Heidi Splete

A teledermatology clinic pioneered by clinicians at George Washington University, Washington, to provide care for underserved populations will serve as a model for four other teledermatology clinics, according to a press release from the university.

Four institutions will receive grants to implement the George Washington University model, which involved partnering with a local organization to provide an entry point for individuals in areas with limited access to medical care, with support from Pfizer Global Medical Grants.

“Targeting those who lack access to quality-based care for inflammatory dermatologic conditions, including atopic dermatitis (AD) and others, the grants will reach communities in Miami-Dade County, Fla., Los Angeles County, Calif., rural communities in Oregon, and downtown Philadelphia,” according to the announcement. GW’s Teledermatology Free Clinic was conceived in the wake of the COVID-19 pandemic, which further highlighted disparities in access to dermatologic care, Adam Friedman, M.D., professor and chair of dermatology at George Washington University, said in the press release.

GW implemented its clinic for residents in underserved areas of Washington, D.C., in partnership with the Rodham Institute and the Temple of Praise Church. “We set up a free clinic at the church through which patients were integrated into the GW medical records system, provided instruction on telemedicine best practices, exposed to comprehensive education about AD and underwent a free telemedicine visit with a member of the department of dermatology,” Dr. Friedman explained.

Most participants – 70% – did not have a dermatologist, 94% were extremely satisfied with the experience, and 90% reported that the clinic had a significant impact on the management of their AD, according to the results of a recently published postengagement survey.

The following are the recipients of the “Quality Improvement Initiative: Bridging the Inflammatory Dermatosis Care Divide with Teledermatology Grant Program”:

• Scott Elman, MD, assistant professor of clinical dermatology and medical director of outpatient dermatology at the University of Miami and his team will create a clinic in partnership with Lotus House, a resource center and residential facility serving homeless women and infants, with focus on interventions in both English and Spanish.
• Nada Elbuluk, MD, associate professor of clinical dermatology and director of the Skin of Color and Pigmentary Disorders Program, at the University of Southern California, will lead a team to expand the role of two programs she created, Derm RISES, which targets inner city students, and Dermmunity, a community-based program that provides dermatology education to underserved communities in the Los Angeles area.
• Alex Ortega-Loayza, MD, associate professor of dermatology at Oregon Health & Science University and his team will partner with the Oregon Rural Practice-based Research Network to implement their teledermatology program at five clinics that serve different portions of rural and underserved communities across Oregon.
• Jules Lipoff, MD, clinical associate professor of dermatology, Temple University, Philadelphia, will lead a pilot program to establish a telemedicine dermatology clinic with Philadelphia FIGHT, a federally qualified health center in downtown Philadelphia where many patients lack high-speed Internet, and patients will be allowed direct access to telemedicine dermatology appointments within the primary care facility. The clinic’s patient population includes patients living with HIV, people who identify as LGBTQ+ and those who identify as trans or with a gender not matching their sex assigned at birth.

All four projects will complete postassessment surveys and quality assessment initiatives.

The GW clinic is ongoing, with plans for expansion and the establishment of additional programs with community partners in the Washington area, Dr. Friedman said in an interview.

“While these partnerships are in their infancy, I have high hopes that we will be able to impact even more individuals afflicted with dermatologic diseases and gain more insights into best practices for community engagement,” he added. “Many individuals who have come through our free clinic have followed up, by telehealth and/or in person at GW, depending on the clinical need to maintain continuity of care. In numerous cases, my impression is that this first point of contact is the key to ongoing treatment success, because it enables the access that may have been missing and engenders trust and confidence.”

A teledermatology clinic pioneered by clinicians at George Washington University, Washington, to provide care for underserved populations will serve as a model for four other teledermatology clinics, according to a press release from the university.

Four institutions will receive grants to implement the George Washington University model, which involved partnering with a local organization to provide an entry point for individuals in areas with limited access to medical care, with support from Pfizer Global Medical Grants.

“Targeting those who lack access to quality-based care for inflammatory dermatologic conditions, including atopic dermatitis (AD) and others, the grants will reach communities in Miami-Dade County, Fla., Los Angeles County, Calif., rural communities in Oregon, and downtown Philadelphia,” according to the announcement. GW’s Teledermatology Free Clinic was conceived in the wake of the COVID-19 pandemic, which further highlighted disparities in access to dermatologic care, Adam Friedman, M.D., professor and chair of dermatology at George Washington University, said in the press release.

GW implemented its clinic for residents in underserved areas of Washington, D.C., in partnership with the Rodham Institute and the Temple of Praise Church. “We set up a free clinic at the church through which patients were integrated into the GW medical records system, provided instruction on telemedicine best practices, exposed to comprehensive education about AD and underwent a free telemedicine visit with a member of the department of dermatology,” Dr. Friedman explained.

Most participants – 70% – did not have a dermatologist, 94% were extremely satisfied with the experience, and 90% reported that the clinic had a significant impact on the management of their AD, according to the results of a recently published postengagement survey.

The following are the recipients of the “Quality Improvement Initiative: Bridging the Inflammatory Dermatosis Care Divide with Teledermatology Grant Program”:

• Scott Elman, MD, assistant professor of clinical dermatology and medical director of outpatient dermatology at the University of Miami and his team will create a clinic in partnership with Lotus House, a resource center and residential facility serving homeless women and infants, with focus on interventions in both English and Spanish.
• Nada Elbuluk, MD, associate professor of clinical dermatology and director of the Skin of Color and Pigmentary Disorders Program, at the University of Southern California, will lead a team to expand the role of two programs she created, Derm RISES, which targets inner city students, and Dermmunity, a community-based program that provides dermatology education to underserved communities in the Los Angeles area.
• Alex Ortega-Loayza, MD, associate professor of dermatology at Oregon Health & Science University and his team will partner with the Oregon Rural Practice-based Research Network to implement their teledermatology program at five clinics that serve different portions of rural and underserved communities across Oregon.
• Jules Lipoff, MD, clinical associate professor of dermatology, Temple University, Philadelphia, will lead a pilot program to establish a telemedicine dermatology clinic with Philadelphia FIGHT, a federally qualified health center in downtown Philadelphia where many patients lack high-speed Internet, and patients will be allowed direct access to telemedicine dermatology appointments within the primary care facility. The clinic’s patient population includes patients living with HIV, people who identify as LGBTQ+ and those who identify as trans or with a gender not matching their sex assigned at birth.

All four projects will complete postassessment surveys and quality assessment initiatives.

The GW clinic is ongoing, with plans for expansion and the establishment of additional programs with community partners in the Washington area, Dr. Friedman said in an interview.

“While these partnerships are in their infancy, I have high hopes that we will be able to impact even more individuals afflicted with dermatologic diseases and gain more insights into best practices for community engagement,” he added. “Many individuals who have come through our free clinic have followed up, by telehealth and/or in person at GW, depending on the clinical need to maintain continuity of care. In numerous cases, my impression is that this first point of contact is the key to ongoing treatment success, because it enables the access that may have been missing and engenders trust and confidence.”

A teledermatology clinic pioneered by clinicians at George Washington University, Washington, to provide care for underserved populations will serve as a model for four other teledermatology clinics, according to a press release from the university.

Four institutions will receive grants to implement the George Washington University model, which involved partnering with a local organization to provide an entry point for individuals in areas with limited access to medical care, with support from Pfizer Global Medical Grants.

“Targeting those who lack access to quality-based care for inflammatory dermatologic conditions, including atopic dermatitis (AD) and others, the grants will reach communities in Miami-Dade County, Fla., Los Angeles County, Calif., rural communities in Oregon, and downtown Philadelphia,” according to the announcement. GW’s Teledermatology Free Clinic was conceived in the wake of the COVID-19 pandemic, which further highlighted disparities in access to dermatologic care, Adam Friedman, M.D., professor and chair of dermatology at George Washington University, said in the press release.

GW implemented its clinic for residents in underserved areas of Washington, D.C., in partnership with the Rodham Institute and the Temple of Praise Church. “We set up a free clinic at the church through which patients were integrated into the GW medical records system, provided instruction on telemedicine best practices, exposed to comprehensive education about AD and underwent a free telemedicine visit with a member of the department of dermatology,” Dr. Friedman explained.

Most participants – 70% – did not have a dermatologist, 94% were extremely satisfied with the experience, and 90% reported that the clinic had a significant impact on the management of their AD, according to the results of a recently published postengagement survey.

The following are the recipients of the “Quality Improvement Initiative: Bridging the Inflammatory Dermatosis Care Divide with Teledermatology Grant Program”:

• Scott Elman, MD, assistant professor of clinical dermatology and medical director of outpatient dermatology at the University of Miami and his team will create a clinic in partnership with Lotus House, a resource center and residential facility serving homeless women and infants, with focus on interventions in both English and Spanish.
• Nada Elbuluk, MD, associate professor of clinical dermatology and director of the Skin of Color and Pigmentary Disorders Program, at the University of Southern California, will lead a team to expand the role of two programs she created, Derm RISES, which targets inner city students, and Dermmunity, a community-based program that provides dermatology education to underserved communities in the Los Angeles area.
• Alex Ortega-Loayza, MD, associate professor of dermatology at Oregon Health & Science University and his team will partner with the Oregon Rural Practice-based Research Network to implement their teledermatology program at five clinics that serve different portions of rural and underserved communities across Oregon.
• Jules Lipoff, MD, clinical associate professor of dermatology, Temple University, Philadelphia, will lead a pilot program to establish a telemedicine dermatology clinic with Philadelphia FIGHT, a federally qualified health center in downtown Philadelphia where many patients lack high-speed Internet, and patients will be allowed direct access to telemedicine dermatology appointments within the primary care facility. The clinic’s patient population includes patients living with HIV, people who identify as LGBTQ+ and those who identify as trans or with a gender not matching their sex assigned at birth.

All four projects will complete postassessment surveys and quality assessment initiatives.

The GW clinic is ongoing, with plans for expansion and the establishment of additional programs with community partners in the Washington area, Dr. Friedman said in an interview.

“While these partnerships are in their infancy, I have high hopes that we will be able to impact even more individuals afflicted with dermatologic diseases and gain more insights into best practices for community engagement,” he added. “Many individuals who have come through our free clinic have followed up, by telehealth and/or in person at GW, depending on the clinical need to maintain continuity of care. In numerous cases, my impression is that this first point of contact is the key to ongoing treatment success, because it enables the access that may have been missing and engenders trust and confidence.”

TOPLINE:

The prevalence of reported diagnosed arthritis in the United States is highest overall in older adults with comorbid chronic conditions.

METHODOLOGY:

• Researchers reviewed data from the National Health Interview Survey (NHIS) from 2019 to 2021 to update the prevalence of self-reported arthritis in the United States.
• The sample sizes for the 2019, 2020, and 2021 NHIS were 31,997, 21,153, and 29,482, with survey response rates of 59.1%, 48.9%, and 50.9%, respectively.
• The unadjusted and age-standardized prevalence estimates were calculated for adults aged 18 years and older and based on self-reported health and demographic data.

TAKEAWAY:

• Overall, arthritis was diagnosed in 53.2 million adults aged 18 years and older in the United States; of these, 88.3% were aged 45 years and older and 48.3% were 65 years and older.
• Age-standardized prevalence of arthritis was higher in women vs men and among veterans vs nonveterans (20.9% vs 16.3% and 24.2% vs 18.5%, respectively).
• When categorized by race, age-standardized prevalence of arthritis was higher among non-Hispanic White individuals, compared with Hispanic or Latino individuals or non-Hispanic Asian individuals (20.1%, 14.7%, and 10.3%, respectively).
• The prevalence of arthritis also was higher among individuals with self-reported diagnosis of chronic conditions including dementia, chronic obstructive pulmonary disease, stroke, heart disease, diabetes, and cancer than in those without these conditions; approximately half of adults aged 65 years and older with arthritis reported at least one of these conditions.

IN PRACTICE:

“These prevalence estimates can be used to guide public health policies and activities to increase equitable access to physical activity opportunities within the built environment and other community-based, arthritis-appropriate, evidence-based interventions,” the authors write.

SOURCE:

The study was led by Elizabeth A. Fallon, PhD, of the Centers for Disease Control and Prevention, Atlanta, Georgia. The data were published online in the CDC’s Morbidity and Mortality Weekly Report.  

LIMITATIONS:

The cross-sectional design prevented conclusions of causality between individual characteristics and arthritis diagnosis; other limitations included the reliance on self-reports, possible response bias, and the inability to calculate prevalence of arthritis subtypes. 

DISCLOSURES:

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

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

TOPLINE:

The prevalence of reported diagnosed arthritis in the United States is highest overall in older adults with comorbid chronic conditions.

METHODOLOGY:

• Researchers reviewed data from the National Health Interview Survey (NHIS) from 2019 to 2021 to update the prevalence of self-reported arthritis in the United States.
• The sample sizes for the 2019, 2020, and 2021 NHIS were 31,997, 21,153, and 29,482, with survey response rates of 59.1%, 48.9%, and 50.9%, respectively.
• The unadjusted and age-standardized prevalence estimates were calculated for adults aged 18 years and older and based on self-reported health and demographic data.

TAKEAWAY:

• Overall, arthritis was diagnosed in 53.2 million adults aged 18 years and older in the United States; of these, 88.3% were aged 45 years and older and 48.3% were 65 years and older.
• Age-standardized prevalence of arthritis was higher in women vs men and among veterans vs nonveterans (20.9% vs 16.3% and 24.2% vs 18.5%, respectively).
• When categorized by race, age-standardized prevalence of arthritis was higher among non-Hispanic White individuals, compared with Hispanic or Latino individuals or non-Hispanic Asian individuals (20.1%, 14.7%, and 10.3%, respectively).
• The prevalence of arthritis also was higher among individuals with self-reported diagnosis of chronic conditions including dementia, chronic obstructive pulmonary disease, stroke, heart disease, diabetes, and cancer than in those without these conditions; approximately half of adults aged 65 years and older with arthritis reported at least one of these conditions.

IN PRACTICE:

“These prevalence estimates can be used to guide public health policies and activities to increase equitable access to physical activity opportunities within the built environment and other community-based, arthritis-appropriate, evidence-based interventions,” the authors write.

SOURCE:

The study was led by Elizabeth A. Fallon, PhD, of the Centers for Disease Control and Prevention, Atlanta, Georgia. The data were published online in the CDC’s Morbidity and Mortality Weekly Report.  

LIMITATIONS:

The cross-sectional design prevented conclusions of causality between individual characteristics and arthritis diagnosis; other limitations included the reliance on self-reports, possible response bias, and the inability to calculate prevalence of arthritis subtypes. 

DISCLOSURES:

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

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

TOPLINE:

The prevalence of reported diagnosed arthritis in the United States is highest overall in older adults with comorbid chronic conditions.

METHODOLOGY:

• Researchers reviewed data from the National Health Interview Survey (NHIS) from 2019 to 2021 to update the prevalence of self-reported arthritis in the United States.
• The sample sizes for the 2019, 2020, and 2021 NHIS were 31,997, 21,153, and 29,482, with survey response rates of 59.1%, 48.9%, and 50.9%, respectively.
• The unadjusted and age-standardized prevalence estimates were calculated for adults aged 18 years and older and based on self-reported health and demographic data.

TAKEAWAY:

• Overall, arthritis was diagnosed in 53.2 million adults aged 18 years and older in the United States; of these, 88.3% were aged 45 years and older and 48.3% were 65 years and older.
• Age-standardized prevalence of arthritis was higher in women vs men and among veterans vs nonveterans (20.9% vs 16.3% and 24.2% vs 18.5%, respectively).
• When categorized by race, age-standardized prevalence of arthritis was higher among non-Hispanic White individuals, compared with Hispanic or Latino individuals or non-Hispanic Asian individuals (20.1%, 14.7%, and 10.3%, respectively).
• The prevalence of arthritis also was higher among individuals with self-reported diagnosis of chronic conditions including dementia, chronic obstructive pulmonary disease, stroke, heart disease, diabetes, and cancer than in those without these conditions; approximately half of adults aged 65 years and older with arthritis reported at least one of these conditions.

IN PRACTICE:

“These prevalence estimates can be used to guide public health policies and activities to increase equitable access to physical activity opportunities within the built environment and other community-based, arthritis-appropriate, evidence-based interventions,” the authors write.

SOURCE:

The study was led by Elizabeth A. Fallon, PhD, of the Centers for Disease Control and Prevention, Atlanta, Georgia. The data were published online in the CDC’s Morbidity and Mortality Weekly Report.  

LIMITATIONS:

The cross-sectional design prevented conclusions of causality between individual characteristics and arthritis diagnosis; other limitations included the reliance on self-reports, possible response bias, and the inability to calculate prevalence of arthritis subtypes. 

DISCLOSURES:

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

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

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.

TOPLINE:

In combination with methotrexate, both abatacept (Orencia) and certolizumab pegol (Cimzia), but not tocilizumab (Actemra), showed superiority over different combinations of active conventional disease-modifying antirheumatic drugs (DMARDs) for promoting remission in patients with early, untreated rheumatoid arthritis.

METHODOLOGY:

The study population included 812 adults from sites in six European countries who had treatment-naive early RA (less than 24 months’ duration) and moderate to severe disease.

Participants were randomly assigned to open-label treatment with methotrexate plus one of four treatments:

• Active conventional therapy (oral , tapered quickly and discontinued after 9 months, or , hydroxychloroquine, and intra-articular glucocorticoid injections in swollen joints).
• Certolizumab pegol.
• Abatacept.
• Tocilizumab.

In all the biologic-treated groups, intra-articular glucocorticoid injections were allowed on demand up to week 12; thereafter, up to 40 mg were allowed every 12 weeks. In all groups, intra-articular glucocorticoids were prohibited in weeks 20-24 and weeks 44-48 to minimize their influence on week 24 and week 48 outcomes.

TAKEAWAY:

• Clinical remission rates at week 48 based on Clinical Disease Activity Index scores of 2.8 or less were 59.3% with abatacept and 52.3% with certolizumab, which were significantly greater than the rate of 39.2% seen with active conventional therapy. The 51.9% rate seen with tocilizumab was not superior to active conventional therapy.
• The co–primary outcome of change in van der Heijde-modified Sharp Score from baseline to week 48 was relatively low across all groups: 0.45 for active conventional therapy, and 0.62, 0.47, and 0.50 for abatacept, certolizumab pegol, and tocilizumab, respectively.
• No new safety signals appeared, nor did any significantly increased risk associated with glucocorticoid use; at least one adverse event was reported in 88.3%, 89.6%, 85.8%, and 96.7% of patients taking conventional therapy, certolizumab pegol, abatacept, and tocilizumab, respectively.

IN PRACTICE:

The results suggest that both abatacept and certolizumab pegol yield higher remission rates than optimized conventional therapy, and “should be considered when the management of patients with newly diagnosed RA is decided, both in clinical practice and in treatment recommendations,” the authors write.

SOURCE:

The lead author on the study was Mikkel Østergaard, MD, PhD, of the Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen. The study was published online in Annals of the Rheumatic Disease.  

LIMITATIONS:

The open-label study design could influence some subjective outcomes, and conventional therapy included two slightly different strategies based on national recommendations for the individual countries.

DISCLOSURES:

The study was funded by multiple public sources to centers from countries participating in the study, as well as the Icelandic Society for Rheumatology, the Swedish Rheumatism Association, and the Research Fund of University Hospital, Reykjavik, Iceland. UCB and Bristol-Myers Squibb provided certolizumab pegol and abatacept, respectively, at no cost, but were not otherwise involved in the study. Many authors, including Dr. Østergaard, report financial relationships with multiple pharmaceutical companies. The full list can be found with the original article.

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

TOPLINE:

In combination with methotrexate, both abatacept (Orencia) and certolizumab pegol (Cimzia), but not tocilizumab (Actemra), showed superiority over different combinations of active conventional disease-modifying antirheumatic drugs (DMARDs) for promoting remission in patients with early, untreated rheumatoid arthritis.

METHODOLOGY:

The study population included 812 adults from sites in six European countries who had treatment-naive early RA (less than 24 months’ duration) and moderate to severe disease.

Participants were randomly assigned to open-label treatment with methotrexate plus one of four treatments:

• Active conventional therapy (oral , tapered quickly and discontinued after 9 months, or , hydroxychloroquine, and intra-articular glucocorticoid injections in swollen joints).
• Certolizumab pegol.
• Abatacept.
• Tocilizumab.

In all the biologic-treated groups, intra-articular glucocorticoid injections were allowed on demand up to week 12; thereafter, up to 40 mg were allowed every 12 weeks. In all groups, intra-articular glucocorticoids were prohibited in weeks 20-24 and weeks 44-48 to minimize their influence on week 24 and week 48 outcomes.

TAKEAWAY:

• Clinical remission rates at week 48 based on Clinical Disease Activity Index scores of 2.8 or less were 59.3% with abatacept and 52.3% with certolizumab, which were significantly greater than the rate of 39.2% seen with active conventional therapy. The 51.9% rate seen with tocilizumab was not superior to active conventional therapy.
• The co–primary outcome of change in van der Heijde-modified Sharp Score from baseline to week 48 was relatively low across all groups: 0.45 for active conventional therapy, and 0.62, 0.47, and 0.50 for abatacept, certolizumab pegol, and tocilizumab, respectively.
• No new safety signals appeared, nor did any significantly increased risk associated with glucocorticoid use; at least one adverse event was reported in 88.3%, 89.6%, 85.8%, and 96.7% of patients taking conventional therapy, certolizumab pegol, abatacept, and tocilizumab, respectively.

IN PRACTICE:

The results suggest that both abatacept and certolizumab pegol yield higher remission rates than optimized conventional therapy, and “should be considered when the management of patients with newly diagnosed RA is decided, both in clinical practice and in treatment recommendations,” the authors write.

SOURCE:

The lead author on the study was Mikkel Østergaard, MD, PhD, of the Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen. The study was published online in Annals of the Rheumatic Disease.  

LIMITATIONS:

The open-label study design could influence some subjective outcomes, and conventional therapy included two slightly different strategies based on national recommendations for the individual countries.

DISCLOSURES:

The study was funded by multiple public sources to centers from countries participating in the study, as well as the Icelandic Society for Rheumatology, the Swedish Rheumatism Association, and the Research Fund of University Hospital, Reykjavik, Iceland. UCB and Bristol-Myers Squibb provided certolizumab pegol and abatacept, respectively, at no cost, but were not otherwise involved in the study. Many authors, including Dr. Østergaard, report financial relationships with multiple pharmaceutical companies. The full list can be found with the original article.

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

TOPLINE:

In combination with methotrexate, both abatacept (Orencia) and certolizumab pegol (Cimzia), but not tocilizumab (Actemra), showed superiority over different combinations of active conventional disease-modifying antirheumatic drugs (DMARDs) for promoting remission in patients with early, untreated rheumatoid arthritis.

METHODOLOGY:

The study population included 812 adults from sites in six European countries who had treatment-naive early RA (less than 24 months’ duration) and moderate to severe disease.

Participants were randomly assigned to open-label treatment with methotrexate plus one of four treatments:

• Active conventional therapy (oral , tapered quickly and discontinued after 9 months, or , hydroxychloroquine, and intra-articular glucocorticoid injections in swollen joints).
• Certolizumab pegol.
• Abatacept.
• Tocilizumab.

In all the biologic-treated groups, intra-articular glucocorticoid injections were allowed on demand up to week 12; thereafter, up to 40 mg were allowed every 12 weeks. In all groups, intra-articular glucocorticoids were prohibited in weeks 20-24 and weeks 44-48 to minimize their influence on week 24 and week 48 outcomes.

TAKEAWAY:

• Clinical remission rates at week 48 based on Clinical Disease Activity Index scores of 2.8 or less were 59.3% with abatacept and 52.3% with certolizumab, which were significantly greater than the rate of 39.2% seen with active conventional therapy. The 51.9% rate seen with tocilizumab was not superior to active conventional therapy.
• The co–primary outcome of change in van der Heijde-modified Sharp Score from baseline to week 48 was relatively low across all groups: 0.45 for active conventional therapy, and 0.62, 0.47, and 0.50 for abatacept, certolizumab pegol, and tocilizumab, respectively.
• No new safety signals appeared, nor did any significantly increased risk associated with glucocorticoid use; at least one adverse event was reported in 88.3%, 89.6%, 85.8%, and 96.7% of patients taking conventional therapy, certolizumab pegol, abatacept, and tocilizumab, respectively.

IN PRACTICE:

The results suggest that both abatacept and certolizumab pegol yield higher remission rates than optimized conventional therapy, and “should be considered when the management of patients with newly diagnosed RA is decided, both in clinical practice and in treatment recommendations,” the authors write.

SOURCE:

The lead author on the study was Mikkel Østergaard, MD, PhD, of the Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen. The study was published online in Annals of the Rheumatic Disease.  

LIMITATIONS:

The open-label study design could influence some subjective outcomes, and conventional therapy included two slightly different strategies based on national recommendations for the individual countries.

DISCLOSURES:

The study was funded by multiple public sources to centers from countries participating in the study, as well as the Icelandic Society for Rheumatology, the Swedish Rheumatism Association, and the Research Fund of University Hospital, Reykjavik, Iceland. UCB and Bristol-Myers Squibb provided certolizumab pegol and abatacept, respectively, at no cost, but were not otherwise involved in the study. Many authors, including Dr. Østergaard, report financial relationships with multiple pharmaceutical companies. The full list can be found with the original article.

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

TOPLINE:

A topical fixed-dose combination of three approved acne treatments significantly improves moderate to severe acne with a strong safety profile.

METHODOLOGY:

• The two multicenter studies included 363 individuals aged 9 years and older with moderate to severe acne from 30 centers, including 15 in North America.
• Moderate to severe acne was defined as having 30-100 inflammatory lesions (papules, pustules, or nodules), 35-150 noninflammatory lesions (open or closed comedones), and at least two nodules.
• Participants were randomly assigned to receive treatment with a combination gel containing  phosphate 1.2%,  0.15%, and  3.1% (known as IDP-126) or a vehicle gel for once-daily application for 12 weeks.
• Treatment success was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) and lesion counts of clear (0) or almost clear (1) at weeks 2, 4, 8, and 12.

TAKEAWAY:

• Treatment success occurred in 49.6% of the IDP-126 group, vs 24.9% of the vehicle group in study 1, and in 50.5% of the IDP-126 group, vs 20.5% of the vehicle group in study 2. Overall treatment compliance was 93.7% and 91.3% for studies 1 and 2, respectively (P < .01 for both).
• Patients in the IDP-126 groups for both studies 1 and 2 had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12 compared to the vehicle patients (P ≤ .001 for all).
• Significantly more patients in the IDP-126 group achieved a grade reduction of 2 or more in EGSS compared with those who received the vehicle, with treatment differences of approximately 32% in both studies. Changes in lesion reductions between the treatment and the vehicle groups were significantly greater as early as week 4.
• The most common treatment-related adverse events among patients treated with IDP-126 were erythema, application-site pain, dryness, irritation, and exfoliation. Discontinuation of the study drug as a result of adverse events occurred in 2.5% and 3.3% of these patients in studies 1 and 2, respectively.

IN PRACTICE:

“With its simple treatment regimen containing 3 recommended acne treatments (benzoyl peroxide, a topical retinoid, and a topical antibiotic), IDP-126 is a potential new treatment option for acne,” the researchers concluded.

SOURCE:

The study was led by Linda Stein Gold, MD, of Henry Ford Hospital, Detroit. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

In both studies, treatment duration was short, and the studies may not reflect patients’ real-world experiences. The results may be affected by interobserver bias or variation in assessment of acne severity.

DISCLOSURES:

Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. Other study coauthors have relationships with multiple companies, including Ortho Dermatologics, which provided medical writing support for the study.

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

TOPLINE:

A topical fixed-dose combination of three approved acne treatments significantly improves moderate to severe acne with a strong safety profile.

METHODOLOGY:

• The two multicenter studies included 363 individuals aged 9 years and older with moderate to severe acne from 30 centers, including 15 in North America.
• Moderate to severe acne was defined as having 30-100 inflammatory lesions (papules, pustules, or nodules), 35-150 noninflammatory lesions (open or closed comedones), and at least two nodules.
• Participants were randomly assigned to receive treatment with a combination gel containing  phosphate 1.2%,  0.15%, and  3.1% (known as IDP-126) or a vehicle gel for once-daily application for 12 weeks.
• Treatment success was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) and lesion counts of clear (0) or almost clear (1) at weeks 2, 4, 8, and 12.

TAKEAWAY:

• Treatment success occurred in 49.6% of the IDP-126 group, vs 24.9% of the vehicle group in study 1, and in 50.5% of the IDP-126 group, vs 20.5% of the vehicle group in study 2. Overall treatment compliance was 93.7% and 91.3% for studies 1 and 2, respectively (P < .01 for both).
• Patients in the IDP-126 groups for both studies 1 and 2 had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12 compared to the vehicle patients (P ≤ .001 for all).
• Significantly more patients in the IDP-126 group achieved a grade reduction of 2 or more in EGSS compared with those who received the vehicle, with treatment differences of approximately 32% in both studies. Changes in lesion reductions between the treatment and the vehicle groups were significantly greater as early as week 4.
• The most common treatment-related adverse events among patients treated with IDP-126 were erythema, application-site pain, dryness, irritation, and exfoliation. Discontinuation of the study drug as a result of adverse events occurred in 2.5% and 3.3% of these patients in studies 1 and 2, respectively.

IN PRACTICE:

“With its simple treatment regimen containing 3 recommended acne treatments (benzoyl peroxide, a topical retinoid, and a topical antibiotic), IDP-126 is a potential new treatment option for acne,” the researchers concluded.

SOURCE:

The study was led by Linda Stein Gold, MD, of Henry Ford Hospital, Detroit. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

In both studies, treatment duration was short, and the studies may not reflect patients’ real-world experiences. The results may be affected by interobserver bias or variation in assessment of acne severity.

DISCLOSURES:

Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. Other study coauthors have relationships with multiple companies, including Ortho Dermatologics, which provided medical writing support for the study.

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

TOPLINE:

A topical fixed-dose combination of three approved acne treatments significantly improves moderate to severe acne with a strong safety profile.

METHODOLOGY:

• The two multicenter studies included 363 individuals aged 9 years and older with moderate to severe acne from 30 centers, including 15 in North America.
• Moderate to severe acne was defined as having 30-100 inflammatory lesions (papules, pustules, or nodules), 35-150 noninflammatory lesions (open or closed comedones), and at least two nodules.
• Participants were randomly assigned to receive treatment with a combination gel containing  phosphate 1.2%,  0.15%, and  3.1% (known as IDP-126) or a vehicle gel for once-daily application for 12 weeks.
• Treatment success was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) and lesion counts of clear (0) or almost clear (1) at weeks 2, 4, 8, and 12.

TAKEAWAY:

• Treatment success occurred in 49.6% of the IDP-126 group, vs 24.9% of the vehicle group in study 1, and in 50.5% of the IDP-126 group, vs 20.5% of the vehicle group in study 2. Overall treatment compliance was 93.7% and 91.3% for studies 1 and 2, respectively (P < .01 for both).
• Patients in the IDP-126 groups for both studies 1 and 2 had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12 compared to the vehicle patients (P ≤ .001 for all).
• Significantly more patients in the IDP-126 group achieved a grade reduction of 2 or more in EGSS compared with those who received the vehicle, with treatment differences of approximately 32% in both studies. Changes in lesion reductions between the treatment and the vehicle groups were significantly greater as early as week 4.
• The most common treatment-related adverse events among patients treated with IDP-126 were erythema, application-site pain, dryness, irritation, and exfoliation. Discontinuation of the study drug as a result of adverse events occurred in 2.5% and 3.3% of these patients in studies 1 and 2, respectively.

IN PRACTICE:

“With its simple treatment regimen containing 3 recommended acne treatments (benzoyl peroxide, a topical retinoid, and a topical antibiotic), IDP-126 is a potential new treatment option for acne,” the researchers concluded.

SOURCE:

The study was led by Linda Stein Gold, MD, of Henry Ford Hospital, Detroit. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

In both studies, treatment duration was short, and the studies may not reflect patients’ real-world experiences. The results may be affected by interobserver bias or variation in assessment of acne severity.

DISCLOSURES:

Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. Other study coauthors have relationships with multiple companies, including Ortho Dermatologics, which provided medical writing support for the study.

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

Routine screening for depression and anxiety at each primary care clinical encounter in order to meet performance metrics could compromise accuracy and clinical care, based on data from more than 380,000 individuals in primary care.

“Prioritizing repetition of intake screening questionnaires at primary care visits may have unintended consequences such as administrative burden, provision of low-value care, and reduced clinical capacity to deliver other, high-value services,” but the accuracy of workflow-based intake screening on subsequent diagnosis has not been explored, wrote Jodi Simon, DrPH, of AllianceChicago, Ill., and colleagues.

In a study published in the Annals of Family Medicine, the researchers reviewed data from screenings performed on 380,057 patients in primary care settings. They examined the accuracy and utility of the Patient Health Questionnaire (PHQ-2) for depression and the Generalized Anxiety Disorder 2 (GAD-2) for anxiety.

The data included 1,883,317 screenings with PHQ-2s and 1,573,107 with GAD-2s. Of these, 92.3% of PHQ-2 screenings and 91.4% of GAD-2 screenings indicated low likelihood of depression or anxiety (defined as cumulative scores of 0 or 1). Mean scores for the PHQ-2 and GAD-2 in the study population were 0.29 and 0.35, respectively.

In the current study, 11% of patients had positive PHQ-2 scores (defined as 2 or higher) vs. 47%-53% seen in previous studies and census data.

In an analysis of new diagnoses of depression and anxiety, the researchers found that 42.3% of patients with a new depression diagnosis were not identified on intake screening; they had scores of 0 or 1 on the PHQ-2 in the past 30 days. Similarly, 42.7% of patients with a new anxiety diagnosis had scores of 0 or 1 on the GAD-2 in the past 30 days.

In other words, “Screening only detected risk in 57.7% of patients subsequently diagnosed with depression and 57.3% of patients subsequently diagnosed with anxiety,” the researchers said. This low positivity rate in patients diagnosed within 30 days merits further research, they added.

More studies are needed, but preliminary interviews with patients, clinicians, and staff indicate that time constraints and variation in the administration of questionnaires are among the factors contributing to inaccurate screening, the researchers noted.

The current study results suggest that screenings for anxiety and depression may occur in a perfunctory or inconsistent manner that might compromise accuracy when they are part of the workflow for each clinical visit in order to meet performance metrics, they said. “Ineffective screening may unintentionally detract from clinical care because care teams and patients have less time and cognitive energy to focus on other priorities during busy clinical encounters,” they added.

Alternatively, screening for anxiety and depression at regular intervals rather than each clinical encounter could improve reliability, the researchers concluded.

The study was funded by the American Medical Association Transformation Initiative. The researchers had no financial conflicts to disclose.

Routine screening for depression and anxiety at each primary care clinical encounter in order to meet performance metrics could compromise accuracy and clinical care, based on data from more than 380,000 individuals in primary care.

“Prioritizing repetition of intake screening questionnaires at primary care visits may have unintended consequences such as administrative burden, provision of low-value care, and reduced clinical capacity to deliver other, high-value services,” but the accuracy of workflow-based intake screening on subsequent diagnosis has not been explored, wrote Jodi Simon, DrPH, of AllianceChicago, Ill., and colleagues.

In a study published in the Annals of Family Medicine, the researchers reviewed data from screenings performed on 380,057 patients in primary care settings. They examined the accuracy and utility of the Patient Health Questionnaire (PHQ-2) for depression and the Generalized Anxiety Disorder 2 (GAD-2) for anxiety.

The data included 1,883,317 screenings with PHQ-2s and 1,573,107 with GAD-2s. Of these, 92.3% of PHQ-2 screenings and 91.4% of GAD-2 screenings indicated low likelihood of depression or anxiety (defined as cumulative scores of 0 or 1). Mean scores for the PHQ-2 and GAD-2 in the study population were 0.29 and 0.35, respectively.

In the current study, 11% of patients had positive PHQ-2 scores (defined as 2 or higher) vs. 47%-53% seen in previous studies and census data.

In an analysis of new diagnoses of depression and anxiety, the researchers found that 42.3% of patients with a new depression diagnosis were not identified on intake screening; they had scores of 0 or 1 on the PHQ-2 in the past 30 days. Similarly, 42.7% of patients with a new anxiety diagnosis had scores of 0 or 1 on the GAD-2 in the past 30 days.

In other words, “Screening only detected risk in 57.7% of patients subsequently diagnosed with depression and 57.3% of patients subsequently diagnosed with anxiety,” the researchers said. This low positivity rate in patients diagnosed within 30 days merits further research, they added.

More studies are needed, but preliminary interviews with patients, clinicians, and staff indicate that time constraints and variation in the administration of questionnaires are among the factors contributing to inaccurate screening, the researchers noted.

The current study results suggest that screenings for anxiety and depression may occur in a perfunctory or inconsistent manner that might compromise accuracy when they are part of the workflow for each clinical visit in order to meet performance metrics, they said. “Ineffective screening may unintentionally detract from clinical care because care teams and patients have less time and cognitive energy to focus on other priorities during busy clinical encounters,” they added.

Alternatively, screening for anxiety and depression at regular intervals rather than each clinical encounter could improve reliability, the researchers concluded.

The study was funded by the American Medical Association Transformation Initiative. The researchers had no financial conflicts to disclose.

Routine screening for depression and anxiety at each primary care clinical encounter in order to meet performance metrics could compromise accuracy and clinical care, based on data from more than 380,000 individuals in primary care.

“Prioritizing repetition of intake screening questionnaires at primary care visits may have unintended consequences such as administrative burden, provision of low-value care, and reduced clinical capacity to deliver other, high-value services,” but the accuracy of workflow-based intake screening on subsequent diagnosis has not been explored, wrote Jodi Simon, DrPH, of AllianceChicago, Ill., and colleagues.

In a study published in the Annals of Family Medicine, the researchers reviewed data from screenings performed on 380,057 patients in primary care settings. They examined the accuracy and utility of the Patient Health Questionnaire (PHQ-2) for depression and the Generalized Anxiety Disorder 2 (GAD-2) for anxiety.

The data included 1,883,317 screenings with PHQ-2s and 1,573,107 with GAD-2s. Of these, 92.3% of PHQ-2 screenings and 91.4% of GAD-2 screenings indicated low likelihood of depression or anxiety (defined as cumulative scores of 0 or 1). Mean scores for the PHQ-2 and GAD-2 in the study population were 0.29 and 0.35, respectively.

In the current study, 11% of patients had positive PHQ-2 scores (defined as 2 or higher) vs. 47%-53% seen in previous studies and census data.

In an analysis of new diagnoses of depression and anxiety, the researchers found that 42.3% of patients with a new depression diagnosis were not identified on intake screening; they had scores of 0 or 1 on the PHQ-2 in the past 30 days. Similarly, 42.7% of patients with a new anxiety diagnosis had scores of 0 or 1 on the GAD-2 in the past 30 days.

In other words, “Screening only detected risk in 57.7% of patients subsequently diagnosed with depression and 57.3% of patients subsequently diagnosed with anxiety,” the researchers said. This low positivity rate in patients diagnosed within 30 days merits further research, they added.

More studies are needed, but preliminary interviews with patients, clinicians, and staff indicate that time constraints and variation in the administration of questionnaires are among the factors contributing to inaccurate screening, the researchers noted.

The current study results suggest that screenings for anxiety and depression may occur in a perfunctory or inconsistent manner that might compromise accuracy when they are part of the workflow for each clinical visit in order to meet performance metrics, they said. “Ineffective screening may unintentionally detract from clinical care because care teams and patients have less time and cognitive energy to focus on other priorities during busy clinical encounters,” they added.

Alternatively, screening for anxiety and depression at regular intervals rather than each clinical encounter could improve reliability, the researchers concluded.

The study was funded by the American Medical Association Transformation Initiative. The researchers had no financial conflicts to disclose.

TOPLINE:

Among pediatric patients with psoriasis, Black children and male children are significantly more likely to have palmoplantar psoriasis.

METHODOLOGY:

• Researchers reviewed data on 330 children and youths aged 0-18 years who had received a primary psoriasis diagnosis and who were seen at an academic pediatric dermatology clinic from 2012 to 2022. Among these patients, 50 cases of palmoplantar psoriasis (PP) were identified by pediatric dermatologists.
• The study population was stratified by race/ethnicity on the basis of self-identification. The cohort included White, Black, and Hispanic/Latino patients, as well as patients who identified as other; 71.5% were White persons, 59.1% were female patients.
• The researchers used a regression analysis to investigate the association between race/ethnicity and PP after controlling for multiple confounding variables, including age and gender.

TAKEAWAY:

• Black children were significantly more likely to have PP than White children (adjusted odds ratio, 6.386; P < .0001). PP was diagnosed in 41.9%, 11.5%, and 8.9% of Black, Hispanic/Latino, and White children, respectively.
• Male gender was also identified as an independent risk factor for PP (aOR, 2.241).
• Nail involvement occurred in significantly more Black and Hispanic/Latino patients than in White patients (53.2%, 50.0%, and 33.9%, respectively).
• Black patients had significantly more palm and sole involvement, compared with the other groups (P < .0001 for both); however, White children had significantly more scalp involvement, compared with the other groups (P = .04).

IN PRACTICE:

“Further research is warranted to better understand the degree to which these associations are affected by racial disparities and environmental factors,” as well as potential genetic associations, the researchers noted.

SOURCE:

The corresponding author on the study was Amy Theos, MD, of the department of dermatology at the University of Alabama, Birmingham. The study was published online in Pediatric Dermatology.

LIMITATIONS:

The findings were limited by the small sample size and incomplete data for some patients.

DISCLOSURES:

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

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

TOPLINE:

Among pediatric patients with psoriasis, Black children and male children are significantly more likely to have palmoplantar psoriasis.

METHODOLOGY:

• Researchers reviewed data on 330 children and youths aged 0-18 years who had received a primary psoriasis diagnosis and who were seen at an academic pediatric dermatology clinic from 2012 to 2022. Among these patients, 50 cases of palmoplantar psoriasis (PP) were identified by pediatric dermatologists.
• The study population was stratified by race/ethnicity on the basis of self-identification. The cohort included White, Black, and Hispanic/Latino patients, as well as patients who identified as other; 71.5% were White persons, 59.1% were female patients.
• The researchers used a regression analysis to investigate the association between race/ethnicity and PP after controlling for multiple confounding variables, including age and gender.

TAKEAWAY:

• Black children were significantly more likely to have PP than White children (adjusted odds ratio, 6.386; P < .0001). PP was diagnosed in 41.9%, 11.5%, and 8.9% of Black, Hispanic/Latino, and White children, respectively.
• Male gender was also identified as an independent risk factor for PP (aOR, 2.241).
• Nail involvement occurred in significantly more Black and Hispanic/Latino patients than in White patients (53.2%, 50.0%, and 33.9%, respectively).
• Black patients had significantly more palm and sole involvement, compared with the other groups (P < .0001 for both); however, White children had significantly more scalp involvement, compared with the other groups (P = .04).

IN PRACTICE:

“Further research is warranted to better understand the degree to which these associations are affected by racial disparities and environmental factors,” as well as potential genetic associations, the researchers noted.

SOURCE:

The corresponding author on the study was Amy Theos, MD, of the department of dermatology at the University of Alabama, Birmingham. The study was published online in Pediatric Dermatology.

LIMITATIONS:

The findings were limited by the small sample size and incomplete data for some patients.

DISCLOSURES:

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

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

TOPLINE:

Among pediatric patients with psoriasis, Black children and male children are significantly more likely to have palmoplantar psoriasis.

METHODOLOGY:

• Researchers reviewed data on 330 children and youths aged 0-18 years who had received a primary psoriasis diagnosis and who were seen at an academic pediatric dermatology clinic from 2012 to 2022. Among these patients, 50 cases of palmoplantar psoriasis (PP) were identified by pediatric dermatologists.
• The study population was stratified by race/ethnicity on the basis of self-identification. The cohort included White, Black, and Hispanic/Latino patients, as well as patients who identified as other; 71.5% were White persons, 59.1% were female patients.
• The researchers used a regression analysis to investigate the association between race/ethnicity and PP after controlling for multiple confounding variables, including age and gender.

TAKEAWAY:

• Black children were significantly more likely to have PP than White children (adjusted odds ratio, 6.386; P < .0001). PP was diagnosed in 41.9%, 11.5%, and 8.9% of Black, Hispanic/Latino, and White children, respectively.
• Male gender was also identified as an independent risk factor for PP (aOR, 2.241).
• Nail involvement occurred in significantly more Black and Hispanic/Latino patients than in White patients (53.2%, 50.0%, and 33.9%, respectively).
• Black patients had significantly more palm and sole involvement, compared with the other groups (P < .0001 for both); however, White children had significantly more scalp involvement, compared with the other groups (P = .04).

IN PRACTICE:

“Further research is warranted to better understand the degree to which these associations are affected by racial disparities and environmental factors,” as well as potential genetic associations, the researchers noted.

SOURCE:

The corresponding author on the study was Amy Theos, MD, of the department of dermatology at the University of Alabama, Birmingham. The study was published online in Pediatric Dermatology.

LIMITATIONS:

The findings were limited by the small sample size and incomplete data for some patients.

DISCLOSURES:

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

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

TOPLINE:

Approximately one-third of women with rheumatic diseases develop anemia by the third trimester of pregnancy, and two-thirds are iron deficient, according to findings from a longitudinal cohort study.

METHODOLOGY:

• Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
• Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
• Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.

TAKEAWAY:

• The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
• The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
• There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
• Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).

IN PRACTICE:

“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.

SOURCE:

The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.

LIMITATIONS:

The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.

DISCLOSURES:

The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.

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

TOPLINE:

Approximately one-third of women with rheumatic diseases develop anemia by the third trimester of pregnancy, and two-thirds are iron deficient, according to findings from a longitudinal cohort study.

METHODOLOGY:

• Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
• Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
• Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.

TAKEAWAY:

• The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
• The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
• There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
• Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).

IN PRACTICE:

“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.

SOURCE:

The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.

LIMITATIONS:

The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.

DISCLOSURES:

The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.

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

TOPLINE:

Approximately one-third of women with rheumatic diseases develop anemia by the third trimester of pregnancy, and two-thirds are iron deficient, according to findings from a longitudinal cohort study.

METHODOLOGY:

• Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
• Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
• Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.

TAKEAWAY:

• The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
• The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
• There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
• Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).

IN PRACTICE:

“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.

SOURCE:

The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.

LIMITATIONS:

The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.

DISCLOSURES:

The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.

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

College-aged women ranked health care providers, the Internet, and school resources as their top resources for seeking information about direct-to-consumer screening for sexually transmitted infections, based on surveys from 92 individuals.

University of North Texas Health Science Center

Direct-to-consumer (DTC) sexually transmitted infection (STI) screening methods involve the use of self-collected samples outside of a clinical setting, and may help reach women who avoid screening or lack access to clinical care, wrote Stacey B. Griner, PhD, of the University of North Texas Health Science Center, Fort Worth, and colleagues.

However, data on the methods used to promote DTC to the young female population are limited, and the goal of the current study was to identify preferred sources and communication channels for DTC STI information in this population, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from 92 women aged 18-24 years at a single university who participated in an online survey. Of these, 24 also participated in in-depth interviews. The mean age of the participants was 20.0 years, and all reported being sexually active in the past year. Approximately two-thirds (68.5%) were White, 24% were Hispanic, 13% were Black or African American; 63.0% overall were heterosexual.

Participants received a description of DTC methods and were asked whether they were interested in receiving more information, and if so, what were their preferred sources for receiving the information. Potential sources included health care providers, friends, family members, partners, the Internet, college resources, classes, and other, and participants were asked to rank these choices in order of preference.

More than half of the participants identified health care providers as their preferred source of information (56.5%), followed by trusted websites (25%), and university-based resources or friends (6.5% for both).

Overall, participants who underwent STI screening in the past 12 months ranked college resources higher than those who had not undergone screening.

Race played a significant role in ranking partners and family members as resources. Compared with Black participants, White participants and those who were biracial/multiracial/another race ranked partners as a significantly more preferred source, but the differences between White and biracial/multiracial/another race were not significant. White participants and Black participants were similar in ranking family as a preferred information source, but White participants, compared with biracial/multiracial/other participants, ranked family as a significantly more preferred source.

Differences in rankings were similar across sexual orientations.

In-depth interviews were conducted on the college campus prior to the COVID-19 pandemic. The mean age of the interview participants was 19.5 years, and most were non-Hispanic White. Sexual orientation was varied, with 50% identifying as heterosexual and 50% identifying as a sexual minority.

In the interviews, health care providers were seen as influential for considering DTC methods, with gynecologists, other specialists, and more experienced physicians deemed the most trustworthy. Interviewees noted social media sites as a way to provide information and raise awareness of DTC methods, such as through the advertisements feature on Instagram. They also identified university orientation as a way to reach students and provide information about DTC options in the context of other health-related orientation topics such as sexual consent and alcohol use.

Many interviewees also mentioned friends as a resource for discussing sex, sexuality, and STI screening, and said they would be accepting of information, knowledge, and emotional support when learning about DTC from friends.

The findings were limited by several factors, including the cross-sectional design, use of data from a single campus setting, and the overrepresentation of White women, and more studies are needed to identify differences by region and campus type that might guide interventions, the researchers noted. The study also was limited by “the lack of specificity of what participants considered to be credible Internet information sources,” they said.

However, the results suggest that using health care providers, trusted websites, and established college resources as dissemination channels may help increase the awareness and use of DTC methods for STI screening in young women, they concluded.

The study was supported in part by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS/STD Prevention at Indiana University and by the University of South Florida College of Public Health. The researchers had no financial conflicts to disclose.

College-aged women ranked health care providers, the Internet, and school resources as their top resources for seeking information about direct-to-consumer screening for sexually transmitted infections, based on surveys from 92 individuals.

University of North Texas Health Science Center

Direct-to-consumer (DTC) sexually transmitted infection (STI) screening methods involve the use of self-collected samples outside of a clinical setting, and may help reach women who avoid screening or lack access to clinical care, wrote Stacey B. Griner, PhD, of the University of North Texas Health Science Center, Fort Worth, and colleagues.

However, data on the methods used to promote DTC to the young female population are limited, and the goal of the current study was to identify preferred sources and communication channels for DTC STI information in this population, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from 92 women aged 18-24 years at a single university who participated in an online survey. Of these, 24 also participated in in-depth interviews. The mean age of the participants was 20.0 years, and all reported being sexually active in the past year. Approximately two-thirds (68.5%) were White, 24% were Hispanic, 13% were Black or African American; 63.0% overall were heterosexual.

Participants received a description of DTC methods and were asked whether they were interested in receiving more information, and if so, what were their preferred sources for receiving the information. Potential sources included health care providers, friends, family members, partners, the Internet, college resources, classes, and other, and participants were asked to rank these choices in order of preference.

More than half of the participants identified health care providers as their preferred source of information (56.5%), followed by trusted websites (25%), and university-based resources or friends (6.5% for both).

Overall, participants who underwent STI screening in the past 12 months ranked college resources higher than those who had not undergone screening.

Race played a significant role in ranking partners and family members as resources. Compared with Black participants, White participants and those who were biracial/multiracial/another race ranked partners as a significantly more preferred source, but the differences between White and biracial/multiracial/another race were not significant. White participants and Black participants were similar in ranking family as a preferred information source, but White participants, compared with biracial/multiracial/other participants, ranked family as a significantly more preferred source.

Differences in rankings were similar across sexual orientations.

In-depth interviews were conducted on the college campus prior to the COVID-19 pandemic. The mean age of the interview participants was 19.5 years, and most were non-Hispanic White. Sexual orientation was varied, with 50% identifying as heterosexual and 50% identifying as a sexual minority.

In the interviews, health care providers were seen as influential for considering DTC methods, with gynecologists, other specialists, and more experienced physicians deemed the most trustworthy. Interviewees noted social media sites as a way to provide information and raise awareness of DTC methods, such as through the advertisements feature on Instagram. They also identified university orientation as a way to reach students and provide information about DTC options in the context of other health-related orientation topics such as sexual consent and alcohol use.

Many interviewees also mentioned friends as a resource for discussing sex, sexuality, and STI screening, and said they would be accepting of information, knowledge, and emotional support when learning about DTC from friends.

The findings were limited by several factors, including the cross-sectional design, use of data from a single campus setting, and the overrepresentation of White women, and more studies are needed to identify differences by region and campus type that might guide interventions, the researchers noted. The study also was limited by “the lack of specificity of what participants considered to be credible Internet information sources,” they said.

However, the results suggest that using health care providers, trusted websites, and established college resources as dissemination channels may help increase the awareness and use of DTC methods for STI screening in young women, they concluded.

The study was supported in part by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS/STD Prevention at Indiana University and by the University of South Florida College of Public Health. The researchers had no financial conflicts to disclose.

College-aged women ranked health care providers, the Internet, and school resources as their top resources for seeking information about direct-to-consumer screening for sexually transmitted infections, based on surveys from 92 individuals.

University of North Texas Health Science Center

Direct-to-consumer (DTC) sexually transmitted infection (STI) screening methods involve the use of self-collected samples outside of a clinical setting, and may help reach women who avoid screening or lack access to clinical care, wrote Stacey B. Griner, PhD, of the University of North Texas Health Science Center, Fort Worth, and colleagues.

However, data on the methods used to promote DTC to the young female population are limited, and the goal of the current study was to identify preferred sources and communication channels for DTC STI information in this population, they said.

In a study published in Sexually Transmitted Diseases, the researchers reviewed data from 92 women aged 18-24 years at a single university who participated in an online survey. Of these, 24 also participated in in-depth interviews. The mean age of the participants was 20.0 years, and all reported being sexually active in the past year. Approximately two-thirds (68.5%) were White, 24% were Hispanic, 13% were Black or African American; 63.0% overall were heterosexual.

Participants received a description of DTC methods and were asked whether they were interested in receiving more information, and if so, what were their preferred sources for receiving the information. Potential sources included health care providers, friends, family members, partners, the Internet, college resources, classes, and other, and participants were asked to rank these choices in order of preference.

More than half of the participants identified health care providers as their preferred source of information (56.5%), followed by trusted websites (25%), and university-based resources or friends (6.5% for both).

Overall, participants who underwent STI screening in the past 12 months ranked college resources higher than those who had not undergone screening.

Race played a significant role in ranking partners and family members as resources. Compared with Black participants, White participants and those who were biracial/multiracial/another race ranked partners as a significantly more preferred source, but the differences between White and biracial/multiracial/another race were not significant. White participants and Black participants were similar in ranking family as a preferred information source, but White participants, compared with biracial/multiracial/other participants, ranked family as a significantly more preferred source.

Differences in rankings were similar across sexual orientations.

In-depth interviews were conducted on the college campus prior to the COVID-19 pandemic. The mean age of the interview participants was 19.5 years, and most were non-Hispanic White. Sexual orientation was varied, with 50% identifying as heterosexual and 50% identifying as a sexual minority.

In the interviews, health care providers were seen as influential for considering DTC methods, with gynecologists, other specialists, and more experienced physicians deemed the most trustworthy. Interviewees noted social media sites as a way to provide information and raise awareness of DTC methods, such as through the advertisements feature on Instagram. They also identified university orientation as a way to reach students and provide information about DTC options in the context of other health-related orientation topics such as sexual consent and alcohol use.

Many interviewees also mentioned friends as a resource for discussing sex, sexuality, and STI screening, and said they would be accepting of information, knowledge, and emotional support when learning about DTC from friends.

The findings were limited by several factors, including the cross-sectional design, use of data from a single campus setting, and the overrepresentation of White women, and more studies are needed to identify differences by region and campus type that might guide interventions, the researchers noted. The study also was limited by “the lack of specificity of what participants considered to be credible Internet information sources,” they said.

However, the results suggest that using health care providers, trusted websites, and established college resources as dissemination channels may help increase the awareness and use of DTC methods for STI screening in young women, they concluded.

The study was supported in part by the Doug Kirby Adolescent Sexual Health Research Grant from the Rural Center for AIDS/STD Prevention at Indiana University and by the University of South Florida College of Public Health. The researchers had no financial conflicts to disclose.

Non-hypoxemic patients with intermediate risk of pulmonary embolism showed no added benefit from supplemental oxygen compared with ambient oxygen in a pilot study of 70 individuals.

Anticoagulation monotherapy is the standard of care for patients with intermediate-risk pulmonary embolism (PE), but persistent short-term complication rates may approach 10%, wrote Deisy Barrios, MD, of Hospital Ramón y Cajal (IRYCIS), Madrid, and colleagues. Additional strategies are needed, and the use of supplemental oxygen in non-hypoxemic patients with intermediate-risk PE has not been explored, they said.

In a study published in the journal Chest, the researchers recruited 36 women and 34 men who were non-hypoxemic with stable PE and intermediate risk, defined as echocardiographic RV enlargement. The study recruitment ended prematurely because of the COVID-19 pandemic. The mean age of the participants was 67.3 years. Patients were randomized within 24 hours of hospital admission to anticoagulation plus supplemental oxygen or anticoagulation alone. The groups were similar in echocardiographic mean RV end-diameter and RV/LV ratios at baseline.

The intervention patients received supplemental oxygen at a 35% concentration (7 L/min) continuously for 48 hours via a face mask, and through a nasal cannula during meal times.

The primary outcome was normalization of right ventricle size (defined as an RV/LV diameter ratio less than 1.0 from the subcostal or apical view) at 48 hours after randomization. Secondary outcomes included change in the right ventricle/left ventricle diameter as measured at 48 hours and 7 days after randomization compared to baseline.

The proportion of patients with an RV/LV ratio of 1.0 or less at 48 hours was not significantly different between the intervention and control groups (42.4% vs. 21.6%, P = .08). Similarly, the proportion of patients with an RV/LV ratio of 1.0 or less at 7 days was not significantly different between the groups (76% vs. 70%).

The between-group reduction in RV/LV ratio was significantly greater in the supplemental oxygen group vs. the control group from baseline to 48 hours (0.28 vs. 0.12 P = .02).

However, the within-group mean RV/LV ratio was significantly reduced in both the supplemental oxygen group and the control group compared to baseline at 48 hours and at 7 days after randomization.

None of the patients experienced hemodynamic collapse or recurrent venous thromboembolism during the follow-up period.

The findings were limited by several factors including the small sample size and open-label design, and lack of power to detect clinical outcomes, the researchers noted.

However, the results suggest that although supplemental oxygen had no significant impact of RV/LV normalization, “supplemental oxygen might increase the likelihood of reducing echocardiographic RV dilatation,” and the findings warrant a definitive clinical outcomes trial of supplemental oxygen vs. ambient air to improve outcomes in non-hypoxemic patients with intermediate-risk PE, they concluded.

The study was supported by the Instituto de Salud Carlos III. Dr. Barrios had no financial conflicts to disclose.

Non-hypoxemic patients with intermediate risk of pulmonary embolism showed no added benefit from supplemental oxygen compared with ambient oxygen in a pilot study of 70 individuals.

Anticoagulation monotherapy is the standard of care for patients with intermediate-risk pulmonary embolism (PE), but persistent short-term complication rates may approach 10%, wrote Deisy Barrios, MD, of Hospital Ramón y Cajal (IRYCIS), Madrid, and colleagues. Additional strategies are needed, and the use of supplemental oxygen in non-hypoxemic patients with intermediate-risk PE has not been explored, they said.

In a study published in the journal Chest, the researchers recruited 36 women and 34 men who were non-hypoxemic with stable PE and intermediate risk, defined as echocardiographic RV enlargement. The study recruitment ended prematurely because of the COVID-19 pandemic. The mean age of the participants was 67.3 years. Patients were randomized within 24 hours of hospital admission to anticoagulation plus supplemental oxygen or anticoagulation alone. The groups were similar in echocardiographic mean RV end-diameter and RV/LV ratios at baseline.

The intervention patients received supplemental oxygen at a 35% concentration (7 L/min) continuously for 48 hours via a face mask, and through a nasal cannula during meal times.

The primary outcome was normalization of right ventricle size (defined as an RV/LV diameter ratio less than 1.0 from the subcostal or apical view) at 48 hours after randomization. Secondary outcomes included change in the right ventricle/left ventricle diameter as measured at 48 hours and 7 days after randomization compared to baseline.

The proportion of patients with an RV/LV ratio of 1.0 or less at 48 hours was not significantly different between the intervention and control groups (42.4% vs. 21.6%, P = .08). Similarly, the proportion of patients with an RV/LV ratio of 1.0 or less at 7 days was not significantly different between the groups (76% vs. 70%).

The between-group reduction in RV/LV ratio was significantly greater in the supplemental oxygen group vs. the control group from baseline to 48 hours (0.28 vs. 0.12 P = .02).

However, the within-group mean RV/LV ratio was significantly reduced in both the supplemental oxygen group and the control group compared to baseline at 48 hours and at 7 days after randomization.

None of the patients experienced hemodynamic collapse or recurrent venous thromboembolism during the follow-up period.

The findings were limited by several factors including the small sample size and open-label design, and lack of power to detect clinical outcomes, the researchers noted.

However, the results suggest that although supplemental oxygen had no significant impact of RV/LV normalization, “supplemental oxygen might increase the likelihood of reducing echocardiographic RV dilatation,” and the findings warrant a definitive clinical outcomes trial of supplemental oxygen vs. ambient air to improve outcomes in non-hypoxemic patients with intermediate-risk PE, they concluded.

The study was supported by the Instituto de Salud Carlos III. Dr. Barrios had no financial conflicts to disclose.

Non-hypoxemic patients with intermediate risk of pulmonary embolism showed no added benefit from supplemental oxygen compared with ambient oxygen in a pilot study of 70 individuals.

Anticoagulation monotherapy is the standard of care for patients with intermediate-risk pulmonary embolism (PE), but persistent short-term complication rates may approach 10%, wrote Deisy Barrios, MD, of Hospital Ramón y Cajal (IRYCIS), Madrid, and colleagues. Additional strategies are needed, and the use of supplemental oxygen in non-hypoxemic patients with intermediate-risk PE has not been explored, they said.

In a study published in the journal Chest, the researchers recruited 36 women and 34 men who were non-hypoxemic with stable PE and intermediate risk, defined as echocardiographic RV enlargement. The study recruitment ended prematurely because of the COVID-19 pandemic. The mean age of the participants was 67.3 years. Patients were randomized within 24 hours of hospital admission to anticoagulation plus supplemental oxygen or anticoagulation alone. The groups were similar in echocardiographic mean RV end-diameter and RV/LV ratios at baseline.

The intervention patients received supplemental oxygen at a 35% concentration (7 L/min) continuously for 48 hours via a face mask, and through a nasal cannula during meal times.

The primary outcome was normalization of right ventricle size (defined as an RV/LV diameter ratio less than 1.0 from the subcostal or apical view) at 48 hours after randomization. Secondary outcomes included change in the right ventricle/left ventricle diameter as measured at 48 hours and 7 days after randomization compared to baseline.

The proportion of patients with an RV/LV ratio of 1.0 or less at 48 hours was not significantly different between the intervention and control groups (42.4% vs. 21.6%, P = .08). Similarly, the proportion of patients with an RV/LV ratio of 1.0 or less at 7 days was not significantly different between the groups (76% vs. 70%).

The between-group reduction in RV/LV ratio was significantly greater in the supplemental oxygen group vs. the control group from baseline to 48 hours (0.28 vs. 0.12 P = .02).

However, the within-group mean RV/LV ratio was significantly reduced in both the supplemental oxygen group and the control group compared to baseline at 48 hours and at 7 days after randomization.

None of the patients experienced hemodynamic collapse or recurrent venous thromboembolism during the follow-up period.

The findings were limited by several factors including the small sample size and open-label design, and lack of power to detect clinical outcomes, the researchers noted.

However, the results suggest that although supplemental oxygen had no significant impact of RV/LV normalization, “supplemental oxygen might increase the likelihood of reducing echocardiographic RV dilatation,” and the findings warrant a definitive clinical outcomes trial of supplemental oxygen vs. ambient air to improve outcomes in non-hypoxemic patients with intermediate-risk PE, they concluded.

The study was supported by the Instituto de Salud Carlos III. Dr. Barrios had no financial conflicts to disclose.