SOX11 may be an accurate diagnostic marker for mantle cell lymphoma (MCL), allowing clinicians to distinguish it from other lymphoproliferative disorders, according to findings from a meta-analysis of 14 case-control studies.

Gio_tto/Thinkstock

Woojoo Lee, PhD, of Inha University, Incheon, Republic of Korea, and coinvestigators, evaluated the diagnostic accuracy of SOX11 immunohistochemistry for the diagnosis of MCL. The results were published in PLoS One.

The researchers searched major databases for studies that evaluated the use of SOX11 immunohistochemistry in patients with MCL and other lymphoproliferative disorders. After applying the search parameters, the team identified 383 studies, 14 of which were included in the meta-analysis. Various data were extracted from eligible studies, including the type and clonality of anti-SOX11 antibody, number of SOX11-positive lymphomas (MCLs and other lymphoproliferative disorders), specificity, sensitivity, and others. After combining the data, the investigators calculated pooled sensitivity, specificity, and area under the curve. Among the included studies, hairy cell leukemia, Burkitt’s lymphoma, and lymphoblastic lymphoma were common among patient populations. In total, clone MRQ-58 mouse antibodies were used in five study populations.

The researchers found that the pooled specificity was 0.95 (95% CI, 0.9-0.97), and sensitivity was 0.9 (95% CI, 0.86-0.92). There was statistically significant substantial heterogeneity observed for specificity, but not for sensitivity, the investigators reported.

“The results demonstrated that SOX11 was a potential diagnostic marker for MCL,” they wrote. “Meta-regression revealed a significant inverse relationship between specificity and proportions of [Burkitt’s lymphoma, lymphoblastic lymphoma, and hairy cell leukemia].”

With respect to antibody type, the clone MRQ-58 mouse antibody showed consistently high specificity in the clinical setting, despite observed heterogeneity.

“Future studies using MRQ-58 are needed to improve our understanding of the diagnostic accuracy of SOX11 immunohistochemistry for MCL,” the investigators wrote.

The study was funded by the Next-Generation BioGreen 21 program (Republic of Korea). The authors reported having no conflicts of interest.

SOURCE: Lee W et al. PLoS One. 2019 Nov 12. doi: 10.1371/journal.pone.0225096.

SOX11 may be an accurate diagnostic marker for mantle cell lymphoma (MCL), allowing clinicians to distinguish it from other lymphoproliferative disorders, according to findings from a meta-analysis of 14 case-control studies.

Gio_tto/Thinkstock

Woojoo Lee, PhD, of Inha University, Incheon, Republic of Korea, and coinvestigators, evaluated the diagnostic accuracy of SOX11 immunohistochemistry for the diagnosis of MCL. The results were published in PLoS One.

The researchers searched major databases for studies that evaluated the use of SOX11 immunohistochemistry in patients with MCL and other lymphoproliferative disorders. After applying the search parameters, the team identified 383 studies, 14 of which were included in the meta-analysis. Various data were extracted from eligible studies, including the type and clonality of anti-SOX11 antibody, number of SOX11-positive lymphomas (MCLs and other lymphoproliferative disorders), specificity, sensitivity, and others. After combining the data, the investigators calculated pooled sensitivity, specificity, and area under the curve. Among the included studies, hairy cell leukemia, Burkitt’s lymphoma, and lymphoblastic lymphoma were common among patient populations. In total, clone MRQ-58 mouse antibodies were used in five study populations.

The researchers found that the pooled specificity was 0.95 (95% CI, 0.9-0.97), and sensitivity was 0.9 (95% CI, 0.86-0.92). There was statistically significant substantial heterogeneity observed for specificity, but not for sensitivity, the investigators reported.

“The results demonstrated that SOX11 was a potential diagnostic marker for MCL,” they wrote. “Meta-regression revealed a significant inverse relationship between specificity and proportions of [Burkitt’s lymphoma, lymphoblastic lymphoma, and hairy cell leukemia].”

With respect to antibody type, the clone MRQ-58 mouse antibody showed consistently high specificity in the clinical setting, despite observed heterogeneity.

“Future studies using MRQ-58 are needed to improve our understanding of the diagnostic accuracy of SOX11 immunohistochemistry for MCL,” the investigators wrote.

The study was funded by the Next-Generation BioGreen 21 program (Republic of Korea). The authors reported having no conflicts of interest.

SOURCE: Lee W et al. PLoS One. 2019 Nov 12. doi: 10.1371/journal.pone.0225096.

SOX11 may be an accurate diagnostic marker for mantle cell lymphoma (MCL), allowing clinicians to distinguish it from other lymphoproliferative disorders, according to findings from a meta-analysis of 14 case-control studies.

Gio_tto/Thinkstock

Woojoo Lee, PhD, of Inha University, Incheon, Republic of Korea, and coinvestigators, evaluated the diagnostic accuracy of SOX11 immunohistochemistry for the diagnosis of MCL. The results were published in PLoS One.

The researchers searched major databases for studies that evaluated the use of SOX11 immunohistochemistry in patients with MCL and other lymphoproliferative disorders. After applying the search parameters, the team identified 383 studies, 14 of which were included in the meta-analysis. Various data were extracted from eligible studies, including the type and clonality of anti-SOX11 antibody, number of SOX11-positive lymphomas (MCLs and other lymphoproliferative disorders), specificity, sensitivity, and others. After combining the data, the investigators calculated pooled sensitivity, specificity, and area under the curve. Among the included studies, hairy cell leukemia, Burkitt’s lymphoma, and lymphoblastic lymphoma were common among patient populations. In total, clone MRQ-58 mouse antibodies were used in five study populations.

The researchers found that the pooled specificity was 0.95 (95% CI, 0.9-0.97), and sensitivity was 0.9 (95% CI, 0.86-0.92). There was statistically significant substantial heterogeneity observed for specificity, but not for sensitivity, the investigators reported.

“The results demonstrated that SOX11 was a potential diagnostic marker for MCL,” they wrote. “Meta-regression revealed a significant inverse relationship between specificity and proportions of [Burkitt’s lymphoma, lymphoblastic lymphoma, and hairy cell leukemia].”

With respect to antibody type, the clone MRQ-58 mouse antibody showed consistently high specificity in the clinical setting, despite observed heterogeneity.

“Future studies using MRQ-58 are needed to improve our understanding of the diagnostic accuracy of SOX11 immunohistochemistry for MCL,” the investigators wrote.

The study was funded by the Next-Generation BioGreen 21 program (Republic of Korea). The authors reported having no conflicts of interest.

SOURCE: Lee W et al. PLoS One. 2019 Nov 12. doi: 10.1371/journal.pone.0225096.

For patients with relapsed or refractory mantle cell lymphoma (MCL), second generation Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib may offer increased response rates and better tolerability compared with other single-agent targeted therapies, based on a recent analysis.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

Improved safety could lead to long-term benefits resulting from extended treatment duration, according to lead author Claire Telford, PhD, of AstraZeneca in Gaithersburg, Md., and colleagues. AstraZeneca manufactures acalabrutinib (Calquence).

Currently, treatment for MCL is guided by a number of clinical considerations, the investigators explained in Clinical Therapeutics.

“The type of treatment recommended for relapsed/refractory MCL depends on multiple factors, namely time to the relapse, extent of disease, previous regimens, candidacy for allogeneic stem cell transplantation, and the patient’s overall health,” they wrote.

To determine how acalabrutinib stacks up with other options, the investigators drew data from the phase 2 ACE-LY-004 trial, which tested acalabrutinib in 124 patients with relapsed or refractory MCL. After matching, the investigators compared the ACE-LY-004 outcomes from 12 other trials, in which patients received different targeted therapies.

Results pointed to higher overall response and complete response rates for acalabrutinib, compared with other single-agent targeted therapy. Specifically, acalabrutinib had a higher overall response rate, compared with ibrutinib (9.3% higher), lenalidomide (38.1% higher), temsirolimus (40.7% higher), and bortezomib (50.6% higher). For each of these, complete responses also were higher.

There was no significant difference in overall response or complete response rates between acalabrutinib and rituximab combinations – bendamustine plus rituximab, ibrutinib plus rituximab, and lenalidomide plus rituximab.

The investigators also highlighted a number of safety advantages. Compared with ibrutinib, acalabrutinib was associated with significantly fewer instances of grade 3 or 4 atrial fibrillation. Risk of grade 3 or 4 thrombocytopenia was significantly lower with acalabrutinib than with ibrutinib, bortezomib, lenalidomide, and temsirolimus.

Still, in some instances, acalabrutinib was comparatively less tolerable. It was associated with a higher risk of grade 3 or 4 infections than bendamustine plus rituximab; and anemia was more common among patients receiving acalabrutinib than among those who had lenalidomide plus rituximab or ibrutinib plus rituximab.

“This comparison of targeted therapies used in the treatment of relapsed/refractory MCL has shown that acalabrutinib has the potential to provide higher response rates, with trends for longer [progression-free survival] and [overall survival], and an improved safety profile,” the investigators wrote.

The study was funded by AstraZeneca. Dr. Telford is an employee of AstraZeneca and other authors reported financial relationships with the company.

SOURCE: Telford C et al. Clin Ther. 2019 Nov 4. doi: 10.1016/j.clinthera.2019.09.012 .

For patients with relapsed or refractory mantle cell lymphoma (MCL), second generation Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib may offer increased response rates and better tolerability compared with other single-agent targeted therapies, based on a recent analysis.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

Improved safety could lead to long-term benefits resulting from extended treatment duration, according to lead author Claire Telford, PhD, of AstraZeneca in Gaithersburg, Md., and colleagues. AstraZeneca manufactures acalabrutinib (Calquence).

Currently, treatment for MCL is guided by a number of clinical considerations, the investigators explained in Clinical Therapeutics.

“The type of treatment recommended for relapsed/refractory MCL depends on multiple factors, namely time to the relapse, extent of disease, previous regimens, candidacy for allogeneic stem cell transplantation, and the patient’s overall health,” they wrote.

To determine how acalabrutinib stacks up with other options, the investigators drew data from the phase 2 ACE-LY-004 trial, which tested acalabrutinib in 124 patients with relapsed or refractory MCL. After matching, the investigators compared the ACE-LY-004 outcomes from 12 other trials, in which patients received different targeted therapies.

Results pointed to higher overall response and complete response rates for acalabrutinib, compared with other single-agent targeted therapy. Specifically, acalabrutinib had a higher overall response rate, compared with ibrutinib (9.3% higher), lenalidomide (38.1% higher), temsirolimus (40.7% higher), and bortezomib (50.6% higher). For each of these, complete responses also were higher.

There was no significant difference in overall response or complete response rates between acalabrutinib and rituximab combinations – bendamustine plus rituximab, ibrutinib plus rituximab, and lenalidomide plus rituximab.

The investigators also highlighted a number of safety advantages. Compared with ibrutinib, acalabrutinib was associated with significantly fewer instances of grade 3 or 4 atrial fibrillation. Risk of grade 3 or 4 thrombocytopenia was significantly lower with acalabrutinib than with ibrutinib, bortezomib, lenalidomide, and temsirolimus.

Still, in some instances, acalabrutinib was comparatively less tolerable. It was associated with a higher risk of grade 3 or 4 infections than bendamustine plus rituximab; and anemia was more common among patients receiving acalabrutinib than among those who had lenalidomide plus rituximab or ibrutinib plus rituximab.

“This comparison of targeted therapies used in the treatment of relapsed/refractory MCL has shown that acalabrutinib has the potential to provide higher response rates, with trends for longer [progression-free survival] and [overall survival], and an improved safety profile,” the investigators wrote.

The study was funded by AstraZeneca. Dr. Telford is an employee of AstraZeneca and other authors reported financial relationships with the company.

SOURCE: Telford C et al. Clin Ther. 2019 Nov 4. doi: 10.1016/j.clinthera.2019.09.012 .

For patients with relapsed or refractory mantle cell lymphoma (MCL), second generation Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib may offer increased response rates and better tolerability compared with other single-agent targeted therapies, based on a recent analysis.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

Improved safety could lead to long-term benefits resulting from extended treatment duration, according to lead author Claire Telford, PhD, of AstraZeneca in Gaithersburg, Md., and colleagues. AstraZeneca manufactures acalabrutinib (Calquence).

Currently, treatment for MCL is guided by a number of clinical considerations, the investigators explained in Clinical Therapeutics.

“The type of treatment recommended for relapsed/refractory MCL depends on multiple factors, namely time to the relapse, extent of disease, previous regimens, candidacy for allogeneic stem cell transplantation, and the patient’s overall health,” they wrote.

To determine how acalabrutinib stacks up with other options, the investigators drew data from the phase 2 ACE-LY-004 trial, which tested acalabrutinib in 124 patients with relapsed or refractory MCL. After matching, the investigators compared the ACE-LY-004 outcomes from 12 other trials, in which patients received different targeted therapies.

Results pointed to higher overall response and complete response rates for acalabrutinib, compared with other single-agent targeted therapy. Specifically, acalabrutinib had a higher overall response rate, compared with ibrutinib (9.3% higher), lenalidomide (38.1% higher), temsirolimus (40.7% higher), and bortezomib (50.6% higher). For each of these, complete responses also were higher.

There was no significant difference in overall response or complete response rates between acalabrutinib and rituximab combinations – bendamustine plus rituximab, ibrutinib plus rituximab, and lenalidomide plus rituximab.

The investigators also highlighted a number of safety advantages. Compared with ibrutinib, acalabrutinib was associated with significantly fewer instances of grade 3 or 4 atrial fibrillation. Risk of grade 3 or 4 thrombocytopenia was significantly lower with acalabrutinib than with ibrutinib, bortezomib, lenalidomide, and temsirolimus.

Still, in some instances, acalabrutinib was comparatively less tolerable. It was associated with a higher risk of grade 3 or 4 infections than bendamustine plus rituximab; and anemia was more common among patients receiving acalabrutinib than among those who had lenalidomide plus rituximab or ibrutinib plus rituximab.

“This comparison of targeted therapies used in the treatment of relapsed/refractory MCL has shown that acalabrutinib has the potential to provide higher response rates, with trends for longer [progression-free survival] and [overall survival], and an improved safety profile,” the investigators wrote.

The study was funded by AstraZeneca. Dr. Telford is an employee of AstraZeneca and other authors reported financial relationships with the company.

SOURCE: Telford C et al. Clin Ther. 2019 Nov 4. doi: 10.1016/j.clinthera.2019.09.012 .

The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with paclitaxel and carboplatin chemotherapy for first-line treatment of adults with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

Atezolizumab has been previously approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations. The monoclonal antibody is also approved to treat adults with metastatic NSCLC who have disease progression during or following chemotherapy, and for those with extensive-stage SCLC.

The current approval was based on a demonstrated improvement in overall survival in the phase 3 IMpower130 trial (NCT02367781). Median overall survival for advanced NSCLC patients who received atezolizumab in combination with chemotherapy was 18.6 months, compared with 13.9 months for patients who received chemotherapy alone (hazard ratio, 0.80; 95% confidence interval, 0.64-0.99; P = .0384) in the intention-to-treat wild-type population of 681 patients.

Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving atezolizumab plus chemotherapy, compared with 60.3% of people receiving chemotherapy alone, according to the company press release.

lnikolaides@mdedge.com

The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with paclitaxel and carboplatin chemotherapy for first-line treatment of adults with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

Atezolizumab has been previously approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations. The monoclonal antibody is also approved to treat adults with metastatic NSCLC who have disease progression during or following chemotherapy, and for those with extensive-stage SCLC.

The current approval was based on a demonstrated improvement in overall survival in the phase 3 IMpower130 trial (NCT02367781). Median overall survival for advanced NSCLC patients who received atezolizumab in combination with chemotherapy was 18.6 months, compared with 13.9 months for patients who received chemotherapy alone (hazard ratio, 0.80; 95% confidence interval, 0.64-0.99; P = .0384) in the intention-to-treat wild-type population of 681 patients.

Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving atezolizumab plus chemotherapy, compared with 60.3% of people receiving chemotherapy alone, according to the company press release.

lnikolaides@mdedge.com

The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with paclitaxel and carboplatin chemotherapy for first-line treatment of adults with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

Atezolizumab has been previously approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations. The monoclonal antibody is also approved to treat adults with metastatic NSCLC who have disease progression during or following chemotherapy, and for those with extensive-stage SCLC.

The current approval was based on a demonstrated improvement in overall survival in the phase 3 IMpower130 trial (NCT02367781). Median overall survival for advanced NSCLC patients who received atezolizumab in combination with chemotherapy was 18.6 months, compared with 13.9 months for patients who received chemotherapy alone (hazard ratio, 0.80; 95% confidence interval, 0.64-0.99; P = .0384) in the intention-to-treat wild-type population of 681 patients.

Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving atezolizumab plus chemotherapy, compared with 60.3% of people receiving chemotherapy alone, according to the company press release.

lnikolaides@mdedge.com

The ideas and opinions expressed in Best of 2019 – The RA Report: Top News Highlights do not necessarily reflect those of the publisher. Frontline Medical Communications will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.

The ideas and opinions expressed in Best of 2019 – The RA Report: Top News Highlights do not necessarily reflect those of the publisher. Frontline Medical Communications will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.

The ideas and opinions expressed in Best of 2019 – The RA Report: Top News Highlights do not necessarily reflect those of the publisher. Frontline Medical Communications will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.

CHICAGO – Individuals who sustain gunshot wounds have an increased risk for rehospitalization years, and even decades, after their initial injury.

Kateywhat/ThinkStock

A study of individuals at a single institution who were hospitalized and had a prior history of gunshot wound found some patterns of injury that set patients up for a greater likelihood of readmission.

In particular, patients who sustained visceral gunshot wounds were over six times more likely to be readmitted to the hospital, Corbin Pomeranz, MD, a radiology resident at Thomas Jefferson University, Philadelphia, said in an interview at the annual meeting of the Radiological Society of North America. Dr. Pomeranz led the retrospective study that begins to fill a knowledge gap about what happens over the long term to those who sustain gunshot wounds.

“There continues to be profound lack of substantial information related to gun violence, particularly in predicting long-term outcomes,” Dr. Pomeranz and coauthors wrote in the abstract accompanying the presentation.

The researchers performed a single-site retrospective analysis over 3 months in 2018, tapping into an imaging database and looking for inpatient imaging exams that were nonacute, but related to gunshot wounds. From this information, the researchers went back to the original gunshot wound injury imaging, and recorded the pattern of injury, classifying wounds as neurologic, vascular, visceral, musculoskeletal, or involving multiple systems.

The investigators were able to glean additional information including the initial admitting hospital unit, information about interval admissions or surgeries, and demographic data. Regarding the nature of the gunshot injury itself, Dr. Pomeranz and coauthors went back to the earlier imaging studies to note bullet morphology, recording whether the bullet was intact, deformed, or had splintered into shrapnel within injured tissues.

In all, 174 imaging studies involving 110 patients were examined. Men made up 92% of the study population; the average age was 49.7 years. Neurologic and visceral gunshot wounds were moderately correlated with subsequent readmission (r = .436; P less than .001). However, some of this effect was blunted when patient age was controlled for in the statistical analysis.

Patients who were initially admitted to the intensive care unit, and who presumably had more severe injuries, were also more likely to be readmitted (r = .494, P less than .001). Here, “controlling for age had very little effect on the strength of the relationship between these two variables,” noted Dr. Pomeranz and coauthors.

A more elaborate statistical model incorporated several independent variables including age, type of injury, and body region involved, as well as bullet morphology. In this model, visceral injury was the strongest predictor for readmission, with an odds ratio of 6.44.

Dr. Pomeranz said that both the initial gunshot wound and subsequent gaps in care can contribute to readmissions. A patient who has a spinal cord injury may not be reimbursed adequately for supportive cushioning, or an appropriate wheelchair, and so may require admission for decubitus ulcers.

The number of admissions for osteomyelitis, which made up more than half of the subsequent admissions, initially surprised Dr. Pomeranz, until he realized that lack of mobility and sensory losses from gunshot-induced spinal cord injuries could easily lead to nonhealing lower extremity wounds, with osteomyelitis as a sequela.

Several patients were admitted for small bowel obstructions with no interval surgery since treatment for the gunshot wound. These readmissions, said Dr. Pomeranz, were assessed as related to the gunshot wound since it’s extremely rare for a patient with no history of abdominal surgery and no malignancy to have a small bowel obstruction. Exploratory laparotomies are common in the context of abdominal trauma caused by gunshot wounds, and either the gunshot itself or the laparotomy was the likely cause of adhesions.

Dr. Pomeranz acknowledged the many limitations of the study, but pointed out that some will be addressed when he and his coauthors conduct a larger study they have planned to look at readmissions from gunshot wounds at multiple hospitals in the Philadelphia area. The small sample size in the current study meant that the impact of socioeconomic status and other lifestyle and social variables and comorbidities couldn’t be adequately addressed in the statistical analysis. By casting a wider net within the greater Philadelphia area, the investigators should be able to track patients who receive care in more than one hospital system, increasing participant numbers, he said.

“Morbidity and outcomes from gun violence can only be assessed after a firm understanding of injury patterns on imaging,” noted Dr. Pomeranz. He said that interdisciplinary research investigating individual and societal short- and long-term costs of gun violence is sorely needed to inform public policy.

Dr. Pomeranz reported no outside sources of funding and reported that he had no conflicts of interest.

koakes@mdedge.com

SOURCE: Pomeranz C et al. RSNA 2019, Presentation HP226-SD-THA3.

CHICAGO – Individuals who sustain gunshot wounds have an increased risk for rehospitalization years, and even decades, after their initial injury.

Kateywhat/ThinkStock

A study of individuals at a single institution who were hospitalized and had a prior history of gunshot wound found some patterns of injury that set patients up for a greater likelihood of readmission.

In particular, patients who sustained visceral gunshot wounds were over six times more likely to be readmitted to the hospital, Corbin Pomeranz, MD, a radiology resident at Thomas Jefferson University, Philadelphia, said in an interview at the annual meeting of the Radiological Society of North America. Dr. Pomeranz led the retrospective study that begins to fill a knowledge gap about what happens over the long term to those who sustain gunshot wounds.

“There continues to be profound lack of substantial information related to gun violence, particularly in predicting long-term outcomes,” Dr. Pomeranz and coauthors wrote in the abstract accompanying the presentation.

The researchers performed a single-site retrospective analysis over 3 months in 2018, tapping into an imaging database and looking for inpatient imaging exams that were nonacute, but related to gunshot wounds. From this information, the researchers went back to the original gunshot wound injury imaging, and recorded the pattern of injury, classifying wounds as neurologic, vascular, visceral, musculoskeletal, or involving multiple systems.

The investigators were able to glean additional information including the initial admitting hospital unit, information about interval admissions or surgeries, and demographic data. Regarding the nature of the gunshot injury itself, Dr. Pomeranz and coauthors went back to the earlier imaging studies to note bullet morphology, recording whether the bullet was intact, deformed, or had splintered into shrapnel within injured tissues.

In all, 174 imaging studies involving 110 patients were examined. Men made up 92% of the study population; the average age was 49.7 years. Neurologic and visceral gunshot wounds were moderately correlated with subsequent readmission (r = .436; P less than .001). However, some of this effect was blunted when patient age was controlled for in the statistical analysis.

Patients who were initially admitted to the intensive care unit, and who presumably had more severe injuries, were also more likely to be readmitted (r = .494, P less than .001). Here, “controlling for age had very little effect on the strength of the relationship between these two variables,” noted Dr. Pomeranz and coauthors.

A more elaborate statistical model incorporated several independent variables including age, type of injury, and body region involved, as well as bullet morphology. In this model, visceral injury was the strongest predictor for readmission, with an odds ratio of 6.44.

Dr. Pomeranz said that both the initial gunshot wound and subsequent gaps in care can contribute to readmissions. A patient who has a spinal cord injury may not be reimbursed adequately for supportive cushioning, or an appropriate wheelchair, and so may require admission for decubitus ulcers.

The number of admissions for osteomyelitis, which made up more than half of the subsequent admissions, initially surprised Dr. Pomeranz, until he realized that lack of mobility and sensory losses from gunshot-induced spinal cord injuries could easily lead to nonhealing lower extremity wounds, with osteomyelitis as a sequela.

Several patients were admitted for small bowel obstructions with no interval surgery since treatment for the gunshot wound. These readmissions, said Dr. Pomeranz, were assessed as related to the gunshot wound since it’s extremely rare for a patient with no history of abdominal surgery and no malignancy to have a small bowel obstruction. Exploratory laparotomies are common in the context of abdominal trauma caused by gunshot wounds, and either the gunshot itself or the laparotomy was the likely cause of adhesions.

Dr. Pomeranz acknowledged the many limitations of the study, but pointed out that some will be addressed when he and his coauthors conduct a larger study they have planned to look at readmissions from gunshot wounds at multiple hospitals in the Philadelphia area. The small sample size in the current study meant that the impact of socioeconomic status and other lifestyle and social variables and comorbidities couldn’t be adequately addressed in the statistical analysis. By casting a wider net within the greater Philadelphia area, the investigators should be able to track patients who receive care in more than one hospital system, increasing participant numbers, he said.

“Morbidity and outcomes from gun violence can only be assessed after a firm understanding of injury patterns on imaging,” noted Dr. Pomeranz. He said that interdisciplinary research investigating individual and societal short- and long-term costs of gun violence is sorely needed to inform public policy.

Dr. Pomeranz reported no outside sources of funding and reported that he had no conflicts of interest.

koakes@mdedge.com

SOURCE: Pomeranz C et al. RSNA 2019, Presentation HP226-SD-THA3.

CHICAGO – Individuals who sustain gunshot wounds have an increased risk for rehospitalization years, and even decades, after their initial injury.

Kateywhat/ThinkStock

A study of individuals at a single institution who were hospitalized and had a prior history of gunshot wound found some patterns of injury that set patients up for a greater likelihood of readmission.

In particular, patients who sustained visceral gunshot wounds were over six times more likely to be readmitted to the hospital, Corbin Pomeranz, MD, a radiology resident at Thomas Jefferson University, Philadelphia, said in an interview at the annual meeting of the Radiological Society of North America. Dr. Pomeranz led the retrospective study that begins to fill a knowledge gap about what happens over the long term to those who sustain gunshot wounds.

“There continues to be profound lack of substantial information related to gun violence, particularly in predicting long-term outcomes,” Dr. Pomeranz and coauthors wrote in the abstract accompanying the presentation.

The researchers performed a single-site retrospective analysis over 3 months in 2018, tapping into an imaging database and looking for inpatient imaging exams that were nonacute, but related to gunshot wounds. From this information, the researchers went back to the original gunshot wound injury imaging, and recorded the pattern of injury, classifying wounds as neurologic, vascular, visceral, musculoskeletal, or involving multiple systems.

The investigators were able to glean additional information including the initial admitting hospital unit, information about interval admissions or surgeries, and demographic data. Regarding the nature of the gunshot injury itself, Dr. Pomeranz and coauthors went back to the earlier imaging studies to note bullet morphology, recording whether the bullet was intact, deformed, or had splintered into shrapnel within injured tissues.

In all, 174 imaging studies involving 110 patients were examined. Men made up 92% of the study population; the average age was 49.7 years. Neurologic and visceral gunshot wounds were moderately correlated with subsequent readmission (r = .436; P less than .001). However, some of this effect was blunted when patient age was controlled for in the statistical analysis.

Patients who were initially admitted to the intensive care unit, and who presumably had more severe injuries, were also more likely to be readmitted (r = .494, P less than .001). Here, “controlling for age had very little effect on the strength of the relationship between these two variables,” noted Dr. Pomeranz and coauthors.

A more elaborate statistical model incorporated several independent variables including age, type of injury, and body region involved, as well as bullet morphology. In this model, visceral injury was the strongest predictor for readmission, with an odds ratio of 6.44.

Dr. Pomeranz said that both the initial gunshot wound and subsequent gaps in care can contribute to readmissions. A patient who has a spinal cord injury may not be reimbursed adequately for supportive cushioning, or an appropriate wheelchair, and so may require admission for decubitus ulcers.

The number of admissions for osteomyelitis, which made up more than half of the subsequent admissions, initially surprised Dr. Pomeranz, until he realized that lack of mobility and sensory losses from gunshot-induced spinal cord injuries could easily lead to nonhealing lower extremity wounds, with osteomyelitis as a sequela.

Several patients were admitted for small bowel obstructions with no interval surgery since treatment for the gunshot wound. These readmissions, said Dr. Pomeranz, were assessed as related to the gunshot wound since it’s extremely rare for a patient with no history of abdominal surgery and no malignancy to have a small bowel obstruction. Exploratory laparotomies are common in the context of abdominal trauma caused by gunshot wounds, and either the gunshot itself or the laparotomy was the likely cause of adhesions.

Dr. Pomeranz acknowledged the many limitations of the study, but pointed out that some will be addressed when he and his coauthors conduct a larger study they have planned to look at readmissions from gunshot wounds at multiple hospitals in the Philadelphia area. The small sample size in the current study meant that the impact of socioeconomic status and other lifestyle and social variables and comorbidities couldn’t be adequately addressed in the statistical analysis. By casting a wider net within the greater Philadelphia area, the investigators should be able to track patients who receive care in more than one hospital system, increasing participant numbers, he said.

“Morbidity and outcomes from gun violence can only be assessed after a firm understanding of injury patterns on imaging,” noted Dr. Pomeranz. He said that interdisciplinary research investigating individual and societal short- and long-term costs of gun violence is sorely needed to inform public policy.

Dr. Pomeranz reported no outside sources of funding and reported that he had no conflicts of interest.

koakes@mdedge.com

SOURCE: Pomeranz C et al. RSNA 2019, Presentation HP226-SD-THA3.

SAN ANTONIO – The therapeutic Dark Ages of nonalcoholic steatohepatitis (NASH) are finally drawing to a close.

Bruce Jancin/MDedge News

“NASH-specific therapies are coming soon – sooner than you think,” Naim Alkhouri, MD, predicted at the annual meeting of the American College of Gastroenterology.

And that, he added, has important implications for clinical practice. Physicians are going to need to step up their game with regard to screening and staging patients with nonalcoholic fatty liver disease to identify the right candidates for the coming effective treatments.

The new treatment era in NASH could dawn as soon as the spring of 2020, by which time the Food and Drug Administration is expected to issue a decision on obeticholic acid, an oral FXR agonist for which the agency has granted breakthrough therapy status. Intercept Pharmaceuticals has filed for marketing approval of obeticholic acid for NASH on the strength of the positive 18-month histologic results of the pivotal phase 3 REGENERATE trial, the first-ever successful phase 3 study of a medication for NASH, noted Dr. Alkhouri, a gastroenterologist at the University of Texas, San Antonio, and director of the Metabolic Health Center at the Texas Liver Institute.

At present there are no FDA-approved pharmacotherapies for NASH. The unmet medical need is huge, since NASH is now recognized to be a full-blown, burgeoning epidemic. NASH will soon become the No. 1 indication for liver transplantation in the United States. A full-throttle race is on to find effective therapies targeting the various dimensions of NASH, with more than 70 drugs now in phase 2 studies. These drugs collectively address all four mechanisms of the disease’s development and progression: the metabolic targets, perturbations in the gut-liver axis, liver inflammation, and fibrosis.

Moreover, even as the FDA considers the application for approval of obeticholic acid in NASH, at least four other investigational drugs are in pivotal phase 3 clinical trials. These include elafibranor, aramchol, resmetirom, and cenicriviroc.

Cenicriviroc is a dual CCR 2/5 receptor antagonist that targets the hepatic inflammation and fibrosis dimensions of NASH. It is now being evaluated in the phase 3 AURORA trial on the strength of the earlier positive phase 2b Centaur study, in which patients randomized to cenicriviroc were twice as likely to experience significant improvement in fibrosis as were placebo-treated controls.

Elafibranor, aramchol, and resmetirom employ different mechanisms of action to address the metabolic derangements of NASH. What they share in common is their aim to reduce the influx of free fatty acids from adipose tissue to the liver, and/or to inhibit lipogenesis from carbohydrate building blocks. In so doing, these medications should result in reduced hepatocyte injury and liver inflammation.

Elafibranor is a peroxisome proliferator-activated receptor alpha/delta agonist that achieved significant biopsy-proven reversal of NASH in moderate- or severely affected patients in the phase 2 GOLDEN study. The phase 3 RESOLVE IT trial is underway.

Aramchol is a first-in-class synthetic fatty acid/bile acid conjugate that inhibits stearoyl-CoA desaturate activity. It’s designed to improve insulin resistance and curb accumulation of triglycerides in hepatocytes. In the 52-week, phase 2 ARREST trial, oral aramchol at 600 mg/day was 4.7-fold more likely than was placebo to achieve NASH resolution without worsening of fibrosis. The drug is now in phase 3 in the ARMOR study.

Resmetirom is a selective thyroid hormone receptor–beta agonist. Activation of the beta receptor lowers LDL cholesterol, triglycerides, and liver fat, whereas activation of the alpha receptor has the unwanted effects of promoting bone loss, thyrotoxicosis, and arrhythmias. In phase 2, 75% of patients on high-dose resmetirom achieved at least a 30% reduction in hepatic fat by MRI at week 12, compared with 18% of placebo-treated controls. And 39% of the high-dose resmetirom group showed histologic resolution of NASH on a week-36 liver biopsy, as did a mere 6% of controls. The phase 3 MAESTRO randomized trial is underway.

Obeticholic acid addresses the gut-liver axis abnormalities present in NASH, especially the exuberant bile acid circulation.

Clinical implications of the coming wave of medications

In Dr. Alkhouri’s view, the target population for pharmacotherapy will be NASH patients with advanced disease, but not too far advanced; that is, those with stage 2 or 3 fibrotic changes in addition to liver inflammation, hepatocyte injury, and steatosis.

“These are the patients with a high chance of progressing to cirrhosis and end-stage liver disease,” the gastroenterologist said.

Patients with earlier-stage nonalcoholic fatty liver disease are best managed via lifestyle changes, with particular emphasis upon 10% weight loss accompanied by exercise. And patients with more advanced disease – NASH with cirrhosis – appear thus far to be beyond the reach of the next-generation therapies.

None of the coming drugs is a cure-all. In the landmark phase 3 REGENERATE trial, for example, the rate of the primary outcome – fibrosis improvement of at least one stage plus no worsening of NASH at 18 months – was 23% in patients randomized to obeticholic acid at 25 mg/day, compared to 12% with placebo.

“These are not like hepatitis C medications, with 97% efficacy, so combination therapy targeting upstream and downstream for NASH is rational,” Dr. Alkhouri observed.

He reported serving on advisory boards for Allergan, Gilead, and Intercept, and receiving research grants from those companies as well as from Galmed, Genfit, and Madrigal.

*This story was updated on 12/5/2019.

bjancin@mdedge.com

SAN ANTONIO – The therapeutic Dark Ages of nonalcoholic steatohepatitis (NASH) are finally drawing to a close.

Bruce Jancin/MDedge News

“NASH-specific therapies are coming soon – sooner than you think,” Naim Alkhouri, MD, predicted at the annual meeting of the American College of Gastroenterology.

And that, he added, has important implications for clinical practice. Physicians are going to need to step up their game with regard to screening and staging patients with nonalcoholic fatty liver disease to identify the right candidates for the coming effective treatments.

The new treatment era in NASH could dawn as soon as the spring of 2020, by which time the Food and Drug Administration is expected to issue a decision on obeticholic acid, an oral FXR agonist for which the agency has granted breakthrough therapy status. Intercept Pharmaceuticals has filed for marketing approval of obeticholic acid for NASH on the strength of the positive 18-month histologic results of the pivotal phase 3 REGENERATE trial, the first-ever successful phase 3 study of a medication for NASH, noted Dr. Alkhouri, a gastroenterologist at the University of Texas, San Antonio, and director of the Metabolic Health Center at the Texas Liver Institute.

At present there are no FDA-approved pharmacotherapies for NASH. The unmet medical need is huge, since NASH is now recognized to be a full-blown, burgeoning epidemic. NASH will soon become the No. 1 indication for liver transplantation in the United States. A full-throttle race is on to find effective therapies targeting the various dimensions of NASH, with more than 70 drugs now in phase 2 studies. These drugs collectively address all four mechanisms of the disease’s development and progression: the metabolic targets, perturbations in the gut-liver axis, liver inflammation, and fibrosis.

Moreover, even as the FDA considers the application for approval of obeticholic acid in NASH, at least four other investigational drugs are in pivotal phase 3 clinical trials. These include elafibranor, aramchol, resmetirom, and cenicriviroc.

Cenicriviroc is a dual CCR 2/5 receptor antagonist that targets the hepatic inflammation and fibrosis dimensions of NASH. It is now being evaluated in the phase 3 AURORA trial on the strength of the earlier positive phase 2b Centaur study, in which patients randomized to cenicriviroc were twice as likely to experience significant improvement in fibrosis as were placebo-treated controls.

Elafibranor, aramchol, and resmetirom employ different mechanisms of action to address the metabolic derangements of NASH. What they share in common is their aim to reduce the influx of free fatty acids from adipose tissue to the liver, and/or to inhibit lipogenesis from carbohydrate building blocks. In so doing, these medications should result in reduced hepatocyte injury and liver inflammation.

Elafibranor is a peroxisome proliferator-activated receptor alpha/delta agonist that achieved significant biopsy-proven reversal of NASH in moderate- or severely affected patients in the phase 2 GOLDEN study. The phase 3 RESOLVE IT trial is underway.

Aramchol is a first-in-class synthetic fatty acid/bile acid conjugate that inhibits stearoyl-CoA desaturate activity. It’s designed to improve insulin resistance and curb accumulation of triglycerides in hepatocytes. In the 52-week, phase 2 ARREST trial, oral aramchol at 600 mg/day was 4.7-fold more likely than was placebo to achieve NASH resolution without worsening of fibrosis. The drug is now in phase 3 in the ARMOR study.

Resmetirom is a selective thyroid hormone receptor–beta agonist. Activation of the beta receptor lowers LDL cholesterol, triglycerides, and liver fat, whereas activation of the alpha receptor has the unwanted effects of promoting bone loss, thyrotoxicosis, and arrhythmias. In phase 2, 75% of patients on high-dose resmetirom achieved at least a 30% reduction in hepatic fat by MRI at week 12, compared with 18% of placebo-treated controls. And 39% of the high-dose resmetirom group showed histologic resolution of NASH on a week-36 liver biopsy, as did a mere 6% of controls. The phase 3 MAESTRO randomized trial is underway.

Obeticholic acid addresses the gut-liver axis abnormalities present in NASH, especially the exuberant bile acid circulation.

Clinical implications of the coming wave of medications

In Dr. Alkhouri’s view, the target population for pharmacotherapy will be NASH patients with advanced disease, but not too far advanced; that is, those with stage 2 or 3 fibrotic changes in addition to liver inflammation, hepatocyte injury, and steatosis.

“These are the patients with a high chance of progressing to cirrhosis and end-stage liver disease,” the gastroenterologist said.

Patients with earlier-stage nonalcoholic fatty liver disease are best managed via lifestyle changes, with particular emphasis upon 10% weight loss accompanied by exercise. And patients with more advanced disease – NASH with cirrhosis – appear thus far to be beyond the reach of the next-generation therapies.

None of the coming drugs is a cure-all. In the landmark phase 3 REGENERATE trial, for example, the rate of the primary outcome – fibrosis improvement of at least one stage plus no worsening of NASH at 18 months – was 23% in patients randomized to obeticholic acid at 25 mg/day, compared to 12% with placebo.

“These are not like hepatitis C medications, with 97% efficacy, so combination therapy targeting upstream and downstream for NASH is rational,” Dr. Alkhouri observed.

He reported serving on advisory boards for Allergan, Gilead, and Intercept, and receiving research grants from those companies as well as from Galmed, Genfit, and Madrigal.

*This story was updated on 12/5/2019.

bjancin@mdedge.com

SAN ANTONIO – The therapeutic Dark Ages of nonalcoholic steatohepatitis (NASH) are finally drawing to a close.

Bruce Jancin/MDedge News

“NASH-specific therapies are coming soon – sooner than you think,” Naim Alkhouri, MD, predicted at the annual meeting of the American College of Gastroenterology.

And that, he added, has important implications for clinical practice. Physicians are going to need to step up their game with regard to screening and staging patients with nonalcoholic fatty liver disease to identify the right candidates for the coming effective treatments.

The new treatment era in NASH could dawn as soon as the spring of 2020, by which time the Food and Drug Administration is expected to issue a decision on obeticholic acid, an oral FXR agonist for which the agency has granted breakthrough therapy status. Intercept Pharmaceuticals has filed for marketing approval of obeticholic acid for NASH on the strength of the positive 18-month histologic results of the pivotal phase 3 REGENERATE trial, the first-ever successful phase 3 study of a medication for NASH, noted Dr. Alkhouri, a gastroenterologist at the University of Texas, San Antonio, and director of the Metabolic Health Center at the Texas Liver Institute.

At present there are no FDA-approved pharmacotherapies for NASH. The unmet medical need is huge, since NASH is now recognized to be a full-blown, burgeoning epidemic. NASH will soon become the No. 1 indication for liver transplantation in the United States. A full-throttle race is on to find effective therapies targeting the various dimensions of NASH, with more than 70 drugs now in phase 2 studies. These drugs collectively address all four mechanisms of the disease’s development and progression: the metabolic targets, perturbations in the gut-liver axis, liver inflammation, and fibrosis.

Moreover, even as the FDA considers the application for approval of obeticholic acid in NASH, at least four other investigational drugs are in pivotal phase 3 clinical trials. These include elafibranor, aramchol, resmetirom, and cenicriviroc.

Cenicriviroc is a dual CCR 2/5 receptor antagonist that targets the hepatic inflammation and fibrosis dimensions of NASH. It is now being evaluated in the phase 3 AURORA trial on the strength of the earlier positive phase 2b Centaur study, in which patients randomized to cenicriviroc were twice as likely to experience significant improvement in fibrosis as were placebo-treated controls.

Elafibranor, aramchol, and resmetirom employ different mechanisms of action to address the metabolic derangements of NASH. What they share in common is their aim to reduce the influx of free fatty acids from adipose tissue to the liver, and/or to inhibit lipogenesis from carbohydrate building blocks. In so doing, these medications should result in reduced hepatocyte injury and liver inflammation.

Elafibranor is a peroxisome proliferator-activated receptor alpha/delta agonist that achieved significant biopsy-proven reversal of NASH in moderate- or severely affected patients in the phase 2 GOLDEN study. The phase 3 RESOLVE IT trial is underway.

Aramchol is a first-in-class synthetic fatty acid/bile acid conjugate that inhibits stearoyl-CoA desaturate activity. It’s designed to improve insulin resistance and curb accumulation of triglycerides in hepatocytes. In the 52-week, phase 2 ARREST trial, oral aramchol at 600 mg/day was 4.7-fold more likely than was placebo to achieve NASH resolution without worsening of fibrosis. The drug is now in phase 3 in the ARMOR study.

Resmetirom is a selective thyroid hormone receptor–beta agonist. Activation of the beta receptor lowers LDL cholesterol, triglycerides, and liver fat, whereas activation of the alpha receptor has the unwanted effects of promoting bone loss, thyrotoxicosis, and arrhythmias. In phase 2, 75% of patients on high-dose resmetirom achieved at least a 30% reduction in hepatic fat by MRI at week 12, compared with 18% of placebo-treated controls. And 39% of the high-dose resmetirom group showed histologic resolution of NASH on a week-36 liver biopsy, as did a mere 6% of controls. The phase 3 MAESTRO randomized trial is underway.

Obeticholic acid addresses the gut-liver axis abnormalities present in NASH, especially the exuberant bile acid circulation.

Clinical implications of the coming wave of medications

In Dr. Alkhouri’s view, the target population for pharmacotherapy will be NASH patients with advanced disease, but not too far advanced; that is, those with stage 2 or 3 fibrotic changes in addition to liver inflammation, hepatocyte injury, and steatosis.

“These are the patients with a high chance of progressing to cirrhosis and end-stage liver disease,” the gastroenterologist said.

Patients with earlier-stage nonalcoholic fatty liver disease are best managed via lifestyle changes, with particular emphasis upon 10% weight loss accompanied by exercise. And patients with more advanced disease – NASH with cirrhosis – appear thus far to be beyond the reach of the next-generation therapies.

None of the coming drugs is a cure-all. In the landmark phase 3 REGENERATE trial, for example, the rate of the primary outcome – fibrosis improvement of at least one stage plus no worsening of NASH at 18 months – was 23% in patients randomized to obeticholic acid at 25 mg/day, compared to 12% with placebo.

“These are not like hepatitis C medications, with 97% efficacy, so combination therapy targeting upstream and downstream for NASH is rational,” Dr. Alkhouri observed.

He reported serving on advisory boards for Allergan, Gilead, and Intercept, and receiving research grants from those companies as well as from Galmed, Genfit, and Madrigal.

*This story was updated on 12/5/2019.

bjancin@mdedge.com

Geriatric Psychiatry Fellowship Position Available effective July 1, 2020

Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center

Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.

Interested applicants can contact Marcelle Shidler, Program Coordinator, at marcelle.shidler@uc.edu or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry

Geriatric Psychiatry Fellowship Position Available effective July 1, 2020

Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center

Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.

Interested applicants can contact Marcelle Shidler, Program Coordinator, at marcelle.shidler@uc.edu or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry

Geriatric Psychiatry Fellowship Position Available effective July 1, 2020

Department of Psychiatry and Behavioral Neuroscience; University of Cincinnati Medical Center

Opening for 1-year fellowship in fully ACGME-accredited Geriatric Psychiatry Program. Dedicated Faculty with strong clinical focus. Experience a rich assortment of clinical environments within the University of Cincinnati Medical Center and Cincinnati VA Medical Center. Rotations include inpatient/outpatient, ECT, Consult/Liaison, Long-Term Care, Alois Alzheimer Center, Home-Based Primary Care, Hospice & Palliative Care & Cognitive Aging Program.

Interested applicants can contact Marcelle Shidler, Program Coordinator, at marcelle.shidler@uc.edu or 513-558-2466, or go to http://med.uc.edu/psychiatry/fellowships/geriatric-psychiatry

The Food and Drug Administration has expanded the indication for Toujeo (insulin glargine 300 units/mL injection; Sanofi) to include children as young as 6 years of age with type 1 diabetes.

The FDA first approved Toujeo in 2015 for adults with type 1 and type 2 diabetes, designed as a more potent follow-up to Sanofi’s top-selling insulin glargine (Lantus).

Last month, Sanofi reported positive results from the phase 3 EDITION JUNIOR trial of Toujeo in children and adolescents with type 1 diabetes. These were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston.

In the trial, 463 children and adolescents (aged 6-17 years) treated for type 1 diabetes for at least 1 year and with A1c between 7.5% and 11.0% at screening were randomized to Toujeo or insulin glargine 100 units/mL (Gla-100); participants continued to take their existing mealtime insulin.

The primary endpoint was noninferior reduction in A_1c after 26 weeks.

The study met its primary endpoint, confirming a noninferior reduction in A_1c with Toujeo versus Gla-100 after 26 weeks (mean reduction, 0.4% vs. 0.4%; difference, 0.004%; 95% confidence interval, –0.17 to 0.18; upper bound was below the prespecified noninferiority margin of 0.3%).

Over 26 weeks, a comparable number of patients in each group experienced one or more hypoglycemic events documented at anytime over 24 hours. Numerically fewer patients taking Toujeo experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking Gla-100.

No unexpected safety concerns were reported based on the established profiles of both products, the company said.

In October 2019, the European Medicines Agency Committee for Medicinal Products for Human Use recommended approval of Toujeo for children age 6 years and older with diabetes.

For more diabetes and endocrinology news, follow us on Twitter and Facebook.
 

This story first appeared on Medscape.com.

The Food and Drug Administration has expanded the indication for Toujeo (insulin glargine 300 units/mL injection; Sanofi) to include children as young as 6 years of age with type 1 diabetes.

The FDA first approved Toujeo in 2015 for adults with type 1 and type 2 diabetes, designed as a more potent follow-up to Sanofi’s top-selling insulin glargine (Lantus).

Last month, Sanofi reported positive results from the phase 3 EDITION JUNIOR trial of Toujeo in children and adolescents with type 1 diabetes. These were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston.

In the trial, 463 children and adolescents (aged 6-17 years) treated for type 1 diabetes for at least 1 year and with A1c between 7.5% and 11.0% at screening were randomized to Toujeo or insulin glargine 100 units/mL (Gla-100); participants continued to take their existing mealtime insulin.

The primary endpoint was noninferior reduction in A_1c after 26 weeks.

The study met its primary endpoint, confirming a noninferior reduction in A_1c with Toujeo versus Gla-100 after 26 weeks (mean reduction, 0.4% vs. 0.4%; difference, 0.004%; 95% confidence interval, –0.17 to 0.18; upper bound was below the prespecified noninferiority margin of 0.3%).

Over 26 weeks, a comparable number of patients in each group experienced one or more hypoglycemic events documented at anytime over 24 hours. Numerically fewer patients taking Toujeo experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking Gla-100.

No unexpected safety concerns were reported based on the established profiles of both products, the company said.

In October 2019, the European Medicines Agency Committee for Medicinal Products for Human Use recommended approval of Toujeo for children age 6 years and older with diabetes.

For more diabetes and endocrinology news, follow us on Twitter and Facebook.
 

This story first appeared on Medscape.com.

The Food and Drug Administration has expanded the indication for Toujeo (insulin glargine 300 units/mL injection; Sanofi) to include children as young as 6 years of age with type 1 diabetes.

The FDA first approved Toujeo in 2015 for adults with type 1 and type 2 diabetes, designed as a more potent follow-up to Sanofi’s top-selling insulin glargine (Lantus).

Last month, Sanofi reported positive results from the phase 3 EDITION JUNIOR trial of Toujeo in children and adolescents with type 1 diabetes. These were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston.

In the trial, 463 children and adolescents (aged 6-17 years) treated for type 1 diabetes for at least 1 year and with A1c between 7.5% and 11.0% at screening were randomized to Toujeo or insulin glargine 100 units/mL (Gla-100); participants continued to take their existing mealtime insulin.

The primary endpoint was noninferior reduction in A_1c after 26 weeks.

The study met its primary endpoint, confirming a noninferior reduction in A_1c with Toujeo versus Gla-100 after 26 weeks (mean reduction, 0.4% vs. 0.4%; difference, 0.004%; 95% confidence interval, –0.17 to 0.18; upper bound was below the prespecified noninferiority margin of 0.3%).

Over 26 weeks, a comparable number of patients in each group experienced one or more hypoglycemic events documented at anytime over 24 hours. Numerically fewer patients taking Toujeo experienced severe hypoglycemia or experienced one or more episodes of hyperglycemia with ketosis compared with those taking Gla-100.

No unexpected safety concerns were reported based on the established profiles of both products, the company said.

In October 2019, the European Medicines Agency Committee for Medicinal Products for Human Use recommended approval of Toujeo for children age 6 years and older with diabetes.

For more diabetes and endocrinology news, follow us on Twitter and Facebook.
 

This story first appeared on Medscape.com.

BUSAN, SOUTH KOREA – The practice of insulin rationing because of cost by people with type 1 diabetes is considerably more common in the United States than in other high-income countries, and is even higher than in some low- and middle-income countries, new data suggest.

Findings from the latest survey conducted by the nonprofit advocacy organization T1International were presented at the International Diabetes Federation Congress 2019 by organization trustee James Elliott, MMSc, of Toronto.

The data were also simultaneously posted on the organization’s website.

The 2018 online survey is an update of T1International’s 2016 survey. It was disseminated through the organization’s website, partner organizations, and social media. The survey questions were developed by people living with type 1 diabetes to ensure they made sense to patients.

A total of 1,478 respondents from 90 countries completed the online survey in 2018.

Overall, 18% reported rationing insulin in the previous year because of cost. About 26% of 627 respondents from the United States reported the practice, compared with 6.5% of 525 respondents from other high-income countries, and 10.9% of 256 respondents from low- and middle-income countries. Rates of rationing suplies for blood glucose testing were even higher.

“The take-home point is that insulin rationing and blood glucose testing rationing is a reality for far more people with diabetes than I think is acknowledged,” said Mr. Elliott.

“One of the key findings is that many people are actually better off living in lower- and middle-income countries than in the United States, which is quite shameful,” Mr. Elliott told Medscape Medical News in an interview.

He advised clinicians to ask patients if they’re insulin rationing, but to be mindful that “not everyone is going to be upfront. There’re a lot of associated stigmas.”

Endocrinologist Irl B. Hirsch, MD, noted that the rationing rate reported for the United States in the survey is similar to that found in a recently published study from Yale University, New Haven, Conn., as reported by Medscape Medical News.

Dr. Hirsch, who is chair of Diabetes Treatment and Teaching at the University of Washington, Seattle, agreed wholeheartedly with Mr. Elliott.

“It is shameful and embarrassing sitting here with colleagues from around the world at IDF. It is time for our elected officials [in the United States] to do something instead of simply talking about it,” Dr. Hirsch said.

Many have no coverage, blood glucose test rationing also common

Overall, 66.2% of survey respondents reported having no financial coverage for diabetes expenses, many instead relying on support from family and friends, charities and nonprofit organizations, donations including online programs such as GoFundMe, and/or assistance from government or pharmaceutical company programs.

By region, the proportions reporting no coverage for diabetes supplies were 79.2% in the United States, 54.0% in other high-income countries, and 59.8% in low- and middle-income countries.

“Many countries still lack any kind of support system to help people with type 1 diabetes survive,” Mr. Elliott noted.

Also asked to comment, Edward W. Gregg, PhD, a professor in the department of epidemiology and biostatistics at Imperial College, London, said: “It’s pretty astounding to me that two thirds of people with type 1 diabetes have no coverage whatsoever for out-of-pocket costs.”

“For as much concern as we have [for the US], it’s really staggering to think about how it must be in the low- and middle-income countries where having to pay for insulin takes away a large proportion of income,” he added.

Rationing of blood glucose testing was considerably more common than insulin rationing, with 33.5% overall reporting having done so in the last year.

The proportion was higher in the United States and in low- and middle-income countries, at 38.6% and 55.5%, respectively, compared with just 17.2% of high-income countries other than the United States.

Mr. Elliott told Medscape Medical News that the recent World Health Organization’s launch of its first-ever insulin prequalification program to expand access to treatment is a “start” and that T1International is pushing to expand that beyond human insulins to also include analogues.

“It’s a tough disease to survive in lower- and middle-income countries. Oftentimes, it’s a death sentence,” Mr. Elliott said.
 

This story first appeared on Medscape.com.

BUSAN, SOUTH KOREA – The practice of insulin rationing because of cost by people with type 1 diabetes is considerably more common in the United States than in other high-income countries, and is even higher than in some low- and middle-income countries, new data suggest.

Findings from the latest survey conducted by the nonprofit advocacy organization T1International were presented at the International Diabetes Federation Congress 2019 by organization trustee James Elliott, MMSc, of Toronto.

The data were also simultaneously posted on the organization’s website.

The 2018 online survey is an update of T1International’s 2016 survey. It was disseminated through the organization’s website, partner organizations, and social media. The survey questions were developed by people living with type 1 diabetes to ensure they made sense to patients.

A total of 1,478 respondents from 90 countries completed the online survey in 2018.

Overall, 18% reported rationing insulin in the previous year because of cost. About 26% of 627 respondents from the United States reported the practice, compared with 6.5% of 525 respondents from other high-income countries, and 10.9% of 256 respondents from low- and middle-income countries. Rates of rationing suplies for blood glucose testing were even higher.

“The take-home point is that insulin rationing and blood glucose testing rationing is a reality for far more people with diabetes than I think is acknowledged,” said Mr. Elliott.

“One of the key findings is that many people are actually better off living in lower- and middle-income countries than in the United States, which is quite shameful,” Mr. Elliott told Medscape Medical News in an interview.

He advised clinicians to ask patients if they’re insulin rationing, but to be mindful that “not everyone is going to be upfront. There’re a lot of associated stigmas.”

Endocrinologist Irl B. Hirsch, MD, noted that the rationing rate reported for the United States in the survey is similar to that found in a recently published study from Yale University, New Haven, Conn., as reported by Medscape Medical News.

Dr. Hirsch, who is chair of Diabetes Treatment and Teaching at the University of Washington, Seattle, agreed wholeheartedly with Mr. Elliott.

“It is shameful and embarrassing sitting here with colleagues from around the world at IDF. It is time for our elected officials [in the United States] to do something instead of simply talking about it,” Dr. Hirsch said.

Many have no coverage, blood glucose test rationing also common

Overall, 66.2% of survey respondents reported having no financial coverage for diabetes expenses, many instead relying on support from family and friends, charities and nonprofit organizations, donations including online programs such as GoFundMe, and/or assistance from government or pharmaceutical company programs.

By region, the proportions reporting no coverage for diabetes supplies were 79.2% in the United States, 54.0% in other high-income countries, and 59.8% in low- and middle-income countries.

“Many countries still lack any kind of support system to help people with type 1 diabetes survive,” Mr. Elliott noted.

Also asked to comment, Edward W. Gregg, PhD, a professor in the department of epidemiology and biostatistics at Imperial College, London, said: “It’s pretty astounding to me that two thirds of people with type 1 diabetes have no coverage whatsoever for out-of-pocket costs.”

“For as much concern as we have [for the US], it’s really staggering to think about how it must be in the low- and middle-income countries where having to pay for insulin takes away a large proportion of income,” he added.

Rationing of blood glucose testing was considerably more common than insulin rationing, with 33.5% overall reporting having done so in the last year.

The proportion was higher in the United States and in low- and middle-income countries, at 38.6% and 55.5%, respectively, compared with just 17.2% of high-income countries other than the United States.

Mr. Elliott told Medscape Medical News that the recent World Health Organization’s launch of its first-ever insulin prequalification program to expand access to treatment is a “start” and that T1International is pushing to expand that beyond human insulins to also include analogues.

“It’s a tough disease to survive in lower- and middle-income countries. Oftentimes, it’s a death sentence,” Mr. Elliott said.
 

This story first appeared on Medscape.com.

BUSAN, SOUTH KOREA – The practice of insulin rationing because of cost by people with type 1 diabetes is considerably more common in the United States than in other high-income countries, and is even higher than in some low- and middle-income countries, new data suggest.

Findings from the latest survey conducted by the nonprofit advocacy organization T1International were presented at the International Diabetes Federation Congress 2019 by organization trustee James Elliott, MMSc, of Toronto.

The data were also simultaneously posted on the organization’s website.

The 2018 online survey is an update of T1International’s 2016 survey. It was disseminated through the organization’s website, partner organizations, and social media. The survey questions were developed by people living with type 1 diabetes to ensure they made sense to patients.

A total of 1,478 respondents from 90 countries completed the online survey in 2018.

Overall, 18% reported rationing insulin in the previous year because of cost. About 26% of 627 respondents from the United States reported the practice, compared with 6.5% of 525 respondents from other high-income countries, and 10.9% of 256 respondents from low- and middle-income countries. Rates of rationing suplies for blood glucose testing were even higher.

“The take-home point is that insulin rationing and blood glucose testing rationing is a reality for far more people with diabetes than I think is acknowledged,” said Mr. Elliott.

“One of the key findings is that many people are actually better off living in lower- and middle-income countries than in the United States, which is quite shameful,” Mr. Elliott told Medscape Medical News in an interview.

He advised clinicians to ask patients if they’re insulin rationing, but to be mindful that “not everyone is going to be upfront. There’re a lot of associated stigmas.”

Endocrinologist Irl B. Hirsch, MD, noted that the rationing rate reported for the United States in the survey is similar to that found in a recently published study from Yale University, New Haven, Conn., as reported by Medscape Medical News.

Dr. Hirsch, who is chair of Diabetes Treatment and Teaching at the University of Washington, Seattle, agreed wholeheartedly with Mr. Elliott.

“It is shameful and embarrassing sitting here with colleagues from around the world at IDF. It is time for our elected officials [in the United States] to do something instead of simply talking about it,” Dr. Hirsch said.

Many have no coverage, blood glucose test rationing also common

Overall, 66.2% of survey respondents reported having no financial coverage for diabetes expenses, many instead relying on support from family and friends, charities and nonprofit organizations, donations including online programs such as GoFundMe, and/or assistance from government or pharmaceutical company programs.

By region, the proportions reporting no coverage for diabetes supplies were 79.2% in the United States, 54.0% in other high-income countries, and 59.8% in low- and middle-income countries.

“Many countries still lack any kind of support system to help people with type 1 diabetes survive,” Mr. Elliott noted.

Also asked to comment, Edward W. Gregg, PhD, a professor in the department of epidemiology and biostatistics at Imperial College, London, said: “It’s pretty astounding to me that two thirds of people with type 1 diabetes have no coverage whatsoever for out-of-pocket costs.”

“For as much concern as we have [for the US], it’s really staggering to think about how it must be in the low- and middle-income countries where having to pay for insulin takes away a large proportion of income,” he added.

Rationing of blood glucose testing was considerably more common than insulin rationing, with 33.5% overall reporting having done so in the last year.

The proportion was higher in the United States and in low- and middle-income countries, at 38.6% and 55.5%, respectively, compared with just 17.2% of high-income countries other than the United States.

Mr. Elliott told Medscape Medical News that the recent World Health Organization’s launch of its first-ever insulin prequalification program to expand access to treatment is a “start” and that T1International is pushing to expand that beyond human insulins to also include analogues.

“It’s a tough disease to survive in lower- and middle-income countries. Oftentimes, it’s a death sentence,” Mr. Elliott said.
 

This story first appeared on Medscape.com.

NATIONAL HARBOR, MD – As it moves to expand the use of virtual health offerings, the US Department of Defense (DoD) Regional Health Command Europe piloted a virtual health (telehealth) program to treat service members with traumatic brain injury (TBI). Ronald Keen, FNP-C, and Steve Cain, PA, reported on the DoD use of virtual health at the 2019 AMSUS annual meeting in Maryland.

The study, conducted between October 2016 and May 2018, included 15 patients stationed in 4 countries, including Poland, Turkey, and Egypt and 67 total health care encounters. Patients were limited to service members in the direct care system or those who were in remote areas where gaps in care existed in the Tricare Network. The virtual health program was centered at Landstuhl Regional Medical Center in Germany and sought to determine whether virtual health was feasible to treat TBI and whether it would increase patient satisfaction. The multidisciplinary program brought together specialists in 7 different disciplines, including sleep medicine, optometry, behavioral health, and occupational therapy.

According to Keen, the results of the 15-patient pilot were promising. He conservatively estimated a savings of $3,700, and more important, the program saved 322 hours of on-duty time. Health care providers used the program an average 2.8 times, and patients used the system 1.6 times on average. Currently the DoD is requiring active permission from patients to receive a telehealth visit.

NATIONAL HARBOR, MD – As it moves to expand the use of virtual health offerings, the US Department of Defense (DoD) Regional Health Command Europe piloted a virtual health (telehealth) program to treat service members with traumatic brain injury (TBI). Ronald Keen, FNP-C, and Steve Cain, PA, reported on the DoD use of virtual health at the 2019 AMSUS annual meeting in Maryland.

The study, conducted between October 2016 and May 2018, included 15 patients stationed in 4 countries, including Poland, Turkey, and Egypt and 67 total health care encounters. Patients were limited to service members in the direct care system or those who were in remote areas where gaps in care existed in the Tricare Network. The virtual health program was centered at Landstuhl Regional Medical Center in Germany and sought to determine whether virtual health was feasible to treat TBI and whether it would increase patient satisfaction. The multidisciplinary program brought together specialists in 7 different disciplines, including sleep medicine, optometry, behavioral health, and occupational therapy.

According to Keen, the results of the 15-patient pilot were promising. He conservatively estimated a savings of $3,700, and more important, the program saved 322 hours of on-duty time. Health care providers used the program an average 2.8 times, and patients used the system 1.6 times on average. Currently the DoD is requiring active permission from patients to receive a telehealth visit.

NATIONAL HARBOR, MD – As it moves to expand the use of virtual health offerings, the US Department of Defense (DoD) Regional Health Command Europe piloted a virtual health (telehealth) program to treat service members with traumatic brain injury (TBI). Ronald Keen, FNP-C, and Steve Cain, PA, reported on the DoD use of virtual health at the 2019 AMSUS annual meeting in Maryland.

The study, conducted between October 2016 and May 2018, included 15 patients stationed in 4 countries, including Poland, Turkey, and Egypt and 67 total health care encounters. Patients were limited to service members in the direct care system or those who were in remote areas where gaps in care existed in the Tricare Network. The virtual health program was centered at Landstuhl Regional Medical Center in Germany and sought to determine whether virtual health was feasible to treat TBI and whether it would increase patient satisfaction. The multidisciplinary program brought together specialists in 7 different disciplines, including sleep medicine, optometry, behavioral health, and occupational therapy.

According to Keen, the results of the 15-patient pilot were promising. He conservatively estimated a savings of $3,700, and more important, the program saved 322 hours of on-duty time. Health care providers used the program an average 2.8 times, and patients used the system 1.6 times on average. Currently the DoD is requiring active permission from patients to receive a telehealth visit.