast cancer patients had significantly higher HSP60 levels and lower HSP70 levels than those of their cancer-free peers. These two proteins have an antagonistic relationship in cardiovascular disease, with HSP60 considered a risk factor for CVD, and HSP70 considered a protective factor. Average HSP60 levels for the breast cancer and control groups were 35 ng/mL and 10.8 ng/mL, respectively; average HSP70 levels were 0.5 ng/mL and 1.3 ng/mL, respectively.

Both diabetes and metabolic syndrome were significantly more common among breast cancer patients vs. controls (19.8% vs. 6.8% and 54.2% vs. 30.7%, respectively). Carotid artery plaque also was more common in breast cancer patients vs. controls (19.8% vs. 9.4%, respectively, P = 0.013).

In addition, systolic and diastolic blood pressure levels were significantly higher among the breast cancer patients, as were triglycerides and glucose.

The findings were limited by several factors including the cross-sectional design that could not prove a causal relationship between CVD risk and breast cancer, the researchers noted.

However, the results demonstrate the increased CVD risk for breast cancer patients, and “[therefore], women diagnosed with breast cancer might receive multidisciplinary care, including cardiology consultation at the time of breast cancer diagnosis and also during oncologic follow-up visits,” they said.

“Heart disease appears more commonly in women treated for breast cancer because of the toxicities of chemotherapy, radiation therapy, and use of aromatase inhibitors, which lower estrogen. Heart-healthy lifestyle modifications will decrease both the risk of recurrent breast cancer and the risk of developing heart disease,” JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said in a statement. “Women should schedule a cardiology consultation when breast cancer is diagnosed and continue with ongoing follow-up after cancer treatments are completed,” she emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Buttros DAB et al. Menopause. 2019. doi: 10.1097/GME.0000000000001348.

Postmenopausal breast cancer survivors are at greater risk for cardiovascular disease than are their peers without breast cancer, according to a new study of nearly 300 women.

Previous studies have shown that cardiovascular risk is greater among postmenopausal women treated for breast cancer compared with those without cancer, but specific risk factors have not been well studied, wrote Daniel de Araujo Brito Buttros, MD, of Paulista State University, Sao Paulo, Brazil, and colleagues.

In a study published in Menopause, the researchers evaluated several CVD risk factors in 96 postmenopausal women with breast cancer and 192 women without breast cancer, including metabolic syndrome, subclinical atherosclerosis, and heat shock proteins (HSP) 60 and 70.

Overall, breast cancer patients had significantly higher HSP60 levels and lower HSP70 levels than those of their cancer-free peers. These two proteins have an antagonistic relationship in cardiovascular disease, with HSP60 considered a risk factor for CVD, and HSP70 considered a protective factor. Average HSP60 levels for the breast cancer and control groups were 35 ng/mL and 10.8 ng/mL, respectively; average HSP70 levels were 0.5 ng/mL and 1.3 ng/mL, respectively.

Both diabetes and metabolic syndrome were significantly more common among breast cancer patients vs. controls (19.8% vs. 6.8% and 54.2% vs. 30.7%, respectively). Carotid artery plaque also was more common in breast cancer patients vs. controls (19.8% vs. 9.4%, respectively, P = 0.013).

In addition, systolic and diastolic blood pressure levels were significantly higher among the breast cancer patients, as were triglycerides and glucose.

The findings were limited by several factors including the cross-sectional design that could not prove a causal relationship between CVD risk and breast cancer, the researchers noted.

However, the results demonstrate the increased CVD risk for breast cancer patients, and “[therefore], women diagnosed with breast cancer might receive multidisciplinary care, including cardiology consultation at the time of breast cancer diagnosis and also during oncologic follow-up visits,” they said.

“Heart disease appears more commonly in women treated for breast cancer because of the toxicities of chemotherapy, radiation therapy, and use of aromatase inhibitors, which lower estrogen. Heart-healthy lifestyle modifications will decrease both the risk of recurrent breast cancer and the risk of developing heart disease,” JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said in a statement. “Women should schedule a cardiology consultation when breast cancer is diagnosed and continue with ongoing follow-up after cancer treatments are completed,” she emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Buttros DAB et al. Menopause. 2019. doi: 10.1097/GME.0000000000001348.

Postmenopausal breast cancer survivors are at greater risk for cardiovascular disease than are their peers without breast cancer, according to a new study of nearly 300 women.

Previous studies have shown that cardiovascular risk is greater among postmenopausal women treated for breast cancer compared with those without cancer, but specific risk factors have not been well studied, wrote Daniel de Araujo Brito Buttros, MD, of Paulista State University, Sao Paulo, Brazil, and colleagues.

In a study published in Menopause, the researchers evaluated several CVD risk factors in 96 postmenopausal women with breast cancer and 192 women without breast cancer, including metabolic syndrome, subclinical atherosclerosis, and heat shock proteins (HSP) 60 and 70.

Overall, breast cancer patients had significantly higher HSP60 levels and lower HSP70 levels than those of their cancer-free peers. These two proteins have an antagonistic relationship in cardiovascular disease, with HSP60 considered a risk factor for CVD, and HSP70 considered a protective factor. Average HSP60 levels for the breast cancer and control groups were 35 ng/mL and 10.8 ng/mL, respectively; average HSP70 levels were 0.5 ng/mL and 1.3 ng/mL, respectively.

Both diabetes and metabolic syndrome were significantly more common among breast cancer patients vs. controls (19.8% vs. 6.8% and 54.2% vs. 30.7%, respectively). Carotid artery plaque also was more common in breast cancer patients vs. controls (19.8% vs. 9.4%, respectively, P = 0.013).

In addition, systolic and diastolic blood pressure levels were significantly higher among the breast cancer patients, as were triglycerides and glucose.

The findings were limited by several factors including the cross-sectional design that could not prove a causal relationship between CVD risk and breast cancer, the researchers noted.

However, the results demonstrate the increased CVD risk for breast cancer patients, and “[therefore], women diagnosed with breast cancer might receive multidisciplinary care, including cardiology consultation at the time of breast cancer diagnosis and also during oncologic follow-up visits,” they said.

“Heart disease appears more commonly in women treated for breast cancer because of the toxicities of chemotherapy, radiation therapy, and use of aromatase inhibitors, which lower estrogen. Heart-healthy lifestyle modifications will decrease both the risk of recurrent breast cancer and the risk of developing heart disease,” JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said in a statement. “Women should schedule a cardiology consultation when breast cancer is diagnosed and continue with ongoing follow-up after cancer treatments are completed,” she emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Buttros DAB et al. Menopause. 2019. doi: 10.1097/GME.0000000000001348.

One in 10 high school students has used an e-cigarette device to vaporize (vape) cannabis and that practice is associated with cigars, waterpipe and e-cigarette use, findings from a survey of nearly 3,000 adolescents have shown.

6okean/iStock/Getty Images Plus

“Although the prevalence of e-cigarette use among youth has increased dramatically in the past decade, little epidemiologic data exist on the prevalence of using e-cigarette devices or other specialised devices to vaporise (‘vape’) cannabis in the form of hash oil, tetrahydrocannabinol (THC) wax or oil, or dried cannabis buds or leaves,” wrote Sarah D. Kowitt, PhD, of the University of North Carolina, Chapel Hill, and colleagues. “This is surprising given that (1) cannabis (also referred to as marijuana) and e-cigarettes are the most commonly used substances by adolescents in the USA, (2) evidence exists that adolescents dual use both tobacco e-cigarettes and cannabis, and (3) longitudinal research suggests that use of e-cigarettes is associated with progression to use of cannabis.”

In a study published in BMJ Open, the researchers used data from the 2017 North Carolina Youth Tobacco Survey, a school-based survey of students in grades 6-12. The study population included 2,835 adolescents in grades 9-12.

Overall, 9.6% of students reported ever vaping cannabis. In multivariate analysis, cannabis vaping was significantly more likely among adolescents who reported using e-cigarettes (adjusted odds ratio 3.18), cigars (aOR 3.76), or water pipes (aOR 2.32) in the past 30 days, compared with peers who didn’t use tobacco.

The researchers found no significant association between smokeless tobacco use or traditional cigarette use in the past 30 days and vaping cannabis.

In a bivariate analysis, vaping cannabis was significantly more common among males vs. females (11% vs. 8.2%) and among non-Hispanic white students (11.3%), Hispanic students (10.5%), and other non-Hispanic students (11.8%) compared with non-Hispanic black students (5.0%).

In addition, prevalence of cannabis vaping increased with grade level, from 4.7% of 9th graders to 15.5% of 12th graders.

The health impacts of vaping cannabis are not well researched, but the researchers note that among the potential safety issues are earlier initiation of tobacco or cannabis use, concomitant tobacco and cannabis use, increased frequency of use or misuse of tobacco or cannabis, or increased potency of cannabis.

The results of the study were limited by several factors including the use of data only from the state of North Carolina, the lack of data on frequency or current vaping cannabis behavior, lack of data on specific products, and lack of data on whether teens used specialized devices or e-cigarettes for cannabis vaping. However, the findings are consistent with studies on prevalence of cannabis vaping in other states such as Connecticut and California. “No studies to our knowledge have examined how adolescents who vape cannabis use other specific tobacco products (i.e., cigarettes, cigars, waterpipe, smokeless tobacco),” the researchers wrote.

The findings confirm that a large number of adolescents who use tobacco products have vaped cannabis as well, and this growing public health issue “is likely to affect and be affected by tobacco control and cannabis policies in states and at the federal level in the USA,” the researchers concluded.

“Increased research investigating how youth use e-cigarette devices for other purposes beyond vaping nicotine, like the current study, is needed,” they added.

The study was supported in part by the National Cancer Institute and the Food and Drug Administration’s Center for Tobacco Products. The researchers had no financial conflicts to disclose.

SOURCE: Kowitt SD et al. BMJ Open. 2019 Jun 13. doi: 10.1136/bmjopen-2018-028535.

One in 10 high school students has used an e-cigarette device to vaporize (vape) cannabis and that practice is associated with cigars, waterpipe and e-cigarette use, findings from a survey of nearly 3,000 adolescents have shown.

6okean/iStock/Getty Images Plus

“Although the prevalence of e-cigarette use among youth has increased dramatically in the past decade, little epidemiologic data exist on the prevalence of using e-cigarette devices or other specialised devices to vaporise (‘vape’) cannabis in the form of hash oil, tetrahydrocannabinol (THC) wax or oil, or dried cannabis buds or leaves,” wrote Sarah D. Kowitt, PhD, of the University of North Carolina, Chapel Hill, and colleagues. “This is surprising given that (1) cannabis (also referred to as marijuana) and e-cigarettes are the most commonly used substances by adolescents in the USA, (2) evidence exists that adolescents dual use both tobacco e-cigarettes and cannabis, and (3) longitudinal research suggests that use of e-cigarettes is associated with progression to use of cannabis.”

In a study published in BMJ Open, the researchers used data from the 2017 North Carolina Youth Tobacco Survey, a school-based survey of students in grades 6-12. The study population included 2,835 adolescents in grades 9-12.

Overall, 9.6% of students reported ever vaping cannabis. In multivariate analysis, cannabis vaping was significantly more likely among adolescents who reported using e-cigarettes (adjusted odds ratio 3.18), cigars (aOR 3.76), or water pipes (aOR 2.32) in the past 30 days, compared with peers who didn’t use tobacco.

The researchers found no significant association between smokeless tobacco use or traditional cigarette use in the past 30 days and vaping cannabis.

In a bivariate analysis, vaping cannabis was significantly more common among males vs. females (11% vs. 8.2%) and among non-Hispanic white students (11.3%), Hispanic students (10.5%), and other non-Hispanic students (11.8%) compared with non-Hispanic black students (5.0%).

In addition, prevalence of cannabis vaping increased with grade level, from 4.7% of 9th graders to 15.5% of 12th graders.

The health impacts of vaping cannabis are not well researched, but the researchers note that among the potential safety issues are earlier initiation of tobacco or cannabis use, concomitant tobacco and cannabis use, increased frequency of use or misuse of tobacco or cannabis, or increased potency of cannabis.

The results of the study were limited by several factors including the use of data only from the state of North Carolina, the lack of data on frequency or current vaping cannabis behavior, lack of data on specific products, and lack of data on whether teens used specialized devices or e-cigarettes for cannabis vaping. However, the findings are consistent with studies on prevalence of cannabis vaping in other states such as Connecticut and California. “No studies to our knowledge have examined how adolescents who vape cannabis use other specific tobacco products (i.e., cigarettes, cigars, waterpipe, smokeless tobacco),” the researchers wrote.

The findings confirm that a large number of adolescents who use tobacco products have vaped cannabis as well, and this growing public health issue “is likely to affect and be affected by tobacco control and cannabis policies in states and at the federal level in the USA,” the researchers concluded.

“Increased research investigating how youth use e-cigarette devices for other purposes beyond vaping nicotine, like the current study, is needed,” they added.

The study was supported in part by the National Cancer Institute and the Food and Drug Administration’s Center for Tobacco Products. The researchers had no financial conflicts to disclose.

SOURCE: Kowitt SD et al. BMJ Open. 2019 Jun 13. doi: 10.1136/bmjopen-2018-028535.

One in 10 high school students has used an e-cigarette device to vaporize (vape) cannabis and that practice is associated with cigars, waterpipe and e-cigarette use, findings from a survey of nearly 3,000 adolescents have shown.

6okean/iStock/Getty Images Plus

“Although the prevalence of e-cigarette use among youth has increased dramatically in the past decade, little epidemiologic data exist on the prevalence of using e-cigarette devices or other specialised devices to vaporise (‘vape’) cannabis in the form of hash oil, tetrahydrocannabinol (THC) wax or oil, or dried cannabis buds or leaves,” wrote Sarah D. Kowitt, PhD, of the University of North Carolina, Chapel Hill, and colleagues. “This is surprising given that (1) cannabis (also referred to as marijuana) and e-cigarettes are the most commonly used substances by adolescents in the USA, (2) evidence exists that adolescents dual use both tobacco e-cigarettes and cannabis, and (3) longitudinal research suggests that use of e-cigarettes is associated with progression to use of cannabis.”

In a study published in BMJ Open, the researchers used data from the 2017 North Carolina Youth Tobacco Survey, a school-based survey of students in grades 6-12. The study population included 2,835 adolescents in grades 9-12.

Overall, 9.6% of students reported ever vaping cannabis. In multivariate analysis, cannabis vaping was significantly more likely among adolescents who reported using e-cigarettes (adjusted odds ratio 3.18), cigars (aOR 3.76), or water pipes (aOR 2.32) in the past 30 days, compared with peers who didn’t use tobacco.

The researchers found no significant association between smokeless tobacco use or traditional cigarette use in the past 30 days and vaping cannabis.

In a bivariate analysis, vaping cannabis was significantly more common among males vs. females (11% vs. 8.2%) and among non-Hispanic white students (11.3%), Hispanic students (10.5%), and other non-Hispanic students (11.8%) compared with non-Hispanic black students (5.0%).

In addition, prevalence of cannabis vaping increased with grade level, from 4.7% of 9th graders to 15.5% of 12th graders.

The health impacts of vaping cannabis are not well researched, but the researchers note that among the potential safety issues are earlier initiation of tobacco or cannabis use, concomitant tobacco and cannabis use, increased frequency of use or misuse of tobacco or cannabis, or increased potency of cannabis.

The results of the study were limited by several factors including the use of data only from the state of North Carolina, the lack of data on frequency or current vaping cannabis behavior, lack of data on specific products, and lack of data on whether teens used specialized devices or e-cigarettes for cannabis vaping. However, the findings are consistent with studies on prevalence of cannabis vaping in other states such as Connecticut and California. “No studies to our knowledge have examined how adolescents who vape cannabis use other specific tobacco products (i.e., cigarettes, cigars, waterpipe, smokeless tobacco),” the researchers wrote.

The findings confirm that a large number of adolescents who use tobacco products have vaped cannabis as well, and this growing public health issue “is likely to affect and be affected by tobacco control and cannabis policies in states and at the federal level in the USA,” the researchers concluded.

“Increased research investigating how youth use e-cigarette devices for other purposes beyond vaping nicotine, like the current study, is needed,” they added.

The study was supported in part by the National Cancer Institute and the Food and Drug Administration’s Center for Tobacco Products. The researchers had no financial conflicts to disclose.

SOURCE: Kowitt SD et al. BMJ Open. 2019 Jun 13. doi: 10.1136/bmjopen-2018-028535.

Suicides in teens and young adults reached 6,241 in 2017, the highest since 2000, according to data from a review of the Centers for Disease Control and Prevention Underlying Cause of Death database.

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The suicide rate overall was 12 per 100,000 in 2017 for 15-19 year olds.

Although suicide rates have increased across all age groups in the United States since 2000, “adolescents are of particular concern, with increases in social media use, anxiety, depression, and self-inflicted injuries,” wrote Oren Miron of Harvard Medical School, Boston, and colleagues.

In a research letter published in JAMA, the researchers analyzed trends in teen and young adult suicides from 2000 to 2017. The combined suicide rate for males and females aged 15-19 years in 2000 was 8 per 100,000 with no significant changes until 2007, followed by an annual percentage change (APC) of 3% from 2007 to 2014 and 10% from 2014 to 2017.

When the data were broken out by gender, males aged 15-19 years showed a spike in suicides in recent years, with an increase in APC of 14% from 2015 to 2017. Of note, these young men showed a decreasing trend in APC of –2% from 2000 to 2007 before increasing.

Among females aged 15-19 years, no increase was noted until 2010, then researchers identified an APC of 8% from 2010 to 2017.

For ages 20-24 years, the combined suicide rate for males and females was 13 per 100,000 in 2000, which rose to 17 per 100,000 in 2017. The APC in the older group was 1% from 2000 to 2013 and 6% from 2013 to 2017. Increasing trends were observed for both males and females over the study period.

The study was limited by the potential inaccuracy in cause of death listed on death certificates, such as mistaking a suicide for an accidental overdose, and the increased suicide rate could reflect more accurate reporting, the researchers noted.

Nonetheless, the results support the need for more studies of contributing factors to teen and young adult suicides to help develop prevention strategies and analysis of factors that may have contributed to declines in suicide rates in the past, they said.

Coauthor Dr. Yu was supported by the Harvard Data Science Fellowship. The researchers had no relevant financial disclosures.

SOURCE: Miron O et al. JAMA. 2019 Jun 28;321:2362-4.

Suicides in teens and young adults reached 6,241 in 2017, the highest since 2000, according to data from a review of the Centers for Disease Control and Prevention Underlying Cause of Death database.

StHelena/Getty Images

The suicide rate overall was 12 per 100,000 in 2017 for 15-19 year olds.

Although suicide rates have increased across all age groups in the United States since 2000, “adolescents are of particular concern, with increases in social media use, anxiety, depression, and self-inflicted injuries,” wrote Oren Miron of Harvard Medical School, Boston, and colleagues.

In a research letter published in JAMA, the researchers analyzed trends in teen and young adult suicides from 2000 to 2017. The combined suicide rate for males and females aged 15-19 years in 2000 was 8 per 100,000 with no significant changes until 2007, followed by an annual percentage change (APC) of 3% from 2007 to 2014 and 10% from 2014 to 2017.

When the data were broken out by gender, males aged 15-19 years showed a spike in suicides in recent years, with an increase in APC of 14% from 2015 to 2017. Of note, these young men showed a decreasing trend in APC of –2% from 2000 to 2007 before increasing.

Among females aged 15-19 years, no increase was noted until 2010, then researchers identified an APC of 8% from 2010 to 2017.

For ages 20-24 years, the combined suicide rate for males and females was 13 per 100,000 in 2000, which rose to 17 per 100,000 in 2017. The APC in the older group was 1% from 2000 to 2013 and 6% from 2013 to 2017. Increasing trends were observed for both males and females over the study period.

The study was limited by the potential inaccuracy in cause of death listed on death certificates, such as mistaking a suicide for an accidental overdose, and the increased suicide rate could reflect more accurate reporting, the researchers noted.

Nonetheless, the results support the need for more studies of contributing factors to teen and young adult suicides to help develop prevention strategies and analysis of factors that may have contributed to declines in suicide rates in the past, they said.

Coauthor Dr. Yu was supported by the Harvard Data Science Fellowship. The researchers had no relevant financial disclosures.

SOURCE: Miron O et al. JAMA. 2019 Jun 28;321:2362-4.

Suicides in teens and young adults reached 6,241 in 2017, the highest since 2000, according to data from a review of the Centers for Disease Control and Prevention Underlying Cause of Death database.

StHelena/Getty Images

The suicide rate overall was 12 per 100,000 in 2017 for 15-19 year olds.

Although suicide rates have increased across all age groups in the United States since 2000, “adolescents are of particular concern, with increases in social media use, anxiety, depression, and self-inflicted injuries,” wrote Oren Miron of Harvard Medical School, Boston, and colleagues.

In a research letter published in JAMA, the researchers analyzed trends in teen and young adult suicides from 2000 to 2017. The combined suicide rate for males and females aged 15-19 years in 2000 was 8 per 100,000 with no significant changes until 2007, followed by an annual percentage change (APC) of 3% from 2007 to 2014 and 10% from 2014 to 2017.

When the data were broken out by gender, males aged 15-19 years showed a spike in suicides in recent years, with an increase in APC of 14% from 2015 to 2017. Of note, these young men showed a decreasing trend in APC of –2% from 2000 to 2007 before increasing.

Among females aged 15-19 years, no increase was noted until 2010, then researchers identified an APC of 8% from 2010 to 2017.

For ages 20-24 years, the combined suicide rate for males and females was 13 per 100,000 in 2000, which rose to 17 per 100,000 in 2017. The APC in the older group was 1% from 2000 to 2013 and 6% from 2013 to 2017. Increasing trends were observed for both males and females over the study period.

The study was limited by the potential inaccuracy in cause of death listed on death certificates, such as mistaking a suicide for an accidental overdose, and the increased suicide rate could reflect more accurate reporting, the researchers noted.

Nonetheless, the results support the need for more studies of contributing factors to teen and young adult suicides to help develop prevention strategies and analysis of factors that may have contributed to declines in suicide rates in the past, they said.

Coauthor Dr. Yu was supported by the Harvard Data Science Fellowship. The researchers had no relevant financial disclosures.

SOURCE: Miron O et al. JAMA. 2019 Jun 28;321:2362-4.

Esketamine nasal spray used with an oral antidepressant was significantly more effective at delaying a relapse of depression compared with placebo, based on data from 297 adults in remission.

Patients with treatment-resistant depression are more likely to relapse, wrote Ella J. Daly, MD, of Janssen Research and Development, Titusville, N.J., and colleagues.

In the SUSTAIN-1 study, published in JAMA Psychiatry, the researchers randomized 297 adults in the maintenance phase of depression treatment to esketamine hydrochloride or placebo. The average age of the patients was 46 years, and 66% were female.

Overall, 26.7% of patients in the esketamine and antidepressant group experienced relapses, compared with 45.3% of the placebo group during the maintenance period among the 176 patients who achieved stable remission. In addition, relapse occurred in 25.8% in the esketamine and antidepressant group and 57.6 in the antidepressant and placebo among the patients who achieved stable response.

The median duration esketamine use during the maintenance phase was 17.7 weeks among patients who achieved stable remission and 19.4 among those who achieved stable response.

The study was designed to include a 4-week screening and prospective observation phase, a 4-week open-label induction phase, a 12-week optimization phase, a maintenance phase, and a 2-week posttreatment follow-up phase.

The most common adverse events reported by esketamine patients were transient dysgeusia, vertigo, dissociation, somnolence, and dizziness. Most of these effects were moderate; no cases of respiratory depression, interstitial cystitis, or death were reported.

The results were limited by several factors, including the transient effects of esketamine that made blinding difficult, the researchers noted. However, the findings support the safety of the spray and “significant, clinically meaningful superiority” of the spray, compared with placebo, for relapse prevention in patients with treatment-resistant depression, they concluded.

Janssen Research and Development funded the study. Dr. Daly and several coauthors are employees of the company.

SOURCE: Daly E et al. JAMA Psychiatry. 2019 Jun 5. doi: 10.1001/jamapsychiatry.2019.1189.

Esketamine nasal spray used with an oral antidepressant was significantly more effective at delaying a relapse of depression compared with placebo, based on data from 297 adults in remission.

Patients with treatment-resistant depression are more likely to relapse, wrote Ella J. Daly, MD, of Janssen Research and Development, Titusville, N.J., and colleagues.

In the SUSTAIN-1 study, published in JAMA Psychiatry, the researchers randomized 297 adults in the maintenance phase of depression treatment to esketamine hydrochloride or placebo. The average age of the patients was 46 years, and 66% were female.

Overall, 26.7% of patients in the esketamine and antidepressant group experienced relapses, compared with 45.3% of the placebo group during the maintenance period among the 176 patients who achieved stable remission. In addition, relapse occurred in 25.8% in the esketamine and antidepressant group and 57.6 in the antidepressant and placebo among the patients who achieved stable response.

The median duration esketamine use during the maintenance phase was 17.7 weeks among patients who achieved stable remission and 19.4 among those who achieved stable response.

The study was designed to include a 4-week screening and prospective observation phase, a 4-week open-label induction phase, a 12-week optimization phase, a maintenance phase, and a 2-week posttreatment follow-up phase.

The most common adverse events reported by esketamine patients were transient dysgeusia, vertigo, dissociation, somnolence, and dizziness. Most of these effects were moderate; no cases of respiratory depression, interstitial cystitis, or death were reported.

The results were limited by several factors, including the transient effects of esketamine that made blinding difficult, the researchers noted. However, the findings support the safety of the spray and “significant, clinically meaningful superiority” of the spray, compared with placebo, for relapse prevention in patients with treatment-resistant depression, they concluded.

Janssen Research and Development funded the study. Dr. Daly and several coauthors are employees of the company.

SOURCE: Daly E et al. JAMA Psychiatry. 2019 Jun 5. doi: 10.1001/jamapsychiatry.2019.1189.

Esketamine nasal spray used with an oral antidepressant was significantly more effective at delaying a relapse of depression compared with placebo, based on data from 297 adults in remission.

Patients with treatment-resistant depression are more likely to relapse, wrote Ella J. Daly, MD, of Janssen Research and Development, Titusville, N.J., and colleagues.

In the SUSTAIN-1 study, published in JAMA Psychiatry, the researchers randomized 297 adults in the maintenance phase of depression treatment to esketamine hydrochloride or placebo. The average age of the patients was 46 years, and 66% were female.

Overall, 26.7% of patients in the esketamine and antidepressant group experienced relapses, compared with 45.3% of the placebo group during the maintenance period among the 176 patients who achieved stable remission. In addition, relapse occurred in 25.8% in the esketamine and antidepressant group and 57.6 in the antidepressant and placebo among the patients who achieved stable response.

The median duration esketamine use during the maintenance phase was 17.7 weeks among patients who achieved stable remission and 19.4 among those who achieved stable response.

The study was designed to include a 4-week screening and prospective observation phase, a 4-week open-label induction phase, a 12-week optimization phase, a maintenance phase, and a 2-week posttreatment follow-up phase.

The most common adverse events reported by esketamine patients were transient dysgeusia, vertigo, dissociation, somnolence, and dizziness. Most of these effects were moderate; no cases of respiratory depression, interstitial cystitis, or death were reported.

The results were limited by several factors, including the transient effects of esketamine that made blinding difficult, the researchers noted. However, the findings support the safety of the spray and “significant, clinically meaningful superiority” of the spray, compared with placebo, for relapse prevention in patients with treatment-resistant depression, they concluded.

Janssen Research and Development funded the study. Dr. Daly and several coauthors are employees of the company.

SOURCE: Daly E et al. JAMA Psychiatry. 2019 Jun 5. doi: 10.1001/jamapsychiatry.2019.1189.

Inflammatory bowel disease (IBD) treatment remains a challenge in part because care is often fragmented among providers in different specialties, according to the American Gastroenterological Association. To address the need for provider coordination, the AGA has issued a new referral pathway for IBD care, published in Gastroenterology.

“The goal of this pathway is to offer guidance to primary care, emergency department, and gastroenterology providers, by helping identify patients at risk of or diagnosed with IBD and provide direction on initiating appropriate patient referrals,” wrote lead author Jami Kinnucan, MD, of the University of Michigan, Ann Arbor, and members of the AGA workgroup.

In particular, the pathway focuses on gaps in IBD care related to inflammatory issues, mental health, and nutrition. The work group included not only gastroenterologists, but also a primary care physician, mental/behavioral health specialist, registered dietitian/nutritionist, critical care specialist, nurse practitioner, physician group representative, and a patient advocacy representative.

The pathway identifies the top three areas where IBD patients usually present with symptoms: the emergency department, primary care office, and gastroenterology office.

The work group developed a list of key characteristics associated with increased morbidity, established IBD, or IBD-related complications that can be separated into high-risk, moderate-risk, and low-risk groups to help clinicians determine the timing of and need for referrals.

The pathway uses a sample patient presenting with GI symptoms such as bloody diarrhea; GI bleeding; anemia; fecal urgency; fever; abdominal pain; weight loss; and pain, swelling, or redness in the joints. Clinicians then apply the key characteristics to triage the patients into the risk groups.

High-risk characteristics include history of perianal or severe rectal disease, or deep ulcers in the GI mucosa; two or more emergency department visits for GI problems within the past 6 months, severe anemia, inadequate response to outpatient IBD therapy, history of IBD-related surgery, and malnourishment.

Moderate-risk characteristics include anemia without clinical symptoms, chronic corticosteroid use, and no emergency department or other GI medical visits within the past year.

Low-risk characteristics include chronic narcotic use, one or more comorbidities (such as heart failure, active hepatitis B, oncologic malignancy, lupus, GI infections, primary sclerosing cholangitis, viral hepatitis, and celiac disease), one or more relevant mental health conditions (such as depression, anxiety, or chronic pain), and nonadherence to IBD medical therapies.

“Referrals should be based on the highest level of risk present, in the event that a patient has characteristics that fall in more than one risk category,” the work group wrote.

To further guide clinicians in referring patients with possible or diagnosed IBD to gastroenterology specialists and to mental health and nutrition specialists, the work group developed an IBD Characteristics Assessment Checklist and a Referral Feedback form to accompany the pathway.

The checklist is designed for use by any health care professional to help identify whether a patient needs to be referred based on the key characteristics; the feedback form gives gastroenterologists a template to communicate with referring physicians about comanagement strategies for the patient.

The pathway also includes more details on how clinicians can tackle barriers to mental health and nutrition care for IBD patients.

“Until further evaluations are conducted, the work group encourages the immediate use of the pathway to begin addressing the needed improvements for IBD care coordination and communication between the different IBD providers,” the authors wrote.

Dr. Kinnucan disclosed serving as a consultant for AbbVie, Janssen, and Pfizer and serving on the Patient Education Committee of the Crohn’s and Colitis Foundation.

SOURCE: Kinnucan J et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.064.

Inflammatory bowel disease (IBD) treatment remains a challenge in part because care is often fragmented among providers in different specialties, according to the American Gastroenterological Association. To address the need for provider coordination, the AGA has issued a new referral pathway for IBD care, published in Gastroenterology.

“The goal of this pathway is to offer guidance to primary care, emergency department, and gastroenterology providers, by helping identify patients at risk of or diagnosed with IBD and provide direction on initiating appropriate patient referrals,” wrote lead author Jami Kinnucan, MD, of the University of Michigan, Ann Arbor, and members of the AGA workgroup.

In particular, the pathway focuses on gaps in IBD care related to inflammatory issues, mental health, and nutrition. The work group included not only gastroenterologists, but also a primary care physician, mental/behavioral health specialist, registered dietitian/nutritionist, critical care specialist, nurse practitioner, physician group representative, and a patient advocacy representative.

The pathway identifies the top three areas where IBD patients usually present with symptoms: the emergency department, primary care office, and gastroenterology office.

The work group developed a list of key characteristics associated with increased morbidity, established IBD, or IBD-related complications that can be separated into high-risk, moderate-risk, and low-risk groups to help clinicians determine the timing of and need for referrals.

The pathway uses a sample patient presenting with GI symptoms such as bloody diarrhea; GI bleeding; anemia; fecal urgency; fever; abdominal pain; weight loss; and pain, swelling, or redness in the joints. Clinicians then apply the key characteristics to triage the patients into the risk groups.

High-risk characteristics include history of perianal or severe rectal disease, or deep ulcers in the GI mucosa; two or more emergency department visits for GI problems within the past 6 months, severe anemia, inadequate response to outpatient IBD therapy, history of IBD-related surgery, and malnourishment.

Moderate-risk characteristics include anemia without clinical symptoms, chronic corticosteroid use, and no emergency department or other GI medical visits within the past year.

Low-risk characteristics include chronic narcotic use, one or more comorbidities (such as heart failure, active hepatitis B, oncologic malignancy, lupus, GI infections, primary sclerosing cholangitis, viral hepatitis, and celiac disease), one or more relevant mental health conditions (such as depression, anxiety, or chronic pain), and nonadherence to IBD medical therapies.

“Referrals should be based on the highest level of risk present, in the event that a patient has characteristics that fall in more than one risk category,” the work group wrote.

To further guide clinicians in referring patients with possible or diagnosed IBD to gastroenterology specialists and to mental health and nutrition specialists, the work group developed an IBD Characteristics Assessment Checklist and a Referral Feedback form to accompany the pathway.

The checklist is designed for use by any health care professional to help identify whether a patient needs to be referred based on the key characteristics; the feedback form gives gastroenterologists a template to communicate with referring physicians about comanagement strategies for the patient.

The pathway also includes more details on how clinicians can tackle barriers to mental health and nutrition care for IBD patients.

“Until further evaluations are conducted, the work group encourages the immediate use of the pathway to begin addressing the needed improvements for IBD care coordination and communication between the different IBD providers,” the authors wrote.

Dr. Kinnucan disclosed serving as a consultant for AbbVie, Janssen, and Pfizer and serving on the Patient Education Committee of the Crohn’s and Colitis Foundation.

SOURCE: Kinnucan J et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.064.

Inflammatory bowel disease (IBD) treatment remains a challenge in part because care is often fragmented among providers in different specialties, according to the American Gastroenterological Association. To address the need for provider coordination, the AGA has issued a new referral pathway for IBD care, published in Gastroenterology.

“The goal of this pathway is to offer guidance to primary care, emergency department, and gastroenterology providers, by helping identify patients at risk of or diagnosed with IBD and provide direction on initiating appropriate patient referrals,” wrote lead author Jami Kinnucan, MD, of the University of Michigan, Ann Arbor, and members of the AGA workgroup.

In particular, the pathway focuses on gaps in IBD care related to inflammatory issues, mental health, and nutrition. The work group included not only gastroenterologists, but also a primary care physician, mental/behavioral health specialist, registered dietitian/nutritionist, critical care specialist, nurse practitioner, physician group representative, and a patient advocacy representative.

The pathway identifies the top three areas where IBD patients usually present with symptoms: the emergency department, primary care office, and gastroenterology office.

The work group developed a list of key characteristics associated with increased morbidity, established IBD, or IBD-related complications that can be separated into high-risk, moderate-risk, and low-risk groups to help clinicians determine the timing of and need for referrals.

The pathway uses a sample patient presenting with GI symptoms such as bloody diarrhea; GI bleeding; anemia; fecal urgency; fever; abdominal pain; weight loss; and pain, swelling, or redness in the joints. Clinicians then apply the key characteristics to triage the patients into the risk groups.

High-risk characteristics include history of perianal or severe rectal disease, or deep ulcers in the GI mucosa; two or more emergency department visits for GI problems within the past 6 months, severe anemia, inadequate response to outpatient IBD therapy, history of IBD-related surgery, and malnourishment.

Moderate-risk characteristics include anemia without clinical symptoms, chronic corticosteroid use, and no emergency department or other GI medical visits within the past year.

Low-risk characteristics include chronic narcotic use, one or more comorbidities (such as heart failure, active hepatitis B, oncologic malignancy, lupus, GI infections, primary sclerosing cholangitis, viral hepatitis, and celiac disease), one or more relevant mental health conditions (such as depression, anxiety, or chronic pain), and nonadherence to IBD medical therapies.

“Referrals should be based on the highest level of risk present, in the event that a patient has characteristics that fall in more than one risk category,” the work group wrote.

To further guide clinicians in referring patients with possible or diagnosed IBD to gastroenterology specialists and to mental health and nutrition specialists, the work group developed an IBD Characteristics Assessment Checklist and a Referral Feedback form to accompany the pathway.

The checklist is designed for use by any health care professional to help identify whether a patient needs to be referred based on the key characteristics; the feedback form gives gastroenterologists a template to communicate with referring physicians about comanagement strategies for the patient.

The pathway also includes more details on how clinicians can tackle barriers to mental health and nutrition care for IBD patients.

“Until further evaluations are conducted, the work group encourages the immediate use of the pathway to begin addressing the needed improvements for IBD care coordination and communication between the different IBD providers,” the authors wrote.

Dr. Kinnucan disclosed serving as a consultant for AbbVie, Janssen, and Pfizer and serving on the Patient Education Committee of the Crohn’s and Colitis Foundation.

SOURCE: Kinnucan J et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.064.

Particular features of the vaginal microbiome were significantly associated with an increased risk of preterm birth in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.

CDC/Janice Carr

Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.

A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.

To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.

Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.

Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.

“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.

In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.

They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.

In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.

“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.

“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”

In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”

The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”

Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.

SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.

Particular features of the vaginal microbiome were significantly associated with an increased risk of preterm birth in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.

CDC/Janice Carr

Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.

A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.

To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.

Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.

Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.

“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.

In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.

They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.

In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.

“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.

“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”

In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”

The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”

Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.

SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.

Particular features of the vaginal microbiome were significantly associated with an increased risk of preterm birth in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.

CDC/Janice Carr

Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.

A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.

To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.

Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.

Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.

“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.

In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.

They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.

In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.

“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.

“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”

In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”

The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”

Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.

SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.

Many patients with hidradenitis suppurativa (HS) experience depression and anxiety, according to data from a systematic review and meta-analysis of more than 40,000 adults.

Previous studies of psychiatric comorbidities in HS patients have suggested an increased rate of depression, anxiety, and suicide risk, but have varied in methodology. “Therefore, the exact magnitude of the prevalence and odds of depression and anxiety in patients with HS is unclear,” wrote Myrela O. Machado, MD, of the division of dermatology, Women’s College Hospital, Toronto, and colleagues.

In a review of PubMed/MEDLINE, Embase, and PsycINFO electronic databases through July 2018, the researchers identified 10 studies comprising 40,307 adults with HS. The overall prevalence of depression was 16.9%, and in the studies that included a comparison group, the odds ratio for depression was 1.84 for HS patients, compared with controls who did not have HS. The overall prevalence of anxiety was 4.9%, but data were insufficient to determine an odds ratio for anxiety. The study was published in JAMA Dermatology.

All 10 studies assessed depression; 4 assessed anxiety. In subgroup analyses, the prevalence of depression was 11.9% in studies with a diagnosis based on clinical criteria and 26.8% in studies that used a screening instrument. The prevalence was 25.9% for outpatients with HS.


“Although our findings indicate that depression and anxiety may be common among people with HS, whether there is a causal relationship in those associations remains to be proved,” the researchers wrote.

However, they noted, “the consequences of depression and anxiety on HS-related outcomes have recently received more attention.”

The study findings were limited by several factors including the lack of data from structured diagnostic interviews, variation in methodological quality, and variation in comparison groups across studies, as well as a high level of heterogeneity across studies, the researchers noted. However, the results support the need to recognize and treat psychiatric conditions in HS patients, and to develop new management strategies, they said.

Dr. Machado had no financial conflicts to disclose. Several coauthors disclosed relationships with Galderma, LEO Pharma, Janssen, Novartis, AbbVie, Celgene, Naos, Lilly, Sanofi, Valeant, and La Roche-Posay.

SOURCE: Machado M et al. JAMA Dermatol. 2019 June 5. doi: 10.1001/jamadermatol.2019.0759.

Many patients with hidradenitis suppurativa (HS) experience depression and anxiety, according to data from a systematic review and meta-analysis of more than 40,000 adults.

Previous studies of psychiatric comorbidities in HS patients have suggested an increased rate of depression, anxiety, and suicide risk, but have varied in methodology. “Therefore, the exact magnitude of the prevalence and odds of depression and anxiety in patients with HS is unclear,” wrote Myrela O. Machado, MD, of the division of dermatology, Women’s College Hospital, Toronto, and colleagues.

In a review of PubMed/MEDLINE, Embase, and PsycINFO electronic databases through July 2018, the researchers identified 10 studies comprising 40,307 adults with HS. The overall prevalence of depression was 16.9%, and in the studies that included a comparison group, the odds ratio for depression was 1.84 for HS patients, compared with controls who did not have HS. The overall prevalence of anxiety was 4.9%, but data were insufficient to determine an odds ratio for anxiety. The study was published in JAMA Dermatology.

All 10 studies assessed depression; 4 assessed anxiety. In subgroup analyses, the prevalence of depression was 11.9% in studies with a diagnosis based on clinical criteria and 26.8% in studies that used a screening instrument. The prevalence was 25.9% for outpatients with HS.


“Although our findings indicate that depression and anxiety may be common among people with HS, whether there is a causal relationship in those associations remains to be proved,” the researchers wrote.

However, they noted, “the consequences of depression and anxiety on HS-related outcomes have recently received more attention.”

The study findings were limited by several factors including the lack of data from structured diagnostic interviews, variation in methodological quality, and variation in comparison groups across studies, as well as a high level of heterogeneity across studies, the researchers noted. However, the results support the need to recognize and treat psychiatric conditions in HS patients, and to develop new management strategies, they said.

Dr. Machado had no financial conflicts to disclose. Several coauthors disclosed relationships with Galderma, LEO Pharma, Janssen, Novartis, AbbVie, Celgene, Naos, Lilly, Sanofi, Valeant, and La Roche-Posay.

SOURCE: Machado M et al. JAMA Dermatol. 2019 June 5. doi: 10.1001/jamadermatol.2019.0759.

Many patients with hidradenitis suppurativa (HS) experience depression and anxiety, according to data from a systematic review and meta-analysis of more than 40,000 adults.

Previous studies of psychiatric comorbidities in HS patients have suggested an increased rate of depression, anxiety, and suicide risk, but have varied in methodology. “Therefore, the exact magnitude of the prevalence and odds of depression and anxiety in patients with HS is unclear,” wrote Myrela O. Machado, MD, of the division of dermatology, Women’s College Hospital, Toronto, and colleagues.

In a review of PubMed/MEDLINE, Embase, and PsycINFO electronic databases through July 2018, the researchers identified 10 studies comprising 40,307 adults with HS. The overall prevalence of depression was 16.9%, and in the studies that included a comparison group, the odds ratio for depression was 1.84 for HS patients, compared with controls who did not have HS. The overall prevalence of anxiety was 4.9%, but data were insufficient to determine an odds ratio for anxiety. The study was published in JAMA Dermatology.

All 10 studies assessed depression; 4 assessed anxiety. In subgroup analyses, the prevalence of depression was 11.9% in studies with a diagnosis based on clinical criteria and 26.8% in studies that used a screening instrument. The prevalence was 25.9% for outpatients with HS.


“Although our findings indicate that depression and anxiety may be common among people with HS, whether there is a causal relationship in those associations remains to be proved,” the researchers wrote.

However, they noted, “the consequences of depression and anxiety on HS-related outcomes have recently received more attention.”

The study findings were limited by several factors including the lack of data from structured diagnostic interviews, variation in methodological quality, and variation in comparison groups across studies, as well as a high level of heterogeneity across studies, the researchers noted. However, the results support the need to recognize and treat psychiatric conditions in HS patients, and to develop new management strategies, they said.

Dr. Machado had no financial conflicts to disclose. Several coauthors disclosed relationships with Galderma, LEO Pharma, Janssen, Novartis, AbbVie, Celgene, Naos, Lilly, Sanofi, Valeant, and La Roche-Posay.

SOURCE: Machado M et al. JAMA Dermatol. 2019 June 5. doi: 10.1001/jamadermatol.2019.0759.

Oral immunotherapy reduced sensitivity to peanuts in allergic individuals, but at the cost of increased risk of anaphylaxis and other reactions, based on a meta-analysis from more than 1,000 patients published in the Lancet.

copyright mates/Fotolia.com

In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).

Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).

In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).

Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.

The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.

The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.

However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.

The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.

Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.

SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.

Oral immunotherapy reduced sensitivity to peanuts in allergic individuals, but at the cost of increased risk of anaphylaxis and other reactions, based on a meta-analysis from more than 1,000 patients published in the Lancet.

copyright mates/Fotolia.com

In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).

Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).

In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).

Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.

The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.

The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.

However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.

The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.

Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.

SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.

Oral immunotherapy reduced sensitivity to peanuts in allergic individuals, but at the cost of increased risk of anaphylaxis and other reactions, based on a meta-analysis from more than 1,000 patients published in the Lancet.

copyright mates/Fotolia.com

In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).

Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).

In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).

Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.

The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.

The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.

However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.

The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.

Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.

SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.