Q)What exactly is the difference between the protein-to-creatinine ratio and the microalbumin in the lab report? How do they compare?

For the non-nephrology provider, the options for evaluating urine protein or albumin can seem confusing. The first thing to understand is the importance of assessing for proteinuria, an established marker for chronic kidney disease (CKD). Higher protein levels are associated with more rapid progression of CKD to end-stage renal disease and increased risk for cardiovascular events and mortality in both the nondiabetic and diabetic populations. Monitoring proteinuria levels can also aid in evaluating response to treatment.¹

Proteinuria and albuminuria are not the same thing. Proteinuria indicates an elevated presence of protein in the urine (normal excretion should be < 150 mg/d), while albuminuria is defined as an “abnormal loss of albumin in the urine.”¹ Albumin is a type of plasma protein normally found in the urine in very small quantities. Albuminuria is a very common (though not universal) finding in CKD patients; is the earliest indicator of glomerular diseases, such as diabetic glomerulosclerosis; and is typically present even before a decrease in the glomerular filtration rate (GFR) or a rise in the serum creatinine.¹

Albuminuria, without or with a reduction in estimated GFR (eGFR), lasting > 3 months is considered a marker of kidney damage. There are 3 categories of persistent albuminuria (see Table).¹ Staging of CKD depends on both the eGFR and the albuminuria category; the results affect treatment considerations.

While there are several ways to assess for proteinuria, their accuracy varies. The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guideline on the evaluation and management of CKD recommends the spot urine albumin-to-creatinine ratio (UACR) as the preferred test for both initial and follow-up testing. While the UACR is typically reported as mg/g, it can also be reported in mg/mmol.¹ Other options include the spot urine protein-to-creatinine ratio (UPCR) and a manual reading of a reagent strip (urine dipstick test) for total protein. Only if the first 2 choices are unavailable should a provider consider using a dipstick.

Reagent strip urinalysis may assess for protein or more specifically for albumin; tests for the latter are becoming more common. These tests are often used in a clinic setting, with results typically reported in the protein testing section. It is important to know which reagent strip urinalysis you are using (protein vs albumin) and how this is being reported. Additionally, test results depend on the urine concentration: Concentrated samples are more likely to indicate higher levels than may actually be present, while dilute samples may test negative (or positive for a trace amount) when in reality higher levels are present.

If a reagent strip urinalysis tests positive for protein, confirmatory testing is recommended using the UACR or the UPCR (if the former is not an option). A 24-hour urine screen for total protein excretion or an albumin excretion rate can be obtained if there are concerns about the accuracy of the previously discussed tests. A urine albumin excretion rate ≥ 30 mg/24 h corresponds to a UACR of ≥ 30 mg/g (≥ 3 mg/mmol).¹ Although 24-hour urine has been considered the gold standard, it is used less frequently today due to potential for improper sample collection, which can negatively affect accuracy, and inconvenience to patients.²

As a final note, if there is suspicion for nonalbumin proteinuria (eg, when increased plasma levels of low-molecular-weight proteins or immunoglobulin light chains are present), testing for specific urine proteins is recommended. This can include assessment with urine protein electrophoresis.¹­ —CS

Cynthia A. Smith, DNP, CNN-NP, FNP-BC, APRN, FNKF
Renal Consultants, PLLC, South Charleston, West Virginia

Q)What exactly is the difference between the protein-to-creatinine ratio and the microalbumin in the lab report? How do they compare?

For the non-nephrology provider, the options for evaluating urine protein or albumin can seem confusing. The first thing to understand is the importance of assessing for proteinuria, an established marker for chronic kidney disease (CKD). Higher protein levels are associated with more rapid progression of CKD to end-stage renal disease and increased risk for cardiovascular events and mortality in both the nondiabetic and diabetic populations. Monitoring proteinuria levels can also aid in evaluating response to treatment.¹

Proteinuria and albuminuria are not the same thing. Proteinuria indicates an elevated presence of protein in the urine (normal excretion should be < 150 mg/d), while albuminuria is defined as an “abnormal loss of albumin in the urine.”¹ Albumin is a type of plasma protein normally found in the urine in very small quantities. Albuminuria is a very common (though not universal) finding in CKD patients; is the earliest indicator of glomerular diseases, such as diabetic glomerulosclerosis; and is typically present even before a decrease in the glomerular filtration rate (GFR) or a rise in the serum creatinine.¹

Albuminuria, without or with a reduction in estimated GFR (eGFR), lasting > 3 months is considered a marker of kidney damage. There are 3 categories of persistent albuminuria (see Table).¹ Staging of CKD depends on both the eGFR and the albuminuria category; the results affect treatment considerations.

While there are several ways to assess for proteinuria, their accuracy varies. The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guideline on the evaluation and management of CKD recommends the spot urine albumin-to-creatinine ratio (UACR) as the preferred test for both initial and follow-up testing. While the UACR is typically reported as mg/g, it can also be reported in mg/mmol.¹ Other options include the spot urine protein-to-creatinine ratio (UPCR) and a manual reading of a reagent strip (urine dipstick test) for total protein. Only if the first 2 choices are unavailable should a provider consider using a dipstick.

Reagent strip urinalysis may assess for protein or more specifically for albumin; tests for the latter are becoming more common. These tests are often used in a clinic setting, with results typically reported in the protein testing section. It is important to know which reagent strip urinalysis you are using (protein vs albumin) and how this is being reported. Additionally, test results depend on the urine concentration: Concentrated samples are more likely to indicate higher levels than may actually be present, while dilute samples may test negative (or positive for a trace amount) when in reality higher levels are present.

If a reagent strip urinalysis tests positive for protein, confirmatory testing is recommended using the UACR or the UPCR (if the former is not an option). A 24-hour urine screen for total protein excretion or an albumin excretion rate can be obtained if there are concerns about the accuracy of the previously discussed tests. A urine albumin excretion rate ≥ 30 mg/24 h corresponds to a UACR of ≥ 30 mg/g (≥ 3 mg/mmol).¹ Although 24-hour urine has been considered the gold standard, it is used less frequently today due to potential for improper sample collection, which can negatively affect accuracy, and inconvenience to patients.²

As a final note, if there is suspicion for nonalbumin proteinuria (eg, when increased plasma levels of low-molecular-weight proteins or immunoglobulin light chains are present), testing for specific urine proteins is recommended. This can include assessment with urine protein electrophoresis.¹­ —CS

Cynthia A. Smith, DNP, CNN-NP, FNP-BC, APRN, FNKF
Renal Consultants, PLLC, South Charleston, West Virginia

Q)What exactly is the difference between the protein-to-creatinine ratio and the microalbumin in the lab report? How do they compare?

For the non-nephrology provider, the options for evaluating urine protein or albumin can seem confusing. The first thing to understand is the importance of assessing for proteinuria, an established marker for chronic kidney disease (CKD). Higher protein levels are associated with more rapid progression of CKD to end-stage renal disease and increased risk for cardiovascular events and mortality in both the nondiabetic and diabetic populations. Monitoring proteinuria levels can also aid in evaluating response to treatment.¹

Proteinuria and albuminuria are not the same thing. Proteinuria indicates an elevated presence of protein in the urine (normal excretion should be < 150 mg/d), while albuminuria is defined as an “abnormal loss of albumin in the urine.”¹ Albumin is a type of plasma protein normally found in the urine in very small quantities. Albuminuria is a very common (though not universal) finding in CKD patients; is the earliest indicator of glomerular diseases, such as diabetic glomerulosclerosis; and is typically present even before a decrease in the glomerular filtration rate (GFR) or a rise in the serum creatinine.¹

Albuminuria, without or with a reduction in estimated GFR (eGFR), lasting > 3 months is considered a marker of kidney damage. There are 3 categories of persistent albuminuria (see Table).¹ Staging of CKD depends on both the eGFR and the albuminuria category; the results affect treatment considerations.

While there are several ways to assess for proteinuria, their accuracy varies. The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guideline on the evaluation and management of CKD recommends the spot urine albumin-to-creatinine ratio (UACR) as the preferred test for both initial and follow-up testing. While the UACR is typically reported as mg/g, it can also be reported in mg/mmol.¹ Other options include the spot urine protein-to-creatinine ratio (UPCR) and a manual reading of a reagent strip (urine dipstick test) for total protein. Only if the first 2 choices are unavailable should a provider consider using a dipstick.

Reagent strip urinalysis may assess for protein or more specifically for albumin; tests for the latter are becoming more common. These tests are often used in a clinic setting, with results typically reported in the protein testing section. It is important to know which reagent strip urinalysis you are using (protein vs albumin) and how this is being reported. Additionally, test results depend on the urine concentration: Concentrated samples are more likely to indicate higher levels than may actually be present, while dilute samples may test negative (or positive for a trace amount) when in reality higher levels are present.

If a reagent strip urinalysis tests positive for protein, confirmatory testing is recommended using the UACR or the UPCR (if the former is not an option). A 24-hour urine screen for total protein excretion or an albumin excretion rate can be obtained if there are concerns about the accuracy of the previously discussed tests. A urine albumin excretion rate ≥ 30 mg/24 h corresponds to a UACR of ≥ 30 mg/g (≥ 3 mg/mmol).¹ Although 24-hour urine has been considered the gold standard, it is used less frequently today due to potential for improper sample collection, which can negatively affect accuracy, and inconvenience to patients.²

As a final note, if there is suspicion for nonalbumin proteinuria (eg, when increased plasma levels of low-molecular-weight proteins or immunoglobulin light chains are present), testing for specific urine proteins is recommended. This can include assessment with urine protein electrophoresis.¹­ —CS

Cynthia A. Smith, DNP, CNN-NP, FNP-BC, APRN, FNKF
Renal Consultants, PLLC, South Charleston, West Virginia

The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.

FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.

While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.

According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.

The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.

“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.

Find the full press release on the Janssen website.

[email protected]

The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.

FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.

While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.

According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.

The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.

“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.

Find the full press release on the Janssen website.

[email protected]

The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.

FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.

While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.

According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.

The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.

“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.

Find the full press release on the Janssen website.

[email protected]

When Shawnté James, MD, picked up the phone at work recently, a male physician on the other end was calling for a peer-to-peer review of a patient’s insurance issue.

“Hi, this is Dr. Y, calling to speak with Shawnté about patient X. Is she available?” asked the physician. “No,” replied Dr. James, an assistant professor of pediatrics at MedStar Georgetown University Hospital, Washington. 

She related the rest of the interaction in a recent tweet:

“I’m Dr. XY calling a peer-to-peer review of a denial. Is Shawnté available?”

Me: “No.”

Him: “Is she in today?”

Me: “There’s no Shawnté here.”

Him: “Oh this is the number I have for Dr. Shawnté James”

Me: “Oh, DR. JAMES. Yes, that’s me. How can I help?”#MyFirstNameIsDoctor

— Shawnté James (@ShawnteJamesMD) October 10, 2019

The tweet, along with many others that used the hashtag #MyFirstNameIsDoctor, struck a chord among female physicians on Twitter. In tweets of their own, they related instance after instance of peers, coworkers, and patients assuming first-name familiarity with them – but not their male colleagues.

“This time it’s a peer-to-peer review. Last time it was being introduced to new hospital leadership as, ‘Shawnté, one of our pediatricians,’ ” Dr. James said in an interview. “The truth is, for physician women – particularly women of color – this is a regular occurrence.”
 

Data show an ongoing problem

Objective evidence that female physicians and scientists are significantly less likely than their male peers to be addressed by their titles came in a just-published study of presentations at the annual meeting of the American Society for Clinical Oncology in 2017 and 2018.

Narjust Duma, MD, the study’s first author, described her growing awareness of the problem.

Dr. Duma recalled a session on the last day of the ASCO 2018 meeting. Five presenters were speaking – four men and a woman. “The woman is the one who knows the most about this subject. She’s the only one at the table who’s a full professor,” Dr. Duma, assistant professor of hematology/oncology at the University of Wisconsin–Madison, said in an interview. “And then everybody is introduced as ‘Dr. So-and-so,’ and when they come to her, they introduce her as ‘Julie.’ ”

“Is it just me?” Dr. Duma asked herself. The same day, she began a Twitter poll to ask whether her female peers were experiencing this phenomenon, and got an “overwhelming” response.

“We need data to learn the extent of the problem,” she said she realized.

The ASCO annual meeting afforded an ideal opportunity for data gathering, said Dr. Duma, because presentations are recorded and written transcripts generated. Dr. Duma assembled a research team that had a 50-50 gender balance and racial and ethnic diversity. The team combed ASCO transcripts to code introductions according to whether title and surname were used or whether speakers were addressed by first name only.

After excluding videos that did not capture speaker introductions, Dr. Duma and collaborators were left with 781 videos to watch and code.

Female speakers overall were less likely to be addressed by their professional title (62% vs. 81% for males, P less than .001). Male introducers used professional titles 53% of the time when introducing female speakers, and 80% of the time when introducing male speakers (P less than .01). No gender differences were seen when females were the introducers (J Clin Oncol. 2019 Oct 11. doi: 10.1200/JCO.19.01608).

Looking further, male introducers addressed female speakers by first name only in 24% of the cases. Female introducers used first names only with female speakers 7% of the time, a statistically significant difference. “This is the part that is really sad,” said Dr. Duma.

She and her coauthors also performed multivariable analysis to adjust for factors such as seniority and geographic location; after adjustment, males were still over 2.5 times as likely as females to be introduced with their professional title, and females were nearly six times as likely as males to be introduced by their first names only. When the introducer was male, a female speaker was over three times more likely to be introduced by her first name only.

Dr. Duma and colleagues are working with the ASCO 2020 planning team to develop a template that standardizes presenter introductions. They’re also planning for prospective data collection at that meeting, and will include self-reported race and ethnicity data for presenters and introducers who choose to provide it.

“We do not plan to create a ‘her versus him’ battle,” said Dr. Duma. “The goal is to use this hardcore data to bring attention to the problem.” She pointed out that, though fewer females introduced other females by first name only, the problem wasn’t limited only to male introducers at ASCO.

“The problem is unconscious bias. Nobody’s exempt,” said Dr. Duma. She related that she herself had just sent a work-related email to a female colleague that addressed her by her first name, and had copied many of their mutual colleagues. Realizing her gaffe, she held herself to her own standard by apologizing to her colleague and copying everyone who saw the first email. “The goal is to bring attention to the difference, so we can improve gender bias in medicine together.”

Patient interactions: Sometimes, a delicate balance

What’s the right approach when a patient, uninvited, addresses you by your first name? Natalie Strand, MD, had been thinking about the best way to handle this sticky situation for some time. Recently, she tried it out on a patient and shared her approach in a tweet:

So proud of myself!

After introducing myself as Dr. Strand to a patient, he looked at my name badge and said- oh, so Natalie.

Usually I’m stuck feeling afraid to rock the boat...

Not today!

“Yes, but I go by Dr. Strand at work! “

I finally said it!!!

— Natalie Strand (@DrNatStrand) October 11, 2019

There was an awkward moment with the patient, Dr. Strand acknowledged, “but we moved past it.”

Asserting one’s hard-earned status despite a societally ingrained desire to please or to avoid confrontation can be difficult, she acknowledged, but it’s worth it. Put simply, she said, “I want to be called Dr. Strand.”

The importance of this issue can sometimes be hard for male colleagues to understand, said Dr. Strand, who practices outpatient interventional pain medicine at the Mayo Clinic, Scottsdale, Ariz. “The people that have privilege – they don’t see it as privilege. And that’s not anybody’s fault. That’s just the reality of it, because that’s the norm. … That’s why putting a name to microaggression and microinsults is so powerful, because once you name it, then you can respond to it.”

Beginning from a point of mutual professionalism is a good place to start, Dr. Strand said in an interview. She always begins by addressing her patients by their surname and waits for patients to invite her to call them by their first names. “The most professional approach is the best first step,” she said. When she has a longstanding relationship with patients and she knows that trust and mutual respect have been established, she may also invite first-name familiarity.

“Patients don’t do this to be mean,” emphasized Dr. Strand, adding that, particularly with older patients, “they are trying to be sweet.” That’s part of the difficulty in finding a gentle but firm way to bring the relationship back to a professional footing.

Judging by the responses she’s gotten from other female physicians, this delicate situation, and the best way to ask for professionalism with patients, is a common struggle. Many of her female peers have said they’ll consider adopting her approach, she said.

“Male physicians are our allies,” said Dr. Strand. “The needs of the patients come first. This isn’t about power; it’s not about holding a power differential against the patient. It’s about having a culture of mutual respect, and being seen as a physician. Not as a female physician, not as a male physician. Just being seen as a physician, so you can act as a physician.”

Whether they come from patients or peers, said Dr. James, who adroitly called out the physician reviewer who asked for her by first name, “These microaggressions are uncomfortable to address at the time they occur – but they are teachable moments that we should all take advantage of. Usually, a gentle correction, such as, ‘I prefer to be addressed as Dr. James while at work,’ is sufficient.” However, she added, “sometimes, a firmer ‘I feel disrespected when you address me by my first name to colleagues and patients’ is needed.”

This article was updated 10/15/19.

[email protected]

When Shawnté James, MD, picked up the phone at work recently, a male physician on the other end was calling for a peer-to-peer review of a patient’s insurance issue.

“Hi, this is Dr. Y, calling to speak with Shawnté about patient X. Is she available?” asked the physician. “No,” replied Dr. James, an assistant professor of pediatrics at MedStar Georgetown University Hospital, Washington. 

She related the rest of the interaction in a recent tweet:

“I’m Dr. XY calling a peer-to-peer review of a denial. Is Shawnté available?”

Me: “No.”

Him: “Is she in today?”

Me: “There’s no Shawnté here.”

Him: “Oh this is the number I have for Dr. Shawnté James”

Me: “Oh, DR. JAMES. Yes, that’s me. How can I help?”#MyFirstNameIsDoctor

— Shawnté James (@ShawnteJamesMD) October 10, 2019

The tweet, along with many others that used the hashtag #MyFirstNameIsDoctor, struck a chord among female physicians on Twitter. In tweets of their own, they related instance after instance of peers, coworkers, and patients assuming first-name familiarity with them – but not their male colleagues.

“This time it’s a peer-to-peer review. Last time it was being introduced to new hospital leadership as, ‘Shawnté, one of our pediatricians,’ ” Dr. James said in an interview. “The truth is, for physician women – particularly women of color – this is a regular occurrence.”
 

Data show an ongoing problem

Objective evidence that female physicians and scientists are significantly less likely than their male peers to be addressed by their titles came in a just-published study of presentations at the annual meeting of the American Society for Clinical Oncology in 2017 and 2018.

Narjust Duma, MD, the study’s first author, described her growing awareness of the problem.

Dr. Duma recalled a session on the last day of the ASCO 2018 meeting. Five presenters were speaking – four men and a woman. “The woman is the one who knows the most about this subject. She’s the only one at the table who’s a full professor,” Dr. Duma, assistant professor of hematology/oncology at the University of Wisconsin–Madison, said in an interview. “And then everybody is introduced as ‘Dr. So-and-so,’ and when they come to her, they introduce her as ‘Julie.’ ”

“Is it just me?” Dr. Duma asked herself. The same day, she began a Twitter poll to ask whether her female peers were experiencing this phenomenon, and got an “overwhelming” response.

“We need data to learn the extent of the problem,” she said she realized.

The ASCO annual meeting afforded an ideal opportunity for data gathering, said Dr. Duma, because presentations are recorded and written transcripts generated. Dr. Duma assembled a research team that had a 50-50 gender balance and racial and ethnic diversity. The team combed ASCO transcripts to code introductions according to whether title and surname were used or whether speakers were addressed by first name only.

After excluding videos that did not capture speaker introductions, Dr. Duma and collaborators were left with 781 videos to watch and code.

Female speakers overall were less likely to be addressed by their professional title (62% vs. 81% for males, P less than .001). Male introducers used professional titles 53% of the time when introducing female speakers, and 80% of the time when introducing male speakers (P less than .01). No gender differences were seen when females were the introducers (J Clin Oncol. 2019 Oct 11. doi: 10.1200/JCO.19.01608).

Looking further, male introducers addressed female speakers by first name only in 24% of the cases. Female introducers used first names only with female speakers 7% of the time, a statistically significant difference. “This is the part that is really sad,” said Dr. Duma.

She and her coauthors also performed multivariable analysis to adjust for factors such as seniority and geographic location; after adjustment, males were still over 2.5 times as likely as females to be introduced with their professional title, and females were nearly six times as likely as males to be introduced by their first names only. When the introducer was male, a female speaker was over three times more likely to be introduced by her first name only.

Dr. Duma and colleagues are working with the ASCO 2020 planning team to develop a template that standardizes presenter introductions. They’re also planning for prospective data collection at that meeting, and will include self-reported race and ethnicity data for presenters and introducers who choose to provide it.

“We do not plan to create a ‘her versus him’ battle,” said Dr. Duma. “The goal is to use this hardcore data to bring attention to the problem.” She pointed out that, though fewer females introduced other females by first name only, the problem wasn’t limited only to male introducers at ASCO.

“The problem is unconscious bias. Nobody’s exempt,” said Dr. Duma. She related that she herself had just sent a work-related email to a female colleague that addressed her by her first name, and had copied many of their mutual colleagues. Realizing her gaffe, she held herself to her own standard by apologizing to her colleague and copying everyone who saw the first email. “The goal is to bring attention to the difference, so we can improve gender bias in medicine together.”

Patient interactions: Sometimes, a delicate balance

What’s the right approach when a patient, uninvited, addresses you by your first name? Natalie Strand, MD, had been thinking about the best way to handle this sticky situation for some time. Recently, she tried it out on a patient and shared her approach in a tweet:

So proud of myself!

After introducing myself as Dr. Strand to a patient, he looked at my name badge and said- oh, so Natalie.

Usually I’m stuck feeling afraid to rock the boat...

Not today!

“Yes, but I go by Dr. Strand at work! “

I finally said it!!!

— Natalie Strand (@DrNatStrand) October 11, 2019

There was an awkward moment with the patient, Dr. Strand acknowledged, “but we moved past it.”

Asserting one’s hard-earned status despite a societally ingrained desire to please or to avoid confrontation can be difficult, she acknowledged, but it’s worth it. Put simply, she said, “I want to be called Dr. Strand.”

The importance of this issue can sometimes be hard for male colleagues to understand, said Dr. Strand, who practices outpatient interventional pain medicine at the Mayo Clinic, Scottsdale, Ariz. “The people that have privilege – they don’t see it as privilege. And that’s not anybody’s fault. That’s just the reality of it, because that’s the norm. … That’s why putting a name to microaggression and microinsults is so powerful, because once you name it, then you can respond to it.”

Beginning from a point of mutual professionalism is a good place to start, Dr. Strand said in an interview. She always begins by addressing her patients by their surname and waits for patients to invite her to call them by their first names. “The most professional approach is the best first step,” she said. When she has a longstanding relationship with patients and she knows that trust and mutual respect have been established, she may also invite first-name familiarity.

“Patients don’t do this to be mean,” emphasized Dr. Strand, adding that, particularly with older patients, “they are trying to be sweet.” That’s part of the difficulty in finding a gentle but firm way to bring the relationship back to a professional footing.

Judging by the responses she’s gotten from other female physicians, this delicate situation, and the best way to ask for professionalism with patients, is a common struggle. Many of her female peers have said they’ll consider adopting her approach, she said.

“Male physicians are our allies,” said Dr. Strand. “The needs of the patients come first. This isn’t about power; it’s not about holding a power differential against the patient. It’s about having a culture of mutual respect, and being seen as a physician. Not as a female physician, not as a male physician. Just being seen as a physician, so you can act as a physician.”

Whether they come from patients or peers, said Dr. James, who adroitly called out the physician reviewer who asked for her by first name, “These microaggressions are uncomfortable to address at the time they occur – but they are teachable moments that we should all take advantage of. Usually, a gentle correction, such as, ‘I prefer to be addressed as Dr. James while at work,’ is sufficient.” However, she added, “sometimes, a firmer ‘I feel disrespected when you address me by my first name to colleagues and patients’ is needed.”

This article was updated 10/15/19.

[email protected]

When Shawnté James, MD, picked up the phone at work recently, a male physician on the other end was calling for a peer-to-peer review of a patient’s insurance issue.

“Hi, this is Dr. Y, calling to speak with Shawnté about patient X. Is she available?” asked the physician. “No,” replied Dr. James, an assistant professor of pediatrics at MedStar Georgetown University Hospital, Washington. 

She related the rest of the interaction in a recent tweet:

“I’m Dr. XY calling a peer-to-peer review of a denial. Is Shawnté available?”

Me: “No.”

Him: “Is she in today?”

Me: “There’s no Shawnté here.”

Him: “Oh this is the number I have for Dr. Shawnté James”

Me: “Oh, DR. JAMES. Yes, that’s me. How can I help?”#MyFirstNameIsDoctor

— Shawnté James (@ShawnteJamesMD) October 10, 2019

The tweet, along with many others that used the hashtag #MyFirstNameIsDoctor, struck a chord among female physicians on Twitter. In tweets of their own, they related instance after instance of peers, coworkers, and patients assuming first-name familiarity with them – but not their male colleagues.

“This time it’s a peer-to-peer review. Last time it was being introduced to new hospital leadership as, ‘Shawnté, one of our pediatricians,’ ” Dr. James said in an interview. “The truth is, for physician women – particularly women of color – this is a regular occurrence.”
 

Data show an ongoing problem

Objective evidence that female physicians and scientists are significantly less likely than their male peers to be addressed by their titles came in a just-published study of presentations at the annual meeting of the American Society for Clinical Oncology in 2017 and 2018.

Narjust Duma, MD, the study’s first author, described her growing awareness of the problem.

Dr. Duma recalled a session on the last day of the ASCO 2018 meeting. Five presenters were speaking – four men and a woman. “The woman is the one who knows the most about this subject. She’s the only one at the table who’s a full professor,” Dr. Duma, assistant professor of hematology/oncology at the University of Wisconsin–Madison, said in an interview. “And then everybody is introduced as ‘Dr. So-and-so,’ and when they come to her, they introduce her as ‘Julie.’ ”

“Is it just me?” Dr. Duma asked herself. The same day, she began a Twitter poll to ask whether her female peers were experiencing this phenomenon, and got an “overwhelming” response.

“We need data to learn the extent of the problem,” she said she realized.

The ASCO annual meeting afforded an ideal opportunity for data gathering, said Dr. Duma, because presentations are recorded and written transcripts generated. Dr. Duma assembled a research team that had a 50-50 gender balance and racial and ethnic diversity. The team combed ASCO transcripts to code introductions according to whether title and surname were used or whether speakers were addressed by first name only.

After excluding videos that did not capture speaker introductions, Dr. Duma and collaborators were left with 781 videos to watch and code.

Female speakers overall were less likely to be addressed by their professional title (62% vs. 81% for males, P less than .001). Male introducers used professional titles 53% of the time when introducing female speakers, and 80% of the time when introducing male speakers (P less than .01). No gender differences were seen when females were the introducers (J Clin Oncol. 2019 Oct 11. doi: 10.1200/JCO.19.01608).

Looking further, male introducers addressed female speakers by first name only in 24% of the cases. Female introducers used first names only with female speakers 7% of the time, a statistically significant difference. “This is the part that is really sad,” said Dr. Duma.

She and her coauthors also performed multivariable analysis to adjust for factors such as seniority and geographic location; after adjustment, males were still over 2.5 times as likely as females to be introduced with their professional title, and females were nearly six times as likely as males to be introduced by their first names only. When the introducer was male, a female speaker was over three times more likely to be introduced by her first name only.

Dr. Duma and colleagues are working with the ASCO 2020 planning team to develop a template that standardizes presenter introductions. They’re also planning for prospective data collection at that meeting, and will include self-reported race and ethnicity data for presenters and introducers who choose to provide it.

“We do not plan to create a ‘her versus him’ battle,” said Dr. Duma. “The goal is to use this hardcore data to bring attention to the problem.” She pointed out that, though fewer females introduced other females by first name only, the problem wasn’t limited only to male introducers at ASCO.

“The problem is unconscious bias. Nobody’s exempt,” said Dr. Duma. She related that she herself had just sent a work-related email to a female colleague that addressed her by her first name, and had copied many of their mutual colleagues. Realizing her gaffe, she held herself to her own standard by apologizing to her colleague and copying everyone who saw the first email. “The goal is to bring attention to the difference, so we can improve gender bias in medicine together.”

Patient interactions: Sometimes, a delicate balance

What’s the right approach when a patient, uninvited, addresses you by your first name? Natalie Strand, MD, had been thinking about the best way to handle this sticky situation for some time. Recently, she tried it out on a patient and shared her approach in a tweet:

So proud of myself!

After introducing myself as Dr. Strand to a patient, he looked at my name badge and said- oh, so Natalie.

Usually I’m stuck feeling afraid to rock the boat...

Not today!

“Yes, but I go by Dr. Strand at work! “

I finally said it!!!

— Natalie Strand (@DrNatStrand) October 11, 2019

There was an awkward moment with the patient, Dr. Strand acknowledged, “but we moved past it.”

Asserting one’s hard-earned status despite a societally ingrained desire to please or to avoid confrontation can be difficult, she acknowledged, but it’s worth it. Put simply, she said, “I want to be called Dr. Strand.”

The importance of this issue can sometimes be hard for male colleagues to understand, said Dr. Strand, who practices outpatient interventional pain medicine at the Mayo Clinic, Scottsdale, Ariz. “The people that have privilege – they don’t see it as privilege. And that’s not anybody’s fault. That’s just the reality of it, because that’s the norm. … That’s why putting a name to microaggression and microinsults is so powerful, because once you name it, then you can respond to it.”

Beginning from a point of mutual professionalism is a good place to start, Dr. Strand said in an interview. She always begins by addressing her patients by their surname and waits for patients to invite her to call them by their first names. “The most professional approach is the best first step,” she said. When she has a longstanding relationship with patients and she knows that trust and mutual respect have been established, she may also invite first-name familiarity.

“Patients don’t do this to be mean,” emphasized Dr. Strand, adding that, particularly with older patients, “they are trying to be sweet.” That’s part of the difficulty in finding a gentle but firm way to bring the relationship back to a professional footing.

Judging by the responses she’s gotten from other female physicians, this delicate situation, and the best way to ask for professionalism with patients, is a common struggle. Many of her female peers have said they’ll consider adopting her approach, she said.

“Male physicians are our allies,” said Dr. Strand. “The needs of the patients come first. This isn’t about power; it’s not about holding a power differential against the patient. It’s about having a culture of mutual respect, and being seen as a physician. Not as a female physician, not as a male physician. Just being seen as a physician, so you can act as a physician.”

Whether they come from patients or peers, said Dr. James, who adroitly called out the physician reviewer who asked for her by first name, “These microaggressions are uncomfortable to address at the time they occur – but they are teachable moments that we should all take advantage of. Usually, a gentle correction, such as, ‘I prefer to be addressed as Dr. James while at work,’ is sufficient.” However, she added, “sometimes, a firmer ‘I feel disrespected when you address me by my first name to colleagues and patients’ is needed.”

This article was updated 10/15/19.

[email protected]

STOCKHOLM – An approach that combines analysis of up to five different proteins and metabolites in the cerebrospinal fluid of individuals with clinically isolated syndrome was accurate in predicting which patients would go on to develop clinically definite multiple sclerosis 4 years later.

Kari Oakes/MDedge News

Further, “combined omics improves diagnostic accuracy” over oligoclonal band (OCB) status alone in differentiating patients with multiple sclerosis (MS) from a group of normal control patients, said Fay Probert, PhD, speaking at a poster session at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Not everyone with clinically isolated syndrome (CIS) converts to clinically definite MS, and there is large variability in the time to progression, explained Dr. Probert, a postdoctoral fellow in the department of pharmacology at Oxford (England) University, and colleagues. Though the revised McDonald criteria now allow earlier diagnosis of MS, individuals who will be early converters cannot be identified by these criteria, they noted, citing earlier work showing that just over half (52%) of CIS patients who are OCB positive will have clinically definite MS at the 3-year mark.

To see whether combining analysis of multiple proteins and metabolites improved diagnostic accuracy, Dr. Probert and colleagues examined cerebrospinal fluid (CSF) samples from 41 patients with clinically definite MS, 71 patients with CIS, and 64 control participants without MS. In their analysis, the investigators used nuclear MR metabolomics and a commercially available proteomics assay that identifies and quantifies more than 5,000 proteins.

The multivariate analysis strategy achieved 10-fold external cross-validation of the samples, repeating training and testing of the analysis model while shuffling data. This, explained Dr. Probert and colleagues, “ensures that any discrimination observed cannot have occurred by chance.” Further analysis “identifies the optimal combination of proteomics and metabolomics features which results in the highest diagnostic accuracy.”

Both the nuclear MR metabolomics and the proteomic analyses were able to discriminate between those with clinically definite MS and the control participants, with accuracy of 71% and 75%, respectively.

The levels of seven metabolites present in CSF were predictive of clinically definite MS, compared with non-MS status, independent of OCB status. In fact, noted Dr. Probert and colleagues, “the CSF myoinositol concentration alone diagnosed [clinically definite] MS in this cohort with a specificity of 74% but did not outperform OCB status overall.”

Using the combined omics approach, though, “significantly improved the discrimination” between the non-MS control CSF samples and those of patients with clinically definite MS, wrote Dr. Probert and colleagues. Using a combination of up to five CSF proteins and metabolites yielded accuracy of 85 plus or minus 2%, sensitivity of 85 plus or minus 3%, and specificity of 85 plus or minus 3%. For comparison, using just OCB status provides accuracy of 74%, sensitivity of 88% and specificity of 63%.

Then, Dr. Probert and colleagues turned to the CSF samples from patients with CIS to look for predictors of “fast” (4 years or less) or “slow” (greater than 4 years) conversion to clinically definite MS. “While important for diagnosis, OCB status was not predictive of early conversion,” the investigators noted. However, baseline CSF proteomics analysis alone did differentiate the fast from the slow converters among the CIS subgroup, with an accuracy of 77%.

For patients with CIS who were OCB positive, their baseline metabolite and proteomic profiles were “indistinguishable” from those with clinically definite MS, wrote Dr. Probert and colleagues. The omics analysis was also able to distinguish between OCB-positive CIS patients and the non-MS control patients.

“These results indicate that combined metabolomics and proteomics analysis could not only be used as an adjunct in diagnosis of [clinically definite] MS but could be used as a prognostic test to identify CIS patients at high risk of a second clinical attack within 4 years of onset,” wrote Dr. Probert and coauthors. They noted that the method reported in the poster is the first to offer this prognostic accuracy, but that more work is needed before routine clinical use.

Dr. Probert reported that she had no financial conflicts of interest. One coauthor reported being a consultant to Novartis. Two coauthors reported financial relationships with multiple pharmaceutical companies, including Merck, which partially funded the study. Numares Health, the U.K. Medical Research Council, and the Multiple Sclerosis Society also provided funding support.
 

[email protected]

SOURCE: Probert F et al. ECTRIMS 2019, Abstract P586.

STOCKHOLM – An approach that combines analysis of up to five different proteins and metabolites in the cerebrospinal fluid of individuals with clinically isolated syndrome was accurate in predicting which patients would go on to develop clinically definite multiple sclerosis 4 years later.

Kari Oakes/MDedge News

Further, “combined omics improves diagnostic accuracy” over oligoclonal band (OCB) status alone in differentiating patients with multiple sclerosis (MS) from a group of normal control patients, said Fay Probert, PhD, speaking at a poster session at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Not everyone with clinically isolated syndrome (CIS) converts to clinically definite MS, and there is large variability in the time to progression, explained Dr. Probert, a postdoctoral fellow in the department of pharmacology at Oxford (England) University, and colleagues. Though the revised McDonald criteria now allow earlier diagnosis of MS, individuals who will be early converters cannot be identified by these criteria, they noted, citing earlier work showing that just over half (52%) of CIS patients who are OCB positive will have clinically definite MS at the 3-year mark.

To see whether combining analysis of multiple proteins and metabolites improved diagnostic accuracy, Dr. Probert and colleagues examined cerebrospinal fluid (CSF) samples from 41 patients with clinically definite MS, 71 patients with CIS, and 64 control participants without MS. In their analysis, the investigators used nuclear MR metabolomics and a commercially available proteomics assay that identifies and quantifies more than 5,000 proteins.

The multivariate analysis strategy achieved 10-fold external cross-validation of the samples, repeating training and testing of the analysis model while shuffling data. This, explained Dr. Probert and colleagues, “ensures that any discrimination observed cannot have occurred by chance.” Further analysis “identifies the optimal combination of proteomics and metabolomics features which results in the highest diagnostic accuracy.”

Both the nuclear MR metabolomics and the proteomic analyses were able to discriminate between those with clinically definite MS and the control participants, with accuracy of 71% and 75%, respectively.

The levels of seven metabolites present in CSF were predictive of clinically definite MS, compared with non-MS status, independent of OCB status. In fact, noted Dr. Probert and colleagues, “the CSF myoinositol concentration alone diagnosed [clinically definite] MS in this cohort with a specificity of 74% but did not outperform OCB status overall.”

Using the combined omics approach, though, “significantly improved the discrimination” between the non-MS control CSF samples and those of patients with clinically definite MS, wrote Dr. Probert and colleagues. Using a combination of up to five CSF proteins and metabolites yielded accuracy of 85 plus or minus 2%, sensitivity of 85 plus or minus 3%, and specificity of 85 plus or minus 3%. For comparison, using just OCB status provides accuracy of 74%, sensitivity of 88% and specificity of 63%.

Then, Dr. Probert and colleagues turned to the CSF samples from patients with CIS to look for predictors of “fast” (4 years or less) or “slow” (greater than 4 years) conversion to clinically definite MS. “While important for diagnosis, OCB status was not predictive of early conversion,” the investigators noted. However, baseline CSF proteomics analysis alone did differentiate the fast from the slow converters among the CIS subgroup, with an accuracy of 77%.

For patients with CIS who were OCB positive, their baseline metabolite and proteomic profiles were “indistinguishable” from those with clinically definite MS, wrote Dr. Probert and colleagues. The omics analysis was also able to distinguish between OCB-positive CIS patients and the non-MS control patients.

“These results indicate that combined metabolomics and proteomics analysis could not only be used as an adjunct in diagnosis of [clinically definite] MS but could be used as a prognostic test to identify CIS patients at high risk of a second clinical attack within 4 years of onset,” wrote Dr. Probert and coauthors. They noted that the method reported in the poster is the first to offer this prognostic accuracy, but that more work is needed before routine clinical use.

Dr. Probert reported that she had no financial conflicts of interest. One coauthor reported being a consultant to Novartis. Two coauthors reported financial relationships with multiple pharmaceutical companies, including Merck, which partially funded the study. Numares Health, the U.K. Medical Research Council, and the Multiple Sclerosis Society also provided funding support.
 

[email protected]

SOURCE: Probert F et al. ECTRIMS 2019, Abstract P586.

STOCKHOLM – An approach that combines analysis of up to five different proteins and metabolites in the cerebrospinal fluid of individuals with clinically isolated syndrome was accurate in predicting which patients would go on to develop clinically definite multiple sclerosis 4 years later.

Kari Oakes/MDedge News

Further, “combined omics improves diagnostic accuracy” over oligoclonal band (OCB) status alone in differentiating patients with multiple sclerosis (MS) from a group of normal control patients, said Fay Probert, PhD, speaking at a poster session at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Not everyone with clinically isolated syndrome (CIS) converts to clinically definite MS, and there is large variability in the time to progression, explained Dr. Probert, a postdoctoral fellow in the department of pharmacology at Oxford (England) University, and colleagues. Though the revised McDonald criteria now allow earlier diagnosis of MS, individuals who will be early converters cannot be identified by these criteria, they noted, citing earlier work showing that just over half (52%) of CIS patients who are OCB positive will have clinically definite MS at the 3-year mark.

To see whether combining analysis of multiple proteins and metabolites improved diagnostic accuracy, Dr. Probert and colleagues examined cerebrospinal fluid (CSF) samples from 41 patients with clinically definite MS, 71 patients with CIS, and 64 control participants without MS. In their analysis, the investigators used nuclear MR metabolomics and a commercially available proteomics assay that identifies and quantifies more than 5,000 proteins.

The multivariate analysis strategy achieved 10-fold external cross-validation of the samples, repeating training and testing of the analysis model while shuffling data. This, explained Dr. Probert and colleagues, “ensures that any discrimination observed cannot have occurred by chance.” Further analysis “identifies the optimal combination of proteomics and metabolomics features which results in the highest diagnostic accuracy.”

Both the nuclear MR metabolomics and the proteomic analyses were able to discriminate between those with clinically definite MS and the control participants, with accuracy of 71% and 75%, respectively.

The levels of seven metabolites present in CSF were predictive of clinically definite MS, compared with non-MS status, independent of OCB status. In fact, noted Dr. Probert and colleagues, “the CSF myoinositol concentration alone diagnosed [clinically definite] MS in this cohort with a specificity of 74% but did not outperform OCB status overall.”

Using the combined omics approach, though, “significantly improved the discrimination” between the non-MS control CSF samples and those of patients with clinically definite MS, wrote Dr. Probert and colleagues. Using a combination of up to five CSF proteins and metabolites yielded accuracy of 85 plus or minus 2%, sensitivity of 85 plus or minus 3%, and specificity of 85 plus or minus 3%. For comparison, using just OCB status provides accuracy of 74%, sensitivity of 88% and specificity of 63%.

Then, Dr. Probert and colleagues turned to the CSF samples from patients with CIS to look for predictors of “fast” (4 years or less) or “slow” (greater than 4 years) conversion to clinically definite MS. “While important for diagnosis, OCB status was not predictive of early conversion,” the investigators noted. However, baseline CSF proteomics analysis alone did differentiate the fast from the slow converters among the CIS subgroup, with an accuracy of 77%.

For patients with CIS who were OCB positive, their baseline metabolite and proteomic profiles were “indistinguishable” from those with clinically definite MS, wrote Dr. Probert and colleagues. The omics analysis was also able to distinguish between OCB-positive CIS patients and the non-MS control patients.

“These results indicate that combined metabolomics and proteomics analysis could not only be used as an adjunct in diagnosis of [clinically definite] MS but could be used as a prognostic test to identify CIS patients at high risk of a second clinical attack within 4 years of onset,” wrote Dr. Probert and coauthors. They noted that the method reported in the poster is the first to offer this prognostic accuracy, but that more work is needed before routine clinical use.

Dr. Probert reported that she had no financial conflicts of interest. One coauthor reported being a consultant to Novartis. Two coauthors reported financial relationships with multiple pharmaceutical companies, including Merck, which partially funded the study. Numares Health, the U.K. Medical Research Council, and the Multiple Sclerosis Society also provided funding support.
 

[email protected]

SOURCE: Probert F et al. ECTRIMS 2019, Abstract P586.

At least three particular species in the Ocimum family have been associated with a wide array of health benefits. This column will briefly discuss the dermatologic effects of Ocimum gratissimum, O. sanctum (also known as O. tenuiflorum), and O. basilicum. Holy basil is used in Ayurvedic medicine as an “adaptogen” to counter life’s stresses. It is called “holy basil” because it is sacred to the Hindus who plant it around shrines.

O. sanctum (O. tenuiflorum)

Known popularly as holy basil in English and Tulsi in Sanskrit (in which the translation is “the incomparable one”), O. tenuiflorum is used for multiple indications in traditional medical practices in Southeast Asia, including Ayurveda, Siddha, and Unani.^1,2

In Ayurvedic medicine, the leaves, stem, flower, root, seeds, and whole plant of O. sanctum have been used to treat various ailments, including skin diseases. Eugenol (1-hydroxy-2-methoxy-4-allylbenzene) is its primary constituent and the wide variety of biological activities associated with the plant (including antifertility, anticancer, antidiabetic, antifungal, antimicrobial, hepatoprotective, cardioprotective, antiemetic, antispasmodic, analgesic, adaptogenic, and diaphoretic) are ascribed to it.³

O. sanctum and its water-soluble flavonoids, orientin, and vicenin – as well as eugenol, its main nonpolar component – have been shown in animal studies and a few small clinical trials to act against various radiation-induced illnesses. Antioxidant, anti-inflammatory, and metal-chelating activity have been linked to these benefits.⁴ Indeed, multiple studies have demonstrated that O. sanctum exerts anti-inflammatory, analgesic, and immunomodulatory activities, among other beneficial functions, with phytochemical constituents such as eugenol, rosmarinic acid, apigenin, myrtenal, luteolin, beta-sitosterol, and carnosic acid playing critical roles.²

Several animal studies have also demonstrated that O. sanctum imparts wound-healing activity, such as increasing the rates of epithelialization and wound contraction and augmenting granulation tissue and hydroxyproline levels, with some evidence of benefits for also healing keloids and hypertrophic scars.^1,5

Yamani et al. studied the antimicrobial activity of the flower spikes, leaves, and essential oil of O. sanctum grown in Australia in 2016. They found that, at concentrations of 4.5% and 2.25%, the oils prevented the growth of Staphylococcus aureus (including methicillin-resistant S. aureus) and Escherichia coli, and partly hindered the growth of Pseudomonas aeruginosa. Further, the investigators identified camphor, eucalyptol, and eugenol as the primary ingredients, among 54 observed, accountable for the antimicrobial activity. They concluded that O. sanctum essential oil has potential as a topical antimicrobial agent.⁶

A 2015 investigation into the antioxidant activities of 10 essential oils and 10 absolutes extracted from Thai aromatic plants revealed that O. sanctum was among four of the essential oils to display robust antioxidant activity in the 2,2-diphenyl-1-1-picrylhydrazyl and thiobarbituric acid reactive species tests. The study by Leelapornpisid et al. suggested that holy basil oil, along with ginger oil, Wan-sao-long leaf oil, and lemongrass oil, appear to have potential for use as natural antioxidants in cosmetic formulations aimed at preventing or treating cutaneous aging.⁷

O. gratissimum

O. gratissimum has been used in traditional medicine to treat a range of conditions, including skin and gastrointestinal infections and wounds.⁸

In 2007, Ajose reported on the results of history questionnaires filed by patients at a dermatology clinic in Lagos, Nigeria and oral interviews with vendors and prescribers of herbal formulations at busy markets in Lagos and Ijebu-Ode in southwest Nigeria, indicating that O. gratissimum was 1 of the 38 plants used for dermatologic purposes.⁹

O. basilicum

Also known as great basil or St. Joseph’s Wort, O. basilicum is native to tropical regions and is found abundantly from Southeast Asia to Africa. In a 2011 single-blind study, Rasul and Akhtar tested a formulation containing 3% basil in the inner aqueous phase and a base devoid of extract. The formulation exhibited significant effects in skin moisturization, and both creams conferred measurable benefits in stemming transepidermal water loss. Skin roughness, scaliness, smoothness, and wrinkles appeared to improve with the formulation as well. The researchers concluded that topically applied O. basilicum can deliver antiaging benefits.¹²

Antioxidant activity from myriad constituents, including quercetin, kaempferol, caffeic acid, rosmarinic acid, ferulic acid, rutin, and catechin, among others, has been cited for the potential of O. basilicum to confer an antiaging result.^13,14

Conclusion

Various species in the Ocimum family have been used in traditional medicine for many years, with several reputed to impart dermatologic benefits. There are compelling reasons to continue to research these species in the continuing search to develop more effective topical formulations in the dermatologic armamentarium. As is often the case with botanical agents, we need to see much more evidence and clinical trials to establish if and how appropriate these Ocimum species are in the skin care realm. The word “adaptogen” is starting to be used frequently in the cosmeceutical world. Holy basil is an adaptogen.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. Write to her at [email protected]

References

1. Rupani R, Chavez A. Clin Dermatol. 2018 May-Jun;36(3):306-9.

2. Baliga MS et al. Nutr Cancer. 2013;65 Suppl 1:26-35.

3. Prakash P, Gupta N. Indian J Physiol Pharmacol. 2005 Apr;49(2):125-31.

4. Baliga MS et al. J Cancer Res Ther. 2016 Jan-Mar;12(1):20-7.

5. Pazyar N et al. Skin Pharmacol Physiol. 2014;27(6):303-10.

6. Yamani HA et al. Front Microbiol. 2016 May 17;7:681.

7. Leelapornpisid P et al. J Cosmet Sci. 2015 Jul-Aug:66(4):219-31.

8. Nweze EI, Eze EE. BMC Complement Altern Med. 2009 Sep 28;9:37.

9. Ajose FOA. Int J Dermatol. 2007 Oct;46 Suppl 1:48-55.

10. Tolino E et al. G Ital Dermatol Venereol. 2018 Dec;153(6):866-871.

11. Keziah EA et al. J Insect Sci. 2015 Apr 15. doi: 10.1093/jisesa/iev025.

12. Rasul A, Akhtar N. Daru. 2011;19(5):344-50.

13. Jadoon S et al. Oxid Med Cell Longev. 2015;2015:709628.

14. Marwat SK et al. Asian J Chem. 2011;23(9):3773-82.
 

At least three particular species in the Ocimum family have been associated with a wide array of health benefits. This column will briefly discuss the dermatologic effects of Ocimum gratissimum, O. sanctum (also known as O. tenuiflorum), and O. basilicum. Holy basil is used in Ayurvedic medicine as an “adaptogen” to counter life’s stresses. It is called “holy basil” because it is sacred to the Hindus who plant it around shrines.

O. sanctum (O. tenuiflorum)

Known popularly as holy basil in English and Tulsi in Sanskrit (in which the translation is “the incomparable one”), O. tenuiflorum is used for multiple indications in traditional medical practices in Southeast Asia, including Ayurveda, Siddha, and Unani.^1,2

In Ayurvedic medicine, the leaves, stem, flower, root, seeds, and whole plant of O. sanctum have been used to treat various ailments, including skin diseases. Eugenol (1-hydroxy-2-methoxy-4-allylbenzene) is its primary constituent and the wide variety of biological activities associated with the plant (including antifertility, anticancer, antidiabetic, antifungal, antimicrobial, hepatoprotective, cardioprotective, antiemetic, antispasmodic, analgesic, adaptogenic, and diaphoretic) are ascribed to it.³

O. sanctum and its water-soluble flavonoids, orientin, and vicenin – as well as eugenol, its main nonpolar component – have been shown in animal studies and a few small clinical trials to act against various radiation-induced illnesses. Antioxidant, anti-inflammatory, and metal-chelating activity have been linked to these benefits.⁴ Indeed, multiple studies have demonstrated that O. sanctum exerts anti-inflammatory, analgesic, and immunomodulatory activities, among other beneficial functions, with phytochemical constituents such as eugenol, rosmarinic acid, apigenin, myrtenal, luteolin, beta-sitosterol, and carnosic acid playing critical roles.²

Several animal studies have also demonstrated that O. sanctum imparts wound-healing activity, such as increasing the rates of epithelialization and wound contraction and augmenting granulation tissue and hydroxyproline levels, with some evidence of benefits for also healing keloids and hypertrophic scars.^1,5

Yamani et al. studied the antimicrobial activity of the flower spikes, leaves, and essential oil of O. sanctum grown in Australia in 2016. They found that, at concentrations of 4.5% and 2.25%, the oils prevented the growth of Staphylococcus aureus (including methicillin-resistant S. aureus) and Escherichia coli, and partly hindered the growth of Pseudomonas aeruginosa. Further, the investigators identified camphor, eucalyptol, and eugenol as the primary ingredients, among 54 observed, accountable for the antimicrobial activity. They concluded that O. sanctum essential oil has potential as a topical antimicrobial agent.⁶

A 2015 investigation into the antioxidant activities of 10 essential oils and 10 absolutes extracted from Thai aromatic plants revealed that O. sanctum was among four of the essential oils to display robust antioxidant activity in the 2,2-diphenyl-1-1-picrylhydrazyl and thiobarbituric acid reactive species tests. The study by Leelapornpisid et al. suggested that holy basil oil, along with ginger oil, Wan-sao-long leaf oil, and lemongrass oil, appear to have potential for use as natural antioxidants in cosmetic formulations aimed at preventing or treating cutaneous aging.⁷

O. gratissimum

O. gratissimum has been used in traditional medicine to treat a range of conditions, including skin and gastrointestinal infections and wounds.⁸

In 2007, Ajose reported on the results of history questionnaires filed by patients at a dermatology clinic in Lagos, Nigeria and oral interviews with vendors and prescribers of herbal formulations at busy markets in Lagos and Ijebu-Ode in southwest Nigeria, indicating that O. gratissimum was 1 of the 38 plants used for dermatologic purposes.⁹

O. basilicum

Also known as great basil or St. Joseph’s Wort, O. basilicum is native to tropical regions and is found abundantly from Southeast Asia to Africa. In a 2011 single-blind study, Rasul and Akhtar tested a formulation containing 3% basil in the inner aqueous phase and a base devoid of extract. The formulation exhibited significant effects in skin moisturization, and both creams conferred measurable benefits in stemming transepidermal water loss. Skin roughness, scaliness, smoothness, and wrinkles appeared to improve with the formulation as well. The researchers concluded that topically applied O. basilicum can deliver antiaging benefits.¹²

Antioxidant activity from myriad constituents, including quercetin, kaempferol, caffeic acid, rosmarinic acid, ferulic acid, rutin, and catechin, among others, has been cited for the potential of O. basilicum to confer an antiaging result.^13,14

Conclusion

Various species in the Ocimum family have been used in traditional medicine for many years, with several reputed to impart dermatologic benefits. There are compelling reasons to continue to research these species in the continuing search to develop more effective topical formulations in the dermatologic armamentarium. As is often the case with botanical agents, we need to see much more evidence and clinical trials to establish if and how appropriate these Ocimum species are in the skin care realm. The word “adaptogen” is starting to be used frequently in the cosmeceutical world. Holy basil is an adaptogen.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. Write to her at [email protected]

References

1. Rupani R, Chavez A. Clin Dermatol. 2018 May-Jun;36(3):306-9.

2. Baliga MS et al. Nutr Cancer. 2013;65 Suppl 1:26-35.

3. Prakash P, Gupta N. Indian J Physiol Pharmacol. 2005 Apr;49(2):125-31.

4. Baliga MS et al. J Cancer Res Ther. 2016 Jan-Mar;12(1):20-7.

5. Pazyar N et al. Skin Pharmacol Physiol. 2014;27(6):303-10.

6. Yamani HA et al. Front Microbiol. 2016 May 17;7:681.

7. Leelapornpisid P et al. J Cosmet Sci. 2015 Jul-Aug:66(4):219-31.

8. Nweze EI, Eze EE. BMC Complement Altern Med. 2009 Sep 28;9:37.

9. Ajose FOA. Int J Dermatol. 2007 Oct;46 Suppl 1:48-55.

10. Tolino E et al. G Ital Dermatol Venereol. 2018 Dec;153(6):866-871.

11. Keziah EA et al. J Insect Sci. 2015 Apr 15. doi: 10.1093/jisesa/iev025.

12. Rasul A, Akhtar N. Daru. 2011;19(5):344-50.

13. Jadoon S et al. Oxid Med Cell Longev. 2015;2015:709628.

14. Marwat SK et al. Asian J Chem. 2011;23(9):3773-82.
 

At least three particular species in the Ocimum family have been associated with a wide array of health benefits. This column will briefly discuss the dermatologic effects of Ocimum gratissimum, O. sanctum (also known as O. tenuiflorum), and O. basilicum. Holy basil is used in Ayurvedic medicine as an “adaptogen” to counter life’s stresses. It is called “holy basil” because it is sacred to the Hindus who plant it around shrines.

O. sanctum (O. tenuiflorum)

Known popularly as holy basil in English and Tulsi in Sanskrit (in which the translation is “the incomparable one”), O. tenuiflorum is used for multiple indications in traditional medical practices in Southeast Asia, including Ayurveda, Siddha, and Unani.^1,2

In Ayurvedic medicine, the leaves, stem, flower, root, seeds, and whole plant of O. sanctum have been used to treat various ailments, including skin diseases. Eugenol (1-hydroxy-2-methoxy-4-allylbenzene) is its primary constituent and the wide variety of biological activities associated with the plant (including antifertility, anticancer, antidiabetic, antifungal, antimicrobial, hepatoprotective, cardioprotective, antiemetic, antispasmodic, analgesic, adaptogenic, and diaphoretic) are ascribed to it.³

O. sanctum and its water-soluble flavonoids, orientin, and vicenin – as well as eugenol, its main nonpolar component – have been shown in animal studies and a few small clinical trials to act against various radiation-induced illnesses. Antioxidant, anti-inflammatory, and metal-chelating activity have been linked to these benefits.⁴ Indeed, multiple studies have demonstrated that O. sanctum exerts anti-inflammatory, analgesic, and immunomodulatory activities, among other beneficial functions, with phytochemical constituents such as eugenol, rosmarinic acid, apigenin, myrtenal, luteolin, beta-sitosterol, and carnosic acid playing critical roles.²

Several animal studies have also demonstrated that O. sanctum imparts wound-healing activity, such as increasing the rates of epithelialization and wound contraction and augmenting granulation tissue and hydroxyproline levels, with some evidence of benefits for also healing keloids and hypertrophic scars.^1,5

Yamani et al. studied the antimicrobial activity of the flower spikes, leaves, and essential oil of O. sanctum grown in Australia in 2016. They found that, at concentrations of 4.5% and 2.25%, the oils prevented the growth of Staphylococcus aureus (including methicillin-resistant S. aureus) and Escherichia coli, and partly hindered the growth of Pseudomonas aeruginosa. Further, the investigators identified camphor, eucalyptol, and eugenol as the primary ingredients, among 54 observed, accountable for the antimicrobial activity. They concluded that O. sanctum essential oil has potential as a topical antimicrobial agent.⁶

A 2015 investigation into the antioxidant activities of 10 essential oils and 10 absolutes extracted from Thai aromatic plants revealed that O. sanctum was among four of the essential oils to display robust antioxidant activity in the 2,2-diphenyl-1-1-picrylhydrazyl and thiobarbituric acid reactive species tests. The study by Leelapornpisid et al. suggested that holy basil oil, along with ginger oil, Wan-sao-long leaf oil, and lemongrass oil, appear to have potential for use as natural antioxidants in cosmetic formulations aimed at preventing or treating cutaneous aging.⁷

O. gratissimum

O. gratissimum has been used in traditional medicine to treat a range of conditions, including skin and gastrointestinal infections and wounds.⁸

In 2007, Ajose reported on the results of history questionnaires filed by patients at a dermatology clinic in Lagos, Nigeria and oral interviews with vendors and prescribers of herbal formulations at busy markets in Lagos and Ijebu-Ode in southwest Nigeria, indicating that O. gratissimum was 1 of the 38 plants used for dermatologic purposes.⁹

O. basilicum

Also known as great basil or St. Joseph’s Wort, O. basilicum is native to tropical regions and is found abundantly from Southeast Asia to Africa. In a 2011 single-blind study, Rasul and Akhtar tested a formulation containing 3% basil in the inner aqueous phase and a base devoid of extract. The formulation exhibited significant effects in skin moisturization, and both creams conferred measurable benefits in stemming transepidermal water loss. Skin roughness, scaliness, smoothness, and wrinkles appeared to improve with the formulation as well. The researchers concluded that topically applied O. basilicum can deliver antiaging benefits.¹²

Antioxidant activity from myriad constituents, including quercetin, kaempferol, caffeic acid, rosmarinic acid, ferulic acid, rutin, and catechin, among others, has been cited for the potential of O. basilicum to confer an antiaging result.^13,14

Conclusion

Various species in the Ocimum family have been used in traditional medicine for many years, with several reputed to impart dermatologic benefits. There are compelling reasons to continue to research these species in the continuing search to develop more effective topical formulations in the dermatologic armamentarium. As is often the case with botanical agents, we need to see much more evidence and clinical trials to establish if and how appropriate these Ocimum species are in the skin care realm. The word “adaptogen” is starting to be used frequently in the cosmeceutical world. Holy basil is an adaptogen.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems. Write to her at [email protected]

References

1. Rupani R, Chavez A. Clin Dermatol. 2018 May-Jun;36(3):306-9.

2. Baliga MS et al. Nutr Cancer. 2013;65 Suppl 1:26-35.

3. Prakash P, Gupta N. Indian J Physiol Pharmacol. 2005 Apr;49(2):125-31.

4. Baliga MS et al. J Cancer Res Ther. 2016 Jan-Mar;12(1):20-7.

5. Pazyar N et al. Skin Pharmacol Physiol. 2014;27(6):303-10.

6. Yamani HA et al. Front Microbiol. 2016 May 17;7:681.

7. Leelapornpisid P et al. J Cosmet Sci. 2015 Jul-Aug:66(4):219-31.

8. Nweze EI, Eze EE. BMC Complement Altern Med. 2009 Sep 28;9:37.

9. Ajose FOA. Int J Dermatol. 2007 Oct;46 Suppl 1:48-55.

10. Tolino E et al. G Ital Dermatol Venereol. 2018 Dec;153(6):866-871.

11. Keziah EA et al. J Insect Sci. 2015 Apr 15. doi: 10.1093/jisesa/iev025.

12. Rasul A, Akhtar N. Daru. 2011;19(5):344-50.

13. Jadoon S et al. Oxid Med Cell Longev. 2015;2015:709628.

14. Marwat SK et al. Asian J Chem. 2011;23(9):3773-82.
 

Dupilumab (Dupixent) significantly reduced patient-reported dysphagia among adults with eosinophilic esophagitis enrolled in a randomized trial, investigators reported.

Treatment with this monoclonal antibody also improved histologic disease features and abnormal endoscopic features, compared with placebo, according to investigators in the phase 2 trial, which included 47 patients enrolled at 14 U.S. study sites.

Injection-site erythema and nasopharyngitis were more common among dupilumab-treated versus placebo-treated patients, and there were no serious adverse events or deaths observed, according to cofirst authors Ikuo Hirano, MD, of Northwestern University, Chicago, and Evan S. Dellon, MD, MPH, of the University of North Carolina at Chapel Hill.

“Dupilumab is the first targeted biologic agent to improve dysphagia, histologic and endoscopic measures of disease, as well as esophageal function, and have an acceptable safety profile in adult patients with active eosinophilic esophagitis,” said Dr. Hirano and Dr. Dellon and associates in the journal Gastroenterology.

The report on the phase 2 trial included 47 adults with active eosinophilic esophagitis randomized to weekly subcutaneous injections of dupilumab at a dose of 300 mg or placebo. All participants had a score of 5 or higher on the Straumann Dysphagia Instrument (SDI), a patient-reported outcome measure.

Change in SDI score from baseline to week 10, the study primary endpoint, was significantly improved for dupilumab, according to investigators, who reported a least-squares mean change of –3.0 from baseline, versus –1.3 for placebo (P = .0304).

The original plan was to measure dupilumab’s effect on SDI out to week 12 of treatment, but because of technical problems with an electronic diary system used in the trial, there was significant data loss, and this primary endpoint was instead evaluated at week 10, investigators said in their report.

Improvements in SDI scores were apparent as early as week 1 after dupilumab treatment started, they added, noting that 39% of dupilumab-treated patients had an improvement in SDI score of at least 3, compared with just 13% of placebo-treated patients (P = .490).

Dupilumab also improved outcomes measured by the eosinophilic esophagitis histology scoring system (EoE-HSS), including a 68.3% improvement in severity and 54.6% in extent of disease from baseline to week 12, investigators said.

Likewise, dupilumab improved endoscopic outcomes at week 12 as measured by the eosinophilic esophagitis Endoscopic Reference Score (EREFS), and improved esophageal distensibility plateau, a measure of esophageal function, by 18%, compared with placebo, according to the report.

The Food and Drug Administration has approved dupilumab for use in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, and has granted orphan drug designation for its use in the treatment of eosinophilic esophagitis, according to Sanofi and Regeneron Pharmaceuticals.

Dupilumab antagonizes the interleukin (IL)–4 receptor-alpha component of the type 2 receptor, thereby inhibiting signaling of IL-4 and IL-13, the investigators noted in their report.

“These results demonstrate that interleukin-4 and interleukin-13 are central pathological mediators of esophageal inflammation and dysfunction in adult patients with active eosinophilic esophagitis,” said investigators in their report.

The anti-IgE monoclonal antibody omalizumab (Xolair) failed to improve dysphagia and histologic features of eosinophilic esophagitis, suggesting the pathogenesis of this disease is not mediated by IgE, they added.

A number of other targeted biologic agents, including the anti–IL-5 agents mepolizumab and reslizumab, have failed to significantly improve dysphagia versus placebo in patients with eosinophilic esophagitis, they added.

The research was sponsored by Sanofi and Regeneron. Several study coauthors indicated that they were current or former employees of those companies. Other study authors provided disclosures related to Adare, Allakos, Banner, Calypso, Enumeral, EsoCap, GlaxoSmithKline, Meritage, Regeneron, Robarts, and Shire, and among others.

SOURCE: Hirano I et al. Gastroenterology. 2019 Oct 5. doi: 10.1053/j.gastro.2019.09.042.

AGA patient education on eosinophilic esophagitis can help your patients better understand the condition. Visit https://www.gastro.org/practice-guidance/gi-patient-center/topic/eosinophilic-esophagitis-eoe.

Dupilumab (Dupixent) significantly reduced patient-reported dysphagia among adults with eosinophilic esophagitis enrolled in a randomized trial, investigators reported.

Treatment with this monoclonal antibody also improved histologic disease features and abnormal endoscopic features, compared with placebo, according to investigators in the phase 2 trial, which included 47 patients enrolled at 14 U.S. study sites.

Injection-site erythema and nasopharyngitis were more common among dupilumab-treated versus placebo-treated patients, and there were no serious adverse events or deaths observed, according to cofirst authors Ikuo Hirano, MD, of Northwestern University, Chicago, and Evan S. Dellon, MD, MPH, of the University of North Carolina at Chapel Hill.

“Dupilumab is the first targeted biologic agent to improve dysphagia, histologic and endoscopic measures of disease, as well as esophageal function, and have an acceptable safety profile in adult patients with active eosinophilic esophagitis,” said Dr. Hirano and Dr. Dellon and associates in the journal Gastroenterology.

The report on the phase 2 trial included 47 adults with active eosinophilic esophagitis randomized to weekly subcutaneous injections of dupilumab at a dose of 300 mg or placebo. All participants had a score of 5 or higher on the Straumann Dysphagia Instrument (SDI), a patient-reported outcome measure.

Change in SDI score from baseline to week 10, the study primary endpoint, was significantly improved for dupilumab, according to investigators, who reported a least-squares mean change of –3.0 from baseline, versus –1.3 for placebo (P = .0304).

The original plan was to measure dupilumab’s effect on SDI out to week 12 of treatment, but because of technical problems with an electronic diary system used in the trial, there was significant data loss, and this primary endpoint was instead evaluated at week 10, investigators said in their report.

Improvements in SDI scores were apparent as early as week 1 after dupilumab treatment started, they added, noting that 39% of dupilumab-treated patients had an improvement in SDI score of at least 3, compared with just 13% of placebo-treated patients (P = .490).

Dupilumab also improved outcomes measured by the eosinophilic esophagitis histology scoring system (EoE-HSS), including a 68.3% improvement in severity and 54.6% in extent of disease from baseline to week 12, investigators said.

Likewise, dupilumab improved endoscopic outcomes at week 12 as measured by the eosinophilic esophagitis Endoscopic Reference Score (EREFS), and improved esophageal distensibility plateau, a measure of esophageal function, by 18%, compared with placebo, according to the report.

The Food and Drug Administration has approved dupilumab for use in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, and has granted orphan drug designation for its use in the treatment of eosinophilic esophagitis, according to Sanofi and Regeneron Pharmaceuticals.

Dupilumab antagonizes the interleukin (IL)–4 receptor-alpha component of the type 2 receptor, thereby inhibiting signaling of IL-4 and IL-13, the investigators noted in their report.

“These results demonstrate that interleukin-4 and interleukin-13 are central pathological mediators of esophageal inflammation and dysfunction in adult patients with active eosinophilic esophagitis,” said investigators in their report.

The anti-IgE monoclonal antibody omalizumab (Xolair) failed to improve dysphagia and histologic features of eosinophilic esophagitis, suggesting the pathogenesis of this disease is not mediated by IgE, they added.

A number of other targeted biologic agents, including the anti–IL-5 agents mepolizumab and reslizumab, have failed to significantly improve dysphagia versus placebo in patients with eosinophilic esophagitis, they added.

The research was sponsored by Sanofi and Regeneron. Several study coauthors indicated that they were current or former employees of those companies. Other study authors provided disclosures related to Adare, Allakos, Banner, Calypso, Enumeral, EsoCap, GlaxoSmithKline, Meritage, Regeneron, Robarts, and Shire, and among others.

SOURCE: Hirano I et al. Gastroenterology. 2019 Oct 5. doi: 10.1053/j.gastro.2019.09.042.

AGA patient education on eosinophilic esophagitis can help your patients better understand the condition. Visit https://www.gastro.org/practice-guidance/gi-patient-center/topic/eosinophilic-esophagitis-eoe.

Dupilumab (Dupixent) significantly reduced patient-reported dysphagia among adults with eosinophilic esophagitis enrolled in a randomized trial, investigators reported.

Treatment with this monoclonal antibody also improved histologic disease features and abnormal endoscopic features, compared with placebo, according to investigators in the phase 2 trial, which included 47 patients enrolled at 14 U.S. study sites.

Injection-site erythema and nasopharyngitis were more common among dupilumab-treated versus placebo-treated patients, and there were no serious adverse events or deaths observed, according to cofirst authors Ikuo Hirano, MD, of Northwestern University, Chicago, and Evan S. Dellon, MD, MPH, of the University of North Carolina at Chapel Hill.

“Dupilumab is the first targeted biologic agent to improve dysphagia, histologic and endoscopic measures of disease, as well as esophageal function, and have an acceptable safety profile in adult patients with active eosinophilic esophagitis,” said Dr. Hirano and Dr. Dellon and associates in the journal Gastroenterology.

The report on the phase 2 trial included 47 adults with active eosinophilic esophagitis randomized to weekly subcutaneous injections of dupilumab at a dose of 300 mg or placebo. All participants had a score of 5 or higher on the Straumann Dysphagia Instrument (SDI), a patient-reported outcome measure.

Change in SDI score from baseline to week 10, the study primary endpoint, was significantly improved for dupilumab, according to investigators, who reported a least-squares mean change of –3.0 from baseline, versus –1.3 for placebo (P = .0304).

The original plan was to measure dupilumab’s effect on SDI out to week 12 of treatment, but because of technical problems with an electronic diary system used in the trial, there was significant data loss, and this primary endpoint was instead evaluated at week 10, investigators said in their report.

Improvements in SDI scores were apparent as early as week 1 after dupilumab treatment started, they added, noting that 39% of dupilumab-treated patients had an improvement in SDI score of at least 3, compared with just 13% of placebo-treated patients (P = .490).

Dupilumab also improved outcomes measured by the eosinophilic esophagitis histology scoring system (EoE-HSS), including a 68.3% improvement in severity and 54.6% in extent of disease from baseline to week 12, investigators said.

Likewise, dupilumab improved endoscopic outcomes at week 12 as measured by the eosinophilic esophagitis Endoscopic Reference Score (EREFS), and improved esophageal distensibility plateau, a measure of esophageal function, by 18%, compared with placebo, according to the report.

The Food and Drug Administration has approved dupilumab for use in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, and has granted orphan drug designation for its use in the treatment of eosinophilic esophagitis, according to Sanofi and Regeneron Pharmaceuticals.

Dupilumab antagonizes the interleukin (IL)–4 receptor-alpha component of the type 2 receptor, thereby inhibiting signaling of IL-4 and IL-13, the investigators noted in their report.

“These results demonstrate that interleukin-4 and interleukin-13 are central pathological mediators of esophageal inflammation and dysfunction in adult patients with active eosinophilic esophagitis,” said investigators in their report.

The anti-IgE monoclonal antibody omalizumab (Xolair) failed to improve dysphagia and histologic features of eosinophilic esophagitis, suggesting the pathogenesis of this disease is not mediated by IgE, they added.

A number of other targeted biologic agents, including the anti–IL-5 agents mepolizumab and reslizumab, have failed to significantly improve dysphagia versus placebo in patients with eosinophilic esophagitis, they added.

The research was sponsored by Sanofi and Regeneron. Several study coauthors indicated that they were current or former employees of those companies. Other study authors provided disclosures related to Adare, Allakos, Banner, Calypso, Enumeral, EsoCap, GlaxoSmithKline, Meritage, Regeneron, Robarts, and Shire, and among others.

SOURCE: Hirano I et al. Gastroenterology. 2019 Oct 5. doi: 10.1053/j.gastro.2019.09.042.

AGA patient education on eosinophilic esophagitis can help your patients better understand the condition. Visit https://www.gastro.org/practice-guidance/gi-patient-center/topic/eosinophilic-esophagitis-eoe.

The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.

The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.

The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.

A skin biopsy of one of the lesions was consistent with pityriasis lichenoides et varioliformis acuta (PLEVA).

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].
 

References

1. J Drugs Dermatol. 2019 Jul 1;18(7):690-1.

2. Pediatr Dermatol. 1991 Mar;8(1):51-7.

3. Arch Dermatol. 2000 Dec;136(12):1483-6.

4. Actas Dermosifiliogr. 2018 Sep;109(7):e6-10.

5. Pediatr Dermatol. 2018 Mar;35(2):213-9.

6. Pediatr Dermatol. 2012 Nov-Dec;29(6):719-24.

7. J Eur Acad Dermatol Venereol. 2019 Jul 18. doi: 10.1111/jdv.15813.

A skin biopsy of one of the lesions was consistent with pityriasis lichenoides et varioliformis acuta (PLEVA).

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].
 

References

1. J Drugs Dermatol. 2019 Jul 1;18(7):690-1.

2. Pediatr Dermatol. 1991 Mar;8(1):51-7.

3. Arch Dermatol. 2000 Dec;136(12):1483-6.

4. Actas Dermosifiliogr. 2018 Sep;109(7):e6-10.

5. Pediatr Dermatol. 2018 Mar;35(2):213-9.

6. Pediatr Dermatol. 2012 Nov-Dec;29(6):719-24.

7. J Eur Acad Dermatol Venereol. 2019 Jul 18. doi: 10.1111/jdv.15813.

A skin biopsy of one of the lesions was consistent with pityriasis lichenoides et varioliformis acuta (PLEVA).

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].
 

References

1. J Drugs Dermatol. 2019 Jul 1;18(7):690-1.

2. Pediatr Dermatol. 1991 Mar;8(1):51-7.

3. Arch Dermatol. 2000 Dec;136(12):1483-6.

4. Actas Dermosifiliogr. 2018 Sep;109(7):e6-10.

5. Pediatr Dermatol. 2018 Mar;35(2):213-9.

6. Pediatr Dermatol. 2012 Nov-Dec;29(6):719-24.

7. J Eur Acad Dermatol Venereol. 2019 Jul 18. doi: 10.1111/jdv.15813.

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

A new study has found that ankylosing spondylitis (AS) and axial psoriatic arthritis (axPsA) may be different diseases with overlapping features rather than entities on the spectrum of the same disease, building on previous research by analyzing AS patients with and without psoriasis and including a longitudinal analysis.

lolostock/Thinkstock

“Our study suggests that axial PsA and AS with psoriasis seem to be two different diseases with different genetics, demographics, and disease expression,” wrote Joy Feld, MD, of the University of Toronto and coauthors. Their findings were published in Rheumatology.

To investigate the similarities and differences between axPsA and AS patients, the researchers compared two adult cohorts recruited from Toronto clinics. The first was made up of AS patients and divided into two groups: with psoriasis (n = 91) and without psoriasis (n = 675). The second was made up of PsA patients and divided into two groups: axPsA (n = 477) and peripheral PsA (n = 826).

In comparing AS patients with and without psoriasis to axPsA patients, AS patients had a younger age at diagnosis (28.7 years and 30.4 years vs. 35.6 years; P less than .001), were more often male (76% and 72% vs. 64%; P less than .001), and were more likely to be HLA-B27 positive (82% and 75% vs. 19%; P less than .001).

At baseline, AS patients had more back pain (90% and 92% vs. 21%; P less than .001) and worse back metrology (Bath Ankylosing Spondylitis Metrology Index [BASMI] of 3.1 and 2.3 vs. 1.9; P less than .001).

The mean follow-up periods in the axial and peripheral PsA groups were 12.6 and 6.7 years, respectively, whereas in the AS groups with and without psoriasis the periods were 5.4 and 3.5 years. Over time and after longitudinal analysis, axPsA patients had more tender and swollen joints than AS patients with and without psoriasis (5.2 vs. 1.5 and 0.9; P less than .001) while AS patients with and without psoriasis had a higher BASMI (2.9 and 2.2 vs. 1.8; P less than .001) and worse axial disease activity scores (4.1 and 3.9 vs. 3.5; P = .02) as measured by the Bath Ankylosing Spondylitis Disease Activity Index.

After univariate analysis, AS with psoriasis was found to be more associated with HLA-B27 (odds ratio, 16.37; 95% confidence interval, 8.89-30.13; P less than .0001), a higher adjusted mean BASMI (OR, 1.41; 95% CI, 1.21-1.63; P less than .0001), worse sacroiliitis (OR, 7.58; 95% CI, 3.68-15.59; P less than .0001), and greater use of biologics (OR, 1.25; 95% CI, 0.77-1; P = .37), compared with axPsA. A multivariate analysis produced similar findings, including the lack of association between AS and active arthritis (OR, 0.75; 95% CI, 0.64-0.86; P less than .0001).

The authors acknowledged their study’s limitations, including the fact that symptoms often dictate which of the two clinics patients will be referred to, which can ultimately define the diagnosis. “Patients with significant back symptoms are more likely to be referred to the AS clinic,” they wrote, “while patients with more prominent peripheral symptoms are more likely to be referred to the PsA clinic.” Patients with AS in the study were also required to have back pain or limitations in spinal range of motion, while PsA patients were accepted even if they were asymptomatic.

Finally, they noted that some milder cases of the two diseases may have been missed in the cohort recruiting process, although they added that mild cases were, in fact, “present in the cohort, which might improve the generalizability of this study to primary rheumatology clinics.”

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation, but this study received no specific funding to carry out the research. Dr. Feld reported being supported by a grant from Novartis. The authors reported no conflicts of interest.

SOURCE: Feld J et al. Rheumatology. 2019 Oct 8. doi: 10.1093/rheumatology/kez457.

Critics of a Trump administration rule that would make it more difficult for immigrants to remain in the United States if they receive health care assistance are applauding several court orders that temporarily block the regulation from taking effect.

In three separate decisions, the U.S. District Court for the Southern District of New York, the U.S. District Court for the Northern District of California, and the U.S. District Court for the Eastern District of Washington temporarily barred the administration’s changes to the public charge rule from moving forward. The judges said lawsuits challenging the rule are likely to prevail in court.

The injunctions are much needed to protect patients and families, said R. Shawn Martin, senior vice president of advocacy, practice advancement, and policy for the American Academy of Family Physicians.

“The court decisions are important,” Mr. Martin said in an interview. “The AAFP believes that the public charge rule, as proposed by the administration, would have an immediate and negative impact on the health of thousands of people, including children. There is evidence that policies such as this create a culture where patients forgo interactions with the health care system out of fear. We should never be a country that compromises the health and well-being of individuals, especially those that are most vulnerable.”

White House Press Secretary Stephanie Grisham called the court rulings extremely disappointing and said the recent changes to the public charge rule restore integrity to the immigration system.

“The rulings today prevent our nation’s immigration officers from ensuring that immigrants seeking entry to the United States will be self-sufficient and instead allow noncitizens to continue taking advantage of our generous but limited public resources reserved for vulnerable Americans,” Ms. Graham said in a statement. “These injunctions are the latest inexplicable example of the administration being ordered to comply with the flawed or lawless guidance of a previous administration instead of the actual laws passed by Congress.”

Under the longstanding public charge rule, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation, which was scheduled to take effect on Oct. 15, 2019, would allow officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs. The revised regulation would continue to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued in Washington state by 14 states. On Oct. 11, Judge Rosanna Malouf Peterson, U.S. district judge for the Eastern District of Washington, issued a nationwide ban of the revised public charge regulation, ruling that the plaintiff states will suffer irreparable harm if the rule moves forward.

“The plaintiff states have shown a significant threat of irreparable injury as a result of the impending enactment of the public charge rule by numerous individuals disenrolling from benefits for which they or their relatives were qualified, out of fear or confusion, that accepting those noncash public benefits will deprive them of an opportunity for legal permanent residency,” Judge Peterson wrote in her decision. “The plaintiff states have further demonstrated how that chilling effect predictably would cause irreparable injury by creating long-term costs to the plaintiff states from providing ongoing triage for residents who have missed opportunities for timely diagnoses, vaccinations, or building a strong foundation in childhood that will allow U.S. citizen children and future U.S. citizens to flourish and contribute to their communities as taxpaying adults.”

Judge Phyllis J. Hamilton, U.S. district judge for the Northern District of California, ruled similarly on Oct. 11, as did George Benjamin Daniels of the U.S. District Court for the Southern District of New York.

Physician associations previously voiced opposition to the administration’s changes to the public charge rule. In a joint statement, the AAFP, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the American College of Physicians, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.

“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”

[email protected]

Critics of a Trump administration rule that would make it more difficult for immigrants to remain in the United States if they receive health care assistance are applauding several court orders that temporarily block the regulation from taking effect.

In three separate decisions, the U.S. District Court for the Southern District of New York, the U.S. District Court for the Northern District of California, and the U.S. District Court for the Eastern District of Washington temporarily barred the administration’s changes to the public charge rule from moving forward. The judges said lawsuits challenging the rule are likely to prevail in court.

The injunctions are much needed to protect patients and families, said R. Shawn Martin, senior vice president of advocacy, practice advancement, and policy for the American Academy of Family Physicians.

“The court decisions are important,” Mr. Martin said in an interview. “The AAFP believes that the public charge rule, as proposed by the administration, would have an immediate and negative impact on the health of thousands of people, including children. There is evidence that policies such as this create a culture where patients forgo interactions with the health care system out of fear. We should never be a country that compromises the health and well-being of individuals, especially those that are most vulnerable.”

White House Press Secretary Stephanie Grisham called the court rulings extremely disappointing and said the recent changes to the public charge rule restore integrity to the immigration system.

“The rulings today prevent our nation’s immigration officers from ensuring that immigrants seeking entry to the United States will be self-sufficient and instead allow noncitizens to continue taking advantage of our generous but limited public resources reserved for vulnerable Americans,” Ms. Graham said in a statement. “These injunctions are the latest inexplicable example of the administration being ordered to comply with the flawed or lawless guidance of a previous administration instead of the actual laws passed by Congress.”

Under the longstanding public charge rule, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation, which was scheduled to take effect on Oct. 15, 2019, would allow officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs. The revised regulation would continue to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued in Washington state by 14 states. On Oct. 11, Judge Rosanna Malouf Peterson, U.S. district judge for the Eastern District of Washington, issued a nationwide ban of the revised public charge regulation, ruling that the plaintiff states will suffer irreparable harm if the rule moves forward.

“The plaintiff states have shown a significant threat of irreparable injury as a result of the impending enactment of the public charge rule by numerous individuals disenrolling from benefits for which they or their relatives were qualified, out of fear or confusion, that accepting those noncash public benefits will deprive them of an opportunity for legal permanent residency,” Judge Peterson wrote in her decision. “The plaintiff states have further demonstrated how that chilling effect predictably would cause irreparable injury by creating long-term costs to the plaintiff states from providing ongoing triage for residents who have missed opportunities for timely diagnoses, vaccinations, or building a strong foundation in childhood that will allow U.S. citizen children and future U.S. citizens to flourish and contribute to their communities as taxpaying adults.”

Judge Phyllis J. Hamilton, U.S. district judge for the Northern District of California, ruled similarly on Oct. 11, as did George Benjamin Daniels of the U.S. District Court for the Southern District of New York.

Physician associations previously voiced opposition to the administration’s changes to the public charge rule. In a joint statement, the AAFP, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the American College of Physicians, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.

“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”

[email protected]

Critics of a Trump administration rule that would make it more difficult for immigrants to remain in the United States if they receive health care assistance are applauding several court orders that temporarily block the regulation from taking effect.

In three separate decisions, the U.S. District Court for the Southern District of New York, the U.S. District Court for the Northern District of California, and the U.S. District Court for the Eastern District of Washington temporarily barred the administration’s changes to the public charge rule from moving forward. The judges said lawsuits challenging the rule are likely to prevail in court.

The injunctions are much needed to protect patients and families, said R. Shawn Martin, senior vice president of advocacy, practice advancement, and policy for the American Academy of Family Physicians.

“The court decisions are important,” Mr. Martin said in an interview. “The AAFP believes that the public charge rule, as proposed by the administration, would have an immediate and negative impact on the health of thousands of people, including children. There is evidence that policies such as this create a culture where patients forgo interactions with the health care system out of fear. We should never be a country that compromises the health and well-being of individuals, especially those that are most vulnerable.”

White House Press Secretary Stephanie Grisham called the court rulings extremely disappointing and said the recent changes to the public charge rule restore integrity to the immigration system.

“The rulings today prevent our nation’s immigration officers from ensuring that immigrants seeking entry to the United States will be self-sufficient and instead allow noncitizens to continue taking advantage of our generous but limited public resources reserved for vulnerable Americans,” Ms. Graham said in a statement. “These injunctions are the latest inexplicable example of the administration being ordered to comply with the flawed or lawless guidance of a previous administration instead of the actual laws passed by Congress.”

Under the longstanding public charge rule, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation, which was scheduled to take effect on Oct. 15, 2019, would allow officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs. The revised regulation would continue to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued in Washington state by 14 states. On Oct. 11, Judge Rosanna Malouf Peterson, U.S. district judge for the Eastern District of Washington, issued a nationwide ban of the revised public charge regulation, ruling that the plaintiff states will suffer irreparable harm if the rule moves forward.

“The plaintiff states have shown a significant threat of irreparable injury as a result of the impending enactment of the public charge rule by numerous individuals disenrolling from benefits for which they or their relatives were qualified, out of fear or confusion, that accepting those noncash public benefits will deprive them of an opportunity for legal permanent residency,” Judge Peterson wrote in her decision. “The plaintiff states have further demonstrated how that chilling effect predictably would cause irreparable injury by creating long-term costs to the plaintiff states from providing ongoing triage for residents who have missed opportunities for timely diagnoses, vaccinations, or building a strong foundation in childhood that will allow U.S. citizen children and future U.S. citizens to flourish and contribute to their communities as taxpaying adults.”

Judge Phyllis J. Hamilton, U.S. district judge for the Northern District of California, ruled similarly on Oct. 11, as did George Benjamin Daniels of the U.S. District Court for the Southern District of New York.

Physician associations previously voiced opposition to the administration’s changes to the public charge rule. In a joint statement, the AAFP, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the American College of Physicians, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.

“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”

[email protected]