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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Link between alcohol consumption, neuroinflammation has possible treatment implications
NEW YORK – Recent discoveries regarding the relationship between alcohol consumption and neuroinflammation suggest a possible role for adjunctive treatments and supplements in addiction treatment, according to Shram Shukla, MD.
For example, a qualitative review of the literature over the past 2-3 years showed that the “neuroinflammatory process in and of itself drives epigenetic changes, which ultimately upregulate neuroinflammation of the brain,” according to Dr. Shukla of Walter Reed National Military Medical Center, Bethesda, Md., who reported the findings in a poster at the annual meeting of the American Psychiatric Association.
In this video interview, he explained that this finding is important because “neuroinflammation leads to neurotoxicity, which leads to neuronal degeneration.”
“As we know, with patients who chronically abuse alcohol, they do have a level of cortical degeneration that we often see on imaging, so there is, perhaps, a role that this may play in that,” he added.
Dr. Shukla said he also found that the neuroinflammatory process, when it drives the epigenetic changes, affects the amygdala, which is known as a “high stress part of the brain.”
“What we found in animal models so far is that if we can impact where that epigenetic change occurs, we can prevent the anxiogenic behaviors we often see in alcohol withdrawal and abstinence; we associate that, in humans, to be the high-stress state we often see in patients when they ... are withdrawing from alcohol.”
This raised questions about whether certain medications and supplements, including vitamin C, pioglitazone, infliximab, and omega-3 fatty acids, could be of benefit, and it was shown that these do affect neuroinflammation and stop neurotoxicity from occurring – and also, in turn, prevent the epigenetic changes, he said.
The take-away is that
“Now we have something, potentially ... that can do some of the ancillary stuff, working on the withdrawal effects, helping with the behavioral response that we see in patients that are suffering from addiction,” he said.
Dr. Shukla reported having no disclosures.
SOURCE: Shukla S et al. APA Poster Session 4, Poster 3.
NEW YORK – Recent discoveries regarding the relationship between alcohol consumption and neuroinflammation suggest a possible role for adjunctive treatments and supplements in addiction treatment, according to Shram Shukla, MD.
For example, a qualitative review of the literature over the past 2-3 years showed that the “neuroinflammatory process in and of itself drives epigenetic changes, which ultimately upregulate neuroinflammation of the brain,” according to Dr. Shukla of Walter Reed National Military Medical Center, Bethesda, Md., who reported the findings in a poster at the annual meeting of the American Psychiatric Association.
In this video interview, he explained that this finding is important because “neuroinflammation leads to neurotoxicity, which leads to neuronal degeneration.”
“As we know, with patients who chronically abuse alcohol, they do have a level of cortical degeneration that we often see on imaging, so there is, perhaps, a role that this may play in that,” he added.
Dr. Shukla said he also found that the neuroinflammatory process, when it drives the epigenetic changes, affects the amygdala, which is known as a “high stress part of the brain.”
“What we found in animal models so far is that if we can impact where that epigenetic change occurs, we can prevent the anxiogenic behaviors we often see in alcohol withdrawal and abstinence; we associate that, in humans, to be the high-stress state we often see in patients when they ... are withdrawing from alcohol.”
This raised questions about whether certain medications and supplements, including vitamin C, pioglitazone, infliximab, and omega-3 fatty acids, could be of benefit, and it was shown that these do affect neuroinflammation and stop neurotoxicity from occurring – and also, in turn, prevent the epigenetic changes, he said.
The take-away is that
“Now we have something, potentially ... that can do some of the ancillary stuff, working on the withdrawal effects, helping with the behavioral response that we see in patients that are suffering from addiction,” he said.
Dr. Shukla reported having no disclosures.
SOURCE: Shukla S et al. APA Poster Session 4, Poster 3.
NEW YORK – Recent discoveries regarding the relationship between alcohol consumption and neuroinflammation suggest a possible role for adjunctive treatments and supplements in addiction treatment, according to Shram Shukla, MD.
For example, a qualitative review of the literature over the past 2-3 years showed that the “neuroinflammatory process in and of itself drives epigenetic changes, which ultimately upregulate neuroinflammation of the brain,” according to Dr. Shukla of Walter Reed National Military Medical Center, Bethesda, Md., who reported the findings in a poster at the annual meeting of the American Psychiatric Association.
In this video interview, he explained that this finding is important because “neuroinflammation leads to neurotoxicity, which leads to neuronal degeneration.”
“As we know, with patients who chronically abuse alcohol, they do have a level of cortical degeneration that we often see on imaging, so there is, perhaps, a role that this may play in that,” he added.
Dr. Shukla said he also found that the neuroinflammatory process, when it drives the epigenetic changes, affects the amygdala, which is known as a “high stress part of the brain.”
“What we found in animal models so far is that if we can impact where that epigenetic change occurs, we can prevent the anxiogenic behaviors we often see in alcohol withdrawal and abstinence; we associate that, in humans, to be the high-stress state we often see in patients when they ... are withdrawing from alcohol.”
This raised questions about whether certain medications and supplements, including vitamin C, pioglitazone, infliximab, and omega-3 fatty acids, could be of benefit, and it was shown that these do affect neuroinflammation and stop neurotoxicity from occurring – and also, in turn, prevent the epigenetic changes, he said.
The take-away is that
“Now we have something, potentially ... that can do some of the ancillary stuff, working on the withdrawal effects, helping with the behavioral response that we see in patients that are suffering from addiction,” he said.
Dr. Shukla reported having no disclosures.
SOURCE: Shukla S et al. APA Poster Session 4, Poster 3.
REPORTING FROM APA
In abdominal myomectomy, cell salvage may reduce transfusions
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
REPORTING FROM SGS 2018
Key clinical point: Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy.
Major finding: Transfusion rates were similar (23% and 17%) despite greater blood loss in the cell salvage group.
Study details: A retrospective review of 138 patients’ charts.
Disclosures: Dr. Gingold reported having no disclosures.
Source: Gingold J et al. SGS 2018 Oral poster 18.
Ocrelizumab safety update: Encouraging rates of serious infection, malignancy
LOS ANGELES – No new safety signals have emerged in multiple sclerosis patients treated with ocrelizumab, according to ongoing follow-up and postmarketing surveillance.
As of September 2017, patients with relapsing or primary progressive MS who were part of the pivotal OPERA I and II and ORATORIO trials – including phases 2 and 3 and open-label extensions – as well as an all-exposure population that included patients from prior studies, had nearly 9,500 patient-years of exposure to ocrelizumab (Ocrevus), a humanized anti-CD20 monoclonal antibody. The all-exposure population contributed about 1,500 of those patient-years, Stephen Hauser, MD, reported at the annual meeting of the American Academy of Neurology.
Postmarketing experience in approximately 37,000 treated patients with an additional 14,000 patient-years shows a fatality rate of 0.28/100 patient-years (49 fatalities) as of March 2018, he said.
“If one compares this to at least two reports of epidemiologic mortality estimates in MS, this is in line with – and in fact a little bit lower than – those estimates that range between 0.37 and 0.9, compared with 0.28,” he said. “So ... the updated safety profile in this all-exposure ocrelizumab population was generally consistent with what was seen during the controlled treatment period, and rates of serious infections fluctuated over time without any sustained increase.”
Only one serious opportunistic infection (Pasteurella) occurred in the controlled trials, and three more (two varicella zoster, one herpes simplex) occurred during open-marketing experience.
The rate of malignancies has been very encouraging, as well, as it appears to continue to align with population expectations, Dr. Hauser said.
Trial participants received 600-mg doses intravenously every 24 weeks in all three trials; in OPERA I/II, they received 96 weeks of treatment with the first dose given as two 300-mg infusions split by 14 days, and, in ORATORIO, they received at least 120 weeks of treatment with all doses split, Dr. Hauser said.
In the phase 2 study, they received split doses of 600-mg or 2,000-mg infusions through week 24; then through week 96, they received either 600-mg or 1,000-mg doses; those receiving 600 mg included those who started at that dose and those who received placebo or interferon beta-1a 30 mcg, and those receiving 1,000 mg were those who started on ocrelizumab at 2,000 mg.
The comparators were placebo in the ORATORIO and phase 2 trials, and interferon beta-1a given at a dose of 44 mcg subcutaneously three times weekly (OPERA I and II) or 30 mcg intramuscularly each week in the phase 2 trial.
All patients were offered enrollment into open-label extension studies, and “there was rather massive interest in joining the open-label extension and continuing open-label extension in both trials,” he said.
“And earlier here at the AAN [meeting] we presented the clinical efficacy data from the open-label extension, now 2 years completed – so 4 years from onset of the study – in patients who received ocrelizumab continuously for [relapsing-remitting] MS during that time period, or who switched from three-times-weekly interferon beta-1a to ocrelizumab ... and the data continue to show the positive outcomes reported in the original trials,” he added.
Further, follow-up data on MRI outcomes from the open-label extensions demonstrate that the effects on focal disease activity and on progression persists and is durable with ongoing treatment, he noted.
“In conclusion, there is no pattern of serious infections or malignancies that has emerged thus far with increased exposure, but obviously long-term follow-up and postmarketing requirement studies are needed to monitor long-term patient safety and rare events that couldn’t be captured here,” he said.
This study was sponsored by F. Hoffmann-La Roche. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Symbiotix, Annexon Biosciences, Bionure, Molecular Stethoscope, and for serving on the Board of Directors of Neurona Therapeutics.
SOURCE: Hauser S et al. Neurology. 2018 Apr 9;(15 Suppl.):S36.001.
LOS ANGELES – No new safety signals have emerged in multiple sclerosis patients treated with ocrelizumab, according to ongoing follow-up and postmarketing surveillance.
As of September 2017, patients with relapsing or primary progressive MS who were part of the pivotal OPERA I and II and ORATORIO trials – including phases 2 and 3 and open-label extensions – as well as an all-exposure population that included patients from prior studies, had nearly 9,500 patient-years of exposure to ocrelizumab (Ocrevus), a humanized anti-CD20 monoclonal antibody. The all-exposure population contributed about 1,500 of those patient-years, Stephen Hauser, MD, reported at the annual meeting of the American Academy of Neurology.
Postmarketing experience in approximately 37,000 treated patients with an additional 14,000 patient-years shows a fatality rate of 0.28/100 patient-years (49 fatalities) as of March 2018, he said.
“If one compares this to at least two reports of epidemiologic mortality estimates in MS, this is in line with – and in fact a little bit lower than – those estimates that range between 0.37 and 0.9, compared with 0.28,” he said. “So ... the updated safety profile in this all-exposure ocrelizumab population was generally consistent with what was seen during the controlled treatment period, and rates of serious infections fluctuated over time without any sustained increase.”
Only one serious opportunistic infection (Pasteurella) occurred in the controlled trials, and three more (two varicella zoster, one herpes simplex) occurred during open-marketing experience.
The rate of malignancies has been very encouraging, as well, as it appears to continue to align with population expectations, Dr. Hauser said.
Trial participants received 600-mg doses intravenously every 24 weeks in all three trials; in OPERA I/II, they received 96 weeks of treatment with the first dose given as two 300-mg infusions split by 14 days, and, in ORATORIO, they received at least 120 weeks of treatment with all doses split, Dr. Hauser said.
In the phase 2 study, they received split doses of 600-mg or 2,000-mg infusions through week 24; then through week 96, they received either 600-mg or 1,000-mg doses; those receiving 600 mg included those who started at that dose and those who received placebo or interferon beta-1a 30 mcg, and those receiving 1,000 mg were those who started on ocrelizumab at 2,000 mg.
The comparators were placebo in the ORATORIO and phase 2 trials, and interferon beta-1a given at a dose of 44 mcg subcutaneously three times weekly (OPERA I and II) or 30 mcg intramuscularly each week in the phase 2 trial.
All patients were offered enrollment into open-label extension studies, and “there was rather massive interest in joining the open-label extension and continuing open-label extension in both trials,” he said.
“And earlier here at the AAN [meeting] we presented the clinical efficacy data from the open-label extension, now 2 years completed – so 4 years from onset of the study – in patients who received ocrelizumab continuously for [relapsing-remitting] MS during that time period, or who switched from three-times-weekly interferon beta-1a to ocrelizumab ... and the data continue to show the positive outcomes reported in the original trials,” he added.
Further, follow-up data on MRI outcomes from the open-label extensions demonstrate that the effects on focal disease activity and on progression persists and is durable with ongoing treatment, he noted.
“In conclusion, there is no pattern of serious infections or malignancies that has emerged thus far with increased exposure, but obviously long-term follow-up and postmarketing requirement studies are needed to monitor long-term patient safety and rare events that couldn’t be captured here,” he said.
This study was sponsored by F. Hoffmann-La Roche. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Symbiotix, Annexon Biosciences, Bionure, Molecular Stethoscope, and for serving on the Board of Directors of Neurona Therapeutics.
SOURCE: Hauser S et al. Neurology. 2018 Apr 9;(15 Suppl.):S36.001.
LOS ANGELES – No new safety signals have emerged in multiple sclerosis patients treated with ocrelizumab, according to ongoing follow-up and postmarketing surveillance.
As of September 2017, patients with relapsing or primary progressive MS who were part of the pivotal OPERA I and II and ORATORIO trials – including phases 2 and 3 and open-label extensions – as well as an all-exposure population that included patients from prior studies, had nearly 9,500 patient-years of exposure to ocrelizumab (Ocrevus), a humanized anti-CD20 monoclonal antibody. The all-exposure population contributed about 1,500 of those patient-years, Stephen Hauser, MD, reported at the annual meeting of the American Academy of Neurology.
Postmarketing experience in approximately 37,000 treated patients with an additional 14,000 patient-years shows a fatality rate of 0.28/100 patient-years (49 fatalities) as of March 2018, he said.
“If one compares this to at least two reports of epidemiologic mortality estimates in MS, this is in line with – and in fact a little bit lower than – those estimates that range between 0.37 and 0.9, compared with 0.28,” he said. “So ... the updated safety profile in this all-exposure ocrelizumab population was generally consistent with what was seen during the controlled treatment period, and rates of serious infections fluctuated over time without any sustained increase.”
Only one serious opportunistic infection (Pasteurella) occurred in the controlled trials, and three more (two varicella zoster, one herpes simplex) occurred during open-marketing experience.
The rate of malignancies has been very encouraging, as well, as it appears to continue to align with population expectations, Dr. Hauser said.
Trial participants received 600-mg doses intravenously every 24 weeks in all three trials; in OPERA I/II, they received 96 weeks of treatment with the first dose given as two 300-mg infusions split by 14 days, and, in ORATORIO, they received at least 120 weeks of treatment with all doses split, Dr. Hauser said.
In the phase 2 study, they received split doses of 600-mg or 2,000-mg infusions through week 24; then through week 96, they received either 600-mg or 1,000-mg doses; those receiving 600 mg included those who started at that dose and those who received placebo or interferon beta-1a 30 mcg, and those receiving 1,000 mg were those who started on ocrelizumab at 2,000 mg.
The comparators were placebo in the ORATORIO and phase 2 trials, and interferon beta-1a given at a dose of 44 mcg subcutaneously three times weekly (OPERA I and II) or 30 mcg intramuscularly each week in the phase 2 trial.
All patients were offered enrollment into open-label extension studies, and “there was rather massive interest in joining the open-label extension and continuing open-label extension in both trials,” he said.
“And earlier here at the AAN [meeting] we presented the clinical efficacy data from the open-label extension, now 2 years completed – so 4 years from onset of the study – in patients who received ocrelizumab continuously for [relapsing-remitting] MS during that time period, or who switched from three-times-weekly interferon beta-1a to ocrelizumab ... and the data continue to show the positive outcomes reported in the original trials,” he added.
Further, follow-up data on MRI outcomes from the open-label extensions demonstrate that the effects on focal disease activity and on progression persists and is durable with ongoing treatment, he noted.
“In conclusion, there is no pattern of serious infections or malignancies that has emerged thus far with increased exposure, but obviously long-term follow-up and postmarketing requirement studies are needed to monitor long-term patient safety and rare events that couldn’t be captured here,” he said.
This study was sponsored by F. Hoffmann-La Roche. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Symbiotix, Annexon Biosciences, Bionure, Molecular Stethoscope, and for serving on the Board of Directors of Neurona Therapeutics.
SOURCE: Hauser S et al. Neurology. 2018 Apr 9;(15 Suppl.):S36.001.
REPORTING FROM AAN 2018
Key clinical point: Follow-up and postmarketing surveillance show no new safety signals with ocrelizumab.
Major finding: The fatality rate was 0.28/100 patient-years as of March 2018.
Study details: Follow-up of patients with nearly 9,500 patient-years of experience with ocrelizumab and postmarketing surveillance in patients with more than 14,000 patient-years of experience.
Disclosures: This study was sponsored by F. Hoffmann-La Roche. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Symbiotix, Annexon Biosciences, Bionure, Molecular Stethoscope, and for serving on the board of directors of Neurona Therapeutics.
Source: Hauser S et al. Neurology. 2018 Apr 9;(15 Suppl.):S36.001.
Interferon treatment does not increase stroke risk in MS
LOS ANGELES – Patients with multiple sclerosis who are treated with subcutaneous interferon beta-1a have no increase in stroke risk, compared with those treated with placebo, according to pooled data from clinical trials and a safety database analysis.
Studies have shown that MS patients have a greater risk of stroke, compared with the general population, but the data with respect to the risk of stroke following interferon treatment are limited, Alan Gillett, PhD, explained in his presentation at the annual meeting of the American Academy of Neurology. He noted that a 2017 report on a series of nested case-control studies showed a 1.8-fold increased risk of stroke in relapsing-remitting MS patients who received interferon.
In the new analysis presented at the meeting, there was a trend toward decreased stroke incidence among patients treated with subcutaneous interferon beta-1a. Stroke incidence was 0.025 per 100 patient-years (25 events) in patients treated with subcutaneous interferon beta-1a vs. 0.051 per 100 patient-years (11 events) in patients who received placebo across 17 phase 2-4 clinical trials. The incidence rate ratio (IRR) and hazard ratio for stroke in interferon- vs. placebo-treated patients were 0.486 and 0.496, respectively, reported Dr. Gillett of EMD Serono, Mississauga, Ont.
Further, no significant difference in stroke incidence was seen between the treatment and placebo groups based on treatment duration, Dr. Gillett said. The IRR in patients treated for less than 2 years was 0.602 vs. 0.469 in those treated for 2 or more years.
“The incidence rate ratio [in both groups] was very comparable to that overall, so this indicates that treatment duration had little impact on the incidence rate of stroke,” he said.
The same was true in an analysis based on dose; the IRRs were similar in those exposed to 44 mcg vs. placebo, and in those receiving any dose vs. placebo, he noted.
The analysis is based on reports of 569 cerebrovascular events occurring over 19 years (2.7 per 10,000 patient-years) in 1,594,414 patient-years of follow-up through May 22, 2017, in the Global Patient Safety Database.
“And according to prescribing information ... this would be classified as rare, with less than 1 in 1,000,” Dr. Gillett said.
“So this led us to our objective to really assess the risk of stroke in patients treated with subcutaneous interferon beta-1a ... and the association with treatment duration and dose,” he said. “What we can conclude from [our] study is that a trend toward decreased risk of stroke for subcutaneous interferon beta-1a, compared to placebo, was observed in 17 clinical trials ... and the safety data from both clinical trials and postmarketing [surveillance] suggests that treatment with subcutaneous interferon beta-1a ... does not increase the risk of stroke in patients with MS.”
This study was supported by Merck KGaA of Darmstadt, Germany. Dr. Gillett is an employee of EMD Serono, the biopharmaceutical division of Merck KGaA.
SOURCE: Sabidó M et al. Neurology. 2018 Apr 90(15 Suppl.):S36.008.
LOS ANGELES – Patients with multiple sclerosis who are treated with subcutaneous interferon beta-1a have no increase in stroke risk, compared with those treated with placebo, according to pooled data from clinical trials and a safety database analysis.
Studies have shown that MS patients have a greater risk of stroke, compared with the general population, but the data with respect to the risk of stroke following interferon treatment are limited, Alan Gillett, PhD, explained in his presentation at the annual meeting of the American Academy of Neurology. He noted that a 2017 report on a series of nested case-control studies showed a 1.8-fold increased risk of stroke in relapsing-remitting MS patients who received interferon.
In the new analysis presented at the meeting, there was a trend toward decreased stroke incidence among patients treated with subcutaneous interferon beta-1a. Stroke incidence was 0.025 per 100 patient-years (25 events) in patients treated with subcutaneous interferon beta-1a vs. 0.051 per 100 patient-years (11 events) in patients who received placebo across 17 phase 2-4 clinical trials. The incidence rate ratio (IRR) and hazard ratio for stroke in interferon- vs. placebo-treated patients were 0.486 and 0.496, respectively, reported Dr. Gillett of EMD Serono, Mississauga, Ont.
Further, no significant difference in stroke incidence was seen between the treatment and placebo groups based on treatment duration, Dr. Gillett said. The IRR in patients treated for less than 2 years was 0.602 vs. 0.469 in those treated for 2 or more years.
“The incidence rate ratio [in both groups] was very comparable to that overall, so this indicates that treatment duration had little impact on the incidence rate of stroke,” he said.
The same was true in an analysis based on dose; the IRRs were similar in those exposed to 44 mcg vs. placebo, and in those receiving any dose vs. placebo, he noted.
The analysis is based on reports of 569 cerebrovascular events occurring over 19 years (2.7 per 10,000 patient-years) in 1,594,414 patient-years of follow-up through May 22, 2017, in the Global Patient Safety Database.
“And according to prescribing information ... this would be classified as rare, with less than 1 in 1,000,” Dr. Gillett said.
“So this led us to our objective to really assess the risk of stroke in patients treated with subcutaneous interferon beta-1a ... and the association with treatment duration and dose,” he said. “What we can conclude from [our] study is that a trend toward decreased risk of stroke for subcutaneous interferon beta-1a, compared to placebo, was observed in 17 clinical trials ... and the safety data from both clinical trials and postmarketing [surveillance] suggests that treatment with subcutaneous interferon beta-1a ... does not increase the risk of stroke in patients with MS.”
This study was supported by Merck KGaA of Darmstadt, Germany. Dr. Gillett is an employee of EMD Serono, the biopharmaceutical division of Merck KGaA.
SOURCE: Sabidó M et al. Neurology. 2018 Apr 90(15 Suppl.):S36.008.
LOS ANGELES – Patients with multiple sclerosis who are treated with subcutaneous interferon beta-1a have no increase in stroke risk, compared with those treated with placebo, according to pooled data from clinical trials and a safety database analysis.
Studies have shown that MS patients have a greater risk of stroke, compared with the general population, but the data with respect to the risk of stroke following interferon treatment are limited, Alan Gillett, PhD, explained in his presentation at the annual meeting of the American Academy of Neurology. He noted that a 2017 report on a series of nested case-control studies showed a 1.8-fold increased risk of stroke in relapsing-remitting MS patients who received interferon.
In the new analysis presented at the meeting, there was a trend toward decreased stroke incidence among patients treated with subcutaneous interferon beta-1a. Stroke incidence was 0.025 per 100 patient-years (25 events) in patients treated with subcutaneous interferon beta-1a vs. 0.051 per 100 patient-years (11 events) in patients who received placebo across 17 phase 2-4 clinical trials. The incidence rate ratio (IRR) and hazard ratio for stroke in interferon- vs. placebo-treated patients were 0.486 and 0.496, respectively, reported Dr. Gillett of EMD Serono, Mississauga, Ont.
Further, no significant difference in stroke incidence was seen between the treatment and placebo groups based on treatment duration, Dr. Gillett said. The IRR in patients treated for less than 2 years was 0.602 vs. 0.469 in those treated for 2 or more years.
“The incidence rate ratio [in both groups] was very comparable to that overall, so this indicates that treatment duration had little impact on the incidence rate of stroke,” he said.
The same was true in an analysis based on dose; the IRRs were similar in those exposed to 44 mcg vs. placebo, and in those receiving any dose vs. placebo, he noted.
The analysis is based on reports of 569 cerebrovascular events occurring over 19 years (2.7 per 10,000 patient-years) in 1,594,414 patient-years of follow-up through May 22, 2017, in the Global Patient Safety Database.
“And according to prescribing information ... this would be classified as rare, with less than 1 in 1,000,” Dr. Gillett said.
“So this led us to our objective to really assess the risk of stroke in patients treated with subcutaneous interferon beta-1a ... and the association with treatment duration and dose,” he said. “What we can conclude from [our] study is that a trend toward decreased risk of stroke for subcutaneous interferon beta-1a, compared to placebo, was observed in 17 clinical trials ... and the safety data from both clinical trials and postmarketing [surveillance] suggests that treatment with subcutaneous interferon beta-1a ... does not increase the risk of stroke in patients with MS.”
This study was supported by Merck KGaA of Darmstadt, Germany. Dr. Gillett is an employee of EMD Serono, the biopharmaceutical division of Merck KGaA.
SOURCE: Sabidó M et al. Neurology. 2018 Apr 90(15 Suppl.):S36.008.
REPORTING FROM AAN 2018
Key clinical point: Pooled data show no increase in stroke risk in MS patients treated with interferon.
Major finding: A trend toward decreased stroke incidence was seen with interferon treatment vs. placebo (IRR, 0.486).
Study details: A review of pooled data from 17 clinical trials and postmarketing surveillance.
Disclosures: This study was supported by Merck KGaA of Darmstadt, Germany. Dr. Gillett is an employee of EMD Serono, the biopharmaceutical division of Merck KGaA.
Source: Sabidó M et al. Neurology. 2018 Apr:90(15 Suppl.):S36.008.
VIDEO: Addressing the opioid epidemic: Psychiatrists are poised to lead
NEW YORK – Psychiatrists are uniquely equipped to take the lead in providing cost-effective, evidence-based addiction treatment services, according to Lama Bazzi, MD, and Elie Aoun, MD.
As cochairs of a session titled, “Psychiatrists at the Helm of the Opioid Epidemic” at the annual meeting of the American Psychiatric Association, Dr. Bazzi and Dr. Aoun addressed how psychiatrists can take the lead as part of multidisciplinary teams, as well as roles they can play in policy and the criminal justice system to “shift the paradigm in terms of how the general public thinks about addiction.”
They also discussed existing models and some new models they have been working on to address the problem.
“We want to empower psychiatrists to feel that they already have the knowledge base to do what needs to be done, and to just ... put out there different ways that we can brainstorm together to do that,” Dr. Bazzi of Maimonides Medical Center, Brooklyn, N.Y., said in a video interview at the meeting.
She and Dr. Aoun also discussed an ongoing project that involves input from law enforcement and support from the APA; an online training module is being developed to address different mental disorders – including substance use disorders – and other issues that officers face, such as racial biases and disparities.
“The curriculum that we’re working on is going to be symptom based,” said Dr. Aoun, of Columbia University, New York, explaining that this approach is more practical for helping law enforcement officers in dealing with issues involving individuals with mental disorders.
Another project focuses on keeping people with mental disorders out of the criminal justice system, he said.
“Every step [of the criminal justice process] is an opportunity to intercept people with mental illness and provide them with intervention,” he said, noting that an adaptation of the model for patients with addictions is also in the works.
He and Dr. Bazzi also focused on where psychiatrists, as experts in both mental health and addiction, can fit into the process.
Dr. Bazzi and Dr. Aoun reported having no disclosures.
NEW YORK – Psychiatrists are uniquely equipped to take the lead in providing cost-effective, evidence-based addiction treatment services, according to Lama Bazzi, MD, and Elie Aoun, MD.
As cochairs of a session titled, “Psychiatrists at the Helm of the Opioid Epidemic” at the annual meeting of the American Psychiatric Association, Dr. Bazzi and Dr. Aoun addressed how psychiatrists can take the lead as part of multidisciplinary teams, as well as roles they can play in policy and the criminal justice system to “shift the paradigm in terms of how the general public thinks about addiction.”
They also discussed existing models and some new models they have been working on to address the problem.
“We want to empower psychiatrists to feel that they already have the knowledge base to do what needs to be done, and to just ... put out there different ways that we can brainstorm together to do that,” Dr. Bazzi of Maimonides Medical Center, Brooklyn, N.Y., said in a video interview at the meeting.
She and Dr. Aoun also discussed an ongoing project that involves input from law enforcement and support from the APA; an online training module is being developed to address different mental disorders – including substance use disorders – and other issues that officers face, such as racial biases and disparities.
“The curriculum that we’re working on is going to be symptom based,” said Dr. Aoun, of Columbia University, New York, explaining that this approach is more practical for helping law enforcement officers in dealing with issues involving individuals with mental disorders.
Another project focuses on keeping people with mental disorders out of the criminal justice system, he said.
“Every step [of the criminal justice process] is an opportunity to intercept people with mental illness and provide them with intervention,” he said, noting that an adaptation of the model for patients with addictions is also in the works.
He and Dr. Bazzi also focused on where psychiatrists, as experts in both mental health and addiction, can fit into the process.
Dr. Bazzi and Dr. Aoun reported having no disclosures.
NEW YORK – Psychiatrists are uniquely equipped to take the lead in providing cost-effective, evidence-based addiction treatment services, according to Lama Bazzi, MD, and Elie Aoun, MD.
As cochairs of a session titled, “Psychiatrists at the Helm of the Opioid Epidemic” at the annual meeting of the American Psychiatric Association, Dr. Bazzi and Dr. Aoun addressed how psychiatrists can take the lead as part of multidisciplinary teams, as well as roles they can play in policy and the criminal justice system to “shift the paradigm in terms of how the general public thinks about addiction.”
They also discussed existing models and some new models they have been working on to address the problem.
“We want to empower psychiatrists to feel that they already have the knowledge base to do what needs to be done, and to just ... put out there different ways that we can brainstorm together to do that,” Dr. Bazzi of Maimonides Medical Center, Brooklyn, N.Y., said in a video interview at the meeting.
She and Dr. Aoun also discussed an ongoing project that involves input from law enforcement and support from the APA; an online training module is being developed to address different mental disorders – including substance use disorders – and other issues that officers face, such as racial biases and disparities.
“The curriculum that we’re working on is going to be symptom based,” said Dr. Aoun, of Columbia University, New York, explaining that this approach is more practical for helping law enforcement officers in dealing with issues involving individuals with mental disorders.
Another project focuses on keeping people with mental disorders out of the criminal justice system, he said.
“Every step [of the criminal justice process] is an opportunity to intercept people with mental illness and provide them with intervention,” he said, noting that an adaptation of the model for patients with addictions is also in the works.
He and Dr. Bazzi also focused on where psychiatrists, as experts in both mental health and addiction, can fit into the process.
Dr. Bazzi and Dr. Aoun reported having no disclosures.
REPORTING FROM APA
Consider heterogeneous experiences among veteran cohorts when treating PTSD
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW YORK – Veterans are not a homogeneous group, and when treating them for posttraumatic stress, it helps to consider their specific cohort, according to Elspeth Cameron Ritchie, MD.
Veterans from the first Gulf War, for example, have lingering concerns regarding medical illness (Gulf War syndrome); those from Vietnam are aging and might have medical problems or find that while they did well while working, now they are experiencing PTSD symptoms for the first time; and those returning from the conflicts in Iraq and Afghanistan might have physical injuries from blasts – the “signature weapon” of those wars. Such blasts can cause amputations, genital injuries, head trauma, and PTSD, said Dr. Ritchie, of the Uniformed Services University of the Health Sciences, Bethesda, Md.
In this video interview, Dr. Ritchie discusses these and other issues related to the treatment of PTSD among veterans as presented during a workshop entitled “Psychiatry and U.S. Veterans,” which she chaired at the annual meeting of the American Psychiatric Association.
The workshop covered the spectrum of treatments that might be helpful for veterans.
“ They don’t want it to just be the doctor giving them a pill,” she said. “Veterans are resilient; they’re tough; they don’t like to be thought of as victims ... and when you’re working with them, it’s very important to link into that dynamic resilient piece and capitalize on their strengths.”
Dr. Ritchie reported having no disclosures.
SOURCE: Ritchie EC et al. APA Workshop.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW YORK – Veterans are not a homogeneous group, and when treating them for posttraumatic stress, it helps to consider their specific cohort, according to Elspeth Cameron Ritchie, MD.
Veterans from the first Gulf War, for example, have lingering concerns regarding medical illness (Gulf War syndrome); those from Vietnam are aging and might have medical problems or find that while they did well while working, now they are experiencing PTSD symptoms for the first time; and those returning from the conflicts in Iraq and Afghanistan might have physical injuries from blasts – the “signature weapon” of those wars. Such blasts can cause amputations, genital injuries, head trauma, and PTSD, said Dr. Ritchie, of the Uniformed Services University of the Health Sciences, Bethesda, Md.
In this video interview, Dr. Ritchie discusses these and other issues related to the treatment of PTSD among veterans as presented during a workshop entitled “Psychiatry and U.S. Veterans,” which she chaired at the annual meeting of the American Psychiatric Association.
The workshop covered the spectrum of treatments that might be helpful for veterans.
“ They don’t want it to just be the doctor giving them a pill,” she said. “Veterans are resilient; they’re tough; they don’t like to be thought of as victims ... and when you’re working with them, it’s very important to link into that dynamic resilient piece and capitalize on their strengths.”
Dr. Ritchie reported having no disclosures.
SOURCE: Ritchie EC et al. APA Workshop.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW YORK – Veterans are not a homogeneous group, and when treating them for posttraumatic stress, it helps to consider their specific cohort, according to Elspeth Cameron Ritchie, MD.
Veterans from the first Gulf War, for example, have lingering concerns regarding medical illness (Gulf War syndrome); those from Vietnam are aging and might have medical problems or find that while they did well while working, now they are experiencing PTSD symptoms for the first time; and those returning from the conflicts in Iraq and Afghanistan might have physical injuries from blasts – the “signature weapon” of those wars. Such blasts can cause amputations, genital injuries, head trauma, and PTSD, said Dr. Ritchie, of the Uniformed Services University of the Health Sciences, Bethesda, Md.
In this video interview, Dr. Ritchie discusses these and other issues related to the treatment of PTSD among veterans as presented during a workshop entitled “Psychiatry and U.S. Veterans,” which she chaired at the annual meeting of the American Psychiatric Association.
The workshop covered the spectrum of treatments that might be helpful for veterans.
“ They don’t want it to just be the doctor giving them a pill,” she said. “Veterans are resilient; they’re tough; they don’t like to be thought of as victims ... and when you’re working with them, it’s very important to link into that dynamic resilient piece and capitalize on their strengths.”
Dr. Ritchie reported having no disclosures.
SOURCE: Ritchie EC et al. APA Workshop.
REPORTING FROM APA
VIDEO: Consider unique stressors when treating members of peacekeeping operations
NEW YORK – Sustained peacekeeping operations are associated with unique psychological stressors, and understanding of these stressors on the part of both community and military psychiatrists can help make a difference at each stage of a deployment cycle, according to Elspeth Cameron Ritchie, MD.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
During a workshop at the annual meeting of the American Psychiatric Association entitled “War and Peace: Understanding the Psychological Stressors Associated with Sustained Peacekeeping Operations (PKOs),” chaired by Dr. Ritchie of the Uniformed Services University of the Health Sciences, Bethesda, Md., various dimensions of salient psychological stress were discussed, as were approaches for minimizing any resultant impact on the psychological health of peacekeepers.
In this video interview, Dr. Ritchie discussed the differences and similarities between peacekeeping operations and military operations with respect to stressors and their effects, and the risk of posttraumatic stress disorder among peacekeepers.
Although treatment for PTSD is “pretty much the same,” it is important to “tailor the treatment for the situation,” she said.
“Lay out the different options, explain them to the patient, and partner with the patient in terms of what is the best option for them,” she said.
Dr. Ritchie reported having no relevant disclosures.
SOURCE: Ritchie EC et al. APA Workshop
NEW YORK – Sustained peacekeeping operations are associated with unique psychological stressors, and understanding of these stressors on the part of both community and military psychiatrists can help make a difference at each stage of a deployment cycle, according to Elspeth Cameron Ritchie, MD.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
During a workshop at the annual meeting of the American Psychiatric Association entitled “War and Peace: Understanding the Psychological Stressors Associated with Sustained Peacekeeping Operations (PKOs),” chaired by Dr. Ritchie of the Uniformed Services University of the Health Sciences, Bethesda, Md., various dimensions of salient psychological stress were discussed, as were approaches for minimizing any resultant impact on the psychological health of peacekeepers.
In this video interview, Dr. Ritchie discussed the differences and similarities between peacekeeping operations and military operations with respect to stressors and their effects, and the risk of posttraumatic stress disorder among peacekeepers.
Although treatment for PTSD is “pretty much the same,” it is important to “tailor the treatment for the situation,” she said.
“Lay out the different options, explain them to the patient, and partner with the patient in terms of what is the best option for them,” she said.
Dr. Ritchie reported having no relevant disclosures.
SOURCE: Ritchie EC et al. APA Workshop
NEW YORK – Sustained peacekeeping operations are associated with unique psychological stressors, and understanding of these stressors on the part of both community and military psychiatrists can help make a difference at each stage of a deployment cycle, according to Elspeth Cameron Ritchie, MD.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
During a workshop at the annual meeting of the American Psychiatric Association entitled “War and Peace: Understanding the Psychological Stressors Associated with Sustained Peacekeeping Operations (PKOs),” chaired by Dr. Ritchie of the Uniformed Services University of the Health Sciences, Bethesda, Md., various dimensions of salient psychological stress were discussed, as were approaches for minimizing any resultant impact on the psychological health of peacekeepers.
In this video interview, Dr. Ritchie discussed the differences and similarities between peacekeeping operations and military operations with respect to stressors and their effects, and the risk of posttraumatic stress disorder among peacekeepers.
Although treatment for PTSD is “pretty much the same,” it is important to “tailor the treatment for the situation,” she said.
“Lay out the different options, explain them to the patient, and partner with the patient in terms of what is the best option for them,” she said.
Dr. Ritchie reported having no relevant disclosures.
SOURCE: Ritchie EC et al. APA Workshop
VIDEO: Research underscores murky relationship between mental illness, gun violence
NEW YORK – Legislation enacted in some states in the wake of mass shootings seeks to limit access to firearms for people with mental illness, but research presented at the annual meeting of the American Psychiatric Association raises questions about the value of that approach.
During a workshop entitled “The ‘Crazed Gunman’ Myth: Examining Mental Illness and Firearm Violence,” researchers from the Yale University in New Haven, Conn., presented new findings that support existing data calling into question whether laws considered to be “common-sense approaches” to stopping gun violence really can reduce the likelihood of mass shootings.
It appears, based on the frequency and context of firearm use in more than 400 crimes that resulted in an insanity acquittal in Connecticut, for example, that individuals with mental illness are less likely than others to misuse firearms.
In this video, workshop chair Reena Kapoor, MD, also of Yale University, discusses the findings and notes that she and her colleagues seek to move past politics and ideology to focus on science that can guide policy and legislative efforts in a potentially more effective direction.
“We’ve also found that in spite of the media narrative, there has also been a slight decrease in how often [mentally ill offenders] use guns, over the years in the study,” she said. “Although the data are preliminary, it doesn’t support this idea that mentally ill people are more dangerous than ever, that they’re using guns more often in their violence; it actually says quite the opposite.”
Dr. Kapoor reported having no disclosures.
SOURCE: Kapoor R et al. APA 2018 Workshop.
NEW YORK – Legislation enacted in some states in the wake of mass shootings seeks to limit access to firearms for people with mental illness, but research presented at the annual meeting of the American Psychiatric Association raises questions about the value of that approach.
During a workshop entitled “The ‘Crazed Gunman’ Myth: Examining Mental Illness and Firearm Violence,” researchers from the Yale University in New Haven, Conn., presented new findings that support existing data calling into question whether laws considered to be “common-sense approaches” to stopping gun violence really can reduce the likelihood of mass shootings.
It appears, based on the frequency and context of firearm use in more than 400 crimes that resulted in an insanity acquittal in Connecticut, for example, that individuals with mental illness are less likely than others to misuse firearms.
In this video, workshop chair Reena Kapoor, MD, also of Yale University, discusses the findings and notes that she and her colleagues seek to move past politics and ideology to focus on science that can guide policy and legislative efforts in a potentially more effective direction.
“We’ve also found that in spite of the media narrative, there has also been a slight decrease in how often [mentally ill offenders] use guns, over the years in the study,” she said. “Although the data are preliminary, it doesn’t support this idea that mentally ill people are more dangerous than ever, that they’re using guns more often in their violence; it actually says quite the opposite.”
Dr. Kapoor reported having no disclosures.
SOURCE: Kapoor R et al. APA 2018 Workshop.
NEW YORK – Legislation enacted in some states in the wake of mass shootings seeks to limit access to firearms for people with mental illness, but research presented at the annual meeting of the American Psychiatric Association raises questions about the value of that approach.
During a workshop entitled “The ‘Crazed Gunman’ Myth: Examining Mental Illness and Firearm Violence,” researchers from the Yale University in New Haven, Conn., presented new findings that support existing data calling into question whether laws considered to be “common-sense approaches” to stopping gun violence really can reduce the likelihood of mass shootings.
It appears, based on the frequency and context of firearm use in more than 400 crimes that resulted in an insanity acquittal in Connecticut, for example, that individuals with mental illness are less likely than others to misuse firearms.
In this video, workshop chair Reena Kapoor, MD, also of Yale University, discusses the findings and notes that she and her colleagues seek to move past politics and ideology to focus on science that can guide policy and legislative efforts in a potentially more effective direction.
“We’ve also found that in spite of the media narrative, there has also been a slight decrease in how often [mentally ill offenders] use guns, over the years in the study,” she said. “Although the data are preliminary, it doesn’t support this idea that mentally ill people are more dangerous than ever, that they’re using guns more often in their violence; it actually says quite the opposite.”
Dr. Kapoor reported having no disclosures.
SOURCE: Kapoor R et al. APA 2018 Workshop.
REPORTING FROM APA
Meta-analyses clarify roles for gabapentin, naltrexone, and psychotherapy in alcohol use disorder
NEW YORK – A meta-analysis of 10 studies provides at least preliminary support for the use of gabapentin for the treatment of alcohol cravings and withdrawal.
In this video interview, Ali Mahmood Khan, MD, of Kings County Hospital, New York, discusses the findings – presented in a poster at the annual meeting of the American Psychiatric Association – which show that patients treated with gabapentin have significantly reduced alcohol craving and withdrawal. While the findings require further study, he said.
Gapapentin also can be used in combination with naltrexone, which was shown in a separate poster presented by Dr. Khan and his colleagues to be useful for treating alcohol use disorders – but mainly through reducing consumption rather than cravings.
In that meta-analysis of 30 studies, no significant added benefit was seen when psychotherapy was combined with naltrexone, he said, noting, however, that additional study is warranted given that various psychotherapies were used across the studies.
Dr. Khan reported having no disclosures.
NEW YORK – A meta-analysis of 10 studies provides at least preliminary support for the use of gabapentin for the treatment of alcohol cravings and withdrawal.
In this video interview, Ali Mahmood Khan, MD, of Kings County Hospital, New York, discusses the findings – presented in a poster at the annual meeting of the American Psychiatric Association – which show that patients treated with gabapentin have significantly reduced alcohol craving and withdrawal. While the findings require further study, he said.
Gapapentin also can be used in combination with naltrexone, which was shown in a separate poster presented by Dr. Khan and his colleagues to be useful for treating alcohol use disorders – but mainly through reducing consumption rather than cravings.
In that meta-analysis of 30 studies, no significant added benefit was seen when psychotherapy was combined with naltrexone, he said, noting, however, that additional study is warranted given that various psychotherapies were used across the studies.
Dr. Khan reported having no disclosures.
NEW YORK – A meta-analysis of 10 studies provides at least preliminary support for the use of gabapentin for the treatment of alcohol cravings and withdrawal.
In this video interview, Ali Mahmood Khan, MD, of Kings County Hospital, New York, discusses the findings – presented in a poster at the annual meeting of the American Psychiatric Association – which show that patients treated with gabapentin have significantly reduced alcohol craving and withdrawal. While the findings require further study, he said.
Gapapentin also can be used in combination with naltrexone, which was shown in a separate poster presented by Dr. Khan and his colleagues to be useful for treating alcohol use disorders – but mainly through reducing consumption rather than cravings.
In that meta-analysis of 30 studies, no significant added benefit was seen when psychotherapy was combined with naltrexone, he said, noting, however, that additional study is warranted given that various psychotherapies were used across the studies.
Dr. Khan reported having no disclosures.
REPORTING FROM APA
EVOLVE-MS-1 study: ALKS 8700 shows promise for RRMS
LOS ANGELES – ALKS 8700, a novel prodrug of monomethyl fumarate, looks promising as an oral, disease-modifying treatment for relapsing forms of multiple sclerosis, according to interim findings from the phase 3 EVOLVE-MS-1 study.
The annualized relapse rate at a median follow-up of 0.93 patient-years (total, 497.1 patient-years) in 578 patients enrolled to date in the 2-year, open-label study was just 0.16, Robert T. Naismith, MD, reported during an emerging science session at the annual meeting of the American Academy of Neurology.
Further, a statistically significant 80% reduction from baseline was seen in the number of gadolinium-enhancing lesions in 374 patients who completed a 1-year MRI assessment (from a mean of 1.5 to 0.3), said Dr. Naismith of Washington University, St. Louis.
Patients enrolled in the ongoing study are adults aged 18-65 years (mean, 41 years) with confirmed relapsing-remitting MS (RRMS), Expanded Disability Status Scale score of 6.0 or less (mean, 2.7), and no evidence of relapse within 30 days prior to starting ALKS 8700. Those with progressive forms of MS are excluded, as are patients who are pregnant or breastfeeding, patients with a history of other clinically significant conditions, and those with clinically significant abnormal laboratory tests at screening or absolute lymphocyte counts less than 0.9 x 103/mcL.
Of those enrolled so far, 72.5% received prior MS therapies, and their mean time since onset and diagnosis of MS was 9.7 and 7.6 years, respectively. The mean number of relapses in the prior year was 0.8.
ALKS 8700, also known as BIIB098, is given at a dose of 462 mg twice daily for up to 96 weeks; planned enrollment in EVOLVE-MS-1 is approximately 900 patients, Dr. Naismith said.
The preliminary findings from EVOLE-MS-1, which is limited by its single-arm, open-label design, “lend credence to ALKS 8700 as an oral treatment for patients with relapsing-remitting MS,” he said.
In addition to continued evaluation for long-term safety and tolerability in the current study, ALKS 8700 is also being evaluated in combination with 240 mg of twice daily dimethyl fumarate (DMF; Tecfidera) in the 5-week, randomized, double-blind EVOLVE-MS-2 study, which is looking at the gastrointestinal tolerability of the combination in patients with RRMS.
Oral DMF is approved for RRMS, and has been shown to significantly reduce clinical and MRI disease activity, but is commonly associated with GI events. Monomethyl fumarate is the active metabolite of DMF, and as a prodrug of monomethyl fumarate, ALKS 8700 is being developed to work in a manner similar to that of DMF, but with improved GI tolerability, Dr. Naismith explained.
EVOLE-MS-1 is funded by Alkermes. Dr. Naismith has served as a consultant and/or speaker for Alkermes, as well as for Acorda, Bayer, Biogen, Genentech, Genzyme, EMD Serono, Novartis, and Teva. He has received research support from the National Institutes of Health and the National Multiple Sclerosis Society.
SOURCE: Naismith R et al. AAN 2018 Emerging Science Abstract 006.
LOS ANGELES – ALKS 8700, a novel prodrug of monomethyl fumarate, looks promising as an oral, disease-modifying treatment for relapsing forms of multiple sclerosis, according to interim findings from the phase 3 EVOLVE-MS-1 study.
The annualized relapse rate at a median follow-up of 0.93 patient-years (total, 497.1 patient-years) in 578 patients enrolled to date in the 2-year, open-label study was just 0.16, Robert T. Naismith, MD, reported during an emerging science session at the annual meeting of the American Academy of Neurology.
Further, a statistically significant 80% reduction from baseline was seen in the number of gadolinium-enhancing lesions in 374 patients who completed a 1-year MRI assessment (from a mean of 1.5 to 0.3), said Dr. Naismith of Washington University, St. Louis.
Patients enrolled in the ongoing study are adults aged 18-65 years (mean, 41 years) with confirmed relapsing-remitting MS (RRMS), Expanded Disability Status Scale score of 6.0 or less (mean, 2.7), and no evidence of relapse within 30 days prior to starting ALKS 8700. Those with progressive forms of MS are excluded, as are patients who are pregnant or breastfeeding, patients with a history of other clinically significant conditions, and those with clinically significant abnormal laboratory tests at screening or absolute lymphocyte counts less than 0.9 x 103/mcL.
Of those enrolled so far, 72.5% received prior MS therapies, and their mean time since onset and diagnosis of MS was 9.7 and 7.6 years, respectively. The mean number of relapses in the prior year was 0.8.
ALKS 8700, also known as BIIB098, is given at a dose of 462 mg twice daily for up to 96 weeks; planned enrollment in EVOLVE-MS-1 is approximately 900 patients, Dr. Naismith said.
The preliminary findings from EVOLE-MS-1, which is limited by its single-arm, open-label design, “lend credence to ALKS 8700 as an oral treatment for patients with relapsing-remitting MS,” he said.
In addition to continued evaluation for long-term safety and tolerability in the current study, ALKS 8700 is also being evaluated in combination with 240 mg of twice daily dimethyl fumarate (DMF; Tecfidera) in the 5-week, randomized, double-blind EVOLVE-MS-2 study, which is looking at the gastrointestinal tolerability of the combination in patients with RRMS.
Oral DMF is approved for RRMS, and has been shown to significantly reduce clinical and MRI disease activity, but is commonly associated with GI events. Monomethyl fumarate is the active metabolite of DMF, and as a prodrug of monomethyl fumarate, ALKS 8700 is being developed to work in a manner similar to that of DMF, but with improved GI tolerability, Dr. Naismith explained.
EVOLE-MS-1 is funded by Alkermes. Dr. Naismith has served as a consultant and/or speaker for Alkermes, as well as for Acorda, Bayer, Biogen, Genentech, Genzyme, EMD Serono, Novartis, and Teva. He has received research support from the National Institutes of Health and the National Multiple Sclerosis Society.
SOURCE: Naismith R et al. AAN 2018 Emerging Science Abstract 006.
LOS ANGELES – ALKS 8700, a novel prodrug of monomethyl fumarate, looks promising as an oral, disease-modifying treatment for relapsing forms of multiple sclerosis, according to interim findings from the phase 3 EVOLVE-MS-1 study.
The annualized relapse rate at a median follow-up of 0.93 patient-years (total, 497.1 patient-years) in 578 patients enrolled to date in the 2-year, open-label study was just 0.16, Robert T. Naismith, MD, reported during an emerging science session at the annual meeting of the American Academy of Neurology.
Further, a statistically significant 80% reduction from baseline was seen in the number of gadolinium-enhancing lesions in 374 patients who completed a 1-year MRI assessment (from a mean of 1.5 to 0.3), said Dr. Naismith of Washington University, St. Louis.
Patients enrolled in the ongoing study are adults aged 18-65 years (mean, 41 years) with confirmed relapsing-remitting MS (RRMS), Expanded Disability Status Scale score of 6.0 or less (mean, 2.7), and no evidence of relapse within 30 days prior to starting ALKS 8700. Those with progressive forms of MS are excluded, as are patients who are pregnant or breastfeeding, patients with a history of other clinically significant conditions, and those with clinically significant abnormal laboratory tests at screening or absolute lymphocyte counts less than 0.9 x 103/mcL.
Of those enrolled so far, 72.5% received prior MS therapies, and their mean time since onset and diagnosis of MS was 9.7 and 7.6 years, respectively. The mean number of relapses in the prior year was 0.8.
ALKS 8700, also known as BIIB098, is given at a dose of 462 mg twice daily for up to 96 weeks; planned enrollment in EVOLVE-MS-1 is approximately 900 patients, Dr. Naismith said.
The preliminary findings from EVOLE-MS-1, which is limited by its single-arm, open-label design, “lend credence to ALKS 8700 as an oral treatment for patients with relapsing-remitting MS,” he said.
In addition to continued evaluation for long-term safety and tolerability in the current study, ALKS 8700 is also being evaluated in combination with 240 mg of twice daily dimethyl fumarate (DMF; Tecfidera) in the 5-week, randomized, double-blind EVOLVE-MS-2 study, which is looking at the gastrointestinal tolerability of the combination in patients with RRMS.
Oral DMF is approved for RRMS, and has been shown to significantly reduce clinical and MRI disease activity, but is commonly associated with GI events. Monomethyl fumarate is the active metabolite of DMF, and as a prodrug of monomethyl fumarate, ALKS 8700 is being developed to work in a manner similar to that of DMF, but with improved GI tolerability, Dr. Naismith explained.
EVOLE-MS-1 is funded by Alkermes. Dr. Naismith has served as a consultant and/or speaker for Alkermes, as well as for Acorda, Bayer, Biogen, Genentech, Genzyme, EMD Serono, Novartis, and Teva. He has received research support from the National Institutes of Health and the National Multiple Sclerosis Society.
SOURCE: Naismith R et al. AAN 2018 Emerging Science Abstract 006.
Key clinical point:
Major finding: The annualized relapse rate at 1 year was just 0.16 vs. 0.8 in the prior year.
Study details: One-year results from 578 patients in an ongoing phase 3, open-label study.
Disclosures: EVOLE-MS-1 is funded by Alkermes. Dr. Naismith has served as a consultant and/or speaker for Alkermes, as well as for Acorda, Bayer, Biogen, Genentech, Genzyme, EMD Serono, Novartis, and Teva. He has received research support from the National Institutes of Health and the National Multiple Sclerosis Society.
Source: Naismith R et al. AAN 2018 Emerging Science Abstract 006.