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Company stops development of eryaspase in ALL
Erytech Pharma said it plans to stop development of eryaspase for acute lymphoblastic leukemia (ALL).
This means withdrawal of the European marketing authorization application for eryaspase as a treatment for relapsed and refractory ALL.
However, Erytech will continue development of eryaspase as a treatment for certain solid tumor malignancies.
Eryaspase consists of L-asparaginase encapsulated inside donor-derived red blood cells. These enzyme-loaded red blood cells function as bioreactors to eliminate circulating asparagine and “starve” cancer cells, thereby inducing their death.
Erytech noted that eryaspase has produced favorable efficacy and safety results in ALL.
However, based on recent feedback from regulatory agencies in Europe and the US, the company believes significant additional investment would be required to seek regulatory approval of eryaspase for the treatment of ALL. Erytech also believes there would be a limited market opportunity for eryaspase in ALL.
Therefore, the company decided to cease further clinical development efforts in ALL. The resources that will become available as a result of this decision will be allocated to the development of eryaspase in solid tumors.
In 2017, Erytech announced results from a phase 2b clinical trial of eryaspase plus chemotherapy in patients with second-line metastatic pancreatic cancer. The company expects to begin enrollment in a phase 3 trial of this patient population in the third quarter of 2018.
In addition, Erytech is preparing for a pair of phase 2 proof-of-concept trials of eryaspase. One is in first-line pancreatic cancer, and the other is in metastatic triple-negative breast cancer. The company is also evaluating development options in additional solid tumor indications with high unmet medical need.
To ensure an adequate supply of eryaspase, Erytech is constructing a large-scale manufacturing facility in Princeton, New Jersey, and is expanding its manufacturing capacity in Lyon, France. The company expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.
Erytech Pharma said it plans to stop development of eryaspase for acute lymphoblastic leukemia (ALL).
This means withdrawal of the European marketing authorization application for eryaspase as a treatment for relapsed and refractory ALL.
However, Erytech will continue development of eryaspase as a treatment for certain solid tumor malignancies.
Eryaspase consists of L-asparaginase encapsulated inside donor-derived red blood cells. These enzyme-loaded red blood cells function as bioreactors to eliminate circulating asparagine and “starve” cancer cells, thereby inducing their death.
Erytech noted that eryaspase has produced favorable efficacy and safety results in ALL.
However, based on recent feedback from regulatory agencies in Europe and the US, the company believes significant additional investment would be required to seek regulatory approval of eryaspase for the treatment of ALL. Erytech also believes there would be a limited market opportunity for eryaspase in ALL.
Therefore, the company decided to cease further clinical development efforts in ALL. The resources that will become available as a result of this decision will be allocated to the development of eryaspase in solid tumors.
In 2017, Erytech announced results from a phase 2b clinical trial of eryaspase plus chemotherapy in patients with second-line metastatic pancreatic cancer. The company expects to begin enrollment in a phase 3 trial of this patient population in the third quarter of 2018.
In addition, Erytech is preparing for a pair of phase 2 proof-of-concept trials of eryaspase. One is in first-line pancreatic cancer, and the other is in metastatic triple-negative breast cancer. The company is also evaluating development options in additional solid tumor indications with high unmet medical need.
To ensure an adequate supply of eryaspase, Erytech is constructing a large-scale manufacturing facility in Princeton, New Jersey, and is expanding its manufacturing capacity in Lyon, France. The company expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.
Erytech Pharma said it plans to stop development of eryaspase for acute lymphoblastic leukemia (ALL).
This means withdrawal of the European marketing authorization application for eryaspase as a treatment for relapsed and refractory ALL.
However, Erytech will continue development of eryaspase as a treatment for certain solid tumor malignancies.
Eryaspase consists of L-asparaginase encapsulated inside donor-derived red blood cells. These enzyme-loaded red blood cells function as bioreactors to eliminate circulating asparagine and “starve” cancer cells, thereby inducing their death.
Erytech noted that eryaspase has produced favorable efficacy and safety results in ALL.
However, based on recent feedback from regulatory agencies in Europe and the US, the company believes significant additional investment would be required to seek regulatory approval of eryaspase for the treatment of ALL. Erytech also believes there would be a limited market opportunity for eryaspase in ALL.
Therefore, the company decided to cease further clinical development efforts in ALL. The resources that will become available as a result of this decision will be allocated to the development of eryaspase in solid tumors.
In 2017, Erytech announced results from a phase 2b clinical trial of eryaspase plus chemotherapy in patients with second-line metastatic pancreatic cancer. The company expects to begin enrollment in a phase 3 trial of this patient population in the third quarter of 2018.
In addition, Erytech is preparing for a pair of phase 2 proof-of-concept trials of eryaspase. One is in first-line pancreatic cancer, and the other is in metastatic triple-negative breast cancer. The company is also evaluating development options in additional solid tumor indications with high unmet medical need.
To ensure an adequate supply of eryaspase, Erytech is constructing a large-scale manufacturing facility in Princeton, New Jersey, and is expanding its manufacturing capacity in Lyon, France. The company expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.
HCV remodels lipid metabolism in infected cells
Hepatitis C virus infection often is associated with the accumulation of fat in hepatocytes, which shows a connection between the virus and the lipid metabolism of the liver, according to Sarah Hoffman, MD, of the Leibniz Institute for Experimental Virology, Hamburg, Germany, and her colleagues. “Our study provides a detailed analysis of the changes in the lipid composition in HCV-infected cells that revealed dependency on FA [fatty acid] elongation and desaturation for effective viral replication and virion production,” they reported.
Dr. Hoffman and her colleagues assessed lipid composition of infected cells in an in vitro study of cell lines, which were assessed 8-11 days post infection, according to the report published in BBA: Molecular and Cell Biology of Lipids. They determined the abundance of each major lipid class and compared the pattern of HCV-infected cells with that of controls.
The researchers found that HCV caused an accumulation of membrane phosopholipids but not neutral lipids and that cholesterol accumulated in the perinuclear region of HCV-infected cells. In addition, lipid species with longer fatty acyl chains were more abundant in HCV-infected cells and free polyunsaturated fatty acid (PUFA) levels were greatly increased.
In further confirmation of the critical role of lipid metabolism in HCV replication, they found that knockdown of fatty acid elongases and desaturases disrupted HCV replication, while overexpression of these enzymes showed a proviral effect.
“We identified several lipid-remodeling pathways that are required for distinct steps in viral infection. Future studies have to address the molecular function of longer fatty acyl chains in HCV RNA replication and why PUFAs are needed for HCV particle production,” the researchers concluded.
The authors reported government and institutional-only funding and no personal disclosures.
SOURCE: Hoffman S et al. Biochim Biophys Acta. 2018 Jun 6;1863(9):1041-56.
Hepatitis C virus infection often is associated with the accumulation of fat in hepatocytes, which shows a connection between the virus and the lipid metabolism of the liver, according to Sarah Hoffman, MD, of the Leibniz Institute for Experimental Virology, Hamburg, Germany, and her colleagues. “Our study provides a detailed analysis of the changes in the lipid composition in HCV-infected cells that revealed dependency on FA [fatty acid] elongation and desaturation for effective viral replication and virion production,” they reported.
Dr. Hoffman and her colleagues assessed lipid composition of infected cells in an in vitro study of cell lines, which were assessed 8-11 days post infection, according to the report published in BBA: Molecular and Cell Biology of Lipids. They determined the abundance of each major lipid class and compared the pattern of HCV-infected cells with that of controls.
The researchers found that HCV caused an accumulation of membrane phosopholipids but not neutral lipids and that cholesterol accumulated in the perinuclear region of HCV-infected cells. In addition, lipid species with longer fatty acyl chains were more abundant in HCV-infected cells and free polyunsaturated fatty acid (PUFA) levels were greatly increased.
In further confirmation of the critical role of lipid metabolism in HCV replication, they found that knockdown of fatty acid elongases and desaturases disrupted HCV replication, while overexpression of these enzymes showed a proviral effect.
“We identified several lipid-remodeling pathways that are required for distinct steps in viral infection. Future studies have to address the molecular function of longer fatty acyl chains in HCV RNA replication and why PUFAs are needed for HCV particle production,” the researchers concluded.
The authors reported government and institutional-only funding and no personal disclosures.
SOURCE: Hoffman S et al. Biochim Biophys Acta. 2018 Jun 6;1863(9):1041-56.
Hepatitis C virus infection often is associated with the accumulation of fat in hepatocytes, which shows a connection between the virus and the lipid metabolism of the liver, according to Sarah Hoffman, MD, of the Leibniz Institute for Experimental Virology, Hamburg, Germany, and her colleagues. “Our study provides a detailed analysis of the changes in the lipid composition in HCV-infected cells that revealed dependency on FA [fatty acid] elongation and desaturation for effective viral replication and virion production,” they reported.
Dr. Hoffman and her colleagues assessed lipid composition of infected cells in an in vitro study of cell lines, which were assessed 8-11 days post infection, according to the report published in BBA: Molecular and Cell Biology of Lipids. They determined the abundance of each major lipid class and compared the pattern of HCV-infected cells with that of controls.
The researchers found that HCV caused an accumulation of membrane phosopholipids but not neutral lipids and that cholesterol accumulated in the perinuclear region of HCV-infected cells. In addition, lipid species with longer fatty acyl chains were more abundant in HCV-infected cells and free polyunsaturated fatty acid (PUFA) levels were greatly increased.
In further confirmation of the critical role of lipid metabolism in HCV replication, they found that knockdown of fatty acid elongases and desaturases disrupted HCV replication, while overexpression of these enzymes showed a proviral effect.
“We identified several lipid-remodeling pathways that are required for distinct steps in viral infection. Future studies have to address the molecular function of longer fatty acyl chains in HCV RNA replication and why PUFAs are needed for HCV particle production,” the researchers concluded.
The authors reported government and institutional-only funding and no personal disclosures.
SOURCE: Hoffman S et al. Biochim Biophys Acta. 2018 Jun 6;1863(9):1041-56.
FROM BBA: MOLECULAR AND CELL BIOLOGY OF LIPIDS
CPAP and oxygen have different cardiac effects in OSA
BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.
“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.
The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.
On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.
The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.
Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.
The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.
Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.
SOURCE: George J et al. Sleep 2018, Abstract 0444.
BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.
“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.
The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.
On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.
The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.
Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.
The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.
Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.
SOURCE: George J et al. Sleep 2018, Abstract 0444.
BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.
“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.
The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.
On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.
The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.
Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.
The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.
Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.
SOURCE: George J et al. Sleep 2018, Abstract 0444.
REPORTING FROM SLEEP 2018
Key clinical point: CPAP and oxygen in sleep apnea have countering effects on ECG.
Major finding: CPAP conferred a 9% reduction in high-frequency power but a 4% increase in low-frequency power.
Study details: Evaluation of 203 participants in the multicenter, randomized controlled Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial.
Disclosures: Dr. George reported no financial relationships. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.
Source: George J et al. Sleep 2018, Abstract 0444.
Prompting during rounds decreases lab utilization in patients nearing discharge
Clinical question: Does prompting hospitalists during interdisciplinary rounds to discontinue lab orders on patients nearing discharge result in a decrease in lab testing?
Background: The Society of Hospital Medicine, as part of the Choosing Wisely campaign, has recommended against “repetitive complete blood count and chemistry testing in the face of clinical and lab stability.” Repeated phlebotomy has been shown to increase iatrogenic anemia and patient discomfort. While past interventions have been effective in decreasing lab testing, this study focused on identifying and intervening on patients who were clinically stable and nearing discharge.
Study design: Prospective, observational study.
Setting: Tertiary care teaching hospital in New York.
Synopsis: As part of structured, bedside, interdisciplinary rounds, over the course of a year, this study incorporated an inquiry to identify patients who were likely to be discharged in the next 24-48 hours; the unit medical director or nurse manager then prompted staff to discontinue labs for these patients when appropriate. This was supplemented by education of clinicians and regular review of lab utilization data with hospitalists.
The percentage of patients with labs ordered in the 24 hours prior to discharge decreased from 50.1% in the preintervention period to 34.5% in the postintervention period (P = .004). The number of labs ordered per patient-day dropped from 1.96 to 1.83 (P = .01).
Bottom line: An intervention with prompting during structured interdisciplinary rounds decreased the frequency of labs ordered for patients nearing hospital discharge.
Citation: Tsega S et al. Bedside assessment of the necessity of daily lab testing for patients nearing discharge. J Hosp Med. 2018 Jan 1;13(1):38-40.
Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.
Clinical question: Does prompting hospitalists during interdisciplinary rounds to discontinue lab orders on patients nearing discharge result in a decrease in lab testing?
Background: The Society of Hospital Medicine, as part of the Choosing Wisely campaign, has recommended against “repetitive complete blood count and chemistry testing in the face of clinical and lab stability.” Repeated phlebotomy has been shown to increase iatrogenic anemia and patient discomfort. While past interventions have been effective in decreasing lab testing, this study focused on identifying and intervening on patients who were clinically stable and nearing discharge.
Study design: Prospective, observational study.
Setting: Tertiary care teaching hospital in New York.
Synopsis: As part of structured, bedside, interdisciplinary rounds, over the course of a year, this study incorporated an inquiry to identify patients who were likely to be discharged in the next 24-48 hours; the unit medical director or nurse manager then prompted staff to discontinue labs for these patients when appropriate. This was supplemented by education of clinicians and regular review of lab utilization data with hospitalists.
The percentage of patients with labs ordered in the 24 hours prior to discharge decreased from 50.1% in the preintervention period to 34.5% in the postintervention period (P = .004). The number of labs ordered per patient-day dropped from 1.96 to 1.83 (P = .01).
Bottom line: An intervention with prompting during structured interdisciplinary rounds decreased the frequency of labs ordered for patients nearing hospital discharge.
Citation: Tsega S et al. Bedside assessment of the necessity of daily lab testing for patients nearing discharge. J Hosp Med. 2018 Jan 1;13(1):38-40.
Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.
Clinical question: Does prompting hospitalists during interdisciplinary rounds to discontinue lab orders on patients nearing discharge result in a decrease in lab testing?
Background: The Society of Hospital Medicine, as part of the Choosing Wisely campaign, has recommended against “repetitive complete blood count and chemistry testing in the face of clinical and lab stability.” Repeated phlebotomy has been shown to increase iatrogenic anemia and patient discomfort. While past interventions have been effective in decreasing lab testing, this study focused on identifying and intervening on patients who were clinically stable and nearing discharge.
Study design: Prospective, observational study.
Setting: Tertiary care teaching hospital in New York.
Synopsis: As part of structured, bedside, interdisciplinary rounds, over the course of a year, this study incorporated an inquiry to identify patients who were likely to be discharged in the next 24-48 hours; the unit medical director or nurse manager then prompted staff to discontinue labs for these patients when appropriate. This was supplemented by education of clinicians and regular review of lab utilization data with hospitalists.
The percentage of patients with labs ordered in the 24 hours prior to discharge decreased from 50.1% in the preintervention period to 34.5% in the postintervention period (P = .004). The number of labs ordered per patient-day dropped from 1.96 to 1.83 (P = .01).
Bottom line: An intervention with prompting during structured interdisciplinary rounds decreased the frequency of labs ordered for patients nearing hospital discharge.
Citation: Tsega S et al. Bedside assessment of the necessity of daily lab testing for patients nearing discharge. J Hosp Med. 2018 Jan 1;13(1):38-40.
Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.
Does expectant management or induction of labor at or beyond term result in better birth outcomes?
WHAT DOES THIS MEAN FOR PRACTICE?
- Induction of labor before 41 weeks’ gestation results in overall better outcomes in mother and newborn
Ozenoxacin is a novel treatment option for impetigo
Ozenoxacin (Xepi cream), a potent novel topical antibacterial agent, is effective and well tolerated for treatment of impetigo in patients aged 2 months and older, according to results of a phase 3 randomized, double-blind, vehicle-controlled clinical trial.
A 1% cream formulation of ozenoxacin had a clinical and microbiologic response that was rapid and superior to placebo, investigators reported in this second phase 3 pivotal study, which demonstrated the efficacy of ozenoxacin cream in impetigo patients.
“With concerns over widespread antibiotic resistance, ozenoxacin is an important potential treatment option with an expanded spectrum against bacterial pathogens, including those resistant to mupirocin, ciprofloxacin, and methicillin, including MRSA [methicillin-resistant Staphylococcus aureus],” Dr. Rosen and his colleagues wrote in a report on their study in JAMA Dermatology.
The clinical trial included 412 patients aged 2 months or older with impetigo. Clinical success, defined as complete absence of the treated lesions, was seen after 5 days of treatment in 112 of the 206 (54.4%) patients randomized to ozenoxacin versus 78 of 206 patients (37.9%) who received placebo (P = .001), which confirmed the superiority of ozenoxacin, Dr. Rosen and his coauthors wrote.
In addition, microbiologic response was seen in 87.2% of patients in the ozenoxacin group during therapy (day 3) versus 63.9% in the placebo group (P = .002); by the end of therapy (day 6), response rates were 92.0% and 73.1%, respectively (P = .005).
All patients with drug-resistant infections had clinical cure or improvement at the end of treatment, including 10 patients with mupirocin-resistant S. aureus and 8 patients with MRSA, investigators wrote.
Adverse event rates were low for both ozenoxacin and placebo groups, at 3.9% and 3.4%, respectively. One patient in the ozenoxacin group experienced a serious adverse event “at least potentially related” to treatment (rosacea and seborrheic dermatitis).
“The lack of systemic adverse effects is consistent with previous studies that demonstrated that topically applied ozenoxacin has negligible systemic absorption,” Dr. Rosen and his coauthors wrote.
The study was partly supported by Ferrer Internacional; two coauthors of the study reported employment with that company. Dr. Rosen reported consulting work with Medimetriks Pharmaceuticals, which developed the agent.
SOURCE: Rosen T et al. JAMA Dermatol. 2018 Jun 13. doi: 10.1001/jamadermatol.2018.1103.
Ozenoxacin (Xepi cream), a potent novel topical antibacterial agent, is effective and well tolerated for treatment of impetigo in patients aged 2 months and older, according to results of a phase 3 randomized, double-blind, vehicle-controlled clinical trial.
A 1% cream formulation of ozenoxacin had a clinical and microbiologic response that was rapid and superior to placebo, investigators reported in this second phase 3 pivotal study, which demonstrated the efficacy of ozenoxacin cream in impetigo patients.
“With concerns over widespread antibiotic resistance, ozenoxacin is an important potential treatment option with an expanded spectrum against bacterial pathogens, including those resistant to mupirocin, ciprofloxacin, and methicillin, including MRSA [methicillin-resistant Staphylococcus aureus],” Dr. Rosen and his colleagues wrote in a report on their study in JAMA Dermatology.
The clinical trial included 412 patients aged 2 months or older with impetigo. Clinical success, defined as complete absence of the treated lesions, was seen after 5 days of treatment in 112 of the 206 (54.4%) patients randomized to ozenoxacin versus 78 of 206 patients (37.9%) who received placebo (P = .001), which confirmed the superiority of ozenoxacin, Dr. Rosen and his coauthors wrote.
In addition, microbiologic response was seen in 87.2% of patients in the ozenoxacin group during therapy (day 3) versus 63.9% in the placebo group (P = .002); by the end of therapy (day 6), response rates were 92.0% and 73.1%, respectively (P = .005).
All patients with drug-resistant infections had clinical cure or improvement at the end of treatment, including 10 patients with mupirocin-resistant S. aureus and 8 patients with MRSA, investigators wrote.
Adverse event rates were low for both ozenoxacin and placebo groups, at 3.9% and 3.4%, respectively. One patient in the ozenoxacin group experienced a serious adverse event “at least potentially related” to treatment (rosacea and seborrheic dermatitis).
“The lack of systemic adverse effects is consistent with previous studies that demonstrated that topically applied ozenoxacin has negligible systemic absorption,” Dr. Rosen and his coauthors wrote.
The study was partly supported by Ferrer Internacional; two coauthors of the study reported employment with that company. Dr. Rosen reported consulting work with Medimetriks Pharmaceuticals, which developed the agent.
SOURCE: Rosen T et al. JAMA Dermatol. 2018 Jun 13. doi: 10.1001/jamadermatol.2018.1103.
Ozenoxacin (Xepi cream), a potent novel topical antibacterial agent, is effective and well tolerated for treatment of impetigo in patients aged 2 months and older, according to results of a phase 3 randomized, double-blind, vehicle-controlled clinical trial.
A 1% cream formulation of ozenoxacin had a clinical and microbiologic response that was rapid and superior to placebo, investigators reported in this second phase 3 pivotal study, which demonstrated the efficacy of ozenoxacin cream in impetigo patients.
“With concerns over widespread antibiotic resistance, ozenoxacin is an important potential treatment option with an expanded spectrum against bacterial pathogens, including those resistant to mupirocin, ciprofloxacin, and methicillin, including MRSA [methicillin-resistant Staphylococcus aureus],” Dr. Rosen and his colleagues wrote in a report on their study in JAMA Dermatology.
The clinical trial included 412 patients aged 2 months or older with impetigo. Clinical success, defined as complete absence of the treated lesions, was seen after 5 days of treatment in 112 of the 206 (54.4%) patients randomized to ozenoxacin versus 78 of 206 patients (37.9%) who received placebo (P = .001), which confirmed the superiority of ozenoxacin, Dr. Rosen and his coauthors wrote.
In addition, microbiologic response was seen in 87.2% of patients in the ozenoxacin group during therapy (day 3) versus 63.9% in the placebo group (P = .002); by the end of therapy (day 6), response rates were 92.0% and 73.1%, respectively (P = .005).
All patients with drug-resistant infections had clinical cure or improvement at the end of treatment, including 10 patients with mupirocin-resistant S. aureus and 8 patients with MRSA, investigators wrote.
Adverse event rates were low for both ozenoxacin and placebo groups, at 3.9% and 3.4%, respectively. One patient in the ozenoxacin group experienced a serious adverse event “at least potentially related” to treatment (rosacea and seborrheic dermatitis).
“The lack of systemic adverse effects is consistent with previous studies that demonstrated that topically applied ozenoxacin has negligible systemic absorption,” Dr. Rosen and his coauthors wrote.
The study was partly supported by Ferrer Internacional; two coauthors of the study reported employment with that company. Dr. Rosen reported consulting work with Medimetriks Pharmaceuticals, which developed the agent.
SOURCE: Rosen T et al. JAMA Dermatol. 2018 Jun 13. doi: 10.1001/jamadermatol.2018.1103.
FROM JAMA DERMATOLOGY
Key clinical point: Ozenoxacin, a novel topical antibacterial agent, is effective and well tolerated for treatment of impetigo
Major finding: Clinical response was seen in 54.4% of ozenoxacin-treated patients and 37.9% of placebo-treated patients (P = .001).
Study details: A phase 3 randomized, double-blind, vehicle-controlled clinical trial that included 411 patients aged 2 months or older with impetigo.
Disclosures: Partial support came from Ferrer Internacional; two coauthors worked for that company. The study’s first author reported consulting work with Medimetriks, the developer of the agent.
Source: Rosen T et al. JAMA Dermatol. 2018 Jun 13. doi: 10.1001/jamadermatol.2018.1103.
Cigarette smoking epidemic among HCV-infected individuals
There is a cigarette smoking epidemic embedded within the hepatitis C virus epidemic in the United States, according to the results of an analysis of data between 1999 and 2014 from the National Health and Nutrition Examination Survey (NHANES).
Smoking and hepatitis C information were available for 90.1% of the NHANES adult population. Of the 39,472 individuals evaluated, 1.3% were hepatitis C+ and 22.3% were current smokers. Hepatitis C+ individuals were almost three times as likely to be smokers as were those who were hepatitis C– (62.4% vs. 22.9%, respectively), according to the report, published in The American Journal of Medicine (Am J Med. 2018 Jun;131[6]:699-75).
Ryung S. Kim, PhD, of Albert Einstein College of Medicine, New York, and his colleagues also found that hepatitis C+ smokers were more likely to be older, male, black, less educated, poor, and uninsured compared with their hepatitis C– smoking counterparts. They also were more likely to use drugs, including heroin, and to be depressed.
Multivariate analysis showed a significant association of both hepatitis C infection and smoking with current depression and hypertension, Dr. Kim and his colleagues wrote.
“It is public health folly to spend tens of millions of dollars annually” on treatment of hepatitis C patients, “and ignore the lethal addiction affecting more than 60% of them. As we enter a new era of hepatitis C treatment, it is a public health imperative to research, develop, and implement tobacco treatments for the hepatitis C+ community,” Dr. Kim and his colleagues concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Kim RS et al. Am J Med. 2018Jun;131[6]:669-75).
There is a cigarette smoking epidemic embedded within the hepatitis C virus epidemic in the United States, according to the results of an analysis of data between 1999 and 2014 from the National Health and Nutrition Examination Survey (NHANES).
Smoking and hepatitis C information were available for 90.1% of the NHANES adult population. Of the 39,472 individuals evaluated, 1.3% were hepatitis C+ and 22.3% were current smokers. Hepatitis C+ individuals were almost three times as likely to be smokers as were those who were hepatitis C– (62.4% vs. 22.9%, respectively), according to the report, published in The American Journal of Medicine (Am J Med. 2018 Jun;131[6]:699-75).
Ryung S. Kim, PhD, of Albert Einstein College of Medicine, New York, and his colleagues also found that hepatitis C+ smokers were more likely to be older, male, black, less educated, poor, and uninsured compared with their hepatitis C– smoking counterparts. They also were more likely to use drugs, including heroin, and to be depressed.
Multivariate analysis showed a significant association of both hepatitis C infection and smoking with current depression and hypertension, Dr. Kim and his colleagues wrote.
“It is public health folly to spend tens of millions of dollars annually” on treatment of hepatitis C patients, “and ignore the lethal addiction affecting more than 60% of them. As we enter a new era of hepatitis C treatment, it is a public health imperative to research, develop, and implement tobacco treatments for the hepatitis C+ community,” Dr. Kim and his colleagues concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Kim RS et al. Am J Med. 2018Jun;131[6]:669-75).
There is a cigarette smoking epidemic embedded within the hepatitis C virus epidemic in the United States, according to the results of an analysis of data between 1999 and 2014 from the National Health and Nutrition Examination Survey (NHANES).
Smoking and hepatitis C information were available for 90.1% of the NHANES adult population. Of the 39,472 individuals evaluated, 1.3% were hepatitis C+ and 22.3% were current smokers. Hepatitis C+ individuals were almost three times as likely to be smokers as were those who were hepatitis C– (62.4% vs. 22.9%, respectively), according to the report, published in The American Journal of Medicine (Am J Med. 2018 Jun;131[6]:699-75).
Ryung S. Kim, PhD, of Albert Einstein College of Medicine, New York, and his colleagues also found that hepatitis C+ smokers were more likely to be older, male, black, less educated, poor, and uninsured compared with their hepatitis C– smoking counterparts. They also were more likely to use drugs, including heroin, and to be depressed.
Multivariate analysis showed a significant association of both hepatitis C infection and smoking with current depression and hypertension, Dr. Kim and his colleagues wrote.
“It is public health folly to spend tens of millions of dollars annually” on treatment of hepatitis C patients, “and ignore the lethal addiction affecting more than 60% of them. As we enter a new era of hepatitis C treatment, it is a public health imperative to research, develop, and implement tobacco treatments for the hepatitis C+ community,” Dr. Kim and his colleagues concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Kim RS et al. Am J Med. 2018Jun;131[6]:669-75).
FROM THE AMERICAN JOURNAL OF MEDICINE
Medicare hospital deaths decline, hospice usage increases
Since 2000, Medicare beneficiaries have become less likely to die in hospitals, and more likely to die in their homes or in community health care facilities.
A review of Medicare records also determined that there was a decline in health care transitions in the final 3 days of life for these patients, Joan M. Teno, MD, and her colleagues wrote in JAMA.
It is not possible to identify a specific reason for the shift, wrote Dr. Teno, professor of medicine at the Oregon Health & Science University, Portland. Between the study years of 2000 and 2015, there were several large efforts to improve care at the end of life.
“Since 2009, programs ranging from ensuring informed patient decision making to enhanced care coordination have had the goal of improving care at the end of life. Specific interventions have included promoting conversations about the goals of care, continued growth of hospice services and palliative care, and the debate and passage of the Affordable Care Act … It is difficult to disentangle efforts such as public education, promotion of advance directives through the Patient Self- Determination Act, increased access to hospice and palliative care services, financial incentives of payment policies, and other secular changes.”
The study mined data from the Centers for Medicare & Medicaid Services, and examined end-of-life outcomes among two Medicare groups: Medicare fee-for-service recipients (1,361,870) during 2009-2015, and Medicare Advantage recipients (871,845), comparing 2011 and 2015. The mean age of both cohorts was 82 years.
Outcomes included site of death and “potentially burdensome transitions,” during the last days of life. These were defined as three or more hospitalizations in the previous 3 months, or two or more hospitalizations for pneumonia, urinary tract infection, dehydration, or sepsis during the last 120 days of life. Prolonged mechanical ventilation also was deemed potentially burdensome.
Among fee-for-service recipients, deaths in acute care hospitals declined from 32.6% to19.8%. Deaths in nursing homes remained steady, at 27.2% and 24.9%. Many of these deaths (42.9%) were preceded by a stay in an ICU. There was a transient increase in end-of-life ICU use, around 2009, but by 2015, the percentage was down to 29%, compared with 65.2% in 2000.
Transitions between a nursing home and hospital in the last 90 days of life were 0.49/person in 2000 and 0.33/person in 2015. Hospitalizations for infection or dehydration fell from 14.6% to12.2%. Hospitalization with prolonged ventilation fell from 3.1% to 2.5%.
Dying in hospice care increased from 21.6% to 50.4%, and people were taking advantage of hospice services longer: the proportion using short-term services (3 days or less) fell from 9.8% to 7.7%.
Among Medicare Advantage recipients, the numbers were somewhat different. More than 50% of recipients entered hospice care in both 2011 and 2015; in both years, 8% had services for more than 3 days. About 27% had ICU care in the last days of life, in both years. Compared to fee-for-service recipients, fewer Medicare Advantage patients were in nursing homes at the time of death, and that number declined from 2011 to 2015 (37.7% to 33.2%).
In each year, about 10% of these patients had a hospitalization for dehydration or infection, and 3% had a stay requiring prolonged mechanical ventilation in each year. The mean number of health care transitions remained steady, at 0.23 and 0.21 per person each year.
Dr. Teno had no financial disclosures.
SOURCE: Teno JM et al. JAMA. 2018 Jun 25. doi: 10.1001/jama.2018.8981.
Since 2000, Medicare beneficiaries have become less likely to die in hospitals, and more likely to die in their homes or in community health care facilities.
A review of Medicare records also determined that there was a decline in health care transitions in the final 3 days of life for these patients, Joan M. Teno, MD, and her colleagues wrote in JAMA.
It is not possible to identify a specific reason for the shift, wrote Dr. Teno, professor of medicine at the Oregon Health & Science University, Portland. Between the study years of 2000 and 2015, there were several large efforts to improve care at the end of life.
“Since 2009, programs ranging from ensuring informed patient decision making to enhanced care coordination have had the goal of improving care at the end of life. Specific interventions have included promoting conversations about the goals of care, continued growth of hospice services and palliative care, and the debate and passage of the Affordable Care Act … It is difficult to disentangle efforts such as public education, promotion of advance directives through the Patient Self- Determination Act, increased access to hospice and palliative care services, financial incentives of payment policies, and other secular changes.”
The study mined data from the Centers for Medicare & Medicaid Services, and examined end-of-life outcomes among two Medicare groups: Medicare fee-for-service recipients (1,361,870) during 2009-2015, and Medicare Advantage recipients (871,845), comparing 2011 and 2015. The mean age of both cohorts was 82 years.
Outcomes included site of death and “potentially burdensome transitions,” during the last days of life. These were defined as three or more hospitalizations in the previous 3 months, or two or more hospitalizations for pneumonia, urinary tract infection, dehydration, or sepsis during the last 120 days of life. Prolonged mechanical ventilation also was deemed potentially burdensome.
Among fee-for-service recipients, deaths in acute care hospitals declined from 32.6% to19.8%. Deaths in nursing homes remained steady, at 27.2% and 24.9%. Many of these deaths (42.9%) were preceded by a stay in an ICU. There was a transient increase in end-of-life ICU use, around 2009, but by 2015, the percentage was down to 29%, compared with 65.2% in 2000.
Transitions between a nursing home and hospital in the last 90 days of life were 0.49/person in 2000 and 0.33/person in 2015. Hospitalizations for infection or dehydration fell from 14.6% to12.2%. Hospitalization with prolonged ventilation fell from 3.1% to 2.5%.
Dying in hospice care increased from 21.6% to 50.4%, and people were taking advantage of hospice services longer: the proportion using short-term services (3 days or less) fell from 9.8% to 7.7%.
Among Medicare Advantage recipients, the numbers were somewhat different. More than 50% of recipients entered hospice care in both 2011 and 2015; in both years, 8% had services for more than 3 days. About 27% had ICU care in the last days of life, in both years. Compared to fee-for-service recipients, fewer Medicare Advantage patients were in nursing homes at the time of death, and that number declined from 2011 to 2015 (37.7% to 33.2%).
In each year, about 10% of these patients had a hospitalization for dehydration or infection, and 3% had a stay requiring prolonged mechanical ventilation in each year. The mean number of health care transitions remained steady, at 0.23 and 0.21 per person each year.
Dr. Teno had no financial disclosures.
SOURCE: Teno JM et al. JAMA. 2018 Jun 25. doi: 10.1001/jama.2018.8981.
Since 2000, Medicare beneficiaries have become less likely to die in hospitals, and more likely to die in their homes or in community health care facilities.
A review of Medicare records also determined that there was a decline in health care transitions in the final 3 days of life for these patients, Joan M. Teno, MD, and her colleagues wrote in JAMA.
It is not possible to identify a specific reason for the shift, wrote Dr. Teno, professor of medicine at the Oregon Health & Science University, Portland. Between the study years of 2000 and 2015, there were several large efforts to improve care at the end of life.
“Since 2009, programs ranging from ensuring informed patient decision making to enhanced care coordination have had the goal of improving care at the end of life. Specific interventions have included promoting conversations about the goals of care, continued growth of hospice services and palliative care, and the debate and passage of the Affordable Care Act … It is difficult to disentangle efforts such as public education, promotion of advance directives through the Patient Self- Determination Act, increased access to hospice and palliative care services, financial incentives of payment policies, and other secular changes.”
The study mined data from the Centers for Medicare & Medicaid Services, and examined end-of-life outcomes among two Medicare groups: Medicare fee-for-service recipients (1,361,870) during 2009-2015, and Medicare Advantage recipients (871,845), comparing 2011 and 2015. The mean age of both cohorts was 82 years.
Outcomes included site of death and “potentially burdensome transitions,” during the last days of life. These were defined as three or more hospitalizations in the previous 3 months, or two or more hospitalizations for pneumonia, urinary tract infection, dehydration, or sepsis during the last 120 days of life. Prolonged mechanical ventilation also was deemed potentially burdensome.
Among fee-for-service recipients, deaths in acute care hospitals declined from 32.6% to19.8%. Deaths in nursing homes remained steady, at 27.2% and 24.9%. Many of these deaths (42.9%) were preceded by a stay in an ICU. There was a transient increase in end-of-life ICU use, around 2009, but by 2015, the percentage was down to 29%, compared with 65.2% in 2000.
Transitions between a nursing home and hospital in the last 90 days of life were 0.49/person in 2000 and 0.33/person in 2015. Hospitalizations for infection or dehydration fell from 14.6% to12.2%. Hospitalization with prolonged ventilation fell from 3.1% to 2.5%.
Dying in hospice care increased from 21.6% to 50.4%, and people were taking advantage of hospice services longer: the proportion using short-term services (3 days or less) fell from 9.8% to 7.7%.
Among Medicare Advantage recipients, the numbers were somewhat different. More than 50% of recipients entered hospice care in both 2011 and 2015; in both years, 8% had services for more than 3 days. About 27% had ICU care in the last days of life, in both years. Compared to fee-for-service recipients, fewer Medicare Advantage patients were in nursing homes at the time of death, and that number declined from 2011 to 2015 (37.7% to 33.2%).
In each year, about 10% of these patients had a hospitalization for dehydration or infection, and 3% had a stay requiring prolonged mechanical ventilation in each year. The mean number of health care transitions remained steady, at 0.23 and 0.21 per person each year.
Dr. Teno had no financial disclosures.
SOURCE: Teno JM et al. JAMA. 2018 Jun 25. doi: 10.1001/jama.2018.8981.
FROM JAMA
Key clinical point: During 2000-2015, Medicare recipients became less likely to die in hospitals.
Major finding:
Study details: The retrospective study comprised more than 2.3 million Medicare recipients.
Disclosures: Dr. Teno had no financial disclosures.
Source: Teno JM et al. JAMA. 2018 Jun 25. doi: 10.1001/jama.2018.8981.
Pediatric special interest group to open new era of opportunity
More visible, systemic pediatric presence within SHM
Editor’s note: Each month, the Society of Hospital Medicine puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Visit www.hospitalmedicine.org for more information on how you can lend your expertise to help improve the care of hospitalized patients.
Why did you become a member of SHM?
After being in a general pediatrics practice for a few years, I saw a lot of value in and got a lot of support from working with other outpatient pediatricians and the American Academy of Pediatrics. When I left that outpatient practice to focus on hospital pediatrics 13 years ago, I needed to find people who knew a lot more than I did about inpatient work and an organization that could support my growth and development in this new role. Of course, SHM was the answer.
I knew there was a ton I could learn from the internists who had been doing this work a lot longer and senior pediatric hospitalists who could share their experiences. I found all of that, and more, and was honored to join the Pediatrics Committee in 2012 to help serve the community that’s helped me so much.
During your time on the Pediatrics Committee, what goals were accomplished?
Over the years, this great committee has been very active at the direction of some fantastic leaders. We have had the privilege and responsibility to advise the SHM Board on pediatric issues and concerns, and we’ve developed some interesting pediatric-specific educational content in areas such as quality and safe handoffs. We’ve worked on the Choosing Wisely campaign and are now in the process of updating the Pediatric Hospital Medicine Core Competencies.
Each year we develop the content for the Pediatric Track of the SHM annual conference, and for several years, I was also on the Annual Conference Committee, which was a fantastic opportunity to bring the pediatric world to the broader work of SHM.
The Pediatrics Committee is transitioning from a committee to a Pediatric Special Interest Group. What can members look forward to in this transition?
I was asked to lead the subcommittee that is working on the SIG transition, and I must say, I am excited! You know, as great as the Pediatrics Committee is, it’s still only 15-20 people. And there are opportunities for pediatric hospitalists to join other SHM committees, but even at that, the footprint of active, engaged pediatric hospitalists within SHM is fairly small. The transition to a much more open-ended pediatric hospitalist SIG will allow many more hospitalists who take care of children to become involved. That’s more people, from more places, with more perspectives and ideas. It’s more energy, more collaboration, and hopefully, in the long run, a more visible and systemic pediatric presence within SHM.
Sure, there are questions and a few concerns, and I’m not sure all the details have been quite worked out, but in the big picture, I think it’s good for pediatric hospital medicine and good for SHM. Stay tuned as the process develops, but I think SHM members are going to see the new opportunity to get involved directly in SIG projects and goals, collaborate with more pediatric hospitalists, and see some real dynamic and forward-thinking leadership in the SIG executive council ... and opportunities to be on that Executive Council in a transparent, collegial way.
What were your main takeaways from Pediatric Hospital Medicine 2017? What can attendees expect at PHM 2018?
The annual Pediatric Hospital Medicine (PHM) meeting is always a bit of a whirlwind and our meeting in Nashville in 2017, hosted by SHM and our very own board member, Kris Rehm, MD, SFHM, was no different. There is always so much to experience and a diversity of offerings, which is really representative of how broad and rapidly growing our field is.
Of course, the “Top Articles in PHM” review is always popular and well received, and the poster and platform research sessions really show how far PHM has come and how much incredibly detailed and diligent work is being done to advance it further. There were some particularly thought-provoking plenary sessions last year on evidence-based health policy challenges and how some things we take as PHM dogma might not even be true! Left us all scratching our heads a bit. The final plenary on magic and pediatrics was inspiring and hilarious.
As far as PHM 2018, I suppose for full disclosure I should mention that I’m on the planning committee, so of course it’s going to be awesome! We really are putting together a fantastic experience. We had so many high-quality submissions for workshops, clinical sessions, research – truly spanning the whole range of PHM work. Whatever you’re coming to learn about, you’ll find it. We have some tremendously gifted plenary speakers lined up; some are sure to inspire, some will make you smile with pride about being a hospitalist, and at least one will almost certainly crack you up. We’ve shortened the length of many of the workshops to allow attendees to have more experiences while making sure the content is still meaningful. There will be several opportunities to mentor and be mentored in a comfortable, casual setting. I could go on and on, but if you take care of kids, come to Atlanta and see for yourself in July!
Do you have any advice for early-stage pediatric hospitalists looking to advance their careers?
This is an exciting time to be a pediatric hospitalist. Like it or hate it, subspecialty designation in PHM is around the corner, the new SHM pediatric SIG is going to open up a new era of opportunities, research in the field is gathering tremendous momentum, and fellowship training is only going to fuel that.
But PHM is still so far from becoming a single, one-size-fits-all path. There is still a huge range of practice locations, settings, responsibilities, and challenges. I tell my junior folks: “Put yourself out there. Try some things. Try a lot of things. If you have opportunities to practice in a few different settings, try it. If there are learners, teach. Join a research or quality improvement group. Go to some big meetings; talk to 50 new people. If you hear someone give a great talk that gets you fired up about something you have a passion for, stick around, go talk with them; they get it, they were you once, and probably not even that long ago. Throw your hat in a ring and help out with a project. It might turn out to not be your ‘thing,’ but it might lead you to your ‘thing.’ Or not, but you’ll come away with some experience and two new friends.”
That’s what makes this journey fun. There is no goal, no endgame. It’s all about the journey and the joy you find in the ride.
Ms. Steele is a marketing communications specialist at the Society of Hospital Medicine.
More visible, systemic pediatric presence within SHM
More visible, systemic pediatric presence within SHM
Editor’s note: Each month, the Society of Hospital Medicine puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Visit www.hospitalmedicine.org for more information on how you can lend your expertise to help improve the care of hospitalized patients.
Why did you become a member of SHM?
After being in a general pediatrics practice for a few years, I saw a lot of value in and got a lot of support from working with other outpatient pediatricians and the American Academy of Pediatrics. When I left that outpatient practice to focus on hospital pediatrics 13 years ago, I needed to find people who knew a lot more than I did about inpatient work and an organization that could support my growth and development in this new role. Of course, SHM was the answer.
I knew there was a ton I could learn from the internists who had been doing this work a lot longer and senior pediatric hospitalists who could share their experiences. I found all of that, and more, and was honored to join the Pediatrics Committee in 2012 to help serve the community that’s helped me so much.
During your time on the Pediatrics Committee, what goals were accomplished?
Over the years, this great committee has been very active at the direction of some fantastic leaders. We have had the privilege and responsibility to advise the SHM Board on pediatric issues and concerns, and we’ve developed some interesting pediatric-specific educational content in areas such as quality and safe handoffs. We’ve worked on the Choosing Wisely campaign and are now in the process of updating the Pediatric Hospital Medicine Core Competencies.
Each year we develop the content for the Pediatric Track of the SHM annual conference, and for several years, I was also on the Annual Conference Committee, which was a fantastic opportunity to bring the pediatric world to the broader work of SHM.
The Pediatrics Committee is transitioning from a committee to a Pediatric Special Interest Group. What can members look forward to in this transition?
I was asked to lead the subcommittee that is working on the SIG transition, and I must say, I am excited! You know, as great as the Pediatrics Committee is, it’s still only 15-20 people. And there are opportunities for pediatric hospitalists to join other SHM committees, but even at that, the footprint of active, engaged pediatric hospitalists within SHM is fairly small. The transition to a much more open-ended pediatric hospitalist SIG will allow many more hospitalists who take care of children to become involved. That’s more people, from more places, with more perspectives and ideas. It’s more energy, more collaboration, and hopefully, in the long run, a more visible and systemic pediatric presence within SHM.
Sure, there are questions and a few concerns, and I’m not sure all the details have been quite worked out, but in the big picture, I think it’s good for pediatric hospital medicine and good for SHM. Stay tuned as the process develops, but I think SHM members are going to see the new opportunity to get involved directly in SIG projects and goals, collaborate with more pediatric hospitalists, and see some real dynamic and forward-thinking leadership in the SIG executive council ... and opportunities to be on that Executive Council in a transparent, collegial way.
What were your main takeaways from Pediatric Hospital Medicine 2017? What can attendees expect at PHM 2018?
The annual Pediatric Hospital Medicine (PHM) meeting is always a bit of a whirlwind and our meeting in Nashville in 2017, hosted by SHM and our very own board member, Kris Rehm, MD, SFHM, was no different. There is always so much to experience and a diversity of offerings, which is really representative of how broad and rapidly growing our field is.
Of course, the “Top Articles in PHM” review is always popular and well received, and the poster and platform research sessions really show how far PHM has come and how much incredibly detailed and diligent work is being done to advance it further. There were some particularly thought-provoking plenary sessions last year on evidence-based health policy challenges and how some things we take as PHM dogma might not even be true! Left us all scratching our heads a bit. The final plenary on magic and pediatrics was inspiring and hilarious.
As far as PHM 2018, I suppose for full disclosure I should mention that I’m on the planning committee, so of course it’s going to be awesome! We really are putting together a fantastic experience. We had so many high-quality submissions for workshops, clinical sessions, research – truly spanning the whole range of PHM work. Whatever you’re coming to learn about, you’ll find it. We have some tremendously gifted plenary speakers lined up; some are sure to inspire, some will make you smile with pride about being a hospitalist, and at least one will almost certainly crack you up. We’ve shortened the length of many of the workshops to allow attendees to have more experiences while making sure the content is still meaningful. There will be several opportunities to mentor and be mentored in a comfortable, casual setting. I could go on and on, but if you take care of kids, come to Atlanta and see for yourself in July!
Do you have any advice for early-stage pediatric hospitalists looking to advance their careers?
This is an exciting time to be a pediatric hospitalist. Like it or hate it, subspecialty designation in PHM is around the corner, the new SHM pediatric SIG is going to open up a new era of opportunities, research in the field is gathering tremendous momentum, and fellowship training is only going to fuel that.
But PHM is still so far from becoming a single, one-size-fits-all path. There is still a huge range of practice locations, settings, responsibilities, and challenges. I tell my junior folks: “Put yourself out there. Try some things. Try a lot of things. If you have opportunities to practice in a few different settings, try it. If there are learners, teach. Join a research or quality improvement group. Go to some big meetings; talk to 50 new people. If you hear someone give a great talk that gets you fired up about something you have a passion for, stick around, go talk with them; they get it, they were you once, and probably not even that long ago. Throw your hat in a ring and help out with a project. It might turn out to not be your ‘thing,’ but it might lead you to your ‘thing.’ Or not, but you’ll come away with some experience and two new friends.”
That’s what makes this journey fun. There is no goal, no endgame. It’s all about the journey and the joy you find in the ride.
Ms. Steele is a marketing communications specialist at the Society of Hospital Medicine.
Editor’s note: Each month, the Society of Hospital Medicine puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Visit www.hospitalmedicine.org for more information on how you can lend your expertise to help improve the care of hospitalized patients.
Why did you become a member of SHM?
After being in a general pediatrics practice for a few years, I saw a lot of value in and got a lot of support from working with other outpatient pediatricians and the American Academy of Pediatrics. When I left that outpatient practice to focus on hospital pediatrics 13 years ago, I needed to find people who knew a lot more than I did about inpatient work and an organization that could support my growth and development in this new role. Of course, SHM was the answer.
I knew there was a ton I could learn from the internists who had been doing this work a lot longer and senior pediatric hospitalists who could share their experiences. I found all of that, and more, and was honored to join the Pediatrics Committee in 2012 to help serve the community that’s helped me so much.
During your time on the Pediatrics Committee, what goals were accomplished?
Over the years, this great committee has been very active at the direction of some fantastic leaders. We have had the privilege and responsibility to advise the SHM Board on pediatric issues and concerns, and we’ve developed some interesting pediatric-specific educational content in areas such as quality and safe handoffs. We’ve worked on the Choosing Wisely campaign and are now in the process of updating the Pediatric Hospital Medicine Core Competencies.
Each year we develop the content for the Pediatric Track of the SHM annual conference, and for several years, I was also on the Annual Conference Committee, which was a fantastic opportunity to bring the pediatric world to the broader work of SHM.
The Pediatrics Committee is transitioning from a committee to a Pediatric Special Interest Group. What can members look forward to in this transition?
I was asked to lead the subcommittee that is working on the SIG transition, and I must say, I am excited! You know, as great as the Pediatrics Committee is, it’s still only 15-20 people. And there are opportunities for pediatric hospitalists to join other SHM committees, but even at that, the footprint of active, engaged pediatric hospitalists within SHM is fairly small. The transition to a much more open-ended pediatric hospitalist SIG will allow many more hospitalists who take care of children to become involved. That’s more people, from more places, with more perspectives and ideas. It’s more energy, more collaboration, and hopefully, in the long run, a more visible and systemic pediatric presence within SHM.
Sure, there are questions and a few concerns, and I’m not sure all the details have been quite worked out, but in the big picture, I think it’s good for pediatric hospital medicine and good for SHM. Stay tuned as the process develops, but I think SHM members are going to see the new opportunity to get involved directly in SIG projects and goals, collaborate with more pediatric hospitalists, and see some real dynamic and forward-thinking leadership in the SIG executive council ... and opportunities to be on that Executive Council in a transparent, collegial way.
What were your main takeaways from Pediatric Hospital Medicine 2017? What can attendees expect at PHM 2018?
The annual Pediatric Hospital Medicine (PHM) meeting is always a bit of a whirlwind and our meeting in Nashville in 2017, hosted by SHM and our very own board member, Kris Rehm, MD, SFHM, was no different. There is always so much to experience and a diversity of offerings, which is really representative of how broad and rapidly growing our field is.
Of course, the “Top Articles in PHM” review is always popular and well received, and the poster and platform research sessions really show how far PHM has come and how much incredibly detailed and diligent work is being done to advance it further. There were some particularly thought-provoking plenary sessions last year on evidence-based health policy challenges and how some things we take as PHM dogma might not even be true! Left us all scratching our heads a bit. The final plenary on magic and pediatrics was inspiring and hilarious.
As far as PHM 2018, I suppose for full disclosure I should mention that I’m on the planning committee, so of course it’s going to be awesome! We really are putting together a fantastic experience. We had so many high-quality submissions for workshops, clinical sessions, research – truly spanning the whole range of PHM work. Whatever you’re coming to learn about, you’ll find it. We have some tremendously gifted plenary speakers lined up; some are sure to inspire, some will make you smile with pride about being a hospitalist, and at least one will almost certainly crack you up. We’ve shortened the length of many of the workshops to allow attendees to have more experiences while making sure the content is still meaningful. There will be several opportunities to mentor and be mentored in a comfortable, casual setting. I could go on and on, but if you take care of kids, come to Atlanta and see for yourself in July!
Do you have any advice for early-stage pediatric hospitalists looking to advance their careers?
This is an exciting time to be a pediatric hospitalist. Like it or hate it, subspecialty designation in PHM is around the corner, the new SHM pediatric SIG is going to open up a new era of opportunities, research in the field is gathering tremendous momentum, and fellowship training is only going to fuel that.
But PHM is still so far from becoming a single, one-size-fits-all path. There is still a huge range of practice locations, settings, responsibilities, and challenges. I tell my junior folks: “Put yourself out there. Try some things. Try a lot of things. If you have opportunities to practice in a few different settings, try it. If there are learners, teach. Join a research or quality improvement group. Go to some big meetings; talk to 50 new people. If you hear someone give a great talk that gets you fired up about something you have a passion for, stick around, go talk with them; they get it, they were you once, and probably not even that long ago. Throw your hat in a ring and help out with a project. It might turn out to not be your ‘thing,’ but it might lead you to your ‘thing.’ Or not, but you’ll come away with some experience and two new friends.”
That’s what makes this journey fun. There is no goal, no endgame. It’s all about the journey and the joy you find in the ride.
Ms. Steele is a marketing communications specialist at the Society of Hospital Medicine.
Combo treatment under review for Waldenstrom macroglobulinemia
by the Food and Drug Administration.
Ibrutinib, a Bruton’s tyrosine kinase inhibitor, is already approved as a single agent for WM. The addition of rituximab to the indication is based on positive results from the phase 3 INNOVATE study. In particular, the trial showed a superior progression-free survival rate at 30 months for the ibrutinib-rituximab combination at 82%, compared with placebo plus rituximab at 28% (N Engl J Med. 2018;378:2399-410).
The study’s lead investigator, Meletios A. Dimopoulos, MD, called the combination a “new standard of care” for WM at the recent annual meeting of the American Society of Clinical Oncology.
Ibrutinib, marketed as Imbruvica, is jointly developed and commercialized by Pharmacyclics and Janssen Biotech.
by the Food and Drug Administration.
Ibrutinib, a Bruton’s tyrosine kinase inhibitor, is already approved as a single agent for WM. The addition of rituximab to the indication is based on positive results from the phase 3 INNOVATE study. In particular, the trial showed a superior progression-free survival rate at 30 months for the ibrutinib-rituximab combination at 82%, compared with placebo plus rituximab at 28% (N Engl J Med. 2018;378:2399-410).
The study’s lead investigator, Meletios A. Dimopoulos, MD, called the combination a “new standard of care” for WM at the recent annual meeting of the American Society of Clinical Oncology.
Ibrutinib, marketed as Imbruvica, is jointly developed and commercialized by Pharmacyclics and Janssen Biotech.
by the Food and Drug Administration.
Ibrutinib, a Bruton’s tyrosine kinase inhibitor, is already approved as a single agent for WM. The addition of rituximab to the indication is based on positive results from the phase 3 INNOVATE study. In particular, the trial showed a superior progression-free survival rate at 30 months for the ibrutinib-rituximab combination at 82%, compared with placebo plus rituximab at 28% (N Engl J Med. 2018;378:2399-410).
The study’s lead investigator, Meletios A. Dimopoulos, MD, called the combination a “new standard of care” for WM at the recent annual meeting of the American Society of Clinical Oncology.
Ibrutinib, marketed as Imbruvica, is jointly developed and commercialized by Pharmacyclics and Janssen Biotech.





