Heidi Splete

The Food and Drug Administration has approved 0.5% lotion formulation of ivermectin (Sklice) as an over-the-counter treatment for head lice infestation in patients aged 6 months and older.

Ivermectin was approved as a prescription treatment for head lice in February 2012, according to an FDA press release, and is now approved as an over-the-counter treatment through an “Rx-to-OTC” switch process. The approval was granted to Arbor Pharmaceuticals.

The expanded approval for ivermectin increases access to effective care for head lice, which is estimated to affect between 6 million and 12 million children each year in the United States, according to the Centers for Disease Control and Prevention.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the press release.

The FDA also noted in the press release that “Sklice, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use.”

The drug is approved only for treating head lice, and should be used on the scalp and dry hair, according to the labeling. In the wake of the approval, ivermectin will no longer be available as a prescription drug, according to the FDA, and patients currently using prescription versions should contact their health care providers.

An Rx-to-OTC switch is contingent on the manufacturer’s data showing that the drug is safe and effective when used as directed. In addition, “the manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional,” according to the FDA.

The Food and Drug Administration has approved 0.5% lotion formulation of ivermectin (Sklice) as an over-the-counter treatment for head lice infestation in patients aged 6 months and older.

Ivermectin was approved as a prescription treatment for head lice in February 2012, according to an FDA press release, and is now approved as an over-the-counter treatment through an “Rx-to-OTC” switch process. The approval was granted to Arbor Pharmaceuticals.

The expanded approval for ivermectin increases access to effective care for head lice, which is estimated to affect between 6 million and 12 million children each year in the United States, according to the Centers for Disease Control and Prevention.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the press release.

The FDA also noted in the press release that “Sklice, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use.”

The drug is approved only for treating head lice, and should be used on the scalp and dry hair, according to the labeling. In the wake of the approval, ivermectin will no longer be available as a prescription drug, according to the FDA, and patients currently using prescription versions should contact their health care providers.

An Rx-to-OTC switch is contingent on the manufacturer’s data showing that the drug is safe and effective when used as directed. In addition, “the manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional,” according to the FDA.

The Food and Drug Administration has approved 0.5% lotion formulation of ivermectin (Sklice) as an over-the-counter treatment for head lice infestation in patients aged 6 months and older.

Ivermectin was approved as a prescription treatment for head lice in February 2012, according to an FDA press release, and is now approved as an over-the-counter treatment through an “Rx-to-OTC” switch process. The approval was granted to Arbor Pharmaceuticals.

The expanded approval for ivermectin increases access to effective care for head lice, which is estimated to affect between 6 million and 12 million children each year in the United States, according to the Centers for Disease Control and Prevention.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the press release.

The FDA also noted in the press release that “Sklice, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use.”

The drug is approved only for treating head lice, and should be used on the scalp and dry hair, according to the labeling. In the wake of the approval, ivermectin will no longer be available as a prescription drug, according to the FDA, and patients currently using prescription versions should contact their health care providers.

An Rx-to-OTC switch is contingent on the manufacturer’s data showing that the drug is safe and effective when used as directed. In addition, “the manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a health care professional,” according to the FDA.

When there is an abnormality in the pituitary gland, many potential areas could be affected because of the extent and range of hormones produced by the “master gland,” Ashlyn Smith, PA-C, of Endocrinology Associates, Scottsdale, Ariz., said in a presentation at the at the virtual meeting of the annual Metabolic and Endocrine Disease Summit held by Global Academy for Medical Education.

The most common demographic for pituitary disorders is women in their 30s and 40s, Ms. Smith said. Early red flags for pituitary problems include patients presenting with headaches and/or blurred or double vision, which could signal bitemporal hemianopsia, she said.

Roughly two-thirds of pituitary adenomas are functional, meaning that they secrete pituitary hormones and cause clinical syndromes, Ms. Smith said. The most common reason for hypersecretion is hyperprolactinemia, she said.

Hyperprolactinemia, like most pituitary conditions, is more common in women than men, Ms. Smith noted. However, symptoms may include not only galactorrhea, but also gynecomastia, and hypogonadism, which may be red flags in men, she noted.

“Prolactin inhibits the gonadal pathway, so we see low gonadal hormones. For example, if men present with atypical hypogonadism for their age, or women present with changes in the menstrual cycle, check the prolactin levels,” she said.

The etiologies of hyperprolactinemia include physiologic reasons such as breastfeeding and pregnancy, as well as intercourse and breast manipulation, stress, and sleep issues. Pathologic reasons for prolactin elevation include prolactinoma, gonad-hormone secreting tumor, hypothyroidism, and renal insufficiency, Ms. Smith said.

Evaluation of patients with suspected hyperprolactinemia includes screening for physiologic causes, renal function and thyroid function tests, and a thyroid-specific MRI. Ordering a dedicated MRI of the pituitary gland is important to help identify compression of the optic nerve, noted Ms. Smith.

A medication review also is essential in evaluating hyperprolactinemia, and especially in the setting of the COVID-19 pandemic, because patients may have made changes to psychiatric medications, said Ms. Smith. Neuroleptics and antipsychotics including risperidone, haloperidol, chlorpromazine, and thiothixene can be associated with hyperprolactinemia, as can benzodiazepines and various analgesics and antidepressants, she said.

Treatment in cases of medication-induced hyperprolactinemia can be challenging if the patients are unable to change a medication, said Ms. Smith. However, patients with hypogonadism or low bone mineral density who can’t change medications may benefit from exogenous gonadal hormones, she said.

Some patients with hyperprolactinemia benefit from treatment with dopamine agonists, which may ease symptoms and reduce the size of the prolactinoma, she explained. However, patients on dopamine agonists should be alert to side effects including constipation and orthostasis. Ms. Smith said she recommends that patients on dopamine agonists for hyperprolactinemia take the medication at night so they are lying down if orthostasis occurs.

Monitor prolactin levels at 1 month, and taper or discontinue if the prolactin returns to normal and the adenoma resolves, which can take approximately 2 years, she said. Ms. Smith then advised follow-up every 3 months for 1 year, then annual prolactin checks.

The risk of recurrence ranges from 26% to 69%, Ms. Smith said, and is higher in patients with higher prolactin levels and larger adenomas, she noted. Recurrence is most likely within a year of withdrawal from treatment, she said.

Ms. Smith disclosed serving as an adviser and speaker for Abbott Nutrition, a speaker for Xeris Pharmaceuticals, and an adviser for Sanofi and Radius.

Global Academy for Medical Education and this news organization are owned by the same parent company.

SOURCE: Smith A. MEDS 2020.

When there is an abnormality in the pituitary gland, many potential areas could be affected because of the extent and range of hormones produced by the “master gland,” Ashlyn Smith, PA-C, of Endocrinology Associates, Scottsdale, Ariz., said in a presentation at the at the virtual meeting of the annual Metabolic and Endocrine Disease Summit held by Global Academy for Medical Education.

The most common demographic for pituitary disorders is women in their 30s and 40s, Ms. Smith said. Early red flags for pituitary problems include patients presenting with headaches and/or blurred or double vision, which could signal bitemporal hemianopsia, she said.

Roughly two-thirds of pituitary adenomas are functional, meaning that they secrete pituitary hormones and cause clinical syndromes, Ms. Smith said. The most common reason for hypersecretion is hyperprolactinemia, she said.

Hyperprolactinemia, like most pituitary conditions, is more common in women than men, Ms. Smith noted. However, symptoms may include not only galactorrhea, but also gynecomastia, and hypogonadism, which may be red flags in men, she noted.

“Prolactin inhibits the gonadal pathway, so we see low gonadal hormones. For example, if men present with atypical hypogonadism for their age, or women present with changes in the menstrual cycle, check the prolactin levels,” she said.

The etiologies of hyperprolactinemia include physiologic reasons such as breastfeeding and pregnancy, as well as intercourse and breast manipulation, stress, and sleep issues. Pathologic reasons for prolactin elevation include prolactinoma, gonad-hormone secreting tumor, hypothyroidism, and renal insufficiency, Ms. Smith said.

Evaluation of patients with suspected hyperprolactinemia includes screening for physiologic causes, renal function and thyroid function tests, and a thyroid-specific MRI. Ordering a dedicated MRI of the pituitary gland is important to help identify compression of the optic nerve, noted Ms. Smith.

A medication review also is essential in evaluating hyperprolactinemia, and especially in the setting of the COVID-19 pandemic, because patients may have made changes to psychiatric medications, said Ms. Smith. Neuroleptics and antipsychotics including risperidone, haloperidol, chlorpromazine, and thiothixene can be associated with hyperprolactinemia, as can benzodiazepines and various analgesics and antidepressants, she said.

Treatment in cases of medication-induced hyperprolactinemia can be challenging if the patients are unable to change a medication, said Ms. Smith. However, patients with hypogonadism or low bone mineral density who can’t change medications may benefit from exogenous gonadal hormones, she said.

Some patients with hyperprolactinemia benefit from treatment with dopamine agonists, which may ease symptoms and reduce the size of the prolactinoma, she explained. However, patients on dopamine agonists should be alert to side effects including constipation and orthostasis. Ms. Smith said she recommends that patients on dopamine agonists for hyperprolactinemia take the medication at night so they are lying down if orthostasis occurs.

Monitor prolactin levels at 1 month, and taper or discontinue if the prolactin returns to normal and the adenoma resolves, which can take approximately 2 years, she said. Ms. Smith then advised follow-up every 3 months for 1 year, then annual prolactin checks.

The risk of recurrence ranges from 26% to 69%, Ms. Smith said, and is higher in patients with higher prolactin levels and larger adenomas, she noted. Recurrence is most likely within a year of withdrawal from treatment, she said.

Ms. Smith disclosed serving as an adviser and speaker for Abbott Nutrition, a speaker for Xeris Pharmaceuticals, and an adviser for Sanofi and Radius.

Global Academy for Medical Education and this news organization are owned by the same parent company.

SOURCE: Smith A. MEDS 2020.

When there is an abnormality in the pituitary gland, many potential areas could be affected because of the extent and range of hormones produced by the “master gland,” Ashlyn Smith, PA-C, of Endocrinology Associates, Scottsdale, Ariz., said in a presentation at the at the virtual meeting of the annual Metabolic and Endocrine Disease Summit held by Global Academy for Medical Education.

The most common demographic for pituitary disorders is women in their 30s and 40s, Ms. Smith said. Early red flags for pituitary problems include patients presenting with headaches and/or blurred or double vision, which could signal bitemporal hemianopsia, she said.

Roughly two-thirds of pituitary adenomas are functional, meaning that they secrete pituitary hormones and cause clinical syndromes, Ms. Smith said. The most common reason for hypersecretion is hyperprolactinemia, she said.

Hyperprolactinemia, like most pituitary conditions, is more common in women than men, Ms. Smith noted. However, symptoms may include not only galactorrhea, but also gynecomastia, and hypogonadism, which may be red flags in men, she noted.

“Prolactin inhibits the gonadal pathway, so we see low gonadal hormones. For example, if men present with atypical hypogonadism for their age, or women present with changes in the menstrual cycle, check the prolactin levels,” she said.

The etiologies of hyperprolactinemia include physiologic reasons such as breastfeeding and pregnancy, as well as intercourse and breast manipulation, stress, and sleep issues. Pathologic reasons for prolactin elevation include prolactinoma, gonad-hormone secreting tumor, hypothyroidism, and renal insufficiency, Ms. Smith said.

Evaluation of patients with suspected hyperprolactinemia includes screening for physiologic causes, renal function and thyroid function tests, and a thyroid-specific MRI. Ordering a dedicated MRI of the pituitary gland is important to help identify compression of the optic nerve, noted Ms. Smith.

A medication review also is essential in evaluating hyperprolactinemia, and especially in the setting of the COVID-19 pandemic, because patients may have made changes to psychiatric medications, said Ms. Smith. Neuroleptics and antipsychotics including risperidone, haloperidol, chlorpromazine, and thiothixene can be associated with hyperprolactinemia, as can benzodiazepines and various analgesics and antidepressants, she said.

Treatment in cases of medication-induced hyperprolactinemia can be challenging if the patients are unable to change a medication, said Ms. Smith. However, patients with hypogonadism or low bone mineral density who can’t change medications may benefit from exogenous gonadal hormones, she said.

Some patients with hyperprolactinemia benefit from treatment with dopamine agonists, which may ease symptoms and reduce the size of the prolactinoma, she explained. However, patients on dopamine agonists should be alert to side effects including constipation and orthostasis. Ms. Smith said she recommends that patients on dopamine agonists for hyperprolactinemia take the medication at night so they are lying down if orthostasis occurs.

Monitor prolactin levels at 1 month, and taper or discontinue if the prolactin returns to normal and the adenoma resolves, which can take approximately 2 years, she said. Ms. Smith then advised follow-up every 3 months for 1 year, then annual prolactin checks.

The risk of recurrence ranges from 26% to 69%, Ms. Smith said, and is higher in patients with higher prolactin levels and larger adenomas, she noted. Recurrence is most likely within a year of withdrawal from treatment, she said.

Ms. Smith disclosed serving as an adviser and speaker for Abbott Nutrition, a speaker for Xeris Pharmaceuticals, and an adviser for Sanofi and Radius.

Global Academy for Medical Education and this news organization are owned by the same parent company.

SOURCE: Smith A. MEDS 2020.

Updated assessment and treatment options provide more tools to help clinicians manage osteoporosis and reduce fracture risk, according to Rick Pope, MPAS, PA-C.

iStock/Thinkstock

Criteria from the National Osteoporosis Foundation for the diagnosis of osteoporosis expanded in 2020 to include a T score measure of –2.5 or less at the wrist in postmenopausal women or in men aged 50 years and older (in addition to existing criteria of –2.5 or lower T scores at the lumbar spine, femoral neck, or total hip), he said in a presentation at the virtual annual Metabolic and Endocrine Disease Summit by Global Academy for Medical Education.

Other updated diagnostic criteria for osteoporosis include a low-trauma hip fracture regardless of bone mineral density, and a history of fracture of the pelvis or wrist in the context of osteopenia (in addition to the existing criteria of fracture of the vertebrae or proximal humerus).

When a diagnosis of osteoporosis is established, the Fracture Risk Assessment Tool calculator continues to serve as useful tool that allows clinicians to easily input patient data and obtain a projection of fracture risk, Mr. Pope said.

During a clinical visit, be sure to measure patients’ height, and look for kyphosis to help evaluate fall risk. Progressive kyphosis is important because the head weight can increase to 40 pounds if the kyphosis progresses to 30 degrees, and puts further stress on the vertebrae, he emphasized. In addition, looking at gait is important, especially for older patients, said Mr. Pope. “I want to get an assessment of how steady they are on their feet.”

Vertebral fracture assessment (VFA) is a useful strategy to evaluate the spine for silent compression fractures, especially in someone who has lost 1.5 inches in height or is on chronic steroids, Mr. Pope said. VFA has several advantages, including lower cost and lower radiation exposure than plain radiographs of the spine.

In addition, trabecular bone score (TBS) allows clinicians to evaluate bone microarchitecture, and this score can serve as an important indicator of fracture risk, Mr. Pope said.

As for treatment options, managing skeletal health in osteoporosis patients includes advising patients on healthy lifestyle practices that include not only adequate calcium and vitamin D, but also smoking cessation and a combination of weight-bearing, dynamic balance, and resistive exercises, he noted.

When considering medications, patient factors determine the most appropriate drug to use, Mr. Pope emphasized.

Bisphosphonates remain an option for treatment and have shown effectiveness at reducing fracture risk in postmenopausal women with osteoporosis, but concerns persist about side effects such as osteonecrosis of the jaw and atypical femoral fractures (AFF), he noted.

Reassure patients that AFF is more of an issue with long-term bisphosphonate use, Mr. Pope said, citing a 2012 study in which the risk of atypical femoral fracture was 1.78 per 100,000 person-years among individuals with 0.1-1.9 years of bisphosphonate exposure, but this jumped to 113 per 100,000 person-years among those with 8-9.9 years of bisphosphonate exposure.

“Eight years seems to be the sweet spot,” before a significant increase, he said. In his clinic, clinicians stop patients at about 8 years of bisphosphonate treatment, and then consider restarting.

However, nonbisphosphonate treatments are also available, including the monoclonal antibody denosumab. “It is different than bisphosphonates, and the effect wears off rapidly,” said Mr. Pope. Also, creatinine clearance is not an issue with denosumab. However, when patients have gone past the 10-year mark, should be switched to an alternative treatment because of an increased fracture risk at that point.

One relatively new treatment, abaloparatide, is currently indicated only for postmenopausal women with osteoporosis. Data have shown an 86% reduction in vertebral fracture risk, but the drug carries a black-box warning for osteosarcoma, said Mr. Pope.

Romosozumab, another newcomer drug, is indicated only for postmenopausal osteoporotic women at high risk for fracture with multiple risk factors who have failed other therapies. Romosozumab carries a black-box warning for cardiovascular risk for those with a history of MI or stroke. “This is a completely different mechanism of action” from other drugs, Mr. Pope said. The drug is given twice a month for a total of 12 months, and must be administered by a health professional in an office setting.

Mr. Pope had no financial conflicts to disclose. Global Academy for Medical Education and this news organization are owned by the same parent company.

Updated assessment and treatment options provide more tools to help clinicians manage osteoporosis and reduce fracture risk, according to Rick Pope, MPAS, PA-C.

iStock/Thinkstock

Criteria from the National Osteoporosis Foundation for the diagnosis of osteoporosis expanded in 2020 to include a T score measure of –2.5 or less at the wrist in postmenopausal women or in men aged 50 years and older (in addition to existing criteria of –2.5 or lower T scores at the lumbar spine, femoral neck, or total hip), he said in a presentation at the virtual annual Metabolic and Endocrine Disease Summit by Global Academy for Medical Education.

Other updated diagnostic criteria for osteoporosis include a low-trauma hip fracture regardless of bone mineral density, and a history of fracture of the pelvis or wrist in the context of osteopenia (in addition to the existing criteria of fracture of the vertebrae or proximal humerus).

When a diagnosis of osteoporosis is established, the Fracture Risk Assessment Tool calculator continues to serve as useful tool that allows clinicians to easily input patient data and obtain a projection of fracture risk, Mr. Pope said.

During a clinical visit, be sure to measure patients’ height, and look for kyphosis to help evaluate fall risk. Progressive kyphosis is important because the head weight can increase to 40 pounds if the kyphosis progresses to 30 degrees, and puts further stress on the vertebrae, he emphasized. In addition, looking at gait is important, especially for older patients, said Mr. Pope. “I want to get an assessment of how steady they are on their feet.”

Vertebral fracture assessment (VFA) is a useful strategy to evaluate the spine for silent compression fractures, especially in someone who has lost 1.5 inches in height or is on chronic steroids, Mr. Pope said. VFA has several advantages, including lower cost and lower radiation exposure than plain radiographs of the spine.

In addition, trabecular bone score (TBS) allows clinicians to evaluate bone microarchitecture, and this score can serve as an important indicator of fracture risk, Mr. Pope said.

As for treatment options, managing skeletal health in osteoporosis patients includes advising patients on healthy lifestyle practices that include not only adequate calcium and vitamin D, but also smoking cessation and a combination of weight-bearing, dynamic balance, and resistive exercises, he noted.

When considering medications, patient factors determine the most appropriate drug to use, Mr. Pope emphasized.

Bisphosphonates remain an option for treatment and have shown effectiveness at reducing fracture risk in postmenopausal women with osteoporosis, but concerns persist about side effects such as osteonecrosis of the jaw and atypical femoral fractures (AFF), he noted.

Reassure patients that AFF is more of an issue with long-term bisphosphonate use, Mr. Pope said, citing a 2012 study in which the risk of atypical femoral fracture was 1.78 per 100,000 person-years among individuals with 0.1-1.9 years of bisphosphonate exposure, but this jumped to 113 per 100,000 person-years among those with 8-9.9 years of bisphosphonate exposure.

“Eight years seems to be the sweet spot,” before a significant increase, he said. In his clinic, clinicians stop patients at about 8 years of bisphosphonate treatment, and then consider restarting.

However, nonbisphosphonate treatments are also available, including the monoclonal antibody denosumab. “It is different than bisphosphonates, and the effect wears off rapidly,” said Mr. Pope. Also, creatinine clearance is not an issue with denosumab. However, when patients have gone past the 10-year mark, should be switched to an alternative treatment because of an increased fracture risk at that point.

One relatively new treatment, abaloparatide, is currently indicated only for postmenopausal women with osteoporosis. Data have shown an 86% reduction in vertebral fracture risk, but the drug carries a black-box warning for osteosarcoma, said Mr. Pope.

Romosozumab, another newcomer drug, is indicated only for postmenopausal osteoporotic women at high risk for fracture with multiple risk factors who have failed other therapies. Romosozumab carries a black-box warning for cardiovascular risk for those with a history of MI or stroke. “This is a completely different mechanism of action” from other drugs, Mr. Pope said. The drug is given twice a month for a total of 12 months, and must be administered by a health professional in an office setting.

Mr. Pope had no financial conflicts to disclose. Global Academy for Medical Education and this news organization are owned by the same parent company.

Updated assessment and treatment options provide more tools to help clinicians manage osteoporosis and reduce fracture risk, according to Rick Pope, MPAS, PA-C.

iStock/Thinkstock

Criteria from the National Osteoporosis Foundation for the diagnosis of osteoporosis expanded in 2020 to include a T score measure of –2.5 or less at the wrist in postmenopausal women or in men aged 50 years and older (in addition to existing criteria of –2.5 or lower T scores at the lumbar spine, femoral neck, or total hip), he said in a presentation at the virtual annual Metabolic and Endocrine Disease Summit by Global Academy for Medical Education.

Other updated diagnostic criteria for osteoporosis include a low-trauma hip fracture regardless of bone mineral density, and a history of fracture of the pelvis or wrist in the context of osteopenia (in addition to the existing criteria of fracture of the vertebrae or proximal humerus).

When a diagnosis of osteoporosis is established, the Fracture Risk Assessment Tool calculator continues to serve as useful tool that allows clinicians to easily input patient data and obtain a projection of fracture risk, Mr. Pope said.

During a clinical visit, be sure to measure patients’ height, and look for kyphosis to help evaluate fall risk. Progressive kyphosis is important because the head weight can increase to 40 pounds if the kyphosis progresses to 30 degrees, and puts further stress on the vertebrae, he emphasized. In addition, looking at gait is important, especially for older patients, said Mr. Pope. “I want to get an assessment of how steady they are on their feet.”

Vertebral fracture assessment (VFA) is a useful strategy to evaluate the spine for silent compression fractures, especially in someone who has lost 1.5 inches in height or is on chronic steroids, Mr. Pope said. VFA has several advantages, including lower cost and lower radiation exposure than plain radiographs of the spine.

In addition, trabecular bone score (TBS) allows clinicians to evaluate bone microarchitecture, and this score can serve as an important indicator of fracture risk, Mr. Pope said.

As for treatment options, managing skeletal health in osteoporosis patients includes advising patients on healthy lifestyle practices that include not only adequate calcium and vitamin D, but also smoking cessation and a combination of weight-bearing, dynamic balance, and resistive exercises, he noted.

When considering medications, patient factors determine the most appropriate drug to use, Mr. Pope emphasized.

Bisphosphonates remain an option for treatment and have shown effectiveness at reducing fracture risk in postmenopausal women with osteoporosis, but concerns persist about side effects such as osteonecrosis of the jaw and atypical femoral fractures (AFF), he noted.

Reassure patients that AFF is more of an issue with long-term bisphosphonate use, Mr. Pope said, citing a 2012 study in which the risk of atypical femoral fracture was 1.78 per 100,000 person-years among individuals with 0.1-1.9 years of bisphosphonate exposure, but this jumped to 113 per 100,000 person-years among those with 8-9.9 years of bisphosphonate exposure.

“Eight years seems to be the sweet spot,” before a significant increase, he said. In his clinic, clinicians stop patients at about 8 years of bisphosphonate treatment, and then consider restarting.

However, nonbisphosphonate treatments are also available, including the monoclonal antibody denosumab. “It is different than bisphosphonates, and the effect wears off rapidly,” said Mr. Pope. Also, creatinine clearance is not an issue with denosumab. However, when patients have gone past the 10-year mark, should be switched to an alternative treatment because of an increased fracture risk at that point.

One relatively new treatment, abaloparatide, is currently indicated only for postmenopausal women with osteoporosis. Data have shown an 86% reduction in vertebral fracture risk, but the drug carries a black-box warning for osteosarcoma, said Mr. Pope.

Romosozumab, another newcomer drug, is indicated only for postmenopausal osteoporotic women at high risk for fracture with multiple risk factors who have failed other therapies. Romosozumab carries a black-box warning for cardiovascular risk for those with a history of MI or stroke. “This is a completely different mechanism of action” from other drugs, Mr. Pope said. The drug is given twice a month for a total of 12 months, and must be administered by a health professional in an office setting.

Mr. Pope had no financial conflicts to disclose. Global Academy for Medical Education and this news organization are owned by the same parent company.

Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.

“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.

In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.

The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).

Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).

Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.

The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.

However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.

Additional studies are needed to validate and examine the clinical significance of the results, they concluded.

“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”

She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.

While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.

“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.

The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
 

SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.

Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.

“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.

In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.

The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).

Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).

Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.

The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.

However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.

Additional studies are needed to validate and examine the clinical significance of the results, they concluded.

“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”

She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.

While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.

“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.

The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
 

SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.

Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.

“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.

In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.

The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).

Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).

Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.

The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.

However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.

Additional studies are needed to validate and examine the clinical significance of the results, they concluded.

“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”

She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.

While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.

“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.

The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
 

SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.

A mini-sponge tamponade device controlled postpartum hemorrhage within 1 minute of placement, according to data from a study of nine women.

Postpartum hemorrhage remains a leading cause of maternal deaths worldwide; however, “nearly all of these deaths could be prevented by timely and appropriate management,” wrote Maria I. Rodriguez, MD, of Oregon Health & Science University, Portland, and colleagues. Other strategies including use of sterile gauze, inflated Foley catheters, condom catheters, and silicone obstetric balloons, have been tried in the management of postpartum hemorrhage, but are not ideal, the researchers said.

The investigators adapted a mini-sponge device originally designed for trauma and conducted a study of a prototype between May 20 and June 12, 2019, at a single site in Zambia.

“To adapt the mini-sponge device for use in the treatment of postpartum hemorrhage, we developed an obstetric applicator for transcervical placement using a digital vaginal route,” the researchers explained. The sponges are made of the same material used in standard surgical sponges and approved for use inside the uterus and vagina, they added.

In a study published in Obstetrics & Gynecology, the investigators assessed placement, removal, and preliminary efficacy of the device. Eligible patients were women aged 16 years and older who experienced postpartum hemorrhage with an estimated blood loss of 500 mL or more because of atony after vaginal delivery.

The device was successfully placed in nine patients, and bleeding resolved within 1 minute. “For all participants, bleeding stopped in less than 1 minute, did not recur, and required no further treatment,” the researchers said.

The average time to device placement was 62 seconds. The sponges were left in place from 0.5 hours to 14 hours with an average of 1 hour, and patients were monitored with physical, visual, and ultrasound to confirm the cessation of bleeding.
 

Evidence of safety

No device-related adverse events were reported, and patients remained afebrile while using the device. The average age of the patients was 29 years; three had a history of anemia and four were living with HIV. One patient received a blood transfusion during labor prior to hemorrhage.

The study findings were limited by the small sample size, the low threshold for diagnosing postpartum hemorrhage, and use of estimated blood loss, which is less precise than quantitative blood loss assessment, the researchers noted. However, the results support the use of the mini-sponge tamponade to treat atonic postpartum hemorrhage, they said.

“This device is being developed to offer a low-cost, easy-to-use product that is of similar or greater efficacy than the condom uterine balloon tamponade,” needs no electricity, and could be used in low-resource areas, they said.

A larger study comparing the sponge and condom uterine balloon tamponade is planned.

“Future studies will include a larger number of participants with quantitative blood loss assessment to determine the device’s effect in managing more patients with severe postpartum hemorrhage,” the investigators noted.
 

Rigorous research needed

“Uterine atony is too often disastrous, and new safe and effective treatments for it would be welcome,” Dwight J. Rouse, MD, associate editor of obstetrics for Obstetrics & Gynecology, wrote in an accompanying editorial.

The current balloon tamponade used to treat postpartum hemorrhage can be difficult to place and require ongoing monitoring, he said.

Although the mini-sponge device showed promise, the study was not randomized or controlled, thus lacking in evidence of effectiveness, said Dr. Rouse.

“We simply know that the participants had the devices placed and most of them stopped bleeding,” he said.

The mechanism of action is sound, but more research is needed, especially in light of other examples of new technologies, such as adhesion barriers and negative pressure wound dressing systems after cesarean deliveries, that “made sense in the abstract but failed to improve outcomes when evaluated in proper randomized trials,” Dr. Rouse noted.

“Absent such trials, we will never really know the relative value of any device to treat uterine atony refractory to medical management,” he said.

Lead author Dr. Rodriguez disclosed that her institution received funding from OBSTETRX, which funded the study, as well as the National Institutes of Health and Merck. Dr. Rodriguez disclosed funding from Bayer, while Dr. Rouse had no financial conflicts to disclose.

SOURCE: Rodriguez MI et al. Obstet Gynecol. 2020 Oct 8. doi: 10.1097/AOG.0000000000004135.

A mini-sponge tamponade device controlled postpartum hemorrhage within 1 minute of placement, according to data from a study of nine women.

Postpartum hemorrhage remains a leading cause of maternal deaths worldwide; however, “nearly all of these deaths could be prevented by timely and appropriate management,” wrote Maria I. Rodriguez, MD, of Oregon Health & Science University, Portland, and colleagues. Other strategies including use of sterile gauze, inflated Foley catheters, condom catheters, and silicone obstetric balloons, have been tried in the management of postpartum hemorrhage, but are not ideal, the researchers said.

The investigators adapted a mini-sponge device originally designed for trauma and conducted a study of a prototype between May 20 and June 12, 2019, at a single site in Zambia.

“To adapt the mini-sponge device for use in the treatment of postpartum hemorrhage, we developed an obstetric applicator for transcervical placement using a digital vaginal route,” the researchers explained. The sponges are made of the same material used in standard surgical sponges and approved for use inside the uterus and vagina, they added.

In a study published in Obstetrics & Gynecology, the investigators assessed placement, removal, and preliminary efficacy of the device. Eligible patients were women aged 16 years and older who experienced postpartum hemorrhage with an estimated blood loss of 500 mL or more because of atony after vaginal delivery.

The device was successfully placed in nine patients, and bleeding resolved within 1 minute. “For all participants, bleeding stopped in less than 1 minute, did not recur, and required no further treatment,” the researchers said.

The average time to device placement was 62 seconds. The sponges were left in place from 0.5 hours to 14 hours with an average of 1 hour, and patients were monitored with physical, visual, and ultrasound to confirm the cessation of bleeding.
 

Evidence of safety

No device-related adverse events were reported, and patients remained afebrile while using the device. The average age of the patients was 29 years; three had a history of anemia and four were living with HIV. One patient received a blood transfusion during labor prior to hemorrhage.

The study findings were limited by the small sample size, the low threshold for diagnosing postpartum hemorrhage, and use of estimated blood loss, which is less precise than quantitative blood loss assessment, the researchers noted. However, the results support the use of the mini-sponge tamponade to treat atonic postpartum hemorrhage, they said.

“This device is being developed to offer a low-cost, easy-to-use product that is of similar or greater efficacy than the condom uterine balloon tamponade,” needs no electricity, and could be used in low-resource areas, they said.

A larger study comparing the sponge and condom uterine balloon tamponade is planned.

“Future studies will include a larger number of participants with quantitative blood loss assessment to determine the device’s effect in managing more patients with severe postpartum hemorrhage,” the investigators noted.
 

Rigorous research needed

“Uterine atony is too often disastrous, and new safe and effective treatments for it would be welcome,” Dwight J. Rouse, MD, associate editor of obstetrics for Obstetrics & Gynecology, wrote in an accompanying editorial.

The current balloon tamponade used to treat postpartum hemorrhage can be difficult to place and require ongoing monitoring, he said.

Although the mini-sponge device showed promise, the study was not randomized or controlled, thus lacking in evidence of effectiveness, said Dr. Rouse.

“We simply know that the participants had the devices placed and most of them stopped bleeding,” he said.

The mechanism of action is sound, but more research is needed, especially in light of other examples of new technologies, such as adhesion barriers and negative pressure wound dressing systems after cesarean deliveries, that “made sense in the abstract but failed to improve outcomes when evaluated in proper randomized trials,” Dr. Rouse noted.

“Absent such trials, we will never really know the relative value of any device to treat uterine atony refractory to medical management,” he said.

Lead author Dr. Rodriguez disclosed that her institution received funding from OBSTETRX, which funded the study, as well as the National Institutes of Health and Merck. Dr. Rodriguez disclosed funding from Bayer, while Dr. Rouse had no financial conflicts to disclose.

SOURCE: Rodriguez MI et al. Obstet Gynecol. 2020 Oct 8. doi: 10.1097/AOG.0000000000004135.

A mini-sponge tamponade device controlled postpartum hemorrhage within 1 minute of placement, according to data from a study of nine women.

Postpartum hemorrhage remains a leading cause of maternal deaths worldwide; however, “nearly all of these deaths could be prevented by timely and appropriate management,” wrote Maria I. Rodriguez, MD, of Oregon Health & Science University, Portland, and colleagues. Other strategies including use of sterile gauze, inflated Foley catheters, condom catheters, and silicone obstetric balloons, have been tried in the management of postpartum hemorrhage, but are not ideal, the researchers said.

The investigators adapted a mini-sponge device originally designed for trauma and conducted a study of a prototype between May 20 and June 12, 2019, at a single site in Zambia.

“To adapt the mini-sponge device for use in the treatment of postpartum hemorrhage, we developed an obstetric applicator for transcervical placement using a digital vaginal route,” the researchers explained. The sponges are made of the same material used in standard surgical sponges and approved for use inside the uterus and vagina, they added.

In a study published in Obstetrics & Gynecology, the investigators assessed placement, removal, and preliminary efficacy of the device. Eligible patients were women aged 16 years and older who experienced postpartum hemorrhage with an estimated blood loss of 500 mL or more because of atony after vaginal delivery.

The device was successfully placed in nine patients, and bleeding resolved within 1 minute. “For all participants, bleeding stopped in less than 1 minute, did not recur, and required no further treatment,” the researchers said.

The average time to device placement was 62 seconds. The sponges were left in place from 0.5 hours to 14 hours with an average of 1 hour, and patients were monitored with physical, visual, and ultrasound to confirm the cessation of bleeding.
 

Evidence of safety

No device-related adverse events were reported, and patients remained afebrile while using the device. The average age of the patients was 29 years; three had a history of anemia and four were living with HIV. One patient received a blood transfusion during labor prior to hemorrhage.

The study findings were limited by the small sample size, the low threshold for diagnosing postpartum hemorrhage, and use of estimated blood loss, which is less precise than quantitative blood loss assessment, the researchers noted. However, the results support the use of the mini-sponge tamponade to treat atonic postpartum hemorrhage, they said.

“This device is being developed to offer a low-cost, easy-to-use product that is of similar or greater efficacy than the condom uterine balloon tamponade,” needs no electricity, and could be used in low-resource areas, they said.

A larger study comparing the sponge and condom uterine balloon tamponade is planned.

“Future studies will include a larger number of participants with quantitative blood loss assessment to determine the device’s effect in managing more patients with severe postpartum hemorrhage,” the investigators noted.
 

Rigorous research needed

“Uterine atony is too often disastrous, and new safe and effective treatments for it would be welcome,” Dwight J. Rouse, MD, associate editor of obstetrics for Obstetrics & Gynecology, wrote in an accompanying editorial.

The current balloon tamponade used to treat postpartum hemorrhage can be difficult to place and require ongoing monitoring, he said.

Although the mini-sponge device showed promise, the study was not randomized or controlled, thus lacking in evidence of effectiveness, said Dr. Rouse.

“We simply know that the participants had the devices placed and most of them stopped bleeding,” he said.

The mechanism of action is sound, but more research is needed, especially in light of other examples of new technologies, such as adhesion barriers and negative pressure wound dressing systems after cesarean deliveries, that “made sense in the abstract but failed to improve outcomes when evaluated in proper randomized trials,” Dr. Rouse noted.

“Absent such trials, we will never really know the relative value of any device to treat uterine atony refractory to medical management,” he said.

Lead author Dr. Rodriguez disclosed that her institution received funding from OBSTETRX, which funded the study, as well as the National Institutes of Health and Merck. Dr. Rodriguez disclosed funding from Bayer, while Dr. Rouse had no financial conflicts to disclose.

SOURCE: Rodriguez MI et al. Obstet Gynecol. 2020 Oct 8. doi: 10.1097/AOG.0000000000004135.

Women account for approximately 78% of the pediatric dermatology workforce, and continue to gain influence through increased numbers of leadership positions and published research, based on data from a review of professional society leaders, grant recipients, and annual meeting presenters from 2010 to 2019.

“Despite extensive research on gender equality in general dermatology, studies have yet to explore the evolving representation of women as leaders and researchers in pediatric dermatology, a field where the majority of board-certified physicians are women,” wrote Catherine Baker, MD, and colleagues. Dr. Baker was a medical student at Geisel School of Medicine at Dartmouth, Hanover, N.H., at the time of the study and is now a resident physician at Brigham and Women’s Hospital, Boston.

In a study published in Pediatric Dermatology, the researchers reviewed data on society leadership, research grants, and annual meeting speakers in order to evaluate the impact of women in pediatric dermatology.

Overall, the Society for Pediatric Dermatology has had 20 women presidents since its founding in 1975 (45%), and 7 of the last 10 since 2011 have been women (70%). The Pediatric Dermatology Research Alliance, founded in 2013, has two cochairs each year, and 75% have been women.

The percentage of women as lead authors of published research in pediatric dermatology increased significantly from 1983 to 2019; 71% of first authors and 65% of senior authors of papers in the journal Pediatric Dermatology in 2019 were women.

In addition, 26 of the 31 physicians (84%) who received SPD/PeDRA pilot project awards between 2008 and 2018 were women, as were 88% of SPD/PeDRA team/collaborative grant winners from 2016 to 2018.

However, named lectures at annual meetings remain an area in which women are underrepresented, the researchers wrote. Although women have been well represented at PeDRA meetings, accounting for 65% of plenary speakers, but they accounted for less than half (44%) of Hurwitz and Founders’ lectures at SPD annual meetings from 2010 to 2019.

The study findings were limited by a lack of data on nonbinary genders and the possibility of error in assessing gender based on name and online profiles, the researchers noted. However, the results suggest that women have increased their influence in pediatric dermatology through leadership and research, although a gender gap persists in roles as senior authors and named lecturers at meetings, they wrote.

Overall, “we expect increasing gender equity in these positions as women continue to play important roles as leaders and researchers in pediatric dermatology,” the researchers concluded.

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

SOURCE: Baker C et al. Pediatr Dermatol. 2020 Jul 9. doi: 10.1111/pde.14266.

Women account for approximately 78% of the pediatric dermatology workforce, and continue to gain influence through increased numbers of leadership positions and published research, based on data from a review of professional society leaders, grant recipients, and annual meeting presenters from 2010 to 2019.

“Despite extensive research on gender equality in general dermatology, studies have yet to explore the evolving representation of women as leaders and researchers in pediatric dermatology, a field where the majority of board-certified physicians are women,” wrote Catherine Baker, MD, and colleagues. Dr. Baker was a medical student at Geisel School of Medicine at Dartmouth, Hanover, N.H., at the time of the study and is now a resident physician at Brigham and Women’s Hospital, Boston.

In a study published in Pediatric Dermatology, the researchers reviewed data on society leadership, research grants, and annual meeting speakers in order to evaluate the impact of women in pediatric dermatology.

Overall, the Society for Pediatric Dermatology has had 20 women presidents since its founding in 1975 (45%), and 7 of the last 10 since 2011 have been women (70%). The Pediatric Dermatology Research Alliance, founded in 2013, has two cochairs each year, and 75% have been women.

The percentage of women as lead authors of published research in pediatric dermatology increased significantly from 1983 to 2019; 71% of first authors and 65% of senior authors of papers in the journal Pediatric Dermatology in 2019 were women.

In addition, 26 of the 31 physicians (84%) who received SPD/PeDRA pilot project awards between 2008 and 2018 were women, as were 88% of SPD/PeDRA team/collaborative grant winners from 2016 to 2018.

However, named lectures at annual meetings remain an area in which women are underrepresented, the researchers wrote. Although women have been well represented at PeDRA meetings, accounting for 65% of plenary speakers, but they accounted for less than half (44%) of Hurwitz and Founders’ lectures at SPD annual meetings from 2010 to 2019.

The study findings were limited by a lack of data on nonbinary genders and the possibility of error in assessing gender based on name and online profiles, the researchers noted. However, the results suggest that women have increased their influence in pediatric dermatology through leadership and research, although a gender gap persists in roles as senior authors and named lecturers at meetings, they wrote.

Overall, “we expect increasing gender equity in these positions as women continue to play important roles as leaders and researchers in pediatric dermatology,” the researchers concluded.

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

SOURCE: Baker C et al. Pediatr Dermatol. 2020 Jul 9. doi: 10.1111/pde.14266.

Women account for approximately 78% of the pediatric dermatology workforce, and continue to gain influence through increased numbers of leadership positions and published research, based on data from a review of professional society leaders, grant recipients, and annual meeting presenters from 2010 to 2019.

“Despite extensive research on gender equality in general dermatology, studies have yet to explore the evolving representation of women as leaders and researchers in pediatric dermatology, a field where the majority of board-certified physicians are women,” wrote Catherine Baker, MD, and colleagues. Dr. Baker was a medical student at Geisel School of Medicine at Dartmouth, Hanover, N.H., at the time of the study and is now a resident physician at Brigham and Women’s Hospital, Boston.

In a study published in Pediatric Dermatology, the researchers reviewed data on society leadership, research grants, and annual meeting speakers in order to evaluate the impact of women in pediatric dermatology.

Overall, the Society for Pediatric Dermatology has had 20 women presidents since its founding in 1975 (45%), and 7 of the last 10 since 2011 have been women (70%). The Pediatric Dermatology Research Alliance, founded in 2013, has two cochairs each year, and 75% have been women.

The percentage of women as lead authors of published research in pediatric dermatology increased significantly from 1983 to 2019; 71% of first authors and 65% of senior authors of papers in the journal Pediatric Dermatology in 2019 were women.

In addition, 26 of the 31 physicians (84%) who received SPD/PeDRA pilot project awards between 2008 and 2018 were women, as were 88% of SPD/PeDRA team/collaborative grant winners from 2016 to 2018.

However, named lectures at annual meetings remain an area in which women are underrepresented, the researchers wrote. Although women have been well represented at PeDRA meetings, accounting for 65% of plenary speakers, but they accounted for less than half (44%) of Hurwitz and Founders’ lectures at SPD annual meetings from 2010 to 2019.

The study findings were limited by a lack of data on nonbinary genders and the possibility of error in assessing gender based on name and online profiles, the researchers noted. However, the results suggest that women have increased their influence in pediatric dermatology through leadership and research, although a gender gap persists in roles as senior authors and named lecturers at meetings, they wrote.

Overall, “we expect increasing gender equity in these positions as women continue to play important roles as leaders and researchers in pediatric dermatology,” the researchers concluded.

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

SOURCE: Baker C et al. Pediatr Dermatol. 2020 Jul 9. doi: 10.1111/pde.14266.

Linked color imaging, a novel endoscopy technique, was significantly more effective than white-light imaging in identifying neoplastic lesions in the upper gastrointestinal tract, based on data from a randomized trial of 1,502 adults with previous or current gastrointestinal cancers.

Linked color imaging (LCI) allows users to detect neoplastic lesions by recognizing subtle differences in mucosal color, wrote Shoko Ono, MD, of Hokkaido University Hospital, Sapporo, Japan, and colleagues.

“Since the recent launch of image-enhanced endoscopy, many studies have evaluated its efficacy in diagnosing upper GI neoplasms as well,” the researchers wrote. However, “most have focused on the evaluation of histologic diagnosis, whereas few have focused on neoplasm detection.”

In a study published in Annals of Internal Medicine, the researchers randomized 750 patients to the LCI group and 752 to a white light–imaging (WLI) group. LCI patients underwent LCI followed by WLI; WLI patients underwent WLI followed by LCI. The primary outcome was a diagnosis of one or more neoplastic lesions in the pharynx, esophagus, or stomach during the first examination.
 

LCI identifies more lesions on first exam

Overall, 60 patients in the LCI group met the primary outcome, compared with 36 patients in the WLI group (8.0% vs. 4.8%, P = .011).

As a secondary endpoint, the researchers assessed the percentage of patients with one or more neoplastic lesions identified in the second examination, but not in the first. The number of overlooked lesions was significantly lower in the LCI group, compared with the WLI group (5 patients, 0.67% vs. 26 patients, 3.5%).

The patients were aged 20-89 years and had previous or current cancer of the pharynx, esophagus, stomach, or large intestine, and were therefore considered at high risk for upper GI tract tumors.

The study findings were limited by the lack of blinding of the endoscopists and the inclusion only of high-risk patients, meaning that the results might not be generalizable to general clinicians and an average-risk population, the researchers noted. “However, LCI images resemble those obtained by conventional WLI. Thus, LCI can be expected to provide efficacy similar to that of conventional white light endoscopy even if general clinicians were to use LCI for cancer screening in an average population.”
 

White light misses lesions

“Our manuscript provides very important messages regarding endoscopic modality for upper GI cancer screening,” corresponding author Mototsugo Kato, MD, of National Hospital Organization Hakodate (Japan) National Hospital, said in an interview. LCI can reduce the number of missed neoplastic lesions when screening patients for upper GI cancer.

In the current study, “white-light imaging missed about 40% of neoplastic lesions. On the other hand, LCI observation missed only 7% of neoplastic lesions. LCI emphasizes the difference in color to make it easier to detect neoplastic lesions,” he emphasized.

“This randomized clinical study demonstrated that LCI can detect neoplastic lesions in the upper GI tract (pharynx, esophagus, and stomach) 1.67 times more frequently than WLI,” said Dr. Kato. “This result indicates that many neoplastic lesions are being overlooked by conventional white light endoscopy performed in routine clinical practice.” There are no particular disadvantages to using LCI over WLI.

As for additional research, “The experts in upper GI endoscopy performed the examinations on populations at high risk for neoplasms in the pharynx, esophagus, or stomach,” Dr. Kato said. “It is unclear whether these examinations, if performed by general clinicians on an average population, would yield results similar to those obtained by the highly experienced endoscopists in this study.”
 

Randomized data are promising, more studies needed

“LCI and other virtual chromoendoscopy technologies have been shown to enhance detection of neoplastic lesions in a number of smaller studies,” said Ziad F. Gellad, MD, of Duke University Medical Center, Durham, N.C., in an interview.

The current study is important because it represents a well-designed randomized, controlled trial to better understand the efficacy of LCI as compared with standard imaging techniques. “This level of scientific rigor is needed to advance the field,” he said.

Dr. Gellad said that the findings are consistent with preliminary data from LCI studies. “In the hands of expert endoscopists who are familiar with the technology, I am not surprised with the results,” which are consistent with other studies of advanced imaging techniques.

“There are two main barriers to use of LCI in clinical practice. The biggest barrier to use of LCI in clinical practice is whether the efficacy seen in expert hands translates when used by a broader group of endoscopists. Obviously, the use of this technology would also require endoscopists to use the Fujinon equipment used in the study. Another barrier is whether the findings will hold in a population that has not been selected for high risk of neoplastic lesions as was the group in this study,” he added.

“Additional research is needed to see whether the efficacy of LCI holds up in the hands of nonexpert endoscopists,” Dr. Gellad emphasized. “Furthermore, clarifying the indications where this technology is appropriate will also be critically important to broader use.”

“Missed neoplasia and dysplasia during cancer surveillance programs among patients with Barrett’s esophagus and gastric intestinal metaplasia remains a concern,” said Avinash Ketwaroo, MD, of Baylor College of Medicine, Houston, in an interview. “Endoscopists await further advances in endoscopic imaging characteristics such as spatial resolution and contrast enhancement that can help improve neoplasia detection.” Given the improvement with narrow-band imaging (NBI) over WLI, Dr. Ketwaroo said he was not surprised that other enhanced imaging modalities such as LCI would be superior to WLI.

However, potential barriers to the clinical adoption of LCI include equipment costs and training time, and the consideration of whether LCI is superior enough to NBI to justify the cost of equipment, Dr. Ketwaroo noted.

“Additionally, our patient population and indications for neoplasia/dysplasia surveillance are different than those described in the study,” he said. Therefore, additional research is needed to compare LCI with NBI, “especially in the context of surveillance programs common in the West (esophageal cancer/Barrett’s esophagus).” .

The study was sponsored by Fujifilm. Lead author Dr. Ono had no financial conflicts to disclose. Dr. Kato disclosed speaking and teaching commitments for Takeda Pharmaceutical and Otsuka Pharmaceutical, and has received scholarship grants from Fujifilm. Dr. Gellad and Dr. Ketwaroo had no disclosures but both serve on the editorial advisory board of GI & Hepatology News.

SOURCE: Ono S et al. Ann Intern Med. 2020 Oct 19. doi: 10.7326/M19-2561.

Linked color imaging, a novel endoscopy technique, was significantly more effective than white-light imaging in identifying neoplastic lesions in the upper gastrointestinal tract, based on data from a randomized trial of 1,502 adults with previous or current gastrointestinal cancers.

Linked color imaging (LCI) allows users to detect neoplastic lesions by recognizing subtle differences in mucosal color, wrote Shoko Ono, MD, of Hokkaido University Hospital, Sapporo, Japan, and colleagues.

“Since the recent launch of image-enhanced endoscopy, many studies have evaluated its efficacy in diagnosing upper GI neoplasms as well,” the researchers wrote. However, “most have focused on the evaluation of histologic diagnosis, whereas few have focused on neoplasm detection.”

In a study published in Annals of Internal Medicine, the researchers randomized 750 patients to the LCI group and 752 to a white light–imaging (WLI) group. LCI patients underwent LCI followed by WLI; WLI patients underwent WLI followed by LCI. The primary outcome was a diagnosis of one or more neoplastic lesions in the pharynx, esophagus, or stomach during the first examination.
 

LCI identifies more lesions on first exam

Overall, 60 patients in the LCI group met the primary outcome, compared with 36 patients in the WLI group (8.0% vs. 4.8%, P = .011).

As a secondary endpoint, the researchers assessed the percentage of patients with one or more neoplastic lesions identified in the second examination, but not in the first. The number of overlooked lesions was significantly lower in the LCI group, compared with the WLI group (5 patients, 0.67% vs. 26 patients, 3.5%).

The patients were aged 20-89 years and had previous or current cancer of the pharynx, esophagus, stomach, or large intestine, and were therefore considered at high risk for upper GI tract tumors.

The study findings were limited by the lack of blinding of the endoscopists and the inclusion only of high-risk patients, meaning that the results might not be generalizable to general clinicians and an average-risk population, the researchers noted. “However, LCI images resemble those obtained by conventional WLI. Thus, LCI can be expected to provide efficacy similar to that of conventional white light endoscopy even if general clinicians were to use LCI for cancer screening in an average population.”
 

White light misses lesions

“Our manuscript provides very important messages regarding endoscopic modality for upper GI cancer screening,” corresponding author Mototsugo Kato, MD, of National Hospital Organization Hakodate (Japan) National Hospital, said in an interview. LCI can reduce the number of missed neoplastic lesions when screening patients for upper GI cancer.

In the current study, “white-light imaging missed about 40% of neoplastic lesions. On the other hand, LCI observation missed only 7% of neoplastic lesions. LCI emphasizes the difference in color to make it easier to detect neoplastic lesions,” he emphasized.

“This randomized clinical study demonstrated that LCI can detect neoplastic lesions in the upper GI tract (pharynx, esophagus, and stomach) 1.67 times more frequently than WLI,” said Dr. Kato. “This result indicates that many neoplastic lesions are being overlooked by conventional white light endoscopy performed in routine clinical practice.” There are no particular disadvantages to using LCI over WLI.

As for additional research, “The experts in upper GI endoscopy performed the examinations on populations at high risk for neoplasms in the pharynx, esophagus, or stomach,” Dr. Kato said. “It is unclear whether these examinations, if performed by general clinicians on an average population, would yield results similar to those obtained by the highly experienced endoscopists in this study.”
 

Randomized data are promising, more studies needed

“LCI and other virtual chromoendoscopy technologies have been shown to enhance detection of neoplastic lesions in a number of smaller studies,” said Ziad F. Gellad, MD, of Duke University Medical Center, Durham, N.C., in an interview.

The current study is important because it represents a well-designed randomized, controlled trial to better understand the efficacy of LCI as compared with standard imaging techniques. “This level of scientific rigor is needed to advance the field,” he said.

Dr. Gellad said that the findings are consistent with preliminary data from LCI studies. “In the hands of expert endoscopists who are familiar with the technology, I am not surprised with the results,” which are consistent with other studies of advanced imaging techniques.

“There are two main barriers to use of LCI in clinical practice. The biggest barrier to use of LCI in clinical practice is whether the efficacy seen in expert hands translates when used by a broader group of endoscopists. Obviously, the use of this technology would also require endoscopists to use the Fujinon equipment used in the study. Another barrier is whether the findings will hold in a population that has not been selected for high risk of neoplastic lesions as was the group in this study,” he added.

“Additional research is needed to see whether the efficacy of LCI holds up in the hands of nonexpert endoscopists,” Dr. Gellad emphasized. “Furthermore, clarifying the indications where this technology is appropriate will also be critically important to broader use.”

“Missed neoplasia and dysplasia during cancer surveillance programs among patients with Barrett’s esophagus and gastric intestinal metaplasia remains a concern,” said Avinash Ketwaroo, MD, of Baylor College of Medicine, Houston, in an interview. “Endoscopists await further advances in endoscopic imaging characteristics such as spatial resolution and contrast enhancement that can help improve neoplasia detection.” Given the improvement with narrow-band imaging (NBI) over WLI, Dr. Ketwaroo said he was not surprised that other enhanced imaging modalities such as LCI would be superior to WLI.

However, potential barriers to the clinical adoption of LCI include equipment costs and training time, and the consideration of whether LCI is superior enough to NBI to justify the cost of equipment, Dr. Ketwaroo noted.

“Additionally, our patient population and indications for neoplasia/dysplasia surveillance are different than those described in the study,” he said. Therefore, additional research is needed to compare LCI with NBI, “especially in the context of surveillance programs common in the West (esophageal cancer/Barrett’s esophagus).” .

The study was sponsored by Fujifilm. Lead author Dr. Ono had no financial conflicts to disclose. Dr. Kato disclosed speaking and teaching commitments for Takeda Pharmaceutical and Otsuka Pharmaceutical, and has received scholarship grants from Fujifilm. Dr. Gellad and Dr. Ketwaroo had no disclosures but both serve on the editorial advisory board of GI & Hepatology News.

SOURCE: Ono S et al. Ann Intern Med. 2020 Oct 19. doi: 10.7326/M19-2561.

Linked color imaging, a novel endoscopy technique, was significantly more effective than white-light imaging in identifying neoplastic lesions in the upper gastrointestinal tract, based on data from a randomized trial of 1,502 adults with previous or current gastrointestinal cancers.

Linked color imaging (LCI) allows users to detect neoplastic lesions by recognizing subtle differences in mucosal color, wrote Shoko Ono, MD, of Hokkaido University Hospital, Sapporo, Japan, and colleagues.

“Since the recent launch of image-enhanced endoscopy, many studies have evaluated its efficacy in diagnosing upper GI neoplasms as well,” the researchers wrote. However, “most have focused on the evaluation of histologic diagnosis, whereas few have focused on neoplasm detection.”

In a study published in Annals of Internal Medicine, the researchers randomized 750 patients to the LCI group and 752 to a white light–imaging (WLI) group. LCI patients underwent LCI followed by WLI; WLI patients underwent WLI followed by LCI. The primary outcome was a diagnosis of one or more neoplastic lesions in the pharynx, esophagus, or stomach during the first examination.
 

LCI identifies more lesions on first exam

Overall, 60 patients in the LCI group met the primary outcome, compared with 36 patients in the WLI group (8.0% vs. 4.8%, P = .011).

As a secondary endpoint, the researchers assessed the percentage of patients with one or more neoplastic lesions identified in the second examination, but not in the first. The number of overlooked lesions was significantly lower in the LCI group, compared with the WLI group (5 patients, 0.67% vs. 26 patients, 3.5%).

The patients were aged 20-89 years and had previous or current cancer of the pharynx, esophagus, stomach, or large intestine, and were therefore considered at high risk for upper GI tract tumors.

The study findings were limited by the lack of blinding of the endoscopists and the inclusion only of high-risk patients, meaning that the results might not be generalizable to general clinicians and an average-risk population, the researchers noted. “However, LCI images resemble those obtained by conventional WLI. Thus, LCI can be expected to provide efficacy similar to that of conventional white light endoscopy even if general clinicians were to use LCI for cancer screening in an average population.”
 

White light misses lesions

“Our manuscript provides very important messages regarding endoscopic modality for upper GI cancer screening,” corresponding author Mototsugo Kato, MD, of National Hospital Organization Hakodate (Japan) National Hospital, said in an interview. LCI can reduce the number of missed neoplastic lesions when screening patients for upper GI cancer.

In the current study, “white-light imaging missed about 40% of neoplastic lesions. On the other hand, LCI observation missed only 7% of neoplastic lesions. LCI emphasizes the difference in color to make it easier to detect neoplastic lesions,” he emphasized.

“This randomized clinical study demonstrated that LCI can detect neoplastic lesions in the upper GI tract (pharynx, esophagus, and stomach) 1.67 times more frequently than WLI,” said Dr. Kato. “This result indicates that many neoplastic lesions are being overlooked by conventional white light endoscopy performed in routine clinical practice.” There are no particular disadvantages to using LCI over WLI.

As for additional research, “The experts in upper GI endoscopy performed the examinations on populations at high risk for neoplasms in the pharynx, esophagus, or stomach,” Dr. Kato said. “It is unclear whether these examinations, if performed by general clinicians on an average population, would yield results similar to those obtained by the highly experienced endoscopists in this study.”
 

Randomized data are promising, more studies needed

“LCI and other virtual chromoendoscopy technologies have been shown to enhance detection of neoplastic lesions in a number of smaller studies,” said Ziad F. Gellad, MD, of Duke University Medical Center, Durham, N.C., in an interview.

The current study is important because it represents a well-designed randomized, controlled trial to better understand the efficacy of LCI as compared with standard imaging techniques. “This level of scientific rigor is needed to advance the field,” he said.

Dr. Gellad said that the findings are consistent with preliminary data from LCI studies. “In the hands of expert endoscopists who are familiar with the technology, I am not surprised with the results,” which are consistent with other studies of advanced imaging techniques.

“There are two main barriers to use of LCI in clinical practice. The biggest barrier to use of LCI in clinical practice is whether the efficacy seen in expert hands translates when used by a broader group of endoscopists. Obviously, the use of this technology would also require endoscopists to use the Fujinon equipment used in the study. Another barrier is whether the findings will hold in a population that has not been selected for high risk of neoplastic lesions as was the group in this study,” he added.

“Additional research is needed to see whether the efficacy of LCI holds up in the hands of nonexpert endoscopists,” Dr. Gellad emphasized. “Furthermore, clarifying the indications where this technology is appropriate will also be critically important to broader use.”

“Missed neoplasia and dysplasia during cancer surveillance programs among patients with Barrett’s esophagus and gastric intestinal metaplasia remains a concern,” said Avinash Ketwaroo, MD, of Baylor College of Medicine, Houston, in an interview. “Endoscopists await further advances in endoscopic imaging characteristics such as spatial resolution and contrast enhancement that can help improve neoplasia detection.” Given the improvement with narrow-band imaging (NBI) over WLI, Dr. Ketwaroo said he was not surprised that other enhanced imaging modalities such as LCI would be superior to WLI.

However, potential barriers to the clinical adoption of LCI include equipment costs and training time, and the consideration of whether LCI is superior enough to NBI to justify the cost of equipment, Dr. Ketwaroo noted.

“Additionally, our patient population and indications for neoplasia/dysplasia surveillance are different than those described in the study,” he said. Therefore, additional research is needed to compare LCI with NBI, “especially in the context of surveillance programs common in the West (esophageal cancer/Barrett’s esophagus).” .

The study was sponsored by Fujifilm. Lead author Dr. Ono had no financial conflicts to disclose. Dr. Kato disclosed speaking and teaching commitments for Takeda Pharmaceutical and Otsuka Pharmaceutical, and has received scholarship grants from Fujifilm. Dr. Gellad and Dr. Ketwaroo had no disclosures but both serve on the editorial advisory board of GI & Hepatology News.

SOURCE: Ono S et al. Ann Intern Med. 2020 Oct 19. doi: 10.7326/M19-2561.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

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

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

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

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Black women living with HIV are a high-risk population for peripartum depressive symptoms, based on data from 143 women.

Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.

Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.

In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.

Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
 

Social factors show significant impact

In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.

The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.

The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
 

Quantitative studies needed

Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.

The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.

“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.

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

SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.

Adults with active psoriatic arthritis (PsA) treated with guselkumab (Tremfya) showed significant improvement in American College of Rheumatology response criteria and disease activity after 1 year, based on data from the phase 3 DISCOVER-2 trial.

The findings, published in Arthritis & Rheumatology, extend the previously published 24-week, primary endpoint results of the trial, which tested guselkumab for adults with PsA who had not previously taken a biologic drug. Guselkumab was approved in July 2020 in the United States.

Iain B. McInnes, MD, PhD, of the University of Glasgow and his colleagues described guselkumab as “a fully-human monoclonal antibody specific to interleukin (IL)-23’s p19-subunit” that offers a potential alternative for PsA patients who discontinue their index tumor necrosis factor inhibitor because of insufficient efficacy.

The study enrolled 739 PsA patients at 118 sites worldwide. Participants were randomized to receive subcutaneous injections of 100 mg guselkumab every 4 weeks; 100 mg guselkumab at week 0 and 4, then every 8 weeks; or a placebo; 238 placebo-treated patients crossed over at 24 weeks to receive 100 mg guselkumab every 4 weeks. Patients on nonbiologic disease-modifying antirheumatic drugs at baseline were allowed to continue stable doses. Overall, about 93% of patients originally randomized to the three groups remained on guselkumab at 52 weeks.

Overall, 71% and 75% of 4-week and 8-week guselkumab patients, respectively, showed an improvement of at least 20% from baseline in ACR response criteria components at 52 weeks, which was up from 64% of patients seen at 24 weeks in both groups.

The study participants had an average disease duration of more than 5 years with no biologic treatment, and an average of 12-13 swollen joints and 20-22 tender joints at baseline. Approximately half were male, half had psoriasis or dactylitis, and two-thirds had enthesitis. Skin disease severity was assessed using the Investigator’s Global Assessment and Psoriasis Area Severity Index (PASI).

At 52 weeks, 75% and 58% of patients in the guselkumab groups had resolution of dactylitis and enthesitis, respectively. In addition, 86% of patients in both guselkumab groups achieved PASI 75 at 52 weeks, and 58% and 53% of the 4-week and 8-week groups, respectively, achieved PASI 100.

In addition, patients treated with guselkumab showed low levels of radiographic progression and significant improvements from baseline in measures of physical function and quality of life.

The most frequently reported adverse events in guselkumab patients were upper respiratory tract infections, nasopharyngitis, bronchitis, and investigator-reported laboratory values of increased alanine aminotransferase and aspartate aminotransferase; these rates were similar to those seen in the previously published 24-week data. Approximately 2% of guselkumab and placebo patients discontinued their treatments because of adverse events.

No patient developed an opportunistic infection or died during the study period.

The study findings were limited by several factors including the relatively short 1-year duration, the shorter duration of placebo, compared with guselkumab, and by potential confounding from missing data on patients who discontinued, the researchers noted. However, the results support the effectiveness of guselkumab for improving a range of manifestations of active PsA, and the overall treatment and safety profiles seen at 24 weeks were maintained, they said.

“Data obtained during the second year of DISCOVER-2 will augment current knowledge of the guselkumab benefit-risk profile and further our understanding of longer-term radiographic outcomes with both guselkumab dosing regimens,” they concluded.

The study was supported by Janssen. Many authors reported financial relationships with Janssen and other pharmaceutical companies. Nine of the 15 authors are employees of Janssen (a subsidiary of Johnson & Johnson) and own Johnson & Johnson stock or stock options.

SOURCE: McInnes IB et al. Arthritis Rheumatol. 2020 Oct 11. doi: 10.1002/art.41553.

Adults with active psoriatic arthritis (PsA) treated with guselkumab (Tremfya) showed significant improvement in American College of Rheumatology response criteria and disease activity after 1 year, based on data from the phase 3 DISCOVER-2 trial.

The findings, published in Arthritis & Rheumatology, extend the previously published 24-week, primary endpoint results of the trial, which tested guselkumab for adults with PsA who had not previously taken a biologic drug. Guselkumab was approved in July 2020 in the United States.

Iain B. McInnes, MD, PhD, of the University of Glasgow and his colleagues described guselkumab as “a fully-human monoclonal antibody specific to interleukin (IL)-23’s p19-subunit” that offers a potential alternative for PsA patients who discontinue their index tumor necrosis factor inhibitor because of insufficient efficacy.

The study enrolled 739 PsA patients at 118 sites worldwide. Participants were randomized to receive subcutaneous injections of 100 mg guselkumab every 4 weeks; 100 mg guselkumab at week 0 and 4, then every 8 weeks; or a placebo; 238 placebo-treated patients crossed over at 24 weeks to receive 100 mg guselkumab every 4 weeks. Patients on nonbiologic disease-modifying antirheumatic drugs at baseline were allowed to continue stable doses. Overall, about 93% of patients originally randomized to the three groups remained on guselkumab at 52 weeks.

Overall, 71% and 75% of 4-week and 8-week guselkumab patients, respectively, showed an improvement of at least 20% from baseline in ACR response criteria components at 52 weeks, which was up from 64% of patients seen at 24 weeks in both groups.

The study participants had an average disease duration of more than 5 years with no biologic treatment, and an average of 12-13 swollen joints and 20-22 tender joints at baseline. Approximately half were male, half had psoriasis or dactylitis, and two-thirds had enthesitis. Skin disease severity was assessed using the Investigator’s Global Assessment and Psoriasis Area Severity Index (PASI).

At 52 weeks, 75% and 58% of patients in the guselkumab groups had resolution of dactylitis and enthesitis, respectively. In addition, 86% of patients in both guselkumab groups achieved PASI 75 at 52 weeks, and 58% and 53% of the 4-week and 8-week groups, respectively, achieved PASI 100.

In addition, patients treated with guselkumab showed low levels of radiographic progression and significant improvements from baseline in measures of physical function and quality of life.

The most frequently reported adverse events in guselkumab patients were upper respiratory tract infections, nasopharyngitis, bronchitis, and investigator-reported laboratory values of increased alanine aminotransferase and aspartate aminotransferase; these rates were similar to those seen in the previously published 24-week data. Approximately 2% of guselkumab and placebo patients discontinued their treatments because of adverse events.

No patient developed an opportunistic infection or died during the study period.

The study findings were limited by several factors including the relatively short 1-year duration, the shorter duration of placebo, compared with guselkumab, and by potential confounding from missing data on patients who discontinued, the researchers noted. However, the results support the effectiveness of guselkumab for improving a range of manifestations of active PsA, and the overall treatment and safety profiles seen at 24 weeks were maintained, they said.

“Data obtained during the second year of DISCOVER-2 will augment current knowledge of the guselkumab benefit-risk profile and further our understanding of longer-term radiographic outcomes with both guselkumab dosing regimens,” they concluded.

The study was supported by Janssen. Many authors reported financial relationships with Janssen and other pharmaceutical companies. Nine of the 15 authors are employees of Janssen (a subsidiary of Johnson & Johnson) and own Johnson & Johnson stock or stock options.

SOURCE: McInnes IB et al. Arthritis Rheumatol. 2020 Oct 11. doi: 10.1002/art.41553.

Adults with active psoriatic arthritis (PsA) treated with guselkumab (Tremfya) showed significant improvement in American College of Rheumatology response criteria and disease activity after 1 year, based on data from the phase 3 DISCOVER-2 trial.

The findings, published in Arthritis & Rheumatology, extend the previously published 24-week, primary endpoint results of the trial, which tested guselkumab for adults with PsA who had not previously taken a biologic drug. Guselkumab was approved in July 2020 in the United States.

Iain B. McInnes, MD, PhD, of the University of Glasgow and his colleagues described guselkumab as “a fully-human monoclonal antibody specific to interleukin (IL)-23’s p19-subunit” that offers a potential alternative for PsA patients who discontinue their index tumor necrosis factor inhibitor because of insufficient efficacy.

The study enrolled 739 PsA patients at 118 sites worldwide. Participants were randomized to receive subcutaneous injections of 100 mg guselkumab every 4 weeks; 100 mg guselkumab at week 0 and 4, then every 8 weeks; or a placebo; 238 placebo-treated patients crossed over at 24 weeks to receive 100 mg guselkumab every 4 weeks. Patients on nonbiologic disease-modifying antirheumatic drugs at baseline were allowed to continue stable doses. Overall, about 93% of patients originally randomized to the three groups remained on guselkumab at 52 weeks.

Overall, 71% and 75% of 4-week and 8-week guselkumab patients, respectively, showed an improvement of at least 20% from baseline in ACR response criteria components at 52 weeks, which was up from 64% of patients seen at 24 weeks in both groups.

The study participants had an average disease duration of more than 5 years with no biologic treatment, and an average of 12-13 swollen joints and 20-22 tender joints at baseline. Approximately half were male, half had psoriasis or dactylitis, and two-thirds had enthesitis. Skin disease severity was assessed using the Investigator’s Global Assessment and Psoriasis Area Severity Index (PASI).

At 52 weeks, 75% and 58% of patients in the guselkumab groups had resolution of dactylitis and enthesitis, respectively. In addition, 86% of patients in both guselkumab groups achieved PASI 75 at 52 weeks, and 58% and 53% of the 4-week and 8-week groups, respectively, achieved PASI 100.

In addition, patients treated with guselkumab showed low levels of radiographic progression and significant improvements from baseline in measures of physical function and quality of life.

The most frequently reported adverse events in guselkumab patients were upper respiratory tract infections, nasopharyngitis, bronchitis, and investigator-reported laboratory values of increased alanine aminotransferase and aspartate aminotransferase; these rates were similar to those seen in the previously published 24-week data. Approximately 2% of guselkumab and placebo patients discontinued their treatments because of adverse events.

No patient developed an opportunistic infection or died during the study period.

The study findings were limited by several factors including the relatively short 1-year duration, the shorter duration of placebo, compared with guselkumab, and by potential confounding from missing data on patients who discontinued, the researchers noted. However, the results support the effectiveness of guselkumab for improving a range of manifestations of active PsA, and the overall treatment and safety profiles seen at 24 weeks were maintained, they said.

“Data obtained during the second year of DISCOVER-2 will augment current knowledge of the guselkumab benefit-risk profile and further our understanding of longer-term radiographic outcomes with both guselkumab dosing regimens,” they concluded.

The study was supported by Janssen. Many authors reported financial relationships with Janssen and other pharmaceutical companies. Nine of the 15 authors are employees of Janssen (a subsidiary of Johnson & Johnson) and own Johnson & Johnson stock or stock options.

SOURCE: McInnes IB et al. Arthritis Rheumatol. 2020 Oct 11. doi: 10.1002/art.41553.

Use of febuxostat (Uloric) decreased among patients with gout in the United States following a Food and Drug Administration–mandated black-box warning that cited cardiovascular concerns, but overall use of urate-lowering therapy remained stable, according to data from a study of commercial insurance enrollees in the United States between 2009 and 2019.

Initiation of urate-lowering therapy (ULT) is recommended for gout patients, and allopurinol remains the first-line treatment, but it is not effective in all patients, and febuxostat was developed as an alternative, wrote Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.

However, based on data from a postmarketing safety trial (the CARES trial) mandated by the FDA, the agency first issued a safety announcement about an increased risk of cardiovascular mortality with febuxostat in November 2017, followed in February 2019 with a black-box warning after full CARES trial results were published in March 2018 showing a greater risk of cardiovascular and all-cause mortality in febuxostat versus allopurinol.

In a study published in Arthritis & Rheumatology, the researchers examined trends in the use of ULT before and after the FDA warning. They analyzed claims data from a national commercial health database that included 838,432 adult ULT users and 633,229 gout patients.

Overall, allopurinol accounted for the majority of ULT use between 2009 (95% in the first quarter) and 2019 (92% in the fourth quarter).

Febuxostat use peaked at 10% of all ULT use in 2013 and 2014, after a gradual increase following its introduction into the market in 2009, the researchers noted, but decreased to 6% of all ULT use in the fourth quarter of 2019. Other medications, including probenecid, lesinurad (Zurampic), and pegloticase (Krystexxa), accounted for no more than 5% of ULT use.

When the researchers examined gout patients in particular, they found a slight increase in any ULT use from 567 per 1,000 patients in the first quarter of 2009 to 656 per 1,000 patients in the fourth quarter of 2019.

The study findings were limited by several factors, including potential lack of generalizability to other health plans and lack of adjustment for comorbid conditions, the researchers noted.

However, the results highlight the suboptimal use of ULT as a class and the need to address the treatment gap in gout patients “with appropriate ULT prescribing and monitoring,” they said. “While the decrease in febuxostat use was accompanied by a compensatory increase in allopurinol use, the proportion of patients with gout without any ULT remained high throughout the study period,” they concluded.

The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Dr. Kim disclosed receiving research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for research unrelated to the current study.

SOURCE: Kim SC et al. Arthritis Rheumatol. 2020 Oct 7. doi: 10.1002/art.41550.

Use of febuxostat (Uloric) decreased among patients with gout in the United States following a Food and Drug Administration–mandated black-box warning that cited cardiovascular concerns, but overall use of urate-lowering therapy remained stable, according to data from a study of commercial insurance enrollees in the United States between 2009 and 2019.

Initiation of urate-lowering therapy (ULT) is recommended for gout patients, and allopurinol remains the first-line treatment, but it is not effective in all patients, and febuxostat was developed as an alternative, wrote Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.

However, based on data from a postmarketing safety trial (the CARES trial) mandated by the FDA, the agency first issued a safety announcement about an increased risk of cardiovascular mortality with febuxostat in November 2017, followed in February 2019 with a black-box warning after full CARES trial results were published in March 2018 showing a greater risk of cardiovascular and all-cause mortality in febuxostat versus allopurinol.

In a study published in Arthritis & Rheumatology, the researchers examined trends in the use of ULT before and after the FDA warning. They analyzed claims data from a national commercial health database that included 838,432 adult ULT users and 633,229 gout patients.

Overall, allopurinol accounted for the majority of ULT use between 2009 (95% in the first quarter) and 2019 (92% in the fourth quarter).

Febuxostat use peaked at 10% of all ULT use in 2013 and 2014, after a gradual increase following its introduction into the market in 2009, the researchers noted, but decreased to 6% of all ULT use in the fourth quarter of 2019. Other medications, including probenecid, lesinurad (Zurampic), and pegloticase (Krystexxa), accounted for no more than 5% of ULT use.

When the researchers examined gout patients in particular, they found a slight increase in any ULT use from 567 per 1,000 patients in the first quarter of 2009 to 656 per 1,000 patients in the fourth quarter of 2019.

The study findings were limited by several factors, including potential lack of generalizability to other health plans and lack of adjustment for comorbid conditions, the researchers noted.

However, the results highlight the suboptimal use of ULT as a class and the need to address the treatment gap in gout patients “with appropriate ULT prescribing and monitoring,” they said. “While the decrease in febuxostat use was accompanied by a compensatory increase in allopurinol use, the proportion of patients with gout without any ULT remained high throughout the study period,” they concluded.

The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Dr. Kim disclosed receiving research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for research unrelated to the current study.

SOURCE: Kim SC et al. Arthritis Rheumatol. 2020 Oct 7. doi: 10.1002/art.41550.

Use of febuxostat (Uloric) decreased among patients with gout in the United States following a Food and Drug Administration–mandated black-box warning that cited cardiovascular concerns, but overall use of urate-lowering therapy remained stable, according to data from a study of commercial insurance enrollees in the United States between 2009 and 2019.

Initiation of urate-lowering therapy (ULT) is recommended for gout patients, and allopurinol remains the first-line treatment, but it is not effective in all patients, and febuxostat was developed as an alternative, wrote Seoyoung C. Kim, MD, ScD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.

However, based on data from a postmarketing safety trial (the CARES trial) mandated by the FDA, the agency first issued a safety announcement about an increased risk of cardiovascular mortality with febuxostat in November 2017, followed in February 2019 with a black-box warning after full CARES trial results were published in March 2018 showing a greater risk of cardiovascular and all-cause mortality in febuxostat versus allopurinol.

In a study published in Arthritis & Rheumatology, the researchers examined trends in the use of ULT before and after the FDA warning. They analyzed claims data from a national commercial health database that included 838,432 adult ULT users and 633,229 gout patients.

Overall, allopurinol accounted for the majority of ULT use between 2009 (95% in the first quarter) and 2019 (92% in the fourth quarter).

Febuxostat use peaked at 10% of all ULT use in 2013 and 2014, after a gradual increase following its introduction into the market in 2009, the researchers noted, but decreased to 6% of all ULT use in the fourth quarter of 2019. Other medications, including probenecid, lesinurad (Zurampic), and pegloticase (Krystexxa), accounted for no more than 5% of ULT use.

When the researchers examined gout patients in particular, they found a slight increase in any ULT use from 567 per 1,000 patients in the first quarter of 2009 to 656 per 1,000 patients in the fourth quarter of 2019.

The study findings were limited by several factors, including potential lack of generalizability to other health plans and lack of adjustment for comorbid conditions, the researchers noted.

However, the results highlight the suboptimal use of ULT as a class and the need to address the treatment gap in gout patients “with appropriate ULT prescribing and monitoring,” they said. “While the decrease in febuxostat use was accompanied by a compensatory increase in allopurinol use, the proportion of patients with gout without any ULT remained high throughout the study period,” they concluded.

The study was supported by the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital. Dr. Kim disclosed receiving research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb for research unrelated to the current study.

SOURCE: Kim SC et al. Arthritis Rheumatol. 2020 Oct 7. doi: 10.1002/art.41550.