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Hypotension ‘dose’ drives mortality in traumatic brain injury
NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.
For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.
However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.
The innovation introduced by Dr. Spaite and his associates in their analysis of the EPIC-TBI data was to drill down into each patient’s hypotensive event, made possible by the 16,711 patients enrolled in EPIC-TBI.
The calculation they performed was limited to patients with EMS records of at least two blood pressure measurements during prehospital transport. These data allowed them to use both the extent to which systolic blood pressure dropped below 90 mm Hg and the amount of time pressure was below this threshold to better define the total hypotension exposure each patient received.
This meant that a TBI patient with a systolic pressure of 80 mm Hg for 10 minutes had twice the hypotension exposure of both a patient with a pressure of 85 mm Hg for 10 minutes, and a patient with a pressure of 80 mm Hg for 5 minutes.
Their analysis also adjusted the relationship of this total hypotensive dose and subsequent mortality based on several baseline demographic and clinical variables, including age, sex, injury severity, trauma type, and head-region severity score. After adjustment, the researchers found a “strikingly linear relationship” between hypotension dose and mortality, Dr. Spaite said, although a clear dose-response relationship was also evident in the unadjusted data.
EPIC-TBI enrolled TBI patients age 10 years or older during 2007-2014 through participation by dozens of EMS providers throughout Arizona. For the current analysis, the researchers identified 7,521 patients from the total group who had at least two blood pressure measurements taken during their prehospital EMS care and also met other inclusion criteria.
The best way to manage hypotension in TBI patients during the prehospital period remains unclear. Simply raising blood pressure with fluid infusion may not necessarily help, because it could exacerbate a patient’s bleeding, Dr. Spaite noted during an interview.
The primary goal of EPIC-TBI is to assess the impact of the third edition of the traumatic brain injury guidelines released in 2007 by the Brain Trauma Foundation. (The fourth edition of these guidelines came out in August 2016.) The new finding by Dr. Spaite and his associates will allow the full EPIC-TBI analysis to correlate patient outcomes with the impact that acute, prehospital treatment had on the hypotension dose received by each patient, he noted.
“What’s remarkable is that the single, prehospital parameter of hypotension for just a few minutes during transport can have such a strong impact on survival, given all the other factors that can influence outcomes” in TBI patients once they reach a hospital and during the period they remain hospitalized, Dr. Spaite said.
mzoler@frontlinemedcom.com On Twitter @mitchelzoler
NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.
For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.
However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.
The innovation introduced by Dr. Spaite and his associates in their analysis of the EPIC-TBI data was to drill down into each patient’s hypotensive event, made possible by the 16,711 patients enrolled in EPIC-TBI.
The calculation they performed was limited to patients with EMS records of at least two blood pressure measurements during prehospital transport. These data allowed them to use both the extent to which systolic blood pressure dropped below 90 mm Hg and the amount of time pressure was below this threshold to better define the total hypotension exposure each patient received.
This meant that a TBI patient with a systolic pressure of 80 mm Hg for 10 minutes had twice the hypotension exposure of both a patient with a pressure of 85 mm Hg for 10 minutes, and a patient with a pressure of 80 mm Hg for 5 minutes.
Their analysis also adjusted the relationship of this total hypotensive dose and subsequent mortality based on several baseline demographic and clinical variables, including age, sex, injury severity, trauma type, and head-region severity score. After adjustment, the researchers found a “strikingly linear relationship” between hypotension dose and mortality, Dr. Spaite said, although a clear dose-response relationship was also evident in the unadjusted data.
EPIC-TBI enrolled TBI patients age 10 years or older during 2007-2014 through participation by dozens of EMS providers throughout Arizona. For the current analysis, the researchers identified 7,521 patients from the total group who had at least two blood pressure measurements taken during their prehospital EMS care and also met other inclusion criteria.
The best way to manage hypotension in TBI patients during the prehospital period remains unclear. Simply raising blood pressure with fluid infusion may not necessarily help, because it could exacerbate a patient’s bleeding, Dr. Spaite noted during an interview.
The primary goal of EPIC-TBI is to assess the impact of the third edition of the traumatic brain injury guidelines released in 2007 by the Brain Trauma Foundation. (The fourth edition of these guidelines came out in August 2016.) The new finding by Dr. Spaite and his associates will allow the full EPIC-TBI analysis to correlate patient outcomes with the impact that acute, prehospital treatment had on the hypotension dose received by each patient, he noted.
“What’s remarkable is that the single, prehospital parameter of hypotension for just a few minutes during transport can have such a strong impact on survival, given all the other factors that can influence outcomes” in TBI patients once they reach a hospital and during the period they remain hospitalized, Dr. Spaite said.
mzoler@frontlinemedcom.com On Twitter @mitchelzoler
NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.
For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.
However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.
The innovation introduced by Dr. Spaite and his associates in their analysis of the EPIC-TBI data was to drill down into each patient’s hypotensive event, made possible by the 16,711 patients enrolled in EPIC-TBI.
The calculation they performed was limited to patients with EMS records of at least two blood pressure measurements during prehospital transport. These data allowed them to use both the extent to which systolic blood pressure dropped below 90 mm Hg and the amount of time pressure was below this threshold to better define the total hypotension exposure each patient received.
This meant that a TBI patient with a systolic pressure of 80 mm Hg for 10 minutes had twice the hypotension exposure of both a patient with a pressure of 85 mm Hg for 10 minutes, and a patient with a pressure of 80 mm Hg for 5 minutes.
Their analysis also adjusted the relationship of this total hypotensive dose and subsequent mortality based on several baseline demographic and clinical variables, including age, sex, injury severity, trauma type, and head-region severity score. After adjustment, the researchers found a “strikingly linear relationship” between hypotension dose and mortality, Dr. Spaite said, although a clear dose-response relationship was also evident in the unadjusted data.
EPIC-TBI enrolled TBI patients age 10 years or older during 2007-2014 through participation by dozens of EMS providers throughout Arizona. For the current analysis, the researchers identified 7,521 patients from the total group who had at least two blood pressure measurements taken during their prehospital EMS care and also met other inclusion criteria.
The best way to manage hypotension in TBI patients during the prehospital period remains unclear. Simply raising blood pressure with fluid infusion may not necessarily help, because it could exacerbate a patient’s bleeding, Dr. Spaite noted during an interview.
The primary goal of EPIC-TBI is to assess the impact of the third edition of the traumatic brain injury guidelines released in 2007 by the Brain Trauma Foundation. (The fourth edition of these guidelines came out in August 2016.) The new finding by Dr. Spaite and his associates will allow the full EPIC-TBI analysis to correlate patient outcomes with the impact that acute, prehospital treatment had on the hypotension dose received by each patient, he noted.
“What’s remarkable is that the single, prehospital parameter of hypotension for just a few minutes during transport can have such a strong impact on survival, given all the other factors that can influence outcomes” in TBI patients once they reach a hospital and during the period they remain hospitalized, Dr. Spaite said.
mzoler@frontlinemedcom.com On Twitter @mitchelzoler
Key clinical point:
Major finding: For each doubling of the dose of prehospital hypotension (a function of severity and duration), mortality rose by 19%.
Data source: EPIC-TBI, a multicenter study with 16,711 patients, including 7,521 who met inclusion criteria for the current analysis.
Disclosures: Dr. Spaite had no disclosures.
New scale bests Milan criteria in predicting posttransplant HCC recurrence
BOSTON – A new scoring system fared better than the Milan criteria in predicting risk for recurrent hepatocellular carcinoma after liver transplant.
The scoring system combines an assessment of the number and size of tumors on the explanted liver with serum alpha-fetoprotein (AFP) score and the presence of microvascular invasion to assign a numeric risk score to patients who have received liver transplant for hepatocellular carcinoma (HCC).
The risk estimation tool showed good model estimation, with a C statistic of 0.82 (95% confidence interval, 0.77-0.86), according to Neil Mehta, MD, who presented the study validating the risk estimation tool at the annual meeting of the American Association for the Study of Liver Diseases. The C statistic is a measure of goodness of fit, with values closer to 1 indicating better fit.
In a paper published simultaneously in JAMA Oncology, Dr. Mehta and his collaborators said that the tool had “superior recurrence risk classification, compared with explant Milan criteria (net reclassification index, 0.40; P = 0.001) in the study’s validation cohort” (JAMA Oncol. 2016 Nov 13. doi: 10:1001/jamaoncol2016/5116).
Under the Milan criteria, patients with HCC are eligible for liver transplant if there are no extrahepatic manifestations and no vascular invasion. One lesion must be smaller than 5 cm, and up to three lesions smaller than 3 cm are permitted.
Dr. Mehta, a gastroenterologist and transplant hepatologist at the University of California, San Francisco, worked with colleagues to narrow down a long list of factors that in previous studies had been associated with HCC recurrence. The final Risk Estimation of Tumor Recurrence After Transplant (RETREAT) score uses just three factors that multivariable analysis found were most highly predictive of HCC recurrence after liver transplant.
The three factors are microvascular invasion; AFP at the time of liver transplant; and the sum of the largest viable tumor diameter plus the number of viable tumors, assessed at the time of explant.
This last factor uses pathology examination, rather than radiology results, to assess tumor number, size, and viability. If a tumor is found to be completely necrotic, for example, it is not included when counting tumors for this component of the RETREAT score.
To develop the scoring system, Dr. Mehta and his coauthors enrolled adult patients with HCC who had liver transplant at three centers, each with a different wait time for transplant – short, medium, or long. Patients in the development cohort (n=721) had Model for End-Stage Liver Disease (MELD) score exception, and patients always met Milan criteria on imaging.
The validation cohort (n=340) had the same inclusion and exclusion criteria, but differed in several significant ways from the development cohort, with more young people, men, and individuals with hepatitis B or alcohol abuse. Individuals in the validation cohort were less likely to have received locoregional therapy (LRT) before liver transplant, but were more likely to have had a single tumor. They had more microvascular invasion, more tumors that were poorly differentiated, and more tumor staging beyond Milan criteria on explant.
The primary outcome measures for the study were overall survival and 5-year post–liver transplant HCC recurrence.
In developing the RETREAT scoring system, investigators used the final multivariable model coefficients to produce a “simplified point scale reflecting the relative impact of model covariables,” Dr. Mehta and his coauthors wrote.
RETREAT scoring ranges from 0 to 8; in the studied patients, the most common score was 1. Any microvascular invasion is assigned a point value of 2. The sum of the largest viable tumor diameter – in centimeters – plus the number of viable tumors is divided into four categories. If there are no tumors, the score is 0. For a sum of 1.1-4.9, the score is 1; a sum of 5.0-9.9 is assigned a score of 2, and a sum or 10 or greater is assigned a score of 3.
Serum AFP at the time of liver transplant (measured in ng/mL) is given a score of 0 if the value is less than 20. AFP of 20-99 is assigned a score of 1, values of 100-999 a score of 2, and 1,000 or greater a score of 3.
“Predicted risk of 1- and 5-year HCC recurrence rose with each point scored such that a patient with a RETREAT score of 5 or higher … had a predicted 1- and 5-year recurrence risk of 39.3 (95% CI, 25.5%-50.5%) and 75.2% (95% CI, 56.7%-85.8%), respectively,” the researchers wrote.
Dr. Mehta and his coauthors emphasized that the RETREAT scoring system represents an effort to strike a balance between including clinically meaningful variables to predict HCC recurrence and retaining simplicity and ease of use.
The researchers suggested guidelines for post–liver transplant HCC recurrence surveillance based on RETREAT scoring. They recommend no follow-up for a score of 0; surveillance scans and AFP monitoring every 6 months for 2 years for a score of 1-3, and every 6 months for 5 years for a score of 4. RETREAT scores of 5 or higher warrant surveillance every 3-4 months for 2 years, followed by every 6 months through year 5.
This surveillance stratification, they said, should help control costs while retaining a vigilant approach for those most at risk of recurrence. This approach is currently in use at University of California, San Francisco.
Study limitations included some missing information on AFP levels in the development cohort, and a small number of missing histologic tumor grading in both cohorts. In order to address limitations in the retrospective design of the present study, Dr. Mehta and his coauthors are planning another multicenter study to evaluate RETREAT as a surveillance tool and confirm its prognostic value.
The authors reported no conflicts of interest. The study was funded by the Biostatistics Core of the UCSF Liver Center.
koakes@frontlinemedcom.com
On Twitter @karioakes
BOSTON – A new scoring system fared better than the Milan criteria in predicting risk for recurrent hepatocellular carcinoma after liver transplant.
The scoring system combines an assessment of the number and size of tumors on the explanted liver with serum alpha-fetoprotein (AFP) score and the presence of microvascular invasion to assign a numeric risk score to patients who have received liver transplant for hepatocellular carcinoma (HCC).
The risk estimation tool showed good model estimation, with a C statistic of 0.82 (95% confidence interval, 0.77-0.86), according to Neil Mehta, MD, who presented the study validating the risk estimation tool at the annual meeting of the American Association for the Study of Liver Diseases. The C statistic is a measure of goodness of fit, with values closer to 1 indicating better fit.
In a paper published simultaneously in JAMA Oncology, Dr. Mehta and his collaborators said that the tool had “superior recurrence risk classification, compared with explant Milan criteria (net reclassification index, 0.40; P = 0.001) in the study’s validation cohort” (JAMA Oncol. 2016 Nov 13. doi: 10:1001/jamaoncol2016/5116).
Under the Milan criteria, patients with HCC are eligible for liver transplant if there are no extrahepatic manifestations and no vascular invasion. One lesion must be smaller than 5 cm, and up to three lesions smaller than 3 cm are permitted.
Dr. Mehta, a gastroenterologist and transplant hepatologist at the University of California, San Francisco, worked with colleagues to narrow down a long list of factors that in previous studies had been associated with HCC recurrence. The final Risk Estimation of Tumor Recurrence After Transplant (RETREAT) score uses just three factors that multivariable analysis found were most highly predictive of HCC recurrence after liver transplant.
The three factors are microvascular invasion; AFP at the time of liver transplant; and the sum of the largest viable tumor diameter plus the number of viable tumors, assessed at the time of explant.
This last factor uses pathology examination, rather than radiology results, to assess tumor number, size, and viability. If a tumor is found to be completely necrotic, for example, it is not included when counting tumors for this component of the RETREAT score.
To develop the scoring system, Dr. Mehta and his coauthors enrolled adult patients with HCC who had liver transplant at three centers, each with a different wait time for transplant – short, medium, or long. Patients in the development cohort (n=721) had Model for End-Stage Liver Disease (MELD) score exception, and patients always met Milan criteria on imaging.
The validation cohort (n=340) had the same inclusion and exclusion criteria, but differed in several significant ways from the development cohort, with more young people, men, and individuals with hepatitis B or alcohol abuse. Individuals in the validation cohort were less likely to have received locoregional therapy (LRT) before liver transplant, but were more likely to have had a single tumor. They had more microvascular invasion, more tumors that were poorly differentiated, and more tumor staging beyond Milan criteria on explant.
The primary outcome measures for the study were overall survival and 5-year post–liver transplant HCC recurrence.
In developing the RETREAT scoring system, investigators used the final multivariable model coefficients to produce a “simplified point scale reflecting the relative impact of model covariables,” Dr. Mehta and his coauthors wrote.
RETREAT scoring ranges from 0 to 8; in the studied patients, the most common score was 1. Any microvascular invasion is assigned a point value of 2. The sum of the largest viable tumor diameter – in centimeters – plus the number of viable tumors is divided into four categories. If there are no tumors, the score is 0. For a sum of 1.1-4.9, the score is 1; a sum of 5.0-9.9 is assigned a score of 2, and a sum or 10 or greater is assigned a score of 3.
Serum AFP at the time of liver transplant (measured in ng/mL) is given a score of 0 if the value is less than 20. AFP of 20-99 is assigned a score of 1, values of 100-999 a score of 2, and 1,000 or greater a score of 3.
“Predicted risk of 1- and 5-year HCC recurrence rose with each point scored such that a patient with a RETREAT score of 5 or higher … had a predicted 1- and 5-year recurrence risk of 39.3 (95% CI, 25.5%-50.5%) and 75.2% (95% CI, 56.7%-85.8%), respectively,” the researchers wrote.
Dr. Mehta and his coauthors emphasized that the RETREAT scoring system represents an effort to strike a balance between including clinically meaningful variables to predict HCC recurrence and retaining simplicity and ease of use.
The researchers suggested guidelines for post–liver transplant HCC recurrence surveillance based on RETREAT scoring. They recommend no follow-up for a score of 0; surveillance scans and AFP monitoring every 6 months for 2 years for a score of 1-3, and every 6 months for 5 years for a score of 4. RETREAT scores of 5 or higher warrant surveillance every 3-4 months for 2 years, followed by every 6 months through year 5.
This surveillance stratification, they said, should help control costs while retaining a vigilant approach for those most at risk of recurrence. This approach is currently in use at University of California, San Francisco.
Study limitations included some missing information on AFP levels in the development cohort, and a small number of missing histologic tumor grading in both cohorts. In order to address limitations in the retrospective design of the present study, Dr. Mehta and his coauthors are planning another multicenter study to evaluate RETREAT as a surveillance tool and confirm its prognostic value.
The authors reported no conflicts of interest. The study was funded by the Biostatistics Core of the UCSF Liver Center.
koakes@frontlinemedcom.com
On Twitter @karioakes
BOSTON – A new scoring system fared better than the Milan criteria in predicting risk for recurrent hepatocellular carcinoma after liver transplant.
The scoring system combines an assessment of the number and size of tumors on the explanted liver with serum alpha-fetoprotein (AFP) score and the presence of microvascular invasion to assign a numeric risk score to patients who have received liver transplant for hepatocellular carcinoma (HCC).
The risk estimation tool showed good model estimation, with a C statistic of 0.82 (95% confidence interval, 0.77-0.86), according to Neil Mehta, MD, who presented the study validating the risk estimation tool at the annual meeting of the American Association for the Study of Liver Diseases. The C statistic is a measure of goodness of fit, with values closer to 1 indicating better fit.
In a paper published simultaneously in JAMA Oncology, Dr. Mehta and his collaborators said that the tool had “superior recurrence risk classification, compared with explant Milan criteria (net reclassification index, 0.40; P = 0.001) in the study’s validation cohort” (JAMA Oncol. 2016 Nov 13. doi: 10:1001/jamaoncol2016/5116).
Under the Milan criteria, patients with HCC are eligible for liver transplant if there are no extrahepatic manifestations and no vascular invasion. One lesion must be smaller than 5 cm, and up to three lesions smaller than 3 cm are permitted.
Dr. Mehta, a gastroenterologist and transplant hepatologist at the University of California, San Francisco, worked with colleagues to narrow down a long list of factors that in previous studies had been associated with HCC recurrence. The final Risk Estimation of Tumor Recurrence After Transplant (RETREAT) score uses just three factors that multivariable analysis found were most highly predictive of HCC recurrence after liver transplant.
The three factors are microvascular invasion; AFP at the time of liver transplant; and the sum of the largest viable tumor diameter plus the number of viable tumors, assessed at the time of explant.
This last factor uses pathology examination, rather than radiology results, to assess tumor number, size, and viability. If a tumor is found to be completely necrotic, for example, it is not included when counting tumors for this component of the RETREAT score.
To develop the scoring system, Dr. Mehta and his coauthors enrolled adult patients with HCC who had liver transplant at three centers, each with a different wait time for transplant – short, medium, or long. Patients in the development cohort (n=721) had Model for End-Stage Liver Disease (MELD) score exception, and patients always met Milan criteria on imaging.
The validation cohort (n=340) had the same inclusion and exclusion criteria, but differed in several significant ways from the development cohort, with more young people, men, and individuals with hepatitis B or alcohol abuse. Individuals in the validation cohort were less likely to have received locoregional therapy (LRT) before liver transplant, but were more likely to have had a single tumor. They had more microvascular invasion, more tumors that were poorly differentiated, and more tumor staging beyond Milan criteria on explant.
The primary outcome measures for the study were overall survival and 5-year post–liver transplant HCC recurrence.
In developing the RETREAT scoring system, investigators used the final multivariable model coefficients to produce a “simplified point scale reflecting the relative impact of model covariables,” Dr. Mehta and his coauthors wrote.
RETREAT scoring ranges from 0 to 8; in the studied patients, the most common score was 1. Any microvascular invasion is assigned a point value of 2. The sum of the largest viable tumor diameter – in centimeters – plus the number of viable tumors is divided into four categories. If there are no tumors, the score is 0. For a sum of 1.1-4.9, the score is 1; a sum of 5.0-9.9 is assigned a score of 2, and a sum or 10 or greater is assigned a score of 3.
Serum AFP at the time of liver transplant (measured in ng/mL) is given a score of 0 if the value is less than 20. AFP of 20-99 is assigned a score of 1, values of 100-999 a score of 2, and 1,000 or greater a score of 3.
“Predicted risk of 1- and 5-year HCC recurrence rose with each point scored such that a patient with a RETREAT score of 5 or higher … had a predicted 1- and 5-year recurrence risk of 39.3 (95% CI, 25.5%-50.5%) and 75.2% (95% CI, 56.7%-85.8%), respectively,” the researchers wrote.
Dr. Mehta and his coauthors emphasized that the RETREAT scoring system represents an effort to strike a balance between including clinically meaningful variables to predict HCC recurrence and retaining simplicity and ease of use.
The researchers suggested guidelines for post–liver transplant HCC recurrence surveillance based on RETREAT scoring. They recommend no follow-up for a score of 0; surveillance scans and AFP monitoring every 6 months for 2 years for a score of 1-3, and every 6 months for 5 years for a score of 4. RETREAT scores of 5 or higher warrant surveillance every 3-4 months for 2 years, followed by every 6 months through year 5.
This surveillance stratification, they said, should help control costs while retaining a vigilant approach for those most at risk of recurrence. This approach is currently in use at University of California, San Francisco.
Study limitations included some missing information on AFP levels in the development cohort, and a small number of missing histologic tumor grading in both cohorts. In order to address limitations in the retrospective design of the present study, Dr. Mehta and his coauthors are planning another multicenter study to evaluate RETREAT as a surveillance tool and confirm its prognostic value.
The authors reported no conflicts of interest. The study was funded by the Biostatistics Core of the UCSF Liver Center.
koakes@frontlinemedcom.com
On Twitter @karioakes
Key clinical point:
Major finding: The RETREAT score was superior to explant Milan criteria in predicting post–liver transplant HCC recurence (P = .001)
Data source: Multivariable analysis of prognostic factors for HCC recurrence in a group of 721 patients in a development cohort and 340 in a validation cohort, all of whom had liver transplant.
Disclosures: The study investigators reported no disclosures. The study was funded by the Biostatistics Core of the University of California, San Francisco Liver Center.
Inpatient telemedicine could bridge infectious disease specialist gap
NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.
Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.
Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.
The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.
“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”
Dr. McCurdy reported having no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.
Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.
Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.
The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.
“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”
Dr. McCurdy reported having no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.
Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.
Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.
The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.
“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”
Dr. McCurdy reported having no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
‘Fight the Resistance’ with Antibiotic Stewardship Mentored Implementation
In conjunction with the Centers for Disease Control & Prevention’s Get Smart about Antibiotics Week, SHM is committed to promoting improved antibiotic-prescribing behaviors among the nation’s hospitalists through its “Fight the Resistance” awareness campaign.
Display SHM’s three downloadable “Fight the Resistance” posters, available at www.fighttheresistance.org. Hang them in your break rooms, hallways, or other high-profile locations to help remind your colleagues about the dangers of antibiotic resistance. SHM will be launching a mentored implementation program on antibiotics in early 2017. To be notified when the program becomes available, visit www.hospitalmedicine.org/ABX16.
In conjunction with the Centers for Disease Control & Prevention’s Get Smart about Antibiotics Week, SHM is committed to promoting improved antibiotic-prescribing behaviors among the nation’s hospitalists through its “Fight the Resistance” awareness campaign.
Display SHM’s three downloadable “Fight the Resistance” posters, available at www.fighttheresistance.org. Hang them in your break rooms, hallways, or other high-profile locations to help remind your colleagues about the dangers of antibiotic resistance. SHM will be launching a mentored implementation program on antibiotics in early 2017. To be notified when the program becomes available, visit www.hospitalmedicine.org/ABX16.
In conjunction with the Centers for Disease Control & Prevention’s Get Smart about Antibiotics Week, SHM is committed to promoting improved antibiotic-prescribing behaviors among the nation’s hospitalists through its “Fight the Resistance” awareness campaign.
Display SHM’s three downloadable “Fight the Resistance” posters, available at www.fighttheresistance.org. Hang them in your break rooms, hallways, or other high-profile locations to help remind your colleagues about the dangers of antibiotic resistance. SHM will be launching a mentored implementation program on antibiotics in early 2017. To be notified when the program becomes available, visit www.hospitalmedicine.org/ABX16.
Track Your Hospital’s Glycemic Control Performance
There is no better time than American Diabetes Month to learn more about SHM’s Glycemic Control Program. Find out how your institution can submit point-of-care data to SHM’s Data Center, generate monthly reports, and be included in the national glucometrics benchmark report. Hospital systems are also encouraged to subscribe in order to track their individual performance as well as compare overall performance.
View a recent case study on three sites that demonstrated more rapid definitive improvements in measurable outcomes with the mentoring program, driving change through ongoing objective support, data collection, and analysis. Don’t wait: Be one of the 100 hospitals nationwide supported by SHM’s respected Glycemic Control Program. Learn more at www.hospitalmedicine.org/gc.
There is no better time than American Diabetes Month to learn more about SHM’s Glycemic Control Program. Find out how your institution can submit point-of-care data to SHM’s Data Center, generate monthly reports, and be included in the national glucometrics benchmark report. Hospital systems are also encouraged to subscribe in order to track their individual performance as well as compare overall performance.
View a recent case study on three sites that demonstrated more rapid definitive improvements in measurable outcomes with the mentoring program, driving change through ongoing objective support, data collection, and analysis. Don’t wait: Be one of the 100 hospitals nationwide supported by SHM’s respected Glycemic Control Program. Learn more at www.hospitalmedicine.org/gc.
There is no better time than American Diabetes Month to learn more about SHM’s Glycemic Control Program. Find out how your institution can submit point-of-care data to SHM’s Data Center, generate monthly reports, and be included in the national glucometrics benchmark report. Hospital systems are also encouraged to subscribe in order to track their individual performance as well as compare overall performance.
View a recent case study on three sites that demonstrated more rapid definitive improvements in measurable outcomes with the mentoring program, driving change through ongoing objective support, data collection, and analysis. Don’t wait: Be one of the 100 hospitals nationwide supported by SHM’s respected Glycemic Control Program. Learn more at www.hospitalmedicine.org/gc.
Become an SHM Ambassador for a Chance at Free Registration to HM17
Now through December 31, 2016, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:
- A $35 credit toward 2017–2018 dues when recruiting 1 new member.
- A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
- A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
- A $125 credit toward 2017–2018 dues when recruiting 10+ new members.
For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.
Now through December 31, 2016, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:
- A $35 credit toward 2017–2018 dues when recruiting 1 new member.
- A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
- A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
- A $125 credit toward 2017–2018 dues when recruiting 10+ new members.
For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.
Now through December 31, 2016, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:
- A $35 credit toward 2017–2018 dues when recruiting 1 new member.
- A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
- A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
- A $125 credit toward 2017–2018 dues when recruiting 10+ new members.
For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.
CHMP recommends drug for hemophilia A
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for lonoctocog alfa (Afstyla), a recombinant factor VIII (FVIII) single-chain therapy.
Lonoctocog alfa is intended for the treatment and prophylaxis of bleeding in hemophilia A patients of all ages.
The CHMP’s recommendation will be reviewed by the European Commission, which is expected to make a decision in the next few months.
Lonoctocog alfa is designed to provide lasting protection from bleeds with 2- to 3-times weekly dosing. The product uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of FVIII and provide longer-lasting FVIII activity.
Lonoctocog alfa is being developed by CSL Behring GmbH.
Clinical trials
The CHMP’s positive opinion of lonoctocog alfa is based on results from the AFFINITY clinical development program, which includes a trial of children (n=84) and a trial of adolescents and adults (n=175).
Among patients who received lonoctocog alfa prophylactically, the median annualized bleeding rate was 1.14 in the adults and adolescents and 3.69 in children younger than 12.
In all, there were 1195 bleeding events—848 in the adults/adolescents and 347 in the children.
Ninety-four percent of bleeds in adults/adolescents and 96% of bleeds in pediatric patients were effectively controlled with no more than 2 infusions of lonoctocog alfa weekly.
Eighty-one percent of bleeds in adults/adolescents and 86% of bleeds in pediatric patients were controlled by a single infusion.
Researchers assessed safety in 258 patients from both studies. Adverse reactions occurred in 14 patients and included hypersensitivity (n=4), dizziness (n=2), paresthesia (n=1), rash (n=1), erythema (n=1), pruritus (n=1), pyrexia (n=1), injection-site pain (n=1), chills (n=1), and feeling hot (n=1).
One patient withdrew from treatment due to hypersensitivity.
None of the patients developed neutralizing antibodies to FVIII or antibodies to host cell proteins. There were no reports of anaphylaxis or thrombosis. 
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for lonoctocog alfa (Afstyla), a recombinant factor VIII (FVIII) single-chain therapy.
Lonoctocog alfa is intended for the treatment and prophylaxis of bleeding in hemophilia A patients of all ages.
The CHMP’s recommendation will be reviewed by the European Commission, which is expected to make a decision in the next few months.
Lonoctocog alfa is designed to provide lasting protection from bleeds with 2- to 3-times weekly dosing. The product uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of FVIII and provide longer-lasting FVIII activity.
Lonoctocog alfa is being developed by CSL Behring GmbH.
Clinical trials
The CHMP’s positive opinion of lonoctocog alfa is based on results from the AFFINITY clinical development program, which includes a trial of children (n=84) and a trial of adolescents and adults (n=175).
Among patients who received lonoctocog alfa prophylactically, the median annualized bleeding rate was 1.14 in the adults and adolescents and 3.69 in children younger than 12.
In all, there were 1195 bleeding events—848 in the adults/adolescents and 347 in the children.
Ninety-four percent of bleeds in adults/adolescents and 96% of bleeds in pediatric patients were effectively controlled with no more than 2 infusions of lonoctocog alfa weekly.
Eighty-one percent of bleeds in adults/adolescents and 86% of bleeds in pediatric patients were controlled by a single infusion.
Researchers assessed safety in 258 patients from both studies. Adverse reactions occurred in 14 patients and included hypersensitivity (n=4), dizziness (n=2), paresthesia (n=1), rash (n=1), erythema (n=1), pruritus (n=1), pyrexia (n=1), injection-site pain (n=1), chills (n=1), and feeling hot (n=1).
One patient withdrew from treatment due to hypersensitivity.
None of the patients developed neutralizing antibodies to FVIII or antibodies to host cell proteins. There were no reports of anaphylaxis or thrombosis.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for lonoctocog alfa (Afstyla), a recombinant factor VIII (FVIII) single-chain therapy.
Lonoctocog alfa is intended for the treatment and prophylaxis of bleeding in hemophilia A patients of all ages.
The CHMP’s recommendation will be reviewed by the European Commission, which is expected to make a decision in the next few months.
Lonoctocog alfa is designed to provide lasting protection from bleeds with 2- to 3-times weekly dosing. The product uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of FVIII and provide longer-lasting FVIII activity.
Lonoctocog alfa is being developed by CSL Behring GmbH.
Clinical trials
The CHMP’s positive opinion of lonoctocog alfa is based on results from the AFFINITY clinical development program, which includes a trial of children (n=84) and a trial of adolescents and adults (n=175).
Among patients who received lonoctocog alfa prophylactically, the median annualized bleeding rate was 1.14 in the adults and adolescents and 3.69 in children younger than 12.
In all, there were 1195 bleeding events—848 in the adults/adolescents and 347 in the children.
Ninety-four percent of bleeds in adults/adolescents and 96% of bleeds in pediatric patients were effectively controlled with no more than 2 infusions of lonoctocog alfa weekly.
Eighty-one percent of bleeds in adults/adolescents and 86% of bleeds in pediatric patients were controlled by a single infusion.
Researchers assessed safety in 258 patients from both studies. Adverse reactions occurred in 14 patients and included hypersensitivity (n=4), dizziness (n=2), paresthesia (n=1), rash (n=1), erythema (n=1), pruritus (n=1), pyrexia (n=1), injection-site pain (n=1), chills (n=1), and feeling hot (n=1).
One patient withdrew from treatment due to hypersensitivity.
None of the patients developed neutralizing antibodies to FVIII or antibodies to host cell proteins. There were no reports of anaphylaxis or thrombosis.
Topical tofacitinib shows promise in atopic dermatitis
Topical tofacitinib showed significant improvements across all endpoints and for pruritus at week 4, compared with vehicle, results of a phase IIa trial have shown.
Tofacitinib is a Janus kinase inhibitor that affects the interleukin (IL)–4, IL-5, and IL-31 signaling pathways, interfering with the immune response that leads to inflammation.
The study could mean “that inhibition of the JAK-STAT pathway may be a new therapeutic target for AD,” wrote the study’s lead author, Robert Bissonnette, MD, president of Innovaderm Research in Montreal. The study was published in the British Journal of Dermatology (2016 Nov;175[5]:902-11).
In the multicenter, double-blind, controlled study of 69 adults with mild to moderate atopic dermatitis randomly assigned to either 2% tofacitinib or vehicle ointment twice daily, the study group achieved an 81.7% mean reduction in baseline Eczema Area and Severity Index (EASI) score, compared with 29.9% of controls over the 4-week study period (P less than .001). EASI scores in the study group were about 80% at a score of 50, 60% at a score of 75, and 40% at a score of 90.
By week 4, about three-quarters of the study group were either clear or almost clear of their skin condition, according to the physician global assessment scale, compared with 22% of controls (P less than .05).
There also was a rapid reduction in patient-reported pruritus in the tofacitinib group per the Itch Severity Item scale, compared with controls, at weeks 2 and 4 (P less than .001 for each time point).
Tolerability was similar across the study, and treatment-related adverse effects were mild, although 44% of the tofacitinib group did report experiencing some form of infection, infestation, or other complication. Two people in the study group dropped out because of the severity of their treatment-emergent adverse events. There were no reported severe or serious infections.
Dr. Bissonnette has numerous pharmaceutical industry relationships, including with Pfizer, the study’s sponsor.
With the discovery of how cytokines such as IL-4, IL-5, IL-13, and IL-31 drive inflammatory disease pathogenesis, more targeted therapies are possible for dermatologic conditions such as atopic dermatitis.
The promise of such pathogenesis-based treatments gives hope to patients with atopic dermatitis, for whom new treatments have not been brought to market in more than 15 years.
While this is reason for excitement, the emergence of several new promising therapies calls for comparison trials, according to Brett A. King, MD, and William Damsky, MD, PhD, both of Yale University, New Haven, Conn.
“Further studies will be needed to address long-term efficacy and safety,” Dr. King and Dr. Damsky noted. The results of Dr. Bissonnette’s phase IIa trial of the topical Janus kinase inhibitor tofacitinib mean there is potentially a third targeted topical agent to emerge as a treatment for atopic dermatitis. The others include the phosphodiesterase-4 inhibitor crisaborole, and dupilumab, a monoclonal antibody that targets IL-4 and IL-13.
“Head-to-head trials involving these agents and superpotent topical steroids would be useful in establishing their place in AD treatment algorithms,” Dr. King and Dr. Damsky said.
Dr. King is an assistant professor of dermatology at Yale University. His coauthor, Dr. Damsky, is a second-year resident in dermatology at Yale University. These remarks are taken from an editorial accompanying Dr. Bissonnette’s study (Br J Dermatol. 2016 Nov;175[5]:861-2). Dr. King disclosed he has industry ties with Eli Lilly and Pfizer, among others. Dr. Damsky had no relevant disclosures.
With the discovery of how cytokines such as IL-4, IL-5, IL-13, and IL-31 drive inflammatory disease pathogenesis, more targeted therapies are possible for dermatologic conditions such as atopic dermatitis.
The promise of such pathogenesis-based treatments gives hope to patients with atopic dermatitis, for whom new treatments have not been brought to market in more than 15 years.
While this is reason for excitement, the emergence of several new promising therapies calls for comparison trials, according to Brett A. King, MD, and William Damsky, MD, PhD, both of Yale University, New Haven, Conn.
“Further studies will be needed to address long-term efficacy and safety,” Dr. King and Dr. Damsky noted. The results of Dr. Bissonnette’s phase IIa trial of the topical Janus kinase inhibitor tofacitinib mean there is potentially a third targeted topical agent to emerge as a treatment for atopic dermatitis. The others include the phosphodiesterase-4 inhibitor crisaborole, and dupilumab, a monoclonal antibody that targets IL-4 and IL-13.
“Head-to-head trials involving these agents and superpotent topical steroids would be useful in establishing their place in AD treatment algorithms,” Dr. King and Dr. Damsky said.
Dr. King is an assistant professor of dermatology at Yale University. His coauthor, Dr. Damsky, is a second-year resident in dermatology at Yale University. These remarks are taken from an editorial accompanying Dr. Bissonnette’s study (Br J Dermatol. 2016 Nov;175[5]:861-2). Dr. King disclosed he has industry ties with Eli Lilly and Pfizer, among others. Dr. Damsky had no relevant disclosures.
With the discovery of how cytokines such as IL-4, IL-5, IL-13, and IL-31 drive inflammatory disease pathogenesis, more targeted therapies are possible for dermatologic conditions such as atopic dermatitis.
The promise of such pathogenesis-based treatments gives hope to patients with atopic dermatitis, for whom new treatments have not been brought to market in more than 15 years.
While this is reason for excitement, the emergence of several new promising therapies calls for comparison trials, according to Brett A. King, MD, and William Damsky, MD, PhD, both of Yale University, New Haven, Conn.
“Further studies will be needed to address long-term efficacy and safety,” Dr. King and Dr. Damsky noted. The results of Dr. Bissonnette’s phase IIa trial of the topical Janus kinase inhibitor tofacitinib mean there is potentially a third targeted topical agent to emerge as a treatment for atopic dermatitis. The others include the phosphodiesterase-4 inhibitor crisaborole, and dupilumab, a monoclonal antibody that targets IL-4 and IL-13.
“Head-to-head trials involving these agents and superpotent topical steroids would be useful in establishing their place in AD treatment algorithms,” Dr. King and Dr. Damsky said.
Dr. King is an assistant professor of dermatology at Yale University. His coauthor, Dr. Damsky, is a second-year resident in dermatology at Yale University. These remarks are taken from an editorial accompanying Dr. Bissonnette’s study (Br J Dermatol. 2016 Nov;175[5]:861-2). Dr. King disclosed he has industry ties with Eli Lilly and Pfizer, among others. Dr. Damsky had no relevant disclosures.
Topical tofacitinib showed significant improvements across all endpoints and for pruritus at week 4, compared with vehicle, results of a phase IIa trial have shown.
Tofacitinib is a Janus kinase inhibitor that affects the interleukin (IL)–4, IL-5, and IL-31 signaling pathways, interfering with the immune response that leads to inflammation.
The study could mean “that inhibition of the JAK-STAT pathway may be a new therapeutic target for AD,” wrote the study’s lead author, Robert Bissonnette, MD, president of Innovaderm Research in Montreal. The study was published in the British Journal of Dermatology (2016 Nov;175[5]:902-11).
In the multicenter, double-blind, controlled study of 69 adults with mild to moderate atopic dermatitis randomly assigned to either 2% tofacitinib or vehicle ointment twice daily, the study group achieved an 81.7% mean reduction in baseline Eczema Area and Severity Index (EASI) score, compared with 29.9% of controls over the 4-week study period (P less than .001). EASI scores in the study group were about 80% at a score of 50, 60% at a score of 75, and 40% at a score of 90.
By week 4, about three-quarters of the study group were either clear or almost clear of their skin condition, according to the physician global assessment scale, compared with 22% of controls (P less than .05).
There also was a rapid reduction in patient-reported pruritus in the tofacitinib group per the Itch Severity Item scale, compared with controls, at weeks 2 and 4 (P less than .001 for each time point).
Tolerability was similar across the study, and treatment-related adverse effects were mild, although 44% of the tofacitinib group did report experiencing some form of infection, infestation, or other complication. Two people in the study group dropped out because of the severity of their treatment-emergent adverse events. There were no reported severe or serious infections.
Dr. Bissonnette has numerous pharmaceutical industry relationships, including with Pfizer, the study’s sponsor.
Topical tofacitinib showed significant improvements across all endpoints and for pruritus at week 4, compared with vehicle, results of a phase IIa trial have shown.
Tofacitinib is a Janus kinase inhibitor that affects the interleukin (IL)–4, IL-5, and IL-31 signaling pathways, interfering with the immune response that leads to inflammation.
The study could mean “that inhibition of the JAK-STAT pathway may be a new therapeutic target for AD,” wrote the study’s lead author, Robert Bissonnette, MD, president of Innovaderm Research in Montreal. The study was published in the British Journal of Dermatology (2016 Nov;175[5]:902-11).
In the multicenter, double-blind, controlled study of 69 adults with mild to moderate atopic dermatitis randomly assigned to either 2% tofacitinib or vehicle ointment twice daily, the study group achieved an 81.7% mean reduction in baseline Eczema Area and Severity Index (EASI) score, compared with 29.9% of controls over the 4-week study period (P less than .001). EASI scores in the study group were about 80% at a score of 50, 60% at a score of 75, and 40% at a score of 90.
By week 4, about three-quarters of the study group were either clear or almost clear of their skin condition, according to the physician global assessment scale, compared with 22% of controls (P less than .05).
There also was a rapid reduction in patient-reported pruritus in the tofacitinib group per the Itch Severity Item scale, compared with controls, at weeks 2 and 4 (P less than .001 for each time point).
Tolerability was similar across the study, and treatment-related adverse effects were mild, although 44% of the tofacitinib group did report experiencing some form of infection, infestation, or other complication. Two people in the study group dropped out because of the severity of their treatment-emergent adverse events. There were no reported severe or serious infections.
Dr. Bissonnette has numerous pharmaceutical industry relationships, including with Pfizer, the study’s sponsor.
FROM BRITISH JOURNAL OF DERMATOLOGY
Key clinical point:
Major finding: Tofacitinib showed significant improvements across all endpoints and for pruritus at week 4, compared with vehicle (P less than .001)
Data source: Multicenter, phase IIa, 4-week, double-blind, controlled study of 69 adults with mild to moderate atopic dermatitis randomly assigned to either 2% tofacitinib or vehicle ointment twice daily.
Disclosures: Dr. Bissonnette has numerous pharmaceutical industry relationships, including with Pfizer, the sponsor of this study.
Infectious disease physicians: Antibiotic shortages are the new norm
NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.
Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.
In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.
The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.
The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.
Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.
“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”
Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.
“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.
“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.
The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.
“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.
“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.
The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”
Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.
“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”
Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.
NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.
Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.
In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.
The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.
The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.
Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.
“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”
Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.
“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.
“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.
The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.
“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.
“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.
The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”
Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.
“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”
Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.
NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.
Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.
In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.
The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.
The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.
Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.
“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”
Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.
“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.
“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.
The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.
“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.
“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.
The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”
Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.
“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”
Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.
AT IDWEEK 2016
Key clinical point:
Major finding: 70% of respondents reported needing to modify their antimicrobial choice because of a shortage in the past 2 years, and 73% said shortages affected patient care or outcomes.
Data source: A follow-up survey of 701 physicians.
Disclosures: Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.
Absorb’s problems will revise coronary scaffold standards
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler