Heidi Splete

The Food and Drug Administration has approved voclosporin (Lupkynis) for the treatment of lupus nephritis, according to a Jan. 22 press release from manufacturer Aurinia Pharmaceuticals.

Lupkynis is a calcineurin-inhibitor immunosuppressant, and is the first oral medication to show effectiveness in lupus nephritis, according to the company. The drug is indicated for the treatment of adult patients with active lupus nephritis in combination with a background immunosuppressive therapy regimen, according to the drug label, which also has a boxed warning describing the increased risk of infections and malignancies, including lymphoma.

The approval of voclosporin was based on data from two studies, the AURORA phase 3 study and the AURA-LV phase 2 study. The studies included 533 adults with lupus nephritis who were randomized to 23.7 mg or placebo of voclosporin twice daily in the form of oral capsules, or placebo capsules, in addition to standard of care (mycophenolate mofetil plus low-dose glucocorticoids).

In the AURORA phase 3 study of 357 patients, close to twice as many patients in the treatment group showed a complete renal response, compared with the placebo group after 1 year (40.8% vs. 22.5%). In addition, patients treated with voclosporin more quickly achieved a significant reduction in urine protein to creatinine ratio, compared with the placebo patients (169 days vs. 372 days).

Severe adverse events were similar between the groups, including the most common complication of infection (10.1% and 11.2% for voclosporin and control groups, respectively). Other adverse reactions reported in at least 3% of the study participants included a decrease in glomerular filtration rate, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, upper abdominal pain, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite, according to the company press release.

Full clinical trial information for the AURORA study is available here.

The Food and Drug Administration has approved voclosporin (Lupkynis) for the treatment of lupus nephritis, according to a Jan. 22 press release from manufacturer Aurinia Pharmaceuticals.

Lupkynis is a calcineurin-inhibitor immunosuppressant, and is the first oral medication to show effectiveness in lupus nephritis, according to the company. The drug is indicated for the treatment of adult patients with active lupus nephritis in combination with a background immunosuppressive therapy regimen, according to the drug label, which also has a boxed warning describing the increased risk of infections and malignancies, including lymphoma.

The approval of voclosporin was based on data from two studies, the AURORA phase 3 study and the AURA-LV phase 2 study. The studies included 533 adults with lupus nephritis who were randomized to 23.7 mg or placebo of voclosporin twice daily in the form of oral capsules, or placebo capsules, in addition to standard of care (mycophenolate mofetil plus low-dose glucocorticoids).

In the AURORA phase 3 study of 357 patients, close to twice as many patients in the treatment group showed a complete renal response, compared with the placebo group after 1 year (40.8% vs. 22.5%). In addition, patients treated with voclosporin more quickly achieved a significant reduction in urine protein to creatinine ratio, compared with the placebo patients (169 days vs. 372 days).

Severe adverse events were similar between the groups, including the most common complication of infection (10.1% and 11.2% for voclosporin and control groups, respectively). Other adverse reactions reported in at least 3% of the study participants included a decrease in glomerular filtration rate, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, upper abdominal pain, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite, according to the company press release.

Full clinical trial information for the AURORA study is available here.

The Food and Drug Administration has approved voclosporin (Lupkynis) for the treatment of lupus nephritis, according to a Jan. 22 press release from manufacturer Aurinia Pharmaceuticals.

Lupkynis is a calcineurin-inhibitor immunosuppressant, and is the first oral medication to show effectiveness in lupus nephritis, according to the company. The drug is indicated for the treatment of adult patients with active lupus nephritis in combination with a background immunosuppressive therapy regimen, according to the drug label, which also has a boxed warning describing the increased risk of infections and malignancies, including lymphoma.

The approval of voclosporin was based on data from two studies, the AURORA phase 3 study and the AURA-LV phase 2 study. The studies included 533 adults with lupus nephritis who were randomized to 23.7 mg or placebo of voclosporin twice daily in the form of oral capsules, or placebo capsules, in addition to standard of care (mycophenolate mofetil plus low-dose glucocorticoids).

In the AURORA phase 3 study of 357 patients, close to twice as many patients in the treatment group showed a complete renal response, compared with the placebo group after 1 year (40.8% vs. 22.5%). In addition, patients treated with voclosporin more quickly achieved a significant reduction in urine protein to creatinine ratio, compared with the placebo patients (169 days vs. 372 days).

Severe adverse events were similar between the groups, including the most common complication of infection (10.1% and 11.2% for voclosporin and control groups, respectively). Other adverse reactions reported in at least 3% of the study participants included a decrease in glomerular filtration rate, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, upper abdominal pain, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite, according to the company press release.

Full clinical trial information for the AURORA study is available here.

Severe renal arteriosclerosis was associated with a ninefold increased risk of atherosclerotic cardiovascular disease in patients with lupus nephritis, based on data from an observational study of 189 individuals.

Mohammed Haneefa Nizamudeen/Getty Images

Atherosclerotic cardiovascular disease (ASCVD) has traditionally been thought to be a late complication of systemic lupus erythematosus (SLE), but this has been challenged in recent population-based studies of patients with SLE and lupus nephritis (LN) that indicated an early and increased risk of ASCVD at the time of diagnosis. However, it is unclear which early risk factors may predispose patients to ASCVD, Shivani Garg, MD, of the University of Wisconsin, Madison, and colleagues wrote in a study published in Arthritis Care & Research.

In patients with IgA nephropathy and renal transplantation, previous studies have shown that severe renal arteriosclerosis (r-ASCL) based on kidney biopsies at the time of diagnosis predicts ASCVD, but “a few studies including LN biopsies failed to report a similar association between the presence of severe r-ASCL and ASCVD occurrence,” possibly because of underreporting of r-ASCL. Dr. Garg and colleagues also noted the problem of underreporting of r-ASCL in their own previous study of its prevalence in LN patients at the time of diagnosis.

To get a more detailed view of how r-ASCL may be linked to early occurrence of ASCVD in LN patients, Dr. Garg and coauthors identified 189 consecutive patients with incident LN who underwent diagnostic biopsies between 1994 and 2017. The median age of the patients was 25 years, 78% were women, and 73% were white. The researchers developed a composite score for r-ASCL severity based on reported and overread biopsies.

Overall, 31% of the patients had any reported r-ASCL, and 7% had moderate-severe r-ASCL. After incorporating systematically reexamined r-ASCL grades, the prevalence of any and moderate-severe r-ASCL increased to 39% and 12%, respectively.

Based on their composite of reported and overread r-ASCL grade, severe r-ASCL in diagnostic LN biopsies was associated with a ninefold increased risk of ASCVD.

The researchers identified 22 incident ASCVD events over an 11-year follow-up for an overall 12% incidence of ASCVD in LN. ASCVD was defined as ischemic heart disease (including myocardial infarction, coronary artery revascularization, abnormal stress test, abnormal angiogram, and events documented by a cardiologist); stroke and transient ischemic attack (TIA); and peripheral vascular disease. Incident ASCVD was defined as the first ASCVD event between 1 and 10 years after LN diagnosis.

The most common ASCVD events were stroke or TIA (12 patients), events related to ischemic heart disease (7 patients), and events related to peripheral vascular disease (3 patients).

Lack of statin use

The researchers also hypothesized that the presence of gaps in statin use among eligible LN patients would be present in their study population. “Among the 20 patients with incident ASCVD events after LN diagnosis in our cohort, none was on statin therapy at the time of LN diagnosis,” the researchers said, noting that current guidelines from the American College of Rheumatology and the European League Against Rheumatism (now known as the European Alliance of Associations for Rheumatology) recommend initiating statin therapy at the time of LN diagnosis in all patients who have hyperlipidemia and chronic kidney disease (CKD) stage ≥3. “Further, 11 patients (55%) met high-risk criteria (hyperlipidemia and CKD stage ≥3) to implement statin therapy at the time of LN diagnosis, yet only one patient (9%) was initiated on statin therapy.” In addition, patients with stage 3 or higher CKD were more likely to develop ASCVD than patients without stage 3 or higher CKD, they said.

The study findings were limited by several factors including the majority white study population, the ability to overread only 25% of the biopsies, and the lack of data on the potential role of chronic lesions in ASCVD, the researchers noted. However, the results were strengthened by the use of a validated LN cohort, and the data provide “the basis to establish severe composite r-ASCL as a predictor of ASCVD events using a larger sample size in different cohorts,” they said.

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

Severe renal arteriosclerosis was associated with a ninefold increased risk of atherosclerotic cardiovascular disease in patients with lupus nephritis, based on data from an observational study of 189 individuals.

Mohammed Haneefa Nizamudeen/Getty Images

Atherosclerotic cardiovascular disease (ASCVD) has traditionally been thought to be a late complication of systemic lupus erythematosus (SLE), but this has been challenged in recent population-based studies of patients with SLE and lupus nephritis (LN) that indicated an early and increased risk of ASCVD at the time of diagnosis. However, it is unclear which early risk factors may predispose patients to ASCVD, Shivani Garg, MD, of the University of Wisconsin, Madison, and colleagues wrote in a study published in Arthritis Care & Research.

In patients with IgA nephropathy and renal transplantation, previous studies have shown that severe renal arteriosclerosis (r-ASCL) based on kidney biopsies at the time of diagnosis predicts ASCVD, but “a few studies including LN biopsies failed to report a similar association between the presence of severe r-ASCL and ASCVD occurrence,” possibly because of underreporting of r-ASCL. Dr. Garg and colleagues also noted the problem of underreporting of r-ASCL in their own previous study of its prevalence in LN patients at the time of diagnosis.

To get a more detailed view of how r-ASCL may be linked to early occurrence of ASCVD in LN patients, Dr. Garg and coauthors identified 189 consecutive patients with incident LN who underwent diagnostic biopsies between 1994 and 2017. The median age of the patients was 25 years, 78% were women, and 73% were white. The researchers developed a composite score for r-ASCL severity based on reported and overread biopsies.

Overall, 31% of the patients had any reported r-ASCL, and 7% had moderate-severe r-ASCL. After incorporating systematically reexamined r-ASCL grades, the prevalence of any and moderate-severe r-ASCL increased to 39% and 12%, respectively.

Based on their composite of reported and overread r-ASCL grade, severe r-ASCL in diagnostic LN biopsies was associated with a ninefold increased risk of ASCVD.

The researchers identified 22 incident ASCVD events over an 11-year follow-up for an overall 12% incidence of ASCVD in LN. ASCVD was defined as ischemic heart disease (including myocardial infarction, coronary artery revascularization, abnormal stress test, abnormal angiogram, and events documented by a cardiologist); stroke and transient ischemic attack (TIA); and peripheral vascular disease. Incident ASCVD was defined as the first ASCVD event between 1 and 10 years after LN diagnosis.

The most common ASCVD events were stroke or TIA (12 patients), events related to ischemic heart disease (7 patients), and events related to peripheral vascular disease (3 patients).

Lack of statin use

The researchers also hypothesized that the presence of gaps in statin use among eligible LN patients would be present in their study population. “Among the 20 patients with incident ASCVD events after LN diagnosis in our cohort, none was on statin therapy at the time of LN diagnosis,” the researchers said, noting that current guidelines from the American College of Rheumatology and the European League Against Rheumatism (now known as the European Alliance of Associations for Rheumatology) recommend initiating statin therapy at the time of LN diagnosis in all patients who have hyperlipidemia and chronic kidney disease (CKD) stage ≥3. “Further, 11 patients (55%) met high-risk criteria (hyperlipidemia and CKD stage ≥3) to implement statin therapy at the time of LN diagnosis, yet only one patient (9%) was initiated on statin therapy.” In addition, patients with stage 3 or higher CKD were more likely to develop ASCVD than patients without stage 3 or higher CKD, they said.

The study findings were limited by several factors including the majority white study population, the ability to overread only 25% of the biopsies, and the lack of data on the potential role of chronic lesions in ASCVD, the researchers noted. However, the results were strengthened by the use of a validated LN cohort, and the data provide “the basis to establish severe composite r-ASCL as a predictor of ASCVD events using a larger sample size in different cohorts,” they said.

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

Severe renal arteriosclerosis was associated with a ninefold increased risk of atherosclerotic cardiovascular disease in patients with lupus nephritis, based on data from an observational study of 189 individuals.

Mohammed Haneefa Nizamudeen/Getty Images

Atherosclerotic cardiovascular disease (ASCVD) has traditionally been thought to be a late complication of systemic lupus erythematosus (SLE), but this has been challenged in recent population-based studies of patients with SLE and lupus nephritis (LN) that indicated an early and increased risk of ASCVD at the time of diagnosis. However, it is unclear which early risk factors may predispose patients to ASCVD, Shivani Garg, MD, of the University of Wisconsin, Madison, and colleagues wrote in a study published in Arthritis Care & Research.

In patients with IgA nephropathy and renal transplantation, previous studies have shown that severe renal arteriosclerosis (r-ASCL) based on kidney biopsies at the time of diagnosis predicts ASCVD, but “a few studies including LN biopsies failed to report a similar association between the presence of severe r-ASCL and ASCVD occurrence,” possibly because of underreporting of r-ASCL. Dr. Garg and colleagues also noted the problem of underreporting of r-ASCL in their own previous study of its prevalence in LN patients at the time of diagnosis.

To get a more detailed view of how r-ASCL may be linked to early occurrence of ASCVD in LN patients, Dr. Garg and coauthors identified 189 consecutive patients with incident LN who underwent diagnostic biopsies between 1994 and 2017. The median age of the patients was 25 years, 78% were women, and 73% were white. The researchers developed a composite score for r-ASCL severity based on reported and overread biopsies.

Overall, 31% of the patients had any reported r-ASCL, and 7% had moderate-severe r-ASCL. After incorporating systematically reexamined r-ASCL grades, the prevalence of any and moderate-severe r-ASCL increased to 39% and 12%, respectively.

Based on their composite of reported and overread r-ASCL grade, severe r-ASCL in diagnostic LN biopsies was associated with a ninefold increased risk of ASCVD.

The researchers identified 22 incident ASCVD events over an 11-year follow-up for an overall 12% incidence of ASCVD in LN. ASCVD was defined as ischemic heart disease (including myocardial infarction, coronary artery revascularization, abnormal stress test, abnormal angiogram, and events documented by a cardiologist); stroke and transient ischemic attack (TIA); and peripheral vascular disease. Incident ASCVD was defined as the first ASCVD event between 1 and 10 years after LN diagnosis.

The most common ASCVD events were stroke or TIA (12 patients), events related to ischemic heart disease (7 patients), and events related to peripheral vascular disease (3 patients).

Lack of statin use

The researchers also hypothesized that the presence of gaps in statin use among eligible LN patients would be present in their study population. “Among the 20 patients with incident ASCVD events after LN diagnosis in our cohort, none was on statin therapy at the time of LN diagnosis,” the researchers said, noting that current guidelines from the American College of Rheumatology and the European League Against Rheumatism (now known as the European Alliance of Associations for Rheumatology) recommend initiating statin therapy at the time of LN diagnosis in all patients who have hyperlipidemia and chronic kidney disease (CKD) stage ≥3. “Further, 11 patients (55%) met high-risk criteria (hyperlipidemia and CKD stage ≥3) to implement statin therapy at the time of LN diagnosis, yet only one patient (9%) was initiated on statin therapy.” In addition, patients with stage 3 or higher CKD were more likely to develop ASCVD than patients without stage 3 or higher CKD, they said.

The study findings were limited by several factors including the majority white study population, the ability to overread only 25% of the biopsies, and the lack of data on the potential role of chronic lesions in ASCVD, the researchers noted. However, the results were strengthened by the use of a validated LN cohort, and the data provide “the basis to establish severe composite r-ASCL as a predictor of ASCVD events using a larger sample size in different cohorts,” they said.

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

Childhood treatment with recombinant human growth hormone was associated with a significantly increased risk of cardiovascular events, based on data from more than 3,000 individuals.

“Both excess levels of growth hormone and [growth hormone deficiency] have been associated with increased cardiovascular morbidity and mortality,” but data on long-term cardiovascular morbidity in individuals treated with growth hormone in childhood are lacking, wrote Anders Tinblad, MD, of Karolinska Institutet, Stockholm, and colleagues.

In a population-based cohort study published in JAMA Pediatrics, the researchers identified 3,408 Swedish patients treated as children with recombinant human growth hormone (rhGH) between Jan. 1, 1985, and Dec. 31, 2010, and compared each with 15 matched controls (a total of 50,036 controls). The patients were treated for one of three conditions: isolated growth hormone deficiency (GHD), small for gestational age (SGA), and idiopathic short stature (ISS).

Data on cardiovascular outcomes were collected from health care and population-based registers and analyzed between Jan. 1, 1985, and Dec. 31, 2014. The average age of the participants at the study’s end was 25.1 years.

In all, 1,809 cardiovascular disease events were recorded over a median follow-up period of 14.9 years, for an incidence rate of 25.6 events per 10,000 person-years in patients and 22.6 events per 10,000 person-years in controls.

When separated by sex, the incidence was higher in female patients compared with controls (31.2 vs. 23.4 events per 10,000 person-years, respectively, but similar in male patients vs. controls (23.3 vs. 22.3 events per 10,000 person-years). “Differences in estrogen levels or responsiveness to rhGH treatment have previously been hypothesized as possible explanations, but the underlying mechanism for this sex difference still remains unclear and merits further investigation,” the researchers wrote.

Overall, the highest adjusted hazard ratios occurred in subgroups of patients with the longest treatment duration (HR 2.08) and highest cumulative dose of growth hormone (HR 2.05), but no association was noted between highest daily hormone dose and cardiovascular event risk. Hazard ratios were higher across all three treatment subgroups of SGA, GHD, and ISS compared with controls (HR 1.97, 1.66, and 1.55, respectively).

“The association between childhood rhGH treatment and CVD events was also seen when assessing only severe CVD outcomes, but with even lower absolute risks,” the researchers noted.

The study findings were limited by several factors including the potential for confounding by treatment indication and the lack of long-term follow-up data given the relatively young age of the study population, the researchers said. The results were strengthened by the large sample size and showed that the absolute risk for overall and severe cardiovascular disease in children treated with growth hormones was low, “which could be reassuring to individual patients,” they added. However, “At the group level, and perhaps especially for female patients and those treated for SGA indication, further close monitoring and future studies of CVD safety are warranted,” they concluded.
 

Safety and ethical concerns persist

Although the study authors cite limited conclusions on causality and low absolute risk, several issues persist that prompt ongoing analysis of pediatric growth hormone use, namely “worrisome indirect evidence, challenges and limitations in the direct evidence, and the changing world of growth hormone treatment,” Adda Grimberg, MD, of the University of Pennsylvania, Philadelphia, wrote in an accompanying editorial.

“Although evidence asserts that neither growth hormone nor insulinlike growth factor I is carcinogenic, the basic science and oncology literatures are rife with reports showing that they can make aberrant cells more aggressive,” and such indirect evidence supports the need for more direct evidence of possible harm from growth hormone treatment, Dr. Grimberg wrote. Most current safety data on growth hormone come from postmarketing surveillance studies, but these studies do not include controls or data on outcomes after discontinuation of treatment, she noted.

The current study, while able to follow patients across the lifespan, cannot indicate “whether the small but increased risk of cardiovascular disease found in this study was caused by the pediatric growth hormone treatment that identified the participants, by the conditions being treated, by other potential confounder(s) not captured by the study’s methods, or by a combination of the above,” said Dr. Grimberg.

In addition, “the move from replacement of GHD to pharmacologic height augmentation in children who already make sufficient growth hormone had the potential to change the safety profile of treatment,” she said.

“Parents of patients in pediatric primary care practices and of patients seeking growth-related care in a subspecialty endocrine clinic rated treatment characteristics (i.e., proven efficacy and safety) as the factor most having a big or extreme effect on their growth-related medical decision-making,” Dr. Grimberg said. “The centrality of treatment safety to patient-family decision-making underscores the importance of continued scrutiny of growth hormone safety as the treatment and its recipients continue to evolve,” she concluded.

The study was supported by the Swedish Research Council, the Stockholm City Council, the Karolinska Institute, the Society for Child Care, Sahlgrenska University Hospital, and the Stockholm County Council’s combined clinical residency and PhD training program. Lead author Dr. Tidblad disclosed funding from the Society for Child Care and Stockholm County Council during the conduct of the study and personal fees from Pfizer. Dr. Grimberg disclosed serving as a member of the steering committee for the Pfizer International Growth Study Database, and as a consultant for the Pediatric Endocrine Society GH Deficiency Knowledge Center, sponsored by Sandoz AG.

Childhood treatment with recombinant human growth hormone was associated with a significantly increased risk of cardiovascular events, based on data from more than 3,000 individuals.

“Both excess levels of growth hormone and [growth hormone deficiency] have been associated with increased cardiovascular morbidity and mortality,” but data on long-term cardiovascular morbidity in individuals treated with growth hormone in childhood are lacking, wrote Anders Tinblad, MD, of Karolinska Institutet, Stockholm, and colleagues.

In a population-based cohort study published in JAMA Pediatrics, the researchers identified 3,408 Swedish patients treated as children with recombinant human growth hormone (rhGH) between Jan. 1, 1985, and Dec. 31, 2010, and compared each with 15 matched controls (a total of 50,036 controls). The patients were treated for one of three conditions: isolated growth hormone deficiency (GHD), small for gestational age (SGA), and idiopathic short stature (ISS).

Data on cardiovascular outcomes were collected from health care and population-based registers and analyzed between Jan. 1, 1985, and Dec. 31, 2014. The average age of the participants at the study’s end was 25.1 years.

In all, 1,809 cardiovascular disease events were recorded over a median follow-up period of 14.9 years, for an incidence rate of 25.6 events per 10,000 person-years in patients and 22.6 events per 10,000 person-years in controls.

When separated by sex, the incidence was higher in female patients compared with controls (31.2 vs. 23.4 events per 10,000 person-years, respectively, but similar in male patients vs. controls (23.3 vs. 22.3 events per 10,000 person-years). “Differences in estrogen levels or responsiveness to rhGH treatment have previously been hypothesized as possible explanations, but the underlying mechanism for this sex difference still remains unclear and merits further investigation,” the researchers wrote.

Overall, the highest adjusted hazard ratios occurred in subgroups of patients with the longest treatment duration (HR 2.08) and highest cumulative dose of growth hormone (HR 2.05), but no association was noted between highest daily hormone dose and cardiovascular event risk. Hazard ratios were higher across all three treatment subgroups of SGA, GHD, and ISS compared with controls (HR 1.97, 1.66, and 1.55, respectively).

“The association between childhood rhGH treatment and CVD events was also seen when assessing only severe CVD outcomes, but with even lower absolute risks,” the researchers noted.

The study findings were limited by several factors including the potential for confounding by treatment indication and the lack of long-term follow-up data given the relatively young age of the study population, the researchers said. The results were strengthened by the large sample size and showed that the absolute risk for overall and severe cardiovascular disease in children treated with growth hormones was low, “which could be reassuring to individual patients,” they added. However, “At the group level, and perhaps especially for female patients and those treated for SGA indication, further close monitoring and future studies of CVD safety are warranted,” they concluded.
 

Safety and ethical concerns persist

Although the study authors cite limited conclusions on causality and low absolute risk, several issues persist that prompt ongoing analysis of pediatric growth hormone use, namely “worrisome indirect evidence, challenges and limitations in the direct evidence, and the changing world of growth hormone treatment,” Adda Grimberg, MD, of the University of Pennsylvania, Philadelphia, wrote in an accompanying editorial.

“Although evidence asserts that neither growth hormone nor insulinlike growth factor I is carcinogenic, the basic science and oncology literatures are rife with reports showing that they can make aberrant cells more aggressive,” and such indirect evidence supports the need for more direct evidence of possible harm from growth hormone treatment, Dr. Grimberg wrote. Most current safety data on growth hormone come from postmarketing surveillance studies, but these studies do not include controls or data on outcomes after discontinuation of treatment, she noted.

The current study, while able to follow patients across the lifespan, cannot indicate “whether the small but increased risk of cardiovascular disease found in this study was caused by the pediatric growth hormone treatment that identified the participants, by the conditions being treated, by other potential confounder(s) not captured by the study’s methods, or by a combination of the above,” said Dr. Grimberg.

In addition, “the move from replacement of GHD to pharmacologic height augmentation in children who already make sufficient growth hormone had the potential to change the safety profile of treatment,” she said.

“Parents of patients in pediatric primary care practices and of patients seeking growth-related care in a subspecialty endocrine clinic rated treatment characteristics (i.e., proven efficacy and safety) as the factor most having a big or extreme effect on their growth-related medical decision-making,” Dr. Grimberg said. “The centrality of treatment safety to patient-family decision-making underscores the importance of continued scrutiny of growth hormone safety as the treatment and its recipients continue to evolve,” she concluded.

The study was supported by the Swedish Research Council, the Stockholm City Council, the Karolinska Institute, the Society for Child Care, Sahlgrenska University Hospital, and the Stockholm County Council’s combined clinical residency and PhD training program. Lead author Dr. Tidblad disclosed funding from the Society for Child Care and Stockholm County Council during the conduct of the study and personal fees from Pfizer. Dr. Grimberg disclosed serving as a member of the steering committee for the Pfizer International Growth Study Database, and as a consultant for the Pediatric Endocrine Society GH Deficiency Knowledge Center, sponsored by Sandoz AG.

Childhood treatment with recombinant human growth hormone was associated with a significantly increased risk of cardiovascular events, based on data from more than 3,000 individuals.

“Both excess levels of growth hormone and [growth hormone deficiency] have been associated with increased cardiovascular morbidity and mortality,” but data on long-term cardiovascular morbidity in individuals treated with growth hormone in childhood are lacking, wrote Anders Tinblad, MD, of Karolinska Institutet, Stockholm, and colleagues.

In a population-based cohort study published in JAMA Pediatrics, the researchers identified 3,408 Swedish patients treated as children with recombinant human growth hormone (rhGH) between Jan. 1, 1985, and Dec. 31, 2010, and compared each with 15 matched controls (a total of 50,036 controls). The patients were treated for one of three conditions: isolated growth hormone deficiency (GHD), small for gestational age (SGA), and idiopathic short stature (ISS).

Data on cardiovascular outcomes were collected from health care and population-based registers and analyzed between Jan. 1, 1985, and Dec. 31, 2014. The average age of the participants at the study’s end was 25.1 years.

In all, 1,809 cardiovascular disease events were recorded over a median follow-up period of 14.9 years, for an incidence rate of 25.6 events per 10,000 person-years in patients and 22.6 events per 10,000 person-years in controls.

When separated by sex, the incidence was higher in female patients compared with controls (31.2 vs. 23.4 events per 10,000 person-years, respectively, but similar in male patients vs. controls (23.3 vs. 22.3 events per 10,000 person-years). “Differences in estrogen levels or responsiveness to rhGH treatment have previously been hypothesized as possible explanations, but the underlying mechanism for this sex difference still remains unclear and merits further investigation,” the researchers wrote.

Overall, the highest adjusted hazard ratios occurred in subgroups of patients with the longest treatment duration (HR 2.08) and highest cumulative dose of growth hormone (HR 2.05), but no association was noted between highest daily hormone dose and cardiovascular event risk. Hazard ratios were higher across all three treatment subgroups of SGA, GHD, and ISS compared with controls (HR 1.97, 1.66, and 1.55, respectively).

“The association between childhood rhGH treatment and CVD events was also seen when assessing only severe CVD outcomes, but with even lower absolute risks,” the researchers noted.

The study findings were limited by several factors including the potential for confounding by treatment indication and the lack of long-term follow-up data given the relatively young age of the study population, the researchers said. The results were strengthened by the large sample size and showed that the absolute risk for overall and severe cardiovascular disease in children treated with growth hormones was low, “which could be reassuring to individual patients,” they added. However, “At the group level, and perhaps especially for female patients and those treated for SGA indication, further close monitoring and future studies of CVD safety are warranted,” they concluded.
 

Safety and ethical concerns persist

Although the study authors cite limited conclusions on causality and low absolute risk, several issues persist that prompt ongoing analysis of pediatric growth hormone use, namely “worrisome indirect evidence, challenges and limitations in the direct evidence, and the changing world of growth hormone treatment,” Adda Grimberg, MD, of the University of Pennsylvania, Philadelphia, wrote in an accompanying editorial.

“Although evidence asserts that neither growth hormone nor insulinlike growth factor I is carcinogenic, the basic science and oncology literatures are rife with reports showing that they can make aberrant cells more aggressive,” and such indirect evidence supports the need for more direct evidence of possible harm from growth hormone treatment, Dr. Grimberg wrote. Most current safety data on growth hormone come from postmarketing surveillance studies, but these studies do not include controls or data on outcomes after discontinuation of treatment, she noted.

The current study, while able to follow patients across the lifespan, cannot indicate “whether the small but increased risk of cardiovascular disease found in this study was caused by the pediatric growth hormone treatment that identified the participants, by the conditions being treated, by other potential confounder(s) not captured by the study’s methods, or by a combination of the above,” said Dr. Grimberg.

In addition, “the move from replacement of GHD to pharmacologic height augmentation in children who already make sufficient growth hormone had the potential to change the safety profile of treatment,” she said.

“Parents of patients in pediatric primary care practices and of patients seeking growth-related care in a subspecialty endocrine clinic rated treatment characteristics (i.e., proven efficacy and safety) as the factor most having a big or extreme effect on their growth-related medical decision-making,” Dr. Grimberg said. “The centrality of treatment safety to patient-family decision-making underscores the importance of continued scrutiny of growth hormone safety as the treatment and its recipients continue to evolve,” she concluded.

The study was supported by the Swedish Research Council, the Stockholm City Council, the Karolinska Institute, the Society for Child Care, Sahlgrenska University Hospital, and the Stockholm County Council’s combined clinical residency and PhD training program. Lead author Dr. Tidblad disclosed funding from the Society for Child Care and Stockholm County Council during the conduct of the study and personal fees from Pfizer. Dr. Grimberg disclosed serving as a member of the steering committee for the Pfizer International Growth Study Database, and as a consultant for the Pediatric Endocrine Society GH Deficiency Knowledge Center, sponsored by Sandoz AG.

Birth rates for women who underwent assisted reproduction using fresh donor oocytes were significantly higher than for women who used cryopreserved-thawed embryos, based on data from more than 33,000 women.

Cryopreserved-thawed embryo transfers in donor oocyte cycles have gained in popularity in recent years for reasons including “convenience, elimination of the need for synchronization between donor and recipient cycles, and/or increasing utilization of preimplantation genetic testing for aneuploidy,” wrote Iris G. Insogna, MD, of Brigham and Women’s Hospital, Boston, and colleagues.“ However, to date, no comparison of pregnancy outcomes has been made between transfers of fresh embryos and cryopreserved-thawed embryos derived exclusively from fresh donor oocytes,” they said.

In a retrospective cohort study published in JAMA, the researchers identified 33,863 women who underwent IVF cycles using freshly retrieved oocytes with a total of 51,942 embryo transfer cycles; 15,308 fresh embryo transfer cycles, and 36,634 cryopreserved-thawed embryo transfer cycles.

Overall, the live birth rate was 56.6% for cycles involving fresh donor oocytes compared to 44.0% for cycles with cryopreserved-thawed embryos, with an adjusted relative risk of 1.42 after the researchers controlled for donor age, day of embryo transfer, use of gestational carrier, and assisted hatching. Demographics were similar between women who received fresh vs. cryopreserved-thawed embryos including median age (42 years for both), gravidity (1 for both), parity (0 vs. 1), and body mass index (24.5 vs. 24.4 kg/m²).

Clinical pregnancy rates for women with fresh vs. cryopreserved-thawed embryo transfers were 66.7% and 54.2%, respectively, and miscarriage rates were approximately 9% for both groups.

The average number of embryos transferred was similar between the groups, and blastocysts were transferred in 92.4% and 96.5% of fresh embryo and cryopreserved-thawed embryo transfer cycles, respectively.

The finding that, in cycles using fresh donor oocytes, fresh embryo transfer yielded higher birth rates than transfer of cryopreserved-thawed embryo transfer “was in contrast to previous investigations of cycles using autologous oocytes that demonstrated higher live birth rates following cryopreserved-thawed embryo transfers,” the researchers noted.

Live birth rates remained higher in cases of fresh embryo transfer when preimplantation genetic testing for aneuploidy (PGT-A) was performed, they added.

The study findings were limited by several factors, including the retrospective design and lack of data on potential confounding factors in the donor population, such as age, ethnicity, BMI, and smoking status, the researchers said. However, the results have implications for clinical practice by providing informed counseling information, given the significantly greater complexity of preparing a fresh transfer of an embryo from a fresh donor oocyte, the researchers noted. In addition, “given the considerable financial investment, these data may influence patient decision-making regarding transferring a fresh embryo derived from a fresh donor oocyte vs. cryopreserving all embryos a priori for convenience,” they said. More data on the cost-effectiveness of fresh vs. cryopreserved-thawed embryo transfer in the study population also would help guide clinical practice, they said.
 

Prospective studies needed to confirm potential

“For women who use autologous oocytes, there is increasing evidence for improved pregnancy rates by frozen embryo transfer (FET) rather than fresh, particularly in women with good ovarian response to gonadotropins,” Mark P. Trolice, MD, of the University of Central Florida, Orlando, said in an interview. The current study was important because it examined “whether the same concept applies with the use of embryos from donor oocytes,” he said.

Dr. Trolice, director of Fertility CARE: The IVF Center, in Orlando, said he was surprised by the study findings. The study “contradicts the experience in cycles using autologous oocytes,” he said. “Fresh embryo superiority remained after a subgroup analysis of first embryo transfers for fresh and frozen cycles as well as for embryos that underwent PGT-A (preimplantation genetic testing for aneuploidy, typically resulting in FET cycles, although a small percentage of cycles underwent fresh embryo transfer), yielding no difference to non-PGT-A fresh cycles. This reinforces the prior evidence for lack of improvement following PGT-A in women less than age 35 years,” he noted.

“Coincidentally, the same findings were discovered using the same SART [Society for Assisted Reproductive Technology] database (from 2013 to 2015), namely fresh embryo transfer from donor oocytes was more likely to result in a live birth – 55.7% versus 39.5%,” said Dr. Trolice. “An abstract presented at the 2017 ASRM annual meeting also used the SART data base (from 2003 to 2014) and demonstrated live birth rates from fresh transfer of embryos using donor oocytes were 15%-20% higher than those from frozen embryo transfers,” he noted.

“In summary, the use of fresh embryos from donor oocytes consistently appears to have superior pregnancy outcomes compared with frozen embryos; a nearly 13% absolute difference in this recent study,” said Dr. Trolice. The strengths of the study included the primary outcome of live births and the heterogeneity, with cycles taken from all participating U.S. SART clinics, Dr. Trolice noted. Limitations included the “retrospective design with the inherent risk of selection bias and the lack of information on the embryo freezing method, i.e., the older ‘slow-freeze’ or the more advanced and popular method of vitrification,” he added. “Randomized, prospective studies are needed to more accurately address this important issue,” he emphasized.

The study received no outside funding. Lead author Dr. Insogna disclosed part-time work as an assistant physician for Teladoc Health. Dr. Trolice had no relevant financial conflicts to disclose.

Birth rates for women who underwent assisted reproduction using fresh donor oocytes were significantly higher than for women who used cryopreserved-thawed embryos, based on data from more than 33,000 women.

Cryopreserved-thawed embryo transfers in donor oocyte cycles have gained in popularity in recent years for reasons including “convenience, elimination of the need for synchronization between donor and recipient cycles, and/or increasing utilization of preimplantation genetic testing for aneuploidy,” wrote Iris G. Insogna, MD, of Brigham and Women’s Hospital, Boston, and colleagues.“ However, to date, no comparison of pregnancy outcomes has been made between transfers of fresh embryos and cryopreserved-thawed embryos derived exclusively from fresh donor oocytes,” they said.

In a retrospective cohort study published in JAMA, the researchers identified 33,863 women who underwent IVF cycles using freshly retrieved oocytes with a total of 51,942 embryo transfer cycles; 15,308 fresh embryo transfer cycles, and 36,634 cryopreserved-thawed embryo transfer cycles.

Overall, the live birth rate was 56.6% for cycles involving fresh donor oocytes compared to 44.0% for cycles with cryopreserved-thawed embryos, with an adjusted relative risk of 1.42 after the researchers controlled for donor age, day of embryo transfer, use of gestational carrier, and assisted hatching. Demographics were similar between women who received fresh vs. cryopreserved-thawed embryos including median age (42 years for both), gravidity (1 for both), parity (0 vs. 1), and body mass index (24.5 vs. 24.4 kg/m²).

Clinical pregnancy rates for women with fresh vs. cryopreserved-thawed embryo transfers were 66.7% and 54.2%, respectively, and miscarriage rates were approximately 9% for both groups.

The average number of embryos transferred was similar between the groups, and blastocysts were transferred in 92.4% and 96.5% of fresh embryo and cryopreserved-thawed embryo transfer cycles, respectively.

The finding that, in cycles using fresh donor oocytes, fresh embryo transfer yielded higher birth rates than transfer of cryopreserved-thawed embryo transfer “was in contrast to previous investigations of cycles using autologous oocytes that demonstrated higher live birth rates following cryopreserved-thawed embryo transfers,” the researchers noted.

Live birth rates remained higher in cases of fresh embryo transfer when preimplantation genetic testing for aneuploidy (PGT-A) was performed, they added.

The study findings were limited by several factors, including the retrospective design and lack of data on potential confounding factors in the donor population, such as age, ethnicity, BMI, and smoking status, the researchers said. However, the results have implications for clinical practice by providing informed counseling information, given the significantly greater complexity of preparing a fresh transfer of an embryo from a fresh donor oocyte, the researchers noted. In addition, “given the considerable financial investment, these data may influence patient decision-making regarding transferring a fresh embryo derived from a fresh donor oocyte vs. cryopreserving all embryos a priori for convenience,” they said. More data on the cost-effectiveness of fresh vs. cryopreserved-thawed embryo transfer in the study population also would help guide clinical practice, they said.
 

Prospective studies needed to confirm potential

“For women who use autologous oocytes, there is increasing evidence for improved pregnancy rates by frozen embryo transfer (FET) rather than fresh, particularly in women with good ovarian response to gonadotropins,” Mark P. Trolice, MD, of the University of Central Florida, Orlando, said in an interview. The current study was important because it examined “whether the same concept applies with the use of embryos from donor oocytes,” he said.

Dr. Trolice, director of Fertility CARE: The IVF Center, in Orlando, said he was surprised by the study findings. The study “contradicts the experience in cycles using autologous oocytes,” he said. “Fresh embryo superiority remained after a subgroup analysis of first embryo transfers for fresh and frozen cycles as well as for embryos that underwent PGT-A (preimplantation genetic testing for aneuploidy, typically resulting in FET cycles, although a small percentage of cycles underwent fresh embryo transfer), yielding no difference to non-PGT-A fresh cycles. This reinforces the prior evidence for lack of improvement following PGT-A in women less than age 35 years,” he noted.

“Coincidentally, the same findings were discovered using the same SART [Society for Assisted Reproductive Technology] database (from 2013 to 2015), namely fresh embryo transfer from donor oocytes was more likely to result in a live birth – 55.7% versus 39.5%,” said Dr. Trolice. “An abstract presented at the 2017 ASRM annual meeting also used the SART data base (from 2003 to 2014) and demonstrated live birth rates from fresh transfer of embryos using donor oocytes were 15%-20% higher than those from frozen embryo transfers,” he noted.

“In summary, the use of fresh embryos from donor oocytes consistently appears to have superior pregnancy outcomes compared with frozen embryos; a nearly 13% absolute difference in this recent study,” said Dr. Trolice. The strengths of the study included the primary outcome of live births and the heterogeneity, with cycles taken from all participating U.S. SART clinics, Dr. Trolice noted. Limitations included the “retrospective design with the inherent risk of selection bias and the lack of information on the embryo freezing method, i.e., the older ‘slow-freeze’ or the more advanced and popular method of vitrification,” he added. “Randomized, prospective studies are needed to more accurately address this important issue,” he emphasized.

The study received no outside funding. Lead author Dr. Insogna disclosed part-time work as an assistant physician for Teladoc Health. Dr. Trolice had no relevant financial conflicts to disclose.

Birth rates for women who underwent assisted reproduction using fresh donor oocytes were significantly higher than for women who used cryopreserved-thawed embryos, based on data from more than 33,000 women.

Cryopreserved-thawed embryo transfers in donor oocyte cycles have gained in popularity in recent years for reasons including “convenience, elimination of the need for synchronization between donor and recipient cycles, and/or increasing utilization of preimplantation genetic testing for aneuploidy,” wrote Iris G. Insogna, MD, of Brigham and Women’s Hospital, Boston, and colleagues.“ However, to date, no comparison of pregnancy outcomes has been made between transfers of fresh embryos and cryopreserved-thawed embryos derived exclusively from fresh donor oocytes,” they said.

In a retrospective cohort study published in JAMA, the researchers identified 33,863 women who underwent IVF cycles using freshly retrieved oocytes with a total of 51,942 embryo transfer cycles; 15,308 fresh embryo transfer cycles, and 36,634 cryopreserved-thawed embryo transfer cycles.

Overall, the live birth rate was 56.6% for cycles involving fresh donor oocytes compared to 44.0% for cycles with cryopreserved-thawed embryos, with an adjusted relative risk of 1.42 after the researchers controlled for donor age, day of embryo transfer, use of gestational carrier, and assisted hatching. Demographics were similar between women who received fresh vs. cryopreserved-thawed embryos including median age (42 years for both), gravidity (1 for both), parity (0 vs. 1), and body mass index (24.5 vs. 24.4 kg/m²).

Clinical pregnancy rates for women with fresh vs. cryopreserved-thawed embryo transfers were 66.7% and 54.2%, respectively, and miscarriage rates were approximately 9% for both groups.

The average number of embryos transferred was similar between the groups, and blastocysts were transferred in 92.4% and 96.5% of fresh embryo and cryopreserved-thawed embryo transfer cycles, respectively.

The finding that, in cycles using fresh donor oocytes, fresh embryo transfer yielded higher birth rates than transfer of cryopreserved-thawed embryo transfer “was in contrast to previous investigations of cycles using autologous oocytes that demonstrated higher live birth rates following cryopreserved-thawed embryo transfers,” the researchers noted.

Live birth rates remained higher in cases of fresh embryo transfer when preimplantation genetic testing for aneuploidy (PGT-A) was performed, they added.

The study findings were limited by several factors, including the retrospective design and lack of data on potential confounding factors in the donor population, such as age, ethnicity, BMI, and smoking status, the researchers said. However, the results have implications for clinical practice by providing informed counseling information, given the significantly greater complexity of preparing a fresh transfer of an embryo from a fresh donor oocyte, the researchers noted. In addition, “given the considerable financial investment, these data may influence patient decision-making regarding transferring a fresh embryo derived from a fresh donor oocyte vs. cryopreserving all embryos a priori for convenience,” they said. More data on the cost-effectiveness of fresh vs. cryopreserved-thawed embryo transfer in the study population also would help guide clinical practice, they said.
 

Prospective studies needed to confirm potential

“For women who use autologous oocytes, there is increasing evidence for improved pregnancy rates by frozen embryo transfer (FET) rather than fresh, particularly in women with good ovarian response to gonadotropins,” Mark P. Trolice, MD, of the University of Central Florida, Orlando, said in an interview. The current study was important because it examined “whether the same concept applies with the use of embryos from donor oocytes,” he said.

Dr. Trolice, director of Fertility CARE: The IVF Center, in Orlando, said he was surprised by the study findings. The study “contradicts the experience in cycles using autologous oocytes,” he said. “Fresh embryo superiority remained after a subgroup analysis of first embryo transfers for fresh and frozen cycles as well as for embryos that underwent PGT-A (preimplantation genetic testing for aneuploidy, typically resulting in FET cycles, although a small percentage of cycles underwent fresh embryo transfer), yielding no difference to non-PGT-A fresh cycles. This reinforces the prior evidence for lack of improvement following PGT-A in women less than age 35 years,” he noted.

“Coincidentally, the same findings were discovered using the same SART [Society for Assisted Reproductive Technology] database (from 2013 to 2015), namely fresh embryo transfer from donor oocytes was more likely to result in a live birth – 55.7% versus 39.5%,” said Dr. Trolice. “An abstract presented at the 2017 ASRM annual meeting also used the SART data base (from 2003 to 2014) and demonstrated live birth rates from fresh transfer of embryos using donor oocytes were 15%-20% higher than those from frozen embryo transfers,” he noted.

“In summary, the use of fresh embryos from donor oocytes consistently appears to have superior pregnancy outcomes compared with frozen embryos; a nearly 13% absolute difference in this recent study,” said Dr. Trolice. The strengths of the study included the primary outcome of live births and the heterogeneity, with cycles taken from all participating U.S. SART clinics, Dr. Trolice noted. Limitations included the “retrospective design with the inherent risk of selection bias and the lack of information on the embryo freezing method, i.e., the older ‘slow-freeze’ or the more advanced and popular method of vitrification,” he added. “Randomized, prospective studies are needed to more accurately address this important issue,” he emphasized.

The study received no outside funding. Lead author Dr. Insogna disclosed part-time work as an assistant physician for Teladoc Health. Dr. Trolice had no relevant financial conflicts 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.

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.

“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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

“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.

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.

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

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.

“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.

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.

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

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.

“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.

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.

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

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.