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Gut bacteria influence HCT outcomes
A multinational study of intestinal microbiota in the United States, Europe, and Japan showed that in all four geographic regions patients scheduled for HCT had about a 100% lower median diversity of intestinal bacteria, compared with healthy volunteers, and that enterococcal species predominated in the transplant candidates, reported Jonathan U. Peled, MD, PhD, from the bone marrow transplantation service at Memorial Sloan Kettering Cancer Center in New York.
The investigators also found that intestinal microbial diversity was significantly associated with overall survival following an HCT.
In a video interview at the annual meeting of the American Society of Hematology, Dr. Peled elaborated on the study findings and described potential pre- and posttransplant interventions that could improve results and increase survival following HCT.
Dr. Peled reported current or prior relationships with Seres Therapeutics, the Parker Institute for Cancer Immunotherapy, and Merck/Society for Immunotherapy of Cancer.
A multinational study of intestinal microbiota in the United States, Europe, and Japan showed that in all four geographic regions patients scheduled for HCT had about a 100% lower median diversity of intestinal bacteria, compared with healthy volunteers, and that enterococcal species predominated in the transplant candidates, reported Jonathan U. Peled, MD, PhD, from the bone marrow transplantation service at Memorial Sloan Kettering Cancer Center in New York.
The investigators also found that intestinal microbial diversity was significantly associated with overall survival following an HCT.
In a video interview at the annual meeting of the American Society of Hematology, Dr. Peled elaborated on the study findings and described potential pre- and posttransplant interventions that could improve results and increase survival following HCT.
Dr. Peled reported current or prior relationships with Seres Therapeutics, the Parker Institute for Cancer Immunotherapy, and Merck/Society for Immunotherapy of Cancer.
A multinational study of intestinal microbiota in the United States, Europe, and Japan showed that in all four geographic regions patients scheduled for HCT had about a 100% lower median diversity of intestinal bacteria, compared with healthy volunteers, and that enterococcal species predominated in the transplant candidates, reported Jonathan U. Peled, MD, PhD, from the bone marrow transplantation service at Memorial Sloan Kettering Cancer Center in New York.
The investigators also found that intestinal microbial diversity was significantly associated with overall survival following an HCT.
In a video interview at the annual meeting of the American Society of Hematology, Dr. Peled elaborated on the study findings and described potential pre- and posttransplant interventions that could improve results and increase survival following HCT.
Dr. Peled reported current or prior relationships with Seres Therapeutics, the Parker Institute for Cancer Immunotherapy, and Merck/Society for Immunotherapy of Cancer.
REPORTING FROM ASH 2018
JULIET: CAR T cells keep trucking against DLBCL
SAN DIEGO – Chimeric antigen receptor T-cell therapy with tisagenlecleucel (Kymriah) is associated with a high rate of durable responses in adults with relapsed or refractory diffuse large B-cell lymphoma, an updated analysis of the JULIET trial showed.
After a median follow-up of 19 months, two-thirds of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had early responses to chimeric antigen receptor (CAR) T-cell therapy with tisagenlecleucel remained in remission with no evidence of minimal residual disease, reported Richard Thomas Maziarz, MD, from the Oregon Health & Science Knight Cancer Institute in Portland, at the annual meeting of the American Society of Hematology.
“Since the previous report, no new deaths have been reported due to any cause other than patient disease progression. No treatment-related mortality was seen throughout the study, and there were three early deaths, all related to lymphoma that progressed,” he said in a briefing prior to presentation of the data in a scientific poster.
The updated study results were published simultaneously online in the New England Journal of Medicine.
JULIET then
In the phase 2, single-arm trial, investigators enrolled adults with DLBCL that had relapsed or was refractory after two or more prior lines of therapy and who were either ineligible for hematopoietic stem cell transplant or who experienced disease progression after transplant.
Interim results of the study were previously reported at the European Hematology Association Congress in 2017.
At that meeting, Gilles Salles, MD, PhD, from the University of Lyon (France), presented results of an analysis of available efficacy data on 51 patients with at least 3 months of follow-up. In this population, the best overall response rate was 59%. The 3-month overall response rate was 45%, consisting of 37% complete responses and 8% partial responses. Relapse-free survival at 6 months was 79% and all patients who had responses at 3 months continued to have responses at the time of data cutoff.
JULIET now
In the most recent analysis, completed after a median time from infusion to data cutoff of 14 months, the investigators reported on efficacy in 93 patients who received CAR T-cell infusions.
The best overall response rate, the primary endpoint, was 52%, comprising 40% complete responses and 12% partial responses. The response rates were consistent across all prognostic subgroups, including age, sex, previous response status, International Prognostic Index score at enrollment, prior therapy, molecular subtype, and other factors.
Estimated relapse-free survival 12 months after documentation of an initial response was 65%, and was 79% among patients who had complete responses.
The median duration of response had not been reached at the time of data cutoff; the median overall survival had not been reached for patients with a complete remission. Overall survival in this heavily pretreated population as a whole (all patients who received CAR T-cell infusions) was 11.1 months.
Adverse events of special interest included grade 3 or 4 cytokine release syndrome (CRS) in 23% of patients, prolonged cytopenia in 34%, infections in 19%, neurologic events in 11%, febrile neutropenia in 15%, and tumor lysis syndrome in 2%.
There were no deaths attributable to CRS or to cerebral edema, a complication of CAR T-cell therapy that appears to be related to the costimulatory molecule used in various constructs.
“Patients with relapsed or refractory DLBCL who are not eligible for high-dose therapy and hematopoietic cell transplantation or for whom such therapy was not successful have very few treatment options. For these patients, tisagenlecleucel shows promise that will need to be confirmed through larger studies with longer follow-up,” the investigators wrote in the New England Journal of Medicine.
The JULIET Trial is supported by Novartis. Dr. Maziar reported personal fees from Incyte, Kite Therapeutics, and Athersys.
SOURCE: Maziarz RT et al. N Engl J Med. 2018 Dec 1. doi: 10.1056/NEJMoa1804980.
SAN DIEGO – Chimeric antigen receptor T-cell therapy with tisagenlecleucel (Kymriah) is associated with a high rate of durable responses in adults with relapsed or refractory diffuse large B-cell lymphoma, an updated analysis of the JULIET trial showed.
After a median follow-up of 19 months, two-thirds of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had early responses to chimeric antigen receptor (CAR) T-cell therapy with tisagenlecleucel remained in remission with no evidence of minimal residual disease, reported Richard Thomas Maziarz, MD, from the Oregon Health & Science Knight Cancer Institute in Portland, at the annual meeting of the American Society of Hematology.
“Since the previous report, no new deaths have been reported due to any cause other than patient disease progression. No treatment-related mortality was seen throughout the study, and there were three early deaths, all related to lymphoma that progressed,” he said in a briefing prior to presentation of the data in a scientific poster.
The updated study results were published simultaneously online in the New England Journal of Medicine.
JULIET then
In the phase 2, single-arm trial, investigators enrolled adults with DLBCL that had relapsed or was refractory after two or more prior lines of therapy and who were either ineligible for hematopoietic stem cell transplant or who experienced disease progression after transplant.
Interim results of the study were previously reported at the European Hematology Association Congress in 2017.
At that meeting, Gilles Salles, MD, PhD, from the University of Lyon (France), presented results of an analysis of available efficacy data on 51 patients with at least 3 months of follow-up. In this population, the best overall response rate was 59%. The 3-month overall response rate was 45%, consisting of 37% complete responses and 8% partial responses. Relapse-free survival at 6 months was 79% and all patients who had responses at 3 months continued to have responses at the time of data cutoff.
JULIET now
In the most recent analysis, completed after a median time from infusion to data cutoff of 14 months, the investigators reported on efficacy in 93 patients who received CAR T-cell infusions.
The best overall response rate, the primary endpoint, was 52%, comprising 40% complete responses and 12% partial responses. The response rates were consistent across all prognostic subgroups, including age, sex, previous response status, International Prognostic Index score at enrollment, prior therapy, molecular subtype, and other factors.
Estimated relapse-free survival 12 months after documentation of an initial response was 65%, and was 79% among patients who had complete responses.
The median duration of response had not been reached at the time of data cutoff; the median overall survival had not been reached for patients with a complete remission. Overall survival in this heavily pretreated population as a whole (all patients who received CAR T-cell infusions) was 11.1 months.
Adverse events of special interest included grade 3 or 4 cytokine release syndrome (CRS) in 23% of patients, prolonged cytopenia in 34%, infections in 19%, neurologic events in 11%, febrile neutropenia in 15%, and tumor lysis syndrome in 2%.
There were no deaths attributable to CRS or to cerebral edema, a complication of CAR T-cell therapy that appears to be related to the costimulatory molecule used in various constructs.
“Patients with relapsed or refractory DLBCL who are not eligible for high-dose therapy and hematopoietic cell transplantation or for whom such therapy was not successful have very few treatment options. For these patients, tisagenlecleucel shows promise that will need to be confirmed through larger studies with longer follow-up,” the investigators wrote in the New England Journal of Medicine.
The JULIET Trial is supported by Novartis. Dr. Maziar reported personal fees from Incyte, Kite Therapeutics, and Athersys.
SOURCE: Maziarz RT et al. N Engl J Med. 2018 Dec 1. doi: 10.1056/NEJMoa1804980.
SAN DIEGO – Chimeric antigen receptor T-cell therapy with tisagenlecleucel (Kymriah) is associated with a high rate of durable responses in adults with relapsed or refractory diffuse large B-cell lymphoma, an updated analysis of the JULIET trial showed.
After a median follow-up of 19 months, two-thirds of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had early responses to chimeric antigen receptor (CAR) T-cell therapy with tisagenlecleucel remained in remission with no evidence of minimal residual disease, reported Richard Thomas Maziarz, MD, from the Oregon Health & Science Knight Cancer Institute in Portland, at the annual meeting of the American Society of Hematology.
“Since the previous report, no new deaths have been reported due to any cause other than patient disease progression. No treatment-related mortality was seen throughout the study, and there were three early deaths, all related to lymphoma that progressed,” he said in a briefing prior to presentation of the data in a scientific poster.
The updated study results were published simultaneously online in the New England Journal of Medicine.
JULIET then
In the phase 2, single-arm trial, investigators enrolled adults with DLBCL that had relapsed or was refractory after two or more prior lines of therapy and who were either ineligible for hematopoietic stem cell transplant or who experienced disease progression after transplant.
Interim results of the study were previously reported at the European Hematology Association Congress in 2017.
At that meeting, Gilles Salles, MD, PhD, from the University of Lyon (France), presented results of an analysis of available efficacy data on 51 patients with at least 3 months of follow-up. In this population, the best overall response rate was 59%. The 3-month overall response rate was 45%, consisting of 37% complete responses and 8% partial responses. Relapse-free survival at 6 months was 79% and all patients who had responses at 3 months continued to have responses at the time of data cutoff.
JULIET now
In the most recent analysis, completed after a median time from infusion to data cutoff of 14 months, the investigators reported on efficacy in 93 patients who received CAR T-cell infusions.
The best overall response rate, the primary endpoint, was 52%, comprising 40% complete responses and 12% partial responses. The response rates were consistent across all prognostic subgroups, including age, sex, previous response status, International Prognostic Index score at enrollment, prior therapy, molecular subtype, and other factors.
Estimated relapse-free survival 12 months after documentation of an initial response was 65%, and was 79% among patients who had complete responses.
The median duration of response had not been reached at the time of data cutoff; the median overall survival had not been reached for patients with a complete remission. Overall survival in this heavily pretreated population as a whole (all patients who received CAR T-cell infusions) was 11.1 months.
Adverse events of special interest included grade 3 or 4 cytokine release syndrome (CRS) in 23% of patients, prolonged cytopenia in 34%, infections in 19%, neurologic events in 11%, febrile neutropenia in 15%, and tumor lysis syndrome in 2%.
There were no deaths attributable to CRS or to cerebral edema, a complication of CAR T-cell therapy that appears to be related to the costimulatory molecule used in various constructs.
“Patients with relapsed or refractory DLBCL who are not eligible for high-dose therapy and hematopoietic cell transplantation or for whom such therapy was not successful have very few treatment options. For these patients, tisagenlecleucel shows promise that will need to be confirmed through larger studies with longer follow-up,” the investigators wrote in the New England Journal of Medicine.
The JULIET Trial is supported by Novartis. Dr. Maziar reported personal fees from Incyte, Kite Therapeutics, and Athersys.
SOURCE: Maziarz RT et al. N Engl J Med. 2018 Dec 1. doi: 10.1056/NEJMoa1804980.
REPORTING FROM ASH 2018
Key clinical point: Chimeric antigen receptor T-cell therapy produced durable responses in patients with heavily pretreated diffuse large B-cell lymphoma.
Major finding: The best overall response rate, the primary endpoint, was 52%, comprising 40% complete responses and 12% partial responses.
Study details: A single-arm, open-label study of tisagenlecleucel in adults with relapsed or refractory diffuse large B-cell lymphoma.
Disclosures: The JULIET trial is supported by Novartis. Dr. Maziarz reported personal fees from Incyte, Kite Therapeutics, and Athersys.
Source: Maziarz RT et al. N Engl J Med. 2018 Dec 1. doi: 10.1056/NEJMoa1804980.
ELIANA update: Tisagenlecleucel responses durable in r/r B-cell ALL
SAN DIEGO – A single infusion of tisagenlecleucel (Kymriah) continues to demonstrate high efficacy a year and a half after pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) were enrolled in the pivotal ELIANA trial, Stephan A. Grupp, MD, PhD, reported at a press conference at the annual meeting of the American Society of Hematology.
Of patients in complete remission after receiving the chimeric antigen receptor (CAR) T-cell therapy, 66% were still in remission at 18 months of follow-up and median survival has yet to be reached.
“We think the efficacy is sustained and excellent,” said Dr. Grupp, of the University of Pennsylvania, Philadelphia. “These are durable complete responses even without further therapy. We haven’t reached median duration of response or overall survival, and we can manage toxicity, so I think this is clearly an opportunity for us to treat our patients both in America and across the world.”
The results of ELIANA were the basis for the approval of tisagenlecleucel (Kymriah) for relapsed/refractory B-cell ALL in the United States, and for subsequent approvals by health authorities in the European Union, Switzerland, and Canada.
The international, single-arm, open-label, phase 2 ELIANA trial included 97 patients aged 3-24 years with relapsed or refractory B-cell ALL, most of whom had previously undergone a hematopoietic stem cell transplant. Of those patients, 79 patients went on to receive a single infusion of the CAR T-cell therapy.
The rate of overall remission, defined as the rate of complete remission or complete remission with incomplete blood count recovery, was 82% (65 patients). Among those patients, 66% were still in remission at 18 months, while overall survival was “excellent” at 70%, Dr. Grupp said, and the median overall survival was not reached.
Adverse events prevalence remained relatively unchanged since the previous analyses, according to Dr. Grupp, who added that appropriately trained personnel were able to effectively manage those adverse events across study sites. Cytokine release syndrome (CRS) occurred in 77% of patients. All cases were reversible; 39% received tocilizumab for treatment of CRS with or without other anticytokine therapies; 48% required ICU-level care for CRS, with a median ICU stay of 7 days.
The other most common grade 3/4 nonhematologic adverse events were neutropenia with a body temperature exceeding 38.3° C (62% within 8 weeks of infusion), hypoxia (20%), and hypotension (20%). Grade 3 neurologic effects occurred in 13% of patients, and none had cerebral edema. Based on laboratory results, 43% had grade 3/4 thrombocytopenia and 54% had neutropenia not resolved by day 28; most of these events resolved to grade 2 or less by 3 months.
There were 25 postinfusion deaths, with 2 occurring within 30 days (1 because of disease progression, 1 because of cerebral hemorrhage). Of the 23 deaths after 30 days (range, 53-859 days), 18 were caused by disease progression. The other deaths were caused by encephalitis, systemic mycosis, vasoocclusive hepatobiliary disorder related to allogeneic SCT, bacterial lung infection, and an unknown reason after study withdrawal.
Follow-up is ongoing in the ELIANA study, which is supported by Novartis, the maker of Kymriah.
Dr. Grupp reported research funding from Novartis, consultancy with Novartis, Jazz Pharmaceuticals, and Adaptimmune Therapeutics, and patents or royalties with the University of Pennsylvania.
SOURCE: Grupp SA et al. ASH 2018, Abstract 895.
SAN DIEGO – A single infusion of tisagenlecleucel (Kymriah) continues to demonstrate high efficacy a year and a half after pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) were enrolled in the pivotal ELIANA trial, Stephan A. Grupp, MD, PhD, reported at a press conference at the annual meeting of the American Society of Hematology.
Of patients in complete remission after receiving the chimeric antigen receptor (CAR) T-cell therapy, 66% were still in remission at 18 months of follow-up and median survival has yet to be reached.
“We think the efficacy is sustained and excellent,” said Dr. Grupp, of the University of Pennsylvania, Philadelphia. “These are durable complete responses even without further therapy. We haven’t reached median duration of response or overall survival, and we can manage toxicity, so I think this is clearly an opportunity for us to treat our patients both in America and across the world.”
The results of ELIANA were the basis for the approval of tisagenlecleucel (Kymriah) for relapsed/refractory B-cell ALL in the United States, and for subsequent approvals by health authorities in the European Union, Switzerland, and Canada.
The international, single-arm, open-label, phase 2 ELIANA trial included 97 patients aged 3-24 years with relapsed or refractory B-cell ALL, most of whom had previously undergone a hematopoietic stem cell transplant. Of those patients, 79 patients went on to receive a single infusion of the CAR T-cell therapy.
The rate of overall remission, defined as the rate of complete remission or complete remission with incomplete blood count recovery, was 82% (65 patients). Among those patients, 66% were still in remission at 18 months, while overall survival was “excellent” at 70%, Dr. Grupp said, and the median overall survival was not reached.
Adverse events prevalence remained relatively unchanged since the previous analyses, according to Dr. Grupp, who added that appropriately trained personnel were able to effectively manage those adverse events across study sites. Cytokine release syndrome (CRS) occurred in 77% of patients. All cases were reversible; 39% received tocilizumab for treatment of CRS with or without other anticytokine therapies; 48% required ICU-level care for CRS, with a median ICU stay of 7 days.
The other most common grade 3/4 nonhematologic adverse events were neutropenia with a body temperature exceeding 38.3° C (62% within 8 weeks of infusion), hypoxia (20%), and hypotension (20%). Grade 3 neurologic effects occurred in 13% of patients, and none had cerebral edema. Based on laboratory results, 43% had grade 3/4 thrombocytopenia and 54% had neutropenia not resolved by day 28; most of these events resolved to grade 2 or less by 3 months.
There were 25 postinfusion deaths, with 2 occurring within 30 days (1 because of disease progression, 1 because of cerebral hemorrhage). Of the 23 deaths after 30 days (range, 53-859 days), 18 were caused by disease progression. The other deaths were caused by encephalitis, systemic mycosis, vasoocclusive hepatobiliary disorder related to allogeneic SCT, bacterial lung infection, and an unknown reason after study withdrawal.
Follow-up is ongoing in the ELIANA study, which is supported by Novartis, the maker of Kymriah.
Dr. Grupp reported research funding from Novartis, consultancy with Novartis, Jazz Pharmaceuticals, and Adaptimmune Therapeutics, and patents or royalties with the University of Pennsylvania.
SOURCE: Grupp SA et al. ASH 2018, Abstract 895.
SAN DIEGO – A single infusion of tisagenlecleucel (Kymriah) continues to demonstrate high efficacy a year and a half after pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) were enrolled in the pivotal ELIANA trial, Stephan A. Grupp, MD, PhD, reported at a press conference at the annual meeting of the American Society of Hematology.
Of patients in complete remission after receiving the chimeric antigen receptor (CAR) T-cell therapy, 66% were still in remission at 18 months of follow-up and median survival has yet to be reached.
“We think the efficacy is sustained and excellent,” said Dr. Grupp, of the University of Pennsylvania, Philadelphia. “These are durable complete responses even without further therapy. We haven’t reached median duration of response or overall survival, and we can manage toxicity, so I think this is clearly an opportunity for us to treat our patients both in America and across the world.”
The results of ELIANA were the basis for the approval of tisagenlecleucel (Kymriah) for relapsed/refractory B-cell ALL in the United States, and for subsequent approvals by health authorities in the European Union, Switzerland, and Canada.
The international, single-arm, open-label, phase 2 ELIANA trial included 97 patients aged 3-24 years with relapsed or refractory B-cell ALL, most of whom had previously undergone a hematopoietic stem cell transplant. Of those patients, 79 patients went on to receive a single infusion of the CAR T-cell therapy.
The rate of overall remission, defined as the rate of complete remission or complete remission with incomplete blood count recovery, was 82% (65 patients). Among those patients, 66% were still in remission at 18 months, while overall survival was “excellent” at 70%, Dr. Grupp said, and the median overall survival was not reached.
Adverse events prevalence remained relatively unchanged since the previous analyses, according to Dr. Grupp, who added that appropriately trained personnel were able to effectively manage those adverse events across study sites. Cytokine release syndrome (CRS) occurred in 77% of patients. All cases were reversible; 39% received tocilizumab for treatment of CRS with or without other anticytokine therapies; 48% required ICU-level care for CRS, with a median ICU stay of 7 days.
The other most common grade 3/4 nonhematologic adverse events were neutropenia with a body temperature exceeding 38.3° C (62% within 8 weeks of infusion), hypoxia (20%), and hypotension (20%). Grade 3 neurologic effects occurred in 13% of patients, and none had cerebral edema. Based on laboratory results, 43% had grade 3/4 thrombocytopenia and 54% had neutropenia not resolved by day 28; most of these events resolved to grade 2 or less by 3 months.
There were 25 postinfusion deaths, with 2 occurring within 30 days (1 because of disease progression, 1 because of cerebral hemorrhage). Of the 23 deaths after 30 days (range, 53-859 days), 18 were caused by disease progression. The other deaths were caused by encephalitis, systemic mycosis, vasoocclusive hepatobiliary disorder related to allogeneic SCT, bacterial lung infection, and an unknown reason after study withdrawal.
Follow-up is ongoing in the ELIANA study, which is supported by Novartis, the maker of Kymriah.
Dr. Grupp reported research funding from Novartis, consultancy with Novartis, Jazz Pharmaceuticals, and Adaptimmune Therapeutics, and patents or royalties with the University of Pennsylvania.
SOURCE: Grupp SA et al. ASH 2018, Abstract 895.
REPORTING FROM ASH 2018
Key clinical point: A single infusion of tisagenlecleucel continues to demonstrate high efficacy a year and a half later in pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia.
Major finding: Among patients who had complete remission, 66% were still in remission at 18 months, while overall survival was 70% and median overall survival had not yet been reached.
Study details: A follow-up of the pivotal ELIANA trial, an international, single-arm, open-label, phase 2 study including 97 patients aged 3-24 years with relapsed or refractory B-cell acute lymphoblastic leukemia.
Disclosures: The study was supported by Novartis. Dr. Grupp reported disclosures with Novartis, Jazz Pharmaceuticals, Adaptimmune Therapeutics, and the University of Pennsylvania.
Source: Grupp SA et al. ASH 2018, Abstract 895.
Tanning use disorder should be added to the DSM-5
Raghav Tripathi and his associates maintained in a letter to the editor of the Journal of the European Academy of Dermatology and Venereology.
“Strong evidence suggests that tanning use disorder should be included in the DSM-5,” they wrote, noting that individuals who show signs of tanning use disorder have problems quitting, and also are more likely to smoke cigarettes, drink alcohol excessively, and engage in other high-risk behaviors.
In the letter, Mr. Tripathi, a medical student at Case Western Reserve University, Cleveland, and his associates also noted that frequent tanners have been found to prefer tanning beds that used UV radiation (UVR) over beds that did not, even though they were blinded to which ones did and did not. Reports of pain relief and improved mood following UVR exposure, withdrawal symptoms upon discontinuation of UVR, and the successful use of opioid antagonists to reduce UVR dependence “underscore the importance of viewing tanning as a use disorder.”
The same “brain circuitry and neurotransmitters involved in the reward pathways of other use disorders” are associated with the addictive characteristics of UVR, they wrote.
In one study, people who were compulsive tanners were found to have an increase in “cerebral blood flow in the mesostriatal reward pathway when exposed to UVR.” In another study, opioid antagonism using naltrexone was found to reduce “UVR preference in frequent tanners.”
Understanding the biologic connections is crucial to advocating for formalization of the condition as a recognized disorder in the DSM-5; classification would not only increase awareness of the condition but also standardize approaches to diagnosis and treatment that are key to improving patient care, the authors wrote. Moreover, inclusion of the disorder in the DSM-5 could help to pave the way for inclusion in the ICD-10, which would have broader implications for limiting the overall harmful effects that tanning poses.
The authors had no relevant financial disclosures to report.
SOURCE: Tripathi R et al. J Eur Acad Dermatol Venereol. 2018 Oct 13. doi: 10.1111/jdv.15286.
Raghav Tripathi and his associates maintained in a letter to the editor of the Journal of the European Academy of Dermatology and Venereology.
“Strong evidence suggests that tanning use disorder should be included in the DSM-5,” they wrote, noting that individuals who show signs of tanning use disorder have problems quitting, and also are more likely to smoke cigarettes, drink alcohol excessively, and engage in other high-risk behaviors.
In the letter, Mr. Tripathi, a medical student at Case Western Reserve University, Cleveland, and his associates also noted that frequent tanners have been found to prefer tanning beds that used UV radiation (UVR) over beds that did not, even though they were blinded to which ones did and did not. Reports of pain relief and improved mood following UVR exposure, withdrawal symptoms upon discontinuation of UVR, and the successful use of opioid antagonists to reduce UVR dependence “underscore the importance of viewing tanning as a use disorder.”
The same “brain circuitry and neurotransmitters involved in the reward pathways of other use disorders” are associated with the addictive characteristics of UVR, they wrote.
In one study, people who were compulsive tanners were found to have an increase in “cerebral blood flow in the mesostriatal reward pathway when exposed to UVR.” In another study, opioid antagonism using naltrexone was found to reduce “UVR preference in frequent tanners.”
Understanding the biologic connections is crucial to advocating for formalization of the condition as a recognized disorder in the DSM-5; classification would not only increase awareness of the condition but also standardize approaches to diagnosis and treatment that are key to improving patient care, the authors wrote. Moreover, inclusion of the disorder in the DSM-5 could help to pave the way for inclusion in the ICD-10, which would have broader implications for limiting the overall harmful effects that tanning poses.
The authors had no relevant financial disclosures to report.
SOURCE: Tripathi R et al. J Eur Acad Dermatol Venereol. 2018 Oct 13. doi: 10.1111/jdv.15286.
Raghav Tripathi and his associates maintained in a letter to the editor of the Journal of the European Academy of Dermatology and Venereology.
“Strong evidence suggests that tanning use disorder should be included in the DSM-5,” they wrote, noting that individuals who show signs of tanning use disorder have problems quitting, and also are more likely to smoke cigarettes, drink alcohol excessively, and engage in other high-risk behaviors.
In the letter, Mr. Tripathi, a medical student at Case Western Reserve University, Cleveland, and his associates also noted that frequent tanners have been found to prefer tanning beds that used UV radiation (UVR) over beds that did not, even though they were blinded to which ones did and did not. Reports of pain relief and improved mood following UVR exposure, withdrawal symptoms upon discontinuation of UVR, and the successful use of opioid antagonists to reduce UVR dependence “underscore the importance of viewing tanning as a use disorder.”
The same “brain circuitry and neurotransmitters involved in the reward pathways of other use disorders” are associated with the addictive characteristics of UVR, they wrote.
In one study, people who were compulsive tanners were found to have an increase in “cerebral blood flow in the mesostriatal reward pathway when exposed to UVR.” In another study, opioid antagonism using naltrexone was found to reduce “UVR preference in frequent tanners.”
Understanding the biologic connections is crucial to advocating for formalization of the condition as a recognized disorder in the DSM-5; classification would not only increase awareness of the condition but also standardize approaches to diagnosis and treatment that are key to improving patient care, the authors wrote. Moreover, inclusion of the disorder in the DSM-5 could help to pave the way for inclusion in the ICD-10, which would have broader implications for limiting the overall harmful effects that tanning poses.
The authors had no relevant financial disclosures to report.
SOURCE: Tripathi R et al. J Eur Acad Dermatol Venereol. 2018 Oct 13. doi: 10.1111/jdv.15286.
FROM THE JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
ARISTOPHANES: Apixaban edges other DOACS for octogenarians
The findings come from an analysis of insurance claims data from more than 50,000 U.S. patients – the largest observational study to date to compare these three direct-acting oral anticoagulants (DOACs) in octogenarians with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, said at the American Heart Association scientific sessions.
“The results may help clinicians evaluate the risk-benefit ratio of the DOACs” in this population, said Dr. Deitelzweig, vice president for medical affairs at Ochsner Medical Center in New Orleans.
He noted that the results were consistent with prior reports from observational data and registries, as well as the results in a recent analysis commissioned by the Agency for Healthcare Research and Quality. “We see a consistent message that apixaban always has less risk for major bleeding, and at least comparable efficacy” when compared with other DOACs, he said in a video interview.
And for the foreseeable future, this sort of data will need to suffice for clinicians trying to decide which DOAC to use because “I know of no head-to-head trials, nor do I anticipate any head-to-head trials” that could provide a more definitive comparison of the DOACs, Dr. Deitelzweig said.
The data came from a large number of patients – about 38% of the U.S. population – which boosts the generalizability of the finding. “I think our data are useful” for helping to make treatment decisions, he concluded.
The analysis he reported came from the ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) study, which pooled U.S. insurance claims data from several sources. For the octogenarian study, Dr. Deitelzweig and his associates used data from about 123 million U.S. residents collected between January 2012 and September 2015 by Medicare and three different commercial insurance databases. The overall level of beneficiary overlap between these four data sources was less than 0.5%.
The researchers identified patients with nonvalvular atrial fibrillation who started anticoagulant treatment with a DOAC and were at least 80 years old. This included 19,752 patients started on apixaban (Eliquis), 6,741 started on dabigatran (Pradaxa), and 27,217 started on rivaroxaban (Xarelto). A majority of the patients were at least 84 years old.
The analysis used propensity-score matching to compare similar patients and to minimize the impact of potentially confounding differences among the patients in each treatment subgroup. During a median follow-up of 7-9 months, the incidence of stroke or systemic embolism was 35% lower in the apixaban-treated patients, compared with those who received dabigatran, and 28% lower in the apixaban patients, compared with those treated with rivaroxaban, both statistically significant differences, Dr. Deitelzweig reported. The incidence of major bleeding episodes was 40% lower with apixaban than with dabigatran and 50% lower with apixaban, compared with rivaroxaban, also statistically significant differences.
When the analysis compared dabigatran with rivaroxaban it showed no statistically significant difference for the efficacy endpoint, but dabigatran produced 23% fewer major bleeds than rivaroxaban, a statistically significant difference.
These findings jibed with a recently published analysis from Dr. Deitelzweig and his associates that used data from all adults with nonvalvular atrial fibrillation started on an oral anticoagulant in an expanded ARISTOPHANES database for 2012-2015 that included more than 180 million U.S. beneficiaries. After propensity-score matching, this created subgroups of about 58,000 patients started on apixaban, nearly 27,000 started on dabigatran, and more than 83,000 started on rivaroxaban. The patients averaged about 73 years old. Again, with about 7-9 months of follow-up, very similar outcomes occurred. Patients on apixaban had significantly fewer strokes and systemic embolic events as well as significantly fewer major bleeds compared with patients treated with one of the other DOACs (Stroke. 2018 Dec;49[12]:2933-44).
The study was funded by Bristol-Myers Squibb and Pfizer, the companies that market apixaban (Eliquis). Dr. Deitelzweig is a consultant to and speaker on behalf of Bristol-Myers Squibb and Pfizer. He is also a consultant to or speaker on behalf of Boehringer Ingelheim, Daiichi-Sankyo, Janssen, and Portola Pharmaceuticals.
SOURCE: Deitelzweig SB et al. Circulation. 2018 Nov 6;138(suppl 1):A14900.
The findings come from an analysis of insurance claims data from more than 50,000 U.S. patients – the largest observational study to date to compare these three direct-acting oral anticoagulants (DOACs) in octogenarians with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, said at the American Heart Association scientific sessions.
“The results may help clinicians evaluate the risk-benefit ratio of the DOACs” in this population, said Dr. Deitelzweig, vice president for medical affairs at Ochsner Medical Center in New Orleans.
He noted that the results were consistent with prior reports from observational data and registries, as well as the results in a recent analysis commissioned by the Agency for Healthcare Research and Quality. “We see a consistent message that apixaban always has less risk for major bleeding, and at least comparable efficacy” when compared with other DOACs, he said in a video interview.
And for the foreseeable future, this sort of data will need to suffice for clinicians trying to decide which DOAC to use because “I know of no head-to-head trials, nor do I anticipate any head-to-head trials” that could provide a more definitive comparison of the DOACs, Dr. Deitelzweig said.
The data came from a large number of patients – about 38% of the U.S. population – which boosts the generalizability of the finding. “I think our data are useful” for helping to make treatment decisions, he concluded.
The analysis he reported came from the ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) study, which pooled U.S. insurance claims data from several sources. For the octogenarian study, Dr. Deitelzweig and his associates used data from about 123 million U.S. residents collected between January 2012 and September 2015 by Medicare and three different commercial insurance databases. The overall level of beneficiary overlap between these four data sources was less than 0.5%.
The researchers identified patients with nonvalvular atrial fibrillation who started anticoagulant treatment with a DOAC and were at least 80 years old. This included 19,752 patients started on apixaban (Eliquis), 6,741 started on dabigatran (Pradaxa), and 27,217 started on rivaroxaban (Xarelto). A majority of the patients were at least 84 years old.
The analysis used propensity-score matching to compare similar patients and to minimize the impact of potentially confounding differences among the patients in each treatment subgroup. During a median follow-up of 7-9 months, the incidence of stroke or systemic embolism was 35% lower in the apixaban-treated patients, compared with those who received dabigatran, and 28% lower in the apixaban patients, compared with those treated with rivaroxaban, both statistically significant differences, Dr. Deitelzweig reported. The incidence of major bleeding episodes was 40% lower with apixaban than with dabigatran and 50% lower with apixaban, compared with rivaroxaban, also statistically significant differences.
When the analysis compared dabigatran with rivaroxaban it showed no statistically significant difference for the efficacy endpoint, but dabigatran produced 23% fewer major bleeds than rivaroxaban, a statistically significant difference.
These findings jibed with a recently published analysis from Dr. Deitelzweig and his associates that used data from all adults with nonvalvular atrial fibrillation started on an oral anticoagulant in an expanded ARISTOPHANES database for 2012-2015 that included more than 180 million U.S. beneficiaries. After propensity-score matching, this created subgroups of about 58,000 patients started on apixaban, nearly 27,000 started on dabigatran, and more than 83,000 started on rivaroxaban. The patients averaged about 73 years old. Again, with about 7-9 months of follow-up, very similar outcomes occurred. Patients on apixaban had significantly fewer strokes and systemic embolic events as well as significantly fewer major bleeds compared with patients treated with one of the other DOACs (Stroke. 2018 Dec;49[12]:2933-44).
The study was funded by Bristol-Myers Squibb and Pfizer, the companies that market apixaban (Eliquis). Dr. Deitelzweig is a consultant to and speaker on behalf of Bristol-Myers Squibb and Pfizer. He is also a consultant to or speaker on behalf of Boehringer Ingelheim, Daiichi-Sankyo, Janssen, and Portola Pharmaceuticals.
SOURCE: Deitelzweig SB et al. Circulation. 2018 Nov 6;138(suppl 1):A14900.
The findings come from an analysis of insurance claims data from more than 50,000 U.S. patients – the largest observational study to date to compare these three direct-acting oral anticoagulants (DOACs) in octogenarians with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, said at the American Heart Association scientific sessions.
“The results may help clinicians evaluate the risk-benefit ratio of the DOACs” in this population, said Dr. Deitelzweig, vice president for medical affairs at Ochsner Medical Center in New Orleans.
He noted that the results were consistent with prior reports from observational data and registries, as well as the results in a recent analysis commissioned by the Agency for Healthcare Research and Quality. “We see a consistent message that apixaban always has less risk for major bleeding, and at least comparable efficacy” when compared with other DOACs, he said in a video interview.
And for the foreseeable future, this sort of data will need to suffice for clinicians trying to decide which DOAC to use because “I know of no head-to-head trials, nor do I anticipate any head-to-head trials” that could provide a more definitive comparison of the DOACs, Dr. Deitelzweig said.
The data came from a large number of patients – about 38% of the U.S. population – which boosts the generalizability of the finding. “I think our data are useful” for helping to make treatment decisions, he concluded.
The analysis he reported came from the ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) study, which pooled U.S. insurance claims data from several sources. For the octogenarian study, Dr. Deitelzweig and his associates used data from about 123 million U.S. residents collected between January 2012 and September 2015 by Medicare and three different commercial insurance databases. The overall level of beneficiary overlap between these four data sources was less than 0.5%.
The researchers identified patients with nonvalvular atrial fibrillation who started anticoagulant treatment with a DOAC and were at least 80 years old. This included 19,752 patients started on apixaban (Eliquis), 6,741 started on dabigatran (Pradaxa), and 27,217 started on rivaroxaban (Xarelto). A majority of the patients were at least 84 years old.
The analysis used propensity-score matching to compare similar patients and to minimize the impact of potentially confounding differences among the patients in each treatment subgroup. During a median follow-up of 7-9 months, the incidence of stroke or systemic embolism was 35% lower in the apixaban-treated patients, compared with those who received dabigatran, and 28% lower in the apixaban patients, compared with those treated with rivaroxaban, both statistically significant differences, Dr. Deitelzweig reported. The incidence of major bleeding episodes was 40% lower with apixaban than with dabigatran and 50% lower with apixaban, compared with rivaroxaban, also statistically significant differences.
When the analysis compared dabigatran with rivaroxaban it showed no statistically significant difference for the efficacy endpoint, but dabigatran produced 23% fewer major bleeds than rivaroxaban, a statistically significant difference.
These findings jibed with a recently published analysis from Dr. Deitelzweig and his associates that used data from all adults with nonvalvular atrial fibrillation started on an oral anticoagulant in an expanded ARISTOPHANES database for 2012-2015 that included more than 180 million U.S. beneficiaries. After propensity-score matching, this created subgroups of about 58,000 patients started on apixaban, nearly 27,000 started on dabigatran, and more than 83,000 started on rivaroxaban. The patients averaged about 73 years old. Again, with about 7-9 months of follow-up, very similar outcomes occurred. Patients on apixaban had significantly fewer strokes and systemic embolic events as well as significantly fewer major bleeds compared with patients treated with one of the other DOACs (Stroke. 2018 Dec;49[12]:2933-44).
The study was funded by Bristol-Myers Squibb and Pfizer, the companies that market apixaban (Eliquis). Dr. Deitelzweig is a consultant to and speaker on behalf of Bristol-Myers Squibb and Pfizer. He is also a consultant to or speaker on behalf of Boehringer Ingelheim, Daiichi-Sankyo, Janssen, and Portola Pharmaceuticals.
SOURCE: Deitelzweig SB et al. Circulation. 2018 Nov 6;138(suppl 1):A14900.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: Apixaban surpassed two other direct-acting oral anticoagulants in a large, observational database.
Major finding: The adjusted stroke or systemic embolism rate with apixaban was 35% less than dabigatran and 28% less than rivaroxaban.
Study details: A retrospective analysis of observational data collected in insurance claims from 53,710 U.S. octogenarians.
Disclosures: The study was funded by Bristol-Myers Squibb and Pfizer, the companies that market apixaban (Eliquis). Dr. Deitelzweig is a consultant to and speaker on behalf of Bristol-Myers Squibb and Pfizer. He is also a consultant to or speaker on behalf of Boehringer Ingelheim, Daiichi-Sankyo, Janssen, and Portola Pharmaceuticals.
Source: Deitelzweig SB et al. Circulation. 2018 Nov 6;138[suppl 1]:A14900.
Program decreased seizure frequency for people with epilepsy
NEW ORLEANS – A self-management program that focused on medication adherence, sleep, nutrition, and stress reduction was associated with decreased seizures and improved quality of life for adults with epilepsy.
SMART (Self‐management for people with epilepsy and a history of negative health events) also was associated with improved depression scores and overall quality of life measures in participants, compared with a wait-listed control group, Martha Sajatovic, MD, said at the annual meeting of the American Epilepsy Society.
“I believe what we’re seeing is a result of improved self-management,” said Dr. Sajatovic, the Willard Brown Chair in Neurological Outcomes Research at Case Western Reserve University, Cleveland. “This is multimodal, including better medication adherence, which in turn is related to better communication with the clinician. For example, if patients are not sleeping well or their medicine makes them nauseated or they experience sexual dysfunction, we encourage them to talk to their docs about what they can live with, and what they can’t.”
Presented as a poster during the meeting, the SMART study was also published in Epilepsia.
SMART is an 8-week online educational program delivered by a nurse educator and a “peer educator,” a person with epilepsy who has had at least three negative health events. The first session is an in-person visit during which the team gets acquainted and discusses goals. The remaining sessions are self-paced and delivered on computer tablets provided by the investigators.
SMART didn’t just focus on the physical issues of living with epilepsy, Dr. Sajatovic said in an interview. Sessions also discussed the stigma still associated with the disorder, and myths that unnecessarily inflate perceptions. Discussions include goal setting, epilepsy complications and how to manage them, the importance of good sleep hygiene, problem-solving skills, nutrition and substance abuse, exercise, and how to deal with medication side effects.
“One thing we really stressed was sharing information in a way that was accessible to all patients and fostered self-motivation,” she said. “Most of our participants had never been in a program like this before. It was very empowering for many.”
The researchers chose participants who were socioeconomically challenged for this project; 88% made less than $25,000 per year and 74% were unemployed. The mean age of participants was 41 years, 70% were black, and most had been living with epilepsy at least half of their life. About 70% lived alone, and 70% had experienced at least one seizure within the month before enrolling. Mental health comorbidities were common; 69% had depression, 32% had anxiety, and 13% had PTSD.
The study enrolled 120 people, who were evenly divided between the intervention group and the wait-list group. The primary outcome was the change in total negative health events from baseline to the study’s end. Negative health events were seizures and ED or hospital admissions for any other causes including attempts at self-harm, falls, and accidents.
Secondary outcomes included changes in depression scores as measured by the Montgomery-Åsberg Depression Rating Scale and the 9-item Patient Health Questionnaire. Quality of life was measured using the 10-item Quality of Life in Epilepsy; functional status was measured using the 36-Item Short-Form Health Survey.
At baseline, the total mean 6-month negative health events count was 15, with 13 events being seizures. The other events were hospital or ED visits for other reasons.
At the end of the study, the intervention group experienced a significant mean decrease of 10 fewer negative health events, compared with a decrease of 2 in the wait-listed group. This was largely driven by a mean of 7.8 fewer seizures in the active group, compared with a decrease of about 1.0 in the wait-listed group. The 6-month ER and hospitalization counts did not significantly change.
Among the secondary outcomes, depression, overall health, and quality of life all improved significantly in the intervention group, compared with the wait-listed group. The intervention group also had significant decreases in depression measures and improvements in daily function measures, Dr. Sajatovic said.
“It was so gratifying to see this. Most of our participants had never been in a program like this before. It was a chance for them to take control of their epilepsy, instead of simply having it control them,” she said.
This study was supported by a grant from the Centers for Disease Control and Prevention. Dr. Sajatovic had no financial disclosures related to this presentation.
SOURCE: Sajatovic M et al.
NEW ORLEANS – A self-management program that focused on medication adherence, sleep, nutrition, and stress reduction was associated with decreased seizures and improved quality of life for adults with epilepsy.
SMART (Self‐management for people with epilepsy and a history of negative health events) also was associated with improved depression scores and overall quality of life measures in participants, compared with a wait-listed control group, Martha Sajatovic, MD, said at the annual meeting of the American Epilepsy Society.
“I believe what we’re seeing is a result of improved self-management,” said Dr. Sajatovic, the Willard Brown Chair in Neurological Outcomes Research at Case Western Reserve University, Cleveland. “This is multimodal, including better medication adherence, which in turn is related to better communication with the clinician. For example, if patients are not sleeping well or their medicine makes them nauseated or they experience sexual dysfunction, we encourage them to talk to their docs about what they can live with, and what they can’t.”
Presented as a poster during the meeting, the SMART study was also published in Epilepsia.
SMART is an 8-week online educational program delivered by a nurse educator and a “peer educator,” a person with epilepsy who has had at least three negative health events. The first session is an in-person visit during which the team gets acquainted and discusses goals. The remaining sessions are self-paced and delivered on computer tablets provided by the investigators.
SMART didn’t just focus on the physical issues of living with epilepsy, Dr. Sajatovic said in an interview. Sessions also discussed the stigma still associated with the disorder, and myths that unnecessarily inflate perceptions. Discussions include goal setting, epilepsy complications and how to manage them, the importance of good sleep hygiene, problem-solving skills, nutrition and substance abuse, exercise, and how to deal with medication side effects.
“One thing we really stressed was sharing information in a way that was accessible to all patients and fostered self-motivation,” she said. “Most of our participants had never been in a program like this before. It was very empowering for many.”
The researchers chose participants who were socioeconomically challenged for this project; 88% made less than $25,000 per year and 74% were unemployed. The mean age of participants was 41 years, 70% were black, and most had been living with epilepsy at least half of their life. About 70% lived alone, and 70% had experienced at least one seizure within the month before enrolling. Mental health comorbidities were common; 69% had depression, 32% had anxiety, and 13% had PTSD.
The study enrolled 120 people, who were evenly divided between the intervention group and the wait-list group. The primary outcome was the change in total negative health events from baseline to the study’s end. Negative health events were seizures and ED or hospital admissions for any other causes including attempts at self-harm, falls, and accidents.
Secondary outcomes included changes in depression scores as measured by the Montgomery-Åsberg Depression Rating Scale and the 9-item Patient Health Questionnaire. Quality of life was measured using the 10-item Quality of Life in Epilepsy; functional status was measured using the 36-Item Short-Form Health Survey.
At baseline, the total mean 6-month negative health events count was 15, with 13 events being seizures. The other events were hospital or ED visits for other reasons.
At the end of the study, the intervention group experienced a significant mean decrease of 10 fewer negative health events, compared with a decrease of 2 in the wait-listed group. This was largely driven by a mean of 7.8 fewer seizures in the active group, compared with a decrease of about 1.0 in the wait-listed group. The 6-month ER and hospitalization counts did not significantly change.
Among the secondary outcomes, depression, overall health, and quality of life all improved significantly in the intervention group, compared with the wait-listed group. The intervention group also had significant decreases in depression measures and improvements in daily function measures, Dr. Sajatovic said.
“It was so gratifying to see this. Most of our participants had never been in a program like this before. It was a chance for them to take control of their epilepsy, instead of simply having it control them,” she said.
This study was supported by a grant from the Centers for Disease Control and Prevention. Dr. Sajatovic had no financial disclosures related to this presentation.
SOURCE: Sajatovic M et al.
NEW ORLEANS – A self-management program that focused on medication adherence, sleep, nutrition, and stress reduction was associated with decreased seizures and improved quality of life for adults with epilepsy.
SMART (Self‐management for people with epilepsy and a history of negative health events) also was associated with improved depression scores and overall quality of life measures in participants, compared with a wait-listed control group, Martha Sajatovic, MD, said at the annual meeting of the American Epilepsy Society.
“I believe what we’re seeing is a result of improved self-management,” said Dr. Sajatovic, the Willard Brown Chair in Neurological Outcomes Research at Case Western Reserve University, Cleveland. “This is multimodal, including better medication adherence, which in turn is related to better communication with the clinician. For example, if patients are not sleeping well or their medicine makes them nauseated or they experience sexual dysfunction, we encourage them to talk to their docs about what they can live with, and what they can’t.”
Presented as a poster during the meeting, the SMART study was also published in Epilepsia.
SMART is an 8-week online educational program delivered by a nurse educator and a “peer educator,” a person with epilepsy who has had at least three negative health events. The first session is an in-person visit during which the team gets acquainted and discusses goals. The remaining sessions are self-paced and delivered on computer tablets provided by the investigators.
SMART didn’t just focus on the physical issues of living with epilepsy, Dr. Sajatovic said in an interview. Sessions also discussed the stigma still associated with the disorder, and myths that unnecessarily inflate perceptions. Discussions include goal setting, epilepsy complications and how to manage them, the importance of good sleep hygiene, problem-solving skills, nutrition and substance abuse, exercise, and how to deal with medication side effects.
“One thing we really stressed was sharing information in a way that was accessible to all patients and fostered self-motivation,” she said. “Most of our participants had never been in a program like this before. It was very empowering for many.”
The researchers chose participants who were socioeconomically challenged for this project; 88% made less than $25,000 per year and 74% were unemployed. The mean age of participants was 41 years, 70% were black, and most had been living with epilepsy at least half of their life. About 70% lived alone, and 70% had experienced at least one seizure within the month before enrolling. Mental health comorbidities were common; 69% had depression, 32% had anxiety, and 13% had PTSD.
The study enrolled 120 people, who were evenly divided between the intervention group and the wait-list group. The primary outcome was the change in total negative health events from baseline to the study’s end. Negative health events were seizures and ED or hospital admissions for any other causes including attempts at self-harm, falls, and accidents.
Secondary outcomes included changes in depression scores as measured by the Montgomery-Åsberg Depression Rating Scale and the 9-item Patient Health Questionnaire. Quality of life was measured using the 10-item Quality of Life in Epilepsy; functional status was measured using the 36-Item Short-Form Health Survey.
At baseline, the total mean 6-month negative health events count was 15, with 13 events being seizures. The other events were hospital or ED visits for other reasons.
At the end of the study, the intervention group experienced a significant mean decrease of 10 fewer negative health events, compared with a decrease of 2 in the wait-listed group. This was largely driven by a mean of 7.8 fewer seizures in the active group, compared with a decrease of about 1.0 in the wait-listed group. The 6-month ER and hospitalization counts did not significantly change.
Among the secondary outcomes, depression, overall health, and quality of life all improved significantly in the intervention group, compared with the wait-listed group. The intervention group also had significant decreases in depression measures and improvements in daily function measures, Dr. Sajatovic said.
“It was so gratifying to see this. Most of our participants had never been in a program like this before. It was a chance for them to take control of their epilepsy, instead of simply having it control them,” she said.
This study was supported by a grant from the Centers for Disease Control and Prevention. Dr. Sajatovic had no financial disclosures related to this presentation.
SOURCE: Sajatovic M et al.
REPORTING FROM AES 2018
Key clinical point: Patients with epilepsy had fewer seizures and improved quality of life after 6 months of participation in a program that teaches self-management techniques.
Major finding: The intervention group had a mean of 7.8 fewer seizures, compared with their baseline count during the 6-month study.
Study details: The prospective study randomized 120 people to either the intervention group or a wait-list group.
Disclosures: This study was supported by a grant from the Centers for Disease Control and Prevention. Dr. Sajatovic reported no financial disclosures related to this presentation.
Source: Sajatovic M et al. AES
Patients with epilepsy may develop tolerance to CBD-enriched oil
NEW ORLEANS – according to a study presented at the annual meeting of the American Epilepsy Society.
“CBD is a good option for children and adults with certain kinds of epilepsy, but as with antiepileptic drugs, it can become less effective over time, and the dose may need to be increased to manage the seizures,” said Shimrit Uliel-Sibony, MD, lead author of the study and head of the pediatric epilepsy service at Tel Aviv Sourasky Medical Center’s Dana-Dwek Children’s Hospital.
Prior studies have found that the efficacy of cannabinoids may wane when used for pain management. Efficacy also declines in animals with seizures.
To assess the tolerance rate of cannabinoids in the treatment of children and adults with epilepsy, researchers in Israel conducted a prospective review of 92 consecutive patients with treatment-resistant epilepsy. Patients were aged 1-37 years (mean age, 11.8 years) and were treated with cannabis oil extract during March 1, 2014–Dec. 31, 2017. The researchers defined tolerance as the need to increase the dose by at least 30% following a reduction in efficacy, or a more than 30% reduction in treatment response.
The patients had various forms of epilepsy (e.g., Dravet syndrome, Lennox-Gastaut syndrome, and epilepsy caused by stroke) and used cannabis oil extract for an average of 19.8 months. Of the 84 patients included in the tolerance analysis, 21 patients (25%) developed tolerance after an average of 7.3 months (range, 1-24 months) at an average dose of 12.6 mg/kg per day. After patients with tolerance received an increased dose, 4 patients returned to their previous response levels, and 10 patients had a response that was “satisfying but less than [the] prior response level,” Dr. Uliel-Sibony and colleagues said.
About a third of patients discontinued treatment because of side effects or lack of efficacy. Side effects included sleepiness, nausea, decreased appetite, and vomiting. In addition, seizures worsened in two patients, and one patient had signs of psychosis; treatment was stopped immediately in those three patients.
The investigators had no disclosures and received no funding for this study.
SOURCE: Uliel-Sibony S et al., AES 2018, Abstract 2.233.
NEW ORLEANS – according to a study presented at the annual meeting of the American Epilepsy Society.
“CBD is a good option for children and adults with certain kinds of epilepsy, but as with antiepileptic drugs, it can become less effective over time, and the dose may need to be increased to manage the seizures,” said Shimrit Uliel-Sibony, MD, lead author of the study and head of the pediatric epilepsy service at Tel Aviv Sourasky Medical Center’s Dana-Dwek Children’s Hospital.
Prior studies have found that the efficacy of cannabinoids may wane when used for pain management. Efficacy also declines in animals with seizures.
To assess the tolerance rate of cannabinoids in the treatment of children and adults with epilepsy, researchers in Israel conducted a prospective review of 92 consecutive patients with treatment-resistant epilepsy. Patients were aged 1-37 years (mean age, 11.8 years) and were treated with cannabis oil extract during March 1, 2014–Dec. 31, 2017. The researchers defined tolerance as the need to increase the dose by at least 30% following a reduction in efficacy, or a more than 30% reduction in treatment response.
The patients had various forms of epilepsy (e.g., Dravet syndrome, Lennox-Gastaut syndrome, and epilepsy caused by stroke) and used cannabis oil extract for an average of 19.8 months. Of the 84 patients included in the tolerance analysis, 21 patients (25%) developed tolerance after an average of 7.3 months (range, 1-24 months) at an average dose of 12.6 mg/kg per day. After patients with tolerance received an increased dose, 4 patients returned to their previous response levels, and 10 patients had a response that was “satisfying but less than [the] prior response level,” Dr. Uliel-Sibony and colleagues said.
About a third of patients discontinued treatment because of side effects or lack of efficacy. Side effects included sleepiness, nausea, decreased appetite, and vomiting. In addition, seizures worsened in two patients, and one patient had signs of psychosis; treatment was stopped immediately in those three patients.
The investigators had no disclosures and received no funding for this study.
SOURCE: Uliel-Sibony S et al., AES 2018, Abstract 2.233.
NEW ORLEANS – according to a study presented at the annual meeting of the American Epilepsy Society.
“CBD is a good option for children and adults with certain kinds of epilepsy, but as with antiepileptic drugs, it can become less effective over time, and the dose may need to be increased to manage the seizures,” said Shimrit Uliel-Sibony, MD, lead author of the study and head of the pediatric epilepsy service at Tel Aviv Sourasky Medical Center’s Dana-Dwek Children’s Hospital.
Prior studies have found that the efficacy of cannabinoids may wane when used for pain management. Efficacy also declines in animals with seizures.
To assess the tolerance rate of cannabinoids in the treatment of children and adults with epilepsy, researchers in Israel conducted a prospective review of 92 consecutive patients with treatment-resistant epilepsy. Patients were aged 1-37 years (mean age, 11.8 years) and were treated with cannabis oil extract during March 1, 2014–Dec. 31, 2017. The researchers defined tolerance as the need to increase the dose by at least 30% following a reduction in efficacy, or a more than 30% reduction in treatment response.
The patients had various forms of epilepsy (e.g., Dravet syndrome, Lennox-Gastaut syndrome, and epilepsy caused by stroke) and used cannabis oil extract for an average of 19.8 months. Of the 84 patients included in the tolerance analysis, 21 patients (25%) developed tolerance after an average of 7.3 months (range, 1-24 months) at an average dose of 12.6 mg/kg per day. After patients with tolerance received an increased dose, 4 patients returned to their previous response levels, and 10 patients had a response that was “satisfying but less than [the] prior response level,” Dr. Uliel-Sibony and colleagues said.
About a third of patients discontinued treatment because of side effects or lack of efficacy. Side effects included sleepiness, nausea, decreased appetite, and vomiting. In addition, seizures worsened in two patients, and one patient had signs of psychosis; treatment was stopped immediately in those three patients.
The investigators had no disclosures and received no funding for this study.
SOURCE: Uliel-Sibony S et al., AES 2018, Abstract 2.233.
REPORTING FROM AES 2018
Key clinical point: Cannabis oil extract may become less effective, and the dose may need to be increased to manage seizures.
Major finding: About a quarter of patients who received cannabis oil extract developed tolerance.
Study details: Prospective review of 92 consecutive patients with treatment-resistant epilepsy.
Disclosures: The investigators had no disclosures and received no funding for this study.
Source: Uliel-Sibony S et al. AES 2018, Abstract 2.233.
Ibrutinib outperforms bendamustine and rituximab in older CLL patients
SAN DIEGO – Ibrutinib alone or in combination with rituximab resulted in superior progression-free survival (PFS) when compared with bendamustine plus rituximab in the randomized, phase 3 Alliance A041202 trial of older patients with previously untreated chronic lymphocytic leukemia (CLL).
“There was no difference in progression-free survival between ibrutinib and ibrutinib plus rituximab,” said Dr. Woyach of the Ohio State University, Columbus.
Median PFS in this study was 43 months in the BR arm, and was not reached in either of the ibrutinib-containing arms, she said. No significant differences in overall survival (OS) were seen among the treatment arms, which may have been because of short follow-up and the fact that patients in the BR arm were allowed to cross over to ibrutinib if they progressed on treatment.
Participants in the international, multicenter trial – a project of the National Cancer Institute National Clinical Trials Network – were 547 adults aged 65 years or older (median, 71 years) with previously untreated, symptomatic CLL. They were enrolled from 219 sites across the United States and Canada between Dec. 9, 2013, and May 16, 2016.
The three arms were well matched with respect to baseline characteristics except for a slightly higher number of patients with complex karyotypes in the IR arm, Dr. Woyach said.
Treatment in the BR arm included bendamustine 90 mg/m2 on days 1 and 2 of each 28-day cycle plus rituximab at a dose of 375 mg/m2 on day 0 of cycle 1 then 500 mg/m2 on day 1 of cycles 2-6. Patients in the ibrutinib arms received 420 mg daily until disease progression either with or without rituximab at 375 mg/m2 weekly for 4 weeks starting at cycle 2 day 1 and then given on day 1 of cycles 3-6.
Grade 3-5 treatment-emergent hematologic adverse events (AEs) occurred in 61%, 41%, and 38% of patients in the BR, ibrutinib, and IR arms, respectively. Neutropenia and thrombocytopenia occurred more often in the BR than in the ibrutinib arms. Nonhematologic AEs occurred in 63%, 74%, and 74%, respectively, with an overall greater incidence in the ibrutinib arms. Infections and sudden deaths were numerically but not significantly higher in the ibrutinib arms.
“We undertook this study to determine the most effective therapy for older patients with CLL,” Dr. Woyach said, explaining that while older patients make up the majority of patients with CLL, they are typically underrepresented in trials.
At the start of the study, BR was widely used and the Bruton’s tyrosine kinase inhibitor ibrutinib was “just entering the clinic,” she noted.
“Despite now-widespread use in the [front-line setting] following FDA approval for this indication in 2016, the efficacy of ibrutinib versus standard chemoimmunotherapy has not previously been investigated,” she said.
Since adding rituximab has been shown to improve PFS and OS when added to chemotherapy in CLL, she and her colleagues also looked at whether this was the case with ibrutinib as well.
“This is the only phase 3 trial designed to answer this question,” she noted, adding that the findings justify the use of ibrutinib as a standard-of-care treatment for CLL patients aged 65 years and older.
David P. Steensma, MD, of Dana-Farber Cancer Institute in Boston, who moderated the press briefing, agreed. “I think this really does indicate that ibrutinib as front-line therapy, which many clinicians have been doing, is a very reasonable practice.”
Dr. Woyach added, however, that while ibrutinib represents a major therapeutic advance, its cost and its toxicities in older patients are a concern that warrant close monitoring and development of strategies to reduce the need for long-term continuous treatment.
Additional phase 3 studies set to open soon will compare ibrutinib in combination with venetoclax and obinutuzumab with standard ibrutinib
Dr. Woyach reported having no disclosures. Dr. Steensma reported receiving research funding from, and/or serving as a consultant, board member, or adviser for Takeda Pharmaceutical, Syros Pharmaceuticals, Otsuka Pharmaceutical, Onconova Therapeutics, Novartis, Kura Oncology, Janssen, H3 Biosciences, Celgene, Amphivena Therapeutics, and Acceleron Pharma.
SOURCE: Woyach JA et al. ASH 2018, Abstract 6.
SAN DIEGO – Ibrutinib alone or in combination with rituximab resulted in superior progression-free survival (PFS) when compared with bendamustine plus rituximab in the randomized, phase 3 Alliance A041202 trial of older patients with previously untreated chronic lymphocytic leukemia (CLL).
“There was no difference in progression-free survival between ibrutinib and ibrutinib plus rituximab,” said Dr. Woyach of the Ohio State University, Columbus.
Median PFS in this study was 43 months in the BR arm, and was not reached in either of the ibrutinib-containing arms, she said. No significant differences in overall survival (OS) were seen among the treatment arms, which may have been because of short follow-up and the fact that patients in the BR arm were allowed to cross over to ibrutinib if they progressed on treatment.
Participants in the international, multicenter trial – a project of the National Cancer Institute National Clinical Trials Network – were 547 adults aged 65 years or older (median, 71 years) with previously untreated, symptomatic CLL. They were enrolled from 219 sites across the United States and Canada between Dec. 9, 2013, and May 16, 2016.
The three arms were well matched with respect to baseline characteristics except for a slightly higher number of patients with complex karyotypes in the IR arm, Dr. Woyach said.
Treatment in the BR arm included bendamustine 90 mg/m2 on days 1 and 2 of each 28-day cycle plus rituximab at a dose of 375 mg/m2 on day 0 of cycle 1 then 500 mg/m2 on day 1 of cycles 2-6. Patients in the ibrutinib arms received 420 mg daily until disease progression either with or without rituximab at 375 mg/m2 weekly for 4 weeks starting at cycle 2 day 1 and then given on day 1 of cycles 3-6.
Grade 3-5 treatment-emergent hematologic adverse events (AEs) occurred in 61%, 41%, and 38% of patients in the BR, ibrutinib, and IR arms, respectively. Neutropenia and thrombocytopenia occurred more often in the BR than in the ibrutinib arms. Nonhematologic AEs occurred in 63%, 74%, and 74%, respectively, with an overall greater incidence in the ibrutinib arms. Infections and sudden deaths were numerically but not significantly higher in the ibrutinib arms.
“We undertook this study to determine the most effective therapy for older patients with CLL,” Dr. Woyach said, explaining that while older patients make up the majority of patients with CLL, they are typically underrepresented in trials.
At the start of the study, BR was widely used and the Bruton’s tyrosine kinase inhibitor ibrutinib was “just entering the clinic,” she noted.
“Despite now-widespread use in the [front-line setting] following FDA approval for this indication in 2016, the efficacy of ibrutinib versus standard chemoimmunotherapy has not previously been investigated,” she said.
Since adding rituximab has been shown to improve PFS and OS when added to chemotherapy in CLL, she and her colleagues also looked at whether this was the case with ibrutinib as well.
“This is the only phase 3 trial designed to answer this question,” she noted, adding that the findings justify the use of ibrutinib as a standard-of-care treatment for CLL patients aged 65 years and older.
David P. Steensma, MD, of Dana-Farber Cancer Institute in Boston, who moderated the press briefing, agreed. “I think this really does indicate that ibrutinib as front-line therapy, which many clinicians have been doing, is a very reasonable practice.”
Dr. Woyach added, however, that while ibrutinib represents a major therapeutic advance, its cost and its toxicities in older patients are a concern that warrant close monitoring and development of strategies to reduce the need for long-term continuous treatment.
Additional phase 3 studies set to open soon will compare ibrutinib in combination with venetoclax and obinutuzumab with standard ibrutinib
Dr. Woyach reported having no disclosures. Dr. Steensma reported receiving research funding from, and/or serving as a consultant, board member, or adviser for Takeda Pharmaceutical, Syros Pharmaceuticals, Otsuka Pharmaceutical, Onconova Therapeutics, Novartis, Kura Oncology, Janssen, H3 Biosciences, Celgene, Amphivena Therapeutics, and Acceleron Pharma.
SOURCE: Woyach JA et al. ASH 2018, Abstract 6.
SAN DIEGO – Ibrutinib alone or in combination with rituximab resulted in superior progression-free survival (PFS) when compared with bendamustine plus rituximab in the randomized, phase 3 Alliance A041202 trial of older patients with previously untreated chronic lymphocytic leukemia (CLL).
“There was no difference in progression-free survival between ibrutinib and ibrutinib plus rituximab,” said Dr. Woyach of the Ohio State University, Columbus.
Median PFS in this study was 43 months in the BR arm, and was not reached in either of the ibrutinib-containing arms, she said. No significant differences in overall survival (OS) were seen among the treatment arms, which may have been because of short follow-up and the fact that patients in the BR arm were allowed to cross over to ibrutinib if they progressed on treatment.
Participants in the international, multicenter trial – a project of the National Cancer Institute National Clinical Trials Network – were 547 adults aged 65 years or older (median, 71 years) with previously untreated, symptomatic CLL. They were enrolled from 219 sites across the United States and Canada between Dec. 9, 2013, and May 16, 2016.
The three arms were well matched with respect to baseline characteristics except for a slightly higher number of patients with complex karyotypes in the IR arm, Dr. Woyach said.
Treatment in the BR arm included bendamustine 90 mg/m2 on days 1 and 2 of each 28-day cycle plus rituximab at a dose of 375 mg/m2 on day 0 of cycle 1 then 500 mg/m2 on day 1 of cycles 2-6. Patients in the ibrutinib arms received 420 mg daily until disease progression either with or without rituximab at 375 mg/m2 weekly for 4 weeks starting at cycle 2 day 1 and then given on day 1 of cycles 3-6.
Grade 3-5 treatment-emergent hematologic adverse events (AEs) occurred in 61%, 41%, and 38% of patients in the BR, ibrutinib, and IR arms, respectively. Neutropenia and thrombocytopenia occurred more often in the BR than in the ibrutinib arms. Nonhematologic AEs occurred in 63%, 74%, and 74%, respectively, with an overall greater incidence in the ibrutinib arms. Infections and sudden deaths were numerically but not significantly higher in the ibrutinib arms.
“We undertook this study to determine the most effective therapy for older patients with CLL,” Dr. Woyach said, explaining that while older patients make up the majority of patients with CLL, they are typically underrepresented in trials.
At the start of the study, BR was widely used and the Bruton’s tyrosine kinase inhibitor ibrutinib was “just entering the clinic,” she noted.
“Despite now-widespread use in the [front-line setting] following FDA approval for this indication in 2016, the efficacy of ibrutinib versus standard chemoimmunotherapy has not previously been investigated,” she said.
Since adding rituximab has been shown to improve PFS and OS when added to chemotherapy in CLL, she and her colleagues also looked at whether this was the case with ibrutinib as well.
“This is the only phase 3 trial designed to answer this question,” she noted, adding that the findings justify the use of ibrutinib as a standard-of-care treatment for CLL patients aged 65 years and older.
David P. Steensma, MD, of Dana-Farber Cancer Institute in Boston, who moderated the press briefing, agreed. “I think this really does indicate that ibrutinib as front-line therapy, which many clinicians have been doing, is a very reasonable practice.”
Dr. Woyach added, however, that while ibrutinib represents a major therapeutic advance, its cost and its toxicities in older patients are a concern that warrant close monitoring and development of strategies to reduce the need for long-term continuous treatment.
Additional phase 3 studies set to open soon will compare ibrutinib in combination with venetoclax and obinutuzumab with standard ibrutinib
Dr. Woyach reported having no disclosures. Dr. Steensma reported receiving research funding from, and/or serving as a consultant, board member, or adviser for Takeda Pharmaceutical, Syros Pharmaceuticals, Otsuka Pharmaceutical, Onconova Therapeutics, Novartis, Kura Oncology, Janssen, H3 Biosciences, Celgene, Amphivena Therapeutics, and Acceleron Pharma.
SOURCE: Woyach JA et al. ASH 2018, Abstract 6.
REPORTING FROM ASH 2018
Key clinical point: In chronic lymphocytic leukemia patients aged 65 years and older, progression-free survival is better with ibrutinib than with bendamustine and rituximab.
Major finding: The 2-year progression-free survival was 74%, 87%, and 88% with bendamustine and rituximab, ibrutinib, and ibrutinib and rituximab, respectively.
Study details: A randomized, phase 3 study of 547 previously untreated patients with CLL.
Disclosures: Dr. Woyach reported having no disclosures. Dr. Steensma reported receiving research funding from, and/or serving as a consultant, board member, or adviser for Takeda Pharmaceutical, Syros Pharmaceuticals, Otsuka Pharmaceutical, Onconova Therapeutics, Novartis, Kura Oncology, Janssen, H3 Biosciences, Celgene, Amphivena Therapeutics, and Acceleron Pharma.
Source: Woyach JA et al. ASH 2018, Abstract 6.
Opioids appear safe for sickle cell pain
SAN DIEGO – Inpatient deaths from opioid overdose in the U.S. population has risen dramatically in recent years, but this is essentially a “never event” among patients with sickle cell disease (SCD).
These findings come from an analysis of hospital discharge data in the National Inpatient Sample from 1998 to 2013. Oladimeji Akinola Akinboro, MBBS, who led the study, said the findings suggest that the current patterns of opioid use in SCD patients are safe and that opioids should not be withheld when they are appropriate.
From 1998 to 2013, the rate of inpatient deaths from opioid overdose in the United States rose 350% overall and approximately 8% annually. In contrast, deaths among SCD patients were flat, with a rate at or near zero throughout the same time period.
Over the 16-year period, there were just nine deaths reported among SCD patients because of opioids in the inpatient setting, Dr. Akinboro of Boston University Medical Center reported at the annual meeting of the American Society of Hematology.
While the reasons behind the difference were not explored in the study, Dr. Akinboro suggested that the sickle cell community has greater experience with opioids and that patients and physicians typically have long-standing clinical relationships that make mitigation of opioid misuse easier to manage.
Opioid-related hospitalizations, however, were comparable among the general U.S. population and SCD patients. And for both groups the rates remained relatively steady throughout the study period, with the exception of a drop among SCD patients in 2002, he noted.
The study also revealed age-related trends in hospitalizations overall. Hospitalizations among sickle cell patients were stable from 1998 to 2013. However, when the researchers broke the data down by age they found that adults aged 18-44 years had an increase in hospitalizations, with the steepest rise in patients aged 65 years and older.
In total, there were more than 1.7 million hospitalizations among SCD patients in the United States from 1998 to 2013. The rate declined by 9.9% each year from 1998 to 2002, then remained flat at around 27 per 100,000 persons from 2002 to 2013.
However, for adults aged 18-44 years, hospitalizations increased from 43 per 100,000 persons in 2002 to 71 per 100,000 persons in 2013 – an annual increase of 3.8%. Patients aged 65 years and older saw their rate of hospitalization increase from 2.7 to 5.4 per 100,000 persons from 1998 to 2013 – a 6.5% increase for each year.
The study did not explore the causes behind the age-related trends but Dr. Akinboro suggested it may be because of fragmentation of adult SCD care and age- and pain-related medical comorbidities.
The researchers reported having no relevant financial disclosures.
SOURCE: Akinboro OA et al. ASH 2018, Abstract 315.
SAN DIEGO – Inpatient deaths from opioid overdose in the U.S. population has risen dramatically in recent years, but this is essentially a “never event” among patients with sickle cell disease (SCD).
These findings come from an analysis of hospital discharge data in the National Inpatient Sample from 1998 to 2013. Oladimeji Akinola Akinboro, MBBS, who led the study, said the findings suggest that the current patterns of opioid use in SCD patients are safe and that opioids should not be withheld when they are appropriate.
From 1998 to 2013, the rate of inpatient deaths from opioid overdose in the United States rose 350% overall and approximately 8% annually. In contrast, deaths among SCD patients were flat, with a rate at or near zero throughout the same time period.
Over the 16-year period, there were just nine deaths reported among SCD patients because of opioids in the inpatient setting, Dr. Akinboro of Boston University Medical Center reported at the annual meeting of the American Society of Hematology.
While the reasons behind the difference were not explored in the study, Dr. Akinboro suggested that the sickle cell community has greater experience with opioids and that patients and physicians typically have long-standing clinical relationships that make mitigation of opioid misuse easier to manage.
Opioid-related hospitalizations, however, were comparable among the general U.S. population and SCD patients. And for both groups the rates remained relatively steady throughout the study period, with the exception of a drop among SCD patients in 2002, he noted.
The study also revealed age-related trends in hospitalizations overall. Hospitalizations among sickle cell patients were stable from 1998 to 2013. However, when the researchers broke the data down by age they found that adults aged 18-44 years had an increase in hospitalizations, with the steepest rise in patients aged 65 years and older.
In total, there were more than 1.7 million hospitalizations among SCD patients in the United States from 1998 to 2013. The rate declined by 9.9% each year from 1998 to 2002, then remained flat at around 27 per 100,000 persons from 2002 to 2013.
However, for adults aged 18-44 years, hospitalizations increased from 43 per 100,000 persons in 2002 to 71 per 100,000 persons in 2013 – an annual increase of 3.8%. Patients aged 65 years and older saw their rate of hospitalization increase from 2.7 to 5.4 per 100,000 persons from 1998 to 2013 – a 6.5% increase for each year.
The study did not explore the causes behind the age-related trends but Dr. Akinboro suggested it may be because of fragmentation of adult SCD care and age- and pain-related medical comorbidities.
The researchers reported having no relevant financial disclosures.
SOURCE: Akinboro OA et al. ASH 2018, Abstract 315.
SAN DIEGO – Inpatient deaths from opioid overdose in the U.S. population has risen dramatically in recent years, but this is essentially a “never event” among patients with sickle cell disease (SCD).
These findings come from an analysis of hospital discharge data in the National Inpatient Sample from 1998 to 2013. Oladimeji Akinola Akinboro, MBBS, who led the study, said the findings suggest that the current patterns of opioid use in SCD patients are safe and that opioids should not be withheld when they are appropriate.
From 1998 to 2013, the rate of inpatient deaths from opioid overdose in the United States rose 350% overall and approximately 8% annually. In contrast, deaths among SCD patients were flat, with a rate at or near zero throughout the same time period.
Over the 16-year period, there were just nine deaths reported among SCD patients because of opioids in the inpatient setting, Dr. Akinboro of Boston University Medical Center reported at the annual meeting of the American Society of Hematology.
While the reasons behind the difference were not explored in the study, Dr. Akinboro suggested that the sickle cell community has greater experience with opioids and that patients and physicians typically have long-standing clinical relationships that make mitigation of opioid misuse easier to manage.
Opioid-related hospitalizations, however, were comparable among the general U.S. population and SCD patients. And for both groups the rates remained relatively steady throughout the study period, with the exception of a drop among SCD patients in 2002, he noted.
The study also revealed age-related trends in hospitalizations overall. Hospitalizations among sickle cell patients were stable from 1998 to 2013. However, when the researchers broke the data down by age they found that adults aged 18-44 years had an increase in hospitalizations, with the steepest rise in patients aged 65 years and older.
In total, there were more than 1.7 million hospitalizations among SCD patients in the United States from 1998 to 2013. The rate declined by 9.9% each year from 1998 to 2002, then remained flat at around 27 per 100,000 persons from 2002 to 2013.
However, for adults aged 18-44 years, hospitalizations increased from 43 per 100,000 persons in 2002 to 71 per 100,000 persons in 2013 – an annual increase of 3.8%. Patients aged 65 years and older saw their rate of hospitalization increase from 2.7 to 5.4 per 100,000 persons from 1998 to 2013 – a 6.5% increase for each year.
The study did not explore the causes behind the age-related trends but Dr. Akinboro suggested it may be because of fragmentation of adult SCD care and age- and pain-related medical comorbidities.
The researchers reported having no relevant financial disclosures.
SOURCE: Akinboro OA et al. ASH 2018, Abstract 315.
REPORTING FROM ASH 2018
Key clinical point:
Major finding: While the rate of inpatient death from opioid overdose rose 350% among the general U.S. population from 1998 to 2013, it remained essentially at zero among patients with sickle cell disease.
Study details: A retrospective analysis of discharge diagnoses from the National Inpatient Sample from 1998 to 2013.
Disclosures: The researchers reported having no relevant financial disclosures.
Source: Akinboro OA et al. ASH 2018, Abstract 315.
SUDEP risk may change over time
, based on study results presented at the annual meeting of the American Epilepsy Society.
Based on 3 years of data collected from over 12,000 people with epilepsy, 27.0% who had been at high risk (three or more generalized tonic-clonic seizures [GTCs] per year) at baseline moved out of the high-risk category. In addition, 32.5% at medium risk (one to two GTCs per year) at baseline changed categories. Finally, 7.0% in the low-risk category (no GTC seizures in the last year) at baseline moved to a higher-risk category.
“An individual’s risk [of SUDEP] is not set in stone,” said Neishay Ayub, MD, of Beth Israel Deaconess Medical Center, Boston, who presented the data at the meeting. “Our findings support the recommendation that for people with epilepsy who have ongoing generalized tonic-clonic seizures, the goal of treatment is to reduce GTCs and thereby lower SUDEP risk.”
A 2017 practice guideline summary from the American Academy of Neurology and the American Epilepsy Society identified the presence and frequency of GTCs and absence of seizure freedom as risk factors for SUDEP. Using these measures, Dr. Ayub and colleagues sought to stratify patients according to their risk of SUDEP and monitor how risk changed over time. They collected information about more than 1.4 million seizures that occurred from December 2007 to February 2018 in 12,402 users of the electronic diary Seizure Tracker.
For each user, the researchers calculated the number of generalized seizures for each year since the initial seizure diary entry. They categorized each user as being at low, medium, or high risk of SUDEP during each year. Low risk was defined as no generalized seizures in a year. Medium risk was defined as one or two generalized seizures in a year. High risk was defined as three or more generalized seizures in a year.
“The next step would be to see if we can confirm this patient-reported data with an objective study to determine when seizures did or did not occur,” said Daniel Goldenholz, MD, PhD, also of Beth Israel Deaconess Medical Center and senior author of the study. “For example, assessing information using new FDA [Food and Drug Administration]-approved wearable seizure tracker devices could give us a more comprehensive picture.”
The study was funded by the Harvard School of Public Health, Boston.
SOURCE: Ayub N et al. AES 2018, Abstract 2.158.
, based on study results presented at the annual meeting of the American Epilepsy Society.
Based on 3 years of data collected from over 12,000 people with epilepsy, 27.0% who had been at high risk (three or more generalized tonic-clonic seizures [GTCs] per year) at baseline moved out of the high-risk category. In addition, 32.5% at medium risk (one to two GTCs per year) at baseline changed categories. Finally, 7.0% in the low-risk category (no GTC seizures in the last year) at baseline moved to a higher-risk category.
“An individual’s risk [of SUDEP] is not set in stone,” said Neishay Ayub, MD, of Beth Israel Deaconess Medical Center, Boston, who presented the data at the meeting. “Our findings support the recommendation that for people with epilepsy who have ongoing generalized tonic-clonic seizures, the goal of treatment is to reduce GTCs and thereby lower SUDEP risk.”
A 2017 practice guideline summary from the American Academy of Neurology and the American Epilepsy Society identified the presence and frequency of GTCs and absence of seizure freedom as risk factors for SUDEP. Using these measures, Dr. Ayub and colleagues sought to stratify patients according to their risk of SUDEP and monitor how risk changed over time. They collected information about more than 1.4 million seizures that occurred from December 2007 to February 2018 in 12,402 users of the electronic diary Seizure Tracker.
For each user, the researchers calculated the number of generalized seizures for each year since the initial seizure diary entry. They categorized each user as being at low, medium, or high risk of SUDEP during each year. Low risk was defined as no generalized seizures in a year. Medium risk was defined as one or two generalized seizures in a year. High risk was defined as three or more generalized seizures in a year.
“The next step would be to see if we can confirm this patient-reported data with an objective study to determine when seizures did or did not occur,” said Daniel Goldenholz, MD, PhD, also of Beth Israel Deaconess Medical Center and senior author of the study. “For example, assessing information using new FDA [Food and Drug Administration]-approved wearable seizure tracker devices could give us a more comprehensive picture.”
The study was funded by the Harvard School of Public Health, Boston.
SOURCE: Ayub N et al. AES 2018, Abstract 2.158.
, based on study results presented at the annual meeting of the American Epilepsy Society.
Based on 3 years of data collected from over 12,000 people with epilepsy, 27.0% who had been at high risk (three or more generalized tonic-clonic seizures [GTCs] per year) at baseline moved out of the high-risk category. In addition, 32.5% at medium risk (one to two GTCs per year) at baseline changed categories. Finally, 7.0% in the low-risk category (no GTC seizures in the last year) at baseline moved to a higher-risk category.
“An individual’s risk [of SUDEP] is not set in stone,” said Neishay Ayub, MD, of Beth Israel Deaconess Medical Center, Boston, who presented the data at the meeting. “Our findings support the recommendation that for people with epilepsy who have ongoing generalized tonic-clonic seizures, the goal of treatment is to reduce GTCs and thereby lower SUDEP risk.”
A 2017 practice guideline summary from the American Academy of Neurology and the American Epilepsy Society identified the presence and frequency of GTCs and absence of seizure freedom as risk factors for SUDEP. Using these measures, Dr. Ayub and colleagues sought to stratify patients according to their risk of SUDEP and monitor how risk changed over time. They collected information about more than 1.4 million seizures that occurred from December 2007 to February 2018 in 12,402 users of the electronic diary Seizure Tracker.
For each user, the researchers calculated the number of generalized seizures for each year since the initial seizure diary entry. They categorized each user as being at low, medium, or high risk of SUDEP during each year. Low risk was defined as no generalized seizures in a year. Medium risk was defined as one or two generalized seizures in a year. High risk was defined as three or more generalized seizures in a year.
“The next step would be to see if we can confirm this patient-reported data with an objective study to determine when seizures did or did not occur,” said Daniel Goldenholz, MD, PhD, also of Beth Israel Deaconess Medical Center and senior author of the study. “For example, assessing information using new FDA [Food and Drug Administration]-approved wearable seizure tracker devices could give us a more comprehensive picture.”
The study was funded by the Harvard School of Public Health, Boston.
SOURCE: Ayub N et al. AES 2018, Abstract 2.158.
REPORTING FROM AES 2018
Key clinical point: Yearly patient risk assessments for sudden unexpected death in epilepsy are advisable.
Major finding: About 7% of people with no generalized tonic-clonic seizures in the last year at baseline moved to a higher-risk category.
Study details: An analysis of self-reported seizures by 12,402 users of Seizure Tracker.
Disclosures: The Harvard School of Public Health, Boston, funded the study.
Source: Ayub N et al. AES 2018, Abstract 2.158.