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Drug receives breakthrough designation for HSCT-TMA
The US Food and Drug Administration (FDA) has granted a second breakthrough therapy designation to OMS721.
OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.
The new breakthrough designation is for OMS721 as a treatment for patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who have persistent TMA despite modification of immunosuppressive therapy.
OMS721 also has breakthrough designation from the FDA for the treatment of immunoglobulin A nephropathy.
Phase 2 trial
The breakthrough designation for HSCT-TMA was granted based on data from an ongoing phase 2 trial (NCT02222545). Omeros Corporation, the company developing OMS721, released some results from this study in February.
The trial is enrolling adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post-transplant. Patients receive weekly OMS721 treatments for 4 to 8 weeks at the discretion of the investigator.
At the time of Omeros’s announcement, 18 patients had been treated on this study.
These patients had a significantly longer median overall survival than historical controls—347 days and 21 days, respectively (P<0.0001).
Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.
The mean platelet count increased from 18,100 x 106/mL at baseline to 52,300 x 106/mL (P=0.017). The mean LDH decreased from 591 U/L to 250 U/L (P<0.001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P=0.003).
Mean creatinine remained stable—at approximately 120 μmol/L—but a majority of patients had co-existing conditions for which they were receiving nephrotoxic medications. These conditions included graft-versus-host disease, cytomegalovirus and human herpes virus 6 infections, prior sepsis, diffuse alveolar hemorrhage, and residual underlying malignancies.
The most commonly reported adverse events in this trial are diarrhea and neutropenia.
Four deaths occurred. One of these—due to acute renal and respiratory failure—was considered possibly related to OMS721.
The other deaths were due to progression of acute myeloid leukemia (n=1) and neutropenic sepsis (n=2).
About breakthrough designation
The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.
The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.
To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
The US Food and Drug Administration (FDA) has granted a second breakthrough therapy designation to OMS721.
OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.
The new breakthrough designation is for OMS721 as a treatment for patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who have persistent TMA despite modification of immunosuppressive therapy.
OMS721 also has breakthrough designation from the FDA for the treatment of immunoglobulin A nephropathy.
Phase 2 trial
The breakthrough designation for HSCT-TMA was granted based on data from an ongoing phase 2 trial (NCT02222545). Omeros Corporation, the company developing OMS721, released some results from this study in February.
The trial is enrolling adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post-transplant. Patients receive weekly OMS721 treatments for 4 to 8 weeks at the discretion of the investigator.
At the time of Omeros’s announcement, 18 patients had been treated on this study.
These patients had a significantly longer median overall survival than historical controls—347 days and 21 days, respectively (P<0.0001).
Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.
The mean platelet count increased from 18,100 x 106/mL at baseline to 52,300 x 106/mL (P=0.017). The mean LDH decreased from 591 U/L to 250 U/L (P<0.001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P=0.003).
Mean creatinine remained stable—at approximately 120 μmol/L—but a majority of patients had co-existing conditions for which they were receiving nephrotoxic medications. These conditions included graft-versus-host disease, cytomegalovirus and human herpes virus 6 infections, prior sepsis, diffuse alveolar hemorrhage, and residual underlying malignancies.
The most commonly reported adverse events in this trial are diarrhea and neutropenia.
Four deaths occurred. One of these—due to acute renal and respiratory failure—was considered possibly related to OMS721.
The other deaths were due to progression of acute myeloid leukemia (n=1) and neutropenic sepsis (n=2).
About breakthrough designation
The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.
The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.
To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
The US Food and Drug Administration (FDA) has granted a second breakthrough therapy designation to OMS721.
OMS721 is a monoclonal antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.
The new breakthrough designation is for OMS721 as a treatment for patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who have persistent TMA despite modification of immunosuppressive therapy.
OMS721 also has breakthrough designation from the FDA for the treatment of immunoglobulin A nephropathy.
Phase 2 trial
The breakthrough designation for HSCT-TMA was granted based on data from an ongoing phase 2 trial (NCT02222545). Omeros Corporation, the company developing OMS721, released some results from this study in February.
The trial is enrolling adults with HSCT-TMA persisting for at least 2 weeks following immunosuppressive regimen modification or more than 30 days post-transplant. Patients receive weekly OMS721 treatments for 4 to 8 weeks at the discretion of the investigator.
At the time of Omeros’s announcement, 18 patients had been treated on this study.
These patients had a significantly longer median overall survival than historical controls—347 days and 21 days, respectively (P<0.0001).
Omeros also reported that markers of TMA activity significantly improved following OMS721 treatment.
The mean platelet count increased from 18,100 x 106/mL at baseline to 52,300 x 106/mL (P=0.017). The mean LDH decreased from 591 U/L to 250 U/L (P<0.001). And the mean haptoglobin increased from 8 mg/dL to 141 mg/dL (P=0.003).
Mean creatinine remained stable—at approximately 120 μmol/L—but a majority of patients had co-existing conditions for which they were receiving nephrotoxic medications. These conditions included graft-versus-host disease, cytomegalovirus and human herpes virus 6 infections, prior sepsis, diffuse alveolar hemorrhage, and residual underlying malignancies.
The most commonly reported adverse events in this trial are diarrhea and neutropenia.
Four deaths occurred. One of these—due to acute renal and respiratory failure—was considered possibly related to OMS721.
The other deaths were due to progression of acute myeloid leukemia (n=1) and neutropenic sepsis (n=2).
About breakthrough designation
The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.
The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.
To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
Universal BRCA testing worthwhile for relatives of high-grade serous ovarian cancer patients
AUSTIN, TEX. – Universal BRCA mutation testing for first-degree relatives of women with high-grade serous ovarian cancer could prevent significantly more cases, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Women with high-grade serous ovarian cancer have a 20% chance of having a BRCA mutation; however, the risk is 50% for first degree relatives of someone with that mutation.
“Until we find an effective screening test for ovarian cancer, which can identify women at an early stage for which there is curative treatment, we need to maximize opportunities for prevention,” said Janice S. Kwon, MD, the gynecologic oncology fellowship program director at the University of British Columbia, Vancouver. “An obvious target group,” she added, are women “at highest risk of developing ovarian cancers, specifically those who inherit mutations in BRCA1 or BRCA2.”
First-degree relatives of ovarian cancer patients have three conceivable options if their BRCA status is unknown, and have no other risk factor for BRCA testing: To not undergo testing; to get tested and, if found to have the mutation, undergo risk-reducing surgery (bilateral salpingo-oophorectomy); or to undergo surgery without testing.
To estimate the efficiency and cost effectiveness of universal BRCA testing of female first-degree relatives of women with high-grade serous ovarian cancer, Dr. Kwon and her colleagues used the “Markov Monte Carlo” simulation model, with a time horizon of 50 years, evaluating the costs and benefits of those three strategies.
They acknowledged that testing excluded women with a personal history of breast cancer and did not include nonhormonal interventions in their analysis.
They found that the average quality-adjusted life year (QUALY) gain of universal BRCA testing was 19.20 years, compared with 18.99 years for no BRCA testing, and 18.48 years for universal surgery with no BRCA testing.
The reason universal surgery was the lowest is because most of these women will be premenopausal at the time of surgery, according to Dr. Kwon. A procedure like a premenopausal oophorectomy has been associated with a 40% increase in all-cause mortality, putting the patient at unnecessary risk, she noted.
Financially, no BRCA testing cost the least, an average of $8,524 Canadian dollars (about US$6,648) followed by universal BRCA at CA$10,103 (about US$7,880) . Universal surgery, with no BRCA testing, cost CA$13,959 (about US$10,888).
Despite the increased cost, the chance to give patients who may be at risk for ovarian cancer a better chance is a good investment, according to Dr. Kwon.
“Any opportunity to prevent ovarian cancer is worthwhile,” Dr. Kwon commented. “If an ovarian cancer patient cannot be tested because she declines testing or, more commonly, because she is deceased, her first-degree relative should have BRCA mutation testing, regardless of other personal or family history or ethnicity.”
She and her coinvestigators reported no relevant financial disclosures.
AUSTIN, TEX. – Universal BRCA mutation testing for first-degree relatives of women with high-grade serous ovarian cancer could prevent significantly more cases, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Women with high-grade serous ovarian cancer have a 20% chance of having a BRCA mutation; however, the risk is 50% for first degree relatives of someone with that mutation.
“Until we find an effective screening test for ovarian cancer, which can identify women at an early stage for which there is curative treatment, we need to maximize opportunities for prevention,” said Janice S. Kwon, MD, the gynecologic oncology fellowship program director at the University of British Columbia, Vancouver. “An obvious target group,” she added, are women “at highest risk of developing ovarian cancers, specifically those who inherit mutations in BRCA1 or BRCA2.”
First-degree relatives of ovarian cancer patients have three conceivable options if their BRCA status is unknown, and have no other risk factor for BRCA testing: To not undergo testing; to get tested and, if found to have the mutation, undergo risk-reducing surgery (bilateral salpingo-oophorectomy); or to undergo surgery without testing.
To estimate the efficiency and cost effectiveness of universal BRCA testing of female first-degree relatives of women with high-grade serous ovarian cancer, Dr. Kwon and her colleagues used the “Markov Monte Carlo” simulation model, with a time horizon of 50 years, evaluating the costs and benefits of those three strategies.
They acknowledged that testing excluded women with a personal history of breast cancer and did not include nonhormonal interventions in their analysis.
They found that the average quality-adjusted life year (QUALY) gain of universal BRCA testing was 19.20 years, compared with 18.99 years for no BRCA testing, and 18.48 years for universal surgery with no BRCA testing.
The reason universal surgery was the lowest is because most of these women will be premenopausal at the time of surgery, according to Dr. Kwon. A procedure like a premenopausal oophorectomy has been associated with a 40% increase in all-cause mortality, putting the patient at unnecessary risk, she noted.
Financially, no BRCA testing cost the least, an average of $8,524 Canadian dollars (about US$6,648) followed by universal BRCA at CA$10,103 (about US$7,880) . Universal surgery, with no BRCA testing, cost CA$13,959 (about US$10,888).
Despite the increased cost, the chance to give patients who may be at risk for ovarian cancer a better chance is a good investment, according to Dr. Kwon.
“Any opportunity to prevent ovarian cancer is worthwhile,” Dr. Kwon commented. “If an ovarian cancer patient cannot be tested because she declines testing or, more commonly, because she is deceased, her first-degree relative should have BRCA mutation testing, regardless of other personal or family history or ethnicity.”
She and her coinvestigators reported no relevant financial disclosures.
AUSTIN, TEX. – Universal BRCA mutation testing for first-degree relatives of women with high-grade serous ovarian cancer could prevent significantly more cases, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Women with high-grade serous ovarian cancer have a 20% chance of having a BRCA mutation; however, the risk is 50% for first degree relatives of someone with that mutation.
“Until we find an effective screening test for ovarian cancer, which can identify women at an early stage for which there is curative treatment, we need to maximize opportunities for prevention,” said Janice S. Kwon, MD, the gynecologic oncology fellowship program director at the University of British Columbia, Vancouver. “An obvious target group,” she added, are women “at highest risk of developing ovarian cancers, specifically those who inherit mutations in BRCA1 or BRCA2.”
First-degree relatives of ovarian cancer patients have three conceivable options if their BRCA status is unknown, and have no other risk factor for BRCA testing: To not undergo testing; to get tested and, if found to have the mutation, undergo risk-reducing surgery (bilateral salpingo-oophorectomy); or to undergo surgery without testing.
To estimate the efficiency and cost effectiveness of universal BRCA testing of female first-degree relatives of women with high-grade serous ovarian cancer, Dr. Kwon and her colleagues used the “Markov Monte Carlo” simulation model, with a time horizon of 50 years, evaluating the costs and benefits of those three strategies.
They acknowledged that testing excluded women with a personal history of breast cancer and did not include nonhormonal interventions in their analysis.
They found that the average quality-adjusted life year (QUALY) gain of universal BRCA testing was 19.20 years, compared with 18.99 years for no BRCA testing, and 18.48 years for universal surgery with no BRCA testing.
The reason universal surgery was the lowest is because most of these women will be premenopausal at the time of surgery, according to Dr. Kwon. A procedure like a premenopausal oophorectomy has been associated with a 40% increase in all-cause mortality, putting the patient at unnecessary risk, she noted.
Financially, no BRCA testing cost the least, an average of $8,524 Canadian dollars (about US$6,648) followed by universal BRCA at CA$10,103 (about US$7,880) . Universal surgery, with no BRCA testing, cost CA$13,959 (about US$10,888).
Despite the increased cost, the chance to give patients who may be at risk for ovarian cancer a better chance is a good investment, according to Dr. Kwon.
“Any opportunity to prevent ovarian cancer is worthwhile,” Dr. Kwon commented. “If an ovarian cancer patient cannot be tested because she declines testing or, more commonly, because she is deceased, her first-degree relative should have BRCA mutation testing, regardless of other personal or family history or ethnicity.”
She and her coinvestigators reported no relevant financial disclosures.
REPORTING FROM ACOG 2018
Key clinical point: BCRA testing should be extended to all first degree family members of ovarian cancer patients.
Major finding: Quality-adjusted life year gain was higher in patients given universal BRCA testing (an average of 19.20 years) compared with universal surgery (18.48 years) and no BRCA testing (18.99 years).
Study details: A simulation model, was used to evaluate the costs and benefits of three possible approaches for female first-degree relatives of women with high-grade serous ovarian cancer.
Disclosures: The authors had no disclosures.
New law allows Maryland students to use sunscreen at school
In early April, Maryland Governor Larry Hogan signed HB 427 into law, making Maryland the second state in 2018 to ensure that state policy allows students to possess and use sunscreen at school.
“The passing of this bill helps encourage children to develop sun-safe behaviors early on, like sunscreen application,” American Society for Dermatologic Surgery Association president Lisa Donofrio, MD, said in a statement issued by the ASDSA. “Maryland’s efforts reinforce the importance of teaching children the risks of sun exposure during outdoor activities and how to best avoid skin cancer,” she added.
ASDSA worked with the Maryland Dermatologic Society in advocating for passage of the law. In the statement, ASDSA Board Member Lawrence Green, MD, of Rockville, Maryland, who testified in favor of SB 217, said, “allowing children to put on sunscreen before recess … would really help protect them from the dangers of the sun.”
More information about SUNucate is available here.
In early April, Maryland Governor Larry Hogan signed HB 427 into law, making Maryland the second state in 2018 to ensure that state policy allows students to possess and use sunscreen at school.
“The passing of this bill helps encourage children to develop sun-safe behaviors early on, like sunscreen application,” American Society for Dermatologic Surgery Association president Lisa Donofrio, MD, said in a statement issued by the ASDSA. “Maryland’s efforts reinforce the importance of teaching children the risks of sun exposure during outdoor activities and how to best avoid skin cancer,” she added.
ASDSA worked with the Maryland Dermatologic Society in advocating for passage of the law. In the statement, ASDSA Board Member Lawrence Green, MD, of Rockville, Maryland, who testified in favor of SB 217, said, “allowing children to put on sunscreen before recess … would really help protect them from the dangers of the sun.”
More information about SUNucate is available here.
In early April, Maryland Governor Larry Hogan signed HB 427 into law, making Maryland the second state in 2018 to ensure that state policy allows students to possess and use sunscreen at school.
“The passing of this bill helps encourage children to develop sun-safe behaviors early on, like sunscreen application,” American Society for Dermatologic Surgery Association president Lisa Donofrio, MD, said in a statement issued by the ASDSA. “Maryland’s efforts reinforce the importance of teaching children the risks of sun exposure during outdoor activities and how to best avoid skin cancer,” she added.
ASDSA worked with the Maryland Dermatologic Society in advocating for passage of the law. In the statement, ASDSA Board Member Lawrence Green, MD, of Rockville, Maryland, who testified in favor of SB 217, said, “allowing children to put on sunscreen before recess … would really help protect them from the dangers of the sun.”
More information about SUNucate is available here.
REM sleep behavior disorder predicts impending synucleinopathy
LOS ANGELES – , according to a years-long, multicenter investigation of 1,280 patients – the largest study of the issue to date.
REM sleep behavior disorder (RBD) has been known for years to increase the risk for synucleinopathies, namely Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy. However, previous studies have mostly been conducted at single institutions, so the exact extent to which RBD increases the risk wasn’t clear.
These findings have important implications for the field. Now that it’s known who’s at risk, “we have a chance to do neuroprotective therapy. It’s time to move forward and start preventing disease,” Dr. Postuma said at the American Academy of Neurology annual meeting. He estimated that it would take only a few hundred patients to do a 2-year trial of neuroprotective therapy.
The 1,280 study subjects were culled from 24 sleep centers on four continents, all participants in the international RBD study group. The patients needed for a trial “are sitting right now” in the study group, “so maybe we can get on with this,” he said.
REM sleep – the dream state – normally paralyzes people, but something breaks down in RBD, and people act out their dreams, sometimes to disturbing effects. It occurs in about 1% of the population, usually in older people and in slightly more men than women.
The risk of neurodegenerative disease in RBD increases even more if patients test positive at baseline for movement declines, cognitive issues, olfactory problems, constipation, color vision loss, erectile dysfunction, or abnormal dopamine transporter scans. Dr. Postuma and his team found no predictive value for somnolence, insomnia, urinary problems, depression, or anxiety. These negative findings were surprising, he said, because mood disorders and sleep troubles are known to increase the risk in the general population.
The subjects all had polysomnographic-proven RBD at baseline, without neurodegenerative disease. Most of them were men and were about 70 years old, on average. Subjects were tested for synucleinopathies and risk variables annually. The mean disease-free follow-up was about 4 years, but ranged out to 19 years. Risks were adjusted for age, sex, and study center.
Cognition deficits were the only thing that distinguished future dementia patients from those destined for movement disorders. “Everything [else] is really the same between who gets dementia and who gets Parkinsonism,” Dr. Postuma said.
The study was funded by the Canadian Institute of Health Research and the Fonds de la Recherche Sante Quebec. Dr. Postuma disclosed consulting, speaking, and other fees from Biotie, Roche/Prothena, Teva Neurosciences, Novartis Canada, Theranexus, Jazz Pharmaceuticals, and GE HealthCare.
SOURCE: Postuma R et al. AAN 2018, plenary session.
LOS ANGELES – , according to a years-long, multicenter investigation of 1,280 patients – the largest study of the issue to date.
REM sleep behavior disorder (RBD) has been known for years to increase the risk for synucleinopathies, namely Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy. However, previous studies have mostly been conducted at single institutions, so the exact extent to which RBD increases the risk wasn’t clear.
These findings have important implications for the field. Now that it’s known who’s at risk, “we have a chance to do neuroprotective therapy. It’s time to move forward and start preventing disease,” Dr. Postuma said at the American Academy of Neurology annual meeting. He estimated that it would take only a few hundred patients to do a 2-year trial of neuroprotective therapy.
The 1,280 study subjects were culled from 24 sleep centers on four continents, all participants in the international RBD study group. The patients needed for a trial “are sitting right now” in the study group, “so maybe we can get on with this,” he said.
REM sleep – the dream state – normally paralyzes people, but something breaks down in RBD, and people act out their dreams, sometimes to disturbing effects. It occurs in about 1% of the population, usually in older people and in slightly more men than women.
The risk of neurodegenerative disease in RBD increases even more if patients test positive at baseline for movement declines, cognitive issues, olfactory problems, constipation, color vision loss, erectile dysfunction, or abnormal dopamine transporter scans. Dr. Postuma and his team found no predictive value for somnolence, insomnia, urinary problems, depression, or anxiety. These negative findings were surprising, he said, because mood disorders and sleep troubles are known to increase the risk in the general population.
The subjects all had polysomnographic-proven RBD at baseline, without neurodegenerative disease. Most of them were men and were about 70 years old, on average. Subjects were tested for synucleinopathies and risk variables annually. The mean disease-free follow-up was about 4 years, but ranged out to 19 years. Risks were adjusted for age, sex, and study center.
Cognition deficits were the only thing that distinguished future dementia patients from those destined for movement disorders. “Everything [else] is really the same between who gets dementia and who gets Parkinsonism,” Dr. Postuma said.
The study was funded by the Canadian Institute of Health Research and the Fonds de la Recherche Sante Quebec. Dr. Postuma disclosed consulting, speaking, and other fees from Biotie, Roche/Prothena, Teva Neurosciences, Novartis Canada, Theranexus, Jazz Pharmaceuticals, and GE HealthCare.
SOURCE: Postuma R et al. AAN 2018, plenary session.
LOS ANGELES – , according to a years-long, multicenter investigation of 1,280 patients – the largest study of the issue to date.
REM sleep behavior disorder (RBD) has been known for years to increase the risk for synucleinopathies, namely Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy. However, previous studies have mostly been conducted at single institutions, so the exact extent to which RBD increases the risk wasn’t clear.
These findings have important implications for the field. Now that it’s known who’s at risk, “we have a chance to do neuroprotective therapy. It’s time to move forward and start preventing disease,” Dr. Postuma said at the American Academy of Neurology annual meeting. He estimated that it would take only a few hundred patients to do a 2-year trial of neuroprotective therapy.
The 1,280 study subjects were culled from 24 sleep centers on four continents, all participants in the international RBD study group. The patients needed for a trial “are sitting right now” in the study group, “so maybe we can get on with this,” he said.
REM sleep – the dream state – normally paralyzes people, but something breaks down in RBD, and people act out their dreams, sometimes to disturbing effects. It occurs in about 1% of the population, usually in older people and in slightly more men than women.
The risk of neurodegenerative disease in RBD increases even more if patients test positive at baseline for movement declines, cognitive issues, olfactory problems, constipation, color vision loss, erectile dysfunction, or abnormal dopamine transporter scans. Dr. Postuma and his team found no predictive value for somnolence, insomnia, urinary problems, depression, or anxiety. These negative findings were surprising, he said, because mood disorders and sleep troubles are known to increase the risk in the general population.
The subjects all had polysomnographic-proven RBD at baseline, without neurodegenerative disease. Most of them were men and were about 70 years old, on average. Subjects were tested for synucleinopathies and risk variables annually. The mean disease-free follow-up was about 4 years, but ranged out to 19 years. Risks were adjusted for age, sex, and study center.
Cognition deficits were the only thing that distinguished future dementia patients from those destined for movement disorders. “Everything [else] is really the same between who gets dementia and who gets Parkinsonism,” Dr. Postuma said.
The study was funded by the Canadian Institute of Health Research and the Fonds de la Recherche Sante Quebec. Dr. Postuma disclosed consulting, speaking, and other fees from Biotie, Roche/Prothena, Teva Neurosciences, Novartis Canada, Theranexus, Jazz Pharmaceuticals, and GE HealthCare.
SOURCE: Postuma R et al. AAN 2018, plenary session.
REPORTING FROM AAN 2018
Key clinical point: Idiopathic REM sleep behavior disorder patients need neuroprotection.
Major finding: At least 70% of patients with idiopathic REM sleep behavior disorder (RBD) will develop a neurodegenerative disease within about a decade.
Study details: An observational study of 1,280 RBD patients from 24 asleep centers on four continents.
Disclosures: The study was funded by the Canadian Institute of Health Research and the Fonds de la Recherche Sante Quebec. Dr. Postuma disclosed consulting, speaking, and other fees from Biotie, Roche/Prothena, Teva Neurosciences, Novartis Canada, Theranexus, Jazz Pharmaceuticals, and GE HealthCare.
Source: Postuma R et al. AAN 2018, plenary session.
VIDEO: Office-based hereditary cancer risk testing is doable
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
REPORTING FROM ACOG 2018
Key clinical point: Ob.gyns. can successfully integrate hereditary cancer risk testing into their practices.
Major finding: Office-based genetic testing increased from 1% to 4% of patients seen.
Study details: Prospective, single-arm process intervention study screening more than 4,000 women at 5 ob.gyn. practice sites.
Disclosures: Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors included employees of Myriad Genetics, some with ownership interests.
Source: DeFrancesco, MS et al. ACOG 2018 poster 3K.
VIDEO: Prepaid prenatal care bundle delivers quality care to uninsured
AUSTIN, TEXAS – The experiences of one safety net hospital showed the feasibility of delivering prenatal care to low-risk, uninsured women in a prepaid, bundled package.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
. The adjusted odds ratio for predefined adequacy of care was 3.75 for the low-risk bundled care recipients compared with those on Medicaid (P = .015), according to the experience at Grady Memorial Hospital, Atlanta, presented at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.
For hospitals with large numbers of undocumented patients and others who are uninsured but ineligible for Medicaid, considerable cost savings could be realized, said Erin Duncan, MD, who completed the work while in training at Emory University.
“Using data from previous studies, Grady Memorial Hospital could see a savings of over $1 million per year by providing care to its undocumented population,” she and her collaborators wrote in the poster accompanying the presentation.
Dr. Duncan said that since implementation in 2010, about 40% of deliveries at the facility have occurred under the “Grady Healthy Baby” (GHB) bundle.
The one-payment package of bundled prenatal care was developed assuming that most participants would have low-risk pregnancies, said Dr. Duncan, who is currently an ob.gyn. in private practice in the Atlanta area.
To look further into maternal and pregnancy characteristics of GHB participants and compare them with those on Medicaid, Dr. Duncan and her collaborators performed a retrospective cohort study. Examining viable singleton pregnancies delivered at Grady between 2011 and 2014, the investigators compared 100 randomly selected GHB participants with 100 randomly selected Medicaid participants.
Comparing patients receiving care under GHB and Medicaid, Dr. Duncan and her colleagues found that “GHB participants were older, more likely to be Hispanic, and less likely to be black compared to Medicaid recipients (P less than .001 for all,)” they wrote in the poster accompanying the presentation.
Hispanic patients made up 59% of the GHB group, compared with 8% of the Medicaid group, said Dr. Duncan, adding in an interview that over half of Hispanics in the state of Georgia during the study period were undocumented.
Parity was similar between the two groups, as were gestational age at delivery and mode of delivery.
In their analysis, Dr. Duncan and her collaborators looked at both complexity and adequacy of care for the 200 patients studied. They found that there was no significant difference in the number of patients in each care group who remained low risk throughout their pregnancies, transitioned from low risk to high risk, or entered prenatal care with a high risk pregnancy, a circumstance that occurred in about 1 in 10 pregnancies.
For the approximately 50% of patients who remained low risk through their pregnancies, care under the GHB model was significantly more likely to be assessed as adequate throughout pregnancy than for those patients on Medicaid (61.7% vs 35.5%, P = .001).
Patients who became high risk during prenatal care were no more likely to receive adequate care under one model than the other.
For high risk patients, delivery of adequate care happened only under the Medicaid care model. Numbers in this group were small; 7 of 100 GHB and 15 of 100 Medicaid patients entered prenatal care with high risk pregnancies. However, no high risk GHB patients received adequate care, while that standard was met for 80% of the Medicaid patients (P less than .001).
Adequacy of care was assessed using the Kotelchuck index for low-risk pregnancies; this model assumes care is “adequate” when 80% of the number of expected visits were attended by the woman receiving prenatal care. Additionally, care was deemed adequate for high-risk pregnancies if at least 80% of the number of expected ultrasound appointments were attended.
“In the current political climate, this study has implications for all pregnancies that begin as uninsured, regardless of maternal documentation status,” wrote Dr. Duncan and her colleagues.
Dr. Duncan reported no conflicts of interest.
SOURCE: Duncan, E et al. ACOG 2018, Abstract 28C.
AUSTIN, TEXAS – The experiences of one safety net hospital showed the feasibility of delivering prenatal care to low-risk, uninsured women in a prepaid, bundled package.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
. The adjusted odds ratio for predefined adequacy of care was 3.75 for the low-risk bundled care recipients compared with those on Medicaid (P = .015), according to the experience at Grady Memorial Hospital, Atlanta, presented at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.
For hospitals with large numbers of undocumented patients and others who are uninsured but ineligible for Medicaid, considerable cost savings could be realized, said Erin Duncan, MD, who completed the work while in training at Emory University.
“Using data from previous studies, Grady Memorial Hospital could see a savings of over $1 million per year by providing care to its undocumented population,” she and her collaborators wrote in the poster accompanying the presentation.
Dr. Duncan said that since implementation in 2010, about 40% of deliveries at the facility have occurred under the “Grady Healthy Baby” (GHB) bundle.
The one-payment package of bundled prenatal care was developed assuming that most participants would have low-risk pregnancies, said Dr. Duncan, who is currently an ob.gyn. in private practice in the Atlanta area.
To look further into maternal and pregnancy characteristics of GHB participants and compare them with those on Medicaid, Dr. Duncan and her collaborators performed a retrospective cohort study. Examining viable singleton pregnancies delivered at Grady between 2011 and 2014, the investigators compared 100 randomly selected GHB participants with 100 randomly selected Medicaid participants.
Comparing patients receiving care under GHB and Medicaid, Dr. Duncan and her colleagues found that “GHB participants were older, more likely to be Hispanic, and less likely to be black compared to Medicaid recipients (P less than .001 for all,)” they wrote in the poster accompanying the presentation.
Hispanic patients made up 59% of the GHB group, compared with 8% of the Medicaid group, said Dr. Duncan, adding in an interview that over half of Hispanics in the state of Georgia during the study period were undocumented.
Parity was similar between the two groups, as were gestational age at delivery and mode of delivery.
In their analysis, Dr. Duncan and her collaborators looked at both complexity and adequacy of care for the 200 patients studied. They found that there was no significant difference in the number of patients in each care group who remained low risk throughout their pregnancies, transitioned from low risk to high risk, or entered prenatal care with a high risk pregnancy, a circumstance that occurred in about 1 in 10 pregnancies.
For the approximately 50% of patients who remained low risk through their pregnancies, care under the GHB model was significantly more likely to be assessed as adequate throughout pregnancy than for those patients on Medicaid (61.7% vs 35.5%, P = .001).
Patients who became high risk during prenatal care were no more likely to receive adequate care under one model than the other.
For high risk patients, delivery of adequate care happened only under the Medicaid care model. Numbers in this group were small; 7 of 100 GHB and 15 of 100 Medicaid patients entered prenatal care with high risk pregnancies. However, no high risk GHB patients received adequate care, while that standard was met for 80% of the Medicaid patients (P less than .001).
Adequacy of care was assessed using the Kotelchuck index for low-risk pregnancies; this model assumes care is “adequate” when 80% of the number of expected visits were attended by the woman receiving prenatal care. Additionally, care was deemed adequate for high-risk pregnancies if at least 80% of the number of expected ultrasound appointments were attended.
“In the current political climate, this study has implications for all pregnancies that begin as uninsured, regardless of maternal documentation status,” wrote Dr. Duncan and her colleagues.
Dr. Duncan reported no conflicts of interest.
SOURCE: Duncan, E et al. ACOG 2018, Abstract 28C.
AUSTIN, TEXAS – The experiences of one safety net hospital showed the feasibility of delivering prenatal care to low-risk, uninsured women in a prepaid, bundled package.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
. The adjusted odds ratio for predefined adequacy of care was 3.75 for the low-risk bundled care recipients compared with those on Medicaid (P = .015), according to the experience at Grady Memorial Hospital, Atlanta, presented at the annual clinical and scientific sessions of the American College of Obstetricians and Gynecologists.
For hospitals with large numbers of undocumented patients and others who are uninsured but ineligible for Medicaid, considerable cost savings could be realized, said Erin Duncan, MD, who completed the work while in training at Emory University.
“Using data from previous studies, Grady Memorial Hospital could see a savings of over $1 million per year by providing care to its undocumented population,” she and her collaborators wrote in the poster accompanying the presentation.
Dr. Duncan said that since implementation in 2010, about 40% of deliveries at the facility have occurred under the “Grady Healthy Baby” (GHB) bundle.
The one-payment package of bundled prenatal care was developed assuming that most participants would have low-risk pregnancies, said Dr. Duncan, who is currently an ob.gyn. in private practice in the Atlanta area.
To look further into maternal and pregnancy characteristics of GHB participants and compare them with those on Medicaid, Dr. Duncan and her collaborators performed a retrospective cohort study. Examining viable singleton pregnancies delivered at Grady between 2011 and 2014, the investigators compared 100 randomly selected GHB participants with 100 randomly selected Medicaid participants.
Comparing patients receiving care under GHB and Medicaid, Dr. Duncan and her colleagues found that “GHB participants were older, more likely to be Hispanic, and less likely to be black compared to Medicaid recipients (P less than .001 for all,)” they wrote in the poster accompanying the presentation.
Hispanic patients made up 59% of the GHB group, compared with 8% of the Medicaid group, said Dr. Duncan, adding in an interview that over half of Hispanics in the state of Georgia during the study period were undocumented.
Parity was similar between the two groups, as were gestational age at delivery and mode of delivery.
In their analysis, Dr. Duncan and her collaborators looked at both complexity and adequacy of care for the 200 patients studied. They found that there was no significant difference in the number of patients in each care group who remained low risk throughout their pregnancies, transitioned from low risk to high risk, or entered prenatal care with a high risk pregnancy, a circumstance that occurred in about 1 in 10 pregnancies.
For the approximately 50% of patients who remained low risk through their pregnancies, care under the GHB model was significantly more likely to be assessed as adequate throughout pregnancy than for those patients on Medicaid (61.7% vs 35.5%, P = .001).
Patients who became high risk during prenatal care were no more likely to receive adequate care under one model than the other.
For high risk patients, delivery of adequate care happened only under the Medicaid care model. Numbers in this group were small; 7 of 100 GHB and 15 of 100 Medicaid patients entered prenatal care with high risk pregnancies. However, no high risk GHB patients received adequate care, while that standard was met for 80% of the Medicaid patients (P less than .001).
Adequacy of care was assessed using the Kotelchuck index for low-risk pregnancies; this model assumes care is “adequate” when 80% of the number of expected visits were attended by the woman receiving prenatal care. Additionally, care was deemed adequate for high-risk pregnancies if at least 80% of the number of expected ultrasound appointments were attended.
“In the current political climate, this study has implications for all pregnancies that begin as uninsured, regardless of maternal documentation status,” wrote Dr. Duncan and her colleagues.
Dr. Duncan reported no conflicts of interest.
SOURCE: Duncan, E et al. ACOG 2018, Abstract 28C.
REPORTING FROM ACOG 2018
Cluster headache presents differently in never-smokers, survey finds
Los Angeles – Cluster headache, a severe, one-sided headache that occurs in cyclical patterns or clusters, is highly associated with smoking, but when it presents in people without any lifetime tobacco exposure, there are key differences – possibly due to a different underlying pathology.
At the American Academy of Neurology annual meeting, Todd D. Rozen, MD, of the Mayo Clinic in Jacksonville, Fla., presented a new analysis from the United States Cluster Headache Survey, an online survey of 1,134 patients with cluster headache, of whom only 12% reported neither personal tobacco use nor a parent who smoked. Dr. Rozen is a coauthor on the original survey, which collected data for a two-month period in late 2008, and has published several analyses using the survey’s data (Headache. 2012 Jan;52[1]:99-113).
Patients not exposed to tobacco developed cluster headache at a younger age than exposed subjects, with a significantly higher percentage reporting onset in their 20s and 30s, while tobacco-exposed people were more likely to see onset at aged 40 years or older.
And there were other important differences. The tobacco-naïve were more likely to have a family history of migraine (65% vs. 50%, P equal to .002). They were significantly more likely to have headache cycles that varied throughout the year rather than being concentrated during specific months or seasons (52% vs. 40%, P equal to .02), which is a hallmark of cluster headache.
Tobacco-exposed patients were more likely to transition from episodic to chronic cluster headaches (23% vs. 14%, P equal to .02) and to have cycles lasting 7 weeks or more (54% vs. 35%, P equal to .0003) compared with those who were tobacco-naïve. They also reported significantly more frequent attacks per day, and were more likely to develop cluster headache during the night (12 pm to 6 am).
“With cluster headache, the majority of patients smoke, and started smoking before they ever developed cluster headache,” Dr. Rozen said. Among the tobacco-exposed patients in the survey, 85% had what he described as a “double hit” – a parent who smoked and a personal history of smoking. “And that may be what’s necessary to develop cluster headache of this classic type,” he said.
Dr. Rozen said he suspects that tobacco-exposed people with cluster headache may have abnormal hypothalamic entrainment related to injury from toxins, though the exact mechanisms are unknown.
“So in times of hypothalamic stress – whether clock change or solstice, the hypothalamus has to work more, it doesn’t work correctly, and headache develops,” he said, noting the highly cyclical nature of the classic cluster phenotype.
As to what causes cluster headache in the non-exposed, Dr. Rozen said it’s possible that genetic factors may be more relevant – a possibility underscored by the higher rate of familial migraine reported among the tobacco-naïve in the cohort.
Dr. Rozen reported no financial conflicts of interest related to his findings.
SOURCE: Rozen TD, et al. AAN2018, P3 122.
Los Angeles – Cluster headache, a severe, one-sided headache that occurs in cyclical patterns or clusters, is highly associated with smoking, but when it presents in people without any lifetime tobacco exposure, there are key differences – possibly due to a different underlying pathology.
At the American Academy of Neurology annual meeting, Todd D. Rozen, MD, of the Mayo Clinic in Jacksonville, Fla., presented a new analysis from the United States Cluster Headache Survey, an online survey of 1,134 patients with cluster headache, of whom only 12% reported neither personal tobacco use nor a parent who smoked. Dr. Rozen is a coauthor on the original survey, which collected data for a two-month period in late 2008, and has published several analyses using the survey’s data (Headache. 2012 Jan;52[1]:99-113).
Patients not exposed to tobacco developed cluster headache at a younger age than exposed subjects, with a significantly higher percentage reporting onset in their 20s and 30s, while tobacco-exposed people were more likely to see onset at aged 40 years or older.
And there were other important differences. The tobacco-naïve were more likely to have a family history of migraine (65% vs. 50%, P equal to .002). They were significantly more likely to have headache cycles that varied throughout the year rather than being concentrated during specific months or seasons (52% vs. 40%, P equal to .02), which is a hallmark of cluster headache.
Tobacco-exposed patients were more likely to transition from episodic to chronic cluster headaches (23% vs. 14%, P equal to .02) and to have cycles lasting 7 weeks or more (54% vs. 35%, P equal to .0003) compared with those who were tobacco-naïve. They also reported significantly more frequent attacks per day, and were more likely to develop cluster headache during the night (12 pm to 6 am).
“With cluster headache, the majority of patients smoke, and started smoking before they ever developed cluster headache,” Dr. Rozen said. Among the tobacco-exposed patients in the survey, 85% had what he described as a “double hit” – a parent who smoked and a personal history of smoking. “And that may be what’s necessary to develop cluster headache of this classic type,” he said.
Dr. Rozen said he suspects that tobacco-exposed people with cluster headache may have abnormal hypothalamic entrainment related to injury from toxins, though the exact mechanisms are unknown.
“So in times of hypothalamic stress – whether clock change or solstice, the hypothalamus has to work more, it doesn’t work correctly, and headache develops,” he said, noting the highly cyclical nature of the classic cluster phenotype.
As to what causes cluster headache in the non-exposed, Dr. Rozen said it’s possible that genetic factors may be more relevant – a possibility underscored by the higher rate of familial migraine reported among the tobacco-naïve in the cohort.
Dr. Rozen reported no financial conflicts of interest related to his findings.
SOURCE: Rozen TD, et al. AAN2018, P3 122.
Los Angeles – Cluster headache, a severe, one-sided headache that occurs in cyclical patterns or clusters, is highly associated with smoking, but when it presents in people without any lifetime tobacco exposure, there are key differences – possibly due to a different underlying pathology.
At the American Academy of Neurology annual meeting, Todd D. Rozen, MD, of the Mayo Clinic in Jacksonville, Fla., presented a new analysis from the United States Cluster Headache Survey, an online survey of 1,134 patients with cluster headache, of whom only 12% reported neither personal tobacco use nor a parent who smoked. Dr. Rozen is a coauthor on the original survey, which collected data for a two-month period in late 2008, and has published several analyses using the survey’s data (Headache. 2012 Jan;52[1]:99-113).
Patients not exposed to tobacco developed cluster headache at a younger age than exposed subjects, with a significantly higher percentage reporting onset in their 20s and 30s, while tobacco-exposed people were more likely to see onset at aged 40 years or older.
And there were other important differences. The tobacco-naïve were more likely to have a family history of migraine (65% vs. 50%, P equal to .002). They were significantly more likely to have headache cycles that varied throughout the year rather than being concentrated during specific months or seasons (52% vs. 40%, P equal to .02), which is a hallmark of cluster headache.
Tobacco-exposed patients were more likely to transition from episodic to chronic cluster headaches (23% vs. 14%, P equal to .02) and to have cycles lasting 7 weeks or more (54% vs. 35%, P equal to .0003) compared with those who were tobacco-naïve. They also reported significantly more frequent attacks per day, and were more likely to develop cluster headache during the night (12 pm to 6 am).
“With cluster headache, the majority of patients smoke, and started smoking before they ever developed cluster headache,” Dr. Rozen said. Among the tobacco-exposed patients in the survey, 85% had what he described as a “double hit” – a parent who smoked and a personal history of smoking. “And that may be what’s necessary to develop cluster headache of this classic type,” he said.
Dr. Rozen said he suspects that tobacco-exposed people with cluster headache may have abnormal hypothalamic entrainment related to injury from toxins, though the exact mechanisms are unknown.
“So in times of hypothalamic stress – whether clock change or solstice, the hypothalamus has to work more, it doesn’t work correctly, and headache develops,” he said, noting the highly cyclical nature of the classic cluster phenotype.
As to what causes cluster headache in the non-exposed, Dr. Rozen said it’s possible that genetic factors may be more relevant – a possibility underscored by the higher rate of familial migraine reported among the tobacco-naïve in the cohort.
Dr. Rozen reported no financial conflicts of interest related to his findings.
SOURCE: Rozen TD, et al. AAN2018, P3 122.
REPORTING FROM AAN 2018
Key clinical point: Tobacco-naïve people with cluster headache have significant differences in symptomology compared with the tobacco-exposed
Major finding: Family history of migraine, earlier age of onset and episodic pattern were seen in non-tobacco exposed patients vs. smokers
Study details: Data came from more than 1,000 cluster headache patients surveyed in the U.S. Cluster Headache Survey.
Disclosures: The authors had no disclosures.
Source: Rozen TD, et al. AAN2018, P3 122.
HIV infection linked to higher risk of non-melanoma skin cancer
A Danish cohort study provides more evidence of a significant link between HIV infection and two types of skin cancer.
, with incidence rate ratios (IRRs) of 1.79 and 5.40, respectively, when compared with a background population, who were HIV-negative.
“The risk of SCC seemed to increase with increasing level of immunosuppression while the increased risk of BCC was restricted to patients reporting MSM [men who have sex with men] as route of infection,” wrote the authors, led by Silje Haukali Omland, MD, PhD, of the department of dermato-venereology, Copenhagen University Hospital.
The Danish nationwide cohort study, which matched each HIV patient with 5 age- and sex-matched individuals from the background population, was published online March 26 in the Journal of the American Academy of Dermatology.
The results are similar to those published elsewhere, as is the finding that HIV-positive patients do not face a higher risk of malignant melanoma. “The results here confirm prior studies and support heightened vigilance for skin conditions, such as SCC and BCC in HIV patients,” said Michael J. Silverberg, PhD, of Kaiser Permanente Division of Research, in an interview after reviewing the study findings. He was not a study author.
Researchers have long noted a connection between various types of cancer and HIV infection. But, as noted in a 2013 study led by Dr. Silverberg, research into links between HIV and non-melanoma skin cancers has been sparse and inconclusive. That study of white adults found higher adjusted rate ratios for SCC (2.6) and BCC (2.1) among those who were HIV-positive compared with those who were HIV-negative (J Natl Cancer Inst. 2013 Mar 6;105[5]:350-60).
In the Danish study, researchers tracked sex-and age-matched cohorts of HIV-infected (4,280) and non-HIV-infected patients (21,399) aged 16 years or older from study inclusion through as late as 2014. All the HIV-positive subjects had taken antiretroviral medications. The researchers also compared the HIV-positive patients to their non-HIV-infected siblings.
Overall, those who were HIV-positive were more likely to develop BCC (IRR, 1.79, 95% CI, 1.43-2.22), and males who reported sex with men had an even higher risk (IRR, 2.30, 95% CI, 1.76-3.02).
As for SCC, the IRR was 5.40 (95% CI, 3.07-9.52) among those who were HIV-positive, compared with the background population, and the researchers found evidence that risk increased with level of immunosuppression. Those who indicated heterosexual and male homosexual transmission had similar rates of SCC.
The rates of BCC or SCC were not higher among siblings of HIV-positive patients.
In addition, the risk of melanoma was not increased among those who were HIV-positive subjects or their siblings, when compared with the background group. However, the researchers noted that the study turned up a low number of HIV-positive subjects with melanoma, potentially throwing off the results.
The researchers noted that the inclusion of siblings in the study suggests that sun exposure in childhood was not a confounding factor. Presumably, they wrote, the siblings had similar levels of exposure as children, although exposure to sun bed tanning could differ between siblings.
“Study methods appear very strong and consistent with other work done in the area,” Dr. Silverberg said in the interview. As for possible causes of the disparities, he noted that exposure to the sun or to tanning beds could explain the greater risk of BCC among men who have sex with men. “For SCC, there may be a biological link, as studies have suggested a link with human papillomavirus for that particular cancer,” he added.
No study funding was reported. The study authors reported disclosures that included grants, research grants, speaker fees, and/or advisory board honoraria from several drug manufacturers. Dr. Silverberg has no relevant disclosures.
A Danish cohort study provides more evidence of a significant link between HIV infection and two types of skin cancer.
, with incidence rate ratios (IRRs) of 1.79 and 5.40, respectively, when compared with a background population, who were HIV-negative.
“The risk of SCC seemed to increase with increasing level of immunosuppression while the increased risk of BCC was restricted to patients reporting MSM [men who have sex with men] as route of infection,” wrote the authors, led by Silje Haukali Omland, MD, PhD, of the department of dermato-venereology, Copenhagen University Hospital.
The Danish nationwide cohort study, which matched each HIV patient with 5 age- and sex-matched individuals from the background population, was published online March 26 in the Journal of the American Academy of Dermatology.
The results are similar to those published elsewhere, as is the finding that HIV-positive patients do not face a higher risk of malignant melanoma. “The results here confirm prior studies and support heightened vigilance for skin conditions, such as SCC and BCC in HIV patients,” said Michael J. Silverberg, PhD, of Kaiser Permanente Division of Research, in an interview after reviewing the study findings. He was not a study author.
Researchers have long noted a connection between various types of cancer and HIV infection. But, as noted in a 2013 study led by Dr. Silverberg, research into links between HIV and non-melanoma skin cancers has been sparse and inconclusive. That study of white adults found higher adjusted rate ratios for SCC (2.6) and BCC (2.1) among those who were HIV-positive compared with those who were HIV-negative (J Natl Cancer Inst. 2013 Mar 6;105[5]:350-60).
In the Danish study, researchers tracked sex-and age-matched cohorts of HIV-infected (4,280) and non-HIV-infected patients (21,399) aged 16 years or older from study inclusion through as late as 2014. All the HIV-positive subjects had taken antiretroviral medications. The researchers also compared the HIV-positive patients to their non-HIV-infected siblings.
Overall, those who were HIV-positive were more likely to develop BCC (IRR, 1.79, 95% CI, 1.43-2.22), and males who reported sex with men had an even higher risk (IRR, 2.30, 95% CI, 1.76-3.02).
As for SCC, the IRR was 5.40 (95% CI, 3.07-9.52) among those who were HIV-positive, compared with the background population, and the researchers found evidence that risk increased with level of immunosuppression. Those who indicated heterosexual and male homosexual transmission had similar rates of SCC.
The rates of BCC or SCC were not higher among siblings of HIV-positive patients.
In addition, the risk of melanoma was not increased among those who were HIV-positive subjects or their siblings, when compared with the background group. However, the researchers noted that the study turned up a low number of HIV-positive subjects with melanoma, potentially throwing off the results.
The researchers noted that the inclusion of siblings in the study suggests that sun exposure in childhood was not a confounding factor. Presumably, they wrote, the siblings had similar levels of exposure as children, although exposure to sun bed tanning could differ between siblings.
“Study methods appear very strong and consistent with other work done in the area,” Dr. Silverberg said in the interview. As for possible causes of the disparities, he noted that exposure to the sun or to tanning beds could explain the greater risk of BCC among men who have sex with men. “For SCC, there may be a biological link, as studies have suggested a link with human papillomavirus for that particular cancer,” he added.
No study funding was reported. The study authors reported disclosures that included grants, research grants, speaker fees, and/or advisory board honoraria from several drug manufacturers. Dr. Silverberg has no relevant disclosures.
A Danish cohort study provides more evidence of a significant link between HIV infection and two types of skin cancer.
, with incidence rate ratios (IRRs) of 1.79 and 5.40, respectively, when compared with a background population, who were HIV-negative.
“The risk of SCC seemed to increase with increasing level of immunosuppression while the increased risk of BCC was restricted to patients reporting MSM [men who have sex with men] as route of infection,” wrote the authors, led by Silje Haukali Omland, MD, PhD, of the department of dermato-venereology, Copenhagen University Hospital.
The Danish nationwide cohort study, which matched each HIV patient with 5 age- and sex-matched individuals from the background population, was published online March 26 in the Journal of the American Academy of Dermatology.
The results are similar to those published elsewhere, as is the finding that HIV-positive patients do not face a higher risk of malignant melanoma. “The results here confirm prior studies and support heightened vigilance for skin conditions, such as SCC and BCC in HIV patients,” said Michael J. Silverberg, PhD, of Kaiser Permanente Division of Research, in an interview after reviewing the study findings. He was not a study author.
Researchers have long noted a connection between various types of cancer and HIV infection. But, as noted in a 2013 study led by Dr. Silverberg, research into links between HIV and non-melanoma skin cancers has been sparse and inconclusive. That study of white adults found higher adjusted rate ratios for SCC (2.6) and BCC (2.1) among those who were HIV-positive compared with those who were HIV-negative (J Natl Cancer Inst. 2013 Mar 6;105[5]:350-60).
In the Danish study, researchers tracked sex-and age-matched cohorts of HIV-infected (4,280) and non-HIV-infected patients (21,399) aged 16 years or older from study inclusion through as late as 2014. All the HIV-positive subjects had taken antiretroviral medications. The researchers also compared the HIV-positive patients to their non-HIV-infected siblings.
Overall, those who were HIV-positive were more likely to develop BCC (IRR, 1.79, 95% CI, 1.43-2.22), and males who reported sex with men had an even higher risk (IRR, 2.30, 95% CI, 1.76-3.02).
As for SCC, the IRR was 5.40 (95% CI, 3.07-9.52) among those who were HIV-positive, compared with the background population, and the researchers found evidence that risk increased with level of immunosuppression. Those who indicated heterosexual and male homosexual transmission had similar rates of SCC.
The rates of BCC or SCC were not higher among siblings of HIV-positive patients.
In addition, the risk of melanoma was not increased among those who were HIV-positive subjects or their siblings, when compared with the background group. However, the researchers noted that the study turned up a low number of HIV-positive subjects with melanoma, potentially throwing off the results.
The researchers noted that the inclusion of siblings in the study suggests that sun exposure in childhood was not a confounding factor. Presumably, they wrote, the siblings had similar levels of exposure as children, although exposure to sun bed tanning could differ between siblings.
“Study methods appear very strong and consistent with other work done in the area,” Dr. Silverberg said in the interview. As for possible causes of the disparities, he noted that exposure to the sun or to tanning beds could explain the greater risk of BCC among men who have sex with men. “For SCC, there may be a biological link, as studies have suggested a link with human papillomavirus for that particular cancer,” he added.
No study funding was reported. The study authors reported disclosures that included grants, research grants, speaker fees, and/or advisory board honoraria from several drug manufacturers. Dr. Silverberg has no relevant disclosures.
FROM JAAD
Key clinical point: HIV-positive patients are at an increased risk for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
Major finding: Among HIV-infected patients, the risk of BCC was increased by almost twofold and the risk of BCC was increased by more than fivefold.
Study details: A Danish population-based cohort study of 4,280 HIV-infected patients and 21,399 age-and sex-matched subjects.
Disclosures: No study funding was reported. The authors reported disclosures that included research grants, speaker fees, and/or advisory board honoraria from several drug manufacturers.
Source: Omland S et al. J Am Acad Dermatol. 2018 Mar 24. pii: S0190-9622(18)30475-4. doi: 10.1016/j.jaad.2018.03.024.
LARC uptake surged immediately after Trump’s election
AUSTIN, TEXAS – , as compared with the same time period 1 year earlier, Aparna Sridhar, MD, reported.
Mr. Trump’s campaign promise to repeal and replace the Affordable Care Act in the first 100 days of his presidency sparked concern in many young women that they would lose access to copay-free contraception. Therefore, based on news reports and data released by insurer AthenaHealth that noted a 19% increase in IUD insertion nationally between October and December 2016, Dr. Sridhar and her colleagues at the University of California, Los Angeles, retrospectively reviewed data on students requesting insertion of a long-acting contraceptive (LARC) at the university’s student health center in the 2 months before and after the 2016 presidential election.
In the 8 weeks prior to the November election, the UCLA doctors inserted 53 LARCs, the majority of which were levonorgestrel-releasing intrauterine systems. In the 8 weeks after the election, that number jumped to 118 insertions, a 123% increase (P = .02), again with a preponderance of hormonal IUDs. There was no statistically significant difference in insertions in the same 2 time periods in 2015, said Dr. Sridhar, of the UCLA department of obstetrics and gynecology.
The investigators also looked at whether the increase they saw could be related to the common year-end practice of maximizing health insurance benefits and found a significant increase in LARC insertions from 2015 to 2016, she added.
She noted that the team continues to monitor LARC insertions to look for additional behavior patterns.
Dr. Sridhar disclosed no financial conflicts of interest related to her presentation.
SOURCE: Sridhar, A et al. ACOG poster presentation.
AUSTIN, TEXAS – , as compared with the same time period 1 year earlier, Aparna Sridhar, MD, reported.
Mr. Trump’s campaign promise to repeal and replace the Affordable Care Act in the first 100 days of his presidency sparked concern in many young women that they would lose access to copay-free contraception. Therefore, based on news reports and data released by insurer AthenaHealth that noted a 19% increase in IUD insertion nationally between October and December 2016, Dr. Sridhar and her colleagues at the University of California, Los Angeles, retrospectively reviewed data on students requesting insertion of a long-acting contraceptive (LARC) at the university’s student health center in the 2 months before and after the 2016 presidential election.
In the 8 weeks prior to the November election, the UCLA doctors inserted 53 LARCs, the majority of which were levonorgestrel-releasing intrauterine systems. In the 8 weeks after the election, that number jumped to 118 insertions, a 123% increase (P = .02), again with a preponderance of hormonal IUDs. There was no statistically significant difference in insertions in the same 2 time periods in 2015, said Dr. Sridhar, of the UCLA department of obstetrics and gynecology.
The investigators also looked at whether the increase they saw could be related to the common year-end practice of maximizing health insurance benefits and found a significant increase in LARC insertions from 2015 to 2016, she added.
She noted that the team continues to monitor LARC insertions to look for additional behavior patterns.
Dr. Sridhar disclosed no financial conflicts of interest related to her presentation.
SOURCE: Sridhar, A et al. ACOG poster presentation.
AUSTIN, TEXAS – , as compared with the same time period 1 year earlier, Aparna Sridhar, MD, reported.
Mr. Trump’s campaign promise to repeal and replace the Affordable Care Act in the first 100 days of his presidency sparked concern in many young women that they would lose access to copay-free contraception. Therefore, based on news reports and data released by insurer AthenaHealth that noted a 19% increase in IUD insertion nationally between October and December 2016, Dr. Sridhar and her colleagues at the University of California, Los Angeles, retrospectively reviewed data on students requesting insertion of a long-acting contraceptive (LARC) at the university’s student health center in the 2 months before and after the 2016 presidential election.
In the 8 weeks prior to the November election, the UCLA doctors inserted 53 LARCs, the majority of which were levonorgestrel-releasing intrauterine systems. In the 8 weeks after the election, that number jumped to 118 insertions, a 123% increase (P = .02), again with a preponderance of hormonal IUDs. There was no statistically significant difference in insertions in the same 2 time periods in 2015, said Dr. Sridhar, of the UCLA department of obstetrics and gynecology.
The investigators also looked at whether the increase they saw could be related to the common year-end practice of maximizing health insurance benefits and found a significant increase in LARC insertions from 2015 to 2016, she added.
She noted that the team continues to monitor LARC insertions to look for additional behavior patterns.
Dr. Sridhar disclosed no financial conflicts of interest related to her presentation.
SOURCE: Sridhar, A et al. ACOG poster presentation.
REPORTING FROM ACOG 2018
Key clinical point: College students actively sought to maintain access to copay-free contraception.
Major finding: LARC insertions increased 123% from July 2016 to February 2017.
Study details: Retrospective review of all LARC insertions at one student health center in 2016.
Disclosures: Dr. Sridhar disclosed no financial conflicts of interest related to her presentation.
Source: Sridhar, A et al. ACOG poster presentation.
CHMP recommends approval for generic carmustine
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Carmustine Obvius, a generic version of Carmubris.
The CHMP is recommending marketing authorization for Carmustine Obvius as second-line treatment for Hodgkin and non-Hodgkin lymphoma as well as to treat new or recurrent brain tumors, including glioblastoma, medulloblastoma, astrocytoma, and metastatic brain tumors.
The CHMP’s opinion on Carmustine Obvius will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP’s recommendation, the commission will grant a centralized marketing authorization that will be valid in the European Union.
The EC typically makes a decision on a product within 67 days of the CHMP’s recommendation.
If approved, Carmustine Obvius will be available as a 100 mg powder and solvent for solution for infusion.
The active substance of Carmustine Obvius is carmustine, an alkylating antineoplastic agent of the nitrosourea type, which prevents DNA replication and transcription by alkylating reactive sites on nucleoproteins.
Carmustine Obvius is a generic of Carmubris, which has been authorized in the European Union since July 31, 1996.
Since Carmustine Obvius is administered intravenously and is 100% bioavailable, a bioequivalence study of the drug versus Carmubris was not required.
Carmustine Obvius is a product of Obvius Investment B.V.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Carmustine Obvius, a generic version of Carmubris.
The CHMP is recommending marketing authorization for Carmustine Obvius as second-line treatment for Hodgkin and non-Hodgkin lymphoma as well as to treat new or recurrent brain tumors, including glioblastoma, medulloblastoma, astrocytoma, and metastatic brain tumors.
The CHMP’s opinion on Carmustine Obvius will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP’s recommendation, the commission will grant a centralized marketing authorization that will be valid in the European Union.
The EC typically makes a decision on a product within 67 days of the CHMP’s recommendation.
If approved, Carmustine Obvius will be available as a 100 mg powder and solvent for solution for infusion.
The active substance of Carmustine Obvius is carmustine, an alkylating antineoplastic agent of the nitrosourea type, which prevents DNA replication and transcription by alkylating reactive sites on nucleoproteins.
Carmustine Obvius is a generic of Carmubris, which has been authorized in the European Union since July 31, 1996.
Since Carmustine Obvius is administered intravenously and is 100% bioavailable, a bioequivalence study of the drug versus Carmubris was not required.
Carmustine Obvius is a product of Obvius Investment B.V.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Carmustine Obvius, a generic version of Carmubris.
The CHMP is recommending marketing authorization for Carmustine Obvius as second-line treatment for Hodgkin and non-Hodgkin lymphoma as well as to treat new or recurrent brain tumors, including glioblastoma, medulloblastoma, astrocytoma, and metastatic brain tumors.
The CHMP’s opinion on Carmustine Obvius will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP’s recommendation, the commission will grant a centralized marketing authorization that will be valid in the European Union.
The EC typically makes a decision on a product within 67 days of the CHMP’s recommendation.
If approved, Carmustine Obvius will be available as a 100 mg powder and solvent for solution for infusion.
The active substance of Carmustine Obvius is carmustine, an alkylating antineoplastic agent of the nitrosourea type, which prevents DNA replication and transcription by alkylating reactive sites on nucleoproteins.
Carmustine Obvius is a generic of Carmubris, which has been authorized in the European Union since July 31, 1996.
Since Carmustine Obvius is administered intravenously and is 100% bioavailable, a bioequivalence study of the drug versus Carmubris was not required.
Carmustine Obvius is a product of Obvius Investment B.V.