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Insufficient sleep impairs women’s insulin sensitivity
Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.
The research was published recently in Diabetes Care.
Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.
Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.
“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.
“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
Prolonged lack of sleep may accelerate diabetes progression
Dr. St-Onge added,
Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”
The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.
Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.
Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”
He continued, “There have been several studies showing the association of sleep and diabetes, but that does not necessarily mean cause and effect.”
On the other hand, Dr. Gabbay said, “randomizing people can help see sleep influences on key metabolic measures of diabetes, [which] helps to build a stronger case that sleep disturbances can cause worsening metabolic health.”
He emphasized that both the quantity and quality of sleep are “critical for optimal diabetes health” and highlighted that the ADA’s Standards of Care “recommends screening for sleep issues and counseling to improve sleep.”
“This study provides new insight into the health effects of even small sleep deficits in women across all stages of adulthood and racial and ethnic backgrounds,” commented Corinne Silva, PhD, program director in the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, which co-funded the study.
The authors note that more than one-third of adults sleep less than the recommended 7 hours per night, which is “concerning given robust associations of short sleep with cardiometabolic diseases.”
Moreover, “women report poorer sleep than men,” explained Marishka Brown, PhD, director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, which also co-funded the study.
“So understanding how sleep disturbances impact their health across the lifespan is critical, especially for postmenopausal women,” she said, particularly because previous studies have not reflected real-world sleep patterns or have focused on men.
The researchers conducted a trial to evaluate the causal impact of prolonged, mild sleep restriction on cardiometabolic risk factors in women as part of the American Heart Association Go Red for Women Strategically Focused Research Network.
They recruited metabolically healthy women aged 20-75 years who were at increased risk for cardiometabolic disease due to having either overweight or class I obesity or at least one parent with type 2 diabetes, hyperlipidemia, or cardiovascular disease.
They were also required to have a habitual total sleep time on actigraphy of 7-9 hours per night and low risk for sleep apnea. Exclusion criteria included excessive caffeine intake, a significantly advanced or delayed sleep phase, shift work, and travel across time zones.
The participants were randomly assigned to either adequate sleep, defined as 7-9 hours per night, or sleep restriction, defined as a reduction in sleep duration of 1.5 hours per night, for 6 weeks. They were then crossed over to the other sleep condition.
Assessments, including MRI and oral glucose tolerance tests, were performed at baseline and at the end of each study phase.
The researchers report on 38 women who took part in the trial, of whom 11 were postmenopausal. The mean age was 37.6 years; 31.6% self-identified as Black and 26.3% as Hispanic. The mean body mass index (BMI) was 25.5.
Postmenopausal women had a higher mean age than other women, at 56.1 years versus 30.1 years, and a higher baseline fasting blood glucose, at 5.26 mmol/L (94.68 mg/dL) versus 4.70 mmol/L (84.6 mg/dL).
The team reported that compliance with the sleep protocol was “excellent,” with women during sleep restriction having a reduction in total sleep time of 1.34 hours per night versus women in the adequate sleep arm (P < .0001).
Sleep restriction was also associated with significant increases in fasting plasma insulin versus adequate sleep, at a beta value of 0.68 pmol/L (P = .016), and significantly increased Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) values (beta = 0.30; P = .016).
The impact on HOMA-IR values was significantly more pronounced in postmenopausal than menopausal women, at beta values of 0.45 versus 0.27 (P for interaction = .042).
Sleep restriction had no significant effect on fasting plasma glucose levels, and the association between sleep duration and cardiometabolic parameters was not modified by the proportion of either total or visceral adipose tissue, or by changes in adiposity.
This clinical trial was supported by the American Heart Association, a National Institutes of Health Clinical and Translational Science Award to Columbia University, and N.Y. Nutrition Obesity Research Center. Individual authors received support from the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.
The research was published recently in Diabetes Care.
Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.
Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.
“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.
“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
Prolonged lack of sleep may accelerate diabetes progression
Dr. St-Onge added,
Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”
The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.
Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.
Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”
He continued, “There have been several studies showing the association of sleep and diabetes, but that does not necessarily mean cause and effect.”
On the other hand, Dr. Gabbay said, “randomizing people can help see sleep influences on key metabolic measures of diabetes, [which] helps to build a stronger case that sleep disturbances can cause worsening metabolic health.”
He emphasized that both the quantity and quality of sleep are “critical for optimal diabetes health” and highlighted that the ADA’s Standards of Care “recommends screening for sleep issues and counseling to improve sleep.”
“This study provides new insight into the health effects of even small sleep deficits in women across all stages of adulthood and racial and ethnic backgrounds,” commented Corinne Silva, PhD, program director in the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, which co-funded the study.
The authors note that more than one-third of adults sleep less than the recommended 7 hours per night, which is “concerning given robust associations of short sleep with cardiometabolic diseases.”
Moreover, “women report poorer sleep than men,” explained Marishka Brown, PhD, director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, which also co-funded the study.
“So understanding how sleep disturbances impact their health across the lifespan is critical, especially for postmenopausal women,” she said, particularly because previous studies have not reflected real-world sleep patterns or have focused on men.
The researchers conducted a trial to evaluate the causal impact of prolonged, mild sleep restriction on cardiometabolic risk factors in women as part of the American Heart Association Go Red for Women Strategically Focused Research Network.
They recruited metabolically healthy women aged 20-75 years who were at increased risk for cardiometabolic disease due to having either overweight or class I obesity or at least one parent with type 2 diabetes, hyperlipidemia, or cardiovascular disease.
They were also required to have a habitual total sleep time on actigraphy of 7-9 hours per night and low risk for sleep apnea. Exclusion criteria included excessive caffeine intake, a significantly advanced or delayed sleep phase, shift work, and travel across time zones.
The participants were randomly assigned to either adequate sleep, defined as 7-9 hours per night, or sleep restriction, defined as a reduction in sleep duration of 1.5 hours per night, for 6 weeks. They were then crossed over to the other sleep condition.
Assessments, including MRI and oral glucose tolerance tests, were performed at baseline and at the end of each study phase.
The researchers report on 38 women who took part in the trial, of whom 11 were postmenopausal. The mean age was 37.6 years; 31.6% self-identified as Black and 26.3% as Hispanic. The mean body mass index (BMI) was 25.5.
Postmenopausal women had a higher mean age than other women, at 56.1 years versus 30.1 years, and a higher baseline fasting blood glucose, at 5.26 mmol/L (94.68 mg/dL) versus 4.70 mmol/L (84.6 mg/dL).
The team reported that compliance with the sleep protocol was “excellent,” with women during sleep restriction having a reduction in total sleep time of 1.34 hours per night versus women in the adequate sleep arm (P < .0001).
Sleep restriction was also associated with significant increases in fasting plasma insulin versus adequate sleep, at a beta value of 0.68 pmol/L (P = .016), and significantly increased Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) values (beta = 0.30; P = .016).
The impact on HOMA-IR values was significantly more pronounced in postmenopausal than menopausal women, at beta values of 0.45 versus 0.27 (P for interaction = .042).
Sleep restriction had no significant effect on fasting plasma glucose levels, and the association between sleep duration and cardiometabolic parameters was not modified by the proportion of either total or visceral adipose tissue, or by changes in adiposity.
This clinical trial was supported by the American Heart Association, a National Institutes of Health Clinical and Translational Science Award to Columbia University, and N.Y. Nutrition Obesity Research Center. Individual authors received support from the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
Women, particularly those who are postmenopausal, who sleep less than the recommended 7 hours per night may have impaired insulin sensitivity regardless of their degree of adiposity, a randomized crossover trial reveals.
The research was published recently in Diabetes Care.
Nearly 40 women were randomly assigned to either restricted sleep or adequate sleep for 6 weeks, then crossed over to the other sleep condition. During sleep restriction, women slept an average of 6.2 hours per night versus 7-9 hours per night.
Both fasting insulin levels and insulin resistance were significantly increased during sleep restriction, with the effect on insulin resistance particularly notable in postmenopausal women. This was independent of adiposity and changes in adiposity.
“What we’re seeing is that more insulin is needed to normalize glucose levels in the women under conditions of sleep restriction,” said senior author Marie-Pierre St-Onge, PhD, director of the Center of Excellence for Sleep and Circadian Research at Columbia University Vagelos College of Physicians and Surgeons, New York, in a release.
“Even then, the insulin may not have been doing enough to counteract rising blood glucose levels of postmenopausal women,” she stated.
Prolonged lack of sleep may accelerate diabetes progression
Dr. St-Onge added,
Dr. St-Onge said in an interview that it was crucial to show the impact of sleep restriction in a randomized study, because “observational studies don’t provide information on causality.”
The study did not rely on people “living in our clinical research facility,” but instead enrolled individuals who were “living their lives,” and the reduction in sleep achieved was “similar to what is seen in the general population with sleep,” she said.
Dr. St-Onge therefore believes the findings indicate that sleep has been overlooked as a contributory factor in insulin sensitivity.
Robert Gabbay, MD, PhD, chief scientific and medical officer at the American Diabetes Association, said in an interview that this is an “important study [that] builds on what we have seen on the importance of sleep for metabolic outcomes and diabetes.”
He continued, “There have been several studies showing the association of sleep and diabetes, but that does not necessarily mean cause and effect.”
On the other hand, Dr. Gabbay said, “randomizing people can help see sleep influences on key metabolic measures of diabetes, [which] helps to build a stronger case that sleep disturbances can cause worsening metabolic health.”
He emphasized that both the quantity and quality of sleep are “critical for optimal diabetes health” and highlighted that the ADA’s Standards of Care “recommends screening for sleep issues and counseling to improve sleep.”
“This study provides new insight into the health effects of even small sleep deficits in women across all stages of adulthood and racial and ethnic backgrounds,” commented Corinne Silva, PhD, program director in the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, which co-funded the study.
The authors note that more than one-third of adults sleep less than the recommended 7 hours per night, which is “concerning given robust associations of short sleep with cardiometabolic diseases.”
Moreover, “women report poorer sleep than men,” explained Marishka Brown, PhD, director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, which also co-funded the study.
“So understanding how sleep disturbances impact their health across the lifespan is critical, especially for postmenopausal women,” she said, particularly because previous studies have not reflected real-world sleep patterns or have focused on men.
The researchers conducted a trial to evaluate the causal impact of prolonged, mild sleep restriction on cardiometabolic risk factors in women as part of the American Heart Association Go Red for Women Strategically Focused Research Network.
They recruited metabolically healthy women aged 20-75 years who were at increased risk for cardiometabolic disease due to having either overweight or class I obesity or at least one parent with type 2 diabetes, hyperlipidemia, or cardiovascular disease.
They were also required to have a habitual total sleep time on actigraphy of 7-9 hours per night and low risk for sleep apnea. Exclusion criteria included excessive caffeine intake, a significantly advanced or delayed sleep phase, shift work, and travel across time zones.
The participants were randomly assigned to either adequate sleep, defined as 7-9 hours per night, or sleep restriction, defined as a reduction in sleep duration of 1.5 hours per night, for 6 weeks. They were then crossed over to the other sleep condition.
Assessments, including MRI and oral glucose tolerance tests, were performed at baseline and at the end of each study phase.
The researchers report on 38 women who took part in the trial, of whom 11 were postmenopausal. The mean age was 37.6 years; 31.6% self-identified as Black and 26.3% as Hispanic. The mean body mass index (BMI) was 25.5.
Postmenopausal women had a higher mean age than other women, at 56.1 years versus 30.1 years, and a higher baseline fasting blood glucose, at 5.26 mmol/L (94.68 mg/dL) versus 4.70 mmol/L (84.6 mg/dL).
The team reported that compliance with the sleep protocol was “excellent,” with women during sleep restriction having a reduction in total sleep time of 1.34 hours per night versus women in the adequate sleep arm (P < .0001).
Sleep restriction was also associated with significant increases in fasting plasma insulin versus adequate sleep, at a beta value of 0.68 pmol/L (P = .016), and significantly increased Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) values (beta = 0.30; P = .016).
The impact on HOMA-IR values was significantly more pronounced in postmenopausal than menopausal women, at beta values of 0.45 versus 0.27 (P for interaction = .042).
Sleep restriction had no significant effect on fasting plasma glucose levels, and the association between sleep duration and cardiometabolic parameters was not modified by the proportion of either total or visceral adipose tissue, or by changes in adiposity.
This clinical trial was supported by the American Heart Association, a National Institutes of Health Clinical and Translational Science Award to Columbia University, and N.Y. Nutrition Obesity Research Center. Individual authors received support from the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. No relevant financial relationships were declared.
A version of this article appeared on Medscape.com.
FROM DIABETES CARE
Novel approach curbs the impact of racism on mental health in Black youth
TOPLINE:
, results of a post hoc analysis of a randomized controlled trial show.
METHODOLOGY:
- SAAF is a 7-week family skills training program delivered at local community centers that targets effective parenting behavior, adolescent self-regulation, and Black pride.
- In the original trial, 472 Black children aged 11-12 years were randomly allocated to SAAF or no treatment control.
- The post hoc analysis investigated changes in adolescent-reported depressive symptoms from age 13 to 14 years using the 20-item Center for Epidemiologic Studies Depression Scale for Children.
TAKEAWAY:
- Exposure to racial discrimination at age 13 years correlated with increased depressive symptoms at age 14 years (P < .001).
- Participation in the SAAF program significantly attenuated the association of racial discrimination at age 13 with increases in depressive symptoms at age 14 (P = .01).
- Racial discrimination was significantly associated with increases in depressive symptoms in the control group (P < .001) but not in the SAAF group.
- This moderating effect was observed using intent-to-treat design; the investigators accounted for family socioeconomic disadvantage and youth gender.
IN PRACTICE:
The findings add to other evidence suggesting that “prevention programs targeting aspects of racial identity, racial socialization processes, and parenting behavior may, to some extent, mitigate the mental health effects associated with racial discrimination. These processes appear to increase positive coping in the aftermath of discrimination, and prevent adolescents internalization of toxic messages regarding racial inferiority,” the authors wrote.
SOURCE:
The study, with first author Steven M. Kogan, PhD, University of Georgia in Athens, was published online in JAMA Network Open with a commentary by Kevin M. Simon, MD, MPH, with Boston Children’s Hospital.
LIMITATIONS:
This was a post hoc analysis of trial data. The sample consisted of Black adolescents from rural areas of Georgia, and the results may not be generalizable to Black adolescents from urban areas or adolescents from other racial groups. Because of the study’s focus on individual-level racial discrimination, the potential for SAAF to buffer the effects of structural and institutional forms of racism is unknown.
DISCLOSURES:
The study had no specific funding. The authors have disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
, results of a post hoc analysis of a randomized controlled trial show.
METHODOLOGY:
- SAAF is a 7-week family skills training program delivered at local community centers that targets effective parenting behavior, adolescent self-regulation, and Black pride.
- In the original trial, 472 Black children aged 11-12 years were randomly allocated to SAAF or no treatment control.
- The post hoc analysis investigated changes in adolescent-reported depressive symptoms from age 13 to 14 years using the 20-item Center for Epidemiologic Studies Depression Scale for Children.
TAKEAWAY:
- Exposure to racial discrimination at age 13 years correlated with increased depressive symptoms at age 14 years (P < .001).
- Participation in the SAAF program significantly attenuated the association of racial discrimination at age 13 with increases in depressive symptoms at age 14 (P = .01).
- Racial discrimination was significantly associated with increases in depressive symptoms in the control group (P < .001) but not in the SAAF group.
- This moderating effect was observed using intent-to-treat design; the investigators accounted for family socioeconomic disadvantage and youth gender.
IN PRACTICE:
The findings add to other evidence suggesting that “prevention programs targeting aspects of racial identity, racial socialization processes, and parenting behavior may, to some extent, mitigate the mental health effects associated with racial discrimination. These processes appear to increase positive coping in the aftermath of discrimination, and prevent adolescents internalization of toxic messages regarding racial inferiority,” the authors wrote.
SOURCE:
The study, with first author Steven M. Kogan, PhD, University of Georgia in Athens, was published online in JAMA Network Open with a commentary by Kevin M. Simon, MD, MPH, with Boston Children’s Hospital.
LIMITATIONS:
This was a post hoc analysis of trial data. The sample consisted of Black adolescents from rural areas of Georgia, and the results may not be generalizable to Black adolescents from urban areas or adolescents from other racial groups. Because of the study’s focus on individual-level racial discrimination, the potential for SAAF to buffer the effects of structural and institutional forms of racism is unknown.
DISCLOSURES:
The study had no specific funding. The authors have disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
, results of a post hoc analysis of a randomized controlled trial show.
METHODOLOGY:
- SAAF is a 7-week family skills training program delivered at local community centers that targets effective parenting behavior, adolescent self-regulation, and Black pride.
- In the original trial, 472 Black children aged 11-12 years were randomly allocated to SAAF or no treatment control.
- The post hoc analysis investigated changes in adolescent-reported depressive symptoms from age 13 to 14 years using the 20-item Center for Epidemiologic Studies Depression Scale for Children.
TAKEAWAY:
- Exposure to racial discrimination at age 13 years correlated with increased depressive symptoms at age 14 years (P < .001).
- Participation in the SAAF program significantly attenuated the association of racial discrimination at age 13 with increases in depressive symptoms at age 14 (P = .01).
- Racial discrimination was significantly associated with increases in depressive symptoms in the control group (P < .001) but not in the SAAF group.
- This moderating effect was observed using intent-to-treat design; the investigators accounted for family socioeconomic disadvantage and youth gender.
IN PRACTICE:
The findings add to other evidence suggesting that “prevention programs targeting aspects of racial identity, racial socialization processes, and parenting behavior may, to some extent, mitigate the mental health effects associated with racial discrimination. These processes appear to increase positive coping in the aftermath of discrimination, and prevent adolescents internalization of toxic messages regarding racial inferiority,” the authors wrote.
SOURCE:
The study, with first author Steven M. Kogan, PhD, University of Georgia in Athens, was published online in JAMA Network Open with a commentary by Kevin M. Simon, MD, MPH, with Boston Children’s Hospital.
LIMITATIONS:
This was a post hoc analysis of trial data. The sample consisted of Black adolescents from rural areas of Georgia, and the results may not be generalizable to Black adolescents from urban areas or adolescents from other racial groups. Because of the study’s focus on individual-level racial discrimination, the potential for SAAF to buffer the effects of structural and institutional forms of racism is unknown.
DISCLOSURES:
The study had no specific funding. The authors have disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FDA OKs new agent to block chemotherapy-induced neutropenia
Efbemalenograstim joins other agents already on the U.S. market, including pegfilgrastim (Neulasta), that aim to reduce the incidence of chemotherapy-induced febrile neutropenia.
The approval of efbemalenograstim was based on two randomized trials. The first included 122 women with either metastatic or nonmetastatic breast cancer who were receiving doxorubicin and docetaxel. These patients were randomly assigned to receive either one subcutaneous injection of efbemalenograstim or placebo on the second day of their first chemotherapy cycle. All patients received efbemalenograstim on the second day of cycles two through four.
The mean duration of grade 4 neutropenia in the first cycle was 1.4 days with efbemalenograstim versus 4.3 days with placebo. Only 4.8% of patients who received efbemalenograstim experienced chemotherapy-induced febrile neutropenia, compared with 25.6% who received the placebo.
The new agent went up against pegfilgrastim in the second trial, which included 393 women who received docetaxel and cyclophosphamide as treatment for nonmetastatic breast cancer. These patients were randomly assigned to receive either a single subcutaneous injection of efbemalenograstim or pegfilgrastim on the second day of each cycle.
During the first cycle, patients in both arms of the trial experienced a mean of 0.2 days of grade 4 neutropenia.
The most common side effects associated with efbemalenograstim were nausea, anemia, and thrombocytopenia. Similar to pegfilgrastim’s label, efbemalenograstim’s label warns of possible splenic rupture, respiratory distress syndrome, sickle cell crisis, and other serious adverse events.
The FDA recommends a dose of 20 mg subcutaneous once per chemotherapy cycle.
A version of this article first appeared on Medscape.com.
Efbemalenograstim joins other agents already on the U.S. market, including pegfilgrastim (Neulasta), that aim to reduce the incidence of chemotherapy-induced febrile neutropenia.
The approval of efbemalenograstim was based on two randomized trials. The first included 122 women with either metastatic or nonmetastatic breast cancer who were receiving doxorubicin and docetaxel. These patients were randomly assigned to receive either one subcutaneous injection of efbemalenograstim or placebo on the second day of their first chemotherapy cycle. All patients received efbemalenograstim on the second day of cycles two through four.
The mean duration of grade 4 neutropenia in the first cycle was 1.4 days with efbemalenograstim versus 4.3 days with placebo. Only 4.8% of patients who received efbemalenograstim experienced chemotherapy-induced febrile neutropenia, compared with 25.6% who received the placebo.
The new agent went up against pegfilgrastim in the second trial, which included 393 women who received docetaxel and cyclophosphamide as treatment for nonmetastatic breast cancer. These patients were randomly assigned to receive either a single subcutaneous injection of efbemalenograstim or pegfilgrastim on the second day of each cycle.
During the first cycle, patients in both arms of the trial experienced a mean of 0.2 days of grade 4 neutropenia.
The most common side effects associated with efbemalenograstim were nausea, anemia, and thrombocytopenia. Similar to pegfilgrastim’s label, efbemalenograstim’s label warns of possible splenic rupture, respiratory distress syndrome, sickle cell crisis, and other serious adverse events.
The FDA recommends a dose of 20 mg subcutaneous once per chemotherapy cycle.
A version of this article first appeared on Medscape.com.
Efbemalenograstim joins other agents already on the U.S. market, including pegfilgrastim (Neulasta), that aim to reduce the incidence of chemotherapy-induced febrile neutropenia.
The approval of efbemalenograstim was based on two randomized trials. The first included 122 women with either metastatic or nonmetastatic breast cancer who were receiving doxorubicin and docetaxel. These patients were randomly assigned to receive either one subcutaneous injection of efbemalenograstim or placebo on the second day of their first chemotherapy cycle. All patients received efbemalenograstim on the second day of cycles two through four.
The mean duration of grade 4 neutropenia in the first cycle was 1.4 days with efbemalenograstim versus 4.3 days with placebo. Only 4.8% of patients who received efbemalenograstim experienced chemotherapy-induced febrile neutropenia, compared with 25.6% who received the placebo.
The new agent went up against pegfilgrastim in the second trial, which included 393 women who received docetaxel and cyclophosphamide as treatment for nonmetastatic breast cancer. These patients were randomly assigned to receive either a single subcutaneous injection of efbemalenograstim or pegfilgrastim on the second day of each cycle.
During the first cycle, patients in both arms of the trial experienced a mean of 0.2 days of grade 4 neutropenia.
The most common side effects associated with efbemalenograstim were nausea, anemia, and thrombocytopenia. Similar to pegfilgrastim’s label, efbemalenograstim’s label warns of possible splenic rupture, respiratory distress syndrome, sickle cell crisis, and other serious adverse events.
The FDA recommends a dose of 20 mg subcutaneous once per chemotherapy cycle.
A version of this article first appeared on Medscape.com.
FDA investigates secondary cancers from CAR T-cell therapies
Secondary cancers are a known risk for this class of immunotherapies, known as B-cell maturation antigen (BCMA)–directed or CD19-directed autologous CAR T-cell therapies, and are included in the prescribing information for these drugs. However, the FDA has received 19 reports of secondary cancers, including CAR-positive lymphoma, since 2017, when the first CAR T-cell treatments were approved, according to Endpoints News.
Most of these reports came from the FDA’s postmarketing adverse event system and others from clinical trial data.
Although the overall benefits of these products continue to outweigh their potential risks, “FDA is investigating the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a press release.
Currently approved products in this class include idecabtagene vicleucel (Abecma), lisocabtagene maraleucel (Breyanzi), ciltacabtagene autoleucel (Carvykti), tisagenlecleucel (Kymriah), brexucabtagene autoleucel (Tecartus), and axicabtagene ciloleucel (Yescarta).
“Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies,” the FDA added.
Suspected adverse events, including T-cell cancers, should be reported by contacting the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
A version of this article first appeared on Medscape.com.
Secondary cancers are a known risk for this class of immunotherapies, known as B-cell maturation antigen (BCMA)–directed or CD19-directed autologous CAR T-cell therapies, and are included in the prescribing information for these drugs. However, the FDA has received 19 reports of secondary cancers, including CAR-positive lymphoma, since 2017, when the first CAR T-cell treatments were approved, according to Endpoints News.
Most of these reports came from the FDA’s postmarketing adverse event system and others from clinical trial data.
Although the overall benefits of these products continue to outweigh their potential risks, “FDA is investigating the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a press release.
Currently approved products in this class include idecabtagene vicleucel (Abecma), lisocabtagene maraleucel (Breyanzi), ciltacabtagene autoleucel (Carvykti), tisagenlecleucel (Kymriah), brexucabtagene autoleucel (Tecartus), and axicabtagene ciloleucel (Yescarta).
“Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies,” the FDA added.
Suspected adverse events, including T-cell cancers, should be reported by contacting the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
A version of this article first appeared on Medscape.com.
Secondary cancers are a known risk for this class of immunotherapies, known as B-cell maturation antigen (BCMA)–directed or CD19-directed autologous CAR T-cell therapies, and are included in the prescribing information for these drugs. However, the FDA has received 19 reports of secondary cancers, including CAR-positive lymphoma, since 2017, when the first CAR T-cell treatments were approved, according to Endpoints News.
Most of these reports came from the FDA’s postmarketing adverse event system and others from clinical trial data.
Although the overall benefits of these products continue to outweigh their potential risks, “FDA is investigating the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a press release.
Currently approved products in this class include idecabtagene vicleucel (Abecma), lisocabtagene maraleucel (Breyanzi), ciltacabtagene autoleucel (Carvykti), tisagenlecleucel (Kymriah), brexucabtagene autoleucel (Tecartus), and axicabtagene ciloleucel (Yescarta).
“Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies,” the FDA added.
Suspected adverse events, including T-cell cancers, should be reported by contacting the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
A version of this article first appeared on Medscape.com.
Chronic Kidney Disease Highlights From ASN 2023
High-impact presentations on chronic kidney disease from the American Society of Nephrology (ASN) 2023 meeting are discussed by Dr Matthew Weir from the University of Maryland School of Medicine in Baltimore.
He starts with the results of the PROTECT and DUPLEX trials, in which sparsentan was compared with irbesartan in immunoglobulin A nephropathy and focal segmental glomerulosclerosis, respectively. In both studies, sparsentan resulted in greater reduction in albuminuria compared with irbesartan but with no significant differences in estimated glomerular filtration rate (GFR).
He also talks about the AYAME study of bardoxolone methyl in diabetic kidney disease, which was intended to examine the percentage of patients reaching a 30% reduction in GFR or end-stage renal disease. Bardoxolone slowed the reduction in the GFR but showed no benefit in reducing end-stage renal disease.
Next, Dr Weir reports the results from the ALCHEMIST trial on spironolactone in patients with chronic hemodialysis, which showed a reduction in hospitalization rates for heart failure in the spironolactone group but no improvement in mortality.
Finally, he discusses two studies looking at combining newer therapies on a background of traditional ones that suggest a potential for reducing albuminuria.
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Matthew R. Weir, MD, Professor and Chief, Division of Nephrology, Department of Medicine, University of Maryland School of Medicine, Lutherville-Timonium, Maryland; Professor and Chief, Division of Nephrology, Department of Medicine, University of Maryland Medical Center, Baltimore, Maryland
Matthew R. Weir, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Bayer; NovoNordisk; Boehringer-Ingelheim; Johnson & Johnson; CSL Vifor
High-impact presentations on chronic kidney disease from the American Society of Nephrology (ASN) 2023 meeting are discussed by Dr Matthew Weir from the University of Maryland School of Medicine in Baltimore.
He starts with the results of the PROTECT and DUPLEX trials, in which sparsentan was compared with irbesartan in immunoglobulin A nephropathy and focal segmental glomerulosclerosis, respectively. In both studies, sparsentan resulted in greater reduction in albuminuria compared with irbesartan but with no significant differences in estimated glomerular filtration rate (GFR).
He also talks about the AYAME study of bardoxolone methyl in diabetic kidney disease, which was intended to examine the percentage of patients reaching a 30% reduction in GFR or end-stage renal disease. Bardoxolone slowed the reduction in the GFR but showed no benefit in reducing end-stage renal disease.
Next, Dr Weir reports the results from the ALCHEMIST trial on spironolactone in patients with chronic hemodialysis, which showed a reduction in hospitalization rates for heart failure in the spironolactone group but no improvement in mortality.
Finally, he discusses two studies looking at combining newer therapies on a background of traditional ones that suggest a potential for reducing albuminuria.
--
Matthew R. Weir, MD, Professor and Chief, Division of Nephrology, Department of Medicine, University of Maryland School of Medicine, Lutherville-Timonium, Maryland; Professor and Chief, Division of Nephrology, Department of Medicine, University of Maryland Medical Center, Baltimore, Maryland
Matthew R. Weir, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Bayer; NovoNordisk; Boehringer-Ingelheim; Johnson & Johnson; CSL Vifor
High-impact presentations on chronic kidney disease from the American Society of Nephrology (ASN) 2023 meeting are discussed by Dr Matthew Weir from the University of Maryland School of Medicine in Baltimore.
He starts with the results of the PROTECT and DUPLEX trials, in which sparsentan was compared with irbesartan in immunoglobulin A nephropathy and focal segmental glomerulosclerosis, respectively. In both studies, sparsentan resulted in greater reduction in albuminuria compared with irbesartan but with no significant differences in estimated glomerular filtration rate (GFR).
He also talks about the AYAME study of bardoxolone methyl in diabetic kidney disease, which was intended to examine the percentage of patients reaching a 30% reduction in GFR or end-stage renal disease. Bardoxolone slowed the reduction in the GFR but showed no benefit in reducing end-stage renal disease.
Next, Dr Weir reports the results from the ALCHEMIST trial on spironolactone in patients with chronic hemodialysis, which showed a reduction in hospitalization rates for heart failure in the spironolactone group but no improvement in mortality.
Finally, he discusses two studies looking at combining newer therapies on a background of traditional ones that suggest a potential for reducing albuminuria.
--
Matthew R. Weir, MD, Professor and Chief, Division of Nephrology, Department of Medicine, University of Maryland School of Medicine, Lutherville-Timonium, Maryland; Professor and Chief, Division of Nephrology, Department of Medicine, University of Maryland Medical Center, Baltimore, Maryland
Matthew R. Weir, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Bayer; NovoNordisk; Boehringer-Ingelheim; Johnson & Johnson; CSL Vifor
Predictors of SARS-CoV-2 breakthrough infections in RA after booster dose vaccination
Key clinical point: Findings from this real-world study identified the protective and risk factors associated with SARS-CoV-2 breakthrough infections (BI) in patients with rheumatoid arthritis (RA) who had no COVID-19 infection and received the booster dose of anti-SARS-CoV-2 vaccine.
Major finding: Older patients who were age > 50 years (adjusted hazard ratio [aHR] 0.38; P = .004) and patients receiving conventional synthetic disease-modifying antirheumatic drugs (aHR 0.52; P = .021) had a significantly lower risk for BI, whereas patients receiving anti-interleukin 6 receptor (aHR 2.01; P = 0.039) and anti-CD20 (aHR 2.88; P = .011) treatments had ~2 and ~3 times higher risks for BI, respectively.
Study details: This prospective study included participants who had never been diagnosed with SARS-CoV-2 and had received three doses of the anti-SARS-CoV-2 vaccine, of whom 194 had RA and 1002 were control individuals.
Disclosures: This study was supported by the Italian Ministry of Health and other sources. The authors declared no conflicts of interest.
Source: Picchianti-Diamanti A et al. Older age, a high titre of neutralising antibodies and therapy with conventional DMARDs are associated with protection from breakthrough infection in rheumatoid arthritis patients after the booster dose of anti-SARS-CoV-2 vaccine. Vaccines. 2023;11(11):1684 (Nov 2). doi: 10.3390/vaccines11111684
Key clinical point: Findings from this real-world study identified the protective and risk factors associated with SARS-CoV-2 breakthrough infections (BI) in patients with rheumatoid arthritis (RA) who had no COVID-19 infection and received the booster dose of anti-SARS-CoV-2 vaccine.
Major finding: Older patients who were age > 50 years (adjusted hazard ratio [aHR] 0.38; P = .004) and patients receiving conventional synthetic disease-modifying antirheumatic drugs (aHR 0.52; P = .021) had a significantly lower risk for BI, whereas patients receiving anti-interleukin 6 receptor (aHR 2.01; P = 0.039) and anti-CD20 (aHR 2.88; P = .011) treatments had ~2 and ~3 times higher risks for BI, respectively.
Study details: This prospective study included participants who had never been diagnosed with SARS-CoV-2 and had received three doses of the anti-SARS-CoV-2 vaccine, of whom 194 had RA and 1002 were control individuals.
Disclosures: This study was supported by the Italian Ministry of Health and other sources. The authors declared no conflicts of interest.
Source: Picchianti-Diamanti A et al. Older age, a high titre of neutralising antibodies and therapy with conventional DMARDs are associated with protection from breakthrough infection in rheumatoid arthritis patients after the booster dose of anti-SARS-CoV-2 vaccine. Vaccines. 2023;11(11):1684 (Nov 2). doi: 10.3390/vaccines11111684
Key clinical point: Findings from this real-world study identified the protective and risk factors associated with SARS-CoV-2 breakthrough infections (BI) in patients with rheumatoid arthritis (RA) who had no COVID-19 infection and received the booster dose of anti-SARS-CoV-2 vaccine.
Major finding: Older patients who were age > 50 years (adjusted hazard ratio [aHR] 0.38; P = .004) and patients receiving conventional synthetic disease-modifying antirheumatic drugs (aHR 0.52; P = .021) had a significantly lower risk for BI, whereas patients receiving anti-interleukin 6 receptor (aHR 2.01; P = 0.039) and anti-CD20 (aHR 2.88; P = .011) treatments had ~2 and ~3 times higher risks for BI, respectively.
Study details: This prospective study included participants who had never been diagnosed with SARS-CoV-2 and had received three doses of the anti-SARS-CoV-2 vaccine, of whom 194 had RA and 1002 were control individuals.
Disclosures: This study was supported by the Italian Ministry of Health and other sources. The authors declared no conflicts of interest.
Source: Picchianti-Diamanti A et al. Older age, a high titre of neutralising antibodies and therapy with conventional DMARDs are associated with protection from breakthrough infection in rheumatoid arthritis patients after the booster dose of anti-SARS-CoV-2 vaccine. Vaccines. 2023;11(11):1684 (Nov 2). doi: 10.3390/vaccines11111684
Insights on methotrexate safety with combination therapies in early RA
Key clinical point: Patients with early rheumatoid arthritis (RA) had a higher frequency of adverse events (AE) with methotrexate + tociluzumab vs methotrexate + active conventional treatment (ACT), which restricted their ability to tolerate the target dose of 25 mg methotrexate per week.
Major finding: The risk for methotrexate-associated AE was significantly higher (hazard ratio 1.48; 95% CI 1.20-1.84) and the proportion of patients able to tolerate 25 mg methotrexate per week at 24 weeks was significantly lower (odds ratio 0.25; P < .001) in the methotrexate + tocilizumab vs methotrexate + ACT group. However, the risks for methotrexate-associated AE were comparable for methotrexate +ACT and the combinations of methotrexate with other biologics like certolizumab-pegol or abatacept.
Study details: This post hoc analysis of the phase 4 NORD-STAR trial included 812 treatment-naive patients with early RA who were randomly assigned to receive methotrexate in combination with ACT, certolizumab-pegol, abatacept, or tocilizumab.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants, contracts, payments, honoraria, or consulting fees from or having other ties with various sources.
Source: Lend K et al. Methotrexate safety and efficacy in combination therapies in patients with early rheumatoid arthritis: A post-hoc analysis of a randomized controlled trial (NORD-STAR). Arthritis Rheumatol. 2023 (Oct 17). doi: 10.1002/art.42730
Key clinical point: Patients with early rheumatoid arthritis (RA) had a higher frequency of adverse events (AE) with methotrexate + tociluzumab vs methotrexate + active conventional treatment (ACT), which restricted their ability to tolerate the target dose of 25 mg methotrexate per week.
Major finding: The risk for methotrexate-associated AE was significantly higher (hazard ratio 1.48; 95% CI 1.20-1.84) and the proportion of patients able to tolerate 25 mg methotrexate per week at 24 weeks was significantly lower (odds ratio 0.25; P < .001) in the methotrexate + tocilizumab vs methotrexate + ACT group. However, the risks for methotrexate-associated AE were comparable for methotrexate +ACT and the combinations of methotrexate with other biologics like certolizumab-pegol or abatacept.
Study details: This post hoc analysis of the phase 4 NORD-STAR trial included 812 treatment-naive patients with early RA who were randomly assigned to receive methotrexate in combination with ACT, certolizumab-pegol, abatacept, or tocilizumab.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants, contracts, payments, honoraria, or consulting fees from or having other ties with various sources.
Source: Lend K et al. Methotrexate safety and efficacy in combination therapies in patients with early rheumatoid arthritis: A post-hoc analysis of a randomized controlled trial (NORD-STAR). Arthritis Rheumatol. 2023 (Oct 17). doi: 10.1002/art.42730
Key clinical point: Patients with early rheumatoid arthritis (RA) had a higher frequency of adverse events (AE) with methotrexate + tociluzumab vs methotrexate + active conventional treatment (ACT), which restricted their ability to tolerate the target dose of 25 mg methotrexate per week.
Major finding: The risk for methotrexate-associated AE was significantly higher (hazard ratio 1.48; 95% CI 1.20-1.84) and the proportion of patients able to tolerate 25 mg methotrexate per week at 24 weeks was significantly lower (odds ratio 0.25; P < .001) in the methotrexate + tocilizumab vs methotrexate + ACT group. However, the risks for methotrexate-associated AE were comparable for methotrexate +ACT and the combinations of methotrexate with other biologics like certolizumab-pegol or abatacept.
Study details: This post hoc analysis of the phase 4 NORD-STAR trial included 812 treatment-naive patients with early RA who were randomly assigned to receive methotrexate in combination with ACT, certolizumab-pegol, abatacept, or tocilizumab.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants, contracts, payments, honoraria, or consulting fees from or having other ties with various sources.
Source: Lend K et al. Methotrexate safety and efficacy in combination therapies in patients with early rheumatoid arthritis: A post-hoc analysis of a randomized controlled trial (NORD-STAR). Arthritis Rheumatol. 2023 (Oct 17). doi: 10.1002/art.42730
Sustained remission tied to better outcomes than sustained LDA in early RA
Key clinical point: Patients with early rheumatoid arthritis (RA) who achieved disease remission and sustained it for 10 years had significantly lower structural progression and functional impairment than those who continued to have low disease activity (LDA).
Major finding: Patients with sustained remission vs sustained LDA had significantly lower mean 10-year structural progression (van der Heijde-modified Total Sharp Score 4.06 vs 14.59; P < .001) and 10-year functional impairment (Health Assessment Questionnaire Disability Index 0.14 vs 0.53; P < .001) scores.
Study details: This study analyzed the data of 252 patients with early RA from the ESPOIR cohort, of whom 48 patients were in sustained remission and 135 patients had sustained LDA.
Disclosures: The ESPOIR cohort was supported by grants from Merck Sharp & Dohme and other sources. The authors declared no conflicts of interest.
Source: Ruyssen-Witrand A et al. Ten-year radiographic and functional outcomes in rheumatoid arthritis patients in remission compared to patients in low disease activity. Arthritis Res Ther. 2023;25:207 (Oct 20). doi: 10.1186/s13075-023-03176-7
Key clinical point: Patients with early rheumatoid arthritis (RA) who achieved disease remission and sustained it for 10 years had significantly lower structural progression and functional impairment than those who continued to have low disease activity (LDA).
Major finding: Patients with sustained remission vs sustained LDA had significantly lower mean 10-year structural progression (van der Heijde-modified Total Sharp Score 4.06 vs 14.59; P < .001) and 10-year functional impairment (Health Assessment Questionnaire Disability Index 0.14 vs 0.53; P < .001) scores.
Study details: This study analyzed the data of 252 patients with early RA from the ESPOIR cohort, of whom 48 patients were in sustained remission and 135 patients had sustained LDA.
Disclosures: The ESPOIR cohort was supported by grants from Merck Sharp & Dohme and other sources. The authors declared no conflicts of interest.
Source: Ruyssen-Witrand A et al. Ten-year radiographic and functional outcomes in rheumatoid arthritis patients in remission compared to patients in low disease activity. Arthritis Res Ther. 2023;25:207 (Oct 20). doi: 10.1186/s13075-023-03176-7
Key clinical point: Patients with early rheumatoid arthritis (RA) who achieved disease remission and sustained it for 10 years had significantly lower structural progression and functional impairment than those who continued to have low disease activity (LDA).
Major finding: Patients with sustained remission vs sustained LDA had significantly lower mean 10-year structural progression (van der Heijde-modified Total Sharp Score 4.06 vs 14.59; P < .001) and 10-year functional impairment (Health Assessment Questionnaire Disability Index 0.14 vs 0.53; P < .001) scores.
Study details: This study analyzed the data of 252 patients with early RA from the ESPOIR cohort, of whom 48 patients were in sustained remission and 135 patients had sustained LDA.
Disclosures: The ESPOIR cohort was supported by grants from Merck Sharp & Dohme and other sources. The authors declared no conflicts of interest.
Source: Ruyssen-Witrand A et al. Ten-year radiographic and functional outcomes in rheumatoid arthritis patients in remission compared to patients in low disease activity. Arthritis Res Ther. 2023;25:207 (Oct 20). doi: 10.1186/s13075-023-03176-7
Four-fold higher risk for interstitial lung abnormalities in RA patients with a history of smoking
Key clinical point: Rheumatoid arthritis (RA) increased the prevalence of interstitial lung abnormalities (ILA) in participants with a history of smoking, which in turn led to a significant increase in the mortality rate.
Major finding: ILA were ~4 times more prevalent in individuals with a history of smoking who did vs did not have RA (adjusted odds ratio 4.15; 95% CI 2.17-7.97). Among patients with RA and a record of smoking, mortality risk was ~3 times higher in those with ILA or indeterminate ILA findings vs those without ILA (adjusted hazard ratio 2.86; 95% CI 1.33-6.16).
Study details: This cross-sectional prospective study included participants with a current or past history of smoking from the COPDGene cohort, of whom 83 participants had RA and were compared with 8725 individuals without RA.
Disclosures: COPDGene was supported by the US National Heart, Lung, and Blood Institute and others. Several authors declared receiving consulting fees, grant support, research support, or having other ties with various sources.
Source: McDermott GC et al. Prevalence and mortality associations of interstitial lung abnormalities in rheumatoid arthritis within a multicentre prospective cohort of smokers. Rheumatology (Oxford). 2023;62(SI3):SI286-SI295 (Oct 23). doi: 10.1093/rheumatology/kead277
Key clinical point: Rheumatoid arthritis (RA) increased the prevalence of interstitial lung abnormalities (ILA) in participants with a history of smoking, which in turn led to a significant increase in the mortality rate.
Major finding: ILA were ~4 times more prevalent in individuals with a history of smoking who did vs did not have RA (adjusted odds ratio 4.15; 95% CI 2.17-7.97). Among patients with RA and a record of smoking, mortality risk was ~3 times higher in those with ILA or indeterminate ILA findings vs those without ILA (adjusted hazard ratio 2.86; 95% CI 1.33-6.16).
Study details: This cross-sectional prospective study included participants with a current or past history of smoking from the COPDGene cohort, of whom 83 participants had RA and were compared with 8725 individuals without RA.
Disclosures: COPDGene was supported by the US National Heart, Lung, and Blood Institute and others. Several authors declared receiving consulting fees, grant support, research support, or having other ties with various sources.
Source: McDermott GC et al. Prevalence and mortality associations of interstitial lung abnormalities in rheumatoid arthritis within a multicentre prospective cohort of smokers. Rheumatology (Oxford). 2023;62(SI3):SI286-SI295 (Oct 23). doi: 10.1093/rheumatology/kead277
Key clinical point: Rheumatoid arthritis (RA) increased the prevalence of interstitial lung abnormalities (ILA) in participants with a history of smoking, which in turn led to a significant increase in the mortality rate.
Major finding: ILA were ~4 times more prevalent in individuals with a history of smoking who did vs did not have RA (adjusted odds ratio 4.15; 95% CI 2.17-7.97). Among patients with RA and a record of smoking, mortality risk was ~3 times higher in those with ILA or indeterminate ILA findings vs those without ILA (adjusted hazard ratio 2.86; 95% CI 1.33-6.16).
Study details: This cross-sectional prospective study included participants with a current or past history of smoking from the COPDGene cohort, of whom 83 participants had RA and were compared with 8725 individuals without RA.
Disclosures: COPDGene was supported by the US National Heart, Lung, and Blood Institute and others. Several authors declared receiving consulting fees, grant support, research support, or having other ties with various sources.
Source: McDermott GC et al. Prevalence and mortality associations of interstitial lung abnormalities in rheumatoid arthritis within a multicentre prospective cohort of smokers. Rheumatology (Oxford). 2023;62(SI3):SI286-SI295 (Oct 23). doi: 10.1093/rheumatology/kead277
Meta-analysis assesses hepatitis B reactivation risk in anti-IL-6-treated RA
Key clinical point: The risk for hepatitis B virus (HBV) reactivation was substantially high in patients with rheumatoid arthritis (RA) and chronic HBV infection who were treated with anti-interleukin-6 (anti-IL-6), with the risk being ~5 times higher in the absence of antiviral prophylaxis.
Major finding: The HBV reactivation rate was 6.7% in patients with chronic HBV infection, with the value further increasing to 31% in patients without antiviral prophylaxis. In patients with resolved HBV infection, the HBV reactivation rate remained ~0% irrespective of antiviral prophylaxis administration.
Study details: This meta-analysis of 19 studies included 372 anti-IL-6-treated patients with RA who had chronic (n = 41) or resolved (n = 279) HBV infection, of whom 19 patients received antiviral prophylaxis.
Disclosures: This study did not receive any funding. Two authors declared receiving honoraria, speaker fees, or research grants from or participating in advisory boards of various sources.
Source: Katelani S et al. HBV reactivation in patients with rheumatoid arthritis treated with anti-interleukin-6: A systematic review and meta-analysis. Rheumatology (Oxford). 2023;62(SI3):SI252-SI259 (Oct 23). doi: 10.1093/rheumatology/kead243
Key clinical point: The risk for hepatitis B virus (HBV) reactivation was substantially high in patients with rheumatoid arthritis (RA) and chronic HBV infection who were treated with anti-interleukin-6 (anti-IL-6), with the risk being ~5 times higher in the absence of antiviral prophylaxis.
Major finding: The HBV reactivation rate was 6.7% in patients with chronic HBV infection, with the value further increasing to 31% in patients without antiviral prophylaxis. In patients with resolved HBV infection, the HBV reactivation rate remained ~0% irrespective of antiviral prophylaxis administration.
Study details: This meta-analysis of 19 studies included 372 anti-IL-6-treated patients with RA who had chronic (n = 41) or resolved (n = 279) HBV infection, of whom 19 patients received antiviral prophylaxis.
Disclosures: This study did not receive any funding. Two authors declared receiving honoraria, speaker fees, or research grants from or participating in advisory boards of various sources.
Source: Katelani S et al. HBV reactivation in patients with rheumatoid arthritis treated with anti-interleukin-6: A systematic review and meta-analysis. Rheumatology (Oxford). 2023;62(SI3):SI252-SI259 (Oct 23). doi: 10.1093/rheumatology/kead243
Key clinical point: The risk for hepatitis B virus (HBV) reactivation was substantially high in patients with rheumatoid arthritis (RA) and chronic HBV infection who were treated with anti-interleukin-6 (anti-IL-6), with the risk being ~5 times higher in the absence of antiviral prophylaxis.
Major finding: The HBV reactivation rate was 6.7% in patients with chronic HBV infection, with the value further increasing to 31% in patients without antiviral prophylaxis. In patients with resolved HBV infection, the HBV reactivation rate remained ~0% irrespective of antiviral prophylaxis administration.
Study details: This meta-analysis of 19 studies included 372 anti-IL-6-treated patients with RA who had chronic (n = 41) or resolved (n = 279) HBV infection, of whom 19 patients received antiviral prophylaxis.
Disclosures: This study did not receive any funding. Two authors declared receiving honoraria, speaker fees, or research grants from or participating in advisory boards of various sources.
Source: Katelani S et al. HBV reactivation in patients with rheumatoid arthritis treated with anti-interleukin-6: A systematic review and meta-analysis. Rheumatology (Oxford). 2023;62(SI3):SI252-SI259 (Oct 23). doi: 10.1093/rheumatology/kead243