Unless someone has already had a heart attack or other cardiovascular event, daily low-dose aspirin does not prolong healthy independent living, according to the ASPirin in Reducing Events in the Elderly (ASPREE) trial.

The study began in 2010, enrolling 19,114 adults aged ≥ 65 years. The participants were treated with 100 mg/d of aspirin or placebo and followed for an average of 4.7 years. Of participants randomly assigned aspirin, 90.3% were still alive at the end of the treatment without persistent physical disability or dementia, as were 90.5% of those on placebo. Rates of dementia were almost identical in both groups. Major cardiovascular events were similar: 448 in the aspirin group and 474 in the placebo group.

The aspirin group had a slightly higher risk of death (5.9% vs 5.2%). The researchers advise interpreting this cautiously: Most of the deaths were due to cancer. A small increase in new cases of cancer was reported for the aspirin group but may have been due to chance. Heart disease accounted for 19% of deaths and major bleeding for 5%. People taking aspirin were more likely to have significant bleeding (3.8% vs 2.7%).

The researchers emphasize that, study findings notwithstanding, older adults should follow their physician’s advice about daily aspirin use. The new findings do not apply to people with an indication for aspirin, including stroke, heart attack, or other cardiovascular disease.

Unless someone has already had a heart attack or other cardiovascular event, daily low-dose aspirin does not prolong healthy independent living, according to the ASPirin in Reducing Events in the Elderly (ASPREE) trial.

The study began in 2010, enrolling 19,114 adults aged ≥ 65 years. The participants were treated with 100 mg/d of aspirin or placebo and followed for an average of 4.7 years. Of participants randomly assigned aspirin, 90.3% were still alive at the end of the treatment without persistent physical disability or dementia, as were 90.5% of those on placebo. Rates of dementia were almost identical in both groups. Major cardiovascular events were similar: 448 in the aspirin group and 474 in the placebo group.

The aspirin group had a slightly higher risk of death (5.9% vs 5.2%). The researchers advise interpreting this cautiously: Most of the deaths were due to cancer. A small increase in new cases of cancer was reported for the aspirin group but may have been due to chance. Heart disease accounted for 19% of deaths and major bleeding for 5%. People taking aspirin were more likely to have significant bleeding (3.8% vs 2.7%).

The researchers emphasize that, study findings notwithstanding, older adults should follow their physician’s advice about daily aspirin use. The new findings do not apply to people with an indication for aspirin, including stroke, heart attack, or other cardiovascular disease.

Unless someone has already had a heart attack or other cardiovascular event, daily low-dose aspirin does not prolong healthy independent living, according to the ASPirin in Reducing Events in the Elderly (ASPREE) trial.

The study began in 2010, enrolling 19,114 adults aged ≥ 65 years. The participants were treated with 100 mg/d of aspirin or placebo and followed for an average of 4.7 years. Of participants randomly assigned aspirin, 90.3% were still alive at the end of the treatment without persistent physical disability or dementia, as were 90.5% of those on placebo. Rates of dementia were almost identical in both groups. Major cardiovascular events were similar: 448 in the aspirin group and 474 in the placebo group.

The aspirin group had a slightly higher risk of death (5.9% vs 5.2%). The researchers advise interpreting this cautiously: Most of the deaths were due to cancer. A small increase in new cases of cancer was reported for the aspirin group but may have been due to chance. Heart disease accounted for 19% of deaths and major bleeding for 5%. People taking aspirin were more likely to have significant bleeding (3.8% vs 2.7%).

The researchers emphasize that, study findings notwithstanding, older adults should follow their physician’s advice about daily aspirin use. The new findings do not apply to people with an indication for aspirin, including stroke, heart attack, or other cardiovascular disease.

follicular lymphoma

The combination of Hu5F9-G4 (5F9) and rituximab was considered safe and produced durable complete responses (CRs) in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) in a phase 1b trial.

Mainly low-grade adverse events (AEs) were observed with rituximab and 5F9, a macrophage-activating immune checkpoint inhibitor blocking CD47.

In addition, the combination produced an objective response rate (ORR) of 50% and a CR rate of 36%.

Most of the responses were ongoing at the time of data cutoff.

“It was very gratifying to see how the treatment was well-tolerated and showed a clinically meaningful response,” said Ranjana Advani, MD, of Stanford University in California.

She and her colleagues reported these results in The New England Journal of Medicine.

The study included 22 patients with relapsed or refractory NHL. Fifteen had diffuse large B-cell lymphoma (DLBCL), and seven had follicular lymphoma (FL).

The patients had received a median of four prior therapies (range, 2-10). Twenty-one patients had disease that was refractory to rituximab (all FL and 14 DLBCL patients).

All patients received 5F9 starting with a priming dose of 1 mg/kg followed by weekly maintenance doses of 10 to 30 mg/kg in three dose-escalation cohorts. The treatment was given until disease progression or lack of clinical benefit.

Patients received rituximab at 375 mg/m² weekly starting on the second week of the first cycle and then monthly for cycles two through six.

Results

The most common treatment-related AEs were chills (41%), headache (41%), anemia (41%), and infusion-related reactions (36%).

Serious AEs included infections (18%), anemia (4.5%), dyspnea (4.5%), pyrexia (4.5%), lactic acidosis (4.5%), retroperitoneal mass (4.5%), pulmonary embolism (4.5%), and infusion-related reaction (4.5%).

For the entire cohort, the ORR was 50% (n=11), and the CR rate was 36% (n=8).

Among DLBCL patients, the ORR was 40% (n=6), and the CR rate was 33% (n=5). In FL patients, the ORR was 71% (n=5), and the CR rate was 43% (n=3).

The median duration of response was not reached in either disease cohort. The median follow-up was 6.2 months for DLBCL and 8.1 months for FL.

Ten of 11 responders (91%) were still in response at the time of data cutoff.

The researchers said a phase 2 trial of 5F9 plus rituximab in relapsed or refractory B-cell NHL is ongoing.

The phase 1b study was supported by Forty Seven, Inc., and the Leukemia and Lymphoma Society. Dr. Advani reported disclosures related to Forty Seven, Inc., Bristol-Myers Squibb, Pharmacyclics, Seattle Genetics, and Roche/Genentech, among others.

follicular lymphoma

The combination of Hu5F9-G4 (5F9) and rituximab was considered safe and produced durable complete responses (CRs) in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) in a phase 1b trial.

Mainly low-grade adverse events (AEs) were observed with rituximab and 5F9, a macrophage-activating immune checkpoint inhibitor blocking CD47.

In addition, the combination produced an objective response rate (ORR) of 50% and a CR rate of 36%.

Most of the responses were ongoing at the time of data cutoff.

“It was very gratifying to see how the treatment was well-tolerated and showed a clinically meaningful response,” said Ranjana Advani, MD, of Stanford University in California.

She and her colleagues reported these results in The New England Journal of Medicine.

The study included 22 patients with relapsed or refractory NHL. Fifteen had diffuse large B-cell lymphoma (DLBCL), and seven had follicular lymphoma (FL).

The patients had received a median of four prior therapies (range, 2-10). Twenty-one patients had disease that was refractory to rituximab (all FL and 14 DLBCL patients).

All patients received 5F9 starting with a priming dose of 1 mg/kg followed by weekly maintenance doses of 10 to 30 mg/kg in three dose-escalation cohorts. The treatment was given until disease progression or lack of clinical benefit.

Patients received rituximab at 375 mg/m² weekly starting on the second week of the first cycle and then monthly for cycles two through six.

Results

The most common treatment-related AEs were chills (41%), headache (41%), anemia (41%), and infusion-related reactions (36%).

Serious AEs included infections (18%), anemia (4.5%), dyspnea (4.5%), pyrexia (4.5%), lactic acidosis (4.5%), retroperitoneal mass (4.5%), pulmonary embolism (4.5%), and infusion-related reaction (4.5%).

For the entire cohort, the ORR was 50% (n=11), and the CR rate was 36% (n=8).

Among DLBCL patients, the ORR was 40% (n=6), and the CR rate was 33% (n=5). In FL patients, the ORR was 71% (n=5), and the CR rate was 43% (n=3).

The median duration of response was not reached in either disease cohort. The median follow-up was 6.2 months for DLBCL and 8.1 months for FL.

Ten of 11 responders (91%) were still in response at the time of data cutoff.

The researchers said a phase 2 trial of 5F9 plus rituximab in relapsed or refractory B-cell NHL is ongoing.

The phase 1b study was supported by Forty Seven, Inc., and the Leukemia and Lymphoma Society. Dr. Advani reported disclosures related to Forty Seven, Inc., Bristol-Myers Squibb, Pharmacyclics, Seattle Genetics, and Roche/Genentech, among others.

follicular lymphoma

The combination of Hu5F9-G4 (5F9) and rituximab was considered safe and produced durable complete responses (CRs) in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) in a phase 1b trial.

Mainly low-grade adverse events (AEs) were observed with rituximab and 5F9, a macrophage-activating immune checkpoint inhibitor blocking CD47.

In addition, the combination produced an objective response rate (ORR) of 50% and a CR rate of 36%.

Most of the responses were ongoing at the time of data cutoff.

“It was very gratifying to see how the treatment was well-tolerated and showed a clinically meaningful response,” said Ranjana Advani, MD, of Stanford University in California.

She and her colleagues reported these results in The New England Journal of Medicine.

The study included 22 patients with relapsed or refractory NHL. Fifteen had diffuse large B-cell lymphoma (DLBCL), and seven had follicular lymphoma (FL).

The patients had received a median of four prior therapies (range, 2-10). Twenty-one patients had disease that was refractory to rituximab (all FL and 14 DLBCL patients).

All patients received 5F9 starting with a priming dose of 1 mg/kg followed by weekly maintenance doses of 10 to 30 mg/kg in three dose-escalation cohorts. The treatment was given until disease progression or lack of clinical benefit.

Patients received rituximab at 375 mg/m² weekly starting on the second week of the first cycle and then monthly for cycles two through six.

Results

The most common treatment-related AEs were chills (41%), headache (41%), anemia (41%), and infusion-related reactions (36%).

Serious AEs included infections (18%), anemia (4.5%), dyspnea (4.5%), pyrexia (4.5%), lactic acidosis (4.5%), retroperitoneal mass (4.5%), pulmonary embolism (4.5%), and infusion-related reaction (4.5%).

For the entire cohort, the ORR was 50% (n=11), and the CR rate was 36% (n=8).

Among DLBCL patients, the ORR was 40% (n=6), and the CR rate was 33% (n=5). In FL patients, the ORR was 71% (n=5), and the CR rate was 43% (n=3).

The median duration of response was not reached in either disease cohort. The median follow-up was 6.2 months for DLBCL and 8.1 months for FL.

Ten of 11 responders (91%) were still in response at the time of data cutoff.

The researchers said a phase 2 trial of 5F9 plus rituximab in relapsed or refractory B-cell NHL is ongoing.

The phase 1b study was supported by Forty Seven, Inc., and the Leukemia and Lymphoma Society. Dr. Advani reported disclosures related to Forty Seven, Inc., Bristol-Myers Squibb, Pharmacyclics, Seattle Genetics, and Roche/Genentech, among others.

AML cells

New research suggests relapse of acute myeloid leukemia (AML) after allogeneic hematopoietic stem cell transplant (HSCT) is related to changes in immune-related gene expression that may be reversible.

Researchers observed downregulation of major histocompatibility complex (MHC) class II genes in samples from patients who relapsed after HSCT.

However, interferon-gamma “rapidly reversed this phenotype” in vitro, according to the researchers.

Matthew J. Christopher, MD, PhD, of Washington University School of Medicine in St. Louis, Missouri, and his colleagues reported these findings in The New England Journal of Medicine.

The researchers set out to determine how genetic and epigenetic changes after HSCT may allow leukemic cells to avoid the graft-vs-leukemia effect and to see whether immune-related genes are affected by HSCT.

The team analyzed paired samples obtained at diagnosis and relapse from 15 AML patients who relapsed after HSCT and 20 AML patients who relapsed after chemotherapy. The team also analyzed additional samples from patients who relapsed after HSCT to validate initial findings.

Methods of analysis included enhanced exome sequencing, RNA sequencing, flow cytometry, and immunohistochemical analysis.

Findings

The researchers first looked for relapse-specific mutations but found no driver mutations associated with relapse after HSCT.

The mutations seen post-HSCT relapse were generally similar to those seen both before treatment and after relapse in patients who had undergone chemotherapy, and the researchers could not identify any patterns of mutations related to relapse.

They then looked for, but did not find, relapse-specific mutations in genes involved in modulation of immune checkpoints, antigen presentation, or cytokine signaling.

The researchers did, however, find evidence of epigenetic changes that were more common in the samples from patients with post-transplant relapses.

RNA sequencing showed that MHC class II genes (HLA-DPA1, HLA-DPB1, HLA-DQB1, and HLA-DRB1) were downregulated three- to 12-fold after transplant.

Flow cytometry and immunohistochemical analysis confirmed that MHC class II expression was decreased at relapse after HSCT in 17 of 34 samples evaluated.

The researchers said there was no association between the downregulation of MHC class II and donor type or use of immunosuppression.

To see whether the downregulation of MHC class II genes was reversible, the researchers treated three post-HSCT relapse samples with interferon-gamma, which is known to upregulate MHC class II on certain cells.

Culturing patient cells with interferon-gamma “rapidly induced MHC class II protein expression on leukemic blasts,” the researchers said. They observed “essentially full restoration of MHC class II protein expression in nearly all AML blasts after 72 hours.”

This study was supported by the National Institutes of Health, Leukemia and Lymphoma Society, and the Barnes-Jewish Hospital Foundation.

Several study authors reported personal fees and/or research support from industry outside the submitted work.

AML cells

New research suggests relapse of acute myeloid leukemia (AML) after allogeneic hematopoietic stem cell transplant (HSCT) is related to changes in immune-related gene expression that may be reversible.

Researchers observed downregulation of major histocompatibility complex (MHC) class II genes in samples from patients who relapsed after HSCT.

However, interferon-gamma “rapidly reversed this phenotype” in vitro, according to the researchers.

Matthew J. Christopher, MD, PhD, of Washington University School of Medicine in St. Louis, Missouri, and his colleagues reported these findings in The New England Journal of Medicine.

The researchers set out to determine how genetic and epigenetic changes after HSCT may allow leukemic cells to avoid the graft-vs-leukemia effect and to see whether immune-related genes are affected by HSCT.

The team analyzed paired samples obtained at diagnosis and relapse from 15 AML patients who relapsed after HSCT and 20 AML patients who relapsed after chemotherapy. The team also analyzed additional samples from patients who relapsed after HSCT to validate initial findings.

Methods of analysis included enhanced exome sequencing, RNA sequencing, flow cytometry, and immunohistochemical analysis.

Findings

The researchers first looked for relapse-specific mutations but found no driver mutations associated with relapse after HSCT.

The mutations seen post-HSCT relapse were generally similar to those seen both before treatment and after relapse in patients who had undergone chemotherapy, and the researchers could not identify any patterns of mutations related to relapse.

They then looked for, but did not find, relapse-specific mutations in genes involved in modulation of immune checkpoints, antigen presentation, or cytokine signaling.

The researchers did, however, find evidence of epigenetic changes that were more common in the samples from patients with post-transplant relapses.

RNA sequencing showed that MHC class II genes (HLA-DPA1, HLA-DPB1, HLA-DQB1, and HLA-DRB1) were downregulated three- to 12-fold after transplant.

Flow cytometry and immunohistochemical analysis confirmed that MHC class II expression was decreased at relapse after HSCT in 17 of 34 samples evaluated.

The researchers said there was no association between the downregulation of MHC class II and donor type or use of immunosuppression.

To see whether the downregulation of MHC class II genes was reversible, the researchers treated three post-HSCT relapse samples with interferon-gamma, which is known to upregulate MHC class II on certain cells.

Culturing patient cells with interferon-gamma “rapidly induced MHC class II protein expression on leukemic blasts,” the researchers said. They observed “essentially full restoration of MHC class II protein expression in nearly all AML blasts after 72 hours.”

This study was supported by the National Institutes of Health, Leukemia and Lymphoma Society, and the Barnes-Jewish Hospital Foundation.

Several study authors reported personal fees and/or research support from industry outside the submitted work.

AML cells

New research suggests relapse of acute myeloid leukemia (AML) after allogeneic hematopoietic stem cell transplant (HSCT) is related to changes in immune-related gene expression that may be reversible.

Researchers observed downregulation of major histocompatibility complex (MHC) class II genes in samples from patients who relapsed after HSCT.

However, interferon-gamma “rapidly reversed this phenotype” in vitro, according to the researchers.

Matthew J. Christopher, MD, PhD, of Washington University School of Medicine in St. Louis, Missouri, and his colleagues reported these findings in The New England Journal of Medicine.

The researchers set out to determine how genetic and epigenetic changes after HSCT may allow leukemic cells to avoid the graft-vs-leukemia effect and to see whether immune-related genes are affected by HSCT.

The team analyzed paired samples obtained at diagnosis and relapse from 15 AML patients who relapsed after HSCT and 20 AML patients who relapsed after chemotherapy. The team also analyzed additional samples from patients who relapsed after HSCT to validate initial findings.

Methods of analysis included enhanced exome sequencing, RNA sequencing, flow cytometry, and immunohistochemical analysis.

Findings

The researchers first looked for relapse-specific mutations but found no driver mutations associated with relapse after HSCT.

The mutations seen post-HSCT relapse were generally similar to those seen both before treatment and after relapse in patients who had undergone chemotherapy, and the researchers could not identify any patterns of mutations related to relapse.

They then looked for, but did not find, relapse-specific mutations in genes involved in modulation of immune checkpoints, antigen presentation, or cytokine signaling.

The researchers did, however, find evidence of epigenetic changes that were more common in the samples from patients with post-transplant relapses.

RNA sequencing showed that MHC class II genes (HLA-DPA1, HLA-DPB1, HLA-DQB1, and HLA-DRB1) were downregulated three- to 12-fold after transplant.

Flow cytometry and immunohistochemical analysis confirmed that MHC class II expression was decreased at relapse after HSCT in 17 of 34 samples evaluated.

The researchers said there was no association between the downregulation of MHC class II and donor type or use of immunosuppression.

To see whether the downregulation of MHC class II genes was reversible, the researchers treated three post-HSCT relapse samples with interferon-gamma, which is known to upregulate MHC class II on certain cells.

Culturing patient cells with interferon-gamma “rapidly induced MHC class II protein expression on leukemic blasts,” the researchers said. They observed “essentially full restoration of MHC class II protein expression in nearly all AML blasts after 72 hours.”

This study was supported by the National Institutes of Health, Leukemia and Lymphoma Society, and the Barnes-Jewish Hospital Foundation.

Several study authors reported personal fees and/or research support from industry outside the submitted work.

Vials and a syringe

Sandoz has decided not to pursue U.S. approval for its rituximab product (GP2013), a proposed biosimiliar of Rituxan/Mabthera.

GP2013 (Rixathon, Riximyo) is already approved outside the U.S.

Sandoz was seeking U.S. approval of GP2013 for all the same indications as the reference product—B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.

The U.S. Food and Drug Administration (FDA) had accepted the biologics license application (BLA) for GP2013 in September 2017.

In May of this year, the FDA issued a complete response letter saying it could not approve GP2013. The agency also requested additional information to complement the BLA submission for GP2013.

At the time of the complete response letter, Sandoz said it was still committed to bringing GP2013 to the U.S. market. Now, the company’s position has changed.

“We appreciate the important conversations with the FDA, which have provided specific requirements for our potential U.S. biosimilar rituximab, but believe the patient and marketplace needs in the U.S. will be satisfied before we can generate the data required,” said Stefan Hendriks, global head of biopharmaceuticals at Sandoz.

“We are disappointed to have to make this decision and stand behind the safety, efficacy, and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand, and Australia.”

The BLA for GP2013 was supported, in part, by the ASSIST-FL trial (NCT01419665), in which researchers compared GP2013 to the reference product. Results from this trial were published in The Lancet Haematology in July 2017.

The phase 3 trial included adults with previously untreated, advanced stage follicular lymphoma. Patients received 8 cycles of cyclophosphamide, vincristine, and prednisone with either GP2013 or reference rituximab. Responders then received GP2013 or rituximab monotherapy as maintenance for up to 2 years.

At a median follow-up of 11.6 months, the overall response rate was 87% (271/311) in the GP2013 arm and 88% in the rituximab arm (274/313). Complete response rates were 15% (n=46) and 13% (n=42), respectively.

Rates of adverse events (AEs) were 93% in the GP2013 arm and 91% in the rituximab arm. Rates of serious AEs were 23% and 20%, respectively. The rate of discontinuation due to AEs was 7% in both arms.

The most common AE was neutropenia, which occurred in 26% of patients in the GP2013 arm and 30% of those in the rituximab arm in the combination phase. Rates of neutropenia in the maintenance phase were 10% and 6%, respectively.

Vials and a syringe

Sandoz has decided not to pursue U.S. approval for its rituximab product (GP2013), a proposed biosimiliar of Rituxan/Mabthera.

GP2013 (Rixathon, Riximyo) is already approved outside the U.S.

Sandoz was seeking U.S. approval of GP2013 for all the same indications as the reference product—B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.

The U.S. Food and Drug Administration (FDA) had accepted the biologics license application (BLA) for GP2013 in September 2017.

In May of this year, the FDA issued a complete response letter saying it could not approve GP2013. The agency also requested additional information to complement the BLA submission for GP2013.

At the time of the complete response letter, Sandoz said it was still committed to bringing GP2013 to the U.S. market. Now, the company’s position has changed.

“We appreciate the important conversations with the FDA, which have provided specific requirements for our potential U.S. biosimilar rituximab, but believe the patient and marketplace needs in the U.S. will be satisfied before we can generate the data required,” said Stefan Hendriks, global head of biopharmaceuticals at Sandoz.

“We are disappointed to have to make this decision and stand behind the safety, efficacy, and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand, and Australia.”

The BLA for GP2013 was supported, in part, by the ASSIST-FL trial (NCT01419665), in which researchers compared GP2013 to the reference product. Results from this trial were published in The Lancet Haematology in July 2017.

The phase 3 trial included adults with previously untreated, advanced stage follicular lymphoma. Patients received 8 cycles of cyclophosphamide, vincristine, and prednisone with either GP2013 or reference rituximab. Responders then received GP2013 or rituximab monotherapy as maintenance for up to 2 years.

At a median follow-up of 11.6 months, the overall response rate was 87% (271/311) in the GP2013 arm and 88% in the rituximab arm (274/313). Complete response rates were 15% (n=46) and 13% (n=42), respectively.

Rates of adverse events (AEs) were 93% in the GP2013 arm and 91% in the rituximab arm. Rates of serious AEs were 23% and 20%, respectively. The rate of discontinuation due to AEs was 7% in both arms.

The most common AE was neutropenia, which occurred in 26% of patients in the GP2013 arm and 30% of those in the rituximab arm in the combination phase. Rates of neutropenia in the maintenance phase were 10% and 6%, respectively.

Vials and a syringe

Sandoz has decided not to pursue U.S. approval for its rituximab product (GP2013), a proposed biosimiliar of Rituxan/Mabthera.

GP2013 (Rixathon, Riximyo) is already approved outside the U.S.

Sandoz was seeking U.S. approval of GP2013 for all the same indications as the reference product—B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.

The U.S. Food and Drug Administration (FDA) had accepted the biologics license application (BLA) for GP2013 in September 2017.

In May of this year, the FDA issued a complete response letter saying it could not approve GP2013. The agency also requested additional information to complement the BLA submission for GP2013.

At the time of the complete response letter, Sandoz said it was still committed to bringing GP2013 to the U.S. market. Now, the company’s position has changed.

“We appreciate the important conversations with the FDA, which have provided specific requirements for our potential U.S. biosimilar rituximab, but believe the patient and marketplace needs in the U.S. will be satisfied before we can generate the data required,” said Stefan Hendriks, global head of biopharmaceuticals at Sandoz.

“We are disappointed to have to make this decision and stand behind the safety, efficacy, and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand, and Australia.”

The BLA for GP2013 was supported, in part, by the ASSIST-FL trial (NCT01419665), in which researchers compared GP2013 to the reference product. Results from this trial were published in The Lancet Haematology in July 2017.

The phase 3 trial included adults with previously untreated, advanced stage follicular lymphoma. Patients received 8 cycles of cyclophosphamide, vincristine, and prednisone with either GP2013 or reference rituximab. Responders then received GP2013 or rituximab monotherapy as maintenance for up to 2 years.

At a median follow-up of 11.6 months, the overall response rate was 87% (271/311) in the GP2013 arm and 88% in the rituximab arm (274/313). Complete response rates were 15% (n=46) and 13% (n=42), respectively.

Rates of adverse events (AEs) were 93% in the GP2013 arm and 91% in the rituximab arm. Rates of serious AEs were 23% and 20%, respectively. The rate of discontinuation due to AEs was 7% in both arms.

The most common AE was neutropenia, which occurred in 26% of patients in the GP2013 arm and 30% of those in the rituximab arm in the combination phase. Rates of neutropenia in the maintenance phase were 10% and 6%, respectively.

Micrograph showing myelofibrosis

The U.S. Food and Drug Administration (FDA) has granted fast track designation to CPI-0610 for the treatment of myelofibrosis (MF).

CPI-0610 is a BET inhibitor being developed by Constellation Pharmaceuticals, Inc.

The company said results from preclinical studies and translational insights from the first-in-human study of CPI-0610 led to the prioritization of CPI-0610 as a potential treatment for MF.

The company is now enrolling patients in the phase 2 portion of the phase 1/2 MANIFEST trial (NCT02158858).

In this trial, researchers are testing CPI-0610 alone or in combination with ruxolitinib in the following patient groups:

• Transfusion-dependent or -independent MF patients who have previously received a JAK inhibitor and are ineligible for or cannot tolerate additional JAK inhibitor therapy, lost response to a JAK inhibitor, or are resistant or refractory to JAK inhibition
• MF patients who are transfusion-dependent or -independent whose disease is not being adequately controlled by ruxolitinib
• MF patients who are anemic and have not previously received a JAK inhibitor.

According to Constellation Pharmaceuticals, CPI-0610 demonstrated clinical activity in the first four patients treated on this trial, all of whom previously received a JAK inhibitor.

The researchers observed reductions in spleen volume and improvements in hemoglobin levels in patients who received monotherapy (n=2) or CPI-0610 plus ruxolitinib (n=2).

One patient treated with the combination experienced resolution of thrombocytosis and became transfusion-independent.

The company said proof-of-concept data from this trial are expected in mid-2019.

About fast track designation

The FDA’s fast track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the product’s development plan and written communications about issues such as trial design and use of biomarkers.

Products that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met. Such products may also be eligible for rolling review, which allows a developer to submit individual sections of a product’s application for review as they are ready, rather than waiting until all sections are complete.

Micrograph showing myelofibrosis

The U.S. Food and Drug Administration (FDA) has granted fast track designation to CPI-0610 for the treatment of myelofibrosis (MF).

CPI-0610 is a BET inhibitor being developed by Constellation Pharmaceuticals, Inc.

The company said results from preclinical studies and translational insights from the first-in-human study of CPI-0610 led to the prioritization of CPI-0610 as a potential treatment for MF.

The company is now enrolling patients in the phase 2 portion of the phase 1/2 MANIFEST trial (NCT02158858).

In this trial, researchers are testing CPI-0610 alone or in combination with ruxolitinib in the following patient groups:

• Transfusion-dependent or -independent MF patients who have previously received a JAK inhibitor and are ineligible for or cannot tolerate additional JAK inhibitor therapy, lost response to a JAK inhibitor, or are resistant or refractory to JAK inhibition
• MF patients who are transfusion-dependent or -independent whose disease is not being adequately controlled by ruxolitinib
• MF patients who are anemic and have not previously received a JAK inhibitor.

According to Constellation Pharmaceuticals, CPI-0610 demonstrated clinical activity in the first four patients treated on this trial, all of whom previously received a JAK inhibitor.

The researchers observed reductions in spleen volume and improvements in hemoglobin levels in patients who received monotherapy (n=2) or CPI-0610 plus ruxolitinib (n=2).

One patient treated with the combination experienced resolution of thrombocytosis and became transfusion-independent.

The company said proof-of-concept data from this trial are expected in mid-2019.

About fast track designation

The FDA’s fast track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the product’s development plan and written communications about issues such as trial design and use of biomarkers.

Products that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met. Such products may also be eligible for rolling review, which allows a developer to submit individual sections of a product’s application for review as they are ready, rather than waiting until all sections are complete.

Micrograph showing myelofibrosis

The U.S. Food and Drug Administration (FDA) has granted fast track designation to CPI-0610 for the treatment of myelofibrosis (MF).

CPI-0610 is a BET inhibitor being developed by Constellation Pharmaceuticals, Inc.

The company said results from preclinical studies and translational insights from the first-in-human study of CPI-0610 led to the prioritization of CPI-0610 as a potential treatment for MF.

The company is now enrolling patients in the phase 2 portion of the phase 1/2 MANIFEST trial (NCT02158858).

In this trial, researchers are testing CPI-0610 alone or in combination with ruxolitinib in the following patient groups:

• Transfusion-dependent or -independent MF patients who have previously received a JAK inhibitor and are ineligible for or cannot tolerate additional JAK inhibitor therapy, lost response to a JAK inhibitor, or are resistant or refractory to JAK inhibition
• MF patients who are transfusion-dependent or -independent whose disease is not being adequately controlled by ruxolitinib
• MF patients who are anemic and have not previously received a JAK inhibitor.

According to Constellation Pharmaceuticals, CPI-0610 demonstrated clinical activity in the first four patients treated on this trial, all of whom previously received a JAK inhibitor.

The researchers observed reductions in spleen volume and improvements in hemoglobin levels in patients who received monotherapy (n=2) or CPI-0610 plus ruxolitinib (n=2).

One patient treated with the combination experienced resolution of thrombocytosis and became transfusion-independent.

The company said proof-of-concept data from this trial are expected in mid-2019.

About fast track designation

The FDA’s fast track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the product’s development plan and written communications about issues such as trial design and use of biomarkers.

Products that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met. Such products may also be eligible for rolling review, which allows a developer to submit individual sections of a product’s application for review as they are ready, rather than waiting until all sections are complete.

SEATTLE – Mindfulness exercises can ease stress for low-income parents and improve mental health measures in their children, results of a small pilot study presented at the American Academy of Child and Adolescent Psychiatry indicate.

The researchers credit the location of the mindfulness intervention, an early childhood developmental center, and the focus on the child rather than the parent for the success of the program. The intervention is designed to help the child, and that is the major message to the parent. “Every parent will do things to help their child, even though not every parent will do things to help themselves,” said Matthew G. Biel, MD, of Georgetown University, Washington, who presented the study at a poster session.

Mindfulness has gained traction among adults and children, but its application to parenting is new, he said. The study was open label and included 33 caregivers of children aged 0-5 years (85% female, 82% African American, 85% with household income less than $50,000/year). All subjects participated in a weekly mindfulness session lasting 60-90 minutes, which was led by an experienced instructor who had strong cultural knowledge of the local community. Sessions were conducted in a circle and included mindfulness practices and parent sharing of experiences. Focal points for mindfulness practices included breathing, body awareness, mindful movement, thoughts, emotions, and mindful listening and speaking.

The intervention was associated with statistically significant improvements in a range of measures, including sleep disturbance (effect size, 0.50; P = .005), parenting stress (ES, 0.33; P = .012), mindful discipline (ES, 0.21; P = .043), parental support (ES, 0.44; P = .007), child autonomy (ES, 032; P = .033), positive affect in parents (ES, 0.28; P = .046) and negative affect in parents (ES, 0.49; P = .028), and overall parental mental health (ES, 0.55; P = .020). “Across the board we’re seeing a positive impact,” said Dr. Biel.

The researchers are now implementing the program in another school and planning an intervention study with a waiting list control.

Satyani McPherson, a coauthor of the study and a mindfulness expert who has been teaching since the 1980s, explained that mindfulness really needs to be experienced to be understood. “You can talk about this all day, and no one gets it until they experience it. As soon as people have their mindfulness practice, they come out of it and they say, ‘Aaah, I feel so much better,’ ” she said in an interview.

The key to success lies in repetition and practice, and parents who did their mindfulness “homework” between sessions saw more benefit in the pilot study, said Ms. McPherson. The good news is that mindfulness can be incorporated into all sorts of daily activities, whether it’s showering, eating, or being stopped at a red light. It can even be used as a sort of time-out for patients. “Go into the restroom, lock the door, and observe your breath for one minute, or just one breath or three breaths. It helps you to ground yourself,” said Ms. McPherson.

Ms McPherson is an employee of Minds Incorporated. Dr. Biel receives research support from the Bainum Family Foundation, Chan-Zuckerberg Initiative, DC Health, Marriott Foundation, and self-funds his research.

SOURCE: AACAP 2018. Abstract 1.40.

SEATTLE – Mindfulness exercises can ease stress for low-income parents and improve mental health measures in their children, results of a small pilot study presented at the American Academy of Child and Adolescent Psychiatry indicate.

The researchers credit the location of the mindfulness intervention, an early childhood developmental center, and the focus on the child rather than the parent for the success of the program. The intervention is designed to help the child, and that is the major message to the parent. “Every parent will do things to help their child, even though not every parent will do things to help themselves,” said Matthew G. Biel, MD, of Georgetown University, Washington, who presented the study at a poster session.

Mindfulness has gained traction among adults and children, but its application to parenting is new, he said. The study was open label and included 33 caregivers of children aged 0-5 years (85% female, 82% African American, 85% with household income less than $50,000/year). All subjects participated in a weekly mindfulness session lasting 60-90 minutes, which was led by an experienced instructor who had strong cultural knowledge of the local community. Sessions were conducted in a circle and included mindfulness practices and parent sharing of experiences. Focal points for mindfulness practices included breathing, body awareness, mindful movement, thoughts, emotions, and mindful listening and speaking.

The intervention was associated with statistically significant improvements in a range of measures, including sleep disturbance (effect size, 0.50; P = .005), parenting stress (ES, 0.33; P = .012), mindful discipline (ES, 0.21; P = .043), parental support (ES, 0.44; P = .007), child autonomy (ES, 032; P = .033), positive affect in parents (ES, 0.28; P = .046) and negative affect in parents (ES, 0.49; P = .028), and overall parental mental health (ES, 0.55; P = .020). “Across the board we’re seeing a positive impact,” said Dr. Biel.

The researchers are now implementing the program in another school and planning an intervention study with a waiting list control.

Satyani McPherson, a coauthor of the study and a mindfulness expert who has been teaching since the 1980s, explained that mindfulness really needs to be experienced to be understood. “You can talk about this all day, and no one gets it until they experience it. As soon as people have their mindfulness practice, they come out of it and they say, ‘Aaah, I feel so much better,’ ” she said in an interview.

The key to success lies in repetition and practice, and parents who did their mindfulness “homework” between sessions saw more benefit in the pilot study, said Ms. McPherson. The good news is that mindfulness can be incorporated into all sorts of daily activities, whether it’s showering, eating, or being stopped at a red light. It can even be used as a sort of time-out for patients. “Go into the restroom, lock the door, and observe your breath for one minute, or just one breath or three breaths. It helps you to ground yourself,” said Ms. McPherson.

Ms McPherson is an employee of Minds Incorporated. Dr. Biel receives research support from the Bainum Family Foundation, Chan-Zuckerberg Initiative, DC Health, Marriott Foundation, and self-funds his research.

SOURCE: AACAP 2018. Abstract 1.40.

SEATTLE – Mindfulness exercises can ease stress for low-income parents and improve mental health measures in their children, results of a small pilot study presented at the American Academy of Child and Adolescent Psychiatry indicate.

The researchers credit the location of the mindfulness intervention, an early childhood developmental center, and the focus on the child rather than the parent for the success of the program. The intervention is designed to help the child, and that is the major message to the parent. “Every parent will do things to help their child, even though not every parent will do things to help themselves,” said Matthew G. Biel, MD, of Georgetown University, Washington, who presented the study at a poster session.

Mindfulness has gained traction among adults and children, but its application to parenting is new, he said. The study was open label and included 33 caregivers of children aged 0-5 years (85% female, 82% African American, 85% with household income less than $50,000/year). All subjects participated in a weekly mindfulness session lasting 60-90 minutes, which was led by an experienced instructor who had strong cultural knowledge of the local community. Sessions were conducted in a circle and included mindfulness practices and parent sharing of experiences. Focal points for mindfulness practices included breathing, body awareness, mindful movement, thoughts, emotions, and mindful listening and speaking.

The intervention was associated with statistically significant improvements in a range of measures, including sleep disturbance (effect size, 0.50; P = .005), parenting stress (ES, 0.33; P = .012), mindful discipline (ES, 0.21; P = .043), parental support (ES, 0.44; P = .007), child autonomy (ES, 032; P = .033), positive affect in parents (ES, 0.28; P = .046) and negative affect in parents (ES, 0.49; P = .028), and overall parental mental health (ES, 0.55; P = .020). “Across the board we’re seeing a positive impact,” said Dr. Biel.

The researchers are now implementing the program in another school and planning an intervention study with a waiting list control.

Satyani McPherson, a coauthor of the study and a mindfulness expert who has been teaching since the 1980s, explained that mindfulness really needs to be experienced to be understood. “You can talk about this all day, and no one gets it until they experience it. As soon as people have their mindfulness practice, they come out of it and they say, ‘Aaah, I feel so much better,’ ” she said in an interview.

The key to success lies in repetition and practice, and parents who did their mindfulness “homework” between sessions saw more benefit in the pilot study, said Ms. McPherson. The good news is that mindfulness can be incorporated into all sorts of daily activities, whether it’s showering, eating, or being stopped at a red light. It can even be used as a sort of time-out for patients. “Go into the restroom, lock the door, and observe your breath for one minute, or just one breath or three breaths. It helps you to ground yourself,” said Ms. McPherson.

Ms McPherson is an employee of Minds Incorporated. Dr. Biel receives research support from the Bainum Family Foundation, Chan-Zuckerberg Initiative, DC Health, Marriott Foundation, and self-funds his research.

SOURCE: AACAP 2018. Abstract 1.40.

Researchers did not find any difference in number of self-reported premenstrual syndrome (PMS) symptoms between migraineurs with and without menstrual migraine (MM), according to a recent study. A total of 237 women from the general population who self-reported migraine in at least 50% of their menstrual periods were invited to a clinical interview and diagnosed by a neurologist. All women were asked to complete a self-administered form containing 11 questions about PMS symptoms adapted from the Diagnostic and Statistical Manual of Mental Disorders. In addition, each participant completed the Headache Impact test (HIT-6) and Migraine Disability Assessment Score (MIDAS). They found:

• 193 women returned a complete PMS questionnaire, of which 67 women were excluded from the analyses due to current use of hormonal contraception (n=61) or because they did not fulfill the ICHD-criteria for migraine (n=6).
• Among the remaining 126 migraineurs, 78 had MM and 48 had non-menstrually related migraine.
• PMS symptoms were equally frequent in migraineurs with and without MM (5.4 vs 5.9).
• Women with MM reported more migraine days/month, longer lasting migraine attacks, and higher HIT-6 scores than those without MM, but MIDAS scores were similar.

Vetvik KG, MacGregor EA, Lundqyist C, Russell MB. Symptoms of premenstrual syndrome in female migraineurs with and without menstrual migraine. [Published online ahead of print October 17, 2018]. J Headache Pain. doi:10.1186/s10194-018-0931-6.

Researchers did not find any difference in number of self-reported premenstrual syndrome (PMS) symptoms between migraineurs with and without menstrual migraine (MM), according to a recent study. A total of 237 women from the general population who self-reported migraine in at least 50% of their menstrual periods were invited to a clinical interview and diagnosed by a neurologist. All women were asked to complete a self-administered form containing 11 questions about PMS symptoms adapted from the Diagnostic and Statistical Manual of Mental Disorders. In addition, each participant completed the Headache Impact test (HIT-6) and Migraine Disability Assessment Score (MIDAS). They found:

• 193 women returned a complete PMS questionnaire, of which 67 women were excluded from the analyses due to current use of hormonal contraception (n=61) or because they did not fulfill the ICHD-criteria for migraine (n=6).
• Among the remaining 126 migraineurs, 78 had MM and 48 had non-menstrually related migraine.
• PMS symptoms were equally frequent in migraineurs with and without MM (5.4 vs 5.9).
• Women with MM reported more migraine days/month, longer lasting migraine attacks, and higher HIT-6 scores than those without MM, but MIDAS scores were similar.

Vetvik KG, MacGregor EA, Lundqyist C, Russell MB. Symptoms of premenstrual syndrome in female migraineurs with and without menstrual migraine. [Published online ahead of print October 17, 2018]. J Headache Pain. doi:10.1186/s10194-018-0931-6.

Researchers did not find any difference in number of self-reported premenstrual syndrome (PMS) symptoms between migraineurs with and without menstrual migraine (MM), according to a recent study. A total of 237 women from the general population who self-reported migraine in at least 50% of their menstrual periods were invited to a clinical interview and diagnosed by a neurologist. All women were asked to complete a self-administered form containing 11 questions about PMS symptoms adapted from the Diagnostic and Statistical Manual of Mental Disorders. In addition, each participant completed the Headache Impact test (HIT-6) and Migraine Disability Assessment Score (MIDAS). They found:

• 193 women returned a complete PMS questionnaire, of which 67 women were excluded from the analyses due to current use of hormonal contraception (n=61) or because they did not fulfill the ICHD-criteria for migraine (n=6).
• Among the remaining 126 migraineurs, 78 had MM and 48 had non-menstrually related migraine.
• PMS symptoms were equally frequent in migraineurs with and without MM (5.4 vs 5.9).
• Women with MM reported more migraine days/month, longer lasting migraine attacks, and higher HIT-6 scores than those without MM, but MIDAS scores were similar.

Vetvik KG, MacGregor EA, Lundqyist C, Russell MB. Symptoms of premenstrual syndrome in female migraineurs with and without menstrual migraine. [Published online ahead of print October 17, 2018]. J Headache Pain. doi:10.1186/s10194-018-0931-6.

Typical aura without headache, a rare subtype of migraine, occurs exclusively in 4% patients with migraine, and may take place at some point in 38% of patients with migraine with aura, according to recent study. Furthermore, typical aura without headache, also known as migraine aura without headache or acephalgic migraine, commonly presents with visual aura without headache, brainstem aura without headache, and can also develop later in life, known as late-onset migraine accompaniment. Its pathophysiology is suggested to be similar to classic migraines, with cortical spreading depression leading to aura formation but without an associated headache. Presently, no clinical trials have been performed to evaluate treatment options, but case reports suggest that most patients will respond to the traditional treatments for migraine with aura.

Shah DR, Dilwali S, Friedman DI. Migraine aura without headache. Curr Pain Headache Rep. 2018;22:77. doi:10.1007/s11916-018-0725-1.

Typical aura without headache, a rare subtype of migraine, occurs exclusively in 4% patients with migraine, and may take place at some point in 38% of patients with migraine with aura, according to recent study. Furthermore, typical aura without headache, also known as migraine aura without headache or acephalgic migraine, commonly presents with visual aura without headache, brainstem aura without headache, and can also develop later in life, known as late-onset migraine accompaniment. Its pathophysiology is suggested to be similar to classic migraines, with cortical spreading depression leading to aura formation but without an associated headache. Presently, no clinical trials have been performed to evaluate treatment options, but case reports suggest that most patients will respond to the traditional treatments for migraine with aura.

Shah DR, Dilwali S, Friedman DI. Migraine aura without headache. Curr Pain Headache Rep. 2018;22:77. doi:10.1007/s11916-018-0725-1.

Typical aura without headache, a rare subtype of migraine, occurs exclusively in 4% patients with migraine, and may take place at some point in 38% of patients with migraine with aura, according to recent study. Furthermore, typical aura without headache, also known as migraine aura without headache or acephalgic migraine, commonly presents with visual aura without headache, brainstem aura without headache, and can also develop later in life, known as late-onset migraine accompaniment. Its pathophysiology is suggested to be similar to classic migraines, with cortical spreading depression leading to aura formation but without an associated headache. Presently, no clinical trials have been performed to evaluate treatment options, but case reports suggest that most patients will respond to the traditional treatments for migraine with aura.

Shah DR, Dilwali S, Friedman DI. Migraine aura without headache. Curr Pain Headache Rep. 2018;22:77. doi:10.1007/s11916-018-0725-1.

Patients with migraines and patients classified as Caucasian had higher odds of being diagnosed with transient global amnesia (TGA), according to a recent study. All minority populations, however, showed a lower rate of diagnosis that fell short of statistical significance.  Data were obtained from the Nationwide Inpatient Sample using ICD-9 and procedure codes. Descriptive and survey logistic regression analyses were conducted and adjusted for influence of comorbidities, demographic characteristics, and hospitalization-related factors. Researchers found:

• Patients with migraines were 5.98 times more likely to also have a diagnosis of TGA compared with patients without migraines.
• Similarly, patients with TGA were more likely to have hypertension, precerebral disease, and hyperlipidemia.
• The odds of being diagnosed with TGA was lower among African Americans and Hispanics as well as among patients classified as Asian/other, compared with Caucasians.
• TGA was associated with lower hospital charges ($14,242 vs $21,319), shorter hospital stays (mean days: 2.49 [SE=0.036] vs 4.72 [SE=0.025]), and routine hospital discharges (91.4% vs 74.5%).

Yi M, Sherzai AZ, Ani C, et al. Strong association between migraine and transient global amnesia: A National Inpatient Sample analysis. [Published online ahead of print October 11, 2018]. J Neuropsychiatry Clin Neurosci. doi:10.1176/appi.neuropsych.17120353.

Patients with migraines and patients classified as Caucasian had higher odds of being diagnosed with transient global amnesia (TGA), according to a recent study. All minority populations, however, showed a lower rate of diagnosis that fell short of statistical significance.  Data were obtained from the Nationwide Inpatient Sample using ICD-9 and procedure codes. Descriptive and survey logistic regression analyses were conducted and adjusted for influence of comorbidities, demographic characteristics, and hospitalization-related factors. Researchers found:

• Patients with migraines were 5.98 times more likely to also have a diagnosis of TGA compared with patients without migraines.
• Similarly, patients with TGA were more likely to have hypertension, precerebral disease, and hyperlipidemia.
• The odds of being diagnosed with TGA was lower among African Americans and Hispanics as well as among patients classified as Asian/other, compared with Caucasians.
• TGA was associated with lower hospital charges ($14,242 vs $21,319), shorter hospital stays (mean days: 2.49 [SE=0.036] vs 4.72 [SE=0.025]), and routine hospital discharges (91.4% vs 74.5%).

Yi M, Sherzai AZ, Ani C, et al. Strong association between migraine and transient global amnesia: A National Inpatient Sample analysis. [Published online ahead of print October 11, 2018]. J Neuropsychiatry Clin Neurosci. doi:10.1176/appi.neuropsych.17120353.

Patients with migraines and patients classified as Caucasian had higher odds of being diagnosed with transient global amnesia (TGA), according to a recent study. All minority populations, however, showed a lower rate of diagnosis that fell short of statistical significance.  Data were obtained from the Nationwide Inpatient Sample using ICD-9 and procedure codes. Descriptive and survey logistic regression analyses were conducted and adjusted for influence of comorbidities, demographic characteristics, and hospitalization-related factors. Researchers found:

• Patients with migraines were 5.98 times more likely to also have a diagnosis of TGA compared with patients without migraines.
• Similarly, patients with TGA were more likely to have hypertension, precerebral disease, and hyperlipidemia.
• The odds of being diagnosed with TGA was lower among African Americans and Hispanics as well as among patients classified as Asian/other, compared with Caucasians.
• TGA was associated with lower hospital charges ($14,242 vs $21,319), shorter hospital stays (mean days: 2.49 [SE=0.036] vs 4.72 [SE=0.025]), and routine hospital discharges (91.4% vs 74.5%).

Yi M, Sherzai AZ, Ani C, et al. Strong association between migraine and transient global amnesia: A National Inpatient Sample analysis. [Published online ahead of print October 11, 2018]. J Neuropsychiatry Clin Neurosci. doi:10.1176/appi.neuropsych.17120353.

ORLANDO – Less than half of children could identify a real gun from a toy gun in photos, regardless of whether their parents owned a gun or had talked to them about firearm safety, according to a new study.

Tara Haelle/MDedge News

“That is very concerning to us because a large percentage of these parents are actually storing their firearms insecurely and then their children cannot tell the difference,” study investigator Kiesha Fraser Doh, MD, reported at the annual conference of the American Academy of Pediatrics.

Dr. Fraser Doh, assistant professor of pediatrics and emergency medicine physician at Emory University School of Medicine and Children’s Healthcare of Atlanta said she was inspired to conduct this study after she noticed she was seeing approximately one firearm injury in children about every 2½ weeks in her institution. She also realized that her own child frequently went on play dates, but she did not always think to ask about firearms in the home of the friends her child visited.

An estimated one in three U.S. children live in homes with a firearm, she explained, and many of these guns are left loaded and/or unlocked.

The researchers enrolled a convenience sample of 297 English-speaking caregivers who presented at one of three pediatrics EDs over 3 months. Two were suburban departments, and one was urban.

Overall, most respondents (79%) were female and 56% were black, while 33% were white. Most of the caregivers responding had some college education (72%), and just over half (51%) had an income greater than $50,000.

The researchers asked caregivers whether they had guns in their own home and whether their child had access to firearms in their own or other homes. They also asked if their child played with toy guns and whether they believed their child could tell the difference between a real gun and a toy one.

Compared with those who did not own guns, gun owners were significantly more likely to be white and have both an income over $50,000 and some college education.

Meanwhile, researchers showed the children, aged 7-17 years, photos of a toy gun and a real gun and asked which was which.

A quarter of the caregivers (25%) owned guns, and half of them (50%) allowed their children to play with guns, compared with 26% of the non-gun owners.

In addition, 86% of the gun owners had discussed gun safety with their children, and the same proportion believed their children could correctly distinguish between a real gun and a toy gun.

By comparison, 58% of the non-gun owners had discussed gun safety with their children, and the same percentage believed their children could tell the difference between real and fake guns.

The children’s confidence in being able to tell the difference was similar regardless of whether their parents owned guns (79%) or didn’t (76%).

Yet less than half of all children correctly identified the real gun in the photos: 39% of the gun owners’ children and 42% of the non-gun owners’ children correctly pointed out the real gun, a nonsignificant difference.

Throughout the entire sample, more than 8 in 10 respondents, both gun owners (86%) and not (84%), believed there should be a law that requires caregivers to store their guns safely. A similar proportion (85% of gun owners and 80% of non-gun owners) believed legal penalties should exist for caregivers “if a child encounters an unsecured firearm.”

Overall, 5% of the respondents (14% of gun owners and 4% of non-gun owners) believed their child could get a gun within 24 hours if desired.

“So what does this mean to us as clinicians? It behooves [pediatricians] to actually continue to educate families at well-child visits on the guidelines about how to store firearms safely, locked up, unloaded, separate from ammunition,” Dr. Fraser Doh said. “On the flip side, parents need to be asking about the presence of firearms in the homes their children visit and also make sure that they’re storing their weapons safety.”

Dr. Fraser Doh said she had no relevant conflicts of interest.

ORLANDO – Less than half of children could identify a real gun from a toy gun in photos, regardless of whether their parents owned a gun or had talked to them about firearm safety, according to a new study.

Tara Haelle/MDedge News

“That is very concerning to us because a large percentage of these parents are actually storing their firearms insecurely and then their children cannot tell the difference,” study investigator Kiesha Fraser Doh, MD, reported at the annual conference of the American Academy of Pediatrics.

Dr. Fraser Doh, assistant professor of pediatrics and emergency medicine physician at Emory University School of Medicine and Children’s Healthcare of Atlanta said she was inspired to conduct this study after she noticed she was seeing approximately one firearm injury in children about every 2½ weeks in her institution. She also realized that her own child frequently went on play dates, but she did not always think to ask about firearms in the home of the friends her child visited.

An estimated one in three U.S. children live in homes with a firearm, she explained, and many of these guns are left loaded and/or unlocked.

The researchers enrolled a convenience sample of 297 English-speaking caregivers who presented at one of three pediatrics EDs over 3 months. Two were suburban departments, and one was urban.

Overall, most respondents (79%) were female and 56% were black, while 33% were white. Most of the caregivers responding had some college education (72%), and just over half (51%) had an income greater than $50,000.

The researchers asked caregivers whether they had guns in their own home and whether their child had access to firearms in their own or other homes. They also asked if their child played with toy guns and whether they believed their child could tell the difference between a real gun and a toy one.

Compared with those who did not own guns, gun owners were significantly more likely to be white and have both an income over $50,000 and some college education.

Meanwhile, researchers showed the children, aged 7-17 years, photos of a toy gun and a real gun and asked which was which.

A quarter of the caregivers (25%) owned guns, and half of them (50%) allowed their children to play with guns, compared with 26% of the non-gun owners.

In addition, 86% of the gun owners had discussed gun safety with their children, and the same proportion believed their children could correctly distinguish between a real gun and a toy gun.

By comparison, 58% of the non-gun owners had discussed gun safety with their children, and the same percentage believed their children could tell the difference between real and fake guns.

The children’s confidence in being able to tell the difference was similar regardless of whether their parents owned guns (79%) or didn’t (76%).

Yet less than half of all children correctly identified the real gun in the photos: 39% of the gun owners’ children and 42% of the non-gun owners’ children correctly pointed out the real gun, a nonsignificant difference.

Throughout the entire sample, more than 8 in 10 respondents, both gun owners (86%) and not (84%), believed there should be a law that requires caregivers to store their guns safely. A similar proportion (85% of gun owners and 80% of non-gun owners) believed legal penalties should exist for caregivers “if a child encounters an unsecured firearm.”

Overall, 5% of the respondents (14% of gun owners and 4% of non-gun owners) believed their child could get a gun within 24 hours if desired.

“So what does this mean to us as clinicians? It behooves [pediatricians] to actually continue to educate families at well-child visits on the guidelines about how to store firearms safely, locked up, unloaded, separate from ammunition,” Dr. Fraser Doh said. “On the flip side, parents need to be asking about the presence of firearms in the homes their children visit and also make sure that they’re storing their weapons safety.”

Dr. Fraser Doh said she had no relevant conflicts of interest.

ORLANDO – Less than half of children could identify a real gun from a toy gun in photos, regardless of whether their parents owned a gun or had talked to them about firearm safety, according to a new study.

Tara Haelle/MDedge News

“That is very concerning to us because a large percentage of these parents are actually storing their firearms insecurely and then their children cannot tell the difference,” study investigator Kiesha Fraser Doh, MD, reported at the annual conference of the American Academy of Pediatrics.

Dr. Fraser Doh, assistant professor of pediatrics and emergency medicine physician at Emory University School of Medicine and Children’s Healthcare of Atlanta said she was inspired to conduct this study after she noticed she was seeing approximately one firearm injury in children about every 2½ weeks in her institution. She also realized that her own child frequently went on play dates, but she did not always think to ask about firearms in the home of the friends her child visited.

An estimated one in three U.S. children live in homes with a firearm, she explained, and many of these guns are left loaded and/or unlocked.

The researchers enrolled a convenience sample of 297 English-speaking caregivers who presented at one of three pediatrics EDs over 3 months. Two were suburban departments, and one was urban.

Overall, most respondents (79%) were female and 56% were black, while 33% were white. Most of the caregivers responding had some college education (72%), and just over half (51%) had an income greater than $50,000.

The researchers asked caregivers whether they had guns in their own home and whether their child had access to firearms in their own or other homes. They also asked if their child played with toy guns and whether they believed their child could tell the difference between a real gun and a toy one.

Compared with those who did not own guns, gun owners were significantly more likely to be white and have both an income over $50,000 and some college education.

Meanwhile, researchers showed the children, aged 7-17 years, photos of a toy gun and a real gun and asked which was which.

A quarter of the caregivers (25%) owned guns, and half of them (50%) allowed their children to play with guns, compared with 26% of the non-gun owners.

In addition, 86% of the gun owners had discussed gun safety with their children, and the same proportion believed their children could correctly distinguish between a real gun and a toy gun.

By comparison, 58% of the non-gun owners had discussed gun safety with their children, and the same percentage believed their children could tell the difference between real and fake guns.

The children’s confidence in being able to tell the difference was similar regardless of whether their parents owned guns (79%) or didn’t (76%).

Yet less than half of all children correctly identified the real gun in the photos: 39% of the gun owners’ children and 42% of the non-gun owners’ children correctly pointed out the real gun, a nonsignificant difference.

Throughout the entire sample, more than 8 in 10 respondents, both gun owners (86%) and not (84%), believed there should be a law that requires caregivers to store their guns safely. A similar proportion (85% of gun owners and 80% of non-gun owners) believed legal penalties should exist for caregivers “if a child encounters an unsecured firearm.”

Overall, 5% of the respondents (14% of gun owners and 4% of non-gun owners) believed their child could get a gun within 24 hours if desired.

“So what does this mean to us as clinicians? It behooves [pediatricians] to actually continue to educate families at well-child visits on the guidelines about how to store firearms safely, locked up, unloaded, separate from ammunition,” Dr. Fraser Doh said. “On the flip side, parents need to be asking about the presence of firearms in the homes their children visit and also make sure that they’re storing their weapons safety.”

Dr. Fraser Doh said she had no relevant conflicts of interest.