Pityriasis rosea carries few risks for pregnant women

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Pregnancy complications in women with pityriasis rosea (PR) were relatively minor, and included no cases of miscarriage, abortion, or fetal death, according to a review of 33 patients.

“Though generally considered benign, PR may be associated with an increased risk of birth complications if acquired during pregnancy,” and previous studies have shown increased rates of complications including miscarriage and neonatal hypotonia in these patients, wrote Julian Stashower of the University of Virginia, Charlottesville, and colleagues.

In a retrospective study published in the Journal of the American Academy of Dermatology, the researchers assessed pregnancy outcomes in women who developed PR during pregnancy. They were identified from medical records at three institutions between September 2010 and June 2020. Diagnosis of PR, a papulosquamous skin eruption associated with human herpesvirus (HHV)–6/7 reactivation, was based on history and physical examination.

Overall, 8 of the 33 women (24%) had birth complications; the rates of preterm delivery, spontaneous pregnancy loss in clinically detectable pregnancies, and oligohydramnios were 6%, 0%, and 3%, respectively. The average onset of PR during pregnancy was earlier among women with complications, compared with those without complications (10.75 weeks’ gestation vs. 15.21 weeks’ gestation), but the difference was not statistically significant.

The researchers noted that their findings differed from the most recent study of PR in pregnancy, which included 60 patients and found a notably higher incidence of overall birth complications (50%), as well as higher incidence of neonatal hypotonia (25%), and miscarriage (13%).

The previous study also showed an increased risk of birth complications when PR onset occurred prior to 15 weeks’ gestation, but the current study did not reflect that finding, they wrote.

The current study findings were limited by several factors including the small sample size, retrospective design, and lack of confirmation of PR with HHV-6/7 testing, as well as lack of exclusion of atypical PR cases, the researchers noted. However, the results suggest that birth complications associated with PR may be lower than previously reported. “Further research is needed to guide future care and fully elucidate this possible association, which has important implications for both pregnant women with PR and their providers.”

The study received no outside funding. The researchers had no financial conflict to disclose.

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Pregnancy complications in women with pityriasis rosea (PR) were relatively minor, and included no cases of miscarriage, abortion, or fetal death, according to a review of 33 patients.

“Though generally considered benign, PR may be associated with an increased risk of birth complications if acquired during pregnancy,” and previous studies have shown increased rates of complications including miscarriage and neonatal hypotonia in these patients, wrote Julian Stashower of the University of Virginia, Charlottesville, and colleagues.

In a retrospective study published in the Journal of the American Academy of Dermatology, the researchers assessed pregnancy outcomes in women who developed PR during pregnancy. They were identified from medical records at three institutions between September 2010 and June 2020. Diagnosis of PR, a papulosquamous skin eruption associated with human herpesvirus (HHV)–6/7 reactivation, was based on history and physical examination.

Overall, 8 of the 33 women (24%) had birth complications; the rates of preterm delivery, spontaneous pregnancy loss in clinically detectable pregnancies, and oligohydramnios were 6%, 0%, and 3%, respectively. The average onset of PR during pregnancy was earlier among women with complications, compared with those without complications (10.75 weeks’ gestation vs. 15.21 weeks’ gestation), but the difference was not statistically significant.

The researchers noted that their findings differed from the most recent study of PR in pregnancy, which included 60 patients and found a notably higher incidence of overall birth complications (50%), as well as higher incidence of neonatal hypotonia (25%), and miscarriage (13%).

The previous study also showed an increased risk of birth complications when PR onset occurred prior to 15 weeks’ gestation, but the current study did not reflect that finding, they wrote.

The current study findings were limited by several factors including the small sample size, retrospective design, and lack of confirmation of PR with HHV-6/7 testing, as well as lack of exclusion of atypical PR cases, the researchers noted. However, the results suggest that birth complications associated with PR may be lower than previously reported. “Further research is needed to guide future care and fully elucidate this possible association, which has important implications for both pregnant women with PR and their providers.”

The study received no outside funding. The researchers had no financial conflict to disclose.

Pregnancy complications in women with pityriasis rosea (PR) were relatively minor, and included no cases of miscarriage, abortion, or fetal death, according to a review of 33 patients.

“Though generally considered benign, PR may be associated with an increased risk of birth complications if acquired during pregnancy,” and previous studies have shown increased rates of complications including miscarriage and neonatal hypotonia in these patients, wrote Julian Stashower of the University of Virginia, Charlottesville, and colleagues.

In a retrospective study published in the Journal of the American Academy of Dermatology, the researchers assessed pregnancy outcomes in women who developed PR during pregnancy. They were identified from medical records at three institutions between September 2010 and June 2020. Diagnosis of PR, a papulosquamous skin eruption associated with human herpesvirus (HHV)–6/7 reactivation, was based on history and physical examination.

Overall, 8 of the 33 women (24%) had birth complications; the rates of preterm delivery, spontaneous pregnancy loss in clinically detectable pregnancies, and oligohydramnios were 6%, 0%, and 3%, respectively. The average onset of PR during pregnancy was earlier among women with complications, compared with those without complications (10.75 weeks’ gestation vs. 15.21 weeks’ gestation), but the difference was not statistically significant.

The researchers noted that their findings differed from the most recent study of PR in pregnancy, which included 60 patients and found a notably higher incidence of overall birth complications (50%), as well as higher incidence of neonatal hypotonia (25%), and miscarriage (13%).

The previous study also showed an increased risk of birth complications when PR onset occurred prior to 15 weeks’ gestation, but the current study did not reflect that finding, they wrote.

The current study findings were limited by several factors including the small sample size, retrospective design, and lack of confirmation of PR with HHV-6/7 testing, as well as lack of exclusion of atypical PR cases, the researchers noted. However, the results suggest that birth complications associated with PR may be lower than previously reported. “Further research is needed to guide future care and fully elucidate this possible association, which has important implications for both pregnant women with PR and their providers.”

The study received no outside funding. The researchers had no financial conflict to disclose.

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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

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Find and manage a kidney in crisis

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“Kidney disease is the most common chronic disease in the United States and the world, and the incidence is on the rise,” said Kim Zuber, PA-C, executive director of the American Academy of Nephrology PAs and outreach chair for the National Kidney Foundation in St. Petersburg, Fla.

Kim Zuber

Kidney disease also is an expensive problem that accounts for approximately 20% of the Medicare budget in the United States, she said in a virtual presentation at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.

“It’s important that we know how to identify it and how to slow the progression if possible, and what to do when we can no longer control the disease,” she said.

Notably, the rate of growth for kidney disease is highest among adults aged 20-45 years, said Ms. Zuber. “That is the group who will live for many years with kidney disease,” but should be in their peak years of working and earning. “That is the group we do not want to develop chronic diseases.”

“Look for kidney disease. It’s not always on the chart; it is often missed because people don’t think of it,” Ms. Zuber said. Anyone over 60 years has likely lost some kidney function. Other risk factors include minority/ethnicity, hypertension or cardiovascular disease, diabetes, and a family history of kidney disease.

Women are more likely to develop chronic kidney disease (CKD), but less likely to go on dialysis, said Ms. Zuber. “What I find fascinating is that a history of oophorectomy” increases risk. Other less obvious risk factors in a medical history that should prompt a kidney disease screening include mothers who drank during pregnancy, individuals with a history of acute kidney disease, lupus, sarcoid, amyloid, gout, or other autoimmune conditions, as well as a history of kidney stones of cancer. Kidney donors or transplant recipients are at increased risk, as are smokers, soda drinkers, and heavy salt users.

CKD is missed by many health care providers, Ms. Zuber said. For example, she cited data from more than 270,000 veterans treated at a Veterans Affairs hospital in Texas, which suggested that the likelihood of adding CKD to a patient’s diagnosis was 43.7% even if lab results confirmed CKD.
 

Find the patients

There are many formulas for defining kidney function, Ms. Zuber said. The estimation of creatinine clearance (eCrCl) and estimated glomerular filtration rate (eGFR) are among them. The most common definition is to calculate eGFR using the CKD-EPI formula. Cystatin C is more exact, but it is not standardized, so a lab in one state does not use the same formula as one in another state.

Overall, all these formulas are plus or minus 30%. “It is an estimate,” she said. Within the stages of CKD, “what we know is that, if you have a high GFR, that’s good, but patients who are losing albumin are at increased risk for CKD.” The albumin is more of a risk factor for CKD than GFR, so the GFR test used doesn’t make much difference, whereas, “if you have a lot of albumin in your urine, you are going downhill,” she said.

Normally, everyone loses kidney function with age, Ms. Zuber said. Starting at age 30, individuals lose about 1 mL/min per year in measures of GFR, however, this progression is more rapid among those with CKD, so “we need to find those people who are progressing more quickly than normal.”

The way to identify the high-risk patients is albumin, Ms. Zuber said. Health care providers need to test the urine and check albumin for high levels of albumin loss through urine, and many providers simply don’t routinely conduct urine tests for patients with other CKD risk factors such as diabetes or hypertension.

Albuminuria levels of 2,000 mg/g are the most concerning, and a urine-albumin-to-creatinine ratio (UACR) test is the most effective tool to monitor kidney function, Ms. Zuber said.

She recommends ordering a UACR test at least once a year to monitor kidney loss in all patients with hypertension, diabetes, lupus, and other risk factors including race and a history of acute kidney injury.
 

 

 

Keep them healthy

Managing patients with chronic kidney disease includes attention to several categories: hypertension, diabetes, obesity, and cardiovascular disease, and mental health, Ms. Zuber said.

“If hypertension doesn’t cause your CKD, your CKD will cause hypertension,” she said. The goal for patients with CKD is a target systolic blood pressure less than 120 mm Hg. “As kidney disease progresses, hypertension becomes harder to control,” she added. Lifestyle changes including exercise, low-fat diet, limited use of salt, weight loss if needed, and stress reduction strategies can help.

For patients with diabetes and CKD, work towards a target hemoglobin A1c of 7.0 for early CKD, and of 8% for stage 4/5 or for older patients with multiple comorbidities, Ms. Zuber said. All types of insulin are safe for CKD patients. “Kidney function declines at twice the normal rate for diabetes patients; however, SGLT2 inhibitors are very renoprotective. You may not see a drop in A1c, but you are protecting the kidney.”

For patients with obesity and CKD, data show that bariatric surgery (gastric bypass) lowers mortality in diabetes and also protects the heart and kidneys, said Ms. Zuber. Overall, central obesity increases CKD risk independent of any other risk factors, but losing weight, either by surgery or diet/lifestyle, helps save the kidneys.

Cardiovascular disease is the cause of death for more than 70% of kidney disease patients, Ms. Zuber said. CKD patients “are two to three times more likely to have atrial fibrillation, so take the time to listen with that stethoscope,” she added, also emphasizing the importance of statins for all CKD and diabetes patients, and decreasing smoking. In addition, “managing metabolic acidosis slows the loss of kidney function and protects the heart.”

Additional pearls for managing chronic kidney disease include paying attention to a patient’s mental health; depression occurs in roughly 25%-47% of CKD patients, and anxiety in approximately 27%, said Ms. Zuber. Depression “is believed to be the most common psychiatric disorder in patients with end stage renal disease,” and data suggest that managing depression can help improve survival in CKD patients.

Global Academy and this news organization are owned by the same parent company. Ms. Zuber had no financial conflicts to disclose.

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“Kidney disease is the most common chronic disease in the United States and the world, and the incidence is on the rise,” said Kim Zuber, PA-C, executive director of the American Academy of Nephrology PAs and outreach chair for the National Kidney Foundation in St. Petersburg, Fla.

Kim Zuber

Kidney disease also is an expensive problem that accounts for approximately 20% of the Medicare budget in the United States, she said in a virtual presentation at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.

“It’s important that we know how to identify it and how to slow the progression if possible, and what to do when we can no longer control the disease,” she said.

Notably, the rate of growth for kidney disease is highest among adults aged 20-45 years, said Ms. Zuber. “That is the group who will live for many years with kidney disease,” but should be in their peak years of working and earning. “That is the group we do not want to develop chronic diseases.”

“Look for kidney disease. It’s not always on the chart; it is often missed because people don’t think of it,” Ms. Zuber said. Anyone over 60 years has likely lost some kidney function. Other risk factors include minority/ethnicity, hypertension or cardiovascular disease, diabetes, and a family history of kidney disease.

Women are more likely to develop chronic kidney disease (CKD), but less likely to go on dialysis, said Ms. Zuber. “What I find fascinating is that a history of oophorectomy” increases risk. Other less obvious risk factors in a medical history that should prompt a kidney disease screening include mothers who drank during pregnancy, individuals with a history of acute kidney disease, lupus, sarcoid, amyloid, gout, or other autoimmune conditions, as well as a history of kidney stones of cancer. Kidney donors or transplant recipients are at increased risk, as are smokers, soda drinkers, and heavy salt users.

CKD is missed by many health care providers, Ms. Zuber said. For example, she cited data from more than 270,000 veterans treated at a Veterans Affairs hospital in Texas, which suggested that the likelihood of adding CKD to a patient’s diagnosis was 43.7% even if lab results confirmed CKD.
 

Find the patients

There are many formulas for defining kidney function, Ms. Zuber said. The estimation of creatinine clearance (eCrCl) and estimated glomerular filtration rate (eGFR) are among them. The most common definition is to calculate eGFR using the CKD-EPI formula. Cystatin C is more exact, but it is not standardized, so a lab in one state does not use the same formula as one in another state.

Overall, all these formulas are plus or minus 30%. “It is an estimate,” she said. Within the stages of CKD, “what we know is that, if you have a high GFR, that’s good, but patients who are losing albumin are at increased risk for CKD.” The albumin is more of a risk factor for CKD than GFR, so the GFR test used doesn’t make much difference, whereas, “if you have a lot of albumin in your urine, you are going downhill,” she said.

Normally, everyone loses kidney function with age, Ms. Zuber said. Starting at age 30, individuals lose about 1 mL/min per year in measures of GFR, however, this progression is more rapid among those with CKD, so “we need to find those people who are progressing more quickly than normal.”

The way to identify the high-risk patients is albumin, Ms. Zuber said. Health care providers need to test the urine and check albumin for high levels of albumin loss through urine, and many providers simply don’t routinely conduct urine tests for patients with other CKD risk factors such as diabetes or hypertension.

Albuminuria levels of 2,000 mg/g are the most concerning, and a urine-albumin-to-creatinine ratio (UACR) test is the most effective tool to monitor kidney function, Ms. Zuber said.

She recommends ordering a UACR test at least once a year to monitor kidney loss in all patients with hypertension, diabetes, lupus, and other risk factors including race and a history of acute kidney injury.
 

 

 

Keep them healthy

Managing patients with chronic kidney disease includes attention to several categories: hypertension, diabetes, obesity, and cardiovascular disease, and mental health, Ms. Zuber said.

“If hypertension doesn’t cause your CKD, your CKD will cause hypertension,” she said. The goal for patients with CKD is a target systolic blood pressure less than 120 mm Hg. “As kidney disease progresses, hypertension becomes harder to control,” she added. Lifestyle changes including exercise, low-fat diet, limited use of salt, weight loss if needed, and stress reduction strategies can help.

For patients with diabetes and CKD, work towards a target hemoglobin A1c of 7.0 for early CKD, and of 8% for stage 4/5 or for older patients with multiple comorbidities, Ms. Zuber said. All types of insulin are safe for CKD patients. “Kidney function declines at twice the normal rate for diabetes patients; however, SGLT2 inhibitors are very renoprotective. You may not see a drop in A1c, but you are protecting the kidney.”

For patients with obesity and CKD, data show that bariatric surgery (gastric bypass) lowers mortality in diabetes and also protects the heart and kidneys, said Ms. Zuber. Overall, central obesity increases CKD risk independent of any other risk factors, but losing weight, either by surgery or diet/lifestyle, helps save the kidneys.

Cardiovascular disease is the cause of death for more than 70% of kidney disease patients, Ms. Zuber said. CKD patients “are two to three times more likely to have atrial fibrillation, so take the time to listen with that stethoscope,” she added, also emphasizing the importance of statins for all CKD and diabetes patients, and decreasing smoking. In addition, “managing metabolic acidosis slows the loss of kidney function and protects the heart.”

Additional pearls for managing chronic kidney disease include paying attention to a patient’s mental health; depression occurs in roughly 25%-47% of CKD patients, and anxiety in approximately 27%, said Ms. Zuber. Depression “is believed to be the most common psychiatric disorder in patients with end stage renal disease,” and data suggest that managing depression can help improve survival in CKD patients.

Global Academy and this news organization are owned by the same parent company. Ms. Zuber had no financial conflicts to disclose.

“Kidney disease is the most common chronic disease in the United States and the world, and the incidence is on the rise,” said Kim Zuber, PA-C, executive director of the American Academy of Nephrology PAs and outreach chair for the National Kidney Foundation in St. Petersburg, Fla.

Kim Zuber

Kidney disease also is an expensive problem that accounts for approximately 20% of the Medicare budget in the United States, she said in a virtual presentation at the Metabolic & Endocrine Disease Summit by Global Academy for Medical Education.

“It’s important that we know how to identify it and how to slow the progression if possible, and what to do when we can no longer control the disease,” she said.

Notably, the rate of growth for kidney disease is highest among adults aged 20-45 years, said Ms. Zuber. “That is the group who will live for many years with kidney disease,” but should be in their peak years of working and earning. “That is the group we do not want to develop chronic diseases.”

“Look for kidney disease. It’s not always on the chart; it is often missed because people don’t think of it,” Ms. Zuber said. Anyone over 60 years has likely lost some kidney function. Other risk factors include minority/ethnicity, hypertension or cardiovascular disease, diabetes, and a family history of kidney disease.

Women are more likely to develop chronic kidney disease (CKD), but less likely to go on dialysis, said Ms. Zuber. “What I find fascinating is that a history of oophorectomy” increases risk. Other less obvious risk factors in a medical history that should prompt a kidney disease screening include mothers who drank during pregnancy, individuals with a history of acute kidney disease, lupus, sarcoid, amyloid, gout, or other autoimmune conditions, as well as a history of kidney stones of cancer. Kidney donors or transplant recipients are at increased risk, as are smokers, soda drinkers, and heavy salt users.

CKD is missed by many health care providers, Ms. Zuber said. For example, she cited data from more than 270,000 veterans treated at a Veterans Affairs hospital in Texas, which suggested that the likelihood of adding CKD to a patient’s diagnosis was 43.7% even if lab results confirmed CKD.
 

Find the patients

There are many formulas for defining kidney function, Ms. Zuber said. The estimation of creatinine clearance (eCrCl) and estimated glomerular filtration rate (eGFR) are among them. The most common definition is to calculate eGFR using the CKD-EPI formula. Cystatin C is more exact, but it is not standardized, so a lab in one state does not use the same formula as one in another state.

Overall, all these formulas are plus or minus 30%. “It is an estimate,” she said. Within the stages of CKD, “what we know is that, if you have a high GFR, that’s good, but patients who are losing albumin are at increased risk for CKD.” The albumin is more of a risk factor for CKD than GFR, so the GFR test used doesn’t make much difference, whereas, “if you have a lot of albumin in your urine, you are going downhill,” she said.

Normally, everyone loses kidney function with age, Ms. Zuber said. Starting at age 30, individuals lose about 1 mL/min per year in measures of GFR, however, this progression is more rapid among those with CKD, so “we need to find those people who are progressing more quickly than normal.”

The way to identify the high-risk patients is albumin, Ms. Zuber said. Health care providers need to test the urine and check albumin for high levels of albumin loss through urine, and many providers simply don’t routinely conduct urine tests for patients with other CKD risk factors such as diabetes or hypertension.

Albuminuria levels of 2,000 mg/g are the most concerning, and a urine-albumin-to-creatinine ratio (UACR) test is the most effective tool to monitor kidney function, Ms. Zuber said.

She recommends ordering a UACR test at least once a year to monitor kidney loss in all patients with hypertension, diabetes, lupus, and other risk factors including race and a history of acute kidney injury.
 

 

 

Keep them healthy

Managing patients with chronic kidney disease includes attention to several categories: hypertension, diabetes, obesity, and cardiovascular disease, and mental health, Ms. Zuber said.

“If hypertension doesn’t cause your CKD, your CKD will cause hypertension,” she said. The goal for patients with CKD is a target systolic blood pressure less than 120 mm Hg. “As kidney disease progresses, hypertension becomes harder to control,” she added. Lifestyle changes including exercise, low-fat diet, limited use of salt, weight loss if needed, and stress reduction strategies can help.

For patients with diabetes and CKD, work towards a target hemoglobin A1c of 7.0 for early CKD, and of 8% for stage 4/5 or for older patients with multiple comorbidities, Ms. Zuber said. All types of insulin are safe for CKD patients. “Kidney function declines at twice the normal rate for diabetes patients; however, SGLT2 inhibitors are very renoprotective. You may not see a drop in A1c, but you are protecting the kidney.”

For patients with obesity and CKD, data show that bariatric surgery (gastric bypass) lowers mortality in diabetes and also protects the heart and kidneys, said Ms. Zuber. Overall, central obesity increases CKD risk independent of any other risk factors, but losing weight, either by surgery or diet/lifestyle, helps save the kidneys.

Cardiovascular disease is the cause of death for more than 70% of kidney disease patients, Ms. Zuber said. CKD patients “are two to three times more likely to have atrial fibrillation, so take the time to listen with that stethoscope,” she added, also emphasizing the importance of statins for all CKD and diabetes patients, and decreasing smoking. In addition, “managing metabolic acidosis slows the loss of kidney function and protects the heart.”

Additional pearls for managing chronic kidney disease include paying attention to a patient’s mental health; depression occurs in roughly 25%-47% of CKD patients, and anxiety in approximately 27%, said Ms. Zuber. Depression “is believed to be the most common psychiatric disorder in patients with end stage renal disease,” and data suggest that managing depression can help improve survival in CKD patients.

Global Academy and this news organization are owned by the same parent company. Ms. Zuber had no financial conflicts to disclose.

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Asthma-COPD overlap: Patients have high disease burden

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Patients with asthma–chronic obstructive pulmonary disease overlap (ACO) experienced a higher burden of disease than patients with either asthma or COPD alone, a recent study has found.

Approximately 20% of chronic obstructive airway disease cases are ACO, but data on these patients are limited, as they are often excluded from clinical trials, wrote Sarah A. Hiles, MD, of the University of Newcastle (Australia) and colleagues.

“Comparing the burden of eosinophilic ACO, eosinophilic severe asthma, and eosinophilic COPD may also help contextualize findings from phenotype-targeted treatments in different diagnostic groups, such as the limited success of anti-IL [interleukin]–5 monoclonal antibodies as therapy in eosinophilic COPD,” they said.

In a cross-sectional, observational study published in Respirology the researchers recruited patients aged 18 years and older with a confirmed diagnosis of COPD only (153) severe asthma only (64), or ACO (106). Patients were assessed for demographic and clinical factors including health-related quality of life, past-year exacerbation, and other indicators of disease burden. In addition, patients were identified as having eosinophilic airway disease based on a blood eosinophil count of at least 0.3x109/L.

Overall, eosinophilic airway disease was present in 41% of the patients; 55%, 44%, and 29% for those with ACO, severe asthma, and COPD, respectively. Reports of poor health-related quality of life and past-year exacerbations were similar for eosinophilic patients across all three conditions.

However, patients with eosinophilic ACO experienced significantly more past-year exacerbations, notably those requiring oral corticosteroids, compared with patients with asthma alone. In addition, the cumulative number of past-year exacerbations in patient with eosinophilic disease was 164 in those with ACO, compared with severe asthma alone (44) and COPD alone (59).

Patients with ACO also had significantly higher disease burden based on the St. George’s Respiratory Questionnaire (SGRQ), which assessed functional limitation. “For 100 patients, the cumulative SGRQ score attributable to eosinophilic airways disease in ACO was 2,872.8, which was higher than in severe asthma (1,942.5) or COPD (1,638.1),” the researchers said.

The study was limited by several factors including the cross-sectional design and use of a single measurement to classify eosinophilia, the researchers noted. “The non-eosinophilic group likely included a mix of patients with treated eosinophilia and patients without eosinophilia, regardless of treatment, which is a limitation to consider when interpreting the disease burden estimates in this group,” they added.

However, the results add to the understanding of blood eosinophils in airway disease and the study “supports eosinophilia as a phenotype that spans across disease labels of severe asthma and COPD, and their overlap,” they concluded.

The study was supported by AstraZeneca; lead author Dr. Hiles received a salary through a grant from AstraZeneca to the University of Newcastle while conducting the study. Other coauthors disclosed relationships with companies including AstraZeneca, GlaxoSmithKline, Menarini, and Novartis.

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Patients with asthma–chronic obstructive pulmonary disease overlap (ACO) experienced a higher burden of disease than patients with either asthma or COPD alone, a recent study has found.

Approximately 20% of chronic obstructive airway disease cases are ACO, but data on these patients are limited, as they are often excluded from clinical trials, wrote Sarah A. Hiles, MD, of the University of Newcastle (Australia) and colleagues.

“Comparing the burden of eosinophilic ACO, eosinophilic severe asthma, and eosinophilic COPD may also help contextualize findings from phenotype-targeted treatments in different diagnostic groups, such as the limited success of anti-IL [interleukin]–5 monoclonal antibodies as therapy in eosinophilic COPD,” they said.

In a cross-sectional, observational study published in Respirology the researchers recruited patients aged 18 years and older with a confirmed diagnosis of COPD only (153) severe asthma only (64), or ACO (106). Patients were assessed for demographic and clinical factors including health-related quality of life, past-year exacerbation, and other indicators of disease burden. In addition, patients were identified as having eosinophilic airway disease based on a blood eosinophil count of at least 0.3x109/L.

Overall, eosinophilic airway disease was present in 41% of the patients; 55%, 44%, and 29% for those with ACO, severe asthma, and COPD, respectively. Reports of poor health-related quality of life and past-year exacerbations were similar for eosinophilic patients across all three conditions.

However, patients with eosinophilic ACO experienced significantly more past-year exacerbations, notably those requiring oral corticosteroids, compared with patients with asthma alone. In addition, the cumulative number of past-year exacerbations in patient with eosinophilic disease was 164 in those with ACO, compared with severe asthma alone (44) and COPD alone (59).

Patients with ACO also had significantly higher disease burden based on the St. George’s Respiratory Questionnaire (SGRQ), which assessed functional limitation. “For 100 patients, the cumulative SGRQ score attributable to eosinophilic airways disease in ACO was 2,872.8, which was higher than in severe asthma (1,942.5) or COPD (1,638.1),” the researchers said.

The study was limited by several factors including the cross-sectional design and use of a single measurement to classify eosinophilia, the researchers noted. “The non-eosinophilic group likely included a mix of patients with treated eosinophilia and patients without eosinophilia, regardless of treatment, which is a limitation to consider when interpreting the disease burden estimates in this group,” they added.

However, the results add to the understanding of blood eosinophils in airway disease and the study “supports eosinophilia as a phenotype that spans across disease labels of severe asthma and COPD, and their overlap,” they concluded.

The study was supported by AstraZeneca; lead author Dr. Hiles received a salary through a grant from AstraZeneca to the University of Newcastle while conducting the study. Other coauthors disclosed relationships with companies including AstraZeneca, GlaxoSmithKline, Menarini, and Novartis.

Patients with asthma–chronic obstructive pulmonary disease overlap (ACO) experienced a higher burden of disease than patients with either asthma or COPD alone, a recent study has found.

Approximately 20% of chronic obstructive airway disease cases are ACO, but data on these patients are limited, as they are often excluded from clinical trials, wrote Sarah A. Hiles, MD, of the University of Newcastle (Australia) and colleagues.

“Comparing the burden of eosinophilic ACO, eosinophilic severe asthma, and eosinophilic COPD may also help contextualize findings from phenotype-targeted treatments in different diagnostic groups, such as the limited success of anti-IL [interleukin]–5 monoclonal antibodies as therapy in eosinophilic COPD,” they said.

In a cross-sectional, observational study published in Respirology the researchers recruited patients aged 18 years and older with a confirmed diagnosis of COPD only (153) severe asthma only (64), or ACO (106). Patients were assessed for demographic and clinical factors including health-related quality of life, past-year exacerbation, and other indicators of disease burden. In addition, patients were identified as having eosinophilic airway disease based on a blood eosinophil count of at least 0.3x109/L.

Overall, eosinophilic airway disease was present in 41% of the patients; 55%, 44%, and 29% for those with ACO, severe asthma, and COPD, respectively. Reports of poor health-related quality of life and past-year exacerbations were similar for eosinophilic patients across all three conditions.

However, patients with eosinophilic ACO experienced significantly more past-year exacerbations, notably those requiring oral corticosteroids, compared with patients with asthma alone. In addition, the cumulative number of past-year exacerbations in patient with eosinophilic disease was 164 in those with ACO, compared with severe asthma alone (44) and COPD alone (59).

Patients with ACO also had significantly higher disease burden based on the St. George’s Respiratory Questionnaire (SGRQ), which assessed functional limitation. “For 100 patients, the cumulative SGRQ score attributable to eosinophilic airways disease in ACO was 2,872.8, which was higher than in severe asthma (1,942.5) or COPD (1,638.1),” the researchers said.

The study was limited by several factors including the cross-sectional design and use of a single measurement to classify eosinophilia, the researchers noted. “The non-eosinophilic group likely included a mix of patients with treated eosinophilia and patients without eosinophilia, regardless of treatment, which is a limitation to consider when interpreting the disease burden estimates in this group,” they added.

However, the results add to the understanding of blood eosinophils in airway disease and the study “supports eosinophilia as a phenotype that spans across disease labels of severe asthma and COPD, and their overlap,” they concluded.

The study was supported by AstraZeneca; lead author Dr. Hiles received a salary through a grant from AstraZeneca to the University of Newcastle while conducting the study. Other coauthors disclosed relationships with companies including AstraZeneca, GlaxoSmithKline, Menarini, and Novartis.

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Childhood smoking and depression contribute to young adult opioid use

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Depression and tobacco use in childhood significantly increased the risk for opioid use in young adults, according to data from a prospective study of approximately 1,000 individuals.

Previous research, including the annual Monitoring the Future study, documents opioid use among adolescents in the United States, but childhood risk factors for opioid use in young adults have not been well studied, wrote Lilly Shanahan, PhD, of the University of Zürich, and colleagues.

In a prospective cohort study published in JAMA Pediatrics, the researchers identified 1,252 non-Hispanic White and American Indian opioid-naive individuals aged 9-16 years in rural North Carolina. They interviewed participants and parents up to 7 times between January 1993 and December 2000, and interviewed participants only at ages 19, 21, 25, and 30 years between January 1999 and December 2015.

Overall, 24.2% of study participants had used a nonheroin opioid by age 30 years, and both chronic depression and dysthymia were significantly associated with this use (odds ratios 5.43 and 7.13, respectively).

In addition, 155 participants (8.8%) reported weekly use of a nonheroin opioid, and 95 (6.6%) reported weekly heroin use by age 30 years. Chronic depression and dysthymia also were strongly associated with weekly nonheroin opioid use (OR 8.89 and 11.51, respectively).

In a multivariate analysis, depression, tobacco use, and cannabis use at ages 9-16 years were strongly associated with overall opioid use at ages 19-30 years.

“One possible reason childhood chronic depression increases the risk of later opioid use is self-medication, including the use of psychoactive substances, to alleviate depression,” the researchers noted. In addition, the mood-altering properties of opioids may increase their appeal to depressed youth as a way to relieve impaired reward system function, they said.

Potential mechanisms for the association between early tobacco use and later opioid use include the alterations to neurodevelopment caused by nicotine exposure in adolescence, as well as increased risk for depression, reduced pain thresholds, and use of nicotine as a gateway to harder drugs, the researchers added.

Several childhood risk factors were not associated with young adult opioid use in multivariate analysis in this study, including alcohol use, sociodemographic status, maltreatment, family dysfunction, and anxiety, the researchers wrote. “Previous studies typically measured these risk factors retrospectively or in late adolescence and young adulthood, and most did not consider depressive disorders, which may mediate associations between select childhood risk factors and later opioid use,” they said.

The study findings were limited by several factors, including the inability to distinguish between medical and nonmedical opioid use, the incomplete list of available opioids, and the exclusion of Black participants because of low sample size, the researchers noted. However, the results were strengthened by the longitudinal, community-representative design and the inclusion of up to 11 assessments of opioid use, they said.

“Our findings suggest strong opportunities for early prevention and intervention, including in primary care settings,” using known evidence-based strategies, they concluded.
 

More screening is needed

“Children in the United States are at high risk of serious adult health issues as a result of childhood factors such as ACEs (adverse childhood experiences),” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “This study looks prospectively at other factors in childhood over a long period of time leading to opioid usage, with its serious risks and health consequences including overdose death,” she said. “It is unclear what the effects of COVID-19 will be on the population of children growing up now and how opioid usage might change as a result,” she noted.

“Some of the links to adult usage are predictable, such as depression, tobacco use, and cannabis use in early adolescence,” said Dr. Boulter. “Surprising was the lack of correlation between anxiety, early alcohol use, child mistreatment, and sociodemographic factors with future opioid use,” she said.

The take-home message for clinicians is to screen children and adolescents for factors leading to opioid usage in young adults “with preventive strategies including avoidance of pain medication prescriptions and early referral and treatment for depression and use of cannabis and tobacco products using tools like SBIRT (Screening, Brief Intervention, and Referral to Treatment),” Dr. Boulter emphasized.

As for additional research, “It would be interesting to study e-cigarette usage and see if the correlation with future opioid usage is similar to older tobacco products,” she said. “Also helpful would be to delve deeper into connections between medical or dental diagnoses when opioids were first prescribed and later usage of those products,” Dr. Boulter noted.

The study was supported in part by the by the National Institute of Mental Health and the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Boulter had no disclosures but serves on the Pediatric News Editorial Advisory Board.

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Depression and tobacco use in childhood significantly increased the risk for opioid use in young adults, according to data from a prospective study of approximately 1,000 individuals.

Previous research, including the annual Monitoring the Future study, documents opioid use among adolescents in the United States, but childhood risk factors for opioid use in young adults have not been well studied, wrote Lilly Shanahan, PhD, of the University of Zürich, and colleagues.

In a prospective cohort study published in JAMA Pediatrics, the researchers identified 1,252 non-Hispanic White and American Indian opioid-naive individuals aged 9-16 years in rural North Carolina. They interviewed participants and parents up to 7 times between January 1993 and December 2000, and interviewed participants only at ages 19, 21, 25, and 30 years between January 1999 and December 2015.

Overall, 24.2% of study participants had used a nonheroin opioid by age 30 years, and both chronic depression and dysthymia were significantly associated with this use (odds ratios 5.43 and 7.13, respectively).

In addition, 155 participants (8.8%) reported weekly use of a nonheroin opioid, and 95 (6.6%) reported weekly heroin use by age 30 years. Chronic depression and dysthymia also were strongly associated with weekly nonheroin opioid use (OR 8.89 and 11.51, respectively).

In a multivariate analysis, depression, tobacco use, and cannabis use at ages 9-16 years were strongly associated with overall opioid use at ages 19-30 years.

“One possible reason childhood chronic depression increases the risk of later opioid use is self-medication, including the use of psychoactive substances, to alleviate depression,” the researchers noted. In addition, the mood-altering properties of opioids may increase their appeal to depressed youth as a way to relieve impaired reward system function, they said.

Potential mechanisms for the association between early tobacco use and later opioid use include the alterations to neurodevelopment caused by nicotine exposure in adolescence, as well as increased risk for depression, reduced pain thresholds, and use of nicotine as a gateway to harder drugs, the researchers added.

Several childhood risk factors were not associated with young adult opioid use in multivariate analysis in this study, including alcohol use, sociodemographic status, maltreatment, family dysfunction, and anxiety, the researchers wrote. “Previous studies typically measured these risk factors retrospectively or in late adolescence and young adulthood, and most did not consider depressive disorders, which may mediate associations between select childhood risk factors and later opioid use,” they said.

The study findings were limited by several factors, including the inability to distinguish between medical and nonmedical opioid use, the incomplete list of available opioids, and the exclusion of Black participants because of low sample size, the researchers noted. However, the results were strengthened by the longitudinal, community-representative design and the inclusion of up to 11 assessments of opioid use, they said.

“Our findings suggest strong opportunities for early prevention and intervention, including in primary care settings,” using known evidence-based strategies, they concluded.
 

More screening is needed

“Children in the United States are at high risk of serious adult health issues as a result of childhood factors such as ACEs (adverse childhood experiences),” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “This study looks prospectively at other factors in childhood over a long period of time leading to opioid usage, with its serious risks and health consequences including overdose death,” she said. “It is unclear what the effects of COVID-19 will be on the population of children growing up now and how opioid usage might change as a result,” she noted.

“Some of the links to adult usage are predictable, such as depression, tobacco use, and cannabis use in early adolescence,” said Dr. Boulter. “Surprising was the lack of correlation between anxiety, early alcohol use, child mistreatment, and sociodemographic factors with future opioid use,” she said.

The take-home message for clinicians is to screen children and adolescents for factors leading to opioid usage in young adults “with preventive strategies including avoidance of pain medication prescriptions and early referral and treatment for depression and use of cannabis and tobacco products using tools like SBIRT (Screening, Brief Intervention, and Referral to Treatment),” Dr. Boulter emphasized.

As for additional research, “It would be interesting to study e-cigarette usage and see if the correlation with future opioid usage is similar to older tobacco products,” she said. “Also helpful would be to delve deeper into connections between medical or dental diagnoses when opioids were first prescribed and later usage of those products,” Dr. Boulter noted.

The study was supported in part by the by the National Institute of Mental Health and the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Boulter had no disclosures but serves on the Pediatric News Editorial Advisory Board.

Depression and tobacco use in childhood significantly increased the risk for opioid use in young adults, according to data from a prospective study of approximately 1,000 individuals.

Previous research, including the annual Monitoring the Future study, documents opioid use among adolescents in the United States, but childhood risk factors for opioid use in young adults have not been well studied, wrote Lilly Shanahan, PhD, of the University of Zürich, and colleagues.

In a prospective cohort study published in JAMA Pediatrics, the researchers identified 1,252 non-Hispanic White and American Indian opioid-naive individuals aged 9-16 years in rural North Carolina. They interviewed participants and parents up to 7 times between January 1993 and December 2000, and interviewed participants only at ages 19, 21, 25, and 30 years between January 1999 and December 2015.

Overall, 24.2% of study participants had used a nonheroin opioid by age 30 years, and both chronic depression and dysthymia were significantly associated with this use (odds ratios 5.43 and 7.13, respectively).

In addition, 155 participants (8.8%) reported weekly use of a nonheroin opioid, and 95 (6.6%) reported weekly heroin use by age 30 years. Chronic depression and dysthymia also were strongly associated with weekly nonheroin opioid use (OR 8.89 and 11.51, respectively).

In a multivariate analysis, depression, tobacco use, and cannabis use at ages 9-16 years were strongly associated with overall opioid use at ages 19-30 years.

“One possible reason childhood chronic depression increases the risk of later opioid use is self-medication, including the use of psychoactive substances, to alleviate depression,” the researchers noted. In addition, the mood-altering properties of opioids may increase their appeal to depressed youth as a way to relieve impaired reward system function, they said.

Potential mechanisms for the association between early tobacco use and later opioid use include the alterations to neurodevelopment caused by nicotine exposure in adolescence, as well as increased risk for depression, reduced pain thresholds, and use of nicotine as a gateway to harder drugs, the researchers added.

Several childhood risk factors were not associated with young adult opioid use in multivariate analysis in this study, including alcohol use, sociodemographic status, maltreatment, family dysfunction, and anxiety, the researchers wrote. “Previous studies typically measured these risk factors retrospectively or in late adolescence and young adulthood, and most did not consider depressive disorders, which may mediate associations between select childhood risk factors and later opioid use,” they said.

The study findings were limited by several factors, including the inability to distinguish between medical and nonmedical opioid use, the incomplete list of available opioids, and the exclusion of Black participants because of low sample size, the researchers noted. However, the results were strengthened by the longitudinal, community-representative design and the inclusion of up to 11 assessments of opioid use, they said.

“Our findings suggest strong opportunities for early prevention and intervention, including in primary care settings,” using known evidence-based strategies, they concluded.
 

More screening is needed

“Children in the United States are at high risk of serious adult health issues as a result of childhood factors such as ACEs (adverse childhood experiences),” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “This study looks prospectively at other factors in childhood over a long period of time leading to opioid usage, with its serious risks and health consequences including overdose death,” she said. “It is unclear what the effects of COVID-19 will be on the population of children growing up now and how opioid usage might change as a result,” she noted.

“Some of the links to adult usage are predictable, such as depression, tobacco use, and cannabis use in early adolescence,” said Dr. Boulter. “Surprising was the lack of correlation between anxiety, early alcohol use, child mistreatment, and sociodemographic factors with future opioid use,” she said.

The take-home message for clinicians is to screen children and adolescents for factors leading to opioid usage in young adults “with preventive strategies including avoidance of pain medication prescriptions and early referral and treatment for depression and use of cannabis and tobacco products using tools like SBIRT (Screening, Brief Intervention, and Referral to Treatment),” Dr. Boulter emphasized.

As for additional research, “It would be interesting to study e-cigarette usage and see if the correlation with future opioid usage is similar to older tobacco products,” she said. “Also helpful would be to delve deeper into connections between medical or dental diagnoses when opioids were first prescribed and later usage of those products,” Dr. Boulter noted.

The study was supported in part by the by the National Institute of Mental Health and the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Boulter had no disclosures but serves on the Pediatric News Editorial Advisory Board.

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Black women show heightened risk for depression after early pregnancy loss

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Black women are significantly more likely than non-Black women to develop major depression within a month of early pregnancy loss, based on data from a secondary analysis of 300 women.

Approximately 25% of women experience a pregnancy loss, and many of these women are at increased risk for psychological problems including major depression, wrote Jade M. Shorter, MD, of Stanford (Calif.) University, and colleagues.

Data from previous studies show that Black women experience higher rates of perinatal depression, compared with other racial groups, and that stress and adverse childhood experiences also are higher among Black individuals, they noted.

“Based on data showing higher rates of pregnancy loss, perinatal depression, and perceived stress in Black women, we hypothesized that the odds of having risk for major depression or high perceived stress 30 days after miscarriage treatment would be higher in Black participants when compared with non-Black participants,” they wrote.

In a study published in Obstetrics & Gynecology, the researchers conducted a secondary analysis of 300 women aged 18 years and older with nonviable intrauterine pregnancy between 5 and 12 weeks’ gestation who were part of a larger randomized trial conducted between May 2014 and April 2017. The women were randomized to medical treatment of either mifepristone 200 mg orally plus misoprostol 800 mcg vaginally after 24 hours or the usual treatment of misoprostol 800 mcg vaginally.

Depression was assessed using the Center for Epidemiological Studies–Depression scale, Perceived Stress Scale, and Adverse Childhood Experience scale. Adverse childhood experience data were collected at baseline; stress and depression data were collected at baseline and at 30 days after treatment.

A total of 120 participants self-identified as Black and 155 self-identified as non-Black.
 

Depression risk doubles in Black women

At 30 days after treatment for early pregnancy loss, 24% of women met criteria for major depression, including 57% of Black women and 43% of non-Black women. The odds of depression were twice as high among Black women, compared with non-Black women (odds ratio 2.02), and Black women were more likely to be younger, have lower levels of education, and have public insurance, compared with non-Black women.

The association between Black race and increased risk for depression at 30 days after treatment persisted after controlling for factors including parity, baseline depression, and adverse childhood experiences, the researchers noted.

The study findings were limited by several factors, including the potential for different depression risk in those from the original study who did and did not participate in the secondary analysis and by the use of the original Adverse Childhood Experience survey, which may not reflect the range of adversity faced by different demographic groups, the researchers noted. However, the results were strengthened by the collection of 30-day outcome data in the clinical setting and by the diverse study population.

“These findings should be not be used to stigmatize Black women; instead, it is important to consider the complex systemic factors, such as structural racism, that are the root causes of disparate health outcomes,” and to support appropriate mental health resources and interventions for all women who experience early pregnancy loss, the researchers emphasized.
 

 

 

Recognize risks, reduce barriers

“Early pregnancy loss is unfortunately a common event that affects 15%-20% of pregnancies,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

However, “the mental health impact of early pregnancy loss is understudied, and as a result mental health disorders often go unnoticed and untreated,” she said.

Growing evidence shows that Black women in particular are at greater risk for chronic stressors that affect their overall health. “Black women are more likely to be exposed to trauma in their lifetime, such as physical and emotional abuse, neglect, and household instability, all of which predispose women to mental health disorders such as depression. Untreated maternal depression has an impact on future pregnancy outcomes such as increasing the risk of having a preterm delivery and/or delivering a low-birth-weight baby, outcomes where Black women are at disproportionately high risk in comparison to non-Black women,” Dr. Krishna said.

“This study found that the risk for depression after an early pregnancy loss is twice as high for Black women in comparison to non-Black women. The findings of this study further underscore the fact that Black women are at disproportionate high risk for poor maternal and pregnancy outcomes,” Dr. Krishna added.

“Structural racism is a major barrier to caring for the health of Black women. To care for the health of Black women we must overcome racial and ethnic disparities. Addressing disparities involves a multitiered approach, including identifying and addressing implicit bias in health care and improving access to health care for women of color,” she said.

“Additional research is needed in identifying at-risk women and mental health interventions that can improve the mental well-being of women after adverse pregnancy outcomes such as early pregnancy loss,” Dr. Krishna concluded.

The study was supported by the Society of Family Planning Research Fund. Lead author Dr. Shorter had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose.

SOURCE: Shorter JM et al. Obstet Gynecol. 2020 Dec 3. doi: 10.1097/AOG.0000000000004212.

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Black women are significantly more likely than non-Black women to develop major depression within a month of early pregnancy loss, based on data from a secondary analysis of 300 women.

Approximately 25% of women experience a pregnancy loss, and many of these women are at increased risk for psychological problems including major depression, wrote Jade M. Shorter, MD, of Stanford (Calif.) University, and colleagues.

Data from previous studies show that Black women experience higher rates of perinatal depression, compared with other racial groups, and that stress and adverse childhood experiences also are higher among Black individuals, they noted.

“Based on data showing higher rates of pregnancy loss, perinatal depression, and perceived stress in Black women, we hypothesized that the odds of having risk for major depression or high perceived stress 30 days after miscarriage treatment would be higher in Black participants when compared with non-Black participants,” they wrote.

In a study published in Obstetrics & Gynecology, the researchers conducted a secondary analysis of 300 women aged 18 years and older with nonviable intrauterine pregnancy between 5 and 12 weeks’ gestation who were part of a larger randomized trial conducted between May 2014 and April 2017. The women were randomized to medical treatment of either mifepristone 200 mg orally plus misoprostol 800 mcg vaginally after 24 hours or the usual treatment of misoprostol 800 mcg vaginally.

Depression was assessed using the Center for Epidemiological Studies–Depression scale, Perceived Stress Scale, and Adverse Childhood Experience scale. Adverse childhood experience data were collected at baseline; stress and depression data were collected at baseline and at 30 days after treatment.

A total of 120 participants self-identified as Black and 155 self-identified as non-Black.
 

Depression risk doubles in Black women

At 30 days after treatment for early pregnancy loss, 24% of women met criteria for major depression, including 57% of Black women and 43% of non-Black women. The odds of depression were twice as high among Black women, compared with non-Black women (odds ratio 2.02), and Black women were more likely to be younger, have lower levels of education, and have public insurance, compared with non-Black women.

The association between Black race and increased risk for depression at 30 days after treatment persisted after controlling for factors including parity, baseline depression, and adverse childhood experiences, the researchers noted.

The study findings were limited by several factors, including the potential for different depression risk in those from the original study who did and did not participate in the secondary analysis and by the use of the original Adverse Childhood Experience survey, which may not reflect the range of adversity faced by different demographic groups, the researchers noted. However, the results were strengthened by the collection of 30-day outcome data in the clinical setting and by the diverse study population.

“These findings should be not be used to stigmatize Black women; instead, it is important to consider the complex systemic factors, such as structural racism, that are the root causes of disparate health outcomes,” and to support appropriate mental health resources and interventions for all women who experience early pregnancy loss, the researchers emphasized.
 

 

 

Recognize risks, reduce barriers

“Early pregnancy loss is unfortunately a common event that affects 15%-20% of pregnancies,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

However, “the mental health impact of early pregnancy loss is understudied, and as a result mental health disorders often go unnoticed and untreated,” she said.

Growing evidence shows that Black women in particular are at greater risk for chronic stressors that affect their overall health. “Black women are more likely to be exposed to trauma in their lifetime, such as physical and emotional abuse, neglect, and household instability, all of which predispose women to mental health disorders such as depression. Untreated maternal depression has an impact on future pregnancy outcomes such as increasing the risk of having a preterm delivery and/or delivering a low-birth-weight baby, outcomes where Black women are at disproportionately high risk in comparison to non-Black women,” Dr. Krishna said.

“This study found that the risk for depression after an early pregnancy loss is twice as high for Black women in comparison to non-Black women. The findings of this study further underscore the fact that Black women are at disproportionate high risk for poor maternal and pregnancy outcomes,” Dr. Krishna added.

“Structural racism is a major barrier to caring for the health of Black women. To care for the health of Black women we must overcome racial and ethnic disparities. Addressing disparities involves a multitiered approach, including identifying and addressing implicit bias in health care and improving access to health care for women of color,” she said.

“Additional research is needed in identifying at-risk women and mental health interventions that can improve the mental well-being of women after adverse pregnancy outcomes such as early pregnancy loss,” Dr. Krishna concluded.

The study was supported by the Society of Family Planning Research Fund. Lead author Dr. Shorter had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose.

SOURCE: Shorter JM et al. Obstet Gynecol. 2020 Dec 3. doi: 10.1097/AOG.0000000000004212.

Black women are significantly more likely than non-Black women to develop major depression within a month of early pregnancy loss, based on data from a secondary analysis of 300 women.

Approximately 25% of women experience a pregnancy loss, and many of these women are at increased risk for psychological problems including major depression, wrote Jade M. Shorter, MD, of Stanford (Calif.) University, and colleagues.

Data from previous studies show that Black women experience higher rates of perinatal depression, compared with other racial groups, and that stress and adverse childhood experiences also are higher among Black individuals, they noted.

“Based on data showing higher rates of pregnancy loss, perinatal depression, and perceived stress in Black women, we hypothesized that the odds of having risk for major depression or high perceived stress 30 days after miscarriage treatment would be higher in Black participants when compared with non-Black participants,” they wrote.

In a study published in Obstetrics & Gynecology, the researchers conducted a secondary analysis of 300 women aged 18 years and older with nonviable intrauterine pregnancy between 5 and 12 weeks’ gestation who were part of a larger randomized trial conducted between May 2014 and April 2017. The women were randomized to medical treatment of either mifepristone 200 mg orally plus misoprostol 800 mcg vaginally after 24 hours or the usual treatment of misoprostol 800 mcg vaginally.

Depression was assessed using the Center for Epidemiological Studies–Depression scale, Perceived Stress Scale, and Adverse Childhood Experience scale. Adverse childhood experience data were collected at baseline; stress and depression data were collected at baseline and at 30 days after treatment.

A total of 120 participants self-identified as Black and 155 self-identified as non-Black.
 

Depression risk doubles in Black women

At 30 days after treatment for early pregnancy loss, 24% of women met criteria for major depression, including 57% of Black women and 43% of non-Black women. The odds of depression were twice as high among Black women, compared with non-Black women (odds ratio 2.02), and Black women were more likely to be younger, have lower levels of education, and have public insurance, compared with non-Black women.

The association between Black race and increased risk for depression at 30 days after treatment persisted after controlling for factors including parity, baseline depression, and adverse childhood experiences, the researchers noted.

The study findings were limited by several factors, including the potential for different depression risk in those from the original study who did and did not participate in the secondary analysis and by the use of the original Adverse Childhood Experience survey, which may not reflect the range of adversity faced by different demographic groups, the researchers noted. However, the results were strengthened by the collection of 30-day outcome data in the clinical setting and by the diverse study population.

“These findings should be not be used to stigmatize Black women; instead, it is important to consider the complex systemic factors, such as structural racism, that are the root causes of disparate health outcomes,” and to support appropriate mental health resources and interventions for all women who experience early pregnancy loss, the researchers emphasized.
 

 

 

Recognize risks, reduce barriers

“Early pregnancy loss is unfortunately a common event that affects 15%-20% of pregnancies,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

However, “the mental health impact of early pregnancy loss is understudied, and as a result mental health disorders often go unnoticed and untreated,” she said.

Growing evidence shows that Black women in particular are at greater risk for chronic stressors that affect their overall health. “Black women are more likely to be exposed to trauma in their lifetime, such as physical and emotional abuse, neglect, and household instability, all of which predispose women to mental health disorders such as depression. Untreated maternal depression has an impact on future pregnancy outcomes such as increasing the risk of having a preterm delivery and/or delivering a low-birth-weight baby, outcomes where Black women are at disproportionately high risk in comparison to non-Black women,” Dr. Krishna said.

“This study found that the risk for depression after an early pregnancy loss is twice as high for Black women in comparison to non-Black women. The findings of this study further underscore the fact that Black women are at disproportionate high risk for poor maternal and pregnancy outcomes,” Dr. Krishna added.

“Structural racism is a major barrier to caring for the health of Black women. To care for the health of Black women we must overcome racial and ethnic disparities. Addressing disparities involves a multitiered approach, including identifying and addressing implicit bias in health care and improving access to health care for women of color,” she said.

“Additional research is needed in identifying at-risk women and mental health interventions that can improve the mental well-being of women after adverse pregnancy outcomes such as early pregnancy loss,” Dr. Krishna concluded.

The study was supported by the Society of Family Planning Research Fund. Lead author Dr. Shorter had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose.

SOURCE: Shorter JM et al. Obstet Gynecol. 2020 Dec 3. doi: 10.1097/AOG.0000000000004212.

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Data call for biologics trials in undertreated juvenile arthritis subtype

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Children with enthesitis-related arthritis often have a high burden of disease and could benefit from medications currently approved for adults with spondyloarthritis, according to a review published in Arthritis Care & Research.

Dr. Pamela F. Weiss

“Enthesitis-related arthritis (ERA) was the JIA [juvenile idiopathic arthritis] category applied to children with spondyloarthritis (SpA), recognizing enthesitis as a defining characteristic,” wrote Pamela F. Weiss, MD, of Children’s Hospital of Philadelphia, and colleagues.

The ERA criteria include “arthritis plus enthesitis; or arthritis or enthesitis plus at least two of the following: sacroiliac tenderness or inflammatory back pain, HLA-B27 positivity, first-degree relative with HLA-B27–associated disease, acute anterior uveitis, and arthritis in a male older than 6 years,” the review authors noted.

“None of the [Food and Drug Administration]–approved therapies for peripheral SpA or nonradiographic axial SpA” have been studied or approved for use in children with ERA, but data support biologic similarity to SpA in adults; notably, studies of the HLA-B27 allele have identified it as a risk factor for both SpA and ERA, they said.
 

Common factors in adult and childhood conditions

“The principal commonalities of children with ERA and axial arthritis, and adults with nonradiographic axial SpA, include enthesitis, arthritis, inflammatory back pain, anterior uveitis, HLA-B27 positivity, and family history of HLA-B27–associated disease,” the review authors wrote.

The first-line treatment for both ERA with axial arthritis and nonradiographic axial SpA is NSAIDs, followed by tumor necrosis factor (TNF) inhibitors if needed, they said. However, conventional disease-modifying antirheumatic drugs (cDMARDs) may be used in cases of peripheral disease affecting five or more joints. Studies of treatment response show similarities between ERA in children and SpA in adults, the authors added, with nearly half of adults with axial disease unable to achieve remission and approximately one-third of children with ERA failing to respond to therapy.



Clinical trials could improve options and outcomes for those with ERA who need advanced therapy and such trials should evaluate response of axial and peripheral disease separately, the review authors emphasized. For example, “Eligibility criteria for children with ERA and axial features could include the presence of some of the following disease features: active inflammatory sacroiliitis based on typical MRI changes according to ASAS/OMERACT [Assessment of SpondyloArthritis international Society/Outcome Measures in Rheumatology Clinical Trials] criteria; elevated CRP [C-reactive protein]; and inadequate response or intolerance to NSAIDs,” they noted. “Considering the similarities between adult spondyloarthritis and ERA in terms of etiology, genetics, pathogenesis, and clinical manifestations, it is evident that medications approved for axial or peripheral SpA should be studied in children with ERA involving axial or peripheral joints, respectively, with the intent to achieve labeling for use in children,” they concluded.

New data highlight ERA disease burden

The need for additional therapies for ERA patients gained more support from a recent study in which a majority of children with ERA or juvenile psoriatic arthritis (jPsA) used biologics, but those with sacroiliitis in particular showed a significant disease burden despite high biologic use.

 

 

Dr. Dax G. Rumsey

The International Leagues Against Rheumatism criteria include seven categories of juvenile idiopathic arthritis, of which ERA and jPsA are the most common; however, characteristics of these children have not been well described, wrote Dax G. Rumsey, MD, of the University of Alberta, Edmonton, and colleagues.

“Children with ERA are more likely to have a clinical picture with predominantly peripheral arthritis, typically described as an oligoarthritis involving the lower limbs with high risk of axial disease, relative to the other categories of JIA,” and report more intense pain and worse health status, compared with children in other categories, the researchers wrote.

To more completely characterize children with ERA and jPsA, the researchers assessed 522 children with ERA and 380 with jPsA. The children were enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. The findings were published in a brief report in Arthritis Care & Research.

Overall, 69% of the children took at least one biologic, including 72% with ERA and 64% with jPsA. Biologic use was even higher (81%) among the 28% of patients with sacroiliitis (40% of ERA patients and 12% of jPsA patients). Approximately 36% of the patients with sacroiliitis were positive for HLA-B27. In addition, Physician Global Assessment scores and clinical Juvenile Arthritis Disease Activity Score-10 (cJADAS10) scores were significantly higher at the first clinical visit with sacroiliitis, compared with the first visit without, which confirms “the clinical impression that active sacroiliitis significantly impacts children and their families,” the researchers said.

The average age at diagnosis was 10.8 years for ERA and 8.2 years for jPsA, and significantly more ERA patients were male (56% vs. 38%). However, more of the patients with sacroiliitis (54%) were female. More than half of the patients reported polyarticular involvement.

The study findings were limited by several factors, including the classification of ERA or jPsA and the reliance on physician diagnoses, as well as the variation in identifying sacroiliitis, the researchers said. However, the results increase understanding of the pathophysiology of ERA and jPsA to help determine optimal treatment, they concluded.
 

Data highlight research and treatment gaps

“Recent research demonstrates a large, unmet medical need in the treatment of JIA with 52%-65% of all JIA patients, including those with ERA and jPsA, having been treated with at least one biologic DMARD and 15%-19% having been treated with an FDA-unapproved biologic. In those with ERA or jPsA, 72%-79% of the children had been treated with a biologic DMARD, although no biologic DMARD has ever been FDA approved for these JIA categories,” Daniel J. Lovell, MD, and Hermine I. Brunner, MD, both with Cincinnati Children’s Hospital Medical Center, wrote in an editorial that accompanied the new study. Dr. Lovell and Dr. Brunner also were coauthors of the review article.

Dr. Daniel J. Lovell

The new study supports findings from other recent publications, the editorialists noted. The new results showed “a significant proportion of the JIA population with active sacroiliitis with high disease burden despite very frequent (over 80% of the population) [treatment] with unstudied and unapproved biologic DMARDs,” they said. “These children with sacroiliitis had significantly greater disease burden with higher physician assessment of disease activity, higher parent assessment of disease impact, and higher disease activity as measured by the Juvenile Idiopathic Arthritis Disease Activity Score, compared to the children with ERA or jPsA without sacroiliitis,” they noted.

Jeff Craven/MDedge News
Dr. Hermine I. Brunner

Previously, “the FDA granted pharmaceutical companies studying new treatments in adult SpA automatic full waivers from doing studies in children for new medications for ‘axial spondyloarthropathies including ankylosing spondylitis’ up until July 2020,” the editorialists said. However, “It is now time now for the pharmaceutical industry to perform FDA-monitored clinical trials of children and adolescents with SpA,” they emphasized. “This will allow for the scientific assessment of proper dosing, efficacy, and safety of the increasing number of new medications that are being licensed by the FDA for the treatment of SpA, such as the anti-TNF, anti–IL[interleukin]-17, and anti–IL-23 biologics, and perhaps JAK [Janus kinase] agents, to address this unmet medical need in these patients with juvenile SpA,” they concluded.

Dr. Weiss disclosed grant support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and financial relationships with Eli Lilly and Pfizer. Dr. Lovell disclosed relationships with companies including Abbott, AbbVie Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Novartis, Pfizer, Takeda, UCB, and Wyeth, as well as serving on the data and safety monitoring board for Forest Research and NIAMS. Dr. Brunner disclosed relationships with companies including Ablynx, AbbVie, AstraZeneca-MedImmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, EMD Serono, F. Hoffmann-La Roche, Genzyme, GlaxoSmithKline, Merck, Novartis, R-Pharm, and Sanofi. The study by Dr. Rumsey and colleagues was supported by Amgen. Dr. Rumsey and colleagues had no relevant financial conflicts to disclose.

SOURCES: Weiss PF et al. Arthritis Care Res. 2020 Dec 5. doi: 10.1002/acr.24529; Rumsey DG et al. Arthritis Care Res. 2020 Dec. 16. doi: 10.1002/acr.24537; Lovell DJ and Brunner HI. Arthritis Care Res. 2020 Dec 16. doi: 10.1002/acr.24536.

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Children with enthesitis-related arthritis often have a high burden of disease and could benefit from medications currently approved for adults with spondyloarthritis, according to a review published in Arthritis Care & Research.

Dr. Pamela F. Weiss

“Enthesitis-related arthritis (ERA) was the JIA [juvenile idiopathic arthritis] category applied to children with spondyloarthritis (SpA), recognizing enthesitis as a defining characteristic,” wrote Pamela F. Weiss, MD, of Children’s Hospital of Philadelphia, and colleagues.

The ERA criteria include “arthritis plus enthesitis; or arthritis or enthesitis plus at least two of the following: sacroiliac tenderness or inflammatory back pain, HLA-B27 positivity, first-degree relative with HLA-B27–associated disease, acute anterior uveitis, and arthritis in a male older than 6 years,” the review authors noted.

“None of the [Food and Drug Administration]–approved therapies for peripheral SpA or nonradiographic axial SpA” have been studied or approved for use in children with ERA, but data support biologic similarity to SpA in adults; notably, studies of the HLA-B27 allele have identified it as a risk factor for both SpA and ERA, they said.
 

Common factors in adult and childhood conditions

“The principal commonalities of children with ERA and axial arthritis, and adults with nonradiographic axial SpA, include enthesitis, arthritis, inflammatory back pain, anterior uveitis, HLA-B27 positivity, and family history of HLA-B27–associated disease,” the review authors wrote.

The first-line treatment for both ERA with axial arthritis and nonradiographic axial SpA is NSAIDs, followed by tumor necrosis factor (TNF) inhibitors if needed, they said. However, conventional disease-modifying antirheumatic drugs (cDMARDs) may be used in cases of peripheral disease affecting five or more joints. Studies of treatment response show similarities between ERA in children and SpA in adults, the authors added, with nearly half of adults with axial disease unable to achieve remission and approximately one-third of children with ERA failing to respond to therapy.



Clinical trials could improve options and outcomes for those with ERA who need advanced therapy and such trials should evaluate response of axial and peripheral disease separately, the review authors emphasized. For example, “Eligibility criteria for children with ERA and axial features could include the presence of some of the following disease features: active inflammatory sacroiliitis based on typical MRI changes according to ASAS/OMERACT [Assessment of SpondyloArthritis international Society/Outcome Measures in Rheumatology Clinical Trials] criteria; elevated CRP [C-reactive protein]; and inadequate response or intolerance to NSAIDs,” they noted. “Considering the similarities between adult spondyloarthritis and ERA in terms of etiology, genetics, pathogenesis, and clinical manifestations, it is evident that medications approved for axial or peripheral SpA should be studied in children with ERA involving axial or peripheral joints, respectively, with the intent to achieve labeling for use in children,” they concluded.

New data highlight ERA disease burden

The need for additional therapies for ERA patients gained more support from a recent study in which a majority of children with ERA or juvenile psoriatic arthritis (jPsA) used biologics, but those with sacroiliitis in particular showed a significant disease burden despite high biologic use.

 

 

Dr. Dax G. Rumsey

The International Leagues Against Rheumatism criteria include seven categories of juvenile idiopathic arthritis, of which ERA and jPsA are the most common; however, characteristics of these children have not been well described, wrote Dax G. Rumsey, MD, of the University of Alberta, Edmonton, and colleagues.

“Children with ERA are more likely to have a clinical picture with predominantly peripheral arthritis, typically described as an oligoarthritis involving the lower limbs with high risk of axial disease, relative to the other categories of JIA,” and report more intense pain and worse health status, compared with children in other categories, the researchers wrote.

To more completely characterize children with ERA and jPsA, the researchers assessed 522 children with ERA and 380 with jPsA. The children were enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. The findings were published in a brief report in Arthritis Care & Research.

Overall, 69% of the children took at least one biologic, including 72% with ERA and 64% with jPsA. Biologic use was even higher (81%) among the 28% of patients with sacroiliitis (40% of ERA patients and 12% of jPsA patients). Approximately 36% of the patients with sacroiliitis were positive for HLA-B27. In addition, Physician Global Assessment scores and clinical Juvenile Arthritis Disease Activity Score-10 (cJADAS10) scores were significantly higher at the first clinical visit with sacroiliitis, compared with the first visit without, which confirms “the clinical impression that active sacroiliitis significantly impacts children and their families,” the researchers said.

The average age at diagnosis was 10.8 years for ERA and 8.2 years for jPsA, and significantly more ERA patients were male (56% vs. 38%). However, more of the patients with sacroiliitis (54%) were female. More than half of the patients reported polyarticular involvement.

The study findings were limited by several factors, including the classification of ERA or jPsA and the reliance on physician diagnoses, as well as the variation in identifying sacroiliitis, the researchers said. However, the results increase understanding of the pathophysiology of ERA and jPsA to help determine optimal treatment, they concluded.
 

Data highlight research and treatment gaps

“Recent research demonstrates a large, unmet medical need in the treatment of JIA with 52%-65% of all JIA patients, including those with ERA and jPsA, having been treated with at least one biologic DMARD and 15%-19% having been treated with an FDA-unapproved biologic. In those with ERA or jPsA, 72%-79% of the children had been treated with a biologic DMARD, although no biologic DMARD has ever been FDA approved for these JIA categories,” Daniel J. Lovell, MD, and Hermine I. Brunner, MD, both with Cincinnati Children’s Hospital Medical Center, wrote in an editorial that accompanied the new study. Dr. Lovell and Dr. Brunner also were coauthors of the review article.

Dr. Daniel J. Lovell

The new study supports findings from other recent publications, the editorialists noted. The new results showed “a significant proportion of the JIA population with active sacroiliitis with high disease burden despite very frequent (over 80% of the population) [treatment] with unstudied and unapproved biologic DMARDs,” they said. “These children with sacroiliitis had significantly greater disease burden with higher physician assessment of disease activity, higher parent assessment of disease impact, and higher disease activity as measured by the Juvenile Idiopathic Arthritis Disease Activity Score, compared to the children with ERA or jPsA without sacroiliitis,” they noted.

Jeff Craven/MDedge News
Dr. Hermine I. Brunner

Previously, “the FDA granted pharmaceutical companies studying new treatments in adult SpA automatic full waivers from doing studies in children for new medications for ‘axial spondyloarthropathies including ankylosing spondylitis’ up until July 2020,” the editorialists said. However, “It is now time now for the pharmaceutical industry to perform FDA-monitored clinical trials of children and adolescents with SpA,” they emphasized. “This will allow for the scientific assessment of proper dosing, efficacy, and safety of the increasing number of new medications that are being licensed by the FDA for the treatment of SpA, such as the anti-TNF, anti–IL[interleukin]-17, and anti–IL-23 biologics, and perhaps JAK [Janus kinase] agents, to address this unmet medical need in these patients with juvenile SpA,” they concluded.

Dr. Weiss disclosed grant support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and financial relationships with Eli Lilly and Pfizer. Dr. Lovell disclosed relationships with companies including Abbott, AbbVie Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Novartis, Pfizer, Takeda, UCB, and Wyeth, as well as serving on the data and safety monitoring board for Forest Research and NIAMS. Dr. Brunner disclosed relationships with companies including Ablynx, AbbVie, AstraZeneca-MedImmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, EMD Serono, F. Hoffmann-La Roche, Genzyme, GlaxoSmithKline, Merck, Novartis, R-Pharm, and Sanofi. The study by Dr. Rumsey and colleagues was supported by Amgen. Dr. Rumsey and colleagues had no relevant financial conflicts to disclose.

SOURCES: Weiss PF et al. Arthritis Care Res. 2020 Dec 5. doi: 10.1002/acr.24529; Rumsey DG et al. Arthritis Care Res. 2020 Dec. 16. doi: 10.1002/acr.24537; Lovell DJ and Brunner HI. Arthritis Care Res. 2020 Dec 16. doi: 10.1002/acr.24536.

 

Children with enthesitis-related arthritis often have a high burden of disease and could benefit from medications currently approved for adults with spondyloarthritis, according to a review published in Arthritis Care & Research.

Dr. Pamela F. Weiss

“Enthesitis-related arthritis (ERA) was the JIA [juvenile idiopathic arthritis] category applied to children with spondyloarthritis (SpA), recognizing enthesitis as a defining characteristic,” wrote Pamela F. Weiss, MD, of Children’s Hospital of Philadelphia, and colleagues.

The ERA criteria include “arthritis plus enthesitis; or arthritis or enthesitis plus at least two of the following: sacroiliac tenderness or inflammatory back pain, HLA-B27 positivity, first-degree relative with HLA-B27–associated disease, acute anterior uveitis, and arthritis in a male older than 6 years,” the review authors noted.

“None of the [Food and Drug Administration]–approved therapies for peripheral SpA or nonradiographic axial SpA” have been studied or approved for use in children with ERA, but data support biologic similarity to SpA in adults; notably, studies of the HLA-B27 allele have identified it as a risk factor for both SpA and ERA, they said.
 

Common factors in adult and childhood conditions

“The principal commonalities of children with ERA and axial arthritis, and adults with nonradiographic axial SpA, include enthesitis, arthritis, inflammatory back pain, anterior uveitis, HLA-B27 positivity, and family history of HLA-B27–associated disease,” the review authors wrote.

The first-line treatment for both ERA with axial arthritis and nonradiographic axial SpA is NSAIDs, followed by tumor necrosis factor (TNF) inhibitors if needed, they said. However, conventional disease-modifying antirheumatic drugs (cDMARDs) may be used in cases of peripheral disease affecting five or more joints. Studies of treatment response show similarities between ERA in children and SpA in adults, the authors added, with nearly half of adults with axial disease unable to achieve remission and approximately one-third of children with ERA failing to respond to therapy.



Clinical trials could improve options and outcomes for those with ERA who need advanced therapy and such trials should evaluate response of axial and peripheral disease separately, the review authors emphasized. For example, “Eligibility criteria for children with ERA and axial features could include the presence of some of the following disease features: active inflammatory sacroiliitis based on typical MRI changes according to ASAS/OMERACT [Assessment of SpondyloArthritis international Society/Outcome Measures in Rheumatology Clinical Trials] criteria; elevated CRP [C-reactive protein]; and inadequate response or intolerance to NSAIDs,” they noted. “Considering the similarities between adult spondyloarthritis and ERA in terms of etiology, genetics, pathogenesis, and clinical manifestations, it is evident that medications approved for axial or peripheral SpA should be studied in children with ERA involving axial or peripheral joints, respectively, with the intent to achieve labeling for use in children,” they concluded.

New data highlight ERA disease burden

The need for additional therapies for ERA patients gained more support from a recent study in which a majority of children with ERA or juvenile psoriatic arthritis (jPsA) used biologics, but those with sacroiliitis in particular showed a significant disease burden despite high biologic use.

 

 

Dr. Dax G. Rumsey

The International Leagues Against Rheumatism criteria include seven categories of juvenile idiopathic arthritis, of which ERA and jPsA are the most common; however, characteristics of these children have not been well described, wrote Dax G. Rumsey, MD, of the University of Alberta, Edmonton, and colleagues.

“Children with ERA are more likely to have a clinical picture with predominantly peripheral arthritis, typically described as an oligoarthritis involving the lower limbs with high risk of axial disease, relative to the other categories of JIA,” and report more intense pain and worse health status, compared with children in other categories, the researchers wrote.

To more completely characterize children with ERA and jPsA, the researchers assessed 522 children with ERA and 380 with jPsA. The children were enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. The findings were published in a brief report in Arthritis Care & Research.

Overall, 69% of the children took at least one biologic, including 72% with ERA and 64% with jPsA. Biologic use was even higher (81%) among the 28% of patients with sacroiliitis (40% of ERA patients and 12% of jPsA patients). Approximately 36% of the patients with sacroiliitis were positive for HLA-B27. In addition, Physician Global Assessment scores and clinical Juvenile Arthritis Disease Activity Score-10 (cJADAS10) scores were significantly higher at the first clinical visit with sacroiliitis, compared with the first visit without, which confirms “the clinical impression that active sacroiliitis significantly impacts children and their families,” the researchers said.

The average age at diagnosis was 10.8 years for ERA and 8.2 years for jPsA, and significantly more ERA patients were male (56% vs. 38%). However, more of the patients with sacroiliitis (54%) were female. More than half of the patients reported polyarticular involvement.

The study findings were limited by several factors, including the classification of ERA or jPsA and the reliance on physician diagnoses, as well as the variation in identifying sacroiliitis, the researchers said. However, the results increase understanding of the pathophysiology of ERA and jPsA to help determine optimal treatment, they concluded.
 

Data highlight research and treatment gaps

“Recent research demonstrates a large, unmet medical need in the treatment of JIA with 52%-65% of all JIA patients, including those with ERA and jPsA, having been treated with at least one biologic DMARD and 15%-19% having been treated with an FDA-unapproved biologic. In those with ERA or jPsA, 72%-79% of the children had been treated with a biologic DMARD, although no biologic DMARD has ever been FDA approved for these JIA categories,” Daniel J. Lovell, MD, and Hermine I. Brunner, MD, both with Cincinnati Children’s Hospital Medical Center, wrote in an editorial that accompanied the new study. Dr. Lovell and Dr. Brunner also were coauthors of the review article.

Dr. Daniel J. Lovell

The new study supports findings from other recent publications, the editorialists noted. The new results showed “a significant proportion of the JIA population with active sacroiliitis with high disease burden despite very frequent (over 80% of the population) [treatment] with unstudied and unapproved biologic DMARDs,” they said. “These children with sacroiliitis had significantly greater disease burden with higher physician assessment of disease activity, higher parent assessment of disease impact, and higher disease activity as measured by the Juvenile Idiopathic Arthritis Disease Activity Score, compared to the children with ERA or jPsA without sacroiliitis,” they noted.

Jeff Craven/MDedge News
Dr. Hermine I. Brunner

Previously, “the FDA granted pharmaceutical companies studying new treatments in adult SpA automatic full waivers from doing studies in children for new medications for ‘axial spondyloarthropathies including ankylosing spondylitis’ up until July 2020,” the editorialists said. However, “It is now time now for the pharmaceutical industry to perform FDA-monitored clinical trials of children and adolescents with SpA,” they emphasized. “This will allow for the scientific assessment of proper dosing, efficacy, and safety of the increasing number of new medications that are being licensed by the FDA for the treatment of SpA, such as the anti-TNF, anti–IL[interleukin]-17, and anti–IL-23 biologics, and perhaps JAK [Janus kinase] agents, to address this unmet medical need in these patients with juvenile SpA,” they concluded.

Dr. Weiss disclosed grant support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and financial relationships with Eli Lilly and Pfizer. Dr. Lovell disclosed relationships with companies including Abbott, AbbVie Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Novartis, Pfizer, Takeda, UCB, and Wyeth, as well as serving on the data and safety monitoring board for Forest Research and NIAMS. Dr. Brunner disclosed relationships with companies including Ablynx, AbbVie, AstraZeneca-MedImmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, EMD Serono, F. Hoffmann-La Roche, Genzyme, GlaxoSmithKline, Merck, Novartis, R-Pharm, and Sanofi. The study by Dr. Rumsey and colleagues was supported by Amgen. Dr. Rumsey and colleagues had no relevant financial conflicts to disclose.

SOURCES: Weiss PF et al. Arthritis Care Res. 2020 Dec 5. doi: 10.1002/acr.24529; Rumsey DG et al. Arthritis Care Res. 2020 Dec. 16. doi: 10.1002/acr.24537; Lovell DJ and Brunner HI. Arthritis Care Res. 2020 Dec 16. doi: 10.1002/acr.24536.

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Younger adults present with more advanced esophageal adenocarcinoma

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The incidence of esophageal adenocarcinoma in adults aged younger than 50 years increased threefold between 1975 and 2015, based on data from more than 34,000 cases.

Esophageal carcinoma rates overall have risen in the United States over the past 4 decades, but the average patient is in their 60s, wrote Don C. Codipilly, MD, of the Mayo Clinic, Rochester, Minn., and colleagues. Therefore, “data on the incidence, stage distribution, and outcomes of this segment of patients [younger than 50 years] with esophageal adenocarcinoma are relatively limited.”

In a study published in Cancer Epidemiology, Biomarkers & Prevention, the researchers identified 34,443 cases of esophageal adenocarcinoma using the Surveillance, Epidemiology, and End Results (SEER) database for the periods of 1975-1989, 1990-1999, and 2000-2015. The cases were limited to histologically confirmed cases and were stratified according to age at diagnosis: younger than 50 years, 50-69 years, and 70 years and older

Overall, the annual incidence of esophageal adenocarcinoma among individuals younger than 50 years increased from 0.08 per 100,000 persons in 1975 to 0.27 per 100,000 persons in 2015.
 

Younger patients show more advanced illness

Although the incidence rose across all three age groups during the study period, the largest increase was seen in those aged 70 years and older. However, the younger group was significantly more likely to present at more-advanced stages, the researchers pointed out: Between 2000 and 2015, localized disease represented only 15.1% of cases in those younger than 50 years, compared with 22.4% in patients aged 50-69 years and 32.2% in those 70 years and older. The incidence of regional/distant disease among younger patients has increased over time, with 81.8% in 1975-1989, 75.5% in 1990-1999, and 84.9% in 2000-2015 (P < .01), and this increase has been faster than among older groups, the researches noted. For comparison, during 2000-2015 only 77.6% of patients aged 50-69 years and 67.8% of patients 70 years and older had regional/distant disease.

In addition, the majority of cases of young-onset esophageal adenocarcinoma occurred in men in a trend that persisted across the study periods; 90% of patients younger than 50 years were male in 1975, and 86% of the younger patients in 2015 were male.

“There is no clear explanation for the higher proportion of advanced disease in younger patients, and further study is required to identify biologic, genetic, and environmental factors that may underlie this observation,” the researchers wrote. “A potential hypothesis is that ‘young-onset esophageal adenocarcinoma’ may involve rapid transition from intestinal metaplasia to esophageal adenocarcinoma, driven by an increase in signaling molecules that are active in the intestine,” they suggested.

The study findings were limited by several factors including the inability to review individual case records to confirm disease stage and to compare outcomes across ethnicities, and the lack of data on comorbidities in the SEER database, the researchers noted.

However, the results were strengthened by overall quality of the SEER database and use of multivariate analysis, they added. The evidence of increased incidence and increased odds of advanced disease in younger adults suggest that “reevaluation of our diagnostic and treatment strategies in this age group might need to be considered.”
 

 

 

Reasons for increase remain unclear

“While esophageal adenocarcinoma is uncommon overall in younger patients, this study importantly highlights that not only has the incidence of esophageal adenocarcinoma increased more than threefold in patients under the age of 50 over the last 4 decades, but that younger patients are presenting with more advanced disease and have overall poorer survival, compared to older patients,” Rahul A. Shimpi, MD, of Duke University, Durham, N.C., said in an interview.

“The reasons for these findings are unclear, but the authors propose a number of potential factors that could explain them. These include differences in tumor biology, rising rates of obesity and [gastroesophageal reflux disease] in younger patients, decreased endoscopic screening for and surveillance of Barrett’s esophagus in this age group, and differing therapeutic approaches to management,” Dr. Shimpi said.

“The findings from this study underscore that, while uncommon, clinicians need to be aware of the rising incidence of esophageal cancer in younger patients. It is important that even younger patients presenting with esophageal symptoms, such as dysphagia, undergo investigation,” he emphasized.

“I would like to see further study into the potential factors driving the findings in this study, including whether trends in differential treatment modalities account for some of the survival differences found in different age groups,” Dr. Shimpi added. “Finally, further research will ideally clarify optimal Barrett’s screening and surveillance approaches in patients younger than age 50 in order to determine whether new strategies might impact esophageal adenocarcinoma incidence and outcomes in this group.”

The study was funded in part by the National Cancer Institute and the National Center for Advancing Translational Sciences. Two authors disclosed relationships outside the submitted work, but Dr. Codipilly and the remaining authors had no financial conflicts to disclose. Dr. Shimpi had no financial conflicts to disclose.

SOURCE: Codipilly DC et al. Cancer Epidemiol Biomarkers Prev. 2020 Dec 11. doi: 10.1158/1055-9965.EPI-20-0944.

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The incidence of esophageal adenocarcinoma in adults aged younger than 50 years increased threefold between 1975 and 2015, based on data from more than 34,000 cases.

Esophageal carcinoma rates overall have risen in the United States over the past 4 decades, but the average patient is in their 60s, wrote Don C. Codipilly, MD, of the Mayo Clinic, Rochester, Minn., and colleagues. Therefore, “data on the incidence, stage distribution, and outcomes of this segment of patients [younger than 50 years] with esophageal adenocarcinoma are relatively limited.”

In a study published in Cancer Epidemiology, Biomarkers & Prevention, the researchers identified 34,443 cases of esophageal adenocarcinoma using the Surveillance, Epidemiology, and End Results (SEER) database for the periods of 1975-1989, 1990-1999, and 2000-2015. The cases were limited to histologically confirmed cases and were stratified according to age at diagnosis: younger than 50 years, 50-69 years, and 70 years and older

Overall, the annual incidence of esophageal adenocarcinoma among individuals younger than 50 years increased from 0.08 per 100,000 persons in 1975 to 0.27 per 100,000 persons in 2015.
 

Younger patients show more advanced illness

Although the incidence rose across all three age groups during the study period, the largest increase was seen in those aged 70 years and older. However, the younger group was significantly more likely to present at more-advanced stages, the researchers pointed out: Between 2000 and 2015, localized disease represented only 15.1% of cases in those younger than 50 years, compared with 22.4% in patients aged 50-69 years and 32.2% in those 70 years and older. The incidence of regional/distant disease among younger patients has increased over time, with 81.8% in 1975-1989, 75.5% in 1990-1999, and 84.9% in 2000-2015 (P < .01), and this increase has been faster than among older groups, the researches noted. For comparison, during 2000-2015 only 77.6% of patients aged 50-69 years and 67.8% of patients 70 years and older had regional/distant disease.

In addition, the majority of cases of young-onset esophageal adenocarcinoma occurred in men in a trend that persisted across the study periods; 90% of patients younger than 50 years were male in 1975, and 86% of the younger patients in 2015 were male.

“There is no clear explanation for the higher proportion of advanced disease in younger patients, and further study is required to identify biologic, genetic, and environmental factors that may underlie this observation,” the researchers wrote. “A potential hypothesis is that ‘young-onset esophageal adenocarcinoma’ may involve rapid transition from intestinal metaplasia to esophageal adenocarcinoma, driven by an increase in signaling molecules that are active in the intestine,” they suggested.

The study findings were limited by several factors including the inability to review individual case records to confirm disease stage and to compare outcomes across ethnicities, and the lack of data on comorbidities in the SEER database, the researchers noted.

However, the results were strengthened by overall quality of the SEER database and use of multivariate analysis, they added. The evidence of increased incidence and increased odds of advanced disease in younger adults suggest that “reevaluation of our diagnostic and treatment strategies in this age group might need to be considered.”
 

 

 

Reasons for increase remain unclear

“While esophageal adenocarcinoma is uncommon overall in younger patients, this study importantly highlights that not only has the incidence of esophageal adenocarcinoma increased more than threefold in patients under the age of 50 over the last 4 decades, but that younger patients are presenting with more advanced disease and have overall poorer survival, compared to older patients,” Rahul A. Shimpi, MD, of Duke University, Durham, N.C., said in an interview.

“The reasons for these findings are unclear, but the authors propose a number of potential factors that could explain them. These include differences in tumor biology, rising rates of obesity and [gastroesophageal reflux disease] in younger patients, decreased endoscopic screening for and surveillance of Barrett’s esophagus in this age group, and differing therapeutic approaches to management,” Dr. Shimpi said.

“The findings from this study underscore that, while uncommon, clinicians need to be aware of the rising incidence of esophageal cancer in younger patients. It is important that even younger patients presenting with esophageal symptoms, such as dysphagia, undergo investigation,” he emphasized.

“I would like to see further study into the potential factors driving the findings in this study, including whether trends in differential treatment modalities account for some of the survival differences found in different age groups,” Dr. Shimpi added. “Finally, further research will ideally clarify optimal Barrett’s screening and surveillance approaches in patients younger than age 50 in order to determine whether new strategies might impact esophageal adenocarcinoma incidence and outcomes in this group.”

The study was funded in part by the National Cancer Institute and the National Center for Advancing Translational Sciences. Two authors disclosed relationships outside the submitted work, but Dr. Codipilly and the remaining authors had no financial conflicts to disclose. Dr. Shimpi had no financial conflicts to disclose.

SOURCE: Codipilly DC et al. Cancer Epidemiol Biomarkers Prev. 2020 Dec 11. doi: 10.1158/1055-9965.EPI-20-0944.

The incidence of esophageal adenocarcinoma in adults aged younger than 50 years increased threefold between 1975 and 2015, based on data from more than 34,000 cases.

Esophageal carcinoma rates overall have risen in the United States over the past 4 decades, but the average patient is in their 60s, wrote Don C. Codipilly, MD, of the Mayo Clinic, Rochester, Minn., and colleagues. Therefore, “data on the incidence, stage distribution, and outcomes of this segment of patients [younger than 50 years] with esophageal adenocarcinoma are relatively limited.”

In a study published in Cancer Epidemiology, Biomarkers & Prevention, the researchers identified 34,443 cases of esophageal adenocarcinoma using the Surveillance, Epidemiology, and End Results (SEER) database for the periods of 1975-1989, 1990-1999, and 2000-2015. The cases were limited to histologically confirmed cases and were stratified according to age at diagnosis: younger than 50 years, 50-69 years, and 70 years and older

Overall, the annual incidence of esophageal adenocarcinoma among individuals younger than 50 years increased from 0.08 per 100,000 persons in 1975 to 0.27 per 100,000 persons in 2015.
 

Younger patients show more advanced illness

Although the incidence rose across all three age groups during the study period, the largest increase was seen in those aged 70 years and older. However, the younger group was significantly more likely to present at more-advanced stages, the researchers pointed out: Between 2000 and 2015, localized disease represented only 15.1% of cases in those younger than 50 years, compared with 22.4% in patients aged 50-69 years and 32.2% in those 70 years and older. The incidence of regional/distant disease among younger patients has increased over time, with 81.8% in 1975-1989, 75.5% in 1990-1999, and 84.9% in 2000-2015 (P < .01), and this increase has been faster than among older groups, the researches noted. For comparison, during 2000-2015 only 77.6% of patients aged 50-69 years and 67.8% of patients 70 years and older had regional/distant disease.

In addition, the majority of cases of young-onset esophageal adenocarcinoma occurred in men in a trend that persisted across the study periods; 90% of patients younger than 50 years were male in 1975, and 86% of the younger patients in 2015 were male.

“There is no clear explanation for the higher proportion of advanced disease in younger patients, and further study is required to identify biologic, genetic, and environmental factors that may underlie this observation,” the researchers wrote. “A potential hypothesis is that ‘young-onset esophageal adenocarcinoma’ may involve rapid transition from intestinal metaplasia to esophageal adenocarcinoma, driven by an increase in signaling molecules that are active in the intestine,” they suggested.

The study findings were limited by several factors including the inability to review individual case records to confirm disease stage and to compare outcomes across ethnicities, and the lack of data on comorbidities in the SEER database, the researchers noted.

However, the results were strengthened by overall quality of the SEER database and use of multivariate analysis, they added. The evidence of increased incidence and increased odds of advanced disease in younger adults suggest that “reevaluation of our diagnostic and treatment strategies in this age group might need to be considered.”
 

 

 

Reasons for increase remain unclear

“While esophageal adenocarcinoma is uncommon overall in younger patients, this study importantly highlights that not only has the incidence of esophageal adenocarcinoma increased more than threefold in patients under the age of 50 over the last 4 decades, but that younger patients are presenting with more advanced disease and have overall poorer survival, compared to older patients,” Rahul A. Shimpi, MD, of Duke University, Durham, N.C., said in an interview.

“The reasons for these findings are unclear, but the authors propose a number of potential factors that could explain them. These include differences in tumor biology, rising rates of obesity and [gastroesophageal reflux disease] in younger patients, decreased endoscopic screening for and surveillance of Barrett’s esophagus in this age group, and differing therapeutic approaches to management,” Dr. Shimpi said.

“The findings from this study underscore that, while uncommon, clinicians need to be aware of the rising incidence of esophageal cancer in younger patients. It is important that even younger patients presenting with esophageal symptoms, such as dysphagia, undergo investigation,” he emphasized.

“I would like to see further study into the potential factors driving the findings in this study, including whether trends in differential treatment modalities account for some of the survival differences found in different age groups,” Dr. Shimpi added. “Finally, further research will ideally clarify optimal Barrett’s screening and surveillance approaches in patients younger than age 50 in order to determine whether new strategies might impact esophageal adenocarcinoma incidence and outcomes in this group.”

The study was funded in part by the National Cancer Institute and the National Center for Advancing Translational Sciences. Two authors disclosed relationships outside the submitted work, but Dr. Codipilly and the remaining authors had no financial conflicts to disclose. Dr. Shimpi had no financial conflicts to disclose.

SOURCE: Codipilly DC et al. Cancer Epidemiol Biomarkers Prev. 2020 Dec 11. doi: 10.1158/1055-9965.EPI-20-0944.

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Higher dose maximizes effects of magnesium sulfate for obese women

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Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m2 or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

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Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m2 or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m2 or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

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Racial, ethnic disparities in maternal mortality, morbidity persist

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Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

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Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

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High hydroxychloroquine blood level may lower thrombosis risk in lupus

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Maintaining an average hydroxychloroquine whole blood level above 1,068 ng/mL significantly reduced the risk of thrombosis in adults with systemic lupus erythematosus, based on data from 739 patients.

Marc Bruxelle/Getty Images

Hydroxychloroquine (HCQ) is a common treatment for systemic lupus erythematosus (SLE); studies suggest that it may protect against thrombosis, but the optimal dosing for this purpose remains unknown, wrote Michelle Petri, MD, of Johns Hopkins University, Baltimore, and colleagues. In a study published in Arthritis & Rheumatology, the researchers examined data on HCQ levels from 739 adults with SLE who were part of the Hopkins Lupus Cohort, a longitudinal study of outcomes in SLE patients. Of these, 38 (5.1%) developed thrombosis during 2,330 person-years of follow-up.

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Dr. Michelle Petri


Overall, the average HCQ blood level was significantly lower in patients who experienced thrombosis, compared to those who did not (720 ng/mL vs. 935 ng/mL; P = .025). “Prescribed hydroxychloroquine doses did not predict hydroxychloroquine blood levels,” the researchers noted.

In addition, Dr. Petri and associates found a dose-response relationship in which the thrombosis rate declined approximately 13% for every 200-ng/mL increase in the mean HCQ blood level measurement and for the most recent HCQ blood level measurement after controlling for factors that included age, ethnicity, lupus anticoagulant, low C3, and hypertension.

In a multivariate analysis, thrombotic events decreased by 69% in patients with mean HCQ blood levels greater than 1,068 ng/mL, compared to those with average HCQ blood levels less than 648 ng/mL.



The average age of the patients at the time HCQ measurements began was 43 years, 93% were female, and 46% were White. Patients visited a clinic every 3 months, and HCQ levels were determined by liquid chromatography-tandem mass spectrometry.

“Between-person and within-person correlation coefficients were used to measure the strength of the linear association between HCQ blood levels and commonly prescribed HCQ doses from 4.5 to 6.5 mg/kg,” the researchers said.

Higher doses of HCQ have been associated with increased risk for retinopathy, and current guidelines recommend using less than 5 mg/kg of ideal body weight, the researchers said. “Importantly, there was no correlation between the prescribed dose and the hydroxychloroquine blood level over the range (4.5 to 6.5 mg/kg) used in clinical practice, highlighting the need for personalized hydroxychloroquine drug level-guided therapy and dose adjustment,” they emphasized.



The study findings were limited by several factors, including the observational design and potential confounding from variables not included in the model, as well as the small sample size, single site, and single rheumatologist involved in the study, the researchers noted.

The results suggest that aiming for a blood HCQ level of 1,068 ng/mL can be done safely to help prevent thrombosis in patients with SLE, the researchers said. “Routine clinical integration of hydroxychloroquine blood level measurement offers an opportunity for personalized drug dosing and risk management beyond rigid empirical dosing recommendations in patients with SLE,” they concluded.

The study was supported in part by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no relevant financial conflicts to disclose.

SOURCE: Petri M et al. Arthritis Rheumatol. 2021 Jan 6. doi: 10.1002/ART.41621.

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Maintaining an average hydroxychloroquine whole blood level above 1,068 ng/mL significantly reduced the risk of thrombosis in adults with systemic lupus erythematosus, based on data from 739 patients.

Marc Bruxelle/Getty Images

Hydroxychloroquine (HCQ) is a common treatment for systemic lupus erythematosus (SLE); studies suggest that it may protect against thrombosis, but the optimal dosing for this purpose remains unknown, wrote Michelle Petri, MD, of Johns Hopkins University, Baltimore, and colleagues. In a study published in Arthritis & Rheumatology, the researchers examined data on HCQ levels from 739 adults with SLE who were part of the Hopkins Lupus Cohort, a longitudinal study of outcomes in SLE patients. Of these, 38 (5.1%) developed thrombosis during 2,330 person-years of follow-up.

M. Alexander Otto/MDedge News
Dr. Michelle Petri


Overall, the average HCQ blood level was significantly lower in patients who experienced thrombosis, compared to those who did not (720 ng/mL vs. 935 ng/mL; P = .025). “Prescribed hydroxychloroquine doses did not predict hydroxychloroquine blood levels,” the researchers noted.

In addition, Dr. Petri and associates found a dose-response relationship in which the thrombosis rate declined approximately 13% for every 200-ng/mL increase in the mean HCQ blood level measurement and for the most recent HCQ blood level measurement after controlling for factors that included age, ethnicity, lupus anticoagulant, low C3, and hypertension.

In a multivariate analysis, thrombotic events decreased by 69% in patients with mean HCQ blood levels greater than 1,068 ng/mL, compared to those with average HCQ blood levels less than 648 ng/mL.



The average age of the patients at the time HCQ measurements began was 43 years, 93% were female, and 46% were White. Patients visited a clinic every 3 months, and HCQ levels were determined by liquid chromatography-tandem mass spectrometry.

“Between-person and within-person correlation coefficients were used to measure the strength of the linear association between HCQ blood levels and commonly prescribed HCQ doses from 4.5 to 6.5 mg/kg,” the researchers said.

Higher doses of HCQ have been associated with increased risk for retinopathy, and current guidelines recommend using less than 5 mg/kg of ideal body weight, the researchers said. “Importantly, there was no correlation between the prescribed dose and the hydroxychloroquine blood level over the range (4.5 to 6.5 mg/kg) used in clinical practice, highlighting the need for personalized hydroxychloroquine drug level-guided therapy and dose adjustment,” they emphasized.



The study findings were limited by several factors, including the observational design and potential confounding from variables not included in the model, as well as the small sample size, single site, and single rheumatologist involved in the study, the researchers noted.

The results suggest that aiming for a blood HCQ level of 1,068 ng/mL can be done safely to help prevent thrombosis in patients with SLE, the researchers said. “Routine clinical integration of hydroxychloroquine blood level measurement offers an opportunity for personalized drug dosing and risk management beyond rigid empirical dosing recommendations in patients with SLE,” they concluded.

The study was supported in part by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no relevant financial conflicts to disclose.

SOURCE: Petri M et al. Arthritis Rheumatol. 2021 Jan 6. doi: 10.1002/ART.41621.

Maintaining an average hydroxychloroquine whole blood level above 1,068 ng/mL significantly reduced the risk of thrombosis in adults with systemic lupus erythematosus, based on data from 739 patients.

Marc Bruxelle/Getty Images

Hydroxychloroquine (HCQ) is a common treatment for systemic lupus erythematosus (SLE); studies suggest that it may protect against thrombosis, but the optimal dosing for this purpose remains unknown, wrote Michelle Petri, MD, of Johns Hopkins University, Baltimore, and colleagues. In a study published in Arthritis & Rheumatology, the researchers examined data on HCQ levels from 739 adults with SLE who were part of the Hopkins Lupus Cohort, a longitudinal study of outcomes in SLE patients. Of these, 38 (5.1%) developed thrombosis during 2,330 person-years of follow-up.

M. Alexander Otto/MDedge News
Dr. Michelle Petri


Overall, the average HCQ blood level was significantly lower in patients who experienced thrombosis, compared to those who did not (720 ng/mL vs. 935 ng/mL; P = .025). “Prescribed hydroxychloroquine doses did not predict hydroxychloroquine blood levels,” the researchers noted.

In addition, Dr. Petri and associates found a dose-response relationship in which the thrombosis rate declined approximately 13% for every 200-ng/mL increase in the mean HCQ blood level measurement and for the most recent HCQ blood level measurement after controlling for factors that included age, ethnicity, lupus anticoagulant, low C3, and hypertension.

In a multivariate analysis, thrombotic events decreased by 69% in patients with mean HCQ blood levels greater than 1,068 ng/mL, compared to those with average HCQ blood levels less than 648 ng/mL.



The average age of the patients at the time HCQ measurements began was 43 years, 93% were female, and 46% were White. Patients visited a clinic every 3 months, and HCQ levels were determined by liquid chromatography-tandem mass spectrometry.

“Between-person and within-person correlation coefficients were used to measure the strength of the linear association between HCQ blood levels and commonly prescribed HCQ doses from 4.5 to 6.5 mg/kg,” the researchers said.

Higher doses of HCQ have been associated with increased risk for retinopathy, and current guidelines recommend using less than 5 mg/kg of ideal body weight, the researchers said. “Importantly, there was no correlation between the prescribed dose and the hydroxychloroquine blood level over the range (4.5 to 6.5 mg/kg) used in clinical practice, highlighting the need for personalized hydroxychloroquine drug level-guided therapy and dose adjustment,” they emphasized.



The study findings were limited by several factors, including the observational design and potential confounding from variables not included in the model, as well as the small sample size, single site, and single rheumatologist involved in the study, the researchers noted.

The results suggest that aiming for a blood HCQ level of 1,068 ng/mL can be done safely to help prevent thrombosis in patients with SLE, the researchers said. “Routine clinical integration of hydroxychloroquine blood level measurement offers an opportunity for personalized drug dosing and risk management beyond rigid empirical dosing recommendations in patients with SLE,” they concluded.

The study was supported in part by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no relevant financial conflicts to disclose.

SOURCE: Petri M et al. Arthritis Rheumatol. 2021 Jan 6. doi: 10.1002/ART.41621.

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Key clinical point: Higher blood levels of hydroxychloroquine (HCQ) were protective against thrombosis in adults with systemic lupus erythematosus (SLE).

Major finding: The average HCQ in SLE patients who developed thrombosis was 720 ng/mL, compared to 935 ng/mL in those without thrombosis (P = .025).

Study details: The data come from an observational study of 739 adults with SLE; 5.1% developed thrombosis during the study period.

Disclosures: The study was supported in part by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no relevant financial conflicts to disclose.

Source: Petri M et al. Arthritis Rheumatol. 2021 Jan 6. doi: 10.1002/ART.41621.

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