Federal Practitioner

Cases of a potentially deadly and increasingly treatment-resistant fungus called Candida auris have skyrocketed 200% since 2019, prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.

C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.

The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.

The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016. 

“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.

Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.

“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.

Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.

The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.

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

Cases of a potentially deadly and increasingly treatment-resistant fungus called Candida auris have skyrocketed 200% since 2019, prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.

C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.

The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.

The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016. 

“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.

Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.

“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.

Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.

The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.

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

Cases of a potentially deadly and increasingly treatment-resistant fungus called Candida auris have skyrocketed 200% since 2019, prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.

C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.

The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.

The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016. 

“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.

Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.

“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.

Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.

The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.

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

Medical school graduates around the US took to social media after last week's Match Day to share their joy ― or explore their options if they did not match.

Take this post March 19 on Twitter: “I went unmatched this year; looking for research position at any institute for internal medicine.”

Most of the fourth-year medical students this news organization has followed in the run-up to Match Day found success, including an international medical graduate who matched into his chosen specialty after multiple disappointments.

“I’ve waited for this email for 8 years,” Sahil Bawa, MD, posted on Twitter on March 13. A few days later, when he learned about his residency position, he posted: “I’m beyond grateful. Will be moving to Alabama soon #familymedicine.”

Dr. Bawa, who matched into UAB Medicine Selma (Ala.), graduated from medical school in India in 2014. He said in an interview that he has visited the United States periodically since then to pass medical tests, obtain letters of recommendation, and participate in research.

Over the years he watched his Indian colleagues give up on becoming American doctors, find alternative careers, or resolve to practice in their native country. But he held onto the few success stories he saw on social media. “There were always one to two every year. It kept me going. If they can do it, I can do it.”

International medical graduates (IMGs) like Dr. Bawa applied in record numbers to Match2023, according to the National Resident Matching Program (NRMP), which announced the results on March 13 of its main residency match and the Supplemental Offer and Acceptance Program (SOAP) for unfilled positions or unmatched applicants.

Overall, 48,156 total applicants registered for the match, which was driven by the increase of non-U.S. IMG applicants and U.S. DO seniors over the past year, NRMP stated in its release. U.S. MD seniors had a match rate of nearly 94%, and U.S. DO seniors, nearly 92%. U.S. IMGs had a match rate of nearly 68%, an “all-time high,” and non-U.S. IMGs, nearly 60%, NRMP stated.

Three specialties that filled all of their 30 or more available positions were orthopedic surgery, plastic surgery (integrated), radiology – diagnostic, and thoracic surgery. Specialties with 30 or more positions that filled with the highest percentage of U.S. MD and DO seniors were plastic surgery (integrated), internal medicine-pediatrics, ob.gyn., and orthopedic surgery.

The number of available primary care positions increased slightly, NRMP reported. Considering “a serious and growing shortage of primary care physicians across the U.S.,” there were 571 more primary care positions than 2022. That’s an increase of about 3% over last year and 17% over the past 5 years. Primary care positions filled at a rate of 94%, which remained steady from 2022.

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

Medical school graduates around the US took to social media after last week's Match Day to share their joy ― or explore their options if they did not match.

Take this post March 19 on Twitter: “I went unmatched this year; looking for research position at any institute for internal medicine.”

Most of the fourth-year medical students this news organization has followed in the run-up to Match Day found success, including an international medical graduate who matched into his chosen specialty after multiple disappointments.

“I’ve waited for this email for 8 years,” Sahil Bawa, MD, posted on Twitter on March 13. A few days later, when he learned about his residency position, he posted: “I’m beyond grateful. Will be moving to Alabama soon #familymedicine.”

Dr. Bawa, who matched into UAB Medicine Selma (Ala.), graduated from medical school in India in 2014. He said in an interview that he has visited the United States periodically since then to pass medical tests, obtain letters of recommendation, and participate in research.

Over the years he watched his Indian colleagues give up on becoming American doctors, find alternative careers, or resolve to practice in their native country. But he held onto the few success stories he saw on social media. “There were always one to two every year. It kept me going. If they can do it, I can do it.”

International medical graduates (IMGs) like Dr. Bawa applied in record numbers to Match2023, according to the National Resident Matching Program (NRMP), which announced the results on March 13 of its main residency match and the Supplemental Offer and Acceptance Program (SOAP) for unfilled positions or unmatched applicants.

Overall, 48,156 total applicants registered for the match, which was driven by the increase of non-U.S. IMG applicants and U.S. DO seniors over the past year, NRMP stated in its release. U.S. MD seniors had a match rate of nearly 94%, and U.S. DO seniors, nearly 92%. U.S. IMGs had a match rate of nearly 68%, an “all-time high,” and non-U.S. IMGs, nearly 60%, NRMP stated.

Three specialties that filled all of their 30 or more available positions were orthopedic surgery, plastic surgery (integrated), radiology – diagnostic, and thoracic surgery. Specialties with 30 or more positions that filled with the highest percentage of U.S. MD and DO seniors were plastic surgery (integrated), internal medicine-pediatrics, ob.gyn., and orthopedic surgery.

The number of available primary care positions increased slightly, NRMP reported. Considering “a serious and growing shortage of primary care physicians across the U.S.,” there were 571 more primary care positions than 2022. That’s an increase of about 3% over last year and 17% over the past 5 years. Primary care positions filled at a rate of 94%, which remained steady from 2022.

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

Medical school graduates around the US took to social media after last week's Match Day to share their joy ― or explore their options if they did not match.

Take this post March 19 on Twitter: “I went unmatched this year; looking for research position at any institute for internal medicine.”

Most of the fourth-year medical students this news organization has followed in the run-up to Match Day found success, including an international medical graduate who matched into his chosen specialty after multiple disappointments.

“I’ve waited for this email for 8 years,” Sahil Bawa, MD, posted on Twitter on March 13. A few days later, when he learned about his residency position, he posted: “I’m beyond grateful. Will be moving to Alabama soon #familymedicine.”

Dr. Bawa, who matched into UAB Medicine Selma (Ala.), graduated from medical school in India in 2014. He said in an interview that he has visited the United States periodically since then to pass medical tests, obtain letters of recommendation, and participate in research.

Over the years he watched his Indian colleagues give up on becoming American doctors, find alternative careers, or resolve to practice in their native country. But he held onto the few success stories he saw on social media. “There were always one to two every year. It kept me going. If they can do it, I can do it.”

International medical graduates (IMGs) like Dr. Bawa applied in record numbers to Match2023, according to the National Resident Matching Program (NRMP), which announced the results on March 13 of its main residency match and the Supplemental Offer and Acceptance Program (SOAP) for unfilled positions or unmatched applicants.

Overall, 48,156 total applicants registered for the match, which was driven by the increase of non-U.S. IMG applicants and U.S. DO seniors over the past year, NRMP stated in its release. U.S. MD seniors had a match rate of nearly 94%, and U.S. DO seniors, nearly 92%. U.S. IMGs had a match rate of nearly 68%, an “all-time high,” and non-U.S. IMGs, nearly 60%, NRMP stated.

Three specialties that filled all of their 30 or more available positions were orthopedic surgery, plastic surgery (integrated), radiology – diagnostic, and thoracic surgery. Specialties with 30 or more positions that filled with the highest percentage of U.S. MD and DO seniors were plastic surgery (integrated), internal medicine-pediatrics, ob.gyn., and orthopedic surgery.

The number of available primary care positions increased slightly, NRMP reported. Considering “a serious and growing shortage of primary care physicians across the U.S.,” there were 571 more primary care positions than 2022. That’s an increase of about 3% over last year and 17% over the past 5 years. Primary care positions filled at a rate of 94%, which remained steady from 2022.

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

When a bacterial infection reaches the bloodstream, every second is critical. The person’s life is on the line. Yet blood tests to identify bacteria take hours to days. While waiting, doctors often prescribe broad-spectrum antibiotics in hopes of killing whatever bug may be at fault.

Someday soon, that wait time could shrink significantly, allowing health care providers to more quickly zero in on the best antibiotic for each infection – thanks to an innovation from Stanford (Calif.) University that identifies bacteria in seconds.

The cutting-edge method relies on old-school tech: an inkjet printer similar the kind you might have at home – except this one has been modified to print blood instead of ink.

This “bioprinter” spits out tiny drops of blood quickly – more than 1,000 per second. Shine a laser on the drops – using a light-based imaging technique called Raman spectroscopy – and the bacteria’s unique cellular “fingerprint” is revealed.

The very small sample size – each drop is two trillionths of a liter, or about a billion times smaller than a raindrop – make spotting bacteria easier. Smaller samples mean fewer cells, so lab techs can more swiftly separate the bacterial spectra from other components, like red blood cells and white blood cells.

To boost efficiency even more, the researchers added gold nanoparticles, which attach to the bacteria, serving like antennas to focus the light. Machine learning – a type of artificial intelligence – helps interpret the spectrum of light and identify which fingerprint goes with which bacteria.

“It kind of wound up being this really interesting historical period where we could put the pieces together from different technologies, including nanophotonics, printing, and artificial intelligence, to help accelerate identification of bacteria in these complex samples,” says study author Jennifer Dionne, PhD, associate professor of materials science and engineering at Stanford.

Compare that to blood culture testing in hospitals, where it takes days for bacterial cells to grow and multiply inside a large machine that looks like a refrigerator. For some bacteria, like the kinds that cause tuberculosis, cultures take weeks.

Then further testing is needed to identify which antibiotics will quell the infection. The new technology from Stanford could accelerate this process, too.

“The promise of our technique is that you don’t need to have a culture of cells to put the antibiotic on top,” says Dr. Dionne. “What we’re finding is that from the Raman scattering, we can use that to identify – even without incubating with antibiotics – which drug the bacteria would respond to, and that’s really exciting.”

If patients can receive the antibiotic best suited for their infection, they will likely have better outcomes.

“Blood cultures can typically take 48-72 hours to come back, and then you base your clinical decisions and adjusting antibiotics based on those blood cultures,” says Richard Watkins, MD, an infectious disease physician and professor of medicine at the Northeastern Ohio Universities, Rootstown. Dr. Watkins was not involved in the study.

“Sometimes, despite your best guess, you’re wrong,” Dr. Watkins says, “and obviously, the patient could have an adverse outcome. So, if you can diagnose the pathogen sooner, that is ideal. Whatever technology enables clinicians to do that is definitely progress and a step forward.”

On a global scale, this technology could help reduce the overuse of broad-spectrum antibiotics, which contributes to antimicrobial resistance, an emerging health threat, says Dr. Dionne.

The team is working to develop the technology further into an instrument the size of a shoebox and, with further testing, commercialize the product. That could take a few years.

This technology has potential beyond bloodstream infections, too. It could be used to identify bacteria in other fluids, such as in wastewater or contaminated food.

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

When a bacterial infection reaches the bloodstream, every second is critical. The person’s life is on the line. Yet blood tests to identify bacteria take hours to days. While waiting, doctors often prescribe broad-spectrum antibiotics in hopes of killing whatever bug may be at fault.

Someday soon, that wait time could shrink significantly, allowing health care providers to more quickly zero in on the best antibiotic for each infection – thanks to an innovation from Stanford (Calif.) University that identifies bacteria in seconds.

The cutting-edge method relies on old-school tech: an inkjet printer similar the kind you might have at home – except this one has been modified to print blood instead of ink.

This “bioprinter” spits out tiny drops of blood quickly – more than 1,000 per second. Shine a laser on the drops – using a light-based imaging technique called Raman spectroscopy – and the bacteria’s unique cellular “fingerprint” is revealed.

The very small sample size – each drop is two trillionths of a liter, or about a billion times smaller than a raindrop – make spotting bacteria easier. Smaller samples mean fewer cells, so lab techs can more swiftly separate the bacterial spectra from other components, like red blood cells and white blood cells.

To boost efficiency even more, the researchers added gold nanoparticles, which attach to the bacteria, serving like antennas to focus the light. Machine learning – a type of artificial intelligence – helps interpret the spectrum of light and identify which fingerprint goes with which bacteria.

“It kind of wound up being this really interesting historical period where we could put the pieces together from different technologies, including nanophotonics, printing, and artificial intelligence, to help accelerate identification of bacteria in these complex samples,” says study author Jennifer Dionne, PhD, associate professor of materials science and engineering at Stanford.

Compare that to blood culture testing in hospitals, where it takes days for bacterial cells to grow and multiply inside a large machine that looks like a refrigerator. For some bacteria, like the kinds that cause tuberculosis, cultures take weeks.

Then further testing is needed to identify which antibiotics will quell the infection. The new technology from Stanford could accelerate this process, too.

“The promise of our technique is that you don’t need to have a culture of cells to put the antibiotic on top,” says Dr. Dionne. “What we’re finding is that from the Raman scattering, we can use that to identify – even without incubating with antibiotics – which drug the bacteria would respond to, and that’s really exciting.”

If patients can receive the antibiotic best suited for their infection, they will likely have better outcomes.

“Blood cultures can typically take 48-72 hours to come back, and then you base your clinical decisions and adjusting antibiotics based on those blood cultures,” says Richard Watkins, MD, an infectious disease physician and professor of medicine at the Northeastern Ohio Universities, Rootstown. Dr. Watkins was not involved in the study.

“Sometimes, despite your best guess, you’re wrong,” Dr. Watkins says, “and obviously, the patient could have an adverse outcome. So, if you can diagnose the pathogen sooner, that is ideal. Whatever technology enables clinicians to do that is definitely progress and a step forward.”

On a global scale, this technology could help reduce the overuse of broad-spectrum antibiotics, which contributes to antimicrobial resistance, an emerging health threat, says Dr. Dionne.

The team is working to develop the technology further into an instrument the size of a shoebox and, with further testing, commercialize the product. That could take a few years.

This technology has potential beyond bloodstream infections, too. It could be used to identify bacteria in other fluids, such as in wastewater or contaminated food.

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

When a bacterial infection reaches the bloodstream, every second is critical. The person’s life is on the line. Yet blood tests to identify bacteria take hours to days. While waiting, doctors often prescribe broad-spectrum antibiotics in hopes of killing whatever bug may be at fault.

Someday soon, that wait time could shrink significantly, allowing health care providers to more quickly zero in on the best antibiotic for each infection – thanks to an innovation from Stanford (Calif.) University that identifies bacteria in seconds.

The cutting-edge method relies on old-school tech: an inkjet printer similar the kind you might have at home – except this one has been modified to print blood instead of ink.

This “bioprinter” spits out tiny drops of blood quickly – more than 1,000 per second. Shine a laser on the drops – using a light-based imaging technique called Raman spectroscopy – and the bacteria’s unique cellular “fingerprint” is revealed.

The very small sample size – each drop is two trillionths of a liter, or about a billion times smaller than a raindrop – make spotting bacteria easier. Smaller samples mean fewer cells, so lab techs can more swiftly separate the bacterial spectra from other components, like red blood cells and white blood cells.

To boost efficiency even more, the researchers added gold nanoparticles, which attach to the bacteria, serving like antennas to focus the light. Machine learning – a type of artificial intelligence – helps interpret the spectrum of light and identify which fingerprint goes with which bacteria.

“It kind of wound up being this really interesting historical period where we could put the pieces together from different technologies, including nanophotonics, printing, and artificial intelligence, to help accelerate identification of bacteria in these complex samples,” says study author Jennifer Dionne, PhD, associate professor of materials science and engineering at Stanford.

Compare that to blood culture testing in hospitals, where it takes days for bacterial cells to grow and multiply inside a large machine that looks like a refrigerator. For some bacteria, like the kinds that cause tuberculosis, cultures take weeks.

Then further testing is needed to identify which antibiotics will quell the infection. The new technology from Stanford could accelerate this process, too.

“The promise of our technique is that you don’t need to have a culture of cells to put the antibiotic on top,” says Dr. Dionne. “What we’re finding is that from the Raman scattering, we can use that to identify – even without incubating with antibiotics – which drug the bacteria would respond to, and that’s really exciting.”

If patients can receive the antibiotic best suited for their infection, they will likely have better outcomes.

“Blood cultures can typically take 48-72 hours to come back, and then you base your clinical decisions and adjusting antibiotics based on those blood cultures,” says Richard Watkins, MD, an infectious disease physician and professor of medicine at the Northeastern Ohio Universities, Rootstown. Dr. Watkins was not involved in the study.

“Sometimes, despite your best guess, you’re wrong,” Dr. Watkins says, “and obviously, the patient could have an adverse outcome. So, if you can diagnose the pathogen sooner, that is ideal. Whatever technology enables clinicians to do that is definitely progress and a step forward.”

On a global scale, this technology could help reduce the overuse of broad-spectrum antibiotics, which contributes to antimicrobial resistance, an emerging health threat, says Dr. Dionne.

The team is working to develop the technology further into an instrument the size of a shoebox and, with further testing, commercialize the product. That could take a few years.

This technology has potential beyond bloodstream infections, too. It could be used to identify bacteria in other fluids, such as in wastewater or contaminated food.

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

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

Dr. Amani Meaidi

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.

“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
 

The study

Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.

Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.

During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.

In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.

Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.

The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
 

An outsider’s perspective

Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.

Northwell Health

Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.

Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”

Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

Dr. Amani Meaidi

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.

“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
 

The study

Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.

Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.

During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.

In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.

Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.

The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
 

An outsider’s perspective

Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.

Northwell Health

Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.

Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”

Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
 

Researchers report that use of any levonorgestrel-releasing intrauterine system was associated with a significantly increased risk of ectopic pregnancy, compared with other hormonal contraceptives, in a study published in JAMA.

Dr. Amani Meaidi

A national health database analysis headed by Amani Meaidi, MD, PhD, of the Danish Cancer Society Research Center, Cancer Surveillance and Pharmacoepidemiology, in Copenhagen, compared the 13.5-mg with the 19.5-mg and 52-mg dosages of levonorgestrel-releasing intrauterine systems (IUSs).

The hormone content in levonorgestrel-releasing IUSs must be high enough to maintain optimal contraceptive effect but sufficiently low to minimize progestin-related adverse events, Dr. Meaidi and colleagues noted; they advised using the middle dosage of 19.5 mg. All dosages are recommended for contraception, with the highest dosage also recommended for heavy menstrual bleeding.

“If 10,000 women using the hormonal IUD for 1 year were given the 19.5-mg hormonal IUD instead of the 13.5-mg hormonal IUD, around nine ectopic pregnancies would be avoided,” Dr. Meaidi said in an interview.

“Ectopic pregnancy is an acknowledged adverse event of hormonal IUD use. Although a rare event, it is a serious one, and a difference in ectopic pregnancy safety between the two low-dose hormonal IUDs would impact my recommendations to women.”
 

The study

Dr. Meaidi’s group followed 963,964 women for 7.8 million person-years. For users of levonorgestrel IUS dosages 52 mg, 19.5 mg, and 13.5 mg, and other hormonal contraceptives, the median ages were 24, 22, 22, and 21 years, respectively.

Eligible women were nulliparous with no previous ectopic pregnancy, abdominal or pelvic surgery, infertility treatment, endometriosis, or use of a levonorgestrel IUS. They were followed from Jan. 1, 2001, or their 15th birthday, until July 1, 2021, age 35, pregnancy, death, emigration, or the occurrence of any exclusion criterion.

During the study period, the cohort registered 2,925 ectopic pregnancies, including 35 at 52 mg, 32 at 19.5 mg, and 80 at 13.5 mg of levonorgestrel. For all other types of hormonal contraception, there were 763 ectopic pregnancies.

In terms of adjusted absolute rates of ectopic pregnancy per 10,000 person-years, compared with other hormonal contraceptives (rate = 2.4), these were 7.7 with 52 mg levonorgestrel IUS, 7.1 with 19.5 mg, and 15.7 with 13.5 mg. They translated to comparative differences of 5.3 (95% confidence interval, 1.9-8.7), 4.8 (95% CI, 1.5-8.0), and 13.4 (95% CI, 8.8-18.1), respectively.

Corresponding adjusted relative rate ratios were 3.4, 4.1, and 7.9. For each levonorgestrel IUS dosage; the ectopic pregnancy rate increased with duration of use.

The adjusted ectopic pregnancy rate difference per 10,000 person-years between the 19.5-mg and 52-mg levonorgestrel dosages was −0.6 , and between the 13.5-mg and 52-mg doses, 8.0, with a rate ratio of 2.3. The rate difference between the 13.5-mg and 19.5-mg levonorgestrel IUS was 8.6, with a rate ratio of 1.9.
 

An outsider’s perspective

Offering an outsider’s perspective on the study, Eran Bornstein, MD, vice-chair of obstetrics and gynecology at Lenox Hill Hospital in New York, said these data should spark further evaluation of risk of ectopic pregnancy with levonorgestrel-releasing IUDs. “The best advice for clinicians is to individualize the choice of which contraceptive to use, and when levonorgestrel IUD is selected, to individualize the appropriate dose and timing of placement,” he said in an interview.

Northwell Health

Several additional factors may determine the best choice, Dr. Bornstein added, including medical conditions that contraindicate other contraceptives and those conditions that justify avoidance of pregnancy, as well as uterine myomas or malformation, the ability of the patient to comply with other options, and informed patient choice. “It is important to remember the potential risk for expulsion and ectopic pregnancy, maintain alertness, and use ultrasound to exclude these potential complications if suspected,” he said.

Dr. Meaidi said the mechanism of ectopic pregnancy with hormonal IUDs is unclear, but in vitro and animal studies have observed that levonorgestrel reduces the ciliary beat frequency in the fallopian tubes. “Thus, it could be hypothesized that if a woman was unfortunate enough to become pregnant using a hormonal IUD, the hormone could inhibit or slow down the movement of the zygote into the uterus for rightful intrauterine implantation and thereby increase the risk of ectopic pregnancy.”

Two coauthors of the study reported financial support from private-sector companies. Dr. Meaidi had no conflicts of interest. Dr. Bornstein disclosed no competing interests.
 

NEW ORLEANS – Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”

Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

NEW ORLEANS – Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”

Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

NEW ORLEANS – Nemolizumab monotherapy for 16 weeks improved itch, skin lesions, and sleep disturbances in adults with prurigo nodularis (PN), results from a phase 3 trial demonstrated.

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the interleukin-31 receptor alpha that blocks signaling from IL-31. “From prior studies we know that it modulates pruritus, but also alters keratinocyte differentiation, inflammation, and fibrosis,” one of the investigators, Shawn G. Kwatra, MD, of the department of dermatology, Johns Hopkins University, Baltimore, said during a late-breaking research session at the annual meeting of the American Academy of Dermatology.

OLYMPIA 2 was a phase 3, multicenter, double-blind study in adults with PN presenting with 20 or more nodules, and Investigator’s Global Assessment (IGA) score of 3 or more, and the Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7 or more. Exclusion criteria included chronic pruritus resulting from an active condition other than PN, such as neuropathic and psychogenic pruritus and active atopic dermatitis. In addition, the use of topical steroids, considered a rescue therapy, was not allowed in the trial, Dr. Kwatra said.

After an initial screening period, 274 patients at 73 sites in nine countries were randomized 2:1 either to the nemolizumab monotherapy or placebo. Following an initial 60-mg subcutaneous dose, patients received 30 mg or 60 mg (depending on their baseline weight) every 4 weeks for 16 weeks. The primary endpoint was the proportion of patients with a 4-point or greater improvement in the PP-NRS from baseline at week 16 and the proportion of patients with IGA success at week 16.

Selected key secondary endpoints included the proportion of patients with a 4 point or greater improvement from baseline in the PP-NRS at week 4, the Sleep Disturbance Numerical Rating Scale at week 4, and the SD-NRS at week 16. Safety endpoints included the incidence and severity of all adverse events.

Of the 274 patients randomized, 183 received nemolizumab and 91 received placebo. A total of 174 patients in the nemolizumab group completed the study, compared with 88 in the placebo group. The mean age of study participants was 53 years, 61% were women, 79% were White, 14% were Asian, and the rest were from other racial groups. More than half (57%) had IGA category 3 disease (moderate) and the remainder had IGA category 4 disease (severe); 63% had 20-100 lesions, and the remainder had more than 100. About one-third of study enrollees (32%) had a history of atopy.
 

Primary, secondary endpoint results

Dr. Kwatra reported that 56.3% of the patients in the nemolizumab group achieved a 4-point or greater improvement in the PP-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001), while 37.7% of those in the nemolizumab group achieved IGA success at week 16, compared with 11% of those in the placebo group (P < .0001).

As for secondary endpoints, 41% of patients in the nemolizumab group achieved a 4-point or greater improvement in PP-NRS at week 4, compared with 7.7% of those in the placebo group (P < .0001); and 37.2% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 4, compared with 9.9% of those in the placebo group (P < .0001). Almost 52% of patients in the nemolizumab group achieved a 4-point or greater improvement in SD-NRS at week 16, compared with 20.9% of those in the placebo group (P < .0001); and 9.8% of those in the nemolizumab group achieved IGA success at week 4, compared with 1.1% of those in the placebo group (P < .0074).
 

Adverse events

Treatment-emergent adverse events occurred in 61.2% of subjects in the nemolizumab group, compared with 52.7% of those in the placebo group. “There were no imbalances overall, [including] no injection-related reactions in either group,” Dr. Kwatra said. There was one case of newly diagnosed asthma in the placebo arm, and none in the treatment arm.

The researchers observed a slightly increased onset of atopic dermatitis in the treatment arm, compared with the placebo arm (5.5% vs. 0%). “Seven out of those 10 patients actually had a history of atopic dermatitis or high IgE [levels] and they were mostly managed with topical steroids without study drug discontinuation,” Dr. Kwatra added. Neurodermatitis, or worsening of PN, occurred in 3.8% of patients in the nemolizumab group, compared with 11% of those in the placebo group.

“The results of this study extend the efficacy and safety findings from the phase 2 study of nemolizumab in patients with PN,” Dr. Kwatra concluded. “I think they also help to usher in a new era of PN [treatment] in prime time.”

Kenneth B. Gordon, MD, who chairs the department of dermatology at the Medical College of Wisconsin, Milwaukee, and was asked to comment on the study, was impressed with nemolizumab’s propensity for blocking IL-31. “To be able to treat PN effectively by simply blocking the itch and not having a significant inflammatory function is really interesting,” he said in an interview at the meeting. If approved, nemolizumab “gives us another treatment option for a disease that is really debilitating. It’s very promising and we hope [the drug] will be available to us in the near future.”

Nemolizumab is being developed by Galderma. According to a press release from the company, nemolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration in December 2019 for the treatment of pruritus associated with PN, a status that was reconfirmed in February 2023.

Dr. Kwatra disclosed that he is an advisory board member/consultant for Galderma, AbbVie, Amgen, Arcutis, ASLAN Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Celldex, Incyte, Johnson and Johnson, Leo Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Gordon disclosed that he is a consultant to, an investigator for, and/or a member of the advisory board for several pharmaceutical companies, but not Galderma.

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

If a patient’s prostate-specific antigen (PSA) spikes 2 points in just 90 days, what is your first thought? This patient has a strong likelihood of aggressive prostate cancer, right? If that same patient also presents with severe, burning bone pain with no precipitating trauma to the area and rest and over-the-counter  painkillers are not helping, you’d think, “check for metastases,” right?

That patient was me in late January 2023.

As a research scientist member of the American Urological Association, I knew enough to know I had to consult my urologist ASAP.

With the above symptoms, I’ll admit I was scared. Fortunately, if that’s the right word, I was no stranger to a rapid, dramatic spike in PSA. In 2021 I was temporarily living in a new city, and I wanted to form a relationship with a good local urologist. The urologist that I was referred to gave me a thorough consultation, including a vigorous digital rectal exam (DRE) and sent me across the street for a blood draw.

To my shock, my PSA had spiked over 2 points, to 9.9 from 7.8 a few months earlier. I freaked. Had my 3-cm tumor burst out into an aggressive cancer? Research on PubMed provided an array of studies showing what could cause PSA to suddenly rise, including a DRE performed 72 hours before the blood draw.1 A week later, my PSA was back down to its normal 7.6. 

But in January 2023, I had none of those previously reported experiences that could suddenly trigger a spike in PSA, like a DRE or riding on a thin bicycle seat for a few hours before the lab visit. 
 

The COVID effect

I went back to PubMed and found a new circumstance that could cause a surge in PSA: COVID-19. A recent study² of 91 men with benign prostatic hypertrophy by researchers in Turkey found that PSA spiked from 0 to 5 points during the COVID infection period and up to 2 points higher 3 months after the infection had cleared. I had tested positive for COVID-19 in mid-December 2022, 4 weeks before my 9.9 PSA reading.

Using Google translate, I communicated with the team in Turkey and found out that the PSA spike can last up to 6 months.

That study helps explain why my PSA dropped over 1.5 points to 8.5 just 2 weeks after the 9.9 reading, with the expectation that it would return to its previous normal of 7.8 within 6 months of infection with SARS-CoV-2. To be safe, my urologist scheduled another PSA test in May, along with an updated multiparametric MRI, which may be followed by an in-bore MRI-guided biopsy of the 3-cm tumor if the mass has enlarged.
 

COVID-19 pain

What about my burning bone pain in my upper right humerus and right rotator cuff that was not precipitated by trauma or strain? A radiograph found no evidence of metastasis, thank goodness. And my research showed that several studies³ have found that COVID-19 can cause burning musculoskeletal pain, including enthesopathy, which is what I had per the radiology report. So my PSA spike and searing pain were likely consequences of the infection.

To avoid the risk for a gross misdiagnosis after a radical spike in PSA, the informed urologist should ask the patient if he has had COVID-19 in the previous 6 months. Overlooking that question could lead to the wrong diagnostic decisions about a rapid jump in PSA or unexplained bone pain.

References

1. Bossens MM et al. Eur J Cancer. 1995;31A:682-5.

2. Cinislioglu AE et al. Urology. 2022;159:16-21.

3. Ciaffi J et al. Joint Bone Spine. 2021;88:105158.

Dr. Keller is founder of the Keller Research Institute, Jacksonville, Fla. He reported serving as a research scientist for the American Urological Association, serving on the advisory board of Active Surveillance Patient’s International, and serving on the boards of numerous nonprofit organizations.

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

Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m².

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m².

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

Girls between 4 and 9 years old were more likely to have high fat mass and a high body mass index if their mothers had excess adiposity – but this relationship was not seen between mothers and sons, or between fathers and sons or daughters, in a new study.

The researchers measured fat mass, lean mass, and BMI in the sons and daughters when they were age 4 (before a phenomenon known as “adiposity rebound”), ages 6-7 (around the adiposity rebound), and ages 8-9 (before or at the onset of puberty).

They also obtained measurements from the mothers and fathers when the offspring were ages 8-9.

The group found “a strong association between the fat mass of mothers and their daughters but not their sons,” Rebecca J. Moon, BM, PhD, and colleagues report.

“It would be important to establish persistence through puberty,” according to the researchers, “but nonetheless, these findings are clinically important, highlighting girls who are born to mothers with high BMI and excess adiposity are at high risk of themselves of becoming overweight/obese or having unfavorable body composition early in childhood.”

The mother-daughter relationship for fat mass appears to be established by age 4 years, note Dr. Moon, of the MRC Lifecourse Epidemiology Centre, University of Southampton (England), and colleagues.

Therefore, “early awareness and intervention is needed in mothers with excess adiposity, and potentially beginning even in the periconception and in utero period.”

Because 97% of the mothers and fathers were White, the findings may not be generalizable to other populations, they caution.

The results, from the Southampton Women’s Survey prospective cohort study, were published online  in the Journal of Clinical Endocrinology & Metabolism.
 

One of the first studies to look at fat mass, not just BMI

Children with overweight or obesity are more likely to have excess weight in adulthood that puts them at risk of developing type 2 diabetes, cardiovascular disease, cancer, and osteoarthritis. Previous research has reported that children with overweight or obesity were more likely to have mothers with adiposity.

However, most prior studies have looked at BMI alone and did not measure fat mass, and it was not known how a father’s obesity might affect offspring or how risk may differ in boy versus girl children.

Researchers analyzed data from a subset of participants in the Southampton Women’s Survey of 3,158 women who were aged 20-34 in 1998-2002 and delivered a liveborn infant.

The current study included 240 mother-father-offspring trios who had data for BMI and dual-energy X-ray absorptiometry (DXA) scans (whole body less head).

Mothers were a mean age of 31 years at delivery and had a median pre-pregnancy BMI of 23.7 kg/m².

The offspring were 129 boys (54%) and 111 girls.

The offspring had DXA scans at ages 4, 6-7, and 8-9 years, and the mothers and fathers had a DXA scan at the last time point.

At ages 6-7 and ages 8-9, BMI and fat mass of the girls reflected that of their mothers (a significant association).

At age 4, BMI and fat mass of the daughters tended to be associated with that of their mothers, but the 95% confidence interval crossed zero.

There were no significant mother-son, father-son, or father-daughter associations for BMI or fat mass at each of the three studied ages.

The study received funding from the Medical Research Council, the British Heart Foundation, the National Institute for Health and Care Research Southampton Biomedical Research Centre, the NIHR Oxford Biomedical Research Centre, the Seventh Framework Program, the Biotechnology and Biological Sciences Research Council, the Horizon 2020 Framework Program, and the National Institute on Aging. Dr. Moon has reported receiving travel bursaries from Kyowa Kirin unrelated to the current study. Disclosures for the other authors are listed with the article.

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

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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

Patients who are already depressed before they receive a lung cancer diagnosis are more likely to have a worse overall survival (OS), and the driver for this may be inflammation, suggests a new study.

The findings underscore the importance of assessing and treating depression in patients with cancer, particularly given the high rate of depression among those with lung cancer versus other types of cancer, the investigators said.

The study involved 186 patients with newly diagnosed stage IV non–small cell lung cancer (NSCLC), of whom 35% had self-reported moderate to severe depressive symptoms.

Depression was reliably associated with lung-relevant systemic inflammation responses (SIRs), which included neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and Advanced Lung Cancer Inflammation Index (ALI) score.

These SIRs were prognostic for 2-year OS.

Overall mortality at 2 years was 61%. Higher NLRs and PLRs and lower ALI scores all predicted worse OS (hazard ratio, 1.91, 2.08, and 0.53, respectively).

The findings were published online in PLoS ONE (2023 Feb 24.

“These patients with high levels of depression are at much higher risk for poor outcomes,” but the key finding was that patients with the highest depression levels were driving the relationship, lead author Barbara Andersen, PhD, professor of psychology at Ohio State University, Columbus, stated in a press release.

“It was patients with high depression levels who had strikingly higher inflammation levels, and that is what really drove the correlation we saw,” she explained.

For example, 56% of patients with no depression symptoms or only mild depression symptoms had a PLR above the cutoff for dangerous levels of inflammation, compared with 42% whose PLR was below the cutoff. However, among those with high depression levels, 77% and 23% had a PLR above and below the cutoff, respectively.

“These highly depressed patients were 1.3-3 times more likely to have high inflammation levels, even after controlling for other factors related to inflammation biomarker levels, including demographics and smoking status,” Dr. Andersen noted.

“Depression levels may be as important or even more important than other factors that have been associated with how people fare with lung cancer,” she suggested.

In a previous study, the team controlled for baseline depression and found that “the trajectory of depression from diagnosis through 2 years (18 assessments) predicted NSCLC patients’ survival (HR, 1.09), above and beyond baseline depression, sociodemographics, smoking status, cell type, and receipt of targeted treatments and immunotherapies.”

“Taken together, data support psychological, behavioral, and biologic toxicities of depression capable of influencing treatment response and/or survival,” they wrote.

“The results may help explain why a substantial portion of lung cancer patients fail to respond to new immunotherapy and targeted treatments that have led to significantly longer survival for many people with the disease,” Dr. Andersen said.

The investigators concluded that “intensive study of depression among patients with NSCLC, combined with measures of cell biology, inflammation, and immunity, is needed to extend these findings and discover their mechanisms, with the long-term aim to improve patients’ quality of life, treatment responses, and longevity.”

This study was funded by the Ohio State University Comprehensive Cancer Center and Pelotonia through grants to individual authors. Dr. Andersen reported having no relevant disclosures.

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

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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

As chair of the Arkansas State Medical Board, Brian T. Hyatt, MD, often sat in judgment of other physicians. Now, state officials are investigating the psychiatrist for alleged Medicaid fraud. He has stepped down as board chair, and state officials have suspended all Medicaid payments to Dr. Hyatt and his practice, Pinnacle Premier Psychiatry in Rogers, Arkansas.

Dr. Hyatt billed 99.95% of the claims for his patients’ hospital care to Medicaid at the highest severity level, according to an affidavit filed by an investigator with the Medicaid Fraud Control Unit, Arkansas Attorney General’s Office. Other Arkansas psychiatrists billed that same level in only about 39% of claims, the affidavit states.

The possible upcoding alleged in the affidavit was a red flag that prompted the state to temporarily suspend Dr. Hyatt’s Medicaid payments.

Dr. Hyatt has until this Friday to file an appeal. He did not respond to requests from this news organization for comment.

The affidavit pointed to other concerns. For example, a whistleblower who worked at the Northwest Medical Center where Dr. Hyatt admitted patients claimed that Dr. Hyatt was only on the floor a few minutes a day and that he had no contact with patients. A review of hundreds of hours of video by state investigators revealed that Dr. Hyatt did not enter patients’ rooms, nor did he have any contact with patients, according to the affidavit. Dr. Hyatt served as the hospital’s behavioral unit director from 2018 until his contract was abruptly terminated in May 2022, according to the affidavit.

However, Dr. Hyatt claimed to have conducted daily face-to-face evaluation and management with patients, according to the affidavit. In addition, the whistleblower claimed that Dr. Hyatt did not want patients to know his name and instructed staff to cover up his name on patient armbands.
 

Detaining patients

Dr. Hyatt also faces accusations that he held patients against their will, according to civil lawsuits filed in Washington County, Ark., reports the Arkansas Advocate. 

Karla Adrian-Caceres filed suit on Jan. 17. Ms. Adrian-Caceres also named Brooke Green, Northwest Arkansas Hospitals, and 25 unidentified hospital employees as defendants.

According to the complaint, Ms. Adrian-Caceres, an engineering student at the University of Arkansas, arrived at the Northwest Medical Emergency Department after accidentally taking too many Tylenol on Jan. 18, 2022. She was then taken by ambulance to a Northwest psychiatric facility in Springdale, court records show.

According to the complaint, Ms. Adrian-Caceres said that she was given a sedative and asked to sign consent for admission while on the way to Northwest. She said that she “signed some documents without being able to read or understand them at the time.”

When she asked when she could go home, Ms. Adrian-Caceres said, “more than one employee told her there was a minimum stay and that if she asked to leave, they would take her to court where a judge would give her a longer stay because the judge always sides with Dr. Hyatt and Northwest,” according to court documents. Northwest employees stripped Ms. Adrian-Caceres, searched her body, took all of her possessions from her and issued underwear and a uniform, according to the lawsuit.

Ms. Adrian-Caceres’ mother, Katty Caceres, claimed in the lawsuit that she was prohibited from seeing her daughter. Ms. Caceres spoke with five different employees, four of whom had only their first names on their badges. Each of them reportedly said that they could not help, or that the plaintiff “would be in there for some time” and that it was Dr. Hyatt’s decision regarding how long that would be, according to court documents.

Katty Caceres hired a local attorney named Aaron Cash to represent her daughter. On Jan. 20, 2022, Mr. Cash faxed a letter to the hospital demanding her release. When Ms. Caceres arrived to pick up her daughter, she claimed that staff members indicated that the daughter was there voluntarily and refused to release her “at the direction of Dr Hyatt.” During a phone call later that day, the plaintiff told her mother that her status was being changed to an involuntary hold, court documents show.

“At one point she was threatened with the longer time in there if she kept asking to leave,” Mr. Cash told this news organization. In addition, staff members reportedly told Ms. Adrian-Caceres that the “judge always sided with Dr Hyatt” and she “would get way longer there, 30-45 days if [she] went before the judge,” according to Mr. Cash.

Mr. Cash said nine other patients have contacted his firm with similar allegations against Dr. Hyatt.

“We’ve talked to many people that have experienced the same threats,” Mr. Cash said. “When they’re asking to leave, they get these threats, they get coerced … and they’re never taken to court. They’re never given opportunity to talk to a judge or to have a public defender appointed.”
 

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