Vaccination may have reduced the rate of sustained Mycobacterium tuberculosis infection in a recent randomized, placebo-controlled clinical trial conducted in a high-risk setting for tuberculosis transmission, despite not meeting the primary endpoint of the study.

Stockdevil/Thinkstock

The study also evaluated a candidate subunit vaccine, H4:IC31, which also reduced the rate of sustained QFT conversion, though the efficacy estimate did not reach statistical significance, investigators reported.

Neither H4:IC31 nor BCG revaccination prevented initial QFT conversion, the primary endpoint of the study; however, both vaccines were immunogenic, they said.

Moreover, the significantly reduced rate of sustained conversion with BCG revaccination provides a “promising signal,” study authors said in the New England Journal of Medicine.

“The durability of this important finding and potential public health significance for protection against tuberculosis disease warrants epidemiologic modeling and further clinical evaluation,” wrote Elisa Nemes, PhD, of the South African Tuberculosis Vaccine Initiative, which is part of the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (South Africa), and her coauthors.

Similarly, the nonsignificantly reduced rate of sustained QFT conversion seen with H4:IC31 suggested that subunit vaccines can have a biologic effect in this setting, which may inform development of new tuberculosis vaccines, Dr. Nemes and her colleagues added.

The phase 2 trial included 990 adolescents in South Africa who had undergone neonatal BCG vaccination. They were randomly assigned to receive BCG revaccination, H4:IC31 vaccine, or placebo.

Neither vaccine met the primary efficacy criterion based on initial QFT conversion rates, which were 13.1% for BCG revaccination, 14.3% for H4:IC31 vaccine, and 15.8% for placebo.

For the secondary endpoint of sustained QFT conversion, the efficacy of BCG revaccination was 45.4% (95% confidence interval, 6.4%-68.1%; P = .03), while the efficacy of H4:IC31 vaccine was 34.2% (95% CI, –10.4% to 60.7%; P = .11).

“These encouraging findings provide an impetus to reevaluate the use of BCG revaccination of populations that are free of M. tuberculosis infection for the prevention of disease,” Dr. Nemes and her coauthors wrote in their report.

Revaccination with BCG was associated with more adverse events, compared with the other groups, although adverse events in the trial were predominantly injection-site reactions that were mild to moderate in severity, investigators reported. There were no serious adverse events judged by investigators to be related to trial vaccine.

Taken together, these results raise important questions regarding the potential benefits of vaccine-mediated prevention of M. tuberculosis infection for control of tuberculosis disease, according to Dr. Nemes and her coauthors.

However, interpretation of the findings is limited because there is no definitive test for M. tuberculosis infection.

Recent infection diagnosed by tuberculin skin test or QFT conversion has been associated with higher risk of disease, compared with nonconversion, according to investigators, while reversion to a negative tuberculin skin test correlates with infection containment and lower risk of tuberculosis.

“Although the clinical significance of QFT reversion remains to be established, we propose that sustained QFT conversion more likely represents sustained M. tuberculosis infection and a higher risk of progression to disease than transient QFT conversion,” they wrote.

The study was supported by Aeras, Sanofi Pasteur, the Bill & Melinda Gates Foundation, the Government of the Netherlands Directorate-General for International Cooperation and Development, and the United Kingdom Department for International Development. Study authors reported disclosures related to GlaxoSmithKline, Sanofi Pasteur, and Aeras.
 

SOURCE: Nemes E et al. N Engl J Med. 2018;379:138-49.

Vaccination may have reduced the rate of sustained Mycobacterium tuberculosis infection in a recent randomized, placebo-controlled clinical trial conducted in a high-risk setting for tuberculosis transmission, despite not meeting the primary endpoint of the study.

Stockdevil/Thinkstock

The study also evaluated a candidate subunit vaccine, H4:IC31, which also reduced the rate of sustained QFT conversion, though the efficacy estimate did not reach statistical significance, investigators reported.

Neither H4:IC31 nor BCG revaccination prevented initial QFT conversion, the primary endpoint of the study; however, both vaccines were immunogenic, they said.

Moreover, the significantly reduced rate of sustained conversion with BCG revaccination provides a “promising signal,” study authors said in the New England Journal of Medicine.

“The durability of this important finding and potential public health significance for protection against tuberculosis disease warrants epidemiologic modeling and further clinical evaluation,” wrote Elisa Nemes, PhD, of the South African Tuberculosis Vaccine Initiative, which is part of the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (South Africa), and her coauthors.

Similarly, the nonsignificantly reduced rate of sustained QFT conversion seen with H4:IC31 suggested that subunit vaccines can have a biologic effect in this setting, which may inform development of new tuberculosis vaccines, Dr. Nemes and her colleagues added.

The phase 2 trial included 990 adolescents in South Africa who had undergone neonatal BCG vaccination. They were randomly assigned to receive BCG revaccination, H4:IC31 vaccine, or placebo.

Neither vaccine met the primary efficacy criterion based on initial QFT conversion rates, which were 13.1% for BCG revaccination, 14.3% for H4:IC31 vaccine, and 15.8% for placebo.

For the secondary endpoint of sustained QFT conversion, the efficacy of BCG revaccination was 45.4% (95% confidence interval, 6.4%-68.1%; P = .03), while the efficacy of H4:IC31 vaccine was 34.2% (95% CI, –10.4% to 60.7%; P = .11).

“These encouraging findings provide an impetus to reevaluate the use of BCG revaccination of populations that are free of M. tuberculosis infection for the prevention of disease,” Dr. Nemes and her coauthors wrote in their report.

Revaccination with BCG was associated with more adverse events, compared with the other groups, although adverse events in the trial were predominantly injection-site reactions that were mild to moderate in severity, investigators reported. There were no serious adverse events judged by investigators to be related to trial vaccine.

Taken together, these results raise important questions regarding the potential benefits of vaccine-mediated prevention of M. tuberculosis infection for control of tuberculosis disease, according to Dr. Nemes and her coauthors.

However, interpretation of the findings is limited because there is no definitive test for M. tuberculosis infection.

Recent infection diagnosed by tuberculin skin test or QFT conversion has been associated with higher risk of disease, compared with nonconversion, according to investigators, while reversion to a negative tuberculin skin test correlates with infection containment and lower risk of tuberculosis.

“Although the clinical significance of QFT reversion remains to be established, we propose that sustained QFT conversion more likely represents sustained M. tuberculosis infection and a higher risk of progression to disease than transient QFT conversion,” they wrote.

The study was supported by Aeras, Sanofi Pasteur, the Bill & Melinda Gates Foundation, the Government of the Netherlands Directorate-General for International Cooperation and Development, and the United Kingdom Department for International Development. Study authors reported disclosures related to GlaxoSmithKline, Sanofi Pasteur, and Aeras.
 

SOURCE: Nemes E et al. N Engl J Med. 2018;379:138-49.

Vaccination may have reduced the rate of sustained Mycobacterium tuberculosis infection in a recent randomized, placebo-controlled clinical trial conducted in a high-risk setting for tuberculosis transmission, despite not meeting the primary endpoint of the study.

Stockdevil/Thinkstock

The study also evaluated a candidate subunit vaccine, H4:IC31, which also reduced the rate of sustained QFT conversion, though the efficacy estimate did not reach statistical significance, investigators reported.

Neither H4:IC31 nor BCG revaccination prevented initial QFT conversion, the primary endpoint of the study; however, both vaccines were immunogenic, they said.

Moreover, the significantly reduced rate of sustained conversion with BCG revaccination provides a “promising signal,” study authors said in the New England Journal of Medicine.

“The durability of this important finding and potential public health significance for protection against tuberculosis disease warrants epidemiologic modeling and further clinical evaluation,” wrote Elisa Nemes, PhD, of the South African Tuberculosis Vaccine Initiative, which is part of the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (South Africa), and her coauthors.

Similarly, the nonsignificantly reduced rate of sustained QFT conversion seen with H4:IC31 suggested that subunit vaccines can have a biologic effect in this setting, which may inform development of new tuberculosis vaccines, Dr. Nemes and her colleagues added.

The phase 2 trial included 990 adolescents in South Africa who had undergone neonatal BCG vaccination. They were randomly assigned to receive BCG revaccination, H4:IC31 vaccine, or placebo.

Neither vaccine met the primary efficacy criterion based on initial QFT conversion rates, which were 13.1% for BCG revaccination, 14.3% for H4:IC31 vaccine, and 15.8% for placebo.

For the secondary endpoint of sustained QFT conversion, the efficacy of BCG revaccination was 45.4% (95% confidence interval, 6.4%-68.1%; P = .03), while the efficacy of H4:IC31 vaccine was 34.2% (95% CI, –10.4% to 60.7%; P = .11).

“These encouraging findings provide an impetus to reevaluate the use of BCG revaccination of populations that are free of M. tuberculosis infection for the prevention of disease,” Dr. Nemes and her coauthors wrote in their report.

Revaccination with BCG was associated with more adverse events, compared with the other groups, although adverse events in the trial were predominantly injection-site reactions that were mild to moderate in severity, investigators reported. There were no serious adverse events judged by investigators to be related to trial vaccine.

Taken together, these results raise important questions regarding the potential benefits of vaccine-mediated prevention of M. tuberculosis infection for control of tuberculosis disease, according to Dr. Nemes and her coauthors.

However, interpretation of the findings is limited because there is no definitive test for M. tuberculosis infection.

Recent infection diagnosed by tuberculin skin test or QFT conversion has been associated with higher risk of disease, compared with nonconversion, according to investigators, while reversion to a negative tuberculin skin test correlates with infection containment and lower risk of tuberculosis.

“Although the clinical significance of QFT reversion remains to be established, we propose that sustained QFT conversion more likely represents sustained M. tuberculosis infection and a higher risk of progression to disease than transient QFT conversion,” they wrote.

The study was supported by Aeras, Sanofi Pasteur, the Bill & Melinda Gates Foundation, the Government of the Netherlands Directorate-General for International Cooperation and Development, and the United Kingdom Department for International Development. Study authors reported disclosures related to GlaxoSmithKline, Sanofi Pasteur, and Aeras.
 

SOURCE: Nemes E et al. N Engl J Med. 2018;379:138-49.

A 17-year-old girl seen in a Portuguese dermatology clinic was found to have a nodular basal cell carcinoma on the parietal region of her scalp. The nodule appeared 6 years after she had received a kidney transplant, according to João Borges-Costa, MD, PhD, who submitted the case report.

Since the transplant, the girl had been maintained on immunosuppressive medication of tacrolimus 1 mg twice daily, mycophenolate sodium 360 mg twice daily, and prednisolone 10 mg every other day. The 1-cm nodule was pigmented; dermatoscopy did not yield clarity about whether the lesion was melanocytic. An excisional biopsy with 0.5-cm margins was performed, and histology confirmed that the lesion was a nodular pigmented basal cell carcinoma that had been excised completely.

The case, said Dr. Borges-Costa, shows that skin cancers can develop earlier than the typical 12-18 years after pediatric transplantation. Most reported cases have been squamous cell cancers and melanomas, and often are associated with lack of appropriate sun protection behavior.

The patient, a Caucasian, was a sailor who used sunscreen but did not typically wear a hat while sailing, reported Dr. Borges-Costa, a dermatologist at the University of Lisbon. Her family history was significant for a grandparent with melanoma.

Dr. Borges noted that the parents and patient were given advice regarding the importance of the lifelong use of sun-protective clothing and headgear. “Education of pediatric organ recipients and their parents about sun protection is important because, as occurred with our patient, protective clothing and hats are frequently forgotten.”

Because of the ongoing potential for skin malignancies, early referral “after transplantation to specialized dermatology outpatient clinics, similar to what is now advocated for transplanted adults, could help in surveillance and improve adherence to sun-protective measures,” he added.

SOURCE: Borges-Costa J et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13537..

A 17-year-old girl seen in a Portuguese dermatology clinic was found to have a nodular basal cell carcinoma on the parietal region of her scalp. The nodule appeared 6 years after she had received a kidney transplant, according to João Borges-Costa, MD, PhD, who submitted the case report.

Since the transplant, the girl had been maintained on immunosuppressive medication of tacrolimus 1 mg twice daily, mycophenolate sodium 360 mg twice daily, and prednisolone 10 mg every other day. The 1-cm nodule was pigmented; dermatoscopy did not yield clarity about whether the lesion was melanocytic. An excisional biopsy with 0.5-cm margins was performed, and histology confirmed that the lesion was a nodular pigmented basal cell carcinoma that had been excised completely.

The case, said Dr. Borges-Costa, shows that skin cancers can develop earlier than the typical 12-18 years after pediatric transplantation. Most reported cases have been squamous cell cancers and melanomas, and often are associated with lack of appropriate sun protection behavior.

The patient, a Caucasian, was a sailor who used sunscreen but did not typically wear a hat while sailing, reported Dr. Borges-Costa, a dermatologist at the University of Lisbon. Her family history was significant for a grandparent with melanoma.

Dr. Borges noted that the parents and patient were given advice regarding the importance of the lifelong use of sun-protective clothing and headgear. “Education of pediatric organ recipients and their parents about sun protection is important because, as occurred with our patient, protective clothing and hats are frequently forgotten.”

Because of the ongoing potential for skin malignancies, early referral “after transplantation to specialized dermatology outpatient clinics, similar to what is now advocated for transplanted adults, could help in surveillance and improve adherence to sun-protective measures,” he added.

SOURCE: Borges-Costa J et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13537..

A 17-year-old girl seen in a Portuguese dermatology clinic was found to have a nodular basal cell carcinoma on the parietal region of her scalp. The nodule appeared 6 years after she had received a kidney transplant, according to João Borges-Costa, MD, PhD, who submitted the case report.

Since the transplant, the girl had been maintained on immunosuppressive medication of tacrolimus 1 mg twice daily, mycophenolate sodium 360 mg twice daily, and prednisolone 10 mg every other day. The 1-cm nodule was pigmented; dermatoscopy did not yield clarity about whether the lesion was melanocytic. An excisional biopsy with 0.5-cm margins was performed, and histology confirmed that the lesion was a nodular pigmented basal cell carcinoma that had been excised completely.

The case, said Dr. Borges-Costa, shows that skin cancers can develop earlier than the typical 12-18 years after pediatric transplantation. Most reported cases have been squamous cell cancers and melanomas, and often are associated with lack of appropriate sun protection behavior.

The patient, a Caucasian, was a sailor who used sunscreen but did not typically wear a hat while sailing, reported Dr. Borges-Costa, a dermatologist at the University of Lisbon. Her family history was significant for a grandparent with melanoma.

Dr. Borges noted that the parents and patient were given advice regarding the importance of the lifelong use of sun-protective clothing and headgear. “Education of pediatric organ recipients and their parents about sun protection is important because, as occurred with our patient, protective clothing and hats are frequently forgotten.”

Because of the ongoing potential for skin malignancies, early referral “after transplantation to specialized dermatology outpatient clinics, similar to what is now advocated for transplanted adults, could help in surveillance and improve adherence to sun-protective measures,” he added.

SOURCE: Borges-Costa J et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13537..

What would the United States look like without Roe v. Wade, the 1973 case that legalized abortion nationwide?

That’s the question now that President Donald Trump has chosen Judge Brett Kavanaugh as his nominee to replace retiring Supreme Court Justice Anthony Kennedy.

trekandshoot/thinkstock

Reversing the landmark case would not automatically make abortion illegal across the country. Instead, it would return the decision about abortion legality to the states, where a patchwork of laws are already in place that render abortion more or less available, largely depending on individual states’ political leanings.

“We think there are 22 states likely to ban abortion without Roe,” because of a combination of factors including existing laws and regulation on the books and the positions of the governor and state legislature, said Amy Myrick, staff attorney at the Center for Reproductive Rights, which represents abortion-rights advocates in court.

“The threat level is very high now,” Ms. Myrick said.

Judge Kavanaugh never opined on Roe v. Wade directly during his tenure on the U.S. District Court in Washington. In his 2006 confirmation hearing for that position, though, he said he would follow Roe v. Wade as a “binding precedent” of the Supreme Court – which lower-court judges are required to do.

Abortion opponents are buoyed by the pick.

“Judge Kavanaugh is an experienced, principled jurist with a strong record of protecting life and constitutional rights,” Marjorie Dannenfelser, president of the Susan B. Anthony List, said in a statement. She spearheaded support for Trump in his presidential campaign after he promised to appoint to the Supreme Court only justices who would overturn Roe v. Wade.

Justice Kennedy, by contrast, was a swing vote on abortion issues. He frequently sided with conservatives to uphold abortion restrictions. However, in key cases in 1992 and 2016, he sided with liberals to uphold Roe’s core finding that the right to abortion is part of a right to privacy that is embedded within the U.S. Constitution.

Even now, with Roe v. Wade’s protections in place, a woman’s ability to access abortion is heavily dependent on where she lives.

According to an analysis by the Guttmacher Institute, a reproductive-rights think tank, 19 states adopted 63 new restrictions on abortion rights and access. At the same time, 21 states adopted 58 measures last year intended to expand access to women’s reproductive health.

Since 2011, states have enacted nearly 1,200 separate abortion restrictions, according to Guttmacher, making these types of laws far more common.

As of now, four states – Louisiana, Mississippi and North and South Dakota – have what are known as abortion “trigger laws.” Those laws – passed long after Roe was handed down – would make abortion illegal if and when the Supreme Court were to say Roe is no more.

“They are designed to make abortion illegal immediately,” said Ms. Myrick.

Another dozen or so states still have abortion bans on the books that predated Roe v. Wade.

Some have been formally blocked by the courts but not repealed. Those bans could, at least in theory, be reinstated, although “someone would have to go into court and ask to lift that injunction,” said Ms. Myrick.

States could simply begin enforcing other bans that were never formally blocked, like one in Alabama that makes abortion providers subject to fines and up to a year in jail.

At the same time, Ms. Myrick said, “there are 20 states where abortion would probably remain safe and legal.”
 

The path to the high court

Several major challenges to state abortion laws are already in the judicial pipeline. One of these will have to get to the Supreme Court to enable a majority to overturn Roe v. Wade.

“It’s not a question of if, it’s a question of what or when,” said Sarah Lipton-Lubet, vice president for reproductive health and rights at the National Partnership for Women & Families.

The cases fall into three major categories.

The first – and most likely type to result in the court taking a broad look at Roe v. Wade – are “gestational” bans that seek to restrict abortion at a certain point in pregnancy, said Ms. Lipton-Lubet.

Mississippi has a 15-week ban, currently being challenged in federal court; Louisiana enacted a similar ban, but it would take effect only if Mississippi’s law is upheld. Iowa earlier this spring passed a 6-week ban, although that is being challenged in state court under the Iowa Constitution.

The second category involves regulations on abortion providers.

One pending case, for instance, involves an Arkansas law that would effectively ban medication abortions. Finally, there are bans on specific procedures, including several in Texas, Arkansas, and Alabama that would outlaw “dilation and evacuation” abortions, which are the most common type used in the second trimester of pregnancy.

Ms. Myrick and Ms. Lipton-Lubet agree that there is no way to predict which abortion case is likely to reach the high court first.

The case that’s actually closest to the Supreme Court, noted Ms. Myrick, is a challenge to an Indiana law that would outlaw abortion if the woman is seeking it for sex selection or because the fetus could be disabled. A federal appeals court found that law unconstitutional in April.

Many analysts also agree that even with the court’s likely philosophical shift, Roe v. Wade might not actually be overturned at all.

Instead, said Ms. Lipton-Lubet, a more conservative court could “just hollow it out” by allowing restrictive state laws to stand.

“The court cares about things like its own legitimacy,” said Ms. Myrick, “and how often a precedent has been upheld in the past.”

Given that Roe’s central finding – that the decision to have an abortion falls under the constitutional right to privacy – has been upheld three times, even an antiabortion court might be loath to overrule it in its entirety.
 

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

What would the United States look like without Roe v. Wade, the 1973 case that legalized abortion nationwide?

That’s the question now that President Donald Trump has chosen Judge Brett Kavanaugh as his nominee to replace retiring Supreme Court Justice Anthony Kennedy.

trekandshoot/thinkstock

Reversing the landmark case would not automatically make abortion illegal across the country. Instead, it would return the decision about abortion legality to the states, where a patchwork of laws are already in place that render abortion more or less available, largely depending on individual states’ political leanings.

“We think there are 22 states likely to ban abortion without Roe,” because of a combination of factors including existing laws and regulation on the books and the positions of the governor and state legislature, said Amy Myrick, staff attorney at the Center for Reproductive Rights, which represents abortion-rights advocates in court.

“The threat level is very high now,” Ms. Myrick said.

Judge Kavanaugh never opined on Roe v. Wade directly during his tenure on the U.S. District Court in Washington. In his 2006 confirmation hearing for that position, though, he said he would follow Roe v. Wade as a “binding precedent” of the Supreme Court – which lower-court judges are required to do.

Abortion opponents are buoyed by the pick.

“Judge Kavanaugh is an experienced, principled jurist with a strong record of protecting life and constitutional rights,” Marjorie Dannenfelser, president of the Susan B. Anthony List, said in a statement. She spearheaded support for Trump in his presidential campaign after he promised to appoint to the Supreme Court only justices who would overturn Roe v. Wade.

Justice Kennedy, by contrast, was a swing vote on abortion issues. He frequently sided with conservatives to uphold abortion restrictions. However, in key cases in 1992 and 2016, he sided with liberals to uphold Roe’s core finding that the right to abortion is part of a right to privacy that is embedded within the U.S. Constitution.

Even now, with Roe v. Wade’s protections in place, a woman’s ability to access abortion is heavily dependent on where she lives.

According to an analysis by the Guttmacher Institute, a reproductive-rights think tank, 19 states adopted 63 new restrictions on abortion rights and access. At the same time, 21 states adopted 58 measures last year intended to expand access to women’s reproductive health.

Since 2011, states have enacted nearly 1,200 separate abortion restrictions, according to Guttmacher, making these types of laws far more common.

As of now, four states – Louisiana, Mississippi and North and South Dakota – have what are known as abortion “trigger laws.” Those laws – passed long after Roe was handed down – would make abortion illegal if and when the Supreme Court were to say Roe is no more.

“They are designed to make abortion illegal immediately,” said Ms. Myrick.

Another dozen or so states still have abortion bans on the books that predated Roe v. Wade.

Some have been formally blocked by the courts but not repealed. Those bans could, at least in theory, be reinstated, although “someone would have to go into court and ask to lift that injunction,” said Ms. Myrick.

States could simply begin enforcing other bans that were never formally blocked, like one in Alabama that makes abortion providers subject to fines and up to a year in jail.

At the same time, Ms. Myrick said, “there are 20 states where abortion would probably remain safe and legal.”
 

The path to the high court

Several major challenges to state abortion laws are already in the judicial pipeline. One of these will have to get to the Supreme Court to enable a majority to overturn Roe v. Wade.

“It’s not a question of if, it’s a question of what or when,” said Sarah Lipton-Lubet, vice president for reproductive health and rights at the National Partnership for Women & Families.

The cases fall into three major categories.

The first – and most likely type to result in the court taking a broad look at Roe v. Wade – are “gestational” bans that seek to restrict abortion at a certain point in pregnancy, said Ms. Lipton-Lubet.

Mississippi has a 15-week ban, currently being challenged in federal court; Louisiana enacted a similar ban, but it would take effect only if Mississippi’s law is upheld. Iowa earlier this spring passed a 6-week ban, although that is being challenged in state court under the Iowa Constitution.

The second category involves regulations on abortion providers.

One pending case, for instance, involves an Arkansas law that would effectively ban medication abortions. Finally, there are bans on specific procedures, including several in Texas, Arkansas, and Alabama that would outlaw “dilation and evacuation” abortions, which are the most common type used in the second trimester of pregnancy.

Ms. Myrick and Ms. Lipton-Lubet agree that there is no way to predict which abortion case is likely to reach the high court first.

The case that’s actually closest to the Supreme Court, noted Ms. Myrick, is a challenge to an Indiana law that would outlaw abortion if the woman is seeking it for sex selection or because the fetus could be disabled. A federal appeals court found that law unconstitutional in April.

Many analysts also agree that even with the court’s likely philosophical shift, Roe v. Wade might not actually be overturned at all.

Instead, said Ms. Lipton-Lubet, a more conservative court could “just hollow it out” by allowing restrictive state laws to stand.

“The court cares about things like its own legitimacy,” said Ms. Myrick, “and how often a precedent has been upheld in the past.”

Given that Roe’s central finding – that the decision to have an abortion falls under the constitutional right to privacy – has been upheld three times, even an antiabortion court might be loath to overrule it in its entirety.
 

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

What would the United States look like without Roe v. Wade, the 1973 case that legalized abortion nationwide?

That’s the question now that President Donald Trump has chosen Judge Brett Kavanaugh as his nominee to replace retiring Supreme Court Justice Anthony Kennedy.

trekandshoot/thinkstock

Reversing the landmark case would not automatically make abortion illegal across the country. Instead, it would return the decision about abortion legality to the states, where a patchwork of laws are already in place that render abortion more or less available, largely depending on individual states’ political leanings.

“We think there are 22 states likely to ban abortion without Roe,” because of a combination of factors including existing laws and regulation on the books and the positions of the governor and state legislature, said Amy Myrick, staff attorney at the Center for Reproductive Rights, which represents abortion-rights advocates in court.

“The threat level is very high now,” Ms. Myrick said.

Judge Kavanaugh never opined on Roe v. Wade directly during his tenure on the U.S. District Court in Washington. In his 2006 confirmation hearing for that position, though, he said he would follow Roe v. Wade as a “binding precedent” of the Supreme Court – which lower-court judges are required to do.

Abortion opponents are buoyed by the pick.

“Judge Kavanaugh is an experienced, principled jurist with a strong record of protecting life and constitutional rights,” Marjorie Dannenfelser, president of the Susan B. Anthony List, said in a statement. She spearheaded support for Trump in his presidential campaign after he promised to appoint to the Supreme Court only justices who would overturn Roe v. Wade.

Justice Kennedy, by contrast, was a swing vote on abortion issues. He frequently sided with conservatives to uphold abortion restrictions. However, in key cases in 1992 and 2016, he sided with liberals to uphold Roe’s core finding that the right to abortion is part of a right to privacy that is embedded within the U.S. Constitution.

Even now, with Roe v. Wade’s protections in place, a woman’s ability to access abortion is heavily dependent on where she lives.

According to an analysis by the Guttmacher Institute, a reproductive-rights think tank, 19 states adopted 63 new restrictions on abortion rights and access. At the same time, 21 states adopted 58 measures last year intended to expand access to women’s reproductive health.

Since 2011, states have enacted nearly 1,200 separate abortion restrictions, according to Guttmacher, making these types of laws far more common.

As of now, four states – Louisiana, Mississippi and North and South Dakota – have what are known as abortion “trigger laws.” Those laws – passed long after Roe was handed down – would make abortion illegal if and when the Supreme Court were to say Roe is no more.

“They are designed to make abortion illegal immediately,” said Ms. Myrick.

Another dozen or so states still have abortion bans on the books that predated Roe v. Wade.

Some have been formally blocked by the courts but not repealed. Those bans could, at least in theory, be reinstated, although “someone would have to go into court and ask to lift that injunction,” said Ms. Myrick.

States could simply begin enforcing other bans that were never formally blocked, like one in Alabama that makes abortion providers subject to fines and up to a year in jail.

At the same time, Ms. Myrick said, “there are 20 states where abortion would probably remain safe and legal.”
 

The path to the high court

Several major challenges to state abortion laws are already in the judicial pipeline. One of these will have to get to the Supreme Court to enable a majority to overturn Roe v. Wade.

“It’s not a question of if, it’s a question of what or when,” said Sarah Lipton-Lubet, vice president for reproductive health and rights at the National Partnership for Women & Families.

The cases fall into three major categories.

The first – and most likely type to result in the court taking a broad look at Roe v. Wade – are “gestational” bans that seek to restrict abortion at a certain point in pregnancy, said Ms. Lipton-Lubet.

Mississippi has a 15-week ban, currently being challenged in federal court; Louisiana enacted a similar ban, but it would take effect only if Mississippi’s law is upheld. Iowa earlier this spring passed a 6-week ban, although that is being challenged in state court under the Iowa Constitution.

The second category involves regulations on abortion providers.

One pending case, for instance, involves an Arkansas law that would effectively ban medication abortions. Finally, there are bans on specific procedures, including several in Texas, Arkansas, and Alabama that would outlaw “dilation and evacuation” abortions, which are the most common type used in the second trimester of pregnancy.

Ms. Myrick and Ms. Lipton-Lubet agree that there is no way to predict which abortion case is likely to reach the high court first.

The case that’s actually closest to the Supreme Court, noted Ms. Myrick, is a challenge to an Indiana law that would outlaw abortion if the woman is seeking it for sex selection or because the fetus could be disabled. A federal appeals court found that law unconstitutional in April.

Many analysts also agree that even with the court’s likely philosophical shift, Roe v. Wade might not actually be overturned at all.

Instead, said Ms. Lipton-Lubet, a more conservative court could “just hollow it out” by allowing restrictive state laws to stand.

“The court cares about things like its own legitimacy,” said Ms. Myrick, “and how often a precedent has been upheld in the past.”

Given that Roe’s central finding – that the decision to have an abortion falls under the constitutional right to privacy – has been upheld three times, even an antiabortion court might be loath to overrule it in its entirety.
 

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Family caregivers of patients with intractable epilepsy are subject to significant stigma because of societal views about the disorder, according to cross-sectional analysis recently published in Epilepsy and Behavior.

• Self-administered surveys were taken by caregivers of adults and children with a confirmed diagnosis of intractable epilepsy.
• Affiliate stigma was defined as perceiving and internalizing negative societal views of the disorder and having a psychological response to those views.
• Caregivers’ psychological burdens were measured using the 30-item Carer’s Assessment of Difficulties Index and the stigma was evaluated with a separate 6-item scale that measured their perceptions of stigma.
• The 136 respondents were mostly white, female, and married.
• Investigators found the link between the stigma of epilepsy and the burden caregivers experienced was stronger among family members caring for adult patients.

Hansena B, Szaflarski M, Bebin EB, Szaflarski JP. Affiliate stigma and caregiver burden in intractable epilepsy. Epilepsy Behav. 2018;85:1-6.

Family caregivers of patients with intractable epilepsy are subject to significant stigma because of societal views about the disorder, according to cross-sectional analysis recently published in Epilepsy and Behavior.

• Self-administered surveys were taken by caregivers of adults and children with a confirmed diagnosis of intractable epilepsy.
• Affiliate stigma was defined as perceiving and internalizing negative societal views of the disorder and having a psychological response to those views.
• Caregivers’ psychological burdens were measured using the 30-item Carer’s Assessment of Difficulties Index and the stigma was evaluated with a separate 6-item scale that measured their perceptions of stigma.
• The 136 respondents were mostly white, female, and married.
• Investigators found the link between the stigma of epilepsy and the burden caregivers experienced was stronger among family members caring for adult patients.

Hansena B, Szaflarski M, Bebin EB, Szaflarski JP. Affiliate stigma and caregiver burden in intractable epilepsy. Epilepsy Behav. 2018;85:1-6.

Family caregivers of patients with intractable epilepsy are subject to significant stigma because of societal views about the disorder, according to cross-sectional analysis recently published in Epilepsy and Behavior.

• Self-administered surveys were taken by caregivers of adults and children with a confirmed diagnosis of intractable epilepsy.
• Affiliate stigma was defined as perceiving and internalizing negative societal views of the disorder and having a psychological response to those views.
• Caregivers’ psychological burdens were measured using the 30-item Carer’s Assessment of Difficulties Index and the stigma was evaluated with a separate 6-item scale that measured their perceptions of stigma.
• The 136 respondents were mostly white, female, and married.
• Investigators found the link between the stigma of epilepsy and the burden caregivers experienced was stronger among family members caring for adult patients.

Hansena B, Szaflarski M, Bebin EB, Szaflarski JP. Affiliate stigma and caregiver burden in intractable epilepsy. Epilepsy Behav. 2018;85:1-6.

About 50% of patients with epilepsy remained untreated for 6 months after their initial diagnosis according to a retrospective analysis of more than 58,000 cases.

• At 6 months after diagnosis, 46.8% were receiving treatment with antiepilepsy medication; at 12 months, that statistic had only climbed to 52.2%.
• Among the 29,226 patients who were receiving medication, nearly three quarters received monotherapy and 1.6% polytherapy as first treatment for 90 days or longer.
• The likelihood of patients remaining on antiepilepsy medication after a year was 61% for those on a single agent and 36.5% for those on more than one drug.

Faught E, Helmers S, Thurman D, et al. Patient characteristics and treatment patterns in patients with newly diagnosed epilepsy: A US database analysis. Epilepsy Behav. 2018;85:37-44.

About 50% of patients with epilepsy remained untreated for 6 months after their initial diagnosis according to a retrospective analysis of more than 58,000 cases.

• At 6 months after diagnosis, 46.8% were receiving treatment with antiepilepsy medication; at 12 months, that statistic had only climbed to 52.2%.
• Among the 29,226 patients who were receiving medication, nearly three quarters received monotherapy and 1.6% polytherapy as first treatment for 90 days or longer.
• The likelihood of patients remaining on antiepilepsy medication after a year was 61% for those on a single agent and 36.5% for those on more than one drug.

Faught E, Helmers S, Thurman D, et al. Patient characteristics and treatment patterns in patients with newly diagnosed epilepsy: A US database analysis. Epilepsy Behav. 2018;85:37-44.

About 50% of patients with epilepsy remained untreated for 6 months after their initial diagnosis according to a retrospective analysis of more than 58,000 cases.

• At 6 months after diagnosis, 46.8% were receiving treatment with antiepilepsy medication; at 12 months, that statistic had only climbed to 52.2%.
• Among the 29,226 patients who were receiving medication, nearly three quarters received monotherapy and 1.6% polytherapy as first treatment for 90 days or longer.
• The likelihood of patients remaining on antiepilepsy medication after a year was 61% for those on a single agent and 36.5% for those on more than one drug.

Faught E, Helmers S, Thurman D, et al. Patient characteristics and treatment patterns in patients with newly diagnosed epilepsy: A US database analysis. Epilepsy Behav. 2018;85:37-44.

Nearly half of patients with epilepsy have symptoms of high anxiety according to a study of adults treated in tertiary care centers.

• The study, which included 540 patients, evaluated the presence of anxiety with the Symptoms Checklist 90-R anxiety subscale. It also evaluated patients for depression with separate scales.
• 250 patients (46.1%) reported high anxiety.
• Focal epilepsy and epilepsy of unknown type, as well as depression scores, were independently linked to high anxiety.
• In patients with focal epilepsy, mesial temporal sclerosis was independently associated with high anxiety.
• Other factors linked to high anxiety included lower education level, being non-white, having Spanish as a native language, prior head trauma, and polydrug therapy for epilepsy.
• The researchers suggest that screening for anxiety in an epilepsy clinic can help spot patients in need of treatment.

Munger Clary HM, Snively BM, Hamberger MJ. Anxiety is common and independently associated with clinical features of epilepsy. Epilepsy Behav. 2018;85:64-71.

Nearly half of patients with epilepsy have symptoms of high anxiety according to a study of adults treated in tertiary care centers.

• The study, which included 540 patients, evaluated the presence of anxiety with the Symptoms Checklist 90-R anxiety subscale. It also evaluated patients for depression with separate scales.
• 250 patients (46.1%) reported high anxiety.
• Focal epilepsy and epilepsy of unknown type, as well as depression scores, were independently linked to high anxiety.
• In patients with focal epilepsy, mesial temporal sclerosis was independently associated with high anxiety.
• Other factors linked to high anxiety included lower education level, being non-white, having Spanish as a native language, prior head trauma, and polydrug therapy for epilepsy.
• The researchers suggest that screening for anxiety in an epilepsy clinic can help spot patients in need of treatment.

Munger Clary HM, Snively BM, Hamberger MJ. Anxiety is common and independently associated with clinical features of epilepsy. Epilepsy Behav. 2018;85:64-71.

Nearly half of patients with epilepsy have symptoms of high anxiety according to a study of adults treated in tertiary care centers.

• The study, which included 540 patients, evaluated the presence of anxiety with the Symptoms Checklist 90-R anxiety subscale. It also evaluated patients for depression with separate scales.
• 250 patients (46.1%) reported high anxiety.
• Focal epilepsy and epilepsy of unknown type, as well as depression scores, were independently linked to high anxiety.
• In patients with focal epilepsy, mesial temporal sclerosis was independently associated with high anxiety.
• Other factors linked to high anxiety included lower education level, being non-white, having Spanish as a native language, prior head trauma, and polydrug therapy for epilepsy.
• The researchers suggest that screening for anxiety in an epilepsy clinic can help spot patients in need of treatment.

Munger Clary HM, Snively BM, Hamberger MJ. Anxiety is common and independently associated with clinical features of epilepsy. Epilepsy Behav. 2018;85:64-71.

BALTIMORE – Researchers have developed an algorithm to calculate circulation time during sleep that may provide another tool to identify the risk of underlying cardiac vascular disease in patients with sleep apnea, one of the study’s lead investigators reported at the annual meeting of the Associated Professional Sleep Societies.

“There’s always been a question that there could be some global or untapped physiological indices that might give us some glimpse into future cardiovascular events or instantaneous cardiovascular vulnerability during sleep apnea events,” said Younghoon Kwon, MD, assistant professor of cardiovascular medicine at the University of Virginia, Charlottesville. “Circulation time that can be derived from a sleep study may be one of these novel indices. Although it has been examined in patients with heart failure with Cheyne-Stokes respiration, it has rarely been studied in patients with obstructive sleep apnea without heart failure.”

He noted that in this study, which utilized a cohort of 686 patients from the Multi-Ethnic Study of Atherosclerosis (MESA), all with an apnea-hypopnea index greater than 15, the automated algorithm the researchers developed to calculate lung-to-finger circulation was correlated highly with visual measurement.

The algorithm used randomly selected polysomnograms from the MESA cohort. It employed the airflow/nasal signal and the oxygen saturation signal, using the visually scored start and endpoint of apnea/hypopnea as a starting point. For each event, the calculation identified two key points: the endpoint of apnea/hypopnea and the endpoint of desaturation to arrive at a calculation of lung-to-finger circulation, Dr. Kwon explained.

The significance of the findings was the correlation between the visual and automated methods of calculating lung-to-finder circulation time. In a matched subgroup of 25 subjects, the correlation was around 95% (P less than .0001); in all cases, the correlation was around 69% (P less than .001). In matched cases, the average lung-to-finger circulation times were identical with visual and automated techniques: 19.5 seconds (P = .92), whereas in all cases the averages differed: 19.6 seconds for visual versus 18.6 seconds for automated (P = .42). “The results showed that the visual against the automated circulatory time measurement was very good,” Dr. Kwon said.

With this algorithm, multiple circulation time measures were automatically derived for each sleep study. Subsequently, average circulation time was derived for each study participant. The average circulation time was 19.4 seconds in the entire cohort, versus 21.0 seconds in those with apnea and 17.6 seconds in patients with hypopnea.

“Older age, male gender, and higher obstructive sleep apnea severity appeared to be independently associated with higher than average lung-to-finger circulation times,” Dr. Kwon said. “However, there was no apparent association between the obstructive event length or the severity of oxygen desaturation and the respective circulation time within subjects. Similarly, sleep positions and sleep stages do not seem to bear any association.”

One of the limitations of the study, he noted, was its assumption of the automated algorithm as the threshold and somewhat limited candidate variables. Future studies should involve more diverse cohorts with prevalent cardiovascular disease to determine the utility of the algorithm in predicting cardiovascular events, he said.

Dr. Kwon reported having no financial relationships, and the American Academy of Sleep Medicine Foundation provided study funding.

SOURCE: Kwon Y et al. SLEEP 2018, Abstract #0450.

BALTIMORE – Researchers have developed an algorithm to calculate circulation time during sleep that may provide another tool to identify the risk of underlying cardiac vascular disease in patients with sleep apnea, one of the study’s lead investigators reported at the annual meeting of the Associated Professional Sleep Societies.

“There’s always been a question that there could be some global or untapped physiological indices that might give us some glimpse into future cardiovascular events or instantaneous cardiovascular vulnerability during sleep apnea events,” said Younghoon Kwon, MD, assistant professor of cardiovascular medicine at the University of Virginia, Charlottesville. “Circulation time that can be derived from a sleep study may be one of these novel indices. Although it has been examined in patients with heart failure with Cheyne-Stokes respiration, it has rarely been studied in patients with obstructive sleep apnea without heart failure.”

He noted that in this study, which utilized a cohort of 686 patients from the Multi-Ethnic Study of Atherosclerosis (MESA), all with an apnea-hypopnea index greater than 15, the automated algorithm the researchers developed to calculate lung-to-finger circulation was correlated highly with visual measurement.

The algorithm used randomly selected polysomnograms from the MESA cohort. It employed the airflow/nasal signal and the oxygen saturation signal, using the visually scored start and endpoint of apnea/hypopnea as a starting point. For each event, the calculation identified two key points: the endpoint of apnea/hypopnea and the endpoint of desaturation to arrive at a calculation of lung-to-finger circulation, Dr. Kwon explained.

The significance of the findings was the correlation between the visual and automated methods of calculating lung-to-finder circulation time. In a matched subgroup of 25 subjects, the correlation was around 95% (P less than .0001); in all cases, the correlation was around 69% (P less than .001). In matched cases, the average lung-to-finger circulation times were identical with visual and automated techniques: 19.5 seconds (P = .92), whereas in all cases the averages differed: 19.6 seconds for visual versus 18.6 seconds for automated (P = .42). “The results showed that the visual against the automated circulatory time measurement was very good,” Dr. Kwon said.

With this algorithm, multiple circulation time measures were automatically derived for each sleep study. Subsequently, average circulation time was derived for each study participant. The average circulation time was 19.4 seconds in the entire cohort, versus 21.0 seconds in those with apnea and 17.6 seconds in patients with hypopnea.

“Older age, male gender, and higher obstructive sleep apnea severity appeared to be independently associated with higher than average lung-to-finger circulation times,” Dr. Kwon said. “However, there was no apparent association between the obstructive event length or the severity of oxygen desaturation and the respective circulation time within subjects. Similarly, sleep positions and sleep stages do not seem to bear any association.”

One of the limitations of the study, he noted, was its assumption of the automated algorithm as the threshold and somewhat limited candidate variables. Future studies should involve more diverse cohorts with prevalent cardiovascular disease to determine the utility of the algorithm in predicting cardiovascular events, he said.

Dr. Kwon reported having no financial relationships, and the American Academy of Sleep Medicine Foundation provided study funding.

SOURCE: Kwon Y et al. SLEEP 2018, Abstract #0450.

BALTIMORE – Researchers have developed an algorithm to calculate circulation time during sleep that may provide another tool to identify the risk of underlying cardiac vascular disease in patients with sleep apnea, one of the study’s lead investigators reported at the annual meeting of the Associated Professional Sleep Societies.

“There’s always been a question that there could be some global or untapped physiological indices that might give us some glimpse into future cardiovascular events or instantaneous cardiovascular vulnerability during sleep apnea events,” said Younghoon Kwon, MD, assistant professor of cardiovascular medicine at the University of Virginia, Charlottesville. “Circulation time that can be derived from a sleep study may be one of these novel indices. Although it has been examined in patients with heart failure with Cheyne-Stokes respiration, it has rarely been studied in patients with obstructive sleep apnea without heart failure.”

He noted that in this study, which utilized a cohort of 686 patients from the Multi-Ethnic Study of Atherosclerosis (MESA), all with an apnea-hypopnea index greater than 15, the automated algorithm the researchers developed to calculate lung-to-finger circulation was correlated highly with visual measurement.

The algorithm used randomly selected polysomnograms from the MESA cohort. It employed the airflow/nasal signal and the oxygen saturation signal, using the visually scored start and endpoint of apnea/hypopnea as a starting point. For each event, the calculation identified two key points: the endpoint of apnea/hypopnea and the endpoint of desaturation to arrive at a calculation of lung-to-finger circulation, Dr. Kwon explained.

The significance of the findings was the correlation between the visual and automated methods of calculating lung-to-finder circulation time. In a matched subgroup of 25 subjects, the correlation was around 95% (P less than .0001); in all cases, the correlation was around 69% (P less than .001). In matched cases, the average lung-to-finger circulation times were identical with visual and automated techniques: 19.5 seconds (P = .92), whereas in all cases the averages differed: 19.6 seconds for visual versus 18.6 seconds for automated (P = .42). “The results showed that the visual against the automated circulatory time measurement was very good,” Dr. Kwon said.

With this algorithm, multiple circulation time measures were automatically derived for each sleep study. Subsequently, average circulation time was derived for each study participant. The average circulation time was 19.4 seconds in the entire cohort, versus 21.0 seconds in those with apnea and 17.6 seconds in patients with hypopnea.

“Older age, male gender, and higher obstructive sleep apnea severity appeared to be independently associated with higher than average lung-to-finger circulation times,” Dr. Kwon said. “However, there was no apparent association between the obstructive event length or the severity of oxygen desaturation and the respective circulation time within subjects. Similarly, sleep positions and sleep stages do not seem to bear any association.”

One of the limitations of the study, he noted, was its assumption of the automated algorithm as the threshold and somewhat limited candidate variables. Future studies should involve more diverse cohorts with prevalent cardiovascular disease to determine the utility of the algorithm in predicting cardiovascular events, he said.

Dr. Kwon reported having no financial relationships, and the American Academy of Sleep Medicine Foundation provided study funding.

SOURCE: Kwon Y et al. SLEEP 2018, Abstract #0450.

In a study of more than 5,000 fifth graders, fewer than a quarter of participants almost always used sunscreen, and the figures were much lower for non-Hispanic black children.

©Vesna Andjic/iStockphoto.com

[email protected]

SOURCE: Correnti CM et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13550.

In a study of more than 5,000 fifth graders, fewer than a quarter of participants almost always used sunscreen, and the figures were much lower for non-Hispanic black children.

©Vesna Andjic/iStockphoto.com

[email protected]

SOURCE: Correnti CM et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13550.

In a study of more than 5,000 fifth graders, fewer than a quarter of participants almost always used sunscreen, and the figures were much lower for non-Hispanic black children.

©Vesna Andjic/iStockphoto.com

[email protected]

SOURCE: Correnti CM et al. Pediatr Dermatol. 2018. doi: 10.1111/pde.13550.

AMSTERDAM – Patients with rheumatoid arthritis who underwent elective knee or hip arthroplasty had a doubled rate of hospitalization for infection when they averaged more than 10 mg/day oral prednisone during the 3 months before surgery, based on a review of about 11,000 U.S. insurance claims.

Mitchel L. Zoler/MDedge News

“Limiting glucocorticoid exposure before surgery should be a focus of perioperative management,” Michael D. George, MD, said at the European Congress of Rheumatology. “Glucocorticoid use, especially greater than 10 mg/day, is associated with a greater risk of infection and hospital readmission,” said Dr. George, a rheumatologist at the University of Pennsylvania in Philadelphia.

The analysis also showed that treatment with any biologic drug – including abatacept (Orencia), rituximab (Rituxan), tocilizumab (Actemra), and any of several tumor necrosis factor (TNF) inhibitors – had a similar impact on both postsurgical infections requiring hospitalization and 30-day hospital readmissions.

The findings suggest “it’s more important to reduce glucocorticoids than biological drugs,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England. “This is a really important question that has been very difficult to answer.”

Mitchel L. Zoler/MDedge News

Dr. George and his associates used data from patients with rheumatoid arthritis during 2006-2015 who underwent knee or hip arthroplasty and were in databases from Medicare, or MarketScan, which includes commercial insurers. This identified 11,021 RA patients on any of several biologic drugs before their surgery: 16% on abatacept, 4% on rituximab, 4% on tocilizumab, and the remaining 76% on a TNF inhibitor, either adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade). About 43% of all patients were on a glucocorticoid during the 3 months before surgery. Biologic use was defined as a minimum of one dose within 8 weeks of surgery, and at least three total dosages during the prior year, except for rituximab, which was at least one dose given 16 weeks before surgery and at least two doses during the prior year.

The rate of hospitalized infections ranged from 6.6% to 8.5% depending on the biologic drug used, and 30-day readmissions ranged from 4.8% to 6.8%. A third outcome the analysis assessed was prosthetic joint infection during 1-year follow-up, which was again similar across most of the biologics, except for patients on tocilizumab, who had prosthetic joint infections roughly threefold more often than the other patients. Although this was a statistically significant difference, Dr. George discounted the finding given the very small number of tocilizumab-treated patients who had these infections and said that any conclusion about tocilizumab’s effect on this outcome had to await data from more patients.

The glucocorticoid analysis divided patients into four subgroups: those not on a glucocorticoid, those on an average daily dosage of 5 mg/day prednisone or equivalent or less, patients on 6-10 mg/day prednisone, and those on more than 10 mg/day. In a propensity-weighted analysis, these three escalating levels of glucocorticoid use showed a dose-response relationship to the rates of both hospitalized infections and 30-day readmissions. At the highest level of glucocorticoid use, hospitalized infections occurred twice as often as in patients not on a glucocorticoid, and 30-day readmissions were more than 50% higher than in those not on an oral steroid, both statistically significant differences. For the outcome of 1-year prosthetic joint infections, the analysis again showed a dose-related link among glucocorticoid users, topping out with a greater than 50% increased rate among those on the highest glucocorticoid dosages when compared with nonusers, but this difference was not statistically significant.

The study was partially funded by Bristol-Myers Squibb, the company that markets abatacept. Dr. George has received research funding from Bristol-Myers Squibb, and some of his coauthors on the study are employees of the company.

[email protected]

SOURCE: George MD et al. EULAR 2018. Abstract OP0228.

AMSTERDAM – Patients with rheumatoid arthritis who underwent elective knee or hip arthroplasty had a doubled rate of hospitalization for infection when they averaged more than 10 mg/day oral prednisone during the 3 months before surgery, based on a review of about 11,000 U.S. insurance claims.

Mitchel L. Zoler/MDedge News

“Limiting glucocorticoid exposure before surgery should be a focus of perioperative management,” Michael D. George, MD, said at the European Congress of Rheumatology. “Glucocorticoid use, especially greater than 10 mg/day, is associated with a greater risk of infection and hospital readmission,” said Dr. George, a rheumatologist at the University of Pennsylvania in Philadelphia.

The analysis also showed that treatment with any biologic drug – including abatacept (Orencia), rituximab (Rituxan), tocilizumab (Actemra), and any of several tumor necrosis factor (TNF) inhibitors – had a similar impact on both postsurgical infections requiring hospitalization and 30-day hospital readmissions.

The findings suggest “it’s more important to reduce glucocorticoids than biological drugs,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England. “This is a really important question that has been very difficult to answer.”

Mitchel L. Zoler/MDedge News

Dr. George and his associates used data from patients with rheumatoid arthritis during 2006-2015 who underwent knee or hip arthroplasty and were in databases from Medicare, or MarketScan, which includes commercial insurers. This identified 11,021 RA patients on any of several biologic drugs before their surgery: 16% on abatacept, 4% on rituximab, 4% on tocilizumab, and the remaining 76% on a TNF inhibitor, either adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade). About 43% of all patients were on a glucocorticoid during the 3 months before surgery. Biologic use was defined as a minimum of one dose within 8 weeks of surgery, and at least three total dosages during the prior year, except for rituximab, which was at least one dose given 16 weeks before surgery and at least two doses during the prior year.

The rate of hospitalized infections ranged from 6.6% to 8.5% depending on the biologic drug used, and 30-day readmissions ranged from 4.8% to 6.8%. A third outcome the analysis assessed was prosthetic joint infection during 1-year follow-up, which was again similar across most of the biologics, except for patients on tocilizumab, who had prosthetic joint infections roughly threefold more often than the other patients. Although this was a statistically significant difference, Dr. George discounted the finding given the very small number of tocilizumab-treated patients who had these infections and said that any conclusion about tocilizumab’s effect on this outcome had to await data from more patients.

The glucocorticoid analysis divided patients into four subgroups: those not on a glucocorticoid, those on an average daily dosage of 5 mg/day prednisone or equivalent or less, patients on 6-10 mg/day prednisone, and those on more than 10 mg/day. In a propensity-weighted analysis, these three escalating levels of glucocorticoid use showed a dose-response relationship to the rates of both hospitalized infections and 30-day readmissions. At the highest level of glucocorticoid use, hospitalized infections occurred twice as often as in patients not on a glucocorticoid, and 30-day readmissions were more than 50% higher than in those not on an oral steroid, both statistically significant differences. For the outcome of 1-year prosthetic joint infections, the analysis again showed a dose-related link among glucocorticoid users, topping out with a greater than 50% increased rate among those on the highest glucocorticoid dosages when compared with nonusers, but this difference was not statistically significant.

The study was partially funded by Bristol-Myers Squibb, the company that markets abatacept. Dr. George has received research funding from Bristol-Myers Squibb, and some of his coauthors on the study are employees of the company.

[email protected]

SOURCE: George MD et al. EULAR 2018. Abstract OP0228.

AMSTERDAM – Patients with rheumatoid arthritis who underwent elective knee or hip arthroplasty had a doubled rate of hospitalization for infection when they averaged more than 10 mg/day oral prednisone during the 3 months before surgery, based on a review of about 11,000 U.S. insurance claims.

Mitchel L. Zoler/MDedge News

“Limiting glucocorticoid exposure before surgery should be a focus of perioperative management,” Michael D. George, MD, said at the European Congress of Rheumatology. “Glucocorticoid use, especially greater than 10 mg/day, is associated with a greater risk of infection and hospital readmission,” said Dr. George, a rheumatologist at the University of Pennsylvania in Philadelphia.

The analysis also showed that treatment with any biologic drug – including abatacept (Orencia), rituximab (Rituxan), tocilizumab (Actemra), and any of several tumor necrosis factor (TNF) inhibitors – had a similar impact on both postsurgical infections requiring hospitalization and 30-day hospital readmissions.

The findings suggest “it’s more important to reduce glucocorticoids than biological drugs,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England. “This is a really important question that has been very difficult to answer.”

Mitchel L. Zoler/MDedge News

Dr. George and his associates used data from patients with rheumatoid arthritis during 2006-2015 who underwent knee or hip arthroplasty and were in databases from Medicare, or MarketScan, which includes commercial insurers. This identified 11,021 RA patients on any of several biologic drugs before their surgery: 16% on abatacept, 4% on rituximab, 4% on tocilizumab, and the remaining 76% on a TNF inhibitor, either adalimumab (Humira), etanercept (Enbrel), or infliximab (Remicade). About 43% of all patients were on a glucocorticoid during the 3 months before surgery. Biologic use was defined as a minimum of one dose within 8 weeks of surgery, and at least three total dosages during the prior year, except for rituximab, which was at least one dose given 16 weeks before surgery and at least two doses during the prior year.

The rate of hospitalized infections ranged from 6.6% to 8.5% depending on the biologic drug used, and 30-day readmissions ranged from 4.8% to 6.8%. A third outcome the analysis assessed was prosthetic joint infection during 1-year follow-up, which was again similar across most of the biologics, except for patients on tocilizumab, who had prosthetic joint infections roughly threefold more often than the other patients. Although this was a statistically significant difference, Dr. George discounted the finding given the very small number of tocilizumab-treated patients who had these infections and said that any conclusion about tocilizumab’s effect on this outcome had to await data from more patients.

The glucocorticoid analysis divided patients into four subgroups: those not on a glucocorticoid, those on an average daily dosage of 5 mg/day prednisone or equivalent or less, patients on 6-10 mg/day prednisone, and those on more than 10 mg/day. In a propensity-weighted analysis, these three escalating levels of glucocorticoid use showed a dose-response relationship to the rates of both hospitalized infections and 30-day readmissions. At the highest level of glucocorticoid use, hospitalized infections occurred twice as often as in patients not on a glucocorticoid, and 30-day readmissions were more than 50% higher than in those not on an oral steroid, both statistically significant differences. For the outcome of 1-year prosthetic joint infections, the analysis again showed a dose-related link among glucocorticoid users, topping out with a greater than 50% increased rate among those on the highest glucocorticoid dosages when compared with nonusers, but this difference was not statistically significant.

The study was partially funded by Bristol-Myers Squibb, the company that markets abatacept. Dr. George has received research funding from Bristol-Myers Squibb, and some of his coauthors on the study are employees of the company.

[email protected]

SOURCE: George MD et al. EULAR 2018. Abstract OP0228.

Older black adults who experienced in-hospital cardiac arrest had a 28% lower relative risk of living to 1 year and a 33% lower relative risk of living to 5 years after discharge, compared with older white adults, suggesting potential racial differences in postdischarge care, according to an article published in Circulation.

The investigators examined data for 8,764 patients in the Get With The Guidelines–Resuscitation registry who were at least 65 years of age and experienced in-hospital cardiac arrest (IHCA) during 2000-2011 and then survived to be discharged. They linked patients to Medicare claims data and tracked survival outcomes for 1 year, 3 years, and 5 years, and evaluated the “proportion of racial differences explained by patient, hospital, and unmeasured factors.”

After discharge and adjustment for hospital site, investigators found older black patients had a 28% lower survival rate, compared with older white patients, at 1 year (43.6% vs. 60.2%), a 29% lower rate at 3 years (31.6% vs. 45.3%), and a 33% lower rate at 5 years (23.5% vs. 35.4%), all statistically significant at P less than .001. While patient factors accounted for 29% and hospital treatment factors accounted for 17% of racial differences at 1 year after discharge, about one-half of the differences remained unexplained. Investigators said these racial differences were potentially “result of differences in care after discharge or unmeasured confounding,” and “generally similar” results were seen in patients at 3 years and 5 years post discharge.

“This finding suggests a need to examine whether racial differences in postdischarge care explain a substantial proportion of racial differences in long-term survival after in-hospital cardiac arrest,” Lena M. Chen, MD, of the University of Michigan, Ann Arbor, and her colleagues wrote in Circulation.

The investigators noted they were unable to determine patient socioeconomic status, income, and social support with the available data, and did not know whether patients used or had an outpatient medical center near them after discharge. Furthermore, the study comprised older adults with fee-for-service Medicare and isn’t necessarily indicative of care for younger adults.

“Further investigation is warranted to better understand whether modifiable aspects of postdischarge care account for the remaining differences and whether interventions can be developed to eliminate racial disparities in care and survival for cardiac arrest survivors,” Dr. Chen and colleagues wrote.

This project was supported by a grant from the American Heart Association Young Investigator Research Seed. Dr. Chen received funding support from the Agency for Healthcare Research and Quality and the National Institute on Aging. Dr. Chen and another investigator received funding support from the National Heart, Lung, and Blood Institute.

SOURCE: Chen LM. Circulation. 2018 Jul 9. doi: 10.1161/circulationaha.117.033211.

Older black adults who experienced in-hospital cardiac arrest had a 28% lower relative risk of living to 1 year and a 33% lower relative risk of living to 5 years after discharge, compared with older white adults, suggesting potential racial differences in postdischarge care, according to an article published in Circulation.

The investigators examined data for 8,764 patients in the Get With The Guidelines–Resuscitation registry who were at least 65 years of age and experienced in-hospital cardiac arrest (IHCA) during 2000-2011 and then survived to be discharged. They linked patients to Medicare claims data and tracked survival outcomes for 1 year, 3 years, and 5 years, and evaluated the “proportion of racial differences explained by patient, hospital, and unmeasured factors.”

After discharge and adjustment for hospital site, investigators found older black patients had a 28% lower survival rate, compared with older white patients, at 1 year (43.6% vs. 60.2%), a 29% lower rate at 3 years (31.6% vs. 45.3%), and a 33% lower rate at 5 years (23.5% vs. 35.4%), all statistically significant at P less than .001. While patient factors accounted for 29% and hospital treatment factors accounted for 17% of racial differences at 1 year after discharge, about one-half of the differences remained unexplained. Investigators said these racial differences were potentially “result of differences in care after discharge or unmeasured confounding,” and “generally similar” results were seen in patients at 3 years and 5 years post discharge.

“This finding suggests a need to examine whether racial differences in postdischarge care explain a substantial proportion of racial differences in long-term survival after in-hospital cardiac arrest,” Lena M. Chen, MD, of the University of Michigan, Ann Arbor, and her colleagues wrote in Circulation.

The investigators noted they were unable to determine patient socioeconomic status, income, and social support with the available data, and did not know whether patients used or had an outpatient medical center near them after discharge. Furthermore, the study comprised older adults with fee-for-service Medicare and isn’t necessarily indicative of care for younger adults.

“Further investigation is warranted to better understand whether modifiable aspects of postdischarge care account for the remaining differences and whether interventions can be developed to eliminate racial disparities in care and survival for cardiac arrest survivors,” Dr. Chen and colleagues wrote.

This project was supported by a grant from the American Heart Association Young Investigator Research Seed. Dr. Chen received funding support from the Agency for Healthcare Research and Quality and the National Institute on Aging. Dr. Chen and another investigator received funding support from the National Heart, Lung, and Blood Institute.

SOURCE: Chen LM. Circulation. 2018 Jul 9. doi: 10.1161/circulationaha.117.033211.

Older black adults who experienced in-hospital cardiac arrest had a 28% lower relative risk of living to 1 year and a 33% lower relative risk of living to 5 years after discharge, compared with older white adults, suggesting potential racial differences in postdischarge care, according to an article published in Circulation.

The investigators examined data for 8,764 patients in the Get With The Guidelines–Resuscitation registry who were at least 65 years of age and experienced in-hospital cardiac arrest (IHCA) during 2000-2011 and then survived to be discharged. They linked patients to Medicare claims data and tracked survival outcomes for 1 year, 3 years, and 5 years, and evaluated the “proportion of racial differences explained by patient, hospital, and unmeasured factors.”

After discharge and adjustment for hospital site, investigators found older black patients had a 28% lower survival rate, compared with older white patients, at 1 year (43.6% vs. 60.2%), a 29% lower rate at 3 years (31.6% vs. 45.3%), and a 33% lower rate at 5 years (23.5% vs. 35.4%), all statistically significant at P less than .001. While patient factors accounted for 29% and hospital treatment factors accounted for 17% of racial differences at 1 year after discharge, about one-half of the differences remained unexplained. Investigators said these racial differences were potentially “result of differences in care after discharge or unmeasured confounding,” and “generally similar” results were seen in patients at 3 years and 5 years post discharge.

“This finding suggests a need to examine whether racial differences in postdischarge care explain a substantial proportion of racial differences in long-term survival after in-hospital cardiac arrest,” Lena M. Chen, MD, of the University of Michigan, Ann Arbor, and her colleagues wrote in Circulation.

The investigators noted they were unable to determine patient socioeconomic status, income, and social support with the available data, and did not know whether patients used or had an outpatient medical center near them after discharge. Furthermore, the study comprised older adults with fee-for-service Medicare and isn’t necessarily indicative of care for younger adults.

“Further investigation is warranted to better understand whether modifiable aspects of postdischarge care account for the remaining differences and whether interventions can be developed to eliminate racial disparities in care and survival for cardiac arrest survivors,” Dr. Chen and colleagues wrote.

This project was supported by a grant from the American Heart Association Young Investigator Research Seed. Dr. Chen received funding support from the Agency for Healthcare Research and Quality and the National Institute on Aging. Dr. Chen and another investigator received funding support from the National Heart, Lung, and Blood Institute.

SOURCE: Chen LM. Circulation. 2018 Jul 9. doi: 10.1161/circulationaha.117.033211.