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Maternal Weight Impacts Childhood Asthma

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Researchers find that extremely high and low weight gains during pregnancy may have an association with the child’s development of asthma.

Extreme weight gain during pregnancy may contribute to  risk factors for early childhood asthma, say researchers from University of South Carolina. They found obesity nearly doubled a woman’s chances of having a child who developed asthma by age 4. Extreme-low weight gain (<5 kg) and extreme-high weight gain (≥25 kg) were both associated with increased risk of asthma.

At 9 months, 2 years, and 4 years, 5%, 8%, and 12% of children, respectively, were diagnosed with asthma. Overall, 15% of children were diagnosed with asthma by age 4. Every 1.0 unit increase in maternal body mass index was associated with increased odds of asthma in children.

Childhood asthma already is believed to have inutero origins, the researchers say. They cite a study that found 40% of children with a diagnosis of asthma by age 7 had reduced airflow and bronchial responsiveness as neonates. Research suggests that maternal weight and gestational weight gain may change the intrauterine environment and affect the development of asthma.

The researchers say, to their knowledge, no studies have examined the association between gestational weight gain and asthma in offspring in a nationally representative sample of children in the U.S. Moreover, previous studies did not account for gestational age, which can affect the amount of weight gained.

Although the researchers note that no single risk factor can entirely account for childhood asthma, maternal obesity is one that is modifiable.

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Researchers find that extremely high and low weight gains during pregnancy may have an association with the child’s development of asthma.
Researchers find that extremely high and low weight gains during pregnancy may have an association with the child’s development of asthma.

Extreme weight gain during pregnancy may contribute to  risk factors for early childhood asthma, say researchers from University of South Carolina. They found obesity nearly doubled a woman’s chances of having a child who developed asthma by age 4. Extreme-low weight gain (<5 kg) and extreme-high weight gain (≥25 kg) were both associated with increased risk of asthma.

At 9 months, 2 years, and 4 years, 5%, 8%, and 12% of children, respectively, were diagnosed with asthma. Overall, 15% of children were diagnosed with asthma by age 4. Every 1.0 unit increase in maternal body mass index was associated with increased odds of asthma in children.

Childhood asthma already is believed to have inutero origins, the researchers say. They cite a study that found 40% of children with a diagnosis of asthma by age 7 had reduced airflow and bronchial responsiveness as neonates. Research suggests that maternal weight and gestational weight gain may change the intrauterine environment and affect the development of asthma.

The researchers say, to their knowledge, no studies have examined the association between gestational weight gain and asthma in offspring in a nationally representative sample of children in the U.S. Moreover, previous studies did not account for gestational age, which can affect the amount of weight gained.

Although the researchers note that no single risk factor can entirely account for childhood asthma, maternal obesity is one that is modifiable.

Extreme weight gain during pregnancy may contribute to  risk factors for early childhood asthma, say researchers from University of South Carolina. They found obesity nearly doubled a woman’s chances of having a child who developed asthma by age 4. Extreme-low weight gain (<5 kg) and extreme-high weight gain (≥25 kg) were both associated with increased risk of asthma.

At 9 months, 2 years, and 4 years, 5%, 8%, and 12% of children, respectively, were diagnosed with asthma. Overall, 15% of children were diagnosed with asthma by age 4. Every 1.0 unit increase in maternal body mass index was associated with increased odds of asthma in children.

Childhood asthma already is believed to have inutero origins, the researchers say. They cite a study that found 40% of children with a diagnosis of asthma by age 7 had reduced airflow and bronchial responsiveness as neonates. Research suggests that maternal weight and gestational weight gain may change the intrauterine environment and affect the development of asthma.

The researchers say, to their knowledge, no studies have examined the association between gestational weight gain and asthma in offspring in a nationally representative sample of children in the U.S. Moreover, previous studies did not account for gestational age, which can affect the amount of weight gained.

Although the researchers note that no single risk factor can entirely account for childhood asthma, maternal obesity is one that is modifiable.

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Rare neurological complication linked to Waldenstrom disease

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Waldenstrom disease, also known as Waldenstrom macroglobulinemia, has been linked to a rare bilateral facial nerve palsy in a second case report.

Bilateral facial nerve palsy has been associated with underlying Waldenstrom disease in only one other known published case report, which was published in 2014. In a more recent case report published in the Journal of Clinical Neuroscience, Gabriel Torrealba-Acosta, MD, and colleagues in the department of neurology at Massachusetts General Hospital, Boston, described a second case involving a 67-year-old Hispanic man with a history of Waldenstrom disease who presented with subacute onset of bilateral facial weakness.

Michail Charakidis, David Joseph Russell/Wikimedia Commons/CC BY 2.0
Waldenstrom disease
“No alternate etiology for the facial weakness was identified after a thorough diagnostic approach,” they wrote.

The patient, who had longstanding painful neuropathy, had presented to urgent care with a new-onset left facial nerve palsy, was then diagnosed with left Bell’s palsy, and began treatment with valacyclovir and prednisone.

The left-sided facial weakness gradually progressed to total paralysis of the left lower face and inability to close the left eye, and 2 weeks later, he developed right facial weakness that ran a similar course. The patient had a complicated clinical course that included symptomatic acute-on-chronic subdural hematoma, among other complications; eventually the patient’s symptoms stabilized and cranial neuropathies gradually improved, according to the report.

Bilateral facial nerve palsy is an extremely rare condition, occurring in just 0.3%-2% of all facial nerve palsy cases, according to the authors. By contrast, unilateral facial nerve palsy (or Bell’s palsy) is far more common, but it still occurs in only 25 patients per 100,000 population, they said.

Most cases of bilateral facial nerve palsy are caused by underlying Guillain-Barré syndrome, though some are congenital, related to trauma, or caused by etiologies that are metabolic, immunologic, or neoplastic in nature. While various types of neurological disturbances – from ischemic and hemorrhagic events to meningoencephalitis – have been documented to occur in up to a quarter of patients with Waldenstrom disease.

“Given the large differential that comprises the assessment of a bilateral facial nerve palsy, it warrants for an extensive work-up, and Waldenstrom’s macroglobulinemia should be sought as an additional possible etiology,” the authors wrote.

Dr. Torrealba-Acosta and coauthors reported having no financial disclosures.

SOURCE: Torrealba-Acosta G et al. J Clin Neurosci. 2017. doi: 10.1016/j.jocn.2017.10.081.

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Waldenstrom disease, also known as Waldenstrom macroglobulinemia, has been linked to a rare bilateral facial nerve palsy in a second case report.

Bilateral facial nerve palsy has been associated with underlying Waldenstrom disease in only one other known published case report, which was published in 2014. In a more recent case report published in the Journal of Clinical Neuroscience, Gabriel Torrealba-Acosta, MD, and colleagues in the department of neurology at Massachusetts General Hospital, Boston, described a second case involving a 67-year-old Hispanic man with a history of Waldenstrom disease who presented with subacute onset of bilateral facial weakness.

Michail Charakidis, David Joseph Russell/Wikimedia Commons/CC BY 2.0
Waldenstrom disease
“No alternate etiology for the facial weakness was identified after a thorough diagnostic approach,” they wrote.

The patient, who had longstanding painful neuropathy, had presented to urgent care with a new-onset left facial nerve palsy, was then diagnosed with left Bell’s palsy, and began treatment with valacyclovir and prednisone.

The left-sided facial weakness gradually progressed to total paralysis of the left lower face and inability to close the left eye, and 2 weeks later, he developed right facial weakness that ran a similar course. The patient had a complicated clinical course that included symptomatic acute-on-chronic subdural hematoma, among other complications; eventually the patient’s symptoms stabilized and cranial neuropathies gradually improved, according to the report.

Bilateral facial nerve palsy is an extremely rare condition, occurring in just 0.3%-2% of all facial nerve palsy cases, according to the authors. By contrast, unilateral facial nerve palsy (or Bell’s palsy) is far more common, but it still occurs in only 25 patients per 100,000 population, they said.

Most cases of bilateral facial nerve palsy are caused by underlying Guillain-Barré syndrome, though some are congenital, related to trauma, or caused by etiologies that are metabolic, immunologic, or neoplastic in nature. While various types of neurological disturbances – from ischemic and hemorrhagic events to meningoencephalitis – have been documented to occur in up to a quarter of patients with Waldenstrom disease.

“Given the large differential that comprises the assessment of a bilateral facial nerve palsy, it warrants for an extensive work-up, and Waldenstrom’s macroglobulinemia should be sought as an additional possible etiology,” the authors wrote.

Dr. Torrealba-Acosta and coauthors reported having no financial disclosures.

SOURCE: Torrealba-Acosta G et al. J Clin Neurosci. 2017. doi: 10.1016/j.jocn.2017.10.081.

 

Waldenstrom disease, also known as Waldenstrom macroglobulinemia, has been linked to a rare bilateral facial nerve palsy in a second case report.

Bilateral facial nerve palsy has been associated with underlying Waldenstrom disease in only one other known published case report, which was published in 2014. In a more recent case report published in the Journal of Clinical Neuroscience, Gabriel Torrealba-Acosta, MD, and colleagues in the department of neurology at Massachusetts General Hospital, Boston, described a second case involving a 67-year-old Hispanic man with a history of Waldenstrom disease who presented with subacute onset of bilateral facial weakness.

Michail Charakidis, David Joseph Russell/Wikimedia Commons/CC BY 2.0
Waldenstrom disease
“No alternate etiology for the facial weakness was identified after a thorough diagnostic approach,” they wrote.

The patient, who had longstanding painful neuropathy, had presented to urgent care with a new-onset left facial nerve palsy, was then diagnosed with left Bell’s palsy, and began treatment with valacyclovir and prednisone.

The left-sided facial weakness gradually progressed to total paralysis of the left lower face and inability to close the left eye, and 2 weeks later, he developed right facial weakness that ran a similar course. The patient had a complicated clinical course that included symptomatic acute-on-chronic subdural hematoma, among other complications; eventually the patient’s symptoms stabilized and cranial neuropathies gradually improved, according to the report.

Bilateral facial nerve palsy is an extremely rare condition, occurring in just 0.3%-2% of all facial nerve palsy cases, according to the authors. By contrast, unilateral facial nerve palsy (or Bell’s palsy) is far more common, but it still occurs in only 25 patients per 100,000 population, they said.

Most cases of bilateral facial nerve palsy are caused by underlying Guillain-Barré syndrome, though some are congenital, related to trauma, or caused by etiologies that are metabolic, immunologic, or neoplastic in nature. While various types of neurological disturbances – from ischemic and hemorrhagic events to meningoencephalitis – have been documented to occur in up to a quarter of patients with Waldenstrom disease.

“Given the large differential that comprises the assessment of a bilateral facial nerve palsy, it warrants for an extensive work-up, and Waldenstrom’s macroglobulinemia should be sought as an additional possible etiology,” the authors wrote.

Dr. Torrealba-Acosta and coauthors reported having no financial disclosures.

SOURCE: Torrealba-Acosta G et al. J Clin Neurosci. 2017. doi: 10.1016/j.jocn.2017.10.081.

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Rituximab may be best choice for splenic MZL

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For patients with splenic marginal zone lymphoma (MZL) requiring treatment, rituximab may be a superior choice, compared with splenectomy, according to authors of a recent review article.

Although treatment with splenectomy and rituximab both are associated with high rates of 10-year survival, splenectomy also is associated with acute surgical complications and late toxicities, mainly from infections, Christina Kalpadakis, MD, of the department of hematology at Heraklion University Hospital, University of Crete, Greece, reported in Best Practice & Research Clinical Haematology.

The review article aims to answer the question of whether rituximab monotherapy should replace splenectomy as the treatment of choice, according to the authors, who said treatment for this rare, low-grade B-cell lymphoma has not been standardized due to a lack of large, randomized trials.

Asymptomatic splenic MZL without significant cytopenias can be managed with a watch-and-wait approach, but when treatment is warranted, the choice is often between splenectomy, rituximab monotherapy, or chemoimmunotherapy.

“Based on the existing retrospective series of patients, rituximab monotherapy appears to be the best choice since it combines high efficacy with the lowest toxicity,” Dr. Kalpadakis and her colleagues wrote.

Until the early 2000s, splenectomy was the standard treatment modality for splenic MZL, offering quick amelioration of symptoms related to splenomegaly in more than 90% of patients, as well as improvements in hypersplenism-related cytopenias, the researchers reported. Among 100 patients with splenic MZL, the median progression-free survival with splenectomy was 8.25 years, and median 10-year overall survival was 67%.

However, responses to splenectomy are not complete because some patients are not good candidates for splenectomy, including those with lymphadenopathy or heavy bone marrow infiltration, according to the authors. Moreover, since it is a major surgical procedure that can be associated with complications and infections, splenectomy is not appropriate for elderly patients or patients with comorbidities with a high surgical risk, they wrote.

“Furthermore, splenectomy cannot eradicate bone marrow disease and has no impact on other extrasplenic disease localization such as lymphadenopathy,” they added.

Rituximab monotherapy, by contrast, has “minimal toxicity” with high efficacy, including complete response rates of around 50% and a 10-year overall survival of 85% reported in a series of 104 patients.

Maintenance with rituximab may further improve the quality of responses, although data are limited. One study, conducted by the review article authors, showed that rituximab maintenance increased the complete response rate from 42% after induction treatment to 71% after maintenance, along with a significant improvement in response duration, though no differences in overall survival have been observed thus far.

Rituximab plus chemotherapy has been evaluated, but with “significant toxicity without improvement in the outcome” versus rituximab monotherapy, the researchers wrote. Splenectomy is “effective” but should be reserved for patients refractory to rituximab, Dr. Kalpadakis and her colleagues wrote.

The researchers reported having no relevant financial disclosures.

SOURCE: Kalpadakis C et al. Best Pract Res Clin Haematol. Mar-Jun 2017. doi:10.1016/j.beha.2017.10.011.

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For patients with splenic marginal zone lymphoma (MZL) requiring treatment, rituximab may be a superior choice, compared with splenectomy, according to authors of a recent review article.

Although treatment with splenectomy and rituximab both are associated with high rates of 10-year survival, splenectomy also is associated with acute surgical complications and late toxicities, mainly from infections, Christina Kalpadakis, MD, of the department of hematology at Heraklion University Hospital, University of Crete, Greece, reported in Best Practice & Research Clinical Haematology.

The review article aims to answer the question of whether rituximab monotherapy should replace splenectomy as the treatment of choice, according to the authors, who said treatment for this rare, low-grade B-cell lymphoma has not been standardized due to a lack of large, randomized trials.

Asymptomatic splenic MZL without significant cytopenias can be managed with a watch-and-wait approach, but when treatment is warranted, the choice is often between splenectomy, rituximab monotherapy, or chemoimmunotherapy.

“Based on the existing retrospective series of patients, rituximab monotherapy appears to be the best choice since it combines high efficacy with the lowest toxicity,” Dr. Kalpadakis and her colleagues wrote.

Until the early 2000s, splenectomy was the standard treatment modality for splenic MZL, offering quick amelioration of symptoms related to splenomegaly in more than 90% of patients, as well as improvements in hypersplenism-related cytopenias, the researchers reported. Among 100 patients with splenic MZL, the median progression-free survival with splenectomy was 8.25 years, and median 10-year overall survival was 67%.

However, responses to splenectomy are not complete because some patients are not good candidates for splenectomy, including those with lymphadenopathy or heavy bone marrow infiltration, according to the authors. Moreover, since it is a major surgical procedure that can be associated with complications and infections, splenectomy is not appropriate for elderly patients or patients with comorbidities with a high surgical risk, they wrote.

“Furthermore, splenectomy cannot eradicate bone marrow disease and has no impact on other extrasplenic disease localization such as lymphadenopathy,” they added.

Rituximab monotherapy, by contrast, has “minimal toxicity” with high efficacy, including complete response rates of around 50% and a 10-year overall survival of 85% reported in a series of 104 patients.

Maintenance with rituximab may further improve the quality of responses, although data are limited. One study, conducted by the review article authors, showed that rituximab maintenance increased the complete response rate from 42% after induction treatment to 71% after maintenance, along with a significant improvement in response duration, though no differences in overall survival have been observed thus far.

Rituximab plus chemotherapy has been evaluated, but with “significant toxicity without improvement in the outcome” versus rituximab monotherapy, the researchers wrote. Splenectomy is “effective” but should be reserved for patients refractory to rituximab, Dr. Kalpadakis and her colleagues wrote.

The researchers reported having no relevant financial disclosures.

SOURCE: Kalpadakis C et al. Best Pract Res Clin Haematol. Mar-Jun 2017. doi:10.1016/j.beha.2017.10.011.

 

For patients with splenic marginal zone lymphoma (MZL) requiring treatment, rituximab may be a superior choice, compared with splenectomy, according to authors of a recent review article.

Although treatment with splenectomy and rituximab both are associated with high rates of 10-year survival, splenectomy also is associated with acute surgical complications and late toxicities, mainly from infections, Christina Kalpadakis, MD, of the department of hematology at Heraklion University Hospital, University of Crete, Greece, reported in Best Practice & Research Clinical Haematology.

The review article aims to answer the question of whether rituximab monotherapy should replace splenectomy as the treatment of choice, according to the authors, who said treatment for this rare, low-grade B-cell lymphoma has not been standardized due to a lack of large, randomized trials.

Asymptomatic splenic MZL without significant cytopenias can be managed with a watch-and-wait approach, but when treatment is warranted, the choice is often between splenectomy, rituximab monotherapy, or chemoimmunotherapy.

“Based on the existing retrospective series of patients, rituximab monotherapy appears to be the best choice since it combines high efficacy with the lowest toxicity,” Dr. Kalpadakis and her colleagues wrote.

Until the early 2000s, splenectomy was the standard treatment modality for splenic MZL, offering quick amelioration of symptoms related to splenomegaly in more than 90% of patients, as well as improvements in hypersplenism-related cytopenias, the researchers reported. Among 100 patients with splenic MZL, the median progression-free survival with splenectomy was 8.25 years, and median 10-year overall survival was 67%.

However, responses to splenectomy are not complete because some patients are not good candidates for splenectomy, including those with lymphadenopathy or heavy bone marrow infiltration, according to the authors. Moreover, since it is a major surgical procedure that can be associated with complications and infections, splenectomy is not appropriate for elderly patients or patients with comorbidities with a high surgical risk, they wrote.

“Furthermore, splenectomy cannot eradicate bone marrow disease and has no impact on other extrasplenic disease localization such as lymphadenopathy,” they added.

Rituximab monotherapy, by contrast, has “minimal toxicity” with high efficacy, including complete response rates of around 50% and a 10-year overall survival of 85% reported in a series of 104 patients.

Maintenance with rituximab may further improve the quality of responses, although data are limited. One study, conducted by the review article authors, showed that rituximab maintenance increased the complete response rate from 42% after induction treatment to 71% after maintenance, along with a significant improvement in response duration, though no differences in overall survival have been observed thus far.

Rituximab plus chemotherapy has been evaluated, but with “significant toxicity without improvement in the outcome” versus rituximab monotherapy, the researchers wrote. Splenectomy is “effective” but should be reserved for patients refractory to rituximab, Dr. Kalpadakis and her colleagues wrote.

The researchers reported having no relevant financial disclosures.

SOURCE: Kalpadakis C et al. Best Pract Res Clin Haematol. Mar-Jun 2017. doi:10.1016/j.beha.2017.10.011.

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FROM BEST PRACTICE & RESEARCH CLINICAL HAEMATOLOGY

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Key clinical point: Rituximab appears to be a better option than is splenectomy when treating splenic marginal zone lymphoma.

Major finding: Both splenectomy and rituximab are associated with high rates of 10-year overalls survival, but splenectomy has higher rates of surgical complications and infection.

Study details: Review article of 63 publications, mostly retrospective studies of marginal zone lymphoma.

Disclosures: The researchers reported having no relevant financial disclosures.

Source: Kalpadakis C et al. Best Pract Res Clin Haematol. 2017 Mar-Jun. doi:10.1016/j.beha.2017.10.011.

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Who’s Smoking What?

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A survey by the CDC and FDA reports on the demographics of smokers and the rate at which they use tobacco.

About 1 in 5 U.S. adults used tobacco in 2015 every day or on some days, according to the CDC and the FDA. The most common tobacco product was cigarettes (15%). About 9.5 million adults used ≥ 2 tobacco products.

This is the first time the CDC and FDA have used the National Health Interview Survey to assess the range of tobacco products used. Survey questions asked about current cigarette smoking since 1965, but only recently began to track other tobacco products.

About 42 million adults, or > 87% of the nearly 49 million tobacco product users in the U.S., reported using cigarettes, cigars, or pipes; the remaining tobacco users reported using e-cigarettes or smokeless tobacco products (eg, chewing tobacco and snuff).

The survey also found that men were more likely than women to use tobacco products (25% vs 15%). Adults aged 25 to 44 years were more likely than those aged ≥ 65 years to use tobacco products (23% vs 11%). By race and ethnicity, tobacco product use ranged from 9% among Asians to 27% among American Indians/Alaska Natives.

Using tobacco products was more common among adults in the Midwest; people with annual incomes less than $35,000; the uninsured or Medicaid insured; those with a disability; and those who are lesbian, gay, or bisexual. Adults with serious psychological distress were more than 2 times as likely to use tobacco as those who reported no serious psychological distress (47% vs 19%).

Cigarette smoking remains the leading preventable cause of death and disease in the U.S. The CDC urges full implementation of comprehensive state tobacco control programs along with FDA regulation of tobacco products and targeted interventions to reach subpopulations with the greatest burden of use.

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A survey by the CDC and FDA reports on the demographics of smokers and the rate at which they use tobacco.
A survey by the CDC and FDA reports on the demographics of smokers and the rate at which they use tobacco.

About 1 in 5 U.S. adults used tobacco in 2015 every day or on some days, according to the CDC and the FDA. The most common tobacco product was cigarettes (15%). About 9.5 million adults used ≥ 2 tobacco products.

This is the first time the CDC and FDA have used the National Health Interview Survey to assess the range of tobacco products used. Survey questions asked about current cigarette smoking since 1965, but only recently began to track other tobacco products.

About 42 million adults, or > 87% of the nearly 49 million tobacco product users in the U.S., reported using cigarettes, cigars, or pipes; the remaining tobacco users reported using e-cigarettes or smokeless tobacco products (eg, chewing tobacco and snuff).

The survey also found that men were more likely than women to use tobacco products (25% vs 15%). Adults aged 25 to 44 years were more likely than those aged ≥ 65 years to use tobacco products (23% vs 11%). By race and ethnicity, tobacco product use ranged from 9% among Asians to 27% among American Indians/Alaska Natives.

Using tobacco products was more common among adults in the Midwest; people with annual incomes less than $35,000; the uninsured or Medicaid insured; those with a disability; and those who are lesbian, gay, or bisexual. Adults with serious psychological distress were more than 2 times as likely to use tobacco as those who reported no serious psychological distress (47% vs 19%).

Cigarette smoking remains the leading preventable cause of death and disease in the U.S. The CDC urges full implementation of comprehensive state tobacco control programs along with FDA regulation of tobacco products and targeted interventions to reach subpopulations with the greatest burden of use.

About 1 in 5 U.S. adults used tobacco in 2015 every day or on some days, according to the CDC and the FDA. The most common tobacco product was cigarettes (15%). About 9.5 million adults used ≥ 2 tobacco products.

This is the first time the CDC and FDA have used the National Health Interview Survey to assess the range of tobacco products used. Survey questions asked about current cigarette smoking since 1965, but only recently began to track other tobacco products.

About 42 million adults, or > 87% of the nearly 49 million tobacco product users in the U.S., reported using cigarettes, cigars, or pipes; the remaining tobacco users reported using e-cigarettes or smokeless tobacco products (eg, chewing tobacco and snuff).

The survey also found that men were more likely than women to use tobacco products (25% vs 15%). Adults aged 25 to 44 years were more likely than those aged ≥ 65 years to use tobacco products (23% vs 11%). By race and ethnicity, tobacco product use ranged from 9% among Asians to 27% among American Indians/Alaska Natives.

Using tobacco products was more common among adults in the Midwest; people with annual incomes less than $35,000; the uninsured or Medicaid insured; those with a disability; and those who are lesbian, gay, or bisexual. Adults with serious psychological distress were more than 2 times as likely to use tobacco as those who reported no serious psychological distress (47% vs 19%).

Cigarette smoking remains the leading preventable cause of death and disease in the U.S. The CDC urges full implementation of comprehensive state tobacco control programs along with FDA regulation of tobacco products and targeted interventions to reach subpopulations with the greatest burden of use.

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VIDEO - New lymphoma drug approvals: Clinical use, future directions

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– 2017 was a banner year for the approval of new drugs to treat hematologic disorders.

At a special interest session at the annual meeting of American Society of Hematology, representatives from the Food and Drug Administration joined forces with clinicians to discuss the use of the newly approved treatments in the real-world setting.

In this video interview, Helen Heslop, MD, provided her perspective on the current use and future directions of three of these treatments: axicabtagene ciloleucel (Yescarta), acalabrutinib (Calquence), and copanlisib (Aliqopa).

“This is extremely exciting,” she said regarding the pace of new approvals for hematologic malignancies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


Axicabtagene ciloleucel, a CAR T-cell product approved in October for the treatment of relapsed/refractory large B-cell lymphoma in adults, is particularly interesting, she said.

“The data shows that if you look at a population of diffuse large B-cell lymphoma patients, that historically have a very poor outcome, there is definitely an impressive response rate and improved survival, compared to the natural history cohort,” said Dr. Heslop of Baylor College of Medicine, Houston.

However, while the findings are encouraging, only 30%-40% are having a durable response, she added.

“So I think there’ll be lots of efforts to try and improve the response rate by combination with other agents such as checkpoint inhibitors or other immunomodulators,” she said.

With respect to the second-generation Bruton’s tyrosine kinase inhibitor acalabrutinib, which was approved in October for adults with mantle cell lymphoma who have been treated with at least one prior therapy, she discussed the potential for improved outcomes and the importance of looking further into its use in patients who have failed ibrutinib therapy, as well as its use in combination with other agents, such as bendamustine and rituximab early in the course of disease.

Copanlisib, a PI3 kinase inhibitor approved in September, is an addition to the armamentarium for adult patients with relapsed follicular lymphoma after two lines of previous therapy.

“It still does have some side effects, as do other drugs in this class, so I think it’s place will still need to be defined,” Dr. Heslop said.

She reported having no relevant financial disclosures.

 

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– 2017 was a banner year for the approval of new drugs to treat hematologic disorders.

At a special interest session at the annual meeting of American Society of Hematology, representatives from the Food and Drug Administration joined forces with clinicians to discuss the use of the newly approved treatments in the real-world setting.

In this video interview, Helen Heslop, MD, provided her perspective on the current use and future directions of three of these treatments: axicabtagene ciloleucel (Yescarta), acalabrutinib (Calquence), and copanlisib (Aliqopa).

“This is extremely exciting,” she said regarding the pace of new approvals for hematologic malignancies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


Axicabtagene ciloleucel, a CAR T-cell product approved in October for the treatment of relapsed/refractory large B-cell lymphoma in adults, is particularly interesting, she said.

“The data shows that if you look at a population of diffuse large B-cell lymphoma patients, that historically have a very poor outcome, there is definitely an impressive response rate and improved survival, compared to the natural history cohort,” said Dr. Heslop of Baylor College of Medicine, Houston.

However, while the findings are encouraging, only 30%-40% are having a durable response, she added.

“So I think there’ll be lots of efforts to try and improve the response rate by combination with other agents such as checkpoint inhibitors or other immunomodulators,” she said.

With respect to the second-generation Bruton’s tyrosine kinase inhibitor acalabrutinib, which was approved in October for adults with mantle cell lymphoma who have been treated with at least one prior therapy, she discussed the potential for improved outcomes and the importance of looking further into its use in patients who have failed ibrutinib therapy, as well as its use in combination with other agents, such as bendamustine and rituximab early in the course of disease.

Copanlisib, a PI3 kinase inhibitor approved in September, is an addition to the armamentarium for adult patients with relapsed follicular lymphoma after two lines of previous therapy.

“It still does have some side effects, as do other drugs in this class, so I think it’s place will still need to be defined,” Dr. Heslop said.

She reported having no relevant financial disclosures.

 

 

– 2017 was a banner year for the approval of new drugs to treat hematologic disorders.

At a special interest session at the annual meeting of American Society of Hematology, representatives from the Food and Drug Administration joined forces with clinicians to discuss the use of the newly approved treatments in the real-world setting.

In this video interview, Helen Heslop, MD, provided her perspective on the current use and future directions of three of these treatments: axicabtagene ciloleucel (Yescarta), acalabrutinib (Calquence), and copanlisib (Aliqopa).

“This is extremely exciting,” she said regarding the pace of new approvals for hematologic malignancies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


Axicabtagene ciloleucel, a CAR T-cell product approved in October for the treatment of relapsed/refractory large B-cell lymphoma in adults, is particularly interesting, she said.

“The data shows that if you look at a population of diffuse large B-cell lymphoma patients, that historically have a very poor outcome, there is definitely an impressive response rate and improved survival, compared to the natural history cohort,” said Dr. Heslop of Baylor College of Medicine, Houston.

However, while the findings are encouraging, only 30%-40% are having a durable response, she added.

“So I think there’ll be lots of efforts to try and improve the response rate by combination with other agents such as checkpoint inhibitors or other immunomodulators,” she said.

With respect to the second-generation Bruton’s tyrosine kinase inhibitor acalabrutinib, which was approved in October for adults with mantle cell lymphoma who have been treated with at least one prior therapy, she discussed the potential for improved outcomes and the importance of looking further into its use in patients who have failed ibrutinib therapy, as well as its use in combination with other agents, such as bendamustine and rituximab early in the course of disease.

Copanlisib, a PI3 kinase inhibitor approved in September, is an addition to the armamentarium for adult patients with relapsed follicular lymphoma after two lines of previous therapy.

“It still does have some side effects, as do other drugs in this class, so I think it’s place will still need to be defined,” Dr. Heslop said.

She reported having no relevant financial disclosures.

 

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Higher Risk of Secondary Cancers for Patients With Mycosis Fungoides

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According to a 20-year longitudinal study, patients with mycosis fungoides have a higher risk of developing secondary solid tumors based on patient age, disease stage, and other factors.

Adult patients with mycosis fungoides (MF) have a higher risk of secondary malignancies, according to a 20-year population-based cohort study. The researchers, from Bezmialem Vakif University in Istanbul, Turkey, say their findings support earlier research about a higher risk of, for instance, Hodgkin lymphoma, chronic leukemia, and lung cancer.

Between 1998 and 2015, the researchers documented 143 cases of cutaneous T-cell lymphoma (CTCL). The majority of patients had early-stage disease.

The researchers also documented 13 cases (9%) of secondary malignancy diagnosed at least 3 months after the diagnosis of CTCL. The cancers included bladder cancer, nasopharynx cancer, renal cell carcinoma, lung cancer, and superficial spreading malignant melanoma.

Older age, stage IV disease, lymphomatoid papulosis, and having CTCL for > 10 years raised the chances of developing secondary solid tumors. In 60% of patients, the secondary malignancies occurred during the first year of diagnosis.

Research has suggested that antilymphoma drugs, particularly alkylating agents, may lead to leukemia, the researchers note. In this study, 6 patients with secondary cancers were getting systemic treatment with interferon or acitretin; 7 were getting no systemic treatment.

The researchers add that MF and hematologic malignancies may share genetic origin, carcinogens, or viruses that affect lymphocyte precursors. They also note that the first neoplasm may produce cytokines that induce development of the secondary neoplasm. The researchers cite research that found MF is a T helper cell 2–mediated disease associated with human leukocyte antigen 2 alleles. Viruses such as Epstein-Barr and herpes simplex also have been implicated.

“Extensive evaluation” for secondary malignancies in adult patients with MF is wise, the researchers advise, particularly if the patient has lymphomatoid papulosis.

Source:

Cengiz FP, Emiroğlu N, Onsun N. Turk J Haematol. 2017;34(4):378-379.

doi: 10.4274/tjh.2017.0234.

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According to a 20-year longitudinal study, patients with mycosis fungoides have a higher risk of developing secondary solid tumors based on patient age, disease stage, and other factors.
According to a 20-year longitudinal study, patients with mycosis fungoides have a higher risk of developing secondary solid tumors based on patient age, disease stage, and other factors.

Adult patients with mycosis fungoides (MF) have a higher risk of secondary malignancies, according to a 20-year population-based cohort study. The researchers, from Bezmialem Vakif University in Istanbul, Turkey, say their findings support earlier research about a higher risk of, for instance, Hodgkin lymphoma, chronic leukemia, and lung cancer.

Between 1998 and 2015, the researchers documented 143 cases of cutaneous T-cell lymphoma (CTCL). The majority of patients had early-stage disease.

The researchers also documented 13 cases (9%) of secondary malignancy diagnosed at least 3 months after the diagnosis of CTCL. The cancers included bladder cancer, nasopharynx cancer, renal cell carcinoma, lung cancer, and superficial spreading malignant melanoma.

Older age, stage IV disease, lymphomatoid papulosis, and having CTCL for > 10 years raised the chances of developing secondary solid tumors. In 60% of patients, the secondary malignancies occurred during the first year of diagnosis.

Research has suggested that antilymphoma drugs, particularly alkylating agents, may lead to leukemia, the researchers note. In this study, 6 patients with secondary cancers were getting systemic treatment with interferon or acitretin; 7 were getting no systemic treatment.

The researchers add that MF and hematologic malignancies may share genetic origin, carcinogens, or viruses that affect lymphocyte precursors. They also note that the first neoplasm may produce cytokines that induce development of the secondary neoplasm. The researchers cite research that found MF is a T helper cell 2–mediated disease associated with human leukocyte antigen 2 alleles. Viruses such as Epstein-Barr and herpes simplex also have been implicated.

“Extensive evaluation” for secondary malignancies in adult patients with MF is wise, the researchers advise, particularly if the patient has lymphomatoid papulosis.

Source:

Cengiz FP, Emiroğlu N, Onsun N. Turk J Haematol. 2017;34(4):378-379.

doi: 10.4274/tjh.2017.0234.

Adult patients with mycosis fungoides (MF) have a higher risk of secondary malignancies, according to a 20-year population-based cohort study. The researchers, from Bezmialem Vakif University in Istanbul, Turkey, say their findings support earlier research about a higher risk of, for instance, Hodgkin lymphoma, chronic leukemia, and lung cancer.

Between 1998 and 2015, the researchers documented 143 cases of cutaneous T-cell lymphoma (CTCL). The majority of patients had early-stage disease.

The researchers also documented 13 cases (9%) of secondary malignancy diagnosed at least 3 months after the diagnosis of CTCL. The cancers included bladder cancer, nasopharynx cancer, renal cell carcinoma, lung cancer, and superficial spreading malignant melanoma.

Older age, stage IV disease, lymphomatoid papulosis, and having CTCL for > 10 years raised the chances of developing secondary solid tumors. In 60% of patients, the secondary malignancies occurred during the first year of diagnosis.

Research has suggested that antilymphoma drugs, particularly alkylating agents, may lead to leukemia, the researchers note. In this study, 6 patients with secondary cancers were getting systemic treatment with interferon or acitretin; 7 were getting no systemic treatment.

The researchers add that MF and hematologic malignancies may share genetic origin, carcinogens, or viruses that affect lymphocyte precursors. They also note that the first neoplasm may produce cytokines that induce development of the secondary neoplasm. The researchers cite research that found MF is a T helper cell 2–mediated disease associated with human leukocyte antigen 2 alleles. Viruses such as Epstein-Barr and herpes simplex also have been implicated.

“Extensive evaluation” for secondary malignancies in adult patients with MF is wise, the researchers advise, particularly if the patient has lymphomatoid papulosis.

Source:

Cengiz FP, Emiroğlu N, Onsun N. Turk J Haematol. 2017;34(4):378-379.

doi: 10.4274/tjh.2017.0234.

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VIDEO: Ibrutinib PFS is nearly 3 years in MCL patients who had one prior therapy

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– Ibrutinib yielded a median progression-free survival (PFS) of nearly 3 years for patients with relapsed or refractory mantle cell lymphoma (MCL) treated with the agent after just one prior line of therapy, according to pooled long-term follow-up data presented at the annual meeting of the American Society of Hematology.

SOURCE: Rule S et al. ASH 2017 Abstract 151.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– Ibrutinib yielded a median progression-free survival (PFS) of nearly 3 years for patients with relapsed or refractory mantle cell lymphoma (MCL) treated with the agent after just one prior line of therapy, according to pooled long-term follow-up data presented at the annual meeting of the American Society of Hematology.

SOURCE: Rule S et al. ASH 2017 Abstract 151.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Ibrutinib yielded a median progression-free survival (PFS) of nearly 3 years for patients with relapsed or refractory mantle cell lymphoma (MCL) treated with the agent after just one prior line of therapy, according to pooled long-term follow-up data presented at the annual meeting of the American Society of Hematology.

SOURCE: Rule S et al. ASH 2017 Abstract 151.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Key clinical point: In relapsed/refractory mantle cell lymphoma, median PFS with ibrutinib was nearly 3 years in patients with one prior line of therapy.

Major finding: Median PFS was 33.6 months for MCL patients with one prior line of therapy, versus 8.4 months for patients who had two or more prior lines of therapy.

Study details: A pooled analysis of 370 patients enrolled in ibrutinib clinical trials with a median 3.5-year follow-up.

Disclosures: Janssen sponsored the research and Janssen Global Services funded writing assistance. Lead author Simon Rule, MD, reported financial relationships with Janssen and several other companies.

Source: Rule S et al. ASH 2017 Abstract 151.

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A Nondrug Way to Relieve Withdrawal Symptoms

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A recent study showed positive results of a nondrug method for treating opioid withdrawal with electrical stimulation in patients.

The FDA has given the nod to a new indication for the NSS-2 Bridge, an electronic device that was cleared for use in acupuncture in 2014. Now it is approved for reducing the symptoms of opioid withdrawal.

The NSS-2 Bridge is a small electrical nerve stimulator placed behind a patient’s ear. A battery-powered chip sends electrical pulses to stimulate branches of certain cranial nerves. Patients can use the device for up to 5 days during the acute phase of physical withdrawal.

The approval was based on results from a clinical study of 73 patients in withdrawal, evaluating their symptoms on the Clinical Opiate Withdrawal Scale (COWS), which measures signs and symptoms such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors, and anxiety. The COWS scores range from 0 to > 36. The higher the score, the more severe the symptoms.

Before patients used the device, their average COWS score was 20.1. Within 30 minutes, all patient scores dropped by at least 31%. Nearly all (88%) the patients transitioned to medication-assisted therapy after 5 days of using the device.

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A recent study showed positive results of a nondrug method for treating opioid withdrawal with electrical stimulation in patients.
A recent study showed positive results of a nondrug method for treating opioid withdrawal with electrical stimulation in patients.

The FDA has given the nod to a new indication for the NSS-2 Bridge, an electronic device that was cleared for use in acupuncture in 2014. Now it is approved for reducing the symptoms of opioid withdrawal.

The NSS-2 Bridge is a small electrical nerve stimulator placed behind a patient’s ear. A battery-powered chip sends electrical pulses to stimulate branches of certain cranial nerves. Patients can use the device for up to 5 days during the acute phase of physical withdrawal.

The approval was based on results from a clinical study of 73 patients in withdrawal, evaluating their symptoms on the Clinical Opiate Withdrawal Scale (COWS), which measures signs and symptoms such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors, and anxiety. The COWS scores range from 0 to > 36. The higher the score, the more severe the symptoms.

Before patients used the device, their average COWS score was 20.1. Within 30 minutes, all patient scores dropped by at least 31%. Nearly all (88%) the patients transitioned to medication-assisted therapy after 5 days of using the device.

The FDA has given the nod to a new indication for the NSS-2 Bridge, an electronic device that was cleared for use in acupuncture in 2014. Now it is approved for reducing the symptoms of opioid withdrawal.

The NSS-2 Bridge is a small electrical nerve stimulator placed behind a patient’s ear. A battery-powered chip sends electrical pulses to stimulate branches of certain cranial nerves. Patients can use the device for up to 5 days during the acute phase of physical withdrawal.

The approval was based on results from a clinical study of 73 patients in withdrawal, evaluating their symptoms on the Clinical Opiate Withdrawal Scale (COWS), which measures signs and symptoms such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors, and anxiety. The COWS scores range from 0 to > 36. The higher the score, the more severe the symptoms.

Before patients used the device, their average COWS score was 20.1. Within 30 minutes, all patient scores dropped by at least 31%. Nearly all (88%) the patients transitioned to medication-assisted therapy after 5 days of using the device.

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Nebulized LAMA for COPD approved

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The Food and Drug Administration has given the nod to the first nebulized long-acting muscarinic antagonist (LAMA) treatment for chronic obstructive pulmonary disease (COPD) in the United States.

This product, glycopyrrolate, has specifically been approved for use as a long-term maintenance treatment of air-flow obstruction in patients with COPD. Glycopyrrolate (Lonhala Magnair) utilizes the eFlow technology system, developed by Pari Pharma. This nebulizing system is portable, virtually silent, and delivers the drug in 2-3 minutes, according to a statement from Sunovion Pharmaceuticals.

“Despite the availability of several therapies, many people still struggle to control their COPD – a challenge that may be affected by the delivery method used to administer a medication,” Gary Ferguson, MD, of Michigan State University and the Pulmonary Research Institute of Southeast Michigan, both in Farmington Hills, said in a statement. “Lonhala Magnair offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique, handheld nebulizer that allows a person to breathe normally while taking their medication.”

The approval of glycopyrrolate is based on the results of the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) trials. The GOLDEN program comprised the GOLDEN-3 and GOLDEN-4 trials, both of which were phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety and efficacy trials, which compared adult glycopyrrolate patients to a placebo group with moderate to severe COPD. At 12 weeks, patients receiving treatment with glycopyrrolate showed clinical and statistically significant improvements in their baseline forced expiratory volume second (FEV1), compared with placebo.

GOLDEN-5, an additional study, followed the same criteria as previous studies, but increased its length to 48 weeks to evaluate the long-term safety and patient tolerability of glycopyrrolate. It also compared treatment of COPD with glycopyrrolate to treatment of COPD with the previously approved LAMA Spiriva (tiotropium bromide), delivered by the Handihaler device. Glycopyrrolate was well tolerated, and the overall treatment emergence of adverse events for glycopyrrolate and tiotropium bromide were similar.

Sunovion expects glycopyrrolate to be available in U.S. pharmacies in early 2018, according to the statement.

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The Food and Drug Administration has given the nod to the first nebulized long-acting muscarinic antagonist (LAMA) treatment for chronic obstructive pulmonary disease (COPD) in the United States.

This product, glycopyrrolate, has specifically been approved for use as a long-term maintenance treatment of air-flow obstruction in patients with COPD. Glycopyrrolate (Lonhala Magnair) utilizes the eFlow technology system, developed by Pari Pharma. This nebulizing system is portable, virtually silent, and delivers the drug in 2-3 minutes, according to a statement from Sunovion Pharmaceuticals.

“Despite the availability of several therapies, many people still struggle to control their COPD – a challenge that may be affected by the delivery method used to administer a medication,” Gary Ferguson, MD, of Michigan State University and the Pulmonary Research Institute of Southeast Michigan, both in Farmington Hills, said in a statement. “Lonhala Magnair offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique, handheld nebulizer that allows a person to breathe normally while taking their medication.”

The approval of glycopyrrolate is based on the results of the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) trials. The GOLDEN program comprised the GOLDEN-3 and GOLDEN-4 trials, both of which were phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety and efficacy trials, which compared adult glycopyrrolate patients to a placebo group with moderate to severe COPD. At 12 weeks, patients receiving treatment with glycopyrrolate showed clinical and statistically significant improvements in their baseline forced expiratory volume second (FEV1), compared with placebo.

GOLDEN-5, an additional study, followed the same criteria as previous studies, but increased its length to 48 weeks to evaluate the long-term safety and patient tolerability of glycopyrrolate. It also compared treatment of COPD with glycopyrrolate to treatment of COPD with the previously approved LAMA Spiriva (tiotropium bromide), delivered by the Handihaler device. Glycopyrrolate was well tolerated, and the overall treatment emergence of adverse events for glycopyrrolate and tiotropium bromide were similar.

Sunovion expects glycopyrrolate to be available in U.S. pharmacies in early 2018, according to the statement.

 

The Food and Drug Administration has given the nod to the first nebulized long-acting muscarinic antagonist (LAMA) treatment for chronic obstructive pulmonary disease (COPD) in the United States.

This product, glycopyrrolate, has specifically been approved for use as a long-term maintenance treatment of air-flow obstruction in patients with COPD. Glycopyrrolate (Lonhala Magnair) utilizes the eFlow technology system, developed by Pari Pharma. This nebulizing system is portable, virtually silent, and delivers the drug in 2-3 minutes, according to a statement from Sunovion Pharmaceuticals.

“Despite the availability of several therapies, many people still struggle to control their COPD – a challenge that may be affected by the delivery method used to administer a medication,” Gary Ferguson, MD, of Michigan State University and the Pulmonary Research Institute of Southeast Michigan, both in Farmington Hills, said in a statement. “Lonhala Magnair offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique, handheld nebulizer that allows a person to breathe normally while taking their medication.”

The approval of glycopyrrolate is based on the results of the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) trials. The GOLDEN program comprised the GOLDEN-3 and GOLDEN-4 trials, both of which were phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety and efficacy trials, which compared adult glycopyrrolate patients to a placebo group with moderate to severe COPD. At 12 weeks, patients receiving treatment with glycopyrrolate showed clinical and statistically significant improvements in their baseline forced expiratory volume second (FEV1), compared with placebo.

GOLDEN-5, an additional study, followed the same criteria as previous studies, but increased its length to 48 weeks to evaluate the long-term safety and patient tolerability of glycopyrrolate. It also compared treatment of COPD with glycopyrrolate to treatment of COPD with the previously approved LAMA Spiriva (tiotropium bromide), delivered by the Handihaler device. Glycopyrrolate was well tolerated, and the overall treatment emergence of adverse events for glycopyrrolate and tiotropium bromide were similar.

Sunovion expects glycopyrrolate to be available in U.S. pharmacies in early 2018, according to the statement.

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VTE rates in lenalidomide-treated NHL may warrant prophylaxis

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– The rate of venous thromboembolism (VTE) in patients with non-Hodgkin lymphoma (NHL) treated with lenalidomide is similar to that seen in multiple myeloma, according to results of recent systematic review and meta-analysis of trials representing more than 10,000 treatment cycles.

Although rates of VTE for NHL and myeloma could not be directly compared statistically, the finding may have clinical implications for NHL patients, said lead study author Samuel Yamshon, MD, an internal medicine resident at Cornell University, New York.

“Although outpatient VTE prophylaxis is not currently recommended, it should be carefully considered in patients with lymphoma being treated with lenalidomide, especially those receiving lenalidomide as a single agent,” Dr. Yamshon said in a presentation of the results at the annual meeting of the American Society of Hematology.

The rate of thrombosis in patients with B cell NHL who received lenalidomide treatment was 0.75 events per 100 patient-cycles, according to results of the meta-analysis, which was based on 28 articles including 10,332 cycles of lenalidomide received by patients with B-cell NHL.

Reported rates of thrombosis in previously untreated myeloma patients treated with lenalidomide are between 0.7 and 0.8 per 100 patient-cycles, Dr. Yamshon said in his presentation.

Notably, single-agent lenalidomide was linked with a significantly increased risk of thrombosis compared with lenalidomide treatment in combinations. The relative risk of VTE for lenalidomide as a single agent versus lenalidomide in combination was 2.01 (95% confidence interval, 1.28-3.16; P = .002), according to the presented data.

The investigators were unsure why single-agent lenalidomide appeared to have caused increased rates of thrombosis compared to lenalidomide in combinations. “Perhaps patients treated with additional agents have a lower tumor burden, leading to less venous obstruction causing clots, or perhaps there’s a direct interaction between lenalidomide and tumor leading to effects on the vasculature and mediators of coagulation,” Dr. Yamshon said.

Chemotherapy and biologic combinations had somewhat different VTE rates when compared to single-agent lenalidomide. The rate in patients receiving lenalidomide alone was 1.06 events per 100 patient-cycles, compared with 0.73 and 0.41 events per 100 patient-cycles, respectively, for lenalidomide plus chemotherapy and lenalidomide plus biologics.

However, the lower event rate with lenalidomide and biologics compared with lenalidomide and chemotherapy was a “nonsignificant trend” that was likely caused by differences in patient characteristics between the two cohorts, according to Dr. Yamshon.

None of the studies included in the meta-analysis were prospectively designed to measure VTE as a primary or secondary outcome, Dr. Yamshon noted in a discussion of the study’s limitations.

Further studies are warranted to determine lenalidomide’s effect on the vasculature and how it effects mediators of coagulation, he added.

Based on the current results, Dr. Yamshon said it may be reasonable to consider VTE prophylaxis in NHL patients receiving lenalidomide.

“If we’re going to be recommending outpatient VTE prophylaxis in everyone on lenalidomide in multiple myeloma, and the rates (of VTE) are the same, I think it certainly makes sense based on the data to recommend it,” he said in a question-and-answer session.

Dr. Yamshon reported no conflicts related to the study. Coauthors reported disclosures related to Roche, Celgene, Seattle Genetics, Pharmacyclics, Cell Medica, Janssen, and AstraZeneca.

SOURCE: Yamshon S et al. Abstract 677.

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– The rate of venous thromboembolism (VTE) in patients with non-Hodgkin lymphoma (NHL) treated with lenalidomide is similar to that seen in multiple myeloma, according to results of recent systematic review and meta-analysis of trials representing more than 10,000 treatment cycles.

Although rates of VTE for NHL and myeloma could not be directly compared statistically, the finding may have clinical implications for NHL patients, said lead study author Samuel Yamshon, MD, an internal medicine resident at Cornell University, New York.

“Although outpatient VTE prophylaxis is not currently recommended, it should be carefully considered in patients with lymphoma being treated with lenalidomide, especially those receiving lenalidomide as a single agent,” Dr. Yamshon said in a presentation of the results at the annual meeting of the American Society of Hematology.

The rate of thrombosis in patients with B cell NHL who received lenalidomide treatment was 0.75 events per 100 patient-cycles, according to results of the meta-analysis, which was based on 28 articles including 10,332 cycles of lenalidomide received by patients with B-cell NHL.

Reported rates of thrombosis in previously untreated myeloma patients treated with lenalidomide are between 0.7 and 0.8 per 100 patient-cycles, Dr. Yamshon said in his presentation.

Notably, single-agent lenalidomide was linked with a significantly increased risk of thrombosis compared with lenalidomide treatment in combinations. The relative risk of VTE for lenalidomide as a single agent versus lenalidomide in combination was 2.01 (95% confidence interval, 1.28-3.16; P = .002), according to the presented data.

The investigators were unsure why single-agent lenalidomide appeared to have caused increased rates of thrombosis compared to lenalidomide in combinations. “Perhaps patients treated with additional agents have a lower tumor burden, leading to less venous obstruction causing clots, or perhaps there’s a direct interaction between lenalidomide and tumor leading to effects on the vasculature and mediators of coagulation,” Dr. Yamshon said.

Chemotherapy and biologic combinations had somewhat different VTE rates when compared to single-agent lenalidomide. The rate in patients receiving lenalidomide alone was 1.06 events per 100 patient-cycles, compared with 0.73 and 0.41 events per 100 patient-cycles, respectively, for lenalidomide plus chemotherapy and lenalidomide plus biologics.

However, the lower event rate with lenalidomide and biologics compared with lenalidomide and chemotherapy was a “nonsignificant trend” that was likely caused by differences in patient characteristics between the two cohorts, according to Dr. Yamshon.

None of the studies included in the meta-analysis were prospectively designed to measure VTE as a primary or secondary outcome, Dr. Yamshon noted in a discussion of the study’s limitations.

Further studies are warranted to determine lenalidomide’s effect on the vasculature and how it effects mediators of coagulation, he added.

Based on the current results, Dr. Yamshon said it may be reasonable to consider VTE prophylaxis in NHL patients receiving lenalidomide.

“If we’re going to be recommending outpatient VTE prophylaxis in everyone on lenalidomide in multiple myeloma, and the rates (of VTE) are the same, I think it certainly makes sense based on the data to recommend it,” he said in a question-and-answer session.

Dr. Yamshon reported no conflicts related to the study. Coauthors reported disclosures related to Roche, Celgene, Seattle Genetics, Pharmacyclics, Cell Medica, Janssen, and AstraZeneca.

SOURCE: Yamshon S et al. Abstract 677.

 

– The rate of venous thromboembolism (VTE) in patients with non-Hodgkin lymphoma (NHL) treated with lenalidomide is similar to that seen in multiple myeloma, according to results of recent systematic review and meta-analysis of trials representing more than 10,000 treatment cycles.

Although rates of VTE for NHL and myeloma could not be directly compared statistically, the finding may have clinical implications for NHL patients, said lead study author Samuel Yamshon, MD, an internal medicine resident at Cornell University, New York.

“Although outpatient VTE prophylaxis is not currently recommended, it should be carefully considered in patients with lymphoma being treated with lenalidomide, especially those receiving lenalidomide as a single agent,” Dr. Yamshon said in a presentation of the results at the annual meeting of the American Society of Hematology.

The rate of thrombosis in patients with B cell NHL who received lenalidomide treatment was 0.75 events per 100 patient-cycles, according to results of the meta-analysis, which was based on 28 articles including 10,332 cycles of lenalidomide received by patients with B-cell NHL.

Reported rates of thrombosis in previously untreated myeloma patients treated with lenalidomide are between 0.7 and 0.8 per 100 patient-cycles, Dr. Yamshon said in his presentation.

Notably, single-agent lenalidomide was linked with a significantly increased risk of thrombosis compared with lenalidomide treatment in combinations. The relative risk of VTE for lenalidomide as a single agent versus lenalidomide in combination was 2.01 (95% confidence interval, 1.28-3.16; P = .002), according to the presented data.

The investigators were unsure why single-agent lenalidomide appeared to have caused increased rates of thrombosis compared to lenalidomide in combinations. “Perhaps patients treated with additional agents have a lower tumor burden, leading to less venous obstruction causing clots, or perhaps there’s a direct interaction between lenalidomide and tumor leading to effects on the vasculature and mediators of coagulation,” Dr. Yamshon said.

Chemotherapy and biologic combinations had somewhat different VTE rates when compared to single-agent lenalidomide. The rate in patients receiving lenalidomide alone was 1.06 events per 100 patient-cycles, compared with 0.73 and 0.41 events per 100 patient-cycles, respectively, for lenalidomide plus chemotherapy and lenalidomide plus biologics.

However, the lower event rate with lenalidomide and biologics compared with lenalidomide and chemotherapy was a “nonsignificant trend” that was likely caused by differences in patient characteristics between the two cohorts, according to Dr. Yamshon.

None of the studies included in the meta-analysis were prospectively designed to measure VTE as a primary or secondary outcome, Dr. Yamshon noted in a discussion of the study’s limitations.

Further studies are warranted to determine lenalidomide’s effect on the vasculature and how it effects mediators of coagulation, he added.

Based on the current results, Dr. Yamshon said it may be reasonable to consider VTE prophylaxis in NHL patients receiving lenalidomide.

“If we’re going to be recommending outpatient VTE prophylaxis in everyone on lenalidomide in multiple myeloma, and the rates (of VTE) are the same, I think it certainly makes sense based on the data to recommend it,” he said in a question-and-answer session.

Dr. Yamshon reported no conflicts related to the study. Coauthors reported disclosures related to Roche, Celgene, Seattle Genetics, Pharmacyclics, Cell Medica, Janssen, and AstraZeneca.

SOURCE: Yamshon S et al. Abstract 677.

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Key clinical point: The rates of VTE in patients on lenalidomide are similar whether they’re being treated for B cell non-Hodgkin lymphoma (NHL) or multiple myeloma, which suggests that VTE prophylaxis should be more carefully considered in B cell NHL patients.

Major finding: The rate of thrombosis in patients with B cell NHL who received lenalidomide treatment was 0.75 events per 100 patient-cycles.

Data source: A systematic review and meta-analysis of 28 articles including 10,332 cycles of lenalidomide received by patients with B cell NHL.

Disclosures: Authors of the study reported disclosures related to Roche, Celgene, Seattle Genetics, Pharmacyclics, Cell Medica, Janssen, and AstraZeneca.

Source: Yamshon S et al. Abstract 677.

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