Pulmonology

SAN DIEGO – After implementation of a new chest pain protocol in the emergency department, a greater proportion of patients with low-risk chest pain were discharged, yet a higher rate of ED recidivism was observed, results from a single-center study in Detroit showed.

While the precise cause of this finding is unclear, it may stem from factors affecting socioeconomically disadvantaged populations, Eric M. Blake, one of the study authors, said at the annual meeting of the American College of Emergency Physicians. “Recurrent ED visits are associated with social determinants of health, including race and economic status,” said Mr. Blake, a second-year student at Wayne State University School of Medicine, Detroit. “Socioeconomically disadvantaged patients often lack the transportation and monetary resources to follow up at an outpatient clinic. Detroit is an example of this type of a community; 83% of our population is African American, 36% of people live below the poverty line, and Detroit has an illiteracy rate of 47% in its adult population.”

He and his colleagues hypothesized that implementation of a standardized chest pain protocol in Detroit Receiving Hospital would safely reduce the number of hospital inpatient admissions and ED recidivism rates. Implemented on Nov. 1, 2012, the protocol uses the thrombolysis in myocardial infarction (TIMI) risk score, electrocardiography, and contemporary sensitivity troponin I to triage patients into low-, intermediate-, and high-risk categories. Low-risk patients were discharged and asked to follow up with a cardiologist within 48 hours. For the current study, the researchers retrospectively analyzed patients older than age 18 who presented with low-risk chest pain in the six months before the protocol was implemented and six months after.

A total of 3,613 patients were studied: 1,837 in the pre-protocol group and 1,776 in the post-protocol group. Their mean age was 47 years, 82% were African American, and 53% were male. No differences were observed between the pre- and post-protocol groups in terms of race (P = .280) or sex (P = .497). There was no statistical difference in the proportion of patients deemed at low risk in the pre- vs. post-protocol periods (P = .167). Significantly more low-risk patients were discharged in the post-protocol group, , compared with the pre-protocol group (55% vs. 44%; P less than .001), however. ED recidivism was also significantly greater in the post-protocol vs. pre-protocol group (3% vs. 1.6%; P = .0035).

“These findings may reflect an embedded racial mistrust of the medical system by certain minority groups,” Mr. Blake said. “Due to an extensive history of racism and segregation, a community like Detroit may have reservations when it comes to medical follow-up at outpatient clinics. Difficulty assessing outpatient follow-up for a variety of logistical and monetary reasons common among underprivileged communities may also be reflected in the increased recidivism rates.”

He concluded that administrators and clinicians in EDs nationwide “need to better understand the needs of underprivileged patients. A reduction in resource expenditures when a patient is discharged must be balanced with the cost of a recidivism in vulnerable populations like Detroit.”

To address poor cardiac outpatient follow-up rates, he and his colleagues are conducting a prospective randomized controlled trial investigating the use of motivational interviewing techniques with these patients.

The study’s senior author was Vijaya “Arun” Kumar, MD of Wayne State University School of Medicine. Mr. Blake reported having no financial disclosures.

SOURCE: Kumar VA et al. Ann Emerg Med. 2018 Oct;72;4:S117-18. doi. 10.1016/j.annemergmed.2018.08.304.

dbrunk@mdedge.com

SAN DIEGO – After implementation of a new chest pain protocol in the emergency department, a greater proportion of patients with low-risk chest pain were discharged, yet a higher rate of ED recidivism was observed, results from a single-center study in Detroit showed.

While the precise cause of this finding is unclear, it may stem from factors affecting socioeconomically disadvantaged populations, Eric M. Blake, one of the study authors, said at the annual meeting of the American College of Emergency Physicians. “Recurrent ED visits are associated with social determinants of health, including race and economic status,” said Mr. Blake, a second-year student at Wayne State University School of Medicine, Detroit. “Socioeconomically disadvantaged patients often lack the transportation and monetary resources to follow up at an outpatient clinic. Detroit is an example of this type of a community; 83% of our population is African American, 36% of people live below the poverty line, and Detroit has an illiteracy rate of 47% in its adult population.”

He and his colleagues hypothesized that implementation of a standardized chest pain protocol in Detroit Receiving Hospital would safely reduce the number of hospital inpatient admissions and ED recidivism rates. Implemented on Nov. 1, 2012, the protocol uses the thrombolysis in myocardial infarction (TIMI) risk score, electrocardiography, and contemporary sensitivity troponin I to triage patients into low-, intermediate-, and high-risk categories. Low-risk patients were discharged and asked to follow up with a cardiologist within 48 hours. For the current study, the researchers retrospectively analyzed patients older than age 18 who presented with low-risk chest pain in the six months before the protocol was implemented and six months after.

A total of 3,613 patients were studied: 1,837 in the pre-protocol group and 1,776 in the post-protocol group. Their mean age was 47 years, 82% were African American, and 53% were male. No differences were observed between the pre- and post-protocol groups in terms of race (P = .280) or sex (P = .497). There was no statistical difference in the proportion of patients deemed at low risk in the pre- vs. post-protocol periods (P = .167). Significantly more low-risk patients were discharged in the post-protocol group, , compared with the pre-protocol group (55% vs. 44%; P less than .001), however. ED recidivism was also significantly greater in the post-protocol vs. pre-protocol group (3% vs. 1.6%; P = .0035).

“These findings may reflect an embedded racial mistrust of the medical system by certain minority groups,” Mr. Blake said. “Due to an extensive history of racism and segregation, a community like Detroit may have reservations when it comes to medical follow-up at outpatient clinics. Difficulty assessing outpatient follow-up for a variety of logistical and monetary reasons common among underprivileged communities may also be reflected in the increased recidivism rates.”

He concluded that administrators and clinicians in EDs nationwide “need to better understand the needs of underprivileged patients. A reduction in resource expenditures when a patient is discharged must be balanced with the cost of a recidivism in vulnerable populations like Detroit.”

To address poor cardiac outpatient follow-up rates, he and his colleagues are conducting a prospective randomized controlled trial investigating the use of motivational interviewing techniques with these patients.

The study’s senior author was Vijaya “Arun” Kumar, MD of Wayne State University School of Medicine. Mr. Blake reported having no financial disclosures.

SOURCE: Kumar VA et al. Ann Emerg Med. 2018 Oct;72;4:S117-18. doi. 10.1016/j.annemergmed.2018.08.304.

dbrunk@mdedge.com

SAN DIEGO – After implementation of a new chest pain protocol in the emergency department, a greater proportion of patients with low-risk chest pain were discharged, yet a higher rate of ED recidivism was observed, results from a single-center study in Detroit showed.

While the precise cause of this finding is unclear, it may stem from factors affecting socioeconomically disadvantaged populations, Eric M. Blake, one of the study authors, said at the annual meeting of the American College of Emergency Physicians. “Recurrent ED visits are associated with social determinants of health, including race and economic status,” said Mr. Blake, a second-year student at Wayne State University School of Medicine, Detroit. “Socioeconomically disadvantaged patients often lack the transportation and monetary resources to follow up at an outpatient clinic. Detroit is an example of this type of a community; 83% of our population is African American, 36% of people live below the poverty line, and Detroit has an illiteracy rate of 47% in its adult population.”

He and his colleagues hypothesized that implementation of a standardized chest pain protocol in Detroit Receiving Hospital would safely reduce the number of hospital inpatient admissions and ED recidivism rates. Implemented on Nov. 1, 2012, the protocol uses the thrombolysis in myocardial infarction (TIMI) risk score, electrocardiography, and contemporary sensitivity troponin I to triage patients into low-, intermediate-, and high-risk categories. Low-risk patients were discharged and asked to follow up with a cardiologist within 48 hours. For the current study, the researchers retrospectively analyzed patients older than age 18 who presented with low-risk chest pain in the six months before the protocol was implemented and six months after.

A total of 3,613 patients were studied: 1,837 in the pre-protocol group and 1,776 in the post-protocol group. Their mean age was 47 years, 82% were African American, and 53% were male. No differences were observed between the pre- and post-protocol groups in terms of race (P = .280) or sex (P = .497). There was no statistical difference in the proportion of patients deemed at low risk in the pre- vs. post-protocol periods (P = .167). Significantly more low-risk patients were discharged in the post-protocol group, , compared with the pre-protocol group (55% vs. 44%; P less than .001), however. ED recidivism was also significantly greater in the post-protocol vs. pre-protocol group (3% vs. 1.6%; P = .0035).

“These findings may reflect an embedded racial mistrust of the medical system by certain minority groups,” Mr. Blake said. “Due to an extensive history of racism and segregation, a community like Detroit may have reservations when it comes to medical follow-up at outpatient clinics. Difficulty assessing outpatient follow-up for a variety of logistical and monetary reasons common among underprivileged communities may also be reflected in the increased recidivism rates.”

He concluded that administrators and clinicians in EDs nationwide “need to better understand the needs of underprivileged patients. A reduction in resource expenditures when a patient is discharged must be balanced with the cost of a recidivism in vulnerable populations like Detroit.”

To address poor cardiac outpatient follow-up rates, he and his colleagues are conducting a prospective randomized controlled trial investigating the use of motivational interviewing techniques with these patients.

The study’s senior author was Vijaya “Arun” Kumar, MD of Wayne State University School of Medicine. Mr. Blake reported having no financial disclosures.

SOURCE: Kumar VA et al. Ann Emerg Med. 2018 Oct;72;4:S117-18. doi. 10.1016/j.annemergmed.2018.08.304.

dbrunk@mdedge.com

The antipsychotic medications haloperidol and ziprasidone are no better than placebo in altering the duration of delirium in patients in intensive care, new research has found.

copyright Andrei Malov/Thinkstock

In a paper published in the New England Journal of Medicine, researchers reported the results of a randomized, double-blind, placebo-controlled trial in 566 patients with acute respiratory failure or shock and hypoactive or hyperactive delirium. Participants were randomized either to a maximum of 20 mg IV haloperidol daily, maximum 40 mg ziprasidone daily, or placebo.

At the end of the 14-day intervention period, the placebo group had a median of 8.5 days alive without delirium or coma, the haloperidol group had a median of 7.9 days, and the ziprasidone group had a median of 8.7 days. The difference between groups was not statistically significant.

There were also no significant differences between the three groups in the secondary end point of duration of delirium and coma, 30-day and 90-day survival, time to freedom from mechanical ventilation, ICU discharge, ICU readmission, or hospital discharge.

Timothy D. Girard, MD, from the department of critical care at the University of Pittsburgh, and his coauthors wrote that their findings echoed those of two previous placebo-controlled trials in smaller numbers of ICU patients.

“One possible reason that we found no evidence that the use of haloperidol or ziprasidone resulted in a fewer days with delirium or coma than placebo is that the mechanism of brain dysfunction that is considered to be targeted by antipsychotic medications – increased dopamine signaling – may not play a major role in the pathogenesis of delirium during critical illness,” they wrote.

“In the current trial, approximately 90% of the patients received one or more doses of sedatives or analgesics, and the doses of sedatives and offtrial antipsychotic medications and the durations of exposures to those agents were similar in all trial groups,” the authors added.

Most of the patients in the trial had hypotensive delirium, which made it difficult to assess the effects of antipsychotics on hypertensive delirium.

The authors also commented that the patients enrolled were a mixed group, so their findings did not rule out the possibility that certain subgroups of patients – such as nonintubated patients with hyperactive delirium, those with alcohol withdrawal, or with other delirium phenotypes – may still benefit from antipsychotics.

Patients treated with ziprasidone were more likely to experience prolongation of the corrected QT interval. Two patients in the haloperidol group developed torsades de pointes but neither had received haloperidol in the 4 days preceding the onset of the arrhythmia.

One patient in each group – including the placebo group – experienced extrapyramidal symptoms and had treatment withheld. One patient in the haloperidol group also had the trial drug withheld because of suspected neuroleptic malignant syndrome, but this was later ruled out, and one patient had haloperidol withheld because of dystonia.

The dose of haloperidol used in the study was considered high, the authors said, but they left open the possibility that even higher doses might help. However, they also noted that doses of 25 mg and above were known to have adverse effects on cognition, which is why they chose the 20-mg dosage.

The study was supported by the National Institutes of Health and the Department of Veterans Affairs Geriatric Research Education and Clinical Center. Most authors declared support from the NIH or VA during the course of the study. Four authors also reported fees and grants from private industry outside the context of the study.

SOURCE: Girard TD et al. N Engl J Med.2018 Oct 22. doi: 10.1056/NEJMoa1808217.

The antipsychotic medications haloperidol and ziprasidone are no better than placebo in altering the duration of delirium in patients in intensive care, new research has found.

copyright Andrei Malov/Thinkstock

In a paper published in the New England Journal of Medicine, researchers reported the results of a randomized, double-blind, placebo-controlled trial in 566 patients with acute respiratory failure or shock and hypoactive or hyperactive delirium. Participants were randomized either to a maximum of 20 mg IV haloperidol daily, maximum 40 mg ziprasidone daily, or placebo.

At the end of the 14-day intervention period, the placebo group had a median of 8.5 days alive without delirium or coma, the haloperidol group had a median of 7.9 days, and the ziprasidone group had a median of 8.7 days. The difference between groups was not statistically significant.

There were also no significant differences between the three groups in the secondary end point of duration of delirium and coma, 30-day and 90-day survival, time to freedom from mechanical ventilation, ICU discharge, ICU readmission, or hospital discharge.

Timothy D. Girard, MD, from the department of critical care at the University of Pittsburgh, and his coauthors wrote that their findings echoed those of two previous placebo-controlled trials in smaller numbers of ICU patients.

“One possible reason that we found no evidence that the use of haloperidol or ziprasidone resulted in a fewer days with delirium or coma than placebo is that the mechanism of brain dysfunction that is considered to be targeted by antipsychotic medications – increased dopamine signaling – may not play a major role in the pathogenesis of delirium during critical illness,” they wrote.

“In the current trial, approximately 90% of the patients received one or more doses of sedatives or analgesics, and the doses of sedatives and offtrial antipsychotic medications and the durations of exposures to those agents were similar in all trial groups,” the authors added.

Most of the patients in the trial had hypotensive delirium, which made it difficult to assess the effects of antipsychotics on hypertensive delirium.

The authors also commented that the patients enrolled were a mixed group, so their findings did not rule out the possibility that certain subgroups of patients – such as nonintubated patients with hyperactive delirium, those with alcohol withdrawal, or with other delirium phenotypes – may still benefit from antipsychotics.

Patients treated with ziprasidone were more likely to experience prolongation of the corrected QT interval. Two patients in the haloperidol group developed torsades de pointes but neither had received haloperidol in the 4 days preceding the onset of the arrhythmia.

One patient in each group – including the placebo group – experienced extrapyramidal symptoms and had treatment withheld. One patient in the haloperidol group also had the trial drug withheld because of suspected neuroleptic malignant syndrome, but this was later ruled out, and one patient had haloperidol withheld because of dystonia.

The dose of haloperidol used in the study was considered high, the authors said, but they left open the possibility that even higher doses might help. However, they also noted that doses of 25 mg and above were known to have adverse effects on cognition, which is why they chose the 20-mg dosage.

The study was supported by the National Institutes of Health and the Department of Veterans Affairs Geriatric Research Education and Clinical Center. Most authors declared support from the NIH or VA during the course of the study. Four authors also reported fees and grants from private industry outside the context of the study.

SOURCE: Girard TD et al. N Engl J Med.2018 Oct 22. doi: 10.1056/NEJMoa1808217.

The antipsychotic medications haloperidol and ziprasidone are no better than placebo in altering the duration of delirium in patients in intensive care, new research has found.

copyright Andrei Malov/Thinkstock

In a paper published in the New England Journal of Medicine, researchers reported the results of a randomized, double-blind, placebo-controlled trial in 566 patients with acute respiratory failure or shock and hypoactive or hyperactive delirium. Participants were randomized either to a maximum of 20 mg IV haloperidol daily, maximum 40 mg ziprasidone daily, or placebo.

At the end of the 14-day intervention period, the placebo group had a median of 8.5 days alive without delirium or coma, the haloperidol group had a median of 7.9 days, and the ziprasidone group had a median of 8.7 days. The difference between groups was not statistically significant.

There were also no significant differences between the three groups in the secondary end point of duration of delirium and coma, 30-day and 90-day survival, time to freedom from mechanical ventilation, ICU discharge, ICU readmission, or hospital discharge.

Timothy D. Girard, MD, from the department of critical care at the University of Pittsburgh, and his coauthors wrote that their findings echoed those of two previous placebo-controlled trials in smaller numbers of ICU patients.

“One possible reason that we found no evidence that the use of haloperidol or ziprasidone resulted in a fewer days with delirium or coma than placebo is that the mechanism of brain dysfunction that is considered to be targeted by antipsychotic medications – increased dopamine signaling – may not play a major role in the pathogenesis of delirium during critical illness,” they wrote.

“In the current trial, approximately 90% of the patients received one or more doses of sedatives or analgesics, and the doses of sedatives and offtrial antipsychotic medications and the durations of exposures to those agents were similar in all trial groups,” the authors added.

Most of the patients in the trial had hypotensive delirium, which made it difficult to assess the effects of antipsychotics on hypertensive delirium.

The authors also commented that the patients enrolled were a mixed group, so their findings did not rule out the possibility that certain subgroups of patients – such as nonintubated patients with hyperactive delirium, those with alcohol withdrawal, or with other delirium phenotypes – may still benefit from antipsychotics.

Patients treated with ziprasidone were more likely to experience prolongation of the corrected QT interval. Two patients in the haloperidol group developed torsades de pointes but neither had received haloperidol in the 4 days preceding the onset of the arrhythmia.

One patient in each group – including the placebo group – experienced extrapyramidal symptoms and had treatment withheld. One patient in the haloperidol group also had the trial drug withheld because of suspected neuroleptic malignant syndrome, but this was later ruled out, and one patient had haloperidol withheld because of dystonia.

The dose of haloperidol used in the study was considered high, the authors said, but they left open the possibility that even higher doses might help. However, they also noted that doses of 25 mg and above were known to have adverse effects on cognition, which is why they chose the 20-mg dosage.

The study was supported by the National Institutes of Health and the Department of Veterans Affairs Geriatric Research Education and Clinical Center. Most authors declared support from the NIH or VA during the course of the study. Four authors also reported fees and grants from private industry outside the context of the study.

SOURCE: Girard TD et al. N Engl J Med.2018 Oct 22. doi: 10.1056/NEJMoa1808217.

The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.

The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.

“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.

Find the full press release on the Abbott Laboratories website.

lfranki@mdedge.com

The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.

The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.

“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.

Find the full press release on the Abbott Laboratories website.

lfranki@mdedge.com

The Food and Drug Administration has cleared Abbott Laboratories’ next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The Influenza A & B 2 assay can detect and differentiate influenza A and B in 13 minutes, with a call-out of positive results at 5 minutes. It can be stored at room temperature, simplifying storage and ordering. The Strep A 2 assay detects group A streptococcus bacterial nucleic acid in 6 minutes, with a call-out of positive results at 2 minutes. Both will be the fastest tests currently on the market in their respective fields, according to a corporate press release.

The assays will be available in a variety of inpatient and outpatient settings, particularly in locations where patients commonly access health care services, such as EDs, physician offices, walk-in clinics, and urgent care centers. This will allow health care providers to make a fast, informed diagnosis and provide appropriate treatment within the span of a single patient visit.

“The ability to obtain early call outs for positive test results with molecular accuracy in as little as 5 minutes for influenza and 2 minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care. Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient’s symptoms, and contributes to antibiotic resistance,” Gregory J. Berry, PhD, director of molecular diagnostics at Northwell Health Laboratories in Lake Success, N.Y., said in the press release.

Find the full press release on the Abbott Laboratories website.

lfranki@mdedge.com

Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.

In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.

In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.

The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.

The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.

The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.

The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.

Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.

Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.

The ACIP committee members had no relevant financial conflicts to disclose.

Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.

In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.

In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.

The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.

The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.

The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.

The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.

Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.

Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.

The ACIP committee members had no relevant financial conflicts to disclose.

Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.

In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.

In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.

The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.

The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.

The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.

The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.

Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.

Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.

The ACIP committee members had no relevant financial conflicts to disclose.

SAN ANTONIO – Obstructive sleep apnea (OSA) in children is associated with an abnormal metabolic profile, but not with body mass index (BMI), according to new research.

Tara Haelle/MDedge News

“Screening for metabolic dysfunction in obese children with obstructive sleep apnea can help identify those at risk for cardiovascular complications,” Kanika Mathur, MD, of the Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, both in New York, told attendees at the annual meeting of the American College of Chest Physicians. Dr. Mathur explained that no consensus currently exists regarding routine cardiac evaluation of children with OSA.

“The American Academy of Pediatrics does not mention any sort of cardiac evaluation in children with OSA while the most recent guidelines from the American Heart Association and the American Thoracic Society recommend echocardiographic evaluation in children with severe obstructive sleep apnea, specifically to evaluate for pulmonary hypertension and right ventricular dysfunction,” Dr. Mathur told attendees.

OSA’s association with obesity, diabetes, and hypertension is well established in adults. It is an independent risk factor for coronary artery disease, heart failure, stroke and atrial fibrillation, and research has suggested OSA treatment can reduce cardiovascular risk in adults, Dr. Mathur explained, but little data on children exist. She and her colleagues set out to understand the relationship of OSA in children with various measures of cardiovascular and metabolic health.

“Despite similar degrees of obesity and systemic blood pressure, pediatric patients with OSA had significantly higher diastolic blood pressure, heart rate, and abnormal metabolic profile, including elevated alanine transaminase, aspartate transaminase, triglycerides and hemoglobin A_1c,” they found.

Their study included patients aged 3-21 years with a BMI of at least the 95th percentile who had undergone sleep study and an echocardiogram at the Children’s Hospital at Montefiore between November 2016 and November 2017.

They excluded those with comorbidities related to cardiovascular morbidity: heart disease, neuromuscular disease, sickle cell disease, rheumatologic diseases, significant cranial facial abnormalities, tracheostomy, and any lung disease. However, 7% of the patients had trisomy 21.

Among the 81 children who met their criteria, 37 were male and 44 were female, with an average age of 14 years old and a mean BMI of 39.4 kg/m² (mean BMI z score of 2.22). Most of the patients (53.1%) had severe OSA (apnea-hypopnea index of at least 10), 21% had moderate OSA (AHI 5-9.9), 12.3% had mild OSA (AHI 2-4.9), and 13.6% did not have OSA. The median AHI of the children was 10.3.

Among all the children, “about half had elevated systolic blood pressure, which is already a risk factor for cardiovascular morbidity,” Mathur reported.

BMI, BMI z score, systolic blood pressure z score, oxygen saturation and cholesterol (overall and both HDL and LDL cholesterol levels) did not significantly differ between children who had OSA and those who did not, but diastolic blood pressure and heart rate did. Those with OSA had a diastolic blood pressure of 65 mm Hg, compared with 58 mm Hg without OSA (P = .008). Heart rate was 89 bpm in the children with OSA, compared with 78 bpm in those without (P = .004).

The children with OSA also showed higher mean levels of several other metabolic biomarkers:

• Alanine transaminase: 26 U/L with OSA vs. 18 U/L without (P = .01).
• Aspartate transaminase: 23 U/L with OSA vs. 18 U/L without (P = .03).
• Triglycerides: 138 mg/dL with OSA vs 84 mg/dL without (P = .004).
• Hemoglobin A_1c: 6.2% with OSA vs. 5.4% without (P = .002).

Children with and without OSA did not have any significant differences in left atrial indexed volume, left ventricular volume, left ventricular ejection fraction, or left ventricular mass (measured by M-mode or 5/6 area length formula). Though research has shown these measures to differ in adults with and without OSA, evidence on echocardiographic changes in children has been conflicting, Dr. Mathur noted.

The researchers also conducted subanalyses according to OSA severity, but BMI, BMI Z-score, systolic or diastolic blood pressure Z-score, heart rate and oxygen saturation did not differ between those with mild OSA vs those with moderate or severe OSA. No differences in echocardiographic measurements existed between these subgroups, either.

However, children with moderate to severe OSA did have higher alanine transaminase (27 U/L with moderate to severe vs. 17 U/L with mild OSA; P = .005) and higher triglycerides (148 vs 74; P = .001).

“Certainly we need further evaluation to see the efficacy of obstructive sleep apnea therapies on metabolic dysfunction and whether weight loss needs to be an adjunct therapy for these patients,” Dr. Mathur told attendees. She also noted the need to define the role of echocardiography in managing children with OSA.

The study had several limitations, including its retrospective cross-sectional nature at a single center and its small sample size.

Andrew D. Bowser/MDedge News

“Additionally, we have a wide variety of ages, which could represent different pathophysiology of the associated metabolic dysfunction in these patients,” Mathur said. “There is an inherent difficulty to performing echocardiograms in a very obese population as well.”

Both the moderators of the pediatrics section, Christopher Carroll, MD, FCCP, of Connecticut Children’s Medical Center in Hartford, and Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital in Columbus, Ohio, were impressed with the research. Dr. Carroll called it a “very elegant” study, and Dr. Sheikh noted the need for these studies in pediatrics “so that we don’t have to rely on grown-up data,” which may or may not generalize to children.

SOURCE: CHEST 2018. https://journal.chestnet.org/article/S0012-3692(18)31935-4/fulltext

SAN ANTONIO – Obstructive sleep apnea (OSA) in children is associated with an abnormal metabolic profile, but not with body mass index (BMI), according to new research.

Tara Haelle/MDedge News

“Screening for metabolic dysfunction in obese children with obstructive sleep apnea can help identify those at risk for cardiovascular complications,” Kanika Mathur, MD, of the Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, both in New York, told attendees at the annual meeting of the American College of Chest Physicians. Dr. Mathur explained that no consensus currently exists regarding routine cardiac evaluation of children with OSA.

“The American Academy of Pediatrics does not mention any sort of cardiac evaluation in children with OSA while the most recent guidelines from the American Heart Association and the American Thoracic Society recommend echocardiographic evaluation in children with severe obstructive sleep apnea, specifically to evaluate for pulmonary hypertension and right ventricular dysfunction,” Dr. Mathur told attendees.

OSA’s association with obesity, diabetes, and hypertension is well established in adults. It is an independent risk factor for coronary artery disease, heart failure, stroke and atrial fibrillation, and research has suggested OSA treatment can reduce cardiovascular risk in adults, Dr. Mathur explained, but little data on children exist. She and her colleagues set out to understand the relationship of OSA in children with various measures of cardiovascular and metabolic health.

“Despite similar degrees of obesity and systemic blood pressure, pediatric patients with OSA had significantly higher diastolic blood pressure, heart rate, and abnormal metabolic profile, including elevated alanine transaminase, aspartate transaminase, triglycerides and hemoglobin A_1c,” they found.

Their study included patients aged 3-21 years with a BMI of at least the 95th percentile who had undergone sleep study and an echocardiogram at the Children’s Hospital at Montefiore between November 2016 and November 2017.

They excluded those with comorbidities related to cardiovascular morbidity: heart disease, neuromuscular disease, sickle cell disease, rheumatologic diseases, significant cranial facial abnormalities, tracheostomy, and any lung disease. However, 7% of the patients had trisomy 21.

Among the 81 children who met their criteria, 37 were male and 44 were female, with an average age of 14 years old and a mean BMI of 39.4 kg/m² (mean BMI z score of 2.22). Most of the patients (53.1%) had severe OSA (apnea-hypopnea index of at least 10), 21% had moderate OSA (AHI 5-9.9), 12.3% had mild OSA (AHI 2-4.9), and 13.6% did not have OSA. The median AHI of the children was 10.3.

Among all the children, “about half had elevated systolic blood pressure, which is already a risk factor for cardiovascular morbidity,” Mathur reported.

BMI, BMI z score, systolic blood pressure z score, oxygen saturation and cholesterol (overall and both HDL and LDL cholesterol levels) did not significantly differ between children who had OSA and those who did not, but diastolic blood pressure and heart rate did. Those with OSA had a diastolic blood pressure of 65 mm Hg, compared with 58 mm Hg without OSA (P = .008). Heart rate was 89 bpm in the children with OSA, compared with 78 bpm in those without (P = .004).

The children with OSA also showed higher mean levels of several other metabolic biomarkers:

• Alanine transaminase: 26 U/L with OSA vs. 18 U/L without (P = .01).
• Aspartate transaminase: 23 U/L with OSA vs. 18 U/L without (P = .03).
• Triglycerides: 138 mg/dL with OSA vs 84 mg/dL without (P = .004).
• Hemoglobin A_1c: 6.2% with OSA vs. 5.4% without (P = .002).

Children with and without OSA did not have any significant differences in left atrial indexed volume, left ventricular volume, left ventricular ejection fraction, or left ventricular mass (measured by M-mode or 5/6 area length formula). Though research has shown these measures to differ in adults with and without OSA, evidence on echocardiographic changes in children has been conflicting, Dr. Mathur noted.

The researchers also conducted subanalyses according to OSA severity, but BMI, BMI Z-score, systolic or diastolic blood pressure Z-score, heart rate and oxygen saturation did not differ between those with mild OSA vs those with moderate or severe OSA. No differences in echocardiographic measurements existed between these subgroups, either.

However, children with moderate to severe OSA did have higher alanine transaminase (27 U/L with moderate to severe vs. 17 U/L with mild OSA; P = .005) and higher triglycerides (148 vs 74; P = .001).

“Certainly we need further evaluation to see the efficacy of obstructive sleep apnea therapies on metabolic dysfunction and whether weight loss needs to be an adjunct therapy for these patients,” Dr. Mathur told attendees. She also noted the need to define the role of echocardiography in managing children with OSA.

The study had several limitations, including its retrospective cross-sectional nature at a single center and its small sample size.

Andrew D. Bowser/MDedge News

“Additionally, we have a wide variety of ages, which could represent different pathophysiology of the associated metabolic dysfunction in these patients,” Mathur said. “There is an inherent difficulty to performing echocardiograms in a very obese population as well.”

Both the moderators of the pediatrics section, Christopher Carroll, MD, FCCP, of Connecticut Children’s Medical Center in Hartford, and Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital in Columbus, Ohio, were impressed with the research. Dr. Carroll called it a “very elegant” study, and Dr. Sheikh noted the need for these studies in pediatrics “so that we don’t have to rely on grown-up data,” which may or may not generalize to children.

SOURCE: CHEST 2018. https://journal.chestnet.org/article/S0012-3692(18)31935-4/fulltext

SAN ANTONIO – Obstructive sleep apnea (OSA) in children is associated with an abnormal metabolic profile, but not with body mass index (BMI), according to new research.

Tara Haelle/MDedge News

“Screening for metabolic dysfunction in obese children with obstructive sleep apnea can help identify those at risk for cardiovascular complications,” Kanika Mathur, MD, of the Albert Einstein College of Medicine and the Children’s Hospital at Montefiore, both in New York, told attendees at the annual meeting of the American College of Chest Physicians. Dr. Mathur explained that no consensus currently exists regarding routine cardiac evaluation of children with OSA.

“The American Academy of Pediatrics does not mention any sort of cardiac evaluation in children with OSA while the most recent guidelines from the American Heart Association and the American Thoracic Society recommend echocardiographic evaluation in children with severe obstructive sleep apnea, specifically to evaluate for pulmonary hypertension and right ventricular dysfunction,” Dr. Mathur told attendees.

OSA’s association with obesity, diabetes, and hypertension is well established in adults. It is an independent risk factor for coronary artery disease, heart failure, stroke and atrial fibrillation, and research has suggested OSA treatment can reduce cardiovascular risk in adults, Dr. Mathur explained, but little data on children exist. She and her colleagues set out to understand the relationship of OSA in children with various measures of cardiovascular and metabolic health.

“Despite similar degrees of obesity and systemic blood pressure, pediatric patients with OSA had significantly higher diastolic blood pressure, heart rate, and abnormal metabolic profile, including elevated alanine transaminase, aspartate transaminase, triglycerides and hemoglobin A_1c,” they found.

Their study included patients aged 3-21 years with a BMI of at least the 95th percentile who had undergone sleep study and an echocardiogram at the Children’s Hospital at Montefiore between November 2016 and November 2017.

They excluded those with comorbidities related to cardiovascular morbidity: heart disease, neuromuscular disease, sickle cell disease, rheumatologic diseases, significant cranial facial abnormalities, tracheostomy, and any lung disease. However, 7% of the patients had trisomy 21.

Among the 81 children who met their criteria, 37 were male and 44 were female, with an average age of 14 years old and a mean BMI of 39.4 kg/m² (mean BMI z score of 2.22). Most of the patients (53.1%) had severe OSA (apnea-hypopnea index of at least 10), 21% had moderate OSA (AHI 5-9.9), 12.3% had mild OSA (AHI 2-4.9), and 13.6% did not have OSA. The median AHI of the children was 10.3.

Among all the children, “about half had elevated systolic blood pressure, which is already a risk factor for cardiovascular morbidity,” Mathur reported.

BMI, BMI z score, systolic blood pressure z score, oxygen saturation and cholesterol (overall and both HDL and LDL cholesterol levels) did not significantly differ between children who had OSA and those who did not, but diastolic blood pressure and heart rate did. Those with OSA had a diastolic blood pressure of 65 mm Hg, compared with 58 mm Hg without OSA (P = .008). Heart rate was 89 bpm in the children with OSA, compared with 78 bpm in those without (P = .004).

The children with OSA also showed higher mean levels of several other metabolic biomarkers:

• Alanine transaminase: 26 U/L with OSA vs. 18 U/L without (P = .01).
• Aspartate transaminase: 23 U/L with OSA vs. 18 U/L without (P = .03).
• Triglycerides: 138 mg/dL with OSA vs 84 mg/dL without (P = .004).
• Hemoglobin A_1c: 6.2% with OSA vs. 5.4% without (P = .002).

Children with and without OSA did not have any significant differences in left atrial indexed volume, left ventricular volume, left ventricular ejection fraction, or left ventricular mass (measured by M-mode or 5/6 area length formula). Though research has shown these measures to differ in adults with and without OSA, evidence on echocardiographic changes in children has been conflicting, Dr. Mathur noted.

The researchers also conducted subanalyses according to OSA severity, but BMI, BMI Z-score, systolic or diastolic blood pressure Z-score, heart rate and oxygen saturation did not differ between those with mild OSA vs those with moderate or severe OSA. No differences in echocardiographic measurements existed between these subgroups, either.

However, children with moderate to severe OSA did have higher alanine transaminase (27 U/L with moderate to severe vs. 17 U/L with mild OSA; P = .005) and higher triglycerides (148 vs 74; P = .001).

“Certainly we need further evaluation to see the efficacy of obstructive sleep apnea therapies on metabolic dysfunction and whether weight loss needs to be an adjunct therapy for these patients,” Dr. Mathur told attendees. She also noted the need to define the role of echocardiography in managing children with OSA.

The study had several limitations, including its retrospective cross-sectional nature at a single center and its small sample size.

Andrew D. Bowser/MDedge News

“Additionally, we have a wide variety of ages, which could represent different pathophysiology of the associated metabolic dysfunction in these patients,” Mathur said. “There is an inherent difficulty to performing echocardiograms in a very obese population as well.”

Both the moderators of the pediatrics section, Christopher Carroll, MD, FCCP, of Connecticut Children’s Medical Center in Hartford, and Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital in Columbus, Ohio, were impressed with the research. Dr. Carroll called it a “very elegant” study, and Dr. Sheikh noted the need for these studies in pediatrics “so that we don’t have to rely on grown-up data,” which may or may not generalize to children.

SOURCE: CHEST 2018. https://journal.chestnet.org/article/S0012-3692(18)31935-4/fulltext

The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.

The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The most common adverse events associated with Xofluza were diarrhea and bronchitis.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

Find the full press release on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.

The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The most common adverse events associated with Xofluza were diarrhea and bronchitis.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

Find the full press release on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for 48 hours or less.

The FDA approval is based on results from two randomized, clinical trials. In both trials, patients who received Xofluza experienced a shorter duration until alleviation of symptoms, compared with patients who received a placebo. In the second trial, patients who received Xofluza and patients who received another approved antiviral influenza medication experienced similar durations until symptom alleviation.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The most common adverse events associated with Xofluza were diarrhea and bronchitis.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, MD, added. “With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

Find the full press release on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has extended the indication for a quadrivalent influenza vaccine (Afluria, marketed by Seqirus) to include infants and younger children.

The expanded approval now includes persons aged 6-59 months; the quadrivalent vaccine had previously been approved for ages 5 years and up. A trivalent version of the Afluria influenza vaccine also now is indicated for people aged 6 months and up, according to an Oct. 4 communication from the FDA.

A total of 172 pediatric influenza-related deaths occurred in the United States during the 2017-2018 season, representing a new high in nonpandemic influenza seasons. About half of the pediatric influenza deaths occurred in otherwise healthy children, and about 22% of children who died were fully vaccinated, according to the Centers for Disease Control and Prevention, reporting U.S. data from 2010 to 2016.

“As we enter a new flu season, we are reminded of the enormous impact that influenza can have on public health,” Seqirus’ vice president of medical affairs Gregg Sylvester, MD, said in a press release announcing the extended indication. “Having another option to fight this disease can translate to saved lives and fewer flu-related hospitalizations this season and going forward.”

According to the CDC, the 2018-2019 influenza vaccine has been updated to provide a better match – and more protection against – viruses circulating in this influenza season. Specifically, says the CDC, the influenza B Victoria lineage and the influenza A(H3N2) components were updated.

In addition to providing protection against these two strains of influenza, trivalent vaccines for the 2018-2019 season are recommended to include protection against H1N1 influenza as well. Quadrivalent vaccines protect against a second influenza B lineage.

Most people will receive a quadrivalent vaccine this year, according to the CDC.

koakes@mdedge.com

The Food and Drug Administration has extended the indication for a quadrivalent influenza vaccine (Afluria, marketed by Seqirus) to include infants and younger children.

The expanded approval now includes persons aged 6-59 months; the quadrivalent vaccine had previously been approved for ages 5 years and up. A trivalent version of the Afluria influenza vaccine also now is indicated for people aged 6 months and up, according to an Oct. 4 communication from the FDA.

A total of 172 pediatric influenza-related deaths occurred in the United States during the 2017-2018 season, representing a new high in nonpandemic influenza seasons. About half of the pediatric influenza deaths occurred in otherwise healthy children, and about 22% of children who died were fully vaccinated, according to the Centers for Disease Control and Prevention, reporting U.S. data from 2010 to 2016.

“As we enter a new flu season, we are reminded of the enormous impact that influenza can have on public health,” Seqirus’ vice president of medical affairs Gregg Sylvester, MD, said in a press release announcing the extended indication. “Having another option to fight this disease can translate to saved lives and fewer flu-related hospitalizations this season and going forward.”

According to the CDC, the 2018-2019 influenza vaccine has been updated to provide a better match – and more protection against – viruses circulating in this influenza season. Specifically, says the CDC, the influenza B Victoria lineage and the influenza A(H3N2) components were updated.

In addition to providing protection against these two strains of influenza, trivalent vaccines for the 2018-2019 season are recommended to include protection against H1N1 influenza as well. Quadrivalent vaccines protect against a second influenza B lineage.

Most people will receive a quadrivalent vaccine this year, according to the CDC.

koakes@mdedge.com

The Food and Drug Administration has extended the indication for a quadrivalent influenza vaccine (Afluria, marketed by Seqirus) to include infants and younger children.

The expanded approval now includes persons aged 6-59 months; the quadrivalent vaccine had previously been approved for ages 5 years and up. A trivalent version of the Afluria influenza vaccine also now is indicated for people aged 6 months and up, according to an Oct. 4 communication from the FDA.

A total of 172 pediatric influenza-related deaths occurred in the United States during the 2017-2018 season, representing a new high in nonpandemic influenza seasons. About half of the pediatric influenza deaths occurred in otherwise healthy children, and about 22% of children who died were fully vaccinated, according to the Centers for Disease Control and Prevention, reporting U.S. data from 2010 to 2016.

“As we enter a new flu season, we are reminded of the enormous impact that influenza can have on public health,” Seqirus’ vice president of medical affairs Gregg Sylvester, MD, said in a press release announcing the extended indication. “Having another option to fight this disease can translate to saved lives and fewer flu-related hospitalizations this season and going forward.”

According to the CDC, the 2018-2019 influenza vaccine has been updated to provide a better match – and more protection against – viruses circulating in this influenza season. Specifically, says the CDC, the influenza B Victoria lineage and the influenza A(H3N2) components were updated.

In addition to providing protection against these two strains of influenza, trivalent vaccines for the 2018-2019 season are recommended to include protection against H1N1 influenza as well. Quadrivalent vaccines protect against a second influenza B lineage.

Most people will receive a quadrivalent vaccine this year, according to the CDC.

koakes@mdedge.com

SAN ANTONIO – Women in medicine have made great strides in cracking the glass ceiling, but it’s not shattered yet, said Stephanie M. Levine, MD, FCCP, the incoming president of CHEST.

At a session on women in medicine at the annual meeting of the American College of Chest Physicians, Dr. Levine discussed the challenges of breaking through the metaphorical invisible barrier. The “glass ceiling” refers to multiple ways in which women lack equality with men in medicine: leadership roles, positions and titles, progress in academic medicine, gaps in salaries and compensation, and overall gender parity in specialties.

For example, according to data from the American Association of Medical Colleges for 2017-2018, women comprise 50% of medical school graduates but only 34% of the physician workforce and 22% of leadership roles. Women are 13% less likely to be promoted to professor. They receive salaries an average 21% lower than those of their male peers, said Dr. Levine, professor of medicine and director of the pulmonary/critical care fellowship program at the University of Texas, San Antonio.

Disparities exist particularly within specialties and subspecialties, she said. Women make 85% of what men earn in primary care but, in the specialties, only 75% of what men earn. Among active fellow trainees in the areas of medicine most represented by CHEST, one-third (32%) of critical care physicians and less than a third (29%) of pulmonary physicians are female.
 

Why the lag in specialty parity?

The reasons for these disparities are complex, Dr. Levine argued, but the problem is not insurmountable. They begin, in a sense, with the problem itself: When there are fewer mentors, role models, sponsors, and leaders, and less overall representation of women in the first place, it is harder for women to advance.

One male audience member, for example, asked how his department could recruit more women, because most turned down interviews despite the fact that more women than men were being invited. “How many women are in your leadership?” Dr. Levine asked. He acknowledged that there were none – and therein lies the likely problem. Applicants are looking for female representation in leadership.

Gender bias and discrimination certainly play a role among peers, leadership, and even patients. Patients referring to female physicians by their first names and asking questions such as “Are you my nurse?” are subtle but cutting examples of the ways in which they reveal implicit bias and reinforce gender stereotypes, Dr. Levine said to weary nods of agreement among the attendees.

Implicit, unconscious bias is also built into the culture of a place and the way things have always been done. Lack of equity in salary, space to work, support, and promotion all compound one another. Work-life integration challenges often do not favor women. Studies have shown that in the hiring process, CVs with female names do not receive as much attention as do CVs with male names, Dr. Levine noted.

Some of the challenges lie with the way women themselves do or do not advocate for themselves. Research has long shown that women do not negotiate as well – or at all – compared with men. Women tend to be less aggressive in seeking higher compensation and leadership roles, possibly because of existing implicit bias against female assertiveness in general.

The catch-22 is that being more assertive or direct can lead others to interpret a woman as being rude or brusk, as one audience member noted when she described how colleagues perceive her simple, direct tone as seeming “upset.”

Conscious bias remains alive and well: The stereotypes that women are caretakers and men are take-charge dominators persist and can reinforce gender disparities in leadership roles.

Women also must make calculations and trade-offs between their academic promotion clocks and their biologic clocks, Dr. Levine explained.

“The 30s are great for both academic and biologic productivity,” she told attendees. The typical age for a person’s first National Institutes of Health Research Project grant (R01) is in the early 40s.
 

How to improve gender equality

Women bring diverse skills and perspectives to the table, Dr. Levine explained. Women tend to have stronger collaborative skills and greater compassion and empathy, for example. They tend to be less hierarchal and better at mentoring and empowerment, she said.

There are many ways to poke more cracks in the ceiling, starting with diversity and inclusion officers who make it a priority to focus on parity. Formal programs can educate staff and colleagues about implicit bias so that they might more easily recognize it when it kicks in, and training for gatekeepers can lead to more proportional hiring of women at every level.

Institutions should review their policies – salary inequities, diversity in promotion, processes for selecting leaders – and set formal interventional goals that are then evaluated in honest, documented annual reviews.

Some of these policies should address work-life balance as well: Offering part-time and flexible work options during early child-rearing years helps not only mothers, but also fathers who are now taking a more active role in parenting. Slowing or prorating the promotion clock can help those building families, and shifting meetings away from times such as 7:00 a.m. and 6:00 p.m. allow mothers and fathers alike to get their kids to and from school and attend children’s events.

Sponsorship of women is an important strategy in breaking the glass ceiling, Dr. Levine said. Sponsors can support women with untapped leadership potential and do the necessary networking and introductions that help make that advance happen. And it must be done by sponsors with power and influence, including men, Dr. Levine said.

Men can play important roles in promoting gender parity by suggesting women for key roles, leadership positions, and committees and also notifying women of upcoming opportunities, such as editorial board spots and other hot jobs. For women who aspire to be leaders, men can seek to convey leadership skills that may be needed to chair committees and other groups. Search committees need to expand beyond looking for “token women,” she said.

Dr. Levine illustrated her address with her own story. She described how many of these strategies had helped her career and how many male supervisors, mentors, and colleagues helped her, including introducing her to other male leaders who then offered her opportunities to contribute to the American College of Chest Physicians. She ran for CHEST president twice before being elected on her third run in September. She is the fifth woman to lead CHEST.

“Don’t give up,” she encouraged women in the audience, telling them to advocate for themselves and to encourage, mentor, and sponsor their female fellows and junior faculty.

“This will result in closing the gaps and will help women achieve leadership roles and competitive salaries as well as work-life integration,” Dr. Levine said.

SAN ANTONIO – Women in medicine have made great strides in cracking the glass ceiling, but it’s not shattered yet, said Stephanie M. Levine, MD, FCCP, the incoming president of CHEST.

At a session on women in medicine at the annual meeting of the American College of Chest Physicians, Dr. Levine discussed the challenges of breaking through the metaphorical invisible barrier. The “glass ceiling” refers to multiple ways in which women lack equality with men in medicine: leadership roles, positions and titles, progress in academic medicine, gaps in salaries and compensation, and overall gender parity in specialties.

For example, according to data from the American Association of Medical Colleges for 2017-2018, women comprise 50% of medical school graduates but only 34% of the physician workforce and 22% of leadership roles. Women are 13% less likely to be promoted to professor. They receive salaries an average 21% lower than those of their male peers, said Dr. Levine, professor of medicine and director of the pulmonary/critical care fellowship program at the University of Texas, San Antonio.

Disparities exist particularly within specialties and subspecialties, she said. Women make 85% of what men earn in primary care but, in the specialties, only 75% of what men earn. Among active fellow trainees in the areas of medicine most represented by CHEST, one-third (32%) of critical care physicians and less than a third (29%) of pulmonary physicians are female.
 

Why the lag in specialty parity?

The reasons for these disparities are complex, Dr. Levine argued, but the problem is not insurmountable. They begin, in a sense, with the problem itself: When there are fewer mentors, role models, sponsors, and leaders, and less overall representation of women in the first place, it is harder for women to advance.

One male audience member, for example, asked how his department could recruit more women, because most turned down interviews despite the fact that more women than men were being invited. “How many women are in your leadership?” Dr. Levine asked. He acknowledged that there were none – and therein lies the likely problem. Applicants are looking for female representation in leadership.

Gender bias and discrimination certainly play a role among peers, leadership, and even patients. Patients referring to female physicians by their first names and asking questions such as “Are you my nurse?” are subtle but cutting examples of the ways in which they reveal implicit bias and reinforce gender stereotypes, Dr. Levine said to weary nods of agreement among the attendees.

Implicit, unconscious bias is also built into the culture of a place and the way things have always been done. Lack of equity in salary, space to work, support, and promotion all compound one another. Work-life integration challenges often do not favor women. Studies have shown that in the hiring process, CVs with female names do not receive as much attention as do CVs with male names, Dr. Levine noted.

Some of the challenges lie with the way women themselves do or do not advocate for themselves. Research has long shown that women do not negotiate as well – or at all – compared with men. Women tend to be less aggressive in seeking higher compensation and leadership roles, possibly because of existing implicit bias against female assertiveness in general.

The catch-22 is that being more assertive or direct can lead others to interpret a woman as being rude or brusk, as one audience member noted when she described how colleagues perceive her simple, direct tone as seeming “upset.”

Conscious bias remains alive and well: The stereotypes that women are caretakers and men are take-charge dominators persist and can reinforce gender disparities in leadership roles.

Women also must make calculations and trade-offs between their academic promotion clocks and their biologic clocks, Dr. Levine explained.

“The 30s are great for both academic and biologic productivity,” she told attendees. The typical age for a person’s first National Institutes of Health Research Project grant (R01) is in the early 40s.
 

How to improve gender equality

Women bring diverse skills and perspectives to the table, Dr. Levine explained. Women tend to have stronger collaborative skills and greater compassion and empathy, for example. They tend to be less hierarchal and better at mentoring and empowerment, she said.

There are many ways to poke more cracks in the ceiling, starting with diversity and inclusion officers who make it a priority to focus on parity. Formal programs can educate staff and colleagues about implicit bias so that they might more easily recognize it when it kicks in, and training for gatekeepers can lead to more proportional hiring of women at every level.

Institutions should review their policies – salary inequities, diversity in promotion, processes for selecting leaders – and set formal interventional goals that are then evaluated in honest, documented annual reviews.

Some of these policies should address work-life balance as well: Offering part-time and flexible work options during early child-rearing years helps not only mothers, but also fathers who are now taking a more active role in parenting. Slowing or prorating the promotion clock can help those building families, and shifting meetings away from times such as 7:00 a.m. and 6:00 p.m. allow mothers and fathers alike to get their kids to and from school and attend children’s events.

Sponsorship of women is an important strategy in breaking the glass ceiling, Dr. Levine said. Sponsors can support women with untapped leadership potential and do the necessary networking and introductions that help make that advance happen. And it must be done by sponsors with power and influence, including men, Dr. Levine said.

Men can play important roles in promoting gender parity by suggesting women for key roles, leadership positions, and committees and also notifying women of upcoming opportunities, such as editorial board spots and other hot jobs. For women who aspire to be leaders, men can seek to convey leadership skills that may be needed to chair committees and other groups. Search committees need to expand beyond looking for “token women,” she said.

Dr. Levine illustrated her address with her own story. She described how many of these strategies had helped her career and how many male supervisors, mentors, and colleagues helped her, including introducing her to other male leaders who then offered her opportunities to contribute to the American College of Chest Physicians. She ran for CHEST president twice before being elected on her third run in September. She is the fifth woman to lead CHEST.

“Don’t give up,” she encouraged women in the audience, telling them to advocate for themselves and to encourage, mentor, and sponsor their female fellows and junior faculty.

“This will result in closing the gaps and will help women achieve leadership roles and competitive salaries as well as work-life integration,” Dr. Levine said.

SAN ANTONIO – Women in medicine have made great strides in cracking the glass ceiling, but it’s not shattered yet, said Stephanie M. Levine, MD, FCCP, the incoming president of CHEST.

At a session on women in medicine at the annual meeting of the American College of Chest Physicians, Dr. Levine discussed the challenges of breaking through the metaphorical invisible barrier. The “glass ceiling” refers to multiple ways in which women lack equality with men in medicine: leadership roles, positions and titles, progress in academic medicine, gaps in salaries and compensation, and overall gender parity in specialties.

For example, according to data from the American Association of Medical Colleges for 2017-2018, women comprise 50% of medical school graduates but only 34% of the physician workforce and 22% of leadership roles. Women are 13% less likely to be promoted to professor. They receive salaries an average 21% lower than those of their male peers, said Dr. Levine, professor of medicine and director of the pulmonary/critical care fellowship program at the University of Texas, San Antonio.

Disparities exist particularly within specialties and subspecialties, she said. Women make 85% of what men earn in primary care but, in the specialties, only 75% of what men earn. Among active fellow trainees in the areas of medicine most represented by CHEST, one-third (32%) of critical care physicians and less than a third (29%) of pulmonary physicians are female.
 

Why the lag in specialty parity?

The reasons for these disparities are complex, Dr. Levine argued, but the problem is not insurmountable. They begin, in a sense, with the problem itself: When there are fewer mentors, role models, sponsors, and leaders, and less overall representation of women in the first place, it is harder for women to advance.

One male audience member, for example, asked how his department could recruit more women, because most turned down interviews despite the fact that more women than men were being invited. “How many women are in your leadership?” Dr. Levine asked. He acknowledged that there were none – and therein lies the likely problem. Applicants are looking for female representation in leadership.

Gender bias and discrimination certainly play a role among peers, leadership, and even patients. Patients referring to female physicians by their first names and asking questions such as “Are you my nurse?” are subtle but cutting examples of the ways in which they reveal implicit bias and reinforce gender stereotypes, Dr. Levine said to weary nods of agreement among the attendees.

Implicit, unconscious bias is also built into the culture of a place and the way things have always been done. Lack of equity in salary, space to work, support, and promotion all compound one another. Work-life integration challenges often do not favor women. Studies have shown that in the hiring process, CVs with female names do not receive as much attention as do CVs with male names, Dr. Levine noted.

Some of the challenges lie with the way women themselves do or do not advocate for themselves. Research has long shown that women do not negotiate as well – or at all – compared with men. Women tend to be less aggressive in seeking higher compensation and leadership roles, possibly because of existing implicit bias against female assertiveness in general.

The catch-22 is that being more assertive or direct can lead others to interpret a woman as being rude or brusk, as one audience member noted when she described how colleagues perceive her simple, direct tone as seeming “upset.”

Conscious bias remains alive and well: The stereotypes that women are caretakers and men are take-charge dominators persist and can reinforce gender disparities in leadership roles.

Women also must make calculations and trade-offs between their academic promotion clocks and their biologic clocks, Dr. Levine explained.

“The 30s are great for both academic and biologic productivity,” she told attendees. The typical age for a person’s first National Institutes of Health Research Project grant (R01) is in the early 40s.
 

How to improve gender equality

Women bring diverse skills and perspectives to the table, Dr. Levine explained. Women tend to have stronger collaborative skills and greater compassion and empathy, for example. They tend to be less hierarchal and better at mentoring and empowerment, she said.

There are many ways to poke more cracks in the ceiling, starting with diversity and inclusion officers who make it a priority to focus on parity. Formal programs can educate staff and colleagues about implicit bias so that they might more easily recognize it when it kicks in, and training for gatekeepers can lead to more proportional hiring of women at every level.

Institutions should review their policies – salary inequities, diversity in promotion, processes for selecting leaders – and set formal interventional goals that are then evaluated in honest, documented annual reviews.

Some of these policies should address work-life balance as well: Offering part-time and flexible work options during early child-rearing years helps not only mothers, but also fathers who are now taking a more active role in parenting. Slowing or prorating the promotion clock can help those building families, and shifting meetings away from times such as 7:00 a.m. and 6:00 p.m. allow mothers and fathers alike to get their kids to and from school and attend children’s events.

Sponsorship of women is an important strategy in breaking the glass ceiling, Dr. Levine said. Sponsors can support women with untapped leadership potential and do the necessary networking and introductions that help make that advance happen. And it must be done by sponsors with power and influence, including men, Dr. Levine said.

Men can play important roles in promoting gender parity by suggesting women for key roles, leadership positions, and committees and also notifying women of upcoming opportunities, such as editorial board spots and other hot jobs. For women who aspire to be leaders, men can seek to convey leadership skills that may be needed to chair committees and other groups. Search committees need to expand beyond looking for “token women,” she said.

Dr. Levine illustrated her address with her own story. She described how many of these strategies had helped her career and how many male supervisors, mentors, and colleagues helped her, including introducing her to other male leaders who then offered her opportunities to contribute to the American College of Chest Physicians. She ran for CHEST president twice before being elected on her third run in September. She is the fifth woman to lead CHEST.

“Don’t give up,” she encouraged women in the audience, telling them to advocate for themselves and to encourage, mentor, and sponsor their female fellows and junior faculty.

“This will result in closing the gaps and will help women achieve leadership roles and competitive salaries as well as work-life integration,” Dr. Levine said.

CHICAGO – Follow-up out to as long as 11 years from treatment confirmed the long-term efficacy and safety of myeloablative autologous stem cell transplantation for patients with severe scleroderma.

This extended follow-up comprised 43 survivors from the 75 patients originally randomized in a controlled, 6-year trial. Follow-up showed that, among the patients who underwent myeloablation and autologous transplant with hematopoietic stem cells, there were no long-term deaths or cancers, there was an 88% survival rate, and 92% remained off disease-modifying treatment, Keith M. Sullivan, MD, said at the annual meeting of the American College of Rheumatology.

Long-term survival among patients randomized to the study’s control arm, who received treatment with cyclophosphamide, was 53%.

Patients with severe scleroderma with significant internal organ damage who “are improved and off of disease-modifying antirheumatic drugs after 10 or more years from treatment is something new in autoimmune disease,” said Dr. Sullivan, a professor of medicine at Duke University, Durham, N.C.

Based on accumulated data from this randomized trial and other studies, the American Society for Blood and Marrow Transplantation issued a position statement in June 2018 that endorsed autologous hematopoietic stem cell transplantation as “standard of care” for systemic sclerosis (Biol Blood Marrow Transplant. 2018 June 25. doi: 10.1016/j.bbmt.2018.06.025), Dr. Sullivan noted in a video interview.

The SCOT (Scleroderma: Cyclophosphamide or Transplantation) trial randomized 75 patients with severe scleroderma and substantial internal organ involvement to receive treatment with either cyclophosphamide or myeloablative radiation followed by immune reconstitution with an autologous hematopoietic stem cell transplant. The trial’s primary endpoint, the global rank composite score at 54 months, showed the superiority of transplantation over standard treatment (N Engl J Med. 2018 Jan 4;378[1]:35-47).

Dr. Sullivan and his associates ran their long-term follow-up study on 43 of these 75 patients (25 from the transplanted group and 18 controls), excluding 21 patients who died during the original study, 4 additional patients from the control arm who died following the end of the original SCOT protocol, and 7 patients either lost to follow-up or who refused to participate in follow-up. Among the 25 transplanted patients, none died during the extended follow-up, 2 experienced cardiac failure, and 23 remained off of any disease-modifying antirheumatic drugs. Among the 18 survivors in the control arm, 3 had cardiac failure, 3 had respiratory failure, and 7 were on treatment with disease-modifying drugs, Dr. Sullivan reported.

In addition, 23 of the 25 (92%) transplanted patients had normal performance status by the Eastern Cooperative Oncology Group criteria, compared with 11 of the 18 controls (61%). A total of 14 (56%) transplant patients were employed, compared with 6 of the 18 controls (33%).

Patients who were transplanted “have their life back, are doing well, and are off treatment,” Dr. Sullivan noted.

Myeloablation and transplant is appropriate for scleroderma patients with significant internal organ involvement, about half of all patients with this disease. The best gauge of severe organ involvement is a pulmonary function test, with a forced vital capacity of 70% or less of predicted as a flag for patients who should consider transplantation, Dr. Sullivan said. He recommended monitoring lung function every 3 months in scleroderma patients because it can deteriorate very suddenly and quickly.

SCOT received no commercial funding. Dr. Sullivan had no disclosures to report.

mzoler@mdedge.com

SOURCE: Sullivan KM et al. ACR Annual Meeting, Abstract 1820.

CHICAGO – Follow-up out to as long as 11 years from treatment confirmed the long-term efficacy and safety of myeloablative autologous stem cell transplantation for patients with severe scleroderma.

This extended follow-up comprised 43 survivors from the 75 patients originally randomized in a controlled, 6-year trial. Follow-up showed that, among the patients who underwent myeloablation and autologous transplant with hematopoietic stem cells, there were no long-term deaths or cancers, there was an 88% survival rate, and 92% remained off disease-modifying treatment, Keith M. Sullivan, MD, said at the annual meeting of the American College of Rheumatology.

Long-term survival among patients randomized to the study’s control arm, who received treatment with cyclophosphamide, was 53%.

Patients with severe scleroderma with significant internal organ damage who “are improved and off of disease-modifying antirheumatic drugs after 10 or more years from treatment is something new in autoimmune disease,” said Dr. Sullivan, a professor of medicine at Duke University, Durham, N.C.

Based on accumulated data from this randomized trial and other studies, the American Society for Blood and Marrow Transplantation issued a position statement in June 2018 that endorsed autologous hematopoietic stem cell transplantation as “standard of care” for systemic sclerosis (Biol Blood Marrow Transplant. 2018 June 25. doi: 10.1016/j.bbmt.2018.06.025), Dr. Sullivan noted in a video interview.

The SCOT (Scleroderma: Cyclophosphamide or Transplantation) trial randomized 75 patients with severe scleroderma and substantial internal organ involvement to receive treatment with either cyclophosphamide or myeloablative radiation followed by immune reconstitution with an autologous hematopoietic stem cell transplant. The trial’s primary endpoint, the global rank composite score at 54 months, showed the superiority of transplantation over standard treatment (N Engl J Med. 2018 Jan 4;378[1]:35-47).

Dr. Sullivan and his associates ran their long-term follow-up study on 43 of these 75 patients (25 from the transplanted group and 18 controls), excluding 21 patients who died during the original study, 4 additional patients from the control arm who died following the end of the original SCOT protocol, and 7 patients either lost to follow-up or who refused to participate in follow-up. Among the 25 transplanted patients, none died during the extended follow-up, 2 experienced cardiac failure, and 23 remained off of any disease-modifying antirheumatic drugs. Among the 18 survivors in the control arm, 3 had cardiac failure, 3 had respiratory failure, and 7 were on treatment with disease-modifying drugs, Dr. Sullivan reported.

In addition, 23 of the 25 (92%) transplanted patients had normal performance status by the Eastern Cooperative Oncology Group criteria, compared with 11 of the 18 controls (61%). A total of 14 (56%) transplant patients were employed, compared with 6 of the 18 controls (33%).

Patients who were transplanted “have their life back, are doing well, and are off treatment,” Dr. Sullivan noted.

Myeloablation and transplant is appropriate for scleroderma patients with significant internal organ involvement, about half of all patients with this disease. The best gauge of severe organ involvement is a pulmonary function test, with a forced vital capacity of 70% or less of predicted as a flag for patients who should consider transplantation, Dr. Sullivan said. He recommended monitoring lung function every 3 months in scleroderma patients because it can deteriorate very suddenly and quickly.

SCOT received no commercial funding. Dr. Sullivan had no disclosures to report.

mzoler@mdedge.com

SOURCE: Sullivan KM et al. ACR Annual Meeting, Abstract 1820.

CHICAGO – Follow-up out to as long as 11 years from treatment confirmed the long-term efficacy and safety of myeloablative autologous stem cell transplantation for patients with severe scleroderma.

This extended follow-up comprised 43 survivors from the 75 patients originally randomized in a controlled, 6-year trial. Follow-up showed that, among the patients who underwent myeloablation and autologous transplant with hematopoietic stem cells, there were no long-term deaths or cancers, there was an 88% survival rate, and 92% remained off disease-modifying treatment, Keith M. Sullivan, MD, said at the annual meeting of the American College of Rheumatology.

Long-term survival among patients randomized to the study’s control arm, who received treatment with cyclophosphamide, was 53%.

Patients with severe scleroderma with significant internal organ damage who “are improved and off of disease-modifying antirheumatic drugs after 10 or more years from treatment is something new in autoimmune disease,” said Dr. Sullivan, a professor of medicine at Duke University, Durham, N.C.

Based on accumulated data from this randomized trial and other studies, the American Society for Blood and Marrow Transplantation issued a position statement in June 2018 that endorsed autologous hematopoietic stem cell transplantation as “standard of care” for systemic sclerosis (Biol Blood Marrow Transplant. 2018 June 25. doi: 10.1016/j.bbmt.2018.06.025), Dr. Sullivan noted in a video interview.

The SCOT (Scleroderma: Cyclophosphamide or Transplantation) trial randomized 75 patients with severe scleroderma and substantial internal organ involvement to receive treatment with either cyclophosphamide or myeloablative radiation followed by immune reconstitution with an autologous hematopoietic stem cell transplant. The trial’s primary endpoint, the global rank composite score at 54 months, showed the superiority of transplantation over standard treatment (N Engl J Med. 2018 Jan 4;378[1]:35-47).

Dr. Sullivan and his associates ran their long-term follow-up study on 43 of these 75 patients (25 from the transplanted group and 18 controls), excluding 21 patients who died during the original study, 4 additional patients from the control arm who died following the end of the original SCOT protocol, and 7 patients either lost to follow-up or who refused to participate in follow-up. Among the 25 transplanted patients, none died during the extended follow-up, 2 experienced cardiac failure, and 23 remained off of any disease-modifying antirheumatic drugs. Among the 18 survivors in the control arm, 3 had cardiac failure, 3 had respiratory failure, and 7 were on treatment with disease-modifying drugs, Dr. Sullivan reported.

In addition, 23 of the 25 (92%) transplanted patients had normal performance status by the Eastern Cooperative Oncology Group criteria, compared with 11 of the 18 controls (61%). A total of 14 (56%) transplant patients were employed, compared with 6 of the 18 controls (33%).

Patients who were transplanted “have their life back, are doing well, and are off treatment,” Dr. Sullivan noted.

Myeloablation and transplant is appropriate for scleroderma patients with significant internal organ involvement, about half of all patients with this disease. The best gauge of severe organ involvement is a pulmonary function test, with a forced vital capacity of 70% or less of predicted as a flag for patients who should consider transplantation, Dr. Sullivan said. He recommended monitoring lung function every 3 months in scleroderma patients because it can deteriorate very suddenly and quickly.

SCOT received no commercial funding. Dr. Sullivan had no disclosures to report.

mzoler@mdedge.com

SOURCE: Sullivan KM et al. ACR Annual Meeting, Abstract 1820.

CHICAGO – Rheumatoid arthritis–associated interstitial lung disease and idiopathic pulmonary fibrosis without RA share a common genetic underpinning whose hallmark is a gain-of-function MUC5B gene promoter variant that cranks up mucin production in the lungs, Pierre-Antoine Juge, MD, reported at the annual meeting of the American College of Rheumatology.

Bruce Jancin/MDedge News

He presented a seven-country genetic case-control study of 620 patients with RA-associated interstitial lung disease (RA-ILD), 614 with RA but no ILD, and 5,448 unaffected controls. The key finding was that the MUC5B promoter variant rs35705950, already known to be the strongest genetic risk factor for idiopathic pulmonary fibrosis (IPF), also contributes substantially to the risk of RA-ILD.

Indeed, the presence of the MUC5B promoter variant in patients with RA proved to be associated with substantially higher risk of RA-ILD than the previously recognized risk factors for RA-ILD, including cigarette smoking and the human leukocyte antigen locus for RA, according to Dr. Juge, a rheumatologist at Bichat Hospital–Claude Bernard and Paris Diderot University.


MUC5B encodes for mucin production in the lungs. The increased risk of RA-ILD conferred by the presence of the MUC5B promoter variant was confined to the 41% of RA-ILD patients with a pattern of usual interstitial pneumonia (UIP) or possible UIP on high-resolution CT. The presence of the MUC5B promoter variant in RA patients was independently associated with an adjusted 6.1-fold increased risk of ILD with a UIP pattern on imaging – marked by honeycombing, reticular abnormalities, and subpleural involvement – compared with RA patients who didn’t possess the gain-of-function MUC5B variant. The risk of other types of RA-ILD wasn’t affected by the presence or absence of the MUC5B variant.

The MUC5B promoter variant was not a risk factor for development of RA.

These findings have potentially important implications for clinical practice, given that clinically significant ILD is present in about 10% of all RA patients and occult ILD is detectable using high-resolution CT in up to half of individuals with RA, Dr. Juge observed. Detection of the MUC5B promoter variant could be used to screen patients with RA for preclinical ILD. Also, there is now a sound rationale to study drugs known to be effective for IPF as potential treatments for RA-ILD, he said.

Dr. Juge reported having no financial conflicts regarding the study, which was sponsored by the National Institutes of Health, the U.S. Department of Defense, the French Rheumatology Society, the Japanese Society for the Promotion of Science, Fondation Arthritis, and the Nina Ireland Program for Lung Health.

In conjunction with his presentation in Chicago, the study was published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1801562).

bjancin@mdedge.com

SOURCE: Juge P-A et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1819.

CHICAGO – Rheumatoid arthritis–associated interstitial lung disease and idiopathic pulmonary fibrosis without RA share a common genetic underpinning whose hallmark is a gain-of-function MUC5B gene promoter variant that cranks up mucin production in the lungs, Pierre-Antoine Juge, MD, reported at the annual meeting of the American College of Rheumatology.

Bruce Jancin/MDedge News

He presented a seven-country genetic case-control study of 620 patients with RA-associated interstitial lung disease (RA-ILD), 614 with RA but no ILD, and 5,448 unaffected controls. The key finding was that the MUC5B promoter variant rs35705950, already known to be the strongest genetic risk factor for idiopathic pulmonary fibrosis (IPF), also contributes substantially to the risk of RA-ILD.

Indeed, the presence of the MUC5B promoter variant in patients with RA proved to be associated with substantially higher risk of RA-ILD than the previously recognized risk factors for RA-ILD, including cigarette smoking and the human leukocyte antigen locus for RA, according to Dr. Juge, a rheumatologist at Bichat Hospital–Claude Bernard and Paris Diderot University.


MUC5B encodes for mucin production in the lungs. The increased risk of RA-ILD conferred by the presence of the MUC5B promoter variant was confined to the 41% of RA-ILD patients with a pattern of usual interstitial pneumonia (UIP) or possible UIP on high-resolution CT. The presence of the MUC5B promoter variant in RA patients was independently associated with an adjusted 6.1-fold increased risk of ILD with a UIP pattern on imaging – marked by honeycombing, reticular abnormalities, and subpleural involvement – compared with RA patients who didn’t possess the gain-of-function MUC5B variant. The risk of other types of RA-ILD wasn’t affected by the presence or absence of the MUC5B variant.

The MUC5B promoter variant was not a risk factor for development of RA.

These findings have potentially important implications for clinical practice, given that clinically significant ILD is present in about 10% of all RA patients and occult ILD is detectable using high-resolution CT in up to half of individuals with RA, Dr. Juge observed. Detection of the MUC5B promoter variant could be used to screen patients with RA for preclinical ILD. Also, there is now a sound rationale to study drugs known to be effective for IPF as potential treatments for RA-ILD, he said.

Dr. Juge reported having no financial conflicts regarding the study, which was sponsored by the National Institutes of Health, the U.S. Department of Defense, the French Rheumatology Society, the Japanese Society for the Promotion of Science, Fondation Arthritis, and the Nina Ireland Program for Lung Health.

In conjunction with his presentation in Chicago, the study was published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1801562).

bjancin@mdedge.com

SOURCE: Juge P-A et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1819.

CHICAGO – Rheumatoid arthritis–associated interstitial lung disease and idiopathic pulmonary fibrosis without RA share a common genetic underpinning whose hallmark is a gain-of-function MUC5B gene promoter variant that cranks up mucin production in the lungs, Pierre-Antoine Juge, MD, reported at the annual meeting of the American College of Rheumatology.

Bruce Jancin/MDedge News

He presented a seven-country genetic case-control study of 620 patients with RA-associated interstitial lung disease (RA-ILD), 614 with RA but no ILD, and 5,448 unaffected controls. The key finding was that the MUC5B promoter variant rs35705950, already known to be the strongest genetic risk factor for idiopathic pulmonary fibrosis (IPF), also contributes substantially to the risk of RA-ILD.

Indeed, the presence of the MUC5B promoter variant in patients with RA proved to be associated with substantially higher risk of RA-ILD than the previously recognized risk factors for RA-ILD, including cigarette smoking and the human leukocyte antigen locus for RA, according to Dr. Juge, a rheumatologist at Bichat Hospital–Claude Bernard and Paris Diderot University.


MUC5B encodes for mucin production in the lungs. The increased risk of RA-ILD conferred by the presence of the MUC5B promoter variant was confined to the 41% of RA-ILD patients with a pattern of usual interstitial pneumonia (UIP) or possible UIP on high-resolution CT. The presence of the MUC5B promoter variant in RA patients was independently associated with an adjusted 6.1-fold increased risk of ILD with a UIP pattern on imaging – marked by honeycombing, reticular abnormalities, and subpleural involvement – compared with RA patients who didn’t possess the gain-of-function MUC5B variant. The risk of other types of RA-ILD wasn’t affected by the presence or absence of the MUC5B variant.

The MUC5B promoter variant was not a risk factor for development of RA.

These findings have potentially important implications for clinical practice, given that clinically significant ILD is present in about 10% of all RA patients and occult ILD is detectable using high-resolution CT in up to half of individuals with RA, Dr. Juge observed. Detection of the MUC5B promoter variant could be used to screen patients with RA for preclinical ILD. Also, there is now a sound rationale to study drugs known to be effective for IPF as potential treatments for RA-ILD, he said.

Dr. Juge reported having no financial conflicts regarding the study, which was sponsored by the National Institutes of Health, the U.S. Department of Defense, the French Rheumatology Society, the Japanese Society for the Promotion of Science, Fondation Arthritis, and the Nina Ireland Program for Lung Health.

In conjunction with his presentation in Chicago, the study was published online in the New England Journal of Medicine (doi: 10.1056/NEJMoa1801562).

bjancin@mdedge.com

SOURCE: Juge P-A et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 1819.