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Digital Mindfulness Program May Reduce Anxiety in Patients With Chronic Obstructive Pulmonary Disease
TOPLINE:
An 8-week smartphone-based mindfulness program using audio-guided meditation reduced anxiety and improved emotional well-being in patients with chronic obstructive pulmonary disease (COPD), also providing relief from stress, anxiety, and dyspnea following each session.
METHODOLOGY:
- A considerable proportion of patients with COPD experience clinically significant anxiety and depressive symptoms; psychological interventions that are easy to implement as add-on treatments can alleviate these symptoms.
- In this pilot study, 30 patients (mean age, 62.68 y; 60.5% women) with COPD and subclinical symptoms of anxiety or depression were enrolled and allocated to an 8-week self-administered digital mindfulness-based intervention (n = 14) or the waitlist control (n = 16).
- Patients in the intervention group had an introductory face-to-face session, followed by daily smartphone audio-guided meditation adapted for patients with COPD. The waitlist group received the same intervention after the study period ended.
- The primary endpoints were the feasibility of the intervention and its effects on anxiety and depression symptoms at baseline, 4 weeks, and 8 weeks.
TAKEAWAY:
- Patients in the intervention group practiced mindfulness on 81.38% of the 56 intervention days.
- After 8 weeks, the intervention group showed a significant reduction in anxiety (P = .010) compared with the waitlist group; however, no significant improvement was observed for depression.
- Similarly, significant improvements were reported for emotional functioning (P = .004), but no significant reductions in perceived stress and hair cortisol levels were observed after 8 weeks.
- Significant reductions were reported for momentary subjective stress (P < .001), anxiety (P = .022), and dyspnea (P < .001) immediately after meditation sessions.
IN PRACTICE:
“The investigated self-administered digital MBI [mindfulness-based intervention], including brief 10- to 15-minute meditations, was feasible and holds potential as low-threshold add-on treatment to alleviate anxiety after 8 weeks and reduce momentary subjective stress, anxiety, and dyspnea in everyday life,” the study authors wrote.
SOURCE:
This study was led by Hannah Tschenett, Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria, and was published online in Respiratory Research.
LIMITATIONS:
This study had several limitations including a small sample size, lack of a true control group, and potential selection bias due to recruitment from centers with patients already interested in mindfulness, which may have inflated adherence. Additionally, generalizability to all patients with COPD was limited, as many were either ineligible or declined to participate.
DISCLOSURES:
This study was funded by the Scientific Medical Fund of the City of Vienna and the Karl Landsteiner Institute (KLI) for Lung Research and Pulmonary Oncology. The KLI received funding from AstraZeneca, Boehringer Ingelheim, Chiesi, Linde plc, Menarini Pharma, Novartis, and Vivisol Austria. Three authors reported being employees of KLI or receiving lecture fees from some of these pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
An 8-week smartphone-based mindfulness program using audio-guided meditation reduced anxiety and improved emotional well-being in patients with chronic obstructive pulmonary disease (COPD), also providing relief from stress, anxiety, and dyspnea following each session.
METHODOLOGY:
- A considerable proportion of patients with COPD experience clinically significant anxiety and depressive symptoms; psychological interventions that are easy to implement as add-on treatments can alleviate these symptoms.
- In this pilot study, 30 patients (mean age, 62.68 y; 60.5% women) with COPD and subclinical symptoms of anxiety or depression were enrolled and allocated to an 8-week self-administered digital mindfulness-based intervention (n = 14) or the waitlist control (n = 16).
- Patients in the intervention group had an introductory face-to-face session, followed by daily smartphone audio-guided meditation adapted for patients with COPD. The waitlist group received the same intervention after the study period ended.
- The primary endpoints were the feasibility of the intervention and its effects on anxiety and depression symptoms at baseline, 4 weeks, and 8 weeks.
TAKEAWAY:
- Patients in the intervention group practiced mindfulness on 81.38% of the 56 intervention days.
- After 8 weeks, the intervention group showed a significant reduction in anxiety (P = .010) compared with the waitlist group; however, no significant improvement was observed for depression.
- Similarly, significant improvements were reported for emotional functioning (P = .004), but no significant reductions in perceived stress and hair cortisol levels were observed after 8 weeks.
- Significant reductions were reported for momentary subjective stress (P < .001), anxiety (P = .022), and dyspnea (P < .001) immediately after meditation sessions.
IN PRACTICE:
“The investigated self-administered digital MBI [mindfulness-based intervention], including brief 10- to 15-minute meditations, was feasible and holds potential as low-threshold add-on treatment to alleviate anxiety after 8 weeks and reduce momentary subjective stress, anxiety, and dyspnea in everyday life,” the study authors wrote.
SOURCE:
This study was led by Hannah Tschenett, Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria, and was published online in Respiratory Research.
LIMITATIONS:
This study had several limitations including a small sample size, lack of a true control group, and potential selection bias due to recruitment from centers with patients already interested in mindfulness, which may have inflated adherence. Additionally, generalizability to all patients with COPD was limited, as many were either ineligible or declined to participate.
DISCLOSURES:
This study was funded by the Scientific Medical Fund of the City of Vienna and the Karl Landsteiner Institute (KLI) for Lung Research and Pulmonary Oncology. The KLI received funding from AstraZeneca, Boehringer Ingelheim, Chiesi, Linde plc, Menarini Pharma, Novartis, and Vivisol Austria. Three authors reported being employees of KLI or receiving lecture fees from some of these pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
An 8-week smartphone-based mindfulness program using audio-guided meditation reduced anxiety and improved emotional well-being in patients with chronic obstructive pulmonary disease (COPD), also providing relief from stress, anxiety, and dyspnea following each session.
METHODOLOGY:
- A considerable proportion of patients with COPD experience clinically significant anxiety and depressive symptoms; psychological interventions that are easy to implement as add-on treatments can alleviate these symptoms.
- In this pilot study, 30 patients (mean age, 62.68 y; 60.5% women) with COPD and subclinical symptoms of anxiety or depression were enrolled and allocated to an 8-week self-administered digital mindfulness-based intervention (n = 14) or the waitlist control (n = 16).
- Patients in the intervention group had an introductory face-to-face session, followed by daily smartphone audio-guided meditation adapted for patients with COPD. The waitlist group received the same intervention after the study period ended.
- The primary endpoints were the feasibility of the intervention and its effects on anxiety and depression symptoms at baseline, 4 weeks, and 8 weeks.
TAKEAWAY:
- Patients in the intervention group practiced mindfulness on 81.38% of the 56 intervention days.
- After 8 weeks, the intervention group showed a significant reduction in anxiety (P = .010) compared with the waitlist group; however, no significant improvement was observed for depression.
- Similarly, significant improvements were reported for emotional functioning (P = .004), but no significant reductions in perceived stress and hair cortisol levels were observed after 8 weeks.
- Significant reductions were reported for momentary subjective stress (P < .001), anxiety (P = .022), and dyspnea (P < .001) immediately after meditation sessions.
IN PRACTICE:
“The investigated self-administered digital MBI [mindfulness-based intervention], including brief 10- to 15-minute meditations, was feasible and holds potential as low-threshold add-on treatment to alleviate anxiety after 8 weeks and reduce momentary subjective stress, anxiety, and dyspnea in everyday life,” the study authors wrote.
SOURCE:
This study was led by Hannah Tschenett, Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria, and was published online in Respiratory Research.
LIMITATIONS:
This study had several limitations including a small sample size, lack of a true control group, and potential selection bias due to recruitment from centers with patients already interested in mindfulness, which may have inflated adherence. Additionally, generalizability to all patients with COPD was limited, as many were either ineligible or declined to participate.
DISCLOSURES:
This study was funded by the Scientific Medical Fund of the City of Vienna and the Karl Landsteiner Institute (KLI) for Lung Research and Pulmonary Oncology. The KLI received funding from AstraZeneca, Boehringer Ingelheim, Chiesi, Linde plc, Menarini Pharma, Novartis, and Vivisol Austria. Three authors reported being employees of KLI or receiving lecture fees from some of these pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Posttraumatic Stress Disorder May Increase Morbidity Risk in Veterans With HIV
TOPLINE:
Posttraumatic stress disorder (PTSD) among veterans living with HIV significantly increased the risk for AIDS and multiple comorbidities, particularly arthritis, cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), and multimorbidity — with the greatest impact seen in the first decade after diagnosis.
METHODOLOGY:
- Researchers conducted a prospective cohort study to assess whether PTSD is associated with increased risk for adverse clinical outcomes in veterans with HIV who received care at the Department of Veterans Affairs.
- They included 3206 veterans (97.4% men; median age at HIV diagnosis, 31.7 years; 42.1% with PTSD) who were deployed in Iraq and Afghanistan while serving in the military and initiated antiretroviral therapy before December 31, 2020.
- Participants were followed-up until December 2022, with censoring at death, the last health care visit, or study termination. The association between PTSD with morbidity and mortality, considering the number of deployments and levels of combat exposure were determined.
TAKEAWAY:
- PTSD significantly increased the overall risks for AIDS by 11% (adjusted hazard ratio [aHR], 1.11), CKD by 21% (aHR, 1.21), COPD by 46% (aHR, 1.46), multimorbidity by 49% (aHR, 1.49), CVD by 57% (aHR, 1.57), and arthritis by two folds (aHR, 1.95; P <.05 for all).
- Among veterans with a single deployment, those with PTSD had 92%, 87%, 80%, 53%, 44%, 32%, and 27% higher risks for asthma, CVD, arthritis, multimorbidity, COPD, liver disease, and AIDS, respectively, than those without PTSD.
- Veterans with PTSD and combat exposure had a lower risk for AIDS but higher risks for multimorbidity, asthma, CVD, and arthritis than those never diagnosed with PTSD and unexposed to combat.
- The associations of PTSD with mortality and morbidity appeared most pronounced in the first decade post-diagnosis, followed by a gradual decline in association strength; however, risks remained elevated.
IN PRACTICE:
“It is recommended that providers who work with VWH [veterans with HIV] consider adopting a trauma-informed model of HIV care and that providers screen veterans for PTSD, so that their unique trauma history can help guide medical decisions and treatment,” the authors wrote.
SOURCE:
This study was led by Kartavya J. Vyas, PhD, Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta. It was published online in AIDS .
LIMITATIONS:
The data could not capture each individual’s true index trauma or the severity of their PTSD. Additionally, the study was limited by considerable loss to follow-up, potential uncontrolled confounding related to homelessness, and a lack of generalizability to veterans with HIV who were not receiving antiretroviral therapy.
DISCLOSURES:
The study did not receive any specific funding. Two authors reported receiving federal research support — one from the Emory Center for AIDS Research and the National Institute of Allergy and Infectious Diseases, and the other from the National Institutes of Health and the CDC — in addition to investigator-initiated grants and consulting fees from various pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Posttraumatic stress disorder (PTSD) among veterans living with HIV significantly increased the risk for AIDS and multiple comorbidities, particularly arthritis, cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), and multimorbidity — with the greatest impact seen in the first decade after diagnosis.
METHODOLOGY:
- Researchers conducted a prospective cohort study to assess whether PTSD is associated with increased risk for adverse clinical outcomes in veterans with HIV who received care at the Department of Veterans Affairs.
- They included 3206 veterans (97.4% men; median age at HIV diagnosis, 31.7 years; 42.1% with PTSD) who were deployed in Iraq and Afghanistan while serving in the military and initiated antiretroviral therapy before December 31, 2020.
- Participants were followed-up until December 2022, with censoring at death, the last health care visit, or study termination. The association between PTSD with morbidity and mortality, considering the number of deployments and levels of combat exposure were determined.
TAKEAWAY:
- PTSD significantly increased the overall risks for AIDS by 11% (adjusted hazard ratio [aHR], 1.11), CKD by 21% (aHR, 1.21), COPD by 46% (aHR, 1.46), multimorbidity by 49% (aHR, 1.49), CVD by 57% (aHR, 1.57), and arthritis by two folds (aHR, 1.95; P <.05 for all).
- Among veterans with a single deployment, those with PTSD had 92%, 87%, 80%, 53%, 44%, 32%, and 27% higher risks for asthma, CVD, arthritis, multimorbidity, COPD, liver disease, and AIDS, respectively, than those without PTSD.
- Veterans with PTSD and combat exposure had a lower risk for AIDS but higher risks for multimorbidity, asthma, CVD, and arthritis than those never diagnosed with PTSD and unexposed to combat.
- The associations of PTSD with mortality and morbidity appeared most pronounced in the first decade post-diagnosis, followed by a gradual decline in association strength; however, risks remained elevated.
IN PRACTICE:
“It is recommended that providers who work with VWH [veterans with HIV] consider adopting a trauma-informed model of HIV care and that providers screen veterans for PTSD, so that their unique trauma history can help guide medical decisions and treatment,” the authors wrote.
SOURCE:
This study was led by Kartavya J. Vyas, PhD, Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta. It was published online in AIDS .
LIMITATIONS:
The data could not capture each individual’s true index trauma or the severity of their PTSD. Additionally, the study was limited by considerable loss to follow-up, potential uncontrolled confounding related to homelessness, and a lack of generalizability to veterans with HIV who were not receiving antiretroviral therapy.
DISCLOSURES:
The study did not receive any specific funding. Two authors reported receiving federal research support — one from the Emory Center for AIDS Research and the National Institute of Allergy and Infectious Diseases, and the other from the National Institutes of Health and the CDC — in addition to investigator-initiated grants and consulting fees from various pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Posttraumatic stress disorder (PTSD) among veterans living with HIV significantly increased the risk for AIDS and multiple comorbidities, particularly arthritis, cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), and multimorbidity — with the greatest impact seen in the first decade after diagnosis.
METHODOLOGY:
- Researchers conducted a prospective cohort study to assess whether PTSD is associated with increased risk for adverse clinical outcomes in veterans with HIV who received care at the Department of Veterans Affairs.
- They included 3206 veterans (97.4% men; median age at HIV diagnosis, 31.7 years; 42.1% with PTSD) who were deployed in Iraq and Afghanistan while serving in the military and initiated antiretroviral therapy before December 31, 2020.
- Participants were followed-up until December 2022, with censoring at death, the last health care visit, or study termination. The association between PTSD with morbidity and mortality, considering the number of deployments and levels of combat exposure were determined.
TAKEAWAY:
- PTSD significantly increased the overall risks for AIDS by 11% (adjusted hazard ratio [aHR], 1.11), CKD by 21% (aHR, 1.21), COPD by 46% (aHR, 1.46), multimorbidity by 49% (aHR, 1.49), CVD by 57% (aHR, 1.57), and arthritis by two folds (aHR, 1.95; P <.05 for all).
- Among veterans with a single deployment, those with PTSD had 92%, 87%, 80%, 53%, 44%, 32%, and 27% higher risks for asthma, CVD, arthritis, multimorbidity, COPD, liver disease, and AIDS, respectively, than those without PTSD.
- Veterans with PTSD and combat exposure had a lower risk for AIDS but higher risks for multimorbidity, asthma, CVD, and arthritis than those never diagnosed with PTSD and unexposed to combat.
- The associations of PTSD with mortality and morbidity appeared most pronounced in the first decade post-diagnosis, followed by a gradual decline in association strength; however, risks remained elevated.
IN PRACTICE:
“It is recommended that providers who work with VWH [veterans with HIV] consider adopting a trauma-informed model of HIV care and that providers screen veterans for PTSD, so that their unique trauma history can help guide medical decisions and treatment,” the authors wrote.
SOURCE:
This study was led by Kartavya J. Vyas, PhD, Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta. It was published online in AIDS .
LIMITATIONS:
The data could not capture each individual’s true index trauma or the severity of their PTSD. Additionally, the study was limited by considerable loss to follow-up, potential uncontrolled confounding related to homelessness, and a lack of generalizability to veterans with HIV who were not receiving antiretroviral therapy.
DISCLOSURES:
The study did not receive any specific funding. Two authors reported receiving federal research support — one from the Emory Center for AIDS Research and the National Institute of Allergy and Infectious Diseases, and the other from the National Institutes of Health and the CDC — in addition to investigator-initiated grants and consulting fees from various pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
New RSV Vaccine Shows Strong Protection in Veterans
TOPLINE:
A single dose of the recombinant respiratory syncytial virus (RSV) vaccine demonstrates effectiveness against infections and associated hospitalizations in veterans aged 60 years or older during the 2023-2024 respiratory illness season. This protection extends across age groups and immunocompromised individuals.
METHODOLOGY:
Researchers conducted a target trial emulation study to evaluate the real-world effectiveness of a single dose of recombinant RSV vaccine (RSVPreF3 or RSVpreF) among veterans enrolled in the Veterans Health Administration in the United States between September 1 and December 31, 2023.
They analyzed 146,852 vaccinated veterans (69.2%, RSVPreF; 29.9%, RSVPreF3) propensity matched with 582,936 unvaccinated ones (median age, ~76 years; ~94% men; immunocompromised individuals, 11.2%) who were followed up for a median of 124 days.
The primary outcome was any positive RSV test result obtained from day 14 after vaccination.
The secondary outcomes were RSV-associated emergency department or urgent care visits, hospitalizations, intensive care unit (ICU) admissions, and death.
TAKEAWAY:
Vaccine effectiveness against documented RSV infections was 78.1% (95% CI, 72.6-83.5), with incidence rates of infections lower in the vaccinated group than in the unvaccinated group (1.7 vs 7.3 per 1000 person-years).
Likewise, vaccine effectiveness against RSV-associated emergency department or urgent care visits was 78.7% (95% CI, 72.2-84.8), with rates of infections lower in the vaccinated group than in the unvaccinated group (1.3 vs 5.7 per 1000 person-years).
Immunocompromised veterans demonstrated a lower vaccine effectiveness of 71.6% (95% CI, 55.4-85.2); however, infection rates remained lower in the vaccinated group than in the unvaccinated group (5.8 vs 19.9 per 1000 person-years).
Hospitalizations, ICU admission rates, and mortality rates were also lower in the vaccinated group than in the unvaccinated group.
IN PRACTICE:
“These results give confidence that an RSV vaccine for older adults is likely to provide protection against RSV infection and RSV disease, at least in the first season following vaccination,” wrote the author of an accompanying comment.
SOURCE:
The study was funded by the US Department of Veterans Affairs Cooperative Studies Program. It was published online on January 20, 2025, in The Lancet Infectious Diseases (2025 Jan 20. doi:10.1016/S1473-3099(24)00796-5)
LIMITATIONS:
This study did not account for veterans who sought care outside of the Veterans Health Administration. While the study employed rigorous matching to ensure the similarity of demographic, geographic, and clinical characteristics, there could still have been residual confounding. Also, the study was not designed to estimate the protective effect of the vaccine against mild RSV illness.
DISCLOSURES:
This study was supported by the US Department of Veterans Affairs Cooperative Studies Program and funded in part by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority and US Food and Drug Administration. One of the authors reported receiving consulting support from Van-Breemen & Hynes and having a subcontract at Oregon State University for a Patient-Centered Outcomes Research Institute grant. Others reported no conflicts of interest.■
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A single dose of the recombinant respiratory syncytial virus (RSV) vaccine demonstrates effectiveness against infections and associated hospitalizations in veterans aged 60 years or older during the 2023-2024 respiratory illness season. This protection extends across age groups and immunocompromised individuals.
METHODOLOGY:
Researchers conducted a target trial emulation study to evaluate the real-world effectiveness of a single dose of recombinant RSV vaccine (RSVPreF3 or RSVpreF) among veterans enrolled in the Veterans Health Administration in the United States between September 1 and December 31, 2023.
They analyzed 146,852 vaccinated veterans (69.2%, RSVPreF; 29.9%, RSVPreF3) propensity matched with 582,936 unvaccinated ones (median age, ~76 years; ~94% men; immunocompromised individuals, 11.2%) who were followed up for a median of 124 days.
The primary outcome was any positive RSV test result obtained from day 14 after vaccination.
The secondary outcomes were RSV-associated emergency department or urgent care visits, hospitalizations, intensive care unit (ICU) admissions, and death.
TAKEAWAY:
Vaccine effectiveness against documented RSV infections was 78.1% (95% CI, 72.6-83.5), with incidence rates of infections lower in the vaccinated group than in the unvaccinated group (1.7 vs 7.3 per 1000 person-years).
Likewise, vaccine effectiveness against RSV-associated emergency department or urgent care visits was 78.7% (95% CI, 72.2-84.8), with rates of infections lower in the vaccinated group than in the unvaccinated group (1.3 vs 5.7 per 1000 person-years).
Immunocompromised veterans demonstrated a lower vaccine effectiveness of 71.6% (95% CI, 55.4-85.2); however, infection rates remained lower in the vaccinated group than in the unvaccinated group (5.8 vs 19.9 per 1000 person-years).
Hospitalizations, ICU admission rates, and mortality rates were also lower in the vaccinated group than in the unvaccinated group.
IN PRACTICE:
“These results give confidence that an RSV vaccine for older adults is likely to provide protection against RSV infection and RSV disease, at least in the first season following vaccination,” wrote the author of an accompanying comment.
SOURCE:
The study was funded by the US Department of Veterans Affairs Cooperative Studies Program. It was published online on January 20, 2025, in The Lancet Infectious Diseases (2025 Jan 20. doi:10.1016/S1473-3099(24)00796-5)
LIMITATIONS:
This study did not account for veterans who sought care outside of the Veterans Health Administration. While the study employed rigorous matching to ensure the similarity of demographic, geographic, and clinical characteristics, there could still have been residual confounding. Also, the study was not designed to estimate the protective effect of the vaccine against mild RSV illness.
DISCLOSURES:
This study was supported by the US Department of Veterans Affairs Cooperative Studies Program and funded in part by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority and US Food and Drug Administration. One of the authors reported receiving consulting support from Van-Breemen & Hynes and having a subcontract at Oregon State University for a Patient-Centered Outcomes Research Institute grant. Others reported no conflicts of interest.■
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A single dose of the recombinant respiratory syncytial virus (RSV) vaccine demonstrates effectiveness against infections and associated hospitalizations in veterans aged 60 years or older during the 2023-2024 respiratory illness season. This protection extends across age groups and immunocompromised individuals.
METHODOLOGY:
Researchers conducted a target trial emulation study to evaluate the real-world effectiveness of a single dose of recombinant RSV vaccine (RSVPreF3 or RSVpreF) among veterans enrolled in the Veterans Health Administration in the United States between September 1 and December 31, 2023.
They analyzed 146,852 vaccinated veterans (69.2%, RSVPreF; 29.9%, RSVPreF3) propensity matched with 582,936 unvaccinated ones (median age, ~76 years; ~94% men; immunocompromised individuals, 11.2%) who were followed up for a median of 124 days.
The primary outcome was any positive RSV test result obtained from day 14 after vaccination.
The secondary outcomes were RSV-associated emergency department or urgent care visits, hospitalizations, intensive care unit (ICU) admissions, and death.
TAKEAWAY:
Vaccine effectiveness against documented RSV infections was 78.1% (95% CI, 72.6-83.5), with incidence rates of infections lower in the vaccinated group than in the unvaccinated group (1.7 vs 7.3 per 1000 person-years).
Likewise, vaccine effectiveness against RSV-associated emergency department or urgent care visits was 78.7% (95% CI, 72.2-84.8), with rates of infections lower in the vaccinated group than in the unvaccinated group (1.3 vs 5.7 per 1000 person-years).
Immunocompromised veterans demonstrated a lower vaccine effectiveness of 71.6% (95% CI, 55.4-85.2); however, infection rates remained lower in the vaccinated group than in the unvaccinated group (5.8 vs 19.9 per 1000 person-years).
Hospitalizations, ICU admission rates, and mortality rates were also lower in the vaccinated group than in the unvaccinated group.
IN PRACTICE:
“These results give confidence that an RSV vaccine for older adults is likely to provide protection against RSV infection and RSV disease, at least in the first season following vaccination,” wrote the author of an accompanying comment.
SOURCE:
The study was funded by the US Department of Veterans Affairs Cooperative Studies Program. It was published online on January 20, 2025, in The Lancet Infectious Diseases (2025 Jan 20. doi:10.1016/S1473-3099(24)00796-5)
LIMITATIONS:
This study did not account for veterans who sought care outside of the Veterans Health Administration. While the study employed rigorous matching to ensure the similarity of demographic, geographic, and clinical characteristics, there could still have been residual confounding. Also, the study was not designed to estimate the protective effect of the vaccine against mild RSV illness.
DISCLOSURES:
This study was supported by the US Department of Veterans Affairs Cooperative Studies Program and funded in part by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority and US Food and Drug Administration. One of the authors reported receiving consulting support from Van-Breemen & Hynes and having a subcontract at Oregon State University for a Patient-Centered Outcomes Research Institute grant. Others reported no conflicts of interest.■
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Cost Barriers Influence Adherence to Asthma Care
TOPLINE:
Nearly one in six adults with asthma in the United States is nonadherent to medications due to costs, with younger patients, women, and those without insurance having an increased likelihood of being nonadherent.
METHODOLOGY:
- Researchers evaluated the prevalence and determinants of cost-related nonadherence (CRN) to medications among adults with asthma in the United States between 2011 and 2022. Data were obtained from the National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics.
- They used the data from the NHIS to include a total of 30,793 adults who had asthma, representing 8.1% of the US population.
- CRN was defined through three components: Skipping medication doses, taking less medication, or delaying medication refills to save money over the past 12 months.
- CRN prevalence, factors associated with CRN, and asthma-related adverse events were analyzed.
TAKEAWAY:
- Overall, 17.8% of US adults with asthma reported CRN; 11.6% skipped medication, 12.4% took less medication, and 15.1% delayed refilling medications to save money.
- Patients aged > 60 years were the least likely to report CRN compared with those aged 18-40 years and 41-60 years; women were more likely to report CRN to medications than men (both P < .01).
- Patients who were current or former smokers or had two or more comorbidities, no health insurance coverage, or a family income below 400% of the federal poverty level had an increased likelihood of reporting CRN.
- Compared with patients without CRN, those who reported CRN had almost double the odds of experiencing asthma attacks (adjusted odds ratio [aOR], 1.95; 95% CI, 1.78-2.13) and increased emergency room visits for asthma (aOR, 1.63; 95% CI, 1.44-1.84).
IN PRACTICE:
“The present study reinforces the recommendation that patients with asthma are best controlled when they are prescribed and take medications that are strongly recommended by clinical guidelines,” the authors wrote. “For healthcare providers, it is imperative to monitor patient’s adherence to medications to prevent asthma exacerbations, especially when treating patients with financial concerns,” they further added.
SOURCE:
The study was led by Chun-Tse Hung, School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan. It was published online in Thorax.
LIMITATIONS:
The reliance on self-reported data introduced potential recall bias, and the absence of medical records may have led to misclassification of disease status. The study could not evaluate the effect of asthma severity due to limited measures in the NHIS. Some important variables reflecting economic indicators, such as the consumer price index, could not be included due to limited measures in the NHIS.
DISCLOSURES:
No disclosures or conflicts of interest statements were provided in the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Nearly one in six adults with asthma in the United States is nonadherent to medications due to costs, with younger patients, women, and those without insurance having an increased likelihood of being nonadherent.
METHODOLOGY:
- Researchers evaluated the prevalence and determinants of cost-related nonadherence (CRN) to medications among adults with asthma in the United States between 2011 and 2022. Data were obtained from the National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics.
- They used the data from the NHIS to include a total of 30,793 adults who had asthma, representing 8.1% of the US population.
- CRN was defined through three components: Skipping medication doses, taking less medication, or delaying medication refills to save money over the past 12 months.
- CRN prevalence, factors associated with CRN, and asthma-related adverse events were analyzed.
TAKEAWAY:
- Overall, 17.8% of US adults with asthma reported CRN; 11.6% skipped medication, 12.4% took less medication, and 15.1% delayed refilling medications to save money.
- Patients aged > 60 years were the least likely to report CRN compared with those aged 18-40 years and 41-60 years; women were more likely to report CRN to medications than men (both P < .01).
- Patients who were current or former smokers or had two or more comorbidities, no health insurance coverage, or a family income below 400% of the federal poverty level had an increased likelihood of reporting CRN.
- Compared with patients without CRN, those who reported CRN had almost double the odds of experiencing asthma attacks (adjusted odds ratio [aOR], 1.95; 95% CI, 1.78-2.13) and increased emergency room visits for asthma (aOR, 1.63; 95% CI, 1.44-1.84).
IN PRACTICE:
“The present study reinforces the recommendation that patients with asthma are best controlled when they are prescribed and take medications that are strongly recommended by clinical guidelines,” the authors wrote. “For healthcare providers, it is imperative to monitor patient’s adherence to medications to prevent asthma exacerbations, especially when treating patients with financial concerns,” they further added.
SOURCE:
The study was led by Chun-Tse Hung, School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan. It was published online in Thorax.
LIMITATIONS:
The reliance on self-reported data introduced potential recall bias, and the absence of medical records may have led to misclassification of disease status. The study could not evaluate the effect of asthma severity due to limited measures in the NHIS. Some important variables reflecting economic indicators, such as the consumer price index, could not be included due to limited measures in the NHIS.
DISCLOSURES:
No disclosures or conflicts of interest statements were provided in the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Nearly one in six adults with asthma in the United States is nonadherent to medications due to costs, with younger patients, women, and those without insurance having an increased likelihood of being nonadherent.
METHODOLOGY:
- Researchers evaluated the prevalence and determinants of cost-related nonadherence (CRN) to medications among adults with asthma in the United States between 2011 and 2022. Data were obtained from the National Health Interview Survey (NHIS) conducted by the National Center for Health Statistics.
- They used the data from the NHIS to include a total of 30,793 adults who had asthma, representing 8.1% of the US population.
- CRN was defined through three components: Skipping medication doses, taking less medication, or delaying medication refills to save money over the past 12 months.
- CRN prevalence, factors associated with CRN, and asthma-related adverse events were analyzed.
TAKEAWAY:
- Overall, 17.8% of US adults with asthma reported CRN; 11.6% skipped medication, 12.4% took less medication, and 15.1% delayed refilling medications to save money.
- Patients aged > 60 years were the least likely to report CRN compared with those aged 18-40 years and 41-60 years; women were more likely to report CRN to medications than men (both P < .01).
- Patients who were current or former smokers or had two or more comorbidities, no health insurance coverage, or a family income below 400% of the federal poverty level had an increased likelihood of reporting CRN.
- Compared with patients without CRN, those who reported CRN had almost double the odds of experiencing asthma attacks (adjusted odds ratio [aOR], 1.95; 95% CI, 1.78-2.13) and increased emergency room visits for asthma (aOR, 1.63; 95% CI, 1.44-1.84).
IN PRACTICE:
“The present study reinforces the recommendation that patients with asthma are best controlled when they are prescribed and take medications that are strongly recommended by clinical guidelines,” the authors wrote. “For healthcare providers, it is imperative to monitor patient’s adherence to medications to prevent asthma exacerbations, especially when treating patients with financial concerns,” they further added.
SOURCE:
The study was led by Chun-Tse Hung, School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan. It was published online in Thorax.
LIMITATIONS:
The reliance on self-reported data introduced potential recall bias, and the absence of medical records may have led to misclassification of disease status. The study could not evaluate the effect of asthma severity due to limited measures in the NHIS. Some important variables reflecting economic indicators, such as the consumer price index, could not be included due to limited measures in the NHIS.
DISCLOSURES:
No disclosures or conflicts of interest statements were provided in the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Hypermucoviscous K pneumoniae Shows Reduced Drug Resistance
TOPLINE:
Hypermucoviscous Klebsiella pneumoniae (hmKp) strains demonstrate a significantly lower prevalence of extended-spectrum beta-lactamase (ESBL) production and slightly lower carbapenem resistance than non-hmKp strains, according to a recent meta-analysis of 2049 clinical isolates.
METHODOLOGY:
- Researchers conducted a meta-analysis to assess the prevalence of ESBL-producing strains and carbapenem-resistant strains among the hmKp and non-hmKp clinical isolates.
- They included 15 studies published between 2014 and 2023, with 2049 clinical isolates of K pneumoniae identified using a string test to distinguish hypermucoviscous from non-hypermucoviscous strains.
- These studies spanned across four continents: Asia, Africa, Europe, and North America.
- The primary outcome was the prevalence of ESBL-producing and carbapenem-resistant strains, determined through antimicrobial susceptibility testing.
TAKEAWAY:
- The hmKp strains were associated with a significantly lower prevalence of ESBL-producing strains than non-hmKp strains (pooled odds ratio [OR], 0.26; P = .003).
- Similarly, hmKp strains were associated with a slightly lower prevalence of carbapenem-resistant strains than non-hmKp strains (pooled OR, 0.63; P = .038).
IN PRACTICE:
“Therapeutic options for CRKP [carbapenem-resistant K pneumoniae] infections are extremely limited due to the scarcity of effective antibacterial drugs. Therefore, it is crucial to consider the risks posed by CRKP strains when administering treatment to patients with hmKp infections and a history of the aforementioned risk factors,” the authors wrote.
SOURCE:
The study was led by Hiroki Namikawa, Department of Medical Education and General Practice, Graduate School of Medicine, Osaka Metropolitan University, Japan. It was published online on December 16, 2024, in Emerging Microbes & Infections.
LIMITATIONS:
Only three databases (PubMed, Scopus, and Cochrane Library) were searched for identifying studies, potentially missing relevant studies from other sources. Furthermore, only articles published in English were included, which may have restricted the scope of analysis. Additionally, geographical distribution was predominantly limited to Asia, limiting the global applicability of the results.
DISCLOSURES:
No funding sources were mentioned, and no conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Hypermucoviscous Klebsiella pneumoniae (hmKp) strains demonstrate a significantly lower prevalence of extended-spectrum beta-lactamase (ESBL) production and slightly lower carbapenem resistance than non-hmKp strains, according to a recent meta-analysis of 2049 clinical isolates.
METHODOLOGY:
- Researchers conducted a meta-analysis to assess the prevalence of ESBL-producing strains and carbapenem-resistant strains among the hmKp and non-hmKp clinical isolates.
- They included 15 studies published between 2014 and 2023, with 2049 clinical isolates of K pneumoniae identified using a string test to distinguish hypermucoviscous from non-hypermucoviscous strains.
- These studies spanned across four continents: Asia, Africa, Europe, and North America.
- The primary outcome was the prevalence of ESBL-producing and carbapenem-resistant strains, determined through antimicrobial susceptibility testing.
TAKEAWAY:
- The hmKp strains were associated with a significantly lower prevalence of ESBL-producing strains than non-hmKp strains (pooled odds ratio [OR], 0.26; P = .003).
- Similarly, hmKp strains were associated with a slightly lower prevalence of carbapenem-resistant strains than non-hmKp strains (pooled OR, 0.63; P = .038).
IN PRACTICE:
“Therapeutic options for CRKP [carbapenem-resistant K pneumoniae] infections are extremely limited due to the scarcity of effective antibacterial drugs. Therefore, it is crucial to consider the risks posed by CRKP strains when administering treatment to patients with hmKp infections and a history of the aforementioned risk factors,” the authors wrote.
SOURCE:
The study was led by Hiroki Namikawa, Department of Medical Education and General Practice, Graduate School of Medicine, Osaka Metropolitan University, Japan. It was published online on December 16, 2024, in Emerging Microbes & Infections.
LIMITATIONS:
Only three databases (PubMed, Scopus, and Cochrane Library) were searched for identifying studies, potentially missing relevant studies from other sources. Furthermore, only articles published in English were included, which may have restricted the scope of analysis. Additionally, geographical distribution was predominantly limited to Asia, limiting the global applicability of the results.
DISCLOSURES:
No funding sources were mentioned, and no conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Hypermucoviscous Klebsiella pneumoniae (hmKp) strains demonstrate a significantly lower prevalence of extended-spectrum beta-lactamase (ESBL) production and slightly lower carbapenem resistance than non-hmKp strains, according to a recent meta-analysis of 2049 clinical isolates.
METHODOLOGY:
- Researchers conducted a meta-analysis to assess the prevalence of ESBL-producing strains and carbapenem-resistant strains among the hmKp and non-hmKp clinical isolates.
- They included 15 studies published between 2014 and 2023, with 2049 clinical isolates of K pneumoniae identified using a string test to distinguish hypermucoviscous from non-hypermucoviscous strains.
- These studies spanned across four continents: Asia, Africa, Europe, and North America.
- The primary outcome was the prevalence of ESBL-producing and carbapenem-resistant strains, determined through antimicrobial susceptibility testing.
TAKEAWAY:
- The hmKp strains were associated with a significantly lower prevalence of ESBL-producing strains than non-hmKp strains (pooled odds ratio [OR], 0.26; P = .003).
- Similarly, hmKp strains were associated with a slightly lower prevalence of carbapenem-resistant strains than non-hmKp strains (pooled OR, 0.63; P = .038).
IN PRACTICE:
“Therapeutic options for CRKP [carbapenem-resistant K pneumoniae] infections are extremely limited due to the scarcity of effective antibacterial drugs. Therefore, it is crucial to consider the risks posed by CRKP strains when administering treatment to patients with hmKp infections and a history of the aforementioned risk factors,” the authors wrote.
SOURCE:
The study was led by Hiroki Namikawa, Department of Medical Education and General Practice, Graduate School of Medicine, Osaka Metropolitan University, Japan. It was published online on December 16, 2024, in Emerging Microbes & Infections.
LIMITATIONS:
Only three databases (PubMed, Scopus, and Cochrane Library) were searched for identifying studies, potentially missing relevant studies from other sources. Furthermore, only articles published in English were included, which may have restricted the scope of analysis. Additionally, geographical distribution was predominantly limited to Asia, limiting the global applicability of the results.
DISCLOSURES:
No funding sources were mentioned, and no conflicts of interest were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Exercising Longer May Boost Weight Loss, Meta-Analysis Shows
TOPLINE:
Aerobic exercise shows a linear relationship with weight loss, with 30 minutes of weekly exercise linked to reduced body weight, waist circumference, and body fat in adults who were overweight or had obesity.
METHODOLOGY:
- Researchers conducted a meta-analysis of randomized clinical trials to investigate the association of varying intensities and durations of aerobic exercise with adiposity measures in adults with obesity or who were overweight.
- Overall, 116 randomized clinical trials that spanned across North America, Asia, Europe, Australia, South America, and Africa and involved 6880 adults (mean age, 46 years; 61% women) were included.
- The trials were required to have intervention durations of at least 8 weeks; all trials used supervised aerobic exercise, such as walking or running, while the control groups remained sedentary or continued usual activities.
- The intensity of exercise was defined as: Light (40%-55% maximum heart rate), moderate (55%-70% maximum heart rate), and vigorous (70%-90% maximum heart rate).
- The primary outcomes were body weight changes and adverse events; the secondary outcomes included changes in waist circumference, quality-of-life scores, and reduction in medications like antihypertensives.
TAKEAWAY:
- Every 30 minutes of aerobic exercise per week was also associated with lower waist circumference (mean difference, −0.56 cm; 95% CI, –0.67 to –0.45), body fat percentage (mean difference, –0.37%; 95% CI, –0.43 to –0.31), and body fat mass (mean difference, –0.20 kg; 95% CI, –0.32 to –0.08), along with reduced visceral and subcutaneous adipose tissue.
- A dose-response meta-analysis revealed that body fat percentage improved most significantly with 150 minutes of aerobic exercise per week, while body weight and waist circumference decreased linearly with increasing duration of aerobic exercise at 300 min/wk at different intensities.
- Adverse events with aerobic exercise were mostly mild or moderate musculoskeletal symptoms.
IN PRACTICE:
“Point-specific estimates for different aerobic exercise duration and intensity can help patients and healthcare professionals select the optimal aerobic exercise duration and intensity according to their weight loss goals,” the authors wrote.
SOURCE:
The study was led by Ahmad Jayedi, PhD, of the Department of Epidemiology and Biostatistics in the School of Public Health at the Imperial College London in England. It was published online on December 26, 2024, in JAMA Network Open.
LIMITATIONS:
High heterogeneity was present in the data. Only one trial included measures of health-related quality of life, and two studies included measures of medication use. Dietary habits and smoking status of participants were not included in studies, so any potential effects were not risk adjusted for.
DISCLOSURES:
No funding sources were reported. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Aerobic exercise shows a linear relationship with weight loss, with 30 minutes of weekly exercise linked to reduced body weight, waist circumference, and body fat in adults who were overweight or had obesity.
METHODOLOGY:
- Researchers conducted a meta-analysis of randomized clinical trials to investigate the association of varying intensities and durations of aerobic exercise with adiposity measures in adults with obesity or who were overweight.
- Overall, 116 randomized clinical trials that spanned across North America, Asia, Europe, Australia, South America, and Africa and involved 6880 adults (mean age, 46 years; 61% women) were included.
- The trials were required to have intervention durations of at least 8 weeks; all trials used supervised aerobic exercise, such as walking or running, while the control groups remained sedentary or continued usual activities.
- The intensity of exercise was defined as: Light (40%-55% maximum heart rate), moderate (55%-70% maximum heart rate), and vigorous (70%-90% maximum heart rate).
- The primary outcomes were body weight changes and adverse events; the secondary outcomes included changes in waist circumference, quality-of-life scores, and reduction in medications like antihypertensives.
TAKEAWAY:
- Every 30 minutes of aerobic exercise per week was also associated with lower waist circumference (mean difference, −0.56 cm; 95% CI, –0.67 to –0.45), body fat percentage (mean difference, –0.37%; 95% CI, –0.43 to –0.31), and body fat mass (mean difference, –0.20 kg; 95% CI, –0.32 to –0.08), along with reduced visceral and subcutaneous adipose tissue.
- A dose-response meta-analysis revealed that body fat percentage improved most significantly with 150 minutes of aerobic exercise per week, while body weight and waist circumference decreased linearly with increasing duration of aerobic exercise at 300 min/wk at different intensities.
- Adverse events with aerobic exercise were mostly mild or moderate musculoskeletal symptoms.
IN PRACTICE:
“Point-specific estimates for different aerobic exercise duration and intensity can help patients and healthcare professionals select the optimal aerobic exercise duration and intensity according to their weight loss goals,” the authors wrote.
SOURCE:
The study was led by Ahmad Jayedi, PhD, of the Department of Epidemiology and Biostatistics in the School of Public Health at the Imperial College London in England. It was published online on December 26, 2024, in JAMA Network Open.
LIMITATIONS:
High heterogeneity was present in the data. Only one trial included measures of health-related quality of life, and two studies included measures of medication use. Dietary habits and smoking status of participants were not included in studies, so any potential effects were not risk adjusted for.
DISCLOSURES:
No funding sources were reported. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Aerobic exercise shows a linear relationship with weight loss, with 30 minutes of weekly exercise linked to reduced body weight, waist circumference, and body fat in adults who were overweight or had obesity.
METHODOLOGY:
- Researchers conducted a meta-analysis of randomized clinical trials to investigate the association of varying intensities and durations of aerobic exercise with adiposity measures in adults with obesity or who were overweight.
- Overall, 116 randomized clinical trials that spanned across North America, Asia, Europe, Australia, South America, and Africa and involved 6880 adults (mean age, 46 years; 61% women) were included.
- The trials were required to have intervention durations of at least 8 weeks; all trials used supervised aerobic exercise, such as walking or running, while the control groups remained sedentary or continued usual activities.
- The intensity of exercise was defined as: Light (40%-55% maximum heart rate), moderate (55%-70% maximum heart rate), and vigorous (70%-90% maximum heart rate).
- The primary outcomes were body weight changes and adverse events; the secondary outcomes included changes in waist circumference, quality-of-life scores, and reduction in medications like antihypertensives.
TAKEAWAY:
- Every 30 minutes of aerobic exercise per week was also associated with lower waist circumference (mean difference, −0.56 cm; 95% CI, –0.67 to –0.45), body fat percentage (mean difference, –0.37%; 95% CI, –0.43 to –0.31), and body fat mass (mean difference, –0.20 kg; 95% CI, –0.32 to –0.08), along with reduced visceral and subcutaneous adipose tissue.
- A dose-response meta-analysis revealed that body fat percentage improved most significantly with 150 minutes of aerobic exercise per week, while body weight and waist circumference decreased linearly with increasing duration of aerobic exercise at 300 min/wk at different intensities.
- Adverse events with aerobic exercise were mostly mild or moderate musculoskeletal symptoms.
IN PRACTICE:
“Point-specific estimates for different aerobic exercise duration and intensity can help patients and healthcare professionals select the optimal aerobic exercise duration and intensity according to their weight loss goals,” the authors wrote.
SOURCE:
The study was led by Ahmad Jayedi, PhD, of the Department of Epidemiology and Biostatistics in the School of Public Health at the Imperial College London in England. It was published online on December 26, 2024, in JAMA Network Open.
LIMITATIONS:
High heterogeneity was present in the data. Only one trial included measures of health-related quality of life, and two studies included measures of medication use. Dietary habits and smoking status of participants were not included in studies, so any potential effects were not risk adjusted for.
DISCLOSURES:
No funding sources were reported. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Education Boosts Safe Sharps Disposal in Diabetic Care
TOPLINE:
A program combining theoretical training with free disposal containers can effectively increase knowledge and improve sharps waste disposal practices among patients with diabetes.
METHODOLOGY:
- A significant number of patients with diabetes administer insulin at home. Unsafe waste disposal including insulin pens, syringes, and lancets increases the risk for needle-stick injuries, microbial infections, and plastic waste accumulation, highlighting the need for safe disposal practices.
- Researchers conducted an experimental study at El-Horraya Polyclinic in Alexandria, Egypt, between November 2022 and April 2023 to evaluate the effectiveness of an intervention program in improving knowledge and practices related to safe sharps disposal among patients with diabetes.
- Overall, 100 patients (median age, 61 years; 92% living in urban areas) with either type 1 or type 2 diabetes were recruited and divided into the educational intervention (n = 50) and nonintervention (n = 50) groups; majority (67%) had diabetes for more than 10 years.
- The intervention group received educational sessions addressing improper disposal risks and environmental impacts along with practical demonstrations of correct sharps disposal methods; they were also given free puncture-resistant containers to safely dispose of the sharp waste generated from diabetes management.
- Assessments were performed at baseline, 2 months, and 4 months postintervention, evaluating knowledge levels (poor: < 50%, fair: 50% to < 70%, good: 70%-100%) and practice scores (poor: 0-6, fair: 7-10, good: 11-14).
TAKEAWAY:
- Overall, 58% of the patients used insulin pens, and approximately 75% required two doses of insulin daily.
- The median monthly disposal was 10 syringes per patient among syringe users and eight pen needles per patient among pen users.
- At baseline, there were no differences in the knowledge scores between the intervention and nonintervention groups; however, at both 2 and 4 months, the intervention group showed a significantly higher median knowledge score than the nonintervention group (P < .001 for both).
- Likewise, practice scores also showed marked improvements in the intervention group, compared with the nonintervention group at the end of the program (P < .001).
IN PRACTICE:
“The success of the environmental education program underscores the need for targeted interventions to enhance patient knowledge and safe sharps disposal practices. By offering accessible disposal options and raising awareness, healthcare facilities can significantly contribute to preventing accidental needle-stick injuries and reducing the risk of infectious disease transmission,” the authors wrote.
SOURCE:
This study was led by Hossam Mohamed Hassan Soliman, High Institute of Public Health, Alexandria University, Egypt. It was published online in Scientific Reports.
LIMITATIONS:
Interview bias and self-reporting bias in data collection were major limitations of this study. The quasi-experimental design, lacking randomization, may have limited the strength of causal inferences.
DISCLOSURES:
No funding was received for this study, and the authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A program combining theoretical training with free disposal containers can effectively increase knowledge and improve sharps waste disposal practices among patients with diabetes.
METHODOLOGY:
- A significant number of patients with diabetes administer insulin at home. Unsafe waste disposal including insulin pens, syringes, and lancets increases the risk for needle-stick injuries, microbial infections, and plastic waste accumulation, highlighting the need for safe disposal practices.
- Researchers conducted an experimental study at El-Horraya Polyclinic in Alexandria, Egypt, between November 2022 and April 2023 to evaluate the effectiveness of an intervention program in improving knowledge and practices related to safe sharps disposal among patients with diabetes.
- Overall, 100 patients (median age, 61 years; 92% living in urban areas) with either type 1 or type 2 diabetes were recruited and divided into the educational intervention (n = 50) and nonintervention (n = 50) groups; majority (67%) had diabetes for more than 10 years.
- The intervention group received educational sessions addressing improper disposal risks and environmental impacts along with practical demonstrations of correct sharps disposal methods; they were also given free puncture-resistant containers to safely dispose of the sharp waste generated from diabetes management.
- Assessments were performed at baseline, 2 months, and 4 months postintervention, evaluating knowledge levels (poor: < 50%, fair: 50% to < 70%, good: 70%-100%) and practice scores (poor: 0-6, fair: 7-10, good: 11-14).
TAKEAWAY:
- Overall, 58% of the patients used insulin pens, and approximately 75% required two doses of insulin daily.
- The median monthly disposal was 10 syringes per patient among syringe users and eight pen needles per patient among pen users.
- At baseline, there were no differences in the knowledge scores between the intervention and nonintervention groups; however, at both 2 and 4 months, the intervention group showed a significantly higher median knowledge score than the nonintervention group (P < .001 for both).
- Likewise, practice scores also showed marked improvements in the intervention group, compared with the nonintervention group at the end of the program (P < .001).
IN PRACTICE:
“The success of the environmental education program underscores the need for targeted interventions to enhance patient knowledge and safe sharps disposal practices. By offering accessible disposal options and raising awareness, healthcare facilities can significantly contribute to preventing accidental needle-stick injuries and reducing the risk of infectious disease transmission,” the authors wrote.
SOURCE:
This study was led by Hossam Mohamed Hassan Soliman, High Institute of Public Health, Alexandria University, Egypt. It was published online in Scientific Reports.
LIMITATIONS:
Interview bias and self-reporting bias in data collection were major limitations of this study. The quasi-experimental design, lacking randomization, may have limited the strength of causal inferences.
DISCLOSURES:
No funding was received for this study, and the authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A program combining theoretical training with free disposal containers can effectively increase knowledge and improve sharps waste disposal practices among patients with diabetes.
METHODOLOGY:
- A significant number of patients with diabetes administer insulin at home. Unsafe waste disposal including insulin pens, syringes, and lancets increases the risk for needle-stick injuries, microbial infections, and plastic waste accumulation, highlighting the need for safe disposal practices.
- Researchers conducted an experimental study at El-Horraya Polyclinic in Alexandria, Egypt, between November 2022 and April 2023 to evaluate the effectiveness of an intervention program in improving knowledge and practices related to safe sharps disposal among patients with diabetes.
- Overall, 100 patients (median age, 61 years; 92% living in urban areas) with either type 1 or type 2 diabetes were recruited and divided into the educational intervention (n = 50) and nonintervention (n = 50) groups; majority (67%) had diabetes for more than 10 years.
- The intervention group received educational sessions addressing improper disposal risks and environmental impacts along with practical demonstrations of correct sharps disposal methods; they were also given free puncture-resistant containers to safely dispose of the sharp waste generated from diabetes management.
- Assessments were performed at baseline, 2 months, and 4 months postintervention, evaluating knowledge levels (poor: < 50%, fair: 50% to < 70%, good: 70%-100%) and practice scores (poor: 0-6, fair: 7-10, good: 11-14).
TAKEAWAY:
- Overall, 58% of the patients used insulin pens, and approximately 75% required two doses of insulin daily.
- The median monthly disposal was 10 syringes per patient among syringe users and eight pen needles per patient among pen users.
- At baseline, there were no differences in the knowledge scores between the intervention and nonintervention groups; however, at both 2 and 4 months, the intervention group showed a significantly higher median knowledge score than the nonintervention group (P < .001 for both).
- Likewise, practice scores also showed marked improvements in the intervention group, compared with the nonintervention group at the end of the program (P < .001).
IN PRACTICE:
“The success of the environmental education program underscores the need for targeted interventions to enhance patient knowledge and safe sharps disposal practices. By offering accessible disposal options and raising awareness, healthcare facilities can significantly contribute to preventing accidental needle-stick injuries and reducing the risk of infectious disease transmission,” the authors wrote.
SOURCE:
This study was led by Hossam Mohamed Hassan Soliman, High Institute of Public Health, Alexandria University, Egypt. It was published online in Scientific Reports.
LIMITATIONS:
Interview bias and self-reporting bias in data collection were major limitations of this study. The quasi-experimental design, lacking randomization, may have limited the strength of causal inferences.
DISCLOSURES:
No funding was received for this study, and the authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Stem Cell Transplant Effective for Children With Arthritis
TOPLINE:
METHODOLOGY:
- Retrospective cohort study of 13 children with refractory systemic juvenile idiopathic arthritis–related lung disease (sJIA-LD) who had allogeneic hematopoietic stem cell transplantation (HSCT).
- Children whose median age was 9 years at transplantation underwent HSCT at nine hospitals in the United States and Europe between January 2018 and October 2022, with a median follow-up of 16 months.
- Outcomes included transplant-related complications, pulmonary outcomes (eg, oxygen dependence and chest CT findings), and overall outcomes (eg, complete response, partial response, and death).
TAKEAWAY:
- Five patients developed acute graft vs host disease of varying grades, but none experienced chronic disease.
- All nine surviving patients achieved a complete response at the last follow-up, with no sJIA characteristics or need for immunosuppressive therapy or supplemental oxygen.
- Four patients died from complications including cytomegalovirus pneumonitis (n = 2), intracranial hemorrhage (n = 1), and progressive sJIA-LD (n = 1).
- Of six patients who underwent posttransplant chest CT, three had improved lung health, two had stable lung disease, and one experienced worsening lung disease, ultimately resulting in death.
IN PRACTICE:
“Allogeneic HSCT should be considered for treatment-refractory sJIA-LD,” the authors wrote.
“Efforts are being pursued for earlier recognition of patients with sJIA-LD at risk of adverse reactions to biologics. Early detection should help to avoid repeated treatments that are less effective and possibly deleterious and consider therapeutic approaches (eg, anti–[interleukin]-18 or [interferon]-delta–targeted treatments) that might act as a bridge therapy to control disease activity before HSCT,” wrote the author of an accompanying editorial.
SOURCE:
Michael G. Matt, MD, and Daniel Drozdov, MD, led the study, which was published online on December 20, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Limitations included sampling bias and heterogeneity in clinical follow-up. The small sample size made it difficult to identify variables affecting survival and the achievement of a complete response. Additionally, many patients had relatively short follow-up periods.
DISCLOSURES:
This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. Several authors reported receiving advisory board fees, consulting fees, honoraria, grant funds, and stocks and shares from various research institutes and pharmaceutical organizations.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Retrospective cohort study of 13 children with refractory systemic juvenile idiopathic arthritis–related lung disease (sJIA-LD) who had allogeneic hematopoietic stem cell transplantation (HSCT).
- Children whose median age was 9 years at transplantation underwent HSCT at nine hospitals in the United States and Europe between January 2018 and October 2022, with a median follow-up of 16 months.
- Outcomes included transplant-related complications, pulmonary outcomes (eg, oxygen dependence and chest CT findings), and overall outcomes (eg, complete response, partial response, and death).
TAKEAWAY:
- Five patients developed acute graft vs host disease of varying grades, but none experienced chronic disease.
- All nine surviving patients achieved a complete response at the last follow-up, with no sJIA characteristics or need for immunosuppressive therapy or supplemental oxygen.
- Four patients died from complications including cytomegalovirus pneumonitis (n = 2), intracranial hemorrhage (n = 1), and progressive sJIA-LD (n = 1).
- Of six patients who underwent posttransplant chest CT, three had improved lung health, two had stable lung disease, and one experienced worsening lung disease, ultimately resulting in death.
IN PRACTICE:
“Allogeneic HSCT should be considered for treatment-refractory sJIA-LD,” the authors wrote.
“Efforts are being pursued for earlier recognition of patients with sJIA-LD at risk of adverse reactions to biologics. Early detection should help to avoid repeated treatments that are less effective and possibly deleterious and consider therapeutic approaches (eg, anti–[interleukin]-18 or [interferon]-delta–targeted treatments) that might act as a bridge therapy to control disease activity before HSCT,” wrote the author of an accompanying editorial.
SOURCE:
Michael G. Matt, MD, and Daniel Drozdov, MD, led the study, which was published online on December 20, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Limitations included sampling bias and heterogeneity in clinical follow-up. The small sample size made it difficult to identify variables affecting survival and the achievement of a complete response. Additionally, many patients had relatively short follow-up periods.
DISCLOSURES:
This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. Several authors reported receiving advisory board fees, consulting fees, honoraria, grant funds, and stocks and shares from various research institutes and pharmaceutical organizations.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Retrospective cohort study of 13 children with refractory systemic juvenile idiopathic arthritis–related lung disease (sJIA-LD) who had allogeneic hematopoietic stem cell transplantation (HSCT).
- Children whose median age was 9 years at transplantation underwent HSCT at nine hospitals in the United States and Europe between January 2018 and October 2022, with a median follow-up of 16 months.
- Outcomes included transplant-related complications, pulmonary outcomes (eg, oxygen dependence and chest CT findings), and overall outcomes (eg, complete response, partial response, and death).
TAKEAWAY:
- Five patients developed acute graft vs host disease of varying grades, but none experienced chronic disease.
- All nine surviving patients achieved a complete response at the last follow-up, with no sJIA characteristics or need for immunosuppressive therapy or supplemental oxygen.
- Four patients died from complications including cytomegalovirus pneumonitis (n = 2), intracranial hemorrhage (n = 1), and progressive sJIA-LD (n = 1).
- Of six patients who underwent posttransplant chest CT, three had improved lung health, two had stable lung disease, and one experienced worsening lung disease, ultimately resulting in death.
IN PRACTICE:
“Allogeneic HSCT should be considered for treatment-refractory sJIA-LD,” the authors wrote.
“Efforts are being pursued for earlier recognition of patients with sJIA-LD at risk of adverse reactions to biologics. Early detection should help to avoid repeated treatments that are less effective and possibly deleterious and consider therapeutic approaches (eg, anti–[interleukin]-18 or [interferon]-delta–targeted treatments) that might act as a bridge therapy to control disease activity before HSCT,” wrote the author of an accompanying editorial.
SOURCE:
Michael G. Matt, MD, and Daniel Drozdov, MD, led the study, which was published online on December 20, 2024, in The Lancet Rheumatology.
LIMITATIONS:
Limitations included sampling bias and heterogeneity in clinical follow-up. The small sample size made it difficult to identify variables affecting survival and the achievement of a complete response. Additionally, many patients had relatively short follow-up periods.
DISCLOSURES:
This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. Several authors reported receiving advisory board fees, consulting fees, honoraria, grant funds, and stocks and shares from various research institutes and pharmaceutical organizations.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Colchicine Gout Flare Prophylaxis May Also Protect Against Cardiovascular Events
TOPLINE:
Gout patients who take colchicine at the start of urate-lowering therapy have a lower risk for cardiovascular events than those who do not receive prophylaxis.
METHODOLOGY:
- Retrospective cohort study of 99,800 patients (mean age, 62.8 years; 74.4% men; 85.1% White) newly diagnosed with gout between January 1997 and March 2021 who initiated urate-lowering therapy.
- Gout flare prophylaxis, defined as a colchicine prescription for 21 days or more, was prescribed to 16,028 patients for a mean duration of 47.3 days at a mean daily dose of 0.97 mg.
- Patients who received colchicine prophylaxis and 83,772 patients who did not receive prophylaxis were followed for a mean of 175.5 and 176.9 days, respectively, in the intention-to-treat analysis.
- The primary outcome was the occurrence of the first cardiovascular event (fatal or nonfatal myocardial infarction or stroke) within 180 days of initiation of urate-lowering therapy.
TAKEAWAY:
- The risk for cardiovascular events was significantly lower with colchicine prophylaxis than without it (weighted hazard ratio [HR], 0.82; 95% CI, 0.69-0.94).
- The risk for a first-ever cardiovascular event was significantly lower with colchicine prophylaxis than without it (adjusted HR, 0.80; 95% CI, 0.62-0.97).
- The findings were similar regardless of analytical approach, and the intention-to-treat analysis did not show an increased risk for diarrhea with colchicine.
IN PRACTICE:
“The findings support consideration for the use of colchicine in people with gout and cardiovascular diseases,” the authors wrote.
“The observed beneficial effect of colchicine concerns a huge group of patients worldwide. In addition, it is conceivable that, if a cardiovascular risk reduction is indeed confirmed, a strong argument arises to recommend the prescription of a course of colchicine to all [flaring] patients with gout, independently of their preference for urate-lowering therapy in general or urate-lowering therapy with or without colchicine prophylaxis more specifically,” experts wrote in a linked commentary.
SOURCE:
Edoardo Cipolletta, MD, Academic Rheumatology, School of Medicine, Nottingham City Hospital, University of Nottingham, England, led the study, which was published online in The Lancet Rheumatology.
LIMITATIONS:
Because of the retrospective nature of the data extraction from a prospective database, the study had variations in follow-up and data completeness. Potential surveillance bias could have been introduced because patients with prior cardiovascular events were included in the study, and patients’ adherence to prescribed medications could not be verified.
DISCLOSURES:
This study was funded by the Foundation for Research in Rheumatology. Some authors reported receiving consulting fees, lecturing fees, and travel grants from various pharmaceutical companies and other additional sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Gout patients who take colchicine at the start of urate-lowering therapy have a lower risk for cardiovascular events than those who do not receive prophylaxis.
METHODOLOGY:
- Retrospective cohort study of 99,800 patients (mean age, 62.8 years; 74.4% men; 85.1% White) newly diagnosed with gout between January 1997 and March 2021 who initiated urate-lowering therapy.
- Gout flare prophylaxis, defined as a colchicine prescription for 21 days or more, was prescribed to 16,028 patients for a mean duration of 47.3 days at a mean daily dose of 0.97 mg.
- Patients who received colchicine prophylaxis and 83,772 patients who did not receive prophylaxis were followed for a mean of 175.5 and 176.9 days, respectively, in the intention-to-treat analysis.
- The primary outcome was the occurrence of the first cardiovascular event (fatal or nonfatal myocardial infarction or stroke) within 180 days of initiation of urate-lowering therapy.
TAKEAWAY:
- The risk for cardiovascular events was significantly lower with colchicine prophylaxis than without it (weighted hazard ratio [HR], 0.82; 95% CI, 0.69-0.94).
- The risk for a first-ever cardiovascular event was significantly lower with colchicine prophylaxis than without it (adjusted HR, 0.80; 95% CI, 0.62-0.97).
- The findings were similar regardless of analytical approach, and the intention-to-treat analysis did not show an increased risk for diarrhea with colchicine.
IN PRACTICE:
“The findings support consideration for the use of colchicine in people with gout and cardiovascular diseases,” the authors wrote.
“The observed beneficial effect of colchicine concerns a huge group of patients worldwide. In addition, it is conceivable that, if a cardiovascular risk reduction is indeed confirmed, a strong argument arises to recommend the prescription of a course of colchicine to all [flaring] patients with gout, independently of their preference for urate-lowering therapy in general or urate-lowering therapy with or without colchicine prophylaxis more specifically,” experts wrote in a linked commentary.
SOURCE:
Edoardo Cipolletta, MD, Academic Rheumatology, School of Medicine, Nottingham City Hospital, University of Nottingham, England, led the study, which was published online in The Lancet Rheumatology.
LIMITATIONS:
Because of the retrospective nature of the data extraction from a prospective database, the study had variations in follow-up and data completeness. Potential surveillance bias could have been introduced because patients with prior cardiovascular events were included in the study, and patients’ adherence to prescribed medications could not be verified.
DISCLOSURES:
This study was funded by the Foundation for Research in Rheumatology. Some authors reported receiving consulting fees, lecturing fees, and travel grants from various pharmaceutical companies and other additional sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Gout patients who take colchicine at the start of urate-lowering therapy have a lower risk for cardiovascular events than those who do not receive prophylaxis.
METHODOLOGY:
- Retrospective cohort study of 99,800 patients (mean age, 62.8 years; 74.4% men; 85.1% White) newly diagnosed with gout between January 1997 and March 2021 who initiated urate-lowering therapy.
- Gout flare prophylaxis, defined as a colchicine prescription for 21 days or more, was prescribed to 16,028 patients for a mean duration of 47.3 days at a mean daily dose of 0.97 mg.
- Patients who received colchicine prophylaxis and 83,772 patients who did not receive prophylaxis were followed for a mean of 175.5 and 176.9 days, respectively, in the intention-to-treat analysis.
- The primary outcome was the occurrence of the first cardiovascular event (fatal or nonfatal myocardial infarction or stroke) within 180 days of initiation of urate-lowering therapy.
TAKEAWAY:
- The risk for cardiovascular events was significantly lower with colchicine prophylaxis than without it (weighted hazard ratio [HR], 0.82; 95% CI, 0.69-0.94).
- The risk for a first-ever cardiovascular event was significantly lower with colchicine prophylaxis than without it (adjusted HR, 0.80; 95% CI, 0.62-0.97).
- The findings were similar regardless of analytical approach, and the intention-to-treat analysis did not show an increased risk for diarrhea with colchicine.
IN PRACTICE:
“The findings support consideration for the use of colchicine in people with gout and cardiovascular diseases,” the authors wrote.
“The observed beneficial effect of colchicine concerns a huge group of patients worldwide. In addition, it is conceivable that, if a cardiovascular risk reduction is indeed confirmed, a strong argument arises to recommend the prescription of a course of colchicine to all [flaring] patients with gout, independently of their preference for urate-lowering therapy in general or urate-lowering therapy with or without colchicine prophylaxis more specifically,” experts wrote in a linked commentary.
SOURCE:
Edoardo Cipolletta, MD, Academic Rheumatology, School of Medicine, Nottingham City Hospital, University of Nottingham, England, led the study, which was published online in The Lancet Rheumatology.
LIMITATIONS:
Because of the retrospective nature of the data extraction from a prospective database, the study had variations in follow-up and data completeness. Potential surveillance bias could have been introduced because patients with prior cardiovascular events were included in the study, and patients’ adherence to prescribed medications could not be verified.
DISCLOSURES:
This study was funded by the Foundation for Research in Rheumatology. Some authors reported receiving consulting fees, lecturing fees, and travel grants from various pharmaceutical companies and other additional sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Novel JAK1 Inhibitor Effective for RA in Phase 3 Study
TOPLINE:
(RA) who have an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
METHODOLOGY:
- This phase 3 trial, conducted across 59 sites in China, evaluated the efficacy and safety of ivarmacitinib in patients with moderate to severe active RA despite treatment with one or more csDMARDs.
- The patients were randomly assigned to receive either placebo (n = 188; mean age, 50.9 years; 85.6% women) or 4 mg ivarmacitinib (n = 189; mean age, 49.7 years; 91% women) or 8 mg ivarmacitinib (n = 189; mean age, 49.8 years; 83.6% women) once daily for 24 weeks, alongside background csDMARDs.
- After 24 weeks, the patients receiving placebo were switched to receive 4 mg ivarmacitinib for the additional 28-week extension period, whereas those receiving ivarmacitinib continued their initial dosage.
- Secondary endpoints included the proportion of patients achieving American College of Rheumatology (ACR) 50/70 responses and, Disease Activity Score 28-joint count C-reactive protein (DAS28(CRP)) score < 2.6 or ≤ 3.2, as well as measures of other patient-reported outcomes such as pain, physical function, and quality of life at 24 and 52 weeks.
TAKEAWAY:
- At 24 weeks, the proportion of patients achieving a 20% improvement in the ACR20 response — the primary endpoint — was higher among those receiving 4 mg ivarmacitinib (70.4%) or 8 mg ivarmacitinib (75.1%) than among those receiving placebo (40.4%; P < .0001 for both comparisons), with the efficacy either maintained or improved through 52 weeks.
- The proportion of patients achieving ACR50/70 responses or a DAS28(CRP) score < 2.6 or ≤ 3.2 was higher in the ivarmacitinib groups than in the placebo group (P < .0001 for all comparisons).
- Compared with the placebo group, both the ivarmacitinib groups showed improvements in patient-reported outcomes such as pain, physical function, quality of life, and duration and severity of morning stiffness.
- The overall rates of treatment discontinuation caused by adverse events were low across all the groups, with no deaths, tuberculosis or gastrointestinal perforations reported throughout the 52 weeks.
IN PRACTICE:
“Based on these findings, ivarmacitinib with background csDMARDs allowed, could be considered a treatment option in patients with moderate to severe active RA who have an inadequate response to csDMARDs,” the authors wrote.
SOURCE:
This study was led by Jinjing Liu and Xiaofeng Zeng, Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, China. It was published online on November 27, 2024, in Annals of the Rheumatic Diseases.
LIMITATIONS:
As the study was conducted in a Chinese population, the findings may have limited applicability across diverse global populations. Additionally, as the placebo-controlled period was limited to 24 weeks because of ethical concerns, comparisons between placebo and ivarmacitinib beyond that period were restricted. Lastly, this study was not powered to compare efficacy and safety between the two active dose regimens.
DISCLOSURES:
This study was funded by Jiangsu Hengrui Pharmaceuticals. Two authors declared being employees of the company. The other authors reported no competing interests.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
(RA) who have an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
METHODOLOGY:
- This phase 3 trial, conducted across 59 sites in China, evaluated the efficacy and safety of ivarmacitinib in patients with moderate to severe active RA despite treatment with one or more csDMARDs.
- The patients were randomly assigned to receive either placebo (n = 188; mean age, 50.9 years; 85.6% women) or 4 mg ivarmacitinib (n = 189; mean age, 49.7 years; 91% women) or 8 mg ivarmacitinib (n = 189; mean age, 49.8 years; 83.6% women) once daily for 24 weeks, alongside background csDMARDs.
- After 24 weeks, the patients receiving placebo were switched to receive 4 mg ivarmacitinib for the additional 28-week extension period, whereas those receiving ivarmacitinib continued their initial dosage.
- Secondary endpoints included the proportion of patients achieving American College of Rheumatology (ACR) 50/70 responses and, Disease Activity Score 28-joint count C-reactive protein (DAS28(CRP)) score < 2.6 or ≤ 3.2, as well as measures of other patient-reported outcomes such as pain, physical function, and quality of life at 24 and 52 weeks.
TAKEAWAY:
- At 24 weeks, the proportion of patients achieving a 20% improvement in the ACR20 response — the primary endpoint — was higher among those receiving 4 mg ivarmacitinib (70.4%) or 8 mg ivarmacitinib (75.1%) than among those receiving placebo (40.4%; P < .0001 for both comparisons), with the efficacy either maintained or improved through 52 weeks.
- The proportion of patients achieving ACR50/70 responses or a DAS28(CRP) score < 2.6 or ≤ 3.2 was higher in the ivarmacitinib groups than in the placebo group (P < .0001 for all comparisons).
- Compared with the placebo group, both the ivarmacitinib groups showed improvements in patient-reported outcomes such as pain, physical function, quality of life, and duration and severity of morning stiffness.
- The overall rates of treatment discontinuation caused by adverse events were low across all the groups, with no deaths, tuberculosis or gastrointestinal perforations reported throughout the 52 weeks.
IN PRACTICE:
“Based on these findings, ivarmacitinib with background csDMARDs allowed, could be considered a treatment option in patients with moderate to severe active RA who have an inadequate response to csDMARDs,” the authors wrote.
SOURCE:
This study was led by Jinjing Liu and Xiaofeng Zeng, Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, China. It was published online on November 27, 2024, in Annals of the Rheumatic Diseases.
LIMITATIONS:
As the study was conducted in a Chinese population, the findings may have limited applicability across diverse global populations. Additionally, as the placebo-controlled period was limited to 24 weeks because of ethical concerns, comparisons between placebo and ivarmacitinib beyond that period were restricted. Lastly, this study was not powered to compare efficacy and safety between the two active dose regimens.
DISCLOSURES:
This study was funded by Jiangsu Hengrui Pharmaceuticals. Two authors declared being employees of the company. The other authors reported no competing interests.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
(RA) who have an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).
METHODOLOGY:
- This phase 3 trial, conducted across 59 sites in China, evaluated the efficacy and safety of ivarmacitinib in patients with moderate to severe active RA despite treatment with one or more csDMARDs.
- The patients were randomly assigned to receive either placebo (n = 188; mean age, 50.9 years; 85.6% women) or 4 mg ivarmacitinib (n = 189; mean age, 49.7 years; 91% women) or 8 mg ivarmacitinib (n = 189; mean age, 49.8 years; 83.6% women) once daily for 24 weeks, alongside background csDMARDs.
- After 24 weeks, the patients receiving placebo were switched to receive 4 mg ivarmacitinib for the additional 28-week extension period, whereas those receiving ivarmacitinib continued their initial dosage.
- Secondary endpoints included the proportion of patients achieving American College of Rheumatology (ACR) 50/70 responses and, Disease Activity Score 28-joint count C-reactive protein (DAS28(CRP)) score < 2.6 or ≤ 3.2, as well as measures of other patient-reported outcomes such as pain, physical function, and quality of life at 24 and 52 weeks.
TAKEAWAY:
- At 24 weeks, the proportion of patients achieving a 20% improvement in the ACR20 response — the primary endpoint — was higher among those receiving 4 mg ivarmacitinib (70.4%) or 8 mg ivarmacitinib (75.1%) than among those receiving placebo (40.4%; P < .0001 for both comparisons), with the efficacy either maintained or improved through 52 weeks.
- The proportion of patients achieving ACR50/70 responses or a DAS28(CRP) score < 2.6 or ≤ 3.2 was higher in the ivarmacitinib groups than in the placebo group (P < .0001 for all comparisons).
- Compared with the placebo group, both the ivarmacitinib groups showed improvements in patient-reported outcomes such as pain, physical function, quality of life, and duration and severity of morning stiffness.
- The overall rates of treatment discontinuation caused by adverse events were low across all the groups, with no deaths, tuberculosis or gastrointestinal perforations reported throughout the 52 weeks.
IN PRACTICE:
“Based on these findings, ivarmacitinib with background csDMARDs allowed, could be considered a treatment option in patients with moderate to severe active RA who have an inadequate response to csDMARDs,” the authors wrote.
SOURCE:
This study was led by Jinjing Liu and Xiaofeng Zeng, Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, China. It was published online on November 27, 2024, in Annals of the Rheumatic Diseases.
LIMITATIONS:
As the study was conducted in a Chinese population, the findings may have limited applicability across diverse global populations. Additionally, as the placebo-controlled period was limited to 24 weeks because of ethical concerns, comparisons between placebo and ivarmacitinib beyond that period were restricted. Lastly, this study was not powered to compare efficacy and safety between the two active dose regimens.
DISCLOSURES:
This study was funded by Jiangsu Hengrui Pharmaceuticals. Two authors declared being employees of the company. The other authors reported no competing interests.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.