In an update to its 2016 recommendations for skin cancer screening, the U.S. Preventive Services Task Force (USPSTF) has once again determined that there is not enough evidence to recommend for or against screening with a visual skin exam in adolescents and adults without symptoms.

This final recommendation applies to the general public and is not meant for those at higher risk, such as people with a family history of skin cancer or who have any signs or symptoms, such as irregular moles.

“The new recommendations are consistent with those from 2016, and we are unable to balance benefits and harms,” said Task Force member Katrina Donahue, MD, MPH, professor and vice chair of research in the department of family medicine at the University of North Carolina, Chapel Hill. “Unfortunately, there is not enough evidence to recommend for or against screening, and health care professionals should use their judgment when deciding whether or not to screen.”

Dr. Donahue told this news organization that this is a call for more research: “Our recommendations are for patients who present to primary care without symptoms, and after a careful assessment of benefit and harms, we didn’t have evidence to push us towards screening as a benefit. We did look at data from two large screening programs, but they were from Europe and not representative of the U.S. population. They also did not show a benefit for reducing melanoma-related mortality.”

The USPSTF final recommendation statement and corresponding evidence summary have been published online in JAMA, as well as on the USPSTF website.

Skin cancer is the most commonly diagnosed cancer in the United States, but there are different types that vary in their incidence and severity. Basal and squamous cell carcinomas are the most common types of skin cancer, but they infrequently lead to death or substantial morbidity, notes the USPTSF. Melanomas represent about 1% of skin cancer and cause the most skin cancer deaths. An estimated 8,000 individuals in the United States will die of melanoma in 2023.

There are racial differences in melanoma incidence; it is about 30 times more common in White versus Black persons, but disease in persons with darker skin color tends to be diagnosed at a later stage. These disparities may be due to differences in risk factors, access to care, and clinical presentation.

In an accompanying editorial, Maryam M. Asgari, MD, MPH, of the department of dermatology, Massachusetts General Hospital, Boston, and Lori A. Crane, PhD, MPH, of the Colorado School of Public Health, University of Colorado, Aurora, point out that people with darker skin phenotypes also tend to be affected by skin cancers that are not associated with UV radiation, such as acral melanoma, which arises on the palms and soles, and skin cancers that arise in areas of chronic inflammation, such as wounds.

Review of evidence

The USPSTF commissioned a systematic review to evaluate the benefits and harms of screening for skin cancer in asymptomatic adolescents and adults, including evidence for both keratinocyte carcinoma (basal cell carcinoma and squamous cell carcinoma) and cutaneous melanoma.

Foundational evidence showed that the sensitivity of visual skin examination by a clinician to detect melanoma ranged from 40% to 70% and specificity ranged from 86% to 98%. Evidence that evaluated the diagnostic accuracy of visual skin examination to detect keratinocyte carcinoma was limited and inconsistent. There were no new studies reporting on diagnostic accuracy for an asymptomatic screening population.

The USPSTF also reviewed 20 studies in 29 articles (n = 6,053,411). This included three nonrandomized studies evaluating two skin cancer screening programs in Germany, but results were inconsistent. In addition, the ecological and nonrandomized design of the studies limited the conclusions that could be drawn and the applicability to a U.S. population was difficult to assess because of differences in population diversity and health care delivery in the United States.

Other nonrandomized studies that looked at various outcomes, such as harms and stage at diagnosis and melanoma or all-cause mortality, also did not provide sufficient evidence to support screening.
 

Research is needed

In a second accompanying editorial published in JAMA Dermatology, Adewole S. Adamson, MD, MPP, of the division of dermatology and dermatologic surgery at the University of Texas, Austin, pointed out that unlike other cancer screening programs, such as those for breast, colon, and prostate cancer, skin cancer screening programs are somewhat less organized.

The other programs focus on defined groups of the population, generally with easily identifiable characteristics such as age, sex, and family history, and importantly, there are always defined ages for initiation and halting of screening and intervals for screening frequency. None of these basic screening parameters have been widely adopted among dermatologists in the United States, he wrote. “One important reason why skin cancer screening has remained inconsistent is that it is not covered by Medicare or by many commercial insurance companies,” Dr. Adamson told this news organization. “The test, in this case the skin exam, is often performed as part of a routine dermatology visit.”

Dermatologists should take the lead on this, he said. “Dermatologists should push for a high quality prospective clinical trial of skin cancer screening, preferably in a high-risk population.”

Dr. Donahue agrees that research is needed, as noted in the recommendation. For example, studies are needed demonstrating consistent data of the effects of screening on morbidity and mortality or early detection of skin cancer, and clearer descriptions of skin color and inclusion of a full spectrum of skin colors in study participants. Clinical research is also needed on outcomes in participants that reflect the diversity of the U.S. population.

“I hope funding agencies will be interested in this area of study,” she said. “We put out the whole systematic review and point out the gaps. We need consistent evidence in detecting cancer early and reducing complications from skin cancer.”

The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

None of the USPSTF authors report any disclosures. Dr. Asgari reported receiving royalties from UpToDate. Dr. Crane did not make any disclosures. Dr. Adamson reported serving as an expert reviewer for the U.S. Preventive Services Task Force skin cancer screening report, as well as support from the Robert Wood Johnson Foundation, the Dermatology Foundation Public Health Career Development Award, the National Institutes of Health, the American Cancer Society, and Meredith’s Mission for Melanoma.

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

In an update to its 2016 recommendations for skin cancer screening, the U.S. Preventive Services Task Force (USPSTF) has once again determined that there is not enough evidence to recommend for or against screening with a visual skin exam in adolescents and adults without symptoms.

This final recommendation applies to the general public and is not meant for those at higher risk, such as people with a family history of skin cancer or who have any signs or symptoms, such as irregular moles.

“The new recommendations are consistent with those from 2016, and we are unable to balance benefits and harms,” said Task Force member Katrina Donahue, MD, MPH, professor and vice chair of research in the department of family medicine at the University of North Carolina, Chapel Hill. “Unfortunately, there is not enough evidence to recommend for or against screening, and health care professionals should use their judgment when deciding whether or not to screen.”

Dr. Donahue told this news organization that this is a call for more research: “Our recommendations are for patients who present to primary care without symptoms, and after a careful assessment of benefit and harms, we didn’t have evidence to push us towards screening as a benefit. We did look at data from two large screening programs, but they were from Europe and not representative of the U.S. population. They also did not show a benefit for reducing melanoma-related mortality.”

The USPSTF final recommendation statement and corresponding evidence summary have been published online in JAMA, as well as on the USPSTF website.

Skin cancer is the most commonly diagnosed cancer in the United States, but there are different types that vary in their incidence and severity. Basal and squamous cell carcinomas are the most common types of skin cancer, but they infrequently lead to death or substantial morbidity, notes the USPTSF. Melanomas represent about 1% of skin cancer and cause the most skin cancer deaths. An estimated 8,000 individuals in the United States will die of melanoma in 2023.

There are racial differences in melanoma incidence; it is about 30 times more common in White versus Black persons, but disease in persons with darker skin color tends to be diagnosed at a later stage. These disparities may be due to differences in risk factors, access to care, and clinical presentation.

In an accompanying editorial, Maryam M. Asgari, MD, MPH, of the department of dermatology, Massachusetts General Hospital, Boston, and Lori A. Crane, PhD, MPH, of the Colorado School of Public Health, University of Colorado, Aurora, point out that people with darker skin phenotypes also tend to be affected by skin cancers that are not associated with UV radiation, such as acral melanoma, which arises on the palms and soles, and skin cancers that arise in areas of chronic inflammation, such as wounds.

Review of evidence

The USPSTF commissioned a systematic review to evaluate the benefits and harms of screening for skin cancer in asymptomatic adolescents and adults, including evidence for both keratinocyte carcinoma (basal cell carcinoma and squamous cell carcinoma) and cutaneous melanoma.

Foundational evidence showed that the sensitivity of visual skin examination by a clinician to detect melanoma ranged from 40% to 70% and specificity ranged from 86% to 98%. Evidence that evaluated the diagnostic accuracy of visual skin examination to detect keratinocyte carcinoma was limited and inconsistent. There were no new studies reporting on diagnostic accuracy for an asymptomatic screening population.

The USPSTF also reviewed 20 studies in 29 articles (n = 6,053,411). This included three nonrandomized studies evaluating two skin cancer screening programs in Germany, but results were inconsistent. In addition, the ecological and nonrandomized design of the studies limited the conclusions that could be drawn and the applicability to a U.S. population was difficult to assess because of differences in population diversity and health care delivery in the United States.

Other nonrandomized studies that looked at various outcomes, such as harms and stage at diagnosis and melanoma or all-cause mortality, also did not provide sufficient evidence to support screening.
 

Research is needed

In a second accompanying editorial published in JAMA Dermatology, Adewole S. Adamson, MD, MPP, of the division of dermatology and dermatologic surgery at the University of Texas, Austin, pointed out that unlike other cancer screening programs, such as those for breast, colon, and prostate cancer, skin cancer screening programs are somewhat less organized.

The other programs focus on defined groups of the population, generally with easily identifiable characteristics such as age, sex, and family history, and importantly, there are always defined ages for initiation and halting of screening and intervals for screening frequency. None of these basic screening parameters have been widely adopted among dermatologists in the United States, he wrote. “One important reason why skin cancer screening has remained inconsistent is that it is not covered by Medicare or by many commercial insurance companies,” Dr. Adamson told this news organization. “The test, in this case the skin exam, is often performed as part of a routine dermatology visit.”

Dermatologists should take the lead on this, he said. “Dermatologists should push for a high quality prospective clinical trial of skin cancer screening, preferably in a high-risk population.”

Dr. Donahue agrees that research is needed, as noted in the recommendation. For example, studies are needed demonstrating consistent data of the effects of screening on morbidity and mortality or early detection of skin cancer, and clearer descriptions of skin color and inclusion of a full spectrum of skin colors in study participants. Clinical research is also needed on outcomes in participants that reflect the diversity of the U.S. population.

“I hope funding agencies will be interested in this area of study,” she said. “We put out the whole systematic review and point out the gaps. We need consistent evidence in detecting cancer early and reducing complications from skin cancer.”

The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

None of the USPSTF authors report any disclosures. Dr. Asgari reported receiving royalties from UpToDate. Dr. Crane did not make any disclosures. Dr. Adamson reported serving as an expert reviewer for the U.S. Preventive Services Task Force skin cancer screening report, as well as support from the Robert Wood Johnson Foundation, the Dermatology Foundation Public Health Career Development Award, the National Institutes of Health, the American Cancer Society, and Meredith’s Mission for Melanoma.

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

In an update to its 2016 recommendations for skin cancer screening, the U.S. Preventive Services Task Force (USPSTF) has once again determined that there is not enough evidence to recommend for or against screening with a visual skin exam in adolescents and adults without symptoms.

This final recommendation applies to the general public and is not meant for those at higher risk, such as people with a family history of skin cancer or who have any signs or symptoms, such as irregular moles.

“The new recommendations are consistent with those from 2016, and we are unable to balance benefits and harms,” said Task Force member Katrina Donahue, MD, MPH, professor and vice chair of research in the department of family medicine at the University of North Carolina, Chapel Hill. “Unfortunately, there is not enough evidence to recommend for or against screening, and health care professionals should use their judgment when deciding whether or not to screen.”

Dr. Donahue told this news organization that this is a call for more research: “Our recommendations are for patients who present to primary care without symptoms, and after a careful assessment of benefit and harms, we didn’t have evidence to push us towards screening as a benefit. We did look at data from two large screening programs, but they were from Europe and not representative of the U.S. population. They also did not show a benefit for reducing melanoma-related mortality.”

The USPSTF final recommendation statement and corresponding evidence summary have been published online in JAMA, as well as on the USPSTF website.

Skin cancer is the most commonly diagnosed cancer in the United States, but there are different types that vary in their incidence and severity. Basal and squamous cell carcinomas are the most common types of skin cancer, but they infrequently lead to death or substantial morbidity, notes the USPTSF. Melanomas represent about 1% of skin cancer and cause the most skin cancer deaths. An estimated 8,000 individuals in the United States will die of melanoma in 2023.

There are racial differences in melanoma incidence; it is about 30 times more common in White versus Black persons, but disease in persons with darker skin color tends to be diagnosed at a later stage. These disparities may be due to differences in risk factors, access to care, and clinical presentation.

In an accompanying editorial, Maryam M. Asgari, MD, MPH, of the department of dermatology, Massachusetts General Hospital, Boston, and Lori A. Crane, PhD, MPH, of the Colorado School of Public Health, University of Colorado, Aurora, point out that people with darker skin phenotypes also tend to be affected by skin cancers that are not associated with UV radiation, such as acral melanoma, which arises on the palms and soles, and skin cancers that arise in areas of chronic inflammation, such as wounds.

Review of evidence

The USPSTF commissioned a systematic review to evaluate the benefits and harms of screening for skin cancer in asymptomatic adolescents and adults, including evidence for both keratinocyte carcinoma (basal cell carcinoma and squamous cell carcinoma) and cutaneous melanoma.

Foundational evidence showed that the sensitivity of visual skin examination by a clinician to detect melanoma ranged from 40% to 70% and specificity ranged from 86% to 98%. Evidence that evaluated the diagnostic accuracy of visual skin examination to detect keratinocyte carcinoma was limited and inconsistent. There were no new studies reporting on diagnostic accuracy for an asymptomatic screening population.

The USPSTF also reviewed 20 studies in 29 articles (n = 6,053,411). This included three nonrandomized studies evaluating two skin cancer screening programs in Germany, but results were inconsistent. In addition, the ecological and nonrandomized design of the studies limited the conclusions that could be drawn and the applicability to a U.S. population was difficult to assess because of differences in population diversity and health care delivery in the United States.

Other nonrandomized studies that looked at various outcomes, such as harms and stage at diagnosis and melanoma or all-cause mortality, also did not provide sufficient evidence to support screening.
 

Research is needed

In a second accompanying editorial published in JAMA Dermatology, Adewole S. Adamson, MD, MPP, of the division of dermatology and dermatologic surgery at the University of Texas, Austin, pointed out that unlike other cancer screening programs, such as those for breast, colon, and prostate cancer, skin cancer screening programs are somewhat less organized.

The other programs focus on defined groups of the population, generally with easily identifiable characteristics such as age, sex, and family history, and importantly, there are always defined ages for initiation and halting of screening and intervals for screening frequency. None of these basic screening parameters have been widely adopted among dermatologists in the United States, he wrote. “One important reason why skin cancer screening has remained inconsistent is that it is not covered by Medicare or by many commercial insurance companies,” Dr. Adamson told this news organization. “The test, in this case the skin exam, is often performed as part of a routine dermatology visit.”

Dermatologists should take the lead on this, he said. “Dermatologists should push for a high quality prospective clinical trial of skin cancer screening, preferably in a high-risk population.”

Dr. Donahue agrees that research is needed, as noted in the recommendation. For example, studies are needed demonstrating consistent data of the effects of screening on morbidity and mortality or early detection of skin cancer, and clearer descriptions of skin color and inclusion of a full spectrum of skin colors in study participants. Clinical research is also needed on outcomes in participants that reflect the diversity of the U.S. population.

“I hope funding agencies will be interested in this area of study,” she said. “We put out the whole systematic review and point out the gaps. We need consistent evidence in detecting cancer early and reducing complications from skin cancer.”

The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

None of the USPSTF authors report any disclosures. Dr. Asgari reported receiving royalties from UpToDate. Dr. Crane did not make any disclosures. Dr. Adamson reported serving as an expert reviewer for the U.S. Preventive Services Task Force skin cancer screening report, as well as support from the Robert Wood Johnson Foundation, the Dermatology Foundation Public Health Career Development Award, the National Institutes of Health, the American Cancer Society, and Meredith’s Mission for Melanoma.

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

Rates of perinatal HIV have dropped so much that the disease is effectively eliminated in the United States, with less than 1 baby for every 100,000 live births having the virus, a new study released by researchers at the Centers for Disease Control and Prevention finds.

The report marks significant progress on the U.S. government’s goal to eradicate perinatal HIV, an immune-weakening and potentially deadly virus that is passed from mother to baby during pregnancy. Just 32 children in the country were diagnosed in 2019, compared with twice as many in 2010, according to the CDC.

Mothers who are HIV positive can prevent transmission of the infection by receiving antiretroviral therapy, according to Monica Gandhi, MD, MPH, a professor of medicine at University of California, San Francisco’s division of HIV, infectious disease and global medicine.

Dr. Gandhi said she could recall only one case of perinatal HIV in the San Francisco area over the last decade.

“This country has been really aggressive about counseling women who are pregnant and getting mothers in care,” Dr. Gandhi said.

The treatment method was discovered more than 30 years ago. Prior to the therapy and ensuing awareness campaigns to prevent transmission, mothers with HIV would typically pass the virus to their child in utero, during delivery, or while breastfeeding.

“There should be zero children born with HIV, given that we’ve had these drugs for so long,” Dr. Ghandi said. 
 

Disparities persist

But challenges remain in some communities, where babies born to Black mothers are disproportionately affected by the disease, the new study found. “Racial and ethnic differences in perinatal HIV diagnoses persisted through the 10-year period,” the report’s authors concluded. “The highest rates of perinatal HIV diagnoses were seen among infants born to Black women.”

Although rates of perinatal HIV declined for babies born to Black mothers over the decade-long study, the diagnosis rate was above the goal of elimination at 3.1 for every 100,000 live births, according to the data.

Meanwhile, transmission rates hovered around 1%-2% for Latinx and Hispanic women and mothers who identified as “other races,” including Native American.

Despite the availability of medication, expectant mothers may face several hurdles to getting the daily treatment they need to prevent transmission to their fetus, according to Jennifer Jao, MD, MPH, a physician of infectious diseases at Lurie Children’s Hospital of Chicago.

They might have trouble securing health insurance or finding transportation to doctor’s appointments, or face other problems like lacking secure housing or food – all factors that prevent them from prioritizing the care.

“All of those things play into the mix,” Dr. Jao said. “We see over and over again that closing the gap means you’ve got to reach the women who are pregnant and who don’t have resources.”
 

Progress in ‘danger’

Experts said they’re not sure what the impact of the COVID-19 pandemic, accompanied by a recent uptick in sexually transmitted diseases, will be on rates of perinatal HIV. Some women were unable to access prenatal health care during the pandemic because they couldn’t access public transportation or childcare, the U.S. Government Accountability Office said in 2022.

Globally, a decline in rates of HIV and AIDS rates has slowed, prompting the World Health Organization to warn last year that progress on the disease is in danger. Researchers only included HIV rates in the United States through 2019, so the data are outdated, Dr. Gandhi noted.

“All of this put together means we don’t know where we are with perinatal transmission over the last 3 years,” she said.

In an accompanying editorial, coauthors Nahida Chakhtoura, MD, MsGH, and Bill Kapogiannis, MD, both with the National Institutes of Health, urge health care professionals to take an active role in eliminating these racial and ethnic disparities in an effort to – as the title of their editorial proclaims – achieve a “road to zero perinatal HIV transmission” in the United States.

“The more proactive we are in identifying and promptly addressing systematic deficiencies that exacerbate health inequities in cutting-edge research innovations and optimal clinical service provision,” they write, “the less reactive we will need to be when new transmissible infections appear at our doorstep.”

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

Rates of perinatal HIV have dropped so much that the disease is effectively eliminated in the United States, with less than 1 baby for every 100,000 live births having the virus, a new study released by researchers at the Centers for Disease Control and Prevention finds.

The report marks significant progress on the U.S. government’s goal to eradicate perinatal HIV, an immune-weakening and potentially deadly virus that is passed from mother to baby during pregnancy. Just 32 children in the country were diagnosed in 2019, compared with twice as many in 2010, according to the CDC.

Mothers who are HIV positive can prevent transmission of the infection by receiving antiretroviral therapy, according to Monica Gandhi, MD, MPH, a professor of medicine at University of California, San Francisco’s division of HIV, infectious disease and global medicine.

Dr. Gandhi said she could recall only one case of perinatal HIV in the San Francisco area over the last decade.

“This country has been really aggressive about counseling women who are pregnant and getting mothers in care,” Dr. Gandhi said.

The treatment method was discovered more than 30 years ago. Prior to the therapy and ensuing awareness campaigns to prevent transmission, mothers with HIV would typically pass the virus to their child in utero, during delivery, or while breastfeeding.

“There should be zero children born with HIV, given that we’ve had these drugs for so long,” Dr. Ghandi said. 
 

Disparities persist

But challenges remain in some communities, where babies born to Black mothers are disproportionately affected by the disease, the new study found. “Racial and ethnic differences in perinatal HIV diagnoses persisted through the 10-year period,” the report’s authors concluded. “The highest rates of perinatal HIV diagnoses were seen among infants born to Black women.”

Although rates of perinatal HIV declined for babies born to Black mothers over the decade-long study, the diagnosis rate was above the goal of elimination at 3.1 for every 100,000 live births, according to the data.

Meanwhile, transmission rates hovered around 1%-2% for Latinx and Hispanic women and mothers who identified as “other races,” including Native American.

Despite the availability of medication, expectant mothers may face several hurdles to getting the daily treatment they need to prevent transmission to their fetus, according to Jennifer Jao, MD, MPH, a physician of infectious diseases at Lurie Children’s Hospital of Chicago.

They might have trouble securing health insurance or finding transportation to doctor’s appointments, or face other problems like lacking secure housing or food – all factors that prevent them from prioritizing the care.

“All of those things play into the mix,” Dr. Jao said. “We see over and over again that closing the gap means you’ve got to reach the women who are pregnant and who don’t have resources.”
 

Progress in ‘danger’

Experts said they’re not sure what the impact of the COVID-19 pandemic, accompanied by a recent uptick in sexually transmitted diseases, will be on rates of perinatal HIV. Some women were unable to access prenatal health care during the pandemic because they couldn’t access public transportation or childcare, the U.S. Government Accountability Office said in 2022.

Globally, a decline in rates of HIV and AIDS rates has slowed, prompting the World Health Organization to warn last year that progress on the disease is in danger. Researchers only included HIV rates in the United States through 2019, so the data are outdated, Dr. Gandhi noted.

“All of this put together means we don’t know where we are with perinatal transmission over the last 3 years,” she said.

In an accompanying editorial, coauthors Nahida Chakhtoura, MD, MsGH, and Bill Kapogiannis, MD, both with the National Institutes of Health, urge health care professionals to take an active role in eliminating these racial and ethnic disparities in an effort to – as the title of their editorial proclaims – achieve a “road to zero perinatal HIV transmission” in the United States.

“The more proactive we are in identifying and promptly addressing systematic deficiencies that exacerbate health inequities in cutting-edge research innovations and optimal clinical service provision,” they write, “the less reactive we will need to be when new transmissible infections appear at our doorstep.”

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

Rates of perinatal HIV have dropped so much that the disease is effectively eliminated in the United States, with less than 1 baby for every 100,000 live births having the virus, a new study released by researchers at the Centers for Disease Control and Prevention finds.

The report marks significant progress on the U.S. government’s goal to eradicate perinatal HIV, an immune-weakening and potentially deadly virus that is passed from mother to baby during pregnancy. Just 32 children in the country were diagnosed in 2019, compared with twice as many in 2010, according to the CDC.

Mothers who are HIV positive can prevent transmission of the infection by receiving antiretroviral therapy, according to Monica Gandhi, MD, MPH, a professor of medicine at University of California, San Francisco’s division of HIV, infectious disease and global medicine.

Dr. Gandhi said she could recall only one case of perinatal HIV in the San Francisco area over the last decade.

“This country has been really aggressive about counseling women who are pregnant and getting mothers in care,” Dr. Gandhi said.

The treatment method was discovered more than 30 years ago. Prior to the therapy and ensuing awareness campaigns to prevent transmission, mothers with HIV would typically pass the virus to their child in utero, during delivery, or while breastfeeding.

“There should be zero children born with HIV, given that we’ve had these drugs for so long,” Dr. Ghandi said. 
 

Disparities persist

But challenges remain in some communities, where babies born to Black mothers are disproportionately affected by the disease, the new study found. “Racial and ethnic differences in perinatal HIV diagnoses persisted through the 10-year period,” the report’s authors concluded. “The highest rates of perinatal HIV diagnoses were seen among infants born to Black women.”

Although rates of perinatal HIV declined for babies born to Black mothers over the decade-long study, the diagnosis rate was above the goal of elimination at 3.1 for every 100,000 live births, according to the data.

Meanwhile, transmission rates hovered around 1%-2% for Latinx and Hispanic women and mothers who identified as “other races,” including Native American.

Despite the availability of medication, expectant mothers may face several hurdles to getting the daily treatment they need to prevent transmission to their fetus, according to Jennifer Jao, MD, MPH, a physician of infectious diseases at Lurie Children’s Hospital of Chicago.

They might have trouble securing health insurance or finding transportation to doctor’s appointments, or face other problems like lacking secure housing or food – all factors that prevent them from prioritizing the care.

“All of those things play into the mix,” Dr. Jao said. “We see over and over again that closing the gap means you’ve got to reach the women who are pregnant and who don’t have resources.”
 

Progress in ‘danger’

Experts said they’re not sure what the impact of the COVID-19 pandemic, accompanied by a recent uptick in sexually transmitted diseases, will be on rates of perinatal HIV. Some women were unable to access prenatal health care during the pandemic because they couldn’t access public transportation or childcare, the U.S. Government Accountability Office said in 2022.

Globally, a decline in rates of HIV and AIDS rates has slowed, prompting the World Health Organization to warn last year that progress on the disease is in danger. Researchers only included HIV rates in the United States through 2019, so the data are outdated, Dr. Gandhi noted.

“All of this put together means we don’t know where we are with perinatal transmission over the last 3 years,” she said.

In an accompanying editorial, coauthors Nahida Chakhtoura, MD, MsGH, and Bill Kapogiannis, MD, both with the National Institutes of Health, urge health care professionals to take an active role in eliminating these racial and ethnic disparities in an effort to – as the title of their editorial proclaims – achieve a “road to zero perinatal HIV transmission” in the United States.

“The more proactive we are in identifying and promptly addressing systematic deficiencies that exacerbate health inequities in cutting-edge research innovations and optimal clinical service provision,” they write, “the less reactive we will need to be when new transmissible infections appear at our doorstep.”

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

The Food and Drug Administration approved omidubicel-onlv (Omisirge) for reducing infections and hastening neutrophil recovery for blood cancer patients aged 12 years and older who are undergoing allogeneic umbilical cord blood stem cell transplants.

Omidubicel is made from umbilical cord donor stem cells that are processed with nicotinamide, a form of vitamin B₃, to enhance and expand the number of progenitor cells, the product’s maker, Jerusalem-based Gamida Cell, explained in a press announcement.

The FDA approval was based on phase 3 testing that pitted the use of omidubicel in 62 patients against standard unmanipulated cord blood transplants in 63 patients following myeloablative conditioning.

The median time to neutrophil recovery was 12 days in the omidubicel group, compared with 22 days with standard care. Overall, 87% of patients who received omidubicel achieved neutrophil recovery versus 83% of patients with standard transplants.

The incidence of grade 2/3 bacterial or grade 3 fungal infections 100 days following transplant was 39% with omidubicel versus 60% with standard transplants.

The FDA’s “approval is an important advance in cell therapy treatment in patients with blood cancers. Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency press release.

Abbey Jenkins, president and CEO of Gamida, called the approval “a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes.”

The most common grade 3–5 adverse reactions in the approval study were pain (33%), mucosal inflammation (31%), hypertension (25%), and gastrointestinal toxicity (19%).

Adverse events are consistent with allogeneic hematopoietic stem cell transplantation. Among 117 patients who received omidubicel for any indication, infusion reactions occurred in 47% of patients, acute graft-versus-host disease occurred in 58%, chronic GVHD occurred in 35%, and graft failure occurred in 3%. Labeling includes a boxed warning of the possibilities. There is also a small risk of infections and malignancies from donor blood.

Omidubicel is manufactured in Gamida’s facility in Kiryat Gat, Israel. It is available for order now and is expected to be delivered to transplant centers within 30 days after the start of manufacturing, the company said.

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

The Food and Drug Administration approved omidubicel-onlv (Omisirge) for reducing infections and hastening neutrophil recovery for blood cancer patients aged 12 years and older who are undergoing allogeneic umbilical cord blood stem cell transplants.

Omidubicel is made from umbilical cord donor stem cells that are processed with nicotinamide, a form of vitamin B₃, to enhance and expand the number of progenitor cells, the product’s maker, Jerusalem-based Gamida Cell, explained in a press announcement.

The FDA approval was based on phase 3 testing that pitted the use of omidubicel in 62 patients against standard unmanipulated cord blood transplants in 63 patients following myeloablative conditioning.

The median time to neutrophil recovery was 12 days in the omidubicel group, compared with 22 days with standard care. Overall, 87% of patients who received omidubicel achieved neutrophil recovery versus 83% of patients with standard transplants.

The incidence of grade 2/3 bacterial or grade 3 fungal infections 100 days following transplant was 39% with omidubicel versus 60% with standard transplants.

The FDA’s “approval is an important advance in cell therapy treatment in patients with blood cancers. Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency press release.

Abbey Jenkins, president and CEO of Gamida, called the approval “a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes.”

The most common grade 3–5 adverse reactions in the approval study were pain (33%), mucosal inflammation (31%), hypertension (25%), and gastrointestinal toxicity (19%).

Adverse events are consistent with allogeneic hematopoietic stem cell transplantation. Among 117 patients who received omidubicel for any indication, infusion reactions occurred in 47% of patients, acute graft-versus-host disease occurred in 58%, chronic GVHD occurred in 35%, and graft failure occurred in 3%. Labeling includes a boxed warning of the possibilities. There is also a small risk of infections and malignancies from donor blood.

Omidubicel is manufactured in Gamida’s facility in Kiryat Gat, Israel. It is available for order now and is expected to be delivered to transplant centers within 30 days after the start of manufacturing, the company said.

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

The Food and Drug Administration approved omidubicel-onlv (Omisirge) for reducing infections and hastening neutrophil recovery for blood cancer patients aged 12 years and older who are undergoing allogeneic umbilical cord blood stem cell transplants.

Omidubicel is made from umbilical cord donor stem cells that are processed with nicotinamide, a form of vitamin B₃, to enhance and expand the number of progenitor cells, the product’s maker, Jerusalem-based Gamida Cell, explained in a press announcement.

The FDA approval was based on phase 3 testing that pitted the use of omidubicel in 62 patients against standard unmanipulated cord blood transplants in 63 patients following myeloablative conditioning.

The median time to neutrophil recovery was 12 days in the omidubicel group, compared with 22 days with standard care. Overall, 87% of patients who received omidubicel achieved neutrophil recovery versus 83% of patients with standard transplants.

The incidence of grade 2/3 bacterial or grade 3 fungal infections 100 days following transplant was 39% with omidubicel versus 60% with standard transplants.

The FDA’s “approval is an important advance in cell therapy treatment in patients with blood cancers. Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency press release.

Abbey Jenkins, president and CEO of Gamida, called the approval “a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes.”

The most common grade 3–5 adverse reactions in the approval study were pain (33%), mucosal inflammation (31%), hypertension (25%), and gastrointestinal toxicity (19%).

Adverse events are consistent with allogeneic hematopoietic stem cell transplantation. Among 117 patients who received omidubicel for any indication, infusion reactions occurred in 47% of patients, acute graft-versus-host disease occurred in 58%, chronic GVHD occurred in 35%, and graft failure occurred in 3%. Labeling includes a boxed warning of the possibilities. There is also a small risk of infections and malignancies from donor blood.

Omidubicel is manufactured in Gamida’s facility in Kiryat Gat, Israel. It is available for order now and is expected to be delivered to transplant centers within 30 days after the start of manufacturing, the company said.

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

Individuals at increased risk of type 2 diabetes may be able to reduce their risk via a novel intervention combining intermittent fasting (IF) with early time-restricted eating, indicate the results of a randomized controlled trial.

The study involved more than 200 individuals randomized to one of three groups: eat only in the morning (from 8:00 a.m. to noon) followed by 20 hours of fasting 3 days per week and eat as desired on the other days; daily calorie restriction to 70% of requirements; or standard weight loss advice.

The IF plus early time-restricted eating intervention was associated with a significant improvement in a key measure of glucose control versus calorie restriction at 6 months, while both interventions were linked to benefits in terms of cardiovascular risk markers and body composition, compared with the standard weight loss advice.

However, the research, published in Nature Medicine, showed that the additional benefit of IF plus early time-restricted eating did not persist, and less than half of participants were still following the plan at 18 months, compared with almost 80% of those in the calorie-restriction group.

“Following a time-restricted, IF diet could help lower the chances of developing type 2 diabetes,” senior author Leonie K. Heilbronn, PhD, University of Adelaide, South Australia, said in a press release.

This is “the largest study in the world to date, and the first powered to assess how the body processes and uses glucose after eating a meal,” with the latter being a better indicator of diabetes risk than a fasting glucose test, added first author Xiao Tong Teong, a PhD student, also at the University of Adelaide.

“The results of this study add to the growing body of evidence to indicate that meal timing and fasting advice extends the health benefits of a restricted-calorie diet, independently from weight loss, and this may be influential in clinical practice,” Ms. Teong added.
 

Adherence difficult to IF plus early time-restricted eating

Asked to comment, Krista Varady, PhD, said that the study design “would have been stronger if the time-restricted eating and IF interventions were separated” and compared.

“Time-restricted eating has been shown to naturally reduce calorie intake by 300-500 kcal/day,” she said in an interview, “so I’m not sure why the investigators chose to combine [it] with IF. It ... defeats the point of time-restricted eating.”

Dr. Varady, who recently coauthored a review of the clinical application of IF for weight loss, also doubted whether individuals would adhere to combined early time-restricted eating and IF. “In all honesty, I don’t think anyone would follow this diet for very long,” she said.

She added that the feasibility of this particular approach is “very questionable. In general, people don’t like diets that require them to skip dinner with family/friends on multiple days of the week,” explained Dr. Varady, professor of nutrition at the University of Illinois, Chicago.  “These regimens make social eating very difficult, which results in high attrition.

“Indeed, evidence from a recent large-scale observational study of nearly 800,000 adults shows that Americans who engage in time-restricted eating placed their eating window in the afternoon or evening,” she noted.

Dr. Varady therefore suggested that future trials should test “more feasible time-restricted eating approaches,” such as those with later eating windows and without “vigilant calorie monitoring.”

“These types of diets are much easier to follow and are more likely to produce lasting weight and glycemic control in people with obesity and prediabetes,” she observed.
 

A novel way to cut calories?

The Australian authors say there is growing interest in extending the established health benefits of calorie restriction through new approaches such as timing of meals and prolonged fasting, with IF – defined as fasting interspersed with days of ad libitum eating – gaining in popularity as an alternative to simple calorie restriction.

Time-restricted eating, which emphasizes shorter daily eating windows in alignment with circadian rhythms, has also become popular in recent years, although the authors acknowledge that current evidence suggests any benefits over calorie restriction alone in terms of body composition, blood lipids, or glucose parameters are small.

To examine the combination of IF plus early time-restricted eating, in the DIRECT trial, the team recruited individuals aged 35-75 years who had a score of at least 12 on the Australian Type 2 Diabetes Risk Assessment Tool but did not have a diagnosis of diabetes and had stable weight for more than 6 months prior to study entry.

The participants were randomized to one of three groups:

• IF plus early time-restricted eating, which allowed consumption of 30% of calculated baseline energy requirements between 8:00 a.m. and midday, followed by a 20-hour fast from midday on 3 nonconsecutive days per week. They consumed their regular diet on nonfasting days.
• Calorie restriction, where they consumed 70% of daily calculated baseline energy requirements each day and were given rotating menu plans, but no specific mealtimes.
• Standard care, where they were given a booklet on current guidelines, with no counseling or meal replacement.

There were clinic visits every 2 weeks for the first 6 months of follow-up, and then monthly visits for 12 months. The two intervention groups had one-on-one diet counseling for the first 6 months. All groups were instructed to maintain their usual physical activity levels.

A total of 209 individuals were enrolled between Sept. 26, 2018, and May 4, 2020. Their mean age was 58 years, and 57% were women. Mean body mass index was 34.8 kg/m².

In all, 40.7% of participants were allocated to IF plus early time-restricted eating, 39.7% to calorie restriction, and the remaining 19.6% to standard care.

The results showed that IF plus early time-restricted eating was associated with a significantly greater improvement in the primary outcome of postprandial glucose area under the curve (AUC) at month 6 compared with calorie restriction, at –10.1 mg/dL/min versus –3.6 mg/dL/min (P = .03).

“To our knowledge, no [prior] studies have been powered for postprandial assessments of glycemia, which are better indicators of diabetes risk than fasting assessment,” the authors underlined.

IF plus early time-restricted eating was also associated with greater reductions in postprandial insulin AUC versus calorie restriction at 6 months (P = .04). However, the differences between the IF plus early time-restricted eating and calorie restriction groups for postmeal insulin did not remain significant at 18 months of follow-up.

Both IF plus early time-restricted eating and calorie restriction were associated with greater reductions in A1c levels at 6 months versus standard care, but there was no significant difference between the two active interventions (P = .46).

Both interventions were also associated with improvements in markers of cardiovascular risk versus standard care, such as systolic blood pressure at 2 months, diastolic blood pressure at 6 months, and fasting triglycerides at both time points, with no significant differences between the two intervention groups.

IF plus early time-restricted eating and calorie restriction were also both associated with greater reductions in BMI and fat mass in the first 6 months, as well as in waist circumference.
 

Calorie restriction easier to stick to, less likely to cause fatigue

When offered the chance to modify their diet plan at 6 months, 46% of participants in the IF plus early time-restricted eating group said they would maintain 3 days of restrictions per week, while 51% chose to reduce the restrictions to 2 days per week.

In contrast, 97% of those who completed the calorie-restriction plan indicated they would continue with their current diet plan.

At 18 months, 42% of participants in the IF plus early time-restricted eating group said they still undertook 2-3 days of restrictions per week, while 78% of those assigned to calorie restriction reported that they followed a calorie-restricted diet.

Fatigue was more common with IF plus early time-restricted eating, reported by 56% of participants versus 37% of those following calorie restriction, and 35% of those in the standard care group at 6 months. Headaches and constipation were more common in the intervention groups than with standard care.

The study was supported by a National Health and Medical Research Council Project Grant, an Australian Government Research Training Program Scholarship from the University of Adelaide, and a Diabetes Australia Research Program Grant.

No relevant financial relationships were declared.
 

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

Individuals at increased risk of type 2 diabetes may be able to reduce their risk via a novel intervention combining intermittent fasting (IF) with early time-restricted eating, indicate the results of a randomized controlled trial.

The study involved more than 200 individuals randomized to one of three groups: eat only in the morning (from 8:00 a.m. to noon) followed by 20 hours of fasting 3 days per week and eat as desired on the other days; daily calorie restriction to 70% of requirements; or standard weight loss advice.

The IF plus early time-restricted eating intervention was associated with a significant improvement in a key measure of glucose control versus calorie restriction at 6 months, while both interventions were linked to benefits in terms of cardiovascular risk markers and body composition, compared with the standard weight loss advice.

However, the research, published in Nature Medicine, showed that the additional benefit of IF plus early time-restricted eating did not persist, and less than half of participants were still following the plan at 18 months, compared with almost 80% of those in the calorie-restriction group.

“Following a time-restricted, IF diet could help lower the chances of developing type 2 diabetes,” senior author Leonie K. Heilbronn, PhD, University of Adelaide, South Australia, said in a press release.

This is “the largest study in the world to date, and the first powered to assess how the body processes and uses glucose after eating a meal,” with the latter being a better indicator of diabetes risk than a fasting glucose test, added first author Xiao Tong Teong, a PhD student, also at the University of Adelaide.

“The results of this study add to the growing body of evidence to indicate that meal timing and fasting advice extends the health benefits of a restricted-calorie diet, independently from weight loss, and this may be influential in clinical practice,” Ms. Teong added.
 

Adherence difficult to IF plus early time-restricted eating

Asked to comment, Krista Varady, PhD, said that the study design “would have been stronger if the time-restricted eating and IF interventions were separated” and compared.

“Time-restricted eating has been shown to naturally reduce calorie intake by 300-500 kcal/day,” she said in an interview, “so I’m not sure why the investigators chose to combine [it] with IF. It ... defeats the point of time-restricted eating.”

Dr. Varady, who recently coauthored a review of the clinical application of IF for weight loss, also doubted whether individuals would adhere to combined early time-restricted eating and IF. “In all honesty, I don’t think anyone would follow this diet for very long,” she said.

She added that the feasibility of this particular approach is “very questionable. In general, people don’t like diets that require them to skip dinner with family/friends on multiple days of the week,” explained Dr. Varady, professor of nutrition at the University of Illinois, Chicago.  “These regimens make social eating very difficult, which results in high attrition.

“Indeed, evidence from a recent large-scale observational study of nearly 800,000 adults shows that Americans who engage in time-restricted eating placed their eating window in the afternoon or evening,” she noted.

Dr. Varady therefore suggested that future trials should test “more feasible time-restricted eating approaches,” such as those with later eating windows and without “vigilant calorie monitoring.”

“These types of diets are much easier to follow and are more likely to produce lasting weight and glycemic control in people with obesity and prediabetes,” she observed.
 

A novel way to cut calories?

The Australian authors say there is growing interest in extending the established health benefits of calorie restriction through new approaches such as timing of meals and prolonged fasting, with IF – defined as fasting interspersed with days of ad libitum eating – gaining in popularity as an alternative to simple calorie restriction.

Time-restricted eating, which emphasizes shorter daily eating windows in alignment with circadian rhythms, has also become popular in recent years, although the authors acknowledge that current evidence suggests any benefits over calorie restriction alone in terms of body composition, blood lipids, or glucose parameters are small.

To examine the combination of IF plus early time-restricted eating, in the DIRECT trial, the team recruited individuals aged 35-75 years who had a score of at least 12 on the Australian Type 2 Diabetes Risk Assessment Tool but did not have a diagnosis of diabetes and had stable weight for more than 6 months prior to study entry.

The participants were randomized to one of three groups:

• IF plus early time-restricted eating, which allowed consumption of 30% of calculated baseline energy requirements between 8:00 a.m. and midday, followed by a 20-hour fast from midday on 3 nonconsecutive days per week. They consumed their regular diet on nonfasting days.
• Calorie restriction, where they consumed 70% of daily calculated baseline energy requirements each day and were given rotating menu plans, but no specific mealtimes.
• Standard care, where they were given a booklet on current guidelines, with no counseling or meal replacement.

There were clinic visits every 2 weeks for the first 6 months of follow-up, and then monthly visits for 12 months. The two intervention groups had one-on-one diet counseling for the first 6 months. All groups were instructed to maintain their usual physical activity levels.

A total of 209 individuals were enrolled between Sept. 26, 2018, and May 4, 2020. Their mean age was 58 years, and 57% were women. Mean body mass index was 34.8 kg/m².

In all, 40.7% of participants were allocated to IF plus early time-restricted eating, 39.7% to calorie restriction, and the remaining 19.6% to standard care.

The results showed that IF plus early time-restricted eating was associated with a significantly greater improvement in the primary outcome of postprandial glucose area under the curve (AUC) at month 6 compared with calorie restriction, at –10.1 mg/dL/min versus –3.6 mg/dL/min (P = .03).

“To our knowledge, no [prior] studies have been powered for postprandial assessments of glycemia, which are better indicators of diabetes risk than fasting assessment,” the authors underlined.

IF plus early time-restricted eating was also associated with greater reductions in postprandial insulin AUC versus calorie restriction at 6 months (P = .04). However, the differences between the IF plus early time-restricted eating and calorie restriction groups for postmeal insulin did not remain significant at 18 months of follow-up.

Both IF plus early time-restricted eating and calorie restriction were associated with greater reductions in A1c levels at 6 months versus standard care, but there was no significant difference between the two active interventions (P = .46).

Both interventions were also associated with improvements in markers of cardiovascular risk versus standard care, such as systolic blood pressure at 2 months, diastolic blood pressure at 6 months, and fasting triglycerides at both time points, with no significant differences between the two intervention groups.

IF plus early time-restricted eating and calorie restriction were also both associated with greater reductions in BMI and fat mass in the first 6 months, as well as in waist circumference.
 

Calorie restriction easier to stick to, less likely to cause fatigue

When offered the chance to modify their diet plan at 6 months, 46% of participants in the IF plus early time-restricted eating group said they would maintain 3 days of restrictions per week, while 51% chose to reduce the restrictions to 2 days per week.

In contrast, 97% of those who completed the calorie-restriction plan indicated they would continue with their current diet plan.

At 18 months, 42% of participants in the IF plus early time-restricted eating group said they still undertook 2-3 days of restrictions per week, while 78% of those assigned to calorie restriction reported that they followed a calorie-restricted diet.

Fatigue was more common with IF plus early time-restricted eating, reported by 56% of participants versus 37% of those following calorie restriction, and 35% of those in the standard care group at 6 months. Headaches and constipation were more common in the intervention groups than with standard care.

The study was supported by a National Health and Medical Research Council Project Grant, an Australian Government Research Training Program Scholarship from the University of Adelaide, and a Diabetes Australia Research Program Grant.

No relevant financial relationships were declared.
 

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

Individuals at increased risk of type 2 diabetes may be able to reduce their risk via a novel intervention combining intermittent fasting (IF) with early time-restricted eating, indicate the results of a randomized controlled trial.

The study involved more than 200 individuals randomized to one of three groups: eat only in the morning (from 8:00 a.m. to noon) followed by 20 hours of fasting 3 days per week and eat as desired on the other days; daily calorie restriction to 70% of requirements; or standard weight loss advice.

The IF plus early time-restricted eating intervention was associated with a significant improvement in a key measure of glucose control versus calorie restriction at 6 months, while both interventions were linked to benefits in terms of cardiovascular risk markers and body composition, compared with the standard weight loss advice.

However, the research, published in Nature Medicine, showed that the additional benefit of IF plus early time-restricted eating did not persist, and less than half of participants were still following the plan at 18 months, compared with almost 80% of those in the calorie-restriction group.

“Following a time-restricted, IF diet could help lower the chances of developing type 2 diabetes,” senior author Leonie K. Heilbronn, PhD, University of Adelaide, South Australia, said in a press release.

This is “the largest study in the world to date, and the first powered to assess how the body processes and uses glucose after eating a meal,” with the latter being a better indicator of diabetes risk than a fasting glucose test, added first author Xiao Tong Teong, a PhD student, also at the University of Adelaide.

“The results of this study add to the growing body of evidence to indicate that meal timing and fasting advice extends the health benefits of a restricted-calorie diet, independently from weight loss, and this may be influential in clinical practice,” Ms. Teong added.
 

Adherence difficult to IF plus early time-restricted eating

Asked to comment, Krista Varady, PhD, said that the study design “would have been stronger if the time-restricted eating and IF interventions were separated” and compared.

“Time-restricted eating has been shown to naturally reduce calorie intake by 300-500 kcal/day,” she said in an interview, “so I’m not sure why the investigators chose to combine [it] with IF. It ... defeats the point of time-restricted eating.”

Dr. Varady, who recently coauthored a review of the clinical application of IF for weight loss, also doubted whether individuals would adhere to combined early time-restricted eating and IF. “In all honesty, I don’t think anyone would follow this diet for very long,” she said.

She added that the feasibility of this particular approach is “very questionable. In general, people don’t like diets that require them to skip dinner with family/friends on multiple days of the week,” explained Dr. Varady, professor of nutrition at the University of Illinois, Chicago.  “These regimens make social eating very difficult, which results in high attrition.

“Indeed, evidence from a recent large-scale observational study of nearly 800,000 adults shows that Americans who engage in time-restricted eating placed their eating window in the afternoon or evening,” she noted.

Dr. Varady therefore suggested that future trials should test “more feasible time-restricted eating approaches,” such as those with later eating windows and without “vigilant calorie monitoring.”

“These types of diets are much easier to follow and are more likely to produce lasting weight and glycemic control in people with obesity and prediabetes,” she observed.
 

A novel way to cut calories?

The Australian authors say there is growing interest in extending the established health benefits of calorie restriction through new approaches such as timing of meals and prolonged fasting, with IF – defined as fasting interspersed with days of ad libitum eating – gaining in popularity as an alternative to simple calorie restriction.

Time-restricted eating, which emphasizes shorter daily eating windows in alignment with circadian rhythms, has also become popular in recent years, although the authors acknowledge that current evidence suggests any benefits over calorie restriction alone in terms of body composition, blood lipids, or glucose parameters are small.

To examine the combination of IF plus early time-restricted eating, in the DIRECT trial, the team recruited individuals aged 35-75 years who had a score of at least 12 on the Australian Type 2 Diabetes Risk Assessment Tool but did not have a diagnosis of diabetes and had stable weight for more than 6 months prior to study entry.

The participants were randomized to one of three groups:

• IF plus early time-restricted eating, which allowed consumption of 30% of calculated baseline energy requirements between 8:00 a.m. and midday, followed by a 20-hour fast from midday on 3 nonconsecutive days per week. They consumed their regular diet on nonfasting days.
• Calorie restriction, where they consumed 70% of daily calculated baseline energy requirements each day and were given rotating menu plans, but no specific mealtimes.
• Standard care, where they were given a booklet on current guidelines, with no counseling or meal replacement.

There were clinic visits every 2 weeks for the first 6 months of follow-up, and then monthly visits for 12 months. The two intervention groups had one-on-one diet counseling for the first 6 months. All groups were instructed to maintain their usual physical activity levels.

A total of 209 individuals were enrolled between Sept. 26, 2018, and May 4, 2020. Their mean age was 58 years, and 57% were women. Mean body mass index was 34.8 kg/m².

In all, 40.7% of participants were allocated to IF plus early time-restricted eating, 39.7% to calorie restriction, and the remaining 19.6% to standard care.

The results showed that IF plus early time-restricted eating was associated with a significantly greater improvement in the primary outcome of postprandial glucose area under the curve (AUC) at month 6 compared with calorie restriction, at –10.1 mg/dL/min versus –3.6 mg/dL/min (P = .03).

“To our knowledge, no [prior] studies have been powered for postprandial assessments of glycemia, which are better indicators of diabetes risk than fasting assessment,” the authors underlined.

IF plus early time-restricted eating was also associated with greater reductions in postprandial insulin AUC versus calorie restriction at 6 months (P = .04). However, the differences between the IF plus early time-restricted eating and calorie restriction groups for postmeal insulin did not remain significant at 18 months of follow-up.

Both IF plus early time-restricted eating and calorie restriction were associated with greater reductions in A1c levels at 6 months versus standard care, but there was no significant difference between the two active interventions (P = .46).

Both interventions were also associated with improvements in markers of cardiovascular risk versus standard care, such as systolic blood pressure at 2 months, diastolic blood pressure at 6 months, and fasting triglycerides at both time points, with no significant differences between the two intervention groups.

IF plus early time-restricted eating and calorie restriction were also both associated with greater reductions in BMI and fat mass in the first 6 months, as well as in waist circumference.
 

Calorie restriction easier to stick to, less likely to cause fatigue

When offered the chance to modify their diet plan at 6 months, 46% of participants in the IF plus early time-restricted eating group said they would maintain 3 days of restrictions per week, while 51% chose to reduce the restrictions to 2 days per week.

In contrast, 97% of those who completed the calorie-restriction plan indicated they would continue with their current diet plan.

At 18 months, 42% of participants in the IF plus early time-restricted eating group said they still undertook 2-3 days of restrictions per week, while 78% of those assigned to calorie restriction reported that they followed a calorie-restricted diet.

Fatigue was more common with IF plus early time-restricted eating, reported by 56% of participants versus 37% of those following calorie restriction, and 35% of those in the standard care group at 6 months. Headaches and constipation were more common in the intervention groups than with standard care.

The study was supported by a National Health and Medical Research Council Project Grant, an Australian Government Research Training Program Scholarship from the University of Adelaide, and a Diabetes Australia Research Program Grant.

No relevant financial relationships were declared.
 

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

Key clinical point: Women with endometriosis seemed prone to migraine, with menstrual-related migraine being the most common type and dysmenorrhea and dysuria being more frequent when endometriosis and migraine coexisted.

Major finding: Overall, 53.4% of women had migraine, of which 64.3% had migraine related to menstruation and 35.7% had non-menstrual migraine. Typical endometriosis-related pain symptoms such as dysmenorrhea (94.3% vs 82.0%; P  =  .03) and dysuria (27.1% vs 9.8%; P < .01) occurred significantly more frequently in patients with vs without migraine.

Study details: This was a prospective, nested case-control study including 131 women with endometriosis with or without migraine.

Disclosures: This study was supported by a grant from Ministero della Salute, Italy. The authors declared no conflicts of interest.

Source: Pasquini B, Seravalli V, et al. Endometriosis and the diagnosis of different forms of migraine: an association with dysmenorrhea. Reprod Biomed Online. 2023 (Apr 6). Doi: 10.1016/j.rbmo.2023.03.020

Key clinical point: Women with endometriosis seemed prone to migraine, with menstrual-related migraine being the most common type and dysmenorrhea and dysuria being more frequent when endometriosis and migraine coexisted.

Major finding: Overall, 53.4% of women had migraine, of which 64.3% had migraine related to menstruation and 35.7% had non-menstrual migraine. Typical endometriosis-related pain symptoms such as dysmenorrhea (94.3% vs 82.0%; P  =  .03) and dysuria (27.1% vs 9.8%; P < .01) occurred significantly more frequently in patients with vs without migraine.

Study details: This was a prospective, nested case-control study including 131 women with endometriosis with or without migraine.

Disclosures: This study was supported by a grant from Ministero della Salute, Italy. The authors declared no conflicts of interest.

Source: Pasquini B, Seravalli V, et al. Endometriosis and the diagnosis of different forms of migraine: an association with dysmenorrhea. Reprod Biomed Online. 2023 (Apr 6). Doi: 10.1016/j.rbmo.2023.03.020

Key clinical point: Women with endometriosis seemed prone to migraine, with menstrual-related migraine being the most common type and dysmenorrhea and dysuria being more frequent when endometriosis and migraine coexisted.

Major finding: Overall, 53.4% of women had migraine, of which 64.3% had migraine related to menstruation and 35.7% had non-menstrual migraine. Typical endometriosis-related pain symptoms such as dysmenorrhea (94.3% vs 82.0%; P  =  .03) and dysuria (27.1% vs 9.8%; P < .01) occurred significantly more frequently in patients with vs without migraine.

Study details: This was a prospective, nested case-control study including 131 women with endometriosis with or without migraine.

Disclosures: This study was supported by a grant from Ministero della Salute, Italy. The authors declared no conflicts of interest.

Source: Pasquini B, Seravalli V, et al. Endometriosis and the diagnosis of different forms of migraine: an association with dysmenorrhea. Reprod Biomed Online. 2023 (Apr 6). Doi: 10.1016/j.rbmo.2023.03.020

Key clinical point: Age, body mass index (BMI), chronic-plaque psoriasis, hospitalization for psoriasis, use of systemic therapy, and genital and nail involvement in psoriasis were the risk factors for psoriatic arthritis (PsA) occurrence in patients with psoriasis.

Major finding: Overall, 226 patients were diagnosed with PsA, with an incidence of 1.9 cases per 100 patient-years. Age between 40-59 years (P < .001), BMI ≥25 (P  =  .015), genital psoriasis (P  =  .027), nail psoriasis (P  =  .038), classic chronic-plaque psoriasis (P  =  .014), previous hospitalization for psoriasis (P < .001), previous use of systemic therapy for psoriasis (P  =  .003), and use of conventional nonbiologic agents (P  =  .014) were significantly associated with PsA occurrence.

Study details: This cohort study included 8895 patients with a confirmed diagnosis of psoriasis from the PsoReal registry.

Disclosures: This study was sponsored by Bristol Myers Squibb. K Heidemeyer and L Naldi declared receiving honoraria from various sources, including AbbVie, Almirall, or Bristol Myers Squibb.

Source: Heidemeyer K et al. Variables associated with joint involvement and development of a prediction rule for arthritis in psoriasis patients. An analysis of the Italian PsoReal database. J Am Acad Dermatol. 2023 (Mar 23). Doi: 10.1016/j.jaad.2023.02.059

Key clinical point: Age, body mass index (BMI), chronic-plaque psoriasis, hospitalization for psoriasis, use of systemic therapy, and genital and nail involvement in psoriasis were the risk factors for psoriatic arthritis (PsA) occurrence in patients with psoriasis.

Major finding: Overall, 226 patients were diagnosed with PsA, with an incidence of 1.9 cases per 100 patient-years. Age between 40-59 years (P < .001), BMI ≥25 (P  =  .015), genital psoriasis (P  =  .027), nail psoriasis (P  =  .038), classic chronic-plaque psoriasis (P  =  .014), previous hospitalization for psoriasis (P < .001), previous use of systemic therapy for psoriasis (P  =  .003), and use of conventional nonbiologic agents (P  =  .014) were significantly associated with PsA occurrence.

Study details: This cohort study included 8895 patients with a confirmed diagnosis of psoriasis from the PsoReal registry.

Disclosures: This study was sponsored by Bristol Myers Squibb. K Heidemeyer and L Naldi declared receiving honoraria from various sources, including AbbVie, Almirall, or Bristol Myers Squibb.

Source: Heidemeyer K et al. Variables associated with joint involvement and development of a prediction rule for arthritis in psoriasis patients. An analysis of the Italian PsoReal database. J Am Acad Dermatol. 2023 (Mar 23). Doi: 10.1016/j.jaad.2023.02.059

Key clinical point: Age, body mass index (BMI), chronic-plaque psoriasis, hospitalization for psoriasis, use of systemic therapy, and genital and nail involvement in psoriasis were the risk factors for psoriatic arthritis (PsA) occurrence in patients with psoriasis.

Major finding: Overall, 226 patients were diagnosed with PsA, with an incidence of 1.9 cases per 100 patient-years. Age between 40-59 years (P < .001), BMI ≥25 (P  =  .015), genital psoriasis (P  =  .027), nail psoriasis (P  =  .038), classic chronic-plaque psoriasis (P  =  .014), previous hospitalization for psoriasis (P < .001), previous use of systemic therapy for psoriasis (P  =  .003), and use of conventional nonbiologic agents (P  =  .014) were significantly associated with PsA occurrence.

Study details: This cohort study included 8895 patients with a confirmed diagnosis of psoriasis from the PsoReal registry.

Disclosures: This study was sponsored by Bristol Myers Squibb. K Heidemeyer and L Naldi declared receiving honoraria from various sources, including AbbVie, Almirall, or Bristol Myers Squibb.

Source: Heidemeyer K et al. Variables associated with joint involvement and development of a prediction rule for arthritis in psoriasis patients. An analysis of the Italian PsoReal database. J Am Acad Dermatol. 2023 (Mar 23). Doi: 10.1016/j.jaad.2023.02.059

Key clinical point: Patients with psoriatic arthritis (PsA) had lower serum vitamin D (25(OH)D₃) levels and bone mineral density (BMD) compared with the general population; however, serum vitamin D levels were higher in patients with PsA vs  psoriasis.

Major finding: The serum 25(OH)D₃ levels in patients with PsA were lower than those in control individuals (mean difference [MD] −6.42; P < .01) but higher than those in patients with psoriasis (MD 2.37; P < .01). Lumbar spine BMD was significantly lower in patients with PsA vs  control individuals (MD −0.08).

Study details: This was a meta-analysis of nine studies, of which four studies included patients with PsA (n = 264) and control individuals from the general population (n = 287) and five studies included patients with PsA (n = 225) and psoriasis (n = 391).

Disclosures: This study was supported by the project “Digitalization and improvement of nutritional care for patients with chronic diseases” cofinanced by the European Regional Development Fund. The authors declared no conflicts of interest.

Source: Radić M et al. Vitamin D in psoriatic arthritis – A systematic review and meta-analysis. Semin Arthritis Rheum. 2023;60:152200 (Apr 1). Doi: 10.1016/j.semarthrit.2023.152200

Key clinical point: Patients with psoriatic arthritis (PsA) had lower serum vitamin D (25(OH)D₃) levels and bone mineral density (BMD) compared with the general population; however, serum vitamin D levels were higher in patients with PsA vs  psoriasis.

Major finding: The serum 25(OH)D₃ levels in patients with PsA were lower than those in control individuals (mean difference [MD] −6.42; P < .01) but higher than those in patients with psoriasis (MD 2.37; P < .01). Lumbar spine BMD was significantly lower in patients with PsA vs  control individuals (MD −0.08).

Study details: This was a meta-analysis of nine studies, of which four studies included patients with PsA (n = 264) and control individuals from the general population (n = 287) and five studies included patients with PsA (n = 225) and psoriasis (n = 391).

Disclosures: This study was supported by the project “Digitalization and improvement of nutritional care for patients with chronic diseases” cofinanced by the European Regional Development Fund. The authors declared no conflicts of interest.

Source: Radić M et al. Vitamin D in psoriatic arthritis – A systematic review and meta-analysis. Semin Arthritis Rheum. 2023;60:152200 (Apr 1). Doi: 10.1016/j.semarthrit.2023.152200

Key clinical point: Patients with psoriatic arthritis (PsA) had lower serum vitamin D (25(OH)D₃) levels and bone mineral density (BMD) compared with the general population; however, serum vitamin D levels were higher in patients with PsA vs  psoriasis.

Major finding: The serum 25(OH)D₃ levels in patients with PsA were lower than those in control individuals (mean difference [MD] −6.42; P < .01) but higher than those in patients with psoriasis (MD 2.37; P < .01). Lumbar spine BMD was significantly lower in patients with PsA vs  control individuals (MD −0.08).

Study details: This was a meta-analysis of nine studies, of which four studies included patients with PsA (n = 264) and control individuals from the general population (n = 287) and five studies included patients with PsA (n = 225) and psoriasis (n = 391).

Disclosures: This study was supported by the project “Digitalization and improvement of nutritional care for patients with chronic diseases” cofinanced by the European Regional Development Fund. The authors declared no conflicts of interest.

Source: Radić M et al. Vitamin D in psoriatic arthritis – A systematic review and meta-analysis. Semin Arthritis Rheum. 2023;60:152200 (Apr 1). Doi: 10.1016/j.semarthrit.2023.152200

Key clinical point: Patients with psoriatic arthritis (PsA) are at a higher risk for overall cancer compared with the general population, highlighting the importance of regular cancer screening among these patients.

Major finding: The risk for overall cancer was slightly higher among patients with PsA vs  age- and sex-matched control individuals (adjusted hazard ratio [aHR] 1.20; 95% CI 1.02-1.41), with the risk being mainly driven by non-melanoma skin cancer (aHR 3.64; 95% CI 1.61-8.23), lymphoma (aHR 2.63, 95% CI 1.30-5.30), and thyroid cancer (aHR 1.83, 95% CI 1.18-2.85).

Study details: The data come from a population-based cohort study including 4688 patients with newly diagnosed PsA and 46,880 age- and sex-matched control individuals without a history of cancer and other coexisting autoimmune diseases from the general population.

Disclosures: This study did not report the source of funding. The authors did not declare conflicts of interest.

Source: Eun Y et al. Risk of cancer in Korean patients with psoriatic arthritis: A nationwide population-based cohort study. RMD Open. 2023;9(1):e002874 (Mar 23). Doi: 10.1136/rmdopen-2022-002874

Key clinical point: Patients with psoriatic arthritis (PsA) are at a higher risk for overall cancer compared with the general population, highlighting the importance of regular cancer screening among these patients.

Major finding: The risk for overall cancer was slightly higher among patients with PsA vs  age- and sex-matched control individuals (adjusted hazard ratio [aHR] 1.20; 95% CI 1.02-1.41), with the risk being mainly driven by non-melanoma skin cancer (aHR 3.64; 95% CI 1.61-8.23), lymphoma (aHR 2.63, 95% CI 1.30-5.30), and thyroid cancer (aHR 1.83, 95% CI 1.18-2.85).

Study details: The data come from a population-based cohort study including 4688 patients with newly diagnosed PsA and 46,880 age- and sex-matched control individuals without a history of cancer and other coexisting autoimmune diseases from the general population.

Disclosures: This study did not report the source of funding. The authors did not declare conflicts of interest.

Source: Eun Y et al. Risk of cancer in Korean patients with psoriatic arthritis: A nationwide population-based cohort study. RMD Open. 2023;9(1):e002874 (Mar 23). Doi: 10.1136/rmdopen-2022-002874

Key clinical point: Patients with psoriatic arthritis (PsA) are at a higher risk for overall cancer compared with the general population, highlighting the importance of regular cancer screening among these patients.

Major finding: The risk for overall cancer was slightly higher among patients with PsA vs  age- and sex-matched control individuals (adjusted hazard ratio [aHR] 1.20; 95% CI 1.02-1.41), with the risk being mainly driven by non-melanoma skin cancer (aHR 3.64; 95% CI 1.61-8.23), lymphoma (aHR 2.63, 95% CI 1.30-5.30), and thyroid cancer (aHR 1.83, 95% CI 1.18-2.85).

Study details: The data come from a population-based cohort study including 4688 patients with newly diagnosed PsA and 46,880 age- and sex-matched control individuals without a history of cancer and other coexisting autoimmune diseases from the general population.

Disclosures: This study did not report the source of funding. The authors did not declare conflicts of interest.

Source: Eun Y et al. Risk of cancer in Korean patients with psoriatic arthritis: A nationwide population-based cohort study. RMD Open. 2023;9(1):e002874 (Mar 23). Doi: 10.1136/rmdopen-2022-002874

Key clinical point: Age at onset of psoriatic arthritis (PsA) influences disease characteristics, with individuals developing PsA at older age having worse functionality and greater structural damage but a lower frequency of enthesitis and dactylitis.

Major finding: Patients with late vs early onset PsA showed greater structural damage (odds ratio [OR] 3.3; 95% CI 1.3-8.1), higher frequency of arthritis in upper limbs (OR 2.8; 95% CI 1.0-7.7), greater loss of functionality (OR 1.3; 95% CI 1.0-1.6), and lower frequency of enthesitis (OR 0.1; 95% CI 0-0.5) and sacroiliitis (OR 0.06; 95% CI 0-0.5).

Study details: This observational cross-sectional study included 231 patients with PsA with <10 years of disease duration from the REGISPONSER and RESPONDIA registries who were categorized into the early onset (≤40 years) or late onset (≥60 years) group depending on age at PsA symptom onset.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Puche-Larrubia MÁ et al. Differences between early vs  late-onset of psoriatic arthritis: Data from the respondia and regisponser registries. Joint Bone Spine. 2023;105563 (Mar 17). Doi: 10.1016/j.jbspin.2023.105563

Key clinical point: Age at onset of psoriatic arthritis (PsA) influences disease characteristics, with individuals developing PsA at older age having worse functionality and greater structural damage but a lower frequency of enthesitis and dactylitis.

Major finding: Patients with late vs early onset PsA showed greater structural damage (odds ratio [OR] 3.3; 95% CI 1.3-8.1), higher frequency of arthritis in upper limbs (OR 2.8; 95% CI 1.0-7.7), greater loss of functionality (OR 1.3; 95% CI 1.0-1.6), and lower frequency of enthesitis (OR 0.1; 95% CI 0-0.5) and sacroiliitis (OR 0.06; 95% CI 0-0.5).

Study details: This observational cross-sectional study included 231 patients with PsA with <10 years of disease duration from the REGISPONSER and RESPONDIA registries who were categorized into the early onset (≤40 years) or late onset (≥60 years) group depending on age at PsA symptom onset.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Puche-Larrubia MÁ et al. Differences between early vs  late-onset of psoriatic arthritis: Data from the respondia and regisponser registries. Joint Bone Spine. 2023;105563 (Mar 17). Doi: 10.1016/j.jbspin.2023.105563

Key clinical point: Age at onset of psoriatic arthritis (PsA) influences disease characteristics, with individuals developing PsA at older age having worse functionality and greater structural damage but a lower frequency of enthesitis and dactylitis.

Major finding: Patients with late vs early onset PsA showed greater structural damage (odds ratio [OR] 3.3; 95% CI 1.3-8.1), higher frequency of arthritis in upper limbs (OR 2.8; 95% CI 1.0-7.7), greater loss of functionality (OR 1.3; 95% CI 1.0-1.6), and lower frequency of enthesitis (OR 0.1; 95% CI 0-0.5) and sacroiliitis (OR 0.06; 95% CI 0-0.5).

Study details: This observational cross-sectional study included 231 patients with PsA with <10 years of disease duration from the REGISPONSER and RESPONDIA registries who were categorized into the early onset (≤40 years) or late onset (≥60 years) group depending on age at PsA symptom onset.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Puche-Larrubia MÁ et al. Differences between early vs  late-onset of psoriatic arthritis: Data from the respondia and regisponser registries. Joint Bone Spine. 2023;105563 (Mar 17). Doi: 10.1016/j.jbspin.2023.105563

Key clinical point: Vitamin D deficiency in patients with psoriatic arthritis (PsA) had worse impact on the retention rate of the first biological disease-modifying antirheumatic drug (bDMARD) and response to methotrexate and was associated with severe disease course in terms of sacroiliitis.

Major finding: The risk for discontinuation of the first bDMARD (hazard ratio [HR] 2.129; P  =  .011) and methotrexate discontinuation because of therapy failure (HR 2.168; P  =  .002) were significantly higher among patients with 25(OH)D level of ≤20 vs  20-30 and ≥30 ng/mL, with the prevalence of sacroiliitis being significantly higher in patients with 25(OH)D level of ≤20 vs  ≥30 ng/mL (P  =  .0001).

Study details: Findings are from a retrospective study including 233 patients with PsA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Rotondo C et al. Vitamin D status and psoriatic arthritis: Association with the risk for sacroiliitis and influence on the retention rate of methotrexate monotherapy and first biological drug survival—A retrospective study. Int J Mol Sci. 2023;24(6):5368 (Mar 10). Doi: 10.3390/ijms24065368

Key clinical point: Vitamin D deficiency in patients with psoriatic arthritis (PsA) had worse impact on the retention rate of the first biological disease-modifying antirheumatic drug (bDMARD) and response to methotrexate and was associated with severe disease course in terms of sacroiliitis.

Major finding: The risk for discontinuation of the first bDMARD (hazard ratio [HR] 2.129; P  =  .011) and methotrexate discontinuation because of therapy failure (HR 2.168; P  =  .002) were significantly higher among patients with 25(OH)D level of ≤20 vs  20-30 and ≥30 ng/mL, with the prevalence of sacroiliitis being significantly higher in patients with 25(OH)D level of ≤20 vs  ≥30 ng/mL (P  =  .0001).

Study details: Findings are from a retrospective study including 233 patients with PsA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Rotondo C et al. Vitamin D status and psoriatic arthritis: Association with the risk for sacroiliitis and influence on the retention rate of methotrexate monotherapy and first biological drug survival—A retrospective study. Int J Mol Sci. 2023;24(6):5368 (Mar 10). Doi: 10.3390/ijms24065368

Key clinical point: Vitamin D deficiency in patients with psoriatic arthritis (PsA) had worse impact on the retention rate of the first biological disease-modifying antirheumatic drug (bDMARD) and response to methotrexate and was associated with severe disease course in terms of sacroiliitis.

Major finding: The risk for discontinuation of the first bDMARD (hazard ratio [HR] 2.129; P  =  .011) and methotrexate discontinuation because of therapy failure (HR 2.168; P  =  .002) were significantly higher among patients with 25(OH)D level of ≤20 vs  20-30 and ≥30 ng/mL, with the prevalence of sacroiliitis being significantly higher in patients with 25(OH)D level of ≤20 vs  ≥30 ng/mL (P  =  .0001).

Study details: Findings are from a retrospective study including 233 patients with PsA.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Rotondo C et al. Vitamin D status and psoriatic arthritis: Association with the risk for sacroiliitis and influence on the retention rate of methotrexate monotherapy and first biological drug survival—A retrospective study. Int J Mol Sci. 2023;24(6):5368 (Mar 10). Doi: 10.3390/ijms24065368