Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Plasma levels of von Willebrand factor may be a useful biomarker of traumatic brain injury (TBI) and its severity, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.

“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
 

A specific marker of acute injury?

Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.

The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.

Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.

The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.

There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.

“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.

In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.

They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.

Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.

Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.

“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.

The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.

“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.

Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
 

Point-of-care test?

Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.

Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.

The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.

The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.

One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.

But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.

“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.

One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”

The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Plasma levels of von Willebrand factor may be a useful biomarker of traumatic brain injury (TBI) and its severity, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.

“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
 

A specific marker of acute injury?

Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.

The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.

Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.

The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.

There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.

“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.

In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.

They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.

Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.

Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.

“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.

The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.

“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.

Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
 

Point-of-care test?

Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.

Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.

The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.

The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.

One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.

But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.

“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.

One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”

The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Plasma levels of von Willebrand factor may be a useful biomarker of traumatic brain injury (TBI) and its severity, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.

“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
 

A specific marker of acute injury?

Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.

The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.

Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.

The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.

There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.

“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.

In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.

They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.

Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.

Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.

“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.

The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.

“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.

Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
 

Point-of-care test?

Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.

Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.

The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.

The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.

One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.

But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.

“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.

One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”

The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular hypothyroid treatment NP Thyroid tablets USP, this time after routine testing found the pills to be subpotent.

Specifically, the affected lots were found to contain less than 90% of the drug’s two labeled ingredients to treat hypothyroidism: liothyronine (LT3) and/or levothyroxine (LT4).

The affected lots include 15-mg, 30-mg, 60-mg, 90-mg and 120-mg formulations of NP Thyroid tablets, packed in 100-count and 7-count bottles.

The list of the specific recalled lots is published on the Food and Drug Administration website.

Acella reports that, so far, 43 reports of serious adverse events that could be related to the recall have been received.

Symptoms suggesting patients may have received a subpotent batch include the common signs of hypothyroidism, such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight, Acella reports.

“There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development,” the company cautions in the recall statement.

Acella adds that toxic cardiac manifestations of hyperthyroidism, including cardiac pain, palpitations or cardiac arrhythmia may occur in elderly patients and patients with underlying cardiac disease.

While Acella is notifying affected parties to discontinue distribution of the recalled products, it advises that patients who are currently taking NP Thyroid from the lots being recalled “should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.”

In November 2020, a recall of NP Thyroid was issued after FDA testing found subpotent levels, as low as 87% of the labeled amount, of LT4 in some lots.

And earlier, in May 2020, the company recalled 13 lots of the tablets due to excessive potency, with FDA testing showing some tablets contained up to 115% of the labeled amount of LT3.

NP Thyroid is a type of desiccated animal thyroid product that was long the standard of care for hypothyroidism prior to the advent of the synthetic hypothyroidism drug, Synthroid (levothyroxine sodium), now the most commonly used hypothyroidism treatment.

On its website, Acella refers to NP Thyroid as a “natural choice for thyroid therapy,” as desiccated thyroid is commonly referred to.

However, one of the most common concerns about desiccated thyroid is a tendency to have unreliable concentrations of active ingredients, as discussed in American Thyroid Association recommendations.

The “amounts of both T4 and T3 can vary in every batch of desiccated thyroid, making it harder to keep blood levels right,” the ATA states.

“Finally, even desiccated thyroid pills have chemicals (binders) in them to hold the pill together, so they are not completely ‘natural.’ ”

Consumers with questions about the recall are advised to email Acella Pharmaceuticals at [email protected] or call 1-888-424-4341, Monday through Friday from 8:00 am to 5:00 pm ET.
 

In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular hypothyroid treatment NP Thyroid tablets USP, this time after routine testing found the pills to be subpotent.

Specifically, the affected lots were found to contain less than 90% of the drug’s two labeled ingredients to treat hypothyroidism: liothyronine (LT3) and/or levothyroxine (LT4).

The affected lots include 15-mg, 30-mg, 60-mg, 90-mg and 120-mg formulations of NP Thyroid tablets, packed in 100-count and 7-count bottles.

The list of the specific recalled lots is published on the Food and Drug Administration website.

Acella reports that, so far, 43 reports of serious adverse events that could be related to the recall have been received.

Symptoms suggesting patients may have received a subpotent batch include the common signs of hypothyroidism, such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight, Acella reports.

“There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development,” the company cautions in the recall statement.

Acella adds that toxic cardiac manifestations of hyperthyroidism, including cardiac pain, palpitations or cardiac arrhythmia may occur in elderly patients and patients with underlying cardiac disease.

While Acella is notifying affected parties to discontinue distribution of the recalled products, it advises that patients who are currently taking NP Thyroid from the lots being recalled “should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.”

In November 2020, a recall of NP Thyroid was issued after FDA testing found subpotent levels, as low as 87% of the labeled amount, of LT4 in some lots.

And earlier, in May 2020, the company recalled 13 lots of the tablets due to excessive potency, with FDA testing showing some tablets contained up to 115% of the labeled amount of LT3.

NP Thyroid is a type of desiccated animal thyroid product that was long the standard of care for hypothyroidism prior to the advent of the synthetic hypothyroidism drug, Synthroid (levothyroxine sodium), now the most commonly used hypothyroidism treatment.

On its website, Acella refers to NP Thyroid as a “natural choice for thyroid therapy,” as desiccated thyroid is commonly referred to.

However, one of the most common concerns about desiccated thyroid is a tendency to have unreliable concentrations of active ingredients, as discussed in American Thyroid Association recommendations.

The “amounts of both T4 and T3 can vary in every batch of desiccated thyroid, making it harder to keep blood levels right,” the ATA states.

“Finally, even desiccated thyroid pills have chemicals (binders) in them to hold the pill together, so they are not completely ‘natural.’ ”

Consumers with questions about the recall are advised to email Acella Pharmaceuticals at [email protected] or call 1-888-424-4341, Monday through Friday from 8:00 am to 5:00 pm ET.
 

In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular hypothyroid treatment NP Thyroid tablets USP, this time after routine testing found the pills to be subpotent.

Specifically, the affected lots were found to contain less than 90% of the drug’s two labeled ingredients to treat hypothyroidism: liothyronine (LT3) and/or levothyroxine (LT4).

The affected lots include 15-mg, 30-mg, 60-mg, 90-mg and 120-mg formulations of NP Thyroid tablets, packed in 100-count and 7-count bottles.

The list of the specific recalled lots is published on the Food and Drug Administration website.

Acella reports that, so far, 43 reports of serious adverse events that could be related to the recall have been received.

Symptoms suggesting patients may have received a subpotent batch include the common signs of hypothyroidism, such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight, Acella reports.

“There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development,” the company cautions in the recall statement.

Acella adds that toxic cardiac manifestations of hyperthyroidism, including cardiac pain, palpitations or cardiac arrhythmia may occur in elderly patients and patients with underlying cardiac disease.

While Acella is notifying affected parties to discontinue distribution of the recalled products, it advises that patients who are currently taking NP Thyroid from the lots being recalled “should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.”

In November 2020, a recall of NP Thyroid was issued after FDA testing found subpotent levels, as low as 87% of the labeled amount, of LT4 in some lots.

And earlier, in May 2020, the company recalled 13 lots of the tablets due to excessive potency, with FDA testing showing some tablets contained up to 115% of the labeled amount of LT3.

NP Thyroid is a type of desiccated animal thyroid product that was long the standard of care for hypothyroidism prior to the advent of the synthetic hypothyroidism drug, Synthroid (levothyroxine sodium), now the most commonly used hypothyroidism treatment.

On its website, Acella refers to NP Thyroid as a “natural choice for thyroid therapy,” as desiccated thyroid is commonly referred to.

However, one of the most common concerns about desiccated thyroid is a tendency to have unreliable concentrations of active ingredients, as discussed in American Thyroid Association recommendations.

The “amounts of both T4 and T3 can vary in every batch of desiccated thyroid, making it harder to keep blood levels right,” the ATA states.

“Finally, even desiccated thyroid pills have chemicals (binders) in them to hold the pill together, so they are not completely ‘natural.’ ”

Consumers with questions about the recall are advised to email Acella Pharmaceuticals at [email protected] or call 1-888-424-4341, Monday through Friday from 8:00 am to 5:00 pm ET.
 

Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Teens with persistent nocturnal asthma symptoms were significantly more likely than were those without nighttime asthma to report poor functional health independent of daytime asthma, based on data from 430 adolescents aged 12-16 years.

Approximately half of children with severe asthma experience at least one night of inadequate sleep per week, and lost sleep among young children with asthma has been associated with impaired physical function, school absence, and worsened mood. However, the effect of asthma-related sleep disruption on daily function in teenagers in particular has not been well studied, according to Anne Zhang of the University of Rochester (N.Y.) and colleagues.

In a poster presented at the virtual meeting of the Pediatric Academic Societies (#542), the researchers reviewed baseline survey data from the School-Based Asthma Care for Teens (SB-ACT) study, a randomized, controlled trial conducted from 2014 to 2018 in Rochester, N.Y.

The average age of the respondents was 13.4 years, 56% were male, 56% were African American, 32% were Hispanic, and 84% had Medicaid insurance.

Persistent nocturnal asthma was defined as 2 or more nights of nighttime awakening in the past 14 days, and intermittent nocturnal asthma was defined as less than 2 nights of nighttime awakening in the past 14 days.

Overall, teens with persistent nocturnal asthma were significantly more likely than were those with intermittent nocturnal asthma to report physical limitations during strenuous activity (58% vs. 41%), moderate activity (32% vs. 19%), and school gym classes (36% vs. 19%; P <.01 for all).

In addition to physical impact, teens with persistent nocturnal asthma were more likely than were those with intermittent nocturnal asthma to report depressive symptoms (41% vs. 23%), asthma-related school absences in the past 14 days (0.81 vs. 0.12), and poorer quality of life (4.6 vs. 5.9, P <.01 for all).

The results remained significant in a multivariate analysis that controlled for daytime asthma symptoms, weight status, race, ethnicity, gender, age, and smoke exposure, the researchers said.

The study findings were limited by several factors including the cross-sectional design, potential of recall bias in survey responses, and lack of data on sleep duration and quality, the researchers noted.

However, the results suggest that improving nighttime asthma control for teens may improve daily function, and providers should ask teens with asthma about the possible effect and burden of nighttime symptoms, they said. Potential strategies to improve persistent nocturnal asthma symptoms include adjusting the timing of medications or physical activity, they added.

“We know that getting adequate, high-quality sleep is important for health - especially for adolescents,” said Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, in an interview. “Just like adults, tired teens are not able to function at their best and are at higher risk of developing mood problems,” she said.

However, “There are already so many barriers for teens getting good sleep, such as screen time/social media, homework, busy social calendars, caffeine use, and early morning school start times,” she said. Underlying medical conditions such as depression, anxiety, and obstructive sleep apnea also can contribute to poor sleep for teens, she added.

“In my practice, I frequently counsel about sleep hygiene because it is so essential and not commonly followed,” said Dr. Curran. “Nocturnal asthma is another contributor to poor sleep - not one that I have been regularly screening for - and something we can potentially intervene in to help improve health and quality of life,” she emphasized.

Dr. Curran said that she was not surprised by the study findings, given what is known about the importance of sleep. In clinical practice, “Teens who have asthma should be screened for nocturnal symptoms as these are linked to worsened quality of life, including limitations in activities, depressive symptoms, and asthma-related school absence,” she said.

However, additional research is needed to better understand whether improving nocturnal asthma symptoms can help improve quality of life and daily functioning in adolescents, she noted.

The SB-ACT was supported by the National Institutes of Health. Ms. Zhang was supported in part by the OME-CACHED for medical student research and an NIH grant. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose.

*This story was updated on May 5. 2021.

Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.

In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.

“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

‘Alarming’ rates of exposure

Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.

Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”

These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.

Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.

To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.

Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.

Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.

This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.

The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.

“These results tell me these individuals are exposed to high levels of violence in their lifetime, which should be alarming,” said Dr. Motley.
 

Protectors or predators?

To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.

Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.

For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.

Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.

Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.

Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.

Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”

These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”

Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.

This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.

It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.

Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”

“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.

“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.

The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.

In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.

“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

‘Alarming’ rates of exposure

Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.

Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”

These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.

Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.

To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.

Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.

Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.

This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.

The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.

“These results tell me these individuals are exposed to high levels of violence in their lifetime, which should be alarming,” said Dr. Motley.
 

Protectors or predators?

To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.

Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.

For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.

Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.

Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.

Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.

Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”

These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”

Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.

This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.

It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.

Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”

“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.

“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.

The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Young Black adults who witness or experience police violence have significantly elevated levels of anxiety, new research shows.

In the first study to quantify the impact of police contact anxiety, investigators found it was associated with moderately severe anxiety levels in this group of individuals, highlighting the need to screen for exposure to police violence in this patient population, study investigator Robert O. Motley Jr, PhD, manager of the Race & Opportunity Lab at Washington University in St. Louis, said in an interview.

“If you’re working in an institution and providing clinical care, mental health care, or behavior health care, these additional measures should be included to get a much more holistic view of the exposure of these individuals in terms of traumatic events. These assessments can inform your decisions around care,” Dr. Motley added.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

‘Alarming’ rates of exposure

Evidence shows anxiety disorders are among the most prevalent conditions for Black people aged 18-29 years – an age group described as “emergent adulthood” because these individuals haven’t yet taken on full responsibilities of adulthood.

Research shows Black emergent adults are three to four times more likely than other ethnic groups to be exposed to actual or threatened nonfatal police violence, said Dr. Motley. “So they didn’t die, but were exposed to force, which could be things like police yelling at them, hitting or kicking them, pointing a gun at them, or tasing them.”

These individuals are also two to three times more likely to experience exposure to fatal police violence, and to be unarmed and killed, said Dr. Motley.

Evidence shows a clear link between exposure to stressful or traumatic events and anxiety disorders, but there has been little research examining the relationship between exposure to police violence and anxiety disorders among Black emergent adults, he said.

To assess the prevalence and correlates of “police contact anxiety” the investigators used computer-assisted surveys to collect data from 300 young Black college students in St. Louis who had been exposed to police violence at some point in their lives. The mean age of the sample was 20.4 years and included an equal number of men and women.

Work status for the previous year showed almost one-quarter (23.6%) were unemployed and about half worked part time. Almost two-thirds (62.6%) had an annual income of less than $10,000.

Respondents reported they had personally experienced police violence almost twice (a mean of 1.89) during their lifetime. The mean number of times they witnessed police using force against someone else was 7.82. Respondents also reported they had watched videos showing police use of force on the internet or television an average of 34.5 times.

This, said Dr. Motley, isn’t surprising given the growing number of young adults – of all races – who are using social media platforms to upload and share videos.

The researchers also looked at witnessing community violence, unrelated to police violence. Here, respondents had an average of 10.9 exposures.

“These results tell me these individuals are exposed to high levels of violence in their lifetime, which should be alarming,” said Dr. Motley.
 

Protectors or predators?

To examine the impact of police contact anxiety caused either by direct experience, or as a result of witnessing, or seeing a video of police use of violence in the past 30 days, the researchers created a “police contact anxiety” scale.

Respondents were asked six questions pertaining specifically to experiences during, or in anticipation of, police contact and its effects on anxiety levels.

For each of the six questions, participants rated the severity of anxiety on a scale of 0 (least severe) to 3 (most severe) for each exposure type. The final score had a potential range of 0-24.

Results showed police contact anxiety was moderately severe for all three exposure types with scores ranging from 13 to 14.

Ordinary least square regression analyses showed that, compared with unemployed participants, those who worked full time were less likely to have higher police contact anxiety as a result of seeing a video of police use of force (P < .05) – a finding Dr. Motley said was not surprising.

Employment, he noted, promotes individual self-efficacy, social participation, and mental health, which may provide a “buffer” to the effects of watching videos of police violence.

Dr. Motley noted that police officers “have been entrusted to serve and protect” the community, but “rarely face consequences when they use force against Black emergent adults; they’re rarely held accountable.”

These young Black adults “may perceive police officers as more of a threat to personal safety instead of a protector of it.”

Additional bivariate analyses showed that males had significantly higher scores than females for police contact anxiety because of witnessing police use of force.

This, too, was not surprising since males are exposed to more violence in general, said Dr. Motley.

It’s important to replicate the findings using a much larger and more diverse sample, he said. His next research project will be to collect data from a nationally representative sample of emerging adults across different ethnic groups and examining a range of different variables.

Commenting on the findings, Jeffrey Borenstein, MD, president and CEO of the Brain & Behavior Research Foundation and editor in chief of Psychiatric News, called it “outstanding.”

“This is a very important issue,” said Dr. Borenstein, who moderated a press briefing that featured the study.

“We know anxiety is an extremely important condition and symptom, across the board for all groups, and often anxiety isn’t evaluated in the way that it needs to be. This is a great study that will lead to further research in this important area,” he added.

The study was funded by the National Institute on Minority Health and Health Disparities. Dr. Motley and Dr. Borenstein have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Guselkumab resulted in significantly higher proportions of patients with psoriatic arthritis (PsA) with resolved enthesitis than placebo, which continued to improve through 1 year.

Major finding: A significantly higher proportion of patients with enthesitis at baseline achieved resolution by week 24 when treated with guselkumab 100 mg every 4 weeks (Q4W) and guselkumab 100 mg at week 0, 4, and then every 8 weeks (Q8W) than placebo (45% and 50% vs. 29%; P = .0301) which continued to rise in patients who continued guselkumab with 58% achieving resolution by week 52.

Study details: Findings are from a pooled analysis of DISCOVER-1 and DISCOVER-2 phase 3 trials involving patients with active PsA despite standard therapies randomly allocated to subcutaneous guselkumab 100 mg Q4W, guselkumab 100 mg Q8W, or placebo.

Disclosures: The work was supported by Janssen Research & Development, LLC. The authors reported receiving research grants, honoraria, and/or consultation/speaker fees from various sources, including Janssen. Some authors declared being employees of Janssen and owning stocks of Johnson & Johnson.

Source: McGonagle D et al. Rheumatology (Oxford). 2021 Apr 6. doi: 10.1093/rheumatology/keab285.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Final analysis of OPAL Balance confirms long-term safety and efficacy of tofacitinib in patients with psoriatic arthritis.

Major finding: Only 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent as reported previously. Efficacy was sustained up to 36 months.

Study details: Findings are from OPAL Balance, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA. Eligible patients (n=180) from the open-label phase entered the randomized, double-blind, 12-month methotrexate withdrawal substudy where they received open-label tofacitinib 5 mg twice daily with either masked placebo or masked methotrexate.

Disclosures: OPAL Balance was funded by Pfizer. The authors including the lead author reported receiving grants/consulting fees, speaker fees, and/or honoraria from various sources including Pfizer. Six of the authors reported being employees and shareholders of Pfizer.

Source: Nash P et al. Lancet Rheumatol. 2021 Apr 1. doi: 10.1016/S2665-9913(21)00010-2.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

Key clinical point: Proportion of patients with psoriatic arthritis with at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib than placebo; however, adverse events were more frequent with upadacitinib.

Major finding: The percentage of patients with ACR20 response at week 12 was higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) vs. placebo (36.2%; P less than .001). Incidence of serious infections and serious adverse events with upadacitinib 15 mg, 30 mg, and placebo were 1.2%, 2.6%, and 0.9% and 3.3%, 6.1%, and 3.1%, respectively.

Study details: Findings are from SELECT-Psa 1, a phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs and were randomly allocated to receive either oral upadacitinib 15 or 30 mg once daily, placebo, or subcutaneous adalimumab (40 mg every other week).

Disclosures: The trial was sponsored by Abbvie. The authors reported receiving consulting fees, advisory board fees, lecture fees, travel support, grant support, and/or being an employee of and/or owning stocks in various pharmaceutical companies, including Abbvie.

Source: McInnes IB et al. N Engl J Med. 2021 Apr 1. doi: 10.1056/NEJMoa2022516.

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

A version of this article first appeared on Medscape.com.

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

A version of this article first appeared on Medscape.com.

Inequities in the initial growth of transcatheter aortic valve replacement (TAVR) programs in American hospitals has led to less use of the transformative procedure in poorer communities, a new cross-sectional study suggests.

Using Medicare claims data, investigators identified 554 new TAVR programs created between January 2012 and December 2018.

Of these, 98% were established in metropolitan areas (>50,000 residents) and 53% were started in areas with preexisting TAVR programs, “thereby increasing the number of programs but not necessarily increasing the geographic availability of the procedure,” said study author Ashwin Nathan, MD, Hospital of the University of Pennsylvania, Philadelphia.

Only 11 programs were started in nonmetropolitan areas over the study period, he noted during the featured clinical research presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 annual scientific sessions, held virtually this year.

Hospitals that established TAVR programs, compared with those that did not, cared for patients with higher median household incomes (difference, $1,305; P = .03) and from areas with better economic well-being based on the Distressed Communities Index (difference, –3.15 units; P < .01), and cared for fewer patients with dual eligibility for Medicaid (difference, –3.15%; P < .01).

When the investigators looked at rates of TAVR between the core-based statistical areas, there were fewer TAVR procedures per 100,000 Medicare beneficiaries in areas with more Medicaid dual-eligible patients (difference, –1.19% per 1% increase), lower average median household incomes (difference, –0.62% per $1,000 decrease), and more average community distress (difference, –0.35% per 1 unit increase; P < .01 for all).

“What we can conclude is that the increased number of TAVR programs that we found during the study period did not necessarily translate to increased access to TAVR ... Wealthy, more privileged patients had more access to TAVR by virtue of the hospitals that serve them,” Dr. Nathan said.

Future steps, he said, are to identify the role of race and ethnicity in inequitable access to TAVR, identify system- and patient-level barriers to access, and to develop and test solutions to address inequitable care.

Elaborating on the latter point during a discussion of the results, study coauthor Jay S. Giri, MD, MPH, also from the Hospital of the University of Pennsylvania, observed that although the data showed rural areas are left behind, not every part of an urban area acts like the area more generally.

As a result, they’re delving into the 25 largest urban areas and trying to disaggregate, based on both socioeconomic status and race within the area, whether inequities exist, he said. “Believe it or not, in some urban areas where there clearly is access – there might even be a dozen TAVR programs within a 25 mile radius – do some of those areas still act like rural areas that don’t have access? So more to come on that.”

Session comoderator Steven Yakubov, MD, MidWest Cardiology Research Foundation in Columbus, Ohio, said the results show TAVR programs tend to be developed in well-served areas but asked whether some of the responsibility falls on patients to seek medical attention. “Do we just not give enough education to patients on how to access care?”

Dr. Giri responded by highlighting the complexity of navigating from even being diagnosed with aortic stenosis to making it through a multidisciplinary TAVR evaluation.

“Individuals with increased health literacy and more means are more likely to make it through that gauntlet. But from a public health perspective, obviously, I’d argue that the onus is probably more on the medical community at large to figure out how to roll these programs out more widespread,” he said.

“It looked to us like market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations,” Dr. Giri added. “And just to point out, those market forces aren’t at the level of the device manufacturers, who are often maligned for cost. This is really about the market forces at the level of hospitals and health systems.”

Session comoderator Megan Coylewright, MD, MPH, Erlanger Heart and Lung Institute, Chattanooga, Tenn., said, “I think that’s really well stated,” and noted that physicians may bear some responsibility as well.

“From a physician responsibility, especially for structural heart, we tended to all aggregate together, all of us that have structural heart training or that have trained in certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access. I think, as Dr. Giri said, there are a lot of solutions and that needs to be the focus for the next couple of years.”

Dr. Nathan reported having no relevant disclosures. Dr. Giri reported serving as a principal investigator for a research study for Boston Scientific, Inari Medical, Abbott, and Recor Medical; consulting for Boston Scientific; and serving on an advisory board for Inari Medical.

A version of this article first appeared on Medscape.com.