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Ultrasound can’t rule out pulmonary embolism in the ED
SAN DIEGO – In the ICU, ultrasound has been shown to reduce the need for CT to evaluate potential pulmonary embolism. But in the ED, this strategy hasn’t worked out so far, according to Joseph Brown, MD, of the department of emergency medicine at the University of California, San Francisco.
Based on the data so far, the ED patients were less likely than the ICU patients to have another etiology identified on ultrasound that explained their symptoms. Further, ultrasound alone missed small subsegmental pulmonary emboli that were detected on subsequent CT scans in 2 of 11 patients.
The study is continuing, and Dr. Brown explains in this interview how ultrasound might be combined with other risk stratification measures to safely achieve reductions in CT scans.
SAN DIEGO – In the ICU, ultrasound has been shown to reduce the need for CT to evaluate potential pulmonary embolism. But in the ED, this strategy hasn’t worked out so far, according to Joseph Brown, MD, of the department of emergency medicine at the University of California, San Francisco.
Based on the data so far, the ED patients were less likely than the ICU patients to have another etiology identified on ultrasound that explained their symptoms. Further, ultrasound alone missed small subsegmental pulmonary emboli that were detected on subsequent CT scans in 2 of 11 patients.
The study is continuing, and Dr. Brown explains in this interview how ultrasound might be combined with other risk stratification measures to safely achieve reductions in CT scans.
SAN DIEGO – In the ICU, ultrasound has been shown to reduce the need for CT to evaluate potential pulmonary embolism. But in the ED, this strategy hasn’t worked out so far, according to Joseph Brown, MD, of the department of emergency medicine at the University of California, San Francisco.
Based on the data so far, the ED patients were less likely than the ICU patients to have another etiology identified on ultrasound that explained their symptoms. Further, ultrasound alone missed small subsegmental pulmonary emboli that were detected on subsequent CT scans in 2 of 11 patients.
The study is continuing, and Dr. Brown explains in this interview how ultrasound might be combined with other risk stratification measures to safely achieve reductions in CT scans.
REPORTING FROM ACEP18
Adding a Cream May Enhance Flu Vaccine Effectiveness
Can a cream help a flu vaccine work better? In a phase 1 clinical trial, researchers from Baylor College of Medicine in Houston, Texas, are testing whether imiquimod cream—commonly used to treat genital warts and some skin cancers—can boost the immune response to an H5N1 flu vaccine. Studies have shown imiquimod generates significantly more robust immune responses.
Participants in the Vaccine and Treatment Evaluation Units trial will be given 2 intradermal doses of an H5N1 vaccine, 21 days apart. In one group, participants will have Aldara (imiquimod cream) applied to their upper arm before each vaccination; in the control group, a placebo cream will be applied.
Participants will return at regular intervals over 7 months to have blood drawn; they also will keep diaries to record symptoms.
The first participant was vaccinated in June. Early results are expected by the end of the year.
Can a cream help a flu vaccine work better? In a phase 1 clinical trial, researchers from Baylor College of Medicine in Houston, Texas, are testing whether imiquimod cream—commonly used to treat genital warts and some skin cancers—can boost the immune response to an H5N1 flu vaccine. Studies have shown imiquimod generates significantly more robust immune responses.
Participants in the Vaccine and Treatment Evaluation Units trial will be given 2 intradermal doses of an H5N1 vaccine, 21 days apart. In one group, participants will have Aldara (imiquimod cream) applied to their upper arm before each vaccination; in the control group, a placebo cream will be applied.
Participants will return at regular intervals over 7 months to have blood drawn; they also will keep diaries to record symptoms.
The first participant was vaccinated in June. Early results are expected by the end of the year.
Can a cream help a flu vaccine work better? In a phase 1 clinical trial, researchers from Baylor College of Medicine in Houston, Texas, are testing whether imiquimod cream—commonly used to treat genital warts and some skin cancers—can boost the immune response to an H5N1 flu vaccine. Studies have shown imiquimod generates significantly more robust immune responses.
Participants in the Vaccine and Treatment Evaluation Units trial will be given 2 intradermal doses of an H5N1 vaccine, 21 days apart. In one group, participants will have Aldara (imiquimod cream) applied to their upper arm before each vaccination; in the control group, a placebo cream will be applied.
Participants will return at regular intervals over 7 months to have blood drawn; they also will keep diaries to record symptoms.
The first participant was vaccinated in June. Early results are expected by the end of the year.
Teens who vape are likely to add cigarette smoking
instead of substituting one for the other, according to research published in Nicotine & Tobacco Research.
“Our work provides more evidence that young people who use e-cigarettes progress to smoking cigarettes in the future,” Michael S. Dunbar, PhD, a behavioral scientist at the RAND Corp. stated in a press release. “This study also suggests that teens don’t substitute vaping products for cigarettes. Instead, they go on to use both products more frequently as they get older.”
Dr. Dunbar and his colleagues followed 2,039 adolescents aged 16-20 years who were originally enrolled in a Los Angeles–based substance use prevention program in sixth and seventh grade (2008) and completed annual Web-based surveys during 2015-2017 on their use of e-cigarettes (EC), cigarettes, alcohol, and marijuana. They also answered questions about their mental health with questions about anxiety and depression. The researchers used two models to measures associations between different factors.
The first model showed an association between EC and cigarette use. Then other factors, such as alcohol use, were introduced. Alcohol use was associated with increased cigarette use, and cigarette use was associated with increased use of alcohol. When introducing marijuana as a factor, associations remained between cigarette use and EC use, with higher EC use associated with greater marijuana use and vice versa. Greater cigarette use, however, was not predictive of later marijuana use. There was no association between EC use and mental health, but more cigarette use was associated with poorer mental health.
Under the second model, there was a moderate to strong association between EC use and cigarette use, and participants with greater EC use and greater cigarette use also reported higher alcohol use. There also was a significant between-person association with higher EC use, cigarette use, and marijuana use. There was a small negative association between mental health and cigarette use, but not with mental health and EC use,the researchers said.
“For young people, using these products may actually lead to more harm in the long run,” Dr. Dunbar said in the press release. “This highlights the importance of taking steps to prevent youth from vaping in the first place. One way to do this could be to limit e-cigarette and other tobacco advertising in kid-accessible spaces.”
This study was funded by grants from the National Institute of Alcohol Abuse and Alcoholism. The authors reported no relevant conflicts of interest.
SOURCE: Dunbar MS et al. Nicotine Tob Res. 2018 Oct 3. doi: 10.1093/ntr/nty179.
instead of substituting one for the other, according to research published in Nicotine & Tobacco Research.
“Our work provides more evidence that young people who use e-cigarettes progress to smoking cigarettes in the future,” Michael S. Dunbar, PhD, a behavioral scientist at the RAND Corp. stated in a press release. “This study also suggests that teens don’t substitute vaping products for cigarettes. Instead, they go on to use both products more frequently as they get older.”
Dr. Dunbar and his colleagues followed 2,039 adolescents aged 16-20 years who were originally enrolled in a Los Angeles–based substance use prevention program in sixth and seventh grade (2008) and completed annual Web-based surveys during 2015-2017 on their use of e-cigarettes (EC), cigarettes, alcohol, and marijuana. They also answered questions about their mental health with questions about anxiety and depression. The researchers used two models to measures associations between different factors.
The first model showed an association between EC and cigarette use. Then other factors, such as alcohol use, were introduced. Alcohol use was associated with increased cigarette use, and cigarette use was associated with increased use of alcohol. When introducing marijuana as a factor, associations remained between cigarette use and EC use, with higher EC use associated with greater marijuana use and vice versa. Greater cigarette use, however, was not predictive of later marijuana use. There was no association between EC use and mental health, but more cigarette use was associated with poorer mental health.
Under the second model, there was a moderate to strong association between EC use and cigarette use, and participants with greater EC use and greater cigarette use also reported higher alcohol use. There also was a significant between-person association with higher EC use, cigarette use, and marijuana use. There was a small negative association between mental health and cigarette use, but not with mental health and EC use,the researchers said.
“For young people, using these products may actually lead to more harm in the long run,” Dr. Dunbar said in the press release. “This highlights the importance of taking steps to prevent youth from vaping in the first place. One way to do this could be to limit e-cigarette and other tobacco advertising in kid-accessible spaces.”
This study was funded by grants from the National Institute of Alcohol Abuse and Alcoholism. The authors reported no relevant conflicts of interest.
SOURCE: Dunbar MS et al. Nicotine Tob Res. 2018 Oct 3. doi: 10.1093/ntr/nty179.
instead of substituting one for the other, according to research published in Nicotine & Tobacco Research.
“Our work provides more evidence that young people who use e-cigarettes progress to smoking cigarettes in the future,” Michael S. Dunbar, PhD, a behavioral scientist at the RAND Corp. stated in a press release. “This study also suggests that teens don’t substitute vaping products for cigarettes. Instead, they go on to use both products more frequently as they get older.”
Dr. Dunbar and his colleagues followed 2,039 adolescents aged 16-20 years who were originally enrolled in a Los Angeles–based substance use prevention program in sixth and seventh grade (2008) and completed annual Web-based surveys during 2015-2017 on their use of e-cigarettes (EC), cigarettes, alcohol, and marijuana. They also answered questions about their mental health with questions about anxiety and depression. The researchers used two models to measures associations between different factors.
The first model showed an association between EC and cigarette use. Then other factors, such as alcohol use, were introduced. Alcohol use was associated with increased cigarette use, and cigarette use was associated with increased use of alcohol. When introducing marijuana as a factor, associations remained between cigarette use and EC use, with higher EC use associated with greater marijuana use and vice versa. Greater cigarette use, however, was not predictive of later marijuana use. There was no association between EC use and mental health, but more cigarette use was associated with poorer mental health.
Under the second model, there was a moderate to strong association between EC use and cigarette use, and participants with greater EC use and greater cigarette use also reported higher alcohol use. There also was a significant between-person association with higher EC use, cigarette use, and marijuana use. There was a small negative association between mental health and cigarette use, but not with mental health and EC use,the researchers said.
“For young people, using these products may actually lead to more harm in the long run,” Dr. Dunbar said in the press release. “This highlights the importance of taking steps to prevent youth from vaping in the first place. One way to do this could be to limit e-cigarette and other tobacco advertising in kid-accessible spaces.”
This study was funded by grants from the National Institute of Alcohol Abuse and Alcoholism. The authors reported no relevant conflicts of interest.
SOURCE: Dunbar MS et al. Nicotine Tob Res. 2018 Oct 3. doi: 10.1093/ntr/nty179.
FROM NICOTINE & TOBACCO RESEARCH
Key clinical point: Adolescents who use e-cigarettes are more likely to progress to cigarette use, while continuing to vape.
Major finding: There was a significant bidirectional association between e-cigarette use and cigarette use, and some third factors such as alcohol use, marijuana use, and mental health.
Study details: A longitudinal study of adolescents aged 16-20 years enrolled in a substance use prevention program.
Disclosures: This study was funded by grants from the National Institute of Alcohol Abuse and Alcoholism. The authors reported no relevant conflicts of interest.
Source: Dunbar MS et al. Nicotine Tob Res. 2018 Oct 3. doi: 10.1093/ntr/nty179.
Two distinct subtypes of SLE-linked pulmonary arterial hypertension described
Patients with pulmonary arterial hypertension as a consequence of systemic lupus erythematosus can be classified into two different subtypes, one of which shows significantly greater mortality, new research suggests.
Systemic lupus erythematosus–associated pulmonary arterial hypertension (SLE-PAH) has a poor prognosis with 3-year mortality ranging from 45% to 88%, leading the first author of the study Fangfang Sun of the School of Medicine at Shanghai (China) Jiaotong University and coauthors to seek “to further differentiate among SLE-PAH patterns to better understand the disease and optimize its management,
In a letter published online in Annals of the Rheumatic Diseases, the researchers presented data from a retrospective study of a derivation cohort of 108 Chinese patients with SLE-PAH and a validation cohort of 87 patients. Using clinical and laboratory characteristics, the researchers classified the derivation cohort into two clusters, which they labeled as the vasculitic and vasculopathic subtypes.
Patients with the vasculitic subtype of SLE-PAH had higher levels of SLE disease activity and manifestations, such as pericarditis, rash, arthritis, nephritis, and neuropsychiatric lupus, while those with the vasculopathic subtype showed “purer” PAH and lower lupus disease activity.
The researchers found that the vasculitic subtype had around a threefold higher 3-year mortality than did the vasculopathic subtype (34.5%-40.2% vs. 13.0%-18.6%; hazard ratio, 2.84-3.15; P less than .05), even after adjusting for differences in treatments.
Patients who developed PAH less than 2 years after being diagnosed with SLE were significantly more likely to have the vasculitic subtype of SLE-PAH (P less than .0001). A SLE disease activity index score greater than nine was also significantly associated with the vasculitic subtype (P = .001).
The prediction model developed based on these two factors had a sensitivity of 98.5% and a specificity of 74.4% (area under the curve = 0.94; P less than .0001), for a weighted score of two or more, in identifying patients with the vasculitic subtype of SLE-PAH.
Dr. Sun and colleagues suggested that the existence of two distinct clinical subtypes of SLE-PAH points to different underlying pathophysiologic mechanisms; one that is autoimmune mediated and one that involves noninflammatory vascular remodeling. However, the authors stressed that their findings needed confirmation in prospective studies.
“The next key question that remains unanswered is how to balance the utility of immunosuppressants and PAH-targeted drugs in patients with different phenotypes,” they wrote.
Two authors declared research funding from academic and government agencies. No conflicts of interest were declared.
SOURCE: Sun F et al. Ann Rheum Dis. 2018 Sep 19. doi: 10.1136/annrheumdis-2018-214197.
Patients with pulmonary arterial hypertension as a consequence of systemic lupus erythematosus can be classified into two different subtypes, one of which shows significantly greater mortality, new research suggests.
Systemic lupus erythematosus–associated pulmonary arterial hypertension (SLE-PAH) has a poor prognosis with 3-year mortality ranging from 45% to 88%, leading the first author of the study Fangfang Sun of the School of Medicine at Shanghai (China) Jiaotong University and coauthors to seek “to further differentiate among SLE-PAH patterns to better understand the disease and optimize its management,
In a letter published online in Annals of the Rheumatic Diseases, the researchers presented data from a retrospective study of a derivation cohort of 108 Chinese patients with SLE-PAH and a validation cohort of 87 patients. Using clinical and laboratory characteristics, the researchers classified the derivation cohort into two clusters, which they labeled as the vasculitic and vasculopathic subtypes.
Patients with the vasculitic subtype of SLE-PAH had higher levels of SLE disease activity and manifestations, such as pericarditis, rash, arthritis, nephritis, and neuropsychiatric lupus, while those with the vasculopathic subtype showed “purer” PAH and lower lupus disease activity.
The researchers found that the vasculitic subtype had around a threefold higher 3-year mortality than did the vasculopathic subtype (34.5%-40.2% vs. 13.0%-18.6%; hazard ratio, 2.84-3.15; P less than .05), even after adjusting for differences in treatments.
Patients who developed PAH less than 2 years after being diagnosed with SLE were significantly more likely to have the vasculitic subtype of SLE-PAH (P less than .0001). A SLE disease activity index score greater than nine was also significantly associated with the vasculitic subtype (P = .001).
The prediction model developed based on these two factors had a sensitivity of 98.5% and a specificity of 74.4% (area under the curve = 0.94; P less than .0001), for a weighted score of two or more, in identifying patients with the vasculitic subtype of SLE-PAH.
Dr. Sun and colleagues suggested that the existence of two distinct clinical subtypes of SLE-PAH points to different underlying pathophysiologic mechanisms; one that is autoimmune mediated and one that involves noninflammatory vascular remodeling. However, the authors stressed that their findings needed confirmation in prospective studies.
“The next key question that remains unanswered is how to balance the utility of immunosuppressants and PAH-targeted drugs in patients with different phenotypes,” they wrote.
Two authors declared research funding from academic and government agencies. No conflicts of interest were declared.
SOURCE: Sun F et al. Ann Rheum Dis. 2018 Sep 19. doi: 10.1136/annrheumdis-2018-214197.
Patients with pulmonary arterial hypertension as a consequence of systemic lupus erythematosus can be classified into two different subtypes, one of which shows significantly greater mortality, new research suggests.
Systemic lupus erythematosus–associated pulmonary arterial hypertension (SLE-PAH) has a poor prognosis with 3-year mortality ranging from 45% to 88%, leading the first author of the study Fangfang Sun of the School of Medicine at Shanghai (China) Jiaotong University and coauthors to seek “to further differentiate among SLE-PAH patterns to better understand the disease and optimize its management,
In a letter published online in Annals of the Rheumatic Diseases, the researchers presented data from a retrospective study of a derivation cohort of 108 Chinese patients with SLE-PAH and a validation cohort of 87 patients. Using clinical and laboratory characteristics, the researchers classified the derivation cohort into two clusters, which they labeled as the vasculitic and vasculopathic subtypes.
Patients with the vasculitic subtype of SLE-PAH had higher levels of SLE disease activity and manifestations, such as pericarditis, rash, arthritis, nephritis, and neuropsychiatric lupus, while those with the vasculopathic subtype showed “purer” PAH and lower lupus disease activity.
The researchers found that the vasculitic subtype had around a threefold higher 3-year mortality than did the vasculopathic subtype (34.5%-40.2% vs. 13.0%-18.6%; hazard ratio, 2.84-3.15; P less than .05), even after adjusting for differences in treatments.
Patients who developed PAH less than 2 years after being diagnosed with SLE were significantly more likely to have the vasculitic subtype of SLE-PAH (P less than .0001). A SLE disease activity index score greater than nine was also significantly associated with the vasculitic subtype (P = .001).
The prediction model developed based on these two factors had a sensitivity of 98.5% and a specificity of 74.4% (area under the curve = 0.94; P less than .0001), for a weighted score of two or more, in identifying patients with the vasculitic subtype of SLE-PAH.
Dr. Sun and colleagues suggested that the existence of two distinct clinical subtypes of SLE-PAH points to different underlying pathophysiologic mechanisms; one that is autoimmune mediated and one that involves noninflammatory vascular remodeling. However, the authors stressed that their findings needed confirmation in prospective studies.
“The next key question that remains unanswered is how to balance the utility of immunosuppressants and PAH-targeted drugs in patients with different phenotypes,” they wrote.
Two authors declared research funding from academic and government agencies. No conflicts of interest were declared.
SOURCE: Sun F et al. Ann Rheum Dis. 2018 Sep 19. doi: 10.1136/annrheumdis-2018-214197.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point: A more vasculitic subtype of SLE-PAH is associated with higher mortality.
Major finding: The more severe vasculitic subtype of SLE-PAH shows threefold higher 3-year mortality than a vasculopathic subtype.
Study details: Retrospective cohort study in 195 patients with SLE-PAH
Disclosures: Two authors declared research funding from academic and government agencies. No conflicts of interest were declared.
Source: Sun F et al. Ann Rheum Dis. 2018 Sep 19. doi: 10.1136/annrheumdis-2018-214197.
Dr. Bernard Maria Recognized With Prestigious Child Neurology Honor
Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.
“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”
Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.
“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”
Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).
Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.
Dr. Maria has held a number of professorial roles o
Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.
“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”
Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.
“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”
Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).
Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.
Dr. Maria has held a number of professorial roles o
Bernard Maria, MD, MBA, Director of the Division of Child Neurology and Developmental Medicine at Goryeb Children’s Hospital in Morristown, NJ, part of the Atlantic Health System, has been recognized with the 2018 Hower Award, the highest recognition from the Child Neurology Society. This prestigious award is given yearly to one member of the Child Neurology Society who is highly regarded by peers as an outstanding teacher and scholar. There is a particular emphasis on contributions to child neurology at national and international levels.
“I am deeply humbled by this award, and the opportunity to honor two of my mentors that were past Hower recipients, Drs. John Menkes and John Freeman,” Dr. Maria said. “I am so grateful to all the children, families, students, and colleagues I have served.”
Dr. Maria has been instrumental in developing specialty services within the Atlantic Health System for children with neurologic and neuromuscular disorders including: autism and development, brain and spinal tumors, concussion, epilepsy, headache and migraine, muscle and nerve diseases, and other neurologic problems. In addition to providing care and shaping future research directions, Dr. Maria has lectured on these topics nationally and internationally. Dr. Maria also is a member of the Neurology Reviews Editorial Advisory Board.
“The Hower Award is the Child Neurology Society’s highest honor, given annually to a child neurologist in recognition for sustained and outstanding contributions to the field of Child Neurology and to the Child Neurology Society,” said Dr. Jonathan W. Mink, MD PhD, President of the Child Neurology Society. “We congratulate Dr. Maria on being the 2018 recipient of this honor and look forward to his presentation at our next annual meeting.”
Dr. Maria received his MD from the Université de Sherbrooke in Sherbrooke, Québec, Canada, and subsequently earned his MBA from the University of Florida. He completed his pediatrics residency at McGill University and pediatric neurology residency at the Johns Hopkins Hospital, where he also served as chief resident. He completed his fellowship in pediatric neuro-oncology at the MD Anderson Cancer Center. He is a diplomate of the American Board of Pediatrics, and American Board of Psychiatry and Neurology (with a special qualification in child neurology).
Dr. Maria is a Fellow of the American Academy of Pediatrics, Fellow of the American Academy of Neurology, Elected Active Member of the Society for Pediatric Research and the American Pediatric Society, the oldest medical society in America. He has been continuously funded by the National Institutes of Health since 2001 for the Neurobiology of Disease in Children (neurobiologyofdisease.com) conferences, and he has been named to national top/best doctors lists multiple times.
Dr. Maria has held a number of professorial roles o
Research Advances Look Bright for VA
Key leadership in research and oncology addressed attendees of the recent AVAHO annual meeting in Chicago. Carolyn Clancy, MD, deputy undersecretary for health discovery, education and affiliated networks, discussed the important role of cancer in the VA’s research and clinical mission. Neil Spector, MD, director of the National Precision Oncology Program (NPOP) outlined the significant growth in the use of tumor sequencing by NPOP, while Michael Kelley, MD, director of operations for National Oncology discussed the significant strides in opening up access to clinical trials at the VA.
Dr. Clancy addressed AVAHO for the first time and remarked upon the impressive array of research conducted by AVAHO members. “I love the idea of telehealth for genomics,” she remarked about the Genomic Medicine Service Uses Group Telehealth Appointments poster abstract, “it’s brilliant and it’s only the beginning.” The VA’s unique blend of clinical care and research puts it in a unique position to provide cutting edge care to its patients.
Clancy also addressed the larger shift in the VA as it moves from a closed integrated health care system to a high performing network. “We are closer than most systems in this country—public or private—to having a research enterprise that is integral to our mission of providing veterans with great care,” she said. “The magic of bringing [research and clinical] groups together is to enhance the visibility. But frankly it’s also to enhance our capability to take advantage of these assets strategically.” That means providing veterans with “cutting-edge care, and what could be better than that? When we do great things in how we deliver health care that helps your work,” she told attendees.
This shift, as outlined by the VA’s new leadership under Secretary Robert Wilkie and Richard A. Stone, MD, executive in charge of the Veterans Health Administration (VHA), is designed to restore veterans’ trust and confidence in the system, foster an environment of continuous learning to improve quality, and transform the VHA into a “high-reliability organization,” to reduce medical errors. The goal, according to Dr. Clancy, is to develop a culture—like the National Aeronautics and Space Administration or air traffic control systems—where all members of the organization search for and eliminate potential problems. Improving safety, she insisted, has to be a top priority for everyone.
Dr. Clancy also reported that 700,000 veterans enrolled in the VA’s Million Veteran Program (MVP) “We not only have the largest repository of genomic information on people but we also have their clinical data” Later, she told AVAHO members “I am hugely optimistic about the work that is being done in oncology research.” In July, the VA made an arrangement with the National Cancer Institute to allows veterans access to clinical trials. “We need to do more of that, she said, “this is only the beginning of the exciting work we will be doing in cancer research.”
Dr. Spector reported on the progress made by NPOP over the previous year. Currently, NPOP is sequencing solid tumors with a recent biopsy (liquid biopsies are acceptable), but hopes to begin examination of sarcomas and hematologic malignancies. NPOP has grown from about 100 samples analyzed monthly in January 2017 to nearly 350 in June 2018 with a goal of reaching 600 monthly samples across the VA. “You should be sending tumor tissues to be sequenced,” he explained. “It’s free, sequencing tumor tissue is the standard of care, and we need to be sequencing our patients to provide them with an opportunity to get patients onto clinical trials.”
Although the initial analysis can take up to 21 days, the program offers a 72-hour turn-around time for e-consultations. Depending on the quality of trial data, patients may be eligible for treatment even if there is no FDA-approved treatment. According to Spector, the goal of the program is to get patients on the right treatment and avoid costly treatment that will not work for a patient’s cancer type. “We do not want to be giving an expensive drug to someone who will not respond,” he explained.
Multiple efforts are underway to streamline and increase access to oncology care in the VA, according to Dr. Kelley. The development of a national cancer strategy is “long overdue” he admitted, but multiple efforts are underway to including the Fast Track to VA Cancer Care, a single national point of entry for VA cancer care, mechanisms to streamline enrolling patients in non-VA clinical trials, virtual tumor boards, and oncology-specific dashboards. “We have to be transparent and show not only to ourselves, but the whole worlds that we are doing a great job,” he told attendees.
One of the biggest challenges the VA faces will be the roll out of a new electronic health record system. While the new Cerner system has an oncology package, it does not have a cancer registry. According to Kelley, the VA is searching for a commercial system that can interface with Cerner to provide a cancer registry.
Kelley also focused on Annie, a new VA texting platform that allow patients to report on symptoms and get advice The Annie system is automated and allows patients to provide self-care. Already, cancer care providers are experimenting with Annie and Kelley expects the program to develop further.
Key leadership in research and oncology addressed attendees of the recent AVAHO annual meeting in Chicago. Carolyn Clancy, MD, deputy undersecretary for health discovery, education and affiliated networks, discussed the important role of cancer in the VA’s research and clinical mission. Neil Spector, MD, director of the National Precision Oncology Program (NPOP) outlined the significant growth in the use of tumor sequencing by NPOP, while Michael Kelley, MD, director of operations for National Oncology discussed the significant strides in opening up access to clinical trials at the VA.
Dr. Clancy addressed AVAHO for the first time and remarked upon the impressive array of research conducted by AVAHO members. “I love the idea of telehealth for genomics,” she remarked about the Genomic Medicine Service Uses Group Telehealth Appointments poster abstract, “it’s brilliant and it’s only the beginning.” The VA’s unique blend of clinical care and research puts it in a unique position to provide cutting edge care to its patients.
Clancy also addressed the larger shift in the VA as it moves from a closed integrated health care system to a high performing network. “We are closer than most systems in this country—public or private—to having a research enterprise that is integral to our mission of providing veterans with great care,” she said. “The magic of bringing [research and clinical] groups together is to enhance the visibility. But frankly it’s also to enhance our capability to take advantage of these assets strategically.” That means providing veterans with “cutting-edge care, and what could be better than that? When we do great things in how we deliver health care that helps your work,” she told attendees.
This shift, as outlined by the VA’s new leadership under Secretary Robert Wilkie and Richard A. Stone, MD, executive in charge of the Veterans Health Administration (VHA), is designed to restore veterans’ trust and confidence in the system, foster an environment of continuous learning to improve quality, and transform the VHA into a “high-reliability organization,” to reduce medical errors. The goal, according to Dr. Clancy, is to develop a culture—like the National Aeronautics and Space Administration or air traffic control systems—where all members of the organization search for and eliminate potential problems. Improving safety, she insisted, has to be a top priority for everyone.
Dr. Clancy also reported that 700,000 veterans enrolled in the VA’s Million Veteran Program (MVP) “We not only have the largest repository of genomic information on people but we also have their clinical data” Later, she told AVAHO members “I am hugely optimistic about the work that is being done in oncology research.” In July, the VA made an arrangement with the National Cancer Institute to allows veterans access to clinical trials. “We need to do more of that, she said, “this is only the beginning of the exciting work we will be doing in cancer research.”
Dr. Spector reported on the progress made by NPOP over the previous year. Currently, NPOP is sequencing solid tumors with a recent biopsy (liquid biopsies are acceptable), but hopes to begin examination of sarcomas and hematologic malignancies. NPOP has grown from about 100 samples analyzed monthly in January 2017 to nearly 350 in June 2018 with a goal of reaching 600 monthly samples across the VA. “You should be sending tumor tissues to be sequenced,” he explained. “It’s free, sequencing tumor tissue is the standard of care, and we need to be sequencing our patients to provide them with an opportunity to get patients onto clinical trials.”
Although the initial analysis can take up to 21 days, the program offers a 72-hour turn-around time for e-consultations. Depending on the quality of trial data, patients may be eligible for treatment even if there is no FDA-approved treatment. According to Spector, the goal of the program is to get patients on the right treatment and avoid costly treatment that will not work for a patient’s cancer type. “We do not want to be giving an expensive drug to someone who will not respond,” he explained.
Multiple efforts are underway to streamline and increase access to oncology care in the VA, according to Dr. Kelley. The development of a national cancer strategy is “long overdue” he admitted, but multiple efforts are underway to including the Fast Track to VA Cancer Care, a single national point of entry for VA cancer care, mechanisms to streamline enrolling patients in non-VA clinical trials, virtual tumor boards, and oncology-specific dashboards. “We have to be transparent and show not only to ourselves, but the whole worlds that we are doing a great job,” he told attendees.
One of the biggest challenges the VA faces will be the roll out of a new electronic health record system. While the new Cerner system has an oncology package, it does not have a cancer registry. According to Kelley, the VA is searching for a commercial system that can interface with Cerner to provide a cancer registry.
Kelley also focused on Annie, a new VA texting platform that allow patients to report on symptoms and get advice The Annie system is automated and allows patients to provide self-care. Already, cancer care providers are experimenting with Annie and Kelley expects the program to develop further.
Key leadership in research and oncology addressed attendees of the recent AVAHO annual meeting in Chicago. Carolyn Clancy, MD, deputy undersecretary for health discovery, education and affiliated networks, discussed the important role of cancer in the VA’s research and clinical mission. Neil Spector, MD, director of the National Precision Oncology Program (NPOP) outlined the significant growth in the use of tumor sequencing by NPOP, while Michael Kelley, MD, director of operations for National Oncology discussed the significant strides in opening up access to clinical trials at the VA.
Dr. Clancy addressed AVAHO for the first time and remarked upon the impressive array of research conducted by AVAHO members. “I love the idea of telehealth for genomics,” she remarked about the Genomic Medicine Service Uses Group Telehealth Appointments poster abstract, “it’s brilliant and it’s only the beginning.” The VA’s unique blend of clinical care and research puts it in a unique position to provide cutting edge care to its patients.
Clancy also addressed the larger shift in the VA as it moves from a closed integrated health care system to a high performing network. “We are closer than most systems in this country—public or private—to having a research enterprise that is integral to our mission of providing veterans with great care,” she said. “The magic of bringing [research and clinical] groups together is to enhance the visibility. But frankly it’s also to enhance our capability to take advantage of these assets strategically.” That means providing veterans with “cutting-edge care, and what could be better than that? When we do great things in how we deliver health care that helps your work,” she told attendees.
This shift, as outlined by the VA’s new leadership under Secretary Robert Wilkie and Richard A. Stone, MD, executive in charge of the Veterans Health Administration (VHA), is designed to restore veterans’ trust and confidence in the system, foster an environment of continuous learning to improve quality, and transform the VHA into a “high-reliability organization,” to reduce medical errors. The goal, according to Dr. Clancy, is to develop a culture—like the National Aeronautics and Space Administration or air traffic control systems—where all members of the organization search for and eliminate potential problems. Improving safety, she insisted, has to be a top priority for everyone.
Dr. Clancy also reported that 700,000 veterans enrolled in the VA’s Million Veteran Program (MVP) “We not only have the largest repository of genomic information on people but we also have their clinical data” Later, she told AVAHO members “I am hugely optimistic about the work that is being done in oncology research.” In July, the VA made an arrangement with the National Cancer Institute to allows veterans access to clinical trials. “We need to do more of that, she said, “this is only the beginning of the exciting work we will be doing in cancer research.”
Dr. Spector reported on the progress made by NPOP over the previous year. Currently, NPOP is sequencing solid tumors with a recent biopsy (liquid biopsies are acceptable), but hopes to begin examination of sarcomas and hematologic malignancies. NPOP has grown from about 100 samples analyzed monthly in January 2017 to nearly 350 in June 2018 with a goal of reaching 600 monthly samples across the VA. “You should be sending tumor tissues to be sequenced,” he explained. “It’s free, sequencing tumor tissue is the standard of care, and we need to be sequencing our patients to provide them with an opportunity to get patients onto clinical trials.”
Although the initial analysis can take up to 21 days, the program offers a 72-hour turn-around time for e-consultations. Depending on the quality of trial data, patients may be eligible for treatment even if there is no FDA-approved treatment. According to Spector, the goal of the program is to get patients on the right treatment and avoid costly treatment that will not work for a patient’s cancer type. “We do not want to be giving an expensive drug to someone who will not respond,” he explained.
Multiple efforts are underway to streamline and increase access to oncology care in the VA, according to Dr. Kelley. The development of a national cancer strategy is “long overdue” he admitted, but multiple efforts are underway to including the Fast Track to VA Cancer Care, a single national point of entry for VA cancer care, mechanisms to streamline enrolling patients in non-VA clinical trials, virtual tumor boards, and oncology-specific dashboards. “We have to be transparent and show not only to ourselves, but the whole worlds that we are doing a great job,” he told attendees.
One of the biggest challenges the VA faces will be the roll out of a new electronic health record system. While the new Cerner system has an oncology package, it does not have a cancer registry. According to Kelley, the VA is searching for a commercial system that can interface with Cerner to provide a cancer registry.
Kelley also focused on Annie, a new VA texting platform that allow patients to report on symptoms and get advice The Annie system is automated and allows patients to provide self-care. Already, cancer care providers are experimenting with Annie and Kelley expects the program to develop further.
FDA approves Arikayce for MAC lung diseases
that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.
In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.
The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.
According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.
More information can be found in the full press announcement.
that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.
In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.
The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.
According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.
More information can be found in the full press announcement.
that has been caused by members of the Mycobacterium avium complex and is refractory to other treatments.
In a randomized, controlled trial, patients with refractory M. avium complex infections were assigned to receive either Arikayce plus a multidrug antibacterial regimen or just the antibacterial regimen. By 6 months, sputum cultures for 29% of those treated with the combination had shown no mycobacterial growth for 3 consecutive months, whereas this was only true for the cultures for 9% of patients on the multidrug antibacterial regimen alone.
The Arikayce prescribing information includes a boxed warning regarding the increased risk of respiratory conditions, including hypersensitivity pneumonitis, bronchospasm, exacerbation of underlying lung disease, and hemoptysis, some of which have proven serious enough to lead to hospitalization. Other side effects include dysphonia, cough, musculoskeletal pain, nausea, and fatigue.
According to the press announcement from the FDA, this is the first approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, which was set up by Congress “to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need.” It does so by allowing a more streamlined clinical development program that may involve smaller, shorter, or fewer clinical trials.
More information can be found in the full press announcement.
Brentuximab vendotin plus CHP meets PFS endpoint in ECHELON-2
Takeda Pharmaceuticals and Seattle Genetics announced top-line results in the ECHELON-2 phase 3 trial of brentuximab vedotin plus CHP (cyclophosphamide, doxorubicin, prednisone) in the frontline treatment of CD-30 expressing peripheral T-cell lymphoma (PTCL).
The combination achieved statistically significant improvement in progression-free survival (PFS), compared with the control arm of standard chemotherapy alone using cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). The PFS was assessed by an Independent Review Facility (hazard ratio, 0.71; P = .0110).
The combination of brentuximab vedotin plus CHP also outperformed CHOP in overall survival, a secondary endpoint of the trial (hazard ratio, 0.66, P = .0244), according to the drug sponsors.
Full results of ECHELON-2 will be presented in December 2018 at the annual meeting of the American Society of Hematology, according to the announcement from Seattle Genetics and Takeda.
Takeda Pharmaceuticals and Seattle Genetics announced top-line results in the ECHELON-2 phase 3 trial of brentuximab vedotin plus CHP (cyclophosphamide, doxorubicin, prednisone) in the frontline treatment of CD-30 expressing peripheral T-cell lymphoma (PTCL).
The combination achieved statistically significant improvement in progression-free survival (PFS), compared with the control arm of standard chemotherapy alone using cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). The PFS was assessed by an Independent Review Facility (hazard ratio, 0.71; P = .0110).
The combination of brentuximab vedotin plus CHP also outperformed CHOP in overall survival, a secondary endpoint of the trial (hazard ratio, 0.66, P = .0244), according to the drug sponsors.
Full results of ECHELON-2 will be presented in December 2018 at the annual meeting of the American Society of Hematology, according to the announcement from Seattle Genetics and Takeda.
Takeda Pharmaceuticals and Seattle Genetics announced top-line results in the ECHELON-2 phase 3 trial of brentuximab vedotin plus CHP (cyclophosphamide, doxorubicin, prednisone) in the frontline treatment of CD-30 expressing peripheral T-cell lymphoma (PTCL).
The combination achieved statistically significant improvement in progression-free survival (PFS), compared with the control arm of standard chemotherapy alone using cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). The PFS was assessed by an Independent Review Facility (hazard ratio, 0.71; P = .0110).
The combination of brentuximab vedotin plus CHP also outperformed CHOP in overall survival, a secondary endpoint of the trial (hazard ratio, 0.66, P = .0244), according to the drug sponsors.
Full results of ECHELON-2 will be presented in December 2018 at the annual meeting of the American Society of Hematology, according to the announcement from Seattle Genetics and Takeda.
CDC: Trivalent adjuvanted influenza vaccine aIIV3 safe in elderly adults
ATLANTA – according to an analysis of reports to the Vaccine Adverse Event Reporting System (VAERS) during July 2016 through March 2018.
VAERS received 630 reports related to the vaccine (aIIV3; FLUAD) during the study period, of which 521 involved adults aged 65 years and older.
“Eighteen (3%) were serious reports, including two death reports (0.4%), all in adults aged [at least] 65 years,” Penina Haber and her colleagues at the Immunization Safety Office at the Centers for Disease Control and Prevention reported in a poster at the International Conference on Emerging Infectious Diseases.
The deaths included a 75-year-old man who died from Sjögren’s syndrome and a 65-year-old man who died from a myocardial infarction. The other serious events included five neurologic disorders (two cases of Guillain-Barré syndrome and one each of Bell’s palsy, Bickerstaff encephalitis, and lower-extremity weakness), five musculoskeletal and connective tissue disorders (three with shoulder pain and two with arm pain), three general disorders and administration site conditions (two cases of fever/chills and one case of cellulitis/bursitis), and one case each of a gastrointestinal disorder (acute diarrhea/gastroenteritis), an injury (a fall), and a skin/subcutaneous tissue disorder (keratosis pilaris rubra), according to the investigators.
There were no reports of anaphylaxis.
For the sake of comparison, the investigators also looked at reports associated with IIV3-HD and IIV3/IIV4 vaccines in adults aged 65 years and older during the same time period; they found that patient characteristics and reported events were similar for all the vaccines. For example, the percentages of reports involving patients aged 65 years and older were 65% or 66% for each, and those involving patients aged 75-84 years were 27%-29%. Further, 0.2%-0.6% of reports for each vaccine involved death.
The most frequently reported events for aIIV3, IIV3-HD, and IIV3/IIV4, respectively, were extremity pain (21%, 17%, and 15%, respectively), injection site erythema (18%, 19%, and 15%), and injection site pain (15%, 16%, and 16%), they said.
The aIIV3 vaccine – the first seasonal inactivated trivalent influenza vaccine produced from three influenza virus strains (two subtype A strains and one type B strain) – was approved by the Food and Drug Administration in 2015 for adults aged 65 years and older. It was the first influenza vaccine containing the adjuvant MF59 – a purified oil-in-water emulsion of squalene oil added to boost immune response in that population. Its safety was assessed in 15 randomized, controlled clinical studies, and several trials in older adults supported its efficacy and safety over nonadjuvanted influenza vaccines, the investigators reported. They noted that the Advisory Committee on Immunization Practices (ACIP) recommended the vaccine as an option for routine use in adults aged 65 years and older during the 2016-2017 flu seasons.
For the 2018-2019 flu season, ACIP determined that “For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV4 are acceptable options.”
The findings of the analysis of the 2017-2018 flu season data are consistent with prelicensure studies, Ms. Haber and her colleagues concluded, noting that data mining did not detect disproportional reporting of any unexpected adverse event.
“[There were] no safety concerns following aIIV3 when compared to the nonadjuvanted influenza vaccines (IIV3-HD or IIV3/IIV4),” they wrote, adding that the “CDC and FDA will continue to monitor and ensure the safety of aIIV3.”
Ms. Haber reported having no disclosures
sworcester@frontlinemedcom.com
SOURCE: Haber P et al. ICEID 2018, Board 320.
ATLANTA – according to an analysis of reports to the Vaccine Adverse Event Reporting System (VAERS) during July 2016 through March 2018.
VAERS received 630 reports related to the vaccine (aIIV3; FLUAD) during the study period, of which 521 involved adults aged 65 years and older.
“Eighteen (3%) were serious reports, including two death reports (0.4%), all in adults aged [at least] 65 years,” Penina Haber and her colleagues at the Immunization Safety Office at the Centers for Disease Control and Prevention reported in a poster at the International Conference on Emerging Infectious Diseases.
The deaths included a 75-year-old man who died from Sjögren’s syndrome and a 65-year-old man who died from a myocardial infarction. The other serious events included five neurologic disorders (two cases of Guillain-Barré syndrome and one each of Bell’s palsy, Bickerstaff encephalitis, and lower-extremity weakness), five musculoskeletal and connective tissue disorders (three with shoulder pain and two with arm pain), three general disorders and administration site conditions (two cases of fever/chills and one case of cellulitis/bursitis), and one case each of a gastrointestinal disorder (acute diarrhea/gastroenteritis), an injury (a fall), and a skin/subcutaneous tissue disorder (keratosis pilaris rubra), according to the investigators.
There were no reports of anaphylaxis.
For the sake of comparison, the investigators also looked at reports associated with IIV3-HD and IIV3/IIV4 vaccines in adults aged 65 years and older during the same time period; they found that patient characteristics and reported events were similar for all the vaccines. For example, the percentages of reports involving patients aged 65 years and older were 65% or 66% for each, and those involving patients aged 75-84 years were 27%-29%. Further, 0.2%-0.6% of reports for each vaccine involved death.
The most frequently reported events for aIIV3, IIV3-HD, and IIV3/IIV4, respectively, were extremity pain (21%, 17%, and 15%, respectively), injection site erythema (18%, 19%, and 15%), and injection site pain (15%, 16%, and 16%), they said.
The aIIV3 vaccine – the first seasonal inactivated trivalent influenza vaccine produced from three influenza virus strains (two subtype A strains and one type B strain) – was approved by the Food and Drug Administration in 2015 for adults aged 65 years and older. It was the first influenza vaccine containing the adjuvant MF59 – a purified oil-in-water emulsion of squalene oil added to boost immune response in that population. Its safety was assessed in 15 randomized, controlled clinical studies, and several trials in older adults supported its efficacy and safety over nonadjuvanted influenza vaccines, the investigators reported. They noted that the Advisory Committee on Immunization Practices (ACIP) recommended the vaccine as an option for routine use in adults aged 65 years and older during the 2016-2017 flu seasons.
For the 2018-2019 flu season, ACIP determined that “For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV4 are acceptable options.”
The findings of the analysis of the 2017-2018 flu season data are consistent with prelicensure studies, Ms. Haber and her colleagues concluded, noting that data mining did not detect disproportional reporting of any unexpected adverse event.
“[There were] no safety concerns following aIIV3 when compared to the nonadjuvanted influenza vaccines (IIV3-HD or IIV3/IIV4),” they wrote, adding that the “CDC and FDA will continue to monitor and ensure the safety of aIIV3.”
Ms. Haber reported having no disclosures
sworcester@frontlinemedcom.com
SOURCE: Haber P et al. ICEID 2018, Board 320.
ATLANTA – according to an analysis of reports to the Vaccine Adverse Event Reporting System (VAERS) during July 2016 through March 2018.
VAERS received 630 reports related to the vaccine (aIIV3; FLUAD) during the study period, of which 521 involved adults aged 65 years and older.
“Eighteen (3%) were serious reports, including two death reports (0.4%), all in adults aged [at least] 65 years,” Penina Haber and her colleagues at the Immunization Safety Office at the Centers for Disease Control and Prevention reported in a poster at the International Conference on Emerging Infectious Diseases.
The deaths included a 75-year-old man who died from Sjögren’s syndrome and a 65-year-old man who died from a myocardial infarction. The other serious events included five neurologic disorders (two cases of Guillain-Barré syndrome and one each of Bell’s palsy, Bickerstaff encephalitis, and lower-extremity weakness), five musculoskeletal and connective tissue disorders (three with shoulder pain and two with arm pain), three general disorders and administration site conditions (two cases of fever/chills and one case of cellulitis/bursitis), and one case each of a gastrointestinal disorder (acute diarrhea/gastroenteritis), an injury (a fall), and a skin/subcutaneous tissue disorder (keratosis pilaris rubra), according to the investigators.
There were no reports of anaphylaxis.
For the sake of comparison, the investigators also looked at reports associated with IIV3-HD and IIV3/IIV4 vaccines in adults aged 65 years and older during the same time period; they found that patient characteristics and reported events were similar for all the vaccines. For example, the percentages of reports involving patients aged 65 years and older were 65% or 66% for each, and those involving patients aged 75-84 years were 27%-29%. Further, 0.2%-0.6% of reports for each vaccine involved death.
The most frequently reported events for aIIV3, IIV3-HD, and IIV3/IIV4, respectively, were extremity pain (21%, 17%, and 15%, respectively), injection site erythema (18%, 19%, and 15%), and injection site pain (15%, 16%, and 16%), they said.
The aIIV3 vaccine – the first seasonal inactivated trivalent influenza vaccine produced from three influenza virus strains (two subtype A strains and one type B strain) – was approved by the Food and Drug Administration in 2015 for adults aged 65 years and older. It was the first influenza vaccine containing the adjuvant MF59 – a purified oil-in-water emulsion of squalene oil added to boost immune response in that population. Its safety was assessed in 15 randomized, controlled clinical studies, and several trials in older adults supported its efficacy and safety over nonadjuvanted influenza vaccines, the investigators reported. They noted that the Advisory Committee on Immunization Practices (ACIP) recommended the vaccine as an option for routine use in adults aged 65 years and older during the 2016-2017 flu seasons.
For the 2018-2019 flu season, ACIP determined that “For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV4 are acceptable options.”
The findings of the analysis of the 2017-2018 flu season data are consistent with prelicensure studies, Ms. Haber and her colleagues concluded, noting that data mining did not detect disproportional reporting of any unexpected adverse event.
“[There were] no safety concerns following aIIV3 when compared to the nonadjuvanted influenza vaccines (IIV3-HD or IIV3/IIV4),” they wrote, adding that the “CDC and FDA will continue to monitor and ensure the safety of aIIV3.”
Ms. Haber reported having no disclosures
sworcester@frontlinemedcom.com
SOURCE: Haber P et al. ICEID 2018, Board 320.
REPORTING FROM ICEID 2018
Key clinical point: No new or unexpected adverse events were reported among the 630 reports related to the vaccine during the study period, of which 521 involved adults aged 65 years and older.
Major finding: Of 521 reports, 18 were serious, and there were two deaths.
Study details: A review of 521 reports to the Vaccine Adverse Event Reporting System in 2017-2018.
Disclosures: Ms. Haber reported having no disclosures.
Source: Haber P et al. ICEID 2018, Board 320.
PCV13 moderately effective in older adults
ATLANTA – (IPD) caused by PCV13 vaccine serotypes in adults aged 65 years and older, according to a case-control study involving Medicare beneficiaries.
Conversely, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) showed limited effectiveness against serotypes unique to that vaccine in the study, which included 699 cases and more than 10,000 controls, Olivia Almendares, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.
“Vaccine efficacy against PCV13 [plus 6C type, which has cross-reactivity with serotype 6A] was 47% in those who received PCV13 vaccine only,” Ms. Almendares said in an interview, noting that efficacy was 26% against serotype 3 and 67% against other PCV13 serotypes (plus 6C). “Vaccine efficacy against PPSV23-unique types was 36% for those who received only PPSV23.”
Neither vaccine showed effectiveness against serotypes not included in the respective vaccines, she said.
The findings are timely given that the Advisory Committee on Immunization Practices (ACIP) is reevaluating its PCV13 recommendation for adults aged 65 years and older, she added.
“Specifically, ACIP is addressing whether PCV13 should be recommended routinely for all immunocompetent adults aged 65 and older given sustained indirect effects,” she said, explaining that, in 2014 when ACIP recommended routine use of the vaccine in series with PPSV23 for adults aged 65 years and older, the committee recognized that herd immunity effects from PCV13 use in children might eventually limit the utility of this recommendation, and therefore it proposed reevaluation and revision as needed after 4 years.
For the current study, she and her colleagues linked IPD cases in persons aged 65 years and older, which were identified through Active Bacterial Core surveillance during 2015-2016, to records for Centers for Medicare & Medicaid Services (CMS) beneficiaries. Vaccination and medical histories were obtained through medical records, and vaccine effectiveness was estimated as one minus the odds ratio for vaccination with PCV13 only or PPSV23 only versus neither vaccine using conditional logistic regression, with adjustment for sex and underlying medical conditions.
Of 2,246 IPD cases, 1,017 (45%) were matched to Medicare beneficiaries, and 699 were included in the analysis after those with noncontinuous enrollment in Medicare, long-term care residence, and missing census tract data were excluded. The cases were matched based on age, census tract of residence, and length of Medicare enrollment to 10,152 matched controls identified through CMS.
IPD associated with PCV13 (plus type 6C) accounted for 164 (23% of cases), of which 88 (12% of cases) involved serotype 3, and invasive pneumococcal disease associated with PPSV23 accounted for 350 cases (50%), she said.
PCV13 vaccine was given alone in 14% and 18% of cases and controls, respectively; PPSV23 alone was given in 22% and 21% of case patients and controls, respectively; and both vaccines were given in 8% of cases and controls.
Compared with controls, case patients were more likely to be of nonwhite race (16% vs. 11%), to have more than one chronic medical condition (88% vs. 58%), and to have one or more immunocompromising conditions (54% vs. 32%), she and her colleagues reported.
“PCV13 showed moderate overall effectiveness in preventing IPD caused by PCV13 (including 6C), but effectiveness may be lower for serotype 3 than for other PCV13 types,” she said.
“These results are in agreement with those from CAPiTA – a large clinical trial conducted in the Netherlands, which showed PCV13 to be effective against IPD caused by vaccine serotypes among community-dwelling adults aged 65 and older,” she noted. “Additionally, data from CDC surveillance suggest that PCV13-serotype [invasive pneumococcal disease] among children and adults aged 65 and older has declined dramatically following PCV13 introduction for children in 2010, as predicted.”
In fact, among adults aged 65 years and older, PCV13-serotype invasive pneumococcal disease declined by 40% after the vaccine was introduced in children. This corresponds to a change in the annual PCV13-serotype incidence from 14 cases per 100,000 population in 2010 to five cases per 100,000 population in 2014, she said; she added that IPD incidence plateaued in 2014-2016 with vaccine serotypes contributing to a small proportion of overall IPD burden among adults aged 65 years and older.
ACIP’s reevaluation of the PCV13 recommendation is ongoing and will be addressed at upcoming meetings.
“As part of the review process, we look at changes in disease incidence focusing primarily on invasive pneumococcal disease and noninvasive pneumonia, vaccine efficacy and effectiveness, and vaccine safety,” she said. She noted that ACIP currently has no plans to consider revising PCV13 recommendations for adults who have immunocompromising conditions, for whom PCV13 has been recommended since 2012.
Ms. Almendares reported having no disclosures.
SOURCE: Almendares O et al. ICEID 2018, Board 376.
ATLANTA – (IPD) caused by PCV13 vaccine serotypes in adults aged 65 years and older, according to a case-control study involving Medicare beneficiaries.
Conversely, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) showed limited effectiveness against serotypes unique to that vaccine in the study, which included 699 cases and more than 10,000 controls, Olivia Almendares, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.
“Vaccine efficacy against PCV13 [plus 6C type, which has cross-reactivity with serotype 6A] was 47% in those who received PCV13 vaccine only,” Ms. Almendares said in an interview, noting that efficacy was 26% against serotype 3 and 67% against other PCV13 serotypes (plus 6C). “Vaccine efficacy against PPSV23-unique types was 36% for those who received only PPSV23.”
Neither vaccine showed effectiveness against serotypes not included in the respective vaccines, she said.
The findings are timely given that the Advisory Committee on Immunization Practices (ACIP) is reevaluating its PCV13 recommendation for adults aged 65 years and older, she added.
“Specifically, ACIP is addressing whether PCV13 should be recommended routinely for all immunocompetent adults aged 65 and older given sustained indirect effects,” she said, explaining that, in 2014 when ACIP recommended routine use of the vaccine in series with PPSV23 for adults aged 65 years and older, the committee recognized that herd immunity effects from PCV13 use in children might eventually limit the utility of this recommendation, and therefore it proposed reevaluation and revision as needed after 4 years.
For the current study, she and her colleagues linked IPD cases in persons aged 65 years and older, which were identified through Active Bacterial Core surveillance during 2015-2016, to records for Centers for Medicare & Medicaid Services (CMS) beneficiaries. Vaccination and medical histories were obtained through medical records, and vaccine effectiveness was estimated as one minus the odds ratio for vaccination with PCV13 only or PPSV23 only versus neither vaccine using conditional logistic regression, with adjustment for sex and underlying medical conditions.
Of 2,246 IPD cases, 1,017 (45%) were matched to Medicare beneficiaries, and 699 were included in the analysis after those with noncontinuous enrollment in Medicare, long-term care residence, and missing census tract data were excluded. The cases were matched based on age, census tract of residence, and length of Medicare enrollment to 10,152 matched controls identified through CMS.
IPD associated with PCV13 (plus type 6C) accounted for 164 (23% of cases), of which 88 (12% of cases) involved serotype 3, and invasive pneumococcal disease associated with PPSV23 accounted for 350 cases (50%), she said.
PCV13 vaccine was given alone in 14% and 18% of cases and controls, respectively; PPSV23 alone was given in 22% and 21% of case patients and controls, respectively; and both vaccines were given in 8% of cases and controls.
Compared with controls, case patients were more likely to be of nonwhite race (16% vs. 11%), to have more than one chronic medical condition (88% vs. 58%), and to have one or more immunocompromising conditions (54% vs. 32%), she and her colleagues reported.
“PCV13 showed moderate overall effectiveness in preventing IPD caused by PCV13 (including 6C), but effectiveness may be lower for serotype 3 than for other PCV13 types,” she said.
“These results are in agreement with those from CAPiTA – a large clinical trial conducted in the Netherlands, which showed PCV13 to be effective against IPD caused by vaccine serotypes among community-dwelling adults aged 65 and older,” she noted. “Additionally, data from CDC surveillance suggest that PCV13-serotype [invasive pneumococcal disease] among children and adults aged 65 and older has declined dramatically following PCV13 introduction for children in 2010, as predicted.”
In fact, among adults aged 65 years and older, PCV13-serotype invasive pneumococcal disease declined by 40% after the vaccine was introduced in children. This corresponds to a change in the annual PCV13-serotype incidence from 14 cases per 100,000 population in 2010 to five cases per 100,000 population in 2014, she said; she added that IPD incidence plateaued in 2014-2016 with vaccine serotypes contributing to a small proportion of overall IPD burden among adults aged 65 years and older.
ACIP’s reevaluation of the PCV13 recommendation is ongoing and will be addressed at upcoming meetings.
“As part of the review process, we look at changes in disease incidence focusing primarily on invasive pneumococcal disease and noninvasive pneumonia, vaccine efficacy and effectiveness, and vaccine safety,” she said. She noted that ACIP currently has no plans to consider revising PCV13 recommendations for adults who have immunocompromising conditions, for whom PCV13 has been recommended since 2012.
Ms. Almendares reported having no disclosures.
SOURCE: Almendares O et al. ICEID 2018, Board 376.
ATLANTA – (IPD) caused by PCV13 vaccine serotypes in adults aged 65 years and older, according to a case-control study involving Medicare beneficiaries.
Conversely, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) showed limited effectiveness against serotypes unique to that vaccine in the study, which included 699 cases and more than 10,000 controls, Olivia Almendares, an epidemiologist at the Centers for Disease Control and Prevention, Atlanta, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.
“Vaccine efficacy against PCV13 [plus 6C type, which has cross-reactivity with serotype 6A] was 47% in those who received PCV13 vaccine only,” Ms. Almendares said in an interview, noting that efficacy was 26% against serotype 3 and 67% against other PCV13 serotypes (plus 6C). “Vaccine efficacy against PPSV23-unique types was 36% for those who received only PPSV23.”
Neither vaccine showed effectiveness against serotypes not included in the respective vaccines, she said.
The findings are timely given that the Advisory Committee on Immunization Practices (ACIP) is reevaluating its PCV13 recommendation for adults aged 65 years and older, she added.
“Specifically, ACIP is addressing whether PCV13 should be recommended routinely for all immunocompetent adults aged 65 and older given sustained indirect effects,” she said, explaining that, in 2014 when ACIP recommended routine use of the vaccine in series with PPSV23 for adults aged 65 years and older, the committee recognized that herd immunity effects from PCV13 use in children might eventually limit the utility of this recommendation, and therefore it proposed reevaluation and revision as needed after 4 years.
For the current study, she and her colleagues linked IPD cases in persons aged 65 years and older, which were identified through Active Bacterial Core surveillance during 2015-2016, to records for Centers for Medicare & Medicaid Services (CMS) beneficiaries. Vaccination and medical histories were obtained through medical records, and vaccine effectiveness was estimated as one minus the odds ratio for vaccination with PCV13 only or PPSV23 only versus neither vaccine using conditional logistic regression, with adjustment for sex and underlying medical conditions.
Of 2,246 IPD cases, 1,017 (45%) were matched to Medicare beneficiaries, and 699 were included in the analysis after those with noncontinuous enrollment in Medicare, long-term care residence, and missing census tract data were excluded. The cases were matched based on age, census tract of residence, and length of Medicare enrollment to 10,152 matched controls identified through CMS.
IPD associated with PCV13 (plus type 6C) accounted for 164 (23% of cases), of which 88 (12% of cases) involved serotype 3, and invasive pneumococcal disease associated with PPSV23 accounted for 350 cases (50%), she said.
PCV13 vaccine was given alone in 14% and 18% of cases and controls, respectively; PPSV23 alone was given in 22% and 21% of case patients and controls, respectively; and both vaccines were given in 8% of cases and controls.
Compared with controls, case patients were more likely to be of nonwhite race (16% vs. 11%), to have more than one chronic medical condition (88% vs. 58%), and to have one or more immunocompromising conditions (54% vs. 32%), she and her colleagues reported.
“PCV13 showed moderate overall effectiveness in preventing IPD caused by PCV13 (including 6C), but effectiveness may be lower for serotype 3 than for other PCV13 types,” she said.
“These results are in agreement with those from CAPiTA – a large clinical trial conducted in the Netherlands, which showed PCV13 to be effective against IPD caused by vaccine serotypes among community-dwelling adults aged 65 and older,” she noted. “Additionally, data from CDC surveillance suggest that PCV13-serotype [invasive pneumococcal disease] among children and adults aged 65 and older has declined dramatically following PCV13 introduction for children in 2010, as predicted.”
In fact, among adults aged 65 years and older, PCV13-serotype invasive pneumococcal disease declined by 40% after the vaccine was introduced in children. This corresponds to a change in the annual PCV13-serotype incidence from 14 cases per 100,000 population in 2010 to five cases per 100,000 population in 2014, she said; she added that IPD incidence plateaued in 2014-2016 with vaccine serotypes contributing to a small proportion of overall IPD burden among adults aged 65 years and older.
ACIP’s reevaluation of the PCV13 recommendation is ongoing and will be addressed at upcoming meetings.
“As part of the review process, we look at changes in disease incidence focusing primarily on invasive pneumococcal disease and noninvasive pneumonia, vaccine efficacy and effectiveness, and vaccine safety,” she said. She noted that ACIP currently has no plans to consider revising PCV13 recommendations for adults who have immunocompromising conditions, for whom PCV13 has been recommended since 2012.
Ms. Almendares reported having no disclosures.
SOURCE: Almendares O et al. ICEID 2018, Board 376.
REPORTING FROM ICEID 2018