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Christopher Palmer has been an associate editor at MDedge News since 2017. When he's not tidying grammar, he writes short pieces about breaking FDA announcements and approvals, as well as journal articles. He proudly holds a BA in English and philosophy. Follow him on Twitter @cmacmpalm.
FDA grants regular approval to venetoclax for CLL/SLL
Venetoclax (Venclexta) has received regular approval from the Food and Drug Administration for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
The approval was based results from the MURANO trial of 389 patients, which was a randomized, multicenter, open-label trial of venetoclax plus rituximab versus bendamustine plus rituximab.
Neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea were the most common adverse events seen in the venetoclax arm. Grade 3 or 4 neutropenia developed in 64% of those patients, and grade 4 in 31%. The most common infection in venetoclax patients was pneumonia, but overall, 21% of patients in that arm experienced some kind of infection.
Because of the rapid reduction in tumor size, tumor lysis syndrome is possible with venetoclax treatment, the FDA noted.
In 2016, the FDA granted accelerated approval to venetoclax for treatment of patients with CLL with 17d deletion who had received at least one prior line of therapy.
Venetoclax (Venclexta) has received regular approval from the Food and Drug Administration for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
The approval was based results from the MURANO trial of 389 patients, which was a randomized, multicenter, open-label trial of venetoclax plus rituximab versus bendamustine plus rituximab.
Neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea were the most common adverse events seen in the venetoclax arm. Grade 3 or 4 neutropenia developed in 64% of those patients, and grade 4 in 31%. The most common infection in venetoclax patients was pneumonia, but overall, 21% of patients in that arm experienced some kind of infection.
Because of the rapid reduction in tumor size, tumor lysis syndrome is possible with venetoclax treatment, the FDA noted.
In 2016, the FDA granted accelerated approval to venetoclax for treatment of patients with CLL with 17d deletion who had received at least one prior line of therapy.
Venetoclax (Venclexta) has received regular approval from the Food and Drug Administration for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
The approval was based results from the MURANO trial of 389 patients, which was a randomized, multicenter, open-label trial of venetoclax plus rituximab versus bendamustine plus rituximab.
Neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea were the most common adverse events seen in the venetoclax arm. Grade 3 or 4 neutropenia developed in 64% of those patients, and grade 4 in 31%. The most common infection in venetoclax patients was pneumonia, but overall, 21% of patients in that arm experienced some kind of infection.
Because of the rapid reduction in tumor size, tumor lysis syndrome is possible with venetoclax treatment, the FDA noted.
In 2016, the FDA granted accelerated approval to venetoclax for treatment of patients with CLL with 17d deletion who had received at least one prior line of therapy.
CDC concerned about multidrug-resistant Shigella
The Centers for Disease Control and Prevention have issued follow-up recommendations for managing and reporting Shigella infections because of concerns about increasing antibiotic resistance and the possibility of treatment failures.
Isolates with no resistance to quinolone antibiotics have ciprofloxacin minimum inhibitory concentration (MIC) values of less than 0.015 mcg/mL. However, the CDC has continued to identify isolates of Shigella that, while still within the susceptible range for the fluoroquinolone antibiotic ciprofloxacin (that is, having MIC values less than 1 mcg/mL), have MIC values for ciprofloxacin of 0.12-1.0 mcg/mL, thus appearing to harbor one or more resistance mechanisms. Furthermore, the CDC has identified an increasing number of isolates that have MIC values for azithromycin exceeding the epidemiologic cutoff value, which suggests some form of acquired resistance.
The recommendations advise that, if clinicians need to use antibiotics to treat patients who have Shigella infections, they should monitor these patients carefully. In the case of an apparent treatment failure for Shigella with either fluoroquinolone or azithromycin, an infectious disease specialist should be contacted to ascertain alternative treatments, and treatment failure information should be reported to the CDC in coordination with local health department. In addition, a stool specimen should be collected for culture; further susceptibility testing should be undertaken, and the isolate should be expedited to the state public health laboratory, which also should notify the CDC to coordinate additional testing.
“CDC is particularly concerned about people who are at high risk for multidrug-resistant Shigella infections and are more likely to require antibiotic treatment, such as men who have sex with men, patients who are homeless, and immunocompromised patients. These patients often have more severe disease, prolonged shedding, and recurrent infections,” the recommendations stated.
More information can be found in the CDC’s Health Alert Network release.
The Centers for Disease Control and Prevention have issued follow-up recommendations for managing and reporting Shigella infections because of concerns about increasing antibiotic resistance and the possibility of treatment failures.
Isolates with no resistance to quinolone antibiotics have ciprofloxacin minimum inhibitory concentration (MIC) values of less than 0.015 mcg/mL. However, the CDC has continued to identify isolates of Shigella that, while still within the susceptible range for the fluoroquinolone antibiotic ciprofloxacin (that is, having MIC values less than 1 mcg/mL), have MIC values for ciprofloxacin of 0.12-1.0 mcg/mL, thus appearing to harbor one or more resistance mechanisms. Furthermore, the CDC has identified an increasing number of isolates that have MIC values for azithromycin exceeding the epidemiologic cutoff value, which suggests some form of acquired resistance.
The recommendations advise that, if clinicians need to use antibiotics to treat patients who have Shigella infections, they should monitor these patients carefully. In the case of an apparent treatment failure for Shigella with either fluoroquinolone or azithromycin, an infectious disease specialist should be contacted to ascertain alternative treatments, and treatment failure information should be reported to the CDC in coordination with local health department. In addition, a stool specimen should be collected for culture; further susceptibility testing should be undertaken, and the isolate should be expedited to the state public health laboratory, which also should notify the CDC to coordinate additional testing.
“CDC is particularly concerned about people who are at high risk for multidrug-resistant Shigella infections and are more likely to require antibiotic treatment, such as men who have sex with men, patients who are homeless, and immunocompromised patients. These patients often have more severe disease, prolonged shedding, and recurrent infections,” the recommendations stated.
More information can be found in the CDC’s Health Alert Network release.
The Centers for Disease Control and Prevention have issued follow-up recommendations for managing and reporting Shigella infections because of concerns about increasing antibiotic resistance and the possibility of treatment failures.
Isolates with no resistance to quinolone antibiotics have ciprofloxacin minimum inhibitory concentration (MIC) values of less than 0.015 mcg/mL. However, the CDC has continued to identify isolates of Shigella that, while still within the susceptible range for the fluoroquinolone antibiotic ciprofloxacin (that is, having MIC values less than 1 mcg/mL), have MIC values for ciprofloxacin of 0.12-1.0 mcg/mL, thus appearing to harbor one or more resistance mechanisms. Furthermore, the CDC has identified an increasing number of isolates that have MIC values for azithromycin exceeding the epidemiologic cutoff value, which suggests some form of acquired resistance.
The recommendations advise that, if clinicians need to use antibiotics to treat patients who have Shigella infections, they should monitor these patients carefully. In the case of an apparent treatment failure for Shigella with either fluoroquinolone or azithromycin, an infectious disease specialist should be contacted to ascertain alternative treatments, and treatment failure information should be reported to the CDC in coordination with local health department. In addition, a stool specimen should be collected for culture; further susceptibility testing should be undertaken, and the isolate should be expedited to the state public health laboratory, which also should notify the CDC to coordinate additional testing.
“CDC is particularly concerned about people who are at high risk for multidrug-resistant Shigella infections and are more likely to require antibiotic treatment, such as men who have sex with men, patients who are homeless, and immunocompromised patients. These patients often have more severe disease, prolonged shedding, and recurrent infections,” the recommendations stated.
More information can be found in the CDC’s Health Alert Network release.
FDA approves long-acting ESA for dialysis-related anemia in children, adolescents
The
patients aged 5-17 years with chronic kidney disease whose hemoglobin had been stabilized with an erythropoiesis-stimulating agent (ESA).
Efficacy was based partly on how well target hemoglobin levels were maintained in this trial, but also on extrapolation from results of trials in adults. The safety profile in these pediatric patients was consistent with those previously observed in adults. Mircera is manufactured by Vifor Pharma.
More information on the approval of Mircera in this population can be found in the FDA release. The prescribing information for Mircera, initially approved in 2007, has also been updated.
The
patients aged 5-17 years with chronic kidney disease whose hemoglobin had been stabilized with an erythropoiesis-stimulating agent (ESA).
Efficacy was based partly on how well target hemoglobin levels were maintained in this trial, but also on extrapolation from results of trials in adults. The safety profile in these pediatric patients was consistent with those previously observed in adults. Mircera is manufactured by Vifor Pharma.
More information on the approval of Mircera in this population can be found in the FDA release. The prescribing information for Mircera, initially approved in 2007, has also been updated.
The
patients aged 5-17 years with chronic kidney disease whose hemoglobin had been stabilized with an erythropoiesis-stimulating agent (ESA).
Efficacy was based partly on how well target hemoglobin levels were maintained in this trial, but also on extrapolation from results of trials in adults. The safety profile in these pediatric patients was consistent with those previously observed in adults. Mircera is manufactured by Vifor Pharma.
More information on the approval of Mircera in this population can be found in the FDA release. The prescribing information for Mircera, initially approved in 2007, has also been updated.
Adolescent suicidal ideation and attempts are on the rise
according to a retrospective analysis by Gregory Plemmons, MD, of Vanderbilt University, Nashville, Tenn., and his coinvestigators.
The researchers also found that suicidal ideation and suicide attempts occurred more often during the spring and fall than in the summer, coinciding with the academic school year, highlighting “the need for further research in the role that schools may play.”
The investigators distinguished three age groups corresponding with commonly accepted definitions of late childhood (5-11 years), early adolescence (12-14 years), and late adolescence (15-17 years). They also looked at differences according to patients’ race/ethnicity and sex, as well as month of the year of the admission.
There were increases in suicidal ideation or attempts across all three age groups, with 50% in late adolescence, 37% in early adolescence, and 13% in late childhood. They also found higher increases among non-Hispanic whites, compared with other races; nearly two-thirds of the suicidal ideation and suicide attempts were among girls.
Only 18.5% of total annual suicidal ideation and suicidal attempts occurred during summer months. Peaks were highest in fall and spring. “We underscore the need for future work to explore the relationship between school and suicidal ideation, recognizing that the role of academics is a complex one, and there may also be other additional influences at play regarding seasonality,” said Dr. Plemmons and his associates.
The investigators wrote that, although the reasons for these increasing trends among these age groups are not entirely clear, some have suggested the rise of cyberbullying and social media could be possible factors. This study and its data, though, “have important implications for exploring age- and sex-specific approaches to suicide screening and prevention interventions, as well as further research in examining causal factors for SI [suicidal ideation] and SA [suicide attempts],” they concluded.
SOURCE: Plemmons G et al. Pediatrics. 2018;141(6):e20172426.
according to a retrospective analysis by Gregory Plemmons, MD, of Vanderbilt University, Nashville, Tenn., and his coinvestigators.
The researchers also found that suicidal ideation and suicide attempts occurred more often during the spring and fall than in the summer, coinciding with the academic school year, highlighting “the need for further research in the role that schools may play.”
The investigators distinguished three age groups corresponding with commonly accepted definitions of late childhood (5-11 years), early adolescence (12-14 years), and late adolescence (15-17 years). They also looked at differences according to patients’ race/ethnicity and sex, as well as month of the year of the admission.
There were increases in suicidal ideation or attempts across all three age groups, with 50% in late adolescence, 37% in early adolescence, and 13% in late childhood. They also found higher increases among non-Hispanic whites, compared with other races; nearly two-thirds of the suicidal ideation and suicide attempts were among girls.
Only 18.5% of total annual suicidal ideation and suicidal attempts occurred during summer months. Peaks were highest in fall and spring. “We underscore the need for future work to explore the relationship between school and suicidal ideation, recognizing that the role of academics is a complex one, and there may also be other additional influences at play regarding seasonality,” said Dr. Plemmons and his associates.
The investigators wrote that, although the reasons for these increasing trends among these age groups are not entirely clear, some have suggested the rise of cyberbullying and social media could be possible factors. This study and its data, though, “have important implications for exploring age- and sex-specific approaches to suicide screening and prevention interventions, as well as further research in examining causal factors for SI [suicidal ideation] and SA [suicide attempts],” they concluded.
SOURCE: Plemmons G et al. Pediatrics. 2018;141(6):e20172426.
according to a retrospective analysis by Gregory Plemmons, MD, of Vanderbilt University, Nashville, Tenn., and his coinvestigators.
The researchers also found that suicidal ideation and suicide attempts occurred more often during the spring and fall than in the summer, coinciding with the academic school year, highlighting “the need for further research in the role that schools may play.”
The investigators distinguished three age groups corresponding with commonly accepted definitions of late childhood (5-11 years), early adolescence (12-14 years), and late adolescence (15-17 years). They also looked at differences according to patients’ race/ethnicity and sex, as well as month of the year of the admission.
There were increases in suicidal ideation or attempts across all three age groups, with 50% in late adolescence, 37% in early adolescence, and 13% in late childhood. They also found higher increases among non-Hispanic whites, compared with other races; nearly two-thirds of the suicidal ideation and suicide attempts were among girls.
Only 18.5% of total annual suicidal ideation and suicidal attempts occurred during summer months. Peaks were highest in fall and spring. “We underscore the need for future work to explore the relationship between school and suicidal ideation, recognizing that the role of academics is a complex one, and there may also be other additional influences at play regarding seasonality,” said Dr. Plemmons and his associates.
The investigators wrote that, although the reasons for these increasing trends among these age groups are not entirely clear, some have suggested the rise of cyberbullying and social media could be possible factors. This study and its data, though, “have important implications for exploring age- and sex-specific approaches to suicide screening and prevention interventions, as well as further research in examining causal factors for SI [suicidal ideation] and SA [suicide attempts],” they concluded.
SOURCE: Plemmons G et al. Pediatrics. 2018;141(6):e20172426.
FROM PEDIATRICS
Unusual skin reactions to aluminum patch test seen in some children
Instead of the usual eczematous reaction confined to the test area, they exhibited erythema and papules distant from the test area.
In one girl, the reaction consisted of erythematous itchy papules across much of her back on day 2, and by day 4, there were even papules on her chest. In the other girl, erythema, infiltration, and occasional papules covered the whole patch area, and erythematous papules also were seen at some distance from the test area, Nadia Raison-Peyron, MD, of Saint-Eloi Hospital, Montpellier, France, and her colleagues, reported in Pediatric Dermatology.
Biopsies were not performed because of the girls’ young age.
SOURCE: Raison-Peyron N et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13481.
Instead of the usual eczematous reaction confined to the test area, they exhibited erythema and papules distant from the test area.
In one girl, the reaction consisted of erythematous itchy papules across much of her back on day 2, and by day 4, there were even papules on her chest. In the other girl, erythema, infiltration, and occasional papules covered the whole patch area, and erythematous papules also were seen at some distance from the test area, Nadia Raison-Peyron, MD, of Saint-Eloi Hospital, Montpellier, France, and her colleagues, reported in Pediatric Dermatology.
Biopsies were not performed because of the girls’ young age.
SOURCE: Raison-Peyron N et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13481.
Instead of the usual eczematous reaction confined to the test area, they exhibited erythema and papules distant from the test area.
In one girl, the reaction consisted of erythematous itchy papules across much of her back on day 2, and by day 4, there were even papules on her chest. In the other girl, erythema, infiltration, and occasional papules covered the whole patch area, and erythematous papules also were seen at some distance from the test area, Nadia Raison-Peyron, MD, of Saint-Eloi Hospital, Montpellier, France, and her colleagues, reported in Pediatric Dermatology.
Biopsies were not performed because of the girls’ young age.
SOURCE: Raison-Peyron N et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13481.
FROM PEDIATRIC DERMATOLOGY
In COPD, tai chi confers long-term benefit
and seems to confer better long-term improvement, suggests a study published online in the journal CHEST®.
Following 12 weeks of participation in tai chi or pulmonary rehabilitation, patients improved in most of the measurements taken, although no significant between-group differences were observed at that time. However, further improvements were observed in the tai chi group 12 weeks after the intervention had ended. These improvements manifested as a statistically significant 4.5 between-group difference in St. George’s Respiratory Questionnaire points in favor of tai chi (P less than .001)
“This observation, supported also by improvements in dyspnea and exercise performance, suggests that tai chi could be substituted for PR [pulmonary rehabilitation] in the treatment of COPD with greater convenience for patients,” the researchers concluded.
SOURCE: Polkey MI et al. CHEST. 2018 May;153[5]:1116-24.
and seems to confer better long-term improvement, suggests a study published online in the journal CHEST®.
Following 12 weeks of participation in tai chi or pulmonary rehabilitation, patients improved in most of the measurements taken, although no significant between-group differences were observed at that time. However, further improvements were observed in the tai chi group 12 weeks after the intervention had ended. These improvements manifested as a statistically significant 4.5 between-group difference in St. George’s Respiratory Questionnaire points in favor of tai chi (P less than .001)
“This observation, supported also by improvements in dyspnea and exercise performance, suggests that tai chi could be substituted for PR [pulmonary rehabilitation] in the treatment of COPD with greater convenience for patients,” the researchers concluded.
SOURCE: Polkey MI et al. CHEST. 2018 May;153[5]:1116-24.
and seems to confer better long-term improvement, suggests a study published online in the journal CHEST®.
Following 12 weeks of participation in tai chi or pulmonary rehabilitation, patients improved in most of the measurements taken, although no significant between-group differences were observed at that time. However, further improvements were observed in the tai chi group 12 weeks after the intervention had ended. These improvements manifested as a statistically significant 4.5 between-group difference in St. George’s Respiratory Questionnaire points in favor of tai chi (P less than .001)
“This observation, supported also by improvements in dyspnea and exercise performance, suggests that tai chi could be substituted for PR [pulmonary rehabilitation] in the treatment of COPD with greater convenience for patients,” the researchers concluded.
SOURCE: Polkey MI et al. CHEST. 2018 May;153[5]:1116-24.
FROM THE JOURNAL CHEST®
MenB vaccine receives breakthrough therapy designation for children aged 1-9 years
according to an April 23, 2018, press statement from the vaccine’s manufacturer.
Trumenba is the first Neisseria meningitidis group B (MenB) vaccine to receive this designation for children as young as 1 year in the United States. In 2014, it became the first MenB vaccine to receive approval in the United States for older patients – aged 10-25 years. “As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%),” according to the statement.
The 2014 approval letter required the vaccine’s manufacturer, Pfizer, to assess the efficacy and safety of Trumenba among children aged 1-9 years. Data from the resulting phase 2 studies supported Pfizer’s request for a breakthrough therapy designation for use of the MenB vaccine in that age group.
For more information, read Pfizer’s full press statement.
according to an April 23, 2018, press statement from the vaccine’s manufacturer.
Trumenba is the first Neisseria meningitidis group B (MenB) vaccine to receive this designation for children as young as 1 year in the United States. In 2014, it became the first MenB vaccine to receive approval in the United States for older patients – aged 10-25 years. “As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%),” according to the statement.
The 2014 approval letter required the vaccine’s manufacturer, Pfizer, to assess the efficacy and safety of Trumenba among children aged 1-9 years. Data from the resulting phase 2 studies supported Pfizer’s request for a breakthrough therapy designation for use of the MenB vaccine in that age group.
For more information, read Pfizer’s full press statement.
according to an April 23, 2018, press statement from the vaccine’s manufacturer.
Trumenba is the first Neisseria meningitidis group B (MenB) vaccine to receive this designation for children as young as 1 year in the United States. In 2014, it became the first MenB vaccine to receive approval in the United States for older patients – aged 10-25 years. “As of 2016, the burden of MenB is highest in adolescents/young adults (32%) and infants (20%), followed by children ages 1 to 4 years (12%) and children ages 5 to 10 years (4%),” according to the statement.
The 2014 approval letter required the vaccine’s manufacturer, Pfizer, to assess the efficacy and safety of Trumenba among children aged 1-9 years. Data from the resulting phase 2 studies supported Pfizer’s request for a breakthrough therapy designation for use of the MenB vaccine in that age group.
For more information, read Pfizer’s full press statement.
Upadacitinib for RA shows encouraging results in phase 3 trial
In a recent phase 3 trial, the investigational oral JAK1 inhibitor upadacitinib met all primary and secondary endpoints in patients with moderate to severe rheumatoid arthritis – including clinical remission – compared with adalimumab and placebo, according to its manufacturer.
The ongoing SELECT-COMPARE trial randomized patients with a stable background on methotrexate but with a limited response to the drug to upadacitinib (n = 651), adalimumab (n = 327), or placebo (n = 651). In terms of primary endpoints, 28% of patients taking upadacitinib achieved remission based on 28-joint Disease Activity Score using C-reactive protein at week 12, compared with 18% of those taking adalimumab and 6% taking placebo. A total of 71% achieved an American College of Rheumatology 20% (ACR20) level of response, compared with 63% of those taking adalimumab and 36% of those taking placebo.
In addition, upadacitinib met the ranked secondary endpoints, showing superiority over adalimumab. It did so in terms of ACR50 and ACR70 at week 12, as well as reduction in patient pain scores and improvement in physical function at week 12. Furthermore, it significantly inhibited radiographic progression.
The safety profile was consistent with previous findings: By week 26, 3.7% of patients taking upadacitinib experienced serious adverse events, compared with 4.3% of patients taking adalimumab and 2.9% of those taking placebo.
Find out more in AbbVie’s press release.
In a recent phase 3 trial, the investigational oral JAK1 inhibitor upadacitinib met all primary and secondary endpoints in patients with moderate to severe rheumatoid arthritis – including clinical remission – compared with adalimumab and placebo, according to its manufacturer.
The ongoing SELECT-COMPARE trial randomized patients with a stable background on methotrexate but with a limited response to the drug to upadacitinib (n = 651), adalimumab (n = 327), or placebo (n = 651). In terms of primary endpoints, 28% of patients taking upadacitinib achieved remission based on 28-joint Disease Activity Score using C-reactive protein at week 12, compared with 18% of those taking adalimumab and 6% taking placebo. A total of 71% achieved an American College of Rheumatology 20% (ACR20) level of response, compared with 63% of those taking adalimumab and 36% of those taking placebo.
In addition, upadacitinib met the ranked secondary endpoints, showing superiority over adalimumab. It did so in terms of ACR50 and ACR70 at week 12, as well as reduction in patient pain scores and improvement in physical function at week 12. Furthermore, it significantly inhibited radiographic progression.
The safety profile was consistent with previous findings: By week 26, 3.7% of patients taking upadacitinib experienced serious adverse events, compared with 4.3% of patients taking adalimumab and 2.9% of those taking placebo.
Find out more in AbbVie’s press release.
In a recent phase 3 trial, the investigational oral JAK1 inhibitor upadacitinib met all primary and secondary endpoints in patients with moderate to severe rheumatoid arthritis – including clinical remission – compared with adalimumab and placebo, according to its manufacturer.
The ongoing SELECT-COMPARE trial randomized patients with a stable background on methotrexate but with a limited response to the drug to upadacitinib (n = 651), adalimumab (n = 327), or placebo (n = 651). In terms of primary endpoints, 28% of patients taking upadacitinib achieved remission based on 28-joint Disease Activity Score using C-reactive protein at week 12, compared with 18% of those taking adalimumab and 6% taking placebo. A total of 71% achieved an American College of Rheumatology 20% (ACR20) level of response, compared with 63% of those taking adalimumab and 36% of those taking placebo.
In addition, upadacitinib met the ranked secondary endpoints, showing superiority over adalimumab. It did so in terms of ACR50 and ACR70 at week 12, as well as reduction in patient pain scores and improvement in physical function at week 12. Furthermore, it significantly inhibited radiographic progression.
The safety profile was consistent with previous findings: By week 26, 3.7% of patients taking upadacitinib experienced serious adverse events, compared with 4.3% of patients taking adalimumab and 2.9% of those taking placebo.
Find out more in AbbVie’s press release.
U.S. adults consumed 17.5 billion total binge drinks in 2015
A new study seeks to elucidate disparities in the binge drinking habits of U.S. adults.
To its authors’ knowledge, the study by Dafna Kanny, PhD, and her coinvestigators is the first to assess total binge drinks consumed, in contrast with other studies that have assessed prevalence alone. This total binge drinks consumed measure is calculated by multiplying the intensity of drinking (greatest number of drinks consumed on one binge-drinking occasion) by the frequency of binge drinking.
Using this measure, Dr. Kanny and her coinvestigators found that 17.1% of U.S. adults reported consuming 17.5 billion total binge drinks, or 470 binge drinks per binge drinker in 2015.
The measure also led to insight into drinking patterns among different U.S. demographic groups. For example, while binge drinking was more common among people aged 18-34 years, half of all binge drinks were consumed by people older than 35 years – which reinforces the notion that binge drinking is a lifelong issue. The researchers also found that, while binge drinking was less common among people with lower incomes and educational attainment, they consumed a higher “total annual number of binge drinks per binge drinker” than did people with higher incomes and educational attainment, Dr. Kanny, of the Centers for Disease Control and Prevention, and her coinvestigators, reported in the American Journal of Preventive Medicine.
In addition to finding disparities among demographic groups, the investigators found disparities between different geographical regions of the country. “The highest annual number of total binge drinks per drinker was reported in Arkansas (841.0), Mississippi (831.8), Kentucky (652.8), and Hawaii (611.7),” they wrote. “Notably, total annual binge drinks per binge drinker and per adult were generally higher in the Mississippi River Valley than in other regions.”
Assessing binge-drinking prevalence alone does not capture some disparities in binge-drinking behavior, the coinvestigators concluded. “Monitoring total binge drinks consumed annually and total binge drinks per binge drinker” could not only overcome those limitations but also help implement approaches to reducing binge drinking and alcohol-related harms.
Dr. Kanny and her coinvestigators reported that their findings “do not necessarily represent the official position” of the CDC. They reported no financial disclosures.
SOURCE: Kanny D et al. Am J Prev Med. 2018;54(4):486-96.
A new study seeks to elucidate disparities in the binge drinking habits of U.S. adults.
To its authors’ knowledge, the study by Dafna Kanny, PhD, and her coinvestigators is the first to assess total binge drinks consumed, in contrast with other studies that have assessed prevalence alone. This total binge drinks consumed measure is calculated by multiplying the intensity of drinking (greatest number of drinks consumed on one binge-drinking occasion) by the frequency of binge drinking.
Using this measure, Dr. Kanny and her coinvestigators found that 17.1% of U.S. adults reported consuming 17.5 billion total binge drinks, or 470 binge drinks per binge drinker in 2015.
The measure also led to insight into drinking patterns among different U.S. demographic groups. For example, while binge drinking was more common among people aged 18-34 years, half of all binge drinks were consumed by people older than 35 years – which reinforces the notion that binge drinking is a lifelong issue. The researchers also found that, while binge drinking was less common among people with lower incomes and educational attainment, they consumed a higher “total annual number of binge drinks per binge drinker” than did people with higher incomes and educational attainment, Dr. Kanny, of the Centers for Disease Control and Prevention, and her coinvestigators, reported in the American Journal of Preventive Medicine.
In addition to finding disparities among demographic groups, the investigators found disparities between different geographical regions of the country. “The highest annual number of total binge drinks per drinker was reported in Arkansas (841.0), Mississippi (831.8), Kentucky (652.8), and Hawaii (611.7),” they wrote. “Notably, total annual binge drinks per binge drinker and per adult were generally higher in the Mississippi River Valley than in other regions.”
Assessing binge-drinking prevalence alone does not capture some disparities in binge-drinking behavior, the coinvestigators concluded. “Monitoring total binge drinks consumed annually and total binge drinks per binge drinker” could not only overcome those limitations but also help implement approaches to reducing binge drinking and alcohol-related harms.
Dr. Kanny and her coinvestigators reported that their findings “do not necessarily represent the official position” of the CDC. They reported no financial disclosures.
SOURCE: Kanny D et al. Am J Prev Med. 2018;54(4):486-96.
A new study seeks to elucidate disparities in the binge drinking habits of U.S. adults.
To its authors’ knowledge, the study by Dafna Kanny, PhD, and her coinvestigators is the first to assess total binge drinks consumed, in contrast with other studies that have assessed prevalence alone. This total binge drinks consumed measure is calculated by multiplying the intensity of drinking (greatest number of drinks consumed on one binge-drinking occasion) by the frequency of binge drinking.
Using this measure, Dr. Kanny and her coinvestigators found that 17.1% of U.S. adults reported consuming 17.5 billion total binge drinks, or 470 binge drinks per binge drinker in 2015.
The measure also led to insight into drinking patterns among different U.S. demographic groups. For example, while binge drinking was more common among people aged 18-34 years, half of all binge drinks were consumed by people older than 35 years – which reinforces the notion that binge drinking is a lifelong issue. The researchers also found that, while binge drinking was less common among people with lower incomes and educational attainment, they consumed a higher “total annual number of binge drinks per binge drinker” than did people with higher incomes and educational attainment, Dr. Kanny, of the Centers for Disease Control and Prevention, and her coinvestigators, reported in the American Journal of Preventive Medicine.
In addition to finding disparities among demographic groups, the investigators found disparities between different geographical regions of the country. “The highest annual number of total binge drinks per drinker was reported in Arkansas (841.0), Mississippi (831.8), Kentucky (652.8), and Hawaii (611.7),” they wrote. “Notably, total annual binge drinks per binge drinker and per adult were generally higher in the Mississippi River Valley than in other regions.”
Assessing binge-drinking prevalence alone does not capture some disparities in binge-drinking behavior, the coinvestigators concluded. “Monitoring total binge drinks consumed annually and total binge drinks per binge drinker” could not only overcome those limitations but also help implement approaches to reducing binge drinking and alcohol-related harms.
Dr. Kanny and her coinvestigators reported that their findings “do not necessarily represent the official position” of the CDC. They reported no financial disclosures.
SOURCE: Kanny D et al. Am J Prev Med. 2018;54(4):486-96.
FROM THE AMERICAN JOURNAL OF PREVENTIVE MEDICINE
Impact of sleep loss on metabolism is highly individualistic
Shift work – and the various light exposures that go with it – can place some people at a greater risk of weight gain and obesity. But the impact of various light exposures inherent in shift work appear to affect the metabolism of each person differently, reported Edward L. Melanson, PhD, and his coinvestigators.
“Such individual differences were not explained by sex, age, weight, fat mass, or fat free mass,” Dr. Melanson and his coinvestigators wrote. “Thus, understanding mechanisms underlying such individual differences in waking and sleep energy metabolism and how they may or may not contribute to health outcomes ... requires additional research.”
The investigators’ conclusions are based on the results of two studies. Both studies used whole-room, indirect calorimetry to measure energy expenditure. The participants, all of whom were free of medications and illicit drugs, maintained a consistent 8-hour sleep schedule before the study took place, and consumed a specified diet throughout the study. .
The first study, comprising 15 healthy young adults, looked for changes in energy expenditure and glucose metabolism in response to different lighting conditions, such as full-spectrum bright light or blue-enriched bright light. In that study, no effects were found on patients’ metabolism. The other study, comprising 14 healthy young adults, used a simulated shift work protocol and found a decrease in 24-hour energy expenditure in certain individuals in response to circadian misalignment. “This finding may help identify individuals who may be at a higher risk of unwanted weight gain and obesity during shift work,” the investigators wrote.
Read the full report in Neurobiology of Sleep and Circadian Rhythms.
SOURCE: Melanson EL et al. Neurobiol Sleep Circadian Rhythms. 2017 Dec 29. doi: 10.1016/j.nbscr.2017.12.002.
Shift work – and the various light exposures that go with it – can place some people at a greater risk of weight gain and obesity. But the impact of various light exposures inherent in shift work appear to affect the metabolism of each person differently, reported Edward L. Melanson, PhD, and his coinvestigators.
“Such individual differences were not explained by sex, age, weight, fat mass, or fat free mass,” Dr. Melanson and his coinvestigators wrote. “Thus, understanding mechanisms underlying such individual differences in waking and sleep energy metabolism and how they may or may not contribute to health outcomes ... requires additional research.”
The investigators’ conclusions are based on the results of two studies. Both studies used whole-room, indirect calorimetry to measure energy expenditure. The participants, all of whom were free of medications and illicit drugs, maintained a consistent 8-hour sleep schedule before the study took place, and consumed a specified diet throughout the study. .
The first study, comprising 15 healthy young adults, looked for changes in energy expenditure and glucose metabolism in response to different lighting conditions, such as full-spectrum bright light or blue-enriched bright light. In that study, no effects were found on patients’ metabolism. The other study, comprising 14 healthy young adults, used a simulated shift work protocol and found a decrease in 24-hour energy expenditure in certain individuals in response to circadian misalignment. “This finding may help identify individuals who may be at a higher risk of unwanted weight gain and obesity during shift work,” the investigators wrote.
Read the full report in Neurobiology of Sleep and Circadian Rhythms.
SOURCE: Melanson EL et al. Neurobiol Sleep Circadian Rhythms. 2017 Dec 29. doi: 10.1016/j.nbscr.2017.12.002.
Shift work – and the various light exposures that go with it – can place some people at a greater risk of weight gain and obesity. But the impact of various light exposures inherent in shift work appear to affect the metabolism of each person differently, reported Edward L. Melanson, PhD, and his coinvestigators.
“Such individual differences were not explained by sex, age, weight, fat mass, or fat free mass,” Dr. Melanson and his coinvestigators wrote. “Thus, understanding mechanisms underlying such individual differences in waking and sleep energy metabolism and how they may or may not contribute to health outcomes ... requires additional research.”
The investigators’ conclusions are based on the results of two studies. Both studies used whole-room, indirect calorimetry to measure energy expenditure. The participants, all of whom were free of medications and illicit drugs, maintained a consistent 8-hour sleep schedule before the study took place, and consumed a specified diet throughout the study. .
The first study, comprising 15 healthy young adults, looked for changes in energy expenditure and glucose metabolism in response to different lighting conditions, such as full-spectrum bright light or blue-enriched bright light. In that study, no effects were found on patients’ metabolism. The other study, comprising 14 healthy young adults, used a simulated shift work protocol and found a decrease in 24-hour energy expenditure in certain individuals in response to circadian misalignment. “This finding may help identify individuals who may be at a higher risk of unwanted weight gain and obesity during shift work,” the investigators wrote.
Read the full report in Neurobiology of Sleep and Circadian Rhythms.
SOURCE: Melanson EL et al. Neurobiol Sleep Circadian Rhythms. 2017 Dec 29. doi: 10.1016/j.nbscr.2017.12.002.
FROM NEUROBIOLOGY OF SLEEP AND CIRCADIAN RHYTHMS