Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

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.

Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

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.

Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

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.

INDIANAPOLIS – Nearly two-thirds of pediatric patients with hidradenitis suppurativa (HS) met criteria for obesity at the time of their diagnosis, and 36% had acne, in a study presented at the annual meeting of the Society for Pediatric Dermatology.

In addition, 44% presented with scarring, which suggests that HS may be underdiagnosed in this patient population. Those are the key findings from the study, a single-center retrospective chart review presented by Stephanie Sanchez during a poster session at the meeting.

Doug Brunk/MDedge News

“There is limited research on HS within the pediatric population,” said Ms. Sanchez, a fourth-year medical student at Boston University. “It’s not very well defined or characterized.” The “unusually high number of pediatric patients with HS” at Boston Medical Center provided “a unique opportunity to study this topic.”

Working with her mentor, Lisa Shen, MD, associate medical director of pediatric dermatology at Boston University, Ms. Sanchez and colleagues retrospectively reviewed the medical records of 303 patients aged 4-18 years who were diagnosed with HS at Boston Medical Center from 2012 to 2021. Boston Medical Center is the largest safety net hospital in New England. All data points and outcome measures were collected within 6 months of the patient’s HS diagnosis date.

Of the 303 patients with HS, 84% were female and 16% were male. Complete information about race was available in 286 patients. Of these, 65% were Black/African American, 11% were White, and the rest were from other racial groups. The mean age at symptom onset was 13 years, while the mean age at diagnosis was 15 years, and the mean delay to diagnosis was 2 years. A family history of HS was reported in 36% of patients.

Elsevier

The most common clinical features in these HS patients were pain/tenderness (90%), pustules/papules (65%), discharge/drainage (62%), and deep-seated nodules (51%). Scarring was present in 44% of patients at the time of diagnosis. The three most common sites of involvement were the axillary area (79%), the pubic area (36%), and the inguinal folds/inner thighs (34%).

Obesity was the most common comorbidity at the time of diagnosis, with 64% of patients affected. The next most common comorbidities were acne vulgaris (36%), acanthosis nigricans (25%), depression (18%), being overweight (17%), polycystic ovary syndrome (16%) and anxiety (13%). None had type 1 diabetes or metabolic syndrome.

Referring to the large population of underserved minority patients at Boston Medical Center, Dr. Shen noted, “we have to make sure not to underestimate the prevalence of obesity in this population as they get older. We need to start from a younger age to incorporate multidisciplinary care such as weight management, nutrition, and working with our pediatric surgery colleagues in trying to tackle [HS] because there is data to suggest that the earlier we intervene, the better outcomes they have. That makes sense.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the findings, said that the study “highlights the impressive and concerning gap and delays in diagnosis, not too dissimilar to what the literature shows in adult HS patients, which unfortunately has tremendous ramifications, both physically and emotionally/psychosocially.”

While this single-center study identified potential risk factors, such as obesity and self-identifying as Black, he said, “it is important to note that this condition does not discriminate and therefore it is important not to miss the cases that don’t follow the textbook nor stigmatize this condition as one that only impacts certain demographics.”

The researchers reported having no financial disclosures. Dr. Friedman, who was not involved with the study, reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is a speaker for companies including, Regeneron, Sanofi, AbbVie, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

INDIANAPOLIS – Nearly two-thirds of pediatric patients with hidradenitis suppurativa (HS) met criteria for obesity at the time of their diagnosis, and 36% had acne, in a study presented at the annual meeting of the Society for Pediatric Dermatology.

In addition, 44% presented with scarring, which suggests that HS may be underdiagnosed in this patient population. Those are the key findings from the study, a single-center retrospective chart review presented by Stephanie Sanchez during a poster session at the meeting.

Doug Brunk/MDedge News

“There is limited research on HS within the pediatric population,” said Ms. Sanchez, a fourth-year medical student at Boston University. “It’s not very well defined or characterized.” The “unusually high number of pediatric patients with HS” at Boston Medical Center provided “a unique opportunity to study this topic.”

Working with her mentor, Lisa Shen, MD, associate medical director of pediatric dermatology at Boston University, Ms. Sanchez and colleagues retrospectively reviewed the medical records of 303 patients aged 4-18 years who were diagnosed with HS at Boston Medical Center from 2012 to 2021. Boston Medical Center is the largest safety net hospital in New England. All data points and outcome measures were collected within 6 months of the patient’s HS diagnosis date.

Of the 303 patients with HS, 84% were female and 16% were male. Complete information about race was available in 286 patients. Of these, 65% were Black/African American, 11% were White, and the rest were from other racial groups. The mean age at symptom onset was 13 years, while the mean age at diagnosis was 15 years, and the mean delay to diagnosis was 2 years. A family history of HS was reported in 36% of patients.

Elsevier

The most common clinical features in these HS patients were pain/tenderness (90%), pustules/papules (65%), discharge/drainage (62%), and deep-seated nodules (51%). Scarring was present in 44% of patients at the time of diagnosis. The three most common sites of involvement were the axillary area (79%), the pubic area (36%), and the inguinal folds/inner thighs (34%).

Obesity was the most common comorbidity at the time of diagnosis, with 64% of patients affected. The next most common comorbidities were acne vulgaris (36%), acanthosis nigricans (25%), depression (18%), being overweight (17%), polycystic ovary syndrome (16%) and anxiety (13%). None had type 1 diabetes or metabolic syndrome.

Referring to the large population of underserved minority patients at Boston Medical Center, Dr. Shen noted, “we have to make sure not to underestimate the prevalence of obesity in this population as they get older. We need to start from a younger age to incorporate multidisciplinary care such as weight management, nutrition, and working with our pediatric surgery colleagues in trying to tackle [HS] because there is data to suggest that the earlier we intervene, the better outcomes they have. That makes sense.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the findings, said that the study “highlights the impressive and concerning gap and delays in diagnosis, not too dissimilar to what the literature shows in adult HS patients, which unfortunately has tremendous ramifications, both physically and emotionally/psychosocially.”

While this single-center study identified potential risk factors, such as obesity and self-identifying as Black, he said, “it is important to note that this condition does not discriminate and therefore it is important not to miss the cases that don’t follow the textbook nor stigmatize this condition as one that only impacts certain demographics.”

The researchers reported having no financial disclosures. Dr. Friedman, who was not involved with the study, reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is a speaker for companies including, Regeneron, Sanofi, AbbVie, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

INDIANAPOLIS – Nearly two-thirds of pediatric patients with hidradenitis suppurativa (HS) met criteria for obesity at the time of their diagnosis, and 36% had acne, in a study presented at the annual meeting of the Society for Pediatric Dermatology.

In addition, 44% presented with scarring, which suggests that HS may be underdiagnosed in this patient population. Those are the key findings from the study, a single-center retrospective chart review presented by Stephanie Sanchez during a poster session at the meeting.

Doug Brunk/MDedge News

“There is limited research on HS within the pediatric population,” said Ms. Sanchez, a fourth-year medical student at Boston University. “It’s not very well defined or characterized.” The “unusually high number of pediatric patients with HS” at Boston Medical Center provided “a unique opportunity to study this topic.”

Working with her mentor, Lisa Shen, MD, associate medical director of pediatric dermatology at Boston University, Ms. Sanchez and colleagues retrospectively reviewed the medical records of 303 patients aged 4-18 years who were diagnosed with HS at Boston Medical Center from 2012 to 2021. Boston Medical Center is the largest safety net hospital in New England. All data points and outcome measures were collected within 6 months of the patient’s HS diagnosis date.

Of the 303 patients with HS, 84% were female and 16% were male. Complete information about race was available in 286 patients. Of these, 65% were Black/African American, 11% were White, and the rest were from other racial groups. The mean age at symptom onset was 13 years, while the mean age at diagnosis was 15 years, and the mean delay to diagnosis was 2 years. A family history of HS was reported in 36% of patients.

Elsevier

The most common clinical features in these HS patients were pain/tenderness (90%), pustules/papules (65%), discharge/drainage (62%), and deep-seated nodules (51%). Scarring was present in 44% of patients at the time of diagnosis. The three most common sites of involvement were the axillary area (79%), the pubic area (36%), and the inguinal folds/inner thighs (34%).

Obesity was the most common comorbidity at the time of diagnosis, with 64% of patients affected. The next most common comorbidities were acne vulgaris (36%), acanthosis nigricans (25%), depression (18%), being overweight (17%), polycystic ovary syndrome (16%) and anxiety (13%). None had type 1 diabetes or metabolic syndrome.

Referring to the large population of underserved minority patients at Boston Medical Center, Dr. Shen noted, “we have to make sure not to underestimate the prevalence of obesity in this population as they get older. We need to start from a younger age to incorporate multidisciplinary care such as weight management, nutrition, and working with our pediatric surgery colleagues in trying to tackle [HS] because there is data to suggest that the earlier we intervene, the better outcomes they have. That makes sense.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the findings, said that the study “highlights the impressive and concerning gap and delays in diagnosis, not too dissimilar to what the literature shows in adult HS patients, which unfortunately has tremendous ramifications, both physically and emotionally/psychosocially.”

While this single-center study identified potential risk factors, such as obesity and self-identifying as Black, he said, “it is important to note that this condition does not discriminate and therefore it is important not to miss the cases that don’t follow the textbook nor stigmatize this condition as one that only impacts certain demographics.”

The researchers reported having no financial disclosures. Dr. Friedman, who was not involved with the study, reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is a speaker for companies including, Regeneron, Sanofi, AbbVie, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Vertex Pharmaceuticals has acquired ViaCyte, bringing together two of the leading biotechnology companies developing stem cell–derived islet cell replacement therapies for type 1 diabetes.

The $320 million cash purchase “will accelerate our goal of transforming, if not curing, type 1 diabetes by expanding our capabilities and bringing additional tools, technologies, and assets to our current stem cell-based programs,” said Vertex Chief Executive Officer and President Reshma Kewalramani, MD, in a company statement.

Last month, Vertex reported on a phase 1/2 multicenter clinical trial for two patients with type 1 diabetes who experienced improved blood glucose control with half doses of the company’s investigational allogeneic stem cell-derived islets (VX-880).

The first person to receive the product remained completely insulin-independent at 9 months post-transplant. A third patient has received the full targeted dose, but the data for this participant have yet to be reported.

For Viacyte’s part, last week the company announced that a clinical hold placed by the U.S. Food and Drug Administration on the trial has been lifted, allowing it to move forward with a planned total enrollment of 17 patients.

“The FDA requested additional information on the program, which we provided expeditiously. We are pleased that the hold has been lifted and look forward to continuing the Phase 1/2 trial in the U.S.,” a Vertex spokesperson told this news organization.

And a company official for ViaCyte presented results for three patients who received pancreatic precursor (PEC-01) cells derived from the company’s proprietary pluripotent stem cell line at the annual meeting of the Endocrine Society held in June. The cells are housed in an open delivery device implanted into a patient’s forearm. All three participants experienced improved blood glucose levels.

That presentation followed ViaCyte’s announcement in February that the first patient with type 1 diabetes had been dosed in a Phase 1 clinical trial of its investigational allogeneic, gene-edited, stem cell-derived product, VCTX210, developed in collaboration with CRISPR Therapeutics’ gene-editing technology. The aim is to generate islet cells that will produce insulin while avoiding recognition by the immune system, thus rendering immunosuppressive drugs unnecessary.

According to Vertex’s announcement, “The acquisition of ViaCyte provides Vertex with complementary assets, capabilities, and technologies, including additional human stem cell lines, intellectual property around stem cell differentiation, and Good Manufacturing Practice ... facilities for cell-based therapies that could accelerate Vertex’s ongoing type 1 diabetes programs. The acquisition also provides access to novel hypoimmune stem cell assets via the ViaCyte collaboration with CRISPR Therapeutics.”

In response to the announcement, the type 1 diabetes advocacy organization JDRF, which has funded the work of both companies, said in a statement that the acquisition “represents a significant stride in cures research for the type 1 diabetes community.”

“The coming together of two leaders in the cell-derived therapies field will undoubtedly accelerate the development of VX-880 by combining their resources, technologies, intellectual property, and more,” it added.

A third company developing stem cell–derived islet cell therapies, Sernova, said in a statement provided to this news organization: “We are very confident that bringing important game-changing technologies together, as we are seeing across the industry, will result in several viable technologies for the millions of people with type 1 diabetes ... We are thrilled that there are several technologies under development using different approaches that have the potential to provide a ‘functional cure’ for this disease.”

Vertex anticipates the acquisition will close later in 2022.

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

Vertex Pharmaceuticals has acquired ViaCyte, bringing together two of the leading biotechnology companies developing stem cell–derived islet cell replacement therapies for type 1 diabetes.

The $320 million cash purchase “will accelerate our goal of transforming, if not curing, type 1 diabetes by expanding our capabilities and bringing additional tools, technologies, and assets to our current stem cell-based programs,” said Vertex Chief Executive Officer and President Reshma Kewalramani, MD, in a company statement.

Last month, Vertex reported on a phase 1/2 multicenter clinical trial for two patients with type 1 diabetes who experienced improved blood glucose control with half doses of the company’s investigational allogeneic stem cell-derived islets (VX-880).

The first person to receive the product remained completely insulin-independent at 9 months post-transplant. A third patient has received the full targeted dose, but the data for this participant have yet to be reported.

For Viacyte’s part, last week the company announced that a clinical hold placed by the U.S. Food and Drug Administration on the trial has been lifted, allowing it to move forward with a planned total enrollment of 17 patients.

“The FDA requested additional information on the program, which we provided expeditiously. We are pleased that the hold has been lifted and look forward to continuing the Phase 1/2 trial in the U.S.,” a Vertex spokesperson told this news organization.

And a company official for ViaCyte presented results for three patients who received pancreatic precursor (PEC-01) cells derived from the company’s proprietary pluripotent stem cell line at the annual meeting of the Endocrine Society held in June. The cells are housed in an open delivery device implanted into a patient’s forearm. All three participants experienced improved blood glucose levels.

That presentation followed ViaCyte’s announcement in February that the first patient with type 1 diabetes had been dosed in a Phase 1 clinical trial of its investigational allogeneic, gene-edited, stem cell-derived product, VCTX210, developed in collaboration with CRISPR Therapeutics’ gene-editing technology. The aim is to generate islet cells that will produce insulin while avoiding recognition by the immune system, thus rendering immunosuppressive drugs unnecessary.

According to Vertex’s announcement, “The acquisition of ViaCyte provides Vertex with complementary assets, capabilities, and technologies, including additional human stem cell lines, intellectual property around stem cell differentiation, and Good Manufacturing Practice ... facilities for cell-based therapies that could accelerate Vertex’s ongoing type 1 diabetes programs. The acquisition also provides access to novel hypoimmune stem cell assets via the ViaCyte collaboration with CRISPR Therapeutics.”

In response to the announcement, the type 1 diabetes advocacy organization JDRF, which has funded the work of both companies, said in a statement that the acquisition “represents a significant stride in cures research for the type 1 diabetes community.”

“The coming together of two leaders in the cell-derived therapies field will undoubtedly accelerate the development of VX-880 by combining their resources, technologies, intellectual property, and more,” it added.

A third company developing stem cell–derived islet cell therapies, Sernova, said in a statement provided to this news organization: “We are very confident that bringing important game-changing technologies together, as we are seeing across the industry, will result in several viable technologies for the millions of people with type 1 diabetes ... We are thrilled that there are several technologies under development using different approaches that have the potential to provide a ‘functional cure’ for this disease.”

Vertex anticipates the acquisition will close later in 2022.

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

Vertex Pharmaceuticals has acquired ViaCyte, bringing together two of the leading biotechnology companies developing stem cell–derived islet cell replacement therapies for type 1 diabetes.

The $320 million cash purchase “will accelerate our goal of transforming, if not curing, type 1 diabetes by expanding our capabilities and bringing additional tools, technologies, and assets to our current stem cell-based programs,” said Vertex Chief Executive Officer and President Reshma Kewalramani, MD, in a company statement.

Last month, Vertex reported on a phase 1/2 multicenter clinical trial for two patients with type 1 diabetes who experienced improved blood glucose control with half doses of the company’s investigational allogeneic stem cell-derived islets (VX-880).

The first person to receive the product remained completely insulin-independent at 9 months post-transplant. A third patient has received the full targeted dose, but the data for this participant have yet to be reported.

For Viacyte’s part, last week the company announced that a clinical hold placed by the U.S. Food and Drug Administration on the trial has been lifted, allowing it to move forward with a planned total enrollment of 17 patients.

“The FDA requested additional information on the program, which we provided expeditiously. We are pleased that the hold has been lifted and look forward to continuing the Phase 1/2 trial in the U.S.,” a Vertex spokesperson told this news organization.

And a company official for ViaCyte presented results for three patients who received pancreatic precursor (PEC-01) cells derived from the company’s proprietary pluripotent stem cell line at the annual meeting of the Endocrine Society held in June. The cells are housed in an open delivery device implanted into a patient’s forearm. All three participants experienced improved blood glucose levels.

That presentation followed ViaCyte’s announcement in February that the first patient with type 1 diabetes had been dosed in a Phase 1 clinical trial of its investigational allogeneic, gene-edited, stem cell-derived product, VCTX210, developed in collaboration with CRISPR Therapeutics’ gene-editing technology. The aim is to generate islet cells that will produce insulin while avoiding recognition by the immune system, thus rendering immunosuppressive drugs unnecessary.

According to Vertex’s announcement, “The acquisition of ViaCyte provides Vertex with complementary assets, capabilities, and technologies, including additional human stem cell lines, intellectual property around stem cell differentiation, and Good Manufacturing Practice ... facilities for cell-based therapies that could accelerate Vertex’s ongoing type 1 diabetes programs. The acquisition also provides access to novel hypoimmune stem cell assets via the ViaCyte collaboration with CRISPR Therapeutics.”

In response to the announcement, the type 1 diabetes advocacy organization JDRF, which has funded the work of both companies, said in a statement that the acquisition “represents a significant stride in cures research for the type 1 diabetes community.”

“The coming together of two leaders in the cell-derived therapies field will undoubtedly accelerate the development of VX-880 by combining their resources, technologies, intellectual property, and more,” it added.

A third company developing stem cell–derived islet cell therapies, Sernova, said in a statement provided to this news organization: “We are very confident that bringing important game-changing technologies together, as we are seeing across the industry, will result in several viable technologies for the millions of people with type 1 diabetes ... We are thrilled that there are several technologies under development using different approaches that have the potential to provide a ‘functional cure’ for this disease.”

Vertex anticipates the acquisition will close later in 2022.

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

When anti–tumor necrosis factor-alpha (anti-TNF) treatment fails to achieve remission for patients with ulcerative colitis (UC), tofacitinib (Xeljanz) appears more effect sooner than vedolizumab (Entyvio), suggests a Dutch registry study.

Data on nearly 150 patients with UC who had already undergone treatment with anti-TNF drugs showed that combined clinical and biochemical remission was about five times more likely with tofacitinib versus vedolizumab within 12 weeks of starting therapy.

However, the differences tailed off over subsequent weeks, such that there was no significant difference in combined remission rates at 52 weeks. There were also no notable differences in safety between the two drugs.

“These results may help in guiding clinical decisionmaking after anti-TNF failure in patients with UC,” the authors write.

The research was published online by Clinical Gastroenterology and Hepatology.
 

Real-world evidence

“This study offers more real-world evidence than a standard randomized controlled trial, since there was no randomization between the two study groups and no strict inclusion and exclusion criteria,” co–senior authors Tessa Straatmijer, MD, PhD candidate, and Marjolijn Duijvestein, MD, Amsterdam University Medical Center, the Netherlands, told this news organization.

They continued: “It is known that tofacitinib is more rapid of action compared to vedolizumab. We therefore expected that the odds ratio of remission rates between the two groups would be higher at weeks 12 and 24, compared to week 52.”

“We will continue with collecting data in our prospective cohort up to 10 years after initiating tofacitinib or vedolizumab,” Dr. Straatmijer and Dr. Duijvestein added. “Hopefully we can provide long-term outcomes after a couple of years.”

The authors highlight that for a “considerable proportion” of patients with UC, their condition does not respond to anti-TNF drugs, they experience adverse effects, or the response diminishes over time. Alternatives, such as vedolizumab and tofacitinib, are typically “prescribed after failure of the anti-TNF,” owing to their price and clinician experience.

While vedolizumab (an α4β7 integrin blocker) and tofacitinib (a Janus kinase inhibitor) have different mechanisms of action, head-to-head randomized controlled trials comparing their efficacy among patients with UC whose condition is refractory to anti-TNF are “lacking,” they add. “However, to guide physician decisionmaking on the most suitable drug choice after anti-TNF failure, effectiveness data comparing tofacitinib with vedolizumab is pivotal.”

To assess the comparative effectiveness and safety of the next therapeutic options, the team examined data from the Dutch Initiative on Crohn and Colitis registry.

They identified nearly 300 adult patients with clinical or biochemical disease activity who had initiated treatment with vedolizumab or tofacitinib. They excluded patients without prior anti-TNF treatment, those who had previously been treated with vedolizumab or tofacitinib, and those who did not have clinical and biochemical or endoscopic disease activity at baseline. The final analysis included 83 patients given vedolizumab and 65 treated with tofacitinib.

Patients given tofacitinib received 10 mg twice daily for the first 8 weeks, followed by maintenance treatment of 5 mg twice daily, with optional dose optimization in case of insufficient response. Vedolizumab was administered intravenously in line with the label; 300 mg was administered at weeks 0, 2, and 6, followed by 300 mg every 8 weeks, with a shortened infusion interval in cases of inadequate response.

There were few differences between the two groups at baseline, although patients given vedolizumab had been treated longer than those in the tofacitinib group (12 years vs. 7 years). Vedolizumab patients were also more likely to be receiving concomitant oral prednisone at baseline (50.6% vs. 30.8%).
 

Early difference fades

Corticosteroid-free clinical remission at week 12 was observed in 27.7% of patients in the vedolizumab group, rising to 38.6% at week 24 and 37.3% at week 52. Among those given tofacitinib, the rates of clinical remission were 56.9% at week 12, 60.0% at week 24, and 55.4% at week 52.

Propensity score-weight analysis revealed that tofacitinib patients were more likely to achieve corticosteroid-free clinical remission at weeks 12, 24, and 52, compared with those given vedolizumab, at odds ratio of 6.33, 3.02, and 1.86, respectively.

Biochemical remission rates among patients treated with vedolizumab were 25.3% at week 12, 28.9% at week 24, and 22.9% at week 52. For the tofacitinib group, the rates were 40.0%, 36.9%, and 27.7%, respectively. Biochemical remission was defined by C-reactive protein or fecal calprotectin levels.

The likelihood of biochemical remission was again greater with tofacitinib than with vedolizumab, at an odds ratio of 3.27 at week 12, 1.87 at week 24, and 1.81 at week 52.

Combined clinical and biochemical remission was more likely among patients given tofacitinib versus vedolizumab at week 12, at an odds ratio of 5.05, and at week 24, at an odds ratio of 2.11. However, at week 52, the difference was no longer significant, at an odds ratio of 1.17.

The authors note that there was no difference in the rate of infection between the two treatment groups, and the rate of severe adverse events was similar. However, three patients receiving tofacitinib experienced herpes simplex infections, compared with none of those given vedolizumab.

But, compared with the tofacitinib group, patients taking vedolizumab were more likely to discontinue treatment before 52 weeks, primarily because of a lack of response to treatment.

“The present study underlines that both vedolizumab and tofacitinib are relatively safe treatment options in patients with UC in a 12-month period,” the team writes.
 

‘Interesting’ efficacy data

Approached for comment, Alan C. Moss, MD, a professor of gastroenterology at Boston University School of Medicine, said that the findings are “interesting” for clinicians.

“We have so many treatment options right now, picking one over the other, particularly in patients like this who fail anti-TNF, is very important,” he told this news organization.

While he noted that registry data such as these are usually powered for “one outcome” (either efficacy or safety), “the immediate conclusions that come to mind are that certainly the efficacy of the two drugs in this patient population looks impressive.

“What we do note, though, is over time, as you get longer into the study, they start to become closer in terms of overall remission,” which Dr. Moss said fits with the current understanding that vedolizumab “takes longer to work.”

The take-away lesson from the study is that the short-term efficacy of tofacitinib is “superior,” Dr. Moss said, but, over the medium to long term, vedolizumab “may turn out to be more equivalent.”

Dr. Moss also pointed out that approximately 40% of patients given tofacitinib in the study began with the higher 10-mg twice-daily dose, “which is not the FDA-approved maintenance dose,” and over time about a quarter stayed on the higher dose.

“What that tells us is that, yes, it works faster if you’re using the higher dose, and over time, a certain proportion of these patients needed a higher dose to get these results,” he said.

Consequently, Dr. Moss said that the two treatment groups were not “equivalent” in terms of the doses given relative to normal maintenance dose.

The Initiative on Crohn and Colitis Fellowship is sponsored by AbbVie, Pfizer, Takeda, Celgene, Janssen Pharmaceutica, Teva Pharmaceutical Industries, Cablon Medical, Ferring Pharmaceuticals, Mundipharma, Dr. Falk Pharma, Sandoz, and Tramedico. Dr. Duijvestein has relationships with Echo Pharma, Robarts Clinical Trials, Janssen, Merck, Pfizer, Takeda, Tillotts Pharma, and Dr. Falk Pharma. Other authors have numerous relationships with industry. Dr. Moss has relationships with Pfizer and Janssen.

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

When anti–tumor necrosis factor-alpha (anti-TNF) treatment fails to achieve remission for patients with ulcerative colitis (UC), tofacitinib (Xeljanz) appears more effect sooner than vedolizumab (Entyvio), suggests a Dutch registry study.

Data on nearly 150 patients with UC who had already undergone treatment with anti-TNF drugs showed that combined clinical and biochemical remission was about five times more likely with tofacitinib versus vedolizumab within 12 weeks of starting therapy.

However, the differences tailed off over subsequent weeks, such that there was no significant difference in combined remission rates at 52 weeks. There were also no notable differences in safety between the two drugs.

“These results may help in guiding clinical decisionmaking after anti-TNF failure in patients with UC,” the authors write.

The research was published online by Clinical Gastroenterology and Hepatology.
 

Real-world evidence

“This study offers more real-world evidence than a standard randomized controlled trial, since there was no randomization between the two study groups and no strict inclusion and exclusion criteria,” co–senior authors Tessa Straatmijer, MD, PhD candidate, and Marjolijn Duijvestein, MD, Amsterdam University Medical Center, the Netherlands, told this news organization.

They continued: “It is known that tofacitinib is more rapid of action compared to vedolizumab. We therefore expected that the odds ratio of remission rates between the two groups would be higher at weeks 12 and 24, compared to week 52.”

“We will continue with collecting data in our prospective cohort up to 10 years after initiating tofacitinib or vedolizumab,” Dr. Straatmijer and Dr. Duijvestein added. “Hopefully we can provide long-term outcomes after a couple of years.”

The authors highlight that for a “considerable proportion” of patients with UC, their condition does not respond to anti-TNF drugs, they experience adverse effects, or the response diminishes over time. Alternatives, such as vedolizumab and tofacitinib, are typically “prescribed after failure of the anti-TNF,” owing to their price and clinician experience.

While vedolizumab (an α4β7 integrin blocker) and tofacitinib (a Janus kinase inhibitor) have different mechanisms of action, head-to-head randomized controlled trials comparing their efficacy among patients with UC whose condition is refractory to anti-TNF are “lacking,” they add. “However, to guide physician decisionmaking on the most suitable drug choice after anti-TNF failure, effectiveness data comparing tofacitinib with vedolizumab is pivotal.”

To assess the comparative effectiveness and safety of the next therapeutic options, the team examined data from the Dutch Initiative on Crohn and Colitis registry.

They identified nearly 300 adult patients with clinical or biochemical disease activity who had initiated treatment with vedolizumab or tofacitinib. They excluded patients without prior anti-TNF treatment, those who had previously been treated with vedolizumab or tofacitinib, and those who did not have clinical and biochemical or endoscopic disease activity at baseline. The final analysis included 83 patients given vedolizumab and 65 treated with tofacitinib.

Patients given tofacitinib received 10 mg twice daily for the first 8 weeks, followed by maintenance treatment of 5 mg twice daily, with optional dose optimization in case of insufficient response. Vedolizumab was administered intravenously in line with the label; 300 mg was administered at weeks 0, 2, and 6, followed by 300 mg every 8 weeks, with a shortened infusion interval in cases of inadequate response.

There were few differences between the two groups at baseline, although patients given vedolizumab had been treated longer than those in the tofacitinib group (12 years vs. 7 years). Vedolizumab patients were also more likely to be receiving concomitant oral prednisone at baseline (50.6% vs. 30.8%).
 

Early difference fades

Corticosteroid-free clinical remission at week 12 was observed in 27.7% of patients in the vedolizumab group, rising to 38.6% at week 24 and 37.3% at week 52. Among those given tofacitinib, the rates of clinical remission were 56.9% at week 12, 60.0% at week 24, and 55.4% at week 52.

Propensity score-weight analysis revealed that tofacitinib patients were more likely to achieve corticosteroid-free clinical remission at weeks 12, 24, and 52, compared with those given vedolizumab, at odds ratio of 6.33, 3.02, and 1.86, respectively.

Biochemical remission rates among patients treated with vedolizumab were 25.3% at week 12, 28.9% at week 24, and 22.9% at week 52. For the tofacitinib group, the rates were 40.0%, 36.9%, and 27.7%, respectively. Biochemical remission was defined by C-reactive protein or fecal calprotectin levels.

The likelihood of biochemical remission was again greater with tofacitinib than with vedolizumab, at an odds ratio of 3.27 at week 12, 1.87 at week 24, and 1.81 at week 52.

Combined clinical and biochemical remission was more likely among patients given tofacitinib versus vedolizumab at week 12, at an odds ratio of 5.05, and at week 24, at an odds ratio of 2.11. However, at week 52, the difference was no longer significant, at an odds ratio of 1.17.

The authors note that there was no difference in the rate of infection between the two treatment groups, and the rate of severe adverse events was similar. However, three patients receiving tofacitinib experienced herpes simplex infections, compared with none of those given vedolizumab.

But, compared with the tofacitinib group, patients taking vedolizumab were more likely to discontinue treatment before 52 weeks, primarily because of a lack of response to treatment.

“The present study underlines that both vedolizumab and tofacitinib are relatively safe treatment options in patients with UC in a 12-month period,” the team writes.
 

‘Interesting’ efficacy data

Approached for comment, Alan C. Moss, MD, a professor of gastroenterology at Boston University School of Medicine, said that the findings are “interesting” for clinicians.

“We have so many treatment options right now, picking one over the other, particularly in patients like this who fail anti-TNF, is very important,” he told this news organization.

While he noted that registry data such as these are usually powered for “one outcome” (either efficacy or safety), “the immediate conclusions that come to mind are that certainly the efficacy of the two drugs in this patient population looks impressive.

“What we do note, though, is over time, as you get longer into the study, they start to become closer in terms of overall remission,” which Dr. Moss said fits with the current understanding that vedolizumab “takes longer to work.”

The take-away lesson from the study is that the short-term efficacy of tofacitinib is “superior,” Dr. Moss said, but, over the medium to long term, vedolizumab “may turn out to be more equivalent.”

Dr. Moss also pointed out that approximately 40% of patients given tofacitinib in the study began with the higher 10-mg twice-daily dose, “which is not the FDA-approved maintenance dose,” and over time about a quarter stayed on the higher dose.

“What that tells us is that, yes, it works faster if you’re using the higher dose, and over time, a certain proportion of these patients needed a higher dose to get these results,” he said.

Consequently, Dr. Moss said that the two treatment groups were not “equivalent” in terms of the doses given relative to normal maintenance dose.

The Initiative on Crohn and Colitis Fellowship is sponsored by AbbVie, Pfizer, Takeda, Celgene, Janssen Pharmaceutica, Teva Pharmaceutical Industries, Cablon Medical, Ferring Pharmaceuticals, Mundipharma, Dr. Falk Pharma, Sandoz, and Tramedico. Dr. Duijvestein has relationships with Echo Pharma, Robarts Clinical Trials, Janssen, Merck, Pfizer, Takeda, Tillotts Pharma, and Dr. Falk Pharma. Other authors have numerous relationships with industry. Dr. Moss has relationships with Pfizer and Janssen.

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

When anti–tumor necrosis factor-alpha (anti-TNF) treatment fails to achieve remission for patients with ulcerative colitis (UC), tofacitinib (Xeljanz) appears more effect sooner than vedolizumab (Entyvio), suggests a Dutch registry study.

Data on nearly 150 patients with UC who had already undergone treatment with anti-TNF drugs showed that combined clinical and biochemical remission was about five times more likely with tofacitinib versus vedolizumab within 12 weeks of starting therapy.

However, the differences tailed off over subsequent weeks, such that there was no significant difference in combined remission rates at 52 weeks. There were also no notable differences in safety between the two drugs.

“These results may help in guiding clinical decisionmaking after anti-TNF failure in patients with UC,” the authors write.

The research was published online by Clinical Gastroenterology and Hepatology.
 

Real-world evidence

“This study offers more real-world evidence than a standard randomized controlled trial, since there was no randomization between the two study groups and no strict inclusion and exclusion criteria,” co–senior authors Tessa Straatmijer, MD, PhD candidate, and Marjolijn Duijvestein, MD, Amsterdam University Medical Center, the Netherlands, told this news organization.

They continued: “It is known that tofacitinib is more rapid of action compared to vedolizumab. We therefore expected that the odds ratio of remission rates between the two groups would be higher at weeks 12 and 24, compared to week 52.”

“We will continue with collecting data in our prospective cohort up to 10 years after initiating tofacitinib or vedolizumab,” Dr. Straatmijer and Dr. Duijvestein added. “Hopefully we can provide long-term outcomes after a couple of years.”

The authors highlight that for a “considerable proportion” of patients with UC, their condition does not respond to anti-TNF drugs, they experience adverse effects, or the response diminishes over time. Alternatives, such as vedolizumab and tofacitinib, are typically “prescribed after failure of the anti-TNF,” owing to their price and clinician experience.

While vedolizumab (an α4β7 integrin blocker) and tofacitinib (a Janus kinase inhibitor) have different mechanisms of action, head-to-head randomized controlled trials comparing their efficacy among patients with UC whose condition is refractory to anti-TNF are “lacking,” they add. “However, to guide physician decisionmaking on the most suitable drug choice after anti-TNF failure, effectiveness data comparing tofacitinib with vedolizumab is pivotal.”

To assess the comparative effectiveness and safety of the next therapeutic options, the team examined data from the Dutch Initiative on Crohn and Colitis registry.

They identified nearly 300 adult patients with clinical or biochemical disease activity who had initiated treatment with vedolizumab or tofacitinib. They excluded patients without prior anti-TNF treatment, those who had previously been treated with vedolizumab or tofacitinib, and those who did not have clinical and biochemical or endoscopic disease activity at baseline. The final analysis included 83 patients given vedolizumab and 65 treated with tofacitinib.

Patients given tofacitinib received 10 mg twice daily for the first 8 weeks, followed by maintenance treatment of 5 mg twice daily, with optional dose optimization in case of insufficient response. Vedolizumab was administered intravenously in line with the label; 300 mg was administered at weeks 0, 2, and 6, followed by 300 mg every 8 weeks, with a shortened infusion interval in cases of inadequate response.

There were few differences between the two groups at baseline, although patients given vedolizumab had been treated longer than those in the tofacitinib group (12 years vs. 7 years). Vedolizumab patients were also more likely to be receiving concomitant oral prednisone at baseline (50.6% vs. 30.8%).
 

Early difference fades

Corticosteroid-free clinical remission at week 12 was observed in 27.7% of patients in the vedolizumab group, rising to 38.6% at week 24 and 37.3% at week 52. Among those given tofacitinib, the rates of clinical remission were 56.9% at week 12, 60.0% at week 24, and 55.4% at week 52.

Propensity score-weight analysis revealed that tofacitinib patients were more likely to achieve corticosteroid-free clinical remission at weeks 12, 24, and 52, compared with those given vedolizumab, at odds ratio of 6.33, 3.02, and 1.86, respectively.

Biochemical remission rates among patients treated with vedolizumab were 25.3% at week 12, 28.9% at week 24, and 22.9% at week 52. For the tofacitinib group, the rates were 40.0%, 36.9%, and 27.7%, respectively. Biochemical remission was defined by C-reactive protein or fecal calprotectin levels.

The likelihood of biochemical remission was again greater with tofacitinib than with vedolizumab, at an odds ratio of 3.27 at week 12, 1.87 at week 24, and 1.81 at week 52.

Combined clinical and biochemical remission was more likely among patients given tofacitinib versus vedolizumab at week 12, at an odds ratio of 5.05, and at week 24, at an odds ratio of 2.11. However, at week 52, the difference was no longer significant, at an odds ratio of 1.17.

The authors note that there was no difference in the rate of infection between the two treatment groups, and the rate of severe adverse events was similar. However, three patients receiving tofacitinib experienced herpes simplex infections, compared with none of those given vedolizumab.

But, compared with the tofacitinib group, patients taking vedolizumab were more likely to discontinue treatment before 52 weeks, primarily because of a lack of response to treatment.

“The present study underlines that both vedolizumab and tofacitinib are relatively safe treatment options in patients with UC in a 12-month period,” the team writes.
 

‘Interesting’ efficacy data

Approached for comment, Alan C. Moss, MD, a professor of gastroenterology at Boston University School of Medicine, said that the findings are “interesting” for clinicians.

“We have so many treatment options right now, picking one over the other, particularly in patients like this who fail anti-TNF, is very important,” he told this news organization.

While he noted that registry data such as these are usually powered for “one outcome” (either efficacy or safety), “the immediate conclusions that come to mind are that certainly the efficacy of the two drugs in this patient population looks impressive.

“What we do note, though, is over time, as you get longer into the study, they start to become closer in terms of overall remission,” which Dr. Moss said fits with the current understanding that vedolizumab “takes longer to work.”

The take-away lesson from the study is that the short-term efficacy of tofacitinib is “superior,” Dr. Moss said, but, over the medium to long term, vedolizumab “may turn out to be more equivalent.”

Dr. Moss also pointed out that approximately 40% of patients given tofacitinib in the study began with the higher 10-mg twice-daily dose, “which is not the FDA-approved maintenance dose,” and over time about a quarter stayed on the higher dose.

“What that tells us is that, yes, it works faster if you’re using the higher dose, and over time, a certain proportion of these patients needed a higher dose to get these results,” he said.

Consequently, Dr. Moss said that the two treatment groups were not “equivalent” in terms of the doses given relative to normal maintenance dose.

The Initiative on Crohn and Colitis Fellowship is sponsored by AbbVie, Pfizer, Takeda, Celgene, Janssen Pharmaceutica, Teva Pharmaceutical Industries, Cablon Medical, Ferring Pharmaceuticals, Mundipharma, Dr. Falk Pharma, Sandoz, and Tramedico. Dr. Duijvestein has relationships with Echo Pharma, Robarts Clinical Trials, Janssen, Merck, Pfizer, Takeda, Tillotts Pharma, and Dr. Falk Pharma. Other authors have numerous relationships with industry. Dr. Moss has relationships with Pfizer and Janssen.

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