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COVID-19 Is a Very Weird Virus
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
In the early days of the pandemic, before we really understood what COVID was, two specialties in the hospital had a foreboding sense that something was very strange about this virus. The first was the pulmonologists, who noticed the striking levels of hypoxemia — low oxygen in the blood — and the rapidity with which patients who had previously been stable would crash in the intensive care unit.
The second, and I mark myself among this group, were the nephrologists. The dialysis machines stopped working right. I remember rounding on patients in the hospital who were on dialysis for kidney failure in the setting of severe COVID infection and seeing clots forming on the dialysis filters. Some patients could barely get in a full treatment because the filters would clog so quickly.
We knew it was worse than flu because of the mortality rates, but these oddities made us realize that it was different too — not just a particularly nasty respiratory virus but one that had effects on the body that we hadn’t really seen before.
That’s why I’ve always been interested in studies that compare what happens to patients after COVID infection vs what happens to patients after other respiratory infections. This week, we’ll look at an intriguing study that suggests that COVID may lead to autoimmune diseases like rheumatoid arthritis, lupus, and vasculitis.
The study appears in the Annals of Internal Medicine and is made possible by the universal electronic health record systems of South Korea and Japan, who collaborated to create a truly staggering cohort of more than 20 million individuals living in those countries from 2020 to 2021.
The exposure of interest? COVID infection, experienced by just under 5% of that cohort over the study period. (Remember, there was a time when COVID infections were relatively controlled, particularly in some countries.)
The researchers wanted to compare the risk for autoimmune disease among COVID-infected individuals against two control groups. The first control group was the general population. This is interesting but a difficult analysis, because people who become infected with COVID might be very different from the general population. The second control group was people infected with influenza. I like this a lot better; the risk factors for COVID and influenza are quite similar, and the fact that this group was diagnosed with flu means at least that they are getting medical care and are sort of “in the system,” so to speak.
But it’s not enough to simply identify these folks and see who ends up with more autoimmune disease. The authors used propensity score matching to pair individuals infected with COVID with individuals from the control groups who were very similar to them. I’ve talked about this strategy before, but the basic idea is that you build a model predicting the likelihood of infection with COVID, based on a slew of factors — and the slew these authors used is pretty big, as shown below — and then stick people with similar risk for COVID together, with one member of the pair having had COVID and the other having eluded it (at least for the study period).
After this statistical balancing, the authors looked at the risk for a variety of autoimmune diseases.
Compared with those infected with flu, those infected with COVID were more likely to be diagnosed with any autoimmune condition, connective tissue disease, and, in Japan at least, inflammatory arthritis.
The authors acknowledge that being diagnosed with a disease might not be the same as actually having the disease, so in another analysis they looked only at people who received treatment for the autoimmune conditions, and the signals were even stronger in that group.
This risk seemed to be highest in the 6 months following the COVID infection, which makes sense biologically if we think that the infection is somehow screwing up the immune system.
And the risk was similar with both COVID variants circulating at the time of the study.
The only factor that reduced the risk? You guessed it: vaccination. This is a particularly interesting finding because the exposure cohort was defined by having been infected with COVID. Therefore, the mechanism of protection is not prevention of infection; it’s something else. Perhaps vaccination helps to get the immune system in a state to respond to COVID infection more… appropriately?
Yes, this study is observational. We can’t draw causal conclusions here. But it does reinforce my long-held belief that COVID is a weird virus, one with effects that are different from the respiratory viruses we are used to. I can’t say for certain whether COVID causes immune system dysfunction that puts someone at risk for autoimmunity — not from this study. But I can say it wouldn’t surprise me.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
In the early days of the pandemic, before we really understood what COVID was, two specialties in the hospital had a foreboding sense that something was very strange about this virus. The first was the pulmonologists, who noticed the striking levels of hypoxemia — low oxygen in the blood — and the rapidity with which patients who had previously been stable would crash in the intensive care unit.
The second, and I mark myself among this group, were the nephrologists. The dialysis machines stopped working right. I remember rounding on patients in the hospital who were on dialysis for kidney failure in the setting of severe COVID infection and seeing clots forming on the dialysis filters. Some patients could barely get in a full treatment because the filters would clog so quickly.
We knew it was worse than flu because of the mortality rates, but these oddities made us realize that it was different too — not just a particularly nasty respiratory virus but one that had effects on the body that we hadn’t really seen before.
That’s why I’ve always been interested in studies that compare what happens to patients after COVID infection vs what happens to patients after other respiratory infections. This week, we’ll look at an intriguing study that suggests that COVID may lead to autoimmune diseases like rheumatoid arthritis, lupus, and vasculitis.
The study appears in the Annals of Internal Medicine and is made possible by the universal electronic health record systems of South Korea and Japan, who collaborated to create a truly staggering cohort of more than 20 million individuals living in those countries from 2020 to 2021.
The exposure of interest? COVID infection, experienced by just under 5% of that cohort over the study period. (Remember, there was a time when COVID infections were relatively controlled, particularly in some countries.)
The researchers wanted to compare the risk for autoimmune disease among COVID-infected individuals against two control groups. The first control group was the general population. This is interesting but a difficult analysis, because people who become infected with COVID might be very different from the general population. The second control group was people infected with influenza. I like this a lot better; the risk factors for COVID and influenza are quite similar, and the fact that this group was diagnosed with flu means at least that they are getting medical care and are sort of “in the system,” so to speak.
But it’s not enough to simply identify these folks and see who ends up with more autoimmune disease. The authors used propensity score matching to pair individuals infected with COVID with individuals from the control groups who were very similar to them. I’ve talked about this strategy before, but the basic idea is that you build a model predicting the likelihood of infection with COVID, based on a slew of factors — and the slew these authors used is pretty big, as shown below — and then stick people with similar risk for COVID together, with one member of the pair having had COVID and the other having eluded it (at least for the study period).
After this statistical balancing, the authors looked at the risk for a variety of autoimmune diseases.
Compared with those infected with flu, those infected with COVID were more likely to be diagnosed with any autoimmune condition, connective tissue disease, and, in Japan at least, inflammatory arthritis.
The authors acknowledge that being diagnosed with a disease might not be the same as actually having the disease, so in another analysis they looked only at people who received treatment for the autoimmune conditions, and the signals were even stronger in that group.
This risk seemed to be highest in the 6 months following the COVID infection, which makes sense biologically if we think that the infection is somehow screwing up the immune system.
And the risk was similar with both COVID variants circulating at the time of the study.
The only factor that reduced the risk? You guessed it: vaccination. This is a particularly interesting finding because the exposure cohort was defined by having been infected with COVID. Therefore, the mechanism of protection is not prevention of infection; it’s something else. Perhaps vaccination helps to get the immune system in a state to respond to COVID infection more… appropriately?
Yes, this study is observational. We can’t draw causal conclusions here. But it does reinforce my long-held belief that COVID is a weird virus, one with effects that are different from the respiratory viruses we are used to. I can’t say for certain whether COVID causes immune system dysfunction that puts someone at risk for autoimmunity — not from this study. But I can say it wouldn’t surprise me.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
In the early days of the pandemic, before we really understood what COVID was, two specialties in the hospital had a foreboding sense that something was very strange about this virus. The first was the pulmonologists, who noticed the striking levels of hypoxemia — low oxygen in the blood — and the rapidity with which patients who had previously been stable would crash in the intensive care unit.
The second, and I mark myself among this group, were the nephrologists. The dialysis machines stopped working right. I remember rounding on patients in the hospital who were on dialysis for kidney failure in the setting of severe COVID infection and seeing clots forming on the dialysis filters. Some patients could barely get in a full treatment because the filters would clog so quickly.
We knew it was worse than flu because of the mortality rates, but these oddities made us realize that it was different too — not just a particularly nasty respiratory virus but one that had effects on the body that we hadn’t really seen before.
That’s why I’ve always been interested in studies that compare what happens to patients after COVID infection vs what happens to patients after other respiratory infections. This week, we’ll look at an intriguing study that suggests that COVID may lead to autoimmune diseases like rheumatoid arthritis, lupus, and vasculitis.
The study appears in the Annals of Internal Medicine and is made possible by the universal electronic health record systems of South Korea and Japan, who collaborated to create a truly staggering cohort of more than 20 million individuals living in those countries from 2020 to 2021.
The exposure of interest? COVID infection, experienced by just under 5% of that cohort over the study period. (Remember, there was a time when COVID infections were relatively controlled, particularly in some countries.)
The researchers wanted to compare the risk for autoimmune disease among COVID-infected individuals against two control groups. The first control group was the general population. This is interesting but a difficult analysis, because people who become infected with COVID might be very different from the general population. The second control group was people infected with influenza. I like this a lot better; the risk factors for COVID and influenza are quite similar, and the fact that this group was diagnosed with flu means at least that they are getting medical care and are sort of “in the system,” so to speak.
But it’s not enough to simply identify these folks and see who ends up with more autoimmune disease. The authors used propensity score matching to pair individuals infected with COVID with individuals from the control groups who were very similar to them. I’ve talked about this strategy before, but the basic idea is that you build a model predicting the likelihood of infection with COVID, based on a slew of factors — and the slew these authors used is pretty big, as shown below — and then stick people with similar risk for COVID together, with one member of the pair having had COVID and the other having eluded it (at least for the study period).
After this statistical balancing, the authors looked at the risk for a variety of autoimmune diseases.
Compared with those infected with flu, those infected with COVID were more likely to be diagnosed with any autoimmune condition, connective tissue disease, and, in Japan at least, inflammatory arthritis.
The authors acknowledge that being diagnosed with a disease might not be the same as actually having the disease, so in another analysis they looked only at people who received treatment for the autoimmune conditions, and the signals were even stronger in that group.
This risk seemed to be highest in the 6 months following the COVID infection, which makes sense biologically if we think that the infection is somehow screwing up the immune system.
And the risk was similar with both COVID variants circulating at the time of the study.
The only factor that reduced the risk? You guessed it: vaccination. This is a particularly interesting finding because the exposure cohort was defined by having been infected with COVID. Therefore, the mechanism of protection is not prevention of infection; it’s something else. Perhaps vaccination helps to get the immune system in a state to respond to COVID infection more… appropriately?
Yes, this study is observational. We can’t draw causal conclusions here. But it does reinforce my long-held belief that COVID is a weird virus, one with effects that are different from the respiratory viruses we are used to. I can’t say for certain whether COVID causes immune system dysfunction that puts someone at risk for autoimmunity — not from this study. But I can say it wouldn’t surprise me.
Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Artificially Sweetened Drinks Linked to Increased AF Risk
TOPLINE:
(AF) in a new observational study.
METHODOLOGY:
- The population-based cohort study looked at the associations of sugar-sweetened beverages, artificial sweetened beverages, and pure fruit juice consumption with the risk for incident AF and evaluated whether genetic susceptibility modifies these associations.
- The authors analyzed data from the UK Biobank on 201,856 participants who were free of baseline AF, had genetic data available, and completed a 24-hour diet questionnaire. The diagnosis of AF was obtained by linkage from primary care, hospital inpatient, and death register records.
- The results were adjusted for a wide range of potential confounders including age, sex, ethnicity, education level, socioeconomic status, smoking, alcohol consumption, physical activity level, sleep duration, body mass index, blood pressure, kidney function, sleep apnea, coronary heart disease, diabetes, and the use of lipid-lowering or antihypertensive medication.
TAKEAWAY:
- During a median follow-up of 9.9 years, 9362 incident AF cases were documented.
- Compared with nonconsumers, individuals who consumed more than 2 L per week of artificially sweetened beverages had a 20% increased risk of developing AF (hazard ratio [HR], 1.20; 95% CI, 1.10-1.31).
- Those who drank more than 2 L per week of sugar-sweetened beverages had a 10% increased risk for AF (HR, 1.10; 95% CI, 1.01-1.20).
- Consumption of 1 L or less per week of pure fruit juice was associated with an 8% lower risk of developing AF (HR, 0.92; 95% CI, 0.87-0.97).
- The associations persisted after adjustment for genetic susceptibility for AF.
IN PRACTICE:
The study authors concluded that this study does not demonstrate that consumption of sugar-sweetened or artificially sweetened beverages alters AF risk but rather that the consumption of these drinks may predict AF risk beyond traditional risk factors. They added that intervention studies and basic research are warranted to confirm whether the observed associations are causal. Commenting on the study, Duane Mellor, MD, registered dietitian at Aston University, Birmingham, England, said it is unclear if the observations in this study are a chance finding as there is a lack of a clear biological link. Naveed Sattar, MD, professor of metabolic medicine at the University of Glasgow, Glasgow, Scotland, added that although the authors tried to adjust for many factors, there is a strong chance that other behavioral aspects linked to beverage choice could be more relevant as a cause of AF rather than the drinks themselves. Tom Sanders, MD, professor emeritus of nutrition and dietetics, King’s College London, London, England, pointed out that as this is the first study that has reported such an effect with artificially sweetened drinks, the finding needs replication before any conclusions can be drawn. “It remains good dietary advice to recommend the consumption of low-calorie artificially sweetened drink in place of sugar-sweetened drinks and alcohol,” he added.
SOURCE:
The study, led by Ying Sun, MD, Shanghai Jiao Tong University School of Medicine, Shanghai, China, was published online in Circulation: Arrhythmia and Electrophysiology.
LIMITATIONS:
The consumption of beverages was self-reported and based on only five separate single-day food intake recalls which were taken over the first 3 years of the study, which was extrapolated to estimate weekly intake. The researchers could not tell whether the sugar-sweetened and artificially sweetened drinks were caffeinated and could not rule out residual confounding by other unmeasured or unknown factors.
DISCLOSURES:
This study was supported by the National Natural Science Foundation of China, Shanghai Municipal Health Commission, Shanghai Municipal Human Resources and Social Security Bureau, Clinical Research Plan of Shanghai Hospital Development Center, Postdoctoral Scientific Research Foundation of Shanghai Ninth People’s Hospital, and Shanghai Jiao Tong University School of Medicine.
A version of this article appeared on Medscape.com.
TOPLINE:
(AF) in a new observational study.
METHODOLOGY:
- The population-based cohort study looked at the associations of sugar-sweetened beverages, artificial sweetened beverages, and pure fruit juice consumption with the risk for incident AF and evaluated whether genetic susceptibility modifies these associations.
- The authors analyzed data from the UK Biobank on 201,856 participants who were free of baseline AF, had genetic data available, and completed a 24-hour diet questionnaire. The diagnosis of AF was obtained by linkage from primary care, hospital inpatient, and death register records.
- The results were adjusted for a wide range of potential confounders including age, sex, ethnicity, education level, socioeconomic status, smoking, alcohol consumption, physical activity level, sleep duration, body mass index, blood pressure, kidney function, sleep apnea, coronary heart disease, diabetes, and the use of lipid-lowering or antihypertensive medication.
TAKEAWAY:
- During a median follow-up of 9.9 years, 9362 incident AF cases were documented.
- Compared with nonconsumers, individuals who consumed more than 2 L per week of artificially sweetened beverages had a 20% increased risk of developing AF (hazard ratio [HR], 1.20; 95% CI, 1.10-1.31).
- Those who drank more than 2 L per week of sugar-sweetened beverages had a 10% increased risk for AF (HR, 1.10; 95% CI, 1.01-1.20).
- Consumption of 1 L or less per week of pure fruit juice was associated with an 8% lower risk of developing AF (HR, 0.92; 95% CI, 0.87-0.97).
- The associations persisted after adjustment for genetic susceptibility for AF.
IN PRACTICE:
The study authors concluded that this study does not demonstrate that consumption of sugar-sweetened or artificially sweetened beverages alters AF risk but rather that the consumption of these drinks may predict AF risk beyond traditional risk factors. They added that intervention studies and basic research are warranted to confirm whether the observed associations are causal. Commenting on the study, Duane Mellor, MD, registered dietitian at Aston University, Birmingham, England, said it is unclear if the observations in this study are a chance finding as there is a lack of a clear biological link. Naveed Sattar, MD, professor of metabolic medicine at the University of Glasgow, Glasgow, Scotland, added that although the authors tried to adjust for many factors, there is a strong chance that other behavioral aspects linked to beverage choice could be more relevant as a cause of AF rather than the drinks themselves. Tom Sanders, MD, professor emeritus of nutrition and dietetics, King’s College London, London, England, pointed out that as this is the first study that has reported such an effect with artificially sweetened drinks, the finding needs replication before any conclusions can be drawn. “It remains good dietary advice to recommend the consumption of low-calorie artificially sweetened drink in place of sugar-sweetened drinks and alcohol,” he added.
SOURCE:
The study, led by Ying Sun, MD, Shanghai Jiao Tong University School of Medicine, Shanghai, China, was published online in Circulation: Arrhythmia and Electrophysiology.
LIMITATIONS:
The consumption of beverages was self-reported and based on only five separate single-day food intake recalls which were taken over the first 3 years of the study, which was extrapolated to estimate weekly intake. The researchers could not tell whether the sugar-sweetened and artificially sweetened drinks were caffeinated and could not rule out residual confounding by other unmeasured or unknown factors.
DISCLOSURES:
This study was supported by the National Natural Science Foundation of China, Shanghai Municipal Health Commission, Shanghai Municipal Human Resources and Social Security Bureau, Clinical Research Plan of Shanghai Hospital Development Center, Postdoctoral Scientific Research Foundation of Shanghai Ninth People’s Hospital, and Shanghai Jiao Tong University School of Medicine.
A version of this article appeared on Medscape.com.
TOPLINE:
(AF) in a new observational study.
METHODOLOGY:
- The population-based cohort study looked at the associations of sugar-sweetened beverages, artificial sweetened beverages, and pure fruit juice consumption with the risk for incident AF and evaluated whether genetic susceptibility modifies these associations.
- The authors analyzed data from the UK Biobank on 201,856 participants who were free of baseline AF, had genetic data available, and completed a 24-hour diet questionnaire. The diagnosis of AF was obtained by linkage from primary care, hospital inpatient, and death register records.
- The results were adjusted for a wide range of potential confounders including age, sex, ethnicity, education level, socioeconomic status, smoking, alcohol consumption, physical activity level, sleep duration, body mass index, blood pressure, kidney function, sleep apnea, coronary heart disease, diabetes, and the use of lipid-lowering or antihypertensive medication.
TAKEAWAY:
- During a median follow-up of 9.9 years, 9362 incident AF cases were documented.
- Compared with nonconsumers, individuals who consumed more than 2 L per week of artificially sweetened beverages had a 20% increased risk of developing AF (hazard ratio [HR], 1.20; 95% CI, 1.10-1.31).
- Those who drank more than 2 L per week of sugar-sweetened beverages had a 10% increased risk for AF (HR, 1.10; 95% CI, 1.01-1.20).
- Consumption of 1 L or less per week of pure fruit juice was associated with an 8% lower risk of developing AF (HR, 0.92; 95% CI, 0.87-0.97).
- The associations persisted after adjustment for genetic susceptibility for AF.
IN PRACTICE:
The study authors concluded that this study does not demonstrate that consumption of sugar-sweetened or artificially sweetened beverages alters AF risk but rather that the consumption of these drinks may predict AF risk beyond traditional risk factors. They added that intervention studies and basic research are warranted to confirm whether the observed associations are causal. Commenting on the study, Duane Mellor, MD, registered dietitian at Aston University, Birmingham, England, said it is unclear if the observations in this study are a chance finding as there is a lack of a clear biological link. Naveed Sattar, MD, professor of metabolic medicine at the University of Glasgow, Glasgow, Scotland, added that although the authors tried to adjust for many factors, there is a strong chance that other behavioral aspects linked to beverage choice could be more relevant as a cause of AF rather than the drinks themselves. Tom Sanders, MD, professor emeritus of nutrition and dietetics, King’s College London, London, England, pointed out that as this is the first study that has reported such an effect with artificially sweetened drinks, the finding needs replication before any conclusions can be drawn. “It remains good dietary advice to recommend the consumption of low-calorie artificially sweetened drink in place of sugar-sweetened drinks and alcohol,” he added.
SOURCE:
The study, led by Ying Sun, MD, Shanghai Jiao Tong University School of Medicine, Shanghai, China, was published online in Circulation: Arrhythmia and Electrophysiology.
LIMITATIONS:
The consumption of beverages was self-reported and based on only five separate single-day food intake recalls which were taken over the first 3 years of the study, which was extrapolated to estimate weekly intake. The researchers could not tell whether the sugar-sweetened and artificially sweetened drinks were caffeinated and could not rule out residual confounding by other unmeasured or unknown factors.
DISCLOSURES:
This study was supported by the National Natural Science Foundation of China, Shanghai Municipal Health Commission, Shanghai Municipal Human Resources and Social Security Bureau, Clinical Research Plan of Shanghai Hospital Development Center, Postdoctoral Scientific Research Foundation of Shanghai Ninth People’s Hospital, and Shanghai Jiao Tong University School of Medicine.
A version of this article appeared on Medscape.com.
Another Neurotoxin for Frown Lines Enters the Market
The Food and Drug Administration (FDA) has approved letibotulinumtoxinA-wlbg, an injectable neurotoxin long used in South Korea for the treatment of moderate to severe glabellar (frown) lines in adults. Developed by Hugel, the product is being marketed under the brand name Letybo.
The FDA’s approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1000 individuals in the United States and Europe. According to information in the package insert, the most common adverse reaction reported in the trials was headache, which occurred in 2% of trial participants. Other adverse events reported by fewer than 1% of trial participants included brow ptosis, eyelid ptosis, and blepharospasm, while the most frequently reported injection site reactions included administrative site swelling, facial pain, folliculitis, and periorbital hematoma.
According to a press release from the company, letibotulinumtoxinA-wlbg has been the leading neurotoxin brand in South Korea for 7 consecutive years, and the product has been sold in more than 50 different countries. Hugel plans to launch Letybo for US-based aesthetic clinicians in the latter half of 2024.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved letibotulinumtoxinA-wlbg, an injectable neurotoxin long used in South Korea for the treatment of moderate to severe glabellar (frown) lines in adults. Developed by Hugel, the product is being marketed under the brand name Letybo.
The FDA’s approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1000 individuals in the United States and Europe. According to information in the package insert, the most common adverse reaction reported in the trials was headache, which occurred in 2% of trial participants. Other adverse events reported by fewer than 1% of trial participants included brow ptosis, eyelid ptosis, and blepharospasm, while the most frequently reported injection site reactions included administrative site swelling, facial pain, folliculitis, and periorbital hematoma.
According to a press release from the company, letibotulinumtoxinA-wlbg has been the leading neurotoxin brand in South Korea for 7 consecutive years, and the product has been sold in more than 50 different countries. Hugel plans to launch Letybo for US-based aesthetic clinicians in the latter half of 2024.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved letibotulinumtoxinA-wlbg, an injectable neurotoxin long used in South Korea for the treatment of moderate to severe glabellar (frown) lines in adults. Developed by Hugel, the product is being marketed under the brand name Letybo.
The FDA’s approval was based on positive results from three phase 3 trials of letibotulinumtoxinA-wlbg that enrolled more than 1000 individuals in the United States and Europe. According to information in the package insert, the most common adverse reaction reported in the trials was headache, which occurred in 2% of trial participants. Other adverse events reported by fewer than 1% of trial participants included brow ptosis, eyelid ptosis, and blepharospasm, while the most frequently reported injection site reactions included administrative site swelling, facial pain, folliculitis, and periorbital hematoma.
According to a press release from the company, letibotulinumtoxinA-wlbg has been the leading neurotoxin brand in South Korea for 7 consecutive years, and the product has been sold in more than 50 different countries. Hugel plans to launch Letybo for US-based aesthetic clinicians in the latter half of 2024.
A version of this article appeared on Medscape.com.
Effect of Metformin Across Renal Function States in Diabetes
TOPLINE:
Metformin cuts the risk for diabetic nephropathy (DN) and major kidney and cardiovascular events in patients with newly diagnosed type 2 diabetes (T2D) across various renal function states.
METHODOLOGY:
Metformin is a first-line treatment in US and South Korean T2D management guidelines, except for patients with advanced chronic kidney disease (CKD) (stage, ≥ 4; estimated glomerular filtration rate [eGFR], < 30).
The study used data from the databases of three tertiary hospitals in South Korea to assess the effect of metformin on long-term renal and cardiovascular outcomes across various renal function states in patients with newly diagnosed T2D.
Four groups of treatment-control comparative cohorts were identified at each hospital: Patients who had not yet developed DN at T2D diagnosis (mean age in treatment and control cohorts, 61-65 years) and those with reduced renal function (CKD stages 3A, 3B, and 4).
Patients who continuously received metformin after T2D diagnosis and beyond the observation period were 1:1 propensity score matched with controls who were prescribed oral hypoglycemic agents other than metformin.
Primary outcomes were net major adverse cardiovascular events including strokes (MACEs) or in-hospital death and a composite of major adverse kidney events (MAKEs) or in-hospital death.
TAKEAWAY:
Among patients without DN at T2D diagnosis, the continuous use of metformin vs other oral hypoglycemic agents was associated with a lower risk for:
Overt DN (incidence rate ratio [IRR], 0.82; 95% CI, 0.71-0.95),
MACEs (IRR, 0.76; 95% CI, 0.64-0.92), and
MAKEs (IRR, 0.45; 95% CI, 0.33-0.62).
Compared with non-metformin or discontinued metformin use, the continuous use of metformin was associated with a lower risk for MACE across CKD stages 3A (IRR, 0.70; 95% CI, 0.57-0.87), 3B (IRR, 0.83; 95% CI, 0.74-0.93), and 4 (IRR, 0.71; 95% CI, 0.60-0.85).
Similarly, the risk for MAKE was lower among continuous metformin users than in nonusers or discontinuous metformin users across CKD stage 3A (IRR, 0.39; 95% CI, 0.35-0.43), 3B (IRR, 0.44; 95% CI, 0.40-0.48), and 4 (IRR, 0.45; 95% CI, 0.39-0.51).
IN PRACTICE:
“The significance of the current study is highlighted by its integration of real-world clinical data, which encompasses patients diagnosed with CDK4 [eGRF, 15-29 mL/min/1.73 m2], a group currently considered contraindicated,” the authors wrote.
SOURCE:
The study, led by Yongjin Yi, MD, PhD, Department of Internal Medicine, Dankook University College of Medicine, Cheonan-si, Republic of Korea, was published in Scientific Reports.
LIMITATIONS:
There may be a possibility of selection bias because of the retrospective and observational nature of this study. Despite achieving a 1:1 propensity score matching to address the confounding factors, some variables, such as serum albumin and A1c levels, remained unbalanced after matching. The paper did not include observation length or patient numbers, but in response to an email query from Medscape, Yi notes that in one hospital, the mean duration of observation for the control and treatment groups was about 6.5 years, and the total number in the treatment groups across data from three hospitals was 11,675, with the same number of matched controls.
DISCLOSURES:
This study was supported by a Young Investigator Research Grant from the Korean Society of Nephrology, a grant from the Seoul National University Bundang Hospital Research Fund, and the Bio&Medical Technology Development Program of the National Research Foundation funded by the Korean government. The authors disclosed no competing interests.
A version of this article appeared on Medscape.com.
TOPLINE:
Metformin cuts the risk for diabetic nephropathy (DN) and major kidney and cardiovascular events in patients with newly diagnosed type 2 diabetes (T2D) across various renal function states.
METHODOLOGY:
Metformin is a first-line treatment in US and South Korean T2D management guidelines, except for patients with advanced chronic kidney disease (CKD) (stage, ≥ 4; estimated glomerular filtration rate [eGFR], < 30).
The study used data from the databases of three tertiary hospitals in South Korea to assess the effect of metformin on long-term renal and cardiovascular outcomes across various renal function states in patients with newly diagnosed T2D.
Four groups of treatment-control comparative cohorts were identified at each hospital: Patients who had not yet developed DN at T2D diagnosis (mean age in treatment and control cohorts, 61-65 years) and those with reduced renal function (CKD stages 3A, 3B, and 4).
Patients who continuously received metformin after T2D diagnosis and beyond the observation period were 1:1 propensity score matched with controls who were prescribed oral hypoglycemic agents other than metformin.
Primary outcomes were net major adverse cardiovascular events including strokes (MACEs) or in-hospital death and a composite of major adverse kidney events (MAKEs) or in-hospital death.
TAKEAWAY:
Among patients without DN at T2D diagnosis, the continuous use of metformin vs other oral hypoglycemic agents was associated with a lower risk for:
Overt DN (incidence rate ratio [IRR], 0.82; 95% CI, 0.71-0.95),
MACEs (IRR, 0.76; 95% CI, 0.64-0.92), and
MAKEs (IRR, 0.45; 95% CI, 0.33-0.62).
Compared with non-metformin or discontinued metformin use, the continuous use of metformin was associated with a lower risk for MACE across CKD stages 3A (IRR, 0.70; 95% CI, 0.57-0.87), 3B (IRR, 0.83; 95% CI, 0.74-0.93), and 4 (IRR, 0.71; 95% CI, 0.60-0.85).
Similarly, the risk for MAKE was lower among continuous metformin users than in nonusers or discontinuous metformin users across CKD stage 3A (IRR, 0.39; 95% CI, 0.35-0.43), 3B (IRR, 0.44; 95% CI, 0.40-0.48), and 4 (IRR, 0.45; 95% CI, 0.39-0.51).
IN PRACTICE:
“The significance of the current study is highlighted by its integration of real-world clinical data, which encompasses patients diagnosed with CDK4 [eGRF, 15-29 mL/min/1.73 m2], a group currently considered contraindicated,” the authors wrote.
SOURCE:
The study, led by Yongjin Yi, MD, PhD, Department of Internal Medicine, Dankook University College of Medicine, Cheonan-si, Republic of Korea, was published in Scientific Reports.
LIMITATIONS:
There may be a possibility of selection bias because of the retrospective and observational nature of this study. Despite achieving a 1:1 propensity score matching to address the confounding factors, some variables, such as serum albumin and A1c levels, remained unbalanced after matching. The paper did not include observation length or patient numbers, but in response to an email query from Medscape, Yi notes that in one hospital, the mean duration of observation for the control and treatment groups was about 6.5 years, and the total number in the treatment groups across data from three hospitals was 11,675, with the same number of matched controls.
DISCLOSURES:
This study was supported by a Young Investigator Research Grant from the Korean Society of Nephrology, a grant from the Seoul National University Bundang Hospital Research Fund, and the Bio&Medical Technology Development Program of the National Research Foundation funded by the Korean government. The authors disclosed no competing interests.
A version of this article appeared on Medscape.com.
TOPLINE:
Metformin cuts the risk for diabetic nephropathy (DN) and major kidney and cardiovascular events in patients with newly diagnosed type 2 diabetes (T2D) across various renal function states.
METHODOLOGY:
Metformin is a first-line treatment in US and South Korean T2D management guidelines, except for patients with advanced chronic kidney disease (CKD) (stage, ≥ 4; estimated glomerular filtration rate [eGFR], < 30).
The study used data from the databases of three tertiary hospitals in South Korea to assess the effect of metformin on long-term renal and cardiovascular outcomes across various renal function states in patients with newly diagnosed T2D.
Four groups of treatment-control comparative cohorts were identified at each hospital: Patients who had not yet developed DN at T2D diagnosis (mean age in treatment and control cohorts, 61-65 years) and those with reduced renal function (CKD stages 3A, 3B, and 4).
Patients who continuously received metformin after T2D diagnosis and beyond the observation period were 1:1 propensity score matched with controls who were prescribed oral hypoglycemic agents other than metformin.
Primary outcomes were net major adverse cardiovascular events including strokes (MACEs) or in-hospital death and a composite of major adverse kidney events (MAKEs) or in-hospital death.
TAKEAWAY:
Among patients without DN at T2D diagnosis, the continuous use of metformin vs other oral hypoglycemic agents was associated with a lower risk for:
Overt DN (incidence rate ratio [IRR], 0.82; 95% CI, 0.71-0.95),
MACEs (IRR, 0.76; 95% CI, 0.64-0.92), and
MAKEs (IRR, 0.45; 95% CI, 0.33-0.62).
Compared with non-metformin or discontinued metformin use, the continuous use of metformin was associated with a lower risk for MACE across CKD stages 3A (IRR, 0.70; 95% CI, 0.57-0.87), 3B (IRR, 0.83; 95% CI, 0.74-0.93), and 4 (IRR, 0.71; 95% CI, 0.60-0.85).
Similarly, the risk for MAKE was lower among continuous metformin users than in nonusers or discontinuous metformin users across CKD stage 3A (IRR, 0.39; 95% CI, 0.35-0.43), 3B (IRR, 0.44; 95% CI, 0.40-0.48), and 4 (IRR, 0.45; 95% CI, 0.39-0.51).
IN PRACTICE:
“The significance of the current study is highlighted by its integration of real-world clinical data, which encompasses patients diagnosed with CDK4 [eGRF, 15-29 mL/min/1.73 m2], a group currently considered contraindicated,” the authors wrote.
SOURCE:
The study, led by Yongjin Yi, MD, PhD, Department of Internal Medicine, Dankook University College of Medicine, Cheonan-si, Republic of Korea, was published in Scientific Reports.
LIMITATIONS:
There may be a possibility of selection bias because of the retrospective and observational nature of this study. Despite achieving a 1:1 propensity score matching to address the confounding factors, some variables, such as serum albumin and A1c levels, remained unbalanced after matching. The paper did not include observation length or patient numbers, but in response to an email query from Medscape, Yi notes that in one hospital, the mean duration of observation for the control and treatment groups was about 6.5 years, and the total number in the treatment groups across data from three hospitals was 11,675, with the same number of matched controls.
DISCLOSURES:
This study was supported by a Young Investigator Research Grant from the Korean Society of Nephrology, a grant from the Seoul National University Bundang Hospital Research Fund, and the Bio&Medical Technology Development Program of the National Research Foundation funded by the Korean government. The authors disclosed no competing interests.
A version of this article appeared on Medscape.com.
Increased Risk of New Rheumatic Disease Follows COVID-19 Infection
The risk of developing a new autoimmune inflammatory rheumatic disease (AIRD) is greater following a COVID-19 infection than after an influenza infection or in the general population, according to a study published March 5 in Annals of Internal Medicine. More severe COVID-19 infections were linked to a greater risk of incident rheumatic disease, but vaccination appeared protective against development of a new AIRD.
“Importantly, this study shows the value of vaccination to prevent severe disease and these types of sequelae,” Anne Davidson, MBBS, a professor in the Institute of Molecular Medicine at The Feinstein Institutes for Medical Research in Manhasset, New York, who was not involved in the study, said in an interview.
Previous research had already identified the likelihood of an association between SARS-CoV-2 infection and subsequent development of a new AIRD. This new study, however, includes much larger cohorts from two different countries and relies on more robust methodology than previous studies, experts said.
“Unique steps were taken by the study authors to make sure that what they were looking at in terms of signal was most likely true,” Alfred Kim, MD, PhD, assistant professor of medicine in rheumatology at Washington University in St. Louis, who was not involved in the study, said in an interview. Dr. Davidson agreed, noting that these authors “were a bit more rigorous with ascertainment of the autoimmune diagnosis, using two codes and also checking that appropriate medications were administered.”
More Robust and Rigorous Research
Past cohort studies finding an increased risk of rheumatic disease after COVID-19 “based their findings solely on comparisons between infected and uninfected groups, which could be influenced by ascertainment bias due to disparities in care, differences in health-seeking tendencies, and inherent risks among the groups,” Min Seo Kim, MD, of the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, and his colleagues reported. Their study, however, required at least two claims with codes for rheumatic disease and compared patients with COVID-19 to those with flu “to adjust for the potentially heightened detection of AIRD in SARS-CoV-2–infected persons owing to their interactions with the health care system.”
Dr. Alfred Kim said the fact that they used at least two claims codes “gives a little more credence that the patients were actually experiencing some sort of autoimmune inflammatory condition as opposed to a very transient issue post COVID that just went away on its own.”
He acknowledged that the previous research was reasonably strong, “especially in light of the fact that there has been so much work done on a molecular level demonstrating that COVID-19 is associated with a substantial increase in autoantibodies in a significant proportion of patients, so this always opened up the possibility that this could associate with some sort of autoimmune disease downstream.”
While the study is well done with a large population, “it still has limitations that might overestimate the effect,” Kevin W. Byram, MD, associate professor of medicine in rheumatology and immunology at Vanderbilt University Medical Center in Nashville, Tennessee, who was not involved in the study, said in an interview. “We certainly have seen individual cases of new rheumatic disease where COVID-19 infection is likely the trigger,” but the phenomenon is not new, he added.
“Many autoimmune diseases are spurred by a loss of tolerance that might be induced by a pathogen of some sort,” Dr. Byram said. “The study is right to point out different forms of bias that might be at play. One in particular that is important to consider in a study like this is the lack of case-level adjudication regarding the diagnosis of rheumatic disease” since the study relied on available ICD-10 codes and medication prescriptions.
The researchers used national claims data to compare risk of incident AIRD in 10,027,506 South Korean and 12,218,680 Japanese adults, aged 20 and older, at 1 month, 6 months, and 12 months after COVID-19 infection, influenza infection, or a matched index date for uninfected control participants. Only patients with at least two claims for AIRD were considered to have a new diagnosis.
Patients who had COVID-19 between January 2020 and December 2021, confirmed by PCR or antigen testing, were matched 1:1 with patients who had test-confirmed influenza during that time and 1:4 with uninfected control participants, whose index date was set to the infection date of their matched COVID-19 patient.
The propensity score matching was based on age, sex, household income, urban versus rural residence, and various clinical characteristics and history: body mass index; blood pressure; fasting blood glucose; glomerular filtration rate; smoking status; alcohol consumption; weekly aerobic physical activity; comorbidity index; hospitalizations and outpatient visits in the previous year; past use of diabetes, hyperlipidemia, or hypertension medication; and history of cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, or respiratory infectious disease.
Patients with a history of AIRD or with coinfection or reinfection of COVID-19 and influenza were excluded, as were patients diagnosed with rheumatic disease within a month of COVID-19 infection.
Risk Varied With Disease Severity and Vaccination Status
Among the Korean patients, 3.9% had a COVID-19 infection and 0.98% had an influenza infection. After matching, the comparison populations included 94,504 patients with COVID-19 versus 94,504 patients with flu, and 177,083 patients with COVID-19 versus 675,750 uninfected controls.
The risk of developing an AIRD at least 1 month after infection in South Korean patients with COVID-19 was 25% higher than in uninfected control participants (adjusted hazard ratio [aHR], 1.25; 95% CI, 1.18–1.31; P < .05) and 30% higher than in influenza patients (aHR, 1.3; 95% CI, 1.02–1.59; P < .05). Specifically, risk in South Korean patients with COVID-19 was significantly increased for connective tissue disease and both treated and untreated AIRD but not for inflammatory arthritis.
Among the Japanese patients, 8.2% had COVID-19 and 0.99% had flu, resulting in matched populations of 115,003 with COVID-19 versus 110,310 with flu, and 960,849 with COVID-19 versus 1,606,873 uninfected patients. The effect size was larger in Japanese patients, with a 79% increased risk for AIRD in patients with COVID-19, compared with the general population (aHR, 1.79; 95% CI, 1.77–1.82; P < .05) and a 14% increased risk, compared with patients with influenza infection (aHR, 1.14; 95% CI, 1.10–1.17; P < .05). In Japanese patients, risk was increased across all four categories, including a doubled risk for inflammatory arthritis (aHR, 2.02; 95% CI, 1.96–2.07; P < .05), compared with the general population.
The researchers had data only from the South Korean cohort to calculate risk based on vaccination status, SARS-CoV-2 variant (wild type versus Delta), and COVID-19 severity. Researchers determined a COVID-19 infection to be moderate-to-severe based on billing codes for ICU admission or requiring oxygen therapy, extracorporeal membrane oxygenation, renal replacement, or CPR.
Infection with both the original strain and the Delta variant were linked to similar increased risks for AIRD, but moderate to severe COVID-19 infections had greater risk of subsequent AIRD (aHR, 1.42; P < .05) than mild infections (aHR, 1.22; P < .05). Vaccination was linked to a lower risk of AIRD within the COVID-19 patient population: One dose was linked to a 41% reduced risk (HR, 0.59; P < .05) and two doses were linked to a 58% reduced risk (HR, 0.42; P < .05), regardless of the vaccine type, compared with unvaccinated patients with COVID-19. The apparent protective effect of vaccination was true only for patients with mild COVID-19, not those with moderate to severe infection.
“One has to wonder whether or not these people were at much higher risk of developing autoimmune disease that just got exposed because they got COVID, so that a fraction of these would have gotten an autoimmune disease downstream,” Dr. Alfred Kim said. Regardless, one clinical implication of the findings is the reduced risk in vaccinated patients, regardless of the vaccine type, given the fact that “mRNA vaccination in particular has not been associated with any autoantibody development,” he said.
Though the correlations in the study cannot translate to causation, several mechanisms might be at play in a viral infection contributing to autoimmune risk, Dr. Davidson said. Given that viral nucleic acids also recognize self-nucleic acids, “a large load of viral nucleic acid may break tolerance,” or “viral proteins could also mimic self-proteins,” she said. “In addition, tolerance may be broken by a highly inflammatory environment associated with the release of cytokines and other inflammatory mediators.”
The association between new-onset autoimmune disease and severe COVID-19 infection suggests multiple mechanisms may be involved in excess immune stimulation, Dr. Davidson said. But she added that it’s unclear how these findings, involving the original strain and Delta variant of SARS-CoV-2, might relate to currently circulating variants.
The research was funded by the National Research Foundation of Korea, the Korea Health Industry Development Institute, and the Ministry of Food and Drug Safety of the Republic of Korea. The authors reported no relevant financial relationships with industry. Dr. Alfred Kim has sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, and Novartis; receives royalties from a patent with Kypha Inc.; and has done consulting or speaking for Amgen, ANI Pharmaceuticals, Aurinia Pharmaceuticals, Exagen Diagnostics, GlaxoSmithKline, Kypha, Miltenyi Biotech, Pfizer, Rheumatology & Arthritis Learning Network, Synthekine, Techtonic Therapeutics, and UpToDate. Dr. Byram reported consulting for TenSixteen Bio. Dr. Davidson had no disclosures.
The risk of developing a new autoimmune inflammatory rheumatic disease (AIRD) is greater following a COVID-19 infection than after an influenza infection or in the general population, according to a study published March 5 in Annals of Internal Medicine. More severe COVID-19 infections were linked to a greater risk of incident rheumatic disease, but vaccination appeared protective against development of a new AIRD.
“Importantly, this study shows the value of vaccination to prevent severe disease and these types of sequelae,” Anne Davidson, MBBS, a professor in the Institute of Molecular Medicine at The Feinstein Institutes for Medical Research in Manhasset, New York, who was not involved in the study, said in an interview.
Previous research had already identified the likelihood of an association between SARS-CoV-2 infection and subsequent development of a new AIRD. This new study, however, includes much larger cohorts from two different countries and relies on more robust methodology than previous studies, experts said.
“Unique steps were taken by the study authors to make sure that what they were looking at in terms of signal was most likely true,” Alfred Kim, MD, PhD, assistant professor of medicine in rheumatology at Washington University in St. Louis, who was not involved in the study, said in an interview. Dr. Davidson agreed, noting that these authors “were a bit more rigorous with ascertainment of the autoimmune diagnosis, using two codes and also checking that appropriate medications were administered.”
More Robust and Rigorous Research
Past cohort studies finding an increased risk of rheumatic disease after COVID-19 “based their findings solely on comparisons between infected and uninfected groups, which could be influenced by ascertainment bias due to disparities in care, differences in health-seeking tendencies, and inherent risks among the groups,” Min Seo Kim, MD, of the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, and his colleagues reported. Their study, however, required at least two claims with codes for rheumatic disease and compared patients with COVID-19 to those with flu “to adjust for the potentially heightened detection of AIRD in SARS-CoV-2–infected persons owing to their interactions with the health care system.”
Dr. Alfred Kim said the fact that they used at least two claims codes “gives a little more credence that the patients were actually experiencing some sort of autoimmune inflammatory condition as opposed to a very transient issue post COVID that just went away on its own.”
He acknowledged that the previous research was reasonably strong, “especially in light of the fact that there has been so much work done on a molecular level demonstrating that COVID-19 is associated with a substantial increase in autoantibodies in a significant proportion of patients, so this always opened up the possibility that this could associate with some sort of autoimmune disease downstream.”
While the study is well done with a large population, “it still has limitations that might overestimate the effect,” Kevin W. Byram, MD, associate professor of medicine in rheumatology and immunology at Vanderbilt University Medical Center in Nashville, Tennessee, who was not involved in the study, said in an interview. “We certainly have seen individual cases of new rheumatic disease where COVID-19 infection is likely the trigger,” but the phenomenon is not new, he added.
“Many autoimmune diseases are spurred by a loss of tolerance that might be induced by a pathogen of some sort,” Dr. Byram said. “The study is right to point out different forms of bias that might be at play. One in particular that is important to consider in a study like this is the lack of case-level adjudication regarding the diagnosis of rheumatic disease” since the study relied on available ICD-10 codes and medication prescriptions.
The researchers used national claims data to compare risk of incident AIRD in 10,027,506 South Korean and 12,218,680 Japanese adults, aged 20 and older, at 1 month, 6 months, and 12 months after COVID-19 infection, influenza infection, or a matched index date for uninfected control participants. Only patients with at least two claims for AIRD were considered to have a new diagnosis.
Patients who had COVID-19 between January 2020 and December 2021, confirmed by PCR or antigen testing, were matched 1:1 with patients who had test-confirmed influenza during that time and 1:4 with uninfected control participants, whose index date was set to the infection date of their matched COVID-19 patient.
The propensity score matching was based on age, sex, household income, urban versus rural residence, and various clinical characteristics and history: body mass index; blood pressure; fasting blood glucose; glomerular filtration rate; smoking status; alcohol consumption; weekly aerobic physical activity; comorbidity index; hospitalizations and outpatient visits in the previous year; past use of diabetes, hyperlipidemia, or hypertension medication; and history of cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, or respiratory infectious disease.
Patients with a history of AIRD or with coinfection or reinfection of COVID-19 and influenza were excluded, as were patients diagnosed with rheumatic disease within a month of COVID-19 infection.
Risk Varied With Disease Severity and Vaccination Status
Among the Korean patients, 3.9% had a COVID-19 infection and 0.98% had an influenza infection. After matching, the comparison populations included 94,504 patients with COVID-19 versus 94,504 patients with flu, and 177,083 patients with COVID-19 versus 675,750 uninfected controls.
The risk of developing an AIRD at least 1 month after infection in South Korean patients with COVID-19 was 25% higher than in uninfected control participants (adjusted hazard ratio [aHR], 1.25; 95% CI, 1.18–1.31; P < .05) and 30% higher than in influenza patients (aHR, 1.3; 95% CI, 1.02–1.59; P < .05). Specifically, risk in South Korean patients with COVID-19 was significantly increased for connective tissue disease and both treated and untreated AIRD but not for inflammatory arthritis.
Among the Japanese patients, 8.2% had COVID-19 and 0.99% had flu, resulting in matched populations of 115,003 with COVID-19 versus 110,310 with flu, and 960,849 with COVID-19 versus 1,606,873 uninfected patients. The effect size was larger in Japanese patients, with a 79% increased risk for AIRD in patients with COVID-19, compared with the general population (aHR, 1.79; 95% CI, 1.77–1.82; P < .05) and a 14% increased risk, compared with patients with influenza infection (aHR, 1.14; 95% CI, 1.10–1.17; P < .05). In Japanese patients, risk was increased across all four categories, including a doubled risk for inflammatory arthritis (aHR, 2.02; 95% CI, 1.96–2.07; P < .05), compared with the general population.
The researchers had data only from the South Korean cohort to calculate risk based on vaccination status, SARS-CoV-2 variant (wild type versus Delta), and COVID-19 severity. Researchers determined a COVID-19 infection to be moderate-to-severe based on billing codes for ICU admission or requiring oxygen therapy, extracorporeal membrane oxygenation, renal replacement, or CPR.
Infection with both the original strain and the Delta variant were linked to similar increased risks for AIRD, but moderate to severe COVID-19 infections had greater risk of subsequent AIRD (aHR, 1.42; P < .05) than mild infections (aHR, 1.22; P < .05). Vaccination was linked to a lower risk of AIRD within the COVID-19 patient population: One dose was linked to a 41% reduced risk (HR, 0.59; P < .05) and two doses were linked to a 58% reduced risk (HR, 0.42; P < .05), regardless of the vaccine type, compared with unvaccinated patients with COVID-19. The apparent protective effect of vaccination was true only for patients with mild COVID-19, not those with moderate to severe infection.
“One has to wonder whether or not these people were at much higher risk of developing autoimmune disease that just got exposed because they got COVID, so that a fraction of these would have gotten an autoimmune disease downstream,” Dr. Alfred Kim said. Regardless, one clinical implication of the findings is the reduced risk in vaccinated patients, regardless of the vaccine type, given the fact that “mRNA vaccination in particular has not been associated with any autoantibody development,” he said.
Though the correlations in the study cannot translate to causation, several mechanisms might be at play in a viral infection contributing to autoimmune risk, Dr. Davidson said. Given that viral nucleic acids also recognize self-nucleic acids, “a large load of viral nucleic acid may break tolerance,” or “viral proteins could also mimic self-proteins,” she said. “In addition, tolerance may be broken by a highly inflammatory environment associated with the release of cytokines and other inflammatory mediators.”
The association between new-onset autoimmune disease and severe COVID-19 infection suggests multiple mechanisms may be involved in excess immune stimulation, Dr. Davidson said. But she added that it’s unclear how these findings, involving the original strain and Delta variant of SARS-CoV-2, might relate to currently circulating variants.
The research was funded by the National Research Foundation of Korea, the Korea Health Industry Development Institute, and the Ministry of Food and Drug Safety of the Republic of Korea. The authors reported no relevant financial relationships with industry. Dr. Alfred Kim has sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, and Novartis; receives royalties from a patent with Kypha Inc.; and has done consulting or speaking for Amgen, ANI Pharmaceuticals, Aurinia Pharmaceuticals, Exagen Diagnostics, GlaxoSmithKline, Kypha, Miltenyi Biotech, Pfizer, Rheumatology & Arthritis Learning Network, Synthekine, Techtonic Therapeutics, and UpToDate. Dr. Byram reported consulting for TenSixteen Bio. Dr. Davidson had no disclosures.
The risk of developing a new autoimmune inflammatory rheumatic disease (AIRD) is greater following a COVID-19 infection than after an influenza infection or in the general population, according to a study published March 5 in Annals of Internal Medicine. More severe COVID-19 infections were linked to a greater risk of incident rheumatic disease, but vaccination appeared protective against development of a new AIRD.
“Importantly, this study shows the value of vaccination to prevent severe disease and these types of sequelae,” Anne Davidson, MBBS, a professor in the Institute of Molecular Medicine at The Feinstein Institutes for Medical Research in Manhasset, New York, who was not involved in the study, said in an interview.
Previous research had already identified the likelihood of an association between SARS-CoV-2 infection and subsequent development of a new AIRD. This new study, however, includes much larger cohorts from two different countries and relies on more robust methodology than previous studies, experts said.
“Unique steps were taken by the study authors to make sure that what they were looking at in terms of signal was most likely true,” Alfred Kim, MD, PhD, assistant professor of medicine in rheumatology at Washington University in St. Louis, who was not involved in the study, said in an interview. Dr. Davidson agreed, noting that these authors “were a bit more rigorous with ascertainment of the autoimmune diagnosis, using two codes and also checking that appropriate medications were administered.”
More Robust and Rigorous Research
Past cohort studies finding an increased risk of rheumatic disease after COVID-19 “based their findings solely on comparisons between infected and uninfected groups, which could be influenced by ascertainment bias due to disparities in care, differences in health-seeking tendencies, and inherent risks among the groups,” Min Seo Kim, MD, of the Broad Institute of MIT and Harvard, Cambridge, Massachusetts, and his colleagues reported. Their study, however, required at least two claims with codes for rheumatic disease and compared patients with COVID-19 to those with flu “to adjust for the potentially heightened detection of AIRD in SARS-CoV-2–infected persons owing to their interactions with the health care system.”
Dr. Alfred Kim said the fact that they used at least two claims codes “gives a little more credence that the patients were actually experiencing some sort of autoimmune inflammatory condition as opposed to a very transient issue post COVID that just went away on its own.”
He acknowledged that the previous research was reasonably strong, “especially in light of the fact that there has been so much work done on a molecular level demonstrating that COVID-19 is associated with a substantial increase in autoantibodies in a significant proportion of patients, so this always opened up the possibility that this could associate with some sort of autoimmune disease downstream.”
While the study is well done with a large population, “it still has limitations that might overestimate the effect,” Kevin W. Byram, MD, associate professor of medicine in rheumatology and immunology at Vanderbilt University Medical Center in Nashville, Tennessee, who was not involved in the study, said in an interview. “We certainly have seen individual cases of new rheumatic disease where COVID-19 infection is likely the trigger,” but the phenomenon is not new, he added.
“Many autoimmune diseases are spurred by a loss of tolerance that might be induced by a pathogen of some sort,” Dr. Byram said. “The study is right to point out different forms of bias that might be at play. One in particular that is important to consider in a study like this is the lack of case-level adjudication regarding the diagnosis of rheumatic disease” since the study relied on available ICD-10 codes and medication prescriptions.
The researchers used national claims data to compare risk of incident AIRD in 10,027,506 South Korean and 12,218,680 Japanese adults, aged 20 and older, at 1 month, 6 months, and 12 months after COVID-19 infection, influenza infection, or a matched index date for uninfected control participants. Only patients with at least two claims for AIRD were considered to have a new diagnosis.
Patients who had COVID-19 between January 2020 and December 2021, confirmed by PCR or antigen testing, were matched 1:1 with patients who had test-confirmed influenza during that time and 1:4 with uninfected control participants, whose index date was set to the infection date of their matched COVID-19 patient.
The propensity score matching was based on age, sex, household income, urban versus rural residence, and various clinical characteristics and history: body mass index; blood pressure; fasting blood glucose; glomerular filtration rate; smoking status; alcohol consumption; weekly aerobic physical activity; comorbidity index; hospitalizations and outpatient visits in the previous year; past use of diabetes, hyperlipidemia, or hypertension medication; and history of cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, or respiratory infectious disease.
Patients with a history of AIRD or with coinfection or reinfection of COVID-19 and influenza were excluded, as were patients diagnosed with rheumatic disease within a month of COVID-19 infection.
Risk Varied With Disease Severity and Vaccination Status
Among the Korean patients, 3.9% had a COVID-19 infection and 0.98% had an influenza infection. After matching, the comparison populations included 94,504 patients with COVID-19 versus 94,504 patients with flu, and 177,083 patients with COVID-19 versus 675,750 uninfected controls.
The risk of developing an AIRD at least 1 month after infection in South Korean patients with COVID-19 was 25% higher than in uninfected control participants (adjusted hazard ratio [aHR], 1.25; 95% CI, 1.18–1.31; P < .05) and 30% higher than in influenza patients (aHR, 1.3; 95% CI, 1.02–1.59; P < .05). Specifically, risk in South Korean patients with COVID-19 was significantly increased for connective tissue disease and both treated and untreated AIRD but not for inflammatory arthritis.
Among the Japanese patients, 8.2% had COVID-19 and 0.99% had flu, resulting in matched populations of 115,003 with COVID-19 versus 110,310 with flu, and 960,849 with COVID-19 versus 1,606,873 uninfected patients. The effect size was larger in Japanese patients, with a 79% increased risk for AIRD in patients with COVID-19, compared with the general population (aHR, 1.79; 95% CI, 1.77–1.82; P < .05) and a 14% increased risk, compared with patients with influenza infection (aHR, 1.14; 95% CI, 1.10–1.17; P < .05). In Japanese patients, risk was increased across all four categories, including a doubled risk for inflammatory arthritis (aHR, 2.02; 95% CI, 1.96–2.07; P < .05), compared with the general population.
The researchers had data only from the South Korean cohort to calculate risk based on vaccination status, SARS-CoV-2 variant (wild type versus Delta), and COVID-19 severity. Researchers determined a COVID-19 infection to be moderate-to-severe based on billing codes for ICU admission or requiring oxygen therapy, extracorporeal membrane oxygenation, renal replacement, or CPR.
Infection with both the original strain and the Delta variant were linked to similar increased risks for AIRD, but moderate to severe COVID-19 infections had greater risk of subsequent AIRD (aHR, 1.42; P < .05) than mild infections (aHR, 1.22; P < .05). Vaccination was linked to a lower risk of AIRD within the COVID-19 patient population: One dose was linked to a 41% reduced risk (HR, 0.59; P < .05) and two doses were linked to a 58% reduced risk (HR, 0.42; P < .05), regardless of the vaccine type, compared with unvaccinated patients with COVID-19. The apparent protective effect of vaccination was true only for patients with mild COVID-19, not those with moderate to severe infection.
“One has to wonder whether or not these people were at much higher risk of developing autoimmune disease that just got exposed because they got COVID, so that a fraction of these would have gotten an autoimmune disease downstream,” Dr. Alfred Kim said. Regardless, one clinical implication of the findings is the reduced risk in vaccinated patients, regardless of the vaccine type, given the fact that “mRNA vaccination in particular has not been associated with any autoantibody development,” he said.
Though the correlations in the study cannot translate to causation, several mechanisms might be at play in a viral infection contributing to autoimmune risk, Dr. Davidson said. Given that viral nucleic acids also recognize self-nucleic acids, “a large load of viral nucleic acid may break tolerance,” or “viral proteins could also mimic self-proteins,” she said. “In addition, tolerance may be broken by a highly inflammatory environment associated with the release of cytokines and other inflammatory mediators.”
The association between new-onset autoimmune disease and severe COVID-19 infection suggests multiple mechanisms may be involved in excess immune stimulation, Dr. Davidson said. But she added that it’s unclear how these findings, involving the original strain and Delta variant of SARS-CoV-2, might relate to currently circulating variants.
The research was funded by the National Research Foundation of Korea, the Korea Health Industry Development Institute, and the Ministry of Food and Drug Safety of the Republic of Korea. The authors reported no relevant financial relationships with industry. Dr. Alfred Kim has sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, and Novartis; receives royalties from a patent with Kypha Inc.; and has done consulting or speaking for Amgen, ANI Pharmaceuticals, Aurinia Pharmaceuticals, Exagen Diagnostics, GlaxoSmithKline, Kypha, Miltenyi Biotech, Pfizer, Rheumatology & Arthritis Learning Network, Synthekine, Techtonic Therapeutics, and UpToDate. Dr. Byram reported consulting for TenSixteen Bio. Dr. Davidson had no disclosures.
FROM ANNALS OF INTERNAL MEDICINE
Obesity Affects More Than 1 Billion Around the World
TOPLINE:
More than a billion children, adolescents, and adults are living with obesity, globally, with rates of obesity among children and adolescents quadrupling between 1990 and 2022.
Obesity rates nearly tripled among adult men and more than doubled among women during the time period, according to results from a collaboration between the NCD Risk Factor Collaboration and the World Health Organization (WHO).
The rates of being underweight have meanwhile declined, making obesity now the most common form of malnutrition in most regions.
METHODOLOGY:
In this global analysis, the authors evaluated 3663 population-based studies conducted in 200 countries and territories, with data on 222 million participants in the general population, including height and weight.
Trends were established according to categories of body mass index (BMI) in groups of adults aged 20 years or older, representing 150 million individuals, and 63 million school-aged children and adolescents aged 5-19 years, spanning from 1990 to 2022.
Assessments of adults focus on the individual and combined prevalence of underweight (BMI < 18.5 kg/m2) and obesity (BMI ≥ 30 kg/m2).
For school-aged children and adolescents, assessments were for thinness (BMI < 2 standard deviation [SD] below the median of the WHO growth reference) and obesity (BMI > 2 SD above the median).
TAKEAWAY:
In 2022, obesity rates were higher than underweight in 177 countries (89%) for women and 145 countries (73%) for men.
Likewise, among school-aged children and adolescents, obesity in 2022 was more prevalent than thinness among girls in 130 countries (67%) and boys in 125 countries (63%), while thinness was more prevalent in only 18% and 21% of the countries, respectively.
In 2022, the combined prevalence of underweight and obesity was highest in island nations in the Caribbean and Polynesia and Micronesia, as well as in countries in the Middle East and North Africa.
Among school-aged children, the countries with the highest combined prevalence of underweight and obesity were Polynesia and Micronesia and the Caribbean for both sexes and Chile and Qatar for boys.
The prevalence of obesity surpassed 60% among women in eight countries (4%) and men in six countries (3%), all in Polynesia and Micronesia.
In the United States, the obesity rate increased from 21.2% in 1990 to 43.8% in 2022 for women and from 16.9% to 41.6% in 2022 for men.
As of 2022, the prevalence of obesity in the United States ranked 36th highest in the world for women and 10th highest in the world for men.
IN PRACTICE:
“It is very concerning that the epidemic of obesity that was evident among adults in much of the world in 1990 is now mirrored in school-aged children and adolescents,” senior author Majid Ezzati, PhD, of Imperial College of London, said in a press statement.
“At the same time, hundreds of millions are still affected by undernutrition, particularly in some of the poorest parts of the world,” he said. “To successfully tackle both forms of malnutrition, it is vital we significantly improve the availability and affordability of healthy, nutritious foods.”
Tedros Adhanom Ghebreyesus, PhD, WHO Director-General, added in the press statement that “this new study highlights the importance of preventing and managing obesity from early life to adulthood, through diet, physical activity, and adequate care, as needed.
“Getting back on track to meet the global targets for curbing obesity will take the work of governments and communities, supported by evidence-based policies from WHO and national public health agencies,” he said.
“Importantly, it requires the cooperation of the private sector, which must be accountable for the health impacts of their products.”
SOURCE:
The study was published on February 29, 2024, in The Lancet. The study was conducted by the NCD Risk Factor Collaboration and the WHO.
LIMITATIONS:
Data differences in countries included that some had limited data and three had none, requiring some estimates to be formed using data from other countries. Data availability was also lower among the youngest and oldest patients, increasing uncertainty of data in those age groups. In addition, data from health surveys can be subject to error, and BMI can be an imperfect measure of the extent or distribution of body fat.
DISCLOSURES:
The study was funded by UK Medical Research Council, UK Research and Innovation, and the European Commission.
A version of this article appeared on Medscape.com.
TOPLINE:
More than a billion children, adolescents, and adults are living with obesity, globally, with rates of obesity among children and adolescents quadrupling between 1990 and 2022.
Obesity rates nearly tripled among adult men and more than doubled among women during the time period, according to results from a collaboration between the NCD Risk Factor Collaboration and the World Health Organization (WHO).
The rates of being underweight have meanwhile declined, making obesity now the most common form of malnutrition in most regions.
METHODOLOGY:
In this global analysis, the authors evaluated 3663 population-based studies conducted in 200 countries and territories, with data on 222 million participants in the general population, including height and weight.
Trends were established according to categories of body mass index (BMI) in groups of adults aged 20 years or older, representing 150 million individuals, and 63 million school-aged children and adolescents aged 5-19 years, spanning from 1990 to 2022.
Assessments of adults focus on the individual and combined prevalence of underweight (BMI < 18.5 kg/m2) and obesity (BMI ≥ 30 kg/m2).
For school-aged children and adolescents, assessments were for thinness (BMI < 2 standard deviation [SD] below the median of the WHO growth reference) and obesity (BMI > 2 SD above the median).
TAKEAWAY:
In 2022, obesity rates were higher than underweight in 177 countries (89%) for women and 145 countries (73%) for men.
Likewise, among school-aged children and adolescents, obesity in 2022 was more prevalent than thinness among girls in 130 countries (67%) and boys in 125 countries (63%), while thinness was more prevalent in only 18% and 21% of the countries, respectively.
In 2022, the combined prevalence of underweight and obesity was highest in island nations in the Caribbean and Polynesia and Micronesia, as well as in countries in the Middle East and North Africa.
Among school-aged children, the countries with the highest combined prevalence of underweight and obesity were Polynesia and Micronesia and the Caribbean for both sexes and Chile and Qatar for boys.
The prevalence of obesity surpassed 60% among women in eight countries (4%) and men in six countries (3%), all in Polynesia and Micronesia.
In the United States, the obesity rate increased from 21.2% in 1990 to 43.8% in 2022 for women and from 16.9% to 41.6% in 2022 for men.
As of 2022, the prevalence of obesity in the United States ranked 36th highest in the world for women and 10th highest in the world for men.
IN PRACTICE:
“It is very concerning that the epidemic of obesity that was evident among adults in much of the world in 1990 is now mirrored in school-aged children and adolescents,” senior author Majid Ezzati, PhD, of Imperial College of London, said in a press statement.
“At the same time, hundreds of millions are still affected by undernutrition, particularly in some of the poorest parts of the world,” he said. “To successfully tackle both forms of malnutrition, it is vital we significantly improve the availability and affordability of healthy, nutritious foods.”
Tedros Adhanom Ghebreyesus, PhD, WHO Director-General, added in the press statement that “this new study highlights the importance of preventing and managing obesity from early life to adulthood, through diet, physical activity, and adequate care, as needed.
“Getting back on track to meet the global targets for curbing obesity will take the work of governments and communities, supported by evidence-based policies from WHO and national public health agencies,” he said.
“Importantly, it requires the cooperation of the private sector, which must be accountable for the health impacts of their products.”
SOURCE:
The study was published on February 29, 2024, in The Lancet. The study was conducted by the NCD Risk Factor Collaboration and the WHO.
LIMITATIONS:
Data differences in countries included that some had limited data and three had none, requiring some estimates to be formed using data from other countries. Data availability was also lower among the youngest and oldest patients, increasing uncertainty of data in those age groups. In addition, data from health surveys can be subject to error, and BMI can be an imperfect measure of the extent or distribution of body fat.
DISCLOSURES:
The study was funded by UK Medical Research Council, UK Research and Innovation, and the European Commission.
A version of this article appeared on Medscape.com.
TOPLINE:
More than a billion children, adolescents, and adults are living with obesity, globally, with rates of obesity among children and adolescents quadrupling between 1990 and 2022.
Obesity rates nearly tripled among adult men and more than doubled among women during the time period, according to results from a collaboration between the NCD Risk Factor Collaboration and the World Health Organization (WHO).
The rates of being underweight have meanwhile declined, making obesity now the most common form of malnutrition in most regions.
METHODOLOGY:
In this global analysis, the authors evaluated 3663 population-based studies conducted in 200 countries and territories, with data on 222 million participants in the general population, including height and weight.
Trends were established according to categories of body mass index (BMI) in groups of adults aged 20 years or older, representing 150 million individuals, and 63 million school-aged children and adolescents aged 5-19 years, spanning from 1990 to 2022.
Assessments of adults focus on the individual and combined prevalence of underweight (BMI < 18.5 kg/m2) and obesity (BMI ≥ 30 kg/m2).
For school-aged children and adolescents, assessments were for thinness (BMI < 2 standard deviation [SD] below the median of the WHO growth reference) and obesity (BMI > 2 SD above the median).
TAKEAWAY:
In 2022, obesity rates were higher than underweight in 177 countries (89%) for women and 145 countries (73%) for men.
Likewise, among school-aged children and adolescents, obesity in 2022 was more prevalent than thinness among girls in 130 countries (67%) and boys in 125 countries (63%), while thinness was more prevalent in only 18% and 21% of the countries, respectively.
In 2022, the combined prevalence of underweight and obesity was highest in island nations in the Caribbean and Polynesia and Micronesia, as well as in countries in the Middle East and North Africa.
Among school-aged children, the countries with the highest combined prevalence of underweight and obesity were Polynesia and Micronesia and the Caribbean for both sexes and Chile and Qatar for boys.
The prevalence of obesity surpassed 60% among women in eight countries (4%) and men in six countries (3%), all in Polynesia and Micronesia.
In the United States, the obesity rate increased from 21.2% in 1990 to 43.8% in 2022 for women and from 16.9% to 41.6% in 2022 for men.
As of 2022, the prevalence of obesity in the United States ranked 36th highest in the world for women and 10th highest in the world for men.
IN PRACTICE:
“It is very concerning that the epidemic of obesity that was evident among adults in much of the world in 1990 is now mirrored in school-aged children and adolescents,” senior author Majid Ezzati, PhD, of Imperial College of London, said in a press statement.
“At the same time, hundreds of millions are still affected by undernutrition, particularly in some of the poorest parts of the world,” he said. “To successfully tackle both forms of malnutrition, it is vital we significantly improve the availability and affordability of healthy, nutritious foods.”
Tedros Adhanom Ghebreyesus, PhD, WHO Director-General, added in the press statement that “this new study highlights the importance of preventing and managing obesity from early life to adulthood, through diet, physical activity, and adequate care, as needed.
“Getting back on track to meet the global targets for curbing obesity will take the work of governments and communities, supported by evidence-based policies from WHO and national public health agencies,” he said.
“Importantly, it requires the cooperation of the private sector, which must be accountable for the health impacts of their products.”
SOURCE:
The study was published on February 29, 2024, in The Lancet. The study was conducted by the NCD Risk Factor Collaboration and the WHO.
LIMITATIONS:
Data differences in countries included that some had limited data and three had none, requiring some estimates to be formed using data from other countries. Data availability was also lower among the youngest and oldest patients, increasing uncertainty of data in those age groups. In addition, data from health surveys can be subject to error, and BMI can be an imperfect measure of the extent or distribution of body fat.
DISCLOSURES:
The study was funded by UK Medical Research Council, UK Research and Innovation, and the European Commission.
A version of this article appeared on Medscape.com.
Diabetes Complication Risk Larger in US Small Towns
TOPLINE:
METHODOLOGY:
Retrospective cohort study using the OptumLabs Data Warehouse used a deidentified data set of US commercial and Medicare Advantage beneficiaries including 2,901,563 adults with diabetes between 2012 and 2021.
Overall, 2.6% lived in remote areas (population < 2500), 14.1% in small towns (2500-50,000), and 83.3% in cities (> 50,000).
Multivariable analysis adjusted for age, sex, health plan type, index year, diabetes type, baseline comorbidities, and medication use.
TAKEAWAY:
Relative to people living in cities, people in remote areas had significantly greater risks for myocardial infarction (hazard ratio, 1.06) and revascularization (1.04) but lower risks for hypoglycemia (0.90) and stroke (0.91).
Compared with cities, people living in small towns had significantly more hyperglycemia (1.06), hypoglycemia (1.15), end-stage kidney disease (1.04), myocardial infarction (1.10), heart failure (1.05), amputation (1.05), other lower-extremity complications (1.02), and revascularization (1.05), but a lower risk for stroke (0.95).
Compared with small towns, people living in remote areas had lower risks for hyperglycemia (0.85), hypoglycemia (0.92), and heart failure (0.94).
No geographic differences were found for retinopathy or atrial fibrillation/flutter.
The results didn’t differ significantly when the 2.5% overall with type 1 diabetes were removed from the dataset.
IN PRACTICE:
“While more research is needed to better understand the underlying causes of disparate diabetes outcomes along the rural-urban continuum, this study establishes the foundational differences to guide improvement efforts and helps to identify complications with the greatest disparities to which policy interventions may be targeted.”
SOURCE:
The study was conducted by Kyle Steiger, MD, Internal Medicine Residency, Mayo Clinic, Rochester, Minnesota, and colleagues, and published February 22 in Diabetes Care.
LIMITATIONS:
Claims data were from a single national health insurance provider that administers multiple private and Medicare Advantage health plans with disproportionate representation of urban populations and without people who have Medicaid or traditional Medicare fee-for-service or who are without insurance (and would be expected to have higher complication rates). There were no data on race/ethnicity. Potential for residual confounding.
DISCLOSURES:
This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Steiger had no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
Retrospective cohort study using the OptumLabs Data Warehouse used a deidentified data set of US commercial and Medicare Advantage beneficiaries including 2,901,563 adults with diabetes between 2012 and 2021.
Overall, 2.6% lived in remote areas (population < 2500), 14.1% in small towns (2500-50,000), and 83.3% in cities (> 50,000).
Multivariable analysis adjusted for age, sex, health plan type, index year, diabetes type, baseline comorbidities, and medication use.
TAKEAWAY:
Relative to people living in cities, people in remote areas had significantly greater risks for myocardial infarction (hazard ratio, 1.06) and revascularization (1.04) but lower risks for hypoglycemia (0.90) and stroke (0.91).
Compared with cities, people living in small towns had significantly more hyperglycemia (1.06), hypoglycemia (1.15), end-stage kidney disease (1.04), myocardial infarction (1.10), heart failure (1.05), amputation (1.05), other lower-extremity complications (1.02), and revascularization (1.05), but a lower risk for stroke (0.95).
Compared with small towns, people living in remote areas had lower risks for hyperglycemia (0.85), hypoglycemia (0.92), and heart failure (0.94).
No geographic differences were found for retinopathy or atrial fibrillation/flutter.
The results didn’t differ significantly when the 2.5% overall with type 1 diabetes were removed from the dataset.
IN PRACTICE:
“While more research is needed to better understand the underlying causes of disparate diabetes outcomes along the rural-urban continuum, this study establishes the foundational differences to guide improvement efforts and helps to identify complications with the greatest disparities to which policy interventions may be targeted.”
SOURCE:
The study was conducted by Kyle Steiger, MD, Internal Medicine Residency, Mayo Clinic, Rochester, Minnesota, and colleagues, and published February 22 in Diabetes Care.
LIMITATIONS:
Claims data were from a single national health insurance provider that administers multiple private and Medicare Advantage health plans with disproportionate representation of urban populations and without people who have Medicaid or traditional Medicare fee-for-service or who are without insurance (and would be expected to have higher complication rates). There were no data on race/ethnicity. Potential for residual confounding.
DISCLOSURES:
This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Steiger had no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
Retrospective cohort study using the OptumLabs Data Warehouse used a deidentified data set of US commercial and Medicare Advantage beneficiaries including 2,901,563 adults with diabetes between 2012 and 2021.
Overall, 2.6% lived in remote areas (population < 2500), 14.1% in small towns (2500-50,000), and 83.3% in cities (> 50,000).
Multivariable analysis adjusted for age, sex, health plan type, index year, diabetes type, baseline comorbidities, and medication use.
TAKEAWAY:
Relative to people living in cities, people in remote areas had significantly greater risks for myocardial infarction (hazard ratio, 1.06) and revascularization (1.04) but lower risks for hypoglycemia (0.90) and stroke (0.91).
Compared with cities, people living in small towns had significantly more hyperglycemia (1.06), hypoglycemia (1.15), end-stage kidney disease (1.04), myocardial infarction (1.10), heart failure (1.05), amputation (1.05), other lower-extremity complications (1.02), and revascularization (1.05), but a lower risk for stroke (0.95).
Compared with small towns, people living in remote areas had lower risks for hyperglycemia (0.85), hypoglycemia (0.92), and heart failure (0.94).
No geographic differences were found for retinopathy or atrial fibrillation/flutter.
The results didn’t differ significantly when the 2.5% overall with type 1 diabetes were removed from the dataset.
IN PRACTICE:
“While more research is needed to better understand the underlying causes of disparate diabetes outcomes along the rural-urban continuum, this study establishes the foundational differences to guide improvement efforts and helps to identify complications with the greatest disparities to which policy interventions may be targeted.”
SOURCE:
The study was conducted by Kyle Steiger, MD, Internal Medicine Residency, Mayo Clinic, Rochester, Minnesota, and colleagues, and published February 22 in Diabetes Care.
LIMITATIONS:
Claims data were from a single national health insurance provider that administers multiple private and Medicare Advantage health plans with disproportionate representation of urban populations and without people who have Medicaid or traditional Medicare fee-for-service or who are without insurance (and would be expected to have higher complication rates). There were no data on race/ethnicity. Potential for residual confounding.
DISCLOSURES:
This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Steiger had no disclosures.
A version of this article appeared on Medscape.com.
How Good are Tools to Screen for Spondyloarthritis in Patients With Psoriasis, Uveitis, IBD?
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.
Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.
“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.
In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.
Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.
All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.
All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.
Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.
Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.
Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
The Case for a Generic Tool
The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.
The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.
The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
Streamlining to Increase Screening
“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.
In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.
“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
Need for Early Identification and Closer Collaboration
A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.
The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.
The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.
“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.
“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.
Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.
More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.
The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Osteoporosis Drug Denosumab May Confer Lower Risk for Diabetes
TOPLINE:
Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.
METHODOLOGY:
- Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
- Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
- Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
- Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
- The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.
TAKEAWAY:
- Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
- In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
- A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
- Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.
IN PRACTICE:
“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.
SOURCE:
This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.
LIMITATIONS:
The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.
DISCLOSURES:
This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.
A version of this article appeared on Medscape.com.
TOPLINE:
Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.
METHODOLOGY:
- Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
- Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
- Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
- Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
- The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.
TAKEAWAY:
- Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
- In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
- A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
- Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.
IN PRACTICE:
“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.
SOURCE:
This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.
LIMITATIONS:
The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.
DISCLOSURES:
This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.
A version of this article appeared on Medscape.com.
TOPLINE:
Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.
METHODOLOGY:
- Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
- Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
- Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
- Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
- The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.
TAKEAWAY:
- Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
- In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
- A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
- Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.
IN PRACTICE:
“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.
SOURCE:
This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.
LIMITATIONS:
The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.
DISCLOSURES:
This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.
A version of this article appeared on Medscape.com.
Older Age Confers a Higher Risk for Second Primary Melanoma: Study
TOPLINE:
.
METHODOLOGY:
- Knowledge about one’s risk for a second primary invasive melanoma over time remains incomplete.
- Using data from the Cancer Registry of Norway, researchers performed a cohort study of 19,196 individuals diagnosed with invasive melanomas during 2008-2020; 51% were women. The mean age at the first primary melanoma diagnosis was 62 years.
- The main outcome of interest was the incidence rate of second primary invasive melanoma after the first diagnosis.
- The researchers used accelerated failure time models to examine potential associations with patient and tumor characteristics. They also calculated the median time between first and second melanomas and the likelihood of second primary melanomas on the same or different site as the first primary melanoma.
TAKEAWAY:
- The incidence rate of a second primary melanoma in the year following a first primary melanoma was 16.8 (95% CI, 14.9-18.7) per 1000 person-years. This decreased to 7.3 (95% CI, 6.0-8.6) per 1000 person-years during the second year and remained stable after that.
- Patient age influenced the median time between first and second primaries. The median interval was 37 months (95% CI, 8-49) in patients aged < 40 years, 18 months (95% CI, 13-24) in patients aged 50-59 years, and 11 months (95% CI, 7-18) in patients aged ≥ 80 years.
- The body site of the second primary melanoma was the same as the first primary in 47% of patients but was located on a different body site in the remaining 53% of patients.
- Among patients who developed a second primary melanoma on the same site as the first, the median interval was shorter for men compared with women: A median of 12 (95% CI, 7-19) months vs 22 (95% CI, 11-35) months, respectively.
IN PRACTICE:
“Our findings suggest that increased surveillance may be considered for older patients, especially men, for at least the first 3 years after their initial diagnosis, regardless of the characteristics of their first melanoma,” the authors wrote.
SOURCE:
Corresponding author Reza Ghiasvand, PhD, of the Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and colleagues conducted the research, published online on February 28, 2024, in JAMA Dermatology.
LIMITATIONS:
Information was lacking on phenotypic characteristics, personal ultraviolet radiation (UVR) exposure, genetic factors, and the number of follow-up skin examinations.
DISCLOSURES:
The study was supported by the South-Eastern Norway Regional Health Authority. The authors reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Knowledge about one’s risk for a second primary invasive melanoma over time remains incomplete.
- Using data from the Cancer Registry of Norway, researchers performed a cohort study of 19,196 individuals diagnosed with invasive melanomas during 2008-2020; 51% were women. The mean age at the first primary melanoma diagnosis was 62 years.
- The main outcome of interest was the incidence rate of second primary invasive melanoma after the first diagnosis.
- The researchers used accelerated failure time models to examine potential associations with patient and tumor characteristics. They also calculated the median time between first and second melanomas and the likelihood of second primary melanomas on the same or different site as the first primary melanoma.
TAKEAWAY:
- The incidence rate of a second primary melanoma in the year following a first primary melanoma was 16.8 (95% CI, 14.9-18.7) per 1000 person-years. This decreased to 7.3 (95% CI, 6.0-8.6) per 1000 person-years during the second year and remained stable after that.
- Patient age influenced the median time between first and second primaries. The median interval was 37 months (95% CI, 8-49) in patients aged < 40 years, 18 months (95% CI, 13-24) in patients aged 50-59 years, and 11 months (95% CI, 7-18) in patients aged ≥ 80 years.
- The body site of the second primary melanoma was the same as the first primary in 47% of patients but was located on a different body site in the remaining 53% of patients.
- Among patients who developed a second primary melanoma on the same site as the first, the median interval was shorter for men compared with women: A median of 12 (95% CI, 7-19) months vs 22 (95% CI, 11-35) months, respectively.
IN PRACTICE:
“Our findings suggest that increased surveillance may be considered for older patients, especially men, for at least the first 3 years after their initial diagnosis, regardless of the characteristics of their first melanoma,” the authors wrote.
SOURCE:
Corresponding author Reza Ghiasvand, PhD, of the Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and colleagues conducted the research, published online on February 28, 2024, in JAMA Dermatology.
LIMITATIONS:
Information was lacking on phenotypic characteristics, personal ultraviolet radiation (UVR) exposure, genetic factors, and the number of follow-up skin examinations.
DISCLOSURES:
The study was supported by the South-Eastern Norway Regional Health Authority. The authors reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Knowledge about one’s risk for a second primary invasive melanoma over time remains incomplete.
- Using data from the Cancer Registry of Norway, researchers performed a cohort study of 19,196 individuals diagnosed with invasive melanomas during 2008-2020; 51% were women. The mean age at the first primary melanoma diagnosis was 62 years.
- The main outcome of interest was the incidence rate of second primary invasive melanoma after the first diagnosis.
- The researchers used accelerated failure time models to examine potential associations with patient and tumor characteristics. They also calculated the median time between first and second melanomas and the likelihood of second primary melanomas on the same or different site as the first primary melanoma.
TAKEAWAY:
- The incidence rate of a second primary melanoma in the year following a first primary melanoma was 16.8 (95% CI, 14.9-18.7) per 1000 person-years. This decreased to 7.3 (95% CI, 6.0-8.6) per 1000 person-years during the second year and remained stable after that.
- Patient age influenced the median time between first and second primaries. The median interval was 37 months (95% CI, 8-49) in patients aged < 40 years, 18 months (95% CI, 13-24) in patients aged 50-59 years, and 11 months (95% CI, 7-18) in patients aged ≥ 80 years.
- The body site of the second primary melanoma was the same as the first primary in 47% of patients but was located on a different body site in the remaining 53% of patients.
- Among patients who developed a second primary melanoma on the same site as the first, the median interval was shorter for men compared with women: A median of 12 (95% CI, 7-19) months vs 22 (95% CI, 11-35) months, respectively.
IN PRACTICE:
“Our findings suggest that increased surveillance may be considered for older patients, especially men, for at least the first 3 years after their initial diagnosis, regardless of the characteristics of their first melanoma,” the authors wrote.
SOURCE:
Corresponding author Reza Ghiasvand, PhD, of the Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and colleagues conducted the research, published online on February 28, 2024, in JAMA Dermatology.
LIMITATIONS:
Information was lacking on phenotypic characteristics, personal ultraviolet radiation (UVR) exposure, genetic factors, and the number of follow-up skin examinations.
DISCLOSURES:
The study was supported by the South-Eastern Norway Regional Health Authority. The authors reported having no disclosures.
A version of this article appeared on Medscape.com.