Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

Of the more than 6 million patients with Alzheimer’s disease in the United States aged 65 or older, nearly two-thirds are women. A new study published online in Cell may help explain the gender gap – and offer clues to new treatments for helping patients of both sexes fight back.

Researchers zeroed in on a gene named USP11, found on the X chromosome. People assigned female at birth have two X chromosomes, while people assigned male at birth have one X and one Y. So while all males have one copy of USP11, females have two.
 

The body’s trash collection system

In the normal course of events, the brain creates waste that must be removed lest it becomes toxic. One waste product is the protein tau. Too little tau can damage nerve cells, explained researchers David Kang, PhD, and Jung-A “Alexa” Woo, PhD, who led the study. But too much becomes toxic and can lead to neurodegenerative diseases such as Alzheimer’s disease. In fact, new research suggests that testing for changes in tau may someday help doctors diagnose Alzheimer’s disease earlier.

To manage tau, the brain uses a regulatory protein called ubiquitin to “tag” or signal the body that extra tau should be removed.

USP11’s job is to give instructions to make an enzyme that removes the ubiquitin tag to maintain balance. But if too much of the enzyme is present, too much tau gets untagged – and not enough of it gets cleared.

“Our study showed USP11 is higher in females than males in both humans and in mice,” Dr. Kang said. “That’s already true before the onset of dementia. But once someone has Alzheimer’s disease, USP11 is much higher – regardless of sex.”

The study adds to a growing body of evidence that shows that women may be more vulnerable than men to higher levels of tau, possibly explaining why women are affected by the disease more often than men.

But what if there was a way to “turn off” or deactivate the USP11 gene? Might that help prevent Alzheimer’s disease? And could it be done safely?
 

What happened when the gene was eliminated?

To examine these questions, researchers used a method of gene manipulation to completely delete the USP11 gene in mice. They then examined the mice for changes. The result? The mice seemed fine.

“The mice bred well. Their brains looked fine,” Dr. Woo said.

It would not be possible – or ethical – to remove a gene from humans. But when a medical condition makes a certain gene unhelpful, that gene can be partially blocked or expression of the gene can be reduced with medication. In fact, medications targeting enzymes are common. Examples include statins for cardiovascular disease or HIV treatments that inhibit protease enzymes.

“If we are able to identify some type of medicine that would inhibit USP11, our study suggests it would be well tolerated and benefit women,” Dr. Woo said.

Dr. Kang also cautions that the process for creating such a therapy takes at least 10-15 years. The researchers said they’d like to shorten the timeline and plan to study currently approved FDA medications to see if any might work to target USP11 gene activity – and hopefully bring forth a new treatment for Alzheimer’s disease sooner.

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

In what is believed to be a record, twins in Oregon were born this past Halloween from embryos that were frozen in 1992.

The National Embryo Donation Center says the twins, named Lydia and Timothy Ridgeway, are the longest frozen embryos to result in live birth, CNN reported.

Lydia was born at 5 pounds, 11 ounces. Timothy was born at 6 pounds, 7 ounces.

“There is something mind-boggling about it,” Philip Ridgeway told CNN as he and wife, Rachel Ridgeway, held their newborns. “I was 5 years old when God gave life to Lydia and Timothy, and he’s been preserving that life ever since.”

The babies were a result of embryo donation, usually from parents who have extra embryos after successfully having babies via in vitro fertilization (IVF).

In the case of newborns Lydia and Timothy, their donor parents are an anonymous married couple. The husband was in his early 50s at the time, and the couple used a 34-year-old egg donor, CNN reported.

After the embryos sat in storage on the West Coast from 1992 to 2007, the donor parents donated them to the National Embryo Donation Center in Knoxville, Tenn.

“In a sense, they’re our oldest children, even though they’re our smallest children,” said Philip Ridgeway.

The couple already had four other children, ages 8, 6, 3, and one that’s almost 2. None of their other children was conceived via IVF or donors.

“We’ve never had in our minds a set number of children we’d like to have,” Philip Ridgeway said. “We’ve always thought we’ll have as many as God wants to give us, and ... when we heard about embryo adoption, we thought that’s something we would like to do.”

In an article for Harvard Medical School, fertility expert Ellen S. Glazer said there are countless IVF-created embryos whose future path has five options.

“Those embarking on an IVF cycle are often laser-focused on the baby they long for,” wrote Ms. Glazer, a clinical social worker whose practice focuses on reproductive issues. “Most hope a cycle will yield several embryos, because it frequently takes more than one embryo transfer to achieve a successful full-term pregnancy. Any remaining embryos may offer the hope of future pregnancies and additional children.”

If the embryos are not used, the five options are:

• Discard the remaining embryos.
• Have another child anyway, even if a larger family wasn’t the original plan.
• Donate the embryos to science.
• Donate the embryos to another person or couple.
• Decide not to decide. (In this situation, clinics use the term “abandon” when a family avoids contact and stops paying storage fees.)

For the Ridgeways, when they were offered information to help them choose among donated embryos, they decided to focus on those with the lowest identification numbers on the list.

“We weren’t looking to get the embryos that have been frozen the longest in the world,” Philip Ridgeway said. “We just wanted the ones that had been waiting the longest.”

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

In what is believed to be a record, twins in Oregon were born this past Halloween from embryos that were frozen in 1992.

The National Embryo Donation Center says the twins, named Lydia and Timothy Ridgeway, are the longest frozen embryos to result in live birth, CNN reported.

Lydia was born at 5 pounds, 11 ounces. Timothy was born at 6 pounds, 7 ounces.

“There is something mind-boggling about it,” Philip Ridgeway told CNN as he and wife, Rachel Ridgeway, held their newborns. “I was 5 years old when God gave life to Lydia and Timothy, and he’s been preserving that life ever since.”

The babies were a result of embryo donation, usually from parents who have extra embryos after successfully having babies via in vitro fertilization (IVF).

In the case of newborns Lydia and Timothy, their donor parents are an anonymous married couple. The husband was in his early 50s at the time, and the couple used a 34-year-old egg donor, CNN reported.

After the embryos sat in storage on the West Coast from 1992 to 2007, the donor parents donated them to the National Embryo Donation Center in Knoxville, Tenn.

“In a sense, they’re our oldest children, even though they’re our smallest children,” said Philip Ridgeway.

The couple already had four other children, ages 8, 6, 3, and one that’s almost 2. None of their other children was conceived via IVF or donors.

“We’ve never had in our minds a set number of children we’d like to have,” Philip Ridgeway said. “We’ve always thought we’ll have as many as God wants to give us, and ... when we heard about embryo adoption, we thought that’s something we would like to do.”

In an article for Harvard Medical School, fertility expert Ellen S. Glazer said there are countless IVF-created embryos whose future path has five options.

“Those embarking on an IVF cycle are often laser-focused on the baby they long for,” wrote Ms. Glazer, a clinical social worker whose practice focuses on reproductive issues. “Most hope a cycle will yield several embryos, because it frequently takes more than one embryo transfer to achieve a successful full-term pregnancy. Any remaining embryos may offer the hope of future pregnancies and additional children.”

If the embryos are not used, the five options are:

• Discard the remaining embryos.
• Have another child anyway, even if a larger family wasn’t the original plan.
• Donate the embryos to science.
• Donate the embryos to another person or couple.
• Decide not to decide. (In this situation, clinics use the term “abandon” when a family avoids contact and stops paying storage fees.)

For the Ridgeways, when they were offered information to help them choose among donated embryos, they decided to focus on those with the lowest identification numbers on the list.

“We weren’t looking to get the embryos that have been frozen the longest in the world,” Philip Ridgeway said. “We just wanted the ones that had been waiting the longest.”

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

In what is believed to be a record, twins in Oregon were born this past Halloween from embryos that were frozen in 1992.

The National Embryo Donation Center says the twins, named Lydia and Timothy Ridgeway, are the longest frozen embryos to result in live birth, CNN reported.

Lydia was born at 5 pounds, 11 ounces. Timothy was born at 6 pounds, 7 ounces.

“There is something mind-boggling about it,” Philip Ridgeway told CNN as he and wife, Rachel Ridgeway, held their newborns. “I was 5 years old when God gave life to Lydia and Timothy, and he’s been preserving that life ever since.”

The babies were a result of embryo donation, usually from parents who have extra embryos after successfully having babies via in vitro fertilization (IVF).

In the case of newborns Lydia and Timothy, their donor parents are an anonymous married couple. The husband was in his early 50s at the time, and the couple used a 34-year-old egg donor, CNN reported.

After the embryos sat in storage on the West Coast from 1992 to 2007, the donor parents donated them to the National Embryo Donation Center in Knoxville, Tenn.

“In a sense, they’re our oldest children, even though they’re our smallest children,” said Philip Ridgeway.

The couple already had four other children, ages 8, 6, 3, and one that’s almost 2. None of their other children was conceived via IVF or donors.

“We’ve never had in our minds a set number of children we’d like to have,” Philip Ridgeway said. “We’ve always thought we’ll have as many as God wants to give us, and ... when we heard about embryo adoption, we thought that’s something we would like to do.”

In an article for Harvard Medical School, fertility expert Ellen S. Glazer said there are countless IVF-created embryos whose future path has five options.

“Those embarking on an IVF cycle are often laser-focused on the baby they long for,” wrote Ms. Glazer, a clinical social worker whose practice focuses on reproductive issues. “Most hope a cycle will yield several embryos, because it frequently takes more than one embryo transfer to achieve a successful full-term pregnancy. Any remaining embryos may offer the hope of future pregnancies and additional children.”

If the embryos are not used, the five options are:

• Discard the remaining embryos.
• Have another child anyway, even if a larger family wasn’t the original plan.
• Donate the embryos to science.
• Donate the embryos to another person or couple.
• Decide not to decide. (In this situation, clinics use the term “abandon” when a family avoids contact and stops paying storage fees.)

For the Ridgeways, when they were offered information to help them choose among donated embryos, they decided to focus on those with the lowest identification numbers on the list.

“We weren’t looking to get the embryos that have been frozen the longest in the world,” Philip Ridgeway said. “We just wanted the ones that had been waiting the longest.”

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

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.

The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”

Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.

The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.

The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.

In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.

And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.

“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.

“CVS should not be selling that test,” he added.

In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.

CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.

Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”

Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.

Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”

Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.

But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”

Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.

Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).

Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.

Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.

Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624

Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.

Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).

Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.

Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.

Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624

Key clinical point: Overall, COVID-19 vaccines were well tolerated in patients with rheumatoid arthritis (RA), with the adverse event (AE) profile being comparable to that in control individuals; patients receiving methotrexate and hydroxychloroquine vs other immunosuppressants reporting fewer minor AE.

Major finding: At 7 days after vaccination, 76.9% of patients with RA reported AE, all being minor and comparable to those in the control group and similar between patients with active and inactive disease. Major AE were reported by 4.2% of patients with RA. Patients receiving methotrexate or hydroxychloroquine vs other immunosuppressants reported fewer minor AE (all P ≤ .05).

Study details: This was a cross-sectional survey-based study of 9462 respondents of an online self-reported questionnaire, including patients with RA (n = 1347), other autoimmune rheumatic diseases (n = 2305), non-rheumatic autoimmune diseases (n = 1079), and the control group (n = 4741) who received at least one dose of any COVID-19 vaccine.

Disclosures: This study did not receive any specific funding. Several authors reported receiving advisory board or speaker honoraria, consulting fees, research grant, or funding from various sources.

Source: Naveen R et al. COVID-19 vaccination in autoimmune diseases (COVAD) Study: Vaccine safety and tolerance in rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 31). Doi: 10.1093/rheumatology/keac624

Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with ≤4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (P_trend = .033).

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (P_trend = .033).

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (P_trend = .033).

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632

Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632

Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632

Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk of developing all types of thyroid dysfunctions, with the risk being the highest for hypothyroidism, followed by subclinical hypothyroidism, subclinical hyperthyroidism, and hyperthyroidism.

Major finding: Patients with RA vs non-RA control individuals were at a higher risk of developing thyroid dysfunctions such as hypothyroidism (pooled OR [pOR] 2.25; 95% CI 1.78-2.84), subclinical hypothyroidism (pOR 2.18; 95% CI 1.32-3.61), subclinical hyperthyroidism (pOR 2.13; 95% CI 1.25-3.63), and hyperthyroidism (OR 1.65; 95% CI 1.24-2.19).

Study details: Findings are from a systematic review and meta-analysis of 29 studies that evaluated thyroid dysfunction in patients with RA (n = 35,708) and non-RA control individuals (n = 149,421).

Disclosures: This study was supported by grants from the Science and Technology Bureau of Quanzhou and the Natural Science Foundation of Fujian Province. The authors declared no conflict of interests.

Source: Liu Y-j et al. Association between rheumatoid arthritis and thyroid dysfunction: A meta-analysis and systematic review. Front Endocrinol. 2022;13:1015516 (Oct 13). Doi: 10.3389/fendo.2022.1015516

Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk of developing all types of thyroid dysfunctions, with the risk being the highest for hypothyroidism, followed by subclinical hypothyroidism, subclinical hyperthyroidism, and hyperthyroidism.

Major finding: Patients with RA vs non-RA control individuals were at a higher risk of developing thyroid dysfunctions such as hypothyroidism (pooled OR [pOR] 2.25; 95% CI 1.78-2.84), subclinical hypothyroidism (pOR 2.18; 95% CI 1.32-3.61), subclinical hyperthyroidism (pOR 2.13; 95% CI 1.25-3.63), and hyperthyroidism (OR 1.65; 95% CI 1.24-2.19).

Study details: Findings are from a systematic review and meta-analysis of 29 studies that evaluated thyroid dysfunction in patients with RA (n = 35,708) and non-RA control individuals (n = 149,421).

Disclosures: This study was supported by grants from the Science and Technology Bureau of Quanzhou and the Natural Science Foundation of Fujian Province. The authors declared no conflict of interests.

Source: Liu Y-j et al. Association between rheumatoid arthritis and thyroid dysfunction: A meta-analysis and systematic review. Front Endocrinol. 2022;13:1015516 (Oct 13). Doi: 10.3389/fendo.2022.1015516

Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk of developing all types of thyroid dysfunctions, with the risk being the highest for hypothyroidism, followed by subclinical hypothyroidism, subclinical hyperthyroidism, and hyperthyroidism.

Major finding: Patients with RA vs non-RA control individuals were at a higher risk of developing thyroid dysfunctions such as hypothyroidism (pooled OR [pOR] 2.25; 95% CI 1.78-2.84), subclinical hypothyroidism (pOR 2.18; 95% CI 1.32-3.61), subclinical hyperthyroidism (pOR 2.13; 95% CI 1.25-3.63), and hyperthyroidism (OR 1.65; 95% CI 1.24-2.19).

Study details: Findings are from a systematic review and meta-analysis of 29 studies that evaluated thyroid dysfunction in patients with RA (n = 35,708) and non-RA control individuals (n = 149,421).

Disclosures: This study was supported by grants from the Science and Technology Bureau of Quanzhou and the Natural Science Foundation of Fujian Province. The authors declared no conflict of interests.

Source: Liu Y-j et al. Association between rheumatoid arthritis and thyroid dysfunction: A meta-analysis and systematic review. Front Endocrinol. 2022;13:1015516 (Oct 13). Doi: 10.3389/fendo.2022.1015516

Key clinical point: Red blood cell distribution width could serve as a useful biomarker and successfully differentiate between patients with rheumatoid arthritis (RA) and control individuals.

Major finding: Patients with RA vs. control individuals had significantly higher values for red blood cell distribution width (standardized mean difference, 0.96; P < .001); however, the mean platelet volume (P = .515) and platelet distribution width (P = .222) were not significantly different between the 2 groups.

Study details: This was a systematic review and meta-analysis of 23 studies, of which 11 studies reported data on red blood cell distribution width and included 1,221 patients with RA and 983 control individuals.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Zinellu A and Mangoni AA et al. Platelet and red blood cell volume indices in patients with rheumatoid arthritis: A systematic review and meta-analysis. Diagnostics. 2022;12(11):2633 (Oct 30). Doi: 10.3390/diagnostics12112633.

Key clinical point: Red blood cell distribution width could serve as a useful biomarker and successfully differentiate between patients with rheumatoid arthritis (RA) and control individuals.

Major finding: Patients with RA vs. control individuals had significantly higher values for red blood cell distribution width (standardized mean difference, 0.96; P < .001); however, the mean platelet volume (P = .515) and platelet distribution width (P = .222) were not significantly different between the 2 groups.

Study details: This was a systematic review and meta-analysis of 23 studies, of which 11 studies reported data on red blood cell distribution width and included 1,221 patients with RA and 983 control individuals.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Zinellu A and Mangoni AA et al. Platelet and red blood cell volume indices in patients with rheumatoid arthritis: A systematic review and meta-analysis. Diagnostics. 2022;12(11):2633 (Oct 30). Doi: 10.3390/diagnostics12112633.

Key clinical point: Red blood cell distribution width could serve as a useful biomarker and successfully differentiate between patients with rheumatoid arthritis (RA) and control individuals.

Major finding: Patients with RA vs. control individuals had significantly higher values for red blood cell distribution width (standardized mean difference, 0.96; P < .001); however, the mean platelet volume (P = .515) and platelet distribution width (P = .222) were not significantly different between the 2 groups.

Study details: This was a systematic review and meta-analysis of 23 studies, of which 11 studies reported data on red blood cell distribution width and included 1,221 patients with RA and 983 control individuals.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Zinellu A and Mangoni AA et al. Platelet and red blood cell volume indices in patients with rheumatoid arthritis: A systematic review and meta-analysis. Diagnostics. 2022;12(11):2633 (Oct 30). Doi: 10.3390/diagnostics12112633.

Key clinical point: Age is an independent contributor to seronegative rheumatoid arthritis (RA), with the effect being prominent in females but not in males.

Major finding: Rates of rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) positivity and RF/anti-CCP double positivity declined significantly with an increase in age at RA diagnosis (all P < .001). The age at disease onset was independently associated with RF (odds ratio [OR] 0.980; P < .001) and anti-CCP (OR 0.976; P < .001) positivity in patients with RA, with both the associations being significant in women (RF positivity: OR 0.979; P < .001; anti-CCP positivity: OR 0.970; P < .001) but not in men.

Study details: This was a cohort study including 1685 patients with RA (mean age at diagnosis, 51.9 years), of which 83.4% were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Takanashi S et al. Impacts of ageing on rheumatoid factor and anti-cyclic citrullinated peptide antibody positivity in patients with rheumatoid arthritis. J Rheumatol. 2022 (Nov 1). Doi: 10.3899/jrheum.220526

Key clinical point: Age is an independent contributor to seronegative rheumatoid arthritis (RA), with the effect being prominent in females but not in males.

Major finding: Rates of rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) positivity and RF/anti-CCP double positivity declined significantly with an increase in age at RA diagnosis (all P < .001). The age at disease onset was independently associated with RF (odds ratio [OR] 0.980; P < .001) and anti-CCP (OR 0.976; P < .001) positivity in patients with RA, with both the associations being significant in women (RF positivity: OR 0.979; P < .001; anti-CCP positivity: OR 0.970; P < .001) but not in men.

Study details: This was a cohort study including 1685 patients with RA (mean age at diagnosis, 51.9 years), of which 83.4% were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Takanashi S et al. Impacts of ageing on rheumatoid factor and anti-cyclic citrullinated peptide antibody positivity in patients with rheumatoid arthritis. J Rheumatol. 2022 (Nov 1). Doi: 10.3899/jrheum.220526

Key clinical point: Age is an independent contributor to seronegative rheumatoid arthritis (RA), with the effect being prominent in females but not in males.

Major finding: Rates of rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) positivity and RF/anti-CCP double positivity declined significantly with an increase in age at RA diagnosis (all P < .001). The age at disease onset was independently associated with RF (odds ratio [OR] 0.980; P < .001) and anti-CCP (OR 0.976; P < .001) positivity in patients with RA, with both the associations being significant in women (RF positivity: OR 0.979; P < .001; anti-CCP positivity: OR 0.970; P < .001) but not in men.

Study details: This was a cohort study including 1685 patients with RA (mean age at diagnosis, 51.9 years), of which 83.4% were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Takanashi S et al. Impacts of ageing on rheumatoid factor and anti-cyclic citrullinated peptide antibody positivity in patients with rheumatoid arthritis. J Rheumatol. 2022 (Nov 1). Doi: 10.3899/jrheum.220526